Activities of Horst SCHNELLHARDT
Plenary speeches (119)
Food hygiene
Vote
Vote
Gaseous and particulate emissions from non-road mobile machinery
Genetically modified organisms
Food safety
Official controls on animal products intended for human consumption
Consumer Policy Strategy 2002-2006
Vote
Foods and food ingredients treated with ionising radiation
Traditional herbal medicinal products
Medicinal products
Floods in Europe
Indication of ingredients present in foodstuffs
Foodstuffs
European Food Authority
Recreational craft
European Food Authority
Animal welfare
Environmental impact of certain plans and programmes
Environmental issues of PVC
Progress of EU and Member State measures to combat BSE
Environment directives
General product safety
BSE and general ban on animal meal in feedingstuffs
Food safety
Beef and beef products
EMAS (Eco-Management and Audit Scheme)
Substances that deplete the ozone layer
Cocoa and chocolate products
Eco-label
Environmental legislation
Vote
Emission of gaseous and particulate pollutants by vehicles
Information on fuel economy in new cars
Flu epidemic (debate)
Animal by-products (debate)
Animal by-products (debate)
Animal by-products (A6-0087/2009, Horst Schnellhardt)
Cosmetic products (recast version) (debate)
Promotion of clean road transport vehicles (debate)
White Paper on Nutrition, Overweight and Obesity-related health issues (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)
Revision of the framework directive on waste (debate)
Hygiene of foodstuffs (debate)
Hygiene of foodstuffs (debate)
Rising food prices in the European Union and developing countries (debate)
Protection of soil - Thematic Strategy for Soil Protection (debate)
Common authorisation procedure for food additives – Food additives – Food enzymes – Flavourings and food ingredients with flavouring properties for use in and on foods (debate)
Definition, description, presentation and labelling of spirit drinks (debate)
Waste - Waste recycling (debate)
Prevention of injury and promotion of safety (debate)
Application of the Aarhus Convention to the EC institutions and bodies (debate)
Rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (debate)
Nutrition and health claims made on foods Addition of vitamins and minerals and of certain other substances to foods (debate)
Application of the Århus Convention to EC institutions and bodies
Humane trapping standards
Waste shipments
Fluorinated greenhouse gases – Emissions from motor vehicle air-conditioning systems
Phthalates in toys and childcare articles
Nutrition and health claims in labelling
Environment and Health Action Plan 2004-2010
Food and feed law, rules on animal health and welfare, plant health, plant reproductive material and plant protection products - Animal health - Protective measures against pests of plants (debate)
Food and feed law, rules on animal health and welfare, plant health, plant reproductive material and plant protection products - Animal health - Protective measures against pests of plants (debate)
Third programme for the Union's action if the field of health (2014-2020) (debate)
Consumer programme 2014-2020 (debate)
Consumer programme 2014-2020 (debate)
Food crisis, fraud in the food chain and the control thereof (A7-0434/2013 - Esther de Lange)
Honey (debate)
Civil protection mechanism (debate)
Food and products of animal origin (debate)
Recent floods in Europe (debate)
Millennium development goals (debate)
Non-commercial movement of pet animals - Animal health requirements governing trade in dogs, cats and ferrets (debate)
Non-commercial movement of pet animals - Animal health requirements governing trade in dogs, cats and ferrets (debate)
Non-commercial movement of pet animals (A7-0371/2012 - Horst Schnellhardt) (vote)
Explanations of vote
Explanations of vote
Environmental impacts of shale gas and shale oil extraction activities - Industrial, energy and other aspects of shale gas and oil (debate)
Electronic identification of bovine animals (debate)
Implementation of EU water legislation (debate)
Explanations of vote
Explanations of vote
Roaming on public mobile communications networks within the Union (debate)
Review of the 6th Environment Action Programme and the setting of priorities for the 7th Environment Action Programme (debate)
Schmallenberg outbreak (debate)
Explanations of vote
Explanations of vote
Explanations of vote
Placing on the market and use of biocidal products (debate)
Fruit juices and certain similar products intended for human consumption (debate)
Fruit juices and certain similar products intended for human consumption (debate)
Fruit juices and certain similar products intended for human consumption (debate)
Public health threat of antimicrobial resistance (debate)
European disaster response: role of civil protection and humanitarian assistance (debate)
Explanations of vote
Legislation on Transmissible Spongiform Encephalopathies (TSE) and on related feed and food controls (debate)
Explanations of vote
Explanations of vote
European environmental economic accounts (debate)
Statement by the President of the European Parliament’s delegation to the Conciliation Committee - Novel foods (continuation of debate)
Vaccination against bluetongue (debate)
Implementation of the Fuel Quality Directive (debate)
Falsified medicinal products (debate)
Patients’ rights in cross-border healthcare (debate)
Waste crisis in Campania (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)
Sludge catastrophe in Hungary (debate)
Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)
Placing on the market and use of biocidal products (debate)
Products from cloned animals in the food chain (debate)
Guidelines for the employment policies of the Member States (debate)
Novel foods (debate)
Explanations of vote
Standards of quality and safety of human organs intended for transplantation - Action plan on organ donation and transplantation (2009-2015) (debate)
Animal health requirements applicable to the non-commercial movement of pet animals (debate)
Experience gained in applying the food hygiene regulations of the European Parliament and of the Council (debate)
European Microfinance Facility for Employment and Social Inclusion (Progress) (debate)
Reports (17)
Report on the proposal for a European Parliament and Council Directive amending Directive 79/112/EEC on the approximation of the laws of th Member States relating to the labelling, presentation and advertising of foodstuffs Committee on the Environment, Public Health and Consumer Protection PDF (55 KB)
Report on the joint text approved by the Conciliation Committee for a directive amending Directive 79/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs Parliament - Delegation to the Conciliation Committee
Report on the proposal for a Council Directive amending Directive 90/539/EEC on animal health conditions governing intra-Community trade in and imports from third countries of poultry and hatching eggs (COM(95)0535 - C4-0027/96 - 95/0268(CNS)); and on a Council Directive amending Directive 91/494/EEC on animal health conditions governing intra-Community trade in, and imports from, third countries of fresh poultry meat (COM(95)0535 - C4-0028/96 95/0269(CNS)) - Committee on the Environment, Public Health and Consumer Protection
Recommendation for second reading on the common position adopted by the Council with a view to adopting a European Parliament and Council regulation laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption - Committee on the Environment, Public Health and Consumer Policy PDF (285 KB) DOC (110 KB)
PDF (150 KB) DOC (91 KB)
Recommendation for second reading on the common position adopted by the Council with a view to adopting a European Parliament and Council directive repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EE and 92/118/EEC and Council Decision 95/408/EC - Committee on the Environment, Public Health and Consumer Policy PDF (125 KB) DOC (39 KB)
Recommendation for second reading on the common position adopted by the Council with a view to adopting a European Parliament and Council regulation laying down specific hygiene rules for food of animal origin - Committee on the Environment, Public Health and Consumer Policy PDF (155 KB) DOC (91 KB)
Report on the proposal for a European Parliament and Council regulation laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption - Committee on the Environment, Public Health and Consumer Policy PDF (370 KB) DOC (299 KB)
Report on the proposal for a European Parliament and Council directive repealing certain Directives on the hygiene of foodstuffs and the health conditions for the production and placing on the market of certain products of animal origin intended fo human consumption, and amending Directives 89/662/EEC and 91/67/EEC - Committee on the Environment, Public Health and Consumer Policy PDF (227 KB) DOC (111 KB)
Report on the proposal for a European Parliament and Council regulation laying down specific hygiene rules for food of animal origin - Committee on the Environment, Public Health and Consumer Policy PDF (348 KB) DOC (297 KB)
Report on the proposal for a European Parliament and Council regulation on the hygiene of foodstuffs - Committee on the Environment, Public Health and Consumer Policy PDF (323 KB) DOC (260 KB)
PDF (36 KB) DOC (123 KB)
REPORT on the proposal for a regulation of the European Parliament and of the Council laying down health rules as regards animal by-products not intended for human consumption (Animal by-products Regulation) PDF (543 KB) DOC (874 KB)
REPORT Proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 852/2004 of the European Parliament and the Council on the hygiene of foodstuffs PDF (190 KB) DOC (196 KB)
REPORT on the proposal for a regulation of the European Parliament and of the Council on the definition, description, presentation and labelling of spirit drinks PDF (865 KB) DOC (1 MB)
REPORT on the proposal for a Regulation of the European Parliament and of the Council on the non-commercial movement of pet animals PDF (423 KB) DOC (763 KB)
REPORT on the proposal for a directive of the European Parliament and of the Council amending Council Directive 92/65/EEC as regards the animal health requirements governing intra-Union trade in and imports into the Union of dogs, cats and ferrets PDF (128 KB) DOC (70 KB)
Shadow reports (3)
REPORT on the proposal for a regulation of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official Controls Regulation) PDF (1 MB) DOC (1 MB)
REPORT on GDP and beyond – Measuring progress in a changing world PDF (251 KB) DOC (174 KB)
REPORT Report on the proposal for a decision of the European Parliament and of the Council repealing Council Decision 79/542/EEC drawing up a list of third countries or parts of third countries, and laying down animal and public health and veterinary certification conditions, for importation into the Community of certain live animals and their fresh meat PDF (149 KB) DOC (77 KB)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005, Directive 2009/128/EC and Regulation (EC) No 1107/2009 and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC
Amendments (723)
Amendment 20 #
2013/2091(INI)
Motion for a resolution
Recital F
Recital F
F. whereas recent fraud cases include, for example, the marketing of ordinary flour as organic flour, of battery cage eggs as organic eggs, of road salt as food salt and of horsemeat as beef, and the use of methanol- contaminated alcohol in spirits; Or. de (Clarification that this list merely provides examples and is not exhaustive.)
Amendment 124 #
2013/2091(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Is convinced that a change of attitude is needed within the competent authorities, moving from an administrative and veterinary approach towards a policing approach, based on the experience of the Danish Food Administration’s ‘flying squad’ and of the Arma dei Carabinieri and the Guardia di Finanza in Italy; (In stresses that such an approactice it is often difficult to deal correctly with violations of food law because the competenth depends on designated courts being staffed by judges lackwith expertise in this area of law and their assessment of the facts is therefore inadequate. Ideally, designated courts would have special competence to deal withfood law; Or. de this area of law.)
Amendment 125 #
2013/2091(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Stresses that enforcementthe carrying-out of controls should be risk-based and include the development of risk profiles and vulnerability assessments for each supply chain and food product, drawing on ongoing academic studies which combine knowledge in the areas of food authenticity and criminology, including research by VU University Amsterdam and the University of Wageningen; Or. de (Clarification)
Amendment 127 #
2013/2091(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Recommends that the FVO and national authoritiescompetent authorities on the spot include in their audits so-called mass balance checks on input and output flows; (The FVO carries out audits on the controls; mass balance checks cannot be carried out in this framework and should not be the task of the FVO. These checks would have to be carriedOr. de out by the competent authorities on the spot.)
Amendment 41 #
2013/0371(COD)
Proposal for a directive
Recital 3
Recital 3
(3) PLightweight plastic carrier bags with a thickness below 50 microns, which represent the vast majority of the total number of plastic carrier bags consumed in the Union, are less frequently re-used than thicker plastic carrier bags and more prone to littering.
Amendment 54 #
2013/0371(COD)
Proposal for a directive
Recital 4 a (new)
Recital 4 a (new)
(4a) The data available concerning the use of plastic carrier bags in the EU clearly show that consumption is low or has been reduced in those Member States where food retailers make plastic carrier bags available not free of charge, but instead against a small payment.
Amendment 57 #
2013/0371(COD)
Proposal for a directive
Recital 5
Recital 5
(5) To promote similar reductions of the average consumption level of lightweight plastic carrier bags, Member States should take measures to reduce the consumption of plastic carrier bags with a thickness below 250 microns in line with the overall objectives of the Union’s waste policy and the Union's waste hierarchy as provided for in Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives. Such reduction measures should take account of current consumption levels of plastic carrier bags in individual Member States, with higher levels requiring more ambitious efforts. To monitor progress in reducing the use of lightweight plastic carrier bags national authorities will provide data on their use under article 17 of Directive 94/62/EC.
Amendment 65 #
2013/0371(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Measures to be taken by Member States may involve the use of economic instruments such as taxes and levies, which have proved particularly effective to reduce the use of plastic carrier bags, as well as marketing restrictions such as bans in derogation of Article 18 of Directive 94/62/EC, subject to the requirements laid down in Articles 34 to 36 of the Treaty on the Functioning of the European Union.
Amendment 86 #
2013/0371(COD)
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8a) In order not to impede the functioning of the internal market, the same conditions should apply throughout the EU in respect of the materials used. Differences in the way certain materials are dealt with in certain Member States are detrimental to recycling and trade.
Amendment 91 #
2013/0371(COD)
Proposal for a directive
Article – point 1
Article – point 1
Directive 94/62/EC
Article 3 – point 2 a
Article 3 – point 2 a
"lightweight plastic carrier bags" shall mean bags made of plastic materials as defined in Article 3(1) of Commission Regulation (EU) No 10/2011* with a wall thickness below 250 microns and which are supplied to consumers at the till in the point of sale of goods or products.
Amendment 119 #
2013/0371(COD)
Proposal for a directive
Article 1 – point 2
Article 1 – point 2
These measures may include the use of national reduction targets, and economic instruments as well as marketing restrictions in derogation from Article 18 of this Directive.
Amendment 1 #
2013/0169(COD)
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
1a. Grants may also be awarded up to the maximum rates set out in Article 6 (1),(2) and (3) for any measures taken on the basis of a suspected and afterwards confirmed outbreak of one of the animal diseases listed pursuant to Article 8;
Amendment 2 #
2013/0169(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) costs of compensation to owners for the value of their animals slaughtered or culled, within the limit of the normal market value of the animals immediately before they were slaughtered or culledany suspicion or confirmation of the disease;
Amendment 3 #
2013/0169(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point b
Article 9 – paragraph 1 – point b
(b) costs of compensation to owners for the value of their destroyed products of animal origin, within the limit of the normal market value of those products immediately before their destructionany suspicion or confirmation of the disease;
Amendment 4 #
2013/0169(COD)
Proposal for a regulation
Article 12 – point c
Article 12 – point c
(c) costs of compensation to owners for the value of their animals slaughtered or culled in the framework of the national programme, within the limit of the normal market value of those animals immediately before they were slaughtered or culledany suspicion or confirmation of the disease;
Amendment 5 #
2013/0169(COD)
Proposal for a regulation
Article 12 – point d
Article 12 – point d
Amendment 6 #
2013/0169(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. Annual national programmes and associated funding shall be approved by 31 January each year0 November or, in case the EU-budget is not approved, at the latest by the 31 December preceding the year in which the programmes begin, by means of a grant decision in relation to the measures implemented and the costs incurred from 1 January to 31 December of thate eligible year. Following submission of the intermediate reports as referred to in Article 15, the Commission may amend such decisions if necessary in relation to the whole eligibility period.
Amendment 7 #
2013/0169(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Multiannual national programmes and associated funding shall be approved by 31 January of the first year of implementation0 November or, in case the EU- budget is not approved, at the latest by the 31 December preceding the year in which the programmes begin, by means of a grant decision in relation to the measures implemented and the costs incurred from 1 January of the first year of implementation until the end of the implementation period.
Amendment 8 #
2013/0169(COD)
Proposal for a regulation
Article 19 – point c a (new)
Article 19 – point c a (new)
(ca) Cost of compensation to the operators for the value of the plants, plant products and other objects destroyed following measures for the eradication or containment of the pest or any other urgency measures taken, within the limit of the normal market value of the plants or plant products immediately before any suspicion or official confirmation of the outbreak of the pest;
Amendment 9 #
2013/0169(COD)
Proposal for a regulation
Article 23 – paragraph 2
Article 23 – paragraph 2
2. Annual survey programmes and associated funding shall be approved by 31 January each year0 November or, in case the EU- budget is not approved, at the latest by the 31 December of the year preceding the commencement of the program and subsequently by means of a grant decision in relation to the measures implemented and the costs incurred from 1 January to 31 December of thate programming year. Following submission of the intermediate reports as referred to in Article 15, the Commission may amend such decisions iof necessary in relation to the whole eligibility period.
Amendment 10 #
2013/0169(COD)
Proposal for a regulation
Article 23 – paragraph 3
Article 23 – paragraph 3
3. Multiannual survey programmes and associated funding shall be approved by 31 January of the first year of implementation0 November or, in case the EU- budget is not approved, at the latest by the 31 December of the year preceding the commencement of the program and subsequently by means of a grant decision in relation to the measures implemented and the costs incurred from 1 January of the first year of implementation until the end of the implementation period.
Amendment 11 #
2013/0169(COD)
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
2. Annual programmes for the outermost regions and associated funding shall be approved by 31 January each year0 November or, in case the EU- budget is not approved, at the latest by the 31 December of the year preceding the commencement of the program and subsequently by means of a grant decision in relation to the measures implemented and the costs incurred from 1 January to 31 December of thate programming year. Following submission of the intermediate reports as referred to in Article 15, the Commission may amend such decisions if necessary in relation to the whole eligibility period.
Amendment 12 #
2013/0169(COD)
Proposal for a regulation
Article 27 – paragraph 3
Article 27 – paragraph 3
3. Multiannual programmes for the outermost regions and associated funding shall be approved by 31 January of the first year of implementation0 November or, in case the EU- budget is not approved, at the latest by the 31 December of the year preceding the commencement of the program and subsequently by means of a grant decision in relation to the measures implemented and the costs incurred from 1 January of the first year of implementation until the end of the implementation period.
Amendment 70 #
2013/0169(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) costs of compensation to owners for the value of their animals slaughtered or culled, within the limit of the market value of the animals immediately before they were slaughtered or cull disease was notified;
Amendment 73 #
2013/0169(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point b
Article 9 – paragraph 1 – point b
(b) costs of compensation to owners for the value of their destroyed products of animal origin, within the limit of the market value of those products immediately before their destruction disease was notified;
Amendment 77 #
2013/0169(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
(e) cost of purchase and administration of vaccines if those are decided or authorised by the Commission; and, in exceptional, duly substantiated cases, cost of losses incurred as a result of using these vaccines.
Amendment 81 #
2013/0169(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Grants may be awarded to Member States' annual or multiannual national programmes for the implementation of the eradication, control and surveillance of the animal diseases and zoonoses listed pursuant to Article 11 (hereinafter "national programmes").
Amendment 83 #
2013/0169(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
(c) costs of compensation to owners for the value of their animals slaughtered or culled in the framework of the national programme, within the limit of the market value of the animals immediately before they were slaughtered or cull disease was notified;
Amendment 85 #
2013/0169(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point d
Article 12 – paragraph 1 – point d
(d) costs of compensation to owners for the value of their destroyed products of animal origin, within the limit of the market value of those products immediately before their destruction disease was notified;
Amendment 86 #
2013/0169(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point f
Article 12 – paragraph 1 – point f
(f) costs of inoculation of vaccine doses to domestic animals in the event of an epidemic outbreak of a disease;
Amendment 87 #
2013/0169(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. Annual national programmes and associated funding shall be approved by 31 January eachfour weeks after the adoption of the EU budget for the coming year by means of a grant decision in relation to the measures implemented and the costs incurred from 1 January to 31 December of that year. Following submission of the intermediate reports as referred to in Article 15, the Commission may amend such decisions if necessary in relation to the whole eligibility period.
Amendment 101 #
2013/0169(COD)
Proposal for a regulation
Article 19 – paragraph 1 – point d a (new)
Article 19 – paragraph 1 – point d a (new)
(da) costs of compensation to owners for the value of their destroyed plants and plant products, within the limit of the market value of those products immediately before the disease was notified;
Amendment 110 #
2013/0169(COD)
Proposal for a regulation
Article 34 – paragraph 3
Article 34 – paragraph 3
3. A Union financial contribution may also be granted to support information and awareness raising initiatives by the EU and the Member States aimed at ensuring improved, compliant and sustainable behaviour in the implementation of the rules referred to in Article 1.
Amendment 112 #
2013/0169(COD)
Proposal for a regulation
Article 41 – paragraph 1
Article 41 – paragraph 1
1. Where appropriate, bBeneficiaries and Member States concerned shall ensure that suitable publicity is given to financial contributions granted under this Regulation in order to inform the public of the role of the Union in the funding of the measures.
Amendment 113 #
2013/0169(COD)
Proposal for a regulation
Article 41 – paragraph 2
Article 41 – paragraph 2
2. The Commission shall implement information and communication actions on the measures funded and results. Moreover, budget allocated to communication under this Regulation shall also cover corporate communication on the political priorities of the Union.
Amendment 59 #
2013/0140(COD)
Proposal for a regulation
Title
Title
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health, plant reproductive material, plant protection products and amending Regulations (EC) No 999/2001, 1829/2003, 1831/2003, 1/2005, 396/2005, 834/2007, 1099/2009, 1069/2009, 1107/2009, Regulations (EU) No 1151/2012, [….]/2013 [Office of Publications, please insert number of Regulation laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material], and Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC, 2008/120/EC and 2009/128/EC (Official controls Regulation) (Text with EEA relevance)
Amendment 61 #
2013/0140(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The Treaty requires a high level of human health protection to be ensured in the definition and implementation of all Union policies and activities. The achievement of that objective should, inter alia, be pursued via measures in the veterinary and phytosanitary fields which have as their direct objective the protection of human health.
Amendment 62 #
2013/0140(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Union legislation provides for a set of harmonised rules to ensure that food and feed are safe and wholesome and that activities which might have an impact on the safety of the food chain or on the protection of consumers interests in relation to food and food information are performed in accordance with specific requirements. Union rules exist also to ensure a high level of human, and animal and plant health and animal welfare along the food chain and in all those areas of activity where a key objective is the fight against the possible spread of animal diseases, in some cases transmissible to humans, or of pests injurious to plants or plant products, and to ensure the protection of the environment from risks that might arise from GMOs and plant protection products. Union rules also guarantee the identity and quality of plant reproductive material. The correct application of those rules, hereinafter collectively referred to as 'Union agri-food chain legislation', contributes to the functioning of the internal market.
Amendment 63 #
2013/0140(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The basic Union rules with regard to food and feed law are laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and setting out procedures in matters of food safety10. In addition to those rules, more specific food and feed law covers different areas such as animal nutrition, including medicated feedingstuffs, food and feed hygiene, zoonoses, animal by-products, residues of veterinary medicinal products, contaminants, control and eradication of animal diseases with a human health impact, food and feed labelling, plant protection products, food and feed additives, vitamins, mineral salts, trace elements and other additives, food contact materials, quality and compositional requirements, drinking water, ionisation, and novel foods and genetically modified organisms (GMOs). __________________ 10 OJ L 31, 01.02.02, p. 1.
Amendment 64 #
2013/0140(COD)
Proposal for a regulation
Recital 7
Recital 7
Amendment 66 #
2013/0140(COD)
Proposal for a regulation
Recital 8
Recital 8
Amendment 68 #
2013/0140(COD)
Proposal for a regulation
Recital 14
Recital 14
Amendment 70 #
2013/0140(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) In order to rationalise and simplify the overall legislative framework, whilst simultaneously pursuing the objective of better regulation, the rules applicable to official controls in specific areas should be integrated into a single legislative framework for official controlshould be more closely integrated, provided that they pursue the same objective with regard to control activities. For that purpose, Regulation (EC) No 882/2004 and other acts currently governing official controls in specific areas should be repealed and replaced by this Regulation.
Amendment 71 #
2013/0140(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Union agri-food chain legislation entrusts the competent authorities of the Member States with specialised tasks to be carried out for the protection of animal health, plant health and animal welfare, for the protection of the environment in relation to GMOs and plant protection products, and in order to ensure the identity and a high quality of plant reproductive material. Those tasks are the public interest activities which the competent authorities of the Member States must carry out for the purpose of eliminating, containing or reducing risks which may arise for human, or animal or plant health, or animal welfare, or for the environment. Those activities, which include product approval, surveying, surveillance and monitoring including for epidemiologic purposes, and the eradication and containment of diseases, and other disease control tasks, are governed by the same sectoral rules which are enforced through the official controls.
Amendment 78 #
2013/0140(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) The competent authorities should ensure that, with the exception of internal reporting obligations, staff responsible for official controls does not disclose information acquired during the performance of such controls which is covered by professional secrecy. UnlessWhere there is an overriding interest justifying disclosure, professional secrecy should include information which would undermine the purpose of inspections, investigations or audits, the protection of commercial interests and the protection of court proceedings and legal advice. However, professional suspicion of risk to human or animal health or of other serious breaches of food law, the competent authorities should take suitable steps to inform the public. The measures taken should be in proportion to the scale of the infringement, in particular when naming specrecy should not prevent competent authorities from disclosing fific products or operators concerned. Factual information on the outcome of an official controls regarding individual operators may be divulged when the operator concerned has been allowed to comment upon it prior to the disclosure and such comments have been taken into account, or and released alongside and at the same time as the information being divulged by the competent authorities. The need to respect professional secrecy is also without prejudice to the obligation to inform the general public where there are reasonable grounds to suspect that food or feed may present a risk for health in accordance with Article 10 of Regulation (EC) No 178/2002. The obligation for competent authorities to inform the general public in cases where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health, in accordance with Article 10 of Regulation (EC) No 178/2002, and the right of individuals to the protection of their personal data as provided for in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data16 should not be affected by this Regulation. __________________ 16 OJ L 281, 23.11.95, p. 31. OJ L 281, 23.11.95, p. 31.
Amendment 79 #
2013/0140(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) To preserve the effectiveness of official controls in the verification of compliance, no warning should be given of the timing of the controls prior to performing controls, unless the nature of the official control activities requires otherwise (as is notably the case of audit activities).
Amendment 81 #
2013/0140(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) To facilitate the identification of non- compliances and streamline the taking of corrective action by the operator concerned, the outcome of official controls which identify non-compliances with the rules should be recorded in a report, a. A copy of whichthat report should also be given to the operator. Where official controls require the continuous or regular presence of the staff of the competent authorities to monitor the operator's activities, a report of each individual inspection or visit to the operator would be disproportionate. In such cases reports should be prepared with a frequency that enables the competent authorities and the operator to be regularly informed of the level of compliance and immediately notified of any identified shortcomings. In the interests of reducing the administrative burden, it should also be sufficient to record the outcome of official controls at border control posts in the Common Health Entry Document.
Amendment 82 #
2013/0140(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) This Regulation establishes a single legislative framework for the organisation of official controls to verify compliance with agri-food chain rules in all the areas that such rules cover. In some of those areas, Union legislation lays down detailed requirements to be complied with which require special skills and specific means for the performance of official controls. To avoid diverging enforcement practices which could generate uneven protection of human, and animal and plant health, and animal welfare and, as regards GMOs and plant protection products, of the environment, disrupt the functioning of the internal market for animals and goods falling within the scope of this Regulation and distort competition, the Commission should be able to supplement the rules laid down in this Regulation through the adoption of specific official control rules capable of catering for the needs of controls of those areas. In particular, such rules should lay down specific requirements for the performance of official controls and minimum frequencies for such controls, specific or additional measures to those provided for in this Regulation that competent authorities should take in relation to non-compliances, specific responsibilities and tasks of the competent authorities in addition to those provided for in this Regulation and specific criteria for triggering the administrative assistance mechanisms provided for in this Regulation. In other cases, such additional rules might become necessary in order to provide a more detailed framework for the performance of official controls in relation to food and feed, where new information emerges about risks to human or animal health or, in relation to GMOs and plant protection products to the environment, indicating that in the absence of common specifications for the performance of official controls across the Member States, the controls would fail to deliver the expected level of protection against those risks, as provided for by Union agri-food chain legislation. (This amendment applies throughout.)
Amendment 84 #
2013/0140(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) To ensure the reliability and consistency of official controls and other official activities across the Union, the methods used for sampling and for laboratory analyses, tests and diagnoses should meet state-of-the-art scientific standards, satisfy the specific analytical, testing and diagnostic need of the laboratory concerned, and offer sound and reliable analytical, test and diagnostic results. Clear rules should be established for the choice of the method to be used where more than one is available from different sources, such as the International Organisation for Standardisation (ISO), the European and Mediterranean Plant Protection Organisation (EPPO), the International Plant Protection Convention (IPPC), the World Organisation for Animal Health (OIE), European Union and national reference laboratories, or national rules.
Amendment 85 #
2013/0140(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) Operators whose animals or goods are subject to sampling, analysis, test or diagnosis in the context of official controls should have the right to apply for a second expert opinion which should include the taking of a second sample for the purposes of counter-analysis, counter-test or counter-diagnosis unless any such second sampling is technically impossible or irrelevant. Such would be the case, in particular, where the prevalence of the hazard is particularly low in the animal or good or its distribution particularly sparse or irregular. The IPPC for that reason rejects the use of counter-samples for assessing the presence of quarantine organisms in plants or plant products.
Amendment 86 #
2013/0140(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) In order to ensure flexibility and proportionality of approach, in particular for animal health or plant health laboratories, provision should be made for the adoption of derogations aimed at allowing certain laboratories not to be accredited for all the methods they use. Moreover, accreditation of a laboratory for all the methods it should use as official laboratory might not be immediately available in certain cases where new or recently modified methods should be used, and in cases of emerging risks or in emergency situations. Under certain conditions, official laboratories should therefore be allowed to carry out analyses, tests and diagnoses for the competent authorities before they obtain the relevant accreditation.
Amendment 87 #
2013/0140(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) Given the risks to human, or animal or plant health, or animal welfare or to the environment that certain animals or goods may pose, they should be subject to specific official controls to be performed upon them at their entry into the Union. Current Union rules require the performance of official controls at Union borders to verify that human health, animal health and animal welfare standards applicable to animals, products of animal origin, germinal products and animal by- products are met and that plants and plant products comply with phytosanitary requirements. Increased controls at entry into the Union are also performed on certain other goods where emerging or known risks so warrant. The specificities of such controls, currently governed by the provisions of Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries18, Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC19, Council Directive 2000/29 and Commission Regulation (EC) No 669/2009 implementing Regulation (EC) No 882/2004 of the European Parliament and the Council as regards the increased level of official controls on imports of certain food and feed of non-animal origin and amending Decision 2006/504/EC20, should be provided for in this Regulation. __________________ 18 19 20OJ L 24, 30.1.1998, p. 9. OJ L 24, 30.01.98, p. 9. 19 OJ L 268, 24.9.1991, p. 56. OJ L 268, 24.09.91, p. 56. 20 OJ L 194, 25.7.2009, p. 11. OJ L 194, 25.07.09, p. 11.
Amendment 89 #
2013/0140(COD)
Proposal for a regulation
Recital 54
Recital 54
(54) Member States should be required to ensure that adequate financial resources are always available in order to appropriately staff and equip the competent authorities performing official controls and other official activities. Although operators are primarily responsible for ensuring that their activities are carried out in compliance with Union agri-food chain rules, the system of own controls that they put in place for that purpose needs to be complemented by a dedicated system of official controls maintained by each Member State to ensure effective market surveillance along the agri-food chain. Such a system is, by its very nature, complex and resource demanding and should be provided with a stable influx of resources for official controls, at a level appropriate to the enforcement needs at any given moment. To reduce the dependency of the official control system from public finances, competent authorities should collect feebe able to collect fees or contributions to costs to cover the costs they incur when performing official controls on certain operators and for certain activities for which Union agri-food chain legislation requires registration or approval in accordance with Union rules on the hygiene of food and feed or rules governing plant health and plant reproductive material. Fee. Fees or contributions to costs should also be collected from operators to compensate the costs of official controls performed in view of issuing an official certificate or attestation, and costs of official controls performed by the competent authorities at border control posts.
Amendment 90 #
2013/0140(COD)
Proposal for a regulation
Recital 55
Recital 55
(55) Fees or contributions to costs should cover, but not exceed, the costs incurred by the competent authorities to perform official controls. Such costs should be calculated on the basis of each individual official control or on the basis of allthe official controls performed over a given period of time. Where fees are applied on the basis of the actual cost of individual official controls, oOperators with a good record of compliance should bear lower overall charges than non-compliant ones, as they should be subject to less frequent official controls. In order to promote compliance with Union legislation by all operators irrespective of the method (based on actual costs or on a flat rate) that each Member States will chose for the calculation of the fees, when these are calculated on the basis offinancing method chosen by each Member State, it should be possible for fees or contributions to costs to be calculated so as to reward ovperall costs incurred by the competent authorities over a given period of time, and charged on all operators irrespective of whether they are subject to an official control during the reference period, those fees should be calculated so as to reward operators with a consistent good record of compliance with Union food chain legisltors with a consistent good record of compliance with Union food chain legislation. When setting the fees or contributions to costs, Member States should take account of the particular situation of the operator concerned in relation to risk factors, turnover, production and processing methods and geographical location.
Amendment 98 #
2013/0140(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) For the performance of official controls and other official activities on the production and marketing of plant reproductive material, and in the field of animal welfare, the competent authorities should have access to updated, reliable and consistent technical data, to research findings, new techniques and expertise necessary for the correct application of Union legislation applicable in those areas. For that purpose the Commission should be able to designate, and rely on the expert assistance of, European Union reference centres for plant reproductive material and for animal welfare.
Amendment 102 #
2013/0140(COD)
Proposal for a regulation
Recital 68
Recital 68
(68) Animals and goods from third countries should comply with the same requirements which apply to Union animals and goods, or with requirements which are recognised to be at least equivalent in relation to the objectives pursued by Union agri-food chain rules. This principle is enshrined in Article 11 of Regulation (EC) No 178/2002, which requires that food and feed imported into the Union must comply with the relevant requirements of the Union's food law or with requirements considered to be at least equivalent thereto. Specific requirements to apply that principle are provided for in Union rules on protective measures against pests of plants, which prohibit the introduction into the Union of certain pests which are not present (or only present to a limited extent) in the Union, in Union rules laying down animal health requirements, which allow the entry of animals and of certain products of animal origin into the Union only from third countries which are included in a list set up for that purpose, and in Union rules for the organisation of official controls on products of animal origin intended for human consumption, which also provide for the establishment of a list of third countries from which those products can enter the Union. Concerning plant reproductive material, an equivalence system is in place whereby third countries from which plant reproductive material can be imported are authorised and listed.
Amendment 103 #
2013/0140(COD)
Proposal for a regulation
Recital 69
Recital 69
(69) In order to ensure that animals and goods entering the Union from third countries comply with all the requirements laid down in Union agri-food chain legislation or with requirements considered equivalent, in addition to the requirements established by Union rules on protective measures against pests of plants, Union rules laying down animal health requirements, and Union rules laying down specific hygiene rules for food of animal origin to ensure that the requirements laid down in Union agri-food legislation in relation to phytosanitary and veterinary concerns are met, the Commission should be allowed to establish conditions for the entry of animals and goods into the Union to the extent necessary to ensure that those animals and goods comply with all relevant requirements of Union agri-food chain legislation or equivalent requirements. Such conditions should apply to animals or goods or categories of animals or goods from all third countries or from certain third countries or regions thereof.
Amendment 104 #
2013/0140(COD)
Proposal for a regulation
Recital 73
Recital 73
(73) It is important for the performance of effective official controls and other official activities that the competent authorities in the Member States, the Commission and, where relevant, operators be able to exchange data and information related to official controls or results therefrom rapidly and efficiently. Several information systems are established by Union legislation and managed by the Commission to allow such data and information to be handled and managed through Union wide computerised and internet-based tools. A system dedicated to recording and tracing official control results is the Trade Control and Expert System (TRACES system), ), established by Commission Decision 2003/24/EC of 30 December 2002 concerning the development of an integrated computerised veterinary system21 and currently used for the management of data and information on animals and products of animal origin and official controls thereon. That system should be upgraded so as to allow its use for all goods for which Union agri-food chain legislation establishes specific requirements or official control modalities. Dedicated computerised systems also exist for the rapid exchange of information between Member States and with the Commission on risks which might arise in the food chain or for animal and plant health. Article 50 of Regulation (EC) No 178/2002 establishes the RASFF, and Article 20 of Regulation (EU) XXX/XXXX [Office of Publications, please insert number, date, title and, in a footnote, the OJ reference for the Regulation on animal health] a system for the notification and reporting on the measures on listed diseases, and Article 97 of Regulation (EU) XXX/XXXX [Office of Publications, please insert number, date, title and, in a footnote, the OJ reference for the Regulation on protective measures against pests of plants] a system for the notification and reporting of the presence of pests and the notification of non- compliances. All such systems should work in a harmonious, consistent manner that makes use of synergies between the different systems, avoids duplications, simplifies their operation and makes them more efficient. __________________ 21 OJ L 8, 14.01.03, p. 44.
Amendment 108 #
2013/0140(COD)
Proposal for a regulation
Recital 77 a (new)
Recital 77 a (new)
(77a) Account should be taken of the specific needs of the developing countries, in particular the least developed countries, who should be given support in organising their official controls so that they can meet the criteria for the import of animals and goods into the EU.
Amendment 109 #
2013/0140(COD)
Proposal for a regulation
Recital 78
Recital 78
(78) This Regulation covers areas that are already covered in certain acts currently in force. To avoid duplications and to establish a coherent legislative framework, the following acts should be repealed and replaced by the rules of this Regulation: Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters23; Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market24; Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra- Community trade in certain live animals and products with a view to the completion of the internal market25; Council Directive 91/496/EEC; Council Decision 92/438/EEC of 13 July 1992 on computerization of veterinary import procedures (Shift project), amending Directives 90/675/EEC, 91/496/EEC, 91/628/EEC and Decision 90/424/EEC, and repealing Decision 88/192/EEC26; Council Directive 96/23/EC; Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products27; Council Directive 97/78/EC; Regulation (EC) No 882/2004; and Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption28. __________________ 23 24 25 26 27 28. __________________ 23 OJ L 351, 21.12.1989, p. 34. O J L 351, 21.12.89, p. 34. 24 OJ L 395, 30.12.1989, p. 13. OJ L 395, 30.12.89, p. 13. 25 OJ L 224, 18.8.1990, p. 29. OJ L 224, 18.08.90, p. 29. 26 OJ L 243, 25.8.1992, p. 27. O J L 243, 25.08.92, p. 27. 27 OJ L 13, 16.01.97, p. 28. OJ L 13, 16.01.97, p. 28. OJ L 139, 30.4.2004, p. 206.
Amendment 110 #
2013/0140(COD)
Proposal for a regulation
Recital 79
Recital 79
(79) In order to ensure consistency, amendments should also be effected to the following acts: Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies29; Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/9730; Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum levels of pesticides in or on food and feed of plant of animal origin and amending Council Directive 91/414//EEC31; Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) 2092/9132; Regulation (EC) No 1069/2009; Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing33; 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/EEC34; Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs35; Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes36; Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens37; Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed38; Regulation (EC) No 1831/2003 of the European Parliament and the Council of 22 September 2003 on additives for use in animal nutrition39; Council Directive 2007/43/EC of 28 June 2007 laying down minimum rules for the protection of chickens kept for meat production40; Council Directive 2008/119/EC of 18 December 2008 laying down minimum standards for the protection of calves41; Council Directive 2008/120/EC of 18 December 2008 laying down minimum standards for the protection of pigs42; Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the Community action to achieve the sustainable use of pesticides43. __________________ 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43OJ L 147, 31.5.2001, p. 1. OJ L 147, 31.5.2001, p. 1. 30 OJ L 3, 5.1.2005, p. 1. OJ L 3, 5.1.2005, p. 1. 31 OJ L 70, 16.3.2005, p. 1. OJ L 70, 16.3.2005, p. 1. 32 OJ L 189, 20.7.2007, p. 1. OJ L 189, 20.7.2007, p. 1. 33 OJ L 303, 18.11.2009, p. 1. OJ L 303, 18.11.2009, p. 1. 34 OJ L 309, 24.11.2009, p. 1. OJ L 309, 24.11.2009, p. 1. 35 OJ L 343, 14.12.2012, p. 1. OJ L 343, 14.12.2012, p. 1. 36 OJ L 221, 8.8.1998, p. 23. OJ L 221, 8.8.1998, p. 23. 37 OJ L 203, 3.8.1999, p. 53. OJ L 203, 3.8.1999, p. 53. 38 OJ L 268, 18.10.2003, p. 1. OJ L 268, 18.10.2003, p. 1. 39 OJ L 268, 18.10.2003, p. 29. OJ L 268, 18.10.2003, p. 29. 40 OJ L 812, 12.7.2007, p. 19. OJ L 812, 12.7.2007, p. 19. 41 OJ L 10, 15.1.2009, p. 7. OJ L 10, 15.1.2009, p. 7. 42 OJ L 47, 18.2.2009, p. 5. OJ L 47, 18.2.2009, p. 5. 43 OJ L 309, 24.11.2009, p. 71. OJ L 309, 24.11.2009, p. 71.
Amendment 118 #
2013/0140(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b
Article 1 – paragraph 2 – point b
Amendment 124 #
2013/0140(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point e
Article 1 – paragraph 2 – point e
Amendment 126 #
2013/0140(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point g
Article 1 – paragraph 2 – point g
Amendment 130 #
2013/0140(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point h
Article 1 – paragraph 2 – point h
Amendment 136 #
2013/0140(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point i
Article 1 – paragraph 2 – point i
Amendment 146 #
2013/0140(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point a
Article 2 – paragraph 1 – point 5 – point a
(a) the central authorities of a Member State responsible for the organisation ofing and carrying out official controls and of other official activities, in accordance with such as issuing certificates and attestations, appointing laboratories, exchanging information in the interest of cooperation between authorities, and taking decisions on measures to remedy breaches of this Regulation and the rules referred to in Article 1(2);
Amendment 150 #
2013/0140(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 6
Article 2 – paragraph 1 – point 6
6. 'animals' means animals as defined in point (1) of Article 4(1) of Regulation (EU) No XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health] with the exception of ‘pets’;
Amendment 155 #
2013/0140(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 12
Article 2 – paragraph 1 – point 12
Amendment 159 #
2013/0140(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 13
Article 2 – paragraph 1 – point 13
Amendment 162 #
2013/0140(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 14
Article 2 – paragraph 1 – point 14
Amendment 166 #
2013/0140(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 15
Article 2 – paragraph 1 – point 15
Amendment 168 #
2013/0140(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 16
Article 2 – paragraph 1 – point 16
Amendment 172 #
2013/0140(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 19
Article 2 – paragraph 1 – point 19
Amendment 190 #
2013/0140(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Article 2 – paragraph 1 – point 30
30. 'audit' means a systematic and independent examination to determine whether activities and the related results of such activities comply with planned arrangements and whether these arrangements are applied effectively and are suitable to achieve objectives;Does not affect English version. Linguistic amendment to German text.
Amendment 199 #
2013/0140(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 41
Article 2 – paragraph 1 – point 41
41. 'screening' means a form of official control performed by conducting a planned sequence of observations or measurements with a view to obtaining an overview of the state of compliance with this Regulation and the rules referred to in Article 1(2);Does not affect the English version. Linguistic amendment to German text.
Amendment 201 #
2013/0140(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 42
Article 2 – paragraph 1 – point 42
42. 'targeted screening' means a form of official control involving observation of one or more operators or their activities;Does not affect the English version. Linguistic amendment to German text.
Amendment 214 #
2013/0140(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 53
Article 2 – paragraph 1 – point 53
53. 'official detention' means the procedure by which the competent authorities ensure that animals and goods subject to official controls are not moved or tampered with pending a decision on their destination; it includes storage by operators in accordance with the instructions and under the control of the competent authorities;
Amendment 227 #
2013/0140(COD)
Proposal for a regulation
Article 3 – paragraph 5
Article 3 – paragraph 5
5. Member States may confer to the competent authorities referred to in paragraph 1 the responsibility to carry out controls for the verification of compliance with, or for the application of, rules, including those regulating specific risks which may arise from the presence of alien species in the Union, other than those referred to in Article 1(2).
Amendment 235 #
2013/0140(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) have arrangements in place to ensure the impartiality, quality and consistencyunity of purpose of official controls and other official activities at all levels;
Amendment 240 #
2013/0140(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point e
Article 4 – paragraph 1 – point e
(e) have, or have access to, a sufficient number of suitably qualified and experienced staff staff whose qualifications and experience are suitable in the light of the control requirements under Article 1(1) and (2) so that official controls and other official activities can be performed fully, efficiently and effectively;
Amendment 245 #
2013/0140(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
Amendment 253 #
2013/0140(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. The Commission may, by means of implementing acts, lay down rulguidelines for the conduct of the audits provided for in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 141 (2).
Amendment 256 #
2013/0140(COD)
Proposal for a regulation
Article 7 – title
Article 7 – title
Amendment 258 #
2013/0140(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Competent authorities shall require members of their staff not to disclose information acquired, except where required to do so within the authority itself, when undertaking their duties in the context of official controls and other official activities which by its nature is covered by professional secrecy, subject to paragraph 2. The confidentiality requirement covers in particular the following information: - preliminary investigation proceedings or current legal proceedings, - personal data, - documents exempted under Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, -information protected under national or EU law and relating in particular to the following: confidentiality requirement, confidentiality of deliberations, international relations and national defence.
Amendment 259 #
2013/0140(COD)
Proposal for a regulation
Article 7 – paragraph 2 – introductory part
Article 7 – paragraph 2 – introductory part
2. Unless there isIf there is reasonable suspicion of a threat to the health of humans or animals, or any overriding public interest in its disclosure, information covered by professional secrecy as referred to in paragraph 1 shall include information whose disclosure would undermine:ther substantial or repeated infringement of this Regulation, the competent authorities shall take appropriate, reasonable and proportionate measures to inform the public of the nature of the hazard or infringement without prejudice to national or Union rules regarding access to documents. For public disclosure of the names of the products or companies concerned, account shall be taken of the nature, severity and extent of the threat or infringement, as well as the measures to be taken to eliminate the hazard or infringement. Public disclosure by the authority shall only be admissible where other equally effective measures, for example notification by the originator of the hazard or infringement, are not possible or cannot be taken in time to protect legitimate consumer interests. If the suspicion proves unfounded or action is taken to end the infringement, the information publicly disclosed by the competent authorities shall be withdrawn.
Amendment 261 #
2013/0140(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point a
Article 7 – paragraph 2 – point a
Amendment 262 #
2013/0140(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point b
Article 7 – paragraph 2 – point b
Amendment 264 #
2013/0140(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point c
Article 7 – paragraph 2 – point c
Amendment 269 #
2013/0140(COD)
Proposal for a regulation
Article 7 – paragraph 3 – introductory part
Article 7 – paragraph 3 – introductory part
3. Paragraphs 1 and 2 shall not prevent the competent authorities from publishing or making otherwise available to the public information about the outcome of official controls regarding individual operators, while taking account of any current preliminary investigations or legal proceedings, provided that the following conditions are met:
Amendment 275 #
2013/0140(COD)
Proposal for a regulation
Article 7 – paragraph 3 – point b
Article 7 – paragraph 3 – point b
(b) the information which is published or made otherwise available to the public takes into account the comments expressed by the operator concerned or is published or released simultaneously and together with such comments.
Amendment 281 #
2013/0140(COD)
Proposal for a regulation
Article 8 – paragraph 1 – introductory part
Article 8 – paragraph 1 – introductory part
1. Competent authorities shall perform official controls on all operatorundertakings regularly, on a risk basis and with appropriate frequency, taking account of:
Amendment 286 #
2013/0140(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point a – point iv
Article 8 – paragraph 1 – point a – point iv
iv) the use of products, processes, materials or substances that may influence food or feed safety, animal health or animal welfare, plant health or plant reproductive material identity and quality, or, in the case of GMOs and plant protection products, may adversely impact on the environment;; (This amendment applies to the entire legislative text.)
Amendment 293 #
2013/0140(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) operatorundertakings' past record as regards the results of official controls performed on them and their compliance with the rules referred to in Article 1(2);
Amendment 300 #
2013/0140(COD)
Proposal for a regulation
Article 8 – paragraph 4 – introductory part
Article 8 – paragraph 4 – introductory part
4. Official controls shall be performed without prior warning as to when they will take place, except where:
Amendment 302 #
2013/0140(COD)
Proposal for a regulation
Article 8 – paragraph 4 – point a
Article 8 – paragraph 4 – point a
(a) prior notification of the operator is necessareparatory measures are necessary to ensure that the control can be carried out effectively;
Amendment 308 #
2013/0140(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. Official controls shall be performed as much as possible in a manner that minimises the burden on the operators. the administrative burden and operational disruption for operators is kept to the necessary minimum.
Amendment 315 #
2013/0140(COD)
Proposal for a regulation
Article 9 – title
Article 9 – title
Persons, processes and, activities, methods and techniques subject to official controls
Amendment 316 #
2013/0140(COD)
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. To the extent necessary to ascertain compliance with the rules referred to in Article 1(2), competent authorities shall perform official controls:
Amendment 325 #
2013/0140(COD)
Proposal for a regulation
Article 9 – paragraph 1 a (new)
Article 9 – paragraph 1 a (new)
The competent authorities shall perform the controls referred to in paragraph 1 using control methods and techniques, including observation, targeted observation, verification, inspection, checking, sampling, analysis, diagnosis and tests.
Amendment 326 #
2013/0140(COD)
Proposal for a regulation
Article 9 – paragraph 1 b (new)
Article 9 – paragraph 1 b (new)
The competent authorities shall perform the controls referred to in paragraph 1 using control methods and techniques, including observation, targeted observation, verification, inspection, checking, sampling, analysis, diagnosis and tests.
Amendment 327 #
2013/0140(COD)
Proposal for a regulation
Article 9 – paragraph 1 c (new)
Article 9 – paragraph 1 c (new)
Amendment 331 #
2013/0140(COD)
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – introductory part
Article 10 – paragraph 1 – subparagraph 2 – introductory part
They shall also ensure the regular and timely publication at least once a year of information on the following:
Amendment 336 #
2013/0140(COD)
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – point c
Article 10 – paragraph 1 – subparagraph 2 – point c
(c) the number of cases where measures were taken by the competent authorities in accordance with Article 135;
Amendment 338 #
2013/0140(COD)
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – point d
Article 10 – paragraph 1 – subparagraph 2 – point d
(d) the number of cases where the penalties referred to in Article 136 were imposed.
Amendment 340 #
2013/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
Amendment 354 #
2013/0140(COD)
Proposal for a regulation
Article 10 – paragraph 3 – point b a (new)
Article 10 – paragraph 3 – point b a (new)
(ba) measures are taken to ensure that the rating reflects average results from the last four controls at least;
Amendment 356 #
2013/0140(COD)
Proposal for a regulation
Article 10 – paragraph 3 – point b b (new)
Article 10 – paragraph 3 – point b b (new)
(bb) if the ratings are unfavourable, the inspection authorities guarantee prompt subsequent inspections to document as soon as possible the measures taken to end the infringement.
Amendment 359 #
2013/0140(COD)
Proposal for a regulation
Article 10 – paragraph 3 a (new)
Article 10 – paragraph 3 a (new)
3a. To enable rating systems to be compared from one Member State to another, the Commission shall be empowered to adopt a delegated act in accordance with Article 139 laying down guidelines for drawing up rating systems as referred to in paragraph 3, which shall be made available to the Member States.
Amendment 360 #
2013/0140(COD)
Proposal for a regulation
Article 12 – title
Article 12 – title
Recording of, and reports on, official controls
Amendment 361 #
2013/0140(COD)
Proposal for a regulation
Article 12 – paragraph 1 – subparagraph 1
Article 12 – paragraph 1 – subparagraph 1
Competent authorities shall draw upkeep documentary repcortds onf every official control that they perform. They shall draw up reports on controls in which this Regulation or the provisions of Article 1(2) were found to have been infringed.
Amendment 363 #
2013/0140(COD)
Proposal for a regulation
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3a. The outcome of official controls performed at a border control post shall be recorded in the Common Health Entry Document in accordance with Article 54(2)(b).
Amendment 364 #
2013/0140(COD)
Proposal for a regulation
Article 13
Article 13
Amendment 382 #
2013/0140(COD)
Proposal for a regulation
Article 14 – paragraph 1 – point b
Article 14 – paragraph 1 – point b
(b) their relevant computerised information management systems;
Amendment 386 #
2013/0140(COD)
Proposal for a regulation
Article 14 – paragraph 1 – point d
Article 14 – paragraph 1 – point d
(d) their relevant documents and any other relevant information and the control subjects listed in Article 9(3).
Amendment 390 #
2013/0140(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. During official controls and other official activities, operators shall assist the staff of the competent authorities in the accomplishment of their tasks. Operators shall supply the competent authorities with sufficient quantities of samples free of charge.
Amendment 392 #
2013/0140(COD)
Proposal for a regulation
Article 14 – paragraph 3 – point b
Article 14 – paragraph 3 – point b
(b) make available allwithout delay all requested information concerning the consignment on paper or electronically.
Amendment 398 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point a
Article 15 – paragraph 1 – point a
(a) the verification, by or under the responsibility of an official veterinarian, of theto check the identity, health, and welfare of the animals and to test for faecal or other contamination prior to the slaughter;
Amendment 399 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point a a (new)
Article 15 – paragraph 1 – point a a (new)
(aa) the verification and analysis of food- chain information;
Amendment 401 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b – point i
Article 15 – paragraph 1 – point b – point i
(i) the hygiene of meat production, covering at least: - the design and maintenance of premises and equipment; - HACCP-based pre-operational, operational, and post-operational principles, in particular to protect against microbiological, chemical, or physical hazards; - personal hygiene; - training in hygiene and work procedures;
Amendment 406 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b – point iv a (new)
Article 15 – paragraph 1 – point b – point iv a (new)
(iva) laboratory testing;
Amendment 409 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b – point iv b (new)
Article 15 – paragraph 1 – point b – point iv b (new)
(ivb) supervision of health marking and use of marks;
Amendment 410 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b – point iv c (new)
Article 15 – paragraph 1 – point b – point iv c (new)
(ivc) pest control;
Amendment 411 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b – point iv d (new)
Article 15 – paragraph 1 – point b – point iv d (new)
(ivd) temperature control;
Amendment 412 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b – point iv e (new)
Article 15 – paragraph 1 – point b – point iv e (new)
(ive) water quality;
Amendment 413 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b – point iv f (new)
Article 15 – paragraph 1 – point b – point iv f (new)
(ivf) controls on food entering and leaving the establishment and any accompanying documentation;
Amendment 414 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b a (new)
Article 15 – paragraph 1 – point b a (new)
(ba) the determination whether staff and staff activities in the establishment at all stages of the production process comply with the relevant requirements;
Amendment 416 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b b (new)
Article 15 – paragraph 1 – point b b (new)
(bb) the verification of the operator’s relevant records.
Amendment 417 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 b (new)
Article 15 – paragraph 1 b (new)
1b. After carrying out the controls specified in paragraph 1, the official veterinarian shall take appropriate measures as regards: - the communication of inspection findings; - decisions concerning food-chain information; - decisions concerning live animals; - decisions concerning animal welfare; and - decisions concerning meat.
Amendment 419 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 b a (new)
Article 15 – paragraph 1 b a (new)
1ba. Official auxiliaries may assist the official veterinarian with official controls. In that event, they shall work as part of an independent team. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning specific rules and restrictions applying to official auxiliaries assisting the official veterinarian with given tasks.
Amendment 421 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1 b b (new)
Article 15 – paragraph 1 b b (new)
1bb. Member States may allow slaughterhouse staff to assist with official controls by carrying out given tasks, under the supervision of the official veterinarian, related to the production of meat from poultry and lagomorphs. If they do so, they shall ensure that staff carrying out such tasks: - have the necessary qualifications and undergo appropriate training in accordance with the provisions laid down; - act independently from production staff; and - report any deficiency to the official veterinarian. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 setting out the specific conditions under which slaughterhouse staff may carry out tasks related to the control of poultrymeat and hare meat production and laying down the design and application of performance assessment tests.
Amendment 424 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1 – introductory part
Article 15 – paragraph 2 – subparagraph 1 – introductory part
The Commission shall be empowered to adopt further delegated acts in accordance with Article 139 concerning specific rules for the performance of official controls on products of animal origin intended for human consumption and on animals intended for the production of such products to verify compliance with the rules referred to in points (a), (c), (d) and (e) of Article 1(2) applicable to those products and animals, and on action to be taken by the competent authorities following official controls. Delegated acts shall allow for the particular circumstances of small businesses and include measures to facilitate the application of HACCP principles in accordance with Article 5 of Regulation (EC) No 852/2004. Those delegated acts shall lay down rules on:
Amendment 425 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1 – point a
Article 15 – paragraph 2 – subparagraph 1 – point a
(a) the specific responsibilities and tasks of the competent authorities, in addition to those provided for in paragraph 1 and Articles 4, 8, 9, 10(1), 11, 12, 13,and 34(1) and (2), and 36;
Amendment 429 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1 – point c
Article 15 – paragraph 2 – subparagraph 1 – point c
Amendment 434 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1 – point d
Article 15 – paragraph 2 – subparagraph 1 – point d
Amendment 435 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 2 – subparagraph 1 – point e
Article 15 – paragraph 2 – subparagraph 1 – point e
Amendment 441 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point a
Article 15 – paragraph 3 – point a
(a) the experience gained by the competent authorities and food business operators oin the application of the procedures referred to in Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council48; __________________ 48 OJ L 139, 30.4.2004, p. 1.
Amendment 442 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point c
Article 15 – paragraph 3 – point c
Amendment 445 #
2013/0140(COD)
Proposal for a regulation
Article 15 – paragraph 4 – point a
Article 15 – paragraph 4 – point a
Amendment 449 #
2013/0140(COD)
Proposal for a regulation
Article 17 – title
Article 17 – title
Specific rules on official controls and on action to be taken by the competent authorities in relation to animals, products of animal origin, and germinal products, animal by-products and derived products
Amendment 450 #
2013/0140(COD)
Proposal for a regulation
Article 17 – paragraph -1 a (new)
Article 17 – paragraph -1 a (new)
Official controls in relation to animals shall include: - the verification of measures for protection against biological and chemical hazards to human and animal health; - the verification of animal welfare measures, without prejudice to the provisions of Article 18; - the verification of disease control or eradication measures.
Amendment 451 #
2013/0140(COD)
Proposal for a regulation
Article 17 – paragraph -1 (new)
Article 17 – paragraph -1 (new)
Official controls in relation to products of animal origin shall include: - the verification of safety and hygiene; - the verification of labelling and packaging.
Amendment 453 #
2013/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning rules for the performance of official controls on animals, on products of animal origin, on germinal products, on animal by-products and on derived products to verify compliance with the Union rules referred to in points (d) and (e) of Article 1(2) and on action to be taken by the competent authorities following official controls. Those delegated acts shall take account of animal health risks related to animals, products of animal origin and germinal products, and of human and animal health risks related to animal by-products and derived products, and lay down rules on:
Amendment 454 #
2013/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) the specific responsibilities and tasks of the competent authorities, in addition to those provided for in Articles 4, 8, 9, 10(1), 11, 12, 13,and 34(1) and (2) and 36;
Amendment 470 #
2013/0140(COD)
Proposal for a regulation
Article 19
Article 19
Amendment 475 #
2013/0140(COD)
Proposal for a regulation
Article 20
Article 20
Amendment 480 #
2013/0140(COD)
Proposal for a regulation
Article 21
Article 21
Amendment 489 #
2013/0140(COD)
Proposal for a regulation
Article 22
Article 22
Amendment 550 #
2013/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – subparagraph 1
Article 34 – paragraph 1 – subparagraph 1
The competent authorities shall ensure that operators, whose animals or goods are subject to sampling, analysis, test or diagnosis in the context of official controls, have the right to apply for a second expert opinion, where this is relevant and technically feasible.
Amendment 553 #
2013/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – subparagraph 2 – point b – introductory part
Article 34 – paragraph 1 – subparagraph 2 – point b – introductory part
(b) where relevant and technically feasible, having regard in particular to the prevalence and distribution of the hazard in the animals or goods, to the perishability of the samples or the goods and to the amount of available substrate, shall entitle the operator to request and oblige the competent authorities to ensure:
Amendment 554 #
2013/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 a (new)
Article 34 – paragraph 1 a (new)
1a. Samples shall be handled and labelled in such a way as to guarantee their legal and technical validity.
Amendment 586 #
2013/0140(COD)
Proposal for a regulation
Article 45 – paragraph 1 – point c
Article 45 – paragraph 1 – point c
Amendment 591 #
2013/0140(COD)
Proposal for a regulation
Article 45 – paragraph 3
Article 45 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 139 concerning amendments of the categories of consignments referred to in paragraph 1, to include other products which may give rise to risks to human, and animal or plant health or, as regards GMOs and plant protection products, to the environmenthealth or animal welfare.
Amendment 600 #
2013/0140(COD)
Proposal for a regulation
Article 47 – paragraph 4 – subparagraph 1
Article 47 – paragraph 4 – subparagraph 1
Physical checks to verify compliance with animal health and welfare requirements or with plant health requirements laid down in the rules referred to in Article 1(2) shall be performed by, or under the supervision of, staff possessing appropriate qualifications in veterinary or phytosanitary matters respectivelymatters, designated by the competent authorities for that purpose.
Amendment 617 #
2013/0140(COD)
Proposal for a regulation
Article 53 – paragraph 2 – subparagraph 1
Article 53 – paragraph 2 – subparagraph 1
Decisions taken following a physical check to verify compliance with animal health and welfare requirements or with plant health requirements shall be taken by staff possessing appropriate qualifications in veterinary or phytosanitary matters respectivelymatters, and designated by the competent authorities for that purpose.
Amendment 638 #
2013/0140(COD)
Proposal for a regulation
Article 61 – paragraph 1
Article 61 – paragraph 1
1. A Member State shall immediately suspend the designation of a border control post and order its activities to be stopped, for all or for certain categories of animals and goods for which the designation was made, in cases where such activities may result in a risk to human, or animal or plant health, or animal welfare or, as regards GMOs and plant protection products, to the environment.
Amendment 659 #
2013/0140(COD)
Proposal for a regulation
Article 65 – paragraph 1
Article 65 – paragraph 1
Where official controls indicate that a consignment of animals or goods presents a risk to human, or animal or plant health, or animal welfare or, as regards GMOs and plant protection products, to the environment, such consignment shall be isolated or quarantined and animals belonging to it shall be kept and treated under appropriate conditions pending any further decision.
Amendment 662 #
2013/0140(COD)
Proposal for a regulation
Article 65 – paragraph 2 – point a
Article 65 – paragraph 2 – point a
(a) order that the operator destroy the consignment in compliance, where appropriate, with the rules referred to in Article 1(2), taking all the measures necessary to protect human, or animal or plant health, or animal welfare or the environment; or
Amendment 667 #
2013/0140(COD)
Proposal for a regulation
Article 66 – paragraph 2 – subparagraph 1
Article 66 – paragraph 2 – subparagraph 1
The competent authorities in the Member State where the official controls were performed shall supervise the application of the measures ordered pursuant to Article 64(3) and (5) and Article 65 to ensure that the consignment does not give rise to adverse effects on human, or animal or plant health, or animal welfare, or the environment, during or pending the application of those measures.
Amendment 671 #
2013/0140(COD)
Proposal for a regulation
Article 67 – paragraph 2 – point b
Article 67 – paragraph 2 – point b
(b) in the cases referred to in Article 65, that the consignment be destroyed in suitable facilities located as close as possible to the border control post, taking all measures necessary to protect human, or animal or plant health, or animal welfare or the environment.
Amendment 693 #
2013/0140(COD)
Proposal for a regulation
Article 75 – paragraph 1 – point d
Article 75 – paragraph 1 – point d
Amendment 697 #
2013/0140(COD)
Proposal for a regulation
Article 75 – paragraph 1 – point h
Article 75 – paragraph 1 – point h
(h) consignments of the categories of animals and goods referred to in points (a), (b) and (cb) of Article 45(1) originating from, and returning to, the Union following a refusal of entry by a third country;
Amendment 704 #
2013/0140(COD)
Proposal for a regulation
Article 76 – paragraph 1
Article 76 – paragraph 1
1. Member States shall ensure that adequate financial resources are available to provide the staff and other resources necessary for the competent authorities to perform official controls and other official activities. With that aim in view they may collect fees or contributions to costs or make resources available from general tax revenue.
Amendment 708 #
2013/0140(COD)
Proposal for a regulation
Article 76 – paragraph 2
Article 76 – paragraph 2
Amendment 716 #
2013/0140(COD)
Proposal for a regulation
Article 76 – paragraph 4
Article 76 – paragraph 4
4. Member States shall consult the operators concerned on the methods used to calculate the fees or contributions to costs provided for in Article 77.
Amendment 717 #
2013/0140(COD)
Proposal for a regulation
Article 77 – title
Article 77 – title
Amendment 722 #
2013/0140(COD)
Proposal for a regulation
Article 77 – paragraph 1 – introductory part
Article 77 – paragraph 1 – introductory part
1. For the purpose of ensuring that competent authorities are provided with adequate resources for the performance of official controls, the competent authorities shallmay collect fees or contributions to costs to recover the costs they incur in relation to:
Amendment 752 #
2013/0140(COD)
Proposal for a regulation
Article 78 – paragraph 1 – introductory part
Article 78 – paragraph 1 – introductory part
1. The competent authorities shallmay collect fees or contributions to costs in accordance with Article 77 to recover the following costs:
Amendment 758 #
2013/0140(COD)
Proposal for a regulation
Article 78 – paragraph 1 – point a
Article 78 – paragraph 1 – point a
(a) the salaries of the staff, including support staff, involved in the performance of official controls, shall not include their social security, pension and insurance costs;
Amendment 759 #
2013/0140(COD)
Proposal for a regulation
Article 78 – paragraph 1 – point b
Article 78 – paragraph 1 – point b
Amendment 763 #
2013/0140(COD)
Proposal for a regulation
Article 78 – paragraph 1 – point d
Article 78 – paragraph 1 – point d
Amendment 776 #
2013/0140(COD)
Proposal for a regulation
Article 79 – title
Article 79 – title
Calculation of fees or contributions to costs
Amendment 779 #
2013/0140(COD)
Proposal for a regulation
Article 79 – paragraph 1 – introductory part
Article 79 – paragraph 1 – introductory part
1. Fees or contributions to costs collected in accordance with Article 77 shall be: levied taking into account: - the nature of the undertaking concerned and the associated risk factors; - the interests of undertakings with small turnovers; - traditional methods of production, processing and marketing; the needs of undertakings situated in regions that are subject to special geographic constraints.
Amendment 782 #
2013/0140(COD)
Proposal for a regulation
Article 79 – paragraph 1 – point -a a (new)
Article 79 – paragraph 1 – point -a a (new)
(-aa) The fees or contributions to costs collected shall be set pursuant to Article 78 in accordance with the costs borne by the competent authorities over a given period. Individual cost elements may be calculated on a flat-rate basis at the discretion of the competent authority and after informing the public.
Amendment 783 #
2013/0140(COD)
Proposal for a regulation
Article 79 – paragraph 1 – point a
Article 79 – paragraph 1 – point a
Amendment 787 #
2013/0140(COD)
Proposal for a regulation
Article 79 – paragraph 1 – point b
Article 79 – paragraph 1 – point b
Amendment 794 #
2013/0140(COD)
Proposal for a regulation
Article 79 – paragraph 3
Article 79 – paragraph 3
3. WherThe fees are calculated in accordance with point (a) of paragraph 1, the feeor contributions to costs collected by competent authorities in accordance with Article 77 shall not exceed the overall costs incurred for the official controls performed over the period of time referred to in point (aa) (new) of paragraph 1.
Amendment 798 #
2013/0140(COD)
Proposal for a regulation
Article 80 – title
Article 80 – title
Amendment 799 #
2013/0140(COD)
Proposal for a regulation
Article 80 – paragraph 1
Article 80 – paragraph 1
Amendment 805 #
2013/0140(COD)
Proposal for a regulation
Article 82
Article 82
Amendment 823 #
2013/0140(COD)
Proposal for a regulation
Article 83 – paragraph 1 – point a
Article 83 – paragraph 1 – point a
(a) the method and data used to establish the fees or contributions to costs provided for in Article 77(1);
Amendment 831 #
2013/0140(COD)
Proposal for a regulation
Article 83 – paragraph 2 – point a
Article 83 – paragraph 2 – point a
(a) the costs to the competent authority for which a fee or contribution to costs is due in accordance with Article 77(1), indicating the breakdown of such costs per activity referred to in Article 77(1) and per cost element referred to in Article 78(1);
Amendment 834 #
2013/0140(COD)
Proposal for a regulation
Article 83 – paragraph 2 – point b
Article 83 – paragraph 2 – point b
(b) the amount of the fees or contributions to costs provided for in Article 77(1) applied to each category of operators, and for each category of official controls;
Amendment 835 #
2013/0140(COD)
Proposal for a regulation
Article 83 – paragraph 2 – point b
Article 83 – paragraph 2 – point b
(b) the amount of the fees or contributions to costs provided for in Article 77(1) applied to each category of operators, and for each category of official controls;
Amendment 838 #
2013/0140(COD)
Proposal for a regulation
Article 83 – paragraph 2 – point c
Article 83 – paragraph 2 – point c
(c) the method used to establish the fees or contributions to costs provided for in Article 77(1), including the data and estimates used for the establishment of the flat rate fees referred to in point (aa) (new) of Article 79(1);
Amendment 840 #
2013/0140(COD)
Proposal for a regulation
Article 83 – paragraph 2 – point d
Article 83 – paragraph 2 – point d
(d) where point (a) of Article 79(1) applies, the method used to adjust the level of the fees or the contribution to costs in accordance with Articles 79(1) and 80;
Amendment 841 #
2013/0140(COD)
Proposal for a regulation
Article 83 – paragraph 2 – point e
Article 83 – paragraph 2 – point e
Amendment 847 #
2013/0140(COD)
Proposal for a regulation
Article 84 – paragraph 1 – subparagraph 1 (new)
Article 84 – paragraph 1 – subparagraph 1 (new)
The fees for additional controls shall be calculated on the basis of the actual costs incurred pursuant to Article 78. If the actual travel expenses are less than the flat-rate amount set pursuant to Article 79(2), the flat-rate amount shall be used to calculate the fees.
Amendment 864 #
2013/0140(COD)
Proposal for a regulation
Article 91 – paragraph 3 – point g a (new)
Article 91 – paragraph 3 – point g a (new)
Amendment 874 #
2013/0140(COD)
Proposal for a regulation
Article 93
Article 93
Amendment 877 #
2013/0140(COD)
Proposal for a regulation
Article 94
Article 94
Amendment 882 #
2013/0140(COD)
Proposal for a regulation
Article 95 – paragraph 3 – point a
Article 95 – paragraph 3 – point a
(a) possess suitably qualified staff with a high level of scientific and technical expertise in human-animal relationship, animal behaviour, animal physiology, animal health and nutrition related to animal welfare, and animal welfare aspects related to the commercial and scientific use of animals; Or. de Justification Because of content overlap with Article 95(3)(b), the two paragraphs were merged., taking ethical aspects into consideration;
Amendment 883 #
2013/0140(COD)
Proposal for a regulation
Article 95 – paragraph 3 – point b
Article 95 – paragraph 3 – point b
Amendment 891 #
2013/0140(COD)
Proposal for a regulation
Article 96 – paragraph 1 – point d
Article 96 – paragraph 1 – point d
(d) coordinating the carrying out of scientific and technical studies on the welfare of animals used for commercial or scientific purposes; Or. de Justification To avoid an overlap of competences with EFSA, the reference centres should be given a coordinating role, while EFSA can continue to carry out its own studies.
Amendment 894 #
2013/0140(COD)
Proposal for a regulation
Article 97 – paragraph 1 – point b
Article 97 – paragraph 1 – point b
Amendment 921 #
2013/0140(COD)
Proposal for a regulation
Article 105 – paragraph 2 – point b
Article 105 – paragraph 2 – point b
(b) the third country has undertaken to provide the assistance necessary to gather evidence of practices that are or appear to be non-compliant with Union rules or that pose a risk to humans, or animals or plants or the environment;
Amendment 965 #
2013/0140(COD)
Proposal for a regulation
Article 119 – paragraph 2 – point g
Article 119 – paragraph 2 – point g
(g) the extent and operation of official controls performed on animals, plants and their products arriving from other third countries; Or. de Justification As a result of the hiving-off of the sectoral provisions on plant health, plant reproductive material and plant protection products, this broadening of the scope is unnecessary.
Amendment 968 #
2013/0140(COD)
Proposal for a regulation
Article 120 – paragraph 1 – point g – point iv
Article 120 – paragraph 1 – point g – point iv
Amendment 971 #
2013/0140(COD)
Proposal for a regulation
Article 120 – paragraph 1 – point g – point v
Article 120 – paragraph 1 – point g – point v
Amendment 976 #
2013/0140(COD)
Proposal for a regulation
Article 124 – paragraph 1 – introductory part
Article 124 – paragraph 1 – introductory part
1. The Commission shall request third countries intending to export animals and goods to the Union to provide the following accurate and up-to-date information on the general organisation and management of sanitary and phytosanitary control systems in their territory: (If adopted, this amendment will apply throughout the article.)
Amendment 1001 #
2013/0140(COD)
Proposal for a regulation
Article 128 a (new)
Article 128 a (new)
Article 128a Supporting developing countries 1. With a view to ensuring that developing countries can comply with the provisions of this Regulation, measures may be taken, and may be implemented for as long as they continue to have a demonstrable impact, to support the following activities: - compliance with the conditions governing the entry into the Union of animals and goods; - drafting of guidelines on the organisation of official controls on products to be exported to the Union; - sending of European Union or Member State experts to developing countries to assist with the organisation of official controls; - involvement of control staff from developing countries in training programmes or courses. 2. The Commission shall be empowered, pursuant to Article 139, to adopt delegated acts setting out provisions covering the forms of support for developing countries referred to in paragraph 1.
Amendment 1004 #
2013/0140(COD)
Proposal for a regulation
Article 130 – paragraph 1
Article 130 – paragraph 1
1. The Commission shall set up and manage a computerised information management system for the integrated operation of the mechanisms and tools through which data, information and documents concerning official controls are automatically forwarded from databases in the Member States and managed and handled ('the IMSOC').
Amendment 1007 #
2013/0140(COD)
Proposal for a regulation
Article 130 – paragraph 1 a (new)
Article 130 – paragraph 1 a (new)
1a. When forwarding electronic certificates or other electronic documents, the Commission and Member States shall use standard international programming languages, message structures and transmission protocols and safe transmission procedures.
Amendment 1009 #
2013/0140(COD)
Proposal for a regulation
Article 130 – paragraph 2 – point b
Article 130 – paragraph 2 – point b
(b) integrate fully and provide the necessary updates to existing computerised systems managed by the Commission and used for the rapid exchange of data, information and documents in relation to risks to human, animal health and welfare, and plant health, as established by Article 50 of Regulation (EC) No 178/2002, Article 20 of Regulation (EU) XXX/XXXX [Office of Publications, please insert number of the Regulation on animal health] and Article 97 of Regulation (EU) XXX/XXXX [Office of Publications, please insert number of the Regulation on protective measures against pests of plants];
Amendment 1026 #
2013/0140(COD)
Proposal for a regulation
Article 136 – paragraph 1 – subparagraph 1 (new)
Article 136 – paragraph 1 – subparagraph 1 (new)
Irrespective of the financial advantage sought, the severity of the penalties should also reflect the degree of risk of damage to consumers' health.
Amendment 1030 #
2013/0140(COD)
Proposal for a regulation
Article 136 – paragraph 3 – point c a (new)
Article 136 – paragraph 3 – point c a (new)
(ca) where consumers' health is damaged.
Amendment 1045 #
2013/0140(COD)
Proposal for a regulation
Article 142 – paragraph 2
Article 142 – paragraph 2
2. Regulation (EC) No 854/2004 and Directives 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC and 97/78/EC are repealed as from [Office of Publications, please insert date of entry into force of this Regulation + 3 years].
Amendment 1058 #
2013/0140(COD)
Proposal for a regulation
Article 161 – paragraph 1 – point b
Article 161 – paragraph 1 – point b
Regulation (EU) No [.…]/2013
Article 29 a (new)
Article 29 a (new)
Amendment 221 #
2013/0136(COD)
Proposal for a regulation
Recital 121
Recital 121
(121) The specific nature of movements of pet animals represents an animal health risk which deviates significantly from that of other kept animals. Specific rules for such movements should therefore be laid down in this Regulation. In order tocontinue to be governed by the provisions already adopted. This will ensure that pet animals do not pose a significant risk for the spread of transmissible animal diseases, t. 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 in respect of the detailed rules for movements of those animals. In order to ensure uniform conditions for the implementation of the animarules concerning the disease prevention and control hmealth requirements laid down in this Regulation concerning the movements of pet animals, implementing powers should be conferred on the Commission to lay down rules concerning the disease prevention and control measures to be taken for such movementssures to be taken for such movements should be conferred on the Commission.
Amendment 226 #
2013/0136(COD)
Proposal for a regulation
Recital 154 – indent 24
Recital 154 – indent 24
Amendment 238 #
2013/0136(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 13
Article 4 – paragraph 1 – point 13
(13) 'non-commercial movement' means any movement of pet animals which does not involve or aim, directly or indirectly, at a financial gain or a transfer of ownership;for non-commercial purposes in keeping with the definition set out in Article 3a of Regulation (EU) No 576/201371a; __________________ 71a OJ L 178, 28.6.2013, p. 1.
Amendment 335 #
2013/0136(COD)
Proposal for a regulation
Article 112 – paragraph 1 – introductory part
Article 112 – paragraph 1 – introductory part
1. Pet keepers shall ensure that terrestrial pet animals of the species listed in Part AB of Annex I which aren moved from one Member State to another Member State: meet the requirements laid down in Regulation (EU) No 576/2013 on the non-commercial movement of pet animals71c. __________________ 71c OJ L 178, 28.6.2013, p. 1.
Amendment 337 #
2013/0136(COD)
Proposal for a regulation
Article 112 – paragraph 1 – point a
Article 112 – paragraph 1 – point a
Amendment 339 #
2013/0136(COD)
Proposal for a regulation
Article 112 – paragraph 1 – point b
Article 112 – paragraph 1 – point b
Amendment 341 #
2013/0136(COD)
Proposal for a regulation
Article 112 – paragraph 2 – introductory part
Article 112 – paragraph 2 – introductory part
2. Pet keepers shall ensure that terrestrial pet animals of the species listed in Part B of Annex I when moved from one Member State to another Member State, and when required by rules adopted pursuant to Articles 114 and 1 comply with the rules laid down in Regulation (EU) No 576/2013 on the non-commercial movement of pet animals71d. __________________ 71d OJ L 178, are: 28.6.2013, p. 1.
Amendment 342 #
2013/0136(COD)
Proposal for a regulation
Article 112 – paragraph 2 – point a
Article 112 – paragraph 2 – point a
Amendment 343 #
2013/0136(COD)
Proposal for a regulation
Article 112 – paragraph 2 – point b
Article 112 – paragraph 2 – point b
Amendment 347 #
2013/0136(COD)
Proposal for a regulation
Article 114 – paragraph 1 – point c – point vi
Article 114 – paragraph 1 – point c – point vi
Amendment 349 #
2013/0136(COD)
Proposal for a regulation
Article 114 – paragraph 1 – point f
Article 114 – paragraph 1 – point f
Amendment 363 #
2013/0136(COD)
Proposal for a regulation
Article 152 – paragraph 1 – introductory part
Article 152 – paragraph 1 – introductory part
1. Pet keepers shall only carry out non- commercial movements of terrestrial pet animals of the species listed in Annex I from one Member State to another Member State where: in compliance with the rules laid down in Regulation (EU) No 576/201371e on the non-commercial movement of pet animals. __________________ 71e OJ L 178, 28.6.2013, p. 1.
Amendment 364 #
2013/0136(COD)
Proposal for a regulation
Article 152 – paragraph 1 – point a
Article 152 – paragraph 1 – point a
Amendment 365 #
2013/0136(COD)
Proposal for a regulation
Article 152 – paragraph 1 – point b
Article 152 – paragraph 1 – point b
Amendment 366 #
2013/0136(COD)
Proposal for a regulation
Article 152 – paragraph 2
Article 152 – paragraph 2
2. TWithout prejudice to Regulation (EU) No 576/2013 on the non-commercial movement of pet animals71f, the Commission shall be empowered to adopt delegated acts in accordance with Article 253 concerning the disease prevention and disease control measures referred to in paragraph 1(b) of this Article to ensure that the terrestrialaquatic pet animals do not pose a significant risk for the spread of diseases referred to in Article 8(1)(d) and emerging diseases to animals during transport and at the place of destination and, when relevant taking into account the health status of the place of destination. __________________ 71f OJ L 178, 28.6.2013, p. 1.
Amendment 367 #
2013/0136(COD)
Proposal for a regulation
Article 152 – paragraph 3 – subparagraph 1
Article 152 – paragraph 3 – subparagraph 1
Amendment 391 #
2013/0136(COD)
Proposal for a regulation
Article 258 – paragraph 2 – subparagraph 1 – indent 24
Article 258 – paragraph 2 – subparagraph 1 – indent 24
Amendment 394 #
2013/0136(COD)
Proposal for a regulation
Article 261
Article 261
Amendment 6 #
2012/2043(INI)
Draft opinion
Paragraph 1 – point 1 (new)
Paragraph 1 – point 1 (new)
1a. Welcomes the European Union Animal Health Strategy 2012–2015, but notes with regret that the importance of healthy animals for public health, as promoted in the concept of ‘Animals + Humans = One Health’, or the link between animal health and animal welfare does not feature in that strategy;
Amendment 9 #
2012/2043(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Welcomes the inclusion of a European Animal Welfare Framework Law in the Strategy, provided that such a legal framework is not allowed to dilute existing national provisions and that the principle of subsidiarity is carefully examined; reiterates that such a Framework Law should be based on up-to- date validated science and should cover all animals, whether domesticated or stray, as well as invasive alien species, and fish; ;
Amendment 27 #
2012/2043(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Stresses that the list of actions included in the Strategy must includeshould be extended as follows:
Amendment 41 #
2012/2043(INI)
Draft opinion
Indent 3
Indent 3
– a legislative proposal introducing a ban on cloning and on the placing on the market of productson the use of meat, meat products and milk from cloned animals and their offspring;
Amendment 62 #
2012/2043(INI)
Draft opinion
Paragraph 6 – point 1 (new)
Paragraph 6 – point 1 (new)
(1) Acknowledges that the use of veterinary medicinal products, including antibiotics, serves to restore animal health and therefore to reduce the suffering of sick animals; points out that such treatment of disease in animals helps prevent zoonoses and thus protect public health;
Amendment 68 #
2012/2043(INI)
Draft opinion
Paragraph 7
Paragraph 7
Amendment 1 #
2012/2041(INI)
Motion for a resolution
Citation 12
Citation 12
– having regard to the secon3rd revision of the WHO list of critically important antimicrobials for human medicine (rReport of the first3rd meeting of the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance [AGISAR], Copenhagen, 2009), 14-17 June 2011, Oslo, Norway), and to the OIE List of Antimicrobial Agents of Veterinary Importance (OIE List, May 2007) and subsequent refinements,
Amendment 14 #
2012/2041(INI)
Motion for a resolution
Recital F
Recital F
F. whereas, given the lack of new antibacterial drug development, it is of paramount importance that the effective exploitation of existing antimicrobials is maintained for as long as possible via preventive measures to contain infection spread prevention, vaccinations, alternative treatments, prudent use and controlled antimicrobial dosage;
Amendment 20 #
2012/2041(INI)
Motion for a resolution
Recital G
Recital G
G. whereas there is a spread of antimicrobial resistance has dangerous implications for both human and animal health and the link between antimicrobials use in animals and the spread of resistance in humans, which requires further research; whereas there is a need for a coordinated, multisectoral policy approach to AMR targeting both practitioners and users in each sector while taking account of the ‘One Health’ approach adopted by the European Union;
Amendment 23 #
2012/2041(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas, despite farmers' primary objective to keep their livestock healthy and productive through good agricultural practices (hygiene, proper feed, appropriate husbandry and good animal management), animals can still become ill, and appropriate therapy and veterinary medicines should be available;
Amendment 24 #
2012/2041(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas to date no standard definition of ‘preventive treatment’ has been adopted and disagreements are constantly arising from different interpretations thereof;
Amendment 28 #
2012/2041(INI)
Motion for a resolution
Recital H b (new)
Recital H b (new)
Hb. whereas failure to respect basic rules of hygiene in a human environment, not only in hospitals but also in the home for example, is causing a further spread of antimicrobial pathogens;
Amendment 46 #
2012/2041(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls on the European Medicines Agency to establish scientific criteria for the reliability and medical necessity of preventive antimicrobial treatment;
Amendment 71 #
2012/2041(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes the important role of vaccines in limiting the development of AMR Calls on the Commission to examine what further preventive measures (for example animal hygiene, extension of vaccination programmes etc.)could be taken, thereby reducing the amounts of antimicrobial agents required to treat infections;
Amendment 115 #
2012/2041(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes the annual European Antibiotic Awareness Day (18 November) instituted to promote the responsible use of antimicrobials; considers, however, that its visibility and potential could be more effectively maximised through coordinated, innovative and high-impact campaigns based on the experience derived from successful European and international initiatives; calls on the Commission to introduce year-round information concerning the correct dosage of prescribed antibiotics;
Amendment 119 #
2012/2041(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Takes the view that effective information and awareness campaigns must be developed with a view to heightening awareness of the dangers of the unintentional spread of antimicrobial pathogens in hospitals and in the home and means of avoiding this;
Amendment 3 #
2012/2031(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Regrets that Council Regulation (EC) No 1/2005 has not been adequately implemented in some Member States; calls on the Commission to seek to ensure swift and full implementation of the provision in all Member States.
Amendment 9 #
2012/2031(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Considers thatalls on the Commission to examine under which criteria reducing the volume of transport by transporting carcasses instead of live animals would have a positive impact on the environment, reducing pollution, improving the carbon footprint of the transport sector, and encouraging the development of local production and consumption;
Amendment 30 #
2012/2031(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Points out that other factors also have a major significance for the welfare of animals during transport, in particular appropriate speed and careful loading and unloading; calls on the Commission to ensure that the introduction of an 8-hour limit for the transport of animals for slaughter does not increase stress on animals during transport;
Amendment 34 #
2012/2031(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Calls on the Commission to examine ways to introduce special training and testing for lorry drivers to qualify them to carry out animal transport under the most humane conditions possible;
Amendment 106 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 1 – point a
Article 1 – point 1 – point a
Directive 2011/92/EU
Article 1 – paragraph 2 – point a – indent 1
Article 1 – paragraph 2 – point a – indent 1
Amendment 137 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 2
Article 1 – point 2
Directive 2011/92/EU
Article 2 – paragraph 3 – subparagraph 1
Article 2 – paragraph 3 – subparagraph 1
3. PIn the case of projects for which the obligation to carry out assessments of the effects on the environment arises simultaneously from this Directive and other Union legislation shall be subject toMember States shall seek to introduce coordinated or joint procedures fulfilling the requirements of the relevant Union legislation where this seems appropriate.
Amendment 151 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 2
Article 1 – point 2
Directive 2011/92/EU
Article 2 – paragraph 3 – subparagraph 4
Article 2 – paragraph 3 – subparagraph 4
Amendment 166 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 3
Article 1 – point 3
Directive 2011/92/EU
Article 3 – point a
Article 3 – point a
(a) population, human health, and biodiversity, with particular attention to species and habitats protected under Council Directive 92/43/EEC(*) and Directive 2009/147/EC of the European Parliament and of the Councilhuman beings, fauna and flora;
Amendment 171 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 3
Article 1 – point 3
2011/92/EG
Article 3 – point b
Article 3 – point b
(b) land, soil, water, air and, climate changand the landscape;
Amendment 180 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 3
Article 1 – point 3
Directive 2011/92/EU
Article 3 – point c
Article 3 – point c
(c) material assets, and the cultural heritage and the landscape;
Amendment 193 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 4 – point a
Article 1 – point 4 – point a
3. For projects listed in Annex II, the developer shall, where necessary and appropriate, provide information on the characteristics of the project, its potential impact on the environment and the measures envisaged in order to avoid and reduce significant effects. The detailed list of information to be provided is specified in Annex II.A.
Amendment 207 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 4 – point a
Article 1 – point 4 – point a
Directive 2011/92/EU
Article 4 – paragraph 4
Article 4 – paragraph 4
4. When a case-by-case examination is carried out or thresholds or criteria are set for the purpose of paragraph 2, the competent authority shall, where necessary, take account of selection criteria related to the characteristics and location of the project and its potential impact on the environment. The detailed list of selection criteria to be used is specified in Annex III.
Amendment 212 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 4 – point b
Article 1 – point 4 – point b
Directive 2011/92/EU
Article 4 – paragraph 5 – introductory part
Article 4 – paragraph 5 – introductory part
5. The competent authority shall make its decision pursuant to paragraph 2, on the basis of the information provided by the developer and taking into account, where relevant, the results of studies with which it is familiar, preliminary verifications or assessments of the effects on the environment arising from other Union legislation. The decision pursuant to paragraph 2 shall:
Amendment 215 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 4 – point b
Article 1 – point 4 – point b
Directive 2011/92/EU
Article 4 – paragraph 5 – point a
Article 4 – paragraph 5 – point a
Amendment 242 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Where an environmental impact assessment must be carried out in accordance with Articles 5 to 10, the developer shall prepare an environmental report. The environmental report shall be based on the determination pursuant to paragraph 2 of this Article and include the information that may reasonably be required for making informed decisions on the environmental impacts of the proposed project, taking into account current knowledge and methods of assessment, the characteristics, technical capacity and location of the project, the characteristics of the potential impact, reasonable alternatives to the proposed projectconsidered by the developer which, taking into account the specific features of the project, could achieve its main objectives to the same extent, and the extent to which certain matters (including the evaluation of alternatives) are more appropriately assessed at different levels including the planning level, or on the basis of other assessment requirements. The detailed list of information to be provided in the environmental report is specified in Annex IV.
Amendment 254 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 2 – subparagraph 1 – introductory part
Article 5 – paragraph 2 – subparagraph 1 – introductory part
2. The competent authority, after having consulted the authorities referred to in Article 6(1) and the developer, shall determine the scope and level of detail of the information to be included by the developer in the environmental report, in accordance with paragraph 1 of this Article, if the operator asks for this. In particular, it shall determininclude:
Amendment 275 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 2 – subparagraph 1 – point d
Article 5 – paragraph 2 – subparagraph 1 – point d
(d) reasonable alternatives relevant to the proposed project and itsdefined in paragraph 1 and their specific characteristics;
Amendment 296 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
(a) the developer shall ensure that the environmental report is prepared by accredited and technically competent experts orpersons, who have the required level of expertise and/or experience (experts in the field),
Amendment 306 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 3 – subparagraph 1 – point b
Article 5 – paragraph 3 – subparagraph 1 – point b
(b) if deemed necessary due to obvious technical deficiencies in the environmental report, the competent authority shall ensure that the environmental report is verified by accredited and technically competent expertsons and/or expert committees of national experts.
Amendment 322 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
Where accredited and technically competent experts assisted the competent authority to prepare the determination referred to in Article 5(2), the same experts shall not be used by the developer for the preparation of the environmental report.
Amendment 324 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 5
Article 1 – point 5
Directive 2011/92/EU
Article 5 – paragraph 3 – subparagraph 3
Article 5 – paragraph 3 – subparagraph 3
Amendment 359 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) ) the main reasons for choosing the project as adopted, in the light of the other alternatives considered, including the likely evolution of the existing state of the environment without implementation of the project (baseline scenario);
Amendment 372 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 2 – subparagraph 1
Article 8 – paragraph 2 – subparagraph 1
1. If the consultations and the information gathered pursuant to Articles 5, 6 and 7 conclude that a project will have significant adverse environmental effects, the competent authority shall, as early as possible and in close cooperation, discuss with the authorities referred to in Article 6(1) and the developer, shall consider whether the environmental report referred to in Article 5(1) should be revised and the project modified to avoid or reduce these adverse effects and whether additional mitigation or compensation measures are needed under the relevant law.
Amendment 377 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 2 – subparagraph 2
Article 8 – paragraph 2 – subparagraph 2
If the competent authority decides to grant development consent, it shall, in accordance with the relevant legislation, ensure that the development consent includes measures to monitor the significant adverse environmental effects, in order to assess the implementation and the expected effectiveness of mitigation and compensation measures, and to identify any unforeseeable adverse effects.
Amendment 383 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 2 – subparagraph 3
Article 8 – paragraph 2 – subparagraph 3
Amendment 387 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2011/92/EU
Article 8 – paragraph 2 – subparagraph 4
Article 8 – paragraph 2 – subparagraph 4
Amendment 404 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Amendment 436 #
2012/0297(COD)
Proposal for a directive
Article 1 – point 11
Article 1 – point 11
Directive 2011/92/EU
Articles 12 a and 12b
Articles 12 a and 12b
Amendment 455 #
2012/0297(COD)
Proposal for a directive
Article 3
Article 3
Projects for which the request for development consent was introduced before the date referred to in the first subparagraph of Article 2(1) and for which the environmental impact assessment has not been concluded before that date shall be subject to the obligations referred to in Articles 3 to 11 of Directive 2011/92/EU as amended by this D, pending entry into force of the amended directive.
Amendment 478 #
2012/0297(COD)
Proposal for a directive
Annex – point 1
Annex – point 1
Directive 2011/92/EU
Annex II.A
Annex II.A
Amendment 507 #
2012/0297(COD)
Proposal for a directive
Annex – point 2
Annex – point 2
Directive 2011/92/EU
Annex III – paragraph 1 – point g
Annex III – paragraph 1 – point g
(g) impacts of the project on climate change (in terms of greenhouse gas emissions including from land use, land- use change and forestry)the local climate, contribution of the project to an improved resilience, and the impacts of climate change on the project (e.g. if the project is coherent with a changing climate);
Amendment 555 #
2012/0297(COD)
Proposal for a directive
Annex – point 2
Annex – point 2
Directive 2011/92/EU
Annex IV – paragraph 2
Annex IV – paragraph 2
2. A description, of the technical, locational or other aspects (e.g. in terms of project design, technical capacity, size and scale) of the alternatives considered, including by the identification of the least environmentally impacting one,veloper and an indication of the main reasons for the choice made, taking into account the environmental effects.
Amendment 560 #
2012/0297(COD)
Proposal for a directive
Annex – point 2
Annex – point 2
Directive 2011/92/EU
Annex IV – paragraph 3
Annex IV – paragraph 3
3. A description of the relevant aspects of the existing state of the environment and the likely evolution thereof without implementation of the project (baseline scenario). This description should cover any existing environmental problems relevant to the project, including, in particular, those relating to any areas of a particular environmental importance and the use of natural resources.
Amendment 107 #
2012/0288(COD)
Proposal for a directive
Recital 5
Recital 5
(5) Based on forecasts of biofuel demand provided by the Member States and estimates of indirect land-use change emissions for different biofuel feedstocks it is likely that greenhouse gas emissions linked to indirect land use change are significant, and could negate some or all of the greenhouse gas savings of individual biofuels. This is because almost the entire biofuel production in 2020 is expected to come from crops grown on land that could be used to satisfy food and feed markets. In order to reduce such emissions, it is appropriate to distinguish between crop groups such as oil crops, cereals, sugars and other starch containing crops accordingly.
Amendment 154 #
2012/0288(COD)
Proposal for a directive
Recital 9
Recital 9
Amendment 178 #
2012/0288(COD)
Proposal for a directive
Recital 11
Recital 11
Amendment 194 #
2012/0288(COD)
Proposal for a directive
Recital 12
Recital 12
Amendment 215 #
2012/0288(COD)
Proposal for a directive
Recital 19
Recital 19
(19) In order to permit adaptation to technical and scientific progress of Directive 2009/28/EC, 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 in respect of the list of biofuel feedstocks that are counted multiple times towards the target set in Article 3(4), the energy content of transport fuels, criteria and geographic ranges for determining highly biodiverse grassland, the methodology for the calculation of indirect land-use change emissions, and the methodological principles and values necessary for assessing whether sustainability criteria have been fulfilled in relation to biofuels and bioliquids.
Amendment 242 #
2012/0288(COD)
Proposal for a directive
Article 1 – point 1 – point a
Article 1 – point 1 – point a
Directive 98/70/EC
Article 7a – paragraph 6
Article 7a – paragraph 6
Amendment 326 #
2012/0288(COD)
Proposal for a directive
Article 2 – point 2 – point b
Article 2 – point 2 – point b
Directive 2009/28/EC
Article 3 – paragraph 1 – subparagraph 2
Article 3 – paragraph 1 – subparagraph 2
Amendment 367 #
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 475 #
2012/0288(COD)
Proposal for a directive
Article 3
Article 3
The Commission shall, before 31 December 201720, submit a report to the European Parliament and to the Council reviewing, on the basis of the best latest availablevidence obtained in accordance with the scientific evidencemethod, the effectiveness of the measures introduced by this Directive in limiting indirect land- use change greenhouse gas emissions associated with the production of biofuel and bioliquids. The report shall, if appropriate, be accompanied by a legislative proposal based on the best availablevidence obtained in accordance with the scientific evidence,method for introducing estimated indirect land use change emissions factors into the appropriate sustainability criteria to be applied from 1st January 2021 and a review of the effectiveness of the incentives provided for biofuels from non- land using feedstocks and non-food crops under Article 3(4)d of Directive 2009/28/EC. The application of the factors referred to in the first paragraph for estimated emissions arising from indirect land use change to biofuel plants which entered into service before 2017 may not have the effect of categorising the biofuels produced there in such a way that they no longer comply with the sustainability criteria. However, this must be conditional on these biofuels achieving an emissions saving of at least 45%. By the end of 2017, this provision should enter into force for all biofuel plants.
Amendment 154 #
2012/0266(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) It should be the responsibility of the Member States to decide on a case-by-case basis whether or not a product falls within the scope of this Regulation. If necessary, the Commission may decide, on a case-by- case basis, whether or not a product falls within the definition of a medical device or of an accessory to a medical device. In the interests of legal certainty, clear reasons should be given for such decisions and the manufacturers concerned should be consulted as part of the decision-making process. Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility to take an EU- wide decision regarding the regulatory status of a product should also be introduced in Regulation No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
Amendment 273 #
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 or on its own initiative and following consultation with the manufacturer in question on the basis of concerns about patient safety or in the light of new scientific findings, by means of implementing acts, determine whether or not a specific product, or 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).
Amendment 390 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 2 a (new)
Article 15 – paragraph 2 a (new)
2a. The Commission, by means of implementing acts, shall lay down guidelines on the reprocessing of medical devices, with stipulations on standardisable, reproducible and effective cleaning, disinfection and sterilisation processes in line with the risk assessment for the respective devices, as well as requirements in relation to systems for hygiene, infection-prevention, quality management and documentation applicable to the natural or legal persons reprocessing the medical devices. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 398 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. The Commission, by means of implementing acts, shall establish and regularly update a list of categories or groups of single-use devices for critical use which may be reprocessed in accordance with paragraph 3. The list shall also include requirements in relation to systems for hygiene, infection- prevention, quality management and documentation applicable to the natural or legal persons reprocessing these particularly sensitive devices. It will be regularly updated. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 400 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 6
Article 15 – paragraph 6
Amendment 495 #
2012/0266(COD)
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. Within 14 days of the submission referred to in paragraph 2, the Commission shall designate a joint assessment team made up of at least twohree experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies. The list shall be drawn up by the Commission in cooperation with the MDCG. At least one of these experts shall be a representative of the Commission who, and at least one other shall come from a Member State other than that in which the applicant conformity assessment body is established; The Commission representative shall lead the joint assessment team.
Amendment 496 #
2012/0266(COD)
Proposal for a regulation
Article 32 – paragraph 4 – subparagraph 2
Article 32 – paragraph 4 – subparagraph 2
Findings regarding non-compliance of a body with the requirements set out in Annex VI shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team with a view to finding common agreement with respect to the assessment of the application. Divergent opinions shall be identified inIn the event of a disagreement, a separate opinion drawn up by the assessment team setting out its reservations regarding notification shall be appended to the assessment report of the national authority responsible.
Amendment 497 #
2012/0266(COD)
Proposal for a regulation
Article 32 – paragraph 5
Article 32 – paragraph 5
5. The national authority responsible for notified bodies shall submit its assessment report and its draft notification to the Commission which shall immediately transmit those documents to the MDCG and to the members of the joint assessment team. If the assessment team draws up a separate opinion, this too shall be submitted to the Commission for forwarding to the MDCG. Upon request by the Commission, those documents shall be submitted by the authority in up to three official Union languages.
Amendment 498 #
2012/0266(COD)
Proposal for a regulation
Article 32 – paragraph 6
Article 32 – paragraph 6
6. The joint assessment team shall provide its final opinion regarding the assessment report and, the draft notification and, where appropriate, the separate opinion drawn up by the assessment team, within 21 days of receipt of those documents and the Commission shall immediately submit this opinion to the MDCG. Within 21 days after receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft notification which the relevant national authority shall duly take into consideration for its decision on the designation of the notified body. If, in taking its decision, the relevant national authority goes against the MDCG's recommendation, it must outline its reasons for so doing to the Commission in writing.
Amendment 559 #
Amendment 669 #
2012/0266(COD)
Proposal for a regulation
Article 67 – paragraph 1
Article 67 – paragraph 1
1. The competent authorities shall perform appropriate checks on the characteristics and performance of devices including, where appropriate, review of documentation and physical or laboratory checks on the basis of adequate samples. They shall take account of established principles regarding risk assessment and risk management, vigilance data and complaints. The competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and, where necessary and justified, and also without announcing their intention, enter the premises of economic operators and take the necessary samples of devices. They may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary.
Amendment 674 #
2012/0266(COD)
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. The Member States shall periodically plan, review and assess the functioning of their surveillance activities. SuchTo this end, Member States shall draw up strategic monitoring plans which lay down a risk classification, surveillance intervals, the nature of the surveillance measures and the human and material resources to be used to carry out the monitoring. A reviews and assessment of the activities shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission. The Commission may make recommendations for adjustments to the monitoring plans. The Member State concerned shall make a summary of the results and of the Commission’s recommendations accessible to the public.
Amendment 80 #
2012/0192(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation, and approval by an ethics committee prior to commencement.
Amendment 253 #
2012/0192(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Ethics Committee 1. Authorisation of a clinical trial shall not be granted before an independent ethics committee has made a positive decision on the clinical trial. The Ethics Committee assessment shall include, in particular, the compliance with the requirements specified in Chapter V, Article 46, Article 47 and Chapter XII. 2. The Ethics Committee shall ensure that the rights, safety and well-being of subjects are protected. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and shall abide by all relevant international norms and standards. The Ethics Committee shall consist of a reasonable number of members, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed trial. 3. Member States shall take the necessary measures to establish Ethics Committees and facilitate their work.
Amendment 260 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The sponsor shall propose one of the Member States concerned as reporting Member StateMember States concerned shall determine which state shall be the reporting Member State according to an established procedure based on objective criteria which are set by the Commission.
Amendment 264 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 269 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within six14 days following submission of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 276 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 214 days, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 280 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 3
Article 5 – paragraph 4 – subparagraph 3
Where the proposed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within threeseven days following receipt of the comments or of the completed application, the application shall be considered complete, the clinical trial shall be considered as falling within the scope of this Regulation, the clinical trial shall be considered as a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 310 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 10 days from the validation date25 days, but no earlier than 15 days after receipt of the successfully validated application, for low-intervention clinical trials;
Amendment 313 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 25 days from the validation date35 days but no earlier than 20 days after receipt of the successfully validated application for clinical trials other than low- intervention clinical trials;
Amendment 317 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 30 days from the validation date40 days but no earlier than 30 days after receipt of the successfully validated application for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 321 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, it shall state the reasons for this deviation in the assessment report.
Amendment 359 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 3 a (new)
Article 8 – paragraph 2 – subparagraph 3 a (new)
Notwithstanding the first and second subparagraphs, in case of other conflict, the Member States involved shall attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision on the conclusion after having heard the Member States involved, and, if appropriate, having taken advice from the European Medicines Agency.
Amendment 375 #
2012/0192(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons, including a significant number of medical doctors, who collectively have the necessary qualifications and experience.
Amendment 409 #
2012/0192(COD)
Proposal for a regulation
Article 15
Article 15
A substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this Chapter, and if it has been approved by an independent ethics committee before its implementation.
Amendment 412 #
2012/0192(COD)
Proposal for a regulation
Article 17 – paragraph 2 – introductory part
Article 17 – paragraph 2 – introductory part
2. Within fourten days following submission of the application dossier, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 425 #
2012/0192(COD)
Proposal for a regulation
Article 20 – paragraph 5 – subparagraph 2
Article 20 – paragraph 5 – subparagraph 2
Notification shall be done by way of one single decision within ten days from the validation dateassessment date according to Article 6 (4).
Amendment 454 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 1 – point d
Article 28 – paragraph 1 – point d
(d) the subject or, where the subject is not able to give informed consent, his or her legal representative has had the opportunity, in a prior interview with a medical doctor who is the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the clinical trial, and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment;
Amendment 460 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Any subject or his legal representative may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent. The withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal.
Amendment 463 #
2012/0192(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Informed consent shall be written, dated and signed and given freely by the subject or his or her legal representative after having been ducomprehensively and comprehensibly informed of the nature, significance, implications and risks of the clinical trial, and after having received the corresponding information in writing. It shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witness may be given in exceptional cases. The subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given.
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 513 #
2012/0192(COD)
Proposal for a regulation
Article 32 – paragraph 1 – point e
Article 32 – paragraph 1 – point e
(e) the Ethics committee positively assesses that a direct benefit of the clinicial trial for the patient is to be expected, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject.
Amendment 532 #
2012/0192(COD)
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
3. Within one year from the end of a clinical trial, the sponsor shall submit to the EU database and to the public EudraPharm database a summary of the results of the clinical trial.
Amendment 570 #
2012/0192(COD)
Proposal for a regulation
Article 40 – paragraph 2 a (new)
Article 40 – paragraph 2 a (new)
2 a. The responsible Ethics Committee shall be involved in the assessment of this information.
Amendment 90 #
2012/0042(COD)
Proposal for a decision
Recital 4
Recital 4
(4) (4) LULUCF accounting rules 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 rules applicable on a mandatory basis to the forestry activities of afforestation, reforestation, deforestation and forest management, and. It should also provide for accounting rules 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 as well as revegetation and wetland drainage and rewetting activities.
Amendment 117 #
2012/0042(COD)
Proposal for a decision
Recital 12
Recital 12
(12) Member State LULUCF Action Plans should set out measures to limit or reduce emissions and to maintain or increase removals from the LULUCF sector. Each LULUCF Action Plan should contain certain information as specified in this Decision. Moreover, to promote best practice, an indicative list of measures that may also be included in those plans should be set out in Annex to this Decision. The Commission should periodically evaluate the content and implementation of Member States’ LULUCF Action Plans and, where appropriate, provide practicable recommendations to enhance Member State action.
Amendment 169 #
2012/0042(COD)
Proposal for a decision
Article 3 – paragraph 1 – subparagraph 1 – point e
Article 3 – paragraph 1 – subparagraph 1 – point e
Amendment 178 #
2012/0042(COD)
Proposal for a decision
Article 3 – paragraph 1 – subparagraph 1 – point f
Article 3 – paragraph 1 – subparagraph 1 – point f
Amendment 186 #
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 and grazing land management, revegetation, and wetland drainage and rewetting.
Amendment 249 #
2012/0042(COD)
Proposal for a decision
Article 8 – paragraph 1
Article 8 – paragraph 1
1. InWhere a Member State draws up and keeps accounts relating to cropland management and grazing land management, Member Statesit shall 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 293 #
2012/0042(COD)
Proposal for a decision
Article 10 – paragraph 3 – subparagraph 1
Article 10 – paragraph 3 – subparagraph 1
The Commission shall evaluate a Member State’s draft LULUCF Action Plan within three months of receiving all relevant information from that Member State. The Commission shall publish the results of that evaluation and may issue practicable recommendations, as appropriate, with a view to enhance Member States’ efforts to limit or reduce emissions and maintain or increase removals.
Amendment 301 #
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 ofnote 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 evaluation.
Amendment 310 #
2012/0042(COD)
Proposal for a decision
Article 10 – paragraph 5 – subparagraph 2
Article 10 – paragraph 5 – subparagraph 2
The Commission shall publish those reports and the results of that evaluation and may issue practicable recommendations, as appropriate, with a view to enhance Member States’ efforts to limit or reduce emissions and maintain or increase removals. Member States shall take due account of the Commission’s findings.
Amendment 180 #
2012/0039(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Maximum number of pet animals (1) The number of pet animals of the species listed in Part A of Annex I which may accompany the owner or an authorised person in the course of an individual movement may not exceed five. (2) By way of derogation from paragraph 1, the number of pet animals of the species listed in Part A of Annex I may exceed five if: a) the non-commercial movement of pet animals is for the purpose of participating in competitions, exhibitions or sporting events or in training for these events; and b) the owner or the authorised person is able to submit a written invitation and a written registration document to the event to be attended under point (a), or has written evidence to prove that the pets are registered with an association that organises events mentioned under point (a). (3) The Commission shall submit a report to the European Parliament and the Council on the implementation of this Regulation not later than 5 years after the entry into force of this Regulation. The Commission shall, where necessary, propose amendments to the Regulation on the basis of its report.
Amendment 194 #
2012/0039(COD)
Proposal for a regulation
Article 17
Article 17
(1) The implantation of a transponder shall be carried out by an approved veterinarian. (2) By way of derogation from paragraph 1, Member States shallmay lay down rules on the minimum qualifications required for the persons carrying out the implantation of transponders in pet animals under the supervision of an authorised veterinarian.
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 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 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 30 #
2011/2307(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes and supports the EU biodiversity strategy to 2020, including its targets and actions; considers, nevertheless, that some actionsthe effectiveness of the actions taken to date should be strengtheexamined;
Amendment 97 #
2011/2307(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Notes the requirement under the CBD to restore 15 % of degraded ecosystems by 2020; considers, however, that this is a minimum and that the EU should have its own, more ambitious target and long-term vision; calls, therefore, on the EU to set higher targets for the restoration of 30 % of degraded ecosystems as its target forby 2020, and urges the Commission to define clearly what is meant by ‘degraded ecosystems’ and to set a baseline against which progress can be measured;
Amendment 143 #
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 the environment and therefore of biodiversity in the wider farmed landscape, improving connectivity and adapting to the effects of climate change; welcomacknowledges the Commission’s CAP reform proposal that provides for a ‘greening’ of the CAP through the allocation of 30 %part of Pillar I payments to a package of worthwhile, basic good 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 Commissioneasures proposed by the Commission should be amended and made less bureaucratic and more flexible;
Amendment 162 #
2011/2307(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls for all CAP payments, to continue to be underpinned by robust cross-compliance rules,; covering the Water Framework Directive, pesticides legislalls for a limitation and significant simplification andof the Birds and Habitats Directivse rules;
Amendment 173 #
2011/2307(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls for a strengthening of Pillar II and for drastic improvements to the environmental focus of that pillar in all Member States and the effectiveness of its agro-environmental measures, including through minimum mandatory spending on environmental measures;
Amendment 187 #
2011/2307(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
Amendment 190 #
2011/2307(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Requests the Commission and Member States to take advantage ofexamine the phenomenon of land abandonment in various parts of Europe to rewild large parts of the landscape as major wilderness areas, providing new socio-economic opportunities for rural development whilst preserving Europe’s and to introduce measures that will lead to further agricultural use in accordance with biodiversity principles;
Amendment 275 #
2011/2307(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. With a view to ensuring adequate financing of the Natura 2000 network, calls on the Commission and the Member States to ensure that at least €5.8 billion per yeardequate funding is provided through EU and Member State fundingas part of budgetary discussions; calls, further, on the Commission and the Member States to ensure that adequate funding is made available through various EU funds (for example through the CAP funds, the European Maritime and Fisheries Fund, the cohesion funds and the LIFE+ fund);
Amendment 22 #
2011/2194(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Considers that the 7th EAP should be an overarching framework that makes it possible to deal with both persistent and emerging environmental challengeschallenges with due regard to existing and planned measures;
Amendment 39 #
2011/2194(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Invites the Commission to include in the 7th EAP binding targets for energy efficiency and/or energy savingstake into account the ongoing discussions on energy efficiency and/or energy savings in the 7th EAP , as set out in the directive on energy efficiency;
Amendment 56 #
2011/2194(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Invites the Commission to already use – and improve – existing resource efficiency indicators where available and set targets without any delay, and to develop as soon as possible new indicators and targets where needed, as requested in the Roadmap;
Amendment 62 #
2011/2194(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Takes the view that the 7th EAP should include objectives on how to specifically deal with urban environmental issuessubsidiarity principle should be applied to a greater extent in the 7th EAP concerning urban environmental issues and that European targets should allow urban areas and other regions sufficient leeway to take measures that reflect the conditions in the respective area;
Amendment 69 #
2011/2194(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Considers that the 7th EAP should provide for full attainment of the goals for sustainable and ecological consumption and production set in the Roadmap, strengthening them where needed, in particular as regards Green Public Procureand that this should be dealt with in the context of general social developments;
Amendment 78 #
2011/2194(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Takes the view that the 7th EAP should provide for full implementation of waste legislation and, by paying particular attention to the 5-stage waste hierarchy, should set very ambitious targets, including a net decrease ofin waste generation and ‘zero landfill’, without driving waste incinerationa strict ban on the dumping of segregated waste in landfills;
Amendment 87 #
2011/2194(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
Amendment 114 #
2011/2194(INI)
Motion for a resolution
Paragraph 20 – indent 3
Paragraph 20 – indent 3
– provide for the development of specific measures relatto examinge to emerging health threatshe effects of new developments on human and animal health, such as nanomaterials or the combination effects of chemicals
Amendment 131 #
2011/2194(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Considers it essential to strengthen the European Union Network for the Implementation and Enforcement of Environmental Law (IMPEL) and urges the Commission to report on possible ways of doing so, including the establishment of a Community environmental inspection force and capacity-building, and asks the Commission to submit a proposal for a directive on environmental inspectionso;
Amendment 143 #
2011/2194(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Takes the view that integrating environmental considerations into other relevantare gaining increasing importance in other sectoral policies – in particular agriculture, fisheries, cohesion policy, transport, industry, energy, trade, employment and research – should be a key priority of the 7th EAPand, accordingly, it would be desirable to integrate environmental considerations into other sectoral policies;
Amendment 148 #
2011/2194(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Invites the Commission to develop indicatorinvestigate whether indicators can be developed without additional expenditures in order to be able to measure improvement of integration;
Amendment 149 #
2011/2194(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Urges the Commission to include in its 7th EAP proposal an aggregated list of allmeasures to establish coherence between the existing environment-related targets for the different policy areas, notably climate change, biodiversity, transport, energy, agriculture, fisheries and cohesion policy, and examine them in conjunction with each other, so as to allow for an appropriate comparison and to ensure that objectives are coherent;
Amendment 153 #
2011/2194(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Takes the view that the 7th EAP should include a strict and detailed plan for the phasing-out of all environmentally harmful subsidies by 2020, in order to respect the Nagoya commitmenttake into account the Nagoya commitments, particularly when granting subsidies;
Amendment 165 #
2011/2194(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Takes the view that the 7th EAP should aim at supporting the development of alternative models to measure growth and welfare ‘beyondthat supplement the GDP’;
Amendment 18 #
2011/2071(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Calls on the Commission, therefore, to propose legally binding national targets for energy efficiency now, taking into account the individual starting points of the Member States, their economic performance and early action undertaken in the fieldreview the European targets for energy efficiency and ensure that targets are translated fully into practice in the Member States;
Amendment 13 #
2011/2068(INI)
Motion for a resolution
Recital C
Recital C
C. whereas intense resource use and dramatically increased global consumption are pushing up prices of raw materials, with real commodity prices having increased by 147% since the turn of the century; whereas the EU is likely to face severe challenges in securing access to, and the uninterrupted supply of, key resources; whereas efficient use of raw materials in industry and at political level is recognised to be crucial to meeting these challenges;
Amendment 47 #
2011/2068(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Calls on the Commission and Member States to stimulate theremove the obstacles to a functioning secondary raw materials market and to foster the demand for recycled materials by developing further end-of- waste criteria and economic incentives, such as reduced VAT rates for secondary materials, by 2013; calls also therefore for the creation of a ‘Schengen area’ for waste in order to move waste for recycling more freely between the Member States;
Amendment 65 #
2011/2068(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Urges the Commission to boost research and technological innovation to speed up the transition to a green economy; underlines that the ‘Innovation Union’, especially the European innovation partnership on raw materials, is one of the engines for a resource-efficient Europe;
Amendment 84 #
2011/2068(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission, before taking any steps to extend the scope of the eco- design directive to non- energy-related products and, to come forward with additional eco-design requirements on the performance of products, including recycled content, durability and reusability, arry out a thorough implementation review of the directive as it stands, focusing order to improven the impact on their environmental impact and promote recycling, the economy, and the operating efficiency of the markets;
Amendment 124 #
2011/2068(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Calls on the Commission, as regards the choice of means, to give preference to incentives and voluntary solutions over state regulation;
Amendment 176 #
2011/2068(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on the Commission and the Member States to increase the transparency of publicly financed research, remove the bureaucratic obstacles to participation in research programmes aimed at enhancing resource efficiency, and involve SMEs to more useful effect in innovation research;
Amendment 178 #
2011/2068(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Calls on the Commission and the Member States, together with the business community and civil society, to devise strategies to foster continuing acceptance of technology and innovation;
Amendment 180 #
2011/2068(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 200 #
2011/2068(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Urges the Commission and Member States to present concrete plans for phasing out all environmentally harmful subsidies before 2020;
Amendment 206 #
2011/2068(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls on the Commission and Member States to assess the economic value of ecosystems and integrate these values into reporting and accounting systems by 2015give more active support to research into ecosystem service assessment methods;
Amendment 219 #
2011/2068(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission to start pilot projects for several resources, e.g. phosphorous, to reach 100%a reuse rate in 2020 that is high as is reasonable, taking into account the outlay of expenditure; emphasises that these pilot projects should receive direct funding from structural funds;
Amendment 230 #
2011/2068(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Highlights the importance of sustainable agriculture, dietary changes to reduce animal protein intake and diminishing imported land use;
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 17 #
2011/2051(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Calls forRecognises that the post-2013 CAP to eliminate all export subsidiwill further reduce all export subsidies – albeit with the proviso that other trading partners (particularly the USA, Canada, Australia and New Zealand) also bring their export support into line with WTO rules – and to decouple direct payments from production, so as to create a levelmake the playing field between EU and developing countries' and EU agricultural products more level; asks the Commission to finance transitional schemes for crops affected by this decoupling, aimed at promoting organic and sustainable farming practices;
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 21 #
2011/2051(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Stresses that greater coherence is needed between the CAP, trade policy and development policy in order to ensure effective development cooperation; also notes that the EU needs to coordinate more effectively with non-state organisations, including the FAO, the United Nations and other international bodies;
Amendment 22 #
2011/2051(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Considers that the CAP plays an important role in relation to development policy, particularly in the area of food security; points out that the CAP has a contribution to make to meeting increased world demand for food;
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 30 #
2011/2051(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. To alleviate the accumulated negative impacts of CAP on developing countries, cCalls on the EU through its trade and development policies to promote sustainable farming practices and food sovereignty in developing countries; safeguardpromoting food security for LDCs and Net Food Importing Developing Countries, and working towards eliminating land grabbing, securtowards guaranteeing the property rights of smallholders, and indigenous farmers, and towards prevendting seed monopolies and dependency on specialised pesticides are essential;
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 41 #
2011/2051(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Takes the view that, in the context of tackling international speculation in agricultural commodity prices, the new CAP should establish appropriate mechanisms and rules to govern trade in agricultural commodity derivatives and enhance transparency; believes that the EU should lead by example, by establishing within its territory local auctioning agricultural markets and local distribution systems, which increase the bargaining power of smallholders in the food supply chainadvocates a worldwide notification system for agricultural stocks; observes that consideration should be given to maintaining stocks of vital agricultural commodities;
Amendment 46 #
2011/2051(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Asks for a radical changen examination to be made tof the negotiating text of the EU-Mercosur agreement, in response to the Commission's impact assessment that warns of a widespread increase ofin illegal logging and illegal industrial farming, at the expense of the rural communities and the environment, andwhich may lead to the loss of millions of rural jobs in Europe, hindering the effectiveness of the CAP.
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 82 #
2011/2051(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Points out that a majority of Europeans currently oppose the use of GMOs in agriculture and food; asks the Commission, therefore, to study the possibility of denying funding to agricultural undertakings involved with GMOsstresses that a uniform EU-wide approach must be found;
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 68 #
2011/0428(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions "Roadmap to a Resource Efficient Europe" (hereinafter the "Roadmap to a Resource Efficient Europe") has set forth the milestones and actions that are needed tocould help put the Union on a path to a resource-efficient and sustainable growth. Therefore, the priority area Environment and Resource Efficiency should support effective implementation of Union environmental policy by the public and private sectors, in particular in the environmental sectors covered by the Roadmap to a Resource Efficient Europe, by facilitating the development and sharing of new solutions and best practices. However, it should exclude those eco- innovation activities that overlap with Horizon 2020.
Amendment 129 #
2011/0428(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
(c) to promote and contribute to a more effective compliance with and enforcement of existing Union environmental legislation in all Member States, in particular by promoting the development and dissemination of best practices and policy approaches;
Amendment 178 #
2011/0428(COD)
Proposal for a regulation
Article 20 – paragraph 2 – subparagraph 1
Article 20 – paragraph 2 – subparagraph 1
Amendment 154 #
2011/0280(COD)
Proposal for a regulation
Recital 15
Recital 15
Amendment 173 #
2011/0280(COD)
Proposal for a regulation
Recital 16
Recital 16
Amendment 706 #
2011/0280(COD)
Proposal for a regulation
Article 11
Article 11
Amendment 23 #
2011/0229(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) Given the technological advances in EID, several Member States have decided to start to implement bovine EID on a voluntary basis. Those initiatives are likely to lead to different systems to be developed in individual Member States or by stakeholders. Such a development would impede later harmonisation of technical standards within the Union. It must be ensured at an early stage that the systems introduced in the Member States are interoperable.
Amendment 36 #
2011/0229(COD)
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) In order to be able to apply identification systems in a harmonised manner in future, it is desirable that, after a transitional period, the use of electronic identifiers, which has previously been voluntary, should become compulsory in all Member States.
Amendment 59 #
2011/0229(COD)
Proposal for a regulation
Article 1 – point 3
Article 1 – point 3
Regulation (EC) No 1760/2000
Article 4 – paragraph 2 – subparagraph 1
Article 4 – paragraph 2 – subparagraph 1
2. Member States may, within a transitional period of five years after the entry into force of this Regulation, introduce national provisions to make compulsory the use of an electronic identifier as one of the two means of identification provided for in paragraph 1. After the expiry of this transitional period, at the latest, the use of an electronic identifier as one of the two means of identification provided for in paragraph 1 shall be compulsory.
Amendment 60 #
2011/0229(COD)
Proposal for a regulation
Article 1 – point 3
Article 1 – point 3
Regulation (EC) No 1760/2000
Article 4 – paragraph 2 – subparagraph 2
Article 4 – paragraph 2 – subparagraph 2
Amendment 63 #
2011/0229(COD)
Proposal for a regulation
Article 1 – point 3 a (new)
Article 1 – point 3 a (new)
5a. The Commission shall ensure that the national identifiers used are interoperable.
Amendment 86 #
2011/0229(COD)
Proposal for a regulation
Article 1 – point 14
Article 1 – point 14
Regulation (EC) No 1760/2000
Articles 16 - 18
Articles 16 - 18
Amendment 327 #
2011/0196(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
Regulation (EC) No 561/2006
Article 13 – paragraph 1 – points d, f und p
Article 13 – paragraph 1 – points d, f und p
The distance of ‘50 km’ referred to in points (d), (f) and (p) of Article 13(1) is replaced by ‘1200 km’.
Amendment 1 #
2010/2249(INI)
Motion for a resolution
Citation 5
Citation 5
– having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin*1 and the report from the Commission to the Council and the European Parliament on the experience gained from the application of the hygiene Regulations (COM(2009)403),
Amendment 2 #
2010/2249(INI)
Motion for a resolution
Citation 7
Citation 7
– having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules*, 1 OJ L 226, 25.6.2004, p.22. 2 OJ L 165, 30.4.2004, p.1.2 and the report from the Commission to the Council and the European Parliament on the application of that Regulation (COM(2009)334), Or. de
Amendment 3 #
2010/2249(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the number of positive BSE cases in the EU has decreased from 2167 cases in 2001 to 67 cases in 2009 (excluding the UK); whereas, in the light of this decreasing number of cases, the legislation implemented during this period can be viewed as having contributed to the eradication of BSE and other TSEs in the EU and whereas, hand-in-hand with this declining epidemiological trend, the legislative provisions should be adapted in line with the actual situation in terms of risk,
Amendment 4 #
2010/2249(INI)
Motion for a resolution
Recital C
Recital C
C. whereas, in view of the continuous declining number of BSE cases, the legislation on TSEs has been modified in recent years and consideration could be given to future changes while ensuring and maintaining the high level of animal and public health in the European Union; whereas these changes could include measures relating to SRM removal, review of the total feed ban provisions, eradication of scrapie, cohort culling and surveillance,
Amendment 7 #
2010/2249(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. UrgesCalls on the Commission to increase the age limits in the 5 remaining Member States only if supported by sound risk assessments in order not to jeopardise a show that the high level of animal health and consumer protection is not being jeopardised;
Amendment 8 #
2010/2249(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Underlines that the surveillance mechanism is an important instrument in monitoring TSE in the EU; expresses its concern aboutconsiders another rise in the age limits for testing in bovine animals in view in particular of the sample size testing whichpossible, provided that the epidemiological trend for BSE permits this without any increased health risk, and is in favour of risk-based testing, for example in the form of the testing of a sample of animals, such as will govern the BSE monitoring system in bovine animals from January 2013; calls on the Commission to inform Parliament about progress and new findings on the sample sizes to be chosen;
Amendment 11 #
2010/2249(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Supports - particularly in the light of the existing protein deficit in the EU - the Commission proposal to lift the feed ban provisions forprovisions banning the feeding of processed animal proteins to non-ruminants, provided that: – the processed animal proteins are only derived from species which are not linked to TSEs, – the production and sterilizsation methods used for processed animal proteins comply with the highest safety standards and with the rules laid down in the animal by-products Regulation and use the newest and safest technology available, that– the existing prohibitions on intra-species recycling ("‘cannibalism"’) remain in place, that– production channels ofor processed animal proteins derived from different species be completely separated, that– the separation of these production channels be controlled by the competent authorities in the Member States and audited by the Commission, that– before the lifting of the feed ban is implemented, a reliable species specific method is in place to identify the species origin of the proteins in animal feed containing processed animal proteins so that intra-species recycling and the presence of ruminant processed animal proteins can be excluded, that the production of processed animal proteins from category 1 or– in accordance with the animal by-products Regulation (Regulation (EC) No 1069/2009), only category 23 material be prohibited and that only category 3 material fit for human consumption be used for the production of processed animal proteinswhich has undergone veterinary inspection and does not pose a risk to public and animal health be used as starting material;
Amendment 15 #
2010/2249(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission to investigate the need for priorseparate authorisation for slaughterhouses in which produceboth non- ruminant and ruminant animal by-products are produced, so as to ensure a clear separation of these by-products;
Amendment 20 #
2010/2249(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Urges the Commission not to propose the introduction of a tolerance level for processed animal proteins in feed for farmed (ruminant) animalsIs in favour of setting a tolerance level for insignificant amounts of non-authorised, non-ruminant animal proteins in feedingstuffs caused through adventitious and technically unavoidable contamination, provided that a method of determining the proportion of these proteins is available;
Amendment 26 #
2010/2249(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. DismissesIs in favour of critically examining the Commission proposal to review the current cohort culling policy in BSE infected herds as this would preventthe event of the occurrence of BSE in bovine herds; stresses that, prior to any change to the cohort culling policy, the following aspects: (1) consumer protection, (2) maintaining consumer trust, (3) any risks to human and animal health and (4) continuing to enable risk managers and legislators fromto takinge the necessary immediate action in the case of a re-emergence of BSE in the EU must be taken into consideration;
Amendment 27 #
2010/2249(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. DismisseConsiders the Commission proposal to review the current cohort culling policy in BSE infected herds as this would prevent risk managers and legislators from taking the necessary immediate actionppropriate, provided that possible negative effects on action by risk managers and legislators in the case of a re-emergence of BSE in the EU are taken into account;
Amendment 32 #
2010/2249(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Expresses its concern about the contamination of food and feed, e. g. with dioxin, and cCalls on the Member States to enforce and apply existing regulations on food and feed controls very strictly and if needed, to strengthen those rules;
Amendment 34 #
2010/2249(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
Amendment 35 #
2010/2249(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Expresses its concern about current rules for the use of animal by-products in biogas plants and possibleCalls on the Commission and the Member States to take measures to ensure that the requirements laid down in Regulation (EC) No 1069/2009 and in implementing Regulation (EU) No 142/2011 relating to the treatment of animal by-products prior to their transformation into biogas and the use or disposal of digestion residues are complied with and illegal diversion into the feed chain is prevented; urges the Commission to investigate the current rulmonitor the way in which the current rules are implemented in the Member States to ensure a closed circuit for this activity;
Amendment 8 #
2010/2111(INI)
Draft opinion
Paragraph 2
Paragraph 2
Amendment 11 #
2010/2111(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls on the Commission to submit to Parliament a report on the current use of slaughter waste, swill and meat and bone meal in the Member States and propose options for their use as protein sources;
Amendment 12 #
2010/2111(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Supports the Commission in its intention of reviewing the ban on feeding animal protein to non-ruminants subject to compliance with the ban on cannibalism (COM(2010)384 final); advocates the introduction of a tolerance threshold for processed animal proteins, expressly advocates full application of the precautionary principle with regard to the possible use of animal protein for animal feed;
Amendment 30 #
2010/2111(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Emphasizes that the treatment of slaughter offal, swill, meat and bone meal shall meet the existing strict provisions on the protection of human health and environment, also methane emissions stemming from the process shall be reduced; considers that under the current regulatory framework animal-waste is best utilised in biogas production and calls on the Commission and Member States to favour the use of animal-waste for that purpose.
Amendment 48 #
2010/2106(INI)
Motion for a resolution
Recital D
Recital D
D. whereas energy generation from solid biomass and biowaste is projected to be 58% of EU renewables by 2020, leading to an intensification of forestry practices andand whereas the proportion of forestry biomass is likely to fall by comparison with agricultural biomass and biowaste, although increases in the ratio of felling to increment to over 100% can nevertheless not be ruled out,
Amendment 53 #
2010/2106(INI)
Motion for a resolution
Recital E
Recital E
E. whereas forest protection and protection of its functions should be mainstreamed in all EU policies affecting forests,
Amendment 79 #
2010/2106(INI)
Motion for a resolution
Recital I
Recital I
I. whereas the EU FAP has four goals: improving long-term competitiveness, protecting the environment, contributing to quality of life and fostering coordination and whereas significant progress has been made mainly in achieving the firstall the goals,
Amendment 89 #
2010/2106(INI)
Motion for a resolution
Recital L
Recital L
L. whereas genetic selection should not favour performance traits at the expense of adaptive onesbe geared to improving the adaptability of the forest ecosystem,
Amendment 108 #
2010/2106(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Is convinced that ecological, economic and social sustainability is the prerequisite for the continuation of the economic and social functions of EU forests for society, the economy and our environment;
Amendment 123 #
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 goalsgoals of the FAP in line with the recommendations of the mid-term evaluation on the implementation of the FAP, thesince this implementation of which is currently lagging behind;
Amendment 152 #
2010/2106(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. AdvocaNotes that active SFM should be made mandatory in the EU in thethe implementation of SFM by third countext of five-year National Forest Programmes incorporating regional priorities and measurable targets and evaluation criteriaries is also very important, and therefore advocates a legally binding agreement at world level in the context of the UN Forum on Forests;
Amendment 182 #
2010/2106(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls on the Commission to present a legislative proposal for a framework for the climate adaptation of EU forestsMember States, on the basis of the outcome of a debate on forest policy, to propose appropriate measures and instruments to intensify and improve SFM, taking particular account of the need for the climate adaptation of EU forests and the contribution this can make to climate mitigation;
Amendment 205 #
2010/2106(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Urges the Commission to present a legislative proposal, in cooperation with the Member States, to present a suitable strategy for Forest Fire Prevention incorporatingunder which, for instance, funding for the European Forest Fires Information System (EFFIS), infrastructure, training and prevention planning can be proposed;
Amendment 242 #
2010/2106(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
Amendment 275 #
2010/2106(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls on the Commission to develop legally binding sustainability criteria for woody biomass and ILUC factors for all forms of biomass; states that there should first be an assessment of experience with certification of liquid biomass and, with regard to timber, existing certification systems (e.g. TEFC and FSC) should be built on;
Amendment 11 #
2010/2088(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the EU 2020 strategy should pave the way to a resource-efficient economy, serve economic growth and create jobs, in particular since the EU has recently suffered a drop in GDP and falling industrial production, and since millions of unemployed women and men represents a human, societal and economic disasterafter the experiences and consequences of the economic and financial crisis,
Amendment 16 #
2010/2088(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the EU 2020 strategy also requires a newdeeper reflection on the methodology to be used in the context of policy-making, including a more efficient and transparent governance structure as well as effective monitoring and evaluation of policy measures,
Amendment 19 #
2010/2088(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that GDP is an indicator of economic market activity and is widely used in policy analysis and debates; recalls that GDP, after its birth in the 1930s, was rapidly adopted as the best-recognised measure of economic performance in the world; underlines that GDP has become a standard benchmark used by policy-makers throughout the world; is concerned that GDP might sometimes be misleading and at other times simply not provide enough information or sufficiently detailed information for certain purposes;
Amendment 26 #
2010/2088(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Emphasises that GDP is based on a clear methodology which allows comparisons to be made over time and between countries and regions; stresses that it was, however, not intended to be an accurate measure to inform policy debates on all issues; underlines that, critically, GDP doeis not intended to directly measure environmental sustainability, resource efficiency, social inclusion or well-being in general, but does indirectly also cover social and ecological issues; underlines the need to base othersupplementary indicators on a clear and valid methodology;
Amendment 37 #
2010/2088(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Takes the view, in the light of the ever closer degree of interdependence between economic, social and environmental issues, that GDP is the only indicator which makes it possible to take proper account of differing socioeconomic characteristics at European level, but emphasises the need to take account of environmental and social factors at national and regional level and to determine suitable criteria for that purpose;
Amendment 44 #
2010/2088(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Considers that GDP is the key indicator for measuring and comparing regional imbalances at European level; does, however, regard the newly-proposed environmental and social criteria for measuring regional prosperity (income distribution, degree to which a region is affected by climate-related problems, gender equality, unemployment, etc.) as a significant addition to the economic criteria;
Amendment 47 #
2010/2088(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. WelcomesTakes note of the growing international recognition of limits to GDP as an indicator for human well-being and sustainable development; acknowledges progress made in different fora, such as the UNDP, World Bank, OECD and Commission, on the development of indicators to measure and analyse progress in policy-making; takes note of indicators developed already for various policy areas; notes, however, that there seem to be many indicators already in use, sometimes even overlapping or competing where they should instead be coordinated or combined; emphasises that there are currently too many indicators and the challenge is to develop a clear and comprehensible policy that is at the same time theoretically consistent, politically relevant and empirically measurable and ensures comparability between countries and regions; stresses the need for this work to be done in close cooperation with other relevant institutions and organisations;
Amendment 54 #
2010/2088(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Underlines the need to keep costs at a reasonable and appropriate level and to also weigh the potential gains of Beyond GDP against the cost associated with it; stresses the importance of budgetary constraints and the necessity of timely impact assessment;
Amendment 77 #
2010/2088(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to step up its efforts in this field by assessingidentify its budgetary needs andin order to provideesent a comprehensive tiered approach that is applicable in day-to-day political work and decision-making, including decisions related to political strategies, financing, legislation and ex- post evaluation; considers that future policies should be based on data that is rigorous, timely, fit for purpose and politically accepted and which covers all essential issues;
Amendment 80 #
2010/2088(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Calls on the Commission to carry out an impact assessment before introducing new indicators, in order to estimate the costs and complexity of data collection for the competent authorities and businesses;
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 18 #
2010/0208(COD)
Proposal for a regulation - amending act
Recital 2
Recital 2
(2) Under this set of legislation, GMOs for cultivation shall undergo an individual risk assessment before being authorised to be placed on the Union market. In accordance with the conclusions of the Environment Council of 4 December 2008, this risk assessment should be enhanced, particularly by taking better account of regional and local circumstances in the context of the assessment by the European Food Safety Authority. The aim of this authorisation procedure is to ensure a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, whilst ensuring the effective functioning of the internal market. The same high level of protection of health and the environment should be sought and maintained throughout the territory of the Union.
Amendment 25 #
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 iIssues related to the placing on the market and the import of GMOs, which should remain regulated at EUnion level to preserve the internal market, c. Cultivation has been acknowledged as an issue with a strong local/regional dimension. In accordance with Article 2(2) TFEUmight require more flexibility in certain instances as it is an issue with a strong local/regional dimension. However, the common authorisation procedure should not be adversely affected by such flexibility. In accordance with Article 2(2) of the Treaty on the Functioning of the European Union, Member States should therefore be entitled to have a possibility to adopt rules concerning the effective cultivation of GMOs in their territory after the GMO has been legally authorised to be placed on the EUnion market, provided that those rules do not adversely affect the free movement and marketing of GMO products and seeds.
Amendment 32 #
2010/0208(COD)
Proposal for a regulation - amending act
Recital 6
Recital 6
(6) In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more freedom to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are entitled to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products. This freedom of action for Member States must not result in distortion of competition between farmers in different Member States of the Union and between the various methods of cultivation (organic, conventional, with GMOs and others).
Amendment 33 #
2010/0208(COD)
Proposal for a regulation - amending act
Recital 6
Recital 6
(6) In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more freedom to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are entitled to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products. This freedom granted to Member States should not result in any distortion of competition between farmers in the various Member States.
Amendment 34 #
2010/0208(COD)
Proposal for a regulation - amending act
Recital 7
Recital 7
(7) Member States should therefore be authorised to adopt measures restricting or prohibiting the cultivation of all or particular GMOGMOs on a case-by-case basis in all or part of their territory, and respectively amend those measures as they deem appropriate, at all stages of the authorisation, re-authorisation or withdrawal from the market of the concerned GMOs. Thi, provided that those measures are adopted and made publicly available to all operators concerned, including growers, at least twelve months before the beginning of the growing season. These measures should not imperil the objective of harmonising the legislation of Member States as provided for in Directive 2001/18/EC and Regulation (EC) No 1829/2003. The possibility of adopting these measures should apply as well to genetically modified varieties of seed and plant propagating material which are placed on the market in accordance with relevant legislation on the marketing of seeds and plant propagating material and, in particular, in accordance with Directives 2002/53/EC and 2002/55/EC. Measures should refer to the cultivation of GMOs only and not to the free circulation and import of genetically modified seeds and plant propagating material, as or in products, and of the products of their harvest. Similarly they should not affect the cultivation of non -genetically modified varieties of seed and plant propagating material in which adventitious or technically unavoidable traces of EU authorised GMOs are found.
Amendment 40 #
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 EUnion cannot be revised by a Member State and this situation mustshould not be altered. However, Member States may adopt measures restricting or prohibiting the cultivation of all or particular GMOGMOs on a case-by-case basis in all or part of their territory on the basis of scientifically substantiated grounds relating to the public interest other thandifferent from those already addrssessed byin accordance with the harmonised set of EUUnion rules which already provide for procedures to take into account the risks that a GMO for cultivation may pose on health and the environment. A prior impact assessment should be performed to demonstrate the necessity and proportionality of these measures. These grounds must depend on factors associated with the management of risks or with other national policies. 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. These measures should also respect the principle of proportionality and the freedom of choice of farmers and consumers. In order to attain the latter objective, the period for which the measures adopted by Member States are to remain in force should be limited to three years, and they should be renewable only on condition that a new impact assessment is performed showing that they are necessary and proportionate. The Commission should assess the need for the establishment of thresholds for labelling GMO traces in conventional seeds at the lowest practicable, proportionate and functional levels for all economic operators.
Amendment 64 #
2010/0208(COD)
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – introductory part
Article 26 b – paragraph 1 – introductory part
Member States may adopt measures restricting or prohibiting the cultivation of all or particular GMOs authorised in accordance with Part C of this Directive or Regulation (EC) No 1829/2003, and consisting of genetically modified varieties placed on the market in accordance with relevant EU legislation on the marketing of seed and plant propagating material, on a case-by-case basis, in all or part of their territory, provided that:
Amendment 83 #
2010/0208(COD)
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a
Article 26 b – paragraph 1 – point a
(a) those measures are scientifically based on grounds other than those related to the assessmentscientific assessment conducted under Part C of Directive 2001/18/EC of the adverse effect on health and environment which might arise from the deliberate release or the placing on the market of GMOs. These measures shall be justified on the following grounds relating to national and/or regional policy: (i) protecting crop diversity; (ii) the impossibility of establishing coexistence measures on account of specific geographical conditions (for example very small islands, mountain regions and/or areas of high nature value, or where the national territory is small); (iii) the absence of data on the potential negative impacts of the release of GMOs on the territory or biodiversity of a region;
Amendment 87 #
2010/0208(COD)
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a a (new)
Article 26 b – paragraph 1 – point a a (new)
(aa) those measures ensure that the freedom of choice of farmers and consumers is duly respected;
Amendment 88 #
2010/0208(COD)
Proposal for a regulation – amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a b (new)
Article 26 b – paragraph 1 – point a b (new)
(ab) those measures do not entail any distortion of competition between farmers in different Member States;
Amendment 94 #
2010/0208(COD)
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a a (new)
Article 26 b – paragraph 1 – point a a (new)
(aa) those measures are adopted and made publicly available to all operators concerned, including growers, at least twelve months prior to the start of the growing season;
Amendment 99 #
2010/0208(COD)
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a c (new)
Article 26 b – paragraph 1 – point a c (new)
(ac) those measures have been the subject of a prior impact assessment showing them to be necessary and proportionate;
Amendment 104 #
2010/0208(COD)
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point ad (new)
Article 26 b – paragraph 1 – point ad (new)
(ad) those measures are adopted for a maximum of three years, and may where appropriate be renewed following the conclusion of a new impact assessment showing that they are necessary and proportionate;
Amendment 107 #
2010/0208(COD)
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point b
Article 26 b – paragraph 1 – point b
(b) that they are in conformity with the Treaties and the Union's international obligations.
Amendment 109 #
2010/0208(COD)
Proposal for a regulation - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 2
Article 26 b – paragraph 2
Amendment 34 #
2010/0195(COD)
Proposal for a directive - amending act
Recital 5
Recital 5
(5) During the transition from Stage III A to Stage III B, the percentage of the number of engines used for application other than propulsion of railcars and, locomotives and inland waterways vessels placed on the market under the flexibility scheme, should be increased from 20% to 50% of the equipment manufacturer's annual salesquantity of equipment placed on the market with engines in that category. The maximumoptional alternative that a fixed number of engines that may be placed on the market under the flexibility scheme should be adapted accordingly.
Amendment 38 #
2010/0195(COD)
Proposal for a directive - amending act
Recital 6
Recital 6
(6) The rules applicable to the flexibility scheme should be adapted to extend theits application of that scheme to engines for use in propulsion of railcars and locomotives.
Amendment 44 #
2010/0195(COD)
Proposal for a directive - amending act
Recital 7
Recital 7
(7) The measures provided in this Directive reflect a temporary difficulty faced by the manufacturing sector. They should therefore be restricted to the transition from Stage III A to Stage III B and expire by 31 December 2013 at the latest; as such, these shall be restricted to Stage III B.
Amendment 50 #
2010/0195(COD)
Proposal for a directive - amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 97/68/CE
Article 2 - last indent
Article 2 - last indent
(-1) In Article 2, the last indent is replaced by the following: – flexibility scheme shall mean the exemption procedure whereby a Member State allows placing on the market of a limited quantity of engines according to Article 10.
Amendment 52 #
2010/0195(COD)
Proposal for a directive - amending act
Article 1 – point -1 a (new)
Article 1 – point -1 a (new)
Directive 97/68/CE
Article 2 - new indent
Article 2 - new indent
(-1a) In Article 2 the following new indent is added: – engine category shall mean the engine classification combining the power range, the exhaust emission stage requirements and the engine classification according to Section I of Annex I.
Amendment 55 #
2010/0195(COD)
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 97/68/CE
Article 4 - paragraph 6
Article 4 - paragraph 6
Amendment 69 #
2010/0195(COD)
Proposal for a directive - amending act
Article 1 – point 2 - point a
Article 1 – point 2 - point a
Directive 97/68/CE
Article 10 - paragraph 7
Article 10 - paragraph 7
(7) Member States shall permit the placing on the market of engines, as defined in Section 1 of Annex I under A(i), A(ii), A(iv) and A(v), under the flexibility scheme in accordance with the provisions in Annex XIII. Spark ignited engines, as defined in Section 1 of Annex I under A(iii), and engines for propulsion of inland waterways vessels are excluded from this procedure. The flexibility scheme shall start when placing on the market of engines becomes compulsory for any given Stage and shall have the duration of any given stage, but not more than three years. The engines shall be type approved according to the Stage immediately preceding the one under consideration.
Amendment 72 #
2010/0195(COD)
Proposal for a directive - amending act
Article 1 – point 2 – point b
Article 1 – point 2 – point b
Directive 97/68/CE
Article 10 – paragraph 8
Article 10 – paragraph 8
Amendment 80 #
2010/0195(COD)
Proposal for a directive - amending act
Annex - introductory part
Annex - introductory part
Directive 97/68/CE
-
-
Amendment 82 #
2010/0195(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 97/68/CE
Annex XIII - section 1 - point 1.1.
Annex XIII - section 1 - point 1.1.
1.1. With the exception of the transition period between Stage III A and Stage III B, an OEM that wishes to make use of the flexibility schemeAn OEM that wishes to make use of the flexibility scheme, with the exception of engines for propulsion of locomotives, shall request permission from any approval authority to purchase from his engine supplifor the OEM’s engine manufacturers, the quantities of engines described in sections 1.1.1. and 1.1.2., that do not comply with the current emission limit values, but are approved to the nearest previous stage of emission limitso place on the market engines intended for the OEM’s exclusive use. With the exception of Stage IIIB, the quantities of engines shall not exceed those described in sections 1.1.1. and 1.1.2.
Amendment 84 #
2010/0195(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 97/68/EC
Annex XIII – section 1 - point 1.1.1.
Annex XIII – section 1 - point 1.1.1.
1.1.1. The number of engines placed on the market under a flexibility scheme shall, in each engine category, not exceed 20 % of the OEM's annual salesquantity of equipment placed on the market with engines in that engine category, (calculated as the average of the latest 5five years sales on the EU market). Where an OEM has. In case an OEM placed on the marketed equipment in the EU for a period offor less than 5five years, the average wishall be calculated based on the period for which the OEM has marketplaced equipment ion the EUmarket.
Amendment 86 #
2010/0195(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 97/68/EC
Annex XIII – section 1 - point 1.1.2
Annex XIII – section 1 - point 1.1.2
1.1.2. As an optional alternative to section 1.1.1. and with the exception of engines for use in propulsion of railcars and locomotives, the OEM may seek permission for hithe OEM’s engine supplimanufacturers to place on the market a fixed number of engines undefor the flexibility schemOEM’s exclusive use. The number of engines in each engine category shall not exceed the following values:
Amendment 89 #
2010/0195(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 97/68/EC
Annex XIII – section 1 - point 1.2.
Annex XIII – section 1 - point 1.2.
1.2 During the transition period from Stage III A to Stage III BBy way of derogation from point 1.1, during Stage III B, but no longer than three years after the beginning of that Stage, with the exception of engines for use in propulsion of railcars and locomotives, an OEM that wishes to make use of the flexibility scheme shall request permission from any approval authority to purchase from his engine suppliers, tfor the OEM’s engine manufacturers to place on the market engines intended for the OEM’s exclusive use. The quantities of engines shall not exceed those described in sections 1.2.1. and 1.2.2., that do not comply with the current emission limit values, but are approved to the nearest previous stage of emission limits.
Amendment 92 #
2010/0195(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 97/68/EC
Annex XIII – section 1 - point 1.2.1.
Annex XIII – section 1 - point 1.2.1.
1.2.1. The number of engines placed on the market under sucha flexibility scheme shall, in each engine category, not exceed 50 % of the OEM's annual salesquantity of equipment placed on the market with engines in that engine category, (calculated as the average of the latest 5five years sales on the EU market). Where an OEM has. In case an OEM placed on the marketed equipment in the EU for a period offor less than 5five years, the average wishall be calculated based on the period for which the OEM has marketplaced equipment ion the EUmarket.
Amendment 96 #
2010/0195(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 97/68/EC
Annex XIII – section 1 - point 1.2.2.
Annex XIII – section 1 - point 1.2.2.
1.2.2. As an optional alternative to section 1.2.1., the OEM may seek permission for hithe OEM’s engine supplimanufacturers to place on the market a fixed number of engines undefor the flexibility schemOEM’s exclusive use. The number of engines in each engine category shall not exceed the following values:
Amendment 99 #
2010/0195(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 97/68/EC
Annex XIII – section 1 - point 1.3.
Annex XIII – section 1 - point 1.3.
Amendment 102 #
2010/0195(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 97/68/EC
Annex XIII – section 1 - point 1.4.
Annex XIII – section 1 - point 1.4.
1.4 As regards engines for use in propulsion of locomotives, during the transition period between Stage III A and Stage III B anthe OEM may seek permission for hithe OEM’s engine supplimanufacturers to place on the market a maximum of 12 engines for use in propulsion of locomotthe OEM’s exclusives under the flexibility schemse.
Amendment 111 #
2010/0195(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 97/68/EC
Annex XIII – section 1 - point 1.5. - introductory part
Annex XIII – section 1 - point 1.5. - introductory part
1.5. The OEM shall include in histhe application to an approval authority the following information:
Amendment 113 #
2010/0195(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 97/68/CE
Annex XIII - section 2
Annex XIII - section 2
2. ACTIONS BY THE ENGINE MANUFACTURER 2.1. An engine manufacturer may place on the market engines under a flexible scheme covered by the permission granted in accordance with Section 1 and 3 of this Annex. 2.2. The engine manufacturer shall mark those engines with the following text: ‘Engine placed on the market under the flexibility scheme’ in conformity with the requirements of Section 3 of Annex I.
Amendment 114 #
2010/0195(COD)
Proposal for a directive - amending act
Annex
Annex
Directive 97/68/CE
Annex XIII - section 3
Annex XIII - section 3
Amendment 48 #
2009/2152(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Emphasises the need to enhance resilience of the agricultural ecosystems by more sustainable use of natural resources, in particular of water and soil;
Amendment 69 #
2009/2152(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Takes the view that a directive on soil would be an essential tool for adaptation, in particular in response to the risk of soil degradation and desertification; therefore urges the Member States to move forward towards the adoption of a directive on soilthe Commission should draw up recommendations for the Member States setting out measures to improve soil quality and prevent desertification;
Amendment 13 #
2009/2105(INI)
Draft opinion
Suggestion 12
Suggestion 12
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 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 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 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 117 #
2009/0076(COD)
Council position
Article 2 – paragraph 8
Article 2 – paragraph 8
(8) Member States may allow for exemptions from this Regulation in specific cases for certain biocidal products, on their own or in a treated article, where necessary in the interests of defence or of animal disease control.
Amendment 107 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 14 a (new)
Recital 14 a (new)
(14a) Counterfeit medicinal products are often found to have been supplied in response to orders placed over the Internet. In accordance with the provisions of the Treaty, particularly Article 168 of the TFEU, Member States are responsible for regulating the marketing of medicinal products at the last level of trade, particularly in pharmacies. This also includes regulating the marketing of medicinal products by mail order and over the Internet. The case law of the Court of Justice permits Member States to impose an absolute ban on the supply of prescription medicines by mail order, in accordance with the wide margin of discretion which they enjoy on account of the dangers associated with this method of marketing.
Amendment 110 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 15 a (new)
Recital 15 a (new)
(15a) It is necessary for the operation of the internal market to establish EU-wide harmonised safety features for medicinal products. The technical implementation of these features and the design of the test methods should, however, be left to the Member States in accordance with the principle of subsidiarity.
Amendment 232 #
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
Article 54a – paragraph 2 – point b
(b) The manufacturing authorisation holder complies with point (o) of Article 54 by replacing the safety feature with a safety feature which is equivalent as regards the possibility to ascertain identification, authenticity and uninterrupted traceability of the medicinal product, and without opening the immediate packaging as defined in Article 1(23). To this effect, the manufacturing authorisation holder shall produce a new outer carton replicating all relevant product and trademark information and subject to carrying safety features as required by Article 54(o); original cartons shall be destroyed;
Amendment 285 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54 a – paragraph 4 – subparagraph 5
Article 54 a – paragraph 4 – subparagraph 5
The measures referred to in this paragraph shall take due account of the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights. It has to be ensured that no collection or commercial processing of data takes place that would enable a link to be made between the medicinal products supplied and the corresponding patients or pharmacies.’
Amendment 320 #
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 2
Article 80 – point i – paragraph 2
Moreover, in cases where these infringements or suspected infringements relate to a falsified medicinal product, the holder of the marketing authorisation or of the trademark that has been falsified shall be informed.’ In the same way, the holder of the marketing authorisation or the trademark shall inform other supply chain operators in cases where it is suspected that falsified products have entered the legal supply chain.
Amendment 44 #
2008/0260(COD)
Proposal for a directive – amending act
Recital 10
Recital 10
(10) In order to make it possible for the healthcare professionals and patients to identify easily the most relevant information about the medicines they use, the summary of the product characteristics and the package leaflet should include a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefitsdescribing the benefits and possible adverse effects of the medicinal product and information aimed at ensuring its safe and effective use.
Amendment 77 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 1 – point a
Article 1 – point 1 – point a
Directive 2001/83/EC
Article 1 – point 11
Article 1 – point 11
Amendment 82 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 1 – point b
Article 1 – point 1 – point b
Directive 2001/83/EC
Article 1 – point 14
Article 1 – point 14
“(14) Suspected adverse reaction: An adverse reaction in respect ofunintended event in which a causal relationship between the event and the medicinal product cannot be excluded.”;
Amendment 149 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 18 – point a
Article 1 – point 18 – point a
Directive 2001/83/EC
Article 59 – paragraph 1 – point aa
Article 59 – paragraph 1 – point aa
“(aa) a summary of the essential information necessary to use the medicinebrief description of the main characteristics of the medicinal product enabling the patient to understand its benefits and possible adverse effects and to use it safely and effectively;”
Amendment 220 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 – paragraphs 1 and 2
Article 107 – paragraphs 1 and 2
1. Marketing authorisation holders shall be required to record all suspected adverse reactions in the Community or in third countries which are brought to their attention, whether reported spontaneously by patients or healthcare professionals or occurring in the context of a post- authorisation safety study. Marketing authorisation holders shall be required to ensure that those reports are accessible at a single point within the Community. By way of derogation to the first subparagraph, suspected adverse reactions occurring in the context of a clinical trial shall be recorded and reported in accordance with Directive 2001/20/EC. 2. The marketing authorisation holder may not refuse reports of suspected adverse reactions received electronically from patients and health-care professionals.
Amendment 234 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 a – paragraph 1 – subparagraph 2
Article 107 a – paragraph 1 – subparagraph 2
Member States shall ensure that reports of such reactions arcan be submitted by means of the national medicines safety web- portals.
Amendment 236 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107 a – paragraph 3
Article 107 a – paragraph 3
3. The Member States shall ensure that reports of medication errors, or of adverse reactions derived from uses outside the authorised summary of the product characteristics, brought to their attention in the framework of suspected adverse reaction reporting for medicinal products are made available to the Eudravigilance database and to any authorities responsible for patient safety within that Member State. They shall also ensure that the authorities responsible for medicinal products within that Member State are informed of any suspected adverse reactions brought to the attention of the authorities responsible for patient safety within that Member State.
Amendment 263 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 23
Article 1 – point 23
Directive 2001/83/EC
Article 116 – paragraph 1
Article 116 – paragraph 1
The competent authorities shall suspend, revoke, withdraw or vary a marketing authorisation if the view is taken that the product is harmful or that it lacks therapeutic efficacy, or that the risk-benefit balance is not positive, or that its qualitative and quantitative composition is not as declared. Therapeutic efficacy shall be considered to be lacking when it is concludedcannot be shown that therapeutic results cannot be obtained from the medicinal product.
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 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 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 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 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 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 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 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 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 108 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 2
Article 1 – point 2
Directive 2001/83/EC
Article 88 – paragraph 4
Article 88 – paragraph 4
4. The prohibition set out in paragraph 1 shall not apply to vaccination campaigns and other campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the Member States.
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 146 #
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;
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 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 140 #
2008/0241(COD)
Proposal for a directive
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
1a. Member States shall ensure that any distributor who cannot prove that the producer of an electrical or electronic appliance has fulfilled its financial or procedural and technical obligations in respect of that appliance shall himself/herself fulfil those obligations or ensure that they are fulfilled before selling the appliance on.
Amendment 143 #
2008/0241(COD)
Proposal for a directive
Article 7 – paragraph 1 b (new)
Article 7 – paragraph 1 b (new)
1b. To establish that the minimum collection rate has been achieved, Member States shall ensure that information on WEEE which: - has been taken to collection facilities in accordance with Article 5(2)(a), - has been taken to distributors in accordance with Article 5(2)(b), - has been separately collected and treated or exported by producers or third parties acting on their behalf, - or has been separately collected and treated, refurbished or exported via any means by other WEEE actor is communicated to them free of charge on annual basis.
Amendment 224 #
2008/0241(COD)
Proposal for a directive
Article 16 – paragraph 2 a (new)
Article 16 – paragraph 2 a (new)
2a. Producers shall be allowed to apply, through the register of one Member State for registration in all the other Member State registers.
Amendment 231 #
2008/0241(COD)
Proposal for a directive
Article 16 – paragraph 4
Article 16 – paragraph 4
Amendment 124 #
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 modules intended for use in a system designed, assembled and installed for permanent operation for power generation for public, commercial and private purposes, provided it can safely be ruled out that the substances used present a risk to people and to the environment;
Amendment 336 #
2008/0240(COD)
Proposal for a directive
Annex VI a (new)
Annex VI a (new)
Annex VIa Applications exempted from the ban in Article 4(1) as regards Category 11 1. Cadmium in thin-film photovoltaic panels based on cadmium telluride
Amendment 61 #
2008/0238(COD)
Proposal for a directive
Recital 2
Recital 2
(2) Risks however are associated with the use of organs in transplantation. The extensive therapeutic use of human organs for transplantation demands that their quality and safety should be such as to minimise any risks associated with the transmission of diseases.
Amendment 68 #
2008/0238(COD)
Proposal for a directive
Recital 7
Recital 7
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 111 #
2008/0238(COD)
Proposal for a directive
Article 3 – paragraph 1 – point r
Article 3 – paragraph 1 – point r
(r) ‘traceability’ means the ability for a competent authority to locate and identify the organ at each stage in the chain from donation to transplantation or disposal, which under specified circumstances in this Directive is authorised to: – identify the donor and the procurement organisation – identify the recipient(s) at the transplantation centre(s) – locate and identify all relevant non- personal information relating to products and materials coming into contact with that organ;
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 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 172 #
2008/0238(COD)
Proposal for a directive
Article 17 – title
Article 17 – title
Amendment 174 #
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 gathered and processed within the scopeframework of this Directive to which third parties have access are rendered anonymous so that neitheror pseudonymous so that donors norand recipients aremain identifiable protected.
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 190 #
2008/0238(COD)
Proposal for a directive
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Member States shall ensure that all exchanges of organs from or to third countries, are authorised by the competent authority.
Amendment 193 #
2008/0238(COD)
Proposal for a directive
Article 21 – paragraph 1 a (new)
Article 21 – paragraph 1 a (new)
1a. Responsibility for authorising organ exchanges with third countries may be transferred by Member States to European organ exchange organisations.
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 55 #
2008/0180(CNS)
Proposal for a regulation
Article 1 – paragraph 1 – subparagraph 2
Article 1 – paragraph 1 – subparagraph 2
However, as regards fish, reptiles, amphibians, crustaceans and cephalopods only Article 3(1) shall apply.
Amendment 61 #
2008/0180(CNS)
Proposal for a regulation
Article 1 – paragraph 2 – point a – sub-point iii a (new)
Article 1 – paragraph 2 – point a – sub-point iii a (new)
(iiia) semi-domesticated deer, shot in the field and processed through a game farm facility
Amendment 84 #
2008/0180(CNS)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1
Article 4 – paragraph 2 – subparagraph 1
2. By way of derogation from paragraph 1, where such methods are prescribquired by religious rites, animals may be killed without prior stunning, provided that the killing takes place in a slaughterhouse and the meat is destined, to the best of the operator’s knowledge, for use by the religious community concerned.
Amendment 87 #
2008/0180(CNS)
Proposal for a regulation
Article 4 – paragraph 2 – point 1
Article 4 – paragraph 2 – point 1
2. By way of derogation from paragraph 1, where such methods are prescribed by religious rites, animals may be killed without prior stunning, provided that the killing takes place in a slaughterhouse and a derogation permit has been obtained.
Amendment 98 #
2008/0180(CNS)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 2 a (new)
Article 4 – paragraph 2 – subparagraph 2 a (new)
The killing of animals without prior stunning shall be carried out in accordance with the rules defined in Annex IVa.
Amendment 111 #
2008/0180(CNS)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The standard operating procedures shall be made available to the competent authority upon request. The official veterinarian shall be notified in writing whenever standard operating procedures have changed.
Amendment 134 #
2008/0180(CNS)
Proposal for a regulation
Article 9 – paragraph 2 a (new)
Article 9 – paragraph 2 a (new)
2a. Animals should only be put in the restraining device when the operator is ready to stun or kill them.
Amendment 158 #
2008/0180(CNS)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Operators shall put in place and implement appropriate monitoring procedures to verify and confirm that: (a) animals for slaughter are effectively stunned in the period between the end of the stunning process and the confirmation of death; and (b) animals must be dead before any other potentially painful carcass-dressing procedure is performed or treatment applied.
Amendment 168 #
2008/0180(CNS)
Proposal for a regulation
Article 14 – paragraph 5
Article 14 – paragraph 5
Amendment 199 #
2008/0180(CNS)
Proposal for a regulation
Article 18 – paragraph 3 – point 2
Article 18 – paragraph 3 – point 2
Certificates of competences shall not be valid for a period exceeding five yearsn unlimited period. Holders of certificates of competence shall be required to undergo regular training.
Amendment 203 #
2008/0180(CNS)
Proposal for a regulation
Article 19 – introductory part
Article 19 – introductory part
For the purpose of Article 54 of Regulation (EC) No 882/2004, the competent authority mayshall in particular:
Amendment 206 #
2008/0180(CNS)
Proposal for a regulation
Article 19 – point a
Article 19 – point a
(a) requestire operators to amend their standard operating procedures and in particular slow down or stop production;
Amendment 218 #
2008/0180(CNS)
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. Until 31 December 2014, Member States may provide for certificates of competence, as referred to in Article 18, to be issued without examination to persons demonstrating relevant uninterrupted professional experience of at least [tenfive] years.
Amendment 227 #
2008/0180(CNS)
Proposal for a regulation
Annex II – point 3.2
Annex II – point 3.2
Amendment 238 #
2008/0180(CNS)
Proposal for a regulation
Annex II – point 7.1
Annex II – point 7.1
7.1 Points 6.1, 6.2, 6.3 and 6.24 shall apply to gas stunning equipment for poultry.
Amendment 254 #
2008/0180(CNS)
Proposal for a regulation
Annex III – point 1.5 – subparagraph 1
Annex III – point 1.5 – subparagraph 1
For the purpose of slaughter, unweaned animals, lactating dairy animals, females having given birth during the journey or animals delivered in containers shall be given priority over other types of animal. If this is not possible, aArrangements shall be made so as to relieve them from their suffering, in particular by:
Amendment 255 #
2008/0180(CNS)
Proposal for a regulation
Annex III – point 1.5 – point a
Annex III – point 1.5 – point a
(a) milking dairy animals at intervals of not molactating animals have to be slaughtered within 12 hours of arrival at the slaughterhouse, or immediately if they are considered than 12 houo be suffering undue stress due to over-full udders;
Amendment 256 #
2008/0180(CNS)
Proposal for a regulation
Annex III – point 1.5 – point a a (new)
Annex III – point 1.5 – point a a (new)
(aa). slaughtering unweaned animals immediately upon arrival or, at the latest, within 2 hours;
Amendment 257 #
2008/0180(CNS)
Proposal for a regulation
Annex III – point 1.5 – subparagraph 1 a (new)
Annex III – point 1.5 – subparagraph 1 a (new)
Ill or injured animals must be slaughtered immediately upon arrival or, at the latest, within 2 hours, if they appear to be in severe pain, to have deep wounds or if they are bleeding severely, they must be slaughtered immediately. Non-ambulatory animals must be slaughtered on the spot.
Amendment 264 #
2008/0180(CNS)
Proposal for a regulation
Annex IV a (new)
Annex IV a (new)
Amendment 138 #
2008/0142(COD)
Council position
Article 1 – paragraph 3 – point c a (new)
Article 1 – paragraph 3 – point c a (new)
(ca) sales of medicinal products and medical devices over the Internet.
Amendment 141 #
2008/0142(COD)
Council position
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) "healthcare" means health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices if these activities are performed in a Member State where the services are provided by members of the health professions under the appropriate professional title;
Amendment 150 #
2008/0142(COD)
Council position
Article 4 – paragraph 2 – point f
Article 4 – paragraph 2 – point f
(f) patients who have received treatment are entitled to a written or electronic medical record of such treatment, and access to at least a copy of this record in conformity with and subject to national measures implementing Union provisions on the protection of personal data, in particular Directives 95/46/EC and 2002/58/EC, without prejudice to the exceptions applicable in the Member States.
Amendment 200 #
2008/0142(COD)
Council position
Article 11 – paragraph 2 – introductory part
Article 11 – paragraph 2 – introductory part
(2) In order to facilitate implementationFor the purposes of paragraph 1, the Commission shall adopsupport:
Amendment 201 #
2008/0142(COD)
Council position
Article 11 – paragraph 2 – point a
Article 11 – paragraph 2 – point a
(a) no later than…. measuresprocesses at Member State level enabling a health professional to verify the authenticity of the prescription and whether the prescription was issued in another Member State by a member of a regulated health profession who is legally entitled to do so through developing a non-exhaustive list of elements to be included in the prescriptions; *Note to OJ: please insert the date - 18 months after the entry into force of this Directive.
Amendment 203 #
2008/0142(COD)
Council position
Article 11 – paragraph 2 – point b
Article 11 – paragraph 2 – point b
(b) guidelines supporting the Member States in developing the interoperability of ePrescriptions; for this purpose it shall draw up guidelines in close collaboration with the Member States;
Amendment 205 #
2008/0142(COD)
Council position
Article 11 – paragraph 2 – point c
Article 11 – paragraph 2 – point c
(c) no later than… measuresprocesses at Member State level to facilitate the correct identification of medicinal products or medical devices prescribed in one Member State and dispensed in another, including measures to address patient safety concerns in relation to their substitution in cross-border healthcare where the legislation of the dispensing Member State permits such substitution. The Commission shall consider, inter alia, using the International Non-proprietary Name and the dosage of medicinal products; *Note to OJ: please insert the date - 18 months after the entry into force of this Directive.
Amendment 206 #
2008/0142(COD)
Council position
Article 11 – paragraph 2 – point d
Article 11 – paragraph 2 – point d
(d) no later than…* measuresprocesses at Member State level to facilitate the comprehensibility of the information to patients concerning the prescription, and the instructions included therein, on the use of the medicinal products or medical devices. *Note to OJ: please insert the date - 18 months after the entry into force of this Directive.
Amendment 208 #
2008/0142(COD)
Council position
Article 11 – paragraph 3
Article 11 – paragraph 3
Amendment 99 #
2008/0110(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point g a (new)
Article 2 – paragraph 2 – point g a (new)
(ga) oleochemical products manufactured from animal fats, in accordance with the conditions laid down in the implementing rules, by means of hydrolysis, saponification or hydrogenation.
Amendment 126 #
2008/0110(COD)
Proposal for a regulation
Article 12 – point d
Article 12 – point d
(d) products of animal origin which have been declared unfit for human consumption due to the potential presence of physical residuforeign bodies in those products;
Amendment 130 #
2008/0110(COD)
Proposal for a regulation
Article 13 – point d
Article 13 – point d
(d) animal by-products, including animal by-products from the retail and wholesale trade, derived from the production of products intended for human consumption, including degreased bones and greaves;
Amendment 133 #
2008/0110(COD)
Proposal for a regulation
Article 13 – point j
Article 13 – point j
(j) aquatic and terrestrial invertebrates other than species pathogenic to humans or animals;
Amendment 153 #
2008/0110(COD)
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. Implementing rules to ensure the uniform application of the prohibitions laid down in paragraph 1 may be laid down by the Commission, and measures permitting: (a) the feeding with processed animal protein derived from bodies or parts of bodies of animals of the same species to fur animals, by way of derogation fromlong with thresholds for feed below which accidental contamination with processed animal protein as referred to in paragraph 1(a); and (b) the feeding of farmed animals with herbage from land to which organic fertilisers or soil improvers have been applied, provided that the grazing or cutting takes place after the lapse of a waiting period which ensures adequate control of risks to public and animal health, by derogation from paragraph 1(c)which cannot be avoided using reasonable technological means shall be regarded as insignificant. 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 48(4).
Amendment 159 #
2008/0110(COD)
Proposal for a regulation
Article 22 – point f
Article 22 – point f
(f) in the case of Category 3 material referred to in Article 13(f) and other animal by-products which are removed in the course of surgical intervention on live animals, if authorised by the competent authoritynational law, disposed of on farm.
Amendment 160 #
2008/0028(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) With a view to provideing consumers with food information that is necessary to make an informed choice, in the case of alcoholic mixed beverages should also provide information on their ingredients, the Commission and the relevant stakeholders will carry out investigations in order to ascertain what information is most useful to consumers and how it can most effectively be provided.
Amendment 168 #
2008/0028(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) It is also important to provide consumers with information on the othermust be clearly established what information consumers need regarding alcoholic beverages. It would therefore be inappropriate for certain provisions of this Regulation to be applicable to alcoholic beverages. Specific Community rules already exist on the labelling of wine.: Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine provides an exhaustive set of technical standards which fully cover all oenological practices, manufacturing methods and means of presentation and labelling of wines, thus ensuring that all stages in the chain are covered and that consumers are protected and properly informed. In particular, this legislation describes in a precise and exhaustive manner the substances likely to be used in the production process, together with the conditions for their use via a positive list of oenological practices and treatments; any practice not included in this list is prohibited. Therefore, it is appropriate to exempt wine at this stage from the obligation to list the ingredients and to provide for a nutrition declaration. As regards beer and spirits as defined in Article 2(1) of Regulation (EC) No. […] of […] of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 , and in order to ensure a consistent approach and coherence with the conditions established for wine, the same kind of exemptions shall applyand Council Regulation (EC) No 1601/91. The same applies to the labelling of spirit drinks (Regulation (EC) No 110/2008 of the European Parliament and of the Council). In order to ensure a consistent approach to information on alcoholic beverages and coherence with other Community provisions, alcoholic beverages should not be subject to any labelling requirements relating to ingredients or nutrition under the terms of this Regulation. However, the Commission will produce a report after five years of the entry into force of this Regulation and may propose, if necessary, specific requirements in the context of this Regulation.
Amendment 177 #
2008/0028(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) In general, consumers are notConsumers should be aware of the potential contribution of alcoholic beverages to their overall diet. Therefore, it is appropriate to ensure that information on the nutrient content of in particular mixed alcoholic beverages is providedthe Commission and the other relevant parties are called upon, during the derogation period, to perform research in order to establish what information is of greatest use to consumers and how it can be provided most effectively.
Amendment 181 #
2008/0028(COD)
Proposal for a regulation
Article 13 – paragraph 3 a (new)
Article 13 – paragraph 3 a (new)
3a. Paragraph 2 of this Article shall not apply in the case of food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, provided that the information on the package is clearly legible.
Amendment 206 #
2008/0028(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point b a (new)
Article 23 – paragraph 1 – point b a (new)
(ba) in units of mass and/or volume in the case of semi liquid or viscous products
Amendment 228 #
2008/0028(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) In general, consumers are notConsumers should be aware of the potential contribution of alcoholic beverages to their overall diet. Therefore, it is appropriate to ensure that information on the nutrient content of in particular mixed alcoholic beverages is providedthe Commission and the other relevant parties should conduct surveys during the derogation period in order to establish what information is most useful to consumers and how it can be made available most effectively.
Amendment 301 #
2008/0028(COD)
Proposal for a regulation
Article 33 – paragraph 2 a (new)
Article 33 – paragraph 2 a (new)
(2a) The energy content, expressed in kcal per 100 g or 100 ml, shall be repeated in the bottom right-hand corner of the ‘front of pack’, in a font size of 3 mm and surrounded by a border. In the case of portion packs with a net quantity of less than 100 g/ 100 ml, the energy content may alternatively be indicated in kcal per portion.
Amendment 321 #
2008/0028(COD)
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
(4) In the case of non-prepacked food, the following provisions of Article 41 shall applshall apply: a) 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 on whether and how the particulars specified in Articles 9 and 10 are to be shown. b) Member States may decide not to require the provision of some of the particulars referred to in paragraph 1, other than those referred to in Article 9(1) (c), provided that the consumer or mass caterer receives sufficient information. c) Member States shall communicate to the Commission the text of the measures referred to in paragraphs 1 and 2 without delay.
Amendment 330 #
2008/0028(COD)
Proposal for a regulation
Article 13 - paragraph 4
Article 13 - paragraph 4
4. In the case of non-prepacked food, the provisions of Article 41 shall applfollowing shall apply: (a) 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. (b) Member States may decide not to require the provision of some of the particulars referred to in paragraph 1, other than those referred to in Article 9(1) (c), provided that the consumer or mass caterer still receives sufficient information. (d) Member States shall communicate to the Commission the text of the measures referred to in paragraphs 1 and 2 without delay.
Amendment 332 #
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 printed on the package or on the label in characters of a font size of at least 3mm and shall be presented in a way so as to ensure a significant contrast between the print and backgroundesented in a way so as to ensure legibility.
Amendment 354 #
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) 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 361 #
2008/0028(COD)
Proposal for a regulation
Annex V – point 19
Annex V – point 19
19. Food directly supplied by the manufacturer of small quantities of products, including handcrafted products produced by micro-enterprises and local retailers, to the final consumer or to local retail establishments directly supplying the final consumer.
Amendment 363 #
2008/0028(COD)
Proposal for a regulation
Article 20 – point d
Article 20 – point d
(d) cheese, butter, fermented milk and cream, to whichprovided that no ingredient has been added other than lactic products, enzymes and micro-organism cultures essential to manufacture, or in the casthe salt needed for the manufacture of cheese other than fresh cheese and processed cheese the salt needed for its manufacture;
Amendment 363 #
2008/0028(COD)
Proposal for a regulation
Article 14 - paragraph 4
Article 14 - paragraph 4
4. The minimum font size referred to in paragraph 1 shall not apply in case of packaging or containers the largest surface of which has an area of less than 100 cm².
Amendment 381 #
2008/0028(COD)
Proposal for a regulation
Annex VI – point 2 a (new)
Annex VI – point 2 a (new)
Part Ba – SPECIFIC REQUIREMENTS CONCERNING THE DESIGNATION OF SAUSAGE CASINGS Sausage casings shall be indicated as follows in the list of ingredients: ‘natural casing’ if the casing used in sausage production is derived from the intestinal tract of even-toed ungulates; ‘artificial casing’ in all other cases. If an artificial casing is not edible, this must be indicated.
Amendment 385 #
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) 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 396 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 2
Article 29 – paragraph 1 – subparagraph 2
This paragraph shall not apply to wine as defined in Council Regulation (EC) No 1493/1999, bever, and spirits as defined in Article 2(1) of Regulation (EC) No. […] of […] of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89ages containing alcohol. The Commission shall produce a report after [five years of the entry into force of this Regulation] concerning the application of this paragraph on these products and may accompany this report by specific measures determining the rules for a mandatoryproviding consumers with nutrition declaral information foron these products. 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).
Amendment 403 #
2008/0028(COD)
Proposal for a regulation
Article 20 - point (e)
Article 20 - point (e)
(e) wine as defined in Council Regulation (EC) No 1493/1999, beer, and spirits as defined in Article 2(1) of Regulation (EC) No. […] of […] of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89alcoholic beverages. The Commission shall produce a report after [five years of the entry into force of this Regulation] concerning the application of Article 19 on these products and may accompany this report by specific measures determining the rules for labelling ingredients. 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);
Amendment 408 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 2 – point d
Article 29 – paragraph 2 – point d
Amendment 455 #
2008/0028(COD)
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. Such additional forms of expression referred to in paragraph 1 shall be identified under a national scheme referred toadopted by the Commission in the light of scientific knowledge of nutrition and its impact on health. These measures to amend non-essential provisions of this Regulation by supplementing them shall be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 449(3).
Amendment 461 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 2
Article 29 – paragraph 1 – subparagraph 2
This paragraph shall not apply to wine as defined in Council Regulation (EC) No 1493/1999, beer, and spirits as defined in Article 2(1) of Regulation (EC) No. […] of […] of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89alcoholic beverages. The Commission shall produce a report after [five years of the entry into force of this Regulation] concerning the application of this paragraph ton these products and may accompany this report by specific measures determining the rules for a mandatoryproviding consumers with nutrition declaral information foron these products. 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).
Amendment 529 #
2008/0028(COD)
Proposal for a regulation
Article 53 – subparagraph 3
Article 53 – subparagraph 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 150 employees and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million, where they shall apply [the first day of the month 5 years after the entry into force]. Member States may adopt their own provisions for these small and medium-sized food business operators.
Amendment 533 #
2008/0028(COD)
Proposal for a regulation
Annex I - point 9
Annex I - point 9
9. ‘polyols’ means alcohols containing more than two hydroxyl groupcarbohydrates which are reduced mono-, di- or oligosaccharides or polysaccharides and are listed as permitted sweeteners;
Amendment 551 #
2008/0028(COD)
Proposal for a regulation
Article 34 - paragraph 1
Article 34 - paragraph 1
1. The particulars referred to 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. With regard to gift packaging, mandatory information should only be communicated in the back of the packaging.
Amendment 564 #
2008/0028(COD)
Proposal for a regulation
Annex VI – part C – listing – row 16 a (new)
Annex VI – part C – listing – row 16 a (new)
Cellulose extract 1 __________________________________ 1It is not necessary to indicate the specific name or the EC number.
Amendment 567 #
2008/0028(COD)
Proposal for a regulation
Annex VIII – paragraph 1
Annex VIII – paragraph 1
1. The net quantity shall not be mandatory in the case of foods: (a) which are subject to considerable losses in their volume or mass and which are sold by number or weighed in the presence of the purchaser; or (b) the net quantity of which is less than 5 g or 5 ml; however, this provision shall not apply to spices and herbs; or (ba) the net quantity of which is less than 50 g for confectionery, chocolate and other cocoa-based products, products based on almonds or nuts or other oilseeds; or (bb) the net quantity of which is less than 100 g for biscuits, cakes and other fine bakery ware; without prejudice to specific Community legislation.
Amendment 709 #
2008/0028(COD)
Proposal for a regulation
Annex VI – part C – list
Annex VI – part C – list
Acid Acidity regulator Anti-caking agent Anti-foaming agent Antioxidant 1 2 The specific name or EC number shall not be required to be indicated. The specific name or EC number shall not be required to be indicated. Bulking agent Colour Emulsifier Emulsifying salts Firming agent Flavour enhancer Flour treatment agent Gelling agent Glazing agent Humectant Modified starch Cellulose extract* Preservative Propelleant gas Raising agent Stabiliser Sweetener Thickener _____ * It is not necessary to indicate the specific name or the EC number.
Amendment 712 #
2008/0028(COD)
Proposal for a regulation
Annex VIII – paragraph 1
Annex VIII – paragraph 1
1. The net quantity shall not be mandatory in the case of foods: (a) which are subject to considerable losses in their volume or mass and which are sold by number or weighed in the presence of the purchaser; or (b) the net quantity of which is less than 5 g or 5 ml; however, this provision shall not apply to spices and herbs. (c) the net quantity of which is less than 50g for confectionary, chocolate and other cocoa based products, products based on almonds or nuts or other oilseeds; (d) the net quantity of which is less than 100g for biscuits, cakes and other fine bakery ware; (e) and without prejudice to specific community legislation.
Amendment 229 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 2 – point (a)
Article 1 – point 2 – point (a)
Directive 2003/87/EC
Article 3 – point (c)
Article 3 – point (c)
Amendment 241 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 2 – point (b)
Article 1 – point 2 – point (b)
Directive 2003/87/EC
Article 3 – point (h)
Article 3 – point (h)
"(h) 'new entrant' means any installation carrying out one or more of the activities indicated in Annex I, which has obtained a greenhouse gas emission permit subsequent to the submission to the Commission of the list referred to in Article 11(1) and increases in capacity in existing installations;"
Amendment 244 #
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 251 #
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 [(v)] (new)
Article 3 – point [(v)] (new)
[v)] “electricity-intensive businesses” are business entities set out in Annex I(4a);”
Amendment 385 #
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 1
Article 10a – paragraph 1 – subparagraph 1
The Commission shall, by 30 June 2011, adopt additional Community -wide and fully- harmonised implementing measures for allocating the allowances referred to in paragraphs 2 to 6 and 8 in a harmonised manner.
Amendment 397 #
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 productionand shall not give incentives to increase emissions.
Amendment 417 #
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 428 #
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 431 #
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 generatorwhich is not generated by combined heat and power plants, to installations for the capture, pipelines for the transport or to storage sites for greenhouse gas emissions.
Amendment 442 #
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 497 #
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 508 #
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. Subject to Article 10b, the amount of allowances allocated free of charge under paragraphs 3 to 6 of this Article [and paragraph 2 of Article 3c] in 2013For the installations listed in Annex I, Community-wide uniform benchmarks shall be set, and shall be 80% 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 noadopted and monitored according to a harmonised procedure. On the basis of these benchmarks, installations shall receive a 100% free allocation. Installations not generating electricity with combined heat and power shall be excluded from this free allocation in 2020.
Amendment 516 #
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. Subject to Article 10b, the amount of allowances allocated free of charge under paragraphs 3 to 6 of this Article [and paragraph 2 of Article 3c] in 2013 shall be 80100 % 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 amoube adjusted using the linear coefficients resulting in no free allocation in 2020ferred to in Article 9.
Amendment 521 #
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 539 #
2008/0013(COD)
Proposal for a regulation – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2003/87/EC
Article 10a - paragraph 8
Article 10a - paragraph 8
8. In 2013 and in each subsequent year up to 2020, installations in sectors which are exposed to a significant risk of carbon leakage shall be allocated allowances free of charge up to 100 percent of the quantity determined in accordance with paragraphs 2 to 6. This shall also apply to similar plants or companies which do not obviously fall within any one sector.
Amendment 541 #
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 555 #
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 559 #
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
Amendment 583 #
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
Measures to support certain energy intensive industries in the event of carbon leakage Not later than June 2011, the Commission shall, in the light of the outcome of the intelectricity-intensive businesses Opernational 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 Council 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. This shall be accompanied byors of electricity-intensive installations as described in Article 3(v) shall receive any appropriate proposals, which may include: – adjusting the proporllocation 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 emissions 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."ased on the amount of CO2 emitted in producing the electricity they consume. This allocation shall be determined on the basis of benchmarks.
Amendment 596 #
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 - introduction
Article 10b - paragraph 1 - introduction
Not later than JuneSeptember 201109, the Commission shall, in the light of the outcome of the international negotiations and the extent to which these lead to glob 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. The measures in support of specific energy- intensive sectors referred to in Article 10(b) may be lifted only by an international agreenhouse gas emission reductions, andment setting the same reduction targets as are imposed on the Member States, after consulting with all relevant social partners, submit to the European Parliament and to the Council an. This 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. This shall be accompanied by any appropriate proposals, which may include:
Amendment 728 #
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 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 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 741 #
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 leading, by 2020, to mandatory reductions of greenhouse gas emissions exceeding the minimum reduction levels agreed upon by the European Council for all countries whose activities in the sectors listed in Annexes 1 and 3 are substantial, and upon the Commission proving that this agreement will lead to comparable CO2 costs for the sectors in Annexes 1 and 3, paragraphs 2, 3 and 4 shall apply.
Amendment 757 #
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 conclusubmission of the international agreementCommission’s analysis referred to in paragraph 1, the linear factor shall increase so that the Community quantity of allowances in 2020 is lower than that established pursuant to Article 9, by a quantity of allowances equivalent to 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. This arrangement shall only enter into force if the Commission’s analysis is submitted before [2015].
Amendment 786 #
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 804 #
2008/0013(COD)
Proposal for a directive – amending act
Annex I - point 4 - column 1
Annex I - point 4 - column 1
Directive 2003/87/EC
Annex I - table - new category 1 - row 6 - column 1
Annex I - table - new category 1 - row 6 - column 1
Production of basic organic chemicals by cracking, reforming, partial or full oxidation or by similar processesethyls and propyls by cracking or reforming, with a production capacity exceeding 100 tonnes per day
Amendment 805 #
2008/0013(COD)
Proposal for a directive – amending act
Annex I - point 4 - column 1
Annex I - point 4 - column 1
Directive 2003/87/EC
Annex I - table - new category 1 - row 7 - column 1
Annex I - table - new category 1 - row 7 - column 1
Production of hydrogen (H2) and synthesis gas by reforming or partial oxidation with a production capacity exceeding 25 tonnes per day
Amendment 812 #
2008/0013(COD)
Proposal for a directive – amending act
Annex I - point 4 a (new) - column 1
Annex I - point 4 a (new) - column 1
Directive 2003/87/EC
Annex I - table - New category
Annex I - table - New category
4a. The following category of activity is added: "Electricity-intensive production processes Production of chlorine, caustic soda, caustic potash and alcoholates by electrolysis Production of hydrofluoric acid through electrolysis Production of gases through air separation Production of carbide compounds in electric furnaces Production of hydrogen peroxide Production of polycrystalline silicon Production of polygranular carbon and graphite"
Amendment 9 #
2007/2285(INI)
Motion for a resolution
Recital A
Recital A
A. whereas overweight and obesity are becoming a growing epidemicgrowing and are a major contributor to the leading causes of morbidity in Europe,
Amendment 19 #
2007/2285(INI)
Motion for a resolution
Recital D
Recital D
D. whereas European citizens are living in an ‘obesogenic’ environment in which the intake of energy-dense products and sedentary lifestyles have raised the risk of obesity,
Amendment 31 #
2007/2285(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas the number of lessons devoted to sport has decreased in the past decade, both at primary and at secondary schools, and there are major disparities among Member States with regard to facilities and equipment,
Amendment 39 #
2007/2285(INI)
Motion for a resolution
Recital H
Recital H
H. considering the social dimension of the problem and in particular that the highest incidence rates of overweight and obesity are registered in lower socio-economic groups; noting with concern that obesity might deepen health and socio-economic inequalities,
Amendment 52 #
2007/2285(INI)
Motion for a resolution
Recital J
Recital J
J. considering the importance of different traditional cuisines which should be preserved as part of our cultural heritage and which should be promoted as valid alternatives to fast-food or pre-cooked food eating culture,
Amendment 61 #
2007/2285(INI)
Motion for a resolution
Recital K
Recital K
K. considering the worsening situation in the marketing sector and the fact that food advertising accounts for around half of all advertising broadcast during children’s TV viewing times and that three quarters of it promotes high-calorie and low-nutrient foods; noting with concern the use of new forms of marketing using all technological means and in particular the so-called ‘advergames’ including cell phones, instant messaging, video games and interactive games on the Internetwhereas numerous food producers, advertising and marketing firms and health and consumer protection associations are already displaying considerable commitment in the EU Platform for Action on Diet, Physical Activity and Health and can already point to successful studies and projects,
Amendment 111 #
2007/2285(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on regions and local entities to develop ‘activity-friendly communities’, especially in the context of urban planning: this can be achieved by mixing commercial and residential development, by organising schools, public means of transport, and accessible sports facilities and by providing biking trails and crosswalks, while at the same time avoiding ‘environmental risk factors’ such as concentration of fast-food outlets, barriers to physical activity, and the absence of sidewalks, parks and recreational faciliticalls on the Commission, using the existing budget appropriations and current subsidy programmes, to submit by 31.12.2008 proposals for the inclusion of sport with the aim of doing more to promote the maintenance and building of sports facilities in Member States; calls on the Commission to mainstream sport in existing action programmes; acknowledges the fact that crime reduction is also an important tool for promoting outdoor physical activity, especially among children and elderly people; invites municipalities to promote a network of ‘Towns for a healthy lifestyle’ providing common actions to fight obesity;
Amendment 166 #
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 reviewadapt portion sizes to needs; asks for a total ban on the saleccount to be taken of scientific knowledge in the provision of foods and beverages high in fat, salt or sugar and at the same time low in nutrients in schools; advocates instead making fresh fruit and vegetables available in vending machines; 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 177 #
2007/2285(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Reminds Member States of its call for sports education to be made compulsory at primary and secondary schools and for the principle to be adopted that the curriculum should include at least three sports lessons per week and calls for schools to receive support in exceeding this compulsory minimum wherever possible;
Amendment 222 #
2007/2285(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls for a ban on trans-fatty acids and uUrges 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 should be provided for PDO (protected designation of origin) and PGI (protected geographical indication) and traditional products in order to preserve original recipes;
Amendment 262 #
2007/2285(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on all operators in the media sector to take voluntary steps toward avoiding any kind of marketing practice involving ‘unhealthy food’ targe, in cooperation with the Member States and sports organisations, to created at children in the media; urges holders of intellectual property rights not to license cartoon characters for advertising this kind of fooddditional incentives for more physical exercise and taking up a sport in all media;
Amendment 272 #
2007/2285(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Is aware of the importance of the media in informing, educating and persuading in connection with a healthy and balanced diet; nevertheless considers the voluntary approach adopted in the proposal for a directive on ‘Audiovisual media services without frontiers’ insufficient;
Amendment 284 #
2007/2285(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Asks for protected times and for restrictions on commercials for unhealthy food specifically targeted at children; isEncourages providers of media services to formulate codes of conduct for inappropriate audiovisual commercial communication accompanying children’s programmes or convtainced that the problem of hidden placement of productsin them and relating to food and beverages containing nutrients or substances with a diet-related ofr poor nutritional value in films and cartoons should also be addressed at European levelhysiological effect, particularly such as fat, trans-fatty acids, salt/sodium and sugar, the excessive consumption of which in the overall diet is not recommended;
Amendment 291 #
2007/2285(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
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 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 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 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 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 267 #
2007/0286(COD)
Council position
Article 46 – paragraph 2 – subparagraph 1 a (new)
Article 46 – paragraph 2 – subparagraph 1 a (new)
For waste co-incineration combustion plants that fire indigenous solid fuel and cannot comply with the emission limit values for sulphur dioxide referred to in Part 4 of Annex VI due to the characteristics of this fuel, Member States may apply instead the minimum rates of desulphurisation set out in Part 5 of Annex V, in accordance with the compliance rules set out in Part 6 of that Annex.
Amendment 14 #
2007/0037B(COD)
Proposal for a regulation – amending act
Recital 5 a (new)
Recital 5 a (new)
(5a) Whereas food business operators may be exempted from the requirement to put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles provided the competent authority considers, on the basis of a company-related and regularly performed hazard analysis, either that there are no hazards needing to be prevented, eliminated or reduced to acceptable levels, or that any hazards identified are sufficiently controlled through the implementation of general and specific food hygiene requirements.
Amendment 17 #
2007/0037B(COD)
Proposal for a regulation – amending act
Article 2
Article 2
Regulation (EC) No 852/2004
Article 5 – paragraph 3
Article 5 – paragraph 3
Without prejudice to the other requirements of this Regulation, paragraph 1 shall not apply to businesses which are micro-enterprises within the meaning of Commission Recommendation 2003/361/EC of 6 May 2003 and the activities of which consist predominantly in the direct sale of food to the final consumerfood business operators may be exempted from the requirement to put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles provided the competent authority considers, on the basis of a company-related and regularly performed hazard analysis, either that there are no hazards needing to be prevented, eliminated or reduced to acceptable levels, or that any hazards identified are sufficiently controlled through the implementation of the general and specific food hygiene requirements laid down in Article 4(2) to (6).
Amendment 40 #
2006/0147(COD)
Article 26a (new)
Regulation (EC) No 110/2008
Annex II
Annex II
Article 26a Amendment to Regulation (EC) No 110/2008 Annex II of Regulation (EC) No 110/2008 shall be amended as follows: 1. Point 24(c) shall be replaced by the following: “(c) Other natural flavouring substances as defined in Article 3(2)(c) of Regulation (EC) No …/…H and/or flavouring preparations as defined in Article 3(2)(d) of that Regulation may additionally be used, but the flavour of these drinks is largely attributable to distillates of caraway (Carum carvi L.) and/or dill (Anethum graveolens L.) seeds, the use of essential oils being prohibited.“ 2. Point 44(a) shall be replaced by the following: “(a) Väkevä glögi or spritglögg is a spirit drink produced by flavouring ethyl alcohol of agricultural origin with natural flavouring of cloves and/or cinnamon using one of the following processes: maceration and/ or distillation, redistillation of the alcohol in the presence of parts of the plants specified above, addition of flavouring substances as defined in Article 3(2)(c) of Regulation (EC) No …/…H of cloves or cinnamon or a combination of these methods.” 3. Point 44(c) shall be replaced by the following: “(c) Other flavourings, flavouring substances and/or flavouring preparations as defined in Article 3(2)(a), (b), and (d) of Regulation (EC) No …/…H may also be used, but the flavour of the specified spices must be predominant.”
Amendment 14 #
2006/0143(COD)
Article 2 – paragraph 1
1. Under each sectoral food law, substances that have been authorised to be placed on the Community market shall be included on a list the content of which is determined by the said law (hereinafter referred to as the "Community list"). The Community list shall be updated by the Commission. It shall be published in the Official Journal of the European Union. Substances authorised on the Community list may be used by all food business operators subject to the conditions applicable to them, provided their use is not restricted under Article 12a.
Amendment 18 #
2006/0143(COD)
Article 7 – paragraph 1
1. Within ninesix months of the Authority giving its opinion, the Commission shall submit to the Committee referred to in Article 14(1) a draft regulation updating the Community list, taking account of the opinion of the Authority, any relevant provisions of Community law and any other legitimate factors relevant to the matter under consideration. In those cases where an opinion of the Authority has not been requested, the ninesix-month period shall start from the date the Commission receives a valid application.
Amendment 19 #
2006/0143(COD)
Article 8 – paragraph 1
1. WhereIn duly justified cases, the Commission may requests additional information from applicants on matters concerning risk management. In those instances, it shall determine, together with the applicant, a period within which that information can be provided. In such cases, the period referred to in Article 7 may be extended accordingly. The Commission shall inform the Member States of the extension and shall make the additional information available to the Member States once it has been provided.
Amendment 21 #
2006/0143(COD)
Article 12 a (new)
Article 12a Scientific data and other information provided by applicants may not be used for the benefit of a subsequent applicant for a period of five years from the date of authorisation, unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where: a) the scientific data and other information were designated as proprietary by the prior applicant at the time the prior application was made; and b) the prior applicant had exclusive rights of reference to the proprietary data at the time the prior application was made; and c) the food additive, food enzyme or food flavouring could not have been authorised without the submission of the proprietary data by the prior applicant.
Amendment 12 #
2005/0283(COD)
The European Parliament rejects the Commission proposal.
Amendment 68 #
2005/0281(COD)
Article 2 – paragraph 1 – point (c)
(c) uncontaminated excavated soil and other naturally occurring material excavated in the course of construction activities where it is certain that the material will be used for the purposes of construction in its natural state on the site from which it was excavated or another site;
Amendment 72 #
2005/0281(COD)
Article 2 – paragraph 2 – sentence 1
2. The following shall be excluded from the scope of this Directive to the extent thatif they are covered by other Community legislation:
Amendment 74 #
2005/0281(COD)
Article 2 – paragraph 2 – point (b)
(b) animal by-products including processed products covered by Regulation (EC) No 1774/2002, except those which are destined for incineration, landfilling or use in a biogas or composting plant;
Amendment 76 #
2005/0281(COD)
Article 2 – paragraph 2 – point (d)
(d) waste resulting from prospecting, extraction, treatment and storage of mineral resourceaw materials and the working of quarries covered by Directive 2006/21/EC.
Amendment 119 #
2005/0281(COD)
Recital 40
(40) In the interests of the simplification of Community legislation and the reflection of environmental benefits, the relevant provisions of Council Directive 75/439/EEC of 16 June 1975 on the disposal of waste oils should be integrated into this Directive. Directive 75/439/EEC should therefore be repealed. The management of waste oils should be conducted in accordance with the guiding principle of the waste hierarchy, and preference should be given to options that deliver the best overall environmental outcomethe priority given to regeneration should be maintained. The separate collection of waste oils remains crucial to their proper management and the prevention of damage to the environment from their improper disposal.
Amendment 186 #
2005/0281(COD)
Article 18 – paragraph 3
3. If waste oils, according to national legWhere technical, economic and organislation, are subject to requirements of regeneration, Member States may prescribe that suchal constraints so allow, Member States shall take the measures necessary to give priority to the processing of waste oils shall bey regenerated if technically feasible andion. Consequently, Member States may, where Articles 11 or 12 of Regulation (EC) No 1013/2006 apply, restrict the transboundary shipment of waste oils from their territory to incineration or co- incineration facilities in order to give priority to the regeneration of waste oils. Or. de (The first sentence is taken from Article 3(1) of Directive 75/439/EC)
Amendment 191 #
2005/0281(COD)
Article 19 – paragraph 2
The Commission shall present a proposal on bio-waste at the latest 2 years after the entry into force of this Directive. To this end, the Commission shall carry out an assessment on the management of bio- waste with a view to submitting a proposal if appropriate.
Amendment 248 #
2005/0281(COD)
Annex II – point R 13 a (new)
R 13a Use of wastes for construction, technical, safety or ecological purposes for which other materials would otherwise have been used.