Activities of Anja WEISGERBER
Plenary speeches (60)
Active inclusion of people excluded from the labour market (A6-0263/2009, Jean Lambert)
Preparation of the Employment Summit - European Globalisation Adjustment Fund - Renewed Social Agenda - Active inclusion of people excluded from the labour market (debate)
Explanations of vote
Explanations of vote
Explanations of vote
Statute for a European private company - Cross-borders transfers of companies' registered offices - Small Business Act - Workers' participation in companies with a European Statute (debate)
Framework for Community action to achieve a sustainable use of pesticides - Placing of plant protection products on the market (debate)
Organisation of working time (debate)
Type-approval of motor vehicles and engines (debate)
Explanations of vote
Explanations of vote
Type-approval of hydrogen powered motor vehicles (debate)
Type-approval of hydrogen powered motor vehicles (debate)
Social package (First part) (debate)
Common authorisation procedure for food additives, food enzymes and food flavourings - Food additives - Flavourings and certain food ingredients with flavouring properties - Food enzymes (debate)
Progress made in equal opportunities and non-discrimination in the EU (debate)
Accreditation and market surveillance relating to the marketing of products - Common framework for the marketing of products - Application of certain national technical rules to products lawfully marketed in another Member State - Safety marking on consumer products (debate)
Explanations of vote
Air pollution: ambient air quality and cleaner air for Europe (debate)
Explanations of vote
Tobacco smoke: policy options at EU level (debate)
Framework directive on the sustainable use of pesticides - Thematic strategy on the sustainable use of pesticides - The placing of plant protection products on the market (debate)
Road Map for renewable energy in Europe (debate)
Portability of supplementary pension rights (debate)
Approval of motor vehicles and their trailers (debate)
Assessment and management of flood risks (debate)
Corrections to votes and voting intentions
Type approval of motor vehicles with respect to emissions and access to vehicle repair information (debate)
The placing on the market of pyrotechnic articles (debate)
Cleaner air for Europe – Thematic strategy on air pollution (debate)
Passenger car related taxes (debate)
Flood assessment and management (debate)
Exposure of workers to optical radiation (debate)
Explanations of vote
Batteries, accumulators and their waste
Health and safety at work: Exposure to optical radiation
Organisation of working time
Health and safety at the workplace
Recognition of professional qualifications and administrative cooperation through the Internal Market Information System (debate)
Pharmacovigilance (amendment of Directive 2001/83/EC) - Pharmacovigilance (amendment of Regulation (EC) No 726/2004) (debate)
Food intended for infants and young children and food for special medical purposes (debate)
Food intended for infants and young children and food for special medical purposes (debate)
Explanations of vote
Explanations of vote
Explanations of vote
Explanations of vote
Harmonised conditions for the marketing of construction products (debate)
Repeal of directives regarding metrology (debate)
Repeal of directives regarding metrology (debate)
Safety of toys (debate)
Information on medicinal products (Community code relating to medicinal products) - Information on medicinal products (Community procedures for the authorisation and supervision of medicinal products) (debate)
Restriction of the use of certain hazardous substances in electrical and electronic equipment (debate)
Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)
Food information to consumers (debate)
Progress towards the achievement of the Millennium Development Goals: mid-term review in preparation of the UN high-level meeting in September 2010 (A7-0165/2010, Michael Cashman) (vote)
Explanations of vote
Explanations of vote
Toy safety (debate)
Explanations of vote
Smoke-free environments (debate)
Reports (2)
REPORT Proposal for a regulation of the European Parliament and of the Council on type-approval of hydrogen powered motor vehicles and amending Directive 2007/46/EC PDF (328 KB) DOC (480 KB)
REPORT Report on the proposal for a directive of the European Parliament and of the Council repealing Council Directives 71/317/EEC, 71/347/EEC, 71/349/EEC, 74/148/EEC, 75/33/EEC, 76/765/EEC, 76/766/EEC, and 86/217/EEC regarding metrology PDF (185 KB) DOC (219 KB)
Shadow reports (1)
REPORT Report on the proposal for a regulation of the European Parliament and of the Council setting emission performance standards for new light commercial vehicles as part of the Community's integrated approach to reduce CO2 emissions from light-duty vehicles PDF (518 KB) DOC (780 KB)
Opinions (7)
OPINION Communication from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions: “Think Small First” - A “Small Business Act” for Europe
OPINION Proposal for a Regulation of the European Parliament and of the Council on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information
OPINION on the proposal for a regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market
AVIS sur la proposition de règlement du Parlement européen et du Conseil relatif à la réception des véhicules à moteur au regard des émissions et aux informations sur la réparation des véhicules, modifiant la directive 72/306/CEE et la directive ../../CE FR
OPINION Proposal for a regulation of the European Parliament and of the Council on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems
OPINION on the proposal for a directive of the European Parliament and of the Council amending Directive 2005/36/EC on the recognition of professional qualifications and the Regulation on administrative cooperation through the Internal Market Information System
OPINION on the proposal for a regulation of the European Parliament and of the Council on the sound level of motor vehicles
Shadow opinions (2)
OPINION Proposal for a directive of the European Parliament and of the Council amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use
OPINION Proposal for a regulation of the European Parliament and of the Council amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
Amendments (1473)
Amendment 101 #
2013/0049(COD)
Proposal for a regulation
Recital 21
Recital 21
Amendment 187 #
2013/0049(COD)
Proposal for a regulation
Article 7
Article 7
Amendment 129 #
2013/0048(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
Amendment 148 #
2013/0048(COD)
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
1. Market surveillance authorities shall perform appropriate checks on the characteristics of safety- or health-related products on an adequate scale and with adequate frequency, by means of a documentary check and, where necessary, a physical and laboratory check on the basis of an adequate sample. They shall record these checks in the information and communication system for market surveillance referred to in Article 21.
Amendment 216 #
2013/0048(COD)
Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 1 – introductory part
Article 9 – paragraph 2 – subparagraph 1 – introductory part
In relation to a product that is subject to Union harmonisation legislation, formal non-compliance with that legislation shallmay give market surveillance authorities sufficient reason to believe that the product may present a risk in any of the following cases:
Amendment 220 #
2013/0048(COD)
Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 2
Article 9 – paragraph 2 – subparagraph 2
Regardless whether the risk assessment shows that the product in fact presents a risk, market surveillance authorities shall require the economic operator toshall rectify the formal non-compliance. If the economic operator fails to do so, market surveillance authorities shallmay ensure that the product is withdrawn or recalled. For minor infringements, a warning may be issued or a penalty payment imposed.
Amendment 255 #
2013/0048(COD)
Proposal for a regulation
Article 10 – paragraph 6
Article 10 – paragraph 6
Amendment 300 #
2013/0048(COD)
Proposal for a regulation
Article 14 – paragraph 3 – subparagraph 2 – introductory part
Article 14 – paragraph 3 – subparagraph 2 – introductory part
In relation to a product which must comply with Union harmonisation legislation when it is released for free circulation, formal non-compliance with that legislation shallmay give the authorities of Member States sufficient reason to believe that the product may present a risk in any of the following cases:
Amendment 307 #
2013/0048(COD)
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. If the market surveillance authorities conclude that a product the release of which was suspended due to formal non- compliance in accordance with the second sub-paragraph of paragraph 3 of Article 14 does not in fact present a risk, the economic operator shall nevertheless rectify the formaly shall take measures, on the basis of the proportionality principle, to bring a criminal prosecution for non-compliance before the product is released.
Amendment 321 #
2013/0048(COD)
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The Commission shall maintain the system for rapid exchange of information (RAPEX). Member States shall use RAPEX for exchanging information about products presenting a considerable risk in accordance with this Regulation.
Amendment 32 #
2012/2031(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Notes that the duration of transport is not the only important indicator for animal welfare and animal health, but that the conditions during transport, such as compartments, the provision of drinking water, the temperature and humidity, also play an important role in animal welfare;
Amendment 74 #
2012/0366(COD)
Proposal for a directive
Recital 18
Recital 18
(18) Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobaccotobacco for oral use which are mainly consumed by older consumers, should be granted an exemption from certain ingredients requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people.
Amendment 122 #
2012/0366(COD)
Proposal for a directive
Recital 18
Recital 18
(18) Considering the Directive's focus on young people, tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobaccotobacco for oral use which are mainly consumed by older consumers, should be granted an exemption from certain ingredients requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people.
Amendment 201 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 10
Article 6 – paragraph 10
10. Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco productstobacco for oral use shall be exempted from the prohibitions laid down in paragraphs 1 and 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to withdraw this exemption if there is a substantial change of circumstances as established in a Commission report.
Amendment 572 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 10
Article 6 – paragraph 10
10. Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco productstobacco for oral use shall be exempted from the prohibitions laid down in paragraphs 1 and 5. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to withdraw this exemption if there is a substantial change of circumstances as established in a Commission report.
Amendment 85 #
2012/0337(COD)
Proposal for a decision
Recital 19 a (new)
Recital 19 a (new)
(19a) Soil plays a vital role in achieving the EU’s biodiversity objective. Its degradation has primarily local and regional causes and impact. Therefore, the principle of subsidiarity should consequently be respected. Member States are called upon to fulfil their obligations in terms of guaranteeing soil quality and keep the soil in good condition. Member States without soil protection legislation are urged to shoulder their responsibilities.
Amendment 174 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 23
Annex 1 – point 23
Amendment 182 #
2012/0337(COD)
Proposal for a decision
Annex 1 – point 23 – footnote 42
Annex 1 – point 23 – footnote 42
Amendment 241 #
2012/0305(COD)
Proposal for a regulation
Article 11 – paragraph 3 – subparagraph 1
Article 11 – paragraph 3 – subparagraph 1
3. The use of fluorinated greenhouse gases, or of mixtures that contain fluorinated greenhouse gases, with a global warming potential of 2500 or more, to service or maintain refrigeration equipment with a charge size equivalent to 540 tonnes of CO2 or more, shall be prohibited from 1 January 20205. This provision shall not apply to recycled and reclaimed fluorinated greenhouse gases until 1 January 2025.
Amendment 251 #
2012/0305(COD)
Proposal for a regulation
Article 12
Article 12
Amendment 389 #
Amendment 390 #
Amendment 393 #
Amendment 400 #
Amendment 403 #
Amendment 412 #
Amendment 102 #
2012/0288(COD)
Proposal for a directive
Recital 5
Recital 5
Amendment 118 #
2012/0288(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Liquid renewable fuels are likely to be required by the transport sector in order to reduce its greenhouse gas emissions. Advanced biofuels, such as those made from wastes and algae, provide high greenhouse gas savings with low risk of causing indirect land use change and do not compete directly for agricultural land for the food and feed markets. It is appropriate, therefore, to encourage greater production of such advanced biofuels as these are currently not commercially available in large quantities, in part due to competition for public subsidies with established food crop based biofuel technologies. Further incentives should be provided by increasing the weighting of advanced biofuels towards 10% target for transport set in Directive 2009/28/EC compared to conventional biofuels, for example from cellulosic feedstocks and algae, as these also have the potential to provide high greenhouse gas savings with low risk of causing indirect land use change. Further incentives should be provided by setting a separate target for advanced biofuels in the transport sector of at least 2% in Directive 2009/28/EC. In this context, only advanced biofuels with low estimated indirect land use change impacts and high overall greenhouse gas savings should be supported as part of the post 2020 renewable energy policy frameworkshould be supported as part of the post 2020 renewable energy policy framework. In order to avoid market distortions and incentives for fraud, advanced biofuels should meet the same sustainability criteria as all other biofuels.
Amendment 155 #
2012/0288(COD)
Proposal for a directive
Recital 9
Recital 9
Amendment 168 #
2012/0288(COD)
Proposal for a directive
Recital 10
Recital 10
(10) The 5% limit set up in Article 3(4)d does not affect the Member States' freedom to arrange their own trajectory as to compliance with this prescribed share of conventional biofuels withConventional biofuels remain vital for the purpose of attaining the overall 10% target. As a consequence, of 10%. As they access to the market of the biofuels produced by the installare more readily available than advanced biofuels, they should cover at least 8% of final energy consumptions in operation before the end of 2013 remains fully open. Therefore this amending directive does not affect the legitimate expectations of the operators of such installationsthe transport section in 2020. The amendment of this Directive therefore does not affect the legitimate expectations of the operators of conventional biofuel production installations. Advanced biofuels should cover at least 2% of final energy consumption by 2020.
Amendment 195 #
2012/0288(COD)
Proposal for a directive
Recital 12
Recital 12
Amendment 348 #
2012/0288(COD)
Proposal for a directive
Article 2 – point 2 – point c – point ii
Article 2 – point 2 – point c – point ii
Directive 2009/28/EC
Article 3 – paragraph 4 – subparagraph 2 – point d
Article 3 – paragraph 4 – subparagraph 2 – point d
(d) for the calculation of biofuels in the numerator, (i) (i) the share of energy from biofuels produced from cereal and other starch rich crops, sugars and oil crops shall be no more than 5%, the estimated share at the end of 2011,the raw materials listed in Annex IX shall be at least 2% of the final consumption of energy in transport in 2020 and (ii) the share of energy from biofuels produced from food crops shall be at least 8% of the final consumption of energy in transport in 2020.
Amendment 368 #
2012/0288(COD)
Proposal for a directive
Article 2 – point 2 – point c – point iii
Article 2 – point 2 – point c – point iii
Directive 2009/28/EC
Article 3 – paragraph 4 – subparagraph 2 – point e
Article 3 – paragraph 4 – subparagraph 2 – point e
Amendment 521 #
2012/0288(COD)
Proposal for a directive
Annex II – point 3
Annex II – point 3
Directive 2009/28/CE
Annex IX
Annex IX
Amendment 527 #
2012/0288(COD)
Proposal for a directive
Annex II – point 3
Annex II – point 3
Directive 2009/28/EC
Annex IX
Annex IX
Annex IX Part A. ‘Feedstocks whoseich contributione towards theattaining the 2% target referred to in Article 3(4) shall be considered to be four times their energy content (a) Algae. (b) Biomass fraction of mixed municipal waste, but not separated household(d)(i) of Directive 2009/28/EC: (a) Algae. (b) Biomass from municipal waste subject to recycling targets under Article 11(2)(a) of Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives. (c) Biomass fraction of industrial waste. (d) Straw. (e) Animal manure and sewage sludge. (f) Palm oil mill effluent and empty palm fruit bunches. (g) Tall oil pitch. (h) Crude glycerine. (i) Bagasse. (j) Grape marcs and wine lees. (k) Nut shells. (l) Husks. (m) Cobs (n) Bark, branches, leaves, saw dust and cutter shavings. Part B. Feedstocks whose contribution towards the target referred to in Article 3(4) shall be considered to be twice their energy content (a(na) Palm oil mill effluent and empty palm fruit bunches. (nb) Used cooking oil. (bnc) Animal fats classified as category I and II in accordance with EC/1774/2002 laying down health rules concerning animal by- products not intended for human consumption. (cnd) Non-food cellulosic material. (dne) Ligno-cellulosic material except saw logs and veneer logs.
Amendment 48 #
2012/0267(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase- policy and stock- management by hospitals, pharmacies and wholesalers. The UDI system should be compatible with other systems already on the market.
Amendment 66 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Before making a device available on the market for the first time, distributors shall verify that the following requirements are met:
Amendment 67 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point b
Article 12 – paragraph 2 – subparagraph 1 – point b
(b) in the absence of a declaration of conformity by the manufacturer or importer, the product is accompanied by the information to be supplied by the manufacturer in accordance with Article 8(7);
Amendment 68 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c
Article 12 – paragraph 2 – subparagraph 1 – point c
(c) the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 22 and Article 11(3) respectively11(3).
Amendment 69 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and, within their respective area of activity, make sure that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 72 #
2012/0267(COD)
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) compatibility with medical device identification systems already on the market.
Amendment 85 #
2012/0267(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock- management by hospitals, pharmacies and in wholesale. The UDI system should be compatible with other systems which are already on the market.
Amendment 143 #
2012/0267(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 169 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Before making a device available on the market for the first time, distributors shall verify that the following requirements are met:
Amendment 170 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point b
Article 12 – paragraph 2 – subparagraph 1 – point b
(b) in the absence of a declaration of conformity by the manufacturer or importer, the product is accompanied by the information to be supplied by the manufacturer in accordance with Article 8(7);
Amendment 171 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c
Article 12 – paragraph 2 – subparagraph 1 – point c
(c) the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 22 and Article 11(3) respectively11(3).
Amendment 173 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and, within their respective area of activity, make sure that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 188 #
2012/0267(COD)
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) compatibility with medical device identification systems already on the market.
Amendment 270 #
Amendment 323 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point b
Article 77 – paragraph 1 – point b
Amendment 325 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point c
Article 77 – paragraph 1 – point c
(c) to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of the clinical evaluation by manufacturers and the assessment by notified bodies;.
Amendment 327 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point e
Article 77 – paragraph 1 – point e
Amendment 328 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point f
Article 77 – paragraph 1 – point f
Amendment 329 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – points f a to f k (new)
Article 77 – paragraph 1 – points f a to f k (new)
(fa) to continuously monitor the technical progress in particular in the field of implantable devices and assess whether the essential requirements on safety and performance provided within this Regulation are appropriate to ensure safety and performance of medical devices and identify the need to amend Annex I; (fb) to develop guidelines on clinical trials of certain medical devices (fc) to contribute to the development of medical devices standards; (fd) to contribute to the development of Common Technical Specifications (CTS) (fe) to develop and maintain a framework for a European market surveillance program; (ff) to develop minimum requirements on a quality management system for national market surveillance authorities . (fg) to organise joint market surveillance and joint testing projects; (fh) to organise training programmes and exchanges of national officials on market surveillance, on notified bodies designation and monitoring and on clinical investigations; (fi) to organise information campaigns and joint visit programmes; (fj) to provide an opinion on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices according to Article 41 paragraph 3 within six months; (fk) to provide at the Commission's request an opinion on a the classification of a device, or category or group of devices according to Article 41 paragraph 4.
Amendment 115 #
2012/0266(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Before making a device available on the market for the first time, distributors shall verify that the following requirements are met:
Amendment 116 #
2012/0266(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point b
Article 12 – paragraph 2 – subparagraph 1 – point b
(b) in the absence of a declaration of conformity by the manufacturer or importer, the product is accompanied by the information to be supplied by the manufacturer in accordance with Article 8(7);
Amendment 117 #
2012/0266(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c
Article 12 – paragraph 2 – subparagraph 1 – point c
(c) the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 24 and Article 11(3) respectively11(3).
Amendment 118 #
2012/0266(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and, within their respective area of activity, make sure that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 139 #
2012/0266(COD)
Proposal for a regulation
Article 24 – paragraph 8 – point e b (new)
Article 24 – paragraph 8 – point e b (new)
(eb) compatibility with medical device identification systems already on the market.
Amendment 161 #
2012/0266(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) There is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices. In order to ensure a high level of health protection, free movement of goods and legal certainty for manufacturers, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial, with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at Union and international level. In the design and, manufacture and conformity assessment of medical devices, the manufacturers should take special care when using nanoparticles that can be released to the human bodyintended for release in the human body, they should have to meet additional basic requirements in respect of the nanomaterials in question and their use in the relevant device group, and those devices should be subject to the most severe conformity assessment procedure.
Amendment 276 #
2012/0266(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Commission may, at the request of a Member State oand after con its own initiativesultating the MDCG and the undertaking concerned, by means of implementing acts, determine whether or not a specific novel product, or new category or group of products, falls within the definitions of 'medical device' or 'accessory to a medical device'. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). This paragraph shall not apply to products already authorised.
Amendment 278 #
2012/0266(COD)
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1a. Following the consultation procedure provided for in paragraph 1, the Commission shall draw up guidelines in order to ensure that there is a science- based procedure for the categorisation of devices.
Amendment 331 #
2012/0266(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Before making a device available on the market for the first time, distributors shall verify that the following requirements are met:
Amendment 332 #
2012/0266(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point b
Article 12 – paragraph 2 – subparagraph 1 – point b
(b) in the absence of a manufacturer’s or importer’s declaration of conformity, the product is accompanied by the information to be supplied by the manufacturer in accordance with Article 8(7);
Amendment 333 #
2012/0266(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c
Article 12 – paragraph 2 – subparagraph 1 – point c
(c) the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 24 and Article 11(3) respectively11(3).
Amendment 337 #
2012/0266(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure, within their field of operations, that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 445 #
2012/0266(COD)
Proposal for a regulation
Article 24 – paragraph 8 – point e a (new)
Article 24 – paragraph 8 – point e a (new)
(ea) compatibility with identification systems for medical devices already on the market.
Amendment 561 #
Amendment 718 #
2012/0266(COD)
Proposal for a regulation
Article 80 – paragraph 1 – point b
Article 80 – paragraph 1 – point b
Amendment 724 #
2012/0266(COD)
Proposal for a regulation
Article 80 – paragraph 1 – point c
Article 80 – paragraph 1 – point c
(c) to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of the clinical evaluation by manufacturers and the assessment by notified bodies;.
Amendment 726 #
2012/0266(COD)
Proposal for a regulation
Article 80 – paragraph 1 – point e
Article 80 – paragraph 1 – point e
Amendment 728 #
2012/0266(COD)
Proposal for a regulation
Article 80 – paragraph 1 – point f
Article 80 – paragraph 1 – point f
Amendment 730 #
2012/0266(COD)
Proposal for a regulation
Article 80 – paragraph 1 – point f a (new)
Article 80 – paragraph 1 – point f a (new)
Amendment 778 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 9 – point 9.2
Annex 1 – part II – point 9 – point 9.2
9.2. Devices that are composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally and that are intended to be absorbed by or dispersed in the human body in order to achieve the desired effect shall comply, by analogy, with the relevant requirements laid down in Annex I to Directive 2001/83/EC.
Amendment 849 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
All devices incorporating or consisting of nanomaterial are in class III unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient’s or user's body when the device is used within its intended purposedeliberately intended to be released into the body are in class III.
Amendment 26 #
2012/0202(COD)
Proposal for a decision
Recital 3 a (new)
Recital 3 a (new)
(3a) In the light of potentially higher prices for certificates the guidelines on certain State aid measures in the context of the greenhouse gas emission allowance trading scheme post-2012 (SWD(2012) 130 final) (SWD(2012) 131 final) (indirect emissions) and the criteria laid down in Article 10 a (14-17) of Directive 2009/29/EC of the European Parliament and of the Council of 23 April 2009 (direct emissions) should be considered for a revision in the light of the risk of carbon leakage and distortion of competition between sectors.
Amendment 474 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) the informed consent of the legal representative has been obtained, whereby; consent shall represent the subject's presumed will and may be revoked at any time, without detriment to the subject;
Amendment 478 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is consideredduly taken into account by the investigator;
Amendment 481 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point h a (new)
Article 30 – paragraph 1 – point h a (new)
(ha) the Ethics Committee, with expertise in the relevant disease and the patient population concerned, or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol;
Amendment 487 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point b
Article 31 – paragraph 1 – point b
(b) the minor has received all relevant information in a way adapted to his or her age and maturity, from professionalsa medical doctor (either the investigator or member of the trial team) trained or experienced in working with children, regarding the trial, the risks and the benefits;
Amendment 491 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point c
Article 31 – paragraph 1 – point c
(c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator in accordance with his or her age and maturity;
Amendment 496 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h b (new)
Article 31 – paragraph 1 – point h b (new)
(hb) the corresponding scientific guidelines of the Agency have been followed;
Amendment 498 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h d (new)
Article 31 – paragraph 1 – point h d (new)
(hd) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol;
Amendment 86 #
2012/0190(COD)
Proposal for a regulation
Article 1 – point 3 a (new)
Article 1 – point 3 a (new)
Regulation 2009/443/EC
Article 5
Article 5
Amendment 92 #
2012/0190(COD)
Proposal for a regulation
Article 1 – point 4
Article 1 – point 4
Regulation 2009/443/EC
Article 5a
Article 5a
Amendment 147 #
2012/0190(COD)
Proposal for a regulation
Article 1 – point 10 – point c
Article 1 – point 10 – point c
Regulation 2009/443/EC
Article 13 – paragraph 5
Article 13 – paragraph 5
5. By 31 December 20147, the Commission shall review the specific emissions targets, modalities and other aspects of this Regulation in order to establish the CO2 emission targets for new passenger cars for the period beyond 2020. If the introduction of a new regulatory test procedure gives rise to changes, these shall be taken into account in the measures implemented pursuant to Article 13(7).
Amendment 153 #
2012/0190(COD)
Proposal for a regulation
Article 1 – point 10 – point d
Article 1 – point 10 – point d
Regulation 2009/443/EC
Article 13 – paragraph 7
Article 13 – paragraph 7
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 14a to adapt the formulae in Annex I in ordersubmit to Parliament and the Council, in accordance with the committee procedure provided for in Article 14, proposals to reflect any change in the regulatory test procedure for the measurement of specific CO2 emissions referred to in Regulation (EC) No 715/2007 and Regulation (EC) No 692/2008 while ensuring. In so doing it shall ensure as far as possible that reduction requirements of comparable stringency for manufacturers and vehicles of different utility are required under the old and new test procedures. ’ Departures from the targets for specific CO2 emissions brought about by the introduction of a new testing system shall be offset by means of a real adaptation programme covering all vehicle categories, technologies and manufacturers. At the same time the Commission shall offer manufacturers the option of proposing by 2020 specific conversion factors for individual models, variants and versions, based on comparative measurements, which could be used for monitoring purposes instead of the adaptations proposed by the Commission. With this aim in view the Commission shall put forward suitable proposals for changes to Articles 3 and 8.
Amendment 74 #
2012/0042(COD)
Proposal for a decision
Recital 2
Recital 2
(2) Article 9 of Decision No 406/2009/EC requires the Commission to assess modalities to include greenhouse gas emissions and removals resulting from activities related to land use, land use change and forestry into the Union's greenhouse gas emission reduction commitment, whilst ensuring the permanence and environmental integrity of the contribution of the sector, and providing for accurate monitoring and accounting of the relevant emissions and removals. This Decision should, therefore, as a first step, set out accounting rules applicable to greenhouse gas emissions and removals from the LULUCF sector. To ensure the preservation and enhancement of carbon stocks in the interim, it should also provide for Member States to adopt LULUCF Action Plans setting out measures to limit or reduce emissions, and to maintain or increase removals, from the LULUCF sector.
Amendment 81 #
2012/0042(COD)
Proposal for a decision
Recital 3
Recital 3
(3) The 17th Conference of the Parties of the UNFCCC, meeting in Durban in December 2011, adopted Decision 2- /CMP.7 of the Conference of the Parties serving as the meeting of the Parties to the Kyoto Protocol (‘'Decision 2-/CMP.7’)') and Decision 16/CMP.1. That decision set out rules for accounting for the LULUCF sector as of a second commitment period under the Kyoto Protocol. This Decision should be in lineconsistent with that decision to ensure an appropriate level of coherence between the Union's internal rules and methodologies agreed within the UNFCCC to avoid any duplication of national reporting. This Decision should also reflect the particularities of the Union LULUCF sector.
Amendment 84 #
2012/0042(COD)
Proposal for a decision
Recital 3 a (new)
Recital 3 a (new)
(3a) In addition to the opportunities directly linked to forestry and agriculture, there are potential mitigation benefits in the related industries (e.g. pulp and paper, wood processing) and renewable energy sectors if agricultural land and forests are managed for the production of timber and energy. Whilst carbon is stored in trees and in other plants and soils, it can also be stored for several decades in products (e.g. construction wood). Industry and consumer oriented policies can make an important contribution to increasing the long term use and recycling of wood and/or the production of pulp, paper and wood products, thereby replacing more emission-intensive equivalents (e.g. concrete, steel, plastics made from fossil fuels). In fact, the bio-based industry can make use of crops grown for material substitution (e.g. hemp and grass for insulation instead of glass fibre, straw for furniture production, car door panels made from flax or sisal plants, bio- plastics) or for energy (e.g. using biomass instead of fossil fuels). Studies show that for each tonne of carbon in wood products substituted for non-wood products an average greenhouse gas emission reduction of approximately two tonnes of carbon can be expected.
Amendment 89 #
2012/0042(COD)
Proposal for a decision
Recital 4
Recital 4
(4) The LULUCF accounting rulaccounts for the LULUCF activities should reflect efforts made in the agriculture and forestry sectors to enhance the contribution of changes made to the use of land resources to the reduction of emissions. This Decision should provide for accounting ruls for the LULUCF activities applicable on a mandatory basis to the forestry activities of afforestation, reforestation, deforestation and forest management, and. It should also provide for accounts applicable on a voluntary basis to the agricultural activities of grazing land management and cropland management. It should also provide for accounting rules applicable on a voluntary basis, to revegetation and, wetland drainage and rewetting activities.
Amendment 97 #
2012/0042(COD)
Proposal for a decision
Recital 5
Recital 5
(5) To ensure the environmental integrity of the LULUCF accounting rules applicable to the Union LULUCF sector, these rules should be based on the accounting principles laid down in Decision -2/CMP.7, and Decision 16/CMP.1 of the Conference of the Parties serving as the meeting of the Parties to the Kyoto Protocol.
Amendment 103 #
2012/0042(COD)
Proposal for a decision
Recital 6
Recital 6
(6) The LULUCF accounting rules should accurately represent human-induced changes in emissions and removals. In that regard, this Decision should provide for the use of specific methodologies in respect of different LULUCF activities. Emissions and removals related to afforestation, reforestation and deforestation are the direct result of human intervention and should therefore be accounted for in their entirety. However, given that not all emissions and removals from forest management are anthropogenic, the relevant accounting rules should provide for the use of reference levels to exclude the effects of natural and country-specific characteristics. Reference levels constitute estimates of the annual net emissions or removals resulting from forest management within the territory of a Member State for the years included in an accounting period, and should be set transparently in accordance with Decision - /CMP.7. They should be updated to reflect improvements to methodologies or data available in the Member States. The accounting rules should provide for an upper limit applicable to net greenhouse gas emissions and removals for forest management that may be entered into accounts, given underlying uncertainties in the projections on which the reference levels are based.
Amendment 105 #
2012/0042(COD)
Proposal for a decision
Recital 6 a (new)
Recital 6 a (new)
(6a) The accounting rules should appropriately reflect the positive contribution of greenhouse gas storage in wood and wood-based products and should contribute to greater use of forests as a resource, within a framework of sustainable forest management, and to increased use of wood products.
Amendment 106 #
2012/0042(COD)
Proposal for a decision
Recital 7
Recital 7
(7) The accounting rules for forest management should ensure that Member States accurately reflect in accounts the time emissions of greenhouse gasses from harvested wood take place, to provide incentives for the use of harvested wood products with long life cycles. The first- order decay function applicable to emissions resulting from harvested wood products should therefore correspond to equation 12.1 of the 2006 Intergovernmental Panel on Climate Change (‘'IPCC’') Guidelines for National Greenhouse Gas Inventories, and the relevant default half-life values should be based on Table 3a.1.3 of the 2003 IPCC Good Practice Guidance for Land Use, Land Use Change and Forestry.
Amendment 109 #
2012/0042(COD)
Proposal for a decision
Recital 8
Recital 8
(8) Since inter-annual fluctuations in greenhouse gas emissions and removals resulting from agricultural activities are much smaller than those related to forestry activities, Member States shouldthat account for greenhouse gas emissions and removals from cropland and grazing land management activities should do so relative to its base year in accordance with their reviewed initial report on base year emission data as submitted to the UNFCCC pursuant to Decision 13/CMP.1 of the Conference of the Parties serving as the meeting of the Parties to the Kyoto Protocol (‘'Decision 13/CMP.1’').
Amendment 112 #
2012/0042(COD)
Proposal for a decision
Recital 10
Recital 10
(10) Reporting rules on greenhouse gas emissions and other information relevant to climate change, including information on the LULUCF sector, fall within the scope of Regulation (EU) No …/….../... [Commission proposal for a Regulation of the European Parliament and of the Council on a mechanism for monitoring and reporting Union greenhouse gas emissions and for reporting other information at national and Union level relevant to climate change (COM/2011/0789 final — 2011/0372 (COD)], and are not theshould be considered by Member States when monitoring and refporeting, although they do not fall within the scope of this Decision.
Amendment 115 #
2012/0042(COD)
Proposal for a decision
Recital 12
Recital 12
Amendment 126 #
2012/0042(COD)
Proposal for a decision
Recital 13
Recital 13
(13) The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to update the definitions laid down in Article 2 in the light of changes to definitions adopted by the bodies of the UNFCCC or the Kyoto Protocol or other multilateral agreement relevant to climate change concluded by the Union, to amend Annex I to add accounting periods and ensure consistency between those accounting periods ands arising in the arelevant periods applicable to Union emission reduction commitments in other sectors, to amend Annex II with updated reference levels in accordance with the proposed reference levels submitted by Member States pursuant to Article 6 subject to corrections made in accordance with this Decisa of climate change concluded by the Union, to revise the information specified in Annex III in accordance with scientific progress and to revise the conditions relating to the accounting rules for natural disturbances laid down in Article 9(2) in the light of scientific progress or to reflect revisionto reflect minor changes to acts adopted by the UNFCCC or Kyoto Protocol bodies. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Amendment 134 #
2012/0042(COD)
Proposal for a decision
Article 1
Article 1
This Decision sets out accounting rules applicable to emissions and removals resulting from land use, land use change and forestry activities. It also provides for Member State LULUCF Action Plans to limit or reduce emissions and to maintain or increase removals, and for the evaluation of those plans by the Commission.
Amendment 144 #
2012/0042(COD)
Proposal for a decision
Article 2 – paragraph 1 – point q
Article 2 – paragraph 1 – point q
(q) ‘'forest’' is an area of land of at least 0.5 hectare,land with tree crown cover (or an equivalent stocking level) of at leastmore than 10 per cent of the area, covered with trees with the potentialand area of more than 0.5 hectare. The trees should be able to reach a minimum height of at least 5 metres at maturity at in situ. A forest may consist eitheir place of growth, including grof closed forest formations where trees of varioups of growing young natural trees, or a plantation that has yet to reach a tree crown cover or equivalent stocking level of at least 10 per cent of the area or tree height of at least 5 metres, including any area thatstoreys and undergrowth cover a high proportion of the ground, or of open forest formations with a continuous vegetation cover in which tree crown cover exceeds 10 percent. Young natural stands and all plantations established for forestry purposes which have yet to reach a crown density of 10 percent or tree height of 5 m are included, as are areas normally formsing part of the forest area but on which therewhich are temporarily no treesunstocked as a result of human intervention, such as harvesting, or as a result of natural causes, but which area can be expected to revert to for or natural causes but which are expected to revert to forest. 'Forest' includes: forest nurseries and seed orchards that constitute an integral part of the forest; forest roads, cleared tracts, firebreaks and other small open areas within the forest; forest in national parks, nature reserves and other protected areas such as those of special environmental, scientific, historical, cultural or spiritual interest; windbreaks and shelterbelts of trees with an area of more than 0.5 hectare and a width of more than 20 metres, rubberwood plantations and cork oak stands. 'Forest' excludes land predominantly used for agricultural practicest;
Amendment 154 #
2012/0042(COD)
Proposal for a decision
Article 2 – paragraph 2
Article 2 – paragraph 2
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 12 to amend the definitions in paragraph 1 of this Article for the purpose of updatingto ensure consistency between those definitions in the light ofand any changes to relevant definitions adopted by the bodies of the UNFCCC or the Kyoto Protocol within the framework of the UNFCCC, or other multilateral agreement relevant to climate change concluded by the Union.
Amendment 168 #
2012/0042(COD)
Proposal for a decision
Article 3 – paragraph 1 – subparagraph 1 – point e
Article 3 – paragraph 1 – subparagraph 1 – point e
Amendment 177 #
2012/0042(COD)
Proposal for a decision
Article 3 – paragraph 1 – subparagraph 1 – point f
Article 3 – paragraph 1 – subparagraph 1 – point f
Amendment 185 #
2012/0042(COD)
Proposal for a decision
Article 3 – paragraph 1 – subparagraph 2
Article 3 – paragraph 1 – subparagraph 2
Member States may also draw up and maintain accounts that accurately reflect emissions and removals resulting from cropland management, grazing land management, revegetation, and wetland drainage and rewetting.
Amendment 193 #
2012/0042(COD)
Proposal for a decision
Article 4 – title
Article 4 – title
Amendment 198 #
2012/0042(COD)
Proposal for a decision
Article 4 – paragraph 7
Article 4 – paragraph 7
7. The Commission shall be empowered to adopt delegated acts in accordance with Article 12 to amend Annex IAny amendment to the obligation to draw up and maintain LULUCF accounts set out in this Article, including changes to addthe accounting periods and to ensure consistency between those accounting periods and the relevant periods applicable to Union emission reduction commitments in other sectorss set out in Annex I, shall be adopted in accordance with the ordinary legislative procedure.
Amendment 222 #
2012/0042(COD)
Proposal for a decision
Article 6 – paragraph 9
Article 6 – paragraph 9
Amendment 234 #
2012/0042(COD)
Proposal for a decision
Article 7 – paragraph 2 – subparagraph 1 – point a
Article 7 – paragraph 2 – subparagraph 1 – point a
(a) pulp and paper;
Amendment 235 #
2012/0042(COD)
Proposal for a decision
Article 7 – paragraph 2 – subparagraph 1 – point c a (new)
Article 7 – paragraph 2 – subparagraph 1 – point c a (new)
(ca) wood for energy production.
Amendment 241 #
2012/0042(COD)
Proposal for a decision
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Where Member States reflect in their accounts emissions resulting from harvested wood products that were harvested for energy purposes, they shall do so also on the basis of the instantaneous oxidation methodtake into account in their calculations the replacement of fossil fuels with adequate national half-life values.
Amendment 247 #
2012/0042(COD)
Proposal for a decision
Article 8 – title
Article 8 – title
Amendment 248 #
2012/0042(COD)
Proposal for a decision
Article 8 – paragraph 1
Article 8 – paragraph 1
1. In accounts relating to cropland management and grazing land management, Member States shallWhere a Member State elects to draw up and maintain accounts for categories referred to in the second subparagraph of Article 3(1), it shall, without prejudice to any future decision on accounting rules at international level, reflect emissions and removals resulting from such activities, calculated as emissions and removals in each accounting period specified in Annex I, minus the value obtained by multiplying the number of years in that accounting period by a Member State's emissions and removals resulting from such activities in its base year, as submitted to the UNFCCC in that Member State's reviewed initial report on base year emission data pursuant to the Annex of Decision 13/CMP.1.
Amendment 260 #
2012/0042(COD)
Proposal for a decision
Article 9 – paragraph 5
Article 9 – paragraph 5
5. The Commission shall be empowered to adopt delegated acts in accordance with Article 12 to revise the conditions referred to in the first subparagraph of paragraph 2 in the light of scientific progress or to reflect revisionto reflect minor changes to acts adopted by UNFCCC or Kyoto Protocol bodies.
Amendment 262 #
Amendment 296 #
2012/0042(COD)
Proposal for a decision
Article 10 – paragraph 3 – subparagraph 1
Article 10 – paragraph 3 – subparagraph 1
The Commission shall evaluate ahold consultations with the Member State’s drafton their LULUCF Action Plan within three months of receiving all relevant information froms. By common accord with thate Member State. Ts the Commission shall publish the results of that evaluose consultations and mayshall issue recommendations, as appropriate, with a view to enhance Member States’ efforts to limit or reduce emissions and maintain or increase removals.
Amendment 302 #
2012/0042(COD)
Proposal for a decision
Article 10 – paragraph 3 – subparagraph 2
Article 10 – paragraph 3 – subparagraph 2
Member States shall take due account of the Commission’s findings and shall publish in electronic form and make available to the public their LULUCF Action Plans within three months of receiving the Commission’s evaluatresults of the consultations with the Commission.
Amendment 313 #
2012/0042(COD)
Proposal for a decision
Article 11 – paragraph 1
Article 11 – paragraph 1
The Commission shall review the accounting rules in this Decision at the latest within a year of the end of the first accounting period specified in Annex I. in the light of international negotiations and the UNFCCC.
Amendment 323 #
2012/0042(COD)
Proposal for a decision
Annex III – "Default half-life values (HL)" – line 1
Annex III – "Default half-life values (HL)" – line 1
2 years for paper and energy-producing wood
Amendment 325 #
Amendment 52 #
2012/0035(COD)
Proposal for a directive
Recital 8
Recital 8
(8) Due to diversity of national measures managing the consumption of medicines, regulating their prices or establishing the conditions of their public funding it is necessary to clarify Directive 89/105/EEC. In particular this Directive should cover all types of measures devised by Member States and susceptible to impact the internal market. Since the adoption of Directive 89/105/EEC, the pricing and reimbursement procedures have evolved and have become more complex. While some Member States have interpreted the scope of Directive 89/105/EEC restrictively, the Court of Justice ruled that those pricing and reimbursement procedures fall within the scope of Directive 89/105/EEC given the objectives of that Directive and the need to ensure its effectiveness. Therefore, this Directive should reflect the developments in national pricing and reimbursement policies. Given thatDespite the existence of specific rules and procedures exist in the area of public procurement and voluntary contractual agreements, national measures involving public procurement and voluntary contractual agreements should only be excluded from the scope of this Directive to the extent that the voluntary agreements also allow transparency about the drug sales price which is of primary concern to the insured person. It must be clear to doctors and pharmacists as distribution points for drugs which costs are incurred by the patient and the health care systems for a medicine in order to be able to choose the most economically rational drug regardless of the type of agreement.
Amendment 65 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 3 – subparagraph 2 a (new)
Article 5 – paragraph 3 – subparagraph 2 a (new)
Member States shall ensure that dispensaries possess information about the actual price of the medicinal product in order to prevent possible distorting effects caused by a lack of transparency in prices displayed on the market.
Amendment 83 #
2012/0035(COD)
Proposal for a directive
Article 1 – paragraph 2 – subparagraph 1 – point a
Article 1 – paragraph 2 – subparagraph 1 – point a
(a) voluntary contractual agreements concluded between public authorities and the holder of a marketing authorisation for a medicinal product that have as their object to enable the effective provision of this medicine to patients under specific conditions, provided that such arrangements also meet the transparency requirements of Article 5, paragraph 3 a (new);
Amendment 90 #
2012/0035(COD)
Proposal for a directive
Article 2 – point 5 a (new)
Article 2 – point 5 a (new)
(5a) "voluntary contractual agreement" as referred to in Article 1(2), point (a) means an agreement concluded between public authorities and the marketing authorisation holder for a medicinal product which is neither mandatory or required by law nor is the agreement the only alternative to be included in the national pricing and reimbursement scheme.
Amendment 172 #
2012/0035(COD)
Proposal for a directive
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3a. Member States shall ensure that dispensaries possess information about the sale price of the medicinal product applicable to the insured person in order to prevent possible distorting effects caused by a lack of transparency in prices displayed on the market.
Amendment 278 #
2012/0035(COD)
Proposal for a directive
Article 19 a (new)
Article 19 a (new)
Article 19a Monitoring and Reporting 1. Three years after entry into force of this Directive the Commission shall submit a report to the European Parliament and to the Council assessing the enforcement of this Directive. 2. The Commission shall be equipped with sufficient resources to monitor the enforcement of the Directive.
Amendment 76 #
2011/2307(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls on the Member States to ensure that civil society is actively involved at all implementation levels and that the relevant stakeholders (the public, local authorities, environmental protection groups and businesses) are made more aware and are included in all stages of the selection, definition and administration of protected areas;
Amendment 85 #
2011/2307(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Welcomes the intention of the Commission, together with the Member States, to launch a major communication campaign for Natura 2000 by 2013, to draw up directives for the relevant local authorities to improve the application of EU environmental protection provisions and to foster the coexistence of environmental protection and sustainable economic growth as equal principles;
Amendment 149 #
2011/2307(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls for the greening of Pillar I in order to make income support for farmers legitimate by ensuring the conservation of biodiversity in the wider farmed landscape, improving connectivity and adapting to the effects of climate change by means of a greening component; welcomes the Commission’s CAP reform proposal that provides for a ‘greening’ of the CAP through the allocation of 30 % of Pillar I payments to a package of worthwhile, basic good greening practices applied at farm level, which should include crop rotation and diversification, permanent pasture and a minimum ‘ecological focus area’; takes the view, however, that the minimum ‘ecological focus area’ should be 10 % of farmland, and not the 7 % proposed by the Commission;is of the view that the targets for increasing environmental contributions through the CAP and for maintaining a productive agricultural sector in Europe can be balanced if those areas that meet the criteria of Annex I of the Flora Fauna Habitat Directive are included in the minimum ‘ecological focus area’ ; Another requirement is that farmers should be allowed to choose for themselves the areas to be set aside as ‘ecological focus areas’.
Amendment 160 #
2011/2307(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls for all CAP payments to be underpinned by robust cross-compliance rules, covering the Water Framework Directive, pesticides legislation and the Birds and Habitats Directivinsofar as these rules are closely related to the agricultural sector or individual agricultural businesses;
Amendment 106 #
2011/2272(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Deplores that advertising for food with high fat, salt and sugar content is aimed at children and young people, who increasingly suffer the consequeCalls on the Member States to combat obesity by educating children and young people about the importances of sedentariness and obesity; calls on the actors involved to educate and inform minors about the importance of a balanced dieta balanced diet and a healthy lifestyle; to this end calls on the Member States to take steps to increase media-literacy skills among children and young people;
Amendment 72 #
2011/2056(INI)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Stresses the importance of domestic raw materials as the basis of raw- materials supply to European industry; calls, therefore, on the Member States to ensure the long-term security of raw material deposits of regional and trans- regional importance; calls, moreover, on the Commission to improve the framework conditions for the exploitation of domestic raw materials in order to ensure that environmental, social and economic demands are given equal weight in any new directives or regulations, or in the revision of existing ones, with a view to securing access to mineral deposits in a sustainable way;
Amendment 2 #
2011/2051(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Calls for the post-2013 CAP to pursue food objectives which encourage new forms ofare designed to encourage sustainable agricultural production which, save energy, reduce the use of chemicalspromote efficient input use and exploit the potential of ecosystems more effectively; points out that it must be capable of responding to environmental challenges, such as climate change, depletion of resources, water pollution and soil erosion, etc.;
Amendment 11 #
2011/2051(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Points out that previous CAP reforms (the 1992 McSharry reform, the ‘Agenda 2000’ reform, the 2003 reform and the 2008 health check) were all aimed at ensuring that European farmers meet the highest standards in the world as far as environmental protection and animal welfare and traceability of foodstuffs are concerned; stresses in this connection that farmers are not compensated by the market for the costs entailed in meeting these standards; (This paragraph should be the new number 1 and therefore be put on the top.)
Amendment 18 #
2011/2051(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Points out that the CAP encompassesplays a crucial role both for farmers and the public in general - who are both taxpayers and consumers - as the latter benefit from safe, reasonably priced food, a healthy environment, good health and prospects of jobs;
Amendment 23 #
2011/2051(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Calls for CAP funding to be based on a model which includes payments linked to natural handicaps and green-point payments or payments for vulnerable regionsrewards compliance with standards that are among the highest in the world and the provision of public goods which are not rewarded by the market; points out, in this connection, that natural handicaps must continue to be compensated for in future;
Amendment 32 #
2011/2051(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Calls for a reinforcement of the concept of funding for both pillars subject to the fulfilment of a number of environmental andcriteria relating to the environment, resource efficiency and helping protect biodiversity criteria, so that high- quality food can continue to be produced using sustainable practices; points out that sufficient funding isbudget appropriations are the only guarantee of the success of targeted new, environmentally-friendly practices and existing agri-environmental measures;
Amendment 37 #
2011/2051(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses that the ‘greening’ of EU agricultural policy is, in reality, nothing new to farmers, as each successive reform has been geared towards strengthening this aspect of the CAP;
Amendment 38 #
2011/2051(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Stresses the services which European farmers provide to European society, in particular maintaining a varied cultivated landscape and making an important contribution to the protection and stewardship of natural resources and to climate protection;
Amendment 47 #
2011/2051(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Emphasises that mandatory greening that respects ecosystems will not only benefit the environment, but alsadditional greening must be based on a win-win approach that brings benefits both for the environment and for farmers and society in terms of resource efficiency and increased productivity and not least respects ecosystems; also stresses that it is necessary to place the emphasis on research, innovation and new technology in order to ensure a sustainable future for EU farming;
Amendment 65 #
2011/2051(INI)
Draft opinion
Paragraph 7
Paragraph 7
Amendment 72 #
2011/2051(INI)
Draft opinion
Paragraph 8
Paragraph 8
8. Deplores the fact that the EU’s biodiversity targets have yet to be met and expects the CAP to be a catalyst for efforts to achieve those goalsStresses that the EU must continue to make significant efforts in the area of biodiversity; points out, in this connection, that a cooperative nature conservation approach is an effective measure to this end;
Amendment 79 #
2011/2051(INI)
Draft opinion
Paragraph 9
Paragraph 9
Amendment 91 #
2011/2051(INI)
Draft opinion
Paragraph 10
Paragraph 10
10. Encourages more EU-funded and -coordinated projects in which farmers and researchers can work together to find innovative ways of cultivating land in an environmentally sustainable manneensuring a competitive and, at the same time, sustainable agricultural sector;
Amendment 44 #
2011/2048(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Recalls its resolution of May 2010 on recent developments in public procurement, which took note of the ECJ case-law and took the view that public- public cooperation was not subject to public procurement rules as long as the following criteria were met: that the purpose of the partnership was the provision of a public-service task conferred on all the local authorities concerned and that the task was carried out solely by the public authorities concerned, i.e. without the involvement of private capital; underlines that those clarifications; considers that the Court of Justice has established sufficient legal certainty by means of its case-law on public-public cooperation, so that public- public cooperation should not be affected by the modernisation of EU public procurement law and should not be codified in the procurement directivesany other context either;
Amendment 50 #
2011/2048(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Underlines the exclusion of service concessions from the scope of European procurement rules; notes the Commission’s intention to propose separate legislation on service concessions; takes the view that this shrecalls that, in its resolution of 18 May 20101 the European Parliament insisted that any proposal for a legal act dealing with service concessions would be justified only with a view to remedying distortions in the functioning of the internal market and observes that no such distortions have so far been identified; takes the view furthermore that separate legal provisions on service concessions would be dealt with in the review of the directives only in order to avoid any further fragmentation of the legislation; __________________ 1 Resolution on new developments in public procurement, Texts adopted, P7_TA(2010)0173
Amendment 113 #
2011/2048(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Points out that increased awareness of the environmental and climate impact of products and activities means that the possibility for public authorities to favour local suppliers should be considered, and the extent to which internal market rules allow this examined; stresses in this connection that, if criteria which are not procurement-related are taken into account, this should be done on a voluntary basis and the decision to employ them must be reserved for the public authorities or the decision-making bodies behind them which possess direct democratic legitimacy following an individual policy-making procedure on the spot;
Amendment 144 #
2011/2048(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Advocates clear and simple rules with a reduction in the level of detail and greater reliance upon the general principles of transparency, equal treatment and non- discrimination; in view of the small number of foreign operators who are interested in local projects and the number of contracts of local extent actually awarded in Europe as a whole, considers that a significant raising of the thresholds would bring about substantial administrative simplification;
Amendment 81 #
2011/0438(COD)
Proposal for a directive
Recital 37
Recital 37
(37) Contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of transparency, non-discrimination and equal treatment. These criteria should guarantee that tenders are assessed in conditions of effective competition, also where contracting authorities require high-quality works, supplies and services that are optimally suited to their needs, for instance where the chosen award criteria include factors linked to the production process. As a result, contracting authorities should be allowed to adopt as award criteria either ‘the most economically advantageous tender’ or ‘the lowest cost’, taking into acchoose ‘the most economically advantageous tender’. In duly substantiated exceptional cases, in particular involving highly standardised products, count that in the latter caseracting authorities should be able to apply the lowest price or the lowest cost as the sole criterion, taking into account that they are free to set adequate quality standards by using technical specifications or contract performance conditions.
Amendment 109 #
2011/0438(COD)
Proposal for a directive
Article 24 – paragraph 1 – subparagraph 4 – introductory part
Article 24 – paragraph 1 – subparagraph 4 – introductory part
Amendment 110 #
2011/0438(COD)
Proposal for a directive
Article 24 – paragraph 1 – subparagraph 5
Article 24 – paragraph 1 – subparagraph 5
Amendment 156 #
2011/0438(COD)
Proposal for a directive
Article 66 – paragraph 1 – subparagraph 1 – introductory part
Article 66 – paragraph 1 – subparagraph 1 – introductory part
Without prejudice to national laws, regulations or administrative provisions concerning the remuneration of certain services, the criteria on which contracting authorities shall base the award of public contracts shall be one of the following:to the economically most advantageous tender.
Amendment 157 #
2011/0438(COD)
Proposal for a directive
Article 66 – paragraph 1 – subparagraph 1 – point a
Article 66 – paragraph 1 – subparagraph 1 – point a
Amendment 160 #
2011/0438(COD)
Proposal for a directive
Article 66 – paragraph 1 – subparagraph 1 – point b
Article 66 – paragraph 1 – subparagraph 1 – point b
Amendment 165 #
2011/0438(COD)
Proposal for a directive
Article 66 – paragraph 1 – subparagraph 2
Article 66 – paragraph 1 – subparagraph 2
Amendment 167 #
2011/0438(COD)
Proposal for a directive
Article 66 – paragraph 2 – introductory part
Article 66 – paragraph 2 – introductory part
2. The most economically advantageous tender referred to in point (a) of paragraph 1 from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject- matter of the public contract in question. Those criteria shall include, in addition to the price or costs referred to in point (b) of paragraph 1, other price or costs and other qualitative, environmental and social criteria linked to the subject-matter of the public contract in question, such as:
Amendment 205 #
2011/0438(COD)
Proposal for a directive
Recital 11
Recital 11
(11) Other categories of services continue by their very nature to have a limited cross- border dimension, namely what are known as services to the person, such as certain social, health and educational services. These services are provided within a particular context that varies widely amongst Member States, due to different cultural traditions. A specific regime should therefore be established for public contracts for these services, with a higher threshold of EUR 51 000 000. Services to the person with values below this threshold will typically not be of interest to providers from other Member States, unless there are concrete indications to the contrary, such as Union financing for transborder projects. Contracts for services to the person above this threshold should be subject to Union-wide transparency. Given the importance of the cultural context and the sensitivity of these services, Member States should be given wide discretion to organise the choice of the service providers in the way they consider most appropriate. In particular, such procedures should be recognised as an alternative to public procurement law which complies with primary law where they are based on the principle that all service providers able to comply with the conditions previously laid down by law should, irrespective of their legal form, be permitted to provide services, provided that account is taken of the general principles of equal treatment, transparency and non-discrimination. The rules of this directive take account of that imperative, imposing only observance of basic principles of transparency and equal treatment and making sure that contracting authorities are able to apply specific quality criteria for the choice of service providers, such as the criteria set out in the voluntary European Quality Framework for Social Services of the European Union's Social Protection Committee17. Member States and/or public authorities remain free to provide these services themselves or to organise social services in a way that does not entail the conclusion of public contracts, for example through the mere financing of such services or by granting licences or authorisations to all economic operators meeting the conditions established beforehand by the contracting authority, without any limits or quotas, provided such a system ensures sufficient advertising and complies with the principles of transparency and non- discrimination.
Amendment 218 #
2011/0438(COD)
Proposal for a directive
Recital 15
Recital 15
(15) There is a widespread need for additional flexibility and in particular for wider access to a procurement procedure providing for negotiations, as is explicitly foreseen in the Agreement, where negotiation is allowed in all procedures. Contracting authorities should, unless otherwise provided in the legislation of the Member State concerned, be able to use a competitive procedure with negotiation as provided for in this Directive, in various situations where open or restricted procedures without negotiations are not likely to lead to satisfactory procurement outcomes. This procedure should be accompanied by adequate safeguards ensuring observance of the principles of equal treatment and transparency. This will give greater leeway to contracting authorities to buy works, supplies and services perfectly adapted to their specific needs. At the same time, it should also increase cross-border trade, as the evaluation has shown that contracts awarded by negotiated procedure with prior publication have a particularly high success rate of cross-border tenders.
Amendment 239 #
2011/0438(COD)
Proposal for a directive
Recital 25
Recital 25
(25) Electronic means of communication are particularly well suited to support centralised purchasing practices and tools because of the possibility they offer to re- use and automatically process data and to minimise information and transaction costs. The use of such electronic means of communication should therefore, as a first step, be rendered compulsory for central purchasing bodies, while also facilitating converging practices across the Union. This should be followed by a general obligation to use electronic means of communication in all procurement procedures after a transition period of twofour years.
Amendment 262 #
2011/0438(COD)
Proposal for a directive
Recital 37
Recital 37
(37) Contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of transparency, non-discrimination and equal treatment. These criteria should guarantee that tenders are assessed in conditions of effective competition, also where contracting authorities require high-quality works, supplies and services that are optimally suited to their needs, for instance where the chosen award criteria include factors linked to the production process. As a result, contracting authorities should be allowed to adopt as award criteria either ‘the most economically advantageous tender’ or ‘the lowest cost’, taking into acchoose ‘the most economically advantageous tender’. In duly substantiated exceptional cases, in particular involving highly standardised products, count that in the latter caseracting authorities should be able to apply the lowest price or the lowest cost as the sole criterion, taking into account that they are free to set adequate quality standards by using technical specifications or contract performance conditions.
Amendment 326 #
2011/0438(COD)
Proposal for a directive
Article 1 – paragraph 2 – subparagraph 1
Article 1 – paragraph 2 – subparagraph 1
2. Procurement within the meaning of this Directive is the purchase or other forms of acquisition of works, supplies or services via public contracts by one or more contracting authorities from economic operators chosen by those contracting authorities, whether or no, provided that the works, suppliesy or services are intended for a public purpose directly benefits the contracting authority economically.
Amendment 327 #
2011/0438(COD)
Proposal for a directive
Article 1 – paragraph 2 – subparagraph 1
Article 1 – paragraph 2 – subparagraph 1
2. Procurement within the meaning of this Directive is the purchase or other forms of acquisition of works, supplies or services by one or more contracting authorities from economic operators chosen by those contracting authorities, whether or not the works, supplies or services are intended for a public purpose.
Amendment 332 #
2011/0438(COD)
Proposal for a directive
Article 1 – paragraph 2 – subparagraph 2
Article 1 – paragraph 2 – subparagraph 2
Amendment 388 #
2011/0438(COD)
Proposal for a directive
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) EUR 2400 000 for public supply and service contracts awarded by sub-central contracting authorities and design contests organised by such authorities.
Amendment 395 #
2011/0438(COD)
Proposal for a directive
Article 4 – paragraph 1 – point d
Article 4 – paragraph 1 – point d
(d) EUR 51 000 000 for public contracts for social and other specific services listed in Annex XVI.
Amendment 427 #
2011/0438(COD)
Proposal for a directive
Article 10 – paragraph 1 – point c a (new)
Article 10 – paragraph 1 – point c a (new)
(ca) the following legal services: (i) legal representation of a client in legal proceedings before the courts or administrative bodies by a lawyer as referred to in Article 1 of Directive 77/249/EEC; (ii) certification and authentication of documents by notaries; (iii) legal services provided by proxies or officially appointed guardians or other legal services for which Member States provide before their courts; (iv) other legal services associated with the performance of public administration duties in the Member States, even if only occasionally.
Amendment 442 #
2011/0438(COD)
Proposal for a directive
Article 10 – paragraph 1 – point f a (new)
Article 10 – paragraph 1 – point f a (new)
(fa) civil protection, emergency response and everyday hazard prevention;
Amendment 444 #
2011/0438(COD)
Proposal for a directive
Article 10 – paragraph 1 – point f a (new)
Article 10 – paragraph 1 – point f a (new)
(fa) civil protection, emergency response and everyday hazard prevention;
Amendment 446 #
2011/0438(COD)
Proposal for a directive
Article 10 – paragraph 1 – point f b (new)
Article 10 – paragraph 1 – point f b (new)
(fb) public service contracts awarded by a contracting authority to a contracting authority or to an association of contracting authorities on the basis of an exclusive right which they enjoy pursuant to a published law, regulation or administrative provision which is compatible with the Treaty.
Amendment 447 #
2011/0438(COD)
Proposal for a directive
Article 10 – paragraph 1 a (new)
Article 10 – paragraph 1 a (new)
Only Articles 40, 41 and 48 of this Directive shall apply to public services contracts relating to the following: (a) supporting and auxiliary transport services; (b) legal advice; (c) building-cleaning services; (d) land transport, including cash transport and courier services; (e) investigation and security services.
Amendment 460 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 1 – subparagraph 1 – point b
Article 11 – paragraph 1 – subparagraph 1 – point b
(b) at least 980 % of the activities of that legal person which are activities governed by the contract are carried out for the controlling contracting authority or for other legal persons controlled by that contracting authority;
Amendment 477 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 1 – subparagraph 1 – point c
Article 11 – paragraph 1 – subparagraph 1 – point c
(c) there is nonly passive private participation, in.e. participation that does not allow any influence on the operational business of the controlled legal person.
Amendment 486 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 1 – subparagraph 2
Article 11 – paragraph 1 – subparagraph 2
Amendment 495 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Paragraph 1 also applies where a controlled entity which is a contracting authority awards a contract to its controlling entity, or to another legal person controlled by the same contracting authority, provided that there is no private participation in the legal person being awarded the public contract.(Does not affect English version.)
Amendment 496 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Paragraph 1 also applies where a controlled entity which is a contracting authority awards a contract to its controlling entity or controlling entities, or to another legal person controlled by the same contracting authority, provided that there is nonly passive private participation in the legal person being awarded the public contract, i.e. participation that does not allow any influence on the operational business of the controlled legal person.
Amendment 503 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 3 – subparagraph 1 – introductory part
Article 11 – paragraph 3 – subparagraph 1 – introductory part
3. A contracting authority, which does not exercise over a legal person control within the meaning of paragraph 1, may nevertheless award a public contract without applyingoutside the scope of this Directive to a legal person which it controls jointly with other contracting authorities, where the following conditions are fulfilled:
Amendment 504 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 3 – subparagraph 1 – point a
Article 11 – paragraph 3 – subparagraph 1 – point a
(a) the contracting authorities exercise jointly over the legal person a control which is similar to that which they exercise over theirpurpose of the legal person is the provision of a public-service task conferred own departmentall the public authorities;
Amendment 508 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 3 – subparagraph 1 – point b
Article 11 – paragraph 3 – subparagraph 1 – point b
(b) at least 980 % of the activities of that legal person which are the subject of the contract are carried out for the controlling contracting authorities or other legal persons controlled by the same contracting authorities;
Amendment 521 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 3 – subparagraph 1 – point c
Article 11 – paragraph 3 – subparagraph 1 – point c
(c) there is nonly passive private participation, in.e. participation that does not allow any influence on the operational business of the controlled legal person.
Amendment 526 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 3 – subparagraph 2
Article 11 – paragraph 3 – subparagraph 2
Amendment 541 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 4 – point a
Article 11 – paragraph 4 – point a
(a) the agreement establishes a genuine cooperation between the participating contracting authorities aimed at carpurpose of the partnership is the provision of a public service task in the public interest conferred on public authorities, or the carrying-out of ancillary purchasing activities within the meaning of Article 2(17), which is necessary ing out jointlyrder to perform their public service tasks and inv in the public interest. A poolving mutual rights and obligations of the parties; of tasks shall also be considered to exist where a municipality is merely obliged to make payment, provided that cooperation enables the municipality to carry out its own obligations more economically or more effectively;
Amendment 550 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 4 – point b
Article 11 – paragraph 4 – point b
(b) the agreement is governed only by considerations relating to the public interesttask is carried out solely by the public authorities concerned without the involvement of active private capital;
Amendment 556 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 4 – point c
Article 11 – paragraph 4 – point c
Amendment 563 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 4 – point d
Article 11 – paragraph 4 – point d
Amendment 568 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 4 – point e
Article 11 – paragraph 4 – point e
Amendment 573 #
2011/0438(COD)
Proposal for a directive
Article 11 – paragraph 5
Article 11 – paragraph 5
Amendment 607 #
2011/0438(COD)
Proposal for a directive
Article 18 – paragraph 1
Article 18 – paragraph 1
1. Unless otherwise provided in this Directive or in the national law concerning access to information, and without prejudice to the obligations relating to the advertising of awarded contracts and to the information to candidates and tenderers set out in Articles 48 and 53 of this Directive, the contracting authority shall not disclose information forwarded to it by economic operators which they have designated as confidential, including, but not limited to, technical or trade secrets and the confidential aspects of tenders.
Amendment 621 #
2011/0438(COD)
Proposal for a directive
Article 19 – paragraph 7 – subparagraph 1
Article 19 – paragraph 7 – subparagraph 1
7. Member States shall ensure that, at the latest 24 years after the date provided for in Article 92(1), all procurement procedures under this Directive are performed using electronic means of communication, in particular e-submission, in accordance with the requirements of this Article.
Amendment 657 #
2011/0438(COD)
Proposal for a directive
Article 24 – paragraph 1 – subparagraph 4 – introductory part
Article 24 – paragraph 1 – subparagraph 4 – introductory part
They may also Member States shall provide that contracting authorities may use a competitive procedure with negotiation or a competitive dialogue in any of the following cases:
Amendment 670 #
2011/0438(COD)
Proposal for a directive
Article 24 – paragraph 1 – subparagraph 4 – point e a (new)
Article 24 – paragraph 1 – subparagraph 4 – point e a (new)
(ea) where the specific procurement requirements of the contracting authority cannot be met without exclusive recourse to standardised solutions.
Amendment 675 #
2011/0438(COD)
Proposal for a directive
Article 24 – paragraph 1 – subparagraph 5
Article 24 – paragraph 1 – subparagraph 5
Amendment 686 #
2011/0438(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 2
Article 25 – paragraph 1 – subparagraph 2
The minimum time limit for the receipt of tenders shall be 4021 days from the date on which the contract notice was sent. That period may be extended to 40 days in particular exceptional cases.
Amendment 691 #
2011/0438(COD)
Proposal for a directive
Article 25 – paragraph 2
Article 25 – paragraph 2
Amendment 694 #
2011/0438(COD)
Proposal for a directive
Article 25 – paragraph 3
Article 25 – paragraph 3
Amendment 696 #
2011/0438(COD)
Proposal for a directive
Article 25 – paragraph 4
Article 25 – paragraph 4
Amendment 699 #
2011/0438(COD)
Proposal for a directive
Article 26 – paragraph 1 – subparagraph 2
Article 26 – paragraph 1 – subparagraph 2
The minimum time limit for receipt of requests to participate shall be 3021 days from the date on which the contract notice or, where a prior information notice is used as a means of calling for competition, the invitation to confirm interest is sent.
Amendment 704 #
2011/0438(COD)
Proposal for a directive
Article 26 – paragraph 2 – subparagraph 2
Article 26 – paragraph 2 – subparagraph 2
The minimum time limit for the receipt of tenders shall be 3521 days from the date on which the invitation to tender is sent.
Amendment 724 #
2011/0438(COD)
Proposal for a directive
Article 27 – paragraph 1 – subparagraph 3
Article 27 – paragraph 1 – subparagraph 3
Amendment 793 #
2011/0438(COD)
Proposal for a directive
Article 30 – paragraph 2 – subparagraph 1 – point a
Article 30 – paragraph 2 – subparagraph 1 – point a
(a) where no tenders or no suitable tenders or no requests to participate have been submitted in response to an open procedure or a restricted procedure, provided that the initial conditions of the contract are not substantially altered and that a report is sent to the Commission or the national oversight body designated according to Article 84 where they so requestaltered.
Amendment 803 #
2011/0438(COD)
Proposal for a directive
Article 30 – paragraph 2 – subparagraph 1 – point c – point i
Article 30 – paragraph 2 – subparagraph 1 – point c – point i
i) the absence of competition for technical or legal reasons;
Amendment 820 #
2011/0438(COD)
Proposal for a directive
Article 30 – paragraph 5 a (new)
Article 30 – paragraph 5 a (new)
5a. Contracting authorities may combine elements of the open procedure with the negotiated procedure.
Amendment 888 #
2011/0438(COD)
Proposal for a directive
Article 39 – paragraph 1 – subparagraph 1
Article 39 – paragraph 1 – subparagraph 1
Before launchinitiating a procurement procedure, contracting authorities may conduct market consultationsurveys in order to assess the structure, capability and capacity of the market andor to inform economic operators of their procurement plans and requirements.
Amendment 890 #
2011/0438(COD)
Proposal for a directive
Article 39 – paragraph 1 – subparagraph 2
Article 39 – paragraph 1 – subparagraph 2
For this purpose, contracting authorities may seek or accept advice from administrative support structures or from third parties or market participants, provided that such advice does not have the effect of precluding competition and does not result in a violation of the principles of non-discrimination and transparency.
Amendment 992 #
2011/0438(COD)
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1
Article 44 – paragraph 1 – subparagraph 1
Public contracts may be subdivided into homogenous or heterogeneous lots. For contracts with a value equal to or greater than the thresholds provided for in Article 4 but not less than EUR 500 000, determined in accordance with Article 5, where the contracting authority does not deem it appropriate to split into lots, it shall provide in the contract notice or in the invitation to confirm interest a specific explanation of its reasons.
Amendment 1005 #
2011/0438(COD)
Proposal for a directive
Article 44 – paragraph 2
Article 44 – paragraph 2
Amendment 1007 #
2011/0438(COD)
Proposal for a directive
Article 44 – paragraph 3
Article 44 – paragraph 3
Amendment 1015 #
2011/0438(COD)
Proposal for a directive
Article 44 – paragraph 4
Article 44 – paragraph 4
Amendment 1024 #
2011/0438(COD)
Proposal for a directive
Article 51 – paragraph 1
Article 51 – paragraph 1
1. Contracting authorities shall offer unrestricted and full direct access free of charge by electronic means to the procurement documents from the date of publication of the notice in accordance with Article 49 or the date on which the invitation to confirm interest is sent. The text of the notice or the invitation to confirm interest shall specify the internet address at which this documentation is accessible. Contracting authorities may make access subject to prior submission by an applicant of his name, address, other details or appropriate documents enabling the applicant’s identity to be clearly established.
Amendment 1027 #
2011/0438(COD)
Proposal for a directive
Article 52 – paragraph 2
Article 52 – paragraph 2
2. The invitations referred to in paragraph 1 shall include a reference to the electronic address onat which the specifications or the descriptive document and any other supporting documents have been made directly available by electronic meanare accessible to tenderers. In addition, they shall include the information set out in Annex X.
Amendment 1095 #
2011/0438(COD)
Proposal for a directive
Article 57 – paragraph 2 a (new)
Article 57 – paragraph 2 a (new)
2a. An extension may be granted for the submission of declarations and proof requested by the contracting authority which were not provided by the deadline for submitting tenders.
Amendment 1124 #
2011/0438(COD)
Proposal for a directive
Article 66 – paragraph 1 – subparagraph 1 – introductory part
Article 66 – paragraph 1 – subparagraph 1 – introductory part
1. Without prejudice to national laws, regulations or administrative provisions concerning the remuneration of certain services, the criteria on which contracting authorities shall base the award of public contracts shall be one of the following:to the most economically advantageous tender.
Amendment 1129 #
2011/0438(COD)
Proposal for a directive
Article 66 – paragraph 1 – subparagraph 1 – point a
Article 66 – paragraph 1 – subparagraph 1 – point a
Amendment 1137 #
2011/0438(COD)
Proposal for a directive
Article 66 – paragraph 1 – subparagraph 1 – point b
Article 66 – paragraph 1 – subparagraph 1 – point b
Amendment 1146 #
2011/0438(COD)
Proposal for a directive
Article 66 – paragraph 1 – subparagraph 2
Article 66 – paragraph 1 – subparagraph 2
Amendment 1154 #
2011/0438(COD)
Proposal for a directive
Article 66 – paragraph 2 – introductory part
Article 66 – paragraph 2 – introductory part
2. The most economically advantageous tender referred to in point (a) of paragraph 1 from the point of view of the contracting authority shall be identified on the basis of criteria linked to the subject- matter of the public contract in question. Those criteria shall include, in addition to the price or costs referred to in point (b) of paragraph 1, other price or costs and other qualitative, environmental and social criteria linked to the subject-matter of the public contract in question, such as:
Amendment 1200 #
2011/0438(COD)
Proposal for a directive
Article 66 – paragraph 4
Article 66 – paragraph 4
Amendment 1233 #
2011/0438(COD)
Proposal for a directive
Article 67 – paragraph 3
Article 67 – paragraph 3
Amendment 1251 #
2011/0438(COD)
Proposal for a directive
Article 69 – paragraph 1 – point a
Article 69 – paragraph 1 – point a
(a) the price or cost charged is more than 530 % lower than the average price or costs of the remaining tenders
Amendment 1267 #
2011/0438(COD)
Proposal for a directive
Article 69 – paragraph 1 – point c
Article 69 – paragraph 1 – point c
(c) at least fivthree tenders have been submitted.
Amendment 1306 #
2011/0438(COD)
Proposal for a directive
Article 70
Article 70
Contracting authorities may lay down special conditions relating to the performance of a contract, provided that they are indicated in the call for competition or in the specifications. Those conditions may, in particular, concern social and environmental considerations. They may also include the requirement that economic operators foresee compensations for risks of price increases that are the result of price fluctuations (hedging) and that could substantially impact the performance of a contract.
Amendment 1359 #
2011/0438(COD)
Proposal for a directive
Article 72 – paragraph 3 – subparagraph 2 a (new)
Article 72 – paragraph 3 – subparagraph 2 a (new)
Neither shall the first subparagraph apply in the event of a change of contracting authority before the end of the contract.
Amendment 1361 #
2011/0438(COD)
Proposal for a directive
Article 72 – paragraph 4
Article 72 – paragraph 4
4. Where the value of a modification can be expressed in monetary terms, the modification shall not in every case be considered to be substantial within the meaning of paragraph 1, where its value does not exceed the thresholds set out in Article 4 and where it is below 510 % of the price of the initial contract, provided that the modification does not alter the overall nature of the contract. Where several successive modifications are made, the value shall be assessed on the basis of the cumulative value of the successive modifications.
Amendment 1401 #
2011/0438(COD)
Proposal for a directive
Article 75 – paragraph 1
Article 75 – paragraph 1
Amendment 1410 #
2011/0438(COD)
Proposal for a directive
Article 75 – paragraph 3 – subparagraph 1
Article 75 – paragraph 3 – subparagraph 1
3. The notices referred to in paragraphs 1 and 2 shall contain the information referred to in Annexes VI Part H and I, in accordance with the standard forms.
Amendment 1415 #
2011/0438(COD)
Proposal for a directive
Article 75 – paragraph 3 – subparagraph 2
Article 75 – paragraph 3 – subparagraph 2
Amendment 1421 #
2011/0438(COD)
Proposal for a directive
Article 75 – paragraph 4
Article 75 – paragraph 4
4. The notices referred to in paragraphs 1 and 2 shall be published in accordance with Article 49.
Amendment 1425 #
2011/0438(COD)
Proposal for a directive
Article 76
Article 76
Amendment 1591 #
2011/0438(COD)
Proposal for a directive
Annex 16 - column 2
Annex 16 - column 2
Health, veterinary and social services Administrative educational, healthcare and cultural services Compulsory social security services Benefit services Other community, social and personal services Services furnished by trade unions Religious services Hotel and restaurant services Rail transport services Shipping Supporting and auxiliary transport services Personnel placement and supply services, apart from employment contracts Investigation and security services, except armoured car services Education and vocational education services Recreation, culture and sport, except contracts for the acquisition, development, production or co-production of programmes by broadcasting organisations and contracts for broadcasting time Other services apart from employment contracts and contracts for the acquisition, development, production or co-production of programmes by broadcasting organisations and contracts for broadcasting time
Amendment 246 #
2011/0437(COD)
Proposal for a directive
Recital 1
Recital 1
Amendment 250 #
2011/0437(COD)
Proposal for a directive
Recital 2
Recital 2
(2) Public procurement plays a key role in the Europe 2020 strategy as one of the market-based instruments to be used to achieve a smart, sustainable and inclusive growth while ensuring the most efficient use of public funds. The award of works concessions is presently subject to basic rules of Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts while the award of services concessions with a cross-border interest is subject to the principles of the Treaty, and in particular the principle of free movement of goods, freedom of establishment and freedom to provide services as well as to the principles deriving therefrom such as equal treatment, non-discrimination, mutual recognition, proportionality and transparency. There is a risk of legal uncertainty related to different interpretations of the principles of the Treaty by national legislators and of wide disparities among the legislations of different Member States. Such risk has been confirmed by the extensive case law of the Court of Justice of the European Union but which has only partially addressed certain aspects of the award of concession contracts. Hence, a uniform concretisation of the Treaty principles across all Member States and the elimination of discrepancies in their understanding following therefrom is necessary at the Union level in order to eliminate persisting distortions of the Internal Market.
Amendment 261 #
2011/0437(COD)
Proposal for a directive
Recital 5
Recital 5
Amendment 267 #
2011/0437(COD)
Proposal for a directive
Recital 5 a (new)
Recital 5 a (new)
(5a) In keeping with the European Parliament resolutions of 14 January 2004, 10 March 2004 and 31 May 2006, the water sector should not be liberalised but should be modernised. It should therefore be excluded from the scope of this Directive.
Amendment 270 #
2011/0437(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Concessions are contracts for pecuniary interest concluded between one or more economic operators and one or more contracting authorities or entities and having as their object the acquisition of works or services where the consideration consists, normally, in the right to exploit the works or services that are the subject of the contract. The execution of these works or services are subject to specific binding obligations defined by the contracting authority or entity which are legally enforceable. By contrast, certain State acts such as authorisations or licences, or approval requirements for the provision of social services, whereby the State or a public authority establishes the conditions for the exercise of an economic activity, should not qualify as concessions. The same applies to certain agreements having as their object the right of an economic operator to exploit certain public domains or resources, such as land lease contracts whereby the State or contracting authority or entity establishes only general conditions for their use without acquiring specific works or services.
Amendment 276 #
2011/0437(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Concessions are contracts for pecuniary interest concluded between one or more economic operators and one or more contracting authorities or entities and having as their object the acquisition of works or services where the consideration consists, normally, in the right to exploit the works or services that are the subject of the contract. The execution of these works or services are subject to specific binding obligations defined by the contracting authority or entity which are legally enforceable. By contrast, certain State acts such as authorisations or licences, or approval requirements for the provision of social services, whereby the State or a public authority establishes the conditions for the exercise of an economic activity, should not qualify as concessions. The same applies to certain agreements having as their object the right of an economic operator to exploit certain public domains or resources, such as land leasetenancy contracts whereby the State or contracting authority or entity establishes only general conditions for their use without acquiring specific works or services. The general conditions contained in both tenancy and land lease contracts are rules concerning the transfer of the rented property to the tenant, the use thereof (e.g. a description of the rented property, provisions on permissible uses of the rented property, provisions on the optimum use of the rented property such as performance indicators and environmental standards), the respective obligations of the landlord and the tenant with regard to the maintenance of the rented property, the duration of the lease and repossession by the landlord of the rented property, the rent and other costs borne by the tenant, including penalties.
Amendment 277 #
2011/0437(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Concessions are contracts for pecuniary interest concluded between one or more economic operators and one or more contracting authorities or entities and having as their object the acquisition of works or services where the consideration consists, normally, in the right to exploit the works or services that are the subject of the contract. The execution of these works or services are subject to specific binding obligations defined by the contracting authority or entity which are legally enforceable. By contrast, certain State acts such as authorisations or licences whereby the State or a public authority establishes the conditions for the exercise of an economic activity, should not qualify as concessions. The same applies to certain agreements having as their object the right of an economic operator to exploit certain public domains or resources, such as land lease contracts whereby the State or contracting authority or entity establishes only general conditions for their use without acquiring specific works or services. This also applies to agreements opening up general and non- discriminatory access to the market to all economic operators meeting the conditions established beforehand by the contracting authority, without any limits or quotas. Town planning contracts are also not concessions.
Amendment 280 #
2011/0437(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Concessions are contracts for pecuniary interest concluded between one or more economic operators and one or more contracting authorities or entities and having as their object the acquisition of works or services where the consideration consists, normally, in the right to exploit the works or services that are the subject of the contract. The execution of these works or services are subject to specific binding obligations defined by the contracting authority or entity which are legally enforceable. By contrast, certain State acts such as authorisations or licences whereby the State or a public authority establishes the conditions for the exercise of an economic activity, should not qualify as concessions. The same applies to certain agreements having as their object the right of an economic operator to exploit certain public domains or resources, such as land lease contracts whereby the State or contracting authority or entity establishes only general conditions for their use without acquiring specific works or services. Simple approvals or the right to use public goods or a public domain are not services concessions.
Amendment 285 #
2011/0437(COD)
Proposal for a directive
Recital 8
Recital 8
(8) Where sector specific regulation provides for a guarantee to the concessionaire on breaking even on investments and costs incurred for operating the contract, such contract should not qualify as a concession within the meaning of this Directive. A distinction should nevertheless be established with cases where the operating risk is limited from the outset. This does not prevent a concession from being accepted (see the case-law of the ECJ in case WAZV Gotha (C-206/08)).
Amendment 293 #
2011/0437(COD)
Proposal for a directive
Recital 10
Recital 10
Amendment 301 #
2011/0437(COD)
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11a) The entities covered by the Directive should not be identified on the basis of their legal status. It should be ensured, therefore, that the equal treatment of contracting entities operating in the public sector and those operating in the private sector is not prejudiced. It is also necessary to ensure, in keeping with Article 345 of the Treaty, that the rules governing the system of property ownership in Member States are not prejudiced.
Amendment 328 #
2011/0437(COD)
Proposal for a directive
Recital 20
Recital 20
Amendment 330 #
2011/0437(COD)
Proposal for a directive
Recital 20
Recital 20
Amendment 342 #
2011/0437(COD)
Proposal for a directive
Recital 22
Recital 22
(22) Given the importance of the cultural context and the sensitivity of these services, Member States should bare given wide discretion to organise the choice of the service providers in the way they consider most appropriate. The rules of this Directive do not prevent Member States to apply specific quality criteria for the choice of service providers, such as the criteria set out in the voluntary European Quality Framework for Social Services of the European Union's Social Protection Committee . Member States and/or public authorities remain free to provide these services themselves or to organise social services in a way that does not entail the conclusion of concessions, for example through the mere financing of such services or by granting licences or authorisations to or concluding agreements with all economic operators meeting the conditions established beforehand by the contracting authority or contracting entity, without any limits or quotas, provided such system ensures sufficient advertising and complies with the principles of transparency and non- discrimination. .
Amendment 376 #
2011/0437(COD)
Proposal for a directive
Recital 39
Recital 39
Amendment 390 #
2011/0437(COD)
Proposal for a directive
Article 1 – paragraph 2 a (new)
Article 1 – paragraph 2 a (new)
2a. This Directive shall not apply where a contracting authority performs its public interest tasks with its own resources or in cooperation with other contracting authorities.
Amendment 415 #
2011/0437(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 7
Article 2 – paragraph 1 – point 7
(7) 'services concession' means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities or contracting entities and having as their object the provision of services other than those referred to in points 2 and 4 where the consideration for the services to be provided consists either solely in the right to exploit the services that are subject of the contract or in that right together with payment. Member State procedures based on the principle that all service providers capable of meeting the conditions established beforehand by law shall be authorised to provide the service are not services concessions, in so far as they comply with the general principles of equal treatment, transparency and non- discrimination.
Amendment 418 #
2011/0437(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 7 a (new)
Article 2 – paragraph 1 – point 7 a (new)
(7a) "services concession" means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities or contracting entities and having as their object the provision of services other than those referred to in points 2 and 4 where the consideration for the services to be provided consists either solely in the right to exploit the services that are subject of the contract or in that right together with payment; Member State procedures based on the principle that all service providers capable of meeting the conditions established beforehand by law, regardless of their legal form, shall be authorised to provide the service shall not be considered services concessions, in so far as they comply with the general principles of equal treatment, transparency and non- discrimination.
Amendment 419 #
2011/0437(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 7 b (new)
Article 2 – paragraph 1 – point 7 b (new)
(7b) "services concession" means a contract for pecuniary interest concluded in writing between one or more economic operators and one or more contracting authorities or contracting entities and having as their object the provision of services other than those referred to in points 2 and 4 where the consideration for the services to be provided consists either solely in the right to exploit the services that are subject of the contract or in that right together with payment; approvals or the simple approval for the use of a public good or public domain are not services concessions within the meaning of this Directive.
Amendment 425 #
2011/0437(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 14
Article 2 – paragraph 1 – point 14
(14) ‘life cycle’ means all consecutive and/or interlinked stages, including production, transport, use and maintenance, throughout the existence of a product or a works or the provision of a service, from raw material acquisition or generation of resources to disposal, and clearance and finalisation.
Amendment 437 #
2011/0437(COD)
Proposal for a directive
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2a. The right to exploit the works or services as referred to in points 2, 4 and 7 of the first paragraph shall imply the transfer to the concessionaire of the operating risk. The concessionaire shall be deemed to assume the operating risk where it is not guaranteed to recoup the investments made or the costs incurred in operating the works or the services which are the subject-matter of the concession. This shall also apply where the operating risk is limited from the outset.
Amendment 443 #
2011/0437(COD)
Proposal for a directive
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. This Directive shall apply to the following concessions the value of which is equal to or greater than EUR 510 000 000:
Amendment 446 #
2011/0437(COD)
Proposal for a directive
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
a) concessions concluded by contracting entities for the pursuit of one of the activities referred to in Annex III and relating to a network or geographically restricted area with at least 100 000 connected customers, or with at least 100 000 inhabitants;
Amendment 454 #
2011/0437(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. The calculation of the estimated value of a concession shall be based on the total amount payable, net of VAT, as estimated by the contracting authority or the contracting entity, including any form of option and any extension of the duration ofequal to the estimated turnover of the concessionaire, net of value added tax, taking account of work and services, including supplies, carried out in the course of executing the concession.
Amendment 458 #
2011/0437(COD)
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
Amendment 484 #
2011/0437(COD)
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
1. This Directive shall not apply to services concessions awarded by a contracting authority or by a contracting entity to an economic operator which is a contracting entity or an association of thereof,concerning networks infrastructure related to the activities set out in Annex III, if (a) the services concession is awarded to an economic operator on the basis of an exclusive right that economic operator enjoys pursuant to applicable and published national law, regulation or administrative provision, and which has been graor (b) the services concession relates to an activity which, when this Directive entedrs in accordance with the Treaty and Union sectoral legislation concerning the management of networks infrastructureto force, is the subject of a nationally regulated tariff laid down in law or regulation, or (c) the services concession is awarded to an economic operator on the basis of an exclusive right that economic operator enjoys pursuant to applicable and published law, regulation or administrative provision, or in respect of services to which regulated to the activities set out in annex III, non- discriminatory access is available when this Directive enters into force.
Amendment 512 #
2011/0437(COD)
Proposal for a directive
Article 8 – paragraph 5 – subparagraph 1 – point d
Article 8 – paragraph 5 – subparagraph 1 – point d
(d) financial services in connection with the issue, sale, purchase or transfer of securities or other financial instruments within the meaning of Directive 2004/39/EC of the European Parliament and of the Council, central bank services and operatransactions conducted with the European Financial Stability Facility (EFSF) as well as operations to raise money or capital for the contracting authority;
Amendment 516 #
2011/0437(COD)
Proposal for a directive
Article 8 – paragraph 5 – subparagraph 1 – point f a (new)
Article 8 – paragraph 5 – subparagraph 1 – point f a (new)
(fa) works or services entailed in the construction and/or management of cableways intended for the business of undertakings managing mobility in mountain areas for tourist, recreational, play, or sporting purposes, with the related services;
Amendment 520 #
2011/0437(COD)
Proposal for a directive
Article 8 – paragraph 5 – subparagraph 1 – point g a (new)
Article 8 – paragraph 5 – subparagraph 1 – point g a (new)
(ga) civil protection, disaster prevention, emergency response and rescue and everyday hazard prevention services.
Amendment 525 #
2011/0437(COD)
Proposal for a directive
Article 8 – paragraph 5 – subparagraph 1 – point g b (new)
Article 8 – paragraph 5 – subparagraph 1 – point g b (new)
(gb) drinking water production, distribution and supply services, sewage treatment and disposal services and the construction, maintenance and operation of the infrastructure used for those purposes.
Amendment 529 #
2011/0437(COD)
Proposal for a directive
Article 8 – paragraph 5 – subparagraph 1 – point g c (new)
Article 8 – paragraph 5 – subparagraph 1 – point g c (new)
(gc) electricity, gas and heat supply services and the construction, maintenance and operation of the infrastructure used for those purposes.
Amendment 539 #
2011/0437(COD)
Proposal for a directive
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Contracting entities shall notify the Commission or the national oversight bodybody with responsibility in this field, if there is one, at their request of any activities which they regard as excluded. The Commission may periodically publish in the Official Journal of the European Union for information purposes, lists of the categories of activities which it considers to be covered by this exclusion. In so doing, the Commission shall respect any sensitive commercial aspects that the contracting entities may point out when forwarding this information.
Amendment 544 #
2011/0437(COD)
Proposal for a directive
Article 11 – paragraph 4 – point a
Article 11 – paragraph 4 – point a
(a) to service concessions provided that at least 80 % of the average total turnover of the affiliated undertaking with respect to services in generalthat are the subject of service concessions for the preceding three years derives from the provision of services to undertakings with which it is affiliated;
Amendment 546 #
2011/0437(COD)
Proposal for a directive
Article 11 – paragraph 4 – point b
Article 11 – paragraph 4 – point b
(b) works concessions provided that at least 80 % of the average total turnover of the affiliated undertaking with respect to works in generalthat are the subject of service concessions for the preceding three years derives from the provision of works to undertakings with which it is affiliated.
Amendment 547 #
2011/0437(COD)
Proposal for a directive
Article 11 – paragraph 4 – point b
Article 11 – paragraph 4 – point b
(b) works concessions provided that at least 80 % of the average total turnoverctivities of the affiliated undertaking with respect to works in general for the preceding three years derives from the provision of works to undertakings with which it is affiliated.
Amendment 556 #
2011/0437(COD)
Proposal for a directive
Article 13 – paragraph 1 – introductory part
Article 13 – paragraph 1 – introductory part
Contracting entities shall notify to the Commission or the national oversight bodybody with responsibility in this field, if there is one, at their request, the following information regarding the application of paragraphs 2 and 3 of Article 11 and of Article 12.
Amendment 558 #
2011/0437(COD)
Proposal for a directive
Article 13 – paragraph 1 – point c
Article 13 – paragraph 1 – point c
(c) proof deemed necessary by the Commission or the national oversight bodybody with responsibility in this field, if there is one, that the relationship between the undertaking or joint venture to which the concessions are awarded and the contracting entity complies with the requirements of Articles 11 or 12.
Amendment 564 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 1 – subparagraph 1 – point a
Article 15 – paragraph 1 – subparagraph 1 – point a
(a) such an authority or entity exercises over the legal person concerned a control which is similar to that which it exercises over its own departments; 100 % ownership by the contracting authority or entity is not a mandatory requirement for establishing control within the meaning of this paragraph.
Amendment 572 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 1 – subparagraph 1 – point b
Article 15 – paragraph 1 – subparagraph 1 – point b
(b) at least 980% of the activities of that legal person that are the subject of the concession are carried out for the controlling contracting authority or entity or for other legal persons controlled by that contracting authority or entity; activities carried out for the controlling contracting authority or entity or for other legal persons controlled by that contracting authority or entity also include activities carried out for third parties where the service forms part of the contracting authority’s statutory remit;
Amendment 577 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 1 – subparagraph 1 – point b a (new)
Article 15 – paragraph 1 – subparagraph 1 – point b a (new)
(ba) ) at least 80% of the average total turnover of the legal person that is the subject of the concession are carried out for the controlling contracting authority or entity or for other legal persons controlled by that contracting authority or entity;
Amendment 578 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 1 – subparagraph 1 – point c
Article 15 – paragraph 1 – subparagraph 1 – point c
Amendment 587 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 1 – subparagraph 2
Article 15 – paragraph 1 – subparagraph 2
Amendment 593 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 2
Article 15 – paragraph 2
2. Paragraph 1 also applies where a controlled entity which is a contracting authority or contracting entity as referred to in paragraph 1 subparagraph 1 of Article 4 awards a concession to its controlling entityunit(s), or to another legal person controlled by the same contracting authority, provided that there is no private participation in the legal person being awarded the public concession.
Amendment 603 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 3 – subparagraph 1 – point a
Article 15 – paragraph 3 – subparagraph 1 – point a
(a) the contracting authorities or entities as referred to in paragraph 1 subparagraph 1 of Article 4 exercise jointly over the legal person a control which is similar to that which it exercises over its own departments; 100 % ownership by the contracting authority or entity is not a mandatory requirement for establishing control within the meaning of this paragraph.
Amendment 612 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 3 – subparagraph 1 – point b
Article 15 – paragraph 3 – subparagraph 1 – point b
(b) at least 9080 % of the activities of that legal person which are the subject of the contract are carried out for the controlling contracting authorities or entities as referred to in paragraph 1 subparagraph 1 of Article 4 or other legal persons controlled by the same contracting authority or entity; activities carried out for the controlling contracting authorities or entities as referred to in paragraph 1 subparagraph 1 of Article 4 or other legal persons controlled by the same contracting authority or entity include activities carried out for third parties where the service forms part of the contracting authority’s statutory remit or is performed for other contracting authorities.
Amendment 616 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 3 – subparagraph 1 – point b a (new)
Article 15 – paragraph 3 – subparagraph 1 – point b a (new)
(ba) at least 80 % of the activities of that legal person, subject to the contract, are carried out for the controlling contracting authorities or other legal persons controlled by the same contracting authorities;
Amendment 617 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 3 – subparagraph 1 – point c
Article 15 – paragraph 3 – subparagraph 1 – point c
Amendment 625 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 3 – subparagraph 2
Article 15 – paragraph 3 – subparagraph 2
Amendment 641 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 4 – point a
Article 15 – paragraph 4 – point a
(a) the agreement establishes a genuine co-operation between the participating contracting authorities or entities aimed at carrying out jointly their public service tasks and involving mutual rights and obligatis governed by considerations relating to the public interest; this principle shall also apply to ancillary services essential to the provisions of the partiservices in the public interest;
Amendment 642 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 4 – point a a (new)
Article 15 – paragraph 4 – point a a (new)
Amendment 644 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 4 – point b
Article 15 – paragraph 4 – point b
Amendment 649 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 4 – point b a (new)
Article 15 – paragraph 4 – point b a (new)
(ba) the task is carried out solely by the public authorities concerned without the involvement of active private capital;
Amendment 652 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 4 – point c
Article 15 – paragraph 4 – point c
Amendment 659 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 4 – point d
Article 15 – paragraph 4 – point d
Amendment 662 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 4 – point e
Article 15 – paragraph 4 – point e
Amendment 670 #
2011/0437(COD)
Proposal for a directive
Article 15 – paragraph 5 – subparagraph 1
Article 15 – paragraph 5 – subparagraph 1
Amendment 721 #
2011/0437(COD)
Proposal for a directive
Article 22 – paragraph 4 – subparagraph 1
Article 22 – paragraph 4 – subparagraph 1
Amendment 740 #
2011/0437(COD)
Proposal for a directive
Article 26 – paragraph 5 – subparagraph 1 – introductory part
Article 26 – paragraph 5 – subparagraph 1 – introductory part
By way of derogation from paragraph 1, the contracting authorities and entities shall not be required to publish a concession notice in any of the following cases:cases referred to in Article 30 of the Public Procurement Directive [replacing Directive 2004/18/EC].
Amendment 741 #
2011/0437(COD)
Proposal for a directive
Article 26 – paragraph 5 – subparagraph 1 – point a
Article 26 – paragraph 5 – subparagraph 1 – point a
Amendment 743 #
2011/0437(COD)
Proposal for a directive
Article 26 – paragraph 5 – subparagraph 1 – point b
Article 26 – paragraph 5 – subparagraph 1 – point b
Amendment 746 #
2011/0437(COD)
Proposal for a directive
Article 26 – paragraph 5 – subparagraph 1 – point c
Article 26 – paragraph 5 – subparagraph 1 – point c
Amendment 799 #
2011/0437(COD)
Proposal for a directive
Article 36 – paragraph 1 – subparagraph 2
Article 36 – paragraph 1 – subparagraph 2
Contracting authorities shall limit any conditions for participation to those that are appropriate to ensure that a candidate or tenderer has the legal and financial capacities and the commercial and technical abilities to perform the concession to be awarded. All requirements shall be related and strictly proportionate to the subject-matter of the contract, and shall takinge into account the need to ensure genuine competition.
Amendment 804 #
2011/0437(COD)
Proposal for a directive
Article 36 – paragraph 2
Article 36 – paragraph 2
Amendment 826 #
2011/0437(COD)
Proposal for a directive
Article 36 – paragraph 6
Article 36 – paragraph 6
6. Any economic operator shall be excluded from participation in a concession where the contracting authority or contracting entity is aware of a decision having the force of res judicata establishing that it has not fulfilled obligations relating to the payment ofrequirement to pay taxes or social security contributions in accordance with the legal provisions of the country in which it is established or with those of the Member State of the contracting authority or entity.
Amendment 852 #
2011/0437(COD)
Proposal for a directive
Article 38 – paragraph 1
Article 38 – paragraph 1
1. Where contracting authorities and contracting entities resort to a concession, the time limit for the submission of applications for the concession shall be not less than 52 calendar days from the date on which the concession notice was sent.
Amendment 864 #
2011/0437(COD)
Proposal for a directive
Article 39 – paragraph 2 – subparagraph 2
Article 39 – paragraph 2 – subparagraph 2
Those criteria shall ensure effective competition and shall be accompanied by requirements which allow the information provided by the tenderers to be effectively verified. Contracting authorities and contracting entities shall verify effectively on the basis ofin what they regard as an appropriate manner, whether the information and proof provided by the tenderers, whether the tenders meet the award criteria meets the award criteria. In so doing they shall comply with the principles of transparency and equal treatment of tenderers.
Amendment 885 #
2011/0437(COD)
Proposal for a directive
Article 41
Article 41
Amendment 894 #
Amendment 928 #
Amendment 932 #
Amendment 942 #
2011/0437(COD)
Proposal for a directive
Annex 3 – paragraphs 2, 3 and 4
Annex 3 – paragraphs 2, 3 and 4
Amendment 950 #
2011/0437(COD)
Proposal for a directive
Annex 3 – paragraph 1 – point 4 – introductory part
Annex 3 – paragraph 1 – point 4 – introductory part
4. Activities relating to the provision or operation of networks providing a service to the public in the field of transport by railway, automated systems, tramway, trolley bus, bus or cable and intended to meet general transport needs of the population.
Amendment 952 #
2011/0437(COD)
Proposal for a directive
Annex 3 – paragraph 1 – point 4 – paragraph 1
Annex 3 – paragraph 1 – point 4 – paragraph 1
As regards transport services, a network shall be considered to exist where the service is provided under operating conditions laid down by a competent authority of a Member State, such as conditions on the routes to be served, the capacity to be made available or the frequency of the service. This provision shall not, under any circumstances, apply to activities relating to transport systems which, given their structural or functional characteristics, are intended solely to carry on the business of providing tourist, recreational, or sports services the performance of which lies outside the tasks of contracting authorities or the activities of contracting entities.
Amendment 955 #
2011/0437(COD)
Proposal for a directive
Annex 4 – point 2
Annex 4 – point 2
Amendment 962 #
2011/0437(COD)
Proposal for a directive
Annex 4 – point 19
Annex 4 – point 19
Amendment 72 #
2011/0435(COD)
Proposal for a directive
Recital 19
Recital 19
(19) Directive 2005/36/EC already provides for clear obligations for professionals to have the necessary language skills. The review of that obligation has shown a need to define these language requirements more precisely and to clarify the role of competent authorities and employers notably in the interest of patients' safety. Language controls should however be reasonable and necessary for the jobs in question and should not constitute grounds for excluding professionals from the labour market in the host Member StatIn the case of occupations which have implications for patients, for example patient safety and treatment and the provision of services and information to patients, it is essential to test language knowledge before authorising a person to practise. Knowledge of the official language(s) of the language area where the professional wishes to work is a conditio sine qua non here. Level C1 of the European Framework of Reference for Languages should be taken as a minimum standard for this purpose.
Amendment 89 #
2011/0435(COD)
Proposal for a directive
Recital 2 a (new)
Recital 2 a (new)
(2a) Dual vocational training systems are a key element for low youth unemployment. Given that they are tailored to the requirements of the economy, they permit a smooth transition from training into working life. They should not just be strengthened in this Regulation, but also taken into consideration in other European legislation on reducing youth unemployment. These vocational training systems and their specific features should, moreover, remain unaffected by the rules of Directive 2005/36/EC.
Amendment 113 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 18 – point a
Article 1 – point 18 – point a
Directive 2005/36/EC
Article 24 – paragraph 2 – subparagraph 1
Article 24 – paragraph 2 – subparagraph 1
2. Basic medical training shall comprise a total of at least fivesix years of study, (which may also, in addition, be expressed withby means of the equivalent ECTS credits), and shall consist of at least 5500 hours of actual theoretical training at a university and practical training provided by, a university or under the supervision of, a university at a non-university hospital. At least 5500 hours of actual training shall not include any components such as private study, examinations or writing of a thesis.
Amendment 118 #
2011/0435(COD)
Proposal for a directive
Recital 8
Recital 8
(8) In order to apply the mechanism of recognition under the general system, it is necessary to group the various national education and training schemes into different levels. Those levels, which are established only for the purpose of the operation of the general system, should have neither effect upon the national education and training structures nor upon the competence of Member States in this field, including a national policy for implementing the European Qualifications Framework. This can be a tool to promote the transparency and comparability of qualifications and can be a useful additional source of information for the competent authorities examining the recognition of qualifications issued in other Member States. The levels established for the operation of the general system should in principle no longer be used as a criterion for excluding Union citizens from the scope of Directive 2005/36/EC when this would be contrary to the principle of life long learning.
Amendment 120 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 23 – point a a (new)
Article 1 – point 23 – point a a (new)
Directive 2005/36/EC
Article 33 – paragraph 2
Article 33 – paragraph 2
(aa) Paragraph 2 is deleted;
Amendment 121 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 23 – point b
Article 1 – point 23 – point b
Directive 2005/36/EC
Article 33 – paragraph 3
Article 33 – paragraph 3
3. Member States shall recognise evidence of formal qualifications in nursing awarded in Poland, to nurses who completed training before 1 May 2004, which did not comply with the minimum training requirements laid down in Article 31, attested by the diploma “'bachelor”' which has been obtained on the basis of a special upgrading programme contained in Article 11 of the Act of 20 April 2004 on the amendment of the Act on professions of nurse and midwife and on some other legal acts (Official Journal of the Republic of Poland of 30 April 2004 No 92, pos. 885), and the Regulation of the Minister of Health of 12 April 2010 amending1 May 2004 on the detailed conditions of delivering studies for nurses and midwives, who hold a certificate of secondary school (final examination — matura) and are graduates of medical lyceum and medical vocational schools teaching in a profession of a nurse and a midwife (Official Journal of the Republic of Poland of 13 May 2004 No 110, pos. 1170, with further amendments), replaced by Article 55.2 of the Act of 15 July 2011 on professions of nurse and midwife (Official Journal of the Republic of Poland of 23 August 2011 No 174, pos. 1039), and the Regulation of the Minister of Health of 11 May4 June 200412 on the detailed conditions of delivering studihigher education courses for nurses and midwives, who hold a certificate of secondary school (final examination -– matura) and are graduates of a medical lyceum and medical vocational schoolssecondary school or a post- secondary teaching in a profession of a nurse and a midwife (Official Journal of the Republic of Poland of 21 April 2010, No 656 July 2012, pos. 42770), with the aim of verifying that the person concerned has a level of knowledge and competence comparable to that of nurses holding the qualifications which, in the case of Poland, are defined in Annex V, point 5.2.2. of Annex V.
Amendment 128 #
2011/0435(COD)
Proposal for a directive
Recital 15
Recital 15
(15) The nursing and midwifery professions have significantly evolved in the last three decades: community-based healthcare, the use of more complex therapies and constantly developing technology presuppose a capacity for higher responsibilities for nurses and midwives. In order to prepare them to meet such complex healthcare needs, nursing and midwifery students need to have a solid general education background before they start the training. Therefore, admission to that training should be increased to twelve years of general education or success in an examination of an equivalent level; the decisive factor, however, is the quality and content of training, which must constantly be brought into line with the challenges facing these professions.
Amendment 131 #
2011/0435(COD)
Proposal for a directive
Article 1 – point 38
Article 1 – point 38
Directive 2005/36/EC
Article 53 – paragraph 2 – subparagraph 2
Article 53 – paragraph 2 – subparagraph 2
In the case of professions with patient safety implications, Member States may confer to the competent authorities the right to carry out language checking covering all professionals concerned if it is expressly requested by the national health care system, or in case of self-employed professionals not affiliated to the nationals health care system, by representative national patient organisationsimplications for patients, including for patient safety, and in the case of treatment of and the provision of services and information to patients, the language knowledge required in order to practise the profession (namely knowledge of the official language(s) of the language area where the professional wishes to work, in accordance with the institutional organisation of the receiving Member State) must be systematically tested by the competent authorities for all professionals concerned. Language checking must be separate from the recognition of professional qualifications, but must be carried out prior to admission to the profession. Level C1 of the European Framework of Reference for Languages should be taken as a minimum standard for this purpose. Member States may confer the right to check language knowledge on third-party bodies as well.
Amendment 152 #
2011/0435(COD)
Proposal for a directive
Recital 21
Recital 21
(21) Directive 2005/36/EC provides for a system of national contact points. Due to the entry into force of Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market24, and the establishment of points of single contact under that Directive, there is a risk of overlap. Therefore, the national contact points established by Directive 2005/36/EC, for example, should become assistance centres which should focus their activities on providing advice to citizens, including face to face advice, in order to ensure that daily application of internal market rules in individual cases of citizens is followed up at national level.
Amendment 160 #
2011/0435(COD)
Proposal for a directive
Recital 23
Recital 23
(23) One of the major difficulties a citizen who is interested to work in another Member State is facing, is complexity and uncertainty of administrative procedures to comply with. Directive 2006/123/EC already obliges Member States to provide easy access to information and procedure completion through the points of single contact. Citizens seeking recognition of their qualifications under Directive 2005/36/EC can already use the points of single contact if they are covered by Directive 2006/123/EC. However, job seekers and health professionals are not covered by Directive 2006/123/EC and available information remains scarce. There is therefore a need to specify that information, from a user perspective, and to ensure that such information is easily available. It is also important that Member States not only take responsibility at national level but also cooperate with each other and the Commission to ensure that professionals throughout the Union have an easy access to a user-friendly and multilingual information and to procedure completionthe easiest possible procedure completion – e.g. within the scope of Directive 2005/36/EC – through the points of single contact. Links should be made available through other websites, such as the Your Europe portal.
Amendment 215 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point a – point ii (new)
Article 1 – paragraph 1 – point 3 – point a – point ii (new)
Directive 2005/36/EC
Article 3 – paragraph 1 – point 1 a (new)
Article 3 – paragraph 1 – point 1 a (new)
la) ‘dual training’: the alternating provision of vocational skills in two learning contexts – the work environment and the vocational school – on the basis of coordinated educational and quality standards. The term ‘vocational skills’ is understood to mean the capacity and willingness to use knowledge, abilities and personal, social and methodological skills both in work situations and for the purpose of professional and personal development;
Amendment 289 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
2005/36/EG
Article 4 d – paragraph 2
Article 4 d – paragraph 2
2. The host Member State shall acknowledge receipt of an application for validation of the European Professional Card within a period of five days. In the cases referred to in Article 16, 21 and 49a, a host Member State shall decide on validation of a European Professional Card under paragraph 1 within one monthfive weeks as from the date of receipt of the European Professional Card transmitted by the home Member State. In case of justified doubts, the host Member State may request additional information from the home Member State. That request shall not suspend the period of one month.
Amendment 296 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
2005/36/EG
Article 4d – paragraph 3
Article 4d – paragraph 3
3. In the cases referred to in Articles 7(4) and 14, a host Member State shall decide on whether to recognise the holder's qualifications or to subject him to compensation measures within two months eight weeks from the date of receipt for validation of the European Professional Card transmitted by the home Member State. In case of justified doubts, the host Member State may request additional information from the home Member State. That request shall not suspend the period of two months.
Amendment 308 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
5. Where the host Member State fails to take a decision within the time limits set out in the paragraphs 2 and 3 or to request additional information within one month from the date offollowing receipt of the European Professional Card by the home Member State, the European Professional Card shall be deemed to be validated by the host Member State and to constitute recognition of the professional qualification to the regulated profession concerned in the host Member State. Where the host state requests additional information, this shall suspend the time limit for no more than four weeks.
Amendment 311 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5 (new)
Article 1 – paragraph 1 – point 5 (new)
2005/36/EG
Article 4d – paragraph 5 (new)
Article 4d – paragraph 5 (new)
5 a. The provisions of the first sentence of Article 4d(5) shall not apply to professions with patient safety implications.
Amendment 341 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
2005/36/EG
Article 4f – paragraph 1 – point b) – Sentence 2
Article 4f – paragraph 1 – point b) – Sentence 2
Amendment 360 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
2005/36/EG
Article 4f – paragraph 2
Article 4f – paragraph 2
2. Partial access shall not be granted to healthcare professions with patient safety implications. Partial access may be rejected if such rejection is justified by an overriding reason of general interest, such as public health, it would secure the attainment of the objective pursued and it would not go beyond what is strictly necessary.
Amendment 374 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 6 – point a
Article 1 – paragraph 1 – point 6 – point a
2005/36/EG
Article 5 –paragraph 1 – point b
Article 5 –paragraph 1 – point b
(b) where the service provider moves, if he has pursued that profession in one or several Member States other than the one in which the service is to be provided for at least two years during the last 10 years preceding the provision of services when the profession is not regulated in the Member State of establishment.
Amendment 381 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 6 – point a
Article 1 – paragraph 1 – point 6 – point a
2005/36/EG
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) where the service provider is accompanying the service recipient, provided that the serviceis not intended either directly or indirectly for recipient's habitual residence is in the service provider's Member State of establishmentin the state of service provision and the profession does not appear on the list referred to in Article 7(4).
Amendment 410 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9 – point b
Article 1 – paragraph 1 – point 9 – point b
Directive 2005/36/EC
Article 11 – Letter c
Article 11 – Letter c
Amendment 415 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9 – point d
Article 1 – paragraph 1 – point 9 – point d
Directive 2005/36/EC
Article 11 – paragraph 2
Article 11 – paragraph 2
Amendment 416 #
2011/0435(COD)
Proposal for a directive
Article 11 – paragraph 2 a (new)
Article 11 – paragraph 2 a (new)
2a. The Commission shall be empowered to adopt delegated acts in accordance with Article 58a in order to revise the list contained in Annex II to take account of forms of training which meet the requirements laid down in paragraph 1(c)(ii).
Amendment 421 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive 2005/36/EC
Article 13 – paragraph 3
Article 13 – paragraph 3
3. In case of an attestation of competence or evidence of formal qualifications referred to in paragraphs 1 and 2 or a certificate certifying regulated education and training or a vocational training with special structure equivalent to the level provided for in Article 11(c)(i), the host Member State shall accept the level attested or certified by the home Member State.
Amendment 425 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive 2005/36/EC
Article 13 – paragraph 4
Article 13 – paragraph 4
4. By derogation to paragraphs 1 and 2 of this Article, the competent authority of the host Member State may refuse access to and pursuit of the profession to holders of an attestation of competence in accordance with Article 11(a) where the national qualification required to exercise the profession on its territory is classified under points (c), (d) or (e) of Article 11.
Amendment 445 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15 a (new)
Article 1 – paragraph 1 – point 15 a (new)
Directive 2005/36/EC
Article 21 – paragraph 4
Article 21 – paragraph 4
(15a) Article 21(4) is replaced by the following: (4) Member States shall not be required, however, to accept evidence of formal qualifications in accordance with Annex V, point 5.6.2, in connection with the establishment of new public pharmacies. For the purposes of this paragraph, pharmacies which have been open for less than three years shall also be regarded as new pharmacies.
Amendment 458 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point a
Article 1 – paragraph 1 – point 18 – point a
Directive 2005/36/EC
Article 24 – paragraph 2
Article 24 – paragraph 2
Basic medical training shall comprise a total of at least five years of study, which may also be expressed as an additional criterion with the equivalent ECTS credits, and shall consist of at least 5500 hours of theoretical and practical training provided by, or under the supervision of, a university.
Amendment 475 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22 – point a
Article 1 – paragraph 1 – point 22 – point a
Directive 2005/36/EC
Article 31 – paragraph 1
Article 31 – paragraph 1
1. Admission to training for nurses responsible for general care shall be contingent upon completion of general education of 12 years, as attested by a diploma, certificate or other evidence issued by the competent authorities or bodies in a Member State or by a certificate attesting success in an examination, of an equivalent level, for admission to a school of nursing.:
Amendment 477 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22 – point a (new)
Article 1 – paragraph 1 – point 22 – point a (new)
Directive 2005/36/EC
Article 31 – paragraph 1 – subparagraph a (new)
Article 31 – paragraph 1 – subparagraph a (new)
a. completion of general education of at least 10 years, as attested by a diploma, certificate or other evidence issued by the competent authorities or bodies in a Member State or by a certificate attesting success in an examination, of an equivalent level, and giving access to a vocational school of nursing, or
Amendment 479 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22 – point a (new)
Article 1 – paragraph 1 – point 22 – point a (new)
Directive 2005/36/EC
Article 31 – paragraph 1 – subparagraph b
Article 31 – paragraph 1 – subparagraph b
b. possession of a diploma, certificate or other evidence of qualification giving access, on the basis of general education of 12 years, to universities or higher education institutes of a level recognised as equivalent.
Amendment 485 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22 – point c a (new)
Article 1 – paragraph 1 – point 22 – point c a (new)
Directive 2005/36/EC
Article 31 – paragraph 4 (new)
Article 31 – paragraph 4 (new)
(4) Theoretical training is that part of nurse training from which trainee nurses acquire the professional knowledge, skills and competences required under paragraphs 6 and 7. The training shall be given by teachers of nursing care and by other competent persons, at universities, at higher education institutes of a level recognised as equivalent or at vocational schools of nursing.
Amendment 486 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22 – point c b (new)
Article 1 – paragraph 1 – point 22 – point c b (new)
Directive 2005/36/EC
Article 31 – paragraph 5 (new)
Article 31 – paragraph 5 (new)
(5) Clinical training is that part of nurse training in which trainee nurses learn, as part of a team and in direct contact with a healthy or sick individual and/or community, to organise, dispense and evaluate the required comprehensive nursing care, on the basis of the knowledge, skills and competences which they have acquired. The trainee nurse shall learn not only how to work in a team, but also how to lead a team and organise overall nursing care, including health education for individuals and small groups, within the health institute or in the community. This training shall take place in hospitals and other health institutions and in the community, under the responsibility of nursing teachers, in cooperation with and assisted by other qualified nurses. Other qualified personnel may also take part in the teaching process. Trainee nurses shall participate in the activities of the department in question insofar as those activities are appropriate to their training, enabling them to learn to assume the responsibilities involved in nursing care.
Amendment 490 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22 – point d
Article 1 – paragraph 1 – point 22 – point d
Amendment 491 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22 – point d
Article 1 – paragraph 1 – point 22 – point d
Directive 2005/36/EC
Article 31 – paragraph 7 – point a
Article 31 – paragraph 7 – point a
(a) the adequacy of knowledge of the sciences of general nurcompetence to take full responsibility for planning, organising, as referred to in point (a) of paragraph 6, in line with scientific and technological progress as well as the necessary competences such knowledge should entail in line with scientific and technological progress and recent developments in educationnd administering nursing care when treating patients on the basis of the knowledge and skills acquired in accordance with paragraph 6 letters a, b and c;
Amendment 492 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22 – point d
Article 1 – paragraph 1 – point 22 – point d
Directive 2005/36/EC
Article 31 – paragraph 7 – point b
Article 31 – paragraph 7 – point b
(b) the degree of sufficiency of understanding of the items referred to in point (a) of paragraph 6 and the necessary competences following from such understanding in line with scientific and technological progress and recent developments in educationcompetence to work together effectively with other actors in the health sector, including participation in the practical training of health personnel on the basis of the knowledge and skills acquired in accordance with paragraph 6 letter d and e;
Amendment 493 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22 – point d
Article 1 – paragraph 1 – point 22 – point d
Directive 2005/36/EC
Article 31 – paragraph 7 – point c
Article 31 – paragraph 7 – point c
(c) the degree of sufficiency of knowledge about the items referred to in point (b) of paragraph 6 and the necessary competences following from such knowledge in line with scientific progress and recent developments in education;competence to empower individuals, families and groups towards healthy lifestyles and self-care on the basis of the knowledge and skills acquired in accordance with paragraph 6 letters a and b.
Amendment 496 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 23 – point a a (new)
Article 1 – paragraph 1 – point 23 – point a a (new)
Directive 2005/36/EC
Article 33 – paragraph 2
Article 33 – paragraph 2
(aa) the whole paragraph 2 of the art. 33 is deleted
Amendment 499 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 24 – point a
Article 1 – paragraph 1 – point 24 – point a
Directive 2005/36/EC
Article 34 – paragraph 2
Article 34 – paragraph 2
Basic dental training shall compriselast a total of at least five years and consist of at least 5000 hours of full-time theoretical and practical study, which may also be expressed as an additional criterion with the equivalent ECTS credits, comprising at least the programme described in Annex V, point 5.3.1 and given inat a university, in or at a higher institute providing training recogniszed as being of an equivalent level, or under the supervision of a university, covering at least the study programme referred to in Annex V, point 5.4.1.
Amendment 519 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 27 – point b
Article 1 – paragraph 1 – point 27 – point b
Directive 2005/36/EC
Article 40 – paragraph 2 – point a
Article 40 – paragraph 2 – point a
(a) completion of at least the 120 years of general school education or a certificate attesting success in an examination, of an equivalent level, for admission to a midwifery school for route I;. This provision shall be without prejudice to the right of Member States to set a longer period of general education as a criterion governing admission to training.
Amendment 524 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 28 (new)
Article 1 – paragraph 1 – point 28 (new)
Directive 2005/36/EC
Article 41 – paragraph 1 – subparagraph a – point i
Article 41 – paragraph 1 – subparagraph a – point i
(i) either made contingent upon possession of a diploma, certificate or other evidence of a qualification giving access to universities or higher education institutions, or otherwise guaranteeing an equivalent level of knowledge; or
Amendment 525 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 28 (new)
Article 1 – paragraph 1 – point 28 (new)
Directive 2005/36/EC
Article 41 – paragraph 1 – subparagraph a – point ii
Article 41 – paragraph 1 – subparagraph a – point ii
(ii) followed by two years of professional practice for which a certificate has been issued in accordance with paragraph 2;
Amendment 529 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 29 a (new)
Article 1 – paragraph 1 – point 29 a (new)
Directive 2005/36/EC
Article 43 – paragraph 3
Article 43 – paragraph 3
(29a) the whole paragraph 3 of Article 43 is deleted
Amendment 531 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 30 – point a
Article 1 – paragraph 1 – point 30 – point a
Directive 2005/36/EC
Article 44 – paragraph 2
Article 44 – paragraph 2
Evidence of formal qualifications as a pharmacist shall attest to training of at least five years' duration, which may also be expressed as an additional criterion with the equivalent ECTS credits, including at least:
Amendment 536 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 31 (new)
Article 1 – paragraph 1 – point 31 (new)
Directive 2005/36/EC
Article 45– paragraph 2 – point h a (new)
Article 45– paragraph 2 – point h a (new)
(ha) Medication management and provision of information and advice about medicinal products and general health information.
Amendment 570 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 35
Article 1 – paragraph 1 – point 35
Directive 2005/36/EC
Article 49 a – paragraph 2 – point c
Article 49 a – paragraph 2 – point c
(c) the common set of knowledge, skills and competences combines the knowledge, skills and competences defined in the systems of education and training applicable in at least one third of all Member States; . If the profession in question is already regulated in a Member State by means of a dual training system within the meaning of Article 3(1)(la), the common training framework shall provide for training under a dual system whilst maintaining current standards;
Amendment 572 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 35
Article 1 – paragraph 1 – point 35
Directive 2005/36/EC
Article 49 a – paragraph 2 – point d
Article 49 a – paragraph 2 – point d
(d) the knowledge, skills and competences for such common training framework shall refer to the levels of the European Qualifications Framework, as dequalifications specifined in Annex II of the Recommendation of the European Parliament and of the Council on the establishment of the European Qualifications Framework for lifelong learningrticle 11 of this Directive (*);
Amendment 575 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 35
Article 1 – paragraph 1 – point 35
Directive 2005/36/EC
Article 49 a – paragraph 2 – point e
Article 49 a – paragraph 2 – point e
(e) the profession concerned is neither covered by another common training framework nor regulated already under Chapter III of Title III; of Title III, Chapter III of Title III or Article 10, point b.
Amendment 580 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 35
Article 1 – paragraph 1 – point 35
Directive 2005/36/EC
Article 49 a – paragraph 2 – point g
Article 49 a – paragraph 2 – point g
(g) the common training framework permits nationals from any Member State to be eligible for acquiring the qualification under such framework without first being required to be a member of any professional organisation or to be registered with such organisation.
Amendment 582 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 35
Article 1 – paragraph 1 – point 35
Directive 2005/36/EC
Article 49 a – paragraph 3
Article 49 a – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 58a specifying the common set of knowledge, skills and competences as well as the qualifications on the common training framework. The degree of detail shall not exceed that of the minimum training requirements laid down in Chapter III of Title III.
Amendment 584 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 35
Article 1 – paragraph 1 – point 35
Directive 2005/36/EC
Article 49 a – paragraph 4
Article 49 a – paragraph 4
Amendment 585 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 35
Article 1 – paragraph 1 – point 35
Directive 2005/36/EC
Article 49 a – paragraph 5
Article 49 a – paragraph 5
5. A Member State may request a derogation from the application ofdeclare within six months following the entry into force of the delegated act referred to in paragraph 3 that the common training framework referred to in paragraph 3 is not applicable on its territory if it wereould otherwise be compelled to introduce a new regulated profession in its territory, if it werould be required to amend existing fundamental domestic principles relating to the structure of professions as regards training and the conditions of access to such professions or if the Member State does not wish to relate its national qualifications system to the qualifications set out in that common training framework. The Commission may adopt an implementing decision, in order to grant such derogation to the Member States concerned.
Amendment 586 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 35
Article 1 – paragraph 1 – point 35
Directive 2005/36/EC
Article 49 b
Article 49 b
Amendment 587 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 35
Article 1 – paragraph 1 – point 35
Directive 2005/36/EC
Article 49 b – title
Article 49 b – title
Amendment 588 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 35
Article 1 – paragraph 1 – point 35
Directive 2005/36/EC
Article 49 b – paragraph 1
Article 49 b – paragraph 1
Amendment 589 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 35
Article 1 – paragraph 1 – point 35
Directive 2005/36/EC
Article 49 b – paragraph 2
Article 49 b – paragraph 2
Amendment 592 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 35
Article 1 – paragraph 1 – point 35
Directive 2005/36/EC
Article 49 b – paragraph 3
Article 49 b – paragraph 3
Amendment 673 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 43
Article 1 – paragraph 1 – point 43
Directive 2005/36/EC
Article 57 – paragraph 1
Article 57 – paragraph 1
1. Member States shall ensure that the following information is available online and regularly updated through the competent authorities or points of single contact:
Amendment 678 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 43
Article 1 – paragraph 1 – point 43
Directive 2005/36/EC
Article 57 – paragraph 3
Article 57 – paragraph 3
3. Member States shall ensure that requests for information addressed to the points of single contact and the competent authorities arespond dealt with as quickly as possible to any request for information addressed to the point of single contact. To this end, they may also refer such request for information to the assistance centers mentioned in Article 57b and inform the citizen concerned.
Amendment 682 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 43
Article 1 – paragraph 1 – point 43
Directive 2005/36/EC
Article 57 – paragraph 4
Article 57 – paragraph 4
4. Member States and the Commission shall take accompanying measures in order to ensure that points of single contact make the information provided for in paragraph 1 is made available in other official languages of the Union. This shall not affect the legislation of Member States on the use of languages in their territory.
Amendment 685 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 44
Article 1 – paragraph 1 – point 44
Directive 2005/36/EC
Article 57 a – paragraph 1
Article 57 a – paragraph 1
1. Member States shall ensure that all requirements, procedures and formalities relating to matters covered by this Directive may be easily completed, at a distance and by electronic means, through the relevant point of single contact, if they fall within the scope of Directive 2005/36/EC.
Amendment 689 #
2011/0435(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 44
Article 1 – paragraph 1 – point 44
Directive 2005/36/EC
Article 57 a – paragraph 4
Article 57 a – paragraph 4
4. All relevant procedures shall be carried out in accordance with the provisions of Directive 2006/123/EC relating to the points of single contact. Any time limits for Member States to be complied with procedures or formalities set out in this Directive shall commence at the point when an application has been submitted by a citizen to a point of single contact.
Amendment 35 #
2011/0429(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3a) Measures to reduce emissions must accord with the ‘polluter pays’ principle. Emissions should therefore, if possible, already be prevented at the immediate source and not only after they have already entered surface water.
Amendment 36 #
2011/0429(COD)
Proposal for a directive
Recital 4
Recital 4
(4) The Commission has conducted a review of the list of priority substances according to Article 16(4) of Directive 2000/60/EC and to Article 8 of Directive 2008/105/EC and come to the conclusion that it is appropriate to amend the list of priority substances by identifying new substances for priority action at Union level, setting EQS for them, or removing existing substances from the list and updating according to scientific progress the EQS for some existing substances, and setting biota EQS for some existing and new priority substances.
Amendment 40 #
2011/0429(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Numerous Union acts have been adopted since the adoption of Directive 2000/60/EC, which constitute emission control measures in accordance with Article 16 of that Directive for individual priority substances. Moreover, many environmental protection measures fall under the scope of other existing Union legislation. Therefore, priority should be given to implementing and revising existing instruments rather than establishing new controls. The inclusion of a substance in Annex X to Directive 2000/60/EC is without prejudicemust not run counter to the application of the provisions of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC or permits issued on the basis thereof.
Amendment 42 #
2011/0429(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Numerous Union acts have been adopted since the adoption of Directive 2000/60/EC, which constitute emission control measures in accordance with Article 16 of that Directive for individual priority substances. Moreover, many environmental protection measures fall under the scope of other existing Union legislation. Therefore, priority should be given to implementing and revising existing instruments rather than establishing new controls. In order to adopt a coherent and coordinated legal instrument concerning priority hazardous substances, it is necessary to establish which measures pertain to what stage in the life cycle of a substance and to demonstrate that, taken collectively, the measures bring about a demonstrable improvement in the environment. The inclusion of a substance in Annex X to Directive 2000/60/EC is without prejudice to the application of the provisions of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.
Amendment 43 #
2011/0429(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Numerous Union acts have been adopted since the adoption of Directive 2000/60/EC, which constitute emission control measures in accordance with Article 16 of that Directive for individual priority substances. Moreover, many environmental protection measures fall under the scope of other existing Union legislation. Therefore, priority should be given to implementing and revising existing instruments rather than establishing new controls. It would be appropriate to take a consistent policy approach regarding pharmaceutical substances, taking into consideration the full societal and medical implications, in full consultation with all relevant stakeholders. To this end, the Commission will produce a report with possible legislative proposals on the environmental effects of pharmaceutical substances for human use in waters and soils, under Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use1 and Regulation (EU) No. 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products2. The inclusion of a substance in Annex X to Directive 2000/60/EC is without prejudice to the application of the provisions of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. _______________ 1 OJ L 348, 31.12.2010, p. 74 2 OJ L 348, 31.12.2010, p. 1
Amendment 58 #
2011/0429(COD)
Proposal for a directive
Recital 12
Recital 12
(12) Persistent, bioaccumulative and toxic substances (PBTs) and other substances that behave like PBTpriority hazardous substances may be found for decades in the aquatic environment at levels posing a significant risk, even ifalthough extensive measures to reduce or eliminate emissions have already been taken, particularly at European level. Some are also capable of long-range transport and are largely ubiquitous in the environment. Several such substances are among the existing and proposed priority hazardous substances and, because of their long-term ubiquity, some of them need special consideration as regards their impact on the presentation. Only in rare cases can these substances be reduced effectively by means of measures at local or regional level. For these substances, international efforts are needed in order to reduce them on a global scale. These substances need special consideration with reference to their long-term impact on the environment, their observation, their influence ofn chemical status under Directive 2000/60/EC and as regards monitoring requirements.
Amendment 92 #
2011/0429(COD)
Proposal for a directive
Article 2 – point 4
Article 2 – point 4
Directive 2008/105/EC
Article 8
Article 8
The Commission shall report to the European Parliament and to the Council the outcome of the regular review of Annex X to Directive 2000/60/EC provided for in Article 16(4) of that Directive. It shall accompany the report, if appropriate, with relevant proposals, in particular proposals to identify new priority substances or priority hazardous substances or to identify certain priority substances as priority hazardous substances and to set corresponding EQS for surface water, sediment or biota, as appropriate. Regular reviews should allow for the possibility, on the basis of scientific data, to adjust quality standards applicable to listed substances or to remove them from the list. If the review shows that a substance listed as a priority substance in Annex X to Directive 2000/60/EC does not present a significant risk to the aquatic environment pursuant to Article 16(2), the Commission should propose that the substance be deleted from Annex X.
Amendment 102 #
2011/0429(COD)
Proposal for a directive
Article 2 – point 5
Article 2 – point 5
Directive 2008/105/EC
Article 8 a – paragraph 1 – point a
Article 8 a – paragraph 1 – point a
(a) prepare additional maps in the distance-to-target presentation which present the chemical status information separately from that for the rest of the substances in the river basin management plans produced in accordance with Article 13 of Directive 2000/60/EC, without prejudice to the requirements of Section 1.4.3 of Annex V to that Directive regarding the presentation of the overall chemical status, and/or
Amendment 114 #
2011/0429(COD)
Proposal for a directive
Article 2 – point 6
Article 2 – point 6
Directive 2008/105/EC
Article 8 b – paragraph 1 – subparagraph 2
Article 8 b – paragraph 1 – subparagraph 2
The watch list shall contain no more than 25 substances or groups of substances at any given time and shall indicate the monitoring matrix for each substance. The substances shall be selected from among those for which the available information indicates that they may pose a significant risk at Union level to or via the aquatic environment and for which high- quality monitoring data and data concerning ecotoxicological effects are required for the risk assessment. In selecting the substances for the watch list the Commission shall take into account all available scientific information including research projects, Member States' characterisation and monitoring programmes under Articles 5 and 8 of Directive 2000/60/EC and information on production volumes, use patterns, concentrations in the environment and effects, including that gathered in accordance with Directives 98/8/EC, 2001/82/EC and 2001/83/EC of the European Parliament and of the Council, and with Regulation (EC) No 1907/2006 and Regulation (EC) No 1107/2009 of the European Parliament and of the Council.
Amendment 130 #
2011/0429(COD)
Proposal for a directive
Article 2 – point 6
Article 2 – point 6
Directive 2008/105/EC
Article 8 b – paragraph 3
Article 8 b – paragraph 3
3. The Commission shall draw up the first watch list as referred to in paragraph 1 by […]. and shall define a scientifically based, technical and transparent procedure for including substances in it or removing them. A given substance may only be included in the watch list for a limited period on the basis of scientifically grounded data.
Amendment 170 #
2011/0429(COD)
Proposal for a directive
Annex I – table – row 36
Annex I – table – row 36
Directive 2000/60/EC
Annex X – table – row 36
Annex X – table – row 36
(36) 124495-18-7 not applicable Quinoxyfen X
Amendment 171 #
2011/0429(COD)
Proposal for a directive
Annex I – table – row 46
Annex I – table – row 46
Directive 2000/60/EC
Annex X – table – row 46
Annex X – table – row 46
Amendment 178 #
2011/0429(COD)
Proposal for a directive
Annex I – table – row 47
Annex I – table – row 47
Directive 2000/60/EC
Annex X – table – row 47
Annex X – table – row 47
Amendment 185 #
2011/0429(COD)
Proposal for a directive
Annex I – table – row 48
Annex I – table – row 48
Directive 2000/60/EC
Annex X – table – row 48
Annex X – table – row 48
Amendment 204 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 23
Annex II – table – row 23
Directive 2008/105/EC
Annex I – table – row 23
Annex I – table – row 23
(23) Nickel and its 7440-02-0 41320 8,6 3420 not 34 not compounds applicable applicable
Amendment 205 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 46
Annex II – table – row 46
Directive 2008/105/EC
Annex I – table – row 46
Annex I – table – row 46
Amendment 210 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 47
Annex II – table – row 47
Amendment 215 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 48
Annex II – table – row 48
Directive 2008/105/EC
Annex I – table – row 48
Annex I – table – row 48
Amendment 273 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 35
Annex II – table – row 35
Directive 2008/105/EC
Annex I – table – row 35
Annex I – table – row 35
(35) Perfluorooctane 1763-23-1 62,5 10-42 1,32,5 10-42 36 7,2 9,1 sulfonic acid and its derivatives (PFOS)
Amendment 33 #
2011/0421(COD)
Proposal for a decision
Recital 1
Recital 1
(1) Article 168 of the Treaty on the Functioning of the European Union states, inter alia, that the Union's action in the field of public health should covermplement the work of the Member States with regard to monitoring, early warning of and combating serious cross-border threats to health, and that a high level of human health protection is to be ensured, inter alia, in the definition and implementation of all Union policies and activities. According to the same provision, Member States must, in liaison with the Commission, coordinate among themselves their policies and programmes in the areas covered by the Union action in the field of public health.
Amendment 35 #
2011/0421(COD)
Proposal for a decision
Recital 3
Recital 3
(3) Apart from communicable diseases, a number of other sources of danger to health, notably related to other biological agents, chemical agents or environmental events, which include hazards related to climate change, may, by reason of their scale or severity, endanger the health of citizens in the entire Union, lead to the malfunctioning of critical sectors of society and economy and jeopardise individual Member State's capacity to react. Therefore, the legal framework set up under Decision No 2119/98/EC should be extended to cover these other threats and provide for a coordinated wider approach to health security at Union level. However, existing Union instruments concerned with early warning, monitoring and coordination must continue to be assigned priority where serious cross-border threats to health arise.
Amendment 36 #
2011/0421(COD)
Proposal for a decision
Recital 5
Recital 5
(5) Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for Disease Prevention and Control (ECDC) provides the ECDC with a mandate covering surveillance, detection and risk assessment of threats to human health from communicable diseases and outbreaks of unknown origin, until their origin is known. The ECDC has progressively taken over the epidemiological surveillance of communicable diseases and the operation of the Early Warning and Response System from the Community network set up under Decision No 2119/98/EC. This development is not reflected in Decision No 2119/98/EC, which was adopted before the creation of the ECDC.
Amendment 39 #
2011/0421(COD)
Proposal for a decision
Recital 11
Recital 11
Amendment 41 #
2011/0421(COD)
Proposal for a decision
Recital 12
Recital 12
(12) A system enabling the notification at the Union level of alerts related to serious cross-border threats to health should be put in place in order to ensure that competent public health authorities in Member States and the Commission are duly and timely informed. Therefore, an Early Warning and Information System should be established, bringing together the various information about serious cross-border health threats of a biological, chemical or environmental nature. This Early Warning and Information System should be integrated into the Early Warning and Response System (EWRS), established under Decision No 2119/98/EC for communicable diseases, should be extended relating to all the serious cross-border threats to health covered by the present Decision. The notification of an alert should be required only where the scale and severity of the threat concerned are or may become so significant that the coordination of the response at the Union level is necessary. The responsibility and scope of the existing instruments should be preserved.
Amendment 43 #
2011/0421(COD)
Proposal for a decision
Recital 13
Recital 13
(13) In order to ensure that the assessment of risks to public health at the Union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective, the available scientific expertise should be mobilised in a coordinated manner, through appropriate channels or structures depending on the type of threat concerned. This risk assessment should be based on robust scientific evidence and independent expertise and provided by the Agencies of the Union in accordance with their missions, or otherwise by expert groups set up by the Commission and the Member States.
Amendment 44 #
2011/0421(COD)
Proposal for a decision
Recital 14
Recital 14
(14) Effectively responding to serious cross-border threats to health at national level requires a consistent approach among Member States, in conjunction with the Commission, necessitating exchange of information, consultation and coordination of actions. Under Decision No 2119/98/EC, the Member States, in cooperation with the Commission, already coordinate the response at the Union level in collaboration with Member States with regard to communicable diseases. A similar mechanism should apply to all serious cross-border threats to health independently of their origin. It should also be recalled that, independently from this Decision, a Member State may, in case of a major emergency, request assistance under Council Decision of 8 November 2007 establishing a Community Civil Protection Mechanism (2007/779/EC, Euratom).
Amendment 46 #
2011/0421(COD)
Proposal for a decision
Recital 19
Recital 19
(19) Since the objectives of this Decision cannot be sufficiently achieved by the Member States alone due to the cross- border dimension of those threats and can, therefore, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union, to support the Member States. In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary in order to achieve those objectives.
Amendment 47 #
2011/0421(COD)
Proposal for a decision
Recital 20
Recital 20
Amendment 48 #
2011/0421(COD)
Proposal for a decision
Recital 21
Recital 21
(21) In order to ensure uniform conditions for the implementation of this Decision, implementing powers should be conferred on the Commission to adopt implementing acts in relation to: the procedures for the coordination, the exchange of information and the mutual consultation on preparedness and response planning; the adoption of a list of communicable diseases subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the setting up and termination of ad hoc monitoring networks and the procedures for the operation of such networks; the adoption of case definitions for serious cross-border threats to health; the procedures for the operation of the Early Warning and Response System; the procedures for the coordination of the responses of the Member StatInformation System; risk assessment procedures; the recognition of situations of emergency at Union level or of pre-pandemic situations with respect to human influenza at Union level. Those implementing powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers.
Amendment 50 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 1 – introductory part
Article 2 – paragraph 1 – introductory part
1. This Decision shall apply in case of serious cross-border threats to public health falling within the following categories:
Amendment 52 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 1 – point a – point ii
Article 2 – paragraph 1 – point a – point ii
(ii) antimicrobial resistance and healthcare- associated infections related to communicable diseases affecting human beings (hereinafter referred to as " the related special health issues") ;
Amendment 53 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
(b) acute threats of chemical origin with the exception of threats arising from ionizing radiation;
Amendment 55 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 1 – point c
Article 2 – paragraph 1 – point c
(c) acute threats of environmental origin, including threats deriving from the effects of climate change;
Amendment 56 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
(d) acute threats of unknown origin, until their origin is known and they fall into one of the categories described in points (a) to (c);
Amendment 57 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 2
Article 2 – paragraph 2
Amendment 59 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 3
Article 2 – paragraph 3
Amendment 60 #
2011/0421(COD)
Proposal for a decision
Article 2 a (new)
Article 2 a (new)
Article 2a It is essential that the scope of the decision should be clearly limited in order to avoid duplication of effort with other Union instruments.
Amendment 61 #
2011/0421(COD)
Proposal for a decision
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘case definition’ means a set of commonly agreed diagnostic criteria that must be fulfilled in order to accurately detect cases of a targetn identified serious cross- border threat to health in a given population, while excluding the detection of other similar threats;
Amendment 63 #
2011/0421(COD)
Proposal for a decision
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
The Commission, in cooperation with the Member States, should arrange for the coordination and exchange of information and the instruments created by this decision. It is the Commission’s task to prevent duplication of effort in the system: existing and new instruments should complement one another.
Amendment 64 #
2011/0421(COD)
Proposal for a decision
Article 3 a (new)
Article 3 a (new)
Article 3a Relationship with existing provisions of EU law 1. The provisions of this decision should not come into conflict with other existing EU instruments in the field of monitoring, early warning, coordination of preparations and contingency planning for serious cross-border threats to health. In this connection, existing instruments establishing standards and indicators for the quality and security of specific goods and indicators should be taken into account. Existing EU laws should therefore remain in force: a. Directive 2001/83/EC, b. Directive 2001/20/EC, c. Directive 2003/94/EC, d. Directive 2004/23/EC, e. Regulation 726/2004/EC, f. Regulation 1394/2007/EC, g. Regulation 540/95/EC, h. Regulation 178/2002/EC, i. Regulation 882/2004/EC j. Council Directive 96/82/EC.
Amendment 65 #
2011/0421(COD)
Proposal for a decision
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) the consistent implementordination of core capacity requirements for surveillance and response as referred to in Articles 5 and 13 of the International Health Regulations (2005).
Amendment 67 #
2011/0421(COD)
Proposal for a decision
Article 4 – paragraph 1 – point b a (new)
Article 4 – paragraph 1 – point b a (new)
(ba) the communication of ‘best practice’ plans.
Amendment 68 #
2011/0421(COD)
Proposal for a decision
Article 4 – paragraph 2 – point i
Article 4 – paragraph 2 – point i
(i) minimum core capacity standards determined at national level for the health sector; these shall also relate to preparations in the field of psychosocial emergency care;
Amendment 71 #
2011/0421(COD)
Proposal for a decision
Article 4 – paragraph 4
Article 4 – paragraph 4
Amendment 73 #
2011/0421(COD)
Proposal for a decision
Article 4 – paragraph 5 – subparagraph 1
Article 4 – paragraph 5 – subparagraph 1
Amendment 75 #
2011/0421(COD)
Proposal for a decision
Article 7 – paragraph 1
Article 7 – paragraph 1
Amendment 76 #
2011/0421(COD)
Proposal for a decision
Article 7 – paragraph 2
Article 7 – paragraph 2
Amendment 77 #
2011/0421(COD)
Proposal for a decision
Article 7 – paragraph 3
Article 7 – paragraph 3
Amendment 78 #
2011/0421(COD)
Proposal for a decision
Article 8 – title
Article 8 – title
Establishment of an early warning and responseinformation system
Amendment 79 #
2011/0421(COD)
Proposal for a decision
Article 8 – paragraph 1
Article 8 – paragraph 1
1. A rapid alert system for notifying at the Union level alerts in relation to serious cross-border threats to health, ‘Early Warning and ResponseInformation System’, is hereby established. This system shall bring into permanent communication the Commission and the competent authorities responsible at national level for alerting, assessing public health risks and determining the measures that may be required to protect public health.
Amendment 81 #
2011/0421(COD)
Proposal for a decision
Article 8 – paragraph 2
Article 8 – paragraph 2
The Commission shall, by means of implementing acts, adopt procedures concerning the information exchange in order to ensure the proper functioning of the Early Warning and ResponseInformation System and the uniform implementation of Articles 8 and 9. In order to be able to cover all kinds of serious cross-border threats to health, the information referred to in Article 3 must also be supplied.
Amendment 82 #
2011/0421(COD)
Proposal for a decision
Article 8 a (new)
Article 8 a (new)
Article 8a The Early Warning and Information System should be placed under the authority of the European Centre for Disease Prevention and Control.
Amendment 83 #
2011/0421(COD)
Proposal for a decision
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. National competent authorities or the Commission shall notify an alert in the Early Warning and ResponseInformation System where the emergence or development of a serious cross-border threat to health fulfils the following conditions:
Amendment 84 #
2011/0421(COD)
Proposal for a decision
Article 9 – paragraph 3 – point h
Article 9 – paragraph 3 – point h
Amendment 85 #
2011/0421(COD)
Proposal for a decision
Article 9 – paragraph 4
Article 9 – paragraph 4
4. The Commission shall make available to the national competent authorities through the Early Warning and ResponseInformation System any information that may be useful for coordinating the response at the Union level, including information on hazards and public health measures related to serious cross-border threats to health transmitted through other Union alert systems.
Amendment 86 #
2011/0421(COD)
Proposal for a decision
Article 10 – paragraph 2 – point c
Article 10 – paragraph 2 – point c
Amendment 88 #
2011/0421(COD)
Proposal for a decision
Article 10 – paragraph 2 – point c a (new)
Article 10 – paragraph 2 – point c a (new)
(ca) where an alert is notified pursuant to Article 9, the Commission shall, if it is necessary for the coordination of the response at Union level, make promptly available to the national competent authorities through the Early Warning and Information System and to the Health Security Committee referred to respectively in Articles 8 and 19 an assessment of the risks to public health;
Amendment 89 #
2011/0421(COD)
Proposal for a decision
Article 10 – paragraph 2 – point c b (new)
Article 10 – paragraph 2 – point c b (new)
(cb) where a sudden man-made disaster occurs, on the opinion of the Monitoring and Information Centre, and/or
Amendment 90 #
2011/0421(COD)
Proposal for a decision
Article 10 – paragraph 2 – point c c (new)
Article 10 – paragraph 2 – point c c (new)
(cc) information supplied by the Scientific Committee on Consumer Products, the Scientific Committee on Health and Environmental Risk or the Scientific Committee on Emerging and Newly Identified Health Risks.
Amendment 92 #
2011/0421(COD)
Proposal for a decision
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Where a Member State intends to adopt public health measures to combat a serious cross-border threat to health, it shall, before adopting those measures, consultinform the other Member States and the Commission, via the Early Warning and Information System, on the nature, purpose and scope of the measures, unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary, or this is required on grounds of national security.
Amendment 94 #
2011/0421(COD)
Proposal for a decision
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States and the Commission, via the Early Warning and Information System, on the nature, purpose and scope of those measures.
Amendment 96 #
2011/0421(COD)
Proposal for a decision
Article 11 – paragraph 5
Article 11 – paragraph 5
Amendment 98 #
2011/0421(COD)
Proposal for a decision
Article 12
Article 12
Amendment 106 #
2011/0421(COD)
Proposal for a decision
Article 16
Article 16
Amendment 108 #
2011/0421(COD)
Proposal for a decision
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
Amendment 111 #
2011/0421(COD)
Proposal for a decision
Article 19 – paragraph 2 – point a
Article 19 – paragraph 2 – point a
(a) support the exchange of information between the Member States and the Commission on the experience acquired with regard to the implementation of this Decision;
Amendment 112 #
2011/0421(COD)
Proposal for a decision
Article 19 – paragraph 2 – point b
Article 19 – paragraph 2 – point b
(b) assist the Commission in providing for the coordination ofe the preparedness and response planning efforts of the Member States in accordance with Article 4;
Amendment 113 #
2011/0421(COD)
Proposal for a decision
Article 19 – paragraph 2 – point c
Article 19 – paragraph 2 – point c
(c) assist the Commission in providing for the coordination ofe the responses of the Member States to serious cross-border threats to health, in accordance with Article 11.
Amendment 114 #
2011/0421(COD)
Proposal for a decision
Article 19 – paragraph 2 – point c a (new)
Article 19 – paragraph 2 – point c a (new)
(ca) advise the Health Ministers and the Commission on the preparation and coordination of contingency plans.
Amendment 116 #
2011/0421(COD)
Proposal for a decision
Article 21
Article 21
Amendment 119 #
2011/0421(COD)
Proposal for a decision
Article 22
Article 22
Amendment 17 #
2011/0409(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) Of the roughly 500 million EU citizens, some 300 million have a driving licence. The European Union accounts for 22 % of all vehicle registrations and 25 % of vehicle production worldwide. Every year, the European automobile industry manufactures up to 17 million new vehicles, and that figure is currently on the increase.
Amendment 18 #
2011/0409(COD)
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Technical measures to reduce the sound level of motor vehicles have to meet a set of competing requirements, such as those of reducing noise and pollutant emissions and improving safety whilst keeping the vehicle in question as cheap and effective as possible. In attempting to meet all these requirements equally and strike a balance between them, the automobile industry all too often runs up against the limits of what is currently physically feasible. Automobile designers have repeatedly managed to push those limits back by using new, innovative materials and methods. Legislation must set a clear framework for innovation in a realistic time frame. This Regulation establishes just such a framework and thus provides an immediate incentive for innovation in keeping with the needs of society, whilst in no way restricting the economic freedom so vital to the industry.
Amendment 19 #
2011/0409(COD)
Proposal for a regulation
Recital 8 b (new)
Recital 8 b (new)
(8b) Noise pollution is primarily a local problem, but one which calls for a Union- wide solution. After all, the first step in any sustainable noise emissions policy must be to devise measures to reduce sound levels at source. The noise source motor vehicle, which is the target of this Regulation, is by definition a mobile one, so that purely national measures would not be sufficient.
Amendment 20 #
2011/0409(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) When cars are driven at average speeds below 45 km/h the loudest noises are those generated by the engine and exhaust, and when they are driven at higher speeds tyre and wind noise are the loudest. These noises are generated regardless of engine type and power. Developments in vehicle design since the 1970s have made engines much quieter, but on average more powerful and heavier. Heavier engines and more elaborate safety features have served to increase the overall weight of vehicles, creating a need to increase the area of tyre which comes into contact with the road surface, in order to improve vehicle stability. Every increase in the width of that contact area leads to an increase in tyre noise.
Amendment 21 #
2011/0409(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) Addressing the problem of noise at source, the aim of this Regulation, offers less potential for noise reduction than measures to change the composition of road surfaces, which is what vehicle tyres come into contact with. The latter form of noise reduction would be technically much more straightforward. Existing types of asphalt, such as whisper asphalt, asphalts with noise-reducing properties or noise-optimised asphalt, employed as part of a holistic approach combining a series of simple construction measures, can already be used to reduce noise levels by 10db on a local basis. The Regulation does not employ this effective approach to the problem of local sources of noise, since it would impose a severe burden on public budgets, in particular those of local authorities. This would be difficult to justify at a time of fiscal crisis and would also encroach on regional and structural policy.
Amendment 25 #
2011/0409(COD)
Proposal for a regulation
Annex III
Annex III
Amendment 27 #
2011/0409(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) EU type-approval rules already exist in relation to CO2 emissions (Regulation (EC) No 443/2009 of the European Parliament and of the Council of 23 April 2009 setting emission performance standards for new passenger cars as part of the Community's integrated approach to reduce CO2 emissions from light-duty vehicles1 and Regulation (EU) No 510/2011 of the European Parliament and of the Council of 11 May 2011 setting emission performance standards for new light commercial vehicles as part of the Union's integrated approach to reduce CO2 emissions from light-duty vehicles2) and in relation to emissions of pollutants (Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information3 and Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009 on type- approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information4). The technical requirements relating to limit values for emissions of CO2 and pollutants must not conflict with the rules on reducing noise emissions. EU type-approval rules should therefore strike a balance among the various objectives. _____________ OJ L 140, 5.6.2009, p. 1. OJ L 145, 31.5.2011, p. 1. OJ L 171, 29.6.2007, p. 1. OJ L 188, 18.7.2009, p. 1.
Amendment 35 #
2011/0409(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) The provision of information on noise emissions to consumers, fleet managers and public authorities may influence purchasing decisions and accelerate the transition to a quieter vehicle fleet. In order to provide the necessary information to the customer, the manufacturer should provide information on noise levels of vehicles in accordance with harmonised testing methods at the point of sale and in technical promotional material. A label, comparable to the labels used for information on CO2 emissions, fuel- consumption and tyre-noise, should inform consumers of the noise emissions of a vehicle.
Amendment 81 #
2011/0409(COD)
Proposal for a regulation
Article 8 a (new)
Article 8 a (new)
Article 8 a Information Vehicle manufacturers and distributors shall ensure that the noise level in decibels (dB(A)) in accordance with harmonised type-approval testing methods for each vehicle is displayed in a prominent position at the point of sale and in technical promotional material. Following a comprehensive impact assessment, the Commission shall, in accordance with the ordinary legislative procedure, submit to the European Parliament and the Council a proposal on consumer information. Such a proposal may be integrated into Directive 1999/94/EC of the European Parliament and of the Council of 13 December 1999 relating to the availability of consumer information on fuel economy and CO2 emissions in respect of the marketing of new passenger cars1. For noise emissions the same display method shall be used as for CO2/emissions. _______________ 1 OJ L 12, 18.1.2000, p. 16.
Amendment 115 #
2011/0409(COD)
Proposal for a regulation
Annex II – Number 4.1.2.1.4.1. – paragraph 1 – points a - c
Annex II – Number 4.1.2.1.4.1. – paragraph 1 – points a - c
(a) If one specific gear ratio gives an acceleration in a tolerance band of 5 % of the reference acceleration awot ref, not exceeding 32,0 m/s2, test with that gear ratio. (b) If none of the gear ratios give the required acceleration, then choose a gear ratio i, with an acceleration higher and a gear ratio i + 1, with an acceleration lower than the reference acceleration. If the acceleration value in gear ratio i does not exceed 32,0 m/s2, use both gear ratios for the test. The weighting ratio in relation to the reference acceleration awot ref is calculated by: k = (awot ref – awot (i+1)) / (awot (i) – awot (i+1)) (c) if the acceleration value of gear ratio i exceeds 3.2,0 m/s2, the first gear ratio shall be used that gives an acceleration below 3.2,0 m/s2 unless gear ratio i + 1 provides acceleration less than aurban. In this case, two gears, i and i + 1 shall be used, including the gear i with acceleration exceeding 32.0 m/s2. The achieved acceleration is then used for the calculation of the part power factor kP instead of awot ref.
Amendment 124 #
2011/0409(COD)
Proposal for a regulation
Annex III
Annex III
Amendment 31 #
2011/0351(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
(5) ‘electromagnetic disturbance’ means any electromagnetic phenomenon which may degrade the performance of equipment, including,. Electromagnetic disturbance can be electromagnetic noise, an unwanted signal or a change in the propagation medium itself;
Amendment 339 #
Amendment 385 #
2011/0284(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
Where the parties have validly agreed to use the Common European Sales Law for a contract, only the Common European Sales Law shall govern the matters addressed in its rules. Provided that the contract was actually concludedWhere the trader offers goods, digital contents or related services with the option of agreeing on the application of the Common European Sales Law, the Common European Sales Law shall also govern the compliance with and remedies for failure to comply with the pre- contractual information duties.
Amendment 459 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 104
Annex 1 – Article 104
Amendment 463 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 106 – paragraph 2
Annex 1 – Article 106 – paragraph 2
2. If the buyer is a trader:, the buyer’s right to rely on lack of conformity shall be subject to the requirements of examination and notification set out in Section 7 of this Chapter.
Amendment 464 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 106 – paragraph 3
Annex 1 – Article 106 – paragraph 3
Amendment 469 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 109
Annex 1 – Article 109
Cure by the seller 1. A seller who has tendered performance early and who has been notified that the performance is not in conformity with the contract may make a new and conforming tender if that can be done within the time allowed for performance. 2. In cases not covered by paragraph 1 a seller who has tendered arendered performance which is not in conformity with the contract may, without undue delay on being notified of the lack of non-conformity, offer to cure it at its own expense. 3. An offer to cure is not precluded by notice of terminationsubsequent performance at its own expense, pursuant to Article 111. 42. The buypurchaser may refuse an offer to curof subsequent performance only if: (a) cursubsequent performance cannot be effected promptly and without significant inconvenience to the buyer;, (b) the buyer has reason to believe that the seller’s future performance cannot be relied on; or (c) delay in performance would amount to a fundamental non-performance. 53. TIf paragraph 2 does not apply, the seller shas a reasonable period of time to effect curell effect subsequent performance within a reasonable period, which, in the case of consumer sales contracts, shall not exceed 30 days. If the buyer stipulates a reasonable period for the seller it shall be binding. 64. The buyer may withhold performance pending cure, but the rights of the buyer which are inconsistent with allowing the seller a period of time to effect cure aruntil subsequent performance has been effected. In so far as they are not compatible with the possibility of subsequent performance, the buyer’s other rights shall be suspended until thate period provided for in paragraph 3 has expired. 75. Notwithstanding cursubsequent performance, the buyer retains the right to claim damages for delay as well as for any harm caused or not prevented by the cursubsequent performance.
Amendment 470 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 110 – paragraph 3 a (new)
Annex 1 – Article 110 – paragraph 3 a (new)
3a. If, in the event of non-conformity, and although requested to do so by the consumer, the trader does not effect remedy, but instead urges the consumer to seek remedy on the basis of a commercial warranty, the trader must allow the actions taken and statements made by the consumer and the warrantor concerning the commercial warranty to be asserted against him in respect of his commitments.
Amendment 471 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 110 – paragraph 3 b (new)
Annex 1 – Article 110 – paragraph 3 b (new)
3b. If the consumer seeks remedy from the trader, until such time as remedy has been completed and the consumer has reacquired physical possession or control in accordance with Article 142, the trader shall bear the full risk of destruction of or damage to the goods. The first sentence shall apply from the time when the consumer, after notifying the trader that he or she is seeking remedy, hands over the article to the trader or, if transport is required, to the first carrier.
Amendment 474 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 111 – paragraph 1
Annex 1 – Article 111 – paragraph 1
1. Where, inIf a consumer sales contract, the trader is required to remedy a lack of conformity pursuant to Article 110(2)can require or if the seller offers subsequent performance, the consumer may choose between repair and replacement unless the option chosen would be unlawful or impossible or, compared to the other option available, would impose costs on the seller that would be disproportionate taking into account:
Amendment 478 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 111 – paragraph 2
Annex 1 – Article 111 – paragraph 2
Amendment 482 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 117 – paragraph 2
Annex 1 – Article 117 – paragraph 2
2. Paragraph 1 does not apply: where no performance at all has been rendered.
Amendment 483 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 119 – paragraph 2 – point a
Annex 1 – Article 119 – paragraph 2 – point a
Amendment 484 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 119 – paragraph 2 – point b
Annex 1 – Article 119 – paragraph 2 – point b
Amendment 504 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 179 – paragraph 2 a (new)
Annex 1 – Article 179 – paragraph 2 a (new)
2a. Prescription shall apply as from the end of the short period.
Amendment 505 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 184 – paragraph 1 and paragraph 2
Annex 1 – Article 184 – paragraph 1 and paragraph 2
1. If the debtor acknowledges the right vis- à- vis the creditor, by part payment, payment of interest, giving of security, set- off or in any other manner, a new short period of prescription begins to run. 2. The same shall apply if the seller has made an attempt at subsequent performance.
Amendment 506 #
2011/0284(COD)
Proposal for a regulation
Annex 1 – Article 186 a (new)
Annex 1 – Article 186 a (new)
Part IX. Other provisions Conciliation If duly requested to do so by the consumer, the trader shall be required to participate in an out-of-court contract dispute resolution procedure within the meaning of the Directive of the European Parliament and of the Council on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC.
Amendment 1098 #
2011/0281(COD)
Proposal for a regulation
Article 39 a (new)
Article 39 a (new)
Amendment 1103 #
2011/0281(COD)
Proposal for a regulation
Article 40 – point c a (new)
Article 40 – point c a (new)
(ca) support programme for wine growing on steep-slope sites pursuant to Article 44a;
Amendment 1133 #
2011/0281(COD)
Proposal for a regulation
Article 44 a (new)
Article 44 a (new)
Article 44a Support programme for wine growing on steep-slope sites The measures taken as part of the support programme for wine growing on steep- slope sites shall be designed to safeguard wine growing on labour-intensive slope, steep-slope and terrace sites in the long term by improving its competitiveness. The support may take the form of a flat- rate per-hectare payment to be set by the Member State concerned or a modulated payment determined by the steepness of the site.
Amendment 1239 #
2011/0281(COD)
Proposal for a regulation
Article 58 – paragraph 1
Article 58 – paragraph 1
1. Marketing standards may apply to the following sectors or products: (a) olive oil and table olives in respect of the products referred to in point (a) of Part VII of Annex I; (b) fruit and vegetables; (c) processed fruit and vegetables; (d) bananas; (e) live plants; (f) spreadable fats; (g) milk and milk products intended for human consumption; (h) poultrymeat. The wine sector shall be excluded. The products for which marketing standards by sectors or products have been laid down may be marketed in the Union only in accordance with such standards.
Amendment 1243 #
2011/0281(COD)
Proposal for a regulation
Article 59 – paragraph 2 – introductory part
Article 59 – paragraph 2 – introductory part
2. The marketing standards referred to in paragraph 1 may cover: relate where appropriate to the requirements for: (a) as regards the fruit and vegetables sector: (i) classification criteria such as grading into classes, weight, sizing, age and category; (ii) the presentation, sales descriptions, labelling linked to obligatory marketing standards, packaging, rules to be applied in relation to packing centres, marking, wrapping, year of harvesting and use of specific terms; (iii) criteria such as appearance, consistency, conformation, product characteristics; (b) as regards the banana sector: (i) classification criteria such as grading into classes, weight, sizing, age and category; (ii) the presentation, sales descriptions, labelling linked to obligatory marketing standards, packaging, rules to be applied in relation to packing centres, marking, wrapping, year of harvesting and use of specific terms; (iii) criteria such as appearance, consistency, conformation, product characteristics; (c) as regards the eggs and poultrymeat sector: (i) classification criteria such as grading into classes, weight, sizing, age and category; (ii) the presentation, sales descriptions, labelling linked to obligatory marketing standards, packaging, rules to be applied in relation to packing centres, marking, wrapping, year of harvesting and use of specific terms; (iii) criteria such as appearance, consistency, conformation, product characteristics; (iv) the conservation method and temperature; (v) as regards the poultrymeat sector, the water content as a percentage; (d) as regards the egg sector: (i) the frequency of collection, delivery, preservation and handling; (ii) the type of farming and production method and related administrative rules, and operating circuit; (iii) restrictions as regards the use of certain substances and/or practices; (iv) storage, transport; (v) time limits. (e) as regards the olive oil and table olives sector: (i) the presentation, sales descriptions, labelling linked to obligatory marketing standards, packaging, rules to be applied in relation to packing centres, marking, wrapping, year of harvesting and use of specific terms; (ii) criteria such as appearance, consistency, conformation, product characteristics; (iii) specific substances used in production, or components or constituents, including their quantitative content, purity and identification. 3. The marketing standards by sectors or products adopted pursuant to paragraph 1 shall be established without prejudice to Title IV of Regulation (EU) No [COM(2010)733] on agricultural product quality schemes, and shall take into account: (a) the specificities of the product concerned; (b) the need to ensure the conditions for a smooth placing of the products on the market; (c) the interest of consumers to receive adequate and transparent product information; (d) the standard recommendations adopted by international bodies.
Amendment 1270 #
2011/0281(COD)
Proposal for a regulation
Article 59 – paragraph 3 – point c
Article 59 – paragraph 3 – point c
(c) the interest of consumers to receive adequate and transparent product information, including the place of farming to be determined on a case by case approach at the appropriate geographical level;
Amendment 1271 #
2011/0281(COD)
Proposal for a regulation
Article 59 – paragraph 3 – point d
Article 59 – paragraph 3 – point d
Amendment 1295 #
2011/0281(COD)
Proposal for a regulation
Article 60 – paragraph 3
Article 60 – paragraph 3
Amendment 1307 #
2011/0281(COD)
Proposal for a regulation
Article 62 – paragraph 3 – subparagraph 1
Article 62 – paragraph 3 – subparagraph 1
The Commission shall, where necessary, adopt methods referred to in point (d) of Article 59(3) for products listed in Part II of Annex VI by means of implementing actsmethods of analysis for determining the composition of the products of the wine sector and the rules whereby it may be established whether these products have undergone processes contrary to authorised oenological practices shall be adopted pursuant to Article 43(2) of the Treaty. Those methods and rules shall be based on anythe relevant methods recommended and published byations of the OIV, unless they would be ineffective or inappropriate in view of the legitimate objective pursued. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 162(2) by the Union.
Amendment 1315 #
2011/0281(COD)
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. Save as otherwise provided for in agreements concluded pursuant to Article 218 of the Treaty, products referred to in paragraph 1 of this Article shall be produced in accordance with oenological practices recommended and published by the OIV or authorised by the Union pursuant to this Regulation.
Amendment 1346 #
2011/0281(COD)
Proposal for a regulation
Article 71 – paragraph 2 – subparagraph 1 a (new)
Article 71 – paragraph 2 – subparagraph 1 a (new)
Amendment 1353 #
2011/0281(COD)
Proposal for a regulation
Article 73 – paragraph 1 – subparagraph 1 a (new)
Article 73 – paragraph 1 – subparagraph 1 a (new)
The application for protection shall be filed with the Member State in whose territory the designation of origin or geographical indication originates. The Member State shall examine the application for protection in order to verify whether it meets the conditions set out in this Subsection. The Member State shall, by means of a national procedure, ensure the adequate publication of the application and provide for a period of at least two months from the date of publication within which any natural or legal person having a legitimate interest and resident or established on its territory may object to the proposed protection by lodging a duly substantiated statement with the Member State.
Amendment 1356 #
2011/0281(COD)
Proposal for a regulation
Article 73 – paragraph 3 – subparagraph 1 (new)
Article 73 – paragraph 3 – subparagraph 1 (new)
(a) publish the single document and the product specification at least on the Internet; and (b) forward to the Commission an application for protection containing the following information: (i) the name and address of the applicant; (ii) the single document referred to in Article 71(1)(d); (iii) a declaration by the Member State that it considers that the application lodged by the applicant meets the conditions required; and (iv) the publication reference, in keeping with point (a). The information referred to in point (b) of the first subparagraph shall be forwarded in one of the official languages of the Union or accompanied by a certified translation into one of those languages.
Amendment 1359 #
2011/0281(COD)
Proposal for a regulation
Article 73 – paragraph 3 a (new)
Article 73 – paragraph 3 a (new)
3a. Member States shall have the laws, regulations or administrative provisions in place that are necessary to comply with Article 118f of Regulation (EC) No 1234/2007 and this Article as from 1 August 2009.
Amendment 1360 #
2011/0281(COD)
Proposal for a regulation
Article 73 – paragraph 3 b (new)
Article 73 – paragraph 3 b (new)
Amendment 1365 #
2011/0281(COD)
Proposal for a regulation
Article 82 – paragraph 1
Article 82 – paragraph 1
An applicant satisfying the conditions laid down pursuant to point (b) of Article 86(4)72 may apply for approval of an amendment to the product specification of a protected designation of origin or a protected geographical indication, in particular to take account of developments in scientific and technical knowledge or to redefine the geographical area concernedreferred to in point (d) of the second subparagraph of Article 71(2). Applications shall describe and give reasons for the amendments requested.
Amendment 1368 #
2011/0281(COD)
Proposal for a regulation
Article 82 – paragraph 1 a (new)
Article 82 – paragraph 1 a (new)
Where the proposed amendment involves one or more amendments to the single document referred to in Article 71(1)(d), Articles 73 to 76 shall apply mutatis mutandis to the amendment application. However, if the proposed amendment is only minor, the Commission shall, by means of implementing acts, decide whether to approve the application without following the procedure laid down in Article 74(2) and Article 75 and, in the event of approval, shall publish the elements referred to in Article 74(3). That implementing act shall be adopted in accordance with the examination procedure referred to in Article 162(2).
Amendment 1370 #
2011/0281(COD)
Proposal for a regulation
Article 82 – paragraph 1 b (new)
Article 82 – paragraph 1 b (new)
Where the proposed amendment does not involve any change to the single document, the following rules shall apply: (a) where the geographical area is in a given Member State, that Member State shall express its position on the amendment and, if it is in favour, shall publish the amended product specification and inform the Commission of the amendments approved and the reasons for them; (b) where the geographical area is in a third country, the Commission shall, by means of implementing acts, decide whether to approve the proposed amendment. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 162(2).
Amendment 1372 #
2011/0281(COD)
Proposal for a regulation
Article 84 – paragraph 3 a (new)
Article 84 – paragraph 3 a (new)
3a. By way of derogation from Article 82(1), a Member State or third country or its competent authority may apply for approval for the amendment of the product specification for existing protected wine names in accordance with paragraph 1 of this Article.
Amendment 1381 #
2011/0281(COD)
Proposal for a regulation
Article 86 – paragraph 4 – point a
Article 86 – paragraph 4 – point a
(a) the elements of the product specifin which cases a single producer may apply for the protection of a designation of origin or geographical indication;
Amendment 1383 #
2011/0281(COD)
Proposal for a regulation
Article 86 – paragraph 4 – point c
Article 86 – paragraph 4 – point c
(c) the conditions to be followed in respect of an application for the protection of a designation of origin or geographical indication, preliminary national procedures, scrutiny by the Commission, objection procedure, and procedures for amendment, cancellation and conversion of protected designations of origin or protected geographical indications;
Amendment 1385 #
2011/0281(COD)
Proposal for a regulation
Article 86 – paragraph 4 – point d
Article 86 – paragraph 4 – point d
(d) the conditionspecific measures related to the national procedures applicable to trans- border applications;
Amendment 1388 #
2011/0281(COD)
Proposal for a regulation
Article 86 – paragraph 4 – point g
Article 86 – paragraph 4 – point g
(g) the conditions related tounder which an amendment is to product specifications.be considered as minor within the meaning of Article 82(2);
Amendment 1395 #
2011/0281(COD)
Proposal for a regulation
Article 89 – paragraph 1 – point a a (new)
Article 89 – paragraph 1 – point a a (new)
(aa) Competent authorities of Member States or third countries or representative professional organisations established in third countries may submit to the Commission an application for protection of traditional terms within the meaning of Article 89.
Amendment 1396 #
2011/0281(COD)
Proposal for a regulation
Article 89 – paragraph 1 a (new)
Article 89 – paragraph 1 a (new)
1a. Traditional terms shall be protected only in the language and for the categories of grape vine products claimed in the application, against: (a) any misuse even if the protected term is accompanied by an expression such as 'style', 'type', 'method', 'as produced in', 'imitation', 'flavour', 'like' or similar; (b) any other false or misleading indication as to the nature, characteristics or essential qualities of the product, on the inner or outer packaging, advertising material or documents relating to it; (c) any other practice liable to mislead the consumer, in particular to give the impression that the wine qualifies for the protected traditional term.
Amendment 1397 #
2011/0281(COD)
Proposal for a regulation
Article 89 – paragraph 1 b (new)
Article 89 – paragraph 1 b (new)
1b. Where a traditional term is protected under this Regulation, the registration of a trademark, the use of which would contravene Article 89c, shall be assessed in accordance with Directive 2008/95/EC of the European Parliament and of the Council ( 1 ) or Council Regulation (EC) No 207/2009 ( 2 ). Trademarks registered in breach of the first subparagraph shall be declared invalid upon request in accordance with the applicable procedures as specified by Directive 2008/95/EC or Regulation (EC) No 207/2009. A trademark, which corresponds to one of the situations referred to in Article 89c of this Regulation, and which has been applied for, registered or established by use, if that possibility is provided for by the legislation concerned, in the territory of the Community before 4 May 2002 or before the date of submission of the application for protection of the traditional term to the Commission, may continue to be used and renewed notwithstanding the protection of the traditional term. In such cases the use of the traditional term shall be permitted alongside the relevant trademark. A name shall not be protected as a traditional term, where in the light of a trademark's reputation and renown, such protection is liable to mislead the consumer as to the true identity, nature, characteristic or quality of the wine.
Amendment 1398 #
2011/0281(COD)
Proposal for a regulation
Article 89 – paragraph 1 c (new)
Article 89 – paragraph 1 c (new)
Amendment 1399 #
2011/0281(COD)
Proposal for a regulation
Article 89 – paragraph 1 d (new)
Article 89 – paragraph 1 d (new)
1d. Within two months from the date of publication of the application by the Commission any Member State or third country, or any natural or legal person having a legitimate interest may object to the proposed recognition by lodging a request of objection.
Amendment 1400 #
2011/0281(COD)
Proposal for a regulation
Article 89 – paragraph 1 e (new)
Article 89 – paragraph 1 e (new)
1e. An applicant may apply for an approval of a modification of a traditional term, the language indicated, the wine or wines concerned or of the summary of the definition or conditions of use of the traditional term concerned.
Amendment 1401 #
2011/0281(COD)
Proposal for a regulation
Article 89 – paragraph 1 f (new)
Article 89 – paragraph 1 f (new)
1f. The Commission may on a duly substantiated request by a Member State, a third country or a natural or legal person having a legitimate interest, by means of an implementing act, decide to cancel the protection of a traditional term if it no longer meets the definition laid down in Article 89. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 162(2).
Amendment 1407 #
2011/0281(COD)
Proposal for a regulation
Article 91 – paragraph 3 – point a
Article 91 – paragraph 3 – point a
Amendment 1408 #
2011/0281(COD)
Proposal for a regulation
Article 91 – paragraph 3 – point c
Article 91 – paragraph 3 – point c
Amendment 1409 #
2011/0281(COD)
Proposal for a regulation
Article 91 – paragraph 3 – point d
Article 91 – paragraph 3 – point d
Amendment 1410 #
2011/0281(COD)
Proposal for a regulation
Article 91 – paragraph 3 – point e
Article 91 – paragraph 3 – point e
Amendment 1660 #
2011/0281(COD)
Proposal for a regulation
Article 106 – paragraph 1 – point d a (new)
Article 106 – paragraph 1 – point d a (new)
(da) market products not covered by Annex I to the Treaty, provided that the proportion of products sold which are not covered by Annex I does not exceed 49 % of the total volume marketed, without this leading to the forfeiture of official status as a producer organisation in the recognised agricultural sector.
Amendment 2180 #
2011/0281(COD)
Proposal for a regulation
Annex I – Part XXI – product line (new)
Annex I – Part XXI – product line (new)
Raw alcohol with an alcohol content of less than 96% by volume which retains the organoleptic qualities associated with the basic raw materials used in its production shall be treated as ethyl alcohol within the meaning of point 1 provided that the raw alcohol in question is, after further processing, marketed or used as ethyl alcohol within the meaning of point 1.
Amendment 17 #
2011/0231(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 3 – point d
Article 2 – paragraph 1 – point 3 – point d
(d) if no alcohol has been added, which has a minimum actual alcoholic strength by volume of 4,5 % vol. and a maximum actual alcoholic strength by volume of less than 14,5 % vol.; if alcohol has been added, which has a minimum actual alcoholic strength by volume of 7,5 % vol. and a maximum actual alcoholic strength by volume of less than 14,5 % vol.
Amendment 18 #
2011/0231(COD)
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
(1a) The oenological practices and restrictions under Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation)1 shall apply to wine products used for the production of aromatised wine products. The Commission shall, if necessary, present a legislative proposal to amend Regulation (EC) No 1234/2007 accordingly. ___________________ 1 OJ L 299, 16.11.2007, p. 1.
Amendment 21 #
2011/0231(COD)
Proposal for a regulation
Article 4 – paragraph 5 a (new)
Article 4 – paragraph 5 a (new)
5a. If aromatised wine-based drinks or aromatised wine-product cocktails are placed on the market in a presentation form or under an invented or brand name that suggests to the consumer that they are spirits-based mixed drinks, then the sales denomination and alcohol content must be placed in the same field of vision, as defined in Article 2(2)(k) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers 1, in the same font size and same colour as the invented or brand name. __________________ 1 OJ L 304, 22.11.2011, p. 18.
Amendment 36 #
2011/0231(COD)
Proposal for a regulation
Article 9
Article 9
Amendment 40 #
2011/0231(COD)
Proposal for a regulation
Article 10
Article 10
For the purposes of this Chapter, "geographical indication" means an indication referring to a region, a specific place or a country, used to describe an aromatised wine product where the wine products come from the Union and where a given quality, reputation or other characteristics of that wine product is essentially attributable to its geographical origin.
Amendment 331 #
2011/0196(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
Regulation (EC) No 561/2006
Article 13 – paragraph 1
Article 13 – paragraph 1
The distance of ‘50 km’ referred to in points (d), (f) and (p) of Article 13(1) is replaced by ‘1200 km’.
Amendment 338 #
2011/0196(COD)
Proposal for a regulation
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
Regulation (EC) No 561/2006
Article 13 – paragraph 1
Article 13 – paragraph 1
Regulation (EC) No 561/2006 is amended as follows: In Article 13, paragraph 1, points (d) and (f) the maximum permissible mass of ‘7.5 t’ is replaced by ‘12 t’.
Amendment 38 #
2011/0172(COD)
Proposal for a directive
Recital 30 a (new)
Recital 30 a (new)
(30a) The necessary increase in energy efficiency will only be achieved through a comprehensive change in society’s thinking. Today’s children are tomorrow’s workers, engineers, architects, entrepreneurs and energy users. The decisions they take will influence the way in which society produces and uses energy in the future. Energy education is therefore important so that future generations can be instructed in how to contribute to efficient energy consumption through their lifestyle and personal behaviour. The Member States should therefore take targeted action to promote energy education in schools, with particular stress on how each individual can contribute to more efficient, sustainable energy use through their personal behaviour.
Amendment 52 #
2011/0172(COD)
Proposal for a directive
Article 1 – paragraph 1 – subparagraph 1
Article 1 – paragraph 1 – subparagraph 1
This Directive establishes a common framework for the promotion of energy efficiency within the Union in order to ensure the achievement, by means of improved energy efficiency, of the Union's target of 20% primary energy savings bycompared to projections for 2020 and to pave the way for further energy efficiency improvements beyond that date.
Amendment 60 #
2011/0172(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
4. '‘public bodies'’ means '‘contracting authorities'’ as defined in Directive 2004/18/EC, with the exception of municipal housing corporations;
Amendment 103 #
2011/0172(COD)
Proposal for a directive
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Without prejudice to Article 7 of Directive 2010/31/EU, Member States shall ensure that as from 1 January 2014, 32% of the total floor area owned by their public bodies is renovated each year to meet at least the minimum energy performance requirements set by the Member State concerned in application of Article 4 of Directive 2010/31/EU. The 32% rate shall be calculated on the total floor area of buildings with a total useful floor area over 250 m2 owned by the public bodies of the Member State concerned that, on 1 January of each year, does not meet the national minimum energy performance requirements set in application of Article 4 of Directive 2010/31/EU. The Member States may decide that the total useful floor area of public buildings, in the case of which the national minimum requirements set out in Article 4 of Directive 2010/31/EU on the estimated economic lifecycle of a building are not cost-efficient, is not included in the renovation quota.
Amendment 111 #
2011/0172(COD)
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States may allow their public bodies to count towards their annual renovation rate the excess of renovated building floor area in a given year as if it has instead been renovated in any of the twohree previous or following years.
Amendment 133 #
2011/0172(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
Member States shall ensure that public bodies purchase only products, services and buildings with high energy efficiency performance, as referred to in Annex III. Public bodies will thus be taking into account cost-effectiveness, economical feasibility and technical arrangements as well as sufficient competition.
Amendment 147 #
2011/0172(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. EachThe Member States shall set up an energy efficiency obligation scheme. This scheme shall ensure that either all energy distributors or all retail energy sales companies operating on the Member State's territorybe obliged to set up incentives schemes to increase energy efficiency among end users in order to achieve annual energy savings equal to 1.5% of their energy sales, by volume, in the previous year in that Member State excluding energy used in transport. This amount of energy savings shall be achieved by the obligated parties among final customers.
Amendment 179 #
2011/0172(COD)
Proposal for a directive
Article 6 – paragraph 10
Article 6 – paragraph 10
Amendment 222 #
2011/0172(COD)
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
1. By 1 January 2014, Member States shall establishanalyse and notify to the Commission a national heating and cooling plan for developingdevelopment of the potential for the application of high-efficiency cogeneration and efficient district heating and cooling, containing the information set out in Annex VII. The planalyses shall be updated and notified to the Commission every five years. Member States shall ensure by means of their regulatory framework that national heating and cooling plans are taken into account in local and regional development plans, including urban and rural spatial plans, and fulfil the design criteria in Annex VII.
Amendment 254 #
2011/0172(COD)
Proposal for a directive
Article 10 – paragraph 4 – subparagraph 1 – point c a (new)
Article 10 – paragraph 4 – subparagraph 1 – point c a (new)
(ca) high efficiency gas or coal-fired power stations are to be permitted for economic reasons or to ensure network stability without cogeneration units.
Amendment 259 #
2011/0172(COD)
Proposal for a directive
Article 10 – paragraph 5
Article 10 – paragraph 5
5. Member States shall ensure that national regulations on urban and rural spatial planning are adapted to the authorisation criteria referred to in paragraph 3 and are in line withtake due account of the national heating and cooling plans referred to in paragraph 1.
Amendment 361 #
2011/0172(COD)
Proposal for a directive
Annex 3 – paragraph 1 – introductory part
Annex 3 – paragraph 1 – introductory part
Public bodies that purchase products, services or buildings shall take all due account of the following guidelines:
Amendment 362 #
2011/0172(COD)
Proposal for a directive
Annex 3 – paragraph 1 – point a
Annex 3 – paragraph 1 – point a
(a) where a product is covered by a delegated act adopted under Directive 2010/30/EU or Commission Directive implementing Directive 92/75/EEC, should purchase only the products that comply with the criterion of belonging to the highest energy efficiency class while taking into account cost-effectiveness, economical feasibility and technical suitability, as well as sufficient competition;
Amendment 364 #
2011/0172(COD)
Proposal for a directive
Annex 3 – paragraph 1 – point b
Annex 3 – paragraph 1 – point b
(b) where a product not covered under point (a) is covered by an implementing measure under Directive 2009/125/EC adopted after the entry into force of this Directive, should purchase only products that comply with energy efficiency benchmarks specified in that implementing measure;
Amendment 365 #
2011/0172(COD)
Proposal for a directive
Annex 3 – paragraph 1 – point c
Annex 3 – paragraph 1 – point c
(c) public bodies should purchase office equipment products covered by Council Decision [2006/1005/EC39] that comply with energy efficiency requirements not less demanding than those listed in Annex C of the Agreement attached to that Decision;
Amendment 366 #
2011/0172(COD)
Proposal for a directive
Annex 3 – paragraph 1 – point d
Annex 3 – paragraph 1 – point d
(d) public bodies should purchase only tyres that comply with the criterion of having the highest fuel energy efficiency class, as defined by Regulation (EC) No 1222/200940. This requirement shall not prevent public bodies from purchasing tyres with the highest wet grip class or external rolling noise class where justified by safety or public health reasons;
Amendment 367 #
2011/0172(COD)
Proposal for a directive
Annex 3 – paragraph 1 – point e
Annex 3 – paragraph 1 – point e
(e) public bodies should require in their tenders for service contracts that service providers use, for the purposes of providing the services in question, only products that comply with the requirements referred to in points (a) to (d), when providing the services in question;
Amendment 369 #
2011/0172(COD)
Proposal for a directive
Annex 3 – paragraph 1 – point f
Annex 3 – paragraph 1 – point f
(f) public bodies should purchase or rent only buildings that comply at least with the minimum energy performance requirements referred to in Article 4(1). Compliance with these requirements shall be verified by means of the energy performance certificates referred to in Article 11 of Directive 2010/31/EU.
Amendment 380 #
2011/0172(COD)
Proposal for a directive
Annex 7 – point 3 – introductory part
Annex 7 – point 3 – introductory part
Amendment 60 #
2011/0156(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) Currently, the statements ‘gluten-free’ and ‘very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. Such statements could be construed as nutrition claims, as defined in Regulation (EC) No 1924/2006. For the sake of simplification, those statements should be regulated solely by Regulation (EC) No 1924/2006 and comply with requirements therein. ItGluten-free foods are the only food source for coeliac disease sufferers. The composition of foods is ndecessary that technical adaptations pursuant to Regulation (EC) No 1924/2006, incorporatisive in managing the nutrcondition claims ‘gluten-free’ and ‘very low gluten’ and their associated conditions of use as regulated under Regulation (EC) No 41/2009 b. Gluten-free foods should therefore come under the scompleted prior to the entry into applicationpe of this Regulation.
Amendment 78 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point c a (new)
Article 1 – paragraph 1 – point c a (new)
(ca) foods for people intolerant to gluten (gluten-free foods);
Amendment 83 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point c b (new)
Article 1 – paragraph 1 – point c b (new)
(cb) foods intended to meet the expenditure of intense muscular effort;
Amendment 85 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point c c (new)
Article 1 – paragraph 1 – point c c (new)
(cc) other foods for infants and young children.
Amendment 90 #
2011/0156(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point g – point ii
Article 2 – paragraph 2 – point g – point ii
Amendment 113 #
2011/0156(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) Currently, the statements 'gluten-free' and 'very low gluten' may be used for food intended for particular nutritional uses and for food for normal consumption under the rules specified in Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. Such statements could be construed as nutrition claims, as defined in Regulation (EC) No 1924/2006. For the sake of simplification, those statements should be regulated solely by Regulation (EC) No 1924/2006 and comply with requirements therein. It is necessary that technical adaptations pursuant to Regulation (EC) No 1924/2006, incorporating the nutrition claims 'gluten-free' and 'very low gluten' and their associated condGluten-free foods are the only food source for coeliac disease sufferers. The composition of foods is decisive in managing the condition. However, neither Regulation (EC) No 1924/2006 nor Regulation (EC) No 1169/2011 takes account of the particular requirements for the compositions of use as regulated under Regulation (EC) No 41/2009 be completed prior to the entry into applicationthese foods. Foods intended for people intolerant to gluten should therefore come under the scope of this Regulation.
Amendment 128 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point b a (new)
Article 1 – paragraph 1 – point b a (new)
(ba) other foods for infants and young children;
Amendment 135 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point c a (new)
Article 1 – paragraph 1 – point c a (new)
(ca) foods for people intolerant to gluten (gluten-free foods).
Amendment 138 #
2011/0156(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point c b (new)
Article 1 – paragraph 1 – point c b (new)
(cb) food intended to meet the requirements of extreme physical activity.
Amendment 148 #
2011/0156(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 154 #
2011/0156(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point g – point ii
Article 2 – paragraph 2 – point g – point ii
Amendment 270 #
2011/0156(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 106 #
2011/0137(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Given that customs authorities take action upon prior application, it is appropriate to provide that the holder of the decision granting an application for action by the customs authorities should reimburse all the costs incurred by the customs authorities in taking action to enforce his/her intellectual property rights. Nevertheless, this should not preclude the holder of the decision from seeking compensation from the infringer or other persons that might be considered liable according to the legislation of the Member State concerned. However, haulage firms should, under certain circumstances, be made directly liable for all reasonable costs incurred by the customs authorities and rights holders when enforcing intellectual property rights. Costs and damages incurred by persons other than customs administrations as a result of a customs action, where the goods are detained on the basis of a claim of a third party based on intellectual property, should be governed by the specific legislation in each particular case.
Amendment 130 #
2011/0137(COD)
Proposal for a regulation
Article 2 – point 5 – point a
Article 2 – point 5 – point a
(a) gGoods, including packaging, which are subject of an action infringing a trade mark and bear without authorisation a trade mark identical to the trade mark validly registered in respect of the same type of goods, or which cannot be distinguished in its essential aspects from such a trade mark and therefore infringes the holder’s rights under the national law of the importing state;
Amendment 151 #
2011/0137(COD)
Proposal for a regulation
Article 2 – point 12 a (new)
Article 2 – point 12 a (new)
(12 a) ‘intermediary’ means a person who is involved in the transport of goods, such as an importer, haulier, recipient of goods, sender of goods or customs declarant, or freight operator;
Amendment 245 #
2011/0137(COD)
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. Where requested by the customs authorities, the holder of the decision granting the application shall reimburse all costs incurred by the customs administration in keeping goods under customs supervision in accordance with Articles 16 and 17 and in destroying goods in accordance with Articles 20 and 23 and in intercepting goods, providing the intermediaries are not liable under Article 27(2)(b).
Amendment 5 #
2010/2304(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
Amendment 7 #
2010/2304(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Considers that the investment risks involved in rolling out new networks can be reduced by measures to drive demand, in particular in the areas of e-procurement, e-commerce, e-governance, e-health services, and smart meters; calls on the Commission to clarify state aid rules that may damage demand; notes that the simplification and streamlining of the subsidy procedure would contribute to the faster introduction of broadband technology;
Amendment 13 #
2010/2304(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Calls on the Commission and BEREC, in consultation with the public authorities, to facilitate public-private partnerships and deploy other European funding instruments, including ERDF, EAFRD and EBRD funds; welcomes the Commission’s plans to add European Investment Bank loans with low interest rates to the list of subsidy instruments;
Amendment 21 #
2010/2304(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Notes that new fibre networks offer consumers high-quality access at consistently higher speeds than existing technology; asks BEREC therefore to ensure that typical broadband speeds experienced by consumers are fairly advertised in the interests of transparency on the benefits of new technology for upload and download; believes that it would be expedient to prioritise the development of fibre optics-based broadband in areas where it represents the most economic and sustainable solution in the long term;
Amendment 52 #
2010/2289(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Supports the proposals of the Single Market Act that aim at developing further administrative cooperation between the Member States, including extending the Internal Market Information S and extending it, subject to positive evaluations of user-friendliness and of the security system, to other legislative areas;
Amendment 69 #
2010/2289(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Encourages Member States to developNotes that the points of single contact provided for under the Services Directive into true one-stop-shops where businesses can easily obtain all the necessary information for their activities, including information on the applicable taxation regimehave not yet been fully made use of in all Member States, as people are as yet unaware that they exist;
Amendment 75 #
2010/2289(INI)
Motion for a resolution
Paragraph 14 – subparagraph 1 (new)
Paragraph 14 – subparagraph 1 (new)
Calls on the Member States to lobby for the use of the single points of contact by means of an appropriate information policy;
Amendment 6 #
2010/2277(INI)
Motion for a resolution
Recital A
Recital A
A. whereas it is important to restorincrease confidence in the Single Market at all levels and to eliminate existing barriers to enterprises entering business; whereas high administrative burdens discourage new entrepreneurs,
Amendment 63 #
2010/2277(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
Amendment 131 #
2010/2277(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Notes that the digital internal market can only be completed when the gap between rural areas and urban centres in terms of broadband connections has been reduced;
Amendment 136 #
2010/2277(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to improve SMEs’ access to capital markets by increasing information available on different EU financing opportunities such as those provided by the Competitiveness and Innovation Programme, the European Investment Bank or the European Investment Fund and by making funding procedures easier, quicker and less bureaucratic;
Amendment 142 #
2010/2277(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Believes that the pluralistic structure of the European banking market meets best the variety of financing needs of SMEs and that the diversity of legal models and business objectives improves access to finance;
Amendment 149 #
2010/2277(INI)
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. points out the importance of interconnected business registers and calls on the Commission to develop a clear legal framework ensuring that information in such business registers is complete and correct;
Amendment 160 #
2010/2277(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. points out the importance of interconnected business registers and calls on the Commission to develop a clear legal framework ensuring that information in such business registers is complete and correct;
Amendment 162 #
2010/2277(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Calls on the European Commission to include within the Single Market Act a proposal for a European retail strategy that identifies and addresses the numerous challenges faced by European businesses looking to retail their products both within the Single Market and to an international customer base. This strategy should consider the specific requirements of individual retail sectors including digital, high-street and travel retail.
Amendment 198 #
2010/2277(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to encourage the development of the business services sector and to take the necessary regulatory measures in order to protect especially SMEs from unfair commercial practices by larger enterprises in the retail sector; recalls its Resolution 2008/2126 (INI) and urges the Commission again to come up with a proposal to prevent the fraudulent practices of Misleading Business Directories;
Amendment 214 #
2010/2277(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
Amendment 17 #
2010/2106(INI)
Motion for a resolution
Recital A
Recital A
A. whereas forests and wooded land cover 42% of the EU's surface, forest-based industries provide more than 2 million jobs and 40% of EU forests are under public ownership, so that the state has a particular responsibility, and a duty to set an example, in connection with the protection and use of forests,
Amendment 28 #
2010/2106(INI)
Motion for a resolution
Recital C
Recital C
C. whereas 30% of NATURA 2000 sites are forest habitats, 66% of which have unfavourable conservation status, and whereas these sites play an important role as links in the network of biotopes,
Amendment 45 #
2010/2106(INI)
Motion for a resolution
Recital D
Recital D
D. whereas energy generation from solid biom, given the steadily increasing demand for timber ass and biowaste is projected to be 58% of EU renewables by 2020, leading to raw material and a source of energy, the ratio of felling to net annual increment may temporarily increase to over 100% in some European countries and intensification of forestry practices and increases in the ratio of fell mathematical terms forests may temporarily shift from being carbon sinks to being sources of emissions if sustainable timber products are not included ing to increment to over 100%, he relevant calculations,
Amendment 57 #
2010/2106(INI)
Motion for a resolution
Recital E
Recital E
E. whereas forest protection is an integral part of sustainable forestry and should be mainstreamed in all EU policies affecting forests, in keeping with the subsidiarity principle,
Amendment 74 #
2010/2106(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas the White Paper entitled ‘Adapting to climate change: towards a European framework for action’ (COM(2009)0147) identifies forests as one area where action is needed, emphasising that the EU’s forestry strategy should be updated to include aspects linked to climate change,
Amendment 101 #
2010/2106(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Recalls that forests, whose resilience depends on the biological diversity not only of trees but of all forest organisms, particularly wild animals living in the forest, are essential for the adaptation of European societies to climate change;
Amendment 126 #
2010/2106(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission and Member States to intensify efforts to achieve the environment and quality of life goals of the FAP, the implementation of which is currently lagging behind;Does not affect English text.
Amendment 148 #
2010/2106(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
Amendment 162 #
2010/2106(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Notes that genetic diversity, natural regeneration and diversity in structure and species mixture among all organisms living in the forest are common elements in forest adaptation options, cutting across all bioclimatic zones, management systems and forest types;
Amendment 178 #
2010/2106(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
Amendment 190 #
2010/2106(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Urges the Commission to report to Parliament and the Council on options for the introduction of paymentsossible compensation for forest ecosystem services taking into account the role of forestation, biodiversity conservation and SFM;
Amendment 206 #
2010/2106(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Urges the Commission to present a legislative proposalpossible EU instruments for Forest Fire Prevention incorporating funding for the European Forest Fires Information System (EFFIS), infrastructure, training and prevention planning;
Amendment 216 #
2010/2106(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Urges the Commission to present a legislative proposal for Forest Information taking into account climate threats and the need for harmonised andrelevant, comparable data in the context of the UNFCCC, CBD, and environmental accountson forests and increased reporting requirements, such as, for instance, under the UNFCCC and CBD;
Amendment 239 #
2010/2106(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Points out that forests play a key role in the socio-economic development of rural areas and in the provision of public goods;
Amendment 268 #
2010/2106(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
Amendment 272 #
2010/2106(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Calls for the establishment of a GHG calculation methodology controlling for longer time horizons and biomass emissions from land use and forest management or forest sink performance, including carbon storage in long-lived timber products;
Amendment 278 #
2010/2106(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls on the Commission to developconsider the introduction of legally binding sustainability criteria for woody biomass and ILUC factors for all forms of biomass on the basis of existing, internationally recognised criteria and indicators for sustainable forest management, in particular those developed by the Ministerial Conference on the Protection of Forests in Europe (FOREST EUROPE);
Amendment 287 #
2010/2106(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Calls foron the application of forest definitions which differentiate between carbon-rich old forests, intensively managed monocultures and other forest types according to biomeCommission and Member States to work towards standard forest definitions in relevant EU documents;
Amendment 16 #
2010/2051(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Holds the view that the integration of the WTO principles in the legal framework should not increase the number of recognised European standardisation organisations (ESOs) beyond the three existing ones, namely CEN, CENELEC, and the European Telecom Standards Institute (ETSI),
Amendment 21 #
2010/2051(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Stresses, however, that these principles are not in themselves sufficient to ensure that small and medium-sized enterprises and societal stakeholders – in particular those representing health and safety, consumer and environmental interests – are adequately represented in the standardisation process; considers, therefore, that a vital element is the addition of the principle of "balancedappropriate representation", given that it is of the utmost importance, whenever the public interest is concerned, to incorporate all stakeholder positions in a balancedappropriate manner, especially in the development of standards intended to support EU legislation and policies, while acknowledging the voluntary nature of European standardisation and the need to engage the most knowledgeable technical experts for a given standardisation project;
Amendment 27 #
2010/2051(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Recognises that service standards often respond to national specificities and that their development is related to the needs of the market, the interests of consumers and the public interest; stresses, however, that the development of European service standards and the drawing-up by professional bodies of their own quality charters or labels, as provided for in Directive 2006/123/EC on services in the internal market, willmay benefit further harmonisation in the services sector, increase the transparency, quality and competitiveness of European services and promote competition, innovation, the reduction of trade barriers and consumer protection;
Amendment 30 #
2010/2051(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Supports, therefore, the Commission’s intention to include service standards in the legal framework of European standardisation, as this will not only ensure the notification of all national service standards that could potentially constitute technical barriers to trade in the internal market, but alsoefforts made by professional bodies to draw up quality charters and labels that apply alongside national and European law governing the professions, and the Commission’s intention to include service standards in the legal framework of European standardisation in the case of services for which standardisation is possible and which do not have quality charters drawn up by professional organisations; stresses that there are definable and indefinable services, whereby highly qualified intellectual and spiritual services are not definable in Europe's understanding of the law, and standardisation in this area can apply only to the framework conditions (technical and actual preconditions, etc); believes that service standards which meet these criteria may provide a proper legal basis on which the Commission can request the European standardisation organisations (ESOs) – namely CEN, CENELEC and the European Telecom Standards Institute (ETSI) – to develop standards in the services sector;
Amendment 55 #
2010/2051(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Stresses the need, which has been recognised since the 1990s, to ensure direct participation by societal stakeholders at European level in order to reflect their views more effectively, given that their representation on national technical committees remains weak; affirms that, as very limited progress has been made to increase societal stakeholder participation at national level, financial and political support for the European organisations established to represent such stakeholders needs to be maintained at least in the period to 2020; , so that they can play a more prominent role in providing advice to Member States and national stakeholder associations, thus ensuring the participation of stakeholders in national mirror committees involved in European standardisation projects; welcomes the efforts of the ESOs and NSBs in implementing the "Toolbox of 58 recommendations" of the Access Study and the recommendations of the EXPRESS report with regard to improving access for all stakeholders;
Amendment 66 #
2010/2051(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
Amendment 72 #
2010/2051(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
Amendment 93 #
2010/2051(INI)
Motion for a resolution
Paragraph 22 c (new)
Paragraph 22 c (new)
22c. Calls on national standard bodies (NSBs) to follow the International Organisation for Standardisation (ISO) Code of Ethics in order to ensure that the impartiality of standards is not endangered from other activities, such as certification.
Amendment 107 #
2010/2051(INI)
Motion for a resolution
Paragraph 26 d (new)
Paragraph 26 d (new)
26d. Calls on Member States and the European Commission to promote education about the role of standards and the benefits of using them at all levels, in economic and technical schools for instance; invites NSBs to enhance their cooperation with trade associations in order to provide plausible information to SMEs on the benefits provided by standards;
Amendment 13 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 a
Article 112 a
Without prejudice to any other provisions applicable to products listed in Annex Iparagraph 1a and to agricultural ethyl alcohol as referred to in Part I of Annex II, as well as the provisions adopted in the veterinary and food sectors to ensure that products comply with hygiene and health standards and to protect animal and human health, this Section lays down the rules concerning the general marketing standard and marketing standards by sector and/or product for products listed in Annex I and agricultural ethyl alcohol amarketing standards for the sectors referred to in Ppart I of Annex IIagraph 1a."
Amendment 14 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 a - paragraph 1 a and 1 b (new)
Article 112 a - paragraph 1 a and 1 b (new)
1a. Marketing standards may be laid down for the following sectors or products: (a) fruit and vegetables; (b) bananas; (c) eggs and poultrymeat; (d) milk and milk products; (e) wine; (f) hops; (g) olive oil and table olives; (h) beef and veal; (i) spreadable fats; (j) live plants. 1b. The products for which marketing standards by sectors or products have been laid down may be marketed in the Union only in accordance with such standard.
Amendment 15 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 b
Article 112 b
Amendment 18 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 c
Article 112 c
Amendment 22 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 d
Article 112 d
Amendment 24 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 1
Article 112 e - paragraph 1
1. In order to take account of the expectations of consumers and to contribute to the improvement of the economic conditions for the production and marketing of agricultural products as well as to their quality, the Commission may, by means of delegated acts under Article 196a, adopt marketing standards byfor the sector s and/or products referred to in Article 112a(1a)(a), (b), (c) and (g), at all stages of the marketing, as well as derogations and exemptions from the application of such standards in order to adapt to the constantly changing market conditions, to the evolving consumer demands, as well as in order to take account of developments in relevant international standards and avoid creating obstacles to product innovation.
Amendment 30 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2, point a
Article 112 e - paragraph 2, point a
(a) the definition, designation and/or sales descriptions other than those set out in this Regulation and listsas regards the fruit and vegetables sector: (i) classification criteria such as grading into classes, weight, sizing, age and category; (ii) the presentation, sales descriptions, labelling linked to obligatory marketing standards, packaging, rules to be applied in relation to packing centres, marking, wrapping, year of charcasses and parts thereof to which Annex XIIa applievesting and use of specific terms; (iii) criteria such as appearance, consistency, conformation, product characteristics;
Amendment 32 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point b
Article 112 e - paragraph 2 - point b
(b) as regards the banana sector: (i) classification criteria such as grading into classes, weight, sizing, age and category; (ii) the presentation, sales descriptions, labelling linked to obligatory marketing standards, packaging, rules to be applied in relation to packing centres, marking, wrapping, year of harvesting and use of specific terms; (iii) criteria such as appearance, consistency, conformation, product characteristics;
Amendment 33 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point c
Article 112 e - paragraph 2 - point c
(c) the plant variety or animal race or the commercial typas regards the eggs and poultrymeat sector: (i) classification criteria such as grading into classes, weight, sizing, age and category; (ii) the presentation, sales descriptions, labelling linked to obligatory marketing standards, packaging, rules to be applied in relation to packing centres, marking, wrapping, year of harvesting and use of specific terms; (iii) criteria such as appearance, consistency, conformation, product characteristics; (iv) the conservation method and temperature; (v) as regards the poultrymeat sector, the water content as a percentage;
Amendment 34 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point d
Article 112 e - paragraph 2 - point d
(d) the presentation, sales descriptions, labelling linked to obligatory marketas regards the egg sector: (i) the frequency of collection, delivery, preservation and handling; (ii) the type of farming standards, packaging, rules to be applied in relation to packing centres, marking, wrapping, year of harvesting and use of specific term production method and related administrative rules, and operating circuit; (iii) restrictions as regards the use of certain substances and/or practices; (iv) storage, transport; (v) time limits;
Amendment 36 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point e
Article 112 e - paragraph 2 - point e
(e) criteria such as appearance, consistency, conformation, product characteristics; as regards the olive oil and table olive sector: (i) the presentation, sales descriptions, labelling linked to obligatory marketing standards, packaging, rules to be applied in relation to packing centres, marking, wrapping, year of harvesting and use of specific terms; (ii) criteria such as appearance, consistency, conformation, product characteristics; (iii) specific substances used in production, or components or constituents, including their quantitative content, purity and identification;
Amendment 37 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point f
Article 112 e - paragraph 2 - point f
Amendment 38 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point g
Article 112 e - paragraph 2 - point g
Amendment 41 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point h
Article 112 e - paragraph 2 - point h
Amendment 43 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2- point i
Article 112 e - paragraph 2- point i
Amendment 46 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point j
Article 112 e - paragraph 2 - point j
Amendment 51 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point k
Article 112 e - paragraph 2 - point k
Amendment 52 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point l
Article 112 e - paragraph 2 - point l
Amendment 53 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point m
Article 112 e - paragraph 2 - point m
Amendment 54 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point n
Article 112 e - paragraph 2 - point n
Amendment 55 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point o
Article 112 e - paragraph 2 - point o
Amendment 56 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point p
Article 112 e - paragraph 2 - point p
Amendment 57 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point q
Article 112 e - paragraph 2 - point q
Amendment 58 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point r
Article 112 e - paragraph 2 - point r
Amendment 59 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point s
Article 112 e - paragraph 2 - point s
Amendment 60 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point t
Article 112 e - paragraph 2 - point t
Amendment 61 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 2 - point u
Article 112 e - paragraph 2 - point u
Amendment 62 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 e - paragraph 3 - point c
Article 112 e - paragraph 3 - point c
(c) the interest of consumers to receive adequate and transparent product information, including the place of farming to be determined on a case by case approach at the appropriate geographical level;
Amendment 74 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 f - paragraph 3
Article 112 f - paragraph 3
Amendment 77 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112g
Article 112g
Amendment 82 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 g a (new)
Article 112 g a (new)
Article 112 ga Country of origin In accordance with Annex […], the indication of the country of origin shall apply to the following sectors and/or products: (a) fruit and vegetables; (b) virgin olive oil.
Amendment 85 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 h - paragraph 1 - subparagraph 2
Article 112 h - paragraph 1 - subparagraph 2
Where there are no methods and rules recommended and published by the OIV, corresponding methods and rules shall be adopted by the Commission as referred to in point(g) of Article 112e(2)uncil and European Parliament on a proposal from the Commission as referred to in the procedure under Article 43(2) of the Treaty on the Functioning of the European Union.
Amendment 86 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 h - paragraph 2
Article 112 h - paragraph 2
Only oenological practices authorised in accordance with Annex XIIc and provided for in point (g) of Article 112e(2) and in Article 112k(2) and (3) shall be used in the production and conservation in the Union of products of the wine sector.
Amendment 88 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 h - paragraph 3
Article 112 h - paragraph 3
3. When making proposals on authorising oenological practices for wine as referred to in point(g) of Article 112e(2)aragraph 1, the Commission shall:
Amendment 91 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 k - paragraph 4 a (new)
Article 112 k - paragraph 4 a (new)
4a. Member States may adopt or maintain national marketing standards for sectors or products, provided that these measures are consistent with EU law.
Amendment 92 #
2010/0354(COD)
Proposal for a regulation - amending act
Article 1 - point 2
Article 1 - point 2
Regulation (EC) No 1234/2007
Article 112 l
Article 112 l
Amendment 114 #
2010/0354(COD)
Proposal for a regulation - amending act
Annex I
Annex I
Regulation (EC) No 1234/2007
Annex XII c - Part I - section C - paragraph 7
Annex XII c - Part I - section C - paragraph 7
7. Acidification and enrichment, except by way of derogation to be adopted by the Commission by means of delegated acts pursuant to Article 112e(1), and acidification and de-acidification of one and the same product shall be mutually exclusive processes.
Amendment 47 #
2010/0254(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 2001/112/EC
Annex I – part I – point 1 – point a – paragraph 2
Annex I – part I – point 1 – point a – paragraph 2
Flavour, pulp, and cells obtained by suitable physical means from the same species of fruitfrom the juice which are separated during processing may be restored to the juice.
Amendment 51 #
2010/0254(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 2001/112/EC
Annex I – part I – point 1 – point a – paragraph 2
Annex I – part I – point 1 – point a – paragraph 2
The product obtained by reconstitutingstoring to the concentrated fruit juice defined in Part I.2 with potable water that meets the criteria of Council Directive 98/83/EC of 3 November 1998 on thewater extracted from that juice during concentration, and restoring the flavour, and, if appropriate, pulp and cells lost from the juice. The water added must display appropriate characteristics, particularly from the chemical, microbiological and organoleptic viewpoints, in such a way as to guarantee the essential qualityies of water intended for human consumption*. ____________ * OJ L 330, 5.12.1998, p. 32the juice.
Amendment 54 #
2010/0254(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 2001/112/EC
Annex I – part I – point 1 – point b – paragraph 5
Annex I – part I – point 1 – point b – paragraph 5
Flavour and, if appropriate, pulp and cells shall be obtained by suitable physical means from the fruit juice in question or from fruit juices from the same species of fruit may beand restored to the fruit juice.
Amendment 27 #
2010/0208(COD)
Proposal for a regulation - amending act
Recital 5
Recital 5
(5) Experience has shown that cultivation of GMOs is an issue which is more thoroughly addressed by Member States, either at central or at regional and local level. Contrary to issues related to the placing on the market and the import of GMOs, which should remain regulated at EU level to preserve the internal market, cultivation has been acknowledged as an issue with a strong local/regional dimension/territorial dimension and as an issue of particular importance for the self-determination of Member States. In accordance with Article 2(2) TFEU Member States should therefore be entitled to have a possibility to adopt rulebinding legislative provisions concerning the effective cultivation of GMOs in their territory after the GMO has been legally authorised to be placed on the EU market.
Amendment 38 #
2010/0208(COD)
Proposal for a regulation - amending act
Recital 8
Recital 8
(8) According to the legal framework for the authorisation of GMOs, the level of protection of human/animal health and of the environment chosen in the EU cannot be revised by a Member State and this situation must not be altered. However Member States may adopt measures restricting or prohibiting the cultivation of all or particular GMOs in all or part of their territory on the basis of grounds relating to the public interest other thancomplementary to, or differing from, those already addrssessed by the harmonised set of EUnion rules which already. The grounds given by the Member States may include consideration of environmental impacts complementary to those already covered by the risk assessment provided for procedures to take into account the risks that a GMO for cultivation may pose on health and the environmentin Part C of Directive 2001/18/EC, or other legitimate factors, such as: the absence or lack of adequate data on the potential negative impacts of GMOs on the ecosystems or public health in a Member State; the invasiveness or persistence of GM crops; grounds relating to changes in agricultural practices linked to the cultivation of GMOs resulting in negative environmental or health impacts; grounds justifying the maintenance and development of agricultural practices which offer the best combination of production with ecosystem sustainability, or the existence of alternative practices to GMO cultivation and with better technical, economic or environmental performance. Those measures should furthermore be in conformity with the Treaties, in particular as regards the principle of non discrimination between national and non national products and Articles 34 and 36 of the Treaty on the Functioning of the European Union, as well as with the relevant international obligations of the Union, notably in the context of the World Trade Organisation.
Amendment 46 #
2010/0208(COD)
Proposal for a regulation - amending act
Recital 9
Recital 9
(9) On the basis of the subsidiarity principle, the purpose of this Regulation is not to harmonize the conditions of cultivation in Member States but to grant freedom to Member States to invoke otherestrict or gprounds than scientific assessment of health and environmental risks to ban cultivationhibit the cultivation of GMOs on their territory on grounds relating to environmental or health impacts which might arise from the deliberate release or the placing on the market of GMOs on r otheir terrilegitimate factorys. In addition one of the purposes of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations which is to allow the Commission to consider the adoption of binding acts at EU level would not be served by the systematic notification of Member States’ measures under that Directive. Moreover, since measures which Member States can adopt under this Regulation cannot have as a subject the placing of the market of GMOs and thus does not modify the conditions of placing on the market of GMOs authorised under the existing legislation, the notification procedure under Directive 98/34/EC does not appear the most appropriate information channel for the Commission. Therefore, by derogation, Directive 98/34/EC should not be applicable. A simpler notification system of the national measures prior to their adoption appears to be a more proportionate tool for the Commission to be aware of these measures. Measures which Member States intend to adopt should thus be communicated together with their reasons to the Commission and to the other Member States one month prior to their adoption for information purposes.
Amendment 80 #
2010/0208(COD)
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
(a) those measures are based on grounds other than those related to the assessment of the adverse effect on health and environment which might arise from the deliberate release or the placing on the market of GMOsrelating to environmental impacts which might arise from the deliberate release or the placing on the market of GMOs, and which are complementary to the environmental impacts examined during the assessment of the negative impacts on the environment conducted under Part C of this Directive, or include other legitimate factors, such as: (i) the absence or lack of adequate data on the potential negative impacts of GMOs on the ecosystems or public health in a Member State; (ii) the invasiveness and persistence of GM crops; (iii) grounds relating to changes in agricultural practices linked to the cultivation of GMOs resulting in negative environmental or health impacts; (iv) grounds justifying the maintenance and development of agricultural practices which offer the best combination of production with ecosystem sustainability, or the existence of alternative practices to GMO cultivation and with better technical, economic or environmental performance;
Amendment 20 #
2009/2175(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Deplores the fact that the aims of the 2004 revision of the public procurement directives have not yet been achieved; expresses the hope, however, that the most recent judgments handed down by the CJEU will help to resolve the outstanding legal issues and that the number of appeal procedures will fall; calls on the Commission to have regard to and actively to pursue the aims of simplifying and streamlining the public procurement procedure in any review of the European rules;
Amendment 69 #
2009/2175(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Notes the Commission Communication of 19 November 2009 on the development of public-private partnerships and awaits the relevant impact assessment with great interest; emphasises that due account must be taken of both the complexity of the procedures and the differences in legal culture and practice between the Member States with regard to service concessions, and doubts, therefore, very strongly whether a proposal for a legal act dealing with service concessions would have any added value; takes the view that with the 2004 public procurement directives and the supplementary case-law of the CJEU the process of defining the term ‘service concession’ and establishing the legal framework governing such concessions has been completed and there is no legislative need for a European directive on service concessions;
Amendment 84 #
2009/2175(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Looks forward with great interest to the CJEU judgment in Case C-451/08 and hopes that it will clarify the issues still under dispute in the area of town planning; takes the view that in the last few years procurement law has permeated areas which are not inherently to be classified under public purchasing and therefore suggests that the criterion of purchasing is emphasised more strongly again in the application of the rules of procurement law; endorses the opinion delivered by the Advocate-General of the CJEU in this case on 17 November 2009 to the effect that ‘the broad and ambitious aims of the directive must be borne in mind when interpreting the Directive but it should not be assumed that, by appealing to the purpose of the measure, its scope can be extended indefinitely’ (point 35); otherwise there would be a danger that ‘all town planning activities would be subject to the Directive since, by definition, provisions on the possible execution of building works substantially alter the value of the land in question’ (point 36)
Amendment 96 #
2009/2175(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Draws attention to the great importance of public procurement for climate protection, energy efficiency, the environment and innovation and reiterates that public authorities should be encouraged and put in a position to base public procurement on ecological, social and other criteria; welcomes calls on the Commission to make clear that public authorities may base public procurement on ecological criteria such as sustainable management, social criteria such as the payment of relevant standard wages and other criteria; calls on the Commission to devise guidelines or other practical assistance given to public authorities and other public bodies in connection with sustainable procurement and urges the Commission and the Member States to organise training courses and campaigns to raise awareness of this issue; supports the idea of a transparent process, involving the Member States, to develop the relevant criteria further; points out that in the area of social criteria in particular such a process offers good prospects for improvements;
Amendment 110 #
2009/2175(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls for the development of a database so that the criteria on which the various labels are based can be used for public procurement purposes; calls on the Commission to put forward initiatives at European and international level with a view to the gradual harmonisation of labels and the criteria on which they are based; expects the Member States and stakeholders to be fully involved in this process; draws attention, at the same time, to the negative impact which a market fragmented by the existence of so many regional, national, European and international labels has on innovation and research;
Amendment 39 #
2009/2153(INI)
Motion for a resolution
Recital M
Recital M
M. whereas it is important to have a mandatory separate collection system, except where separating bio-waste from other types of waste would not be viable from the environmental and economic point of view (in particular where the logistics of separate collection do not make it possible to prevent bio-waste from being contaminated with other types of waste or polluting substances, or where separate collection infrastructure is not environmentally justified in rural or sparsely populated areas),
Amendment 66 #
2009/2153(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to establish a mandatory separate collection system for the Member States, except where this is not viable or is not the best option from the environmental and economic point of view;
Amendment 25 #
2009/2152(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Emphasises that research efforts should be strengthened, within the framework of the current Seventh Framework Programme and future research framework programmes, in order to address existing knowledge gaps andin relation to hazards (past and likely future weather-related disasters) and other relevant factors such as socio-economic developments (current and future geographical distribution of assets at risk) in specific places and at specific times, and to develop modalities and techniques for assessing the costs of measures for adaptation to the impacts of climate change and their respective contribution to reducing exposure or vulnerability to climatic risks;
Amendment 28 #
2009/2152(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Underlines the need for further research into appropriate forward-looking and multi-dimensional risk modelling at regional and local levels, as well as the need to define adaptive capacity across the territory of the EU;
Amendment 32 #
2009/2152(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Encourages the Commission to ensure easy access to detailed data (including metadata describing the dataset methodologies) for all public and private stakeholders; takes the view that climate change data should be considered to be a public good and thus, in line with Article 14 of the INSPIRE Directive, be made available to the public free of charge or at a charge that covers the cost of maintaining datasets and the corresponding data services;
Amendment 36 #
2009/2152(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Takes the view that the Commission should ensure that the Clearing House Mechanism is not redundant given developed as a portal, which will integrate other existence of othering systems such as the Shared Environmental Information System (SEIS) and Global Monitoring for Environment and Security (GMES) and should add value in terms of preparing the EU, the Member States and private stakeholders to plan, fund and implement proper adaptation plans;
Amendment 54 #
2009/2152(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Encourages the Commission to maintain the possibility for the Member States to allocate EU funds to a contribution to agricultural insurance premiums, which was introduced as part of the CAP Health Check, while also improving the current provisions 68 to 70 of the regulation on direct support schemes for farmers so as to make the system more effective and thereby facilitate better risk management in the agricultural sector;
Amendment 64 #
2009/2152(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
Amendment 80 #
2009/2152(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
Amendment 89 #
2009/2152(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Underlines that medium and long-term investments in infrastructure projects should take full account of the predicted future climatic conditions and resulting risks, while maintaining a certain flexibilityadaptive capacity to changing risks;
Amendment 94 #
2009/2152(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Stresses the need to ensure that, as part of environmental impact assessment, all building permits and urban plans, licences to operate, urban plans and land-use planning in general take into account different adaptation scenarios;
Amendment 100 #
2009/2152(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Suggests that the Commission should consider ways of encouraging appropriate land-use planning (including risk and hazard mapping) among the possibilities that it intends to explore in connection with the climate impact assessment of public and private investment;
Amendment 101 #
2009/2152(INI)
Motion for a resolution
Paragraph 20 b (new)
Paragraph 20 b (new)
20b. Encourages the Commission to go ahead with its plan to incorporate climate impacts into construction standards (such as Eurocodes) in order to improve the resilience of buildings located in risk- prone areas;
Amendment 141 #
2009/2152(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Calls on the Commission and Member States to develop the public- private partnerships needed to create a long-term, strong and effective climate risk management framework (covering all aspects from risk awareness to risk sharing and recovery), with strong leadership by and the involvement of the public authorities;
Amendment 142 #
2009/2152(INI)
Motion for a resolution
Paragraph 25 b (new)
Paragraph 25 b (new)
25b. Invites the Commission to develop a comprehensive approach to the involvement of the insurance industry in the design and implementation of each stage in risk management;
Amendment 146 #
2009/2152(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Stresses that the next multiannual financial framework should, compared to the current one, accord a higher ranking to climate change, and in particular to adaptation measures, ensuring that the necessary funds are available; and the EU funds that Member States may allocate to the contribution to agricultural insurance premiums, as introduced in the CAP health check1, ensuring that the necessary funds are available; 1 Provisions 68-70 of the regulation on direct support schemes for farmers.
Amendment 149 #
2009/2152(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls for the future reform of the structural funds, which should be driven by objective and common key performance indicators, to prioritise climate change, in particular adaptation;
Amendment 152 #
2009/2152(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Urges the Council and the Commission to reactivate the process of revision of the Solidarity Fund Regulation (EUSF), which will make it possiblein order to limit pure ex-post compensation and favour ex-ante financing schemes, to ensure that the allocated funds are invested in a way that increases the resilience to climate change, and to address damage caused by natural or man- made disasters in a more effective, flexible and timely manner;
Amendment 169 #
2009/2152(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Supports the proposal of the Commission to set up an impact and adaptation steering group; asks the Commission to ensure that this group includes representatives of Parliament as observers as well as of relevant private stakeholders (in particular the insurance industry) as experts;
Amendment 21 #
2009/0173(COD)
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) To enhance the competitiveness of the European automotive industry, incentive schemes such as the offsetting of eco-innovations and the award of super-credits should be used in preference to prohibitions incurring criminal penalties.
Amendment 26 #
2009/0173(COD)
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) In order to provide the purchasers of light commercial vehicles with the information necessary to take purchasing decisions, manufacturers should provide potential customers with information on these vehicles’ CO2 emissions and fuel consumption.
Amendment 34 #
2009/0173(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Manufacturers should have flexibility to decide how to meet their targets under this Regulation and should be allowed to average emissions over their new vehicle fleet rather than having to respect CO2 targets for each individual vehicle. Manufacturers should therefore be required to ensure that the average specific emission for all the new light commercial vehicles registered in the Community for which they are responsible does not exceed the average of the emissions targets for those vehicles. This requirement should be phased in between 20145 and 20167 in order to facilitate its introduction. This is consistent with the lead times given and the duration of the phase-in period set in Regulation 443/2009.
Amendment 35 #
2009/0173(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) In order to ensure that targets reflect the particularities of small and niche manufacturers and are consistent with the manufacturer's reduction potential, alternative emission reduction targets should be set for such manufacturers taking into account the technological potential of a given manufacturer's vehicles to reduce their specific emissions of CO2 and consistently with the characteristics of the market segments concerned. This derogation should be covered by the review of the specific emission targets in Annex I, to be completed by the beginning of 20134 at the latest.
Amendment 38 #
2009/0173(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) The Community Strategy to reduce CO2 emissions from passenger cars and light commercial vehicles established an integrated approach with a view to reaching the Community target of 120 g CO2/km by 2012, while also presenting a longer-term vision of further emission reductions. Regulation (EC) No 443/2009 substantiates this longer-term view by setting a target of 95 g CO2/km as average emissions for the new car fleet. In order to ensure consistency with that approach and to provide planning certainty for the industry, a long-term targets for the specific emissions of CO2 of light commercial vehicles in 2020 and 2025 should be set.
Amendment 41 #
2009/0173(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Manufacturers' compliance with the targets under this Regulation should be assessed at the Community level. Manufacturers whose average specific emissions of CO2 exceed those permitted under this Regulation should pay an excess emissions premium with respect to each calendar year from 1. January 20145. The premium should be modulated as a function of the extent to which manufacturers fail to comply with their target. In order to ensure consistency, the premium mechanism should be similar to the one set in Regulation (EC) No 443/2009. The amounts of the excess emissions premium should be considered as revenue in the General Budget of the European Union.
Amendment 52 #
2009/0173(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) The speed of road vehicles has a stris onge influence on their fuel consumption and CO2 emissions. In addition, in the absence of speed limitation for light commercial vehicles, it is possible that there is an element of competition as regards top speed which could lead to oversized powertraline with the principle that, in reducing CO2 emissions, more use should be made of economic incentives and less of prohibitions, a voluntary scheme granting manufacturers, in return for the installation of speed limiters, certain credits in respect of the CO2 emissions saved might contribute to promotinsg and associated inefficiencies in slower operating condit more fuel-efficient and environmentally friendly fleet of LCVs in the Unions. It is therefore appropriate to investigate the feasibility of extendingFirst, however, urgent measures should be taken to investigate scientifically whether significant quantities of CO2 emissions can be saved by the installation of speed limiters and if so whether it is possible to extend the scope of Council Directive 92/6/EEC on the installation and use of speed limitation devices for certain categories of motor vehicles in the Community, in the framework of a voluntary scheme with bonuses, with the aim of including light commercial vehicles covered in this Regulation.
Amendment 59 #
2009/0173(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. From 20206, this Regulation sets a target of 135 g CO2/km for the average emissions of new light commercial vehicles registered in the Community, provided the Commission has confirmed the feasibility of this target in its review pursuant to Article 12(4).
Amendment 65 #
2009/0173(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. From 2020, this Regulation sets a target of 13560 g CO2/km for the average emissions of new light commercial vehicles registered in the Community, provided the Commission has confirmed the feasibility of this target in its review pursuant to Article 12(4).
Amendment 74 #
2009/0173(COD)
Proposal for a regulation
Article 1 – paragraph 2 a (new)
Article 1 – paragraph 2 a (new)
2a. From 2025, this Regulation sets a target of 135 g CO2/km for the average emissions of new light commercial vehicles registered in the Union, provided the Commission has confirmed the feasibility of this target in its review pursuant to Article 12(4).
Amendment 77 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
For the calendar year commencing 1 January 20145 and each subsequent calendar year, each manufacturer of light commercial vehicles shall ensure that its average specific emissions of CO2 do not exceed its specific emissions target determined in accordance with Annex I or, where a manufacturer is granted a derogation under Article 10, in accordance with that derogation.
Amendment 78 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 1 a (new)
Article 4 – paragraph 1 – subparagraph 1 a (new)
For the purpose of determining each manufacturer’s specific emissions of CO2, a progressive reduction towards the target value of 135 g CO2/km in 2026 shall be set for all of a given manufacturer’s new light commercial vehicles: - 175 g CO2/km in 2018 - 165 g CO2/km in 2020 - 155 g CO2/km in 2022 - 145 g CO2/km in 2024 - 135 g CO2/km in 2026.
Amendment 86 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 2 – indents 1, 2 and 3
Article 4 – paragraph 2 – indents 1, 2 and 3
– 65% in 2015, – 75% in 20146, – 80% in 2015,7. – 100% from 20168 onwards.
Amendment 91 #
2009/0173(COD)
Proposal for a regulation
Article 5 – introductory part – indents 1, 2 and 3
Article 5 – introductory part – indents 1, 2 and 3
In calculating the average specific emissions of CO2, each new light commercial vehicle with specific emissions of CO2 of less than 50 g CO2/km shall be counted as: – 2,5 light commercial vehicles in 2014, – 1,5 light commercial vehicles in 2015% of the indicative specific CO2 emissions pursuant to Annex I shall be counted as: – 3,5 light commercial vehicles in 2016, – 3,5 light commercial vehicles in 2017, – 2,5 light commercial vehicles in 2018, – 2,5 light commercial vehicles in 2019, – 1,5 light commercial vehicles in 2020, – 1,5 light commercial vehicles in 2021, – 1 light commercial vehicle from 201622.
Amendment 97 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
For the calendar year commencing 1 January 20145 and each subsequent calendar year, each manufacturer of light commercial vehicles shall ensure that its average specific emissions of CO2 do not exceed its specific emissions target determined in accordance with Annex I or, where a manufacturer is granted a derogation under Article 10, in accordance with that derogation.
Amendment 107 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
Manufacturers shall take the appropriate measures to gradually reduce the average CO2 emissions of new light commercial vehicles registered in the Union so as to reach the target of 135 g CO2/km in 2025, taking account – in order to promote continuing innovation – of the following non-binding targets: - 165 g CO2/km in 2019 - 145 g CO2/km in 2023.
Amendment 112 #
Amendment 121 #
Amendment 138 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 2 – indent 3
Article 4 – paragraph 2 – indent 3
–100% from 20167 onwards.
Amendment 141 #
2009/0173(COD)
Proposal for a regulation
Article 12 – paragraph 4 – subparagraph 1 – introductory part
Article 12 – paragraph 4 – subparagraph 1 – introductory part
By 1 January 20134, the Commission shall complete a review of the specific emissions targets in Annex I and of the derogations in Article 10, with the aim of defining:
Amendment 142 #
2009/0173(COD)
Proposal for a regulation
Article 12 – paragraph 4 – subparagraph 1 – indent 1
Article 12 – paragraph 4 – subparagraph 1 – indent 1
– subject to confirmation of its feasibility on the basis of updated impact assessment results, the modalities for reaching, by the year 20206, a long-term target of 135 g CO2/km in a cost-effective manner; and
Amendment 147 #
2009/0173(COD)
Proposal for a regulation
Article 5 a (new)
Article 5 a (new)
Article 5a Specific emission target for alternative fuel vehicles For the purpose of determining compliance by a manufacturer with its specific emissions target referred to in Article 4, the specified emissions of CO2 of each vehicle which is designed to be capable of running on a mixture of petrol with 85 % ethanol (‘E85’), and which meets relevant Union legislation or European technical standards, shall be reduced by 5 % by 31 December 2015 in recognition of the greater technological and emissions reduction capability when running on biofuels. This reduction shall apply only where at least 30 % of the filling stations in the Member State in which the vehicle is registered provide this type of alternative fuel complying with the sustainability criteria for biofuels set out in relevant Union legislation.
Amendment 152 #
2009/0173(COD)
Proposal for a regulation
Article 5 – introductory part
Article 5 – introductory part
In calculating the average specific emissions of CO2, each new light commercial vehicle with specific emissions of CO2 of less than 50 g CO2/km% of the indicative specific CO2 emissions pursuant to Annex I shall be counted as:
Amendment 161 #
2009/0173(COD)
Proposal for a regulation
Article 5 – indent 1
Article 5 – indent 1
2,5 light commercial vehicles in 20145,
Amendment 165 #
2009/0173(COD)
Proposal for a regulation
Article 5 – indent 2
Article 5 – indent 2
Amendment 168 #
2009/0173(COD)
Proposal for a regulation
Article 5 – indent 3
Article 5 – indent 3
Amendment 172 #
2009/0173(COD)
Proposal for a regulation
Article 7 a (new)
Article 7 a (new)
Amendment 195 #
2009/0173(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. In respect of the period 1 January 20145 and every calendar year thereafter, the Commission shall impose an excess emissions premium on a manufacturer or pool manager, as appropriate, where a manufacturer's average specific emissions of CO2 exceed its specific emissions target.
Amendment 201 #
2009/0173(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point a – introductory part
Article 8 – paragraph 2 – subparagraph 1 – point a – introductory part
(a) From 20145 to 2018:
Amendment 240 #
2009/0173(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. From the 31 October 20145, the list published under paragraph 1 shall also indicate whether the manufacturer has complied with the requirements of Article 4 with respect to the preceding calendar year.
Amendment 242 #
2009/0173(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Upon application by a supplier or a manufacturer, CO2 savings achieved through the use of innovative technologies shall be considered. The total contribution of those technologies to reducing the specific emissions target of a manufacturer may be up to 7 g CO2/km.
Amendment 245 #
2009/0173(COD)
Proposal for a regulation
Article 11 – paragraph 2 – introductory part
Article 11 – paragraph 2 – introductory part
2. The Commission shall by 31 December 2012, adopt detailed provisions for a procedure to approve such innovative technologies in accordance with the regulatory procedure referred to in Article 13(2). Those detailed provisions shall be in conformity with the provisions of Article 12(2) of Regulation (EC) No 443/2009 and shall be based on the following criteria for innovative technologies:
Amendment 246 #
2009/0173(COD)
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 a (new)
Article 11 – paragraph 2 – subparagraph 1 a (new)
These detailed provisions shall respect the following principles: (a) the regularly updated European Union list of approved eco-innovations shall guarantee that eco-innovations are standardised within the European Union and ensure that these technologies are applied effectively by the authorities responsible for type-approval in the Member States; (b) the authorities responsible for type- approval in the Member States shall assess and approve the use of eco- innovations and the way in which their respective contributions to CO2 reduction are taken into account, so that every vehicle model can be assigned a specific eco-innovation pack; (c) the Commission shall decide on the application from the supplier or manufacturer within six months of receipt of the application; (d) a technology shall be approved as an eco-innovation where a maximum of 40% of its contributions to CO2 reduction are measurable in the type test cycle; (e) a technology shall be approved as an eco-innovation where its contributions to CO2 reduction amount to more than 0.2 g/km.
Amendment 255 #
2009/0173(COD)
Proposal for a regulation
Article 12 – paragraph 4 – subparagraph 1 – indent 1
Article 12 – paragraph 4 – subparagraph 1 – indent 1
– subject to confirmation of its feasibilitywhether, on the basis of updated impact assessment results, the modalities for reaching, by the yearit is possible to reach a long-term target of 160 g CO2/km by 2020, and a long-term target of 135 g CO2/km by 2025 in a cost-effective manner; and
Amendment 272 #
2009/0173(COD)
Proposal for a regulation
Article 12 – paragraph 4 – subparagraph 2 – indent 2
Article 12 – paragraph 4 – subparagraph 2 – indent 2
– confirm themake a proposal to inclusionde in this Regulation of vehicles in category N2 and M2 as defined in Annex II to Directive 2007/46/EC with a reference mass not exceeding 2 610 kg and to vehicles to which type-approval is extended in accordance with Article 2(2) of Regulation (EC) No 715/2007, with a view to the long-term target from 2020.
Amendment 284 #
2009/0173(COD)
Proposal for a regulation
Article 12 – paragraph 6 – subparagraph 2
Article 12 – paragraph 6 – subparagraph 2
Amendment 292 #
2009/0173(COD)
Proposal for a regulation
Annex 1 – point 1 – subpoint a – line 1
Annex 1 – point 1 – subpoint a – line 1
(a) From 20145 to 2017:
Amendment 106 #
2009/0076(COD)
Proposal for a regulation
Recital 66
Recital 66
(66) Taking into consideration that some products were not previously covered by the Community legislation in the field of biocidal products, it is appropriate to allow for a transitional period for the companies to be prepared to apply the rules concerning in situ generated active substances, and treated articles and materials and food contact materials.
Amendment 109 #
2009/0076(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point p a (new)
Article 2 – paragraph 2 – point p a (new)
pa) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC;
Amendment 111 #
2009/0076(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point s
Article 3 – paragraph 1 – point s
Amendment 136 #
2009/0076(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point i
Article 3 – paragraph 1 – point i
(i) 'placing on the market' means the first supply of a biocidal product for distribution or for use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;to third parties, whether in return for payment or free of charge, or the making available of a biocidal product to third parties. Importation shall be deemed to be placing on the market. No supply to third parties is involved, for example, when in the course of a commercial activity treated materials or products are individually manufactured and then incorporated by the manufacturer.
Amendment 137 #
2009/0076(COD)
Proposal for a regulation
Article 47 – paragraph 2 – point a
Article 47 – paragraph 2 – point a
a) the name, using wherever possible common nomenclature (e.g. INCI) of all active substances that were used to treat the article or materials or that were incorporated in the articles or materials;, where relevant and for all active substances which are intended to be released under normal or foreseeable conditions of use from the treated article or material, unless labelling requirements or alternative means to meet information requirements already exist under sector- specific legislation.
Amendment 139 #
2009/0076(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point k a (new)
Article 3 – paragraph 1 – point k a (new)
ka. 'External biocidal effect' means the effect of applications whereby the incorporated biocidal product is intended to be released under normal conditions of use which can reasonably be foreseen.
Amendment 139 #
2009/0076(COD)
Proposal for a regulation
Article 47 – paragraph 2 – point b
Article 47 – paragraph 2 – point b
b) where relevant, the biocidal property attributed to treated articles or materials;
Amendment 140 #
2009/0076(COD)
Proposal for a regulation
Article 47 – paragraph 2 – point c
Article 47 – paragraph 2 – point c
Amendment 142 #
2009/0076(COD)
Proposal for a regulation
Article 47 – paragraph 2 – point d
Article 47 – paragraph 2 – point d
d) only for treated articles and where relevant, any hazard statement or precautionary statement set out in the authorisation for the biocidal product.
Amendment 152 #
2009/0076(COD)
Proposal for a regulation
Article 82
Article 82
Amendment 227 #
2009/0076(COD)
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1
Article 15 – paragraph 2 – subparagraph 1
2. Application for authorisation shall be made by, or on behalf of, the person who shall be responsible for the initial placing on the market of a biocidal product in a particular Member State or in the Community.
Amendment 393 #
2009/0076(COD)
Proposal for a regulation
Article 47 – paragraph 1
Article 47 – paragraph 1
1. Treated materials or articles that incorporate one or more biocidal productactive substances shall not be placed on the market unless the biocidal productactive substance(s) used for treating the materials or articles are listed in Annex I (the positive list for active substances) and from a source supported by the named applicant listed alongside the Annex I inclusion for that active substance. authorised for this use in the Community or in at least one Member State.
Amendment 402 #
2009/0076(COD)
Proposal for a regulation
Article 47 – paragraph 2 – point b
Article 47 – paragraph 2 – point b
b) where relevant, the biocidal propertyies attributed to treated articles materials or products if the biocidal product is intended to be released under nor materialsl conditions of use which can reasonably be foreseen;
Amendment 407 #
2009/0076(COD)
Proposal for a regulation
Article 47 – paragraph 2 – point d
Article 47 – paragraph 2 – point d
d) any hazard statement or precautionary statement set out in the authorisation for the biocidal product if the biocidal product is intended to be released under normal conditions of use which can reasonably be foreseen.
Amendment 412 #
2009/0076(COD)
Proposal for a regulation
Article 47 – paragraph 2 – subparagraph 3
Article 47 – paragraph 2 – subparagraph 3
Where this is necessary because of the size or the function of the treated article or material, the labelling shall be printed on the packaging, on the instructions for use or on the warranty of the treated article or material. In the case of treated materials or articles which are not produced as part of a series, but rather designed and manufactured to meet a specific order, the manufacturer may agree other methods of providing the relevant information with the customer.
Amendment 418 #
2009/0076(COD)
Proposal for a regulation
Article 52 – paragraph 3
Article 52 – paragraph 3
3. Where no such agreement is reached two months after the request was made according to Article 51(2), both the owner of the information and the prospective applicant shall without delay inform the Agency and the owner of the information thereof. Within two months of being informed about the failure to reach an agreement, the Agency shall give the prospective applicant the right to refer to the tests or studies involving tests on vertebrate animals. National courtsBoth the owner of the information and the prospective applicant will submit to legally binding abitration. The arbitration will be carried out under the rules of a recognised independent arbitration institute decided by the owner of the information after consulting with the prospective applicant. An arbitration shall be started and concluded promptly and in any event be concluded within 6 months of the parties informing the Agency of their failure to reach an agreement. An arbitration shall decide on the proportionate share of all the costs associated with the generation and use of the information that the prospective applicant shall pay to the data owner.
Amendment 433 #
2009/0076(COD)
Proposal for a regulation
Article 56 – paragraph 3 a (new)
Article 56 – paragraph 3 a (new)
3a. Public access shall be granted free of charge to an inventory containing details of biocidal products authorised pursuant to Article 16(3) and of the corresponding manufacturers.
Amendment 437 #
2009/0076(COD)
Proposal for a regulation
Article 58 – paragraph 2 – introductory part
Article 58 – paragraph 2 – introductory part
2. Labels shall not be misleading and, in any case, shall not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or similar indications. The description 'low-risk biocidal product' shall be reserved for products authorised pursuant to Article 16(3). In addition, the label must show clearly and indelibly the following information:
Amendment 442 #
2009/0076(COD)
Proposal for a regulation
Article 58 – paragraph 2 – point m a (new)
Article 58 – paragraph 2 – point m a (new)
(ma) where appropriate, the description 'low-risk biocidal product' for products authorised pursuant to Article 16(3).
Amendment 446 #
2009/0076(COD)
Proposal for a regulation
Article 62 – paragraph 3
Article 62 – paragraph 3
3. Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health or the environment. In any case, the advertising of a biocidal product shall not mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or any similar indication. Advertising employing the description 'low-risk biocidal product' shall be permissible only for products authorised pursuant to Article 16(3).
Amendment 456 #
2009/0076(COD)
Proposal for a regulation
Article 70 – paragraph 2 – point e a (new)
Article 70 – paragraph 2 – point e a (new)
(ea) fees may not exceed EUR 45 000.
Amendment 473 #
2009/0076(COD)
Proposal for a regulation
Article 81
Article 81
By way of derogation from Article 47, treated articles and materials that incorporate biocidal products which are not authorised in the Community or in at least one Member State and which were available on the market on ... [OJ: insert the date referred to in the first subparagraph of Article 85] may, until the date of a decision granting authorisation to these biocidal products, continue to be placed on the market if the application for authorisation is submitted at the latest by 1 January 2017. In the case of a refusal to grant an authorisation to place a biocidal product on the market, treated articles and materials that incorporate such biocidal product shall no longer be placed on the market within six12 months after such decision. The deadline must be extended to take account of importers' business cycles. Traders order goods up to 18 months before they appear on the shelves. A 12-month deadline would guarantee importers the legal security they need.Or.deJustification
Amendment 10 #
2009/0054(COD)
Proposal for a directive
Recital 16
Recital 16
(16) SurveysExperience shows that public authorities often require contractual payment periods for commercial transactions that areare often significantly longer than 30 days. Therefore, payment periods for procurement contracts awarded by public authorities should be as a general rule limitin commercial transactions should be as a general rule limited to a maximum of 30 days; in cases where longer payment periods are duly justified in accordance with the principle of necessity or with special provisions of national law and where an explicit agreement has been made between the debtor and the creditor, the payment period could be extended to a maximum of 360 days.
Amendment 18 #
2009/0054(COD)
Proposal for a directive
Article 3
Article 3
Amendment 26 #
2009/0054(COD)
Proposal for a directive
Article 5 – title
Article 5 – title
Amendment 29 #
2009/0054(COD)
Proposal for a directive
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. Member States shall ensure that, in commercial transactions leading to the delivery of goods or the provision of services for remuneration to public authorities, the creditor is entitled, without the necessity of a reminder, to interest for late payment equal to statutory interest if the following conditions are satisfied:
Amendment 32 #
2009/0054(COD)
Proposal for a directive
Recital 16
Recital 16
(16) SurveysExperience shows that public authorities often require contractual payment periods for commercial transactions that areare often significantly longer than 30 days. Therefore, payment periods for procurement contracts awarded by public authorities should be as a general rule limitin commercial transactions should be as a general rule limited to a maximum of 30 days; in cases where longer payment periods are duly justified in accordance with the principle of necessity or with special provisions of national law and where an explicit agreement has been made between the debtor and the creditor, the payment period could be extended to a maximum of 360 days.
Amendment 42 #
2009/0054(COD)
Proposal for a directive
Article 5 – paragraph 4
Article 5 – paragraph 4
4. Member States shall ensure that: (a) the period for payment fixed in the contract shall not exceed the time limits provided for in paragraph 2(b), unless it is duly justified in accordance with the principle of necessity or in accordance with special provisions laid down by national law and unless it is specifically agreed between the debtor and the creditor, and is duly justified in the light of particular circumstances such as an objective need to schedule payment over a longer periodn any event never exceeds 60 days; (b) the date of receipt of the invoice is not subject to a contractual agreement between debtor and creditor. Member States may, if necessary, deviate from the requirements laid down in paragraph (a) in cases of arrangements for payment by instalments or staggered payments which have been specifically agreed between the debtor and the creditor.
Amendment 44 #
2009/0054(COD)
Proposal for a directive
Recital 17
Recital 17
(17) Late payment is particularly regrettable if it occurs despite the debtor’s solvency. Surveys show that in some Member States public authorities often pay invoices very late after expiration of the applicable payment period. Public authorities may face lighter financing constraints because they may benefit from more secure, predictable and continuous revenue streams than private undertakings. At the same time, they depend less than private undertakings on building stable commercial relationships for the achievement of their aims. Consequently, public authorities may have less incentive to pay on time. In addition, many public authorities can obtain financing at more attractive conditions than private undertakings. Therefore, late payment by public authorities not only leads to unjustified costs for private undertakings, but to inefficiency in general. It is therefore appropriate to introduce correspondingly higher dissuasive compensation in case of late payment by public authorities.
Amendment 46 #
2009/0054(COD)
Proposal for a directive
Article 5 – paragraph 5
Article 5 – paragraph 5
5. Member States shall ensure that when interest for late payment becomes payable, the creditor is entitled to a lump sum compensation payments amounting to: (a) compensation equal to 52% of the amount due. This compensation shall be additional to the interest for late payment. from the date interest becomes payable; (b) compensation equal to 5% of the amount due after 30 days from the date interest becomes payable. Or. en (The original COM-AM is split into (a) and (b))
Amendment 49 #
2009/0054(COD)
Proposal for a directive
Article 5 – paragraph 6 – introductory part
Article 5 – paragraph 6 – introductory part
6. Member States shall ensure that the applicable reference rate in commercial transactions leading to the delivery of goods or the provision of services for remuneration to public authorities:
Amendment 79 #
2009/0054(COD)
Proposal for a directive
Article 2 – point 9 b (new)
Article 2 – point 9 b (new)
(9b) “checkable invoice” means a clearly drawn up final invoice which keeps to the agreed order of items and uses the descriptions contained in the contract. The quantity calculations, drawings and other supporting documents required to prove the nature and scope of the work performed must be enclosed with the invoice;
Amendment 136 #
2009/0054(COD)
Proposal for a directive
Article 5 – title
Article 5 – title
Amendment 146 #
2009/0054(COD)
Proposal for a directive
Article 5 – paragraph 2 – point b
Article 5 – paragraph 2 – point b
(b) if the date or period for payment is not fixed in the contract, interest for late payment shall become payable automatically within any of the following time limits: (i) 30 days following the date of receipt by the debtor of the checkable invoice or an equivalent request for payment; (ii) if the debtor receives the checkable invoice or the equivalent request for payment earlier than the goods or the services, 30 days after the receipt of the goods or services; (iii) if a procedure of acceptance or verification, by which the conformity of the goods or services with the contract is to be ascertained, is provided for by statute or in the contract and if the debtor receives the checkable invoice or the equivalent request for payment earlier or on the date on which such acceptance or verification takes place, 30 days after that date.
Amendment 163 #
2009/0054(COD)
Proposal for a directive
Article 5 – paragraph 4
Article 5 – paragraph 4
4. Member States shall ensure that: (a) the period for payment fixed in the contract shall not exceed the time limits provided for in paragraph 2(b), unless it is duly justified in accordance with the principle of necessity or in accordance with special provisions laid down by national law and unless it is specifically agreed between the debtor and the creditor, and is duly justified in the lightn any event never exceeds 60 days. (b) Member States may, if necessary, deviate from the requirements laid down in paragraph (a) in cases of arrangements ofn particular circumstances such as an objective need to schedule payment over a longer periodyment by instalments or staggered payments which have been specifically agreed between the debtor and the creditor. (c) Member States shall ensure that the date of receipt of the invoice is not subject to a contractual agreement between debtor and creditor.
Amendment 191 #
2009/0054(COD)
Proposal for a directive
Article 5 – paragraph 6
Article 5 – paragraph 6
6. Member States shall ensure that the applicable reference rate in commercial transactions leading to the delivery of goods or the provision of services for remuneration to public authorities:
Amendment 65 #
2009/0006(COD)
Proposal for a regulation
Recital 19 b (new)
Recital 19 b (new)
(19b) This Regulation is limited to rules concerning the harmonisation of textile fibre names and the labelling of the fibre composition of textile products. In order, however, to eliminate obstacles that might arise to the proper functioning of the internal market caused by diverging provisions or practices of Member States, and in order to keep pace with the development of electronic commerce and future challenges in the market of textile products, it would be desirable to examine the harmonisation or standardisation of other aspects of textile labelling with a view to facilitate the free movement of textile products in the internal market and achieve throughout the EU a uniform and high level of consumer protection. To that end, the Commission should submit a report to the European Parliament and the Council regarding possible new labelling requirements to be introduced at Union level.
Amendment 94 #
2009/0006(COD)
Proposal for a regulation
Article 20 a (new)
Article 20 a (new)
Article 20a Review By ...* at the latest, the Commission shall submit a report to the European Parliament and the Council regarding the possible introduction of new labelling requirements at Union level. ___________ * Two years from the date of entry into force of this Regulation.
Amendment 69 #
2008/2306(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the need to increase transparency at European level and national level, especially with regardi to streng thening environmental impact assessments and including socio- economic and health dimensions, in order to improve citizens' confidence in the authorisation procedure;
Amendment 95 #
2008/2306(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Underlines the need for further harmonstandardisation of practices and methods of assessing the environmental risks of GMOs, especially as, under Regulation (EC) No 1829/2003, the environmental evaluationrisk assessment is not centralised but delegated by the European Food Safety Authority (EFSA) to a Member State;
Amendment 96 #
2008/2306(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Considers that in the long term the environmental risk assessment should no longer be delegated to individual Member States, but should be taken over by the EFSA itself, on the basis of its own scientific expertise;
Amendment 202 #
2008/2306(INI)
Motion for a resolution
Subheading after paragraph 23
Subheading after paragraph 23
Amendment 222 #
2008/2306(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Stresses that, in addition to those possibilities, regions in the Member States must be allowed the right to prohibit completelydecide for themselves about the cultivation of GMOs in restricted geographical areas, for instance in sites belonging to the Natura 2000 network; this is also based on the subsidiarity principle;
Amendment 231 #
2008/2306(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Invites the Commission and Member States to clarify the legal definition of GMO-free zoneszones free of GMO cultivation;
Amendment 42 #
2008/2237(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Envisages a need for further development of the Small Business Act in the area of labour law, especially in view of the flexicurity principle, which enables SMEs in particular to respond more quickly to changes in the market and therefore to guarantee a higher level of employment and the competitiveness of the company, as well as international competitiveness, while taking into account the necessary social protection; in this connection refers to its resolution of 29 November 2007 on flexicurity1; stresses that one of the main pillars of flexicurity is a simple and predictable labour law, which is of crucial importance to SMEs in particular, because these businesses often cannot afford to have a legal department;
Amendment 48 #
2008/2237(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Notes that, despite the clear commitment made in the European Charter for Small Enterprises, the voice of SMEs remain muted within the context of the social dialogue; urges that this deficit is formally corrected by appropriate proposals within the context of the Small Business Act;
Amendment 151 #
2008/2237(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Emphasises the fundamental importance of evaluating the impact of future legislative initiatives on SMEs; therefore calls for systematic and targeted impact assessments for SMEs, a so called ‘SME test’ for all new proposals for EU legislation affecting business; considers it necessary that the results of the SME test are subject to an independent evaluation which should be available to the EU legislative bodies;
Amendment 9 #
2008/2211(INI)
Motion for a resolution
Recital I a (new)
Recital I a (new)
Ia. Whereas the use of Magnetic Resonance Imaging (MRI) must not be threatened by Directive 2004/40/EC as MRI technology is at the cutting edge of research, diagnosis and treatment of life- threatening diseases for patients in Europe,
Amendment 11 #
2008/2211(INI)
Motion for a resolution
Recital I b (new)
Recital I b (new)
Ib. Whereas MRI has been safely used over 25 years with over 500 million patients exposed to up to 100 times the exposure limit set by the Directive without evidence of harm to workers or patients.
Amendment 12 #
2008/2211(INI)
Motion for a resolution
Recital I c (new)
Recital I c (new)
Ic. Whereas the MR safety standard IEC/EN 60601-2-33 establishes limit values for electromagnetic fields which have been set so that any danger to patients and workers is excluded.
Amendment 35 #
2008/2211(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Commission to find a solution enabling Directive 2004/40/EC to be implemented more rapidly and thus ensure that workers are properly protected against electromagnetic fields, just as they are already protected under two other Community acts against noise and vibration and to introduce a derogation for Magnetic Resonance Imaging under Article 1 of that Directive.
Amendment 10 #
2008/2208(INI)
Motion for a resolution
Recital C
Recital C
C. whereas nanomaterials are likelycontribute to be the next "big thing", especially given that manipulating all matter has been man's ultimate dream for centuriesresolution of global challenges and help the European Union in its aim to become ‘the most competitive and dynamic knowledge-based economy in the world’ (Lisbon Strategy),
Amendment 20 #
2008/2208(INI)
Motion for a resolution
Recital F
Recital F
F. whereas there is no clear information about the actual use of nanomaterials in consumer products, for instance: − while inventories by renowned institutions list more than 800 manufacturer-identified nanotechnology-based consumer products currently on the market, trade associations of the same manufacturers question these figures, on the basis that they are overestimations, without providing any concrete figures themselves, − while companies happily use "nano- claims", as the term “nano” seems to have a positive marketing effect, they are strictly opposed to objective labelling requirement varies from one information source to another and whereas REACH will provide a clear picture of such uses,
Amendment 25 #
2008/2208(INI)
Motion for a resolution
Recital H
Recital H
H. whereas there is a major controversy debate about the possibility of assessing the safety of nanomaterials: while is ongoing, and the scientific committees of the Commission point to major deficiencies not only in key data, but even and the OECD have noted that the available testing methods of obtaining such data, manyare applicable in principle; whereas this view is shared by most representatives of the industry claim that all relevant data are available and that there are no methodological deficiencies, who also observe that the necessary data for assessing the safety of commercial products are available in respect of the vast majority of the nanomaterials currently manufactured,
Amendment 40 #
2008/2208(INI)
Motion for a resolution
Recital L
Recital L
L. whereas the Commission’s overview shows that there are no nano-specific provisions in Community legislation for the time beingare not necessary, since nanomaterials are substances and since substances are sufficiently covered by legislation on chemical substances and by sector-specific legislation,
Amendment 56 #
2008/2208(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Considers it highly misleading for the Commission to state, in the absence of any nano-specific provisions in Community law, that current legislation covers in principle the relevant risks relating to nanomaterials, when due to the lack of appropriatSupports the Commission’s view that current legislation covers in principle the risks of nanomaterials; agrees that the data and methods to assess the risks arelating to nanomaterials it is effectively blind to its risk applicable in principle, and that the further adaptation of these methods must be tested by the OECD Working Party on Manufactured Nanomaterials;
Amendment 62 #
2008/2208(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Considers that as long as current legislation is devoid of any nano-specific provisions, and as long as data and even methods to assess the risks of nanomaterials are missing, betterwhile nanomaterials are adequately covered by current law and the OECD has confirmed the applicability of the testing methods, the instruments for the implementation of the current law alone cannot bring about the necessary level of protectionegislation need to be further developed;
Amendment 64 #
2008/2208(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Considers that the proposed implementation focus does not provide thenecessary steps are being taken towards the implementation of a "safe and integrated approach" to nanotechnologies as advocated by the Commission, given that numerous nanomaterials are already on the market, particularly in sensitive applications such as personal care products or cleaning products, without adequate safety;
Amendment 84 #
2008/2208(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
Amendment 100 #
2008/2208(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls for potential patent rights to be limited to specific applications or production methods of nanomaterials, and not to be extended to nanomaterials themselves, to avoid stifling innovation and to avoid creating a North-South "nano-divide"granted in accordance with existing patent law in order to ensure an appropriate level of protection for patent holders and not to discourage innovations by strict supervision of the patent criteria;
Amendment 109 #
2008/2208(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
Amendment 18 #
2008/2085(INI)
Motion for a resolution
Recital D
Recital D
D. Whereas the objective of the PWD – to provide for a climate of fair competition and measures guaranteeing respect for the rights of workers – is more important than ever; in an economic era in which transnational provision of services is expanding, the PWD is expected to play a key-role in protecting the posted workers concerned, while respecting the framework of labour law and industrial relations of Member States,
Amendment 24 #
2008/2085(INI)
Motion for a resolution
Recital G
Recital G
G. Whereas the nucleus provisions in Article 3(1) of the PWD consists of international mandatory rules which the MS have commonly agreed upon; the public order provisions in Article 3(10) also consist of international mandatory rules but un such a way that MS themselves can define them; the use of Article 3(10) is important for MS to be able to consider a variety of labour market, social policy and other concerns including protection of workers, with a respect for principle of equal treatment,
Amendment 29 #
2008/2085(INI)
Motion for a resolution
Recital J
Recital J
J. Whereas the European Council has set up principles to create labour market models that have as well as a high level of security as a high level of flexibility, the so called flexicurity model; it is recognised that an important part of a successful flexicurity model includes strong social partners with a significant scope for collective bargaining,; it is stated that flexicurity should promote more open, responsive and inclusive labour markets overcoming segmentation;
Amendment 32 #
2008/2085(INI)
Motion for a resolution
Recital K
Recital K
K. Whereas the Albany judgement (C- 67/96) in the field of competition law gave substantial and large space for trade unions to regulate labour market issues; in fact, at that time the ECJ rejected the direct horizontal effect for competition rules on collective bargaining,
Amendment 36 #
2008/2085(INI)
Motion for a resolution
Recital L
Recital L
Amendment 45 #
2008/2085(INI)
Motion for a resolution
Recital M
Recital M
Amendment 54 #
2008/2085(INI)
Motion for a resolution
Recital N
Recital N
N. Whereas the ECJ in the Rüffert case has significantly diminishdisclosed the scope for Member States to regulate theitransfer collective bargaining and also narrows down the purpose of the PWD, neglectto foreign employees and employers seen in relation to the aim of the Posted Workers Directive, by revealing the PWD’s two fold aim of the Posted Workers Directive – protection of workers and free movement,;
Amendment 62 #
2008/2085(INI)
Motion for a resolution
Recital O
Recital O
O. Whereas the ECJ in the Viking case introduces a horizontal direct effect of Articles 43 and 49 which can be used by employers and service providers to challenge collective agreements and industrial actions with a cross-border effect; the autonomy for collective bargaining from competition rules is thereby not extended to the field of free movement with a risk that industrial relations in the Member States will be put under legal scrutiny; consequently, this new uncertainty in industrial relations could result in a “flood” of cases to the ECJ,allows that the fundamental right to use collective action and the internal market freedoms can be brought in line with each other;
Amendment 89 #
2008/2085(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Emphasises that the freedom to provide services is not superior to the fundamental right for trade unions to take industrial action; especially, since this is a constitutional right in several Member StatesECJ has ruled that the right for trade unions to take industrial action must be recognised as a fundamental right; however, the exercise of that may non the less be subject to restrictions as emphasized by the ECJ;
Amendment 97 #
2008/2085(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Emphasises that the freedom to conduct a business in accordance with Union law and national laws and practices is spelled out in the Charter of Fundamental Rights; however notes that the right of collective bargaining, equally mentioned in the Charter of Fundamental Rights, must be conducted in accordance with Union law and national law and practices and is equally limited through the proportionality principle as spelled out by the Court of Justice in the Viking case;
Amendment 107 #
2008/2085(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Stresses that Article 3(7) of the PWD clearly states that trade unions should be able to demand terms and conditions of employment which are more favourable to workersstates that Article 3(1-6) shall not prevent application of terms and conditions of employment which are more favourable to workers; also stresses that, according to the ECJ as stated in the Laval case, this article cannot be interpreted as allowing the host Member State to make the provision of services in its territory conditional on the observance of terms and conditions of employment which go beyond the mandatory rules for minimum protection;
Amendment 111 #
2008/2085(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Points outStresses that recital 22 in the PWD states that provisions laid down in the PWD should have no effecthe directive is without prejudice to the law of the Member States concerning collective action to defend the interests of trades and professions; equally stresses that the ECJ stated in the Laval case that the right to take collective action falls within the scope of application of Community law and therefore must be justified by an overriding reason of public interest and be proportionate; emphasizes in that con the right to take industrial actitext that the ECJ has ruled that the right to take collective action for the protection of the workers constitute such an overriding reason;
Amendment 124 #
2008/2085(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Underlines the importance of not allowing the verdicts to negatively effectsupport for labour market models that already today are able to combine a high degree of flexibility on the labour market with a high level of security and, instead, of further promoting this approach;
Amendment 129 #
2008/2085(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Underlines that the verdicts fully respect the different labour market models that combine a high degree of flexibility on the labour market with a high level of security;
Amendment 134 #
2008/2085(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
Amendment 147 #
2008/2085(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Regretsiterates the fact that all conditions imposed on foreign employers above minimum levels are seen as obstacles to free movement, if employees do not already receive more favourable conditions in the country of origin;
Amendment 153 #
2008/2085(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Underlines that the PWD seeks to bring about the freedom to provide services, which is one of the fundamental freedoms guaranteed by the Treaty, while guaranteeing the adequate protection of posted workers, and that a proportionate balance between these interests must be maintained;
Amendment 156 #
2008/2085(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
Amendment 168 #
2008/2085(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Emphasises that the PWD as interpreted by the ECJ would prevent demands for equal pay for work for all workers regardless of their nationality or that of their employer in the place where the service is provided; this runs counter to the principle of nprinciple of equal pay and of non-discrimination which are established in the Treaty will continue to apply with regard to workers moving to another Member State to seek for a job or take up employment there, and that trade unions will continue to have the right to take action to uphold equal treatment and secure decent working con-discrimination which is established in the Treaty especially with regard to the mobility of workerstions at national level for migrant workers; takes for granted that the ECJ does not pronounce itself in a way counter to the non-discriminatory principle;
Amendment 177 #
2008/2085(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
Amendment 182 #
2008/2085(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Underlines that the ECJ is the ultimate interpreter of the PWD and all other EC legislation and that the ECJ takes into account in particular the objective and the legal base in the Treaty when interpreting EC legislation;
Amendment 183 #
2008/2085(INI)
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. Recalls that the PWD seeks to bring about the freedom to provide services, and that it has to be interpreted, like all directives adopted on an internal market legal basis, in the light of the rules of the Treaty on the freedom to provide services as interpreted by the ECJ, whilst taking into account other objectives pursued by EC legislation, such as social policy objectives;
Amendment 189 #
2008/2085(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. RegretNotes that the social considerations referred to in Articles 26 and 27 in Directive 2004/18, do not include terms and conditions of employment which go beyond the mandatory rules for minimum protection;
Amendment 192 #
2008/2085(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 207 #
2008/2085(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Emphasises that the current situation could lead to a situatiECJ ruling in the Laval case is not the base for an attack on wthere workers in host countries will be pressured by low wage competition; this, in turn, could lead to xenophobia and counterproductive anger against the EU fundamental rights of the trade unions to use collective action, but it restricts the aim of collective action to the objective of protecting posted workers and securing their minimum rights;
Amendment 217 #
2008/2085(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Regrets that the ECJ fails to consider ILO convention 94, and fears that the ECJ judgement in Rüffert may impede the ratification of ILO 94; this would be counter to the further development of social clauses in public procurement regulations, which is an aim of the Public procurement directive 2004Underlines that Member States can only implement international conventions that are in line with EC legislation;
Amendment 222 #
2008/2085(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
Amendment 234 #
2008/2085(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
Amendment 252 #
2008/2085(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Therefore calls on the Commission to take immediate action to make necessary changes in European legislrecommend the Member States to enhance their administrative cooperation in order to counfacilitater the possible detrimental social, economical and political effects of the ECJ judgementseffective implementation and enforcement of the Community legislation in this field;
Amendment 254 #
2008/2085(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Underlines that the ECJ rulings in the cases of Viking, Laval and Rüffert do not necessitate a change of EC legislation; a call for a change of legislation after each ECJ ruling will cause imbalance in the division of the democratic powers within, and principles of, the European Union;
Amendment 258 #
2008/2085(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Therefore welcomes the Commission's statement from 3 April 2008 which clearly states that they will continue to fight social dumpprovide "easily accessible, accurate and up to date information" to competent authorities and other actors involved, such as social partners, undertakings and that the freedom to provide services is not superior to the fundamental rights of trade unionsworkers "to prevent emergence of conflicts, problematic situations and abuses"; this should help in creating a climate of mutual trust and confidence;
Amendment 268 #
2008/2085(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Therefore cCalls on the Commission to review the PWD and consider the following issues: - a new legal basis for the PWD to better protect workers; workers posted within the framework of services should be regarded as using the right of freedom of movement of workers and not the free movement of services; - a possibility inand the Member States to remedy any lack of implementation, application and enforcement of the Ddirective for Member States to refer in law or collective agreements to the 'habitual wages' applicable in the place of work in the host country as defined in the ILO 94 and not only ‘minimum’ rates of pay; - a limit to the period of time during which workers can be considered as being 'posted' to a Member State other than the Member State of their ordinary place of work in the framework of services; after that period the rules on free movement of workers should apply, i.e. host country rules with regard to wages and working conditions have full application; - an even clearer expression that the Directive and other EU legislation do not prohibit Member States and trade unions from demanding more favourable conditions for the worker; and - the recognition of a wider range of methods of organizing labour markets than those currently covered by Article 3(8)96/71/EG; urgently calls on the Commission to take appropriate measures against Member States who do not apply the Community legislation in this area in line with the interpretation of the ECJ;
Amendment 293 #
2008/2085(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
Amendment 28 #
2008/2041(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Points out that the Commission recommends almost exclusively measures, such as setting up pedestrian areas or introducing speed limits, which have no cross-border impact and which are subject to the subsidiarity principle, so that the European Union has no competence in this respect.
Amendment 29 #
2008/2041(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Points out that the Treaty of Lisbon and the protocol on services of general interest attached to it recognise the right of local authorities to self-government, and that this agreement is already being respected by the European institutions in the period prior to the formal entry into force of the Treaty;
Amendment 32 #
2008/2041(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Considers that, in the light of the major regional differences in the quality of transport in Europe, it would be advisable to make non-binding guidelines (know-how) available to all local authorities via the internet; points out, however, that these guidelines should imply no obligations which would become binding for towns and cities in the framework of a subsequent review of the aims of the Green Paper by the Commission;
Amendment 126 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - introductory part (new)
Article 1 – point 2 a - paragraph 1 - introductory part (new)
-1) In Article 1, the following point 2a is inserted after point 2: 2a. Falsified medicinal product: Any medicinal product that has been deliberately falsified in relation to its:
Amendment 132 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point a (new)
Article 1 – point 2 a - paragraph 1 - point a (new)
(a) identity, including its packaging, labelling, name and composition in terms of both ingredients, including excipients and active ingredients, and the dosage thereof;
Amendment 143 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point b (new)
Article 1 – point 2 a - paragraph 1 - point b (new)
(b) source, including the manufacturer, the country of origin and the marketing authorisation holder;
Amendment 145 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point c (new)
Article 1 – point 2 a - paragraph 1 - point c (new)
(c) history, including the registers and documents enabling the distribution chain to be identified.
Amendment 152 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 2 (new)
Article 1 – point 2 a - paragraph 2 (new)
The Commission shall be empowered to update this definition on the basis of technical and scientific progress and international agreements. This definition is not related to infringements of legislation on intellectual and industrial property rights or patent rights. This definition does not include manufacturing errors.
Amendment 162 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 2001/83/EC
Article 1 – point 17 b (new)
Article 1 – point 17 b (new)
(1a) In Article 1, the following point 17b is inserted after point 17a: 17b. Persons authorised to supply medicinal products: Persons or entities in possession of a wholesale distribution authorisation without prejudice to persons or entities exempt from holding an authorisation to supply medicinal products.
Amendment 234 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 – point b - subparagraph 1 a (new)
Article 54a – paragraph 2 – point b - subparagraph 1 a (new)
Safety features shall be considered equivalent where they are equally efficient in identifying, authenticating, tracing and preventing tampering with medicinal product, and where they are equally technical difficult to duplicate. This paragraph shall also apply to the removal, replacement or covering up of new safety features unless the primary safety feature is a covert one and cannot be recognised.
Amendment 241 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 - point c a (new)
Article 54a – paragraph 2 - point c a (new)
(c a) The safety features referred to in point (o) of Article 54 shall be applied without discrimination between distribution channels.
Amendment 297 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 11
Article 1 – point 11
Directive 2001/83/EC
Title VII – Heading
Title VII – Heading
“Wholesale distribution and trad, trading and brokering of medicinal products”
Amendment 301 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 11 b (new)
Article 1 – point 11 b (new)
Directive 2001/83/EC
Article 77 – paragraph 1
Article 77 – paragraph 1
(11b) In Article 77, paragraph 1 is replaced by the following: ‘1. Member States shall take all appropriate measures to ensure that the wholesale distribution, trade and brokerage of medicinal products is subject to the possession of an authorization to engage in activity as a wholesaler, trader or broker in medicinal products, stating the place for which it is valid.’
Amendment 302 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 12 a (new)
Article 1 – point 12 a (new)
Directive 2001/83/EC
Article 77 – paragraph 5
Article 77 – paragraph 5
(12a) In Article 77, paragraph 5 is replaced by the following: 5. Checks on the persons authorized to engage in the activity of wholesaling, trading or brokering in medicinal products and the inspection of their premises, as applicable, shall be carried out under the responsibility of the Member State which granted the authorization.
Amendment 303 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 12 b (new)
Article 1 – point 12 b (new)
Directive 2001/83/EC
Article 77 – paragraph 6
Article 77 – paragraph 6
(12b) In Article 77, paragraph 6 is replaced by the following: 6. The Member State which granted the authorization referred to in paragraph 1 shall suspend or revoke that authorisation, after having notified the holder thereof, if the conditions of authorisation cease to be met or if the authorisation has not been used for more than three years, except in cases where the authorisation was not used on account of the time reasonably necessary to comply with the obligations under this Directive. That Member State shall forthwith inform the other Member States and the Commission thereof.
Amendment 305 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 12 c (new)
Article 1 – point 12 c (new)
Directive 2001/83/EC
Article 78
Article 78
(12c) Article 78 is replaced by the following: Member States shall ensure that the time taken for the procedure for examining the application for the distribution, trade or brokerage authorization does not exceed 90 days from the day on which the competent authority of the Member State concerned receives the application. The competent authority may, if need be, require the applicant to supply all necessary information concerning the conditions of authorization. Where the authority exercises this option, the period laid down in the first paragraph shall be suspended until the requisite additional data have been supplied.’
Amendment 307 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 12 d (new)
Article 1 – point 12 d (new)
Directive 2001/83/EC
Article 79 a (new)
Article 79 a (new)
(12d) The following Article 79a is inserted: ‘Article 79a The Commission shall, in cooperation with the Agency and Member State authorities, lay down rules and criteria for obtaining trade and brokerage authorisations. Applicants must fulfil the following minimum requirements: (a) they must have a permanent address or contact details, so as to ensure accurate identification and location of their official place of business; (b) they must undertake to ensure that they conduct their activities only with those persons or entities that are able to fulfil their obligations under the terms of Article 80.'
Amendment 308 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 13 - point -a (new)
Article 1 – point 13 - point -a (new)
Directive 2001/83/EC
Article 80 – introductory sentence
Article 80 – introductory sentence
(-a) The introductory sentence is replaced by the following: ‘Holders of the authorisation for distributing, trading or brokering medicinal products must fulfil the following minimum requirements:’
Amendment 310 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 13 - point -a a (new)
Article 1 – point 13 - point -a a (new)
Directive 2001/83/EC
Article 80 – point c a (new)
Article 80 – point c a (new)
(-a a) The following point (ca) is added: '(ca) they must randomly verify that the medicinal products they have purchased are not falsified by checking the safety feature on the outer packaging, as referred to in point (o) of Article 54;'
Amendment 312 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 13 – point a
Article 1 – point 13 – point a
Directive 2001/83/EC
Article 80 – point e
Article 80 – point e
(e) they must keep records either in the form of purchase/sales invoices or on computer, or in any other form, giving for any transaction in medicinal products received, dispatched or, traded or brokered at least the following information: - date, - name of the medicinal product, - quantity received, supplied or trad, traded or brokered, - name and address of the supplier or consignee, as appropriate;’;, - national identification number, where appropriate,
Amendment 314 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 13 – point a a (new)
Article 1 – point 13 – point a a (new)
Directive 2001/83/EC
Article 80 – point g
Article 80 – point g
(aa) Point (g) is replaced by the following: ‘(g) they must comply with the principles and guidelines of good distribution practice, or principles and guidelines of good trade practices, or principles and guidelines of good brokerage practices for medicinal products as laid down in Article 84.’
Amendment 316 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 13 – point b
Article 1 – point 13 – point b
Directive 2001/83/EC
Article 80 – point i – paragraph 1
Article 80 – point i – paragraph 1
(i) they must inform the competent authority of products they receive, trade or broker which they identify as infringing, or they suspect of infringing, either of the following:
Amendment 323 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 13 – point c
Article 1 – point 13 – point c
Directive 2001/83/EC
Article 80 – subparagraph 1 a
Article 80 – subparagraph 1 a
Amendment 326 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 13 a (new)
Article 1 – point 13 a (new)
Directive 2001/83/EC
Article 84
Article 84
(13a) Article 84 is replaced by the following: ‘Article 84 The Commission shall publish guidelines on good distribution, trading and brokering practice for medicinal products. To this end, it shall consult the Committee for Proprietary Medicinal Products and the Pharmaceutical Committee established by Council Decision 75/320/EEC1. 1 OJ L 147, 9.6.1975, p. 23.’
Amendment 347 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 15 – point b
Article 1 – point 15 – point b
Directive 2001/83/EC
Article 111 – paragraph 3
Article 111 – paragraph 3
3. After every inspection as referred to in paragraph 1, the competent authority shall report on whether the manufacturer, importer, or wholesale distributor, trader or broker complies with the principles and guidelines of good manufacturing practice and, good distribution practices, good trading practice, or good brokerage practice referred to in Articles 47 and 84 or on whether the marketing authorization holder complies with the requirements laid down in Title IX. The competent authority which carried out the inspection shall communicate the content of those reports to the manufacturer, importer, marketing authorization holder, or to the wholesale distributor, trading authorisation holder or brokerage authorisation holder who has undergone the inspection. Before adopting the report, the competent authority shall give the manufacturer, importer, marketing authorization holder, or wholesale distributor, trader or broker concerned the opportunity to submit their comments.’
Amendment 348 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 15 – point c
Article 1 – point 15 – point c
Directive 2001/83/EC
Article 111 – paragraph 5 – subparagraph 1
Article 111 – paragraph 5 – subparagraph 1
5. Within 90 days of an inspection as referred to in paragraph 1, a certificate of good manufacturing practice or, good distribution practice, good trading practices, or good brokerage practice shall be issued to the manufacturer, importer, or wholesale distributor, trader or broker if the outcome of the inspection shows that the person complies with the principles and guidelines of good manufacturing practice or, good distribution practice, good trading practices, or good brokering practice as provided for by CommunityUnion legislation.
Amendment 349 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 15 – point c
Article 1 – point 15 – point c
Directive 2001/83/EC
Article 111 – paragraph 6
Article 111 – paragraph 6
6. Member States shall enter the certificates of good manufacturing practice and, good distribution practice, good trading practice and good brokering practice which they issue in a Community database managed by the Agency on behalf of the Community.
Amendment 351 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 15 – point c
Article 1 – point 15 – point c
Directive 2001/83/EC
Article 111 – paragraph 7
Article 111 – paragraph 7
7. If the outcome of the inspection as referred to in paragraph 1 is that the person does not comply with the principles and guidelines of good manufacturing practices or good distribution practices, good trading practices or good brokering practices as provided for by Community legislation, the information shall be entered in the Community database referred to in paragraph 6.
Amendment 359 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118a
Article 118a
The competent authorities shall issue the accreditation referred to in Articles 46(f) and 80(b) if the applicant can demonstrate that he is competent to carry out verification of compliance with good manufacturing practices or, in the case of wholesale distributors, good distribution practices or, in the case of traders, good trading practices or, in the case of brokers, good brokering practices.
Amendment 25 #
2008/0260(COD)
Proposal for a directive – amending act
Recital 9
Recital 9
(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensivecontinuously monitored on the market. PAs with all medicines, patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).
Amendment 34 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 3 – point b
Article 1 – point 3 – point b
Directive 2001/83/EC
Article 11
Article 11
“For the purpose of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No. 726/2004, the summary shall include the statement: “This medicinal product is under intensivehas been proven to be of benefit for patients with your condition. As with all medicines it is subject to safety monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>“
Amendment 38 #
2008/0260(COD)
Proposal for a directive – amending act
Recital 9
Recital 9
(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensivecontinuously monitored on the market. PAs applies to all medicines, patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).
Amendment 49 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Directive 2001/83/EC
Article 59 – paragraph 1
Article 59 – paragraph 1
For medicinal products included on the list referred to in Article 23 of Regulation (EC) No. 726/2004, the following additional statement shall be included “This medicinal product is under intensivehas been proven to be of benefit for patients with your condition. As with all medicines, it is subject to safety monitoring.. All suspected adverse reactions should be reported to your healthcare professional or to <name and web-address of the national competent authority >“.
Amendment 55 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 1
Article 106 – point 1
(1) a summary of risk management systems for medicinal products authorised in accordance with this Directive;
Amendment 57 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 2
Article 106 – point 2
(2) the list of medicinal products under intensive monitoring referred to in Article 23 of Regulation (EC) No 726/2004 whose authorisation is subject to certain conditions or requirements;
Amendment 61 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 3 a (new) and point 3 b (new)
Article 106 – point 3 a (new) and point 3 b (new)
(3a) the most up-to-date electronic version of the package leaflet and Summary of Product Characteristics for all existing and new medicinal products; (3b) a brief document history of changes made to the product information. All information on the safety web-portals, including all of the information set out in points 1 to 3b, shall be presented in an understandable way for the general public.
Amendment 115 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 3 – point b
Article 1 – point 3 – point b
Directive 2001/83/EC
Article 11 – paragraph 3
Article 11 – paragraph 3
“For the purposes of point (3a) of the first subparagraph, for medicinal products included on the list referred to in Article 23 of Regulation (EC) No. 726/2004, the summary shall include the statement: “This medicinal product is under intensivehas been proven to be of benefit to patients with your condition. As with all medicines it is subject to safety monitoring. All suspected adverse reactions should be reported to <name and web-address of the national competent authority>“.”
Amendment 155 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraph 2
Article 59 – paragraph 1 – subparagraph 2
“The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. form that is clearly legible, prominent and clearly distinguishable from the rest of the text. Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol and text “New information”.
Amendment 161 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraph 3
Article 59 – paragraph 1 – subparagraph 3
For medicinal products included on the list referred to in Article 23 of Regulation (EC) No. 726/2004, the following additional statement shall be included “‘This medicinal product is under intensivehas been proven to be of benefit to patients with your condition. As with all medicines, it is subject to safety monitoring.. All suspected adverse reactions should be reported to your healthcare professional or to <name and web-address of the national competent authority >”’.”
Amendment 215 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106
Article 106
(1) a summary of risk management systems for medicinal products authorised in accordance with this Directive; (2) the list of medicinal products under intensive monitoring referred to in Article 23 of Regulation (EC) No 726/2004 whose authorisation is subject to certain conditions or requirements; (3) web-based structured forms for the reporting of suspected adverse reactions by healthcare professionals and patients based on the forms referred to in Article 25 of Regulation (EC) No 726/2004. ; (4) the most up-to-date electronic version of the package leaflet and summary of product characteristics for all existing and new medicinal products; (5) a brief document history of changes made to the product information. All information on the safety web-portals, including all of the above, shall be presented in a manner that is comprehensible to the general public.
Amendment 11 #
2008/0257(COD)
Proposal for a regulation – amending act
Recital 15
Recital 15
(15) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or subject to conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensivecontinuously monitored on the market. PAs with all medicines, patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be kept up to date by the Agency.
Amendment 14 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 — point 11
Article 1 — point 11
Regulation (EC) No 726/2004
Article 23 – paragraph 1
Article 23 – paragraph 1
The Agency shall establish and make public a list of medicinal products for human use under intensive monitoring.
Amendment 18 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 — point 11
Article 1 — point 11
Regulation (EC) No 726/2004
Article 26 — point 4
Article 26 — point 4
(4) the list of medicinal products under intensive monitoring referred to in Article 23 of this Regulation whose authorisation is subject to certain conditions or requirements;
Amendment 20 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 — point 11
Article 1 — point 11
Regulation (EC) No 726/2004
Article 26 – paragraph 4 a (new)
Article 26 – paragraph 4 a (new)
(4a) the most up-to-date electronic version of the package leaflet and Summary of Product Characteristics for all existing and new medicinal products;
Amendment 21 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 — point 11
Article 1 — point 11
Regulation (EC) No 726/2004
Article 26 – point 4 b (new)
Article 26 – point 4 b (new)
(4b) a brief document history of changes made to the product information. All information on the safety web-portals, including all of that set out in points 1 to 4b of this Article, shall be presented in an understandable way for the general public.
Amendment 31 #
2008/0257(COD)
Proposal for a regulation – amending act
Recital 15
Recital 15
(15) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensivecontinuously monitored on the market. PAs with all medicines, patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (hereinafter referred to as the ‘Agency’).
Amendment 42 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 23 – subparagraph 1
Article 23 – subparagraph 1
The Agency shall establish and make public a list of medicinal products for human use under intensive monitoring.
Amendment 53 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 11
Article 1 – point 11
Regulation EC/726/2004
Article 26 – points 4, 4 a (new), 4 b (new)
Article 26 – points 4, 4 a (new), 4 b (new)
(4) the list of medicinal products under intensive monitoring referred to in Article 23 of this Regulation;referred to in Article 23 of this Regulation whose authorisation is subject to certain conditions or requirements; (4a) the most up-to-date electronic version of the package leaflet and summary of product characteristics for all existing and new medicinal products; (4b) a brief document history of changes made to the product information; All information on the medicines safety web-portals, including all of the above, shall be presented in a manner that is comprehensible to the general public.
Amendment 28 #
2008/0256(COD)
Proposal for a directive – amending act
Recital 2
Recital 2
(2) In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to health-care professionals) and the package leaflet (inserted in the product’s packaging when it is dispensed to the patient). On the other hand, as regards the disseminationmaking available of information from the marketing authorisation holder to patients and the general public, the Directive only provides that certain information activities are not covered by the rules on advertising, without providing for a harmonised framework on the contents and the quality of non -promotional information on medicinal products or on the channels through which this information may be disseminated.made available. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 29 #
2008/0256(COD)
Proposal for a directive – amending act
Recital 4
Recital 4
(4) Experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to providmake information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout)
Amendment 30 #
2008/0256(COD)
Proposal for a directive – amending act
Recital 5
Recital 5
(5) Those disparities in the interpretation of the Community rules on advertising, and between national provisions on information have a negative impact on the uniform application of Community rules on advertising, and on the effectiveness of the provisions on product information contained in the summary of products’ characteristics and the package leaflet. Although those rules are fully harmonised to ensure the same level of protection of public health across the Community, this objective is undermined if widely divergent national rules on the disseminationmaking available of such key information are allowed. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout)
Amendment 31 #
2008/0256(COD)
Proposal for a directive – amending act
Recital 7
Recital 7
(7) In the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the European Union have become increasingly active as regards healthcare, it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good-quality, objective, reliable and non -promotional information on medicinal products by placing emphasis on the interests of patients. They should have the right to easily access certain information such as a summary of product characteristics and the package leaflet in electronic and printed form.
Amendment 32 #
2008/0256(COD)
Proposal for a directive – amending act
Recital 8
Recital 8
(8) National competent authorities and health care professionals should remain importantthe main sources of information on medicinal products for the general public. Member States should facilitate the access of citizens to high-quality information through appropriate channels. MWithout prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public, marketing authorisation holders may be a valuablen additional source of non -promotional information on their medicinal products. This Directive should therefore establish a legal framework for the disseminationmaking available of specific information on medicinal products by marketing authorisation holders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained.
Amendment 34 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 2
Recital 2
(2) In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to health-care professionals) and the package leaflet (inserted in the product's packaging when it is dispensed to the patient). On the other hand, as regards the disseminationmaking available of information from the marketing authorisation holder to patients and the general public, the Directive only provides that certain information activities are not covered by the rules on advertising, without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be disseminated.made available. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 34 #
2008/0256(COD)
Proposal for a directive – amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminatmake available only high-quality information and to distinguish non-promotional information from advertising, the types of information which may be disseminatedmade available should be defined. It is appropriate to allow marketing authorisation holders to disseminatmake available the contents of the approved summaries of product characteristics and package leaflets, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product-related information. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 36 #
2008/0256(COD)
Proposal for a directive – amending act
Recital 12 a (new)
Recital 12 a (new)
(12a) The Internet is a major source of information for a growing number of patients. This trend is likely to increase in the coming years. In order to adapt to this development and to add to the growing importance of e-health, information on medicinal products should also be made available via national health Internet websites. These websites should be monitored by competent authorities in the Member States. Member States in cooperation with stakeholders such as health care professionals or patient organisations should be responsible for managing these websites.
Amendment 37 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point -1 a (new)
Article 1 – point -1 a (new)
Directive 2001/83/EC
Article 59 – paragraph 3 a (new)
Article 59 – paragraph 3 a (new)
(-1a) The following paragraph shall be inserted: “3a. The package leaflet shall correspond to the real needs of patients. To this end, patient organisations should be involved in developing and reviewing the information on medicinal products by national regulatory authorities and the European Medicines Agency. The package leaflet entails a short paragraph which sets out the benefit and potential harm of a medicinal product as well as a short description of further information aiming at a safe and effective use of a medicinal product.”
Amendment 39 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 4
Article 86 – paragraph 2 – indent 4
– information made available by the marketing authorisation holder to the general public on medicinal products subject to medical prescription, which is subject to the provisions of Title VIIIa.
Amendment 41 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 1
Article 100 a – paragraph 1
1. Member States shall allow the marketing authorisation holder to disseminatmake available, either directly or indirectly through a third party, information to the general public or members thereof on authorised medicinal products subject to medical prescription provided that it is in accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIII. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout)
Amendment 42 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 4
Recital 4
(4) Experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to providmake information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 44 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 1 a (new)
Article 100 a – paragraph 1 a (new)
Amendment 45 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – introductory part
Article 100 b – introductory part
The following types of information on authorised medicinal products subject to medical prescription may be disseminatedmade available by the marketing authorisation holder to the general public or members thereof: (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 46 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 7
Recital 7
(7) In the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the European Union have become increasingly active as regards healthcare, it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good-quality, objective, reliable and non promotional information on medicinal products by placing emphasis on the interests of patients. They should have the right to easily access certain information such as a summary of product characteristics, and the package leaflet in electronic and printed form.
Amendment 46 #
2008/0256(COD)
Proposal for a directive – amending actArticle 1 – point 5 Directive 2001/83/EC
Article 100 b – introductory part
Article 100 b – introductory part
1. The following types of information onmarketing authorisation holder shall, in respect of authorised medicinal products subject to medical prescription, may be disseminated by the marketing authoriske available to the general public or members thereof a summary of the product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities, and the publicly accessible version of the assessment report drawn up by the competent authorities. This information should be made available both in electronic and in printed form and in a format accessible to people with disabilities. 2. In addition, the following types of information may also be made availabler to the general public or members thereof by the marketing authorisation holder:
Amendment 47 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Amendment 49 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 8
Recital 8
(8) National competent authorities and health care professionals should remain importantthe main sources of information on medicinal products for the general public. Member States should facilitate the access of citizens to high-quality information through appropriate channels. Marketing authorisation holders may be a valuable source of non promotional information on their medicinal products. This Directive should therefore establish a legal framework for the dissemination of specific information on medicinal products by marketing authorisatWhile there is already a lot of independent information on pharmaceuticals, for example by national authorities or health care professionals, the situation differs very much between Member States and among the different products available. Member States and Commission shoulders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained take much more efforts to facilitate the access of citizens to high-quality information through appropriate channels.
Amendment 49 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point b
Article 100 b – point b
(ba) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different wayway that is comprehensible to the general public or members thereof without jeopardising the quality or reliability of the information;
Amendment 51 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point c
Article 100 b – point c
(cb) information on the environmental imparelating to the disposal of unused medicinal products of ther waste derived from medicinal products, as well as reference to any collection system in place; information on prices and factual, informative announcements and reference material on a medicinal product, relating, for example, to pack changes or adverse- reaction warnings;
Amendment 52 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point d a (new)
Article 100 b – point d a (new)
(da) the pharmaceutical and pre-clinical tests or clinical trials of the medicinal product concerned that are contained in the publicly accessible version of the assessment report referred to in paragraph 1.
Amendment 53 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 8 a (new)
Recital 8 a (new)
(8a) Without prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public, marketing authorisation holders may be an additional source of non-promotional information on their medicinal products. This Directive should therefore establish a legal framework for the making available of specific information on medicinal products by marketing authorisation holders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained.
Amendment 54 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 9
Recital 9
(9) In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to the supply of information on prescription-only medicinal products that has been approved by the competent authorities by the marketing authorisation holder, as current Community rules allow the advertising to the general public of medicinal products not subject to prescription, under certain conditions.
Amendment 54 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – introductory part
Article 100 c – introductory part
Information on authorised medicinal products subject to medical prescription disseminatedmade available by the marketing authorisation holder to the general public or members thereof shall not be made available on television or ra, radio or in the printed medioa. It shall only be made available through the following channels:
Amendment 57 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point a
Article 100 c – point a
(a) health-related publications as defined by the Member State of publicCommission’s guidelines concerning the information allowed, such as booklets, leaflets, and other categories of printed information, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 58 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 10
Recital 10
(10) Provisions should be established to ensure that only high-quality non- promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated. The information should take into account patients needs and expectations in order to empower patients, allow informed choices and enhance the rational use of medicinal products. Therefore, any information to the general public on prescription-only medicinal products should comply with a set of quality criteriabe approved in advance by the competent authorities und should be supplied only in the approved form.
Amendment 58 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point b
Article 100 c – point b
(b) imarketing authorisation holders’ Internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 60 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c a (new)
Article 100 c a (new)
Article 100ca 1. Member States shall ensure that the mandatory information as referred to in Article 100b(1) shall be made available through national health Internet websites in the official language(s) of the Member State where the website is registered. Such websites shall be monitored by a competent authority of the Member State or by a body assigned by the competent authority in accordance with Article 100g. The websites shall be administered and managed in cooperation with stakeholders such as health care professionals and patient organisations. 2. The information shall communicate both benefits and risks in a clear descriptive manner that is patient friendly and linked to the national medicinal products safety website. The Internet websites shall provide patients with the mandatory information on all available medicinal products in that Member State both centrally approved by the European Medicines Agency and locally approved in that Member State. 3. The Internet websites should also include general information about medicinal and non-medicinal treatment of various diseases, including rare diseases, in order to promote a high level of public health. They may also contain other information as referred to in Article 100b(2) and as defined by the Commission’s guidelines concerning information allowed.
Amendment 63 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 – subparagraph 2 a (new)
Article 100 h – paragraph 2 – subparagraph 2 a (new)
Without prejudice to this prohibition, Internet websites registered in accordance with paragraph 1 can provide video content when it is aimed at supporting the safe and effective use of medicinal products in general and provided that it does not contain any promotional claims relating to medicinal products. Compliance with these two conditions shall be subject to monitoring in accordance with Article 100g.
Amendment 64 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminatmake available only high-quality information and to distinguish non-promotional information from advertising, the types of information which may be disseminatedmade available should be defined. It is appropriate to allow marketing authorisation holders to disseminatmake available the contents of the approved summaries of product characteristics and package leaflet, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product-related information. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 64 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 – subparagraph 2 b (new)
Article 100 h – paragraph 2 – subparagraph 2 b (new)
The registered Internet websites shall display a notification at the top of each website page informing the public that the information contained therein is developed by a named marketing authorisation holder. A link to the EudraPharm database on medicinal products shall also be included in that notification.
Amendment 67 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminate only high-quality information andcompetent authority- approved high-quality information in approved form and in order to distinguish non-promotional information from advertising, the types of information which may be disseminated should be defined. It is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflets, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product- related informationcluding the "drug-fact-box".
Amendment 72 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 12
Recital 12
(12) Information to the general public on prescription-only medicinal products that has been approved by the competent authorities should only be provided through specific channels of communication, including Internet and health-related publications, by the marketing authority holder to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public. Where information is disseminated via television or radioby the marketing authority holder via television, radio or newspapers, magazines and similar publications, patients are not protected against such unsolicited information and such disseminsupply of information should therefore not be allowed.
Amendment 74 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 12 a (new)
Recital 12 a (new)
(12 a) The internet is a major source of information for a growing number of patients. This trend is likely increase in the coming years. In order to adapt to this development and to add to the growing importance of e-health, information on medicinal products should also be made available via independent national health internet websites. These websites should be monitored by competent authorities in the Member States. Member States in co- operation with stakeholders such as health care professionals or patient organisations should be responsible for managing these websites.
Amendment 75 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 14
Recital 14
(14) Monitoring of information on prescription-only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with Directive 2001/83/EC. Member States should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non-compliance. Monitoring should be based on the control of information prior to its dissemination, unless the substance of thesupply. Only such information thas already been agreedt has been approved in advance by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoringshould be provided, and it should be provided in the approved form only.
Amendment 88 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 1a (new)
Article 86 – paragraph 2 – indent 1a (new)
– correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
Amendment 95 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 4
Article 86 – paragraph 2 – indent 4
- information by the marketing authorisation holderon medicinal products that has been approved by the competent authorities in the Member States and that has been made available to the general public oin medicinal productapproved form by the marketing authorisation holder and that is subject to medical prescription, which is subject to the provisions of Title VIIIa.
Amendment 111 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 - a (new), to be inserted before Article 100a
Article 100 - a (new), to be inserted before Article 100a
Article 100 -a Member States and the European Commission shall support independent information on medical products to the general public. To this end the Member States shall present a national program on information to patients following consultation with stakeholders such as health care professionals and patient organisations. Information shall be presented in electronic as well as in printed form. The Commission shall provide assistance and organise the exchange of best practice. Member States and the Commission shall grant financial support to independent drug information centres, encourage the development of independent, continuing education programmes for health professionals and the development of their critical appraisal skills.
Amendment 112 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 - a a (new), to be inserted before Article 100a
Article 100 - a a (new), to be inserted before Article 100a
Amendment 116 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a - paragraph 1
Article 100 a - paragraph 1
1. Member States shall allow the marketing authorisation holder to disseminatmake available, either directly or indirectly through a third party, information that is acting in the name of the marketing authorization holder, information that has been approved by the competent authorities to the general public or members thereof on authorised medicinal products subject to medical prescription provided that ithis information and the way it is supplied is in accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIII. When such information is made available, the marketing authorisation holder and any third party shall be identified, and any third party that acts on behalf of the marketing authorisation holder shall be clearly identified as such.
Amendment 129 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – introductory part and point a
Article 100 b – introductory part and point a
The following types of information onmarketing authorisation holder shall, in respect of authorised medicinal products subject to medical prescription may be disseminated by the, marketing authorisation holder available to the general public or members thereof: a) the summary of product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities, and the publicly accessible version of the assessment report drawn up by the competent authorities;. A drug-fact-box shall be added to the package leaflet. The information provided in the drug-fact-box shall be presented in a form that is clearly legible, prominent and clearly distinguishable from the rest of the text. This drug-fact-box shall contain a short description of the necessary facts of the medicinal product in order to enable the patient to understand the utility and the possible risks of the medicinal product and in order to apply the medicinal product safely and in the right way. It shall also contain a short summary of the results of the clinical trials. Before supplying it, the drug-fact-box shall be approved by the competent authorities; and prior to such approval, patient organizations shall be heard in an appropriate way in order to guarantee a form that is suitable to the patients. This information shall be made available both in electronic and printed form in all languages of the EU and in a format accessible to people with disabilities.
Amendment 145 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point b
Article 100 b – point b
b) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different way; way that is comprehensible to the general public or member thereof without jeopardising the quality or reliability of the information;
Amendment 162 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point d
Article 100 b – point d
d) medicinal product-related information about non-interventional scientific studies, or accompanying measures to prevention and medical treatment, or. Such information which presents the medicinal product in the context of the condition to be prevented or treatedshall be vetted by the Agency prior to its being made available in accordance with Article 20 b (1) of Regulation EC (No) 726/2004.
Amendment 165 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – introductory part
Article 100 c – introductory part
Information on authorised medicinal products subject to medical prescription disseminatedthat has been approved by the competent authorities and is made available by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio. It, radio or newspapers, magazines and similar publications. The marketing authorisation holder shall be allowed to supply the information approved in Article 100b on the internet. This information shall not be supplied to the general public or members thereof unasked or actively and shall only be made available through the following channels:
Amendment 177 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point a
Article 100 c – point a
a) health-related publications as defined by the Member State of publicationCommission's guidelines concerning the information allowed, such as booklets, leaflet, and other categories of printed information including peer reviewed medical journals, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 182 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point b
Article 100 c – point b
b) marketing authorisation holders' internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 190 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 1 a (new)
Article 100 d – paragraph 1 a (new)
1a. Within one year of the entry into force of this Directive, the Commission shall, following a public consultation with patient and consumer organisations, doctor and pharmacist organisations, Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability and the accuracy of the summaries of product characteristics and the packaging leaflets and their value to the general public and healthcare professionals. Following an analysis of the above data, the Commission shall, if appropriate, put forward guideline proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.
Amendment 231 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 g – paragraph 1 – subparagraph 1
Article 100 g – paragraph 1 – subparagraph 1
1. Member States shall ensure that there are adequate and effective methods of monitoring to avoid misuse when information on authorised medicinal products subject to medical prescription is disseminated by the marketing authorisation holder to the general public or members thereofmisuse is avoided by securing that only the marketing authorisation holder supplies information, and only such information which has been approved by the competent authorities about approved medicines subject to medical prescription, and in the form which has been approved for the dissemination to the general public or members thereof. By way of derogation Member States may continue those types of control mechanism which they have been implemented before 31.12.2008. The Commission verifies and approves these systems.
Amendment 248 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 1 – subparagraph 1
Article 100 h – paragraph 1 – subparagraph 1
1. Member States shall ensure that marketing authorisation holders register Internet websites containing authority- approved information on medicinal products with the national competent authorities of the Member State of the country code Top Level Domain used by the website concerned, prior to making it available to the general public. Where the website does not use a country code Top Level Domain, the marketing authorisation holder shall select the Member State of registration.
Amendment 259 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 – subparagraph 2
Article 100 h – paragraph 2 – subparagraph 2
Internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites without their explicit prior consent or the appearance therein of unsolicited material actively distributed to the general public or members thereof. Those websites shall not contain web-TVInternet websites may provide video content if it is useful for the safe and effective use of the medicine. Video contents shall only reflect the package leaflet, the summary of the characteristics and the drug-fact-box and hints how to use this medicine safe and effectively. Before publication video contents must be approved by the competent authorities.
Amendment 267 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 a (new)
Article 100 h – paragraph 2 a (new)
2a. The registered internet websites shall display a notification at the top of each website page informing the public that the information contained therein is developed by a named marketing authorization holder. A link to the EudraPharm database on medicinal products shall also be included in that notification.
Amendment 274 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 4 – point a
Article 100 h – paragraph 4 – point a
(a) If a Member State has reasons for doubts as to whether the translation of the reproduced information is correct, it may require a marketing authorisation holder to provide for a certified translation of the authority-approved information disseminated on the Internet website registered with the national competent authority of another Member State.
Amendment 275 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 4 – point b
Article 100 h – paragraph 4 – point b
(b) If a Member State has reasons for doubts as to whether the authority- approved information disseminated on an Internet website registered with the national competent authorities of another Member State complies with the requirements of this Title, it shall inform that Member State of the reasons for its doubts. The Member States concerned shall use their best endeavours to reach agreement on the action to be taken. If they fail to reach an agreement within two months, the case shall be referred to the Pharmaceutical Committee set up by Decision 75/320/EEC. Any necessary measures may only be adopted after an opinion has been delivered by that Committee. Member States shall take account of opinions delivered by the Pharmaceutical Committee and shall inform the Committee of how its opinion has been taken into account.
Amendment 279 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 5
Article 100 h – paragraph 5
5. Member States shall allow marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this Directive. The statement shall identify the national competent authority monitoring the website concerned. It shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval.
Amendment 288 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 j – point a
Article 100 j – point a
a) keep available for the competent authorities or bodies responsible for monitoring information on medicinal products that have approved the information in advance, a sample of all information disseminatedmade available in accordance with this Title and information on its volume of disseminatprovision, together with a statement indicating the persons to whom it is addressed, the method of disseminatprovision and the date of first disseminatprovision,
Amendment 295 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 l
Article 100 l
By [insert specific date five years from the entry into force of amending directive] at the latest, the Commission shall publish a report on the experience acquired in the implementation of this Title after consulting the patient organisations and the members of health care professions and shall also assess the need for a review thereof. The Commission shall submit this report to the European Parliament and to the Council.
Amendment 10 #
2008/0255(COD)
Proposal for a regulation – amending act
Recital 4
Recital 4
(4) Directive 2001/83/EC provides that certain types of information are subject to control by the Member States' national competent authorities prior to their disseminationbeing made available. This concerns information about non-interventional scientific studies, or accompanying measures to prevention and medical treatment, or information which presents the medicinal product in the context of the condition to be prevented or treated. In the case of medicinal products for human use authorised pursuant to Title II of Regulation (EC) No 726/2004, provision should also be made for certain types of information to be subject to prior vetting by the European Medicines Agency (hereinafter referred to as the 'Agency').
Amendment 13 #
2008/0255(COD)
Proposal for a regulation – amending act
Article 1 – point 1
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 1
Article 20b – paragraph 1
1. By way of derogation from Article 100g(1) of Directive 2001/83/EC, medicinal product-related information referred to in Article 100b(d) of that Directive shall be subject to vetting by the Agency prior to its disseminationbeing made available.
Amendment 14 #
2008/0255(COD)
Proposal for a regulation – amending act
Article 1 – point 1
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 2
Article 20b – paragraph 2
2. For the purposes of paragraph 1, the marketing authorisation holder shall submit to the Agency a mock-up of the information to be disseminatedmade available.
Amendment 15 #
2008/0255(COD)
Proposal for a regulation – amending act
Article 1 – point 1
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 3
Article 20b – paragraph 3
3. The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC within 60 days after receipt of the notification. If the Agency does not object within 60 days, the information shall be deemed accepted and may be published.
Amendment 45 #
2008/0241(COD)
Proposal for a directive
Recital 10 a (new)
Recital 10 a (new)
(10a) General and industrial heating, cooling and water-heating plant and products attached permanently to buildings should be excluded from the Directive’s scope because they are fixed installations operated permanently at a specific location, they are assembled and disassembled by specialist personnel and they therefore represent a regulated waste stream.
Amendment 69 #
2008/0241(COD)
Proposal for a directive
Article 2 – paragraph 3 – point e a (new)
Article 2 – paragraph 3 – point e a (new)
(ea) fixed installations;
Amendment 111 #
2008/0241(COD)
Proposal for a directive
Article 3 – point s a (new)
Article 3 – point s a (new)
(sa) “fixed installation” means an installation within the meaning of Article 2(c) of Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility1. This covers, for example, general and industrial heating, cooling and water-heating products and the components permanently attached to them, including apparatus for measuring consumption. 1 OJ L 390, 31.12.2004, p. 24.
Amendment 132 #
2008/0241(COD)
Proposal for a directive
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Without prejudice to Article 5(1), Member States shall ensure that producers or third parties acting on their behalf achieve a minimum collection rate of 655% is achieved. The collection rate is calculated on the basis of the total weight of WEEE collected in accordance with Articles 5 and 6 in a given year in that Member State, expressed as a percentage of the average weight of electrical and electronic equipment placed on the market in the twohree preceding years in that Member State. This collection rate shall be achieved annually and starting in 2016. From 2013 until the end of 2015, Member States shall ensure that an identically calculated minimum collection rate of 45% is achieved annually.
Amendment 141 #
2008/0241(COD)
Proposal for a directive
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
Amendment 210 #
2008/0241(COD)
Proposal for a directive
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3a. Member States may exempt small producers, who, in relation to the size of the national market, place on it relatively modest quantities of EEE, from the obligations laid down in Articles 12 and 16, insofar as such exemption does not jeopardise take-back, collection or recycling systems.
Amendment 217 #
2008/0241(COD)
Proposal for a directive
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
1a. In order to enhance the user's awareness, Member States shall ensure that distributors - excluding SMEs - put in place appropriate collection and awareness schemes for very small volume waste. Such collection schemes: (a) shall enable end-users to discard this kind of waste at an accessible and visible collection point in the retailer’s shop; (b) shall require retailers to take back waste very small volume EEE at no charge when supplying very small volume EEE; (c) shall not involve any charge to end- users when discarding this waste, nor any obligation to buy a new product of the same type;
Amendment 273 #
2008/0241(COD)
Proposal for a directive
Annex II – paragraph 1 - indent 12
Annex II – paragraph 1 - indent 12
Amendment 88 #
2008/0240(COD)
Proposal for a directive
Recital 12
Recital 12
(12) As soon as scientific evidence is available and taking into account the precautionary principle, the prohibition of other hazardous substances and their substitution by more environmentally friendly alternatives which ensure at least the same level of protection of consumers should be examined, paying. This examination should include a full impact assessment with consultation of relevant stakeholders. The examination should also pay attention to coherency with other Community legislation, and in particular to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Specific account should be taken of the potential impact on SMEs.
Amendment 89 #
2008/0240(COD)
Proposal for a directive
Recital 12a (new)
Recital 12a (new)
Amendment 107 #
2008/0240(COD)
Proposal for a directive
Article 2 - paragraph 1
Article 2 - paragraph 1
1. This Directive shall apply to electrical and electronic equipment, including electrical cables, electrical or electronic consumables and electrical or electronic accessories, falling under the categories set out in Annex I as specified in Annex II.
Amendment 117 #
2008/0240(COD)
Proposal for a directive
Article 2 - paragraph 3- point b
Article 2 - paragraph 3- point b
(b) equipment which is specifically designed as part of another type ofthe part of an installation, equipment, that does not fall within the scope of this Directive and can fulfil its function only if it is part of that equipment;ransport equipment, consumable or accessory that is not electrical or electronic.
Amendment 126 #
2008/0240(COD)
Proposal for a directive
Article 2 - paragraph 3- point c a (new)
Article 2 - paragraph 3- point c a (new)
(ca) parts of and means of transport for persons or goods;
Amendment 127 #
2008/0240(COD)
Proposal for a directive
Article 2 - paragraph 3- point c a (new)
Article 2 - paragraph 3- point c a (new)
(ca) means of road transport for persons or goods
Amendment 142 #
2008/0240(COD)
Proposal for a directive
Article 2 - paragraph 3- point c a (new)
Article 2 - paragraph 3- point c a (new)
(ca) photovoltaic solar panels intended for use in a system designed, assembled and installed for permanent operation in a defined location to generate electricity for public, commercial and private purposes;
Amendment 156 #
2008/0240(COD)
Proposal for a directive
Article 3 - point l
Article 3 - point l
l) "homogeneous material" means either: - a material of uniform composition throughoutthat consists of only one material throughout - a combination of multiple materials that cannot be mechanically disjointed into different materials, meaning that the materials cannot, in principle be separated by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes excluding surface coatings, or - a surface coating, or - small components or materials of equal to or less than 4 mm³ in size
Amendment 157 #
2008/0240(COD)
Proposal for a directive
Article 3 - point l a (new)
Article 3 - point l a (new)
(la) "mechanically disjointed" means materials can, in principle be separated by mechanical actions, such as unscrewing, cutting, crushing, grinding and abrasive processes
Amendment 200 #
2008/0240(COD)
Proposal for a directive
Article 4 - paragraph 7
Article 4 - paragraph 7
7. When there is an unacceptable risk to human health or the environment, arising from the use of substances, and in particular the substances listed in Annex III, which needs to be addressed on a Community-wide basis, the list of prohibited substances in Annex IV shall be reviewed using a methodology based a substance during the recycling, recovery or disposal of waste electrical electronic equipment, the Commission may, taking account of the opinion of the Committee for Risk Assessment and the Committee for Socio-Economic Analysis of the European Chemicals Agency, review the list of prohibited substances in Annex IV on the basis of a methodology containing all of the following criteria: 1. Evidence that existing measures are not sufficient to adequately control the risk posed by the substance when present in waste electrical and electronic equipment; 2. Information on the risks to human health and the environment related to the manufacture, use, and disposal of alternatives; 3. A comparative assessment of the substance and the proposed alternative(s); 4. A justification that action is required on a Union-wide basis and that a restriction is the most appropriate measure taking into account its effectiveness, practicality and monitorability; and 5. The extent to which the risk posed by a substance in waste electrical and electronic equipment is outweighed by the benefits it brings to consumer safety. The Commission shall use the same methodology mutatis mutandis to remove a substance from the list of prohibited substances in Annex IV. Before Annex IV is amended, the Commission shall consult inter alia producers of substances used in electrical and electronic equipment, producers of electrical and electronic equipment, recyclers, treatment operators, environmental organisations and employee and consumer associations. The Commission shall make publicly available on its website all proposals and justifications the process set refor and allow all interested parties an opportunity to comment. The Commission shall take account in Articles 69 to 72 of Regulation (EC) No 1907/2006of the views received, which it shall also forward to the Committee referred to in Article 18. Those measures designed to amend non essential elements of this Directive shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 18(2).
Amendment 230 #
2008/0240(COD)
Proposal for a directive
Article 5 - paragraph 2
Article 5 - paragraph 2
2. Measures adopted in accordance with point b of paragraph 1 shall have a maximum validity period of up to four years and may be renewed. The Commission shall decide in due time on any. Based on the facts presented in the application, a longer exemption period may be exceptionally granted, on a case-by-case basis. No later than 9 months after the application has been submitted, the Commission shall decide on an application for an exemption or for the renewal of an exemption. An application for renewal tshat isll be submitted no later than 18 months before an exemption expires. Where the Commission rejects an application for renewal, it shall grant a grace period for the placing on the market of the equipment, except in cases where continued placing on the market would constitute an unacceptable risk to human health or the environment. The grace period shall not exceed 6 months for the placing on the market and an additional 18 months for the putting into service of the equipment concerned.
Amendment 240 #
2008/0240(COD)
Proposal for a directive
Article 5 - paragraph 3
Article 5 - paragraph 3
3. Before Annexes are amended, the Commission shall inter aliamake an impact assessment. It shall also consult producers of electrical and electronic equipment, recyclers, treatment operators, environmental organisations and employee and consumer associations.
Amendment 243 #
2008/0240(COD)
Proposal for a directive
Article 5 - paragraph 4
Article 5 - paragraph 4
4. As long as materials or components are included in Annexes V and VI to this Directive, on the basis of Article 5(1)(b) of this Directive, those applications shall also be considered exempted from the authorisation requirements set out in Article 58(2) of the regulation (EC) No 1907/2006 for the validity period of the exemption granted under this Directive. As long as the use of a substance is authorised in accordance with Regulation (EC) No 1907/2006, those applications shall also be considered exempted from the requirements relating to applications for an exemption set out in this Directive, for the validity period of the authorisation granted under Regulation (EC) No 1907/2006.
Amendment 65 #
2008/0238(COD)
Proposal for a directive
Recital 4
Recital 4
(4) Every year organs are exchanged between Member States. The exchange of organs is an important way of expanding the pool of organs available and ensuring a better match between donor and recipient and therefore improving the quality of the transplant. This is particularly important for the optimum treatment of specific patients such as patients requiring urgent treatments, hypersensitised patients or paediatric patients. Available organs should be able to cross borders without unnecessary problems and delays.
Amendment 66 #
2008/0238(COD)
Proposal for a directive
Recital 6
Recital 6
(6) There is therefore a need, while duly respecting the subsidiarity principle pursuant to Article 168(7) TFEU (formerly Article 152(5) TEC), for common quality and safety standards for the procurement, transport and use of human organs at Community level. These standards would facilitate exchanges of organs to the benefit of thousands of European patients in need of this type of therapy each year. Community legislation should ensure that human organs comply with acceptablerecognised standards of quality and safety. Therefore such standards will help to reassure the public that human organs procured in another Member State nonetheless carry the same basic quality and safety guarantees as those obtained in their own country.
Amendment 68 #
2008/0238(COD)
Proposal for a directive
Recital 7
Recital 7
Amendment 75 #
2008/0238(COD)
Proposal for a directive
Recital 15
Recital 15
(15) As a general principle, exchange of organs from/to third countries should be supervised by the Competent Authority. Authorisation should be granted only if standards equivalent to those provided for in this Directive are met. However, the important role played by existing European organ exchange organisations in the exchange of organs between the Member States and third countries participating in such organisations should be taken into account. It should also be possible for a blanket authorisation to be granted in respect of a third country or a procurement organisation located in a third country.
Amendment 87 #
2008/0238(COD)
Proposal for a directive
Article 2 – paragraph 1 a (new)
Article 2 – paragraph 1 a (new)
1a. It shall apply also to parts of organs if it is their function to be used for the same purpose as the entire organ in the human body and to complex tissues.
Amendment 89 #
2008/0238(COD)
Proposal for a directive
Article 3 – point a
Article 3 – point a
(a) ‘authorisation‘ means authorisccreditation, accreditation, designation or licensinguthorisation, licensing or certification, depending ofn the conceptregulatory approaches used in each Member State;
Amendment 92 #
2008/0238(COD)
Proposal for a directive
Article 3 – point c
Article 3 – point c
Amendment 95 #
2008/0238(COD)
Proposal for a directive
Article 3 – point d
Article 3 – point d
(d) ‘donation’ means donating human organs for transplantthe provision of human organs intended for human applications ;
Amendment 98 #
2008/0238(COD)
Proposal for a directive
Article 3 – point g
Article 3 – point g
(g) ‘organ’ means both a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy and parts of organs if it is their function to be used for the same purpose as the entire organ in the human body and complex tissues ;
Amendment 102 #
2008/0238(COD)
Proposal for a directive
Article 3 – point i
Article 3 – point i
(i) ‘procurement’ means a coordinated process by which the donated organs become available;
Amendment 103 #
2008/0238(COD)
Proposal for a directive
Article 3 – point i a (new)
Article 3 – point i a (new)
ia)'making available' means the preparation, manipulation, preservation, packaging and transport of human organs;
Amendment 104 #
2008/0238(COD)
Proposal for a directive
Article 3 –point j
Article 3 –point j
(j) "procurement organisation" means a health care establishment, a team or a unit of a hospital or another body which is authorised by the competent authority to undertakes procurement ofone or more public or private non-profit making body or bodies/organisation(s)/institution(s) engaged particularly in the coordinated process of procuring and making available human organs;
Amendment 105 #
2008/0238(COD)
Proposal for a directive
Article 3 – point j a (new)
Article 3 – point j a (new)
ja) 'competent authority' means one or more public or private non-profit making, competent body or bodies/organisation(s)/institution(s) particularly involved in the implementation of this Directive;
Amendment 106 #
2008/0238(COD)
Proposal for a directive
Article 3 – point k
Article 3 – point k
(k) ‘preservation’ means the use of chemical agents, alterations in environmental conditions or other means during processingwhile making available human organs to prevent or retard the biological or physical deterioration of human organsthereof from the procurement until the transplantation;
Amendment 107 #
2008/0238(COD)
Proposal for a directive
Article 3 – point m
Article 3 – point m
(m) ‘serious adverse event’ means any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantationthe procurement, preservation and making available of organs that might lead to the transmission of a communicablen infectious disease, to death or a life- threatening, disabling, or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity condition or to the disabling of donors or recipients, necessitate hospitalisation or cause another illness, providing it is not a matter of the side- effects of immune suppression;
Amendment 108 #
2008/0238(COD)
Proposal for a directive
Article 3 – point n
Article 3 – point n
(n) ) ‘serious adverse reaction’ means an unintended or unexpected serious response, including a communicable disease, in the donor or in the recipient associated with any stage of the chain from donation tothe donation, procurement, preservation, making available or transplantation of an organ, that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidityunexpected morbidity; side-effects of immune suppression are excluded;
Amendment 110 #
2008/0238(COD)
Proposal for a directive
Article 3 – point p
Article 3 – point p
(p) ‘transplantation’ means the process of restoring certain functions of the human body by transferring equivalenthuman organs to a recipient;
Amendment 125 #
2008/0238(COD)
Proposal for a directive
Article 4 – paragraph 3 – point b – indent 3
Article 4 – paragraph 3 – point b – indent 3
– the responsibilities of procurement organisations and transplantation centres in the process of reporting pursuant to Article 11(1).
Amendment 130 #
2008/0238(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Member States shall ensure that the procurement takes place in procurement organisationsand making available of organs take place through one or more public or private non-profit making body or bodies/organisation(s)/institution(s) that comply with the rules laid down in this Directive.
Amendment 143 #
2008/0238(COD)
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Competent authority shall indicate in the accreditation, designation, authorisation or licence which activities the transplantation centre concerned may undertake.
Amendment 154 #
2008/0238(COD)
Proposal for a directive
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Member States shall prohibit advertising the need for or,the offering or making availabilityle of, human organs where such advertising hasith a view to offering or seeking financial gain or comparable advantage.
Amendment 155 #
2008/0238(COD)
Proposal for a directive
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Member States shall ensure that the procurement of organs is carried out on a non-profit basisnot commercialised.
Amendment 162 #
2008/0238(COD)
Proposal for a directive
Article 15 – paragraph 2
Article 15 – paragraph 2
2. Member States shall ensure that living donors are selected on the basis of their health and medical history, including a psychological evaluation if deemed necessary, by qualified and trained professionals. Such assessments may provide for the exclusion of persons whose donation could present a health risk to others, such as the possibility of transmitting diseases, or a serious risk to themselves. Member States shall also ensure that living donors are legally insured.
Amendment 171 #
2008/0238(COD)
Proposal for a directive
Article 17 – title
Article 17 – title
Amendment 175 #
2008/0238(COD)
Proposal for a directive
Article 17
Article 17
Member States shall take all necessary measures to ensure that all personal data of donors and recipients processedgathered and processed in connection within the scopeimplementation of this Directive in the organ donation process are rendered anpseudonymous so that neitherin order to protect donors norand recipients remainfrom identifiablecation by unauthorised third parties.
Amendment 176 #
2008/0238(COD)
Proposal for a directive
Article 18 – title
Article 18 – title
Designation and tasks of the competent authoritiesbody or bodies, organisation(s) or institution(s)
Amendment 178 #
2008/0238(COD)
Proposal for a directive
Article 18 – paragraph 1
Article 18 – paragraph 1
Member States shall designate the competent authority, or authorities (hereafter competent authority),public or private, non-profit making body or bodies/organisation(s)/institution(s) particularly involved in the implementation of these provisions responsible for implementing the requirements of this Directive.
Amendment 180 #
2008/0238(COD)
Proposal for a directive
Article 18 – paragraph 2 – introductory part
Article 18 – paragraph 2 – introductory part
The competent authoritiesy or institution(s) shall, in particular, take the following measures:
Amendment 186 #
2008/0238(COD)
Proposal for a directive
Article 19 – paragraph 1 – introductory part
Article 19 – paragraph 1 – introductory part
1. Member States shall ensure that the competent authoritybody or bodies, organisation(s) or institution(s):
Amendment 187 #
2008/0238(COD)
Proposal for a directive
Article 19 – paragraph 1 – point c
Article 19 – paragraph 1 – point c
(c) establishes and maintains a register of procurementhealth care establishments, teams or departments of a hospital org anisatioother establishment authorised to procure human organs and transplantation centres.
Amendment 188 #
2008/0238(COD)
Proposal for a directive
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Member States shall, upon the request of the Commission or another Member State, provide information on the register of procurementhealth care establishments, teams or departments of a hospital org anisatioother establishment authorised to procure human organs and transplantation centres.
Amendment 189 #
2008/0238(COD)
Proposal for a directive
Article 20 – paragraph 1
Article 20 – paragraph 1
1. The Commission shall set up a network of the competent authoritiesbody (bodies), organisation(s) or institution(s) with a view to exchanging information on the experience acquired with regard to the implementation of this Directive.
Amendment 196 #
2008/0238(COD)
Proposal for a directive
Article 25 – paragraph 1 – point a
Article 25 – paragraph 1 – point a
(a) rules for the updating and transmission of information on human organs and donor characterisation as detailed in the Annex;
Amendment 197 #
2008/0238(COD)
Proposal for a directive
Article 25 – paragraph 1 – point c
Article 25 – paragraph 1 – point c
(c) procedures for ensuring the reporting of unexpected serious adverse events and reactions.
Amendment 198 #
2008/0238(COD)
Proposal for a directive
Article 25 – paragraph 2 – point a
Article 25 – paragraph 2 – point a
(a) the interconnection between the reporting systems on unexpected adverse events and reactions referred to in Article 11 (3);
Amendment 199 #
2008/0238(COD)
Proposal for a directive
Article 25 – paragraph 2 – point b
Article 25 – paragraph 2 – point b
(b) the establishment and ability to functioning of the network of the competent authorities referred to in Article 20.
Amendment 203 #
2008/0238(COD)
Proposal for a directive
Annex – Introduction
Annex – Introduction
For the purpose of Article 7 the following information shall be gathered by the procurement organisation or procurement team on the characteristics of the organ and of the donor, following testing where necessarybearing in mind the individual circumstances, and processed in line with the legal requirements on the protection of personal data and confidentiality. In the absence of data, a decision shall be taken about the transplant after individual risk assessment of the donor and the recipient:
Amendment 11 #
2008/0227(COD)
Proposal for a directive
Recital 5
Recital 5
(5) Technical progress and innovation with regard to measuring instruments covered by the Directives being repealed iswill be ensured in practice either by the voluntary application of the international and European standards which have been developed or by the application of national provisions implementing such new specifications or in line with the principles of better law-making, by including additional provisions in Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments1. Furthermore, the free circulation within the internal market of all products concerned by them is ensured by the satisfactory application of Articles 28 to 30 of the EC Treaty and of the mutual recognition principle. 1 OJ L 135, 30.4.2004, p. 1.
Amendment 14 #
2008/0227(COD)
Proposal for a directive
Article 1
Article 1
Directives 71/317/EEC, 71/347/EEC, 71/349/EEC, 74/148/EEC, 75/33/EEC, 76/765/EEC, 76/766/EEC and 86/217/EEC are repealed with effect from {1 JanuarMay 2010}4.
Amendment 16 #
2008/0227(COD)
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
1. Member States shall adopt and publish, by {31 December 2009} at the latest0 April 2014}, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. They shall apply those provisions from {1 JanuarMay 20104}.
Amendment 35 #
2008/0221(COD)
Proposal for a directive
Article 6 - points 1 - 4
Article 6 - points 1 - 4
(1) car suppliers and car distributors shall ensure that technical promotional literature provides information oncustomers are informed about tyres which are fitted on new vehicles at the point of sale; that information shall include the fuel efficiency class as set out in Annex I, Part A, the external rolling noise measured value as set out in Annex I, Part C and, for C1 tyres, the wet grip class as set out in Annex I, Part B; (2) where different tyre types may be fitted on a new vehicle, without end-users being offered a choice between them, the lowest fuel efficiency class, wet grip class and the highest external rolling noise measured value of these tyre types shall be mentioned in the technical promotional literature in the order specified in Annex III; (3) where end-users are offered a choice between different tyre types to be fitted on a new vehicle, car suppliers shall state the fuel efficiency class, wet grip class and external rolling noise measured value of these tyre types in the technical promotional literature in the order specified in Annex III; (4) where end-users are offered a choice between different tyre types to be fitted on a new vehicle, car distributors shall provide information on the fuel efficiency class, wet grip class and external rolling noise measured value of these tyre types before sale.
Amendment 36 #
2008/0221(COD)
Proposal for a directive
Article 8
Article 8
Member States shall assess the conformity of the declared fuel efficiency and wet grip classes, within the meaning of Annex I Parts A and B, and the declared external rolling noise measured value within the meaning of Annex I Part C, for aftermarket tyres, in accordance with the procedure laid down in Annex IV.
Amendment 39 #
2008/0221(COD)
Proposal for a directive
Annex IV - introductory part
Annex IV - introductory part
The conformity of the declared fuel efficiency and wet grip classes as well as the declared external rolling noise measured value shall be assessed for each aftermarket tyre type or each grouping of aftermarket tyres as determined by the tyre supplier; according to the following procedure:
Amendment 101 #
2008/0198(COD)
Council position
Article 1
Article 1
This Regulation lays down the obligations of operators who place or make available timber and timber products on the internal market for the first time, to minimise the risk of placing illegally harvested timber or timber products derived from such timber on the market.
Amendment 121 #
2008/0198(COD)
Council position
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
c) Except where the risk identified in course of the risk assessment procedures referred to in point (b) or on the basis of objective criteria is negligible, risk mitigation procedures which consist of a set of measures and procedures that are adequate and proportionate to minimise effectively that risk and which may include requiring additional information or documents and/or requiring third party verification.
Amendment 126 #
2008/0198(COD)
Council position
Article 5 a (new)
Article 5 a (new)
Article 5 a The Member States may permit market participants to label legally and sustainably produced timber, solely on a voluntary basis, and to adopt to that end rules for their area to exclude abuse or counterfeiting.
Amendment 155 #
2008/0198(COD)
Council position
Article 17
Article 17
The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented promptly. The penalties provided for must be effective, proportionate and dissuasive. Within the framework of national legislation and national competences, fines, confiscation of timber and withdrawal of trading licences for the internal market may be considered appropriate instruments. Interim measures taken by the competent authorities must be such as to prevent continued offending. The Member States shall notify those provisions to the Commission and shall notify it without delay of any subsequent amendments affecting them.
Amendment 266 #
2008/0196(COD)
Proposal for a directive
Recital 13
Recital 13
(13) The particular circumstances under which an offer was made or the contract was negotiated should not be relevant in the definition of a distance contract. The fact that the trader is an occasional distance seller or that he uses an organised scheme run by a third party such as an online platform, should not deprive consumers of their protection . Similarly, a transaction negotiated face to face between the trader and the consumer away from business premises should be a distance contract, if the contract has then been concluded through the exclusive use of means of distance communication, such as the Internet or telephone. For traders, a simpler definition of a distance contract should improve legal certainty and protect them from unfair competition.Does not affect English version.)
Amendment 399 #
2008/0196(COD)
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
Amendment 410 #
2008/0196(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
(1) 'consumer' means any natural person who, in contracts covered by this Directive, is acting for purposes which are outsideother than in the exercise of his trade, business, craft or profession;
Amendment 418 #
2008/0196(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
(2) 'tradconsumer' means any natural or legal person who, in contracts covered by this Directive, is acting for purposes relating toin the exercise of his trade, business, craft or profession and anyone acting in the name of or on behalf of a trader;
Amendment 447 #
2008/0196(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 5 a (new)
Article 2 – paragraph 1 – point 5 a (new)
(5a) ‘utility supply contracts’ means sales and service contracts for the supply of gas and water, where they are not put up for sale in a limited volume or set quantity, and for the supply of electricity;
Amendment 461 #
2008/0196(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 8 – point a
Article 2 – paragraph 1 – point 8 – point a
(a) any sales or service contract concluded away from business premises with the simultaneous physical presence of the trader anbetween a trader and a consumer which the consumer was persuaded theo consumer or any sales or service contract for which an offer was made by the consumer in the same circumstancclude through negotiations initiated or conducted by the trader with the consumer and in his presence, off the trader’s business premises, or at a leisure event;
Amendment 470 #
2008/0196(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 8 – point b
Article 2 – paragraph 1 – point 8 – point b
Amendment 500 #
2008/0196(COD)
Proposal for a directive
Article 3 – paragraph 1
Article 3 – paragraph 1
1. This Directive shall apply, under the conditions and to the extent set out in its provisions, to sales and service contracts concluded between the trader and the consumer. The provisions of this Directive applying to service contracts shall apply to utility supply contracts within the meaning of Article 2 (5a) irrespective of whether they are classified as sales or service contracts.
Amendment 554 #
2008/0196(COD)
Proposal for a directive
Article 4 b (new)
Article 4 b (new)
Amendment 811 #
2008/0196(COD)
Proposal for a directive
Article 11 – paragraph 4 (new)
Article 11 – paragraph 4 (new)
4a. A contract in electronic commerce covering provision of a good or service against payment whereby the consumer’s order is placed directly on the vendor’s website shall only become effective if the consumer has, before placing the order with the vendor, received notification of the fact that payment is involved and been given the information under Article 5 (1)(c) in a clear, typographically visible form and confirmed in a declaration separate from the order that he has read and understood this information.
Amendment 823 #
2008/0196(COD)
Proposal for a directive
Article 11 – paragraph 5
Article 11 – paragraph 5
5. Member States shall not impose any formal requirements other than those provided for in paragraphs 1 to 4. The Member States’ rules on unfair commercial practices, particularly those implementing Article 5 in combination with Appendix 1, No 26 of Directive 26/2005/EC of the European Parliament and of the Council, shall be unaffected.
Amendment 905 #
2008/0196(COD)
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The trader shall reimburse any payment received from the consumer within thirty days from the day on whichout delay as soon as he receives the communication of withdrawal.
Amendment 916 #
2008/0196(COD)
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
Amendment 957 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 1 – introductory part
Article 19 – paragraph 1 – introductory part
1. In respect of distance contracts and off- premises contracts, the right of withdrawal shall not apply as regards the following:
Amendment 964 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 1 – point a
Article 19 – paragraph 1 – point a
(a) services where performance has begunin the case of a service contract where the contract has been completely performed by both parties, with the consumer'’s prior express consent, before the end of the fourteen day period referred to in Article 12consumer has exercised the right of withdrawal;
Amendment 970 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 1 – point b
Article 19 – paragraph 1 – point b
Amendment 974 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 1 – point c
Article 19 – paragraph 1 – point c
(c) the supply of goods made to the consumer's specificontracts for which the consumer, in order to respond to an immediate emergency, has requested the immediate performance of the contract by the trader; if, on this occatsions or clearly personalized or which are liable to deteriorate or expire rapidly, the trader provides or sells additional services or goods other than those which are strictly necessary to meet the immediate emergency of the consumer, the right of withdrawal shall apply to those additional services or goods;
Amendment 990 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 1 – point d
Article 19 – paragraph 1 – point d
(d) the supply of wine, the price of which has been agreed upon at the time of the conclusion of the sales contract, the delivery of which can only take place beyond the time-limit referred to in Article 22(1) and the actual value of which is dependent on fluctuations contracts for which the consumer has specifically requested the trader to visit him at home for the purpose of carrying out repairs or maintenance; if on this occasion, the trader provides services in addition to those specifically requested by the consumer or goods other than replacement parts necessarily used in performing the maintenance or in making the market which cannot be controlled by the traderrepairs, the right of withdrawal shall apply to those additional services or goods;
Amendment 993 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 1 – point e
Article 19 – paragraph 1 – point e
Amendment 997 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 1 – point f
Article 19 – paragraph 1 – point f
Amendment 1002 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 1 – point g
Article 19 – paragraph 1 – point g
Amendment 1010 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 1 – point h
Article 19 – paragraph 1 – point h
Amendment 1013 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 2 – introductory part
Article 19 – paragraph 2 – introductory part
2. In respect of off-premisesdistance contracts, the right of withdrawal shall not apply as regards the followingin addition not apply if:
Amendment 1016 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 2 – point b
Article 19 – paragraph 2 – point b
(b) contracts for which the consumer, in order to respond to an immediate emergency, has requested the immediate performance of the contract by the trader; if, on this occasion, the trader provides or sells additional services or goods other than those which are strictly necessary to meet the immediate emergency of the consumer, the right of withdrawal shall apply to those additional services or goodsthe supply of goods or services for which the price is dependent on fluctuations in the financial market which cannot be controlled by the trader;
Amendment 1018 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 2 – point c
Article 19 – paragraph 2 – point c
(c) contracts for which the consumer has specifically requested the trader, by means of distance communication, to visit his home for the purpose of repairing or performing maintenance upon his property; if on this occasion, the trader provides services in addition to those specifically requested by the consumer or goods other than replacement parts necessarily used in performing the maintenance or in making the repairs, the right of withdrawal shall apply to those additional services or goods.the supply of wine, the price of which has been agreed upon at the time of the conclusion of the contract, the delivery of which can only take place beyond the time-limit referred to in Article 22(1) and the current value of which is dependent on fluctuations in the market which cannot be controlled by the trader;
Amendment 1020 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 2 – point c a (new)
Article 19 – paragraph 2 – point c a (new)
(ca) the supply of sealed audio or video recordings or sealed computer software which were unsealed by the consumer;
Amendment 1021 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 2 – point c b (new)
Article 19 – paragraph 2 – point c b (new)
(cb) newspapers, periodicals and magazines unless the consumer's agreement to the contract was given by telephone;
Amendment 1022 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 2 – point c c (new)
Article 19 – paragraph 2 – point c c (new)
(cc) gaming and lottery services unless the consumer's agreement to the contract was given by telephone;
Amendment 1023 #
2008/0196(COD)
Proposal for a directive
Article 19 – paragraph 2 – point c d (new)
Article 19 – paragraph 2 – point c d (new)
(cd) contracts concluded at a public auction.
Amendment 1073 #
2008/0196(COD)
Proposal for a directive
Article 21 – paragraph 3
Article 21 – paragraph 3
Amendment 1081 #
2008/0196(COD)
Proposal for a directive
Article 22
Article 22
Amendment 1137 #
2008/0196(COD)
Proposal for a directive
Article 24 – paragraph 1
Article 24 – paragraph 1
1. The trader shall be obliged to deliver the goods to the consumer in conformity with the sales contract.
Amendment 1141 #
2008/0196(COD)
Proposal for a directive
Article 24 – paragraph 2 – introductory part
Article 24 – paragraph 2 – introductory part
2. Delivered gGoods shall be presumed to be in conformity with the contract if they satisfy the following conditions:
Amendment 1143 #
2008/0196(COD)
Proposal for a directive
Article 24 – paragraph 2 – point a
Article 24 – paragraph 2 – point a
(a) they comply with the description given by the trader andif their nature is in accordance with that agreed by the parties and, in particular, they possess the qualities of the goods which the trader has presented to the consumer as a sample or model;
Amendment 1146 #
2008/0196(COD)
Proposal for a directive
Article 24 – paragraph 2 – point b
Article 24 – paragraph 2 – point b
(b) if, in they are fit for anbsence of an agreement on their nature, they particulare fit for the purpose for which the consumer requires them and which he made known to the traderparties to the contract intended them at the time of the conclusion of the contract and which the trader has accepted;
Amendment 1151 #
2008/0196(COD)
Proposal for a directive
Article 24 – paragraph 2 – point c
Article 24 – paragraph 2 – point c
(c) otherwise, if they are fit for the purposes for which goods of the sameat type are normally used or;
Amendment 1156 #
2008/0196(COD)
Proposal for a directive
Article 24 – paragraph 2 – point d
Article 24 – paragraph 2 – point d
(d) if, in addition, they show the quality and performanceies which are normal in goods of the sameat type and which the consumer can reasonably expect, given the nature of the goods andexpect, taking into account any public statements on the specific characteristics of the goods made about them by the trader, the producer or his representative, particularly in advertising or on labelling, unless the trader was unaware and need not have been aware of the statements in question, the statements were justified at the time of the conclusion of the contract or they could not have influenced the decision to purchase.
Amendment 1159 #
2008/0196(COD)
Proposal for a directive
Article 24 – paragraph 3
Article 24 – paragraph 3
Amendment 1165 #
2008/0196(COD)
Proposal for a directive
Article 24 – paragraph 4 – introductory part
Article 24 – paragraph 4 – introductory part
Amendment 1170 #
2008/0196(COD)
Proposal for a directive
Article 24 – paragraph 5
Article 24 – paragraph 5
Amendment 1175 #
2008/0196(COD)
Proposal for a directive
Article 24 a (new)
Article 24 a (new)
Lack of conformity Goods delivered shall be deemed not to be in conformity with the contract inter alia if (a) the installation formed part of the sales contract and the goods were installed incorrectly by the trader or under his responsibility; (b) the goods, intended to be installed by the consumer, are installed by the consumer and the incorrect installation is due to a shortcoming in the installation instructions; (c) the goods delivered were not those due to be delivered or they were delivered in insufficient quantity.
Amendment 1177 #
2008/0196(COD)
Proposal for a directive
Article 25 – title
Article 25 – title
Amendment 1179 #
2008/0196(COD)
Proposal for a directive
Article 25 – paragraph 1
Article 25 – paragraph 1
The trader shall be liable to the consumer for any lack of conformity which exists at the time the risk passes toconsumer may not rely on a claim for lack of conformity with the contract if at the time of its conclusion he was aware of the lack of conformity or if he remained unaware of it as a result of gross negligence and the trader did not fraudulently conceal it, or if the lack of conformity has its origin in materials supplied by the consumer.
Amendment 1184 #
2008/0196(COD)
Proposal for a directive
Article 26
Article 26
Amendment 1192 #
2008/0196(COD)
Proposal for a directive
Article 26 – paragraph 1 – introductory part
Article 26 – paragraph 1 – introductory part
1. As provided for in paragraphs 2 to 5, whereIf the goods delivered do not conform to the contract, the consumer is at the time the risk passes to the consumer, the consumer shall have the following legal entitled toments:
Amendment 1199 #
2008/0196(COD)
Proposal for a directive
Article 26 – paragraph 1 – point a
Article 26 – paragraph 1 – point a
Amendment 1211 #
2008/0196(COD)
Proposal for a directive
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
Amendment 1219 #
2008/0196(COD)
Proposal for a directive
Article 26 – paragraph 1 – point c
Article 26 – paragraph 1 – point c
Amendment 1268 #
2008/0196(COD)
Proposal for a directive
Article 26 – paragraph 4 – introductory part
Article 26 – paragraph 4 – introductory part
4. TWhere the consumer may resort to any remedy available under paragraph 1, where one of the following situations exists:can require the goods to be repaired and the deadline for the trader to effect the repair has passed without result, the consumer may undertake the repair himself and require compensation from the trader for the necessary expenditure thereby entailed. It shall not be necessary to set a deadline if the trader has refused to effect the repair or if, taking account of the interests of both parties, special circumstances justify the consumer undertaking it himself immediately.
Amendment 1272 #
2008/0196(COD)
Proposal for a directive
Article 26 – paragraph 4 – point a
Article 26 – paragraph 4 – point a
Amendment 1277 #
2008/0196(COD)
Proposal for a directive
Article 26 – paragraph 4 – point b
Article 26 – paragraph 4 – point b
Amendment 1279 #
2008/0196(COD)
Proposal for a directive
Article 26 – paragraph 4 – point c
Article 26 – paragraph 4 – point c
Amendment 1284 #
2008/0196(COD)
Proposal for a directive
Article 26 – paragraph 4 – point d
Article 26 – paragraph 4 – point d
d) the same defect has reappeared more than once within a short period of time.eleted
Amendment 1297 #
2008/0196(COD)
Proposal for a directive
Article 26 – paragraph 5
Article 26 – paragraph 5
5. The significant inconveniencIf it is impossible for the consumer and the reasonable time neededunreasonable for the trader to remedy the lack of conformity shall be assessed taking into account the nature of the goods or the purpose for which the consumer acquired the goods as provided for by Article 24(2)(b), or if the lack of conformity is not remedied within a reasonable period, the consumer may demand an appropriate reduction in the purchase price or withdraw from the contract. A minor lack of conformity shall not give rise to a right of withdrawal.
Amendment 1302 #
2008/0196(COD)
Proposal for a directive
Article 27
Article 27
Amendment 1308 #
2008/0196(COD)
Proposal for a directive
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
1a. When the trader has remedied the lack of conformity by replacement, or when the consumer has withdrawn from the contract on the grounds of the lack of conformity of the product, in addition to the action provided for in paragraph 1 the trader shall reimburse to the consumer the cost of installing and removing the product concerned, provided that the product requires installation in order to be used for its intended purpose.
Amendment 1316 #
2008/0196(COD)
Proposal for a directive
Article 27 – paragraph 2
Article 27 – paragraph 2
2. WSubject to the provisions of applicable national law, and without prejudice to the provisions of this Chapter, the consumer may claim damages for any loss not remedied in accordance with Article 26.
Amendment 1345 #
2008/0196(COD)
Proposal for a directive
Article 28 – paragraph 2 a (new)
Article 28 – paragraph 2 a (new)
2a. When the trader has remedied the lack of conformity by repair, the relevant liability period shall be extended by the period during which the consumer was not in material possession of the product owing to the need to effect a repair.
Amendment 1346 #
2008/0196(COD)
Proposal for a directive
Article 28 – paragraph 2 b (new)
Article 28 – paragraph 2 b (new)
2b. When the trader has used spare parts in bringing the product into conformity with the contract of sale by effecting a repair, he shall be liable for the lack of conformity of the spare parts until the relevant liability period for the product has expired, and for no less than six months following completion of the repair.
Amendment 1364 #
2008/0196(COD)
Proposal for a directive
Article 28 – paragraph 5
Article 28 – paragraph 5
5. Unless proved otherwise, any lack of conformity which becomes apparent within six12 months of the time when the risk passed to the consumer, shall be presumed to have existed at that time unless this presumption is incompatible with the nature of the goods and the nature of the lack of conformity. If the lack of conformity is remedied by replacement, the period referred to in the first sentence shall be deemed to start when material possession is taken of the replacement product.
Amendment 1378 #
2008/0196(COD)
Proposal for a directive
Article 28 a (new)
Article 28 a (new)
Communication and contactability The trader shall ensure that throughout the duration of a service contract, or, following the conclusion of a contract of sale, until the time limit referred to in Article 28(1) for formal offers, notifications and questions by the consumer relating to rights and obligations under the service contract or contract of sale has expired, he can be contacted under reasonable conditions. In particular, he shall ensure that formal offers by the consumer in respect of the contract reach him without delay and that the consumer is notified of their receipt immediately. The cost of receiving and dealing with formal offers, notifications and questions concerning the service contract or the contract of sale by telephone may not be charged to the consumer; the right of the telecommunications service provider to charge for such calls shall not be affected.
Amendment 1509 #
2008/0196(COD)
Proposal for a directive
Article 38 – paragraph 2 a (new)
Article 38 – paragraph 2 a (new)
2a. Member States shall ensure that traders are required to make the contract terms as referred to in Chapter V which are used in legal transactions available to bodies as referred to in Article 41(2) at the latter’s request in an appropriate form and free of charge.
Amendment 35 #
2008/0193(COD)
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 92/85/EEC
Article 8 – paragraph 1
Article 8 – paragraph 1
Amendment 38 #
2008/0193(COD)
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 92/85/EEC
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 42 #
2008/0193(COD)
Proposal for a directive – amending act
Article 1 – point 1
Article 1 – point 1
Directive 92/85/EEC
Article 8 – paragraph 2 a (new)
Article 8 – paragraph 2 a (new)
(2a) The worker must indicate her chosen period of maternity leave at last two months before the starting date.
Amendment 52 #
2008/0193(COD)
Proposal for a directive – amending act
Article 1 – point 3 − point b
Article 1 – point 3 − point b
Directive 92/85/EEC
Article 11 – point 2 − point (c a) (new)
Article 11 – point 2 − point (c a) (new)
(ca) Workers within the meaning of Article 2 shall maintain their opportunities for career development through education and training.
Amendment 57 #
2008/0193(COD)
Proposal for a directive – amending act
Article 1 – point 4
Article 1 – point 4
Directive 92/85/EEC
Article 12a
Article 12a
Amendment 59 #
2008/0193(COD)
Proposal for a directive – amending act
Article 1 – point 6
Article 1 – point 6
Directive 92/85/EEC
Article 12c
Article 12c
Member States shall lay down the rules on penalties applicable to breaches of national provisions adopted pursuant to this Directive, and shall take all measures necessary to ensure that they are applied. Penalties may comprise payment of compensation, which may not be limited by the fixing of a prior upper limit, and must be effective, proportionate and dissuasive.
Amendment 33 #
2008/0152(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The Community Ecolabel scheme is part of the sustainable consumption and production policy of the Community, which aims at reducing the negative impact of consumption and production on the environment, health, and natural resources. The scheme is intended to promote those products which have a high level of environmental performance through the use of the Ecolabel. To this effect, it is appropriate to require that the criteria which products must comply with in order to bear the Ecolabel be based on the best environmental performance achieved by products on the Community market. Those criteria should be simple to understand and to use, and should therefore bebe based on scientific evidence, taking into consideration the latest technological developments. Those criteria should be market-oriented and limited to the most significant environmental impacts of products during their full lifecycle.
Amendment 60 #
2008/0152(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The environmental performance of products shall be determined on the basis of the best performing products on the Community market. To this end, the most significant environmental impacts during the life cycle of products, in particular the impact on climate change, impact on nature and biodiversity, energy and resource consumption, generation of waste, emissions to all environmental media, and pollution through physical effects and use and release of hazardous substances, shall be considered.
Amendment 64 #
2008/0152(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Ecolabel criteria shall set out the environmental requirements, based on sound scientific evidence, that a product must fulfil in order to bear the Ecolabel.
Amendment 97 #
2008/0152(COD)
Proposal for a regulation
Annex I – part A – point 2 – subparagraph 2 – indent 1
Annex I – part A – point 2 – subparagraph 2 – indent 1
- they shall be based on the environmental performance throughout the life-cycle of the product of the best performing products on the market and correspond, as far as possible, to 1020 % of the best performing products available on the market;
Amendment 9 #
Amendment 10 #
2008/0151(COD)
Proposal for a directive
Recital 2
Recital 2
(2) The disparities between the laws or administrative measures adopted by the Member States in relation to the ecodesign of energy related products can create barriers to trade and distort competition in the Community and may thus have a direct impact on the establishment and functioning of the internal market. The harmonisation of national laws is the only means to prevent such barriers to trade and unfair competition. The extension of the scope to all energy related products ensures that ecodesign requirements for all significant energy related products can be harmonised at Community level. The extension of the scope to energy related products must not result in excessive commercial constraints for SMEs, thus hampering their competitiveness.
Amendment 12 #
2008/0151(COD)
Proposal for a directive
Recital 2 a (new)
Recital 2 a (new)
(2a) Construction products should not be included within the scope of this Directive. The general environmental performance of construction products, as well as in particular, their energy efficiency, cannot be assessed or measured at product level but only at building level.
Amendment 42 #
2008/0151(COD)
Proposal for a directive
Article 1 - paragraph 2 a (new)
Article 1 - paragraph 2 a (new)
2a. Custom-made devices shall be excluded from the scope of this Directive.
Amendment 43 #
2008/0151(COD)
Proposal for a directive
Article 1 - paragraph 2 b (new)
Article 1 - paragraph 2 b (new)
2b. The provisions of this Directive shall be without prejudice to the provisions laid down in Community instruments on technical requirements with respect to environmental protection.
Amendment 44 #
2008/0151(COD)
Proposal for a directive
Article 1 - paragraph 3
Article 1 - paragraph 3
3. This Directive shall not apply to means of transport for persons or goods or to building and construction products.
Amendment 46 #
2008/0151(COD)
Proposal for a directive
Article 2 - point 1
Article 2 - point 1
1. ‘Energy related product’, hereinafter referred to as 'product', means any good having an substantial impact on energy consumption during use which is placed on the market and/or put into service in the European Union, including parts intended to be incorporated into energy related products covered by this Directive which are placed on the market and/or put into service as individual parts for end-users and of which the environmental performance can be assessed independently;
Amendment 71 #
2008/0151(COD)
Proposal for a directive
Article 16 - paragraph 1
Article 16 - paragraph 1
1. In accordance with the criteria set out in Article 15 and having consulted the Consultation Forum referred to in Article 18, the Commission shall not later than 6 July 200731 December 2009 and every three years thereafter establish a draft working plan that shall take into account the extension of the scope to energy related products and which shall be made publicly available. The draft working plan shall set out for the following three years an indicativ complete list of product groups which will be considered as priorities for the adoption of implementing measures. The draft working plan shall be amended periodically by the Commission after consultation with the Consultation Forumsubmitted to the European Parliament for consideration. The European Parliament shall consider each individual product group separately. The final working plan shall only include product groups to which the European Parliament has given its assent. No other product groups should be considered by the Commission for the adoption of implementing measures. These may be re-submitted to the European Parliament for its assent in a future draft working plan.
Amendment 77 #
2008/0151(COD)
Proposal for a directive
Article 21
Article 21
Not later than 20125 the Commission shall review the appropriateness of extending the scope of the Directive to non energy related products, the effectiveness of this Directive and of its implementing measures, the threshold for implementing measures, market surveillance mechanisms and any relevant self-regulation stimulated, after consultation of the Consultation Forum referred to in Article 18, and, as appropriate, present proposals to the European Parliament and the Council for amending this Directive.
Amendment 81 #
2008/0151(COD)
Proposal for a directive
Annex I - part 1 - point 1.3 - point d
Annex I - part 1 - point 1.3 - point d
(d) use of substances classified as hazardous to health and/or the environment according to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packing and labelling of dangerous substancesmeeting the criteria in Article 57 of Regulation 1907/2006/EC (REACH) and identified in accordance with Article 59(1) of that Regulation, and taking into account legislation on the marketing and use of specific substances, such as Directives 76/769/EEC or 2002/95/EC;
Amendment 41 #
2008/0142(COD)
Proposal for a directive
Recital 3
Recital 3
(3) This Directive respects the fundamental rights and observes the general principles of law as recognised in particular by the Charter of Fundamental Rights of the European Union. The right of access to healthcare and the right to benefit from medical treatment under conditions established by national law and practices are recognised by Article 35 of the Charter of Fundamental Rights of the European Union.. Specifically, this Directive has to be implemented and applied with due respect for the rights to private and family life, protection of personal data, equality before the law and the principle of non- discrimination, the fundamental ethical choices of Member States and the right to an effective remedy and to a fair trial, in accordance with the general principles of law, as enshrined in Articles 7, 8, 20, 21, 47 of the Charter.
Amendment 44 #
2008/0142(COD)
Proposal for a directive
Recital 5 a (new)
Recital 5 a (new)
(5a) This Directive respects and does not prejudice the freedom of each Member State to decide what type of health care it considers appropriate. No provision of this Directive shall be interpreted in a way as to undermine the fundamental ethical choices of Member States, in particular as regards the protection of the right to life of every human being.
Amendment 56 #
2008/0142(COD)
Proposal for a directive
Recital 11
Recital 11
(11) As recognised by the Member States in the Council Conclusions on Common values and principles in European Union Health Systems there is a set of operating principles that are shared by health systems throughout the Community. These operating principles include quality, safety, care that is based on evidence and ethics, patient involvement, redress, the fundamental right to privacy with respect to the processing of personal data, and confidentiality. Patients, professionals and authorities responsible for health systems must be able to rely on these shared principles being respected and structures provided for their implementation throughout the Community. It is therefore appropriate to require that it is the authorities of the Member State on whose territory the healthcare is provided, who are responsible for ensuring compliance with those operating principles. This is necessary to ensure the confidence of patients in cross-border healthcare, which is itself necessary for achieving patients' mobility and free movement of provision of healthcare in the internal market as well as a high level of health protection. In view of these common values it is nevertheless accepted that Member States take different decisions on ethical grounds as regards the availability of certain treatments and the concrete access conditions. This Directive is without prejudice to the ethical diversity. It does not impose on Member States to make treatments and services accessible their territory or to reimburse costs for those treatments (received in another Member State) which are not allowed according to national laws, regulations and codes of conduct of the medical professions.
Amendment 60 #
2008/0142(COD)
Proposal for a directive
Recital 3
Recital 3
(3) This Directive respects the fundamental rights and observes the general principles of law as recognised in particular by the Charter of Fundamental Rights of the European Union. The right of access to healthcare and the right to benefit from medical treatment under conditions established by national law and practices are recognised by Article 35 of the Charter of Fundamental Rights of the European Union. Specifically, this Directive has to be implemented and applied with due respect for the rights to private and family life, protection of personal data, equality before the law and the principle of non- discrimination, the fundamental ethical choices of Member States and the right to an effective remedy and to a fair trial, in accordance with the general principles of law, as enshrined in Articles 7, 8, 20, 21, 47 of the Charter.
Amendment 65 #
2008/0142(COD)
Proposal for a directive
Recital 5 a (new)
Recital 5 a (new)
(5a) This Directive respects and does not prejudice the freedom of each Member State to decide what type of healthcare it considers appropriate. No provision of this Directive should be interpreted in such a way as to undermine the fundamental ethical choices of Member States, in particular as regards the protection of the right to life of every human being.
Amendment 87 #
2008/0142(COD)
Proposal for a directive
Recital 30
Recital 30
(30) There is no definition of what constitutes hospital care throughout the different health systems of the Community, and different interpretations could. It is the refore constitute an obstacle to the freedom for patients to receive healthcare. In order to overcome that obstacle, it is necessary to provide a Community definition of hospital caresponsibility of the Member States to adopt these definitions. Hospital care generally means care requiring the overnight accommodation of the patient. However, it may be appropriate to submit to the same regime of hospital care also certain other kinds of healthcare, if that healthcare requires use of highly specialised and cost-intensive medical infrastructure or medical equipment (e.g. high-technology scanners used for diagnosis) or involving treatments presenting a particular risk for the patient or the population (e.g. treatment of serious infectious diseases). A regularly updated list of such treatments shall be specifically defined by the Commission through the comitology procedureThe definition can also apply to healthcare treatment that, under the concepts of provision in the Member State of insurance, provides for a planned infrastructure on other grounds.
Amendment 87 #
2008/0142(COD)
Proposal for a directive
Recital 11
Recital 11
(11) As recognised by the Member States in the Council Conclusions on Common values and principles in European Union Health Systems there is a set of operating principles that are shared by health systems throughout the Community. These operating principles include quality, safety, care that is based on evidence and ethics, patient involvement, redress, the fundamental right to privacy with respect to the processing of personal data, and confidentiality. Patients, professionals and authorities responsible for health systems must be able to rely on these shared principles being respected and structures provided for their implementation throughout the Community. It is therefore appropriate to require that it is the authorities of the Member State on whose territory the healthcare is provided, who are responsible for ensuring compliance with those operating principles. This is necessary to ensure the confidence of patients in cross-border healthcare, which is itself necessary for achieving patients' mobility and free movement of provision of healthcare in the internal market as well as a high level of health protection. In view of these common values it is nevertheless accepted that Member States take different decisions on ethical grounds as regards the availability of certain treatments and the concrete access conditions. This Directive is without prejudice to ethical diversity. It does not impose on Member States to make treatments and services accessible their territory or to reimburse costs for those treatments (received in another Member State) which are not allowed under national laws, regulations and codes of conduct of the medical professions.
Amendment 89 #
2008/0142(COD)
Proposal for a directive
Recital 31
Recital 31
(31) The evidence available indicates that the application of free movement principles regarding use of healthcare in another Member State within the limits of the cover guaranteed by the statutory sickness insurance scheme of the Member State of affiliation will not undermine the health systems of the Member States or financial sustainability of their social security systems. However, the Court of Justice has recognised that it cannot be excluded that the possible risk of seriously undermining a social security system's financial balance or the objective of maintaining a balanced medical and hospital service open to all may constitute overriding reasons in the general interest capable of justifying a barrier to the principle of freedom to provide services. The Court of Justice has also recognised that the number of hospitals, their geographical distribution, the way in which they are organised and the facilities with which they are provided, and even the nature of the medical services which they are able to offer, are all matters for which planning must be possible. This Directive should provide for a system of prior authorisation for assumption of costs for hospital care received in another Member State, where the following conditions are met : had the treatment been provided on its territory, it would have been assumed by its social security system and the consequent outflow of patients due to the implementation of the directive seriously undermines or is likely to seriously undermine the financial balance of the social security system and/or this outflow of patients seriously undermines, or is likely to seriously undermine the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member. As the assessment of the precise impact of an expected outflow of patients requires complex assumptions and calculations, the Directive allows for a system of prior authorisation if there is sufficient reason to expect that the social security system will be seriously undermined. This should also cover cases of already existing systems of prior authorisation which are in conformity with conditions laid down in Article 8The Member States may provide for a system of prior authorisation for hospital and specialised care and decide on the care sectors in which they consider it necessary to plan needs.
Amendment 95 #
2008/0142(COD)
Proposal for a directive
Recital 36
Recital 36
(36) The Member States should decide on the form of those national contact points as well as the number of them. The national contact points may be also incorporated in or build on activities of existing information centres provided that it is clearly indicated that they are also national contact points for cross-border healthcare. The national contact points should have appropriate facilities to provide information on the main aspects of cross- border healthcare and to provide practical assistance to patients if needed. The contact point should not provide legal advice in individual cases. The Commission should work together with the Member States in order to facilitate cooperation regarding national contact points for cross-border healthcare, including making relevant information available at Community level, such as through the European Health Portal. The existence of national contact points should not preclude Member States from establishing other linked contact points at regional or local level, reflecting the specific organisation of their healthcare system. Consequently, the contact points may be based within the competent professional organisations entrusted with this task by the Member States, as well as in the administrative authorities.
Amendment 102 #
2008/0142(COD)
Proposal for a directive
Recital 45
Recital 45
Amendment 140 #
2008/0142(COD)
Council position
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) "healthcare" means health services provided to patients by health professionals to patients to assess, maintain or restore theibelonging to the regulated health professions if these activities are performed in a Member sState of health, including the prescription, dispensation and provision of medicinal products and medical deviceswhere the services are provided by members of a regulated health profession under the appropriate professional title;
Amendment 141 #
2008/0142(COD)
Proposal for a directive
Recital 30
Recital 30
(30) There is no definition of what constitutes hospital care throughout the different health systems of the Community, and different interpretations could. It is the refore constitute an obstacle to the freedom for patients to receive healthcare. In order to overcome that obstacle, it is necessary to provide a Community definition of hospital caresponsibility of the Member States to adopt these definitions. Hospital care generally means care requiring the overnight accommodation of the patient. However, it may be appropriate to submit to the same regime of hospital care also certain other kinds of healthcare, if that healthcare requires use of highly specialised and cost-intensive medical infrastructure or medical equipment (e.g. high-technology scanners used for diagnosis) or involving treatments presenting a particular risk for the patient or the population (e.g. treatment of serious infectious diseases). A regularly updated list of such treatments shall be specifically defined by the Commission through the comitology procedureThe definition can also apply to the same healthcare treatment that, under the concepts of provision in the Member State of insurance, provides for a planned infrastructure on other grounds.
Amendment 147 #
2008/0142(COD)
Proposal for a directive
Recital 31
Recital 31
(31) The evidence available indicates that the application of free movement principles regarding use of healthcare in another Member State within the limits of the cover guaranteed by the statutory sickness insurance scheme of the Member State of affiliation will not undermine the health systems of the Member States or financial sustainability of their social security systems. However, the Court of Justice has recognised that it cannot be excluded that the possible risk of seriously undermining a social security system’s financial balance or the objective of maintaining a balanced medical and hospital service open to all may constitute overriding reasons in the general interest capable of justifying a barrier to the principle of freedom to provide services. The Court of Justice has also recognised that the number of hospitals, their geographical distribution, the way in which they are organised and the facilities with which they are provided, and even the nature of the medical services which they are able to offer, are all matters for which planning must be possible. This Directive should provide for a system of prior authorisation for assumption of costs for hospital care received in another Member State, where the following conditions are met : had the treatment been provided on its territory, it would have been assumed by its social security system and the consequent outflow of patients due to the implementation of the directive seriously undermines or is likely to seriously undermine the financial balance of the social security system and/or this outflow of patients seriously undermines, or is likely to seriously undermine the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concerned Member. As the assessment of the precise impact of an expected outflow of patients requires complex assumptions and calculations, the Directive allows for a system of prior authorisation if there is sufficient reason to expect that the social security system will be seriously undermined. This should also cover cases of already existing systems of prior authorisation which are in conformity with conditions laid down in Article 8The Member States may provide for a system of prior authorisation for hospital and specialised care and decide on the care sectors in which they consider it necessary to plan needs.
Amendment 174 #
2008/0142(COD)
Proposal for a directive
Recital 40
Recital 40
(40) European reference networks should provide healthcare to all patients who have conditions requiring a particular concentration of resources or expertise, in order to provide affordable, high quality and cost-effective care and could also be focal points for medical training and research, information dissemination and evaluation. The mechanism for identification and development of the European refMember States shall facilitate the development of the European reference networks of healthcare providers in the form of voluntary groupings with the aim of exchanging scientific experience networks should be established with the aim to organise at European level equal access to high level shared expertise in a given medical fieldin order to improve healthcare possibilities for all patients as well as for health professionalswith rarer illnesses, based on the open coordination method.
Amendment 181 #
2008/0142(COD)
Proposal for a directive
Recital 45
Recital 45
Amendment 234 #
2008/0142(COD)
Proposal for a directive – amending act
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Member State of affiliation may impose on a patient seeking healthcare provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities including codes of conduct of the medical professions for receiving healthcare and reimbursement of healthcare costs as it would impose if the same or similar healthcare was provided in its territory, in so far as they are not neither discriminatory nor an obstacle to freedom of movement of persons.
Amendment 254 #
2008/0142(COD)
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
1. For the purposes of reimbursement of healthcare provided in another Member State in accordance with this Directive, hospital care shall mean: (a) healthcare which requires overnight accommodation of the patient in question for at least one night. (b) healthealthcare which, in accordance with the rules of the Member State of affiliation concerned, is the subject of appropriate care and needs planning to ensure efficient, economic and universal medical care, included in a specific list, that does not that State, shall be deemed to be hospital and specialised care. In addition to healthcare which requires overnight accommodation of the patient in question for at least one night. This list shall be limited to: – healthcare that requires or the use of highly specialised and cost-intensive medical infrastructure or medical equipment; or – healthcarewhich involvinges treatments presenting a particular risk for the patient or the population, such care may also include healthcare which, in accordance with the care approach of the Member State of affiliation concerned, requires a planned infrastructure for other reasons.
Amendment 262 #
2008/0142(COD)
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 269 #
2008/0142(COD)
Proposal for a directive
Article 8 – paragraph 3
Article 8 – paragraph 3
3. The Member State of affiliation may provide for a system ofset prior authorisation as a condition for reimbursement by its social security system of the cost of hospital care provided in another Member State where the following conditions are met: (a) had the healthcare been provided in its territory, it would have been assumed by the Member State's social security system; and (b) the purpose of the system is to address the consequent outflow of patients due to the implementation of the present Article and to prevent it from seriously undermining, or being likely to seriously undermine: (i) the financial balance of the Member State's social security system; and/or (ii) the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concernedof the cost of hospital or specialised care, as defined by itself pursuant to paragraph 1, which is provided in another Member State.
Amendment 281 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (h)
Article 4 - point (h)
(h) "Member State of affiliation" means the Member State where the patient is an insured person; if the institution of the place of residence is the competent institution pursuant to the second subparagraph of Article 22(3) of Regulation (EEC) No 1408/71 or Article 20(4) or Article 27(5) of Regulation (EEC) No 883/2004, the State of residence shall be deemed to be the Member State of affiliation;
Amendment 305 #
2008/0142(COD)
Proposal for a directive
Article 5
Article 5
Amendment 387 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State where the treatment in question is among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled. The Member State of affiliation shall reimburse the costs to the insured person, which would have been paid for by its statutory social security system for treatment carried out generally and lege artis in the Member State of treatment on the basis of the given diagnosis at the level thadt the same or similar healthcare been provided in its territorycosts would have been reimbursed to the insured person for treatment carried out generally and lege artis in his Member State of affiliation. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided.
Amendment 413 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Member State of affiliation may impose on a patient seeking healthcare provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities including codes of conduct of the medical professions for receiving healthcare and reimbursement of healthcare costs as it would impose if the same or similar healthcare was provided in its territory, in so far as they are neitherot discriminatory nor an obstacle to freedom of movement of persons.
Amendment 447 #
2008/0142(COD)
Proposal for a directive
Article 8 – paragraph 1
Article 8 – paragraph 1
1. For the purposes of reimbursement of healthcare provided in another Member State in accordance with this Directive, hospital care shall mean: (a) healthcare which requires overnight accommodation of the patient in question for at least one night. (b) healthealthcare which, in accordance with the rules of the Member State of affiliation concerned, is the subject of appropriate care and needs planning to ensure efficient, economic and universal medical care, included in a specific list, that does not that State, shall be deemed to be hospital and specialised care. In addition to healthcare which requires overnight accommodation of the patient in question for at least one night. This list shall be limited to: - healthcare that requires or the use of highly specialised and cost-intensive medical infrastructure or medical equipment; or - healthcarewhich involvinges treatments presenting a particular risk for the patient or the population, such care may also include healthcare which, in accordance with the care approach of the Member State of affiliation concerned, requires a planned infrastructure for other reasons.
Amendment 470 #
2008/0142(COD)
Proposal for a directive
Article 8 – paragraph 3
Article 8 – paragraph 3
3. The Member State of affiliation may provide for a system ofset prior authorisation as a condition for reimbursement by its social security system of the cost of hospital care provided in another Member State where the following conditions are met: (a) had the healthcare been provided in its territory, it would have been assumed by the Member State's social security system; and (b) the purpose of the system is to address the consequent outflow of patients due to the implementation of the present Article and to prevent it from seriously undermining, or being likely to seriously undermine: (i) the financial balance of the Member State's social security system; and/or (ii) the planning and rationalisation carried out in the hospital sector to avoid hospital overcapacity, imbalance in the supply of hospital care and logistical and financial wastage, the maintenance of a balanced medical and hospital service open to all, or the maintenance of treatment capacity or medical competence on the territory of the concernedof the cost of hospital or specialised care, as defined by itself pursuant to paragraph 1, which is provided in another Member State.
Amendment 572 #
2008/0142(COD)
Proposal for a directive
Article 12 – paragraph 2 – point a
Article 12 – paragraph 2 – point a
(a) provide and disseminate objective information of a general nature to patients in particular on their rights related to cross- border healthcare, and the guarantees ofinformation about quality and safety, protection of personal data, procedures for complaints and means of redress available for healthcare provided in another Member State, and on the terms and conditions applicable. No recommendations concerning the service providers (rankings) should be supplied;
Amendment 615 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. If a medicinal product is authorised to be marketed on theirits territory in accordance with Article 6(1) of Directive 2001/83/EC, a Member States shall ensure that prescriptions for this medicinal product issued by an authorised person in another Member State for a named patient can after recognition by a doctor be used in theirits territory and that any restrictions on recognition of individual prescriptions are prohibited unless they: (a) are limited to what is necessary and proportionate to safeguard human health and are non-discriminatory or (b) are based on legitimate and justified doubts about the authenticity or content of an individual prescription or about the authority of the prescriber. Costs will be reimbursed according to the conditions applying in the Member State of affiliation.
Amendment 620 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 1 – subparagraph 1 a (new)
Article 14 – paragraph 1 – subparagraph 1 a (new)
The recognition of such a prescription shall not affect the application of the following national regulations: (i) rules governing the dispensing of medicinal products, including generic substitution, (ii) rules relating to pricing and reimbursement, (iii) professional or ethical rules which would require the pharmacist to refuse to dispense had the prescription been issued in his own Member State.
Amendment 633 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(b) measures to ensure that medicinal products prescribed in one Member State and dispensed in another are correctly identified and that the information to patients concerning the product is comprehensible; prescriptions issued in accordance with this EU template shall be written in International Nonproprietary Names (INN).
Amendment 635 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 2 – point ba (new)
Article 14 – paragraph 2 – point ba (new)
(ba) measures to facilitate the establishment of contacts between the prescriber and the dispenser, so as to clarify any doubts concerning the prescription.
Amendment 639 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 2 – point c
Article 14 – paragraph 2 – point c
Amendment 646 #
2008/0142(COD)
Proposal for a directive
Article 15 - paragraph 1
Article 15 - paragraph 1
1. Reference networks are voluntary associations for the exchange of scientific experience with the aim of improving the possibilities for healthcare provision for patients with rare diseases and are based on the open coordination method. Reference networks present an opportunity to demonstrate Europe's excellence in medical research and treatment. Member States shall facilitate the development of the European reference networks of healthcare providers. Those networks shall at all times be open for new healthcare providers which might wish to join them, provided that such healthcare providers fulfil all the required conditions and criteria.
Amendment 651 #
2008/0142(COD)
Proposal for a directive
Article 15 - paragraph 2
Article 15 - paragraph 2
Amendment 656 #
2008/0142(COD)
Proposal for a directive
Article 15 - paragraph 3
Article 15 - paragraph 3
Amendment 672 #
2008/0142(COD)
Proposal for a directive
Article 15 - paragraph 4
Article 15 - paragraph 4
Amendment 691 #
2008/0142(COD)
Proposal for a directive
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
1a. The network shall act on the basis of an operational framework based on the principles of good governance. These principles include inter alia transparency of procedures, a formal right of appeal, objectiveness, impartiality and the full involvement of all relevant stakeholders.
Amendment 696 #
2008/0142(COD)
Proposal for a directive
Article 17 – paragraph 4
Article 17 – paragraph 4
4. The Commission shall, in accordance with the procedure referred to in Article 19(23), adopt the necessary measures for the establishment and the management of this network and specifying the nature and type of the information to be exchanged.
Amendment 698 #
2008/0142(COD)
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. Member States shall transmit the data referred to in paragraph 1 to the Commission for statistical purposes at least annually, except for data that are already collected pursuant to Directive 2005/36/EC.
Amendment 23 #
2008/0140(CNS)
Proposal for a directive
Recital 3
Recital 3
(3) This Directive respects the fundamental rights and observes the fundamental principles recognised in particular by the Charter of Fundamental Rights of the European Union. Article 10 of the Charter recognises the right to freedom of thought, conscience and religion; Article 21 prohibits discrimination, including on grounds of religion or belief, disability, age or sexual orientation; and Article 26 acknowledges the right of persons with disabilities to benefit from measures designed to ensure their independence.
Amendment 24 #
2008/0140(CNS)
Proposal for a directive
Recital 4 a (new)
Recital 4 a (new)
Amendment 25 #
2008/0140(CNS)
Proposal for a directive
Recital 8
Recital 8
(8) The Community has adopted three legal instruments12 on the basis of aArticle 13(1) of the EC Treaty to prevent and combat discrimination on grounds of sex, racial and ethnic origin, religion or belief, disability, age and sexual orientation. These instruments have demonstrated the value of legislation in the fight against discrimination. In particular, Directive 2000/78/EC establishes a general framework for equal treatment in employment and occupation on the grounds of religion or belief, disability, age and sexual orientation. However, variations remain between Member States on the degree and the form of protection from discrimination on these grounds beyond the areas of employment. ________________ 1 Directive 2000/43/EC, Directive 2000/78/EC and Directive 2004/113/EC 2 Directive 2000/43/EC, Directive 2000/78/EC and Directive 2004/113/EC
Amendment 27 #
2008/0140(CNS)
Proposal for a directive
Recital 9
Recital 9
(9) Therefore, legislation should prohibit discrimination based on religion or belief, disability, age or sexual orientation in a range of areas outside the labour market, including social protection, education and access to and supply of goods and services, including housing. It should provide for measures to ensure the equal access of persons with disabilities to the areas covered.
Amendment 32 #
2008/0140(CNS)
Proposal for a directive
Recital 13
Recital 13
(13) In implementing the principle of equal treatment irrespective of religion or belief, disability, age or sexual orientation, the Community should, in accordance with Article 3(2) of the EC Treaty, aim to eliminate inequalities, and to promote equality between men and women, especially since women are often the victims of multiple discrimination.
Amendment 33 #
2008/0140(CNS)
Proposal for a directive
Article 4 a (new)
Article 4 a (new)
Amendment 34 #
2008/0140(CNS)
Proposal for a directive
Recital 15
Recital 15
(15) Actuarial and risk factors related to disability and to age are used in the provision of insurance, banking and other financial services. These should not be regarded as constituting discrimination where the factors arcan be shown to be key factors for the assessment of risk.
Amendment 36 #
2008/0140(CNS)
Proposal for a directive
Recital 16
Recital 16
(16) All individuals enjoy the freedom to contract, including the freedom to choose a contractual partner for a transaction. This Directive should not apply to economic transactions undertaken by individuals for whom these transactions do not constitute their professional or commercial activity.
Amendment 40 #
2008/0140(CNS)
Proposal for a directive
Recital 17
Recital 17
(17) While prohibiting discrimination, it is important to respect other fundamental rights and freedoms, including the protection of private and family life and transactions carried out in that context, the freedom of religion, and the freedom of association. This Directive is without prejudice to national laws con marital or family status, including on reproductive rightscerning the family and marriage and the value thereof. It is also without prejudice to the secular nature of the State, state institutions or bodies, or education.
Amendment 44 #
2008/0140(CNS)
Proposal for a directive
Recital 7 a (new)
Recital 7 a (new)
(7a) In its accompanying communication ‘Non-discrimination and equal opportunities: A renewed commitment’ of 2 July 2008 (COM(2008)0420 final), the Commission affirmed that the European Union already has one of the most advanced non-discrimination legal frameworks in the world.
Amendment 44 #
2008/0140(CNS)
Proposal for a directive
Recital 18
Recital 18
(18) Member States are responsible for the organisation and content of education. The Commission Communication on Competences for the 21st Century: An Agenda for European Cooperation on Schools draws attention to the need for special attention to be paid to disadvantaged children and those with special educational needs. In particular national law may provide for differences in access to educational institutions based on religion or belief. Member States may also allow or prohibit the wearing or display of religious symbols at school.
Amendment 46 #
2008/0140(CNS)
Proposal for a directive
Recital 21
Recital 21
(21) The prohibition of discrimination should be without prejudice to the maintenance or adoption by Member States of measures intended to prevent or compensate for disadvantages suffered by a group of persons of a particular religion or belief, disability, age or sexual orientation. Such measures may permit organisations of persons of a particular religion or belief, disability, age or sexual orientation where their main object is the promotion of the special needs of those persons.
Amendment 47 #
2008/0140(CNS)
Proposal for a directive
Recital 23
Recital 23
(23) Persons who have been subject to discrimination based on religion or belief, disability, age or sexual orientation should have adequate means of legal protection. To provide a more effective level of protection, associations, organisations and other legal entities should be empowered to engage in proceedings, including on behalf of or in support of any victim, without prejudice to national rules of procedure concerning representation and defence before the courts.
Amendment 48 #
2008/0140(CNS)
Proposal for a directive
Recital 9
Recital 9
Therefore, legislation should prohibit discrimination based on religion or belief, disability, age or sexual orientation in a range of areas outside the labour market, including social protection, education and access to and supply of goods and services, including housing. It should provide for measures to ensure the equal access of persons with disabilities to the areas covered.
Amendment 48 #
2008/0140(CNS)
Proposal for a directive
Recital 24
Recital 24
(24) The rules on the burden of proof must be adapted when there is a prima facie case of discrimination and, for the principle of equal treatment to be applied effectively, the burden of proof must shift back to the respondent when evidence of such discrimination is brought. However, it is not for the respondent to prove that the plaintiff adheres to a particular religion or belief, has a particular disability, is of a particular age or has a particular sexual orientation.
Amendment 49 #
2008/0140(CNS)
Proposal for a directive
Article 1
Article 1
This Directive lays down a framework for combating discrimination on the grounds of religion or belief, disability, age, or sexual orientation, with a view to putting into effect in the Member States the principle of equal treatment other than in the field of employment and occupation.
Amendment 50 #
2008/0140(CNS)
Proposal for a directive
Article 2 - paragraph 2 - point b
Article 2 - paragraph 2 - point b
(b) indirect discrimination shall be taken to occur where an apparently neutral provision, criterion or practice would put persons of a particular religion or belief, a particular disability, a particular age, or a particular sexual orientation at a particular disadvantage compared with other persons, unless that provision, criterion or practice is objectively justified by a legitimate aim and the means of achieving that aim are appropriate and necessary.
Amendment 61 #
2008/0140(CNS)
Proposal for a directive
Recital 12 a (new)
Recital 12 a (new)
(12a) Owing to the excessive burden on small and medium-sized enterprises (SMEs), they should be afforded special protection, following the model of the US Civil Rights Act.
Amendment 65 #
2008/0140(CNS)
Proposal for a directive
Article 2 - paragraph 7
Article 2 - paragraph 7
7. Notwithstanding paragraph 2, in the provision of financial services Member States may permit proportionate differences in treatment may be permitted where, for the product in question, the use of age or disability is a key factor in the assessment of risk based on relevant and accurate actuarial or statistical databased on an appropriate risk calculation using relevant mathematical or statistical data or principles and medical experience.
Amendment 68 #
2008/0140(CNS)
Proposal for a directive
Recital 13
Recital 13
(13) In implementing the principle of equal treatment irrespective of religion or belief, disability, age or sexual orientation, the Community should, in accordance with Article 3(2) of the EC Treaty, aim to eliminate inequalities, and to promote equality between men and women, especially since women are often the victims of multiple discrimination.
Amendment 74 #
2008/0140(CNS)
Proposal for a directive
Article 3 - paragraph 1 - point d - subparagraph 2
Article 3 - paragraph 1 - point d - subparagraph 2
(d) Subparagraph (d) shall apply to individuals only in so far as they are performing a professional or commercial activity.
Amendment 76 #
2008/0140(CNS)
Proposal for a directive
Article 3 - paragraph 2
Article 3 - paragraph 2
2. This Directive is without prejudice to national laws con marital or family status and reproductive rightscerning the family and marriage and the value thereof.
Amendment 77 #
2008/0140(CNS)
Proposal for a directive
Recital 15
Recital 15
(15) Actuarial and risk factors related to disability and to age are used in the provision of insurance, banking and other financial services. These should not be regarded as constituting discrimination where the factors arcan be shown to be key factors for the assessment of risk.
Amendment 80 #
2008/0140(CNS)
Proposal for a directive
Article 3 - paragraph 3
Article 3 - paragraph 3
3. This Directive is without prejudice to the responsibilities of Member States for the content of teaching, activities and the organisation of their educational systems, including the provision of special needs education. Member States may provide for differences in treatment in access to educational institutions based on religion or belief.
Amendment 86 #
2008/0140(CNS)
Proposal for a directive
Recital 16
Recital 16
(16) All individuals enjoy the freedom to contract, including the freedom to choose a contractual partner for a transaction. This Directive should not apply to economic transactions undertaken by individuals for whom these transactions do not constitute their professional or commercial activity.
Amendment 96 #
2008/0140(CNS)
Proposal for a directive
Article 5
Article 5
With a view to ensuring full equality in practice, the principle of equal treatment shall not prevent any Member State from maintaining or adopting specific measures to prevent or compensate for disadvantages linked to religion or belief, disability, age, or sexual orientation.
Amendment 98 #
2008/0140(CNS)
Proposal for a directive
Recital 17
Recital 17
(17) While prohibiting discrimination, it is important to respect other fundamental rights and freedoms, including the protection of private and family life and transactions carried out in that context, the freedom of religion, and the freedom of association. This Directive is without prejudice to national laws on marital or family status and the value thereof, including on reproductive and adoption rights. It is also without prejudice to the secular nature of the State, state institutions or bodies, or education.
Amendment 101 #
2008/0140(CNS)
Proposal for a directive
Article 12 - paragraph 1
Article 12 - paragraph 1
1. Member States shall designate a body or bodies for the promotion of equal treatment of all persons irrespective of their religion or belief, disability, age, or sexual orientation. These bodies may form part of agencies charged at national level with the defence of human rights or the safeguard of individuals' rights, including rights under other Community acts including Directives 2000/43/EC and 2004/113/EC.
Amendment 116 #
2008/0140(CNS)
Proposal for a directive
Recital 19
Recital 19
(19) The European Union in its Declaration No 11 on the status of churches and non- confessional organisations, annexed to the Final Act of the Amsterdam Treaty, has explicitly recognised that it respects and does not prejudice the status under national law of churches and religious associations or communities in the Member States and that it equally respects the status of philosophical and non-confessional organisations. This Directive therefore respects national legislation guaranteeing their status and activities and shall not apply thereto. Measures to enable persons with disabilities to have effective non- discriminatory access to the areas covered by this Directive play an important part in ensuring full equality in practice. Furthermore, individual measures of reasonable accommodation may be required in some cases to ensure such access. In neither case are measures required that would impose a disproportionate burden. In assessing whether the burden is disproportionate, account should be taken of a number of factors including the size, resources and nature of the organisation. The principle of reasonable accommodation and disproportionate burden are established in Directive 2000/78/EC and the UN Convention on the Rights of Persons with Disabilities.
Amendment 120 #
2008/0140(CNS)
Proposal for a directive
Recital 21
Recital 21
(21) The prohibition of discrimination should be without prejudice to the maintenance or adoption by Member States of measures intended to prevent or compensate for disadvantages suffered by a group of persons of a particular religion or belief, disability, age or sexual orientation. Such measures may permit organisations of persons of a particular religion or belief, disability, age or sexual orientation where their main object is the promotion of the special needs of those persons.
Amendment 124 #
2008/0140(CNS)
Proposal for a directive
Recital 23
Recital 23
(23) Persons who have been subject to discrimination based on religion or belief, disability, age or sexual orientation should have adequate means of legal protection. To provide a more effective level of protection, associations, organisations and other legal entities should be empowered to engage in proceedings, including on behalf of or in support of any victim, without prejudice to national rules of procedure concerning representation and defence before the courts.
Amendment 132 #
2008/0140(CNS)
Proposal for a directive
Article 1
Article 1
This Directive lays down a framework for combating discrimination on the grounds of religion or belief, disability, age, or sexual orientation, with a view to putting into effect in the Member States the principle of equal treatment other than in the field of employment and occupation.
Amendment 142 #
2008/0140(CNS)
Proposal for a directive
Article 2 – paragraph 2 – point (b)
Article 2 – paragraph 2 – point (b)
(b) indirect discrimination shall be taken to occur where an apparently neutral provision, criterion or practice would put persons of a particular religion or belief, a particular disability, a particular age, or a particular sexual orientation at a particular disadvantage compared with other persons, unless that provision, criterion or practice is objectively justified by a legitimate aim and the means of achieving that aim are appropriate and necessary.
Amendment 144 #
2008/0140(CNS)
Proposal for a directive
Article 2 – paragraph 3
Article 2 – paragraph 3
Amendment 147 #
2008/0140(CNS)
Proposal for a directive
Article 2 – paragraph 3
Article 2 – paragraph 3
3. Harassment shall be deemed to be a form of discrimination within the meaning of paragraph 1, when unwanted conduct related to any of the grounds referred to in Article 1 takes place with the purpose or effect of violating the dignity of a person and of creating an intimidating, hostile, degrading, humiliating or offensive environment. In this context, the concepts of harassment and unwanted conduct may be defined in accordance with the national laws and practice of the Member States.
Amendment 152 #
2008/0140(CNS)
Proposal for a directive
Article 2 – paragraph 3
Article 2 – paragraph 3
3. Harassment shallmay also be deemed to be a form of discrimination within the meaning of paragraph 1, when unwanted conduct related to any of the grounds referred to in Article 1 takes place with the purpose or effect of violating the dignity of a person and of creating an intimidating, hostile, degrading, humiliating or offensive environment.
Amendment 167 #
2008/0140(CNS)
Proposal for a directive
Article 2 – paragraph 6
Article 2 – paragraph 6
6. Notwithstanding paragraph 2, Member States may provide that differences of treatment on the grounds of agelaid down in Article 1 shall not constitute discrimination, if, within the context of national law, they are justified by a legitimate aim, and if the means of achieving that aim are appropriate and necessary there is an objective reason for the violation thereof. In particular, this Directive shall not preclude the fixing of a specific age for access to social benefits, education and certain goods or services.
Amendment 176 #
2008/0140(CNS)
Proposal for a directive
Article 2 – paragraph 7
Article 2 – paragraph 7
7. Notwithstanding paragraph 2, in the provision of financial services Member States may permit proportionate differences in treatment where, for the product in question, the use of age or disability is a keydetermining factor in the assessment of risk based on relevant and accurate actuarial or statistical datactuarial principles, accurate statistical data or medical knowledge shall not be considered discrimination for the purposes of this Directive.
Amendment 189 #
2008/0140(CNS)
Proposal for a directive
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Within the limits of the powers conferred upon the Community, the prohibition of discrimination shall apply to all persons, as regards both the public and private sectors, including public bodies, provided they are performing a professional or commercial activity, in relation to:
Amendment 190 #
Amendment 196 #
2008/0140(CNS)
Proposal for a directive
Article 3 – paragraph 1 - point d
Article 3 – paragraph 1 - point d
(d) access to and supply of goods and services which are available to the public, including housing. Subparagraph (d) shall apply to individuals only insofar as they are performing a professional or commercial activity.
Amendment 200 #
2008/0140(CNS)
Proposal for a directive
Article 3 – paragraph 1 - point d
Article 3 – paragraph 1 - point d
(d) Access to and supply of goods and other services which are available to the public, including housing. Subparagraph (d) shall apply to individuals only insofar as they are performing a professional or commercial activity.
Amendment 208 #
2008/0140(CNS)
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. This Directive is without prejudice to national laws on marital or family statusegislation on marriage, family status and the benefits dependent thereon and reproductive rights.
Amendment 211 #
2008/0140(CNS)
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. This Directive is without prejudice to national laws on marital or family status and reproductivetheir importance and reproductive and adoption rights.
Amendment 253 #
2008/0140(CNS)
Proposal for a directive
Article 4 – paragraph 1 – point a a (new)
Article 4 – paragraph 1 – point a a (new)
(aa) No breach of the ban on disadvantaging individuals shall be deemed to have occurred if there is an objective reason justifying a difference in treatment on grounds of religion or belief, disability, age or sexual orientation. In particular, this may be the case if the difference in treatment 1. is intended to rule out risks or prevent damage or to serve other, similar purposes, 2. takes account of the requirement to protect privacy or personal safety, 3. offers special advantages and there can be no interest in enforcing equal treatment. In connection with the rental of housing, different treatment with a view to establishing and maintaining socially stable tenancy patterns and balanced settlement structures and balanced economic, social and cultural conditions shall be admissible.
Amendment 266 #
2008/0140(CNS)
Proposal for a directive
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2a. When defining what constitutes a ‘disproportionate burden’ within the meaning of the second sentence of paragraph 1(a) and paragraph 1(b), due account shall be taken of the laws on equal treatment of persons with disabilities in force in each Member State and the interpretation of those laws by national courts.
Amendment 274 #
2008/0140(CNS)
Proposal for a directive
Article 5
Article 5
5. With a view to ensuring full equality in practice, the principle of equal treatment shall not prevent any Member State from maintaining or adopting specific measures to prevent or compensate for disadvantages linked to religion or belief, disability, age, or sexual orientation.
Amendment 278 #
2008/0140(CNS)
Proposal for a directive
Article 7 – paragraph 2
Article 7 – paragraph 2
Amendment 287 #
2008/0140(CNS)
Proposal for a directive
Article 7 – paragraph 3 a (new)
Article 7 – paragraph 3 a (new)
3a. Member States shall ensure, in accordance with their national judicial systems, that all persons who consider themselves wronged by failure to apply the principle of equal treatment to them can take legal action to assert their rights.
Amendment 289 #
2008/0140(CNS)
Proposal for a directive
Article 8
Article 8
Amendment 299 #
2008/0140(CNS)
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Member States shall designate a body or bodies for the promotion of equal treatment of all persons irrespective of their religion or belief, disability, age, or sexual orientation. These bodies may form part of agencies charged at national level with the defence of human rights or the safeguard of individuals' rights, including rights under other Community acts including Directives 2000/43/EC and 2004/113/EC.
Amendment 318 #
2008/0140(CNS)
Proposal for a directive
Article 14
Article 14
Member States shall lay down the rules on sanctions applicable to breaches of the national provisions adopted pursuant to this Directive, and shall take all measures necessary to ensure that they are applied. Sanctions may comprise the payment of compensation, which may not be restricted by the fixing of a prior upper limit, and must be effective, proportionate and dissuasive.
Amendment 321 #
2008/0140(CNS)
Proposal for a directive
Article 15 – paragraph 1 – subparagraph 1
Article 15 – paragraph 1 – subparagraph 1
1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive by …. at the latest [twohree years after adoption]. They shall forthwith inform the Commission thereof and shall communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
Amendment 86 #
2008/0110(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) In addition, in order to prevent risks arising from wild animals, carcasses or parts of carcasses of such animals suspected of being infected with a transmissible disease should be subject to the rules laid down in this Regulation. This inclusion should not imply an obligation to collect and dispose of bodies of wild animals that have died or that are hunted in their natural habitat. If good hunting practicelaw requirements are observed, intestines and other body parts of wild game may be disposed of safely on site. Animal by- products from hunted game should only be subject to the provisions of this Regulation insofar as food hygiene legislation applies to the placing on the market of such game and involves operations carried out by game- handling establishments.
Amendment 95 #
2008/0110(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point d
Article 2 – paragraph 2 – point d
(d) liquidraw milk, colostrum and products derived thereof which are obtained, kept, disposed of or used on the farm of origin;
Amendment 100 #
2008/0110(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point g a (new)
Article 2 – paragraph 2 – point g a (new)
(ga) animal by-products for feeding to carnivorous or omnivorous animals of wild species which are being kept under human supervision and which are not intended for human consumption, provided that the animal by-products in question form part of or are based on the animals’ natural diet and are not likely to pose an increased TSE risk.
Amendment 101 #
2008/0110(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point g b (new)
Article 2 – paragraph 2 – point g b (new)
(gb) pet food for use on site derived from animals slaughtered on the farm of origin for use as foodstuffs by the farmer and his family only, in accordance with national legislation;
Amendment 102 #
2008/0110(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point g c (new)
Article 2 – paragraph 2 – point g c (new)
(gc) pet food manufactured in registered food production establishments from material suitable for use in foodstuffs and under the same hygiene conditions as foodstuffs;
Amendment 103 #
2008/0110(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point g d (new)
Article 2 – paragraph 2 – point g d (new)
(gd) pet food manufactured solely from carcases or slaughter animals suitable for human consumption originating from retail shops or premises adjacent to sale points where the cutting, processing and storage are performed solely for the purpose of supplying the consumer directly on the spot;
Amendment 113 #
2008/0110(COD)
Proposal for a regulation
Article 7 – title
Article 7 – title
Exemptions from the requirement for approval approval and requirement for registration
Amendment 114 #
2008/0110(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) operations covered by the approval or registration of plants andf establishments approved or registered in accordance with: (i) Regulation (EC) No 853/2004; or (ii) Regulation (EC) No 183/2005;
Amendment 115 #
2008/0110(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a ) operations covered by the approval or registration of plants andf establishments approved or registered in accordance with: (i) Regulation (EC) No 853/2004; or (ii) Regulation (EC) No 183/2005;
Amendment 116 #
2008/0110(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point c
Article 7 – paragraph 1 – point c
Amendment 119 #
2008/0110(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Plants andOperators whose plants or establishments are exempt from approval in accordance with paragraph 1(a), (b) and (c) shall, be registered by the competent authority upon application by the operator. The application must containfore commencing operations, and with a view to registration, notify the relevant competent authority of the existence of the plants or establishments in the manner required by that authority. Operators must at least provide the following information: (a) the category of animal by-products used; (b) the nature of the operations performed using animal by-products or derived products as starting material for which the application is made.
Amendment 120 #
2008/0110(COD)
Proposal for a regulation
Article 7 – paragraph 3 a (new)
Article 7 – paragraph 3 a (new)
3a. Establishments which are approved or registered pursuant to other Community provisions and which pick up, collect, store, transport, handle or process animal by-products must also comply with the provisions of this Regulation.
Amendment 121 #
2008/0110(COD)
Proposal for a regulation
Article 8 – title
Article 8 – title
Approval of plants Approval of establishments and plants
Amendment 122 #
2008/0110(COD)
Proposal for a regulation
Article 8 – paragraph 1 – introductory part
Article 8 – paragraph 1 – introductory part
1. The competent authority shall approve an establishment or plant provided that the operator submits together with his application, evidence that:
Amendment 123 #
2008/0110(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point d a (new)
Article 8 – paragraph 1 – point d a (new)
(da) if animal by-products as referred to in Article 2(1)(a) are stored or processed, the processing of these products is kept permanently separate, by means of organisational and physical measures, from the processing of certain products intended for human consumption and that all products are labelled as foodstuffs or animal by-products, as appropriate; end products must be stored in a separate room or a separate facility, which shall be named accordingly. The operator must ensure that end products cannot enter the human food chain;
Amendment 124 #
2008/0110(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. The plant shall only be approved following an on-site visit by the competent authorityUpon receipt of an application for approval pursuant to this Regulation from an operator, the competent authority shall make an on-site visit. It shall approve an establishment for the activities concerned only if the operator has demonstrated that it complies with the requirements of this Regulation and is sufficiently reliable. The competent authority may grant conditional approval if it appears that the plaestablishment meets all the rinfrastructure and equirepments referred to in paragraph 1(a) and (b)quirements. It shall grant full approval only if it appears from a new official control of the plaestablishment, carried out within three months of granting conditional approval, that the plaestablishment meets the other applicablerelevant requirements. of this Regulation. If clear progress has been made but the plaestablishment still does not meet all the applicablerelevant requirements, the competent authority may prolong conditional approval. However, conditional approval shall not exceed a total of six months. The competent authority shall keep the approval of establishments and plants under review when carrying out official controls. If the competent authority identifies serious deficiencies or has to stop production at an establishment or plant repeatedly and the operator is not able to provide adequate guarantees regarding future production, the competent authority shall initiate procedures to withdraw the establishment's or plant's approval. However, the competent authority may suspend an establishment's or plant's approval if the operator can guarantee that it will resolve deficiencies within a reasonable time.
Amendment 125 #
2008/0110(COD)
Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 2
Article 10 – paragraph 2 – subparagraph 2
Amendment 129 #
2008/0110(COD)
Proposal for a regulation
Article 13 – point b – introductory part
Article 13 – point b – introductory part
(b) the following parts originating either from animals that have been slaughtered in a slaughterhouse and were considered fit for slaughter for human consumption following an ante-mortem inspection, from poultry and lagomorphs slaughtered on the farm pursuant to Article 1(3)(d) of Regulation (EC) No 853/2004 or from game killed for human consumption in accordance with Community legislation:
Amendment 131 #
2008/0110(COD)
Proposal for a regulation
Article 13 – point e
Article 13 – point e
(e) products of animal origin, other than catering waste, which, after having been placed on the market for human consumption or for feeding to animals as feed manufactured from Category 3 material, are no longer intended for such consumption or such feeding for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;
Amendment 138 #
2008/0110(COD)
Proposal for a regulation
Article 14
Article 14
Articles 11, 12 and 13 may be amended by the Commission in order to take into account progress in science as regards the assessment of the level of risk, provided such progress can be identified on the basis of a risk assessment carried out by the appropriate scientific institution. However, no animal by-products listed in those Articles may be removed from those lists and only changes of categorisation of such products may be made or additional animal by-products may be added to those lists. Those measures designed to amend non essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 48(4).4 deleted Changes of categories
Amendment 139 #
2008/0110(COD)
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1
Article 15 – paragraph 2 – subparagraph 1
2. Operators shall ensure thatAnyone transporting animal by- products and derived products are accompanied during transportationshall ensure that they are accompanied by a commercial document and, when required by this Regulation or by a measure adopted in accordance with paragraph 5, by a health certificate.
Amendment 141 #
2008/0110(COD)
Proposal for a regulation
Article 15 – paragraph 3 – subparagraph 1 a (new)
Article 15 – paragraph 3 – subparagraph 1 a (new)
Amendment 142 #
2008/0110(COD)
Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 1
Article 16 – paragraph 1 – subparagraph 1
Any person consigning, transporting or receiving animal by-products or derived products shall keep a record of consignments and related. Provided that all the relevant details are contained in the commercial documents or health certificates, no further record need be kept.
Amendment 145 #
2008/0110(COD)
Proposal for a regulation
Article 17 – paragraph 3 – point e
Article 17 – paragraph 3 – point e
Amendment 146 #
2008/0110(COD)
Proposal for a regulation
Article 17 a (new)
Article 17 a (new)
Article 17a Traceability 1. The traceability of animal by-products shall be established at all stages of production, processing and distribution. 2. Operators shall be able to identify any person by whom they have been supplied with an animal by-product. To this end, operators shall have in place systems and procedures by means of which this information can be made available to the competent authorities on demand. 3. Operators shall have in place systems and procedures to identify other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand. 4. Animal by-products which are placed on the market or are likely to be placed on the market in the Community shall be adequately labelled or identified to facilitate their traceability, through relevant documentation or information in accordance with the relevant requirements of more specific provisions. 5. Provisions for the purpose of applying the requirements of this article in respect of specific sectors may be adopted in accordance with the regulatory procedure with scrutiny laid down in Article 48(4).
Amendment 150 #
2008/0110(COD)
Proposal for a regulation
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
(c) the feespreading of farmed animals with herbage, either directly by grazing or by feeding with cut herbage, from land to which organic fertilisers or soil improvers, other than manure, have been appliedn grassland of fertilisers and soil improvers manufactured using animal by-products other than manure and stomach content;
Amendment 151 #
2008/0110(COD)
Proposal for a regulation
Article 18 – paragraph 1 – point d
Article 18 – paragraph 1 – point d
Amendment 156 #
2008/0110(COD)
Proposal for a regulation
Article 21 – point c – point i
Article 21 – point c – point i
(i) as feed material for farmed animals or for the feeding to farmed animals other than fur animals, and placed on the market in accordance with Article 24, except in the case of material referred to in Article 13(l) and (m);
Amendment 160 #
2008/0110(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
Amendment 166 #
2008/0110(COD)
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
2. The competent authority may authorise, by way of derogation from Sections 1 and 2, and in accordance with conditions laid down pursuant to paragraph 3 of this Article, the feeding of the Category 1 material referred to in Article 11(b)(ii) to zoo animals and to endangered or protected species of necrophagous birds living in their natural habitat.
Amendment 178 #
2008/0110(COD)
Proposal for a regulation
Article 31 – paragraph 1 – subparagraph 1
Article 31 – paragraph 1 – subparagraph 1
1. If the official controls and supervision carried out by the competent authority reveal that one or more of requirements of this Regulation are not met, it shallthe competent authority may take appropriate action.
Amendment 182 #
2008/0110(COD)
Proposal for a regulation
Article 41 – paragraph 1 – point a
Article 41 – paragraph 1 – point a
(a) those products are (i) not intended for use as feed material for the feeding to farmed animals or for application to land from which suchfarmed animals are to be fed, or (ii) intended for feeding to fur animals; and
Amendment 75 #
2008/0100(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Vehicles in categories M1 shall be equipped with a Tyre Pressure Monitoring System, capable of warning the driver when any tyre is operating at a dangerously low pressure level, and advisof loss of pressure in the tyres, which is in the interests of optimum fuel consumption and road safety. Appropriate limits ing the driver when any tyre is operating at a pressure level significantly below the optimum pressure for good fueltechnical specifications shall be set to achieve this, which shall furthermore allow for a technology-neutral and cost- effective approach to the development of accurate Tyre Pressure Monitoring Systems, with no excessive costs for industry, and, consequently, consumptioners.
Amendment 97 #
2008/0100(COD)
Proposal for a regulation
Article 11 - paragraph 1 a (new)
Article 11 - paragraph 1 a (new)
1a. With effect from 12 months after the adoption of technical measures in respect of this Regulation, implementation dates for electronic stability control systems (Article 5(2)(b)) should be determined following the lead times set out in regulation UN/ECE R13.11.
Amendment 101 #
2008/0100(COD)
Proposal for a regulation
Article 11 - paragraph 2 a (new)
Article 11 - paragraph 2 a (new)
2a. With effect from 12 months after the adoption of technical measures in respect of this Regulation, implementation dates for electronic stability control systems (Article 5(2)(b)) should be determined following the lead times set out in regulation UN/ECE R13.11.
Amendment 51 #
2008/0098(COD)
Council position
Recital 8 a (new)
Recital 8 a (new)
(8a) The activities of contractors should not fall within the scope of this Regulation. The erection of construction works is a service and not the placing on the market of a product by a manufacturer. Construction activities may in specific cases include individually manufactured or custom-made parts of the construction work, which are then incorporated into the construction work by the contractor.
Amendment 52 #
2008/0098(COD)
Council position
Recital 15
Recital 15
(15) Threshold levels determined by the Commission pursuant to this Regulation should be generally recognised values for the essential characteristics of the construction product in question with regard to the provisions in Member Statesshould ensure a high level of protection within the meaning of Article 114 TFEU.
Amendment 66 #
2008/0098(COD)
Council position
Recital 50 a (new)
Recital 50 a (new)
(50 a) Wherever possible, uniform European provisions should be laid down for establishing compliance with the basic requirements set out in Annex I.
Amendment 73 #
2008/0098(COD)
Council position
Article 2 –point 15
Article 2 –point 15
15. ''"Specific Technical Documentation''" means documentation demonstrating that methods within the applicable system for assessment and verification of constancy of performance have been replaced by other methods, provided that the results obtained by those other methods are equivalent to the results obtained by the test methods of the corresponding harmonised standardby which other methods the procedures provided for in the harmonised technical specifications have been replaced within the applicable system for assessment and verification of constancy of performance;
Amendment 74 #
2008/0098(COD)
Council position
Article 4 – paragraph 1
Article 4 – paragraph 1
1. When a construction product is covered by a harmonised standard or a European Technical AssessAssessment Document has been issued for it, the manufacturer shall draw up a declaration of performance when such a product is placed on the market.
Amendment 76 #
2008/0098(COD)
Council position
Article 4 – paragraph 2
Article 4 – paragraph 2
2. When a construction product is covered by a harmonised standard or a European Technical AssessAssessment Document has been issued for it, information in any form about its performance in relation to the essential characteristics, as defined in the applicable harmonised technical specification, shall be provided only if included and specified in the declaration of performance.
Amendment 84 #
2008/0098(COD)
Council position
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
a) the construction product is individually manufactured or custom-made in a non- series process in response to a specific order, and installed in a single identified construction work, by a manufacturer who is responsible for the safe incorporation of the product into the construction works, in compliance with the applicable national rules and under the responsibility of those responsible for the safe execution of the construction works designated under the applicable national rules for a single identified construction work;
Amendment 85 #
2008/0098(COD)
Council position
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 88 #
2008/0098(COD)
Council position
Article 5 –point c
Article 5 –point c
(c) the construction product is manufactured in a traditional mannermanner appropriate to heritage conservation and in a non- industrial process for adequately renovating construction works officially protected as part of a designated environment or because of their special architectural or historic merit, in compliance with the applicable national rules.
Amendment 97 #
2008/0098(COD)
Council position
Article 6 – paragraph 3 – point c
Article 6 – paragraph 3 – point c
(c) the performance of at least one ofll the essential characteristics of the construction product, relevant for the declared intended use or uses;
Amendment 98 #
2008/0098(COD)
Council position
Article 6 – paragraph 3 – point d
Article 6 – paragraph 3 – point d
(d) where applicable, the performance of the construction product, by levels or classes, or in a description or based on a calculation, in relation to its essential characteristics determined in accordance with Article 3(3);
Amendment 100 #
2008/0098(COD)
Council position
Article 6 – paragraph 3 – point e
Article 6 – paragraph 3 – point e
Amendment 105 #
2008/0098(COD)
Council position
Article 6 – paragraph 3 – point f
Article 6 – paragraph 3 – point f
(f) for the listed essential characteristics for which no performance is declared, the letters "NPD" (No Performance Determined), if the harmonised specification provides for this option;
Amendment 132 #
2008/0098(COD)
Council position
Article 19 – paragraph 1 a (new)
Article 19 – paragraph 1 a (new)
1a. Where European Assessment Documents already exist, the organisation of TABs pursuant to Article 31(1) shall have the following purposes: (a) updating in accordance with the state of the art at appropriate intervals; (b) combining the European Assessment Documents which have been produced for individual products into a new European Assessment Document covering a whole product family.
Amendment 152 #
2008/0098(COD)
Council position
Article 37 – paragraph 1
Article 37 – paragraph 1
Micro-enterprises manufacturing construction products covered by a harmonised standard may replace the determination of the product-type on the basis of type-testing for the applicable systems 3 and 4 as set out in Annex V by using methods differing from those contained in the applicable harmonised standard, subject to conditions laid down there. Those manufacturers may also treat construction products to which system 3 applies in accordance with provisions for system 4. When a manufacturer uses these simplified procedures, he shall demonstrate compliance of the construction product with the applicable requirements by means of a Specific Technical Documentation and shall demonstrate the equivalence of the procedures used to the procedures prescribed in the harmonised technical specifications.
Amendment 155 #
2008/0098(COD)
Council position
Article 38 – paragraph 1
Article 38 – paragraph 1
1. In relation to construction products covered by a harmonised standard and which are individually manufactured or custom-made in a non-series process in response to a specific order, and which are installed in a single identified construction work, the performance assessment part of the applicable system, as set out in Annex V, may be replaced by the manufacturer by Specific Technical Documentation demonstrating compliance of that product with the applicable requirements and equivalence of the procedures employed with the procedures prescribed in the harmonised technical specifications.
Amendment 163 #
2008/0098(COD)
Council position
Article 60 – paragraph 1 – introductory part
Article 60 – paragraph 1 – introductory part
For the purposes of achieving the objectives of this Regulation, in particular removing and avoiding restrictions on making construction products available on the market, the following matters shall be delegated to the Commission in accordance with Article 61, and subject to the conditions laid down in Articles 62 and 63, and the Commission shall deal with them after consulting the committee provided for in Article 64:
Amendment 166 #
2008/0098(COD)
Council position
Annex I – paragraph 1
Annex I – paragraph 1
Construction works as a whole and in their separate parts must be fit for their intended use. Subject to normal maintenance, construction works must satisfy these basic requirements for construction works for an economically reasonable working life. The essential product characteristics and the methods and criteria for ascertaining product performances with reference to the basic requirements laid down in this annex shall be determined in the Technical Specifications. Wherever possible, harmonised European rules (e.g. ‘Eurocodes’) shall be used to show that the basic requirements are met.
Amendment 175 #
2008/0098(COD)
Council position
Annex II – part 5 – title
Annex II – part 5 – title
5. Commission participationParticipation by the Commission and the manufacturer
Amendment 176 #
2008/0098(COD)
Council position
Annex II – part 5 – paragraph 1
Annex II – part 5 – paragraph 1
A Commission representative and a representative of the manufacturer may participate, as observers, toin all the parts of the execution of the work programme.
Amendment 178 #
2008/0098(COD)
Council position
Annex II – part 7 – paragraph 2
Annex II – part 7 – paragraph 2
If, within fifteen working days of receipt, the Commission communicates to the organisation of TABs its observations on the draftcopy of the European Assessment Document, the organisation of TABs shall amend the draft accordinglyexamine the observations and shall send a copy of the adopted European Assessment Document, as then amended or not, as the case may be, to the manufacturer and the Commission.
Amendment 109 #
2008/0028(COD)
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
3. This Regulation applies to all stages of the food chain, where the activities of food businesses concern the provision of food information to consumers. the final consumer is concerned. It shall apply to all prepacked foods intended for delivery to the final consumer, including foods delivered by mass caterers and foods intended for supply to mass caterers. It shall not apply to foods which are packaged directly at the place of sale before delivery to the final consumers.
Amendment 111 #
2008/0028(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point e a (new)
Article 2 – paragraph 2 – point e a (new)
(ea) 'non-prepacked food' means food which is offered for sale to the final consumer without packaging and is packaged only at the time of sale to the final consumer and food and fresh products which are prepacked at the place of sale for immediate sale;
Amendment 113 #
2008/0028(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point t a (new)
Article 2 – paragraph 2 – point t a (new)
(ta) ‘Food imitation’ means food that gives the impression of being another food in which an ingredient usually used is wholly or partly replaced by another.
Amendment 119 #
2008/0028(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a a (new)
Article 7 – paragraph 1 – point a a (new)
(aa) by pictorial representations that mislead the consumer as to the origin, nature or composition of the food;
Amendment 120 #
2008/0028(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a b (new)
Article 7 – paragraph 1 – point a b (new)
(ab) in that the description or pictorial representations on the packaging suggest a particular product or an ingredient although in reality the product which the packaging contains is an imitation food or contains a substitute for an ingredient normally used in a product. In such cases, the packaging must prominently bear the marking 'imitation' or 'produced with (designation of the substitute ingredient) instead of (designation of the ingredient replaced)';
Amendment 142 #
2008/0028(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Without prejudice to specific Community legislation applicable to particular foods as regards to the requirements referred to in Article 9(1)(a) to (k), when appearing on the package or on the label attached thereto, the mandatory particulars listed in Article 9(1) shall be printedappear on the package or on the label in characters ofa manner which ensures the legibility thereof. In a fcont size of at least 3mm and shall be presented in a way so as to ensure a significant contrast between the prsultation procedure with representatives of the relevant interest groups, the European Commission shall draw up binding rules governing the legibility of food information for consumers. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted, int and background. ccordance with the regulatory procedure with scrutiny referred to in Article 49(3).
Amendment 156 #
2008/0028(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. In the case of packaging or containers the largest printable surface of which has an area of less than 100 cm2 only the particulars listed in Article 9(1) (a), (c), (e) and (f) and Article 29(1)(a) shall be mandatory on the package or on the label. The particulars referred to in Article 9(1)(b) shall be provided through other means or shall be available at the request of the consumer.
Amendment 159 #
2008/0028(COD)
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 1 a (new)
Article 17 – paragraph 2 – subparagraph 1 a (new)
The particulars listed in Articles 9 and 29 shall not be mandatory for nonprepacked goods, including those provided by mass caterers within the meaning of Article 2(2)(d).
Amendment 195 #
2008/0028(COD)
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. The amount of energy and nutrients referred to in paragraph 1 shall be expressed per 100 g or per 100 ml or, subject to Article 32(2) and (3), per portion per portion. If the food is prepacked as an individual portion, the energy and nutrition values referred to in paragraph 1 must also be indicated per portion. In addition, the amount of energy and nutrients may be indicated per portion If information is provided per portion, the number of portions which the package contains shall be indicated, the portion size must be realistic and the information shall be presented or explained in a manner which is comprehensible to the average consumer. In cooperation with food enterprises and the competent authorities of the Member States, the Commission shall develop guidelines for the indication of realistic portion sizes. These measures designed to amend non-essential elements of this Regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).
Amendment 202 #
2008/0028(COD)
Proposal for a regulation
Article 31 – paragraph 3
Article 31 – paragraph 3
3. The mandatory nutrition declaration shallnutrition declaration for the following nutritional values (energy content, fat, saturates, sugars, salt) shall in addition be expressed, as appropriate, as a percentage of the reference intakes set out in Part B of Annex XI in relation to per 100 g or per 100 ml or, pursuant to Article 31(2), per portion. When provided, the declaration on vitamins and minerals shall also be expressed as a percentage of the reference intakes set out in point 1 of Part A of Annex XI.
Amendment 204 #
2008/0028(COD)
Proposal for a regulation
Article 32
Article 32
Amendment 212 #
2008/0028(COD)
Proposal for a regulation
Article 33
Article 33
1. In addition to the forms of expression referred to in Article 31(2) and (3), the nutrition declaration may be given by othergraphic forms of expression provided that the following essential requirements are met: (a) the form of expression aims to facilitate consumer understanding of the contribution or importance of the food to the energy and nutrient content of a diet; and (b) it is based either on harmonised reference intakes, or in their absence,on the reference intakes indicated in Annex XI, Part B, in relation to 100 g or 100 ml. If a product is prepacked as an individual portion or if it is supplied in quantities of less than 100 g/ml, an indication per portion relating to the quantity supplied shall be sufficient. In the absence of such reference intakes, the nutrition declaration is based on generally accepted scientific advice on intakes for energy or nutrients; and (c) it is supported by evidence of understanding of and use of the presentation of the information by the average consumer. 2. Such additional forms of expression referred to in paragraph 1 shall be identified under a national scheme referred to in Article 44Model graphic presentations are shown in Annex XIII, Part Ca.
Amendment 223 #
2008/0028(COD)
Proposal for a regulation
Article 34 – paragraph 5
Article 34 – paragraph 5
Amendment 252 #
2008/0028(COD)
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
Articles 29 to 34 shall apply from [the first day of the month 3 years after the entry into force] except in the case of foods labelled by food business operators with, on the date of entry into force, less than 100 employees and whose annual turnover and/or annual balance sheet total does not exceed EUR 25 million where they shall apply [the first day of the month 5 years after the entry into force]. Article 14(1) shall apply from [the first day of the month 5 years after the entry into force]. Foods placed on the market prior to the entry into force of this Regulation may be marketed until stocks are exhausted.
Amendment 255 #
2008/0028(COD)
Proposal for a regulation
Annex I – point 8
Annex I – point 8
8. ‘sugars’ means all monosaccharides and disaccharides present in food, but excludes polyols, isomaltulose and D-tagatose;
Amendment 258 #
2008/0028(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point s a (new)
Article 2 – paragraph 2 – point s a (new)
sa) ‘use by date of a food' means the date by which a food must be consumed. After that date, the food may no longer be delivered to consumers or further processed.
Amendment 261 #
2008/0028(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point t a (new)
Article 2 – paragraph 2 – point t a (new)
(ta) ‘Food imitation’ means food that gives the impression of being another food in which an ingredient usually used is wholly or partly replaced by another.
Amendment 261 #
2008/0028(COD)
Proposal for a regulation
Annex IV – indent 16
Annex IV – indent 16
food in packaging or containers the largest surface of which has an area of less than 25100 cm2;
Amendment 263 #
2008/0028(COD)
Proposal for a regulation
Annex IV – indent 17 a (new)
Annex IV – indent 17 a (new)
- non-prepacked food, including mass catering products, intended for immediate consumption;
Amendment 270 #
2008/0028(COD)
Proposal for a regulation
Annex V – part C a (new)
Annex V – part C a (new)
Amendment 271 #
2008/0028(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a a (new)
Article 7 – paragraph 1 – point a a (new)
aa) by pictorial representations that mislead the consumer as to the origin, nature or composition of the food;
Amendment 282 #
2008/0028(COD)
Proposal for a regulation
Annex XIII – Part C a (new)
Annex XIII – Part C a (new)
Amendment 298 #
2008/0028(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The particulars referred to in paragraph 1 shall be indicated with words and numbers unless the consumers are informed, as regards one or more particulars, by other forms of expression established by implementing measures adopted by the Commission. Those measures designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 49(3). This paragraph shall be without prejudice to Article 34(1).
Amendment 307 #
2008/0028(COD)
Proposal for a regulation
Article 33 – paragraph 3 – point a
Article 33 – paragraph 3 – point a
(a) in a field of vision different from the one referred to in paragraph 1 of this Article; and, in which case the energy value may also be indicated separately from the other particulars on the ‘front of pack’;
Amendment 309 #
2008/0028(COD)
Proposal for a regulation
Article 33 – paragraph 3 – point b
Article 33 – paragraph 3 – point b
(b) in a format different from that specified in paragraph 2 of this Article. and which may take the form of a graphic in order to be more eye-catching, or
Amendment 310 #
2008/0028(COD)
Proposal for a regulation
Article 33 – paragraph 3 – point b a (new)
Article 33 – paragraph 3 – point b a (new)
(ba) solely on a per portion or per consumption unit basis with the percentage of the reference intakes set out in Part B of Annex XIII, in which case the energy value may also be indicated separately from the other particulars.
Amendment 382 #
2008/0028(COD)
Proposal for a regulation
Annex VI – point 4
Annex VI – point 4
4. In the case of foods in which a component or ingredient that consumers expect to be normally used or naturally present has been substituted with a different component or ingredient, the labelling shall bear – in addition to the list of ingredients –and in a clear indication of thly visible manner – one of the following indications: (a) ‘[designation of the food] produced with [designation of the substitute component(s) or the ingredient that has been used for the partial or whole substitution. (s)] instead of [designation of the component(s) or ingredient(s) replaced]’ or (b) ‘[designation of the food] with [designation of the component(s) or ingredient(s) replaced] substitute’ or ‘[designation of the food] with imitation [designation of the component(s) or ingredient(s) replaced]’.
Amendment 389 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1– point b
Article 29 – paragraph 1– point b
(b) the amounts of fat, saturates, carbohydrates with specific reference to sugars, and salt.
Amendment 436 #
2008/0028(COD)
Proposal for a regulation
Article 31 – paragraph 3
Article 31 – paragraph 3
3. The mandatory nutrition declaration shall be expressed, as appropriate,relating to energy content, fat, saturated fats, sugar and salt, shall in addition be expressed as a percentage of the reference intakes set out in Part B of Annex XI in relation to per 100 g or per 100 ml or, subject to Article 31(2), per portion. When provided, the declaration on vitamins and minerals shall also be expressed as a percentage of the reference intakes set out in point 1 of Part A of Annex XI.
Amendment 454 #
2008/0028(COD)
Proposal for a regulation
Article 33 – paragraph 1
Article 33 – paragraph 1
1. In addition to the forms of expression referred to in Article 31(2) and (3), the nutrition declaration may be given by othergraphic forms of expression provided that the following essential requirements are met: (a) the form of expression aims to facilitate consumer understanding of the contribution or importance of the food to the energy and nutrient content of a diet; and (b) it is based either on harmonised reference intakes, or in their absence,on the reference intakes indicated in Annex XI, Part B, in relation to 100 g or 100 ml. If a product is prepacked as an individual portion or if it is supplied in quantities of less than 100 g/ml, an indication per portion relating to the quantity supplied shall be sufficient. In the absence of such reference intakes, the nutrition declaration is based on generally accepted scientific advice on intakes for energy or nutrients; and (c) it is supported by evidence of understanding of and use of the presentation of the information by the average consumer. 2. Such additional forms of expression referred to in paragraph 1 shall be identified under a national scheme referred to in Article 44A model graphic presentation is shown in Annex XIII, Part D.
Amendment 461 #
2008/0028(COD)
Proposal for a regulation
Article 34 – paragraph 1
Article 34 – paragraph 1
1. The particulars referred to in Article 31(1) and (2) related to the mandatory nutrition declaration shall be included in the principalsame field of vision. They shall be presented, where appropriate, together in a clear format in the following order: energy, fat, saturates, carbohydrates with specific reference to sugars, and salt in a single table. The mandatory indications shall be presented in the following order: energy, fat, saturates, salt and sugar. Additional voluntary indications shall be provided in the order laid down in Annex XIII.
Amendment 468 #
2008/0028(COD)
Proposal for a regulation
Article 34 – paragraph 1 a (new)
Article 34 – paragraph 1 a (new)
1a. In addition to the presentation pursuant to Article 34(1) per 100 g/ml or per portion pursuant to Article 31(2), the energy content labelling in kcal required pursuant to Article 29(1)(a) and Annex XI, Part B, may appear on the front of the packaging.
Amendment 500 #
2008/0028(COD)
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. The amount of energy and nutrients referred to in paragraph 1 shall be expressed per 100 g or per 100 ml or, subject to Article 32(2) and (3), per portionand, in addition, per net quantity of the food.
Amendment 508 #
2008/0028(COD)
Proposal for a regulation
Article 31 – paragraph 3
Article 31 – paragraph 3
3. The mandatory nutrition declaration shall be expressed, as appropriate, as a percentage of the reference intakes set out in Part B of Annex XI in relation to per 100 g or per 100 ml or per portion. When provided, the declaration on vitamins and minerals shall also be expressed as a percentage of the reference intakes set out in point 1 of Part A of Annex XI.
Amendment 528 #
2008/0028(COD)
Proposal for a regulation
Article 53 – subparagraphs 3 and 3 a (new)
Article 53 – subparagraphs 3 and 3 a (new)
Articles 29 to 34 shall apply from [the first day of the month 3 years after the entry into force] except in the case of foods labelled by food business operators with, on the date of entry into force, less than 100 employees and whose annual turnover and/or annual balance sheet total does not exceed EUR 25 million where they shall apply [the first day of the month 5 years after the entry into force]. Foods placed on the market prior to the entry into force of this Regulation may continue to be marketed until stocks are exhausted.
Amendment 535 #
2008/0028(COD)
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
Amendment 539 #
2008/0028(COD)
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
Amendment 548 #
2008/0028(COD)
Proposal for a regulation
Article 34 - paragraph 1
Article 34 - paragraph 1
1. The particulars referred to in Article 31(2) related to the mandatory nutrition declaration shall be included in the principal field of vision. They shall be presented, where appropriate, together in a clear format in the following order: energy, fat, saturates, carbohydrates with specific reference to sugars, and salt. The particular required by Article 31(3) shall also be represented graphically.
Amendment 557 #
2008/0028(COD)
Proposal for a regulation
Annex V – part C a (new)
Annex V – part C a (new)
Amendment 574 #
2008/0028(COD)
Proposal for a regulation
Annex XIII – part C a (new)
Annex XIII – part C a (new)
Amendment 577 #
2008/0028(COD)
Proposal for a regulation
Article 34 - paragraph 5
Article 34 - paragraph 5
Amendment 582 #
2008/0028(COD)
Proposal for a regulation
Article 34 - paragraph 6
Article 34 - paragraph 6
Amendment 629 #
2008/0028(COD)
Proposal for a regulation
Article 41 – paragraph 1
Article 41 – paragraph 1
1. Where foods are offered for sale to the final consumer or to mass caterers without prepackaging, or where foods are packed on the sales premises at the consumer's request or prepacked for direct sale, the Member States may adopt detailed rules concerning the manner in which the particulars specified in Articles 9 and 10 are to be shown. The particulars referred to in Article 9(1)(c) shall at all events be so presented that the consumer can ascertain them without putting questions.
Amendment 637 #
2008/0028(COD)
Proposal for a regulation
Article 44 - paragraph 1
Article 44 - paragraph 1
1. Member States may adopt, recommend or otherwise endorse national schemes consisting of exclusively non-binding rules, such as recommendations, guidance, standards or any other non binding rules, (hereinafter referred to as the ‘national schemes’) aimed at ensuring the application of the following provisions and in compliance with the essential requirements set out therein: (a) Article 33(2), relating to additional forms of expression of the nutritional declaration; (b) Article 34(5), relating to, and in compliance with the pressentation of the nutrition declaration.ial requirements set out therein:
Amendment 108 #
2008/0018(COD)
Proposal for a directive
Article 2 – point 15 a (new)
Article 2 – point 15 a (new)
(15a) 'Specifically designed or intended for children of the age group x': a term that means that children must possess the dexterity and mental abilities corresponding to this particular age group.
Amendment 109 #
2008/0018(COD)
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 2
Article 10 – paragraph 1 – subparagraph 2
Amendment 143 #
2008/0018(COD)
Proposal for a directive
Annex II – Part III – point 5 a (new)
Annex II – Part III – point 5 a (new)
5a. Toys or parts of toys which are intended to be placed in the mouth must comply with the provisions for migration limit values for food packaging, irrespective of the age of the children for which they are intended, as set out in Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food.
Amendment 146 #
2008/0018(COD)
Proposal for a directive
Annex II – Part III – point 7
Annex II – Part III – point 7
7. Toys shall not contain the following allergenic fragrances: (1) Alanroot (Inula helenium) (2) Allylisothiocyanate (3) Benzyl cyanide (4) 4 tert-Butylphenol (5) Chenopodium oil (6) Cyclamen alcohol (7) Diethyl maleate (8) Dihydrocoumarin (9) 2,4-Dihydroxy-3-methylbenzaldehyde (10) 3,7-Dimethyl-2-octen-1-ol (6,7- Dihydrogeraniol) (11) 4,6-Dimethyl-8-tert-butylcoumarin (12) Dimethyl citraconate (13) 7,11-Dimethyl-4,6,10-dodecatrien-3- one (14) 6,10-Dimethyl-3,5,9-undecatrien-2- one (15) Diphenylamine (16) Ethyl acrylate (17) Fig leaf, fresh and preparations (18) trans-2-Heptenal (19) trans-2-Hexenal diethyl acetal (20) trans-2-Hexenal dimethyl acetal (21) Hydroabietyl alcohol (22) 4-Ethoxy-phenol (23) 6-lsopropyl-2- decahydronaphthalenol (24) 7-Methoxycoumarin (25) 4-Methoxyphenol (26) 4-(p-Methoxyphenyl)-3- butene-2-one (27) 1-(p-Methoxyphenyl)-1- penten-3-one (28) Methyl trans-2-butenoate (29) 6-Methylcoumarin (30) 7-Methylcoumarin (31) 5-Methyl-2,3-hexanedione (32) Costus root oil (Saussurea lappa Clarke) (33) 7-Ethoxy-4-methylcoumarin (34) Hexahydrocoumarin (35) Peru balsam (Myroxylonpereirae Klotzsch) (36) 2-Pentylidene-cyclohexanone (37) 3,6,10-Trimethyl-3,5,9- undecatrien-2-one (38) Verbana oil (Lippia citriodora Kunth). (39) Amyl cinnamal (40) Amylcinnamyl alcohol (41) Anisyl alcohol (42) Benzyl alcohol (43) Benzyl benzoate (44) Benzyl cinnamate (45) Benzyl salicylate (46) Cinnamal (47) Cinnamyl alcohol (48) Citral (49) Citronellol (50) Coumarin (51) Eugenol (52) Farnesol (53) Geraniol (54) Hexyl cinnamaldehyde (55) Hydroxy-citronellal (56) Hydroxy- methylpentylcyclohexenecarboxaldehyde (57) Isoeugenol (58) Lilial (referred to in the Cosmetics Directive in entry 83 as: 2-(4-tert- Butylbenzyl) propionaldehyde (59) d-Limonene (60) Linalool (61) Methyl heptine carbonate (62) 3-methyl-4-(2,6,6-trimethyl-2- cyclohexen-1-yl)-3-buten-2-one (63) Oakmoss extracts (64) Treemoss extracts However, the presence of traces of these substances shall be allowed provided that such a presence is technically unavoidable in good manufacturing practice.
Amendment 148 #
2008/0018(COD)
Proposal for a directive
Annex II – Part III – point 7 – subparagraph 2
Annex II – Part III – point 7 – subparagraph 2
Amendment 149 #
2008/0018(COD)
Proposal for a directive
Annex II – Part III – point 7 – subparagraph 3
Annex II – Part III – point 7 – subparagraph 3
Amendment 245 #
2008/0018(COD)
Proposal for a directive
Article 52
Article 52
Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which weare placed on the market before this Directive entered into for[2 years after the entry into force of this Directive]. Annex II, Part III shall only apply to toys placed or at the latest 2n the market after [5 years after this Directive enteredry into force. of this Directive/31 May 2013]
Amendment 251 #
2008/0018(COD)
Proposal for a directive
Annex I – point 17 a (new)
Annex I – point 17 a (new)
17a. Books that do not contain any elements or added objects others than those in paper or cardboard.
Amendment 302 #
2008/0018(COD)
Proposal for a directive
Annex II – Part III – point 3
Annex II – Part III – point 3
3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys of substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) according to Directive 67/548/EEC in individual concentrations equal to or greater than the relevant concentrations established for the classification of preparations containing the substances in accordance with the provisions of Directive 1999/45/EC shall be prohibited, except if the substances are contained in components of toys or micro- structurally distinct parts of toys that are not accessible to any physical contact by children if used pursuant to Article 9(2)(1).
Amendment 339 #
2008/0018(COD)
Proposal for a directive
Annex II – Part III – point 7
Annex II – Part III – point 7
7. Toys shall not contain the following allergenic fragrances: (1) Alanroot (Inula helenium) (2) Allylisothiocyanate (3) Benzyl cyanide (4) 4 tert-Butylphenol (5) Chenopodium oil (6) Cyclamen alcohol (7) Diethyl maleate (8) Dihydrocoumarin (9) 2,4-Dihydroxy-3-methylbenzaldehyde (10) 3,7-Dimethyl-2-octen-1-ol (6,7- Dihydrogeraniol) (11) 4,6-Dimethyl-8-tert-butylcoumarin (12) Dimethyl citraconate (13) 7,11-Dimethyl-4,6,10-dodecatrien-3- one (14) 6,10-Dimethyl-3,5,9-undecatrien-2- one (15) Diphenylamine (16) Ethyl acrylate (17) Fig leaf, fresh and preparations (18) trans-2-Heptenal (19) trans-2-Hexenal diethyl acetal (20) trans-2-Hexenal dimethyl acetal (21) Hydroabietyl alcohol (22) 4-Ethoxy-phenol (23) 6-lsopropyl-2-decahydronaphthalenol (24) 7-Methoxycoumarin (25) 4-Methoxyphenol (26) 4-(p-Methoxyphenyl)-3-butene-2-one (27) 1-(p-Methoxyphenyl)-1-penten-3-one (28) Methyl trans-2-butenoate (29) 6-Methylcoumarin (30) 7-Methylcoumarin (31) 5-Methyl-2,3-hexanedione (32) Costus root oil (Saussurea lappa Clarke) (33) 7-Ethoxy-4-methylcoumarin (34) Hexahydrocoumarin (35) Peru balsam (Myroxylonpereirae Klotzsch) (36) 2-Pentylidene-cyclohexanone (37) 3,6,10-Trimethyl-3,5,9-undecatrien-2- one (38) Verbana oil (Lippia citriodora Kunth). (39) Musk ambrette (40) 4-Phenyl-3-buten-2-one (41) Amyl cinnamal (42) Amylcinnamyl alcohol (43) Benzyl alcohol (44) Benzyl salicylate (45) Cinnamyl alcohol (46) Cinnamal (47) Citral (48) Coumarin (49) Eugenol (50) Geraniol (51) Hydroxycitronellal (52) Hydroxymethylpentylcyclohe xenecarboxaldehyde (53) Isoeugenol However, the presence of traces of these substances shall be allowed provided that such presence is technically unavoidable in good manufacturing practice. In addition the following allergenic fragrances shall be listed if added to toys, as such, at concentrations exceeding 0,01 % by weight: (1) Amyl cinnamal (2) Amylcinnamyl alcohol (3) Anisyl alcohol (4) Benzyl alcohol (5nisyl alcohol (2) Benzyl benzoate (63) Benzyl cinnamate (7) Benzyl salicylate (8) Cinnamal (9) Cinnamyl alcohol (10) Citral (11) Citronellol (12) Coumarin (13) Eugenol (14) Farnesol (15) Geraniol (14) Citronellol (5) Farnesol (6) Hexyl cinnamaldehyde (17) Hydroxy-citronellal (18) Hydroxy- methylpentylcyclohexenecarboxaldehyde (19) Isoeugenol (20) Lilial (referred to in the Cosmetics Directive in entry 83 as: 2-(4-tert- Butylbenzyl) propionaldehyde (21Lilial (8) d-Limonene (229) Linalool (2310) Methyl heptine carbonate (24) 11)3-methyl-4-(2,6,6-trimethyl-2- cyclohexen-1-yl)-3-buten-2-one (125) Oakmoss extracts (2613) Treemoss extracts
Amendment 370 #
2008/0018(COD)
Proposal for a directive
Annex V - Part B - Point 7
Annex V - Part B - Point 7
Toys contained in food or co-mingled with food shall contain the warning: “Adult supervision strongly recommended”.
Amendment 118 #
2008/0016(COD)
Proposal for a directive
Recital 57 a (new)
Recital 57 a (new)
(57a) In order to facilitate the expedient development of renewable infrastructure it shall be important to ensure full coherence with Directives 2000/60/EC, 79/409/EEC, 92/43/EEC.
Amendment 119 #
2008/0016(COD)
Proposal for a directive
Article 1
Article 1
This Directive establishes a common framework for the promotion of energy from renewable sources which strengthens the existing national support schemes of the Member States and makes it possible for them to attain the development objectives. It sets mandatory targets for the overall share of energy from renewable sources in energy consumption and for the share of energy from renewable sources in transport. It lays down rules relating to guarantees of origin, administrative procedures and electricity grid connections in relation to energy from renewable sources. It establishes environmental sustainability criteria for biofuels and other bioliquids and permits the joint attainment of the binding development objectives by more than one Member State.
Amendment 136 #
2008/0016(COD)
Proposal for a directive
Article 2 – point (g a) (new)
Article 2 – point (g a) (new)
(ga) 'transfer accounting certificate (TAC)' means a specially marked electronic document which serves as evidence that a particular quantity of energy has been produced from renewable sources and may be credited towards the binding targets in the issuing Member State or other Member States;
Amendment 137 #
2008/0016(COD)
Proposal for a directive
Article 2 – point (h)
Article 2 – point (h)
(h) “support scheme” means a scheme, originating from a market intervention by a Member State, that helps energy from renewable sources to find a market by reducing the cost of production of this energy, increasing the price at which it can be sold, or increasing, by means of a renewable energy obligation or otherwise, the volume of such energy purchased which creates or enhances incentives for the further development and the use of energy from renewable sources. Such national support schemes comprise in particular green certificates, investment grants, tax exemptions or concessions, tax rebates and direct price support systems, particularly feed-in remuneration and feed-in premium systems;
Amendment 138 #
2008/0016(COD)
Proposal for a directive
Article 2 – paragraph 1 a (new)
Article 2 – paragraph 1 a (new)
Amendment 140 #
2008/0016(COD)
Proposal for a directive
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1a. Two or more Member States may jointly meet the targets indicated in Annex I, Part A, in order to exploit synergetic effects. (a) For this purpose, Member States may create a system which allows people to transfer to third parties 'transfer accounting certificates' (TAC), which, pursuant to Article 10, can be credited towards national targets. (b) Two or more Member States may agree to statistically transfer energy from renewable sources between themselves in order to credit it towards their national targets. (c) Member States may agree to carry out joint projects in which one or more Member States support projects to promote renewable energies in another Member State with a view to having the renewable energy which has thus been obtained credited to themselves proportionally. (d) Two or more Member States may agree to meet targets jointly, in particular by creating joint cross-border support schemes or opening up their national schemes to energy from other Member States. In this case they must jointly prove the share of renewable energy in their final energy consumption which they would achieve cumulatively if they were to meet their targets individually.
Amendment 143 #
2008/0016(COD)
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Each Member State shall ensure that the share of energy from renewable sources in transport in 2020 is at least 10% of final consumption of energy in transport in that Member State. In calculating total energy consumed in transport for the purposes of the first subparagraph, petroleum products oIf no European support scheme for energy from renewable sources exists, it is necessary for various national support schemes to work effectively towards the attainment of the objectives of this Directive, in particular - to attain national and European development objectives, - to attain the environmental protection objectives on which national support schemes are based in a way which best accords with national potentials and the respective national situation, and - to ensure a secure and balanced energy supply. In order to actually attain the objectives laid down in this Directive, Member States must be free to decide whether and to what extent to provide support from their than petrol and diesel shall not be taken into accountnational support scheme to energy produced from renewable sources in other Member States. In so far as necessary, this may also result in a restriction of trade.
Amendment 157 #
2008/0016(COD)
Proposal for a directive
Article 5 – paragraph 1 – points (a) - (c)
Article 5 – paragraph 1 – points (a) - (c)
(a) physical final consumption of electricity from renewable energy sources; (b) physical final consumption of energy from renewable sources for heating and cooling; and (c) physical final energy from renewable sources consumed in transport.
Amendment 160 #
2008/0016(COD)
Proposal for a directive
Article 5 – paragraph 9
Article 5 – paragraph 9
9. Electricity produced from renewable energy sources in third countries and energy in the transport sector shall only be taken into account for the purposes of measuring compliance with the requirements of this Directive concerning national targets if: (a) it isthey are consumed in the Community; (b) the electricity isy are produced by an installation that became operational after the date of entry into force of this Directive; and (c) the electricity isy are issued with a guarantee of origin that forms part of a system of guarantee of origin equivalent to that laid down by this Directive.
Amendment 161 #
2008/0016(COD)
Proposal for a directive
Article 5 – paragraph 9 – point (b) a (new)
Article 5 – paragraph 9 – point (b) a (new)
(ba) the proportion of energy from renewable sources in total energy production in the third country is not reduced on account of the import of energy into the Community; and
Amendment 162 #
2008/0016(COD)
Proposal for a directive
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4a. As an alternative to guarantees of origin, Member States may voluntarily issue transfer accounting certificates (TAC), on which this Directive does not base any legal entitlement. Member States shall ensure that transfer accounting certificates (TAC) accord with paragraphs 1 to 4. In addition, Member States shall ensure that transfer accounting certificates (TAC) are explicitly marked as such and are cancelled electronically.
Amendment 163 #
2008/0016(COD)
Proposal for a directive
Article 6 – paragraph 4 b (new)
Article 6 – paragraph 4 b (new)
4b. Guarantees of origin (GO) and transfer accounting certificates (TAC) shall not in themselves give rise to any entitlement to support from national support schemes.
Amendment 164 #
2008/0016(COD)
Proposal for a directive
Article 7 – heading and paragraph 1
Article 7 – heading and paragraph 1
Competent bodies and registers of Competent bodies and registers for guarantees of origin transfer accounting certificates (TAC) 1. Each Member State shall designate a single competent body to undertake the following tasks: (a) establish and maintain a national register of guarantees of origin; (b) issue guarantees of origin; (c) record any transfer of guarantees of origin; (d) cancel guarantees of origin;transfer accounting certificates (TAC), (b) issue transfer accounting certificates (TAC), (c) record any transfer of transfer accounting certificates (TAC); (d) cancel transfer accounting certificates (TAC), (e) publish an annual report on the quantities of guarantees of origintransfer accounting certificates (TAC) issued, transferred to or from each of the other competent bodies and cancelled. (Horizontal amendment: throughout the Directive, the term 'guarantees of origin' should be replaced with 'transfer accounting certificates (TAC)'.)
Amendment 165 #
2008/0016(COD)
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The national register of guarantees of origin shall record the guarantees of origin held by each person. A guarantee of origintransfer accounting certificates (TAC) shall record the transfer accounting certificates (TAC) held by each person. A transfer accounting certificates (TAC) shall only be held in one register at one time.
Amendment 166 #
2008/0016(COD)
Proposal for a directive
Article 7 – paragraph 3 a (new)
Article 7 – paragraph 3 a (new)
3a. The competent body shall bear sole responsibility for each installation operated in the Member State concerned. It shall not be responsible for the issuing of transfer accounting certificates (TAC) from installations which are operated in another Member State. Member States shall ensure that the competence which this Directive vests in competent bodies in other Member States is not violated.
Amendment 167 #
2008/0016(COD)
Proposal for a directive
Article 8 – paragraph 3 a (new)
Article 8 – paragraph 3 a (new)
3a. Member States which do not issue any transfer accounting certificates (TAC) may decide that transfer accounting certificates (TAC) issued in other Member States must be cancelled pursuant to paragraph 1. In this case they shall designate a single competent body to take responsibility for this.
Amendment 168 #
2008/0016(COD)
Proposal for a directive
Article 10 – heading and introduction
Article 10 – heading and introduction
Effects of the cancellation of the guarantees of origin When a competent body cancels a guarantee of originransfer accounting certificates (TAC) 1. Member States which issue transfer accounting certificates (TAC) may credit transfer accounting certificates (TAC) from other Member States towards their national targets in accordance with paragraph 2. 2. When a competent body cancels a transfer accounting certificates (TAC) that it did not itself issue, an equivalent quantity of energy from renewable sources shall, for the purposes of measuring compliance with the requirements of this Directive concerning national targets:
Amendment 172 #
2008/0016(COD)
Proposal for a directive
Article 12 – paragraph 4 – introduction
Article 12 – paragraph 4 – introduction
In their building regulations and codes Member States shall require the use of minimum levels of energy from renewable sources in new or refurbished buildings. Any exemption from those minimum levels shall be transparent and based on criteria relating to:
Amendment 173 #
2008/0016(COD)
Proposal for a directive
Article 12 – paragraph 4 – point (b) a (new)
Article 12 – paragraph 4 – point (b) a (new)
(ba) the use of heat from combined heat and power plants, provided that they are highly efficient as defined in EU Directive 2004/8/EC.
Amendment 180 #
2008/0016(COD)
Proposal for a directive
Article 14 –paragraph 1
Article 14 –paragraph 1
1. Member States shall take theall necessary steps to develop grid infrastructure to accommodate the further development of electricity production from renewable energy sources, including interconnectors between Member States.
Amendment 182 #
2008/0016(COD)
Proposal for a directive
Article 14 –paragraph 2
Article 14 –paragraph 2
2. Without prejudice to the maintenance of the reliability and safety of the grid, Member States shall ensure that transmission system operators and distribution system operators in their territory guarantee priority grid access and the transmission and distribution of electricity produced from renewable energy sources. They shall also provide for priority access to the grid system of electricity produced from renewable energy sources. When dispatching electricity generating installations, transmission system operators shall give priority to generating installations using renewable energy sources insofar as the security of the national electricity system permits.
Amendment 185 #
2008/0016(COD)
Proposal for a directive
Article 15 – paragraph 1 – introduction
Article 15 – paragraph 1 – introduction
1. Biofuels and other bioliquidEnergy from biomass shall be taken into account for the purposes listed under letters (a), (b) and (c) below only if ithey fulfils the criteria set out in paragraphs 2 to 58:
Amendment 197 #
2008/0016(COD)
Proposal for a directive
Article 15 – paragraph 2 – subparagraph 1 a (new)
Article 15 – paragraph 2 – subparagraph 1 a (new)
With effect from 1 January 2015, reductions in greenhouse gas emissions achieved through the use of biofuels and other bioliquids that are taken into account for the purposes referred to in paragraph 1 must amount to at least 45%. With effect from 1 January 2020, reductions in greenhouse gas emissions achieved through the use of biofuels and other bioliquids that are taken into account for the purposes referred to in paragraph 1 must amount to at least 55%.
Amendment 202 #
2008/0016(COD)
Proposal for a directive
Article 15 – paragraph 3 – subparagraph 1 – introductory part
Article 15 – paragraph 3 – subparagraph 1 – introductory part
3. Biofuels and other bioliquids taken into account for the purposes referred to in paragraph 1 shall not be made from raw material obtained from land with recognised high biodiversity value, that is to say land that had one of the following statuses in or after JanuarySeptember 20083, whether or not the land still has this status:
Amendment 211 #
2008/0016(COD)
Proposal for a directive
Article 15 – paragraph 4 – subparagraph 1 – introductory part
Article 15 – paragraph 4 – subparagraph 1 – introductory part
4. Biofuels and other bioliquids taken into account for the purposes referred to in paragraph 1 shall not be made from raw material obtained from land with high carbon stock, that is to say land that had one of the following statuses in JanuarySeptember 20083 and no longer has this status:
Amendment 223 #
2008/0016(COD)
Proposal for a directive
Article 15 – paragraph 5 – subparagraph 1 a (new)
Article 15 – paragraph 5 – subparagraph 1 a (new)
Amendment 230 #
2008/0016(COD)
Proposal for a directive
Article 15 - paragraph 7 a (new)
Article 15 - paragraph 7 a (new)
7a. Irrespective of whether the raw materials were cultivated inside or outside the territory of the Community, biofuels and bioliquids shall not be taken into account for the purposes referred to in paragraph 1 unless the raw material from which they were produced was cultivated in accordance with the following criteria: (a) compliance with international norms on the rights to consent and consultation of indigenous peoples and local communities and the protection of children derived from the United Nations agencies and conventions (b) United Nations derived human rights norms are respected during the production cycle of the raw materials Compliance with the criteria listed in paragraph 8 must be verified in accordance with Article 16, in particular through participation in voluntary international or national schemes setting standards for the production of sustainable biofuels and other bioliquids and certifying that production of biofuels and other bioliquids meet those standards
Amendment 233 #
2008/0016(COD)
Proposal for a directive
Article 16 – paragraph 4
Article 16 – paragraph 4
Amendment 236 #
2008/0016(COD)
Proposal for a directive
Article 16 – paragraph 5
Article 16 – paragraph 5
Amendment 237 #
2008/0016(COD)
Proposal for a directive
Article 16 – paragraph 6
Article 16 – paragraph 6
Amendment 240 #
2008/0016(COD)
Proposal for a directive
Article 16 – paragraph 7
Article 16 – paragraph 7
Amendment 244 #
2008/0016(COD)
Proposal for a directive
Recital 28
Recital 28
(28) A coordinated approach is needed to develop training and appropriate certification should be made available to small scale renewable energy equipment installers in order to avoid market distortions and to ensure high quality products and service provision for consumers. National certification schemes should be mutually recognised by Member States and should therefore be based on minimum harmonised principles, taking into account European technology standards, and existing training and qualification regimes for renewable energy equipment installers. Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications should continue to apply to issues not governed by this Directive, such as the recognition of professional qualifications of installers notgovern the recognition of professional qualifications for regulated professions. In so far as entering or exercising the profession of installer is regulated, the preconditions for recognition of professional qualifications are laid down in Directive 2005/36/EC; these preconditions should also apply to installers certified in onea Member State.
Amendment 247 #
2008/0016(COD)
Proposal for a directive
Article 17 – paragraph 1 – point c
Article 17 – paragraph 1 – point c
(c) by using a value calculated in accordance with the methodology laid down in Part C of Annex VII as the sum of actual values for some of the steps of the production process and the disaggregated default values in Part D or E of Annex VII for the other steps of the production process. This shall be conditional upon the manufacturing process being identical with the manufacturing process based on the standard disaggregated values set out in Annex VII Part D or Part E for the other steps in the manufacturing process.
Amendment 259 #
2008/0016(COD)
Proposal for a directive
Article 18 – paragraph 3 a (new)
Article 18 – paragraph 3 a (new)
Amendment 260 #
2008/0016(COD)
Proposal for a directive
Article 18 – paragraph 4
Article 18 – paragraph 4
Amendment 264 #
2008/0016(COD)
Proposal for a directive
Article 18 – paragraph 4 a (new)
Article 18 – paragraph 4 a (new)
4a. The Commission shall by 31 December 2009 propose appropriate measures to strike a balance between domestic production and imports.
Amendment 269 #
2008/0016(COD)
Proposal for a directive
Article 20 – paragraph 5 – point a
Article 20 – paragraph 5 – point a
(a) the relative environmental benefits and costs of different biofuels, the effects of the Community’s import policies thereon, the security of supply implications and the ways of achieving a balanced approach between domestic production and imports;
Amendment 271 #
2008/0016(COD)
Proposal for a directive
Article 20 – paragraph 5 – point d
Article 20 – paragraph 5 – point d
(d) the impact of increased demand for biomass on biomass using sectorEU biofuel policy on land conflict and displacement of peoples within exporting countries.
Amendment 272 #
2008/0016(COD)
Proposal for a directive
Article 20 – paragraph 5 – point d a (new)
Article 20 – paragraph 5 – point d a (new)
(da) the availability and research into biofuels made from wastes, residues, algae, non-food cellulosic material and ligno-cellulosic material and sustainability issues related with the use of these biofuels while taking into account the waste hierarchy.
Amendment 275 #
2008/0016(COD)
Proposal for a directive
Article 20 – paragraph 5 – point d a (new)
Article 20 – paragraph 5 – point d a (new)
(da) the indirect effects of land use change (displacing the previous use to a different area of ground with high carbon stocks).
Amendment 285 #
2008/0016(COD)
Proposal for a directive
Annex VII – part C – paragraph 1 – subparagraph 1
Annex VII – part C – paragraph 1 – subparagraph 1
1. Greenhouse gas emissions from the production and use of transport fuels, biofuels and other bioliquids shall be calculated as: E = eec + el + ep + etd + eu – eccs - eccr – eee, where E = total emissions from the use of the fuel; eec = emissions from the extraction or cultivation of raw materials; el = annualised emissions from carbon stock changes caused by land use change; ep = emissions from processing; etd = emissions from transport and distribution; eu = emissions from the fuel in use; eccs = emission savings from carbon capture and sequestration; eccr = emission savings from carbon capture and replacement; and eee = emission savings from excess electricity from cogeneration; and eesea= emission savings from emissions trading.
Amendment 286 #
2008/0016(COD)
Proposal for a directive
Annex VII – part C – paragraph 1 – subparagraph 1
Annex VII – part C – paragraph 1 – subparagraph 1
1. Greenhouse gas emissions from the production and use of transport fuels, biofuels and other bioliquids shall be calculated as: E = eec + el + ep + etd + eu – eccs - eccriluc + esca+ ep + etd + eu – eee, where E = total emissions from the use of the fuel; eec = emissions from the extraction or cultivation of raw materials; el = annualised emissions from carbon stock changes caused by land use change;esca = emission savings from soil carbon accumulation via improved agricultural management ep = emissions from processing; etd = emissions from transport and distribution; eu = emissions from the fuel in use; eccs = emission savings from carbon capture and sequestration; eccru = emission savings from carbon capture and replacementuse; and eee = emission savings from excess electricity from cogeneration.
Amendment 291 #
2008/0016(COD)
Proposal for a directive
Annex VII – part C – paragraph 8 – introductory part
Annex VII – part C – paragraph 8 – introductory part
8. For the purposes of paragraph 7, except in the case of land use changes within the meaning of Article 15, paragraphs 3 and 4, the following values may be used for both CSR and CSA
Amendment 294 #
2008/0016(COD)
Proposal for a directive
Annex VII – part C – paragraph 10
Annex VII – part C – paragraph 10
10. Emissions from transport and distribution, etd, shall include emissions from the transport and storage of raw and semi-finished materials and from the storage and distribution of finished materials – with the exception of the emissions from primary production to be taken into account pursuant to paragraph 6.
Amendment 298 #
2008/0016(COD)
Proposal for a directive
Annex VII – part C – paragraph 15
Annex VII – part C – paragraph 15
15. Where a fuel production process produces, in combination, the fuel for which emissions are being calculated and one or more other products ("co- products"), greenhouse gas emissions shall be correctly divided between the fuel or its intermediate product and the co-products in proportion to their energy content (determined in principle by lower heating value in the case of co-products other than electricity).
Amendment 300 #
2008/0016(COD)
Proposal for a directive
Annex VII – part C – paragraph 16 – subparagraph 2
Annex VII – part C – paragraph 16 – subparagraph 2
In the case of biofuels and other bioliquids, all co-products, including electricity that does not fall under the scope of paragraph 14, shall be taken into account for the purposes of this calculation, except for agricultural crop residues, including straw, bagasse, husks, cobs and nut shells. Co- products that have a negative energy content shall be considered to have an energy content of zero for the purpose of the calculation, except where biofuels are produced from such crop residues.
Amendment 302 #
2008/0016(COD)
Proposal for a directive
Annex VII – part C – paragraph 17 – subparagraph 1
Annex VII – part C – paragraph 17 – subparagraph 1
17. For biofuels, for the purposes of the calculation referred to in paragraph 4, the fossil fuel comparator EF shall be the latest available actual average emissions from petrol and diesel consumed in the Community as reported under [Directive 98/70/EC]. If no such data are available, the value used shall be 83.8 91gCO2eq/MJ.
Amendment 710 #
2008/0016(COD)
Proposal for a directive
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Member States shall develop certensure that certification schemes or equivalent qualification schemes for installers of small-scale biomass boilers and stoves, solar photovoltaic and solar thermal systems and heat pumps. Those schemes shall be based on the criteria laid down in Annex IV are available. Each Member State shall recognise certification awarded by other Member States in accordance with these criteria; this shall not affect Directive 2005/36/EC.
Amendment 1037 #
Amendment 43 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 2
Recital 2
(2) The ultimate objective of the United Nations Framework Convention on Climate Change, which was approved on behalf of the European Community by Council Decision 94/69/EC of 15 December 1993 concerning the conclusion of the United Nations Framework Convention on Climate Change (UNFCCC), is to stabilise greenhouse gas concentrations in the atmosphere at a level that would prevent dangerous anthropogenic interference with the climate system. In order to meet that objective, the overall global annual mean surface temperature increase should not exceed 2°C above pre-industrial levels. The latest Intergovernmental Panel on Climate Change Assessment (IPCC) report shows that, in order to reach that objective, global emissions of greenhouse gases must peak by 2020. This implies the increasing of efforts by the Community and the quick involvement of developed and newly industrialised countries and encouraging the participation of developing countries in the emission reduction process.
Amendment 53 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 4
Recital 4
(4) In order to contribute to achieving those long-term objectives, it is appropriate to set out a predictable path according to which the emissions of installations covered by the Community scheme should be reduced. To achieve cost-effectively the commitment of the Community to at least a 20% reduction in greenhouse gas emissions below 1990 levels, emission allowances allocated in respect of those installations should be 21% below their 2005 emission levels by 2020, which is more than 30 % below their 1990 levels.
Amendment 74 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 10
Recital 10
(10) Where equivalent measures to reduce greenhouse gas emissions, in particular taxation, are in place for small installations whose emissions do not exceed a threshold of 1025 000 tonnes of CO2 per year, there should be a procedure for enabling Member States to exclude such small installations from the emissions trading system for so long as those measures are applied. This threshold relatively offers the maximum gain in terms of reduction of administrative costs for each tonne excluded from the system, for reasons of administrative simplicity. As a consequence of the move from five-year allocation periods, and in order to increase certainty and predictability, provisions should be set on the frequency of revision of greenhouse gas emission permits.
Amendment 84 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 12
Recital 12
(12) This contribution is equivalent to a reduction of emissions in 2020 in the Community scheme of 21% below reported 2005 levels, which is more than 30 % below their 1990 levels, including the effect of the increased scope from the period 2005 to 2007 to the period 2008 to 2012 and the 2005 emission figures for the trading sector used for the assessment of the Bulgarian and Romanian national allocation plan for the period 2008 to 2012, leading to an issue of a maximum of 1 720 million allowances in the year 2020. Exact quantities of emissions will be calculated once Member States have issued allowances pursuant to Commission Decisions on their national allocation plans for the period 2008 to 2012, as the approval of allocations to some installations was contingent upon their emissions having been substantiated and verified. Once the issue of allowances for the period 2008 to 2012 has taken place, the Commission will publish the Community-wide quantity. Adjustments should be made to the Community-wide quantity in relation to installations which are included in the Community scheme during the period 2008 to 2012 or from 2013 onwards.
Amendment 134 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 17
Recital 17
(17) For other sectors covered by the Community scheme, a transitional system should be foreseen for which grants free allocation in 2013 would be 80% of the amount that corresponded to the percentage of the overall Community- wide emissions, throughout the period 2005 to 2007 that those installations emitted as a proportion of the annual Community-wide total quantity of allowances. Thereafter, the free allocation should decrease each year by equal amounts resulting in no free allocation in 2020o the extent feasible, based on sector specific benchmarks.
Amendment 144 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 18
Recital 18
(18) TransitionalIn the absence of an international agreement which provides for equal treatment of the sectors affected, free allocation to installations should be provided for through harmonised Community-wide rules (sector specific "benchmarks") in order to minimise distortions of competition within the Community. These rules should take accountbe based ofn the most greenhouse gas and energy efficient techniques and technologies, and take account of the potential, including the technical potential, to reduce emissions, substitutes, alternative production processes, use of biomass, renewables and greenhouse gas capture and storage and renewables. Any such rules should not give incentives to increase emissions and ensure that an increasing proportion of these allowances is aper unit of productioned. Allocations must be fixed prior to the trading period so as to enable the market to function properly. They shall also avoid undue distortions of competition on the markets for electricity and heat supplied to industrial installations. These rules should apply to new entrants carrying out the same activities as existing installations receiving transitional free allocations. To avoid any distortion of competition within the internal market, no free allocation should be made in respect of the production of electricity by new entrants. Allowances which remain in the set-aside for new entrants in 2020 should be auctioned. In defining the principles for setting benchmarks in individual sectors, the Commission should consult with the sectors concerned.
Amendment 146 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 18
Recital 18
(18) Transitional free allocation to installations should be provided for through harmonised Community-wide rules ("benchmarks") in order to minimise distortions of competition within the Community. These rules should take account of the most greenhouse gas and energy efficient techniques, substitutes, alternative production processes, use of biomass, renewables and greenhouse gas capture and storage. Any such rules should not give incentives to increase emissions and ensure that an increasing proportion of these allowances is auctioned. Allocations must be fixed prior to the trading period so as to enable the market to function properly. They shall also avoid undue distortions of competition on the markets for electricity and heat supplied to industrial installations. They shall further avoid undue distortions of competition between industrial activities carried out in installations operated by a single operator and production in outsourced installations. These rules should apply to new entrants carrying out the same activities as existing installations receiving transitional free allocations. To avoid any distortion of competition within the internal market, no free allocation should be made in respect of the production of electricity by new entrants, which is not the case of electricity recovered from unavoidable waste gases and other residues, and electricity produced in connection with industrial heat consumption for the own consumption of the operators of the installations. Allowances which remain in the set-aside for new entrants in 2020 should be auctioned.
Amendment 150 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 18
Recital 18
(18) Transitional free allocation to installations should be provided for through harmonized Community-wide rules ("benchmarks") in order to minimise distortions of competition within the Community. These rules should take account of the most greenhouse gas and energy efficient techniques, substitutes, alternative production processes, use of biomass, renewables, clean energy carriers such as hydrogen and greenhouse gas capture and storage. Any such rules should not give incentives to increase emissions and ensure that an increasing proportion of these allowances is auctioned. Allocations must be fixed prior to the trading period so as to enable the market to function properly. They shall also avoid undue distortions of competition on the markets for electricity and heat, heat and industrial gases supplied to industrial installations. These rules should apply to new entrants carrying out the same activities as existing installations receiving transitional free allocations. To avoid any distortion of competition within the internal market, no free allocation should be made in respect of the production of electricity by new entrants. Allowances which remain in the set-aside for new entrants in 2020 should be auctioned.
Amendment 167 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 19
Recital 19
(19) The Community will continue to take the lead in the negotiation of an ambitious international agreement that will achieve the objective of limiting global temperature increase to 2°C and is encouraged by the progress made in Bali towards this objective. In the event that other developed countries and other major emitters of greenhouse gases do not participate in this international agreement, this could lead to an increase in greenhouse gas emissions in third countries where industry would not be subject to comparable carbon constraints (“carbon leakage”), and at the same time could put certain energy- intensive sectors and sub-sectors, and parts of installations including heat or industrial gases supply thereto owned and/or operated by third parties, in the Community which are subject to international competition at an economic disadvantage. This could undermine the environmental integrity and benefit of actions by the Community. To address the risk of carbon leakage, the Community will allocate allowances free of charge up to 100% to sectors or sub-sectors meeting the relevant criteria. The definition of these sectors and sub-sectors and the measures required will be subject to re-assessment to ensure that action is taken where necessary and to avoid overcompensation. For those specific sectors or sub-sectors where it can be duly substantiated that the risk of carbon leakage cannot be prevented otherwise, where electricity constitutes a high proportion of production costs and is produced efficiently, the action taken may take into account the electricity consumption in the production process, without changing the total quantity of allowances.
Amendment 177 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 20
Recital 20
(20) The Commission should therefore review the situation by June 2011 at the latest, consult with all relevant social partners, and, in the light of the outcome of the international negotiations, submit a report accompanied by any appropriate proposals. In this context, the Commission should identify whichn analytical report assessing the situation with special regard to energy -intensive industry sectors or sub-sectors are likely to be subject to carbon leakage not later than 30 June 2010. It should base its analysis on the assessment of the inability to pass on the cost of required allowances in product prices without significant loss of market share to installations outside the Community not taking comparable action to reduce emissions. Energy-intensive industries which are determined to be exposed to a significant risk of carbon leakage could receive a higher amount of free allocation orsectors exposed to a significant risk of carbon leakage. This report should be accompanied by any appropriate proposals which may include adjusting the proportion of allowances received free of charge and, as a complementary measure, an effective carbon equalisation system could be introduced, with a view to putting installations from the Community which are at significant risk of carbon leakage and those from third countries on a comparable footing. Such a system could apply requirements to importers that would be no less favourable than those applicable to installations within the EU, for example by requiring the surrender of allowances but also address exports. Any action taken would need to be in conformity with the principles of the UNFCCC, in particular the principle of common but differentiated responsibilities and respective capabilities, taking into account the particular situation of Least Developed Countries. It would also need to be in conformity with the international obligations of the Community including the WTO agreement.
Amendment 243 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 2 – point (c)
Article 1 – point 2 – point (c)
Directive 2003/87/EC
Article 3 – point [(t)]
Article 3 – point [(t)]
"[(t)] 'Combustion installation' means any stationary technical unit in which fuels are oxidised producing heat or mechanical energy or both, and other directly associated activities including waste gas scrubbing are carried outfor delivery to end-users outside the combustion installation concerned;
Amendment 284 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2003/87/EC
Article 9 – paragraph 3
Article 9 – paragraph 3
The Commission shall review the linear factor no later than 202516.
Amendment 328 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - Point 7
Article 1 - Point 7
Directive 2003/87/EC
Article 10 - paragraph 3 - point a
Article 10 - paragraph 3 - point a
(a) to reduce greenhouse gas emissions, including by contributing to the Global Energy Efficiency and Renewable Energy Fund, to adapt to the impacts of climate change and to fund research and development of the industries within the scope of this Directive for reducing emissions and adapting, including participation in initiatives within the framework of European Strategic Energy Technology Plan and the European Technology Platforms;
Amendment 332 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - Point 7
Article 1 - Point 7
Directive 2003/87/EC
Article 10 - paragraph 3 - point c
Article 10 - paragraph 3 - point c
(c) for the capture and geological storage of greenhouse gases, in particular from coal power stations;
Amendment 389 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 1 – subparagraph 3
Article 10a – paragraph 1 – subparagraph 3
The measures referred to in the first subparagraph shall, to the extent feasible, establish harmonised sector specific benchmarks to ensure that allocation takes place in a manner that gives incentives for greenhouse gas and energy efficient techniques and for reductions in emissions, by taking. They shall be based on the most efficient techniques and technologies, and take into account of the most efficient techniquepotential, including the technical potential, to reduce emissions, substitutes, alternative production processes, and the use of biomass and greenhouse gas capture and storage, and. The measures shall not give incentives to increase emissions per unit of production. No free allocation shall be made in respect of any electricity production. In defining the principles for setting benchmarks in individual sectors, the Commission shall consult with the sectors concerned.
Amendment 400 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 1 – subparagraph 3
Article 10a – paragraph 1 – subparagraph 3
The measures referred to in the first subparagraph shall, to the extent feasible, ensure that allocation takes place in a manner that gives incentives for greenhouse gas and energy efficient techniques and for reductions in emissions, by taking account of the most efficient techniques, substitutes, alternative production processes, use of biomass and greenhouse gas capture and storage, and shall not give incentives to increase emissions. No free allocation shall be made in respect of any electricity production, except for electricity produced in connection with industrial heat consumption or produced from residues from an industrial process provided that it is for the own consumption of the operators of the installations; such allocations shall be made under the same allocation principles as applied to that industrial activity as mentioned in Annex I. However, where a waste gas from a production process is used as a fuel, all allowances shall be allocated for free to the operator of the installation generating the waste gas according to the same allocation principles as applied for that installation.
Amendment 402 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 1 – subparagraph 3
Article 10a – paragraph 1 – subparagraph 3
The measures referred to in the first subparagraph shall, to the extent feasible, ensure that allocation takes place in a manner that gives incentives for greenhouse gas and energy efficient techniques and for reductions in emissions, by taking account of the most efficient techniques, substitutes, alternative production processes, use of biomass and greenhouse gas capture and storage and inevitable CO2 emissions from the raw material input, and shall not give incentives to increase emissions. No free allocation shall be made in respect of any electricity production.
Amendment 418 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 1 – subparagraph 3
Article 10a – paragraph 1 – subparagraph 3
The measures referred to in the first subparagraph shall, to the extent feasible, ensure that allocation takes place in a manner that gives incentives for greenhouse gas and energy efficient techniques and for reductions in emissions, by taking account of the most efficient techniques, substitutes, alternative production processes, use of biomass and greenhouse gas capture and storage, and shall not give incentives to increase emissions. No free allocation shall be made in respect of any electricity production unless it takes place in combined heat and power plants to meet the country’s own needs.
Amendment 429 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 2
Article 10a – paragraph 2
2. Subject to paragraph 3, no free allocation shall be given to electricity generator-only plants apart from combined heat and power plants to meet the country’s own needs, to installations for the capture, pipelines for the transport or to storage sites for greenhouse gas emissions.
Amendment 443 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 3
Article 10a – paragraph 3
3. Free allocation may be given to electricity generators in respect of the production of heat through high efficiency cogeneration as defined by Directive 2004/8/EC for economically justifiable demand to ensure equaElectricity plants which entail combined heat and power to meet the country’s own needs as set out in Directive 2004/8/EC shall treatment with regard to other producers of heat. In each year subsequent to 2013, the total allocation to such installationceive free allocation of credits ion respect of the production of that heat shall be adjusted by the linear factor referred to in Article 9the basis of benchmarks which are harmonised Europe-wide.
Amendment 444 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 3
Article 10a – paragraph 3
3. Free allocation mayshall be given to electricity generators in respect of the production of heatthe production of heat that is supplied to industries and other consumers through high efficiency cogeneration as defined by Directive 2004/8/EC for economically justifiable demand to ensure equal treatment with regard to other producers of heat. In each year subsequent to 2013, the total allocation to such installations in respect of the production of that heat shall be adjusted by the linear factor referred to in Article 9.
Amendment 466 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 4
Article 10a – paragraph 4
Amendment 472 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 5
Article 10a – paragraph 5
Amendment 492 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 6 – subparagraph 3
Article 10a – paragraph 6 – subparagraph 3
No free allocation shall be made in respect of any electricity production by new entrants, except for electricity produced in connection with industrial heat consumption or produced from residues from an industrial process provided that it is for the own consumption of the operators of the installations; such allocations shall be made under the same allocation principles as applied to that industrial activity as mentioned in Annex I. However, where a waste gas from a production process is used as a fuel, all allowances shall be allocated for free to the operator of the installation generating the waste gas with the same allocation principles as applied for that installation.
Amendment 498 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 6 – subparagraph 3
Article 10a – paragraph 6 – subparagraph 3
No free allocation shall be made in respect of any electricity production by new entrants unless it takes place in combined heat and power to meet the country’s own needs.
Amendment 509 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 7
Article 10a – paragraph 7
7. SUntil an international agreement enters into force and subject to Articles 10b and 28, the amount of allowances allocated free of charge under paragraphs 3 to 6 of this Article [and paragraph 2 of Article 3c] in 2013to installations not covered by paragraph 2 in 2013 and each subsequent year shall be 8100% of the quantity determined in accordance with the measures referred to in paragraph 1 and thereafter the free allocation shall decrease each year by equal amounts resulting in no free allocation in 2020without changing the total quantity of allowances according to Article 9.
Amendment 524 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 8
Article 10a – paragraph 8
Amendment 540 #
2008/0013(COD)
Proposal for a regulation – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2003/87/EC
Article 10a - paragraph 9
Article 10a - paragraph 9
Amendment 556 #
2008/0013(COD)
Proposal for a regulation – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2003/87/EC
Article 10a - paragraph 9 - subparagraph 1
Article 10a - paragraph 9 - subparagraph 1
At the latest by 30 June 20109 and every 35 years thereafter the Commission shall determine the sectors referred to in paragraph 8.
Amendment 587 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2003/87/EC
Article 10b
Article 10b
1. Not later than June 2011 and thereafter every five years, the Commission shall, in the light of the outcome of the international negotiations and the extent to which these lead to global greenhouse gas emission reductions, whilst providing for equal treatment of competing industries and after consulting with all relevant social partners, submit to the European Parliament and to the Council an analytical report assessing the situation with special regard to energy-intensive sectors or sub- sectors that have beeno determined to beheir exposured to significant risks of carbon leakage. This shall be accompanied by any appropriate proposals, which may include: - adjusting the proportion of allowances received free of charge by those sectors or sub-sectors under Article 10a; - inclusion in the Community scheme of importers of products produced by the sectors or sub-sectors determined in accordance with Article 10a. Any binding sectoral agreements which lead to global emiss according to paragraph 3. 2. The analytical report referred to in paragraph 1 shall be accompanied by any appropriate proposals, which take into consideration the timeframe until full implementation and shall include: - adjusting the proportion of allowances received free of charge by those sectors or sub-sectors under Article 10a; - for leakage effects not covered by other measures carbon equalisation systems for exporters and importers of products produced by the sectors covered by Article 10a. Such systems shall not reduce liquidity of the allowance market. Any binding sectoral agreements which provide for equal treatment of competing industries and which are monitorable, verifiable and subject to mandatory enforcement arrangements shall also be taken into account when considering what measures are appropriate. 3. In the determinations reductions of the magnitude required to effectively address climate change, and which are monitorable, verifiable and subject to mandatory enforcement arrangements shall also be taken into account when considering what measures are appropriate. ferred to in paragraph 1, the Commission shall take into account the extent to which it is possible for the sector or sub-sector concerned to pass on the cost of the required allowances in product prices without significant loss of market share to installations operating in countries outside the Community that did not impose equivalent and verifiable constraints on emissions, taking into account the following: (a) the extent to which auctioning would lead to a substantial increase in production cost; (b) the extent to which it is possible for individual installations in the sector concerned to reduce emission levels for instance on the basis of the most efficient techniques; (c) market structure, relevant geographic and product market, the exposure of the sectors to international competition; (d) the effect of climate change and energy policies implemented, or expected to be implemented outside the EU in the sectors concerned; (e) the effect of passing through CO2 costs in electricity prices in the sector or sub- sector concerned. For the purposes of evaluating whether the cost increase resulting from the Community scheme can be passed on, estimates of lost sales resulting from the increased carbon price or the impact on the profitability of the installations concerned may inter alia be used. That measure, designed to amend non- essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article [23(3)].
Amendment 597 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2003/87/EC
Article 10b - paragraph 1
Article 10b - paragraph 1
Not later than June 2011, the Commission shall, in the light of the outcome of the international negotiations and the extent to which these lead to global greenhouse gas emission reductions, and after consulting with all relevant social partners, submit to the European Parliament and to the CouncilSeptember 2009, the Commission shall submit an analytical report assessing the situation with regard to energy- intensive sectors or sub-sectors that have been determined to be exposed to significant risks of carbon leakage. Thise measures in support of specific energy- intensive sectors referred to in Article 10(b) may be lifted only by an international agreement setting the same reduction targets as are imposed on the Member States. This analytical report shall be accompanied by any appropriate proposals, which may include:
Amendment 708 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - point 21
Article 1 - point 21
Directive 2003/87/EC
Article 27
Article 27
Exclusion of small combustion installations subject to equivalent measureemitters 1. Member States may exclude, from the Community scheme, combustion installations which have a rated thermal input below 25MW, reported emissions to the competent authority of less than 1025 000 tonnes of carbon dioxide equivalent, excluding emissions from biomass, in each of the preceding 3 years, and which are subject to measures that will achieve an equivalent contribution to emission reductions, if the Member State concerned complies with the following conditions: a) it notifies the Commission of each such installation, specifying the equivalent measures that are in place, b) it confirms that monitoring arrangements are in place to assess whether any installation emits 10 000 tonnes or more of carbon dioxide equivalent, excluding emissions from biomass, in any one calendar year; c) it confirms that if any installation emits 10 000 tonnes or more of carbon dioxide equivalent, excluding emissions from biomass, in any one calendar year or the equivalent measures are no longer in place, the installation will be re- introduced into the system; d) it publishes the information referred to in points (a), (b) and (c) for public comment. 2. If, following a period of three months from the date of notification for the public to comment, the Commission does not object within a further period of six months, the notification shall be considered to be granted.: Following the surrender of allowances in respect of the period during which the installation is in the emissions trading system, the installation shall be excluded and the Member State shall issue no further free allowances to the installation pursuant to Article 10a.
Amendment 720 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - point 21
Article 1 - point 21
Directive 2003/87/EC
Article 27 - paragraph 1
Article 27 - paragraph 1
1. Member States mayshall at the request of the operator exclude, from the Community scheme, combustion installations which have a rated thermal input below 25 MW, reported emissions to the competent authority of less than 1025 000 tonnes of carbon dioxide equivalent, excluding emissions from biomass, in each of the preceding 3 years, and which are subject to measures that will achieve an equivalent contribution to emission reductions, if the Member State concerned complies with the following conditions: (a) it notifies the Commission of each such installation, specifying the equivalent measures that are in place, (b) it confirms that monitoring arrangements are in place to assess whether any installation emits 1025 000 tonnes or more of carbon dioxide equivalent, excluding emissions from biomass, in any one calendar year; (c) it confirms that if any installation emits 1025 000 tonnes or more of carbon dioxide equivalent, excluding emissions from biomass, in any one calendar year or the equivalent measures are no longer in place, the installation will be re-introduced into the system; (d) it publishes the information referred to in points (a), (b) and (c) for public comment.
Amendment 744 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - point 21
Article 1 - point 21
Directive 2003/87/EC
Article 28 - paragraph 1
Article 28 - paragraph 1
1. Upon the conclusion by the Community of an international agreement on climate change fulfilling the minimum criteria listed in Annex Ia and leading, by 2020, to mandatory reductions of greenhouse gas emissions exceeding the minimum reduction levels agreed upon by the European Council, paragraphs 2, 3 and 4 shall apply.
Amendment 751 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - point 21
Article 1 - point 21
Directive 2003/87/EC
Article 28 - paragraph 2
Article 28 - paragraph 2
2. From the year following the conclusion of the international agreement referred to in paragraph 1, the linear factor shall increase so that the Community quantity of allowances in 2020 is lower Commission shall, on the basis of a full impact assessment of the cost effectiveness of the means to achieve these reductions as well as impacts of other measures detailed withain that established pursuant to Article 9, by a quantity of allowances equivalent toe international agreement, submit a legislative proposal to the European Parliament and the Council suggesting a further reduction of the Community quantity of allowances in 2020 taking into account the overall reduction of greenhouse gas emissions by the Community below 20% to which the international agreement commits the Community, multiplied by the share of overall greenhouse gas emission reductions in 2020 which the Community scheme is contributing pursuant to Articles 9 and 9a.
Amendment 758 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - point 21
Article 1 - point 21
Directive 2003/87/EC
Article 28 - paragraph 2 a (new)
Article 28 - paragraph 2 a (new)
2a. An international agreement as referred to in paragraphs 1 and 2 shall be an agreement between countries which leads to global emissions reductions of the magnitude required to effectively address climate change, and which are monitorable, verifiable and subject to mandatory enforcement arrangements. Such an international agreement should include a critical mass of world wide sectoral production. Countries subject to such an international agreement shall agree to implement and enforce measures which result in an equivalent burden for industries exposed to international competition.
Amendment 787 #
2008/0013(COD)
Proposal for a directive – amending act
Annex I - point 2
Annex I - point 2
Directive 2003/87/EC
Annex I - point 2
Annex I - point 2
Amendment 820 #
2008/0013(COD)
Proposal for a directive – amending act
Annex I a (new)
Annex I a (new)
Directive 2003/87/EC
Annex I a (new)
Annex I a (new)
ANNEX Ia The following is added as Annex Ia to Directive 2003/87/EC: "Annex I a Minimum elements of an international agreement to restrict carbon leakage (a) An international agreement including energy-intensive industries exposed to significant risk of carbon leakage, or a sector specific international agreement regarding such industries, must comply at least with the following criteria in order to provide a level playing field at installation level in such industries: (i) the participation of countries representing a critical mass of production; and (ii) equivalent CO2 emission targets with equivalent effects by 2020 at the latest imposed upon all participating countries; and (iii) an effective international monitoring and verification system. (b) In addition: (i) in countries with non-equivalent CO2 emission targets, measures with equivalent effects should be imposed by 2020 at the latest upon sectors which, in the European Union, are covered by the Community scheme; (ii) measures should be implemented by the EU to include importers from countries not covered by the agreement."
Amendment 113 #
2008/0002(COD)
Proposal for a regulation
Article 6 – point (c a) (new)
Article 6 – point (c a) (new)
(ca) there are no ethical objections to it.
Amendment 163 #
2008/0002(COD)
Proposal for a regulation
Article 10 – subparagraph 1 a (new)
Article 10 – subparagraph 1 a (new)
In the event of ethical objections an opinion shall be sought, over and above the safety assessment, from the European Group on Ethics in Science and New Technologies (EGE).
Amendment 53 #
2007/2285(INI)
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas consumers in Europe should have access to the necessary information to enable them to select the best sources of nutrition for an optimal diet in the light of their individual life-style and state of health,
Amendment 145 #
2007/2285(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls for information campaignawareness to be raise awarenessd among pregnant women about the importance of a balanced diet and of optimal provision of certain nutrients during pregnancy and about the importance of exclusive breastfeeding for a minimum of six months; recalls that babies breastfed for nine months show an overall reduction of risk of 31%;
Amendment 173 #
2007/2285(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Further, asks Member States, local entities and school authorities to monitor and to improve the quality and nutritional standards of school meals and to review portion sizes; asks for a total ban on the sale of foods and beverages high in fat, salt or sugar in schoolschildren to be educated about balanced diet; advocates instead making fresh fruit and vegetables available in vending machinesat points of sale; invites the Member States to ensure that more hours of school timetables are devoted to physical activities and to provide plans for the construction of new public sports facilities;
Amendment 188 #
2007/2285(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Considers it essential that every kind of sponsorship and advertising for so- called HSSF products (high in sugar, salt, fat) should be banned in schools; aAsks for a voluntary commitment by all sports organisations and teams in order to promote balanced nutrition and physical activity and urges them to avoid sponsorship and promotion of food of poor nutritional value;
Amendment 208 #
2007/2285(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Warmly welcomes commitments undertaken on a voluntary basis by producers to implementing nutrition criteria for the formulation of foods; calls on Member States to ensure that no type of diet or food suffers discrimination anywhere in the EU;
Amendment 227 #
2007/2285(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls for a ban on trans-fatty acids, with the exception of naturally occurring trans-fatty acids of milk fat, and urges EU Member States to follow good practices in controlling the content of substances in food (e.g. salt content); nevertheless points out that special exemptions shouldmust be provided for PDO (protected designation of origin) and PGI (protected geographical indication) and traditional products in order to preserve original recipeagricultural products;
Amendment 237 #
2007/2285(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
Amendment 240 #
2007/2285(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls on Member States to promote consumers’ understanding of nutrition, good food suppliers and other favourable dietary components such as fresh fruit and vegetables so that consumers in Europe, particularly old people and mothers with children, can themselves choose how to attain and ensure an optimal diet, taking account of their individual life style and state of health;
Amendment 308 #
2007/2285(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Acknowledges that general practithealth care professionerals should be made aware of their essential role in the early identification of people at risk of overweight and the fact that they should be the main actors in the fight against the obesity epidemic; recommends that further training and scientific information on behavioural therapies be made accessible in order to support health care professionals;
Amendment 330 #
2007/2285(INI)
Motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
29a. Observes that the success of the efforts of many Europeans to be careful about their weight by means of dietary products and diet programmes which are not based on sound clinical studies is undermined, as these make misleading claims and are not medically licensed; calls on the Commission to perform a thorough assessment of the market for weight reduction products and programmes and in doing so to distinguish explicitly between clinically tested products and other products;
Amendment 12 #
2007/2261(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Points out that as the televised broadcasting of sports competitions is increasinglyalso taking place on encrypted and prepaid channels, such competitions are becoming inaccessible to a number ofsome consumers; calls for guaranteed access for the largest possible number of consumers to majordraws attention to Article 3j of Council Directive 89/552/EEC of 3 October 19891 on the pursuit of television broadcasting activities, which states that a substantial proportion of the public may not be excluded from sports events through the medium of free televised broadcasting;which the Member State regards as being of major importance for society; 1 OJ L 298, 17.10.1989, p. 23., most recently amended by Directive 2007/65/EG of the European Parliament and of the Council, of 11 December 2007 (OJ L 332, 18.12.2007, p. 27).
Amendment 15 #
2007/2261(INI)
Draft opinion
Paragraph 8
Paragraph 8
8. Supports the principle of the collective sale of television broadcasting rights, in order to ensure the equitable redistribution of this important financial resourcemedia rights, in order to ensure the equitable redistribution of this important financial resource; stresses the importance of the solidarity mechanism that ensures equitable redistribution of revenues between clubs, and should therefore be applied in every case; underlines the importance of equal competition conditions on the European market; calls on European sports organisations to set up a transparent and non-discriminatory licensing procedure to ensure greater transparency of financial flows and prevent distortions of competition;
Amendment 16 #
2007/2261(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Underlines the necessity for better control of the sports betting market and preservation of sport’s integrity, asks the Commission to come forward with a proposal ensuring a functioning sports betting market in the European Union on the basis of a State or State-controlled licensing system, providing for Member States to take necessary and appropriate measures against compulsive gambling, respecting the sport event organisers’ rights and, preventing misuse and corruption and allowing the possibility of a stable source of funding to promote professional and amateur sport;
Amendment 38 #
2007/2252(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls, therefore, on the Commission to revonsiders that in cases in which an appreciable risek the criteria laid down in its aforementioned Communication as regards recourse to the precautionary principle pursuant to European Court of Justice case-law, in order to ensure that an action and security principle based on the adoption of provisional and proportionate measures lies at the heart of Community health and environment policieo children and adults has been identified and in which there is no scientific certainty and additional research work is needed, the precautionary principle, as presented in Communication COM(2000)001 from the Commission, should be applied in the risk management process;
Amendment 45 #
2007/2252(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls once again upon the Commission to publish a Green Paper on indoor air quality which would enable coherent EU guidelines on health and safety indoors to be established, with particular reference to the properties of construction materials, the energy efficiency of buildings and the safety and the harmlessness of chemical compounds used in equipment and furnishingby integrating existing relevant policies and by tackling the identified priority stressors relevant to health as described in the scientific opinion given by the Scientific Committee on Health and Environmental Risks (SCHER) using the WHO health thresholds;
Amendment 62 #
2007/2252(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Advises the Commission to envisage (by 2010 and under the ‘second round’ of the health and environment action plan) refocusing its initiatives on vulnerable populations and to devise new methods ofby applying existing scientific risk-bassessment,ed approaches, to be continuously checked against upcoming robust scientific evidence taking into account the fundamental fact that children are particularly vulnerable;
Amendment 39 #
2007/0297(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) Manufacturers' compliance with the targets under this Regulation should be assessed at the Community level. Manufacturers whose average specific emissions of CO2 exceed those permitted under this Regulation should pay an excess emissions premium in respect of each calendar year from 2012 onwards. The premium should be modulated as a function of the extent to which manufacturers fail to comply with their target. It should increase over time. In order to provide a sufficient incentive to take measures to reduce specific emissions of CO2 from passenger cars, the premium should reflect technological costs. The amounts of the excess emissions premium should be considered as revenue for the budget of the European Unionbut at the same time to ensure that the penalty is proportional by comparison with other sectors' CO2 emissions and consistent with other CO2-reduction instruments, the level of the premium should be based on the amount to be paid under the European emissions trading system.
Amendment 67 #
2007/0297(COD)
Proposal for a regulation
Article 1
Article 1
This Regulation establishes CO2 emission performance requirements for new passenger cars in order to ensure proper functioning of the internal market and achieve the EU's overall objective that the average new car fleet should achieve CO2 emissions of 120 g CO2/km. The Regulation sets the average CO2 emissions for new passenger cars at 130 g CO2/km by means of improvement in vehicle motor technology as measured in accordance with Regulation (EC) No 715/2007 and its implementing measures. This Regulation will be complemented by additional measures corresponding to 10 g/km as part of the Community's integrated approach. intended to achieve a further reduction of 10 g/km as part of the Community's integrated approach. In 2014, on the basis of a stock-taking exercise and a legislative impact assessment, the Commission shall propose medium- and long-term targets for newly- registered vehicles as from 2020 and submit them to the Council and Parliament for a decision. At the same time, the Commission shall submit a proposal for a comprehensive approach to identifying all measures to reduce CO2 emissions, with the aim of removing the distinction between engine-/vehicle- related and additional measures and eco- innovations. A target shall be set for 2020 which guarantees, through the aggregate impact of all relevant measures, a reduction in average CO2 emissions of at least 20% by comparison with 2008. In that connection, the Commission shall take account of the possible incorporation of road transport into the European emissions trading system, as proposed in the context of the revision of that trading system. As the basis for this proposal, a comprehensive assessment of the implications for the automobile industry and for upstream sectors shall be drawn up. This shall include a cost-benefit analysis, in the light of all relevant technological innovations designed to reduce CO2 emissions, covering all segments of the car market. When a long-term target is set, due account shall be taken of developments relating to international climate protection agreements.
Amendment 71 #
2007/0297(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) Manufacturers' compliance with the targets under this Regulation should be assessed at the Community level. Manufacturers whose average specific emissions of CO2 exceed those permitted under this Regulation should pay an excess emissions premium in respect of each calendar year from 2012 onwards. The premium should be modulated as a function of the extent to which manufacturers fail to comply with their target. It should increase over time. In order to provide a sufficient incentive to take measures to reduce specific emissions of CO2 from passenger cars, the premium should reflect technological costs. The amounts of the excess emissions premium should be considered as revenue for the budget of the European Union – while at the same time ensuring that this sanction, in comparison to other CO2-emitting sectors, is proportionate and consistent with other CO2 reduction instruments – the level of the excess emissions premium should be based on the amount payable under the EU Emissions Trading System.
Amendment 93 #
2007/0297(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point f a (new)
Article 3 – paragraph 1 – point f a (new)
(fa) ‘eco-innovation’ means any technological innovation which, regardless of driver behaviour, delivers a proven, quantifiable contribution to reducing CO2 emissions and which is not included or insufficiently taken into account in the new European testing cycle (Regulation (EC) No 715/2007) and is not covered by the additional measures referred to in Article 1.
Amendment 94 #
2007/0297(COD)
Proposal for a regulation
Article 1 – paragraph 1a (new)
Article 1 – paragraph 1a (new)
Further eco-innovations may count towards the objective in accordance with Article 6(8a).
Amendment 96 #
2007/0297(COD)
Proposal for a regulation
Article 1 – paragraph 1b (new)
Article 1 – paragraph 1b (new)
In 2014, following a thorough practice- based impact assessment, and in the light of expected technological progress, an ambitious average CO2 limit value should be set for the European new car fleet for 2020. The process of setting CO2 limit values must take into account any new test cycle.
Amendment 112 #
2007/0297(COD)
Proposal for a regulation
Article 4
Article 4
For the calendar year commencing 1 January 2012 and each subsequent calendar year, each manufacturer of passenger cars shall ensure that itn 2012 25%, in 2013 50%, in 2014 75% and in 2015 and each subsequent calendar year 100% of the fleet’s average specific emissions of CO2 do not exceed itsthe specific emissions target for a manufacturer's fleet determined in accordance with Annex I or, where a manufacturer is granted a derogation under Article 9, in accordance with that derogation.
Amendment 125 #
2007/0297(COD)
Proposal for a regulation
Article 4 – subparagraph 1 a (new)
Article 4 – subparagraph 1 a (new)
For manufacturers which produce cars with specific CO2 emissions which are 20%, 30%, 40% and 50% lower than the target set in Annex I, when average specific CO2 emissions are calculated every new vehicle registered over the period to 2015 inclusive shall be counted as two, three, four or five, in keeping with the percentage by which emissions fall below the set target.
Amendment 138 #
2007/0297(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. For the year beginning 1 January 20102 and each subsequent year, each Member State shall record information for each new passenger car registered in its territory in accordance with Part A of Annex II.
Amendment 169 #
2007/0297(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The excess emissions premium pursuant to Article 1 shall be: (a) in relation to excess emissions in the calendar year 2012, 20 eurosEUR 10; (b) in relation to excess emissions in the calendar year 2013, 35 eurosEUR 20; (c) in relation to excess emissions in the calendar year 2014, 60 euros; andEUR 30; (d) in relation to excess emissions in the calendar year 2015 and subsequent calendar years, 95 eurosEUR 40.
Amendment 182 #
2007/0297(COD)
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. The amounts of the excess emissions premium shall be considerpaid into a fund which must be used asto revenue for the budget of the European Unionduce CO2 emissions in the road transport sector and for research into new, energy-efficient technologies.
Amendment 187 #
2007/0297(COD)
Proposal for a regulation
Annex I – paragraph 1
Annex I – paragraph 1
1. For each new passenger car, the permitted specific emissions of CO2, measured in grams per kilometre shall be determined in accordance with the following formula: Permitted specific emissions of CO2 = 130 + a × (M – M0) Where: : M = mass of the vehicle in kilograms (kg) M0 = 1289.0 × f f = (1 + AMI)6 Autonomous mass increase (AMI) = 0 % % a = 0.0457609
Amendment 202 #
2007/0297(COD)
Proposal for a regulation
Article 9 a (new)
Article 9 a (new)
Amendment 225 #
2007/0297(COD)
Proposal for a regulation
Article 11
Article 11
Amendment 245 #
Amendment 265 #
2007/0297(COD)
Proposal for a regulation
Annex II a (new)
Annex II a (new)
Amendment 11 #
2007/0295(COD)
Proposal for a regulation
Article 8 - paragraph 2 - subparagraph 1
Article 8 - paragraph 2 - subparagraph 1
With effect from 1 October 2014[48 months after the entry into force of the implementing measures referred to in Article 4 (3), the first subparagraph of Article 5 (4) and the first subparagraph of Article 6(2)], national authorities shall, in the case of new vehicles which do not comply with this Regulation, consider certificates of conformity to be no longer valid for the purposes of Article 26 of Directive 2007/46/EC and shall, on grounds relating to emissions, prohibit the registration, the sale and entry into service of such vehicles
Amendment 13 #
2007/0295(COD)
Proposal for a regulation
Article 10 - paragraph 1 - subparagraph 2
Article 10 - paragraph 1 - subparagraph 2
Those incentives shall apply to all new vehicles put on the market of the Member State concerned, which comply with this Regulation and its implementing measures. However, they shall cease to apply on 1 October 2014[48 months after the entry into force of the implementing measures referred to in Article 4 (3), the first subparagraph of Article 5 (4) and the first subparagraph of Article 6(2)], at the latest
Amendment 15 #
2007/0295(COD)
Proposal for a regulation
Article 15 - paragraph 1
Article 15 - paragraph 1
Council Directive 80/1269/EEC, Commission Directives 88/195/EEC, 97/21/EC, 1999/99/EC and 2005/78/EC, and Directive 2005/55/EC are repealed with effect from 1 October 2014[48 months after the entry into force of the implementing measures referred to in Article 4 (3), the first subparagraph of Article 5 (4) and the first subparagraph of Article 6(2)].
Amendment 16 #
2007/0295(COD)
Proposal for a regulation
Article 16 - paragraph 2
Article 16 - paragraph 2
It shall apply from 1st April 2013. However, Articles 8(3) and 10 shall apply from the date of entry into force and points 1(a)(i), 1(b)(i), 2(a), 3(a)(i), 3(b)(i), 3(c)(i) and 3(d)(i) of Annex II shall apply from 1 October 2014[36 months after the entry into force of the implementing measures referred to in Article 4 (3), the first subparagraph of Article 5 (4) and the first subparagraph of Article 6(2)].. However, Articles 8(3) and 10 shall apply from the date of entry into force and points 1(a)(i), 1(b)(i), 2(a), 3(a)(i), 3(b)(i), 3(c)(i) and 3(d)(i) of Annex II shall apply from [48 months after the entry into force of the implementing measures referred to in Article 4 (3), the first subparagraph of Article 5 (4) and the first subparagraph of Article 6(2)].
Amendment 17 #
2007/0295(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) Achieving EU air quality objectives requires a continuing effort to reduce vehicle emissions. For that reason, industry should be provided with clear information on future emission limit values and should be allowed an appropriate period of time in which to attain them and pursue the requisite technical developments.
Amendment 17 #
Amendment 18 #
2007/0295(COD)
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) It is essential to develop a European standard format for on-board diagnostic, repair and maintenance information. The existing OASIS format cannot be used fully for on-board diagnostic, repair and maintenance information for heavy goods vehicles, so that CEN has been entrusted with the task of devising an extended standard format for this information. This new standard format should be based on the OASIS format and take account of the particular features of heavy goods vehicles. Until this new standard format has been adopted by CEN, on-board diagnostic, repair and maintenance information for heavy goods vehicles should be provided in an easy-to- read and non-discriminatory form. The information should be published on the websites of the manufacturers or, if this is impossible because of the nature of the information, in another appropriate form. The specifications for the extent of the technical information prescribed in OASIS Document SC1-D2 should be laid down in the implementing provisions for the present regulation.
Amendment 19 #
2007/0295(COD)
Proposal for a regulation
Article 5 - paragraph 4 - subparagraph 2
Article 5 - paragraph 4 - subparagraph 2
Amendment 20 #
2007/0295(COD)
Proposal for a regulation
Article 6 - paragraph 1
Article 6 - paragraph 1
1. Manufacturers shall provide unrestricted and standardised access to on-board diagnostic (OBD) information and vehicle repair and maintenance information to independent operators. Articles 6 and 7 of Regulation (EC) No 715/2007 shall applyIn the case of multi-stage type approval, the manufacturer responsible for the respective type approval shall also be responsible for communicating repair information relating to the particular stage to both the final manufacturer and independent operators. The final manufacturer shall be responsible for communicating information about the whole vehicle to independent operators. Charges for access time shall be levied only once. Articles 6 and 7 of Regulation (EC) No 715/2007 shall apply mutatis mutandis. On-board diagnostic, repair and maintenance information shall accord with the CEN norm as soon as the latter is adopted. Until the adoption of this new standard format by CEN, on-board diagnostic, repair and maintenance information for vehicles shall be submitted in an easy-to- read and non-discriminatory form. The information shall be published on the websites of the manufacturers or, if this is impossible because of the nature of the information, in another appropriate form.
Amendment 22 #
2007/0295(COD)
Proposal for a regulation
Article 8 - paragraph 2 - subparagraph 1
Article 8 - paragraph 2 - subparagraph 1
2. With effect from 1 October 201448 months after the entry into force of the measures referred to in Articles 4(3), 5(4) and 6(2) for the implementation of this Regulation, national authorities shall, in the case of new vehicles which do not comply with this Regulation, consider certificates of conformity to be no longer valid for the purposes of Article 26 of Directive 2007/46/EC and shall, on grounds relating to emissions, prohibit the registration, the sale and entry into service of such vehicles.
Amendment 25 #
2007/0295(COD)
Proposal for a regulation
Article 10 - paragraph 1 - subparagraph 2
Article 10 - paragraph 1 - subparagraph 2
Those incentives shall apply to all new vehicles put on the market of the Member State concerned, which comply with this Regulation and its implementing measures. However, they shall cease to apply on 1 October 2014 at the latest, at the latest, 48 months after the entry into force of the measures for the implementation of this Regulation referred to in Articles 4(3), 5(4) and 6(2).
Amendment 28 #
2007/0295(COD)
Proposal for a regulation
Article 15 - paragraph 1
Article 15 - paragraph 1
1. Council Directive 80/1269/EEC, Commission Directives 88/195/EEC, 97/21/EC, 1999/99/EC and 2005/78/EC, and Directive 2005/55/EC are repealed with effect from 1 October 201448 months after the entry into force of the measures for the implementation of this Regulation referred to in Articles 4(3), 5(4) and 6(2).
Amendment 30 #
2007/0295(COD)
Proposal for a regulation
Article 16 - paragraph 2
Article 16 - paragraph 2
It shall apply from 1st April 201336 months after the entry into force of the measures for the implementation of this Regulation referred to in Articles 4(3), 5(4) and 6(2). However, Articles 8(3) and 10 shall apply from the date of entry into force and points 1(a)(i), 1(b)(i), 2(a), 3(a)(i), 3(b)(i), 3(c)(i) and 3(d)(i) of Annex II shall apply from 1 October 201448 months after the entry into force of the measures for the implementation of this Regulation referred to in Articles 4(3), 5(4) and 6(2).
Amendment 31 #
2007/0295(COD)
Proposal for a regulation
Article 16 - paragraph 2 a (new)
Article 16 - paragraph 2 a (new)
The Commission shall adopt the implementing measures referred to in Articles 4(3), 5(4) and 6(2) by 31 December 2009.
Amendment 32 #
2007/0295(COD)
Proposal for a regulation
Annex I
Annex I
ANNEX I Euro VI Emission Limits Limit values CO THC NMHC CH4 NOx (3) NH3 PM Mass PM (1) (mg/kWh) (mg/kWh) (mg/kWh) (mg/kWh) (mg/kWh) (ppm) (mg/kWh) number (#/kWh) ESC 1500 130 4500 10 10 (CI) ETC 4000 160 4500 10 10 (CI) ETC 4000 160 500 4500 10 10 (PI) WHSC (2) WHTC (2)
Amendment 67 #
2007/0286(COD)
Proposal for a directive
Recital 11
Recital 11
(11) In order to take into account certain specific circumstances, competent authorities should be able to grant derogations to allow emission limit values to exceed the emission levels associated with the best available techniques as described in the BAT reference documents. Such derogations should be based on well defined criteria and should not exceed emission limit values set out in this Directive.
Amendment 70 #
2007/0286(COD)
Proposal for a directive
Recital 16
Recital 16
Amendment 74 #
2007/0286(COD)
Proposal for a directive
Recital 17
Recital 17
(17) In order to ensure an effective implementation and enforcement of this Directive, operators should regularly report on compliance with permit conditions to the competent authority. Member States should ensure that those conditions are complied with by the operator and that the operator and the competent authority take necessary measures in a case of non- compliance with this Directive and provide for a system of environmental inspections. It is for the Member States to determine the most appropriate enforcement regimes, including how emission limit values should be complied with.
Amendment 89 #
2007/0286(COD)
Proposal for a directive
Article 3 – point 5 a (new)
Article 3 – point 5 a (new)
(5a) 'Emission levels associated with best available techniques' means the range of emissions achieved from the application of best available techniques as described in the BAT reference documents during normal conditions of operation and expressed as averages over a period of time.
Amendment 94 #
2007/0286(COD)
Proposal for a directive
Article 3 – paragraph 9 – subparagraph 1 a (new)
Article 3 – paragraph 9 – subparagraph 1 a (new)
In determining the best available techniques, special consideration should be given to the items listed in Annex III;
Amendment 96 #
2007/0286(COD)
Council position
Article 11 – point h
Article 11 – point h
Amendment 97 #
2007/0286(COD)
Council position
Article 11 – point h
Article 11 – point h
(h) the necessary measures are taken upon definitive cessation of activities to avoid any risk of pollution and return the site of operation to the satisfactory state defined in accordance with Article 22a correct state.
Amendment 98 #
2007/0286(COD)
Council position
Article 12 – paragraph 1 – point e
Article 12 – paragraph 1 – point e
Amendment 98 #
2007/0286(COD)
Proposal for a directive
Article 3 – point 13
Article 3 – point 13
(13) 'emerging technique' means a novel technique for anthat, if industrial activity that, ifly proven and commercially developed, could provide a higher or similar general level of protection of the environment or higher or similar cost savings than existing best available techniques;
Amendment 104 #
2007/0286(COD)
Council position
Article 13 – paragraph 5
Article 13 – paragraph 5
5. DThe Commission shall adopt decisions on the BAT conclusions shall be adopted in accordance with the regulatory procedurby means of delegated acts in accordance with Article 76. This shall only be applicable to BAT reference documents for which the review begins after the date referred to in Article 75(2)83.
Amendment 106 #
2007/0286(COD)
Proposal for a directive
Article 3 – point 20
Article 3 – point 20
(20) ‘biomass’ means any of the following: (a) products consisting of any vegetable matter from agriculture or forestry which can be used as a fuel for the purpose of recovering its energy content; (b) the following waste used as a fuel: (i) vegetable waste from agriculture and forestry; (ii) vegetable waste from the food processing industry, if the heat generated is recovered; (iii) fibrous vegetable waste from virgin pulp production and from production of paper from pulp, if it is co-incineratedthe biodegradable part of products, waste and residues from agriculture (including vegetal and animal substances), forestry and related industries, as well ats the place of production and the heat generated is recovered; (iv) cork waste; (v) wood waste with the exception of wood waste which may contain halogenated organic compounds or heavy metals as a result of treatment with wood preservatives or coatingbiodegradable part of industrial and municipal waste;
Amendment 113 #
2007/0286(COD)
Council position
Article 13 – paragraph 5 a (new)
Article 13 – paragraph 5 a (new)
5a. Where the report referred to in paragraph 5a identifies the need for Union-wide minimum requirements for emission limit values and rules on monitoring and compliance, the Commission shall adopt, by means of delegated acts in accordance with Article 76, minimum requirements for emission limit values and rules on monitoring and compliance for the activities concerned. Minimum requirements shall be set in such a way as to allow for the application of Article 15(4). Before the minimum requirements for emission limit values and rules on monitoring and compliance for the activities concerned are adopted, the Commission shall consult the forum referred to in paragraph 3. The Commission shall provide a report on the information it receives.
Amendment 114 #
2007/0286(COD)
Council position
Article 13 – paragraph 5 b (new)
Article 13 – paragraph 5 b (new)
5b. The Commission shall set the minimum requirements for emission limit values, equivalent parameters or technical measures and rules on monitoring and compliance for the activities concerned referred to in paragraph 5a by means of delegated acts in accordance with Article 76. These minimum requirements shall be directed to significant environmental impacts of the activities or installations concerned, and shall be based on BAT- AELs. Minimum requirements shall be set appropriately above the BAT-AELs so that less stringent emission limit values can be established in accordance with the first subparagraph of Article 15(4). Before the minimum requirements for emission limit values and rules on monitoring and compliance for the activities concerned are adopted, the Commission shall consult the forum referred to in Article 13(3) and report on the outcome of the consultations and how these have been taken into account.
Amendment 115 #
2007/0286(COD)
Proposal for a directive
Article 3 – point 34 a (new)
Article 3 – point 34 a (new)
(34a) 'Emission levels associated with best available techniques' means the range of emissions achieved from the application of best available techniques as described in the BAT reference documents during normal conditions of operation and expressed as averages over a period of time. The BAT-AELs provide an appropriate reference point to assist in the determination of emission limit values in the permit, and differ from emission limit values as emission limit values also need to take into account monitoring and compliance requirements as well as the technical characteristics, the geographical location and the local environmental conditions of each particular installation.
Amendment 122 #
2007/0286(COD)
Council position
Article 14 – paragraph 4
Article 14 – paragraph 4
Amendment 123 #
2007/0286(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. TWithout prejudice to other requirements laid down in national or Community legislation, the competent authority shall grant a permit ifcontaining conditions guaranteeing that the installation complies with the requirements of this Directive.
Amendment 131 #
2007/0286(COD)
Council position
Article 15 – paragraph 4 – subparagraph 1
Article 15 – paragraph 4 – subparagraph 1
By way of derogation from paragraph 3, the competent authority may, in specific cases, on the basis of an assessment of the environmental and economic costs and benefits taking into account the technical characteristics of the installation concerned, its geographical location and the local environmental conditions, set emission limi and without prejudice to Article 18, the competent authority may, as an exception, set less strict emission limit values. Such a derogation may apply only where an assessment demonstrates that: a) the geographical location or the local environmental conditions of the installation concerned prevent the implementation in the whole, or part, of that installation of best available techniques described in the BAT reference documents; or b) the technical characteristics of the installation concerned prevent the implementation in the whole, or part, of that installation of best available techniques described in the BAT reference documents; or c) the economic costs of the implementation of best avalues deviating from those set by the application of paragraph 3. ilable techniques as described in the BAT reference documents would be disproportionally high compared to the environmental benefits.
Amendment 144 #
2007/0286(COD)
Council position
Article 15 – paragraph 4 – subparagraph 2
Article 15 – paragraph 4 – subparagraph 2
The competent authority shall providedocument the reasons for the application of the first subparagraph including the result of the assessment and the justification for the conditions imposed in the annex to the permit conditions and publish the permit conditions and the annex on the Internet.
Amendment 144 #
2007/0286(COD)
Proposal for a directive
Article 14 – title
Article 14 – title
BAT reference documents and minimum requirements
Amendment 153 #
2007/0286(COD)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Commission shall adopt BAT reference documents based on the resultsthe outcome of the information exchange referred to in Article 29 as BAT reference documents.
Amendment 154 #
2007/0286(COD)
Council position
Article 15 – paragraph 4 – subparagraph 3
Article 15 – paragraph 4 – subparagraph 3
Amendment 154 #
2007/0286(COD)
Proposal for a directive
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
(1a) Notwithstanding the provisions of paragraph 4 and Article 68, on the basis of new or updated BAT reference documents the Commission may, where appropriate, make proposals for measures to limit emissions (emission limit values, equivalent parameters or technical measures) and monitoring and compliance requirements as minimum requirements for the industrial activity in question. The Commission may propose to set minimum requirements for specific substances that have been identified to be of EU-wide concern and relevance for the industrial activity concerned. These minimum requirements shall take into account the feasibility of the industry across the EU concerned, and in particular the technical characteristics, cross-media effects, and, where appropriate, lay down transition periods for specific activities. The proposals on such minimum requirements shall be subject to a EU- wide sectoral impact assessment, looking at the various situations in all the Member States The Commission shall in making proposals on minimum requirements consult the relevant stakeholders involved in the information exchange referred to in Article 29. Those measures, designed to amend non- essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 69(2).
Amendment 157 #
2007/0286(COD)
Council position
Article 15 – paragraph 4 – subparagraph 3 a (new)
Article 15 – paragraph 4 – subparagraph 3 a (new)
Member States shall ensure that the members of the public concerned are given early and effective opportunities to participate in the decision-making process relating to the granting of the derogation referred to in this paragraph. Every year Member States shall provide the Commission with a report on the derogations granted. The Commission shall publish these reports on the Internet.
Amendment 159 #
2007/0286(COD)
Proposal for a directive
Article 14 – paragraph 2
Article 14 – paragraph 2
Amendment 167 #
2007/0286(COD)
Council position
Article 21 – paragraph 3
Article 21 – paragraph 3
3.Within five years of publication of Where the Commission publishes decisions on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, the competent authority shall ensure that: a) all the permit conditions for the installation concerned areMember States shall ensure that the competent authority reconsidereds and, ifwhere necessary, updateds to ensure compliance with this Directive, in particular, with Article 15(3) and (4), where applicable; b) the installation complies with those permit conditions. The reconsideration shall take into account all the new or updated BAT conclusions applicable to the installation and adopted in accordance with Article 13(5) since the permit was granted or last reconsideredhe permit conditions for the installation concerned within five years of the publication of the reference documents. The first subparagraph shall also apply to any derogation granted in accordance with Article 15(4).
Amendment 176 #
2007/0286(COD)
Proposal for a directive
Article 15 – paragraph 3
Article 15 – paragraph 3
3. BAT reference documents shall be the reference for setting the permit conditions by the competent authority without prescribing the use of any technique or specific technology, but taking into account the technical characteristics of the installation concerned, its geographical location and the local environmental conditions, on the basis of the criteria listed in Annex III, and after determination of the best available techniques together with the operator.
Amendment 181 #
Amendment 185 #
2007/0286(COD)
Proposal for a directive
Article 16 – paragraph 2 – subparagraph 2
Article 16 – paragraph 2 – subparagraph 2
Taking account of the technical characteristics of the installation in question, its geographical location and local environmental conditions, the competent authority shall setlay down emission limit values that, equivalent parameters or technical measures and monitoring and compliance requirements in such a way that the resulting emission levels for the installation do not exceed the corresponding emission levels associated with the best available techniques as described in the BAT reference documents.
Amendment 245 #
2007/0286(COD)
Proposal for a directive
Article 23
Article 23
Amendment 257 #
2007/0286(COD)
Proposal for a directive
Article 24
Article 24
The report on compliance referred to in point (1) of Article 8 shall include a comparison between the operation of the installation, including the level of emissions, andlevel of emissions and the emission levels associated with the best available techniques as described in the BAT reference documents.
Amendment 262 #
2007/0286(COD)
Proposal for a directive
Article 25 – paragraph 2
Article 25 – paragraph 2
Amendment 263 #
2007/0286(COD)
Proposal for a directive
Article 25 – paragraph 3
Article 25 – paragraph 3
Amendment 266 #
2007/0286(COD)
Proposal for a directive
Article 25 – paragraph 4 – subparagraph 2
Article 25 – paragraph 4 – subparagraph 2
Those programmes shall include at least one site visit every twelvenot later than every thirty-six months, for each installation, unless those programmes are based on a systematic appraisal of the environmental risks of the particular installations concernedfor particular installations that present high environmental risks, programmes shall include one site visit every twelve months.
Amendment 267 #
2007/0286(COD)
Proposal for a directive
Article 25 – paragraph 4 – subparagraph 2
Article 25 – paragraph 4 – subparagraph 2
Those programmes shall include at least one site visit every twelve months, for each installation, unless those programmes are based on a systematic appraisal of the environmental risks of the particular installations concernednot later than every thirty-six months, for each installation; for particular installations that present high environmental risks, programmes shall include one site visit every twelve months.
Amendment 272 #
2007/0286(COD)
Proposal for a directive
Article 25 – paragraph 4 – subparagraph 3
Article 25 – paragraph 4 – subparagraph 3
Amendment 274 #
2007/0286(COD)
Proposal for a directive
Article 25 – paragraph 4 – subparagraph 4
Article 25 – paragraph 4 – subparagraph 4
Amendment 277 #
2007/0286(COD)
Proposal for a directive
Article 25 – paragraph 6
Article 25 – paragraph 6
6. Non-routine inspections shall be carried out to investigate serious environmental complaints, serious environmental accidents, incidents and occurrences of non-compliance or facts that seriously affect human health as soon as possible and, where appropriate, before the issue, reconsideration or update of a permit.
Amendment 280 #
2007/0286(COD)
Proposal for a directive
Article 25 – paragraph 6
Article 25 – paragraph 6
6. Non-routine inspections shall be carried out to investigate serious environmental complaints, serious environmental accidents, incidents and occurrences of non-compliance or facts that seriously affect human health as soon as possible and, where appropriate, before the issue, reconsideration or update of a permit.
Amendment 285 #
2007/0286(COD)
Proposal for a directive
Article 25 – paragraph 7
Article 25 – paragraph 7
Amendment 290 #
2007/0286(COD)
Council position
Annex I – point 3.5
Annex I – point 3.5
3.5. Manufacture of ceramic products by firing, in particular roofing tiles, bricks, refractory bricks, tiles, stoneware or porcelain, with a production capacity exceeding 75 tonnes per day and/or with a kiln capacity exceeding 4m³ and with a setting density per kiln exceeding 300 kg/m³3
Amendment 305 #
2007/0286(COD)
Proposal for a directive
Article 29 – introductory part
Article 29 – introductory part
The Commission shall organise an exchange of information withbetween Member States, the industries concerned, the Commission and non- governmental organisations promoting environmental protection on the following:
Amendment 335 #
2007/0286(COD)
Proposal for a directive
Article 38 – paragraph 2 – point a – subpoint i
Article 38 – paragraph 2 – point a – subpoint i
Amendment 388 #
2007/0286(COD)
Proposal for a directive
Annex I – point 3.5.
Annex I – point 3.5.
3.5. Manufacture of ceramic products by firing, in particular roofing tiles, bricks, refractory bricks, tiles, stoneware or porcelain, with a production capacity exceeding 75 tonnes per day orand with a setting density per kiln exceeding 300 kg/m3
Amendment 398 #
2007/0286(COD)
Proposal for a directive
Annex I – point 5.3. – point d
Annex I – point 5.3. – point d
(d) treatment of slags and ashes not covered by other categories of industrial activities;
Amendment 399 #
2007/0286(COD)
Proposal for a directive
Annex I – point 5.3. – point e
Annex I – point 5.3. – point e
Amendment 403 #
2007/0286(COD)
Proposal for a directive
Annex I – point 5.3. – point e
Annex I – point 5.3. – point e
(e) treatment of scrap metal not covered by other categories of industrial activities.
Amendment 408 #
2007/0286(COD)
Proposal for a directive
Annex I – point 6.4. – point b – subpoint ii
Annex I – point 6.4. – point b – subpoint ii
(ii) vegetable raw materials with a finished product production capacity greater than 300 tonnes per day (average value on a quarterly basis)
Amendment 507 #
2007/0286(COD)
Proposal for a directive
Annex VI – Part 6 – point 2.5 - subparagraph 1
Annex VI – Part 6 – point 2.5 - subparagraph 1
2.5. The competent authority may decide not to require continuous measurements for HCI, HF and SO2 in waste incineration plants or waste co-incineration plants and require periodic measurements as set out in point 2.1(c) or no measurements if the operator can prove that the emissions of those pollutants can under no circumstances be higher than the prescribed emission limit values.
Amendment 513 #
2007/0286(COD)
Annex VI – Part 6 – point 2.5 - subparagraph 2
Amendment 93 #
2007/0248(COD)
Proposal for a directive – amending act
Recital 24
Recital 24
(24) A television broadcast is a linearLegal “must-carry” obligations may be applied, to specified radio and audiovisual media services as dend complementary services supplied by a specifined in themedia service provider. Audiovisual Mmedia Sservices Directiveare defined in the Directive 2007/65/EC of the European Parliament and of the Council of [….] 2007, which is provided by11 December 2007 a mendia service provider for simultaneous viewing of programmes on the basis of a programme schedule; a media service provider may provide a number of audng Council Directive 89/552/EEC on the coordination of certain provisions laid down by law, regulation or audio visual programme schedules (channels). Legal “must-carry” obligations may be applied, but only to specified broadcast channels supplied by a specified media service providerdministrative action in Member States concerning the pursuit of television broadcasting activities1. Member States should provide a clear justification for the “must carry” obligations in their national law so as to ensure that such obligations are transparent, proportionate and properly defined. In that regard, “must carry” rules should be designed in a way which provides sufficient incentives for efficient investment in infrastructure. “Must carry” rules should be periodically reviewed in order to keep them up-to-date with technological and market evolution in order to ensure that they continue to be proportionate to the objectives to be achieved. Given the rapid change in technology and market conditions such a full review would need to be carried out at least every three years and would require a public consultation of all stakeholders. One or more broadcast channels may be complemented byComplementary services include, but are not limited to, services to improve accessibility for users with disabilities, such as a videotext service, subtitling service, an audio description or sign language. _______ 1 OJ L 332, 18.12.2007, p. 27.
Amendment 250 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 19
Article 1 – point 19
Directive 2002/22/EC
Article 31 – paragraph 1 – subparagraph 1
Article 31 – paragraph 1 – subparagraph 1
Member States may impose reasonable “must carry” obligations, for the transmission of specified radio and television broadcast channels and accessibilitaudiovisual media services and complementary services, on undertakings under their jurisdiction providing electronic communications networks used for the distribution of radio or television broadcastaudiovisual media services to the public where a significant number of end-users of such networks use them as their principal means to receive radio and television broadcastor audiovisual media services. Such obligations shall only be imposed where they are necessary to meet general interest objectives as clearly and specifically defined by each Member State in its national law and shall be proportionate and transparent.
Amendment 254 #
2007/0248(COD)
Proposal for a directive – amending act
Article 1 – point 19
Article 1 – point 19
Directive 2002/22/EC
Article 31 – paragraph 1 – subparagraph 3
Article 31 – paragraph 1 – subparagraph 3
Member States shall review “must carry” obligations at least every three yearon a regular basis.
Amendment 1 #
2007/0214(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) The CARS21 (Competitive Automotive Regulatory System for the 21st century) Final Report1 stated that "efforts with a view to increasing international harmonisation of motor vehicle regulations should be maintained where appropriate, with a view to involving the key vehicle markets and to extending harmonisation to areas not yet covered, notably in the framework of both the 1958 and the 1998 Agreements of the UNECE". In line with this recommendation, the Commission should continue to support the development of internationally harmonised requirements for motor vehicles under the auspices of the UNECE. In particular, if a Global Technical Regulation (GTR) on hydrogen and fuel cell vehicles is adopted, the Commission should consider the possibility of adapting the requirements of this Regulation to those of the GTR. 1 http://ec.europa.eu/enterprise/automotive/pagesba ckground/competitiveness/cars21finalreport.pdf
Amendment 2 #
2007/0214(COD)
Proposal for a regulation
Recital 6 b (new)
Recital 6 b (new)
(6b) Hydrogen mixtures could be used as a transition fuel to facilitate the introduction of hydrogen-powered vehicles in countries where there is a good natural gas infrastructure. The Commission should therefore develop requirements for the use of mixtures of hydrogen and natural gas/biomethane, especially the mixing ratio of hydrogen and gas, taking into account the technical feasibility and the environmental benefits.
Amendment 5 #
2007/0214(COD)
Proposal for a regulation
Article 3 – point 1
Article 3 – point 1
1) "hydrogen powered vehicle" means any motor vehicle that uses pure hydrogen or a mixture of hydrogen and natural gas as fuel to propel the vehicle;
Amendment 6 #
2007/0214(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point b – indent – 1 (new)
Article 12 – paragraph 2 – point b – indent – 1 (new)
- use of pure hydrogen or a mixture of hydrogen and natural gas/biomethane;
Amendment 10 #
2007/0214(COD)
Proposal for a regulation – amending act
Recital 6 a (new)
Recital 6 a (new)
(6a) The CARS 21 High Level Group final report stated that 'efforts with a view to increasing international harmonisation of motor vehicle regulations should be maintained where appropriate, with a view to involve the key vehicle markets and to extend harmonisation to areas not yet covered, notably both in the framework of the 1958 and the 1998 Agreements of the UNECE'. In line with this recommendation, the Commission should continue to support the development of internationally harmonised requirements for motor vehicles under the auspices of UNECE. In particular, if a Global Technical Regulation (GTR) on hydrogen and fuel cell vehicles is adopted, the Commission should consider the possibility of adapting the requirements of this Regulation to those of that GTR. 1 http://ec.europa.eu/enterprise/automotive/pagesba ckground/competitiveness/cars21finalreport.pdf
Amendment 11 #
2007/0214(COD)
Proposal for a regulation – amending act
Recital 6 b (new)
Recital 6 b (new)
Amendment 13 #
2007/0214(COD)
Proposal for a regulation – amending act
Recital 14 b (new)
Recital 14 b (new)
(14b) Innovative small vehicles, under EC type-approval legislation designated as L category vehicles, are considered as early adopters of hydrogen as a fuel. This is because introducing hydrogen for these vehicles requires less effort, as the technical challenge and level of investment required is not as high as with cars. The type-approval of hydrogen L category vehicles should therefore be included in this Regulation.
Amendment 14 #
2007/0214(COD)
Proposal for a regulation – amending act
Article 3 - point 1
Article 3 - point 1
(1) "hydrogen powered vehicle" means any motor vehicle that uses pure hydrogen or a mixture of hydrogen and natural gas as fuel to propel the vehicle;
Amendment 16 #
2007/0214(COD)
Proposal for a regulation – amending act
Article 12 - paragraph 2 - point b - indent - 1 (new)
Article 12 - paragraph 2 - point b - indent - 1 (new)
- use of pure hydrogen or a mixture of hydrogen and natural gas/biomethane;
Amendment 17 #
2007/0214(COD)
Proposal for a regulation – amending act
Annex III - point c
Annex III - point c
(c) Endurance test: The purpose of the test is to provide evidence that the hydrogen components are capable of reliable operation continuously. The test consists of carrying out a specific number of test cycles for the hydrogen component under variousspecified temperature and pressure conditions. A test cycle means the normal operation (i.e. one opening and one closing) of the hydrogen component.
Amendment 227 #
2006/0136(COD)
Article 4 – paragraph 1 – subparagraph 2
The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied, including points 3.6.5 and 3.8.2 once specific scientific criteria have been adopted for these annex points in accordance with Article 78(2).
Amendment 236 #
2006/0136(COD)
Article 4 – paragraph 7 – subparagraph 1
7. By way of derogation from paragraph 1, where on the basis of documented evidence an active substance is necessary to control a serious danger to plant health, including the development of resistance, which cannot be contained by other availablppropriate means, such active substance may be approved for a time limited period not exceeding five years even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005.
Amendment 244 #
2006/0136(COD)
Article 4 – paragraph 7 – subparagraph 1 a (new)
If a Member State applies for a derogation under this paragraph the Commission shall, within two months, put forward the measures as proposed in this application to the Standing Committee for opinion and take a decision in accordance with the regulatory procedure referred to in Art. 79 (3). The derogation may in some cases be limited to only that Member State making the application.
Amendment 255 #
2006/0136(COD)
Article 30 – paragraph 1 - subparagraph 1 a (new)
If no decision concerning the active substance has been made before the provisional period of authorisation for the plant protection product has expired, the Member State may extend this authorisation upon application up to the date when a decision is made on the authorisation of the active substance.
Amendment 257 #
2006/0136(COD)
Article 30 – paragraph 2
2. In such cases the Member State may start its evaluation regarding a provisional authorisation as soon as there is evidence that the deadlines for the substance authorisation will not be met and shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the authorisation, giving at least the information provided for in Article 57 (1).
Amendment 268 #
2006/0136(COD)
Article 36 – paragraph 2
2. The Member States concerned shall grant or refuse authorisations within 180 days of receiving an application accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 31 and 32.
Amendment 270 #
2006/0136(COD)
Article 36 – paragraph 3
3. By way of derogation from paragraph 2 and subject to Community law, appropriate conditions may be imposed with respect to the requirements referred to in points (a) and (b) of Article 31(3) and other risk mitigation measures deriving from specific conditions of use. W taking into account non-comparable agricultural, plant health or environmental conditions. In very exceptional cases, where the concerns of a Member State related to human or animal health or the environmenthealth cannot be controlled by the establishment of national risk mitigation measures referred to in the first subparagraph, a Member State may as a last resort refuse authorisation of the plant protection product in its territory if, due to its very specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question poses a serious risk to human or animal health or the environmenthealth. It shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefore. The Commission shall within 90 days present a report with a conclusion concerning the decision of the Member State to refuse authorisation of the plant protection product in its territory. Member States shall provide for a possibility to challenge a decision refusing the authorisation of such product before the national courts or other instances of appeal.
Amendment 273 #
2006/0136(COD)
Article 41 – paragraph 1
1. The Member State to which an application under Article 40 is submitted shall authorise the plant protection product concerned under the same conditions as the Member State examining the application excep. Where the agricultural, plant where Article 36(3)alth or environmental conditions are non- comparable, Article 36(2) and (3) shall appliesy.
Amendment 275 #
2006/0136(COD)
Article 46
Where a Member State withdraws or amends an authorisation or does not renew it, it may grant a grace period for the disposal, storage, placing on the market and use of existing stocks. in line with Article 20(2). Where the reasons for withdrawal, amendment or not renewing the authorisation permit it, the grace period shall be limited and not exceed six monthsone year for the placing on the market and ain addition al maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. If the authorisation is withdrawn or not renewed because of immediate concerns for human or animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately.
Amendment 277 #
2006/0136(COD)
Article 50 – paragraph 2
Amendment 284 #
2006/0136(COD)
Article 52 – paragraph 10 a (new)
10a. Without prejudice to Article 63, Member State authorities shall make publicly available information about parallel trade permits..
Amendment 287 #
2006/0136(COD)
Article 58
Amendment 290 #
2006/0136(COD)
Article 59 – paragraph 1 – subparagraph 7
A study shall also be protected if it was necessary for the renewal or review of an authorisation. The period for data protection shall be 2 years and 6 months. The first to fourth subparagraphs shall apply with due changesubmitted for the renewal or review of an authorisation shall not be protected except where required for the purposes of legislative changes or updates to scientific and technical knowledge, in which case the time period of protection shall be equivalent to that set out in the fourth subparagraph.
Amendment 301 #
2006/0136(COD)
Annex II - point 3.6.3.
3.6.3. An active substance, safener or synergist shall only be approved, if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances, safener or synergist and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as carcinogen category 1 or 2, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, i.e. the product is used in closed systems or in other conditions excluding contact withmargin of safety for humans aund where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value alistic proposed conditions of all usets in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/s higher than 2005.
Amendment 304 #
2006/0136(COD)
Annex II - point 3.6.4.
3.6.4. An active substance, safener or synergist shall only be approved if, on the basis of assessment of reproductive toxicity testing carried out in accordance with the data requirements for the active substances, safeners or synergists and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as toxic for reproduction category 1 or 2, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, i.e. the product is used in closed systems or in other conditions excluding contact withmargin of safety for humans aund where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value alistic proposed conditions of all usets in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/s higher than 2005.
Amendment 308 #
2006/0136(COD)
Annex II - point 3.6.5.
3.6.5. An active substance, safener or synergist shall only be approved, if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information including a review of the scientific literature, reviewed by the Authority, it is not, on the basis of specific scientific criteria once they are adopted in accordance with Article 78(2), considered to have endocrine disrupting properties that may cause adverse effect in humans unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, i.e. the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with Article 18(1) (b) of Regulation (EC) No 396/2005.
Amendment 320 #
2006/0136(COD)
Annex II - point 3.8.2.
3.8.2. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines, it is not, on the basis of specific scientific criteria once they are adopted in accordance with Article 78(2), considered to have endocrine disrupting properties that may cause adverse effects on non-target organisms unless the exposure of non- target organisms to that active substance in a plant protection product under realistic proposed conditions of use is negligible.
Amendment 15 #
2005/0283(COD)
Proposal for a directive
Recital 11
Recital 11
(11) Clean and energy efficient vehicles initially have a higher price than conventional ones. Creating sufficient demand for such vehicles shcould ensure that economies of scale can lead to cost reductions.
Amendment 16 #
2005/0283(COD)
Proposal for a directive
Recital 13
Recital 13
(13) The biggestOne impact on the market, together with the best cost/benefit result ismay be obtained through mandatory inclusion of lifetime costs for energy consumption, CO2 emissions, and pollutant emissions as award criteria in the procurement of vehicles for public transport services.
Amendment 17 #
2005/0283(COD)
Proposal for a directive
Recital 14
Recital 14
(14) Including energy consumption, CO2 emissions, and pollutant emissions in the award criteria does not impose higher total costs but rathermay serve to anticipates lifetime costs in the procurement decision. Complementary to the Euro emissions standard legislation, which sets maximum emission limits, this approach monetises the actual pollutant emission and does not require any additional standard setting.
Amendment 21 #
2005/0283(COD)
Proposal for a directive
Recital 16
Recital 16
(16) MandatoVoluntary application of criteria for the procurement of clean and energy efficient vehicles does not preclude the inclusion of other relevant award criteria. It also does not prevent the choice of retro- fitted vehicles upgraded for higher environmental performance.
Amendment 24 #
2005/0283(COD)
Proposal for a directive
Recital 19
Recital 19
Amendment 22 #
2004/0209(COD)
Recital 6 a (new)
(6a) The likelihood of sickness in companies that require staff to work on Sundays is greater than in companies that do not require staff to work on Sundays. The health of workers depends, among other factors, on their opportunities to reconcile work and family life, to establish and maintain social ties and to pursue their spiritual needs. Sunday, as the traditional weekly rest day, contributes to these objectives more than any other day of the week.
Amendment 23 #
2004/0209(COD)
Recital 6 a (new)
(6a) The likelihood of sickness in companies that require staff to work on Sundays is greater than in companies that do not require staff to work on Sundays. The health of workers depends, among other factors, on their opportunities to reconcile work and family life, to establish and maintain social ties and to pursue their spiritual needs. Sunday, as the traditional weekly rest day, contributes to these objectives more than any other day of the week.
Amendment 30 #
2004/0209(COD)
Article 1 – point -1 (new)
Directive 2003/88/EC
Article 1 – paragraph 4 a (new)
Article 1 – paragraph 4 a (new)
(-1) In Article 1, paragraph 4a shall be added: "4a. This directive shall not apply in the following areas: combating danger and terrorism, fire brigades and airport fire brigades of , civil protection, public security and order. The Member States shall be entitled to identify the sensitive sectors, areas and sites, as well as the services and activities to be provided there, which are to be excluded from the scope of this directive. Care shall be taken in any event to ensure the greatest possible safety of and the provision of comprehensive health protection for employees."
Amendment 37 #
2004/0209(COD)
Article 1 – point 2
Directive 2003/88/EC
Article 2a – subparagraph 1
Article 2a – subparagraph 1
The inacentivre parteriod of on-call time shall not be regarded as working time unless national law or, in accordance with national law and/or practice, a collective agreement or an agreement between the social partners provides otherwise, including the inactive parts, shall in principle be regarded as working time but by collective agreement or other agreement between the two sides of industry or by means of laws or regulations, inactive parts of on-call time shall be calculated in a specific manner in order to comply with the maximum weekly average working time laid down in Article 6, subject to compliance with the general principles relating to the protection of the safety and health of workers.
Amendment 38 #
2004/0209(COD)
Article 1 – point 2
Directive 2003/88/EC
Article 2a – subparagraph 2
Article 2a – subparagraph 2
The inactive part of on-call time mayshall be calculated on the basis of an average number of hours or a proportion of on-call time, taking account of experience in the sector concerned, by collective agreement or agreement between the social partners or by national legislation following consultation of the social partners.
Amendment 39 #
2004/0209(COD)
Article 1 – point 2
Directive 2003/88/EC
Article 2a – subparagraph 3
Article 2a – subparagraph 3
The inactive part of on-call time shall not be taken into account in calculating the daily or weekly rest periods laid down in Articles 3 and 5 respectively, unless otherwise provided for: (a) in a collective agreement or an agreement between the social partners; or (b) by means of national legislation following consultation of the social partners.
Amendment 43 #
2004/0209(COD)
Article 1 – point 2
Directive 2003/88/EC
Article 2b – subparagraphs 2 and 3
Article 2b – subparagraphs 2 and 3
The Member States shall ensure, without prejudice to Directive 2002/14/EC of the European Parliament and of the Council of 11 March 2002 establishing a general framework for informing and consulting employees in the European Community and in consultation with the social partners, that: - employers inform workers in due time of any substantialwell in advance of any changes in the pattern or organisation of their working time. Taking into account workers' needs for flexibility in their working hours and patterns, the Member States shall, in accordance with national practices, also encourage employers to examine requests for changes to such working hours and patterns, subject to business needs, and to both employers' and workers' needs for flexibilitf working time, and - workers have the right to request changes to their hours and patterns of work and employers have the obligation to consider such requests fairly, having regard to the needs for flexibility of both employers and employees. An employer may refuse such a request only if the organisational disadvantages for the employer are disproportionate to the benefit to the worker. - the minimum rest period referred to in Article 5(1) of Directive 2003/88/EC shall, in principle, include Sunday.
Amendment 47 #
2004/0209(COD)
Article 1 – point 2 a (new)
Directive 2003/88/EC
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
(2a) In Article 5, paragraph 2a shall be added: "The minimum rest period referred to in the first paragraph shall in principle include Sunday."
Amendment 48 #
2004/0209(COD)
Article 1 – point 2 a (new)
Directive 2003/88/EC
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
(2a) In Article 5, paragraph 2a shall be added: "The minimum rest period referred to in the first paragraph shall in principle include Sunday."
Amendment 60 #
2004/0209(COD)
Article 1 – point 6
Directive 2003/88/EC
Article 22 – paragraph 2 – point d
Article 22 – paragraph 2 – point d
(d) no worker who has given an agreement under this Article shall, over a period of seven days, work more than: (i) 60 hours, calculated as an average over a period of three months, unless otherwise provided for in a collective agreement or an agreement between the social partners and when the inactive part of on-call time is calculated in a specific manner in accordance with Article 2a.; or (ii) 65 hours, calculated as an average over a period of three months, in the absence of a collective agreement and when the inactive parts of on-call time is regarded as working time in accordance with Art. 2a without using the possibility of calculating it in a specific manner;