1064 Amendments of Thomas ULMER
Amendment 15 #
2013/0222(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The provisions on pharmacovigilance relating to medicinal products of human use laid down in Regulation (EC) No 726/2004 and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use12 were amended by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use13 , Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products14 , Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance15 and Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance16 . Those amendments only cover medicinal products for human use. Those amendments provide for new pharmacovigilance tasks for the Agency including Union-wide pharmacovigilance procedures, the monitoring of literature cases, the improved information technology tools and the provision of more information to the general public. Furthermore, the pharmacovigilance legislation stipulates that the Agency should be enabled to fund those activities from fees charged to marketing authorisation holders. New categories of fees should therefore be created to cover the new and specific tasks of the Agency. __________________ 12 13 14 15 16However, taking into account the benefit for society as a whole, due respect should be given to pharmacovigilance as a sovereign task. Therefore, the percentage share of EU funding in the financing of the EMA budget should be kept, at least, at the status quo before the implementation of this Regulation. The contribution should be used to reduce the costs for financing the routine tasks and hence the annual flat fee. New categories of fees should therefore be created to cover the new and specific tasks of the Agency. __________________ 12 OJ L 311, 28.11.2001, p. 67. OJ L 311, 28.11.2001, p. 67. 13 OJ L 348, 31.12.2010, p.74. OJ L 348, 31.12.2010, p.74. 14 OJ L 348, 31.12.2010, p.1. OJ L 348, 31.12.2010, p.1. 15 OJ L 299, 27.10.2012, p.1. OJ L 299, 27.10.2012, p.1. 16 OJ L 316, 14.11.2012, p.38. OJ L 316, 14.11.2012, p.38.
Amendment 40 #
2013/0222(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency shall levy a fee for the assessment of periodic safety update reports referred to in 107e and 107g of Directive 2001/83/EC and in Article 28 of Regulation (EC) No 726/2004 with assessment criteria according to Annex I of Directive 2001/83/EC.
Amendment 44 #
2013/0222(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The amount of the fee is laid down in Part I of the Annex. The Agency shall define 3 clusters of PSUR assessments reflecting the workload.
Amendment 45 #
2013/0222(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Where only one marketing authorisation holder is subject to the obligation to submit a periodic safety update report in the context of the procedures referred to in paragraph 1, the Agency shall levy the total amount of the applicable fee on that marketing authorisation holder. However, in hardship cases, e.g. for economic reasons related to the concerned product, a maximum upper limit of the fee shall apply.
Amendment 89 #
2013/0222(COD)
Proposal for a regulation
Annex – part I – paragraph 1 a (new)
Annex – part I – paragraph 1 a (new)
1a. In application of Article 4(2), the following fees apply: (i) category 1: 100 % of the applicable amount; (ii) category 2: 50 % of the applicable amount; (iii) category 3: 10 % of the applicable amount.
Amendment 92 #
2013/0222(COD)
Proposal for a regulation
Annex – part I – paragraph 2 a (new)
Annex – part I – paragraph 2 a (new)
2a. In application of Article 4(3), in hardship cases, the concerned marketing authorisation holder shall pay a maximum fee of 40 % of the applicable amount.
Amendment 109 #
2013/0222(COD)
Proposal for a regulation
Annex – part IV – paragraph 3
Annex – part IV – paragraph 3
3. Holders of marketing authorisations for medicinal products (other than authorised homeopathic medicinal products) referred to in Article 7(5) shall pay 80 % of the amount applicable to the chargeable units corresponding to those products. Holders of marketing authorisations for homeopathic medicinal products shall pay the percentage equivalent to the ICT services applicable to the chargeable unit corresponding to those products.
Amendment 357 #
2013/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16 – point c
Article 1 – paragraph 1 – point 16 – point c
Directive 96/53/EC
Annex I – point 2.3.1 – indent 3
Annex I – point 2.3.1 – indent 3
two-axle buses: 19.5 tonnes
Amendment 162 #
2013/0029(COD)
Proposal for a directive
Article 1 – point 1 – point a
Article 1 – point 1 – point a
Directive 2012/34/EU
Article 3 – point 2
Article 3 – point 2
(2) ‘infrastructure manager’ means any body or firm ensuring theresponsible for any or all of the following functions: development, operation and maintenance of railway infrastructure on a network; development includes network planning, financial and investment planning as well as building and upgrades of the infrastructure; operation of the infrastructure includes all elements of the process of train path allocation, including both the definition and the assessment of availability and the allocation of individual paths, traffic management and infrastructure charging, including determination and collection of the charges; maintenance includes infrastructure renewals and the other asset management activities;
Amendment 97 #
2013/0028(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) It must still be possible to employ direct award procedures, for example in cases where the specific characteristics of the contract in question are likely to deter a sufficient number of bidders from taking part.
Amendment 161 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 2
Article 1 – point 2
Regulation (EC) No. 1370/2007
Article 2 a (new) – paragraph 1 – subparagraph 1 – point b
Article 2 a (new) – paragraph 1 – subparagraph 1 – point b
basic requirements to be fulfilled by public transport offer such as accessibility for persons with disabilities, territorial connectivity, security, modal and intermodal interconnections at main connecting hubs, offer characteristics such as times of operation, frequency of services and minimum degree of capacity utilisation;
Amendment 297 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 4 – point a
Article 1 – point 4 – point a
Regulation (EC) No 1370/2007
Article 5 – paragraph 4
Article 5 – paragraph 4
Amendment 320 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 4 – point a
Article 1 – point 4 – point a
Regulation (EC) No 1370/2007
Article 5 – paragraph 4 – subparagraph 2
Article 5 – paragraph 4 – subparagraph 2
In the case of a public service contract directly awarded to a small or medium- sized enterprise operating not more than 2350 road vehicles, these thresholds may be increased to either an average annual value estimated at less than EUR 2 000 000 or to an annual provision of less than 600 000 kilometres of public passenger transport services.
Amendment 340 #
2013/0028(COD)
Proposal for a regulation
Article 1 – point 4 – point b a (new)
Article 1 – point 4 – point b a (new)
Regulation (EC) No 1370/2007
Article 5 – paragraph 6 a (new)
Article 5 – paragraph 6 a (new)
The following paragraph 6a is inserted: If the competent authority awards a public transport service contract directly, it shall publish at least nine months prior to the start of the contract a statement explaining how this award method guarantees enforceability, efficiency and quality. This statement shall also be forwarded to the independent national regulator, for information.
Amendment 411 #
2013/0028(COD)
Proposal for a regulation
Article 1 point 8 – point c Regulation (EC) No. 1370/2007
Article 1 point 8 – point c Regulation (EC) No. 1370/2007
Article 8 – paragraph 3
Amendment 190 #
2013/0016(COD)
Proposal for a directive
Article 4 – paragraph 2 – subparagraph 1 – introductory part
Article 4 – paragraph 2 – subparagraph 1 – introductory part
Member States shall ensureand the European Union Agency for Railways shall ensure, on the basis of their respective competences, that the responsibility for the safe operation of the rail system and the control of risks associated with it is laid upon the infrastructure managers and railway undertakingsentities operating within the rail system, obliging them:
Amendment 193 #
2013/0016(COD)
Proposal for a directive
Article 4 – paragraph 2 – subparagraph 1 – point c
Article 4 – paragraph 2 – subparagraph 1 – point c
(c) to establish safety or maintenance management systems in accordance with this Directive.
Amendment 198 #
2013/0016(COD)
Proposal for a directive
Article 4 – paragraph 2 – subparagraph 2
Article 4 – paragraph 2 – subparagraph 2
Amendment 73 #
2013/0015(COD)
Proposal for a directive
Recital 2
Recital 2
(2) In order to enable citizens of the Union, economic operators and regional and local authorities to benefit to the full from the advantages deriving from the establishing of an area without internal frontiers, it is appropriate, in particular, to improve the interlinking and interoperability of the national rail networks as well as access thereto, including for passengers with disabilities implementing any measures that may prove necessary in the field of technical standardisation.
Amendment 85 #
2013/0015(COD)
Proposal for a directive
Recital 24
Recital 24
(24) The United Nations Convention on the Rights of Persons with Disabilities to which the Union is a party establishes accessibility as one of its general principles and requires States Parties to take appropriate measures to ensure to persons with disabilities access on an equal basis with others, including by developing, promulgating and monitoring the implementation of minimum standards and guidelines for accessibility. Accessibility for persons with disabilities and persons with reduced mobility is therefore an important requirement for the interoperability of the rail system.
Amendment 123 #
2013/0015(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 13
Article 2 – paragraph 1 – point 13
(13) ‘"renewal’" means any significant substitution work on a subsystem, a vehicle or part of it which does not change the overall performance of the subsystem; each TSI should be designated 'significant' for the vehicle or subsystem concerned;
Amendment 144 #
2013/0015(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 37
Article 2 – paragraph 1 – point 37
(37) ‘disabled personperson with disabilities and person with reduced mobility’ shall include any person who has a permanent or temporary physical, mental, intellectual or sensory impairment which, in interaction with various barriers, may hinder their full and effective use of transport on an equal basis with other passengers or whose mobility when using transport is reduced due to age.
Amendment 223 #
2013/0015(COD)
Proposal for a directive
Article 18 – paragraph 2 – subparagraph 1
Article 18 – paragraph 2 – subparagraph 1
Each national safety authority shall authorise the placing in service of theoperate as a one-stop shop for all permanently installed system components: energy and infrastructure subsystems which are located or oper, rail control command and signalling facilities, plus the subsystems thereof, located in the territory of its Member State.
Amendment 389 #
2013/0015(COD)
Proposal for a directive
Article 29 – paragraph 1 – point a
Article 29 – paragraph 1 – point a
(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified as well as training on accessibility issues;
Amendment 411 #
2013/0015(COD)
Proposal for a directive
Article 45 – paragraph 5
Article 45 – paragraph 5
5. Other registers, such as a register on accessibility, may for persons with disabilities and persons with reduced mobility, shall also be associated to the register of infrastructure.
Amendment 183 #
2013/0014(COD)
Proposal for a regulation
Article 18 – title
Article 18 – title
Authorisations for placing in service of the trackside control-command and signallingEuropean Rail Traffic sub-systems Management System
Amendment 189 #
2013/0014(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
The Agency shall issube the authorisations for placing in service of the trackside control- command and signalling subsystems located or operated in the entire Unioning authority for the trackside European Rail Traffic Management System in accordance with Article 18 of Directive … [the Interoperability Directive].
Amendment 68 #
2012/0366(COD)
Proposal for a directive
Recital 8
Recital 8
(8) In accordance with Article 114(3) of the Treaty of the Functioning of the European Union (hereinafter: "Treaty"), a high level of health protection should be taken as a basis, regard being had, in particular, to any new developments based on scientific facts. Tobacco products are not ordinary commodities and in view of the particularly harmful effects of tobacco, health protection should be given high importance, in particular to reduce smoking prevalence among young people. In accordance with the principle of producer responsibility, manufacturers of tobacco products should therefore be made responsible for all health costs arising as a consequence of tobacco consumption.
Amendment 94 #
2012/0366(COD)
Proposal for a directive
Recital 14 a (new)
Recital 14 a (new)
(14a) In order to protect human health, the safety of additives for use in tobacco products should be assessed (risk assessment) and they should receive authorisation from the Commission prior to being marketed in the Community. Additives should only then be permitted for use in tobacco products if they are included in an EU list of authorised additives.
Amendment 151 #
2012/0366(COD)
Proposal for a directive
Recital 23
Recital 23
(23) In order to ensure the integrity and the visibility of health warnings and maximise their efficacy, provisions should be made regarding the dimension of the warnings as well as regarding certain aspects of the appearance of the tobacco package, including the opening mechanism. The package and the products may mislead consumers, in particular young people, suggesting that products are less harmful. For instance, this is the case with certain texts or features, such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘mild’, '‘natural'’, '‘organic'’, ‘without additives’, ‘without flavours’, '‘slim'’, names, pictures, and figurative or other signs. Likewise, the size and appearance of individual cigarettes can mislead consumers by creating the impression that they are less harmful. A recent study has also shown that smokers of slim cigarettes were more likely to believe that their own brand might be less harmful. This should be addressed.
Amendment 153 #
2012/0366(COD)
Proposal for a directive
Recital 23 a (new)
Recital 23 a (new)
(23a) Tobacco products have been shown to contain and emit many noxious substances and known carcinogens hazardous to human health when burnt. Scientific studies have clearly proven that passive smoking is a cause of death, illness and disability and that passive smoking is dangerous in particular to unborn children and infants. It can cause or aggravate respiratory problems in persons inhaling smoke. The health warnings should therefore also draw attention to the dangers to health of passive smoking.
Amendment 260 #
2012/0366(COD)
Proposal for a directive
Article 1 – paragraph 1 – subparagraph 2
Article 1 – paragraph 1 – subparagraph 2
Amendment 263 #
2012/0366(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
(2) '‘additive'’ means a substance contained in a tobacco product, its unitwhich is used in the manufacture of a tobacco product, including its components such as paper, filter, inks, capsules, adhesives, packet or anyd outside packaging, and is still present, including in modified form, in the finished product with the exception of tobacco leaves and other natural or unprocessed parts of tobacco plants;
Amendment 276 #
2012/0366(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
Amendment 301 #
2012/0366(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 18
Article 2 – paragraph 1 – point 18
(18) '‘ingredient'’ means an additive, tobacco (leaves and other natural, processed or unprocessed parts of tobacco plants including expanded and reconstituted tobacco), as well as any substance present in a finished tobacco product including paper, filter, inks, capsules and adhesives and tobacco;
Amendment 309 #
2012/0366(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 18 b (new)
Article 2 – paragraph 1 – point 18 b (new)
(18b) 'tobacco' means leaves and other processed or unprocessed parts of tobacco plants, including expanded and reconstituted tobacco;
Amendment 422 #
2012/0366(COD)
Proposal for a directive
Article 5 – paragraph 1 a (new)
Article 5 – paragraph 1 a (new)
1a. First and foremost, Member States shall examine tobacco product ingredients so as to assess the need to take measures under Regulations (EC) No 1907/2006 (REACH) and (EC) No 1272/2008 (CLP). On the basis of those examinations, and taking account of the precautionary principle, Member States shall submit scientific dossiers to the European Chemicals Agency, in particular pursuant to Articles 59(3) and 69(4) of Regulation (EC) No 1907/2006 and Article 37(1) of Regulation (EC) No 1272/2008. Member States shall report regularly to the Commission on the measures under examination in connection with tobacco product ingredients and on the steps which they have taken, where appropriate, on that basis. Every three years, the Commission shall publish a report on the progress made by Member States in this connection.
Amendment 425 #
2012/0366(COD)
Proposal for a directive
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The list shall be accompanied by a statement setting out the reasons for the inclusion of such ingredients in those tobacco products. The list shall indicate their status, including whether the ingredients have been registered under Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as well as their classification under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures. The list shall also be accompanied by the toxicological data available to the manufacturer or importer regarding these ingredients in burnt or unburnt form as appropriate, referring in particular to their effects on health of consumers and taking into account, inter alia, any addictive effects. The list shall be established in descending order of the weight of each ingredient included in the product. Within one year following the entry into force of this Directive, manufacturers and importers of tobacco products shall submit the list of ingredients and all the accompanying information referred to above. Member States shall penalise manufacturers and importers of tobacco products who fail to submit that list and the accompanying information by the time limit. Other than for tar, nicotine and carbon monoxide and for emissions referred to in Article 4 paragraph 4, the manufacturers and importers shall indicate the measurement methods used. Member States may also require manufacturers or importers to carry out other tests as may be laid down by the competent national authorities in order to assess the effects of substances on health, taking into account, inter alia, their addictiveness and toxicity.
Amendment 445 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
Amendment 462 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
Amendment 482 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 3
Article 6 – paragraph 1 – subparagraph 3
Amendment 492 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
Amendment 500 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
Amendment 508 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
Amendment 514 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 4
Article 6 – paragraph 4
Amendment 517 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 4 – point a
Article 6 – paragraph 4 – point a
Amendment 521 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 4 – point b
Article 6 – paragraph 4 – point b
Amendment 524 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 4 – point c
Article 6 – paragraph 4 – point c
Amendment 530 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 5
Article 6 – paragraph 5
Amendment 539 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 6
Article 6 – paragraph 6
Amendment 540 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 1
Article 6 – paragraph 7 – subparagraph 1
Amendment 547 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2
Article 6 – paragraph 7 – subparagraph 2
Amendment 551 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 8
Article 6 – paragraph 8
Amendment 556 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 9
Article 6 – paragraph 9
Amendment 567 #
2012/0366(COD)
Proposal for a directive
Article 6 – paragraph 10
Article 6 – paragraph 10
Amendment 595 #
2012/0366(COD)
Proposal for a directive
Article 7 – paragraph 3
Article 7 – paragraph 3
3. In order to ensure their graphic integrity and visibility, health warnings shall be irremovably printed, indelible and in no way hidden or interrupted, including by tax stamps, price marks, tracking and tracing marks, security features or by any type of wrapper, pouch, jacket, box or other device or by the opening of the unit packet. In the case of tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco products health warnings may be affixed by means of stickers, provided that these cannot be removed.
Amendment 675 #
2012/0366(COD)
Proposal for a directive
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) cover 765 % of the external area of both the front and back surface of the unit packet and any outside packaging;
Amendment 718 #
2012/0366(COD)
Proposal for a directive
Article 9 – paragraph 1 – point g – point i
Article 9 – paragraph 1 – point g – point i
(i) height: not less than 6455 mm;
Amendment 775 #
2012/0366(COD)
Proposal for a directive
Article 10 – paragraph 3 a (new)
Article 10 – paragraph 3 a (new)
3a. In the case of packets whose most visible side has an area exceeding 75 cm², the warnings referred to in paragraphs 2 and 3 must, however, cover an area of at least 22.5 cm² on each side. That area shall be increased to 24 cm² for Member States with two official languages and 26.25 cm² for Member States with three official languages.
Amendment 801 #
2012/0366(COD)
Proposal for a directive
Article 11 – paragraph 1 – subparagraph 2
Article 11 – paragraph 1 – subparagraph 2
This tobacco product canis damageing to your health and is addictive
Amendment 817 #
2012/0366(COD)
Proposal for a directive
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
1. The labelling of a unit packet and any outside packaging and the tobacco product itself shall not include any information about nicotine, tar or carbon monoxide content or any element or feature that:
Amendment 877 #
2012/0366(COD)
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
1. A unit packet of cigarettes shall have a cuboid shape. A unit packet of roll-your- own tobacco shall have the form of a pouch, i.e. a rectangular pocket with a flap that covers the opening. The flap of the pouch shall cover at least 70% of the front of the packet. A unit packet of cigarettes shall include at least 20 cigarettes. A unit packet of roll- your-own tobacco shall contain tobacco weighing at least 40 g.
Amendment 890 #
2012/0366(COD)
Proposal for a directive
Article 13 – paragraph 2
Article 13 – paragraph 2
Amendment 925 #
2012/0366(COD)
Proposal for a directive
Article 13 – paragraph 4
Article 13 – paragraph 4
Amendment 1257 #
2012/0366(COD)
Proposal for a directive
Article 19 – paragraph 1 – subparagraph 1
Article 19 – paragraph 1 – subparagraph 1
This product can damages your health.
Amendment 1271 #
2012/0366(COD)
Proposal for a directive
Article 22 – paragraph 2
Article 22 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(104), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(5) shall be conferred on the Commission for an indeterminate period of time from [Office of Publications: please insert the date of the entry into force of this Directive].
Amendment 1283 #
2012/0366(COD)
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. The delegation of powers referred to in Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(104), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(5) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 1293 #
2012/0366(COD)
Proposal for a directive
Article 22 – paragraph 5
Article 22 – paragraph 5
5. A delegated act pursuant to Articles 3(2), 3(3), 4(3), 4(4), 6(3), 6(9), 6(104), 8(4), 9(3), 10(5), 11(3), 13(3), 13(4), 14(9), 18(2) and 18(5) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Amendment 1323 #
2012/0366(COD)
Proposal for a directive
Article 25 – paragraph 1
Article 25 – paragraph 1
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [Publications Office, please insert the exact date: entry into force + 18 months] and in the case of Article 6 by [Publications Office, please insert the exact date: entry into force + 36 months] at the latest. They shall forthwith communicate to the Commission the text of those provisions.
Amendment 110 #
2012/0278(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
This Regulation does not apply to genetic resources for which access and benefit- sharing is governed by a specialised international instruments to which the Union is a Party.
Amendment 112 #
2012/0278(COD)
Proposal for a regulation
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
Given the specific nature of biodiversity in the agricultural sphere, its characteristics and its problems, which call for specific solutions, this Regulation shall not apply to genetic resources for food and agriculture in so far as these fall within the scope of existing or future specialised instruments under Articles 4, 8c, 19 and 20 of the Nagoya Protocol.
Amendment 126 #
2012/0278(COD)
Proposal for a regulation
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1a. The due diligence referred to in paragraph 1 shall not apply to subsequent uses of the product developed from the original resource (e.g. a plant variety) if the product is not a usable genetic resource.
Amendment 156 #
2012/0278(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Users shall declare to the competent authorities established under Article 6(1) that they exercised due diligence in accordance with Article 4 on the occasion of requesting market approval for a product developed on the basis of genetic resources or traditional knowledge associated with such resources, or at the time of commercialisation where a market approval is not required. This declaration shall not be required if the country of origin of the genetic resource used does not insist on Prior Informed Consent and Mutually Agreed Terms in accordance with Article 6 of the Nagoya Protocol.
Amendment 85 #
2012/0267(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock- management by hospitals, pharmacies and in wholesale. The UDI system should be compatible with other systems which are already on the market.
Amendment 86 #
2012/0267(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock- management by hospitals, wholesalers and pharmacists and be compatible with other authentication systems already in place in those settings.
Amendment 111 #
2012/0267(COD)
Proposal for a regulation
Article 1 – paragraph 6
Article 1 – paragraph 6
6. This Regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide on other category C tests after consultation with stakeholders.
Amendment 120 #
2012/0267(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
(12a) ‘ device for genetic testing’ means an in vitro diagnostic medical device the purpose of which is to identify a genetic characteristic of a person which is inherited or acquired during prenatal development.
Amendment 144 #
2012/0267(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 169 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Before making a device available on the market for the first time, distributors shall verify that the following requirements are met:
Amendment 170 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point b
Article 12 – paragraph 2 – subparagraph 1 – point b
(b) in the absence of a declaration of conformity by the manufacturer or importer, the product is accompanied by the information to be supplied by the manufacturer in accordance with Article 8(7);
Amendment 171 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c
Article 12 – paragraph 2 – subparagraph 1 – point c
(c) the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 22 and Article 11(3) respectively11(3).
Amendment 173 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and, within their respective area of activity, make sure that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 174 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that, within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 177 #
2012/0267(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point a
Article 13 – paragraph 1 – point a
(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices;
Amendment 179 #
2012/0267(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point b
Article 13 – paragraph 1 – point b
(b) fivetwo years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.
Amendment 188 #
2012/0267(COD)
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) compatibility with medical device identification systems already on the market.
Amendment 189 #
2012/0267(COD)
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) the compatibility with other traceability systems used by the stakeholders involved with medical devices.
Amendment 259 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 2
Article 40 – paragraph 2 – subparagraph 2
In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safeas specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX. Laboratory tests performed by a reference laboratory shall focus on in particular analytic sensitivity and sperformance that is at least equivalent, as specified in Section 5.4 of Annex VIII ancificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established in Sfection 3.5 of Annex IX.
Amendment 309 #
2012/0267(COD)
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
Article 59 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures to encourage healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
Amendment 323 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point b
Article 77 – paragraph 1 – point b
Amendment 325 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point c
Article 77 – paragraph 1 – point c
(c) to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of the clinical evaluation by manufacturers and the assessment by notified bodies;.
Amendment 327 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point e
Article 77 – paragraph 1 – point e
Amendment 328 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – point f
Article 77 – paragraph 1 – point f
Amendment 329 #
2012/0267(COD)
Proposal for a regulation
Article 77 – paragraph 1 – points f a to f k (new)
Article 77 – paragraph 1 – points f a to f k (new)
(fa) to continuously monitor the technical progress in particular in the field of implantable devices and assess whether the essential requirements on safety and performance provided within this Regulation are appropriate to ensure safety and performance of medical devices and identify the need to amend Annex I; (fb) to develop guidelines on clinical trials of certain medical devices (fc) to contribute to the development of medical devices standards; (fd) to contribute to the development of Common Technical Specifications (CTS) (fe) to develop and maintain a framework for a European market surveillance program; (ff) to develop minimum requirements on a quality management system for national market surveillance authorities . (fg) to organise joint market surveillance and joint testing projects; (fh) to organise training programmes and exchanges of national officials on market surveillance, on notified bodies designation and monitoring and on clinical investigations; (fi) to organise information campaigns and joint visit programmes; (fj) to provide an opinion on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices according to Article 41 paragraph 3 within six months; (fk) to provide at the Commission's request an opinion on a the classification of a device, or category or group of devices according to Article 41 paragraph 4.
Amendment 155 #
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, in cooperation with the MDCG and the Council, 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. 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 157 #
2012/0266(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) Devices for use in blood donation and blood therapy should meet the requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC.
Amendment 219 #
2012/0266(COD)
Proposal for a regulation
Recital 64
Recital 64
(64) In order to maintain a high level of health and safety, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the products subject to this Regulation that are similar to medical devices but do not necessarily have a medical purpose; adaptation of the definition of nanomaterial to technical progress and to developments at Union and international level; adaptation to technical progress of the general safety and performance requirements, of the elements to be addressed in the technical documentation, of the minimum content of the EU declaration of conformity and of the certificates issued by notified bodies, of the minimum requirements to be met by notified bodies, of the classification rules, of the conformity assessment procedures, and of the documentation to be submitted for the approval of clinical investigations; the establishment of the UDI system; the information to be submitted for the registration of medical devices and certain economic operators; the level and structure of fees for the designation and monitoring of notified bodies; the publicly available information in respect of clinical investigations; the adoption of preventive health protection measures at EU level; and the tasks of and criteria for European Union reference laboratories and the level and structure of fees for scientific opinions delivered by them. However, basic aspects of this Regulation such as general safety and performance requirements, stipulations on technical documentation and the requirements for CE mark certification, as well as any amendments or additions to it, should be provided for only through the ordinary legislative procedure. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
Amendment 225 #
2012/0266(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point f
Article 1 – paragraph 2 – point f
(f) products that contain or consist of biological substances or organisms other than those referred to in points (c) and (e) that are viable, including living micro- organisms, bacteria, fungi or viru and that achieve their principal action by pharmacological, immunological or metabolic means;
Amendment 245 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 4 – introductory part
(4) ‘active device’ means any device, the operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or by gravity and which acts by changing the density of or converting this energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be considered to be active devices.
Amendment 246 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4 – paragraph 1
Article 2 – paragraph 1 – subparagraph 1 – point 4 – paragraph 1
Amendment 260 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 31 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 31 a (new)
(31a) ‘safety’ means the absence or elimination of unacceptable risks to patients or users.
Amendment 262 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 33
Article 2 – paragraph 1 – subparagraph 1 – point 33
(33) ‘clinical investigation’ means any systematic investigation in one or more human subjects, undertaken to assess the safety or, performance or effectiveness of a device;
Amendment 264 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 37
Article 2 – paragraph 1 – subparagraph 1 – point 37
(37) ‘sponsor’ means an individual, company, institution or organisation which takes responsibility for the initiation and, management and direction and/or financing of a clinical investigation;
Amendment 266 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 37 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 37 a (new)
(37a) ‘conformity assessment’ of a clinical study means the checking by the authorities responsible of the relevant official documentation, facilities and records and of the existence of sufficient insurance cover. Such checking may be carried out on the premises of the sponsor and/or the research establishment or wherever the authority responsible may deem checks to be necessary.
Amendment 269 #
2012/0266(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 40 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 40 – introductory part
(40) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer;
Amendment 284 #
2012/0266(COD)
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
Amendment 293 #
2012/0266(COD)
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
1a. It should be possible for the Commission, if such necessary standards do not exist or if competent bodies or specialists have highlighted shortcomings in them, to delegate to specialists the task of proposing amendments in this specific area. These would then be incorporated into this Regulation in the form of implementing acts.
Amendment 298 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2
Article 8 – paragraph 2 – subparagraph 2
Amendment 299 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 4 – subparagraph 2
Article 8 – paragraph 4 – subparagraph 2
Amendment 303 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 1
Article 8 – paragraph 6 – subparagraph 1
Proportionate to the risk class and the type of device, manufacturers of devices, other than custom-made devices, shall institute and keep up to date a systematic procedure to collect and review experience gained from their devices placed on the market or put into service and to apply any necessary corrective action, hereinafter referred to as ‘post-market surveillance plan’. The post- market surveillance plan shall set out the process for collecting, recording and investigating complaints and reports from healthcare professionals, patients or users on suspected incidents related to a device, keeping a register of non-conforming products and product recalls or withdrawals, and if deemed appropriate due to the nature of the device, sample testing of marketed devices. Part of the post-market surveillance plan shall be a plan for post-market clinical follow-up in accordance with Part B of Annex XIII. The analysis and reporting of clinical follow- up should include reference to independent organisations. Where post- market clinical follow-up is not deemed necessary, this shall be duly justified and documented in the post- market surveillance plan.
Amendment 309 #
2012/0266(COD)
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
9. Manufacturers shall, in response to a reasoned request from a competent authority, a recognised medical institution or an association organised at European level, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any corrective action taken to eliminate the risks posed by devices which they have placed on the market or put into service.
Amendment 331 #
2012/0266(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Before making a device available on the market for the first time, distributors shall verify that the following requirements are met:
Amendment 332 #
2012/0266(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point b
Article 12 – paragraph 2 – subparagraph 1 – point b
(b) in the absence of a manufacturer’s or importer’s declaration of conformity, the product is accompanied by the information to be supplied by the manufacturer in accordance with Article 8(7);
Amendment 333 #
2012/0266(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c
Article 12 – paragraph 2 – subparagraph 1 – point c
(c) the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 24 and Article 11(3) respectively11(3).
Amendment 337 #
2012/0266(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure, within their field of operations, that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 344 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – introductory part
Article 13 – paragraph 1 – subparagraph 1 – introductory part
Manufacturers shall have available within their organisation at least one qualified person who possesses expert knowledgthe requisite expertise in the field of medical devices. The expert knowledgrequisite expertise shall be demonstrated by either of the following qualifications:
Amendment 346 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point a
Article 13 – paragraph 1 – subparagraph 1 – point a
Amendment 348 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point a
Article 13 – paragraph 1 – subparagraph 1 – point a
(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices;in natural sciences, medicine or technology, or
Amendment 351 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point b
Article 13 – paragraph 1 – subparagraph 1 – point b
Amendment 353 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1 – point b
Article 13 – paragraph 1 – subparagraph 1 – point b
(b) five years of professional experience in regulatory affairs or in quality management systems relating to medical devicesan educational qualification attesting to competence to perform the tasks listed in paragraph 2 and at least two years’ professional experience. Proof of expertise must be supplied on request to the authorities responsible.
Amendment 358 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 2
Article 13 – paragraph 1 – subparagraph 2
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate their expert knowledgise referred to in the first subparagraphentence by at least two years of professional experience within the relevant field of manufacture.
Amendment 363 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point b
Article 13 – paragraph 2 – point b
(b) that the technical documentation and the declaration of conformity are drawn up and kept up-to-datereporting obligations in accordance with Articles 61 to 66 are fulfilled;
Amendment 365 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point d
Article 13 – paragraph 2 – point d
Amendment 368 #
2012/0266(COD)
Proposal for a regulation
Article 13 – paragraph 2 – subparagraph 1 (new)
Article 13 – paragraph 2 – subparagraph 1 (new)
If a number of qualified persons are jointly responsible in respect of the provision in the first sentence, their respective areas of responsibility shall be stipulated in writing.
Amendment 384 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation. Hospitals that reprocess single-use devices in house shall not be deemed to be manufacturers. They must, however, demonstrate that they have the requisite technical expertise for in-house reprocessing and must possess liability insurance covering them in the event of problems with the reprocessing.
Amendment 392 #
2012/0266(COD)
Proposal for a regulation
Article 15 – paragraph 3
Article 15 – paragraph 3
3. In the case of reprocessing of single-use devices for critical use, only reprocessing that is considered safe according to the latest scientific evidence may be carried out; the hygiene requirements for the reprocessing of medical devices recommended by the Commission for Hospital Hygiene and the Prevention of Infection (KRINKO), attached to the Robert Koch Institute (RKI) and the German Federal Institute for Drugs and Medical Devices (BfArM) should serve as examples of practice in this regard.
Amendment 410 #
2012/0266(COD)
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The manufacturer of an implantable device shall providein sterile packaging shall provide in advance to the relevant health professional, together with the device, an implant card which shall be made available to the particular patient who has been implanted with the device. The implanter shall be responsible for making the card available to the patient and entering the data in the relevant database. The following types of implant shall be exempt: stitches, clips, screws, plates and accessories to orthopaedic implants. The Commission, by means of implementing acts, shall regularly review and update this list of exempted implants. Those implementing acts shall be adopted in accordance with Article 88(3).
Amendment 426 #
2012/0266(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. The EU declaration of conformity shall state that fulfilment of the requirements specified in this Regulation has been demonstrated. It shall be continuously updated. The minimum content of the EU declaration of conformity is set out in Annex III. It shall be translated into theissued in an EU official Union language or languages required by the Member State(s) in which the device is made availableplaced on the market, and also in English if the device is made available in other Member States.
Amendment 430 #
2012/0266(COD)
Proposal for a regulation
Article 17 – paragraph 4
Article 17 – paragraph 4
Amendment 435 #
2012/0266(COD)
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. An article that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics of the device shall be considered as a device. and must meet the requirements laid down in this Regulation.
Amendment 436 #
2012/0266(COD)
Proposal for a regulation
Article 21 – paragraph 2 a (new)
Article 21 – paragraph 2 a (new)
2a. Any natural or legal person who reprocesses a device in accordance with the manufacturer’s recommendations must ensure that he does not adversely affect the characteristics or the safety of the device.
Amendment 437 #
2012/0266(COD)
Proposal for a regulation
Article 21 – paragraph 2 b (new)
Article 21 – paragraph 2 b (new)
2b. Any natural or legal person who reprocesses a device without reference to the manufacturer’s recommendations on reprocessing or who disregards or violates those recommendations shall be considered as a manufacturer within the meaning of this Regulation.
Amendment 440 #
2012/0266(COD)
Proposal for a regulation
Article 24 – paragraph 1 – introductory part
Article 24 – paragraph 1 – introductory part
1. For class II devices, other than custom- made and investigational devices, a system for Unique Device Identification shall be put in place in the Union. The UDI system shall allow the identification and traceability of devices and shall consist of the following:
Amendment 445 #
2012/0266(COD)
Proposal for a regulation
Article 24 – paragraph 8 – point e a (new)
Article 24 – paragraph 8 – point e a (new)
(ea) compatibility with identification systems for medical devices already on the market.
Amendment 451 #
2012/0266(COD)
Proposal for a regulation
Article 25 – paragraph 2
Article 25 – paragraph 2
2. Before a device, other than a custom- made or investigational device, is placed on the market the manufacturer or his authorised representative shall submit to the electronic system the information referred to in paragraph 1. Steps shall be taken to ensure that no additional national registration procedures are necessary.
Amendment 452 #
2012/0266(COD)
Proposal for a regulation
Article 25 – paragraph 5
Article 25 – paragraph 5
5. Not later than twofive years after submission of the information in accordance with paragraphs 2 and 3, and then every secondfifth year, the relevant economic operator shall confirm the accuracy of the data. In the event of failure to confirm within six months of the due date, any Member State may take measures to suspend or otherwise restrict the making available of the device in question within its territory until the obligation referred to in this paragraph is complied with.
Amendment 458 #
2012/0266(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a summaryreport ofn safety and clinical performance which sets out the results of the clinical studies and trials. It shall be written in a way that is clear to the intended user. The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with Article 42 and shall be validated by that body.
Amendment 465 #
2012/0266(COD)
Proposal for a regulation
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
1a. Doctors and healthcare professionals should have access to all areas of Eudamed.
Amendment 466 #
2012/0266(COD)
Proposal for a regulation
Article 27 – paragraph 1 b (new)
Article 27 – paragraph 1 b (new)
1b. the data submitted shall be checked and assessed by Eudamed before being made available.
Amendment 467 #
2012/0266(COD)
Proposal for a regulation
Article 27 – paragraph 1 – point a
Article 27 – paragraph 1 – point a
(a) to enable the public to be adequately informed about devices placed on the market, about the corresponding certificates issued by notified bodies and about the relevant economic operators, with the proviso that manufacturers must be able to maintain commercial confidentiality on this highly innovative market;
Amendment 476 #
2012/0266(COD)
Proposal for a regulation
Article 27 – paragraph 4
Article 27 – paragraph 4
4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors, healthcare professionals and the public to the extent defined in the provisions referred to in paragraph 2.
Amendment 489 #
2012/0266(COD)
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
Amendment 500 #
2012/0266(COD)
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. Member States may notify only conformity assessment bodies which satisfy the requirements set out in Annex VI and the requirements laid down by the joint assessment team, as provided for in Article 32(3), and which have received a positive assessment from the MDCG (Article 44 a (new)).
Amendment 532 #
2012/0266(COD)
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. The Member State where the bodies are established shall levycollect fees onfrom applicant conformity assessment bodies and on notified bodies. These fees shall, wholly or partly, cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this Regulation. The Commission shall set the level of the fees. These shall be standard fees which are collected in all the Member States in the same way.
Amendment 534 #
2012/0266(COD)
Proposal for a regulation
Article 41 – paragraph 2 – subparagraph 2
Article 41 – paragraph 2 – subparagraph 2
At least 14 days prior to any decision, the competent authority shall notify the MDCG and the Commission of its envisaged decision. The final decision shall be made available in the European Database.
Amendment 536 #
2012/0266(COD)
Proposal for a regulation
Article 41 – paragraph 3 – subparagraph 1
Article 41 – paragraph 3 – subparagraph 1
The Commission may, at the request of a Member State or on its own initiative, by means of implementing acts, decide on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices, with a view to determining their classification. Decisions of this kind shall primarily be taken in order to ensure that Member States do not apply differing classification criteria to a given device or category or group of devices.
Amendment 551 #
2012/0266(COD)
Proposal for a regulation
Article 42 – paragraph 11
Article 42 – paragraph 11
Amendment 560 #
Amendment 598 #
2012/0266(COD)
Proposal for a regulation
Article 44 a (new)
Article 44 a (new)
Amendment 605 #
2012/0266(COD)
Proposal for a regulation
Article 47 – paragraph 1
Article 47 – paragraph 1
1. By way of derogation from Article 42, any competent authority may authorise, on duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the procedures referred to in Article 42 have not been carried out and use of which is in the interest of public health or patient safety, provided that the Medical Device Coordination Group has authorised it. This derogation shall be possible only if the manufacturer submits the requisite clinical data to the competent authority within the prescribed period.
Amendment 608 #
2012/0266(COD)
Proposal for a regulation
Article 50 – paragraph 1 – point a
Article 50 – paragraph 1 – point a
(a) to verify that, under normal conditions of use, devices are designed, manufactured and packaged in such a way that they are suitable for one or more of the specific purposes of a medical device referred to in number (1) of Article 2(1), and achieve the performances intended as specified by the manufacturer or sponsor;
Amendment 609 #
2012/0266(COD)
Proposal for a regulation
Article 50 – paragraph 1 – point b
Article 50 – paragraph 1 – point b
(b) to verify that devices achieve the intended benefits to the patient as specified by the manufacturer or sponsor;
Amendment 610 #
2012/0266(COD)
Proposal for a regulation
Article 50 – paragraph 3
Article 50 – paragraph 3
3. Clinical investigations shall be designed and conducted in a way that the rights, safety and well-being of the subjects participating in a clinical investigation are protected and that the clinical data generated in the clinical investigation are going to be reliable and robust. Clinical investigations shall not be conducted if the associated risks exceed the possible benefit to be derived from the medical device. Member States should have the option of prohibiting clinical investigations of certain product groups or test fields or demanding that certain conditions be complied with.
Amendment 611 #
2012/0266(COD)
Proposal for a regulation
Article 51 – paragraph 2 – subparagraph 1
Article 51 – paragraph 2 – subparagraph 1
The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the investigation is to be conducted accompanied by the documentation referred to in Chapter II of Annex XIV. Within six14 days after receipt of the application, the Member State concerned shall notify the sponsor whether the clinical investigationperformance study falls within the scope of this Regulation and whether the application is complete.
Amendment 613 #
2012/0266(COD)
Proposal for a regulation
Article 51 – paragraph 3 – subparagraph 3
Article 51 – paragraph 3 – subparagraph 3
Where the Member State has not notified the sponsor according to paragraph 2 within threesix days following receipt of the comments or of the completed application, the clinical investigation shall be considered as falling within the scope of this Regulation and the application shall be considered complete.
Amendment 614 #
2012/0266(COD)
Proposal for a regulation
Article 51 – paragraph 5 a (new)
Article 51 – paragraph 5 a (new)
5a. Member States shall ensure that they interrupt, terminate or suspend a clinical investigation if new scientific findings are available and the competent authority therefore would no longer authorise the clinical investigation or if the ethics committee would no longer authorise it.
Amendment 615 #
2012/0266(COD)
Proposal for a regulation
Article 51 – paragraph 5 – point a
Article 51 – paragraph 5 – point a
(a) in the case of investigational devices classified as class III and implantable or long-term invasive devices classified as class IIa or IIb, as soon as the Member State concerned has notified the sponsor of its approval;
Amendment 616 #
2012/0266(COD)
Proposal for a regulation
Article 51 – paragraph 5 – point b
Article 51 – paragraph 5 – point b
Amendment 617 #
2012/0266(COD)
Proposal for a regulation
Article 51 – paragraph 5 – point c
Article 51 – paragraph 5 – point c
(c) after the expiry of 3560 days after the validation date referred to in paragraph 4, unless the Member State concerned has notified the sponsor within that period of its refusal based on considerations of public health, patient safety or public policy.
Amendment 618 #
2012/0266(COD)
Proposal for a regulation
Article 51 a (new)
Article 51 a (new)
Ethics committee A clinical investigation may only be authorised if an independent ethics committee has delivered a positive assessment of the investigation. The statement by the ethics committee should take into account medical feasibility, the consent of the subjects after they have received full information about the possible risks and dangers associated with the clinical investigation, and the suitability of the investigating establishments and of the investigators. The ethics committee has the purpose of protecting the rights, welfare and safety of subjects, users and third parties. The committee must be independent of the research, the sponsor and any other influence. Both national and international standards must be complied with. The ethics committee shall be composed of an adequate number of suitably qualified members. The ethics committee shall, however, also include representatives of civil society.
Amendment 644 #
2012/0266(COD)
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission and, to the notified bodies and also to manufacturers where the information pertains to their own product.
Amendment 646 #
2012/0266(COD)
Proposal for a regulation
Article 62 – paragraph 3
Article 62 – paragraph 3
3. The Commission shall ensure that healthcare professionals have full access to the electronic system and that the public have an appropriate levels of access to ithe electronic system.
Amendment 650 #
2012/0266(COD)
Proposal for a regulation
Article 62 – paragraph 5 a (new)
Article 62 – paragraph 5 a (new)
5a. No additional national notification system should be established: instead, only the European notification system should apply.
Amendment 663 #
2012/0266(COD)
Proposal for a regulation
Article 64 – paragraph 1 a (new)
Article 64 – paragraph 1 a (new)
Medical devices which fall under legal acts of the European Union concerning the quality and safety of blood 1. This Regulation shall not [sic: verb apparently omitted - translator’s note] existing and implemented provisions at European level relating to the collection, testing, processing, storage and distribution of blood and blood components. 2. Medical devices for the collection, testing, processing, storage and distribution of blood and blood components are dealt with mainly under European Union Directive 2002/98 and the standards adopted by the Council on 27 January 2003 for quality and safety in connection with collection, testing, processing, storage and distribution. 3. Measures relating to traceability and vigilance in the field of blood and blood components are of a higher standard than is the case in this Regulation. They should be retained in the interests of patients.
Amendment 673 #
2012/0266(COD)
Proposal for a regulation
Article 67 – paragraph 1 a (new)
Article 67 – paragraph 1 a (new)
1a. The nature and extent of unannounced inspections, and costs incurred by the economic operator as a result of unannounced inspections, may be credited against regular inspections provided that no significant shortcomings are identified during the inspection. The organisation and implementation of unannounced inspections must always take account of the principle of proportionality, particularly with reference to the hazard potential of a particular product.
Amendment 718 #
2012/0266(COD)
Proposal for a regulation
Article 80 – paragraph 1 – point b
Article 80 – paragraph 1 – point b
Amendment 724 #
2012/0266(COD)
Proposal for a regulation
Article 80 – paragraph 1 – point c
Article 80 – paragraph 1 – point c
(c) to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of the clinical evaluation by manufacturers and the assessment by notified bodies;.
Amendment 726 #
2012/0266(COD)
Proposal for a regulation
Article 80 – paragraph 1 – point e
Article 80 – paragraph 1 – point e
Amendment 728 #
2012/0266(COD)
Proposal for a regulation
Article 80 – paragraph 1 – point f
Article 80 – paragraph 1 – point f
Amendment 730 #
2012/0266(COD)
Proposal for a regulation
Article 80 – paragraph 1 – point f a (new)
Article 80 – paragraph 1 – point f a (new)
Amendment 756 #
2012/0266(COD)
Proposal for a regulation
Article 94 – paragraph 4
Article 94 – paragraph 4
4. By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified before its date of application. Notified bodies which are designated and notified in accordance with this Regulation may apply the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation before its date of application if it has been ensured that the relevant delegated legal acts and implementing acts have been implemented.
Amendment 771 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 9 – introductory part
Annex 1 – part II – point 9 – introductory part
9. Devices incorporating a substance considered to be a medicinal product and devices composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally
Amendment 775 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 9 – point 9.2
Annex 1 – part II – point 9 – point 9.2
Amendment 781 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 11 – point 11.7
Annex 1 – part II – point 11 – point 11.7
11.7. Devices shall be designed and manufactured in such a way as to facilitate the safe disposal of the device, of substances with which it has been treated and/or of any waste substances by the user, patient or other person and, where possible and appropriate, the device shall be replaced with a device with a higher safety standard. This should particularly be intended to reduce dangers to patients and users which may arise from exposure to chemical or nuclear material.
Amendment 783 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 13 – point 13.1 – point a
Annex 1 – part II – point 13 – point 13.1 – point a
(a) Devices shall be designed and manufactured and packaged in such a way that exposure of patients, users and other persons to any emitted radiation shall be reduced as far as possible and appropriate, compatible with the intended purpose, and if possible these applications shall be replaced with applications with a higher safety standard, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes.
Amendment 784 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 13 – point 13.3 – paragraph 1
Annex 1 – part II – point 13 – point 13.3 – paragraph 1
Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible and appropriate: where possible, methods should be selected which reduce the exposure to radiation of patients, users and other persons who may be affected.
Amendment 785 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 13 – point 13.4 – point a
Annex 1 – part II – point 13 – point 13.4 – point a
(a) Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure that, where possible, the quantity, geometry and energy distribution (or quality) of radiation emitted can be varied and controlled taking into account the intended use, and if possible, devices should be used that can at any time during and after treatment monitor the emission of radiation.
Amendment 786 #
2012/0266(COD)
Proposal for a regulation
Annex 1 – part II – point 16 – introductory part
Annex 1 – part II – point 16 – introductory part
16. Protection against mechanical and thermal risksrisks arising from devices which are intended by manufacturers for self-testing
Amendment 795 #
2012/0266(COD)
Proposal for a regulation
Annex 2 – paragraph 1 – point 5 – paragraph 1 – introductory part
Annex 2 – paragraph 1 – point 5 – paragraph 1 – introductory part
The documentation shall contain a summary ofll available information concerning:
Amendment 798 #
2012/0266(COD)
Proposal for a regulation
Annex 4 – point 1 – introductory part
Annex 4 – point 1 – introductory part
1. The CE marking shall consist of the initials ‘“CE” with the addition of the words ‘medical device’ taking the following form:
Amendment 839 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 4 – point 4.2 – paragraph 1 – indent 1
Annex 7 – part III – point 4 – point 4.2 – paragraph 1 – indent 1
– are active and implantable devices intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in cClass III,
Amendment 840 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 4 – point 4.2 – paragraph 1 – indent 1
Annex 7 – part III – point 4 – point 4.2 – paragraph 1 – indent 1
Amendment 841 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 4 – point 4.2 – paragraph 1 – indent 3
Annex 7 – part III – point 4 – point 4.2 – paragraph 1 – indent 3
– are intended specifically for use in direct contact with the central nervous systemactive and implantable devices intended specifically for use for monitoring or diagnosis or to detect or correct faults in the central nervous system, involving direct contact with these parts of the body, in which case they are in class III,
Amendment 842 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 4 – point 4.3 – paragraph 1 – indent 1
Annex 7 – part III – point 4 – point 4.3 – paragraph 1 – indent 1
– are active or implantable devices intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in class III,
Amendment 843 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 4 – point 4.3 – paragraph 1 – indent 1
Annex 7 – part III – point 4 – point 4.3 – paragraph 1 – indent 1
Amendment 844 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 4 – point 4.3 – paragraph 1 – indent 2
Annex 7 – part III – point 4 – point 4.3 – paragraph 1 – indent 2
– are active or implantable devices intended specifically for use in direct contact with the central nervous system, in which case they are in class III,
Amendment 846 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 4 – point 4.4 – paragraph 1 – indent 8
Annex 7 – part III – point 4 – point 4.4 – paragraph 1 – indent 8
– are spinal disc replacement implants and implantable devices that come into contact with the spinal column, in which case they are in class III.
Amendment 850 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
All devices incorporating or consisting of nanomaterial are in class III unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient’s or user's body when the device is used within its intended purposewhose mode of functioning entails the deliberate release of nanomaterial into the human body are in class III.
Amendment 854 #
2012/0266(COD)
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.8 – paragraph 1
Annex 7 – part III – point 6 – point 6.8 – paragraph 1
Amendment 890 #
2012/0266(COD)
Proposal for a regulation
Annex 13 – point 2
Annex 13 – point 2
2. Confirmation of conformity with the requirements concerning the characteristics and performances referred to in Section 1 of Annex I, under the normal conditions of use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit/risk ratio referred to in Sections 1 and 5 of Annex I, shall be based on clinical data. Data from independent scientific institutions or medical societies based on their own collections of clinical data shall also be taken into account.
Amendment 894 #
2012/0266(COD)
Proposal for a regulation
Annex 13 – point 5
Annex 13 – point 5
5. In the case of implantable devices and devices falling within class III, clinical investigations shall be performed unless it is duly justified to rely on existing clinical data alone. DIn the case of novel devices, demonstration of equivalence in accordance with Section 4 shall generally not be considered as sufficient justification within the meaning of the first sentence of this paragraph.
Amendment 898 #
2012/0266(COD)
Proposal for a regulation
Annex 14 – part I – point 1 – paragraph 1
Annex 14 – part I – point 1 – paragraph 1
Every step in the clinical investigation, from first consideration of the need and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical principles, as for example those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th World Medical Association General Assembly in Helsinki, Finland, in 1964, and last amended by the 59th World Medical Association General Assembly in Seoul, Korea, in 2008. Regulation of the detailed requirements relating to the participation of subjects in clinical trials shall be the responsibility of the Member States.
Amendment 901 #
2012/0266(COD)
Proposal for a regulation
Annex 14 – part II – point 3 – point 3.1 – point 3.1.3
Annex 14 – part II – point 3 – point 3.1 – point 3.1.3
3.1.3. Information on the principal investigator, coordinating investigator, including their qualifications, and on the investigation site(s), as well as information about the contract between the sponsor and the investigating establishment, together with details of the funding.
Amendment 902 #
2012/0266(COD)
Proposal for a regulation
Annex 14 – part II – point 3 – point 3.1 – point 3.1.4
Annex 14 – part II – point 3 – point 3.1 – point 3.1.4
3.1.4. Overall synopsis of the clinical investigation in the national language of the country concerned.
Amendment 903 #
2012/0266(COD)
Proposal for a regulation
Annex 14 – part II – point 3 – point 3.15 a (new)
Annex 14 – part II – point 3 – point 3.15 a (new)
3.15 a. A plan for the further treatment of subjects after the clinical investigation.
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 101 #
2012/0192(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In case of an urgent situation as well as for rare and ultra-rare diseases which are life-threatening and for which therapeutic options and expertise are limited and geographically spread across the world, Member-States should have the possibility to assess and authorise clinical trial applications in priority.
Amendment 116 #
2012/0192(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) Whereas most clinical trials are conducted for the assessment of therapies, targeted at large patient populations, and involving a large sample of patient populations, the present regulation should not discriminate against patients suffering from rare and ultra-rare diseases, and should integrate the specificities of low- prevalence conditions into the assessment of a trial.
Amendment 166 #
2012/0192(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) The database should contain all relevant information as regards the clinical trial. No personal data of data subjects participating in a clinical trial should be recorded in the database and allow public dissemination of objective information in order to support European research and to increase knowledge in the field of public health. It should not undermine innovation or competitiveness of European industries. No personal data of data subjects participating in a clinical trial should be recorded in the database, and it should not hamper the protection of commercial interests, including intellectual property, as provided for by Article 4 of Regulation 1049/2001. The information in the database should be public, unless specific reasons require that a piece of information should not be published, in order to protect the right of the individual to private life and the right to the protection of personal data, recognised by Articles 7 and 8 of the Charter of Fundamental Rights of the European Union, or commercially confidential information, as foreseen by Article 4 of Regulation 1049/2001.
Amendment 169 #
2012/0192(COD)
Proposal for a regulation
Recital 52 a (new)
Recital 52 a (new)
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 293 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a – point i – indent 3
Article 6 – paragraph 1 – point a – point i – indent 3
– the reliability and robustness of the data generated in the clinical trial, taking account of statistical approaches, design of the trial and, methodology (including sample size and randomisation, comparator and endpoints); and the prevalence of the condition, especially for rare diseases (which affect no more than five persons per 10 000), and ultra-rare diseases (which meet a prevalence threshold of no more than one affected person per 50 000).
Amendment 300 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a – point ii – indent 4 a (new)
Article 6 – paragraph 1 – point a – point ii – indent 4 a (new)
- the life-threatening and debilitating effects of certain diseases, such as some rare and ultra-rare diseases for which there are limited existing treatment options;
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 335 #
2012/0192(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point a a (new)
Article 7 – paragraph 1 – subparagraph 1 – point a a (new)
(a a) compliance with national legislative provisions related to ethics;
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 391 #
2012/0192(COD)
Proposal for a regulation
Article 11 a (new)
Article 11 a (new)
Article 11a Clinical trial applications shall be prioritized by Member States to improve, where possible, the defined timelines when the clinical trial is related to a condition that is a rare or ultra-rare disease and, as such, is subject to significant administrative burden due to the extremely small patient populations. Rare and ultra-rare disease are defined as severe, debilitating and often life- threatening diseases which affect fewer than 5 persons per 10 000 or fewer than one person 50 000 in the Union respectively.
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 539 #
2012/0192(COD)
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 2 a (new)
Article 34 – paragraph 3 – subparagraph 2 a (new)
In order to protect personal data and commercially confidential information, and subject to the provisions of Article 78(3), the summary of the results of a clinical trial intended to obtain a marketing authorisation shall be made public 30 days after the date of the marketing authorisation, or one year after the end of the clinical trial in case of the discontinuation of the product development.
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 119 #
2012/0190(COD)
Proposal for a regulation
Article 1 – point 5
Article 1 – point 5
Regulation 2009/443/EC
Article 8 – paragraph 9 – subparagraph 1
Article 8 – paragraph 9 – subparagraph 1
9. The Commission shall adopt detailed rules onbe empowered to adopt delegated acts in accordance with Article 14a concerning the procedures for monitoring and reporting of data under this Article and on the application of Annex II by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2).
Amendment 121 #
2012/0190(COD)
Proposal for a regulation
Article 1 – point 6
Article 1 – point 6
Regulation 2009/443/EC
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The Commission shall adopt detailed arrangements for the collection of excess emissions premiums under paragraph 1 by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2).be empowered to adopt delegated acts in accordance with Article 14a concerning the arrangements for the collection of excess emissions premiums under paragraph 1
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 81 #
2012/0035(COD)
Proposal for a directive
Article 1 – paragraph 1 – subparagraph 1a (new)
Article 1 – paragraph 1 – subparagraph 1a (new)
This Directive shall also apply to medicinal products which are available on prescription, but are not refundable by the national health insurance system.
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 8 #
2011/2307(INI)
Motion for a resolution
Citation 4
Citation 4
– having particular regard to the outcome of the 10th Conference of the Parties (COP 10) to the UN Convention on Biological Diversity (CBD), in particular the Strategic Plan for Biodiversity 2011-2020 and the Aichi targets, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of the benefits arising from their utilisation, and the strategy to mobilise resources for global biodiversity,
Amendment 27 #
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 actions should be strengthened;
Amendment 96 #
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 the restoration of 30 % of degraded ecosystems as its target for 2020, and urges on the Commission to define clearly what is meant by ‘degraded ecosystems’, to present a proposal for an improvement and to set a baseline against which progress can be measured accordingly;
Amendment 106 #
2011/2307(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Urges the Commission to adopt a specific Green Infrastructure Strategy by 2012 at the latest, with biodiversity protection as a primary objective; in this context, rejects the further loss of productive agricultural land;
Amendment 133 #
2011/2307(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Recalling that over half of Europe’s territory is managed by farmers and that funding for the common agricultural policy (CAP) represents thea largest single part of the EU budget, stresses thatregards the CAP is an absolutely crucial tool for biodiversity; calls, therefore, for a strong reorientation of the CAP towards the delivery of public gexpects future agricultural policy also to face up to the new challenges, such as climate change and changes in the energy situation, and to ensure the security of high-quality foods;
Amendment 161 #
2011/2307(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls for all CAP payments, including those made after 2014, to be underpinned by robust cross-compliance rules,; covering the Water Framework Directive, pesticides legislation and the Birds and Habitats Directivesalls for simple and transparent rules for those affected;
Amendment 174 #
2011/2307(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls for a strengthening of Pillar II in all EU Member States and for drastic improvements to the environmental focus of that pillar and the effectiveness of its agro-environmental measures, including through minimum mandatory spending on environmental measures; calls for the introduction of genuine incentive components with the aim of rewarding services to the ecosystem in agriculture;
Amendment 224 #
2011/2307(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission and the Member States to ensure that measures taken to prevent both the entry of new invasive alien species into the EU and the spread of currently established invasive alien species to new areas are recorded and documented to enable risk assessments to be carried out and recommendations to be made;
Amendment 261 #
2011/2307(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls on the Commission and Member States to identify all existing environmentally harmful subsidies according to objective criteria, and calls on the Commission to publish by the end of 2012 an action plan to phase such subsidies out by 2020, in line with the Nagoya commitments;
Amendment 39 #
2011/2147(INI)
Draft opinion
Paragraph 7 d (new)
Paragraph 7 d (new)
7d. Calls on the Commission, in future legislation on health and safety at work and where applicable, to promote the use of technologies that reduce the risks posed by dangerous substances in the event of occupational accidents and, where possible, for these technologies to replace the use of chemical and radioactive substances;
Amendment 8 #
2011/2096(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Is aware that CO2 emissions, as well as emissions of CO, NOx, VOC and SO4 and brake and tyre wear particles, have a strong influence on air quality, first and foremost in urban areas, and hence on human health in the form of lung diseases and different forms of cancer;
Amendment 144 #
2011/2095(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
Amendment 247 #
2011/2095(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Welcomes the progress exceeding expectations that has been made by vehicle manufacturers in reducing CO2 emissions from passenger cars since 2007, and stresses the importance of accelerating further fuel efficiency improvements; affirms that in preparing its forthcoming review the Commission should be proposing ways of ensuring that average CO2 emissions by new cars meet the agreed 2020 target of not more than 95g/km by 2020, and do not exceed 70g/km by 2025;
Amendment 74 #
2011/2051(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas European agriculture can meet the challenges of the further market orientation in the context of international competition, particularly by means of innovation and high-quality production,
Amendment 135 #
2011/2051(INI)
Motion for a resolution
Recital M
Recital M
M. whereas effective measures should be taken to maximise added value in the food chain by means of quality production and to ensure a fair and equitable distribution of profits in the food chain,
Amendment 172 #
2011/2051(INI)
Motion for a resolution
Recital P
Recital P
P. whereas rural development is an important instrument of the CAP and whereas the new programmes should be geared even more strongly to the priority objectives of rural development and of farmers (employmentcompetitiveness of agriculture, employment, value added, the agricultural environment, water, climate change, innovation and education),
Amendment 426 #
2011/2051(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. In the case of direct farm payments, advocates moving away from historical and individual reference values and calls for a transition to a uniform area-based regional or national premium for decoupled payments in the next financing period; recognises, however, that the situationtarting points in the individual Member States arin 2013 will be very disparate, requiringso that special measures per region may be required;
Amendment 541 #
2011/2051(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls – without casting any doubt on the results of the 2008 Health Check of the CAP – for Member States to have the option of allocating appropriations under Article 68 of Regulation (EC) No 73/2009 primarily to be allocated for measures to promote territorial coherence and boost key sectors (e.g. the dairy and sheep sectors and suckler cows), for area-based environmental measures (e.g. organic farming) which to date have not been included in the second pillar; considers that the budget for the optional measures under Article 68 could – subject to contrary results of an impact assessment – cover up to 10% of direct payments;
Amendment 989 #
2011/2051(INI)
Motion for a resolution
Paragraph 43
Paragraph 43
43. Takes the view, therefore, that the Commission should devise common rules on optional support from Member States for risk management systems, possibly by creating common rules conforming to WTO rules in the common market organisation, in order to keep to a minimumeliminate any distortion of competition and tradein the internal market; calls, furthermore, on the Commission to notify all measures to introduce risk management and to submit an appropriate impact assessment with the legislative proposal;
Amendment 1042 #
2011/2051(INI)
Motion for a resolution
Paragraph 47
Paragraph 47
47. Observes that manipulative speculation in agricultural commodities should be combated; advocates a worldwide notification system for agricultural stocks; observes that consideration should be given to maintaining stocks of vital agricultural commoditiesrecognises however the importance of a functioning futures market in agricultural commodities; advocates therefore the adoption of worldwide measures to improve market transparency in respect of commodities and derivatives and calls for international measures to be envisaged with a view to combating effectively the undesired consequences of speculation;
Amendment 1048 #
2011/2051(INI)
Motion for a resolution
Paragraph 47 a (new)
Paragraph 47 a (new)
47a. Advocates a worldwide notification system for agricultural stocks; points out that, at international level, consideration should be given to the importance of maintaining stocks of vital agricultural commodities;
Amendment 1064 #
2011/2051(INI)
Motion for a resolution
Paragraph 48
Paragraph 48
48. Is aware of the importance of the second pillar, in view of its environmental, modernisation and structural improvement achievements, but also for attaining political objectives, which should also benefit farmers; calls therefore for second- pillar measures to be better suited to their objectives, so that the effectiveness of growth, employment and anti-climate change measures and measures for the benefit of rural areas can be increased; considers that, in this context, particular attention should be devoted to improving the competitiveness of European farmers and assisting young farmers;
Amendment 1172 #
2011/2051(INI)
Motion for a resolution
Paragraph 51
Paragraph 51
51. Stresses at the same time, however, that rural structures differ widely in the Member States and therefore require different measures; calls therefore for greater flexibility to allow the Member States and regions, in shaping their development plans for rural areas, to adopt voluntary measures, the cofinancing rate for which should be based on the rates current at the time;
Amendment 35 #
2011/0429(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3a) Measures to reduce emissions must accord with the ‘polluter pays’ principle. Emissions should therefore, if possible, already be prevented at the immediate source and not only after they have already entered surface water.
Amendment 102 #
2011/0429(COD)
Proposal for a directive
Article 2 – point 5
Article 2 – point 5
Directive 2008/105/EC
Article 8 a – paragraph 1 – point a
Article 8 a – paragraph 1 – point a
(a) prepare additional maps in the distance-to-target presentation which present the chemical status information separately from that for the rest of the substances in the river basin management plans produced in accordance with Article 13 of Directive 2000/60/EC, without prejudice to the requirements of Section 1.4.3 of Annex V to that Directive regarding the presentation of the overall chemical status, and/or
Amendment 156 #
2011/0429(COD)
Proposal for a directive
Article 2 – point 6 a (new)
Article 2 – point 6 a (new)
Directive 2008/105/EC
Article 8 c (new)
Article 8 c (new)
Amendment 173 #
2011/0429(COD)
Proposal for a directive
Annex I – table – row 46
Annex I – table – row 46
Directive 2000/60/EC
Annex X – table – row 46
Annex X – table – row 46
Amendment 180 #
2011/0429(COD)
Proposal for a directive
Annex I – table – row 47
Annex I – table – row 47
Directive 2000/60/EC
Annex X– table – row 47
Annex X– table – row 47
Amendment 187 #
2011/0429(COD)
Proposal for a directive
Annex I – table – row 48
Annex I – table – row 48
Directive 2000/60/EC
Annex X – table – row 48
Annex X – table – row 48
Amendment 207 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 46
Annex II – table – row 46
Directive 2008/105/EC
Annex I – table – row 46
Annex I – table – row 46
Amendment 212 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 47
Annex II – table – row 47
Directive 2008/105/EC
Annex I – table – row 47
Annex I – table – row 47
Amendment 217 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 48
Annex II – table – row 48
Directive 2008/105/EC
Annex I – table – row 48
Annex I – table – row 48
Amendment 264 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 5
Annex II – table – row 5
Directive 2008/105/EC
Annex I – table – row 5
Annex I – table – row 5
(5) Brominated 32534819 4,9 10-8 2,4 10-9 0,14 0,014 0,0085 diphenylethers 0,0005 0,0002 not not not diphenylethers applicab applicabl applica le e ble
Amendment 266 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 15
Annex II – table – row 15
Directive 2008/105/EC
Annex I – table – row 15
Annex I – table – row 15
(15) Fluoranthene 206440 0,00631 0,0063 0,121 1 0,121 30 -
Amendment 268 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 21
Annex II – table – row 21
Directive 2008/105/EC
Annex I – table – row 21
Annex I – table – row 21
(21) Mercury and its 7439976 0,05 0,05 0,07 0,07 20 compounds
Amendment 270 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 22
Annex II – table – row 22
Directive 2008/105/EC
Annex I – table – row 22
Annex I – table – row 22
(22) Naphthalene 91203 2? 2? 130 ? 130 ? ?
Amendment 271 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 35
Annex II – table – row 35
Directive 2008/105/EC
Annex I – table – row 35
Annex I – table – row 35
(35) Perfluorooctane 1763-23-1 6,5 10-4 1,3 10-4- - 36 7,2 9,1 sulfonic acid and its derivatives (PFOS)
Amendment 275 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 38
Annex II – table – row 38
Directive 2008/105/EC
Annex I – table – row 38
Annex I – table – row 38
(38) Aclonifen 74070-46-5 0,12? 0,012 0,12 0,012 ? ? ?
Amendment 278 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 41
Annex II – table – row 41
Directive 2008/105/EC
Annex I – table – row 41
Annex I – table – row 41
(41) Cypermethrin 52315-07-8 8 10-5? ? 8 10-6 6 10-4 6 10-5 ? ?
Amendment 280 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 42
Annex II – table – row 42
Directive 2008/105/EC
Annex I – table – row 42
Annex I – table – row 42
(42) Dichlorvos 62-73-7 6 10-4 6 10-5 7 10-4 7 10-5? ? ? ?
Amendment 282 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 43
Annex II – table – row 43
Directive 2008/105/EC
Annex I – table – row 43
Annex I – table – row 43
(43) Hexabromocycl See footnote 12 in 0,0016 0,0008 0,5? ? ? 0,05 167? ododecane Annex X to Directive (HBCDD) 2000/60/EC
Amendment 285 #
2011/0429(COD)
Proposal for a directive
Annex II – table – row 45
Annex II – table – row 45
Directive 2008/105/EC
Annex I – table – row 45
Annex I – table – row 45
(45) Terbutryn 886-50-0 0,065 0,0065 0,34? ? ? 0,034 ?
Amendment 130 #
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 Union environmental legislation, in particular by promoting the development and dissemination of best practices and policy approaches;
Amendment 131 #
2011/0428(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point d
Article 12 – paragraph 1 – point d
(d) to promote better environmental governance by broadening stakeholder involvement, including NGOs, in policy consultation and implementation.
Amendment 138 #
2011/0428(COD)
Proposal for a regulation
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
(a) to promote critical awareness -raising on climate matters, including generating public and stakeholders support toin Union policy-making in the field of climate, and to promote education for sustainable development;
Amendment 139 #
2011/0428(COD)
Proposal for a regulation
Article 16 – paragraph 1 – point c
Article 16 – paragraph 1 – point c
(c) to promote and contribute to a more effective compliance with and enforcement of Union climate legislation, in particular by promoting the development and dissemination of best practices and policy approaches;
Amendment 140 #
2011/0428(COD)
Proposal for a regulation
Article 16 – paragraph 1 – point d
Article 16 – paragraph 1 – point d
(d) to promote better climate governance by broadening stakeholder involvement, including NGOs, in policy consultation and implementation.
Amendment 144 #
2011/0428(COD)
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 1 – point c a (new)
Article 19 – paragraph 1 – subparagraph 1 – point c a (new)
(ca) being politically neutral.
Amendment 195 #
2011/0428(COD)
Proposal for a regulation
Article 22 – paragraph 1 – point a
Article 22 – paragraph 1 – point a
Amendment 196 #
2011/0428(COD)
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
The LIFE Programme may fund public and private bodies.
Amendment 33 #
2011/0421(COD)
Proposal for a decision
Recital 1
Recital 1
(1) Article 168 of the Treaty on the Functioning of the European Union states, inter alia, that the Union's action in the field of public health should covermplement the work of the Member States with regard to monitoring, early warning of and combating serious cross-border threats to health, and that a high level of human health protection is to be ensured, inter alia, in the definition and implementation of all Union policies and activities. According to the same provision, Member States must, in liaison with the Commission, coordinate among themselves their policies and programmes in the areas covered by the Union action in the field of public health.
Amendment 35 #
2011/0421(COD)
Proposal for a decision
Recital 3
Recital 3
(3) Apart from communicable diseases, a number of other sources of danger to health, notably related to other biological agents, chemical agents or environmental events, which include hazards related to climate change, may, by reason of their scale or severity, endanger the health of citizens in the entire Union, lead to the malfunctioning of critical sectors of society and economy and jeopardise individual Member State's capacity to react. Therefore, the legal framework set up under Decision No 2119/98/EC should be extended to cover these other threats and provide for a coordinated wider approach to health security at Union level. However, existing Union instruments concerned with early warning, monitoring and coordination must continue to be assigned priority where serious cross-border threats to health arise.
Amendment 36 #
2011/0421(COD)
Proposal for a decision
Recital 5
Recital 5
(5) Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for Disease Prevention and Control (ECDC) provides the ECDC with a mandate covering surveillance, detection and risk assessment of threats to human health from communicable diseases and outbreaks of unknown origin, until their origin is known. The ECDC has progressively taken over the epidemiological surveillance of communicable diseases and the operation of the Early Warning and Response System from the Community network set up under Decision No 2119/98/EC. This development is not reflected in Decision No 2119/98/EC, which was adopted before the creation of the ECDC.
Amendment 39 #
2011/0421(COD)
Proposal for a decision
Recital 11
Recital 11
Amendment 41 #
2011/0421(COD)
Proposal for a decision
Recital 12
Recital 12
(12) A system enabling the notification at the Union level of alerts related to serious cross-border threats to health should be put in place in order to ensure that competent public health authorities in Member States and the Commission are duly and timely informed. Therefore, an Early Warning and Information System should be established, bringing together the various information about serious cross-border health threats of a biological, chemical or environmental nature. This Early Warning and Information System should be integrated into the Early Warning and Response System (EWRS), established under Decision No 2119/98/EC for communicable diseases, should be extended relating to all the serious cross-border threats to health covered by the present Decision. The notification of an alert should be required only where the scale and severity of the threat concerned are or may become so significant that the coordination of the response at the Union level is necessary. The responsibility and scope of the existing instruments should be preserved.
Amendment 43 #
2011/0421(COD)
Proposal for a decision
Recital 13
Recital 13
(13) In order to ensure that the assessment of risks to public health at the Union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective, the available scientific expertise should be mobilised in a coordinated manner, through appropriate channels or structures depending on the type of threat concerned. This risk assessment should be based on robust scientific evidence and independent expertise and provided by the Agencies of the Union in accordance with their missions, or otherwise by expert groups set up by the Commission and the Member States.
Amendment 44 #
2011/0421(COD)
Proposal for a decision
Recital 14
Recital 14
(14) Effectively responding to serious cross-border threats to health at national level requires a consistent approach among Member States, in conjunction with the Commission, necessitating exchange of information, consultation and coordination of actions. Under Decision No 2119/98/EC, the Member States, in cooperation with the Commission, already coordinate the response at the Union level in collaboration with Member States with regard to communicable diseases. A similar mechanism should apply to all serious cross-border threats to health independently of their origin. It should also be recalled that, independently from this Decision, a Member State may, in case of a major emergency, request assistance under Council Decision of 8 November 2007 establishing a Community Civil Protection Mechanism (2007/779/EC, Euratom).
Amendment 46 #
2011/0421(COD)
Proposal for a decision
Recital 19
Recital 19
(19) Since the objectives of this Decision cannot be sufficiently achieved by the Member States alone due to the cross- border dimension of those threats and can, therefore, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union, to support the Member States. In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary in order to achieve those objectives.
Amendment 47 #
2011/0421(COD)
Proposal for a decision
Recital 20
Recital 20
Amendment 48 #
2011/0421(COD)
Proposal for a decision
Recital 21
Recital 21
(21) In order to ensure uniform conditions for the implementation of this Decision, implementing powers should be conferred on the Commission to adopt implementing acts in relation to: the procedures for the coordination, the exchange of information and the mutual consultation on preparedness and response planning; the adoption of a list of communicable diseases subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the setting up and termination of ad hoc monitoring networks and the procedures for the operation of such networks; the adoption of case definitions for serious cross-border threats to health; the procedures for the operation of the Early Warning and Response System; the procedures for the coordination of the responses of the Member StatInformation System; risk assessment procedures; the recognition of situations of emergency at Union level or of pre-pandemic situations with respect to human influenza at Union level. Those implementing powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers.
Amendment 50 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 1 – introductory part
Article 2 – paragraph 1 – introductory part
1. This Decision shall apply in case of serious cross-border threats to public health falling within the following categories:
Amendment 52 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 1 – point a – point ii
Article 2 – paragraph 1 – point a – point ii
(ii) antimicrobial resistance and healthcare- associated infections related to communicable diseases affecting human beings (hereinafter referred to as " the related special health issues") ;
Amendment 53 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
(b) acute threats of chemical origin with the exception of threats arising from ionizing radiation;
Amendment 55 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 1 – point c
Article 2 – paragraph 1 – point c
(c) acute threats of environmental origin, including threats deriving from the effects of climate change;
Amendment 56 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
(d) acute threats of unknown origin, until their origin is known and they fall into one of the categories described in points (a) to (c);
Amendment 57 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 2
Article 2 – paragraph 2
Amendment 59 #
2011/0421(COD)
Proposal for a decision
Article 2 – paragraph 3
Article 2 – paragraph 3
Amendment 60 #
2011/0421(COD)
Proposal for a decision
Article 2 a (new)
Article 2 a (new)
Article 2a It is essential that the scope of the decision should be clearly limited in order to avoid duplication of effort with other Union instruments.
Amendment 61 #
2011/0421(COD)
Proposal for a decision
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘case definition’ means a set of commonly agreed diagnostic criteria that must be fulfilled in order to accurately detect cases of a targetn identified serious cross- border threat to health in a given population, while excluding the detection of other similar threats;
Amendment 63 #
2011/0421(COD)
Proposal for a decision
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
The Commission, in cooperation with the Member States, should arrange for the coordination and exchange of information and the instruments created by this decision. It is the Commission’s task to prevent duplication of effort in the system: existing and new instruments should complement one another.
Amendment 64 #
2011/0421(COD)
Proposal for a decision
Article 3 a (new)
Article 3 a (new)
Article 3a Relationship with existing provisions of EU law 1. The provisions of this decision should not come into conflict with other existing EU instruments in the field of monitoring, early warning, coordination of preparations and contingency planning for serious cross-border threats to health. In this connection, existing instruments establishing standards and indicators for the quality and security of specific goods and indicators should be taken into account. Existing EU laws should therefore remain in force: a. Directive 2001/83/EC, b. Directive 2001/20/EC, c. Directive 2003/94/EC, d. Directive 2004/23/EC, e. Regulation 726/2004/EC, f. Regulation 1394/2007/EC, g. Regulation 540/95/EC, h. Regulation 178/2002/EC, i. Regulation 882/2004/EC j. Council Directive 96/82/EC.
Amendment 65 #
2011/0421(COD)
Proposal for a decision
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) the consistent implementordination of core capacity requirements for surveillance and response as referred to in Articles 5 and 13 of the International Health Regulations (2005).
Amendment 67 #
2011/0421(COD)
Proposal for a decision
Article 4 – paragraph 1 – point b a (new)
Article 4 – paragraph 1 – point b a (new)
(ba) the communication of ‘best practice’ plans.
Amendment 68 #
2011/0421(COD)
Proposal for a decision
Article 4 – paragraph 2 – point i
Article 4 – paragraph 2 – point i
(i) minimum core capacity standards determined at national level for the health sector; these shall also relate to preparations in the field of psychosocial emergency care;
Amendment 71 #
2011/0421(COD)
Proposal for a decision
Article 4 – paragraph 4
Article 4 – paragraph 4
Amendment 73 #
2011/0421(COD)
Proposal for a decision
Article 4 – paragraph 5 – subparagraph 1
Article 4 – paragraph 5 – subparagraph 1
Amendment 75 #
2011/0421(COD)
Proposal for a decision
Article 7 – paragraph 1
Article 7 – paragraph 1
Amendment 76 #
2011/0421(COD)
Proposal for a decision
Article 7 – paragraph 2
Article 7 – paragraph 2
Amendment 77 #
2011/0421(COD)
Proposal for a decision
Article 7 – paragraph 3
Article 7 – paragraph 3
Amendment 78 #
2011/0421(COD)
Proposal for a decision
Article 8 – title
Article 8 – title
Establishment of an early warning and responseinformation system
Amendment 79 #
2011/0421(COD)
Proposal for a decision
Article 8 – paragraph 1
Article 8 – paragraph 1
1. A rapid alert system for notifying at the Union level alerts in relation to serious cross-border threats to health, ‘Early Warning and ResponseInformation System’, is hereby established. This system shall bring into permanent communication the Commission and the competent authorities responsible at national level for alerting, assessing public health risks and determining the measures that may be required to protect public health.
Amendment 81 #
2011/0421(COD)
Proposal for a decision
Article 8 – paragraph 2
Article 8 – paragraph 2
The Commission shall, by means of implementing acts, adopt procedures concerning the information exchange in order to ensure the proper functioning of the Early Warning and ResponseInformation System and the uniform implementation of Articles 8 and 9. In order to be able to cover all kinds of serious cross-border threats to health, the information referred to in Article 3 must also be supplied.
Amendment 82 #
2011/0421(COD)
Proposal for a decision
Article 8 a (new)
Article 8 a (new)
Article 8a The Early Warning and Information System should be placed under the authority of the European Centre for Disease Prevention and Control.
Amendment 83 #
2011/0421(COD)
Proposal for a decision
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. National competent authorities or the Commission shall notify an alert in the Early Warning and ResponseInformation System where the emergence or development of a serious cross-border threat to health fulfils the following conditions:
Amendment 84 #
2011/0421(COD)
Proposal for a decision
Article 9 – paragraph 3 – point h
Article 9 – paragraph 3 – point h
Amendment 85 #
2011/0421(COD)
Proposal for a decision
Article 9 – paragraph 4
Article 9 – paragraph 4
4. The Commission shall make available to the national competent authorities through the Early Warning and ResponseInformation System any information that may be useful for coordinating the response at the Union level, including information on hazards and public health measures related to serious cross-border threats to health transmitted through other Union alert systems.
Amendment 86 #
2011/0421(COD)
Proposal for a decision
Article 10 – paragraph 2 – point c
Article 10 – paragraph 2 – point c
Amendment 88 #
2011/0421(COD)
Proposal for a decision
Article 10 – paragraph 2 – point c a (new)
Article 10 – paragraph 2 – point c a (new)
(ca) where an alert is notified pursuant to Article 9, the Commission shall, if it is necessary for the coordination of the response at Union level, make promptly available to the national competent authorities through the Early Warning and Information System and to the Health Security Committee referred to respectively in Articles 8 and 19 an assessment of the risks to public health;
Amendment 89 #
2011/0421(COD)
Proposal for a decision
Article 10 – paragraph 2 – point c b (new)
Article 10 – paragraph 2 – point c b (new)
(cb) where a sudden man-made disaster occurs, on the opinion of the Monitoring and Information Centre, and/or
Amendment 90 #
2011/0421(COD)
Proposal for a decision
Article 10 – paragraph 2 – point c c (new)
Article 10 – paragraph 2 – point c c (new)
(cc) information supplied by the Scientific Committee on Consumer Products, the Scientific Committee on Health and Environmental Risk or the Scientific Committee on Emerging and Newly Identified Health Risks.
Amendment 92 #
2011/0421(COD)
Proposal for a decision
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Where a Member State intends to adopt public health measures to combat a serious cross-border threat to health, it shall, before adopting those measures, consultinform the other Member States and the Commission, via the Early Warning and Information System, on the nature, purpose and scope of the measures, unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary, or this is required on grounds of national security.
Amendment 94 #
2011/0421(COD)
Proposal for a decision
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States and the Commission, via the Early Warning and Information System, on the nature, purpose and scope of those measures.
Amendment 96 #
2011/0421(COD)
Proposal for a decision
Article 11 – paragraph 5
Article 11 – paragraph 5
Amendment 98 #
2011/0421(COD)
Proposal for a decision
Article 12
Article 12
Amendment 106 #
2011/0421(COD)
Proposal for a decision
Article 16
Article 16
Amendment 108 #
2011/0421(COD)
Proposal for a decision
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
Amendment 111 #
2011/0421(COD)
Proposal for a decision
Article 19 – paragraph 2 – point a
Article 19 – paragraph 2 – point a
(a) support the exchange of information between the Member States and the Commission on the experience acquired with regard to the implementation of this Decision;
Amendment 112 #
2011/0421(COD)
Proposal for a decision
Article 19 – paragraph 2 – point b
Article 19 – paragraph 2 – point b
(b) assist the Commission in providing for the coordination ofe the preparedness and response planning efforts of the Member States in accordance with Article 4;
Amendment 113 #
2011/0421(COD)
Proposal for a decision
Article 19 – paragraph 2 – point c
Article 19 – paragraph 2 – point c
(c) assist the Commission in providing for the coordination ofe the responses of the Member States to serious cross-border threats to health, in accordance with Article 11.
Amendment 114 #
2011/0421(COD)
Proposal for a decision
Article 19 – paragraph 2 – point c a (new)
Article 19 – paragraph 2 – point c a (new)
(ca) advise the Health Ministers and the Commission on the preparation and coordination of contingency plans.
Amendment 116 #
2011/0421(COD)
Proposal for a decision
Article 21
Article 21
Amendment 119 #
2011/0421(COD)
Proposal for a decision
Article 22
Article 22
Amendment 68 #
2011/0409(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
Amendment 122 #
2011/0409(COD)
Proposal for a regulation
Annex III
Annex III
Amendment 125 #
2011/0409(COD)
Proposal for a regulation
Annex III
Annex III
Annex III Limit values The sound level measured in accordance with the provisions of Annex II shall not exceed the following limits: Vehicle Description of vehicle Limit values expressed in dB(A) [decibels (A)] c Category category Limit values for Limit values for Limit values for for Type- approval Type-approval registration, sale and approval of of new vehicles of new vehicle entry into service of new vehiclenew types types new vehicles types Phase 1 valid Phase 2 valid Phase 3 valid from from from [7 (8 years after [2 (1 years after [5(6 years after publication]) publication]) publication]) Off- Off- General General Off-General Off-road General road General Groad road Vehicles used for the carriage M of passengeral Off-road * s M1 no of seats ≤ 9; ≤ 125 kW/ton 72 74*** 70 73*** 70 73*** road * no of seats ≤ 9; 125kW/ton < M1 power to mass ratio ≤ 73 75*** 71 *74*** 71 74*** Vehicles used for the M carriage of passengers M1 150kW/ton no of seats ≤ 9; M1 no of seats < 9power to mass ratio > 75 70 71** 684 69** 74 68 69** 150kW/ton no of seats < 9; M1≤ 4 including pdriver; Power to mass ratio > M1 71 71200kw/ton; R point of the 69 77 69 / 69 76 / 6976 / 150 kW/ton driver seat < 450 mm from ground no of seats > 9; mass <≤ 2.5 M2 72 72 70 70 70 70 70 tons no of seats > 9; 2.5 tons < M2 73 74 75 742 713 72 71 72 73 mass <≤ 3.,5 tons no of seats > 9; 3.,5 tons < M2 < mass <≤ 5 tons; M2 rated engine 76 77 75 76 75 76 74 power < 150kW 75 72 73 72 73 no of seats > 9; 3,5 tons < M2 mass ≤ 5 tons; rated engine power < 77 78 150 kW no of seats > 9; 3.5 tons <76 77 76 77 power ≥ 150kW no of seats > 9; mass <> 5 tons; M2 M3 76 77 785 746 76 745 76 rated engine power > 150 kW ≤ 180kW no of seats > 9; mass > 5 tons; M3 180 kW < rated engine power 759 80 768 739 74 738 74 rated engine power <9 1≤ 250 kW no of seats > 9; mass > 5 tons; M3 7780 81 79 7580 77 759 77 80 rated engine power > 1250 kW Vehicles used for the carriage N carriage of goods N1 mass <≤ 2.5 tons 71 72 714 6970 6972 69 70 69 N1 72 N1 2.5 tons < mass <≤ 3.,5 tons 72 74 735 702 713 70 71 72 73 3.,5 tons < mass <≤ 12 tons; N2 74 77 78 756 727 73 726 73 7 rated engine power < 75 150kW 3.3,5 tons < mass <≤ 12 tons; N2 75 78 79 767 738 74 737 74 8 75 < rated engine power < ≥150 kW 3.5 tons < mass <> 12 tons; N2 N3 779 80 7978 759 77 758 77 9 rated engine power > 150 kW ≤180kW mass > 12 tons; N3 75180 < rated engine power 77 81 782 7580 7681 75 7680 81 < 1≤250 kW N3 mass > 12 tons; N3 80 82 78 80 78 802 83 81 rated engine power > 82 81 82 150 kW * Increased limit values shall only be valid rated engine power >250 kW *** For M1 vehicles if the vehicle complies with the relevant definition for off-road vehicles set out in point 4 of Section A according to article A.4 of Annex II tof EU Directive 20076/46/EC. ** For M1 vehicles the increased limit values for off-road vehicles are only valid if the maximum authorised mass > 2 tonnes. and in addition have a wading depth exceeding 500 mm and a hill climbing capability of 35°. Remark Limits for N3 only if "Normal Tyres" are allowed to be used for the test
Amendment 225 #
2011/0254(NLE)
Article 74
Amendment 175 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 4 – paragraph 1
Article 4 – paragraph 1
Location data shall be recorded to allow the identification of the starting and ending place of the daily work period. For that purpose, vehicles put into service for the first time [4860 months after the entry into force of this Regulation] shall be fitted with recording equipment connected to a global navigation satellite system (GNSS).
Amendment 183 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1a. As regards the voluntary connection of the tachograph to a global navigation satellite system (GNSS), as referred to in paragraph 1, use shall be made only of satellite positioning service connections that exploit a positioning service free of charge. No position data other than those expressed, wherever possible, in geographical coordinates for determining the starting and ending points referred to in paragraph 1 shall be stored in the tachograph.
Amendment 189 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 5 – paragraph 1
Article 5 – paragraph 1
(1) In order to facilitate targeted roadside checks by the competent control authorities, the recording equipment installed in vehicles put into service for the first time [4860 months after the entry into force of this Regulation] shall be able to communicate while the vehicle is in motion to those authorities.
Amendment 192 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 5 – paragraph 2
Article 5 – paragraph 2
(2) Communication shall be established with the recording equipment only when so requested by the equipment of the control authorities. It shall be secured to ensure data integrity and authentication of the recording and control equipment. It must be clearly visible on the recording equipment that the data transfer was initiated by the authorities.
Amendment 210 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 39 concerning the supplementing of Annex IB with the specifications of the interface, access rights and the list of data which may be accessed.
Amendment 248 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 29 – paragraph -1 (new)
Article 29 – paragraph -1 (new)
Amendment 249 #
2011/0196(COD)
Proposal for a regulationArticle 1 – point 1 Council Regulation (EEC) No 3821/85
Article 29 – paragraph 3
Article 29 – paragraph 3
(3) A transport undertaking shall not be liable for infringements against this Regulation committed deliberately or negligently by drivers of the undertaking. Without prejudice to the right of Member States to hold transport undertakings fully liable, Member States may consider any evidence that the transport undertaking cannot reasonably be held responsible for the infringement committed.
Amendment 268 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EC) No 561/2006 Article 8, paragraph 6, in conjunction with Article 4(h)
Article 2 – paragraph 2 (new)
Article 2 – paragraph 2 (new)
Over a 4-week period, a total weekly rest period of 140 hours must be observed, with the minimum weekly rest period being 24 hours per week. Any shortfall in rest periods must be made up within this 4-week period.
Amendment 269 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EC) No 561/2006 Article 8, paragraph 2, in conjunction with Article 4(g)
Article 2 – paragraph 4 (new)
Article 2 – paragraph 4 (new)
(1a) The 12-day rule should also be applied nationally and not just be restricted to one single trip. Prior to and following a trip lasting longer than 6 times 24 hours, one regular 45-hour weekly rest period should be observed. A total weekly rest period of 140 hours must be observed within a 4-week period.
Amendment 270 #
2011/0196(COD)
Proposal for a regulation
Article 2 – point 1 a (new)
Article 2 – point 1 a (new)
(1a) After a driving period of four and a half hours a driver shall take a break of not less than 45 minutes. This break can, however, be replaced by a number of shorter breaks of at least 15 minutes.
Amendment 274 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 33 – paragraph 1 – subparagraph 2
Article 33 – paragraph 1 – subparagraph 2
If the vehicle is unable to return to the premises within a period of one week calculated from the day of the breakdown or of the discovery of defective operation, the repair shall be carried out en route. This should not be at an uneconomically high cost to the undertaking.
Amendment 275 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 33 – paragraph 1 – subparagraph 3
Article 33 – paragraph 1 – subparagraph 3
Measures taken by Member States pursuant to Article 37 may give the competent authorities power to prohibit the use of the vehicle in cases where breakdown or faulty operation has not been remedied as provided in the first and the second subparagraphs. The Commission will check here that national and foreign vehicles are treated in the same way in order to eliminate discrimination.
Amendment 277 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
3a. If a Member State fails to train its control officers, automatic sanctions in the form of cuts in regional aid shall enter into force.
Amendment 294 #
2011/0196(COD)
Proposal for a regulation
Article 1 – point 1
Article 1 – point 1
Council Regulation (EEC) No 3821/85
Article 39 – paragraph 1
Article 39 – paragraph 1
(1) The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. The delegated acts may not cover the fields of data protection and privacy rights.
Amendment 300 #
2011/0196(COD)
Proposal for a regulation
Article 2 – point 1
Article 2 – point 1
Regulation (EC) No 561/2006
Article 4 (o) (new)
Article 4 (o) (new)
Article 4 of Regulation (EC) No 561/2006 is amended as follows: (oa) ‘Multi-manning’ also refers to the situation where the second driver of a bus is not on board the vehicle during the first and last 2-hour periods of a journey.
Amendment 322 #
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, p
Article 13 – paragraph 1 – points d, f, p
The distance of ‘50 km’ referred to in points (d), (f) and (p) of Article 13(1) is replaced by ‘1200 km’.
Amendment 3 #
2010/2272(INI)
Draft opinion
Paragraph A a (new)
Paragraph A a (new)
Aa. whereas over a third of people aged over 75 have a disability,
Amendment 4 #
2010/2272(INI)
Draft opinion
Paragraph A b (new)
Paragraph A b (new)
Ab. whereas, due to demographic change, the number of people with disabilities will continue to rise in the coming years,
Amendment 23 #
2010/2272(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls on the Member States to promote the use of Braille and sign language;
Amendment 3 #
2010/2211(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Recalls that the next financial perspectives should achieve the EU 2020 Strategy objectives, especially the 20/20/20 climate and energy objectives, including a rise to 30% of the target for emission reductions, and meet the "Resource Efficient Europe" flagship initiative goals;
Amendment 4 #
2010/2211(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Reiterates the importance of transforming the EU economy into a resource-efficient economy; considers therefore that the EU should use its budget to drive reductions in the use of resources and dependency on imports, while increasing recycling and restoration in the fields of waste, water, materials and land;
Amendment 6 #
2010/2211(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Emphasises the need to strengthen integration of EU environmental and climate legislation and objectives into sectoral policies (including the CAP, the cohesion policy and, the CFP and development policy); suggests therefore mainstreaming EU finances to ensure compliance with EU environmental legislation and policy objectives and as suggested by the Commission's budget review include an obligation to identify in a transparent manner where sectoral programmes have promoted climate objectives specified in the Europe 2020 Strategy; underlines the importance of future research and innovation programmes in delivering the EU's objectives of smart, sustainable and inclusive growth;
Amendment 9 #
2010/2211(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Is convinced that the EU budget should support the provision of public goods that are unlikely to be sufficiently delivered by the market; environmental public goods include the preservation of biodiversity and ecosystem, wilderness, climate stability and carbon absorption capacity, water provision and quality, air and soil quality, resilience to fire and floods, as well as the maintenance of valued cultural and historic landscapes; believes, therefore, that the Common Agricultural Policy should reward farmers and land managers for the delivery of public goods, such as an attractive countryside rich in biodiversity, and that the Structural and Cohesion Funds should foster ecological sustainable development and the transition to a low energy-consumption and resource-efficient society;
Amendment 34 #
2010/2211(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls for education and lifelong learning to be regarded as key factors in improving public health;
Amendment 35 #
2010/2211(INI)
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Is convinced that economic growth, job security and a preventive approach to healthcare must be promoted jointly;
Amendment 36 #
2010/2211(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Underlines the importance of the LIFE+ programme as the main EU instrument entirely dedicated to environmental financing and underlines the need to strengthen LIFE+ in the future financial framework to achieve EU environmental objectives while promoting synergies with other EU financial instruments;
Amendment 1 #
2010/2179(DEC)
Draft opinion
Paragraph 3
Paragraph 3
3. Regrets once again, as it did in its discharge opinion 2008, the high level of carry-overs representing 42% of Title II and 63% of Title III; reminds the Centre of the principle of annuality; will monitor very carefully the budget implementation in 2010 and 2011 when proposing the level of EU subsidies for 2012;
Amendment 2 #
2010/2179(DEC)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Deplores the Centre’s failure to comply with the principle of annuality and calls for this to be taken into account when the utilisation rate for 2010 and 2011 appropriations is calculated;
Amendment 3 #
2010/2179(DEC)
Draft opinion
Paragraph 4
Paragraph 4
4. Considers, nevertheless, the European Centre for Disease Prevention and Control as an important institution to strengthen and develop European disease surveillance, to assess and communicate current and emerging threats to human health posed by infectious diseases; points to the important contributions made by the Centre to measures to fight the H1N1 pandemic in 2009;
Amendment 4 #
2010/2179(DEC)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
Amendment 5 #
2010/2179(DEC)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b.Takes the view that the Centre’s powers must be strengthened so that the EU has an independent capacity to assess the severity of the risk of infection should a pandemic occur and coordination between the Member States can be improved;
Amendment 1 #
2010/2178(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. Underlines the European Food Safety Authority's role in providing high quality independent advice to ensure compliance with EU safety standards and in ensuring scientific excellence and independence on all matters with a direct or indirect impact on food and feed safety and plant protection; recommends measures to further foster and monitor internal rules on declaration of interests for EFSA staff and experts working for the Authority;
Amendment 3 #
2010/2178(DEC)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
Amendment 2 #
2010/2173(DEC)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Points out that a procurement plan as part of a coherent recruitment procedure would not only rule out financial irregularities, but also emphasise the Agency’s openness and credibility;
Amendment 3 #
2010/2173(DEC)
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Deplores the fact that errors were made in the calculations used in connection with the award of a major framework contract for IT services; looking ahead to future procedures, urges the Agency to keep comprehensive, orderly files;
Amendment 4 #
2010/2173(DEC)
Draft opinion
Paragraph 7 c (new)
Paragraph 7 c (new)
7c. Notes that in the area of the Agency’s own revenue coordination between the financial and scientific departments was in some cases inadequate; calls on the Agency to continue its efforts to improve coordination between those departments;
Amendment 1 #
2010/2170(DEC)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls on the Agency to deal with these four fields as a matter of priority and to do more to advance their further development;
Amendment 2 #
2010/2170(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. Encourages the Agency, once again, to continue its efforts to further develop its communication methods in order to attract more media coverage for its findings and thus feed public debate on important environmental issues, such as climate change, biodiversity and the management of natural resources; considers that such measures may lead to a more transparent working method and greater public interest in the Agency’s work;
Amendment 52 #
2010/2154(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission to submit, after two years, a report on costs and benefits and on health impacts.
Amendment 11 #
2010/2153(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the national and international health authorities, including the WHO, were aware as early as May 2009 that the H1N1 influenza was not virulent, with this moderate virulence beinghaving since been confirmed by the very low mortality rate observed as a result of this influenza ‘pandemic’ in comparison with the officially recognised figures for seasonal influenza,
Amendment 19 #
2010/2153(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the criteria for defining a ‘pandemic’, as adopted by the WHO in 2009, andre based solely on the propagation of the virus while discounting the severity of the infection, distorted the meaning of the word ‘pandemic’ and triggered a false alarm worldwide, with that alarmism giving rise to inappropriate public health decisions and a disproportionate response among the public and administrations of the European Union and its Member States,
Amendment 32 #
2010/2153(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the exaggerated costs arising from the management of this crisis in the Member States are primarily a direct consequence of the EU’s lack of independence and critical acumen in relation to the risk evaluation concould perhaps have been reducted by the WHO,
Amendment 41 #
2010/2153(INI)
Motion for a resolution
Recital E
Recital E
Amendment 53 #
2010/2153(INI)
Motion for a resolution
Recital F
Recital F
F. whereas the differing recommendations made within the EU and the Member States on the subject of the priority groups targeted for vaccination illustrate the huge uncertainties surrounding the evaluation of the H1N1 vaccines recommenddiffered,
Amendment 54 #
2010/2153(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas assessments of the vaccines differed,
Amendment 58 #
2010/2153(INI)
Motion for a resolution
Recital G
Recital G
Amendment 61 #
2010/2153(INI)
Motion for a resolution
Recital I
Recital I
Amendment 71 #
2010/2153(INI)
Motion for a resolution
Recital J
Recital J
J. whereas information has been garnered by various parliamentary committees and evaluation missions conductedby means of evaluation measures carried out in the EU Member States on the action taken to combat H1N1 influenza,
Amendment 78 #
2010/2153(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Calls for the prevention plans established in the EU and its Member States to be revised to make them sufficiently autonomous and flexible toflexible so that they can be adapted as swiftly as possible and on a case by case basis to the actual risk, based not least on the latest scientific information available;
Amendment 93 #
2010/2153(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Takes the view that the powers of the European Centre for Disease Prevention and Control (ECDC) should be reinforced so that the EU has its own means of assessing the severity of infection risk, by establishing, if necessary, its own health alert scale independent of inter cooperation with national organisations such as the WHO;
Amendment 96 #
2010/2153(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
Amendment 107 #
2010/2153(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls for immediate clarifications on the effectiveness of the influenza vaccination strategies recommended in the EU, given the weight of evidence casting doubt on their effectiveness, the absence of reliable data guaranteeing that effectiveness and the lingering uncertainties surrounding their benefit-risk profile;
Amendment 129 #
2010/2153(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
Amendment 138 #
2010/2153(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
Amendment 159 #
2010/2153(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Demands precise definition of the roles, duties, remits, limits, relations and responsibilities of the Commission, the ECDC, the EMA and the Member States and also of more informal entities such as the Health Security Committee, the HEOF and the ‘public health’ group, composed of senior officials able to intervene in the decision-making process regarding the management of a health crisis;
Amendment 165 #
2010/2153(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Expresses its approval of the introduction of a procedure enabling the Member States to make group purchases of anti-viral vaccines and medicinal products on a voluntary basis where the positive benefit-risk profile of their preventive/therapeutic effect is clearly demonstrated and indisputable, in order to obtain, for a given product, advantageous rates approaching its cost price;
Amendment 1 #
2010/2142(DEC)
Draft opinion
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Observes that communication between the agencies and the Institutions, and also between the agencies and the European public, leaves a certain amount to be desired; encourages all parties concerned at the agencies and in the Institutions to improve mutual communication and work harder at public relations;
Amendment 19 #
2010/2111(INI)
Draft opinion
Paragraph 4
Paragraph 4
Amendment 29 #
2010/2111(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Emphasizes that the treatment of slaughter offal, swill, meat and bone meal shall meet 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 8 #
2010/2108(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the Union faces the problem of poorlate implementation of energy legislation and overall energy strategies which calls for strong leadership from the Commission to bridge this gapan absence of overall or coordinated energy strategies,
Amendment 19 #
2010/2108(INI)
Motion for a resolution
Recital D
Recital D
D. whereas major energy investments are needed, notably in new power plants and grids within the next decade, which will shape the energy mix for an even longer- period and which will require a new diversification of financing instruments or new market design,
Amendment 23 #
2010/2108(INI)
Motion for a resolution
Recital E
Recital E
E. whereas investments in the energy sector are very capital intensive, and there is a need to create a stable long-term regulatory framework and which therefore enables companies to take environmentally and economically sound investment decisions, and whereas this must on no account entail distortions of competition,
Amendment 26 #
2010/2108(INI)
Motion for a resolution
Recital F
Recital F
F. whereas energy network infrastructure needs to be financed first and foremost by energy tariffs; but whereas EU funding might also be needed where markets alone can not finance such investments, especially in the least developed regions,
Amendment 30 #
2010/2108(INI)
Motion for a resolution
Recital H
Recital H
H. whereas a sustainable and dynamic economy should strive to decouple economic growth from energy consumption, notably by increasing the energy efficiency per unit of output,
Amendment 44 #
2010/2108(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Underlines that the proposed strategy should also be carried out, above all, in the spirit of solidarity and responsibility, where no Member State can be left behind or isolated and all Member States take measures to ensure the Union's mutual security; stresses the inclusion of a specific chapter on energy (article 194 TFEU) ensuring a firm legal basis for Union action based on the Community method;
Amendment 59 #
2010/2108(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Stresses that the completion of the European internal energy market is indispensable for the fulfilment of the EU's policy objectives; believes this should be based onat a clear legal framework, where legislation is strictly enforced and the Commission refers more member states to the ECJ for infringements if need for this exists and must now be implemented;
Amendment 67 #
2010/2108(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Strongly stresses and underlines the need to fully implement in full the current EU energy legislation and to fulfil the EU energy targets; underscores the need for the rapid implementation of 3rd Energy pPackage rules to be implemented on schedule;
Amendment 72 #
2010/2108(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
Amendment 79 #
2010/2108(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Believes that the role of energy market regulators and the cooperation between national regulators and the Commission should be strengthened, especially in regards to retail and wholesale markets; notes that if the ACER and ENTSOs competencescompetences of the ACER prove to be insufficient to create a more integrated regional and European energy markets, it might become necessary to amend theirits mandates;
Amendment 90 #
2010/2108(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
Amendment 113 #
2010/2108(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Believes that the TYNDP plans to integrate the EU's electricity and gas grid networks should be implemented and completed by 2020by 2020 should provide the technological and methodological bases for new legislation on infrastructure; stresses the need for better gas grid interconnections and LNG terminals which should lead to the ending of the market isolation of some Member States;
Amendment 123 #
2010/2108(INI)
Motion for a resolution
Paragraph 15 – point a
Paragraph 15 – point a
a) evaluate the problem of authorisation permits for energy infrastructure and public opposition to it and remove red tape;
Amendment 130 #
2010/2108(INI)
Motion for a resolution
Paragraph 15 – point b
Paragraph 15 – point b
b) seupport priority projects and set criteria to identify key investments for the development of the internal energy market;
Amendment 141 #
2010/2108(INI)
Motion for a resolution
Paragraph 15 – point e
Paragraph 15 – point e
e) create a cross-border cost sharing model, especially in terms of coordinated development of infrastructure and renewables;
Amendment 146 #
2010/2108(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
Amendment 151 #
2010/2108(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Believes that a modern EU-wide electricity grid will play a key role in achieving the 20% development target for renewables; calls on the Commission, therefore, to develop an appropriate system of incentives for investment in power plants in specific regions, in order to achieve optimal economic effect and avoid inefficient investments in networks; points out, in this regard, that an overall strategy must address the energy system in its entirety from producers to consumers;
Amendment 172 #
2010/2108(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
Amendment 202 #
2010/2108(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Asks the Commission to come forward with an impact assessment study onf the future of the world and EU gas market, including the impact of the already planned gas infrastructure projects (i.e. Nabucco), new LNG terminals, the impact of shale gas on the US gas market (notably on LNG import needs) and the impact of possible shale gas developments in the EU on future gas security of gas supply and prices before the end of the year, by next year; the study should reflect, and take as a starting point, the current state of infrastructure development;
Amendment 246 #
2010/2108(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Supports a multi-level governance and decentralised approach to energy policy and energy efficiency, including the Smart Cities initiative;
Amendment 251 #
2010/2108(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
Amendment 280 #
2010/2108(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Believes that in coordination with the EEAS, the Commission should ensure that the Union speaks with one voice on energxternal energy policy;
Amendment 289 #
2010/2108(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Considers that all external pipelines and other energy networks entering the territory of the European Union should be governed by transparent agreements and subject to internal market rules, including rules on third party access and, destination clauses, allocation and bottleneck management rules and the duration of contracts; calls on the Commission to assure that current and future pipelines and commercial agreements respect the European energy acquis and to take action if necessary;
Amendment 307 #
2010/2108(INI)
Motion for a resolution
Paragraph 36
Paragraph 36
36. Calls on the Commission and the involved Member States to further proceed with the implementation of the EU pipeline project Nabuccos, which could significantly enhance the security of gas supply of the European Union; asks for the vacancy of the EU Nabucco co-ordinator post to be filled as soon as possible;
Amendment 368 #
2010/2108(INI)
Motion for a resolution
Paragraph 43
Paragraph 43
43. Calls on the Commission to promote and support financially pilot projects in the EU for the exploitation of unconventional domestic energy sources, including shale gas; asks the commission to assist Member States to carry out geological surveys to determine the level of available resourceerves of shale gas in the Union and asks for it to be included in the long term strategy of the Union;
Amendment 381 #
2010/2108(INI)
Motion for a resolution
Paragraph 45
Paragraph 45
45. As cited in the Second Energy Review, coal is still a key domestic source of energy and therefore the Union should continue research towards clean coal technologies such as CCS, coal gasification and coal liquefaction;
Amendment 409 #
2010/2108(INI)
Motion for a resolution
Paragraph 50
Paragraph 50
50. Ask the Commission for a monitoring and report to the European Parliament on the implementation of the 3rd internal market package as regards national measures to prevent energy poverty and reminds the Member States of their obligations under existing legal provisions;
Amendment 414 #
2010/2108(INI)
Motion for a resolution
Paragraph 51
Paragraph 51
51. Reminds the energy industry of its obligations under the 3rd energy package to introduce clear and understandable energy invoices; believes that the Commission's Citizens' Energy Forum templates for invoices should be used as a basis for standardised energy invoices across the Union;
Amendment 18 #
2010/2089(INI)
Motion for a resolution
Recital C
Recital C
C. whereas health inequalities have also an important gender dimension: women in general live longer than men but may spend a longer proportion of their lives in ill health,
Amendment 33 #
2010/2089(INI)
Motion for a resolution
Recital F
Recital F
F. whereas rates of morbidity are usually higher among those in lower educational, occupational and income groups and substantial inequalities are also found in the prevalence of most specific diseases, including mental illness, and most specific forms of disability,
Amendment 35 #
2010/2089(INI)
Motion for a resolution
Recital F
Recital F
F. whereas rates of morbidity are usually higher among those in lower educational, occupational and income groups and substantial inequalities are also found in the prevalence of most specific diseases, including mental illness, oral diseases and most specific forms of disability,
Amendment 37 #
2010/2089(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas inequalities also exist in the prevalence of most specific illnesses, including mental illnesses, and of most specific types of disability,
Amendment 38 #
2010/2089(INI)
Motion for a resolution
Recital G
Recital G
Amendment 48 #
2010/2089(INI)
Motion for a resolution
Recital H
Recital H
H. whereas health inequalities are due to differences between population groups in a wide range of factors which affect health, including: living conditions; health-related behaviours; education, occupation and income; health care, disease prevention and health promotion services; and public policies influencing to some extent the quantity, quality and distribution of these factors,
Amendment 105 #
2010/2089(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Member States to improve their capacity to monitor closely the social impacts of the crisis;
Amendment 117 #
2010/2089(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Encourages all the Member States, in the context of subsidiarity, to invest in social, educational, environmental and health services infrastructure;
Amendment 123 #
2010/2089(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Member States to promote policies aiming at ensuring healthy life conditions for all infants and children, including actions to support pregnant women and parents, particularly in the area of oral health;
Amendment 128 #
2010/2089(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Calls on the Commission and the Member States to ensure that equitable access to healthcare and treatment options for older patients are included in their health policies and programmes;
Amendment 135 #
2010/2089(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Points to the importance of raising the average level of healthcare and decreasing the inequalities between different social groups, and underlines that these objectives could be achieved through the optimisation of public spending for healthcare;
Amendment 138 #
2010/2089(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Points to the importance of raising the average level of healthcare and decreasing the inequalities between different social and age groups, and underlines that these objectives could be achieved through the optimisation of public spending for healthcare and improved access to health and treatment options for all citizens, regardless of their age, gender or societal status;
Amendment 193 #
2010/2089(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls on the Commission to draw up guidelines to improve the mechanisms to monitor inequalities in health across the EU (between and within Member States) by improving data collection via more systematic and comparable information that complements existing data on health inequalities and via regular monitoring and analysis;
Amendment 4 #
2010/2088(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the need to improvevalue of compiling data and indicators to complement GDP as a proxy indicator for overall societal development is increasingly recognised,
Amendment 18 #
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;
Amendment 46 #
2010/2088(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
Amendment 62 #
2010/2088(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
Amendment 13 #
2010/2084(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the number of people suffering from neurodegenerative diseases in Europe is estimated to be 8.6 million, with Alzheimer’s accounting for the vast majority of those cases; whereas neurodegenerative diseases represent one of the main causes of disability in the elderly, and whereas the number of people suffering from these diseases is expected to rise dramatically by 2020, owing to increased life expectancy and a decreasing ratio of working to retired populations,
Amendment 41 #
2010/2084(INI)
Motion for a resolution
Recital F
Recital F
F. whereas there is a growing awareness that the impact of neurodegenerative diseases on the population in Europe is of such a magnitude that no Member State is capable of resolving it alone; whereas it is therefore necessary in the EU to significantly strengthen cooperation and coordination of research efforts and the level of financial investment in this area, in order to combat neurodegenerative diseases, particularly Alzheimer’s, which is a major challenge for European societies,
Amendment 50 #
2010/2084(INI)
Motion for a resolution
Recital G
Recital G
G. whereas dementia is not only a devastating disorder for the patients themselves, but also a very heavy burden placed on the shoulders of the patients’ relatives, given the emotional, physical and financial difficulties faced by the relatives and friends of those affected by all types of dementia,
Amendment 62 #
2010/2084(INI)
Motion for a resolution
Recital H
Recital H
H. whereas, although social awareness and scientific knowledge of Alzheimer’s disease have increased dramatically in the past 20 years, therapeutic options are still limited to symptomatic drugs, and diagnosis is still largely based on individual physician experience and subjective judgement,
Amendment 81 #
2010/2084(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
Amendment 113 #
2010/2084(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Points to the importance of a multidisciplinary approach on ways in which cooperation and coordination in the field of research at European level can improve knowledge, diagnosis, treatment, prevention, and social research into the welfare of patients and their families and carers; believes that early diagnostic tests, research into risk factors and criteria for early diagnosis are crucial; this being the case, sees clear added value in conducting large-scale epidemiological and clinical studies in transnational collaboration;
Amendment 144 #
2010/2084(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls on the Commission to draw up, in conjunction with research organisations, guidelines for the training of staff who work in whatever capacity with Alzheimer’s patients (medical and paramedical professions), and for the training of family carers to ensure competent and effective use of the existing resources;
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 11 #
2009/2219(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Rejects the global harmonisation of environmental and health standards;
Amendment 15 #
2009/2219(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Advocates the granting of preferences to threshold countries; threshold countries are countries which no longer display all the typical characteristics of developing countries and for which it can be assumed that the dynamism of economic activity will enable these countries to overcome the typical structural characteristics of a developing country in the foreseeable future;
Amendment 2 #
2009/2118(DEC)
Draft opinion
paragraph 3 a (new)
paragraph 3 a (new)
3a. Observes that the financial relief for small and medium-sized enterprises was a success;
Amendment 1 #
2009/2104(INI)
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
- having regard to the report by David Matas and David Kilgour entitled 'Bloody Harvest. The killing of the Falung Gong for their organs',
Amendment 3 #
2009/2104(INI)
Motion for a resolution
Recital H
Recital H
H. whereas it is recognised that, ideally, the best way of fighting against organ trafficking and trafficking in personthe trafficking of organs and of human beings for the purpose of the removal ofing organs is to increase the number of available organconstitutes a severe violation of human rights,
Amendment 4 #
2009/2104(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas there is a strong link between illegal organ trafficking and the trafficking of persons for the purpose of removing organs and the legal system of organ donation because, on the one hand, the non-availability of organs in the legal system acts as an incentive for illegal activities, and, on the other, illegal activities severly undermine the credibility of the legal system of organ donation,
Amendment 5 #
2009/2104(INI)
Motion for a resolution
Recital J
Recital J
J. whereas living donation rates also differ substantially between Member States, and it seems that not all Member States realise their potential for living donationcan be a helpful additional measure for patients who cannot get the organ they need via post- mortem transplantation, but emphasising that living donation can only be considered if any illegal activity and payment for the donation has been ruled out,
Amendment 8 #
2009/2104(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the proposal to establish a European Action Plan on Organ Donation and Transplantation for the period 2009- 2015(2009-2015) adopted by the European Commission in December 2008, which sets out a cooperative approach between Member States through a set of priority actions, based on the identification and development of common objectives and the evaluation of donation and transplantation activities through agreed indicators that might help to identify benchmarks and best practices;
Amendment 9 #
2009/2104(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
Amendment 12 #
2009/2104(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Considers that to ensure that organs available for therapy are not wasted, it is important that there are no legal barriers tois a clearly defined legal framework regarding their use and that society trusts the donation and transplantation system;
Amendment 13 #
2009/2104(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Welcomes the activities of Eurotransplant and Scanditransplant, but notes that exchanges of organs outside these systems and between these systems can be significantly improved, especially for the benefit of patients in small countries;
Amendment 14 #
2009/2104(INI)
Motion for a resolution
Paragraph 9 (renumbering)
Paragraph 9 (renumbering)
Amendment 15 #
2009/2104(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses that donation should be voluntary, unpaid and altruistic, and take place in clearly defined legal and ethical contexts;
Amendment 16 #
2009/2104(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Endorses measures which aim at protecting living donors and ensuring that organ donation is made altruistically and voluntarily, without any payment other than compensation which is strictly limited to covermaking good the expenses and inconvenience relating to donationincurred in donating an organ, such as travel expenses, childminding costs, loss of earnings or recovery costs, prohibiting any financial incentives or disadvantages for a potential donor; urges Member States to define the conditions under which compensation may be granted;
Amendment 21 #
2009/2104(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls on Member States to reach the full potential of deceased donation by establishing efficient systems for identifying organ donors and by promoting transplant donor coordinators in hospitals across Europe; asks Member States to evaluate the use of organs from "expanded" criteria donors, taking into account (i.e. older donors or those who have certain diseases), taking into account donor and recipient protection and the quality and safety aspects;
Amendment 22 #
2009/2104(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on Member States to explore the promotion of donation from living donors as a complement to deceasedEmphasises that living donation should be seen as subsidiary to post- mortem donations and should only serve as a last resort where no suitable alternative, such as organs from a deceased donor, is available; advises the Member States to allow living donation only among close relatives and between spouses owing to the implicit danger of exploitation; insists that Member States that extend living donation to other groups must have strict regulations in place to prevent any kind of pressure being exerted or payment being made for the donations; .
Amendment 24 #
2009/2104(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Stresses that living donors should be treated in accordance with the highest medical standards and without any financial burden for themselves when a medical problem occurs which is caused by the transplantation process, and any loss of earning as consequence of the transplantation or any medical problem should be avoided. The donors should be protected against discrimination in the social system.
Amendment 25 #
2009/2104(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Points out that there is a link between organ shortage and organ trafficking and trafficking in persons for the purpose of the removal of organs; eEmphasises that any commercial exploitation of organs that denies an equitable access to transplantation is unethical, is inconsistent with the most basic human values, contravenes Article 21 of the Convention on Human Rights and Biomedicine and is prohibited under Article 3(2) of the EU Charter on Fundamental Rights; stresses that increasing organ availability in the Member States will contribute to a better control of these practices by avoiding citizens of the Union having to search for an organ outside the EU and national legislative and ethical frameworks;
Amendment 26 #
2009/2104(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Points out that the organ shortage and organ trafficking and trafficking in persons for the purpose of the removal of organs are linked in two ways: firstly, increased organ availability in the Member States would contribute to better monitoring of these practices, by obviating any need for EU citizens to consider seeking an organ outside the EU, and, secondly, illegal activity seriously undermines the credibility of the legal organ donation system:
Amendment 27 #
2009/2104(INI)
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23b. Repeats the recommendations on the fight against the organ trade made in the Adamou-report on organ donation and transplantation1 and takes the view that these should be taken fully into account by the Commission when drafting the action plan; insists that awareness of the problem within the Commission and Europol needs to be increased; 1 European Parliament resolution of 22 April 2008 on organ donation and transplantation: Policy actions at EU level (2007/2210 (INI))
Amendment 28 #
2009/2104(INI)
Motion for a resolution
Paragraph 23 c (new)
Paragraph 23 c (new)
Amendment 29 #
2009/2104(INI)
Motion for a resolution
Paragraph 23 d (new)
Paragraph 23 d (new)
23d. Welcomes the joint Council of Europe/United Nations study on trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs;
Amendment 30 #
2009/2104(INI)
Motion for a resolution
Paragraph 23 e (new)
Paragraph 23 e (new)
23e. Notes the report by David Matas and David Kilgour entitled 'Bloody Harvest. The killing of the Falun Gong for their organs', and asks the Commission to present a report on the allegations made in the book to the European Parliament and the Council;
Amendment 31 #
2009/2104(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Strongly rejects the behaviour of some health insurance organisations in encouraging patients to participate in transplant tourism and asks the Member States to monitor strictly and punish such behaviour;
Amendment 32 #
2009/2104(INI)
Motion for a resolution
Paragraph 24 b (new)
Paragraph 24 b (new)
24b. Emphasises that patients who have received an organ under illegal circumstances cannot be excluded from healthcare in the European Union; points out that as in any other case a distinction should be drawn between the punishment for illegal activity and the need for treatment;
Amendment 229 #
2009/2096(INI)
Motion for a resolution
Paragraph 12a (new)
Paragraph 12a (new)
12a. Is convinced that the key answers, in terms of achieving further CO2 reductions in road transport, lie, in the short to medium term, in improvements in the efficiency of combustion engines and auxiliary units and, in the medium to long term, in diversification of drive systems, with a particular but not exclusive focus on electrification;
Amendment 231 #
2009/2096(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Is convinced that European efficiency and safety technologies, not least highly efficient diesel technology, open up considerable export opportunities for European companies worldwide, and therefore merit political support in the interests of sustainability and competitiveness;
Amendment 2 #
2009/2068(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. Calls on the Commission to develop further assistance and specific training for applicants and user-friendly guidelines; stresses that more attention should be given to the parts of the programme that have a low level of implementation or that these parts should be questioned;
Amendment 4 #
2009/2068(DEC)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls for care to be taken to ensure that planned projects are worthwhile in terms of their size and financing.
Amendment 21 #
2009/0173(COD)
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) To enhance the competitiveness of the European automotive industry, incentive schemes such as the offsetting of eco-innovations and the award of super-credits should be used in preference to prohibitions incurring criminal penalties.
Amendment 26 #
2009/0173(COD)
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) In order to provide the purchasers of light commercial vehicles with the information necessary to take purchasing decisions, manufacturers should provide potential customers with information on these vehicles’ CO2 emissions and fuel consumption.
Amendment 34 #
2009/0173(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Manufacturers should have flexibility to decide how to meet their targets under this Regulation and should be allowed to average emissions over their new vehicle fleet rather than having to respect CO2 targets for each individual vehicle. Manufacturers should therefore be required to ensure that the average specific emission for all the new light commercial vehicles registered in the Community for which they are responsible does not exceed the average of the emissions targets for those vehicles. This requirement should be phased in between 20145 and 20167 in order to facilitate its introduction. This is consistent with the lead times given and the duration of the phase-in period set in Regulation 443/2009.
Amendment 35 #
2009/0173(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) In order to ensure that targets reflect the particularities of small and niche manufacturers and are consistent with the manufacturer's reduction potential, alternative emission reduction targets should be set for such manufacturers taking into account the technological potential of a given manufacturer's vehicles to reduce their specific emissions of CO2 and consistently with the characteristics of the market segments concerned. This derogation should be covered by the review of the specific emission targets in Annex I, to be completed by the beginning of 20134 at the latest.
Amendment 38 #
2009/0173(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) The Community Strategy to reduce CO2 emissions from passenger cars and light commercial vehicles established an integrated approach with a view to reaching the Community target of 120 g CO2/km by 2012, while also presenting a longer-term vision of further emission reductions. Regulation (EC) No 443/2009 substantiates this longer-term view by setting a target of 95 g CO2/km as average emissions for the new car fleet. In order to ensure consistency with that approach and to provide planning certainty for the industry, a long-term targets for the specific emissions of CO2 of light commercial vehicles in 2020 and 2025 should be set.
Amendment 41 #
2009/0173(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Manufacturers' compliance with the targets under this Regulation should be assessed at the Community level. Manufacturers whose average specific emissions of CO2 exceed those permitted under this Regulation should pay an excess emissions premium with respect to each calendar year from 1. January 20145. The premium should be modulated as a function of the extent to which manufacturers fail to comply with their target. In order to ensure consistency, the premium mechanism should be similar to the one set in Regulation (EC) No 443/2009. The amounts of the excess emissions premium should be considered as revenue in the General Budget of the European Union.
Amendment 52 #
2009/0173(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) The speed of road vehicles has a stris onge influence on their fuel consumption and CO2 emissions. In addition, in the absence of speed limitation for light commercial vehicles, it is possible that there is an element of competition as regards top speed which could lead to oversized powertraline with the principle that, in reducing CO2 emissions, more use should be made of economic incentives and less of prohibitions, a voluntary scheme granting manufacturers, in return for the installation of speed limiters, certain credits in respect of the CO2 emissions saved might contribute to promotinsg and associated inefficiencies in slower operating condit more fuel-efficient and environmentally friendly fleet of LCVs in the Unions. It is therefore appropriate to investigate the feasibility of extendingFirst, however, urgent measures should be taken to investigate scientifically whether significant quantities of CO2 emissions can be saved by the installation of speed limiters and if so whether it is possible to extend the scope of Council Directive 92/6/EEC on the installation and use of speed limitation devices for certain categories of motor vehicles in the Community, in the framework of a voluntary scheme with bonuses, with the aim of including light commercial vehicles covered in this Regulation.
Amendment 59 #
2009/0173(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. From 20206, this Regulation sets a target of 135 g CO2/km for the average emissions of new light commercial vehicles registered in the Community, provided the Commission has confirmed the feasibility of this target in its review pursuant to Article 12(4).
Amendment 65 #
2009/0173(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. From 2020, this Regulation sets a target of 13560 g CO2/km for the average emissions of new light commercial vehicles registered in the Community, provided the Commission has confirmed the feasibility of this target in its review pursuant to Article 12(4).
Amendment 74 #
2009/0173(COD)
Proposal for a regulation
Article 1 – paragraph 2 a (new)
Article 1 – paragraph 2 a (new)
2a. From 2025, this Regulation sets a target of 135 g CO2/km for the average emissions of new light commercial vehicles registered in the Union, provided the Commission has confirmed the feasibility of this target in its review pursuant to Article 12(4).
Amendment 77 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
For the calendar year commencing 1 January 20145 and each subsequent calendar year, each manufacturer of light commercial vehicles shall ensure that its average specific emissions of CO2 do not exceed its specific emissions target determined in accordance with Annex I or, where a manufacturer is granted a derogation under Article 10, in accordance with that derogation.
Amendment 78 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 1 a (new)
Article 4 – paragraph 1 – subparagraph 1 a (new)
For the purpose of determining each manufacturer’s specific emissions of CO2, a progressive reduction towards the target value of 135 g CO2/km in 2026 shall be set for all of a given manufacturer’s new light commercial vehicles: - 175 g CO2/km in 2018 - 165 g CO2/km in 2020 - 155 g CO2/km in 2022 - 145 g CO2/km in 2024 - 135 g CO2/km in 2026.
Amendment 86 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 2 – indents 1, 2 and 3
Article 4 – paragraph 2 – indents 1, 2 and 3
– 65% in 2015, – 75% in 20146, – 80% in 2015,7. – 100% from 20168 onwards.
Amendment 91 #
2009/0173(COD)
Proposal for a regulation
Article 5 – introductory part – indents 1, 2 and 3
Article 5 – introductory part – indents 1, 2 and 3
In calculating the average specific emissions of CO2, each new light commercial vehicle with specific emissions of CO2 of less than 50 g CO2/km shall be counted as: – 2,5 light commercial vehicles in 2014, – 1,5 light commercial vehicles in 2015% of the indicative specific CO2 emissions pursuant to Annex I shall be counted as: – 3,5 light commercial vehicles in 2016, – 3,5 light commercial vehicles in 2017, – 2,5 light commercial vehicles in 2018, – 2,5 light commercial vehicles in 2019, – 1,5 light commercial vehicles in 2020, – 1,5 light commercial vehicles in 2021, – 1 light commercial vehicle from 201622.
Amendment 97 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
For the calendar year commencing 1 January 20145 and each subsequent calendar year, each manufacturer of light commercial vehicles shall ensure that its average specific emissions of CO2 do not exceed its specific emissions target determined in accordance with Annex I or, where a manufacturer is granted a derogation under Article 10, in accordance with that derogation.
Amendment 107 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
Manufacturers shall take the appropriate measures to gradually reduce the average CO2 emissions of new light commercial vehicles registered in the Union so as to reach the target of 135 g CO2/km in 2025, taking account – in order to promote continuing innovation – of the following non-binding targets: - 165 g CO2/km in 2019 - 145 g CO2/km in 2023.
Amendment 112 #
Amendment 121 #
Amendment 138 #
2009/0173(COD)
Proposal for a regulation
Article 4 – paragraph 2 – indent 3
Article 4 – paragraph 2 – indent 3
–100% from 20167 onwards.
Amendment 141 #
2009/0173(COD)
Proposal for a regulation
Article 12 – paragraph 4 – subparagraph 1 – introductory part
Article 12 – paragraph 4 – subparagraph 1 – introductory part
By 1 January 20134, the Commission shall complete a review of the specific emissions targets in Annex I and of the derogations in Article 10, with the aim of defining:
Amendment 142 #
2009/0173(COD)
Proposal for a regulation
Article 12 – paragraph 4 – subparagraph 1 – indent 1
Article 12 – paragraph 4 – subparagraph 1 – indent 1
– subject to confirmation of its feasibility on the basis of updated impact assessment results, the modalities for reaching, by the year 20206, a long-term target of 135 g CO2/km in a cost-effective manner; and
Amendment 147 #
2009/0173(COD)
Proposal for a regulation
Article 5 a (new)
Article 5 a (new)
Article 5a Specific emission target for alternative fuel vehicles For the purpose of determining compliance by a manufacturer with its specific emissions target referred to in Article 4, the specified emissions of CO2 of each vehicle which is designed to be capable of running on a mixture of petrol with 85 % ethanol (‘E85’), and which meets relevant Union legislation or European technical standards, shall be reduced by 5 % by 31 December 2015 in recognition of the greater technological and emissions reduction capability when running on biofuels. This reduction shall apply only where at least 30 % of the filling stations in the Member State in which the vehicle is registered provide this type of alternative fuel complying with the sustainability criteria for biofuels set out in relevant Union legislation.
Amendment 152 #
2009/0173(COD)
Proposal for a regulation
Article 5 – introductory part
Article 5 – introductory part
In calculating the average specific emissions of CO2, each new light commercial vehicle with specific emissions of CO2 of less than 50 g CO2/km% of the indicative specific CO2 emissions pursuant to Annex I shall be counted as:
Amendment 161 #
2009/0173(COD)
Proposal for a regulation
Article 5 – indent 1
Article 5 – indent 1
2,5 light commercial vehicles in 20145,
Amendment 165 #
2009/0173(COD)
Proposal for a regulation
Article 5 – indent 2
Article 5 – indent 2
Amendment 168 #
2009/0173(COD)
Proposal for a regulation
Article 5 – indent 3
Article 5 – indent 3
Amendment 172 #
2009/0173(COD)
Proposal for a regulation
Article 7 a (new)
Article 7 a (new)
Amendment 195 #
2009/0173(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. In respect of the period 1 January 20145 and every calendar year thereafter, the Commission shall impose an excess emissions premium on a manufacturer or pool manager, as appropriate, where a manufacturer's average specific emissions of CO2 exceed its specific emissions target.
Amendment 201 #
2009/0173(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point a – introductory part
Article 8 – paragraph 2 – subparagraph 1 – point a – introductory part
(a) From 20145 to 2018:
Amendment 240 #
2009/0173(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. From the 31 October 20145, the list published under paragraph 1 shall also indicate whether the manufacturer has complied with the requirements of Article 4 with respect to the preceding calendar year.
Amendment 242 #
2009/0173(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Upon application by a supplier or a manufacturer, CO2 savings achieved through the use of innovative technologies shall be considered. The total contribution of those technologies to reducing the specific emissions target of a manufacturer may be up to 7 g CO2/km.
Amendment 245 #
2009/0173(COD)
Proposal for a regulation
Article 11 – paragraph 2 – introductory part
Article 11 – paragraph 2 – introductory part
2. The Commission shall by 31 December 2012, adopt detailed provisions for a procedure to approve such innovative technologies in accordance with the regulatory procedure referred to in Article 13(2). Those detailed provisions shall be in conformity with the provisions of Article 12(2) of Regulation (EC) No 443/2009 and shall be based on the following criteria for innovative technologies:
Amendment 246 #
2009/0173(COD)
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 a (new)
Article 11 – paragraph 2 – subparagraph 1 a (new)
These detailed provisions shall respect the following principles: (a) the regularly updated European Union list of approved eco-innovations shall guarantee that eco-innovations are standardised within the European Union and ensure that these technologies are applied effectively by the authorities responsible for type-approval in the Member States; (b) the authorities responsible for type- approval in the Member States shall assess and approve the use of eco- innovations and the way in which their respective contributions to CO2 reduction are taken into account, so that every vehicle model can be assigned a specific eco-innovation pack; (c) the Commission shall decide on the application from the supplier or manufacturer within six months of receipt of the application; (d) a technology shall be approved as an eco-innovation where a maximum of 40% of its contributions to CO2 reduction are measurable in the type test cycle; (e) a technology shall be approved as an eco-innovation where its contributions to CO2 reduction amount to more than 0.2 g/km.
Amendment 255 #
2009/0173(COD)
Proposal for a regulation
Article 12 – paragraph 4 – subparagraph 1 – indent 1
Article 12 – paragraph 4 – subparagraph 1 – indent 1
– subject to confirmation of its feasibilitywhether, on the basis of updated impact assessment results, the modalities for reaching, by the yearit is possible to reach a long-term target of 160 g CO2/km by 2020, and a long-term target of 135 g CO2/km by 2025 in a cost-effective manner; and
Amendment 272 #
2009/0173(COD)
Proposal for a regulation
Article 12 – paragraph 4 – subparagraph 2 – indent 2
Article 12 – paragraph 4 – subparagraph 2 – indent 2
– confirm themake a proposal to inclusionde in this Regulation of vehicles in category N2 and M2 as defined in Annex II to Directive 2007/46/EC with a reference mass not exceeding 2 610 kg and to vehicles to which type-approval is extended in accordance with Article 2(2) of Regulation (EC) No 715/2007, with a view to the long-term target from 2020.
Amendment 284 #
2009/0173(COD)
Proposal for a regulation
Article 12 – paragraph 6 – subparagraph 2
Article 12 – paragraph 6 – subparagraph 2
Amendment 292 #
2009/0173(COD)
Proposal for a regulation
Annex 1 – point 1 – subpoint a – line 1
Annex 1 – point 1 – subpoint a – line 1
(a) From 20145 to 2017:
Amendment 23 #
2009/0108(COD)
Proposal for a regulation
Citation 1
Citation 1
Having regards to the Treaty establishon the Functioning of the European CommunityUnion, and in particular Article 95122 thereof,
Amendment 24 #
2009/0108(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The failure of the largest single gas infrastructure or gas supply source, the so- called N-1 principle, is a realistic scenario. Using the failure of such infrastructure or supply source as a benchmark of what Member States should be able to compensate is a valid starting point for ensuring their security of gas supply.
Amendment 25 #
2009/0108(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Investments in new gas infrastructure should be strongly promoted. They should enhance the security of gas supply while ensuring the proper functioning of the internal market in natural gas. Investments should as a matter of fundamental principle be made by undertakings and be based on economic incentives. Where an infrastructure investment is of cross-border nature the Agency for the Cooperation of Energy Regulators established by Regulation (EC) No .../… of the European Parliament and of the Council ("ACER") and the European Network of Transmission System Operators for Gas ("ENTSO-G") should be closely involved in order to take better account of the cross-border implications.
Amendment 28 #
2009/0108(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) It is essential for the well-functioning of the market that the necessary investments in indigenous production and infrastructures, such as interconnections, or equipment allowing physical bidirectional flows on pipelines, storage, and LNG re- gasification facilities, are made by the natural gas undertakings in time, bearing in mind possible supply disruptions such as the one that occurred in January 2009.
Amendment 30 #
2009/0108(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) To strengthen the solidarity between Member States in the case of a Community Emergency and in particular to support Member States which are exposed to less favourable geographical or geological conditions, Member States should devise specific measures to exercise solidarity, including measures such as commercial agreements between natural gas undertakings, compensation mechanisms, or increased gas exports or increased releases from storages. Solidarity measures may be particularly appropriate between Member States for which the Commission recommends the establishment of joint preventive actions plans or emergency plans at regional level. Commercial agreements between undertakings based on the establishment of joint preventive action plans and emergency plans should be promoted.
Amendment 34 #
2009/0108(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 1
Article 2 – paragraph 2 – point 1
(1) "protected customers" means all household customers already connected to a gas distribution network, and, if the Member State concerned so decides, can also include small and medium-sized enterprises, schools and hospitals provided that they are already connected to a gas distribution network;
Amendment 36 #
2009/0108(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Security of gas supply is a task of the natural gas undertakings, Competent Authorities of the Member States, the industrial gas customers, and the Commission within their respective areas of responsibility. It requires a high degree of cooperation between them. Regarding the handling of a major gas supply disruption, this Regulation provides for a system based on a three-stage approach. During the first stage, it is individual undertakings or groups of undertakings that respond to the disruption of supply; if that proves insufficient, Member States should take measures to remedy the supply disruption. Only if the measures taken at stages one and two seem unlikely to succeed should appropriate measures be taken at Community level. Preferential consideration should be given to regional cross-border solutions.
Amendment 37 #
2009/0108(COD)
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. The Commission shall coordinate the Competent Authorities at the Community level through the Gas Coordination Group in particular in the case of a Community EmergencyGas Coordination Group shall take charge of cooperation at Community level pursuant to Article 11, in particular in a Community Emergency. In the event of a Community Emergency, the Gas Coordination Group shall convene a crisis management group pursuant to Article 10(3). The Member States concerned shall appoint the participants.
Amendment 39 #
2009/0108(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Before adopting those Plans the Competent Authorities shall exchange information and consult each other and the Commission to ensure that their Plans and measures are mutually consistent at the appropriate regional level. These consultations shall cover, as a minimum, interconnections, cross-border supplies, storage across borders and the physical capacity to transport gas in both directions. In the course of them, the confidentiality of commercially sensitive information shall be safeguarded.
Amendment 41 #
2009/0108(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. During the process mentioned in paragraph 2 the CommissionGas Coordination Group may recommend at which regional level the exchange of information and consultations shall take place. The CommissionGas Coordination Group, after consultation of the European Network of Transmission System Operators for Gas ("ENTSO-G") and the Agency for the Cooperation of Energy Regulators ("ACER"), may also recommend the establishment of a joint Plan at regional level.
Amendment 43 #
2009/0108(COD)
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
5. The Competent Authority shall publish its Plans, including amended versions according to paragraph 6, and notify them to the CommissionGas Coordination Group without delay.
Amendment 44 #
2009/0108(COD)
Proposal for a regulation
Article 4 – paragraph 6 – subparagraph 1
Article 4 – paragraph 6 – subparagraph 1
6. Within six months after the notification of the Plans by the Competent Authorities, the Commission shall assessreview the Plans of all Member States. The Commission shall consult in consultation with ACER, ENTSO-G, ACER, the Gas Coordination Group and other parties concerned stakeholders on those plans. Where the Commission. Where the Commission and the Gas Coordination Group considers that a Plan is not effective to mitigate the risks as identified in the risk assessment or inconsistent with the risk scenarios or the Plans of other Member States, or that it does not comply with the provisions of this Regulation or other provisions of Community law, ithey shall jointly require the revision of the Plan. Within six months after notification of the Commission's request, the Competent Authority concerned shall amend its Plan and notify the amended Plan to the Commission or shall set out to the Commission why it does not agree with the request. In this case the Commission may amend or withdraw its request. If within two months the Commission decides not to amend or withdraw its request, the Competent Authority shall comply with the Commission's request within three months after notification of the Commission's decision.
Amendment 45 #
2009/0108(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. The transmission system operators shall enable permanent physical capacity to transport gas in both directions on all interconnections within twohree years from the entry into force of this Regulation, except in cases where at the request of a Competent Authority, the Commissionies decides that the addition of al bi- directional flow capacity would not enhance the security of supply of any Member Statein the Member States concerned would not enhance compliance with the n-1 standard. Such decision may be reviewed if circumstances change. The level of the bi-directional flow capacity shall be reached in a cost efficient way and at least take into account the capacity required to meet the supply standard set in Article 7. Within that twohree year period, the gas transmission system operator shall adapt the functioning of the transmission system as a whole so as to enable bi- directional gas flows.
Amendment 48 #
2009/0108(COD)
Proposal for a regulation
Article 8 – paragraph 1 – introductory part
Article 8 – paragraph 1 – introductory part
1. By [30 September 2010; 6 months after entry into force] each Competent Authority shall fully assess the risks affecting the security of gas supply in its Member State by:
Amendment 50 #
2009/0108(COD)
Proposal for a regulation
Article 9 - paragraph 3
Article 9 - paragraph 3
3. The national Emergency Plan shall ensure that cross-border access to the storage facilities is maintained also in case of emergency. The Emergency Plan shall not introduce any measure unduly restricting the flow of gas across the borders.
Amendment 51 #
2009/0108(COD)
Proposal for a regulation
Article 9 - paragraph 4
Article 9 - paragraph 4
4. The Competent Authority shall immediately inform the Commission and provide it with all the necessary information when it declares any of the crisisthe alert or emergency levels. In the event of an emergency which may result in a call for assistance from the EU and its Member States the Competent Authority of the Member State concerned shall without delay notify the Commission’s Civil Protection Monitoring and Information Centre.
Amendment 52 #
2009/0108(COD)
Proposal for a regulation
Article 9 - paragraph 5
Article 9 - paragraph 5
5. When the Competent Authority declares an Emergency it shall follow the pre- defined actions as defined in its Emergency Plan and shall immediately inform the Commission in particular of the actions it intends to take according to Article 9(1). The Commission mayshall convene the Gas Coordination Group.
Amendment 54 #
2009/0108(COD)
Proposal for a regulation
Article 10 - paragraph 1
Article 10 - paragraph 1
1. The Commission may declare a Community Emergency at theupon request of one Competent Authority or when the Community loses more than 120% of its daily gas import from third countries as calculated by ENTSO-G. It shall declare a Community Emergency where more than one Competent Authority has declared Emergency following the verification in accordance with Article 9(6). It may declare a Community Emergency for specifically affected geographical regions comprising more than one Member State.
Amendment 58 #
2009/0108(COD)
Proposal for a regulation
Article 10 - paragraph 6
Article 10 - paragraph 6
6. In a Community Emergency, the Member States shall ensure that cross- border access to the storage facilities is maintained in accordance with commercial agreements and shall not introduce any legal provisions which unduly restrict the flows of gas to the affected markets.
Amendment 59 #
2009/0108(COD)
Proposal for a regulation
Article 10 - paragraph 7
Article 10 - paragraph 7
Amendment 60 #
2009/0108(COD)
Proposal for a regulation
Article 11 - paragraph 1
Article 11 - paragraph 1
1. A Gas Coordination Group is established to facilitate the coordination of measures concerning the security of supply. The Group shall be composed of representatives of the Competent Authorities, ACER, ENTSO-G and representative bodies of the industry concerned and relevant customers. The CommissionMember States shall decide on the composition of the Group ensuring its representativity and shall chair the Group. The Group shall establish its rules of procedure.
Amendment 61 #
2009/0108(COD)
Proposal for a regulation
Article 11 – paragraph 2 – introductory part
Article 11 – paragraph 2 – introductory part
2. The Gas Coordination Group shall assdviste the Commission in particular on issues related to:
Amendment 63 #
2009/0108(COD)
Proposal for a regulation
Annex III – paragraph 1 – introductory part
Annex III – paragraph 1 – introductory part
In developing the Preventive and Emergency Plans the Competent Authority shall consider the contribution of the following measures only in the case of an Emergency, taking into account the following non-exhaustive list of measures:
Amendment 23 #
2009/0003(CNS)
Proposal for a recommendation
Recital 7
Recital 7
(7) Evidence suggests that EU Member States are at different levels in the development and implementation of effective and comprehensive patient safety strategies. Therefore, this initiative intends to create a framework to stimulate policy development and future action in and between Member States to address the key patient safety issues confronting the EU. In accordance with Article 152 of the Treaty establishing the European Community, however, there must be no encroachment upon Member States' competences.
Amendment 25 #
2009/0003(CNS)
Proposal for a recommendation
Recital 8
Recital 8
(8) Patients should be informed and empowered by involving them in the patient safety process; they should be informed of levels of safety and on how they can find accessible and comprehensible information on complaints and redress systems. The individual Member State shall, however, be competent for the type and method of compensation.
Amendment 26 #
2009/0003(CNS)
Proposal for a recommendation
Recital 10
Recital 10
(10) Comparable and aggregate data should be collected at Community level to establish efficient and transparent patient safety programmes, structures and policies, and best practices should be disseminated among the Member States. These data should only be used for the purposes of patient safety with respect to the control of healthcare associated infections. To facilitate mutual learning, a common terminology for patient safety and common indicators need to be developed through cooperation between Member States and the European Commission, taking into account the work of relevant international organisations.
Amendment 38 #
2009/0003(CNS)
Proposal for a recommendation
Part I – Chapter II – point 3
Part I – Chapter II – point 3
Amendment 41 #
2009/0003(CNS)
Proposal for a recommendation
Part I – Chapter II – point 5 – point c
Part I – Chapter II – point 5 – point c
(c) To gather and share comparable data and information on patient safety outcomes in terms of type and number at EU level to facilitate mutual learning and inform priority setting. The scale and cost of the data collection, and use of the data collected, should not be disproportionate to the expected benefits. The data should only be collected in order to achieve the objective of reducing treatment-related infections through common learning. It shall be the responsibility of the Member States alone to set priorities for possible follow-up action, as these issues relate to the organisation of healthcare systems.
Amendment 53 #
2009/0003(CNS)
Proposal for a recommendation
Annex 1 – line 9 – column 2
Annex 1 – line 9 – column 2
Amendment 54 #
2009/0003(CNS)
Proposal for a recommendation
Annex 1 – line 7 – column 2
Annex 1 – line 7 – column 2
Health professionals working in clinical wards/departmentthe corresponding sectors who act as a liaison between their wards/departmentsork sector and the Infection Prevention and Control Team. Infection control link staff help promote infection prevention and control in their wards/departmentsectors and give feedback to the Infection Prevention and Control Team.
Amendment 55 #
2009/0003(CNS)
Proposal for a recommendation
Annex 2 – Chapter 1 – point 1 – point b a (new)
Annex 2 – Chapter 1 – point 1 – point b a (new)
(ba) Accepting and facilitating the use of information and communication technology tools, such as electronic instructions for use, in order to improve the understanding of users of the medical products.
Amendment 7 #
2008/2249(INI)
Motion for a resolution
Recital F
Recital F
F. whereas, although subcontracting has many positive aspects and has allowed for increased productive capacity, it is also generating some economic and social imbalances among workers and might foster a race to the bottom in working conditions, which is a matter of concern,
Amendment 9 #
2008/2249(INI)
Motion for a resolution
Recital G
Recital G
G. whereas, subcontracting may also be carried out by pure manpower firms that sometimes operate as so-called letterbox companies, which highlights the nature of the construction industry as a sector of rapidly changing, often fixed term employment relationships where the position of workers is often precarious,
Amendment 14 #
2008/2249(INI)
Motion for a resolution
Recital H
Recital H
Amendment 16 #
2008/2249(INI)
Motion for a resolution
Recital I
Recital I
I. whereas employment relations in thethe externalisation of activities and/or labour forces through sub- construaction sector have been redefined and, at the same time, haveng or employment agencies may reduced the direct social responsibility of the 'principal contractor', as labour has been externalised by the use of subcontractors and employment agencies, making the supply of cheap, often unskilled labour an integral part of lower level subcontractingcompanies, when used extensively,
Amendment 20 #
2008/2249(INI)
Motion for a resolution
Recital J
Recital J
J. whereas, the constructionsome sectors hasve been especially vulnerable to abuses in itstheir often complicated subcontracting chains,
Amendment 23 #
2008/2249(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
Amendment 36 #
2008/2249(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Takes note of the Commission's proposal for a Directive providing for sanctions against employers of illegally staying third-country nationals, in which the Commission introduces the idea of joint and several liability into Community legislation;
Amendment 44 #
2008/2249(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Emphasises the particular challenges faced by small businesses, calls on policymakers to develop appropriate tools to raise awareness in this sector;
Amendment 45 #
2008/2249(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Reminds all stakeholders that, in its aforementioned resolution on the posting of workers, Parliament called on the Commission to regulate the joint and several liability of general or principal undertakings, in order to deal withconsider abuses in the subcontracting and outsourcing of cross- border workers, and to set up a transparent and competitive internal market for all companies;
Amendment 47 #
2008/2249(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Reiterates its message by calling on the Commission to establish a clear-cut Community legal instrument introducing joint and several liability at European level whilst respecting the different legal systems in place in the Member States and the principles of subsidiarity and proportionalityCalls on the Commission to report on joint and several liability at European level;
Amendment 51 #
2008/2249(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Is convinced that such an instrumentinformation and exchange of best practices would benefit not only employees, but also Member State authorities, employers and especially SMEs in their fight against the grey economy, as clear, transparent Community rules would drive dubious operators out of the market, thus improving the functioning of the single market;
Amendment 53 #
2008/2249(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
Amendment 61 #
2008/2249(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Warns also against conflicts and overlapping between, and duplication of provisions found in codes of conduct and in labour law, codes of conduct, standards and guidelines adopted by public authorities and collective agreements in force; for this reason, emphasises the need for undertakings to adhere, as a matter of priority, to codes of conduct, standards and guidelines drafted at the level of supranational organisations (OECD, ILO), national, or sector level;
Amendment 64 #
2008/2249(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Stresses that the fight against the potential negative social consequences of subcontracting can be tacklstrengthened by enhanced social dialogue between employers' organisations and trade unions, also with the participation of socially active NGOs and civil society organisations.
Amendment 29 #
2008/2239(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the present economic crisis is further hampering investment in energy infrastructure,
Amendment 57 #
2008/2239(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on Member States, in the light of the growing risks which the EU is running in terms of energy security, to speak with a single voice; notes that their current practices are anything but geared to this aspiration; considers it imperative, in the interests both of solidarity and of the effectiveness of negotiations with a view to determining the international regulatory framework, for Member States to draw up a European energy policy in accordance with their competences: international relations, energy efficiency, combating climate change, regulationmonitoring of the internal market, negotiation of international treaties, forward studies and dialogue with producers, and energy research;
Amendment 74 #
2008/2239(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Notes a very significant delay in the building of the priority and European- interest transport and energy networks as far as the production sector is concerned; stresses that this low level of investment is acting as a brake on the proper functioning of the internal market and is responsible for the fact that, in all energy sectors, capacity is stretched or even inadequate; notes moreover that industry is only to a limited extent responsible for this and expresses its concern about the general resistance of many members of the public to new infrastructure projects and production projects; calls on national regulatory authorities to do whatever they can within their fields of decision-making to accelerate investment;
Amendment 80 #
2008/2239(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Welcomes the idea of increasing European financing with the aim of encouraging investment in networks; advocates the establishment of a European fund to guarantee non- commercial risks of certain energy production and transmission projects of European interest;
Amendment 85 #
2008/2239(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Supports the development of gas and electricity interconnections through Central and South-eastern Europe along a north- south axis, recalling that the networks in Northern Europe are inadequate and that these regions are isolated; calls therefore, by way of example, for gas to be supplied to Poland from Eastern Germany;
Amendment 101 #
2008/2239(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Expresses its support for the Nabucco projects to diversify sources of supply; is concerned, however, about the progress of themany projects and the risks to sources of supply for the gas pipeline; stresses the importance of complying with existing requirements under the existing Directive 2004/67/EC before new requirements are defined or existing requirements extended; recalls that additional measures often also give rise to additional costs which cannot be borne exclusively by industry;
Amendment 113 #
2008/2239(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
Amendment 125 #
2008/2239(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. 100% energy security is impossible; despite technically complex and tried and tested technical systems, the complex process chain of energy supply can be stopped or interrupted; therefore, only a part of the risk can ever be controlled and monitored by energy policy;
Amendment 127 #
2008/2239(INI)
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Notes that the stable operation of electricity networks requires suitable and balanced sharing of energy production within that network; calls on the Commission to take into account that production can occur not only in coastal regions, but also close to consumers who are situated far from the coast; calls on the Commission to come forward with a report analysing and comparing the advantages and disadvantages of locations near to and far from the coast for the purposes of producing electricity;
Amendment 128 #
2008/2239(INI)
Motion for a resolution
Paragraph 10 c (new)
Paragraph 10 c (new)
10c. Endorses investment in electricity and gas transport networks in the European Union, and calls on the regulatory authorities to ensure an appropriate legal framework;
Amendment 129 #
2008/2239(INI)
Motion for a resolution
Paragraph 10 d (new)
Paragraph 10 d (new)
10d. Recalls that cross-border links already exist between various countries; observes also that regional initiatives (such as the Pentalateral Forum) have devised usable practical solutions which accelerate the completion of the internal market; encourages those responsible for these initiatives to continue their successful work;
Amendment 130 #
2008/2239(INI)
Motion for a resolution
Paragraph 10 e (new)
Paragraph 10 e (new)
10e. Welcomes initiatives by industry which contribute to the completion of the internal market in energy by means of cross-border projects;
Amendment 133 #
2008/2239(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on the Commission and Member States to draw up strategic guidelines intended for lasting application, while leaving it to private industrial undertakings to implement them, striking a balance between market mechanisms and regulation; stresses the importance of finalising the negotiations on the legislative package on the internal energy market and calls on the Commission and Member States to set up an independent agency for cooperation between energy regulators, with strong powers, including powers relating to security of supply;
Amendment 145 #
2008/2239(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls on the Commission to focus on the implementation of existing legislation for the internal market, and emphasises once again the need for investment in the internal energy market and the related need for stable regulatory framework conditions;
Amendment 148 #
2008/2239(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
Amendment 157 #
2008/2239(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Stresses that the completion of the market will be a success if it makes it possible ultimately to avoid volatility of energy pricessufficient liquidity is available on the market and that Directive 2003/87/EC, which is currently being revised, provides, in a comprehensible and predictable manner, an assessment of carbon dioxide costs;
Amendment 171 #
2008/2239(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the EU to cooperate with the countries of North Africa in view of their significant energy resource potential and substantial opportunities for development of Africa; the same applies to the Middle East;
Amendment 180 #
2008/2239(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Advocates an approach geared to conciliation in the dialogue with Russia, which supplies 42% of the EU's gas, as well as 100% of the gas imported by Poland, Finland and the Baltic States; notes that relations between the EU and Russia are based on interdependence and that, in the continuation of the negotiations, the EU should refrain from demanding ratification of the Energy Charter, while reminding the Russian authorities of their endorsement of the principles of the Charter; hopes, by way of example, that the Nabucco gas pipeline project will be carried out in cooperation with Russia in order to avoid competition between two gas pipelines and to be able ultimately to transmit gas from Russia, Iran or the Caspian Sea;
Amendment 191 #
2008/2239(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Welcomes the Commission’s efforts to strengthen relations with producer countries and to help European industries to develop the necessary cooperation; is concerned about the Commission’s selective choices; fears that explicitly naming individual projects may lead to other projects being put at a disadvantage and therefore to a disruption of the market;
Amendment 199 #
2008/2239(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission to clarify individual initiatives such as the Caspian development mechanism and asks on what criteria the selection of industry participation in such projects is based and what procedures are followed; is concerned that the efforts to create a working internal energy market will be thwarted by market distortions in the upstream sector;
Amendment 201 #
2008/2239(INI)
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17b. Supports all infrastructure projects and, at the same time, greater diversification of resources for more security of supply and more competition;
Amendment 203 #
2008/2239(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
Amendment 212 #
2008/2239(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Notes that, because of the high cost of strategic gas stocks, it is preferable to promote transparency of commercial stocks and diversification of connections; proposes, however, that Member States introduce emergency measures, such as strategic stocks of the order of 10% and/or contracts which can be interrupted in the event of a crisis;
Amendment 215 #
2008/2239(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Expresses its concern about possible security sharing agreements; believes that the present market mechanisms are functioning and fears that any requirement for operators in the LNG sector which conclude a security sharing agreement could increase the costs of such projects and reduce the likelihood of investment;
Amendment 216 #
2008/2239(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
Amendment 221 #
2008/2239(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Considers that improving energy efficiency by 20% by 2020 is the priority with a view to contributing to sustainable development and competitiveness objectives and is also a very effective and inexpensive way of improving energy security; calls on the Commission and Member States to step up awareness campaigns and make practical information available concerning the solutions to be adopted;
Amendment 228 #
2008/2239(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Welcomes the Commission's intention of observing carefully the progress of CHP, and calls on it to submit further support measures as part of the review of the Energy Efficiency Action Plan in 2009; reminds the Commission that savings on primary energy, cost efficiency and security of supply are the prime aims of the CHP process, irrespective of what technology is used; considers that it must be left to the market to develop and select the most effective technologies;
Amendment 245 #
2008/2239(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Considers that renewable energies, such as wind, solar, hydro, biomass and marine resources, are the most important potential source of energy available to the EU, which can help to stabilise energy prices, and welcomes the initiative to submit a communication on eliminating obstacles to renewable energies; stresses in this connection that new initiatives must not result in any postponement of existing projects;
Amendment 266 #
2008/2239(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Recalls that coalhard coal and lignite remains an element in the EU's supplies and an alternative to oil and gas; recalls the large volume of indigenous reserves and the wide diversification of suppliers in politically stable countries; stresses, however, that the major disadvantage of coal lies in its very high rate of carbon dioxide emissions;
Amendment 275 #
2008/2239(INI)
Motion for a resolution
Paragraph 31 a (new)
Paragraph 31 a (new)
31a. Welcomes the Commission's generally supportive stance regarding nuclear energy; points out, however, that it does not adequately address the issue of final disposal of radioactive waste, despite its immense importance for public perception; calls on the Member States concerned to step up their efforts with regard to resolving the problem of final disposal of all types of radioactive waste, but especially highly radioactive waste;
Amendment 1 #
2008/2219(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Whereas soil is the basis for the production of human foodstuffs, fodder, textiles and fuels, and whereas it plays an important role in CO2 capture; whereas, however, soil is more than ever at risk of irreversible damage caused by erosion, pollution, salinisation, sealing, depletion of organic substances and the loss of soil biodiversity; whereas account should be taken of the historic responsibility of Member States;
Amendment 6 #
2008/2219(INI)
Draft opinion
Paragraph 2
Paragraph 2
Amendment 9 #
2008/2211(INI)
Motion for a resolution
Recital I a (new)
Recital I a (new)
Ia. Whereas the use of Magnetic Resonance Imaging (MRI) must not be threatened by Directive 2004/40/EC as MRI technology is at the cutting edge of research, diagnosis and treatment of life- threatening diseases for patients in Europe,
Amendment 11 #
2008/2211(INI)
Motion for a resolution
Recital I b (new)
Recital I b (new)
Ib. Whereas MRI has been safely used over 25 years with over 500 million patients exposed to up to 100 times the exposure limit set by the Directive without evidence of harm to workers or patients.
Amendment 12 #
2008/2211(INI)
Motion for a resolution
Recital I c (new)
Recital I c (new)
Ic. Whereas the MR safety standard IEC/EN 60601-2-33 establishes limit values for electromagnetic fields which have been set so that any danger to patients and workers is excluded.
Amendment 35 #
2008/2211(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Commission to find a solution enabling Directive 2004/40/EC to be implemented more rapidly and thus ensure that workers are properly protected against electromagnetic fields, just as they are already protected under two other Community acts against noise and vibration and to introduce a derogation for Magnetic Resonance Imaging under Article 1 of that Directive.
Amendment 13 #
2008/2209(INI)
Motion for a resolution
Recital H
Recital H
H. whereas the financial cost to society of mental ill-health is estimated at between 3% and 4%accounts for a significant proportion of the Member States' GDP and whereas most of that expenditure is spent outside the health sector, primarily because of systematic absence from work, incapacity for work and early retirement,
Amendment 14 #
2008/2209(INI)
Motion for a resolution
Recital I
Recital I
I. whereas social and economic disparities can increase mental health problems and whereas the rates of mental ill-health are higher among vulnerable groups,
Amendment 17 #
2008/2209(INI)
Motion for a resolution
Recital J
Recital J
J. whereas in most European Union countries there has been a move from long-term institutionalised care towards supported living in the community; whereas, however, this process has taken place without proper planning and resourcing, without control mechanisms and often with budget cutsoffer care in the community as an alternative to long-term institutionalised care,
Amendment 19 #
2008/2209(INI)
Motion for a resolution
Recital K
Recital K
K. whereas, while physical and mental health are of equal importance and there is interaction between them, mental health often remains undiagnosed or underestimated and receives inand is consequently not adequately treatmented,
Amendment 24 #
2008/2209(INI)
Motion for a resolution
Recital N
Recital N
N. whereas the ageing of the EU's population entails more frequent occurrence of neurodegenerative disorderpresents neurology and psychiatry with new challenges,
Amendment 58 #
2008/2209(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Member States to implement cross-sectoral programmes for the prevention of suicide, promoting a healthy lifestyle, reducing the risk factors and providing support for people who have made suicide attempts and for the family environment of those who have committed suicideestablish anonymous drop-in centres for mental illness sufferers and those at risk of suicide, including the option of family therapy;
Amendment 73 #
2008/2209(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls on employers to promote a healthy working climate, paying attention to work-related stress, the underlying causes of mental disorder at the workplace, and tackling those causes, as far as possible, to take account of psychological principles at the workplace;
Amendment 75 #
2008/2209(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. EncouragesCalls on employers, as part of their health and safety at work strategies, to adopt programmes to promote the emotional and mental wellbeing of their workers and calls on the Commission tond the Member States, in accordance with the directives, to refrain from dissecriminate positive models by publishing such programmes on the Interneting against mental illness sufferers;
Amendment 78 #
2008/2209(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
Amendment 89 #
2008/2209(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Calls on the Commission and the Member States, in the context of the open method of coordination on social protection and integration, to develop guidelines for nursing and long-term care in order to help prevent maltreatment of the elderlysubmit meaningful reports and statistics;
Amendment 92 #
2008/2209(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls for the organisation of public information and awareness campaigns through the media, the Internet, schools and places of work, in order to promote emotional health, increase knowledge about the most common symptoms of depression and suicidal tendencies, destigmatise mental disorders and promote early seeking of assistance and the active integration of people experiencing mental health problemsensure that assistance is offered in good time;
Amendment 1 #
2008/2208(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Acknowledges that nanotechnology and the use of nanomaterials have potential benefits, including in terms of job creation; underlines, however, that products are being made today without knowing whether nanoparticles are released from them and what their potential impthere being any completely reliable data on interact ions with human beings and the environment may be;
Amendment 3 #
2008/2208(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Furthermore underlines that nanotechnology and nanomaterials raise major challenges for occupational health and safety as many workers along the production chain are exposed to these materials without knowing whether the safety procedures implemented and the protection measures taken are adequate and efficient; notes that the number and diversity of workers exposed to the effects of nanomaterials are expected to increase in the futureits application will give rise to new challenges for health and safety at work;
Amendment 6 #
2008/2208(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Recognises that current knowledge on the toxicity of nanoparticles is limited and that comprehensive information on what risks different nanoparticles may pose on workers is not available yet; but notes that preliminary results in most published studies indicate that the toxicity of insoluble particles of similar composition increases with decreasing particle diameter and increasing particle surface area; furthermore notes that those studies reveal a risk of serious health effects of ultrafine particles, air pollution and fibresspecialist knowledge on the biocompatibility and toxicity of nanoparticles is limited;
Amendment 7 #
2008/2208(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Underlines the utmost importance of the safe and responsible use of nanomaterials in the short, medium and long term, as well as of the development of responsible nanotechnology which integrates health and safety considerations with production and application approaches; considers it therefore necessary to formulate adequate thresholds which are scientifically justifiable;
Amendment 9 #
2008/2208(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Draws attention to the fact that different categories of people might be at risk at different stages of the product lifecycle: in the production and handling, in packaging, transport and maintenance, disposal and demolition, secondary and end-users, and consumers; recalls that risk assessment has to be based on normal use and accidents, as well as the fact that the features are inhalation, dermal and other routes of exposure; stresses that the relevant legislation has to take into account the categories of people at risk as well as the risks related to these categories;
Amendment 10 #
2008/2208(INI)
Motion for a resolution
Recital C
Recital C
C. whereas nanomaterials are likelycontribute to be the next "big thing", especially given that manipulating all matter has been man's ultimate dream for centuriesresolution of global challenges and help the European Union in its aim to become ‘the most competitive and dynamic knowledge-based economy in the world’ (Lisbon Strategy),
Amendment 12 #
2008/2208(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Calls on the Commission and Member States to provide additional incentives to foster compliance with the regulatory framework, including by strengthening labour inspectoration bodies and other enforcement and professional agencies; also calls on Member States to ensure adequate training for health and safety specialists necessary to prevent known as well as potential exposures to nanomaterials;
Amendment 13 #
2008/2208(INI)
Draft opinion
Paragraph 10
Paragraph 10
10. Draws attention to the need for prevention and risk reduction measures to be undertaken even when the dangers of substances used are still unknown; iInvites the Bilbao Agency Risk Observatory and Member States to step up their efforts in awareness raising and exchange of good practice;
Amendment 16 #
2008/2208(INI)
Draft opinion
Paragraph 12
Paragraph 12
12. Considers that placing on the market has to take into account the free movement of products which can lead to secondary and end-use being in another country; considers therefore that requirements regarding customer information and the labelling of products have to be clarified, and invites the Member States to ensure the obligation to indicate, in the necessary languages, whether a product is nanobased so that workers are provided with transparent information and that a precautionary approach can be applied;
Amendment 18 #
2008/2208(INI)
Draft opinion
Paragraph 13
Paragraph 13
13. Furthermore points out that handling by foreign, migrant workers as another cross b, in individual cases, provisions on wordker aspect of the use of nanomaterials has to be taken into full consideration; therefore calls on Member States to ensure that employers have to guarantee translation into the necessary languages of all relevant health and safety information, including the instruction for handling, for the workers involvedprotection and safety concerning nanomaterials should be available in several languages;
Amendment 19 #
2008/2208(INI)
Draft opinion
Paragraph 14
Paragraph 14
Amendment 20 #
2008/2208(INI)
Motion for a resolution
Recital F
Recital F
F. whereas there is no clear information about the actual use of nanomaterials in consumer products, for instance: − while inventories by renowned institutions list more than 800 manufacturer-identified nanotechnology-based consumer products currently on the market, trade associations of the same manufacturers question these figures, on the basis that they are overestimations, without providing any concrete figures themselves, − while companies happily use "nano- claims", as the term “nano” seems to have a positive marketing effect, they are strictly opposed to objective labelling requirement varies from one information source to another and whereas REACH will provide a clear picture of such uses,
Amendment 21 #
2008/2208(INI)
Draft opinion
Paragraph 16
Paragraph 16
Amendment 25 #
2008/2208(INI)
Motion for a resolution
Recital H
Recital H
H. whereas there is a major controversy debate about the possibility of assessing the safety of nanomaterials: while is ongoing, and the scientific committees of the Commission point to major deficiencies not only in key data, but even and the OECD have noted that the available testing methods of obtaining such data, manyare applicable in principle; whereas this view is shared by most representatives of the industry claim that all relevant data are available and that there are no methodological deficiencies, who also observe that the necessary data for assessing the safety of commercial products are available in respect of the vast majority of the nanomaterials currently manufactured,
Amendment 40 #
2008/2208(INI)
Motion for a resolution
Recital L
Recital L
L. whereas the Commission’s overview shows that there are no nano-specific provisions in Community legislation for the time beingare not necessary, since nanomaterials are substances and since substances are sufficiently covered by legislation on chemical substances and by sector-specific legislation,
Amendment 56 #
2008/2208(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Considers it highly misleading for the Commission to state, in the absence of any nano-specific provisions in Community law, that current legislation covers in principle the relevant risks relating to nanomaterials, when due to the lack of appropriatSupports the Commission’s view that current legislation covers in principle the risks of nanomaterials; agrees that the data and methods to assess the risks arelating to nanomaterials it is effectively blind to its risk applicable in principle, and that the further adaptation of these methods must be tested by the OECD Working Party on Manufactured Nanomaterials;
Amendment 62 #
2008/2208(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Considers that as long as current legislation is devoid of any nano-specific provisions, and as long as data and even methods to assess the risks of nanomaterials are missing, betterwhile nanomaterials are adequately covered by current law and the OECD has confirmed the applicability of the testing methods, the instruments for the implementation of the current law alone cannot bring about the necessary level of protectionegislation need to be further developed;
Amendment 64 #
2008/2208(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Considers that the proposed implementation focus does not provide thenecessary steps are being taken towards the implementation of a "safe and integrated approach" to nanotechnologies as advocated by the Commission, given that numerous nanomaterials are already on the market, particularly in sensitive applications such as personal care products or cleaning products, without adequate safety;
Amendment 84 #
2008/2208(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
Amendment 100 #
2008/2208(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls for potential patent rights to be limited to specific applications or production methods of nanomaterials, and not to be extended to nanomaterials themselves, to avoid stifling innovation and to avoid creating a North-South "nano-divide"granted in accordance with existing patent law in order to ensure an appropriate level of protection for patent holders and not to discourage innovations by strict supervision of the patent criteria;
Amendment 109 #
2008/2208(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
Amendment 53 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 3 a (new)
Recital 3 a (new)
(3a) In the light of this Directive the Commission should submit every year to the European Parliament and to the Council a statistical report with reliable and accurate data on the current situation, trends and developments in counterfeiting/falsified medicines, including details of where, how and by whom the counterfeit products were detected, the country from which they came, and the ‘counterfeit’ element itself (identity, source and/or ingredient/components) in the Member States.
Amendment 73 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 7
Recital 7
(7) In order to take account of new risk profiles, while at the same time ensuring the functioning of the internal market for medicinal products, safety features designed to ensure the identification, and authentication and traceability of prescription medicinal products should be established at Community level. When introducing obligatory safety features for prescription medicinal products, due account should be taken of the particularities of certain products or categories of products, such as generic medicines. This includes the risk of falsifications in view of their price and past incidences in the Community and abroad, as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated.
Amendment 78 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 7
Recital 7
(7) In order to take account of new risk profiles, while at the same time ensuring the functioning of the internal market for medicinal products, safety features designed to ensure the identification, authentication and traceability of prescription medicinal products should be established at Community level. When introducing obligatory safety features for prescription medicinal products, due account should be taken of the particularities of certain products or categories of products, such as generic medicines and homeopathic medicines. This includes the risk of falsifications in view of their price and past incidences in the Community and abroad, as well as the consequences of falsifications for public health in view of the specific characteristics of the products concerned or of the severity of the conditions intended to be treated. No later than five years after the date of entry into force of this Directive, the Commission should submit to the European Parliament and to the Council an assessment report on the application of the safety features referred to in point (o) of Article 54 of Directive 2001/83/EC and their estimated contribution to the reduction of the number of falsified medicines in the legal supply chain in Europe. The report should include an assessment of the safety features of other categories of medicines, including medicinal products not subject to medical prescription as defined in Title VI of Directive 2001/83/EC.
Amendment 86 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) Member States, working together with stakeholders, should be free to determine the particular aspects of medicines authentication which they consider most appropriate for their medicine distribution system, taking into account the safety features adopted pursuant to this Directive.
Amendment 98 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 11 a (new)
Recital 11 a (new)
(11a) European citizens should be made aware of the risks of ordering medicinal products from illegal suppliers. In particular, awareness campaigns should be promoted at Member States and EU level. The Commission together with the Member States should adopt measures to increase awareness among the general public of the risks related to purchasing medicinal products on the internet.
Amendment 100 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 12
Recital 12
(12) Falsified active pharmaceutical ingredients pose the risk of sub-standard active pharmaceutical ingredients. This risk should be addressed. In particular, manufacturers of medicinal products should ensure either by themselves of through a body accredited for that purpos by combining an effective inspection system with a system ensuring the traceability of active pharmaceutical ingredients. In particular, manufacturers of medicinal products should themselves ensure that the supplying manufacturer of active pharmaceutical ingredients complies with good manufacturing practices.
Amendment 101 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 13
Recital 13
(13) TIn order to ensure sufficient protection of public health the manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices and should comply with the information submitted within, or supplied to, the Marketing Authorisation Application, irrespective of whether those ingredients were manufactured in the Community or imported. WTherefore, with regard to the manufacture of active pharmaceutical ingredients in third countries, it should be ensured that the rul intended for medicinal products marketed in the Union, it should be ensured through repeated, mandatory inspections and enforcement by the Union’s competent authorities for the manufacture of active pharmaceutical ingredients intended for export to the Community, including inspection and enforcement, provide for a level of protection of public health equivalent to that provided for by Community legislationby authorities with mutual recognition agreements covering active pharmaceutical ingredients in force, that manufacture is taking place in compliance with both of the above- mentioned requirements.
Amendment 102 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 13
Recital 13
(13) The manufacture of active pharmaceutical ingredients should be subject to good manufacturing practices irrespective of whether those ingredients were manufactured in the Community of imported. With regard to the manufacture of active pharmaceutical ingredients or excipients in third countries, it should be ensured that the rules for the manufacture of active pharmaceutical ingredients or excipients intended for export to the Community, including inspection and enforcement, provide for a level of protection of public health equivalent to that provided for by Community legislation.
Amendment 116 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) Member States should collaborate, including through Europol, to enforce existing restrictions on the illegal internet supply of medicines.
Amendment 120 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18a) 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 121 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
Amendment 122 #
2008/0261(COD)
Proposal for a directive – amending act
Recital 18 a (new)
Recital 18 a (new)
(18b) 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 126 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - introductory part (new)
Article 1 – point 2 a - paragraph 1 - introductory part (new)
-1) In Article 1, the following point 2a is inserted after point 2: 2a. Falsified medicinal product: Any medicinal product that has been deliberately falsified in relation to its:
Amendment 132 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point a (new)
Article 1 – point 2 a - paragraph 1 - point a (new)
(a) identity, including its packaging, labelling, name and composition in terms of both ingredients, including excipients and active ingredients, and the dosage thereof;
Amendment 143 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point b (new)
Article 1 – point 2 a - paragraph 1 - point b (new)
(b) source, including the manufacturer, the country of origin and the marketing authorisation holder;
Amendment 145 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 1 - point c (new)
Article 1 – point 2 a - paragraph 1 - point c (new)
(c) history, including the registers and documents enabling the distribution chain to be identified.
Amendment 152 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point -1 (new)
Article 1 – point -1 (new)
Directive 2001/83/EC
Article 1 – point 2 a - paragraph 2 (new)
Article 1 – point 2 a - paragraph 2 (new)
The Commission shall be empowered to update this definition on the basis of technical and scientific progress and international agreements. This definition is not related to infringements of legislation on intellectual and industrial property rights or patent rights. This definition does not include manufacturing errors.
Amendment 169 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 3 – point a
Article 1 – point 3 – point a
Directive 2001/83/EC
Article 46 – point f – subparagraph 1
Article 46 – point f – subparagraph 1
Amendment 173 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 3 – point a
Article 1 – point 3 – point a
Directive 2001/83/EC
Article 46 – point f – subparagraph 1
Article 46 – point f – subparagraph 1
(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials. To this end, the holder of the manufacturing authorization shall verify compliance of the active substances manufacturer with good manufacturing practices by himself, another holder of a manufacturing authorisation obtaining the same material from this manufacturer or through a body accredited for this purpose by the competent authority of a Member State.
Amendment 179 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 3 – point a a (new)
Article 1 – point 3 – point a a (new)
Directive 2001/83/EC
Article 46 – point f – subparagraph 2
Article 46 – point f – subparagraph 2
(aa) The second subparagraph of point (f) is replaced by the following: This point shall also be applicable to certain excipients, the list of which as well as the specific conditions of application of which shall be established by the Commission by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c. Only excipients which have been manufactured in accordance with the standards for quality control of ISO 9000/ISO 9001 should be used in medicinal products.
Amendment 180 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 3 - point a a (new)
Article 1 – point 3 - point a a (new)
Directive 2001/83/EC
Article 46 - point f - subparagraph 2
Article 46 - point f - subparagraph 2
Amendment 185 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 3 – point b a (new)
Article 1 – point 3 – point b a (new)
Directive 2001/83/EC
Article 46 – point h
Article 46 – point h
(ba) The following point (h) is added: h) In the light of this Directive the Commission shall submit to the European Parliament and to the Council a statistical report with reliable and accurate data on the current situation, trends and developments in counterfeiting/falsified medicines in the Member States on a yearly basis. That report shall clearly distinguish counterfeiting/falsified medicines from patent infringement.
Amendment 187 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 3 – point b a (new)
Article 1 – point 3 – point b a (new)
Directive 2001/83/EC
Article 46 – point h
Article 46 – point h
(ba) The following point (h) is added: (h) to assume legal liability for the accuracy of the findings of inspections and checks he has carried out or commissioned, without it being possible to delegate that liability.
Amendment 189 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 4
Article 1 – point 4
Directive 2001/83/EC
Article 46b – paragraph 2 – introductory part
Article 46b – paragraph 2 – introductory part
2. Active substances used as starting material shallmay only be imported if:
Amendment 190 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 4
Article 1 – point 4
Directive 2001/83/EC
Article 46b – paragraph 2 – point b
Article 46b – paragraph 2 – point b
(b) they are accompanied by a written confirmation from the exporting third country that the standards of good manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to those laid down by the Community, and that the planthave, in the past three years, successfully passed an inspection specifically covering active pharmaceutical ingredients carried out by a competent Community authority or an authority of a country with which a mutual recognition agreement is in force. The passing of the inspection shall be documented by a certificate is subject to control and enforcement ensuring that thoseed by a competent authority, attesting compliance with good manufacturing practices cannot be circumvented.
Amendment 207 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2001/83/EC
Article 54 - point o
Article 54 - point o
‘(o) safety features making it possible to ascertain identification, and authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI.’
Amendment 209 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2001/83/EC
Article 54 - point o
Article 54 - point o
(o) safety features making it possible to ascertain identification, authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI, where the Commission decides that there is a risk that a medicinal product will be counterfeited due to the price or past incidences.
Amendment 213 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2001/83/EC
Article 54 - point o
Article 54 - point o
(o) safety features making it possible to ascertain identification, authenticity and traceability of medicinal products, other than radiopharmaceuticals, subject to medical prescription as defined in Title VI. Homeopathic medicinal products are exempt in accordance with Article 1(5). Where a medicinal product, such as a homeopathic medicinal product, is not subject to medical prescription, the safety features may be applied on a voluntary basis.
Amendment 230 #
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 traceabil and authenticity of the medicinal product, and without opening the immediate packaging as defined in Article 1(23);
Amendment 234 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 – point b - subparagraph 1 a (new)
Article 54a – paragraph 2 – point b - subparagraph 1 a (new)
Safety features shall be considered equivalent where they are equally efficient in identifying, authenticating, tracing and preventing tampering with medicinal product, and where they are equally technical difficult to duplicate. This paragraph shall also apply to the removal, replacement or covering up of new safety features unless the primary safety feature is a covert one and cannot be recognised.
Amendment 241 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 2 - point c a (new)
Article 54a – paragraph 2 - point c a (new)
(c a) The safety features referred to in point (o) of Article 54 shall be applied without discrimination between distribution channels.
Amendment 247 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 1
Article 54a – paragraph 4 – subparagraph 1
Amendment 280 #
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 ofat least all of the following: (a) the cost-effectiveness of the system, in order to guarantee that any measure that is applied is based on a cost-benefit analysis; (b) the proportional application of costs related to the measures to all participants in the supply chain and the linking of those costs to the price of the medicinal product concerned; (c) the independence of the system and the legitimate interests to protect information of a commercially confidential nature and of the protection of industrial and commercial property rights and personal data.
Amendment 283 #
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 provided and the corresponding patients or pharmacies.’
Amendment 313 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 13 – point a a (new)
Article 1 – point 13 – point a a (new)
Directive 2001/83/EC
Article 80 – point g
Article 80 – point g
(aa) Point (g) is replaced by the following: '(g) they must comply with the principles and guidelines of good distribution, trading and brokering practice for medicinal products as laid down in Article 84.'
Amendment 319 #
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 a marketing authorisation or trademark shall inform other supply chain operators in case where counterfeit products are suspected of having infiltrated the legal supply chain.'
Amendment 341 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 14 e (new)
Article 1 – point 14 e (new)
Directive 2001/83/EC
Article 88a a (new)
Article 88a a (new)
(14e) The following Article 88a a is inserted: 'Article 88aa Member States with the collaboration of the Commission and following consultation with stakeholders should develop an information strategy regarding the reliability of medicinal products suppliers. The strategy shall take into account the different national legislation regulating the supply of medicinal products as well as the risks of certain ways of supplying medicines, such as through illegal internet traders.
Amendment 342 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 15 – point -a (new)
Article 1 – point 15 – point -a (new)
Directive 2001/83/EC
Article 111 – paragraph 1
Article 111 – paragraph 1
(-a) Paragraph 1 is replaced by the following: '1. The competent authorities of the Member State concerned shall, under the Agency's coordination, ensure by means of repeated, and where necessary unannounced, inspections, that the legal requirements governing medicinal products are complied with, and shall, where appropriate, commission an official medicinal product test laboratory, or another laboratory designated for that purpose, to carry out sampling tests. Such inspections shall be carried out by officials representing the competent authority who shall be empowered to: (a) inspect manufacturing or commercial establishments and any laboratories entrusted by the holder of the manufacturing authorization with the task of carrying out checks pursuant to Article 20; (b) take samples; (c) examine any documents which relate to the object of the inspection, subject to the provisions in force in the Member States on 21 May 1975, and which place restrictions on these powers with regard to the descriptions of the method of preparation.'
Amendment 343 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 15 – point a a (new)
Article 1 – point 15 – point a a (new)
Directive 2001/83/EC
Article 111 – paragraph 1 – subparagraph 2
Article 111 – paragraph 1 – subparagraph 2
(aa) In Article 111(1), subparagraph 2 is replaced by the following: '2. The competent authorities shall carry out repeated, and where necessary unannounced, inspections of the premises of producers, distributors or importers of active ingredients used as starting materials, the premises of manufacturing authorisation holders, the premises of medicinal product traders and brokers or the premises of excipient producers, importers and distributors where there are sound grounds for suspecting, on the basis of information available to the authorities or of previous cases, that legal obligations or the guidelines are not being complied with. Such inspections may also be carried out at the request of a Member State, the Commission or the Agency.'
Amendment 352 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111a
Article 111a
The Commission shall adopt detailed guidelines laying down the principles for inspections referred to in Article 111 and, in particular, the Union or national bodies responsible for carrying out inspections.
Amendment 354 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111b – paragraph 1 – introductory part
Article 111b – paragraph 1 – introductory part
1. The Commission shall, following a request from a third country and the satisfactory conclusion of the inspection by the body responsible pursuant to Article 111a, list that country by way of a Decision if its regulatory framework for active substances exported to the Community and the respective control and enforcement ensure a protection of public health equivalent to that in the Community. Particular account shall be taken of:
Amendment 357 #
2008/0261(COD)
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111b – paragraph 3
Article 111b – paragraph 3
3. The Commission, in cooperation with the Agency and competent authorities of the Member States, shall verify regularly whether the conditions set out in paragraph 1 are fulfilled. The first verification shall take place no later than 3 years after the country has been listed in accordance with paragraph 1be conducted with a view to confirming compliance with the criteria set out in paragraph 1 and shall be followed by regular verifications at intervals of no less than 3 years.
Amendment 373 #
2008/0261(COD)
Proposal for a directive – amending act
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2a. Nothing in this Directive shall affect the right of Member States to restrict or prohibit the sale of prescription medicines through the internet.
Amendment 28 #
2008/0260(COD)
Proposal for a directive – amending act
Recital 5
Recital 5
(5) For the sake of clarity, the definition of adverse reaction should be amended to ensure that it not only covers noxious and unintended effects derived not only from the authorised use of a medicinal product at the normal doses, but also from medication errors and uses outside the authorised summary of the product characteristics, including the misuse and abuse of the product.
Amendment 41 #
2008/0260(COD)
Proposal for a directive – amending act
Recital 9
Recital 9
(9) Where a medicinal product is authorized subject to the requirement to conduct a post-authorisation safety study or where there are conditions or restrictions with regard to the safe and effective use of the medicinal product, the medicinal product should be intensively monitored on the market. It is essential that a strengthened system of pharmacovigilance does not lead to the premature granting of market authorisations. Patients and healthcare professionals should be encouraged to report all suspect adverse reactions to such medicinal products, and a publicly available list of such medicinal products should be maintained up to date by the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency12 (hereinafter referred to as the ‘Agency’).
Amendment 43 #
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 medicines they use, the summary of the product characteristics and the package leaflet should include, for all medicinal products except those referred to in Articles 10, 10a and 10c, 14, 16 and 16a of Directive 2001/83/EC, a concise section on the key information about the medicinal product and information how to minimize its risks and maximize its benefits.
Amendment 48 #
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 64 #
2008/0260(COD)
Proposal for a directive – amending act
Recitals 20 a (new)
Recitals 20 a (new)
(20a) Reporting through health professionals should be especially encouraged in cases where their input could be essential to understand the significance of the adverse reaction, and in such cases adverse reaction linked to medication errors. In order to facilitate this reporting, health professionals’ access to medication data contained in the patient health record should be facilitated.
Amendment 73 #
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 76 #
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
(11) Adverse reaction: A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in the human body for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.
Amendment 79 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 1 – point a a (new)
Article 1 – point 1 – point a a (new)
Directive 2001/83/EC
Article 1 – point 11 a (new)
Article 1 – point 11 a (new)
(aa) The following point is inserted: “11a. Medication error: A response that is not an adverse reaction but that is due to errors and uses of a medicinal product outside the authorised summary of product characteristics, including the misuse and abuse of the product.”
Amendment 83 #
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 105 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 3 – point a
Article 1 – point 3 – point a
Directive 2001/83/EC
Article 11 – paragraph 1 – point 3a
Article 11 – paragraph 1 – point 3a
“(3a) for all medicinal products, except for those referred to in Articles 10, 10a and 10c, 14, 16 and 16a, a summary of the essential information necessary to use the medicine safely and effectively.”
Amendment 148 #
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 medicine safely and effectively; except for the medicinal products referred to in Articles 10, 10a and 10c, 14, 16 and 16a.”
Amendment 150 #
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 155 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 18 – point b
Article 1 – point 18 – point b
Directive 2001/83/EC
Article 59 – paragraph 1 – subparagraph 2
Article 59 – paragraph 1 – subparagraph 2
“The information referred to in point (aa) of the first subparagraph shall be presented in a box surrounded by a black border. form that is clearly legible, prominent and clearly distinguishable from the rest of the text. Any new or amended text shall for a period of 1-year be presented in bold text and preceded by the following symbol and text “New information”.
Amendment 167 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 20 a (new)
Article 1 – point 20 a (new)
Directive 2001/83/EC
Article 86 – paragraph 2
Article 86 – paragraph 2
20a. The first indent of Article 86(2) is amended as follows: “– the labelling and the accompanying package leaflets, which are subject to the provisions of Title V, and the summary of the product characteristics, insofar as they are made available to the public independently of the delivery of the medicinal product in unchanged wording and without additional promotional elements,”
Amendment 169 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 101 – paragraph 3
Article 101 – paragraph 3
3. Each Member State shall designate aone or more competent authorityies for the conduct of pharmacovigilance tasks.
Amendment 197 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 104 – paragraph 2 – subparagraph 2
Article 104 – paragraph 2 – subparagraph 2
The marketing authorisation holder shall be required to perform a regular audit of his pharmacovigilance system. He shall place a note concerning the main findings of the audit on the pharmacovigilance system master file and, based on the audit findings, ensure that an appropriate corrective action plan is prepared and followed.
Amendment 216 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 106 – point 3
Article 106 – point 3
(3) web-based structured forms for the reporting of suspected adverse reactions by healthcare professionals, if applicable, and patients based on the forms referred to in Article 25 of Regulation (EC) No 726/2004.
Amendment 223 #
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 231 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107a – paragraph 1 – subparagraph 1
Article 107a – paragraph 1 – subparagraph 1
The Member States shall record all suspected adverse reactions that occur in their territory which are brought to their attention from healthcare professionals and patients. . Concerning suspected adverse reactions reported by patients, Member States may decide whether those are reported directly or via health care professionals.
Amendment 235 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107a – paragraph 1 – subparagraph 2
Article 107a – 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 238 #
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 246 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107b – paragraph 3 – introduction
Article 107b – paragraph 3 – introduction
3. By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c and 16, and holders of registrations for medicinal products referred to in Articles 14 or 16a, shall be required to submit periodic safety update reports for such products only in the following cases:
Amendment 247 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107b – paragraph 3 – introduction
Article 107b – paragraph 3 – introduction
3. By way of derogation from paragraph 1 of this Article, holders of marketing authorisations for medicinal products referred to in Articles 10, 10a or 10c, and holders of marketing authorisations for products containing active substances fulfilling the criteria of the concept of well-established medicinal use mentioned in Annex I, Part II, Point 1 (a) of this Directive, and holders of registrations for medicinal products referred to in Articles 146 or 16a, shall be required to submit periodic safety update reports for such products only in the following cases:
Amendment 248 #
2008/0260(COD)
Proposal for a directive – amending act
Article 1 – point 21
Article 1 – point 21
Directive 2001/83/EC
Article 107c – paragraph 2 – subparagraph 1
Article 107c – paragraph 2 – subparagraph 1
2. Holders of marketing authorisations which were granted before [insert concrete date - date set out in the second subparagraph of Article 3(1)], and for which the frequency and dates of submission of the periodic safety update reports are not laid down as a condition to the marketing authorisation, shall submit the periodic safety update reports in accordance with the second subparagraph of this paragraph until another frequency or other dates of submission of the reports are laid down in the marketing authorisation or determined in accordance with paragraphs 3, 4, 5 or 6. This obligation does not cover products referred to in Art. 107b(3) unless the conditions set out in points (a) and (b) of Article 107b(3) apply.
Amendment 82 #
2008/0257(COD)
Proposal for a regulation – amending act
Article 1 – point 18 a (new)
Article 1 – point 18 a (new)
Regulation EC/726/2004
Article 80a (new)
Article 80a (new)
(18a) The following Article is inserted: Article 80a Holders of marketing authorisations may appeal against assessment reports or opinions by the Committee mentioned in point (aa) of Article 56(1) of this Regulation in order to review its decisions by an Agency body independent from the Agency’s Committees. The appropriate measures and procedures shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 87(2a) of this Regulation.
Amendment 33 #
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 dissemination of information from the marketing authorisation holder to the general public, the Directive only provides that certain information activities are not covered by the rules on advertising, without providing for a harmonised frameworkThese rules should be improved and better enforced in order to allow for improvements onf the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be disseminatedreadability of these documents.
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 45 #
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 productsrelevant, independent, and comparative health information and to protect patients from misleading or biased information.
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 60 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c a (new)
Article 100 c a (new)
Article 100ca 1. Member States shall ensure that the mandatory information as referred to in Article 100b(1) shall be made available through national health Internet websites in the official language(s) of the Member State where the website is registered. Such websites shall be monitored by a competent authority of the Member State or by a body assigned by the competent authority in accordance with Article 100g. The websites shall be administered and managed in cooperation with stakeholders such as health care professionals and patient organisations. 2. The information shall communicate both benefits and risks in a clear descriptive manner that is patient friendly and linked to the national medicinal products safety website. The Internet websites shall provide patients with the mandatory information on all available medicinal products in that Member State both centrally approved by the European Medicines Agency and locally approved in that Member State. 3. The Internet websites should also include general information about medicinal and non-medicinal treatment of various diseases, including rare diseases, in order to promote a high level of public health. They may also contain other information as referred to in Article 100b(2) and as defined by the Commission’s guidelines concerning information allowed.
Amendment 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 72 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 12
Recital 12
(12) Information to the general public on prescription-only medicinal products that has been approved by the competent authorities should only be provided through specific channels of communication, including Internet and health-related publications, by the marketing authority holder to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public. Where information is disseminated via television or radioby the marketing authority holder via television, radio or newspapers, magazines and similar publications, patients are not protected against such unsolicited information and such disseminsupply of information should therefore not be allowed.
Amendment 74 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 12 a (new)
Recital 12 a (new)
(12 a) The internet is a major source of information for a growing number of patients. This trend is likely increase in the coming years. In order to adapt to this development and to add to the growing importance of e-health, information on medicinal products should also be made available via independent national health internet websites. These websites should be monitored by competent authorities in the Member States. Member States in co- operation with stakeholders such as health care professionals or patient organisations should be responsible for managing these websites.
Amendment 75 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 14
Recital 14
(14) Monitoring of information on prescription-only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with Directive 2001/83/EC. Member States should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non-compliance. Monitoring should be based on the control of information prior to its dissemination, unless the substance of thesupply. Only such information thas already been agreedt has been approved in advance by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoringshould be provided, and it should be provided in the approved form only.
Amendment 88 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 1a (new)
Article 86 – paragraph 2 – indent 1a (new)
– correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
Amendment 95 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 4
Article 86 – paragraph 2 – indent 4
- information by the marketing authorisation holderon medicinal products that has been approved by the competent authorities in the Member States and that has been made available to the general public oin medicinal productapproved form by the marketing authorisation holder and that is subject to medical prescription, which is subject to the provisions of Title VIIIa.
Amendment 100 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 1 a (new)
Article 1 – point 1 a (new)
Directive 2001/83/EC
Article 86 – paragraph 2 a (new)
Article 86 – paragraph 2 a (new)
(1a) In Article 86, the following paragraph shall be inserted: “(2a) When exemption to advertising referred to in paragraph are made available, the marketing authorisation holder and any third party acting on behalf of the marketing authorisation holder shall be identified as such.”
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 111 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 - a (new), to be inserted before Article 100a
Article 100 - a (new), to be inserted before Article 100a
Article 100 -a Member States and the European Commission shall support independent information on medical products to the general public. To this end the Member States shall present a national program on information to patients following consultation with stakeholders such as health care professionals and patient organisations. Information shall be presented in electronic as well as in printed form. The Commission shall provide assistance and organise the exchange of best practice. Member States and the Commission shall grant financial support to independent drug information centres, encourage the development of independent, continuing education programmes for health professionals and the development of their critical appraisal skills.
Amendment 112 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 - a a (new), to be inserted before Article 100a
Article 100 - a a (new), to be inserted before Article 100a
Amendment 116 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a - paragraph 1
Article 100 a - paragraph 1
1. Member States shall allow the marketing authorisation holder to disseminatmake available, either directly or indirectly through a third party, information that is acting in the name of the marketing authorization holder, information that has been approved by the competent authorities to the general public or members thereof on authorised medicinal products subject to medical prescription provided that ithis information and the way it is supplied is in accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIII. When such information is made available, the marketing authorisation holder and any third party shall be identified, and any third party that acts on behalf of the marketing authorisation holder shall be clearly identified as such.
Amendment 145 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point b
Article 100 b – point b
b) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different way; way that is comprehensible to the general public or member thereof without jeopardising the quality or reliability of the information;
Amendment 154 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point c
Article 100 b – point c
c) information on the environmental impact of the medicinal product, prices and factual, informative announcements and reference material relating, for example, to pack changes or adverse-reaction warnings, interactions and contraindications;
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 169 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – introductory part
Article 100 c – introductory part
Information on authorised medicinal products subject to medical prescription disseminatedmade available by the marketing authorisation holder to the general public or members thereof shall not be made available on television, web TV, video broadcast materials, newspapers, magazines and similar productions or radio. It 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 183 #
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' own 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 192 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5 – introductory part
Article 1 – point 5 – introductory part
Directive 2001/83/EC
Article 100 d – paragraph 2 – introductory part
Article 100 d – paragraph 2 – introductory part
2. Any informationfactual, informative announcements on authorised medicinal products subject to medical prescription referred to in Article 86(2) disseminated by the marketing authorisation holder to the general public shall include:
Amendment 207 #
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 3 – point a
Article 100 d– paragraph 3 – point a
Amendment 220 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 e – paragraph 1 b (new)
Article 100 e – paragraph 1 b (new)
Amendment 223 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 e – Paragraph 1 b (new)
Article 100 e – Paragraph 1 b (new)
1b. The summary of the European Public Assessment Reports referred to in Article 13 of Regulation (EC) No 726/2004 shall list the other available therapeutic options and whether the new medicinal product brings about a tangible therapeutic advantage.
Amendment 225 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 e – paragraph 1 c (new)
Article 100 e – paragraph 1 c (new)
1c. The summary of the European Public Assessment Reports referred to in Article 13 of Regulation (EC) No 726/2004 shall be hyperlinked with the corresponding studies in the clinical trials database provided for in Article 11 of Directive 2001/20/EC (hereinafter ‘the EudraCT database’).
Amendment 230 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 f – paragraph 1
Article 100 f – paragraph 1
1. Member States shall, without creating a disproportionate burden for the marketing authorisation holder, ensure that marketing authorisation holders make information provided in accordance with this Title accessible to persons with disabilities.
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 238 #
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 2 – indent 2
Article 100 g – paragraph 1 – subparagraph 2 – indent 2
- an equivalent level of adequate, industry- independent and effective monitoring is ensured through a different mechanism.
Amendment 239 #
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 3
Article 100 g – paragraph 1 – subparagraph 3
Amendment 244 #
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 2
Article 100 g – paragraph 2
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 255 #
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 2 a (new)
Article 100 h – paragraph 1 – subparagraph 2 a (new)
After registration of the Internet website, any amendments to the content relating to medicinal products subject to medical prescription shall be subject to monitoring in accordance with paragraph 3.
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 265 #
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 or the appearance therein of unsolicited material actively distributed to the general public or members thereof. Those websites shall not contain web-TV or video broadcast materials.
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 270 #
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 3
Article 100 h – paragraph 3
3. The Member State where the Internet website has been registered shall be responsible for the monitoring of the contents disseminated on thatmarketing authorisation holder shall send the new contents and changes to the competent authorities of the Member State where the Internet website has been registered for prior approval before making available the new contents or changes on its website.
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 276 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Amendment 278 #
2008/0256(COD)
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 5
Article 100 h – paragraph 5
5. Member States shall allowrequire marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this Directivemessage at the top of each website page informing the public that information contained therein is developed by the marketing authorisation holder and is therefore subject to monitoring in order to avoid advertising of prescription medicines. The statement shall identify the national competent authority monitoring the website concerned. It shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval. and shall include a link to the EudraPharm database specifying that validated information is available there.
Amendment 279 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 5
Article 100 h – paragraph 5
5. Member States shall allow marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this Directive. The statement shall identify the national competent authority monitoring the website concerned. It shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval.
Amendment 288 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 j – point a
Article 100 j – point a
a) keep available for the competent authorities or bodies responsible for monitoring information on medicinal products that have approved the information in advance, a sample of all information disseminatedmade available in accordance with this Title and information on its volume of disseminatprovision, together with a statement indicating the persons to whom it is addressed, the method of disseminatprovision and the date of first disseminatprovision,
Amendment 295 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 l
Article 100 l
By [insert specific date five years from the entry into force of amending directive] at the latest, the Commission shall publish a report on the experience acquired in the implementation of this Title after consulting the patient organisations and the members of health care professions and shall also assess the need for a review thereof. The Commission shall submit this report to the European Parliament and to the Council.
Amendment 299 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 l c (new)
Article 100 l c (new)
Amendment 111 #
2008/0247(COD)
Council position
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2a. In defining rail freight corridors the infrastructure managers involved must be allowed the greatest possible flexibility in the actual routing.
Amendment 123 #
2008/0247(COD)
Council position
Article 7 – paragraph 6
Article 7 – paragraph 6
6. The management board shall set up an advisory group made up of managers and owners of the terminals of the freight corridor, including sea and inland waterway ports, as well as railway undertakings, including rail freight and passenger operators, shippers, forwarders and/or their representative bodies The management board shall inform the advisory group regularly and in due time about all matters which affect them and the timeframe for dealing with them in the management board and the executive board. This advisory group mayshall issue an opinion on any proposal by the management board which has direct consequences for investment and the management of terminalts members. The advisory group may also issue own-initiative opinions. The management board shall take anyll of these opinions into account. The final decision, however, shall be taken by the management board. The management board shall provide the advisory group with reasons for any decision which differs from the opinion of the advisory group. In the event of disagreement between the management board and the advisory group, the latter may refer the matter to the executive board. The executive board shall act as an intermediary and provide its opinion in due time.
Amendment 136 #
2008/0247(COD)
Council position
Article 12 - paragraph 1
Article 12 - paragraph 1
1. The management board forshall require each national infrastructure manager involved in a freight corridor shallto designate or establish a joint body and/or an information system through collaboration between infrastructure managers offering applicants the opportunity to request, in a single place and a single operation, infrastructure capacity for freight trains crossing at least one border along the freight corridor (the "one-stop shop")one-stop shop for receiving and replying to requests for train paths for freight trains crossing at least one border along the corridor (international train path). The infrastructure managers involved in the freight corridor shall provide, in accordance with the provisions of this regulation concerning the use of IT applications, the necessary information in order to deal with international train path requests.
Amendment 156 #
2008/0247(COD)
Council position
Article 18 - paragraph 1
Article 18 - paragraph 1
(1) The regulatory bodies referred to in Article 30 of Directive 2001/14/EC shall cooperate in monitoring the competition in the rail freight corridor. In particular, they shall ensure non-discriminatory access to the corridor and shall be the appeal bodies provided under Article 30(2) of that Directive. They shall exchange the necessary information obtained from infrastructure managers and oThey shall exchange the necessary information obtained from infrastructure managers and other relevant parties. They shall cooperate in order to support the establishment of a comparable regulatory level in their relevant partiesMember State.
Amendment 159 #
2008/0247(COD)
Council position
Article 18 - paragraph 1 a (new)
Article 18 - paragraph 1 a (new)
1a. The regulatory bodies referred to in Article 30 of Directive 2001/14/EC shall ensure non-discriminatory access to the corridor and shall be the appeal bodies provided under Article 30(2) of Directive 2001/14/EC. In order to foster free and fair competition along the corridor, a comparable regulatory level shall be established throughout Europe.
Amendment 141 #
2008/0241(COD)
Proposal for a directive
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
Amendment 217 #
2008/0241(COD)
Proposal for a directive
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
1a. In order to enhance the user's awareness, Member States shall ensure that distributors - excluding SMEs - put in place appropriate collection and awareness schemes for very small volume waste. Such collection schemes: (a) shall enable end-users to discard this kind of waste at an accessible and visible collection point in the retailer’s shop; (b) shall require retailers to take back waste very small volume EEE at no charge when supplying very small volume EEE; (c) shall not involve any charge to end- users when discarding this waste, nor any obligation to buy a new product of the same type;
Amendment 88 #
2008/0240(COD)
Proposal for a directive
Recital 12
Recital 12
(12) As soon as scientific evidence is available and taking into account the precautionary principle, the prohibition of other hazardous substances and their substitution by more environmentally friendly alternatives which ensure at least the same level of protection of consumers should be examined, paying. This examination should include a full impact assessment with consultation of relevant stakeholders. The examination should also pay attention to coherency with other Community legislation, and in particular to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Specific account should be taken of the potential impact on SMEs.
Amendment 108 #
2008/0240(COD)
Proposal for a directive
Article 2 - paragraph 1
Article 2 - paragraph 1
1. This Directive shall apply to electrical and electronic equipment, including electrical cables, falling under the categories set out in Annex I as specified in Annex II.
Amendment 137 #
2008/0240(COD)
Proposal for a directive
Article 2 - paragraph 3- point c a (new)
Article 2 - paragraph 3- point c a (new)
(ca) equipment which is manufactured in the Community or imported for the purposes of research and development.
Amendment 156 #
2008/0240(COD)
Proposal for a directive
Article 3 - point l
Article 3 - point l
l) "homogeneous material" means either: - a material of uniform composition throughoutthat consists of only one material throughout - a combination of multiple materials that cannot be mechanically disjointed into different materials, meaning that the materials cannot, in principle be separated by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes excluding surface coatings, or - a surface coating, or - small components or materials of equal to or less than 4 mm³ in size
Amendment 157 #
2008/0240(COD)
Proposal for a directive
Article 3 - point l a (new)
Article 3 - point l a (new)
(la) "mechanically disjointed" means materials can, in principle be separated by mechanical actions, such as unscrewing, cutting, crushing, grinding and abrasive processes
Amendment 230 #
2008/0240(COD)
Proposal for a directive
Article 5 - paragraph 2
Article 5 - paragraph 2
2. Measures adopted in accordance with point b of paragraph 1 shall have a maximum validity period of up to four years and may be renewed. The Commission shall decide in due time on any. Based on the facts presented in the application, a longer exemption period may be exceptionally granted, on a case-by-case basis. No later than 9 months after the application has been submitted, the Commission shall decide on an application for an exemption or for the renewal of an exemption. An application for renewal tshat isll be submitted no later than 18 months before an exemption expires. Where the Commission rejects an application for renewal, it shall grant a grace period for the placing on the market of the equipment, except in cases where continued placing on the market would constitute an unacceptable risk to human health or the environment. The grace period shall not exceed 6 months for the placing on the market and an additional 18 months for the putting into service of the equipment concerned.
Amendment 240 #
2008/0240(COD)
Proposal for a directive
Article 5 - paragraph 3
Article 5 - paragraph 3
3. Before Annexes are amended, the Commission shall inter aliamake an impact assessment. It shall also consult producers of electrical and electronic equipment, recyclers, treatment operators, environmental organisations and employee and consumer associations.
Amendment 243 #
2008/0240(COD)
Proposal for a directive
Article 5 - paragraph 4
Article 5 - paragraph 4
4. As long as materials or components are included in Annexes V and VI to this Directive, on the basis of Article 5(1)(b) of this Directive, those applications shall also be considered exempted from the authorisation requirements set out in Article 58(2) of the regulation (EC) No 1907/2006 for the validity period of the exemption granted under this Directive. As long as the use of a substance is authorised in accordance with Regulation (EC) No 1907/2006, those applications shall also be considered exempted from the requirements relating to applications for an exemption set out in this Directive, for the validity period of the authorisation granted under Regulation (EC) No 1907/2006.
Amendment 66 #
2008/0238(COD)
Proposal for a directive
Recital 6
Recital 6
(6) There is therefore a need, while duly respecting the subsidiarity principle pursuant to Article 168(7) TFEU (formerly Article 152(5) TEC), for common quality and safety standards for the procurement, transport and use of human organs at Community level. These standards would facilitate exchanges of organs to the benefit of thousands of European patients in need of this type of therapy each year. Community legislation should ensure that human organs comply with acceptablerecognised standards of quality and safety. Therefore such standards will help to reassure the public that human organs procured in another Member State nonetheless carry the same basic quality and safety guarantees as those obtained in their own country.
Amendment 68 #
2008/0238(COD)
Proposal for a directive
Recital 7
Recital 7
Amendment 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 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 138 #
2008/0238(COD)
Proposal for a directive
Article 8 – paragraph 1 – point b – indent 1
Article 8 – paragraph 1 – point b – indent 1
– identification of the procurement organisation and the donor's hospital, including its address and telephone number;
Amendment 143 #
2008/0238(COD)
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Competent authority shall indicate in the accreditation, designation, authorisation or licence which activities the transplantation centre concerned may undertake.
Amendment 154 #
2008/0238(COD)
Proposal for a directive
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Member States shall prohibit advertising the need for or,the offering or making availabilityle of, human organs where such advertising hasith a view to offering or seeking financial gain or comparable advantage.
Amendment 155 #
2008/0238(COD)
Proposal for a directive
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Member States shall ensure that the procurement of organs is carried out on a non-profit basisnot commercialised.
Amendment 162 #
2008/0238(COD)
Proposal for a directive
Article 15 – paragraph 2
Article 15 – paragraph 2
2. Member States shall ensure that living donors are selected on the basis of their health and medical history, including a psychological evaluation if deemed necessary, by qualified and trained professionals. Such assessments may provide for the exclusion of persons whose donation could present a health risk to others, such as the possibility of transmitting diseases, or a serious risk to themselves. Member States shall also ensure that living donors are legally insured.
Amendment 171 #
2008/0238(COD)
Proposal for a directive
Article 17 – title
Article 17 – title
Amendment 175 #
2008/0238(COD)
Proposal for a directive
Article 17
Article 17
Member States shall take all necessary measures to ensure that all personal data of donors and recipients processedgathered and processed in connection within the scopeimplementation of this Directive in the organ donation process are rendered anpseudonymous so that neitherin order to protect donors norand recipients remainfrom identifiablecation by unauthorised third parties.
Amendment 176 #
2008/0238(COD)
Proposal for a directive
Article 18 – title
Article 18 – title
Designation and tasks of the competent authoritiesbody or bodies, organisation(s) or institution(s)
Amendment 178 #
2008/0238(COD)
Proposal for a directive
Article 18 – paragraph 1
Article 18 – paragraph 1
Member States shall designate the competent authority, or authorities (hereafter competent authority),public or private, non-profit making body or bodies/organisation(s)/institution(s) particularly involved in the implementation of these provisions responsible for implementing the requirements of this Directive.
Amendment 180 #
2008/0238(COD)
Proposal for a directive
Article 18 – paragraph 2 – introductory part
Article 18 – paragraph 2 – introductory part
The competent authoritiesy or institution(s) shall, in particular, take the following measures:
Amendment 186 #
2008/0238(COD)
Proposal for a directive
Article 19 – paragraph 1 – introductory part
Article 19 – paragraph 1 – introductory part
1. Member States shall ensure that the competent authoritybody or bodies, organisation(s) or institution(s):
Amendment 187 #
2008/0238(COD)
Proposal for a directive
Article 19 – paragraph 1 – point c
Article 19 – paragraph 1 – point c
(c) establishes and maintains a register of procurementhealth care establishments, teams or departments of a hospital org anisatioother establishment authorised to procure human organs and transplantation centres.
Amendment 188 #
2008/0238(COD)
Proposal for a directive
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Member States shall, upon the request of the Commission or another Member State, provide information on the register of procurementhealth care establishments, teams or departments of a hospital org anisatioother establishment authorised to procure human organs and transplantation centres.
Amendment 189 #
2008/0238(COD)
Proposal for a directive
Article 20 – paragraph 1
Article 20 – paragraph 1
1. The Commission shall set up a network of the competent authoritiesbody (bodies), organisation(s) or institution(s) with a view to exchanging information on the experience acquired with regard to the implementation of this Directive.
Amendment 196 #
2008/0238(COD)
Proposal for a directive
Article 25 – paragraph 1 – point a
Article 25 – paragraph 1 – point a
(a) rules for the updating and transmission of information on human organs and donor characterisation as detailed in the Annex;
Amendment 197 #
2008/0238(COD)
Proposal for a directive
Article 25 – paragraph 1 – point c
Article 25 – paragraph 1 – point c
(c) procedures for ensuring the reporting of unexpected serious adverse events and reactions.
Amendment 198 #
2008/0238(COD)
Proposal for a directive
Article 25 – paragraph 2 – point a
Article 25 – paragraph 2 – point a
(a) the interconnection between the reporting systems on unexpected adverse events and reactions referred to in Article 11 (3);
Amendment 199 #
2008/0238(COD)
Proposal for a directive
Article 25 – paragraph 2 – point b
Article 25 – paragraph 2 – point b
(b) the establishment and ability to functioning of the network of the competent authorities referred to in Article 20.
Amendment 203 #
2008/0238(COD)
Proposal for a directive
Annex – Introduction
Annex – Introduction
For the purpose of Article 7 the following information shall be gathered by the procurement organisation or procurement team on the characteristics of the organ and of the donor, following testing where necessarybearing in mind the individual circumstances, and processed in line with the legal requirements on the protection of personal data and confidentiality. In the absence of data, a decision shall be taken about the transplant after individual risk assessment of the donor and the recipient:
Amendment 75 #
2008/0237(COD)
Council position – amending act
Article 3 - point r
Article 3 - point r
(r) "cancellation" means the non-operation of a regular service which was previously scheduled for which at least one reservation within the meaning of Article 2(n) has been made;
Amendment 81 #
2008/0237(COD)
Council position – amending act
Article 10 - paragraph 3
Article 10 - paragraph 3
(3) If a disabled person or a person with reduced mobility, who holds a reservation or has a ticket and has complied with the requirements of Article 14(1)(a), is nonetheless refused permission to board on the grounds of his disability or reduced mobility, that person and any accompanying person pursuant to paragraph 4 of this Article shall be offered the choice between: (a) the right to reimbursement, and where relevant a return service free of charge to the first point of departure, as set out in the transport contract, at the earliest opportunity; (b) e. Except where not feasible, continuation ofthe bus and/or coach undertaking shall provide information about the possibilities for continuing the journey or re-routing by reasonable alternative transport services to the place of destination set out in the transport contract.
Amendment 91 #
2008/0237(COD)
Council position – amending act
Article 19 - paragraph 1
Article 19 - paragraph 1
(1) Where a carrier reasonably expects a regular service to be cancelled or delayed in departure from a terminal for more than 120 minutes, the passenger shall immediately be offered the choice between: (a) except where not feasible, continuation or re-routing to the final destination, under comparable conditions, as set out in the transport contract, at the earliest opportunity; (b) failing that, reimbursement of the ticket price, and, where relevant, a return service by bus or coach free of charge to the first point of departure, as set out in the transport contract, at the earliest opportunity.
Amendment 93 #
2008/0237(COD)
Council position – amending act
Article 19 - paragraph 2
Article 19 - paragraph 2
(2) Where aIf the cancellation or delay is the regsular service it of: (a) circumstances not connected with the operation of bus and coach transport services and which the bus cancelled or delayd/or coach undertaking could not have avoided, in departure from a bus stop for more than 120 minutes, passengers shall have the right to such continuation or re- routing orspite of having taken the care required in the particular circumstances of the case, and the consequences of which it was unable to prevent; (b) passenger negligence; or (c) the actions of a third party which the bus and/or coach undertaking could not have avoided, in spite of having taken the care required in the particular circumstances of the case, and the consequences of which it was unable to prevent passengers shall have the right only to reimbursement of the ticket price from the carrier. .
Amendment 5 #
2008/0225(COD)
Proposal for a regulation – amending act
Recital 5
Recital 5
(5) To ensure the adequate funding of these activities related to informationthe monitoring of the marketing authorisation holder's communications to the public, provision should be made for the collection of fees charged to marketing authorisation holders by the Agency.
Amendment 7 #
2008/0225(COD)
Proposal for a regulation – amending act
Article 1 – point -1 a (new)
Article 1 – point -1 a (new)
Regulation (EC) No 726/2004
Article 9 – paragraph 4 – point a
Article 9 – paragraph 4 – point a
(-1a) In Article 9(4), point (a) shall be replaced by the following: "(a) a draft of the summary of product characteristics, as referred to in Article 11 of Directive 2001/83/EC. It shall list other therapeutic options available and indicate whether the new medicinal product brings about a therapeutic advance. It shall also mention the voting results within the Agency’s scientific committees, notably the number of votes approving the medicine;"
Amendment 9 #
2008/0225(COD)
Proposal for a regulation – amending act
Article 1 – point -1 b (new)
Article 1 – point -1 b (new)
Regulation (EC) No 726/2004
Article 9 – paragraph 4 – point e
Article 9 – paragraph 4 – point e
(-1b) In Article 9(4), point (e) shall be replaced by the following: "(e) the assessment report, which shall include as an annex the preliminary report on the medicinal product prepared by the rapporteurs as well as the marketing authorisation holder’s comments;"
Amendment 11 #
2008/0225(COD)
Proposal for a regulation – amending act
Article 1 – point -1 c (new)
Article 1 – point -1 c (new)
Regulation (EC) No 726/2004
Article 9 – paragraph 4 – point e a (new)
Article 9 – paragraph 4 – point e a (new)
Amendment 14 #
2008/0225(COD)
Proposal for a regulation – amending act
Article 1 – point -1 e (new)
Article 1 – point -1 e (new)
Regulation (EC) No 726/2004
Article 13 – paragraph 3 – subparagraph 2
Article 13 – paragraph 3 – subparagraph 2
(-1e) In Article 13(3), the second subparagraph shall be replaced by the following: " The European Public Assessment Report (EPAR) shall include a summary written in a manner that is understandable to the public. The summary shall contain [...] a section relating to the conditions of use of the medicinal product as well as a section listing other therapeutic options available and indicating whether the new medicinal product brings about a therapeutic advance."
Amendment 20 #
2008/0225(COD)
Proposal for a regulation – amending act
Article 1 – point 2 a (new)
Article 1 – point 2 a (new)
(2a) In Article 57(1), the following point is added: "(ua) promoting existing sources of independent reliable health information."
Amendment 35 #
2008/0221(COD)
Proposal for a directive
Article 6 - points 1 - 4
Article 6 - points 1 - 4
(1) car suppliers and car distributors shall ensure that technical promotional literature provides information oncustomers are informed about tyres which are fitted on new vehicles at the point of sale; that information shall include the fuel efficiency class as set out in Annex I, Part A, the external rolling noise measured value as set out in Annex I, Part C and, for C1 tyres, the wet grip class as set out in Annex I, Part B; (2) where different tyre types may be fitted on a new vehicle, without end-users being offered a choice between them, the lowest fuel efficiency class, wet grip class and the highest external rolling noise measured value of these tyre types shall be mentioned in the technical promotional literature in the order specified in Annex III; (3) where end-users are offered a choice between different tyre types to be fitted on a new vehicle, car suppliers shall state the fuel efficiency class, wet grip class and external rolling noise measured value of these tyre types in the technical promotional literature in the order specified in Annex III; (4) where end-users are offered a choice between different tyre types to be fitted on a new vehicle, car distributors shall provide information on the fuel efficiency class, wet grip class and external rolling noise measured value of these tyre types before sale.
Amendment 36 #
2008/0221(COD)
Proposal for a directive
Article 8
Article 8
Member States shall assess the conformity of the declared fuel efficiency and wet grip classes, within the meaning of Annex I Parts A and B, and the declared external rolling noise measured value within the meaning of Annex I Part C, for aftermarket tyres, in accordance with the procedure laid down in Annex IV.
Amendment 39 #
2008/0221(COD)
Proposal for a directive
Annex IV - introductory part
Annex IV - introductory part
The conformity of the declared fuel efficiency and wet grip classes as well as the declared external rolling noise measured value shall be assessed for each aftermarket tyre type or each grouping of aftermarket tyres as determined by the tyre supplier; according to the following procedure:
Amendment 26 #
2008/0218(CNS)
(5a) establish at the national level multi- stakeholder advisory groups comprising all interested stakeholders should be established at the national level to guide governments in the implementation of national action plans for rare diseases. These should ensure that governments are well-informed and that the decisions taken at a national level reflect the views of society.
Amendment 37 #
2008/0218(CNS)
(b) European guidelines on population screening and diagnostic tests, including genetic tests like heterozygote testing and polar body diagnosis, ensuring high- quality testing and appropriate genetic counselling while respecting ethical diversity in the Member states;
Amendment 42 #
2008/0218(CNS)
6. Empowerment of independent patient organisations (1) take action to ensure that patients and independent patients’ representatives are duly consulted at all steps of the policy and decision- making processes in the field of rare diseases, including for the establishment and management of centres of expertise and of European reference networks and for the elaboration of national plans; (2) support the activities performed by independent patient organisations, such as awareness- raising, capacity-building and training, exchange of information and best practices, networking, outreach to very isolated patients; (3) include in the national plans for rare diseases provisions on the support to and the consultation of patient organisations as referred to in paragraphs (1) and (2).
Amendment 44 #
2008/0218(CNS)
(2a) ensure that funding for patient organisations which is not directly linked to single pharmaceutical companies is provided;
Amendment 45 #
2008/0218(CNS)
(3) include in the national plans for rare diseases provisions on the support to and the consultation of independent patient organisations as referred to in paragraphs (1) and (2).
Amendment 39 #
2008/0165(COD)
Proposal for a regulation
Article 3 – point 10
Article 3 – point 10
(10) ‘production’ means the amount of controlled substances produced , including the amount produced as by-product , less the amount destroyed by technologies approved by the Parties and less the amount entirely used as feedstock or as a processing agent in the manufacture of other chemicals. No amount recovered, recycled or reclaimed shall be considered as ‘production’,
Amendment 41 #
2008/0165(COD)
Proposal for a regulation
Article 3 – paragraph 17
Article 3 – paragraph 17
(17) ‘use’ means the utilisation of controlled substances or new substances in the production or maintenance, in particular refilling, of products or equipment or in other processes except for feedstock and processing agent uses,
Amendment 48 #
2008/0165(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. By way of derogation from Articles 4 and 5, controlled substances may be produced, placed on the market and used as feedstock for the licensed export to Parties operating under Article 5 of the Montreal Protocol for essential uses.
Amendment 50 #
2008/0165(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
Amendment 51 #
2008/0165(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
Amendment 59 #
2008/0165(COD)
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Controlled substances produced or placed on the market for essential laboratory and analytical uses may only be used for that purpose or for destruction within the Community in accordance with the requirements for destruction laid out in Article 22(1).
Amendment 65 #
2008/0165(COD)
Proposal for a regulation
Article 10 – paragraph 6 – subparagraph 2 a (new)
Article 10 – paragraph 6 – subparagraph 2 a (new)
The Commission shall determine minimum allocation levels for companies based upon licenses awarded for laboratory and analytical uses in the period 2005-2007.
Amendment 67 #
2008/0165(COD)
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 2
Article 11 – paragraph 2 – subparagraph 2
Until 31 December 2014, recycled hydrochlorofluorocarbons may be used for the maintenance and servicing of existing refrigeration and air-conditioning equipment provided that they have been recovered from any such equipment within the European Union by the undertaking concerned, to be used in any such equipment of the same undertaking within the European Union. The plant logbook will provide legal evidence with regards to the origin as well as the re-use of such recycled substances.
Amendment 73 #
2008/0165(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point c
Article 15 – paragraph 2 – point c
(c) controlled substances that are intended for destruction or for re-analysis and destruction,
Amendment 74 #
2008/0165(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point g a (new)
Article 15 – paragraph 2 – point g a (new)
(ga) Controlled substances, when related to an inward-processing procedure, only if the controlled substances are to be used in the customs territory of the Community under the system of suspension provided for in Article 114(2) (a) of Regulation (EEC) No 2913/92, and under the condition that the compensating products are re-exported to a State where the production, consumption or import of that controlled substance is not prohibited. Approval shall be given by the competent authority of the Member State in which the inward-processing operation is to take place.
Amendment 82 #
2008/0165(COD)
Proposal for a regulation
Article 17 – paragraph 2 – point a
Article 17 – paragraph 2 – point a
(a) controlled substances to satisfy essential uses referred to in Article 10(2) of Parties;
Amendment 92 #
2008/0165(COD)
Proposal for a regulation
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)
1a. Hydrochlorofluorocarbons contained in containers, used for the transportation or storage of these substances, which have been placed on the market and which can no longer be used, shall be recovered. The hydrochlorofluorocarbons may be exported, in compliance with Articles 17 and 18, or destroyed applying the technologies referred to in the first subparagraph.
Amendment 99 #
2008/0165(COD)
Proposal for a regulation
Article 22 – paragraph 3 – subparagraph 3 a (new)
Article 22 – paragraph 3 – subparagraph 3 a (new)
In preparing its proposal for the Annex, the Commission shall consult Member States and all interested parties as to the products and equipment to be identified, the technical and economical feasibility of recovery or destruction without prior recovery and the technologies to be applied for each product and equipment identified.
Amendment 106 #
2008/0165(COD)
Proposal for a regulation
Article 24 – paragraph 3
Article 24 – paragraph 3
3. In the light of relevant scientific information, the Commission may include in Part B of Annex II any substances that are not controlled substances but that are found to have an ozone-depleting potential of 0.01 or more and an atmospheric life- time greater than sixty days. Those measures, designed to amend non- essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 25 (3).
Amendment 107 #
2008/0165(COD)
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. Every year before 31 March, each undertaking shall communicate to the Commission, sending a copy to the competent authority of the Member State concerned, the data listed in paragraphs 2 to 5 as specified below for each controlled substance and each new substance listed in Annex II Part A in respect of the period 1 January to 31 December of the preceding year.
Amendment 110 #
2008/0165(COD)
Proposal for a regulation
Annex II – Part B – Table – row 1
Annex II – Part B – Table – row 1
Amendment 111 #
2008/0165(COD)
Proposal for a regulation
Annex II – Part B – Table – row 3
Annex II – Part B – Table – row 3
Amendment 33 #
2008/0152(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The Community Ecolabel scheme is part of the sustainable consumption and production policy of the Community, which aims at reducing the negative impact of consumption and production on the environment, health, and natural resources. The scheme is intended to promote those products which have a high level of environmental performance through the use of the Ecolabel. To this effect, it is appropriate to require that the criteria which products must comply with in order to bear the Ecolabel be based on the best environmental performance achieved by products on the Community market. Those criteria should be simple to understand and to use, and should therefore bebe based on scientific evidence, taking into consideration the latest technological developments. Those criteria should be market-oriented and limited to the most significant environmental impacts of products during their full lifecycle.
Amendment 60 #
2008/0152(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The environmental performance of products shall be determined on the basis of the best performing products on the Community market. To this end, the most significant environmental impacts during the life cycle of products, in particular the impact on climate change, impact on nature and biodiversity, energy and resource consumption, generation of waste, emissions to all environmental media, and pollution through physical effects and use and release of hazardous substances, shall be considered.
Amendment 64 #
2008/0152(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Ecolabel criteria shall set out the environmental requirements, based on sound scientific evidence, that a product must fulfil in order to bear the Ecolabel.
Amendment 97 #
2008/0152(COD)
Proposal for a regulation
Annex I – part A – point 2 – subparagraph 2 – indent 1
Annex I – part A – point 2 – subparagraph 2 – indent 1
- they shall be based on the environmental performance throughout the life-cycle of the product of the best performing products on the market and correspond, as far as possible, to 1020 % of the best performing products available on the market;
Amendment 44 #
2008/0151(COD)
Proposal for a directive
Article 1 - paragraph 3
Article 1 - paragraph 3
3. This Directive shall not apply to means of transport for persons or goods or to building and construction products.
Amendment 57 #
2008/0151(COD)
Proposal for a directive
Article 2 - point 21
Article 2 - point 21
21. ‘Environmental performance’ of a product means the results of the manufacturer's management of the environmental aspproduct’s overall effects ofn the productenvironment throughout its life cycle, as reflected in its technical documentation file;
Amendment 65 #
2008/0151(COD)
Proposal for a directive
Article 15 - paragraph 2 - point (c) - introductory part
Article 15 - paragraph 2 - point (c) - introductory part
(c) the product shall present significanttechnically feasible and economically justified potential for improvement in terms of its environmental impact without entailing excessive costs, based on a life-cycle cost analysis, taking into account in particular:
Amendment 60 #
2008/0142(COD)
Proposal for a directive
Recital 3
Recital 3
(3) This Directive respects the fundamental rights and observes the general principles of law as recognised in particular by the Charter of Fundamental Rights of the European Union. The right of access to healthcare and the right to benefit from medical treatment under conditions established by national law and practices are recognised by Article 35 of the Charter of Fundamental Rights of the European Union. Specifically, this Directive has to be implemented and applied with due respect for the rights to private and family life, protection of personal data, equality before the law and the principle of non- discrimination, the fundamental ethical choices of Member States and the right to an effective remedy and to a fair trial, in accordance with the general principles of law, as enshrined in Articles 7, 8, 20, 21, 47 of the Charter.
Amendment 65 #
2008/0142(COD)
Proposal for a directive
Recital 5 a (new)
Recital 5 a (new)
(5a) This Directive respects and does not prejudice the freedom of each Member State to decide what type of healthcare it considers appropriate. No provision of this Directive should be interpreted in such a way as to undermine the fundamental ethical choices of Member States, in particular as regards the protection of the right to life of every human being.
Amendment 73 #
2008/0142(COD)
Proposal for a directive
Recital 8
Recital 8
(8) This directive aims to establish a general framework for provision of safe, high quality and efficient cross-border healthcare in the Community and to ensure patients mobility and freedom to provide healthcare and high level of protection of health, whilst fully respecting the responsibilities of the Member States for the definition of social security benefits related to health and the organisation and delivery of healthcare and medical care and social security benefits in particular for sickness.Does not affect English version.)
Amendment 74 #
2008/0142(COD)
Proposal for a directive
Recital 9
Recital 9
(9) This Directive on the application of patients’ rights in cross-border healthcare applies to all types of healthcare. As confirmed by the Court of Justice, neither their special nature nor the way in which they are organised or financed removes them from the ambit of the fundamental principle of freedom of movement. As regards long-term care, the Directive does not apply to assistance and support for families or individuals who are, over an extended period of time, in a particular state of need. It does not apply, for example, to residential homes or housing, or assistance provided to elderly people or children by social workers or volunteer carers or professionals other than health professionalneed of nursing, support or care in so far as this involves specific expert treatment or help provided by a social security system. This covers first and foremost such long term care services as are considered necessary in order to provide the person in need of care with as full and independent a life as possible. These include, in particular, services in the field of basic care (e.g. bathing/showering, dressing/undressing, cutting up food and feeding, assistance in getting up and going to bed, walking/standing, trips to the toilet for emptying the bladder or bowel), domestic care (such as cleaning, heating, washing dishes, cooking, shopping, administrative formalities and trips to social events) and medical treatment (such as help in changing dressings, pain relief, administering medication, etc). The Directive does not apply, for example, to care in long-term residential care establishments or in assisted-living facilities.
Amendment 77 #
2008/0142(COD)
Proposal for a directive
Recital 10
Recital 10
(10) For the purpose of this Directive, the concept of "cross-border healthcare" covers the following modes of supply of healthcare: – Use of healthcare abroad (i.e.: a patient moving to a healthcare provider in another Member State for treatment); this is what is referred to as 'patient mobility'; – Cross-border provision of healthcare (i.e.: delivery of service from the territory of one Member State into the territory of another); such as telemedicine services, remote diagnosis and prescription, laboratory services; – Permanent presenconly covers the use of a healthcare provider (i.e.: establishment of a healthcare provider in another Member State); and – Temporary presence of persons (i.e.: mobility of health professionals, for example moving temporarily to the Member State of the patient to provide services)abroad.
Amendment 87 #
2008/0142(COD)
Proposal for a directive
Recital 11
Recital 11
(11) As recognised by the Member States in the Council Conclusions on Common values and principles in European Union Health Systems there is a set of operating principles that are shared by health systems throughout the Community. These operating principles include quality, safety, care that is based on evidence and ethics, patient involvement, redress, the fundamental right to privacy with respect to the processing of personal data, and confidentiality. Patients, professionals and authorities responsible for health systems must be able to rely on these shared principles being respected and structures provided for their implementation throughout the Community. It is therefore appropriate to require that it is the authorities of the Member State on whose territory the healthcare is provided, who are responsible for ensuring compliance with those operating principles. This is necessary to ensure the confidence of patients in cross-border healthcare, which is itself necessary for achieving patients' mobility and free movement of provision of healthcare in the internal market as well as a high level of health protection. In view of these common values it is nevertheless accepted that Member States take different decisions on ethical grounds as regards the availability of certain treatments and the concrete access conditions. This Directive is without prejudice to ethical diversity. It does not impose on Member States to make treatments and services accessible their territory or to reimburse costs for those treatments (received in another Member State) which are not allowed under national laws, regulations and codes of conduct of the medical professions.
Amendment 93 #
2008/0142(COD)
Proposal for a directive
Recital 12
Recital 12
(12) Given that it is impossible to know in advance whether a given healthcare provider will supply healthcare to a patient coming from another Member State or a patient from their own Member State, it is necessary that the requirements to ensure that healthcare is provided according to common principles and clear quality and safety standards are applicable to all type of healthcare in order to ensure the freedom to provide and obtain cross border healthcare which is the aim of the directive. Member States' authorities have to respect the shared overarching values of universality, access to good quality care, equity and solidarity, which have been already widely recognised by the Community institutions and by all the Member States as constituting a set of values that are shared by health systems across Europe. Members States also have to ensure that these values are respected with regard to patients and citizens from other Member States, and that all patients are treated equitably (which also expressly means no discrimination against national patients and providers) on the basis of their healthcare need rather than their Member State of social security affiliation. In doing so, Member States must respect the principles of freedom of movement within the internal market, non- discrimination inter alia with regard to nationality (or in the case of legal persons, with regard to the Member State in which they are established), necessity and proportionality of any restrictions on free movement. However, nothing in this Directive requires healthcare providers to accept for planned treatment or to prioritise patients from other Member States to the detriment of other patients with similar health needs, such as through increasing waiting time for treatment.
Amendment 103 #
2008/0142(COD)
Proposal for a directive
Recital 17
Recital 17
(17) The right to the protection of personal data is a fundamental right recognised by Article 8 of the Charter of Fundamental Rights of the European Union. Ensuring continuity of cross-border healthcare depends on transfer of personal data concerning patient's health. These personal data should be able to flow freely from one Member State to another, but in the same time the fundamental rights of the individuals should be safeguarded. 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 data establishes the right for individuals to have access to their personal data concerning their health, for example in the patient's medical records containing such matters as diagnosis, examination results, assessments by treating physicians and any treatment or interventions provided. These provisions also apply in the context of cross-border healthcare covered by this Directive. The patient should be able to stop the release of his data at any point and receive confirmation that his data have been deleted.
Amendment 135 #
2008/0142(COD)
Proposal for a directive
Recital 27
Recital 27
(27) This Directive provides also for the right for a patient to receive any medicinal product authorised for marketing in the Member State where healthcare is provided in that Member State, even if the medicinal product is not authorised for marketing in the Member State of affiliation, insofar as it is an indispensable part of obtaining effective treatment in another Member State.
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 139 #
2008/0142(COD)
Proposal for a directive
Recital 30
Recital 30
(30) There is no definition of what constitutes hospital care throughout the different health systems of the Community, and different interpretations could therefore constitute an obstacle to the freedom for patients to receive healthcare. In order to overcome that obstacle, it is necessary to provide a Community definition of hospital care. Hospital care generally means care requiring the overnight accommodation of the patient. However, it may be appropriate to submit to the same regime of hospital care also certain other kindmust remain within Member States’ legal jurisdiction. This ensures that, in qualified competition, expert further developments can be integrated into the system (i.e. that the assumption of more and more complex tasks by advanced technology, e.g. operations in the non-hospital sphere, remains possible). The specific distinction between hospitalisation and non-hospital care will be made on the basis of thealthcare, if that healthcare requires use of highly specialised and cost-intensive medical infrastruct practice of patient treatment in the country of provision in the typical course or medical equipment (e.g. high-technology scanners used for diagnosis) or involving treatments presenting a particular risk for thef events. Should significant differences emerge between cross-border patient or the population (e.g. treatment of serious infectious diseases). A regularly updated list of such treatments shall be specifically defined by the Commisss, the Commission has a direct right to intervene and take corrective action, through the comitology procedurea body to be set up.
Amendment 140 #
2008/0142(COD)
Council position
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) "healthcare" means health services provided to patients by health professionals to patients to assess, maintain or restore theibelonging to the regulated health professions if these activities are performed in a Member sState of health, including the prescription, dispensation and provision of medicinal products and medical deviceswhere the services are provided by members of a regulated health profession under the appropriate professional title;
Amendment 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 174 #
2008/0142(COD)
Proposal for a directive
Recital 40
Recital 40
(40) European reference networks should provide healthcare to all patients who have conditions requiring a particular concentration of resources or expertise, in order to provide affordable, high quality and cost-effective care and could also be focal points for medical training and research, information dissemination and evaluation. The mechanism for identification and development of the European refMember States shall facilitate the development of the European reference networks of healthcare providers in the form of voluntary groupings with the aim of exchanging scientific experience networks should be established with the aim to organise at European level equal access to high level shared expertise in a given medical fieldin order to improve healthcare possibilities for all patients as well as for health professionalswith rarer illnesses, based on the open coordination method.
Amendment 199 #
2008/0142(COD)
Proposal for a directive
Article 1
Article 1
This Directive establishes a general framework for the provision of safe, high quality and efficient healthcare and the re- imbursement of cross-border healthcare.
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 214 #
2008/0142(COD)
Proposal for a directive
Article 2
Article 2
This Directive shall apply to provision of healthcare regardless of how it is organised, delivered and financed or whether it is public or private. This Directive shall not apply to services whose main focus is in the field of long-term care, especially including those services provided over an extended period of time whose purpose is to support people in need of assistance in carrying out routine, everyday tasks.
Amendment 251 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (a)
Article 4 - point (a)
(a) "healthcare" means a health service provids or products, in particular medical or pharmaceutical services and medicinal products or medical devices, provided by, prescribed by or under the supervision of a health professional in the exercise of his profession, and regardless of the ways in which it isthey are organised, delivered and financed at national level or whether it isthey are public or private;
Amendment 281 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (h)
Article 4 - point (h)
(h) "Member State of affiliation" means the Member State where the patient is an insured person; if the institution of the place of residence is the competent institution pursuant to the second subparagraph of Article 22(3) of Regulation (EEC) No 1408/71 or Article 20(4) or Article 27(5) of Regulation (EEC) No 883/2004, the State of residence shall be deemed to be the Member State of affiliation;
Amendment 298 #
2008/0142(COD)
Proposal for a directive
Article 4 - point (l)
Article 4 - point (l)
(l) "harm" means adverse health outcomes or injuries stemming from the provision of healthcare and which can only be related to the obligation of effort of the health professional.
Amendment 305 #
2008/0142(COD)
Proposal for a directive
Article 5
Article 5
Amendment 387 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State where the treatment in question is among the benefits provided for by the legislation of the Member State of affiliation to which the insured person is entitled. The Member State of affiliation shall reimburse the costs to the insured person, which would have been paid for by its statutory social security system for treatment carried out generally and lege artis in the Member State of treatment on the basis of the given diagnosis at the level thadt the same or similar healthcare been provided in its territorycosts would have been reimbursed to the insured person for treatment carried out generally and lege artis in his Member State of affiliation. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided.
Amendment 413 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Member State of affiliation may impose on a patient seeking healthcare provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities including codes of conduct of the medical professions for receiving healthcare and reimbursement of healthcare costs as it would impose if the same or similar healthcare was provided in its territory, in so far as they are neitherot discriminatory nor an obstacle to freedom of movement of persons.
Amendment 455 #
2008/0142(COD)
Proposal for a directive
Article 8 – paragraph 1 – point (a)
Article 8 – paragraph 1 – point (a)
(a) healthcare which requires overnight accommodation of the patient in question for at least one night, or which is defined as such by the legislation of Member States of affiliation.
Amendment 457 #
2008/0142(COD)
Proposal for a directive
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 518 #
2008/0142(COD)
Proposal for a directive
Article 9 – paragraph 3
Article 9 – paragraph 3
Amendment 528 #
2008/0142(COD)
Proposal for a directive
Article 9 – paragraph 4
Article 9 – paragraph 4
Amendment 572 #
2008/0142(COD)
Proposal for a directive
Article 12 – paragraph 2 – point a
Article 12 – paragraph 2 – point a
(a) provide and disseminate objective information of a general nature to patients in particular on their rights related to cross- border healthcare, and the guarantees ofinformation about quality and safety, protection of personal data, procedures for complaints and means of redress available for healthcare provided in another Member State, and on the terms and conditions applicable. No recommendations concerning the service providers (rankings) should be supplied;
Amendment 596 #
2008/0142(COD)
Proposal for a directive
Article 12 – paragraph 3 – point c
Article 12 – paragraph 3 – point c
Amendment 615 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. If a medicinal product is authorised to be marketed on theirits territory in accordance with Article 6(1) of Directive 2001/83/EC, a Member States shall ensure that prescriptions for this medicinal product issued by an authorised person in another Member State for a named patient can after recognition by a doctor be used in theirits territory and that any restrictions on recognition of individual prescriptions are prohibited unless they: (a) are limited to what is necessary and proportionate to safeguard human health and are non-discriminatory or (b) are based on legitimate and justified doubts about the authenticity or content of an individual prescription or about the authority of the prescriber. Costs will be reimbursed according to the conditions applying in the Member State of affiliation.
Amendment 620 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 1 – subparagraph 1 a (new)
Article 14 – paragraph 1 – subparagraph 1 a (new)
The recognition of such a prescription shall not affect the application of the following national regulations: (i) rules governing the dispensing of medicinal products, including generic substitution, (ii) rules relating to pricing and reimbursement, (iii) professional or ethical rules which would require the pharmacist to refuse to dispense had the prescription been issued in his own Member State.
Amendment 633 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(b) measures to ensure that medicinal products prescribed in one Member State and dispensed in another are correctly identified and that the information to patients concerning the product is comprehensible; prescriptions issued in accordance with this EU template shall be written in International Nonproprietary Names (INN).
Amendment 635 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 2 – point ba (new)
Article 14 – paragraph 2 – point ba (new)
(ba) measures to facilitate the establishment of contacts between the prescriber and the dispenser, so as to clarify any doubts concerning the prescription.
Amendment 639 #
2008/0142(COD)
Proposal for a directive
Article 14 – paragraph 2 – point c
Article 14 – paragraph 2 – point c
Amendment 646 #
2008/0142(COD)
Proposal for a directive
Article 15 - paragraph 1
Article 15 - paragraph 1
1. Reference networks are voluntary associations for the exchange of scientific experience with the aim of improving the possibilities for healthcare provision for patients with rare diseases and are based on the open coordination method. Reference networks present an opportunity to demonstrate Europe's excellence in medical research and treatment. Member States shall facilitate the development of the European reference networks of healthcare providers. Those networks shall at all times be open for new healthcare providers which might wish to join them, provided that such healthcare providers fulfil all the required conditions and criteria.
Amendment 651 #
2008/0142(COD)
Proposal for a directive
Article 15 - paragraph 2
Article 15 - paragraph 2
Amendment 656 #
2008/0142(COD)
Proposal for a directive
Article 15 - paragraph 3
Article 15 - paragraph 3
Amendment 672 #
2008/0142(COD)
Proposal for a directive
Article 15 - paragraph 4
Article 15 - paragraph 4
Amendment 680 #
2008/0142(COD)
Proposal for a directive
Article 16
Article 16
The CommissionMember States shall, in accordance with the procedure referred to in Article 19(2), adopt specific measures necessary for achieving the interoperability of information and communication technology systems in the healthcare field, applicable whenever Member States decide to introduce them. Those measures shall reflect developments in health technologies and medical science and respect the fundamental right to the protection of personal data in accordance with the applicable law. They shall specify in particular the necessary standards and terminologies for inter-operability of relevant information and communication technology systems to ensure safe, high- quality and efficient provision of cross- border health services.
Amendment 691 #
2008/0142(COD)
Proposal for a directive
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
1a. The network shall act on the basis of an operational framework based on the principles of good governance. These principles include inter alia transparency of procedures, a formal right of appeal, objectiveness, impartiality and the full involvement of all relevant stakeholders.
Amendment 696 #
2008/0142(COD)
Proposal for a directive
Article 17 – paragraph 4
Article 17 – paragraph 4
4. The Commission shall, in accordance with the procedure referred to in Article 19(23), adopt the necessary measures for the establishment and the management of this network and specifying the nature and type of the information to be exchanged.
Amendment 698 #
2008/0142(COD)
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. Member States shall transmit the data referred to in paragraph 1 to the Commission for statistical purposes at least annually, except for data that are already collected pursuant to Directive 2005/36/EC.
Amendment 701 #
2008/0142(COD)
Proposal for a directive
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The Commission shall be assisted by a Committee, consisting of representatives of and chaired by the Member States and chaired by the Commission . The Committee may be completed by representatives of patients, payer organisations and healthcare presentativeofessionals.
Amendment 106 #
2008/0110(COD)
Proposal for a regulation
Article 3 – paragraph 25 a (new)
Article 3 – paragraph 25 a (new)
(25a) ‘centrifuge or separator sludge’ means material collected as a by-product of purification/separation of raw milk into skimmed milk and cream.
Amendment 137 #
2008/0110(COD)
Proposal for a regulation
Article 13 – point m a (new)
Article 13 – point m a (new)
(ma) centrifuge or separator sludge from milk processing following thermal treatment pursuant to Annex VIII, Chapter I, point H (method 8).
Amendment 5 #
2008/0045(COD)
Proposal for a directive – amending act
Recital 6 a (new)
Recital 6 a (new)
(6a) For reasons of proportionality and in the case of marketing authorisations not resulting from a centralised marketing authorisation procedure, a mutual recognition procedure or a decentralised procedure (so-called purely national marketing authorisations), the harmonised rules for post-authorisation amendments to the terms of marketing authorisations of medicinal products should only apply to those medicinal products that are authorised after the date this Directive has to be transposed into the national law of the Member States. This is necessary to preserve pharmaceutical companies with a high number of purely national marketing authorisations, a lot of them SMEs, from additional expense and a further regulatory burden resulting from the change from the established national regulatory framework in the Member State concerned to the European framework. However, this Directive should not prevent a Member State from extending the harmonised rules for post- authorisation amendments to the terms of marketing authorisations of medicinal products to medicinal products having a purely national marketing authorisation and having been authorised before the date this Directive has to be transposed into the national law of the Member States on a voluntary basis.
Amendment 18 #
2008/0045(COD)
Proposal for a directive – amending act
Article 2 – point 1
Article 2 – point 1
Directive 2001/83/EC
Article 23 b – paragraph 2 a (new)
Article 23 b – paragraph 2 a (new)
Amendment 159 #
2008/0028(COD)
Proposal for a regulation
Recital 27
Recital 27
Amendment 165 #
2008/0028(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Without prejudice to specific Union provisions applicable to particular foods as regards the requirements referred to in points (a) to (k) of Article 9(1), 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 using a font size where the x-height, as defined in Annex IV, is equal to or greater than 1,2 0,9 mm. The mandatory particulars shall be presented in such a way as to ensure a significant contrast between the print and the background.
Amendment 167 #
2008/0028(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) It is also important to provide consumers with information on the other 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 apply. 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
Article 13 – paragraph 3
Article 13 – paragraph 3
3. In case of packaging or containers the largest surface of which has an area of less than 60 cm2, the x-height of the font size referred to in paragraph 2 shall be equal to or greater than 0,9 mmnot apply.
Amendment 207 #
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 241 #
2008/0028(COD)
Proposal for a regulation
Article 25 – paragraph 3 – subparagraph 1 – introductory part
Article 25 – paragraph 3 – subparagraph 1 – introductory part
Amendment 284 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
3. Where the labelling of a prepacked food provides the mandatory nutrition declaration referred to in Art. 29 paragraph 1, the information on energy value andshall be repeated in the principal field of vision. In addition, the amounts of fat, saturates, sugars, and salt may also be repeated thereon.
Amendment 296 #
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 portion, shall be repeated, in a clear format and surrounded by a border, in the principal field of vision.
Amendment 320 #
2008/0028(COD)
Proposal for a regulation
Article 34 – paragraph 2 a (new)
Article 34 – paragraph 2 a (new)
2a. If the nutrition declaration for foods listed in Annex V is mandatory because a nutrition or health claim is made, the nutrition declaration or any part of it shall not be required to appear in the principal field of vision.
Amendment 328 #
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 333 #
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 361 #
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 386 #
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 389 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1– point b
Article 29 – paragraph 1– point b
(b) the amounts of fat, saturates, carbohydrates with specific reference to sugars, and salt.
Amendment 400 #
2008/0028(COD)
Proposal for a regulation
Annex XIII – section 1 – title
Annex XIII – section 1 – title
DAILY REFERENCE INTAKES FOR VITAMINS AND MINERALS (ADULTS)
Amendment 401 #
2008/0028(COD)
Proposal for a regulation
Article 20 - point (e)
Article 20 - point (e)
Amendment 436 #
2008/0028(COD)
Proposal for a regulation
Article 31 – paragraph 3
Article 31 – paragraph 3
3. The mandatory nutrition declaration shall be expressed, as appropriate,relating to energy content, fat, saturated fats, sugar and salt, shall in addition be expressed as a percentage of the reference intakes set out in Part B of Annex XI in relation to per 100 g or per 100 ml or, subject to Article 31(2), per portion. When provided, the declaration on vitamins and minerals shall also be expressed as a percentage of the reference intakes set out in point 1 of Part A of Annex XI.
Amendment 438 #
2008/0028(COD)
Proposal for a regulation
Article 27 – paragraph 2 a (new)
Article 27 – paragraph 2 a (new)
2a. The total grams of pure alcohol per 100 ml or units should also be stated on the label.
Amendment 448 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 1 – point b
Article 29 – paragraph 1 – subparagraph 1 – point b
(b) the amounts of fat, saturatesprotein, carbohydrates with specific reference to sugars, and salt.
Amendment 454 #
2008/0028(COD)
Proposal for a regulation
Article 33 – paragraph 1
Article 33 – paragraph 1
1. In addition to the forms of expression referred to in Article 31(2) and (3), the nutrition declaration may be given by othergraphic forms of expression provided that the following essential requirements are met: (a) the form of expression aims to facilitate consumer understanding of the contribution or importance of the food to the energy and nutrient content of a diet; and (b) it is based either on harmonised reference intakes, or in their absence,on the reference intakes indicated in Annex XI, Part B, in relation to 100 g or 100 ml. If a product is prepacked as an individual portion or if it is supplied in quantities of less than 100 g/ml, an indication per portion relating to the quantity supplied shall be sufficient. In the absence of such reference intakes, the nutrition declaration is based on generally accepted scientific advice on intakes for energy or nutrients; and (c) it is supported by evidence of understanding of and use of the presentation of the information by the average consumer. 2. Such additional forms of expression referred to in paragraph 1 shall be identified under a national scheme referred to in Article 44A model graphic presentation is shown in Annex XIII, Part D.
Amendment 463 #
2008/0028(COD)
Proposal for a regulation
Article 29 – paragraph 1 - subparagraph 2
Article 29 – paragraph 1 - subparagraph 2
Amendment 471 #
2008/0028(COD)
Proposal for a regulation
Article 34 – paragraph 2
Article 34 – paragraph 2
Amendment 474 #
2008/0028(COD)
Proposal for a regulation
Article 34 – paragraph 2
Article 34 – paragraph 2
2. The nutrition declaration in relation to the nutrients referred to in Article 29(2) shall appear together in one place and, as appropriate, in the order of presentation provided in Part C of Annex XIII. When this nutrition declaration does not appear in the principal field of vision, it shall be presented in tabular form, with the numbers aligned if space permits. Where space does not permit, the declaration shall appear in linear form. If the nutrition declaration for foods listed in Annex IV is mandatory because a nutrition or health claim is made, the nutrition declaration shall not be required to appear in the principal field of vision.
Amendment 574 #
2008/0028(COD)
Proposal for a regulation
Annex XIII – part C a (new)
Annex XIII – part C a (new)
Amendment 682 #
2008/0028(COD)
Proposal for a regulation
Annex IV
Annex IV
FOODS WHICH ARE EXEMPTED FROM THE REQUIREMENT FOR THE MANDATORY NUTRITION DECLARATION - unprocessed products that comprise 1 2 largest surface of which has an area of less than 25a single ingredient or category of a single ingredient or category of ingredients; ingredients; - processed products which the only - processed products which the only processing they have been processing they have been subjected to is smoking or maturing subjected to is smoking or maturing and that comprise a single and that comprise a single ingredient or category of ingredient or category of ingredients; ingredients; - waters intended for human - waters intended for human consumption, including those consumption, including those where the only added ingredients where the only added ingredients are carbon dioxide and/or are carbon dioxide and/or flavourings; flavourings; - a herb, a spice or mixtures thereof; - a herb, a spice or mixtures thereof; - salt and salt substitutes; - salt and salt substitutes; - products covered by - products covered by Directive 1999/4/EC of the Directive 1999/4/EC of the European Parliament and of the European Parliament and of the Council of 22 February 1999 Council of 22 February 1999 relating to coffee extracts and relating to coffee extracts and chicory extracts1, whole or milled chicory extracts2, whole or milled coffee beans and whole or milled coffee beans and whole or milled decaffeinated coffee beans; decaffeinated coffee beans; - herbal infusion, tea, decaffeinated - herbal infusion, tea, decaffeinated tea, instant or soluble tea or tea tea, instant or soluble tea or tea extract, decaffeinated instant or extract, decaffeinated instant or soluble tea or tea extract, which do soluble tea or tea extract, which do not contain added ingredients; not contain added ingredients; - fermented vinegars and substitutes - fermented vinegars and substitutes for vinegar, including those where for vinegar, including those where the only added ingredients are the only added ingredients are flavourings; flavourings; - flavourings; - flavourings; - food additives; - food additives; - processing aids; - processing aids; - food enzymes; - food enzymes; - gelatine; - gelatine; - jam setting compounds; - jam setting compounds; - yeast; - yeast - food in packaging or containers the - food in packaging or containers the OJ L 66, 13.3.1999, p. 26. OJ L 66, 13.3.1999, p. 26. largest surface of which has an area of less than 100 cm2; - food sold by private persons in the context of occasional activities, and not as part of an undertaking that would imply a certain continuity of activities and a certain degree of organisation; - figure-shaped sugar confectionery; - figure-shaped chocolate products; - food directly supplied by the manufacturer of small quantities of products to the final consumer or to local retail establishments directly supplying the final consumer; - food in inner package not designed for sale without the outer package (nutrition information shall be provided on the outer package unless it belongs to the categories of foods that are exempted under this Annex). - assortments and giftings; - mixed multi-packs. - chewing gum.
Amendment 713 #
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 133 #
2008/0018(COD)
Proposal for a directive
Annex II – Part I – point 4 – subparagraph 2
Annex II – Part I – point 4 – subparagraph 2
2. The packaging in which toys are contained for retail sale must not present risk of strangulation or asphyxiation caused by airwayn internal obstruction of the lower airways and the airways external to the mouth and nose.
Amendment 86 #
2008/0015(COD)
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) The CO2 capture, transport and storage components have all separately been the subject of pilot projects, but they have yet to be incorporated into a complete CCS process, and the costs of the technology still have to be reduced. The largest CO2 storage projects in which European undertakings are involved are the Sleipner project in the North Sea (Statoil) and the In Salah project in Algeria (Statoil, PB and Sonatrach). Other current pilot projects are the Vattenfall project in Schwarze Pumpe in Germany/the Land of Brandenburg and the CCS project being carried out by Total in the Lacq area in France.
Amendment 101 #
2008/0015(COD)
Proposal for a directive – amending act
Recital 16
Recital 16
(16) Member States should determine in which cases exploration is required to generate the information necessary for the site selection. Such exploration should be made subject to a permit requirement. Member States should ensure that the procedures for the granting of exploration permits are open to all entities possessing the necessary capacities and that the permits are granted on the basis of objective, published criteria. In order to protect and encourage exploration investments, exploration permits should be granted for a limited volume area and for a limited timethe period which is necessary to carry out the activities, during which time the holder of the permit should have the sole right to explore the potential CO2 storage complex. Member States should ensure that no conflicting uses of the complex are permitted during this time. In the event that no activities are carried out, the Member States have to ensure that the exploration permit is withdrawn and can be granted to other entities.
Amendment 105 #
2008/0015(COD)
Proposal for a directive – amending act
Recital 17
Recital 17
(17) Storage sites should not be operated without a storage permit. The storage permit should be the core instrument to ensure that the substantial requirements of the Directive are met and that geological storage hence takes place in an environmentally safe way. The explorations carried out and the necessary investments made therefore justify anticipation by the holder of the exploration permit that they will be the holder of the storage permit.
Amendment 109 #
2008/0015(COD)
Proposal for a directive – amending act
Recital 18
Recital 18
(18) All draft storage permits should be submitted to the Commission in order for it to be able to issue an opinion on the draft permits within six months of their submission. The national authorities should take this opinion into consideration when taking a decision on the permit and should justify any departure from the Commission's opinion. The review at Community level should help to ensure consistency in implementation of the requirements of the Directive across the Community and also enhance public confidence in CCS, especially in the early phase of the implementation of the DirectiveMember States should have the opportunity to submit the draft storage permit to the Commission for verification.
Amendment 121 #
2008/0015(COD)
Proposal for a directive – amending act
Recital 26
Recital 26
(26) The responsibility for the storage site, including all ensuing legal obligations, should be transferred to the competent authority, if and when all available evidence indicates that the stored CO2 will be completely contained for the indefinite future. To this end, the operator should prepare a report documenting that the criterion has been fulfilled and submit it to the competent authority for approval of the transfer. All draft approval decisions should be submitted to the Commission in order for it to be able to issue an opinion on the draft approval decisions within six months of their submission. The national authorities should take this opinion into consideration when taking a decision on the approval and should justify any departure from the Commission’s opinion. As the review of draft storage permits at Community level, the review of draft approval decisions should help to ensure consistency in implementation of the requirements of the Directive across the Community and also enhance public confidence in CCS, especially in the early phase of the implementation of the Directive.
Amendment 127 #
2008/0015(COD)
Proposal for a directive – amending act
Recital 28
Recital 28
(28) Financial provision should be made provided in order to raise confidence that closure and post-closure obligations, obligations arising from inclusion under Directive 2003/87/EC, and obligations under this Directive to take corrective measures in case of significant irregularities or leakages, can be met. Member States should ensure that financial provisions, by way of financial security or any other equivalent, are made by the applicant prior to the submission of the permit applicationuse of the storage.
Amendment 165 #
2008/0015(COD)
Proposal for a directive – amending act
Article 3 - point 3
Article 3 - point 3
(3) 'storage site' means a specific part of a geological formation usedthat is adequate for the geological storage of CO2;
Amendment 170 #
2008/0015(COD)
Proposal for a directive – amending act
Article 3 - point 5
Article 3 - point 5
(5) 'leakage' means the not insignificanyt release of CO2 from the storage complex;
Amendment 200 #
2008/0015(COD)
Proposal for a directive – amending act
Article 3 - point 20 a (new)
Article 3 - point 20 a (new)
(20a) 'hydraulic unit' means a hydraulically connected pore space where pressure communication can be measured by technical means.
Amendment 229 #
2008/0015(COD)
Proposal for a directive – amending act
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Exploration permits shall be granted for a limited volume area and for a maximum of two years, renewable once for a maximum of two yearthe period needed to carry out the activities for which the exploration permit is granted. The exploration permit may be prolonged. Before granting exploration permits, Member States shall make arrangements to ensure that the permit is not illegally used to prevent investments.
Amendment 236 #
2008/0015(COD)
Proposal for a directive – amending act
Article 5 – paragraph 4
Article 5 – paragraph 4
4. The holder of an exploration permit shall have the sole right to explore the potential CO2 storage complex. Member States shall ensure that no conflicting uses of the complex are permitted during the period of validity of the permit. After this period, the CO2 storage exploration permit shall either be converted into a CO2 storage permit or else be relinquished for the total area covered.
Amendment 247 #
2008/0015(COD)
Proposal for a directive – amending act
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2a. The holder of a storage permit shall have the sole right to store CO2 in the storage site. Member States shall ensure that no conflicting uses of the storage site are permitted during the validity of the storage permit.
Amendment 270 #
2008/0015(COD)
Proposal for a directive – amending act
Article 8 – point 2
Article 8 – point 2
(2) the Commission hasmay issued, on request of the Member States, its opinion on the draft permit pursuant to Article 10(12);
Amendment 274 #
2008/0015(COD)
Proposal for a directive – amending act
Article 8 – point 3
Article 8 – point 3
Amendment 279 #
2008/0015(COD)
Proposal for a directive – amending act
Article 9 – point 2
Article 9 – point 2
(2) precise location and delimitation of the storage site and, the storage complex and the hydraulic unit;
Amendment 286 #
2008/0015(COD)
Proposal for a directive – amending act
Article 10 –title
Article 10 –title
Amendment 288 #
2008/0015(COD)
Proposal for a directive – amending act
Article 10 – paragraph 1
Article 10 – paragraph 1
1. Member States shall inform the Commission of all draft storage permits, the permit applications and any other material taken into consideration by the competent authority when adopting its draft decision. Within six months of their submission to the Commission, the Commission may issue an opinion on the draftabout granted CO2 storage permits or rejected applications for storage permits.
Amendment 293 #
2008/0015(COD)
Proposal for a directive – amending act
Article 10 – paragraph 2
Article 10 – paragraph 2
2. The competent authority shall notify the final decision to the Commission, stating the reasons if it deviates fromMember States may inform the Commission of draft storage permits, permit applications and any other material taken into consideration by the Ccommission petent authority when adopting its draft decision.
Amendment 303 #
2008/0015(COD)
Proposal for a directive – amending act
Article 11 – paragraph 3 – point d
Article 11 – paragraph 3 – point d
Amendment 316 #
2008/0015(COD)
Proposal for a directive – amending act
Article 12 – paragraph 1
Article 12 – paragraph 1
1. A CO2 stream shall consist overwhelmingly of carbon dioxide. To this end, no waste and other matter may be added for the purpose of disposing of that waste or other matter. However, a CO2 stream may contain incidental associated substances from the source, capture or injection process and substances necessary for the transport on safety grounds. Concentrations of those substances shall be below levels that would adversely affect the integrity of the storage site and relevant transport infrastructure and pose a significant risk to the environment or breach the requirements of applicable Community legislation.
Amendment 343 #
2008/0015(COD)
Proposal for a directive – amending act
Article 18 – paragraph 2
Article 18 – paragraph 2
Amendment 349 #
2008/0015(COD)
Proposal for a directive – amending act
Article 18 – paragraph 3
Article 18 – paragraph 3
Amendment 364 #
2008/0015(COD)
Proposal for a directive – amending act
Article 19 – paragraph 1
Article 19 – paragraph 1
1. Member States shall ensure that adequate provisions, by way of financial security or any other equivalent, on the basis of modalities to be decided by the Member States, are made by the applicant prior to the submission of the application for aare made by the applicant in accordance with a transparent procedure for establishing his creditworthiness and a risk-based assessment of the potential level of damage, to be carried out at the commencement of storage permit, to ensure that all obligations arising under the permit issued pursuant to this Directive, including closure procedures and post-closure provisions, as well as any obligations arising from inclusion under Directive 2003/87/EC can be met.
Amendment 367 #
2008/0015(COD)
Proposal for a directive – amending act
Article 19 – paragraph 1
Article 19 – paragraph 1
1. Member States shall ensure that adequate provisions, by way of financial security or any other equivalent, on the basis of modalities to be decided by the Member States, are made by the applicant prior to the submission of the application forafter the granting of a storage permit to ensure that all obligations arising under the permit issued pursuant to this Directive, including closure procedures and post- closure provisions, as well as any obligations arising from inclusion under Directive 2003/87/EC can be met.
Amendment 391 #
2008/0015(COD)
Proposal for a directive – amending act
Article 23
Article 23
In cases of transboundary transport of CO2, transboundary storage sites or transboundary storage complexes, the competent authorities of the Member States concerned shall meet the requirements of this Directive and of other relevant Community legislation jointly. For transboundary storage sites, the national authority responsible for granting permits shall be that of the Member State on whose territory the foreseeably largest part of the storage site is located.
Amendment 422 #
2008/0015(COD)
Proposal for a directive – amending act
Annex I – paragraph 1
Annex I – paragraph 1
The characterisation and assessment of storage sites referred to in Article 4 shall be carried out in four steps according to the following criteria and on the basis of best available techniques. Derogations from one or more of these criteria are permitted so long as the capacity of the characterisation and assessment to enable the determinations pursuant to Article 4 is not affected.
Amendment 424 #
2008/0015(COD)
Proposal for a directive – amending act
Annex I – Step 1 – point (h)
Annex I – Step 1 – point (h)
(h) Domains surrounding the storage complex that may be affected by the storage of CO2 in the storage site, as well as the delimitation of the hydraulic unit;
Amendment 87 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 13
Recital 13
(13) The additional effort to be made by the European economy requires inter alia that the revised Community scheme operate with the highest possible degree of economic efficiency and on the basis of fully harmonised conditions of allocation within the Community. Auctioning should therefore be the basic principle for allocation, as it is the simplest and generally considered to be the most economically efficient systemFree allocation based on benchmarks and actual production is the most economically efficient system that can provide for setting incentives for low carbon technologies and for the achievement of the reduction target. This should also eliminate windfall profits and put new entrants and higher than average growing economies on the same competitive footing as existing installations.
Amendment 110 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 16
Recital 16
(16) Consequently, full auctioning should be the rule from 2013 onwards for the power sector, taking into account their ability to pass on the increased cost of CO2, and no free Emissions trading is an instrument designed to help meet the CO2 reduction targets at minimal cost. Free allocation based on benchmarks and actual production sets the necessary incentives to efficiency improvements. Costs generated by the Community scheme both for participating installocation should be given for carbon capture and storage as the incentive for this arises from allowances not being required to be surrendered in respect of emissions which are stored. Electricity generators may receive free allowances for heat produced through high efficiency cogeneration as defined by Directive 2004/8/EC s as well as indirectly for consumers can thereby be limited to the financial needs for abating the CO2 emissions to be reduced in accordance with the target set. The CO2 emissions still allowed in line with the cap consequently do not cause costs for the community. They will only do so once they fall under a future, strengthened reduction target. Such a limitation in no way jeopardises the climate change policy goals. The achievement of the CO2 reduction target can be safeguarded by setting the event that such heat produced by installations in obenchmarks correctly. The option of a downward adjustment of the benchmarks in subsequent years provides for ther sectors were to be given free allocations, in order to avoid distortions of competition. urity to really meet the overall reduction target. Consequently, free allocation based on benchmarks and actual production should be the rule from 2013 onwards for all sectors and the entire period.
Amendment 160 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 19
Recital 19
(19) The Community will continue to take the lead in the negotiation of an ambitious international agreement that will achieve the objective of limiting global temperature increase to 2°C and is encouraged by the progress made in Bali towards this objective. In the event that other developed countries and other major emitters of greenhouse gases do not participate in this international agreement, this could lead to an increase in greenhouse gas emissions in third countries where industry would not be subject to comparable carbon constraints (“carbon leakage”), and at the same time could put certain energy- intensive sectors and sub-sectors in the Community which are subject to international competition at an economic disadvantage. This could undermine the environmental integrity and benefit of actions by the Community. To address the risk of carbon leakage, the Community will allocate allowances free of charge up to 100% totake over, for sectors or sub-sectors meeting the relevant criteria. The definition of these sectors and sub-sectors and the measures required will be subject to re-assessment to ensure that action is taken where necessary and to avoid overcompensation. For those specific sectors or sub-sectors where it can be duly substantiated that the r, the principle of free allocation on the basisk of carbon leakage cannot be prevented otherwise, where electricity constitutes a high proportion of production costs and is produced efficiently, the action taken may take into account the electricity consumption in the production process, without changing the total quantity of allowanceslegal provisions harmonised at Community level.
Amendment 175 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 20
Recital 20
The Commission should therefore review the situation by June 20110 at the latest, consult with all relevant social partners, and, in the light of the outcome of the international negotiations, submit a report accompanied by any appropriate proposals. In this context, the Commission should identify which energy intensive industry sectors or sub-sectors are likely to be subject to carbon leakage not later than 30 June 20109. It should base its analysis on the assessment of the inability to pass on the cost of required allowances in product prices without significant loss of market share to installations outside the Community not taking comparable action to reduce emissions. Energy-intensive industries which are determined to be exposed to a significant risk of carbon leakage could receive a higher amount of free allocation or an effective carbon equalisation system could be introduced with a view to putting installations from the Community which are at significant risk of carbon leakage and those from third countries on a comparable footing. Such a system could apply requirements to importers that would be no less favourable than those applicable to installations within the EU, for example by requiring the surrender of allowances. Any action taken would need to be in conformity with the principles of the UNFCCC, in particular the principle of common but differentiated responsibilities and respective capabilities, taking into account the particular situation of Least Developed Countries. It would also need to be in conformity with the international obligations of the Community including the WTO agreement.
Amendment 216 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 34
Recital 34
The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission. In particular power should be conferred on the Commission to adopt measures for the auctioning of allowances, for transitional Community- wide allocation of allowanceson the basis of the benchmark model, for the monitoring, reporting and verification of emissions, for the accreditation of verifiers and for implementing harmonised rules for projects. Since those measures are of general scope and are designed to amend non-essential elements of this Directive and to supplement this Directive by the addition or modification of new non- essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Amendment 291 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 9a – paragraph 3 a (new)
Article 9a – paragraph 3 a (new)
3a. Should the quantity of allowances that were additionally allocated to the operators in a specific sector due to production increases in accordance with the second sentence of Article 10a(2) exceed the quantity of allowances returned by operators in that specific sector due to reduced reduction according to the ex-post adjustments, the benchmarks for this specific sector shall be reduced in the year following the year in which the imbalance occurred in accordance with the regulatory procedure with scrutiny referred to in Article [23(3)] in a way that ensures the achievement of overall reduction of emissions within the scope of Article 9. For this purpose, the competent authorities shall inform the Commission by 30 April of each year whether the quantity of emission allowances has been exceeded.
Amendment 293 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - Point 7
Article 1 - Point 7
Directive 2003/87/EC
Article 10
Article 10
Amendment 367 #
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
Article 10a – paragraph 1
1. Starting from the year 2013, Member States shall allocate all allowances free of charge for the entire period. The Commission shall, by 30 June 201109, adopt Community wide and fully harmonised implementing measures for allocating the allowances referred to in paragraphs 2 to 6 and 83 in a harmonised manner. Those measures, designed to amend non- essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article [23(3)]. The definition of sectors to which the Directive applies constitutes however an essential element and shall therefore be the subject of a proposal in accordance with Article 251 of the Treaty. 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. The Commission shall, upon the conclusion by the Community of an international agreement on climate change leading to mandatory reductions of greenhouse gas emissions comparable to those of the Community, review those measures to provide that free allocation only takes place where this is fully justified in the light of that agreementand shall not give incentives to increase emissions.
Amendment 423 #
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 generators, to installations for the capture, pipelines for the transport or to storage sites for greenhouse gas emissions. Installations shall be allocated the number of allowances corresponding to the arithmetical product of the expected average annual production volume, the installation’s respective benchmark, as well as the number of calendar years within the allocation period since commissioning. Should the production volume in one calendar year deviate from the expected average annual production, the operator shall, in the event of a decrease in production, return to the relevant authority, by 30 April of the following year, the number of allowances that results from the multiplication of the production volume with the benchmark allocated to the plant. In the event of an increase in production, the relevant authority shall, following application and by 30 April of the following year, allocate additional allowances on the basis of the same calculation. The benchmarks shall be determined in accordance with the regulatory procedure with scrutiny referred to in Article [23(3)]. They shall take into consideration the technical reduction potential of the respective plants. Technically unavoidable process- related emissions shall not be reduced when determining the benchmark. The same shall apply for unavoidable waste gases. Where a waste gas is used as a fuel, allowances shall be allocated to the operator of the installation generating the waste gas according to the same allocation principles as applied for this Directive.
Amendment 438 #
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 a (new)
Article 10a – paragraph 2 a (new)
2a. Where for certain products or processes no benchmarks have been determined in accordance with the regulatory procedure with scrutiny referred to in Article [23(3)], the relevant installation shall be allocated emission allowances corresponding to the annual average allocation for the second ETS- trading period, adjusted by the linear factor referred to in Article 9. The technical reduction potential of the respective plants is to be taken into consideration. If the products or processes were not covered by the second ETS-trading period, grandfathering shall apply.
Amendment 441 #
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 equal treatment with regard to other producers of heat. In each year subsequent to 2013, the total allocation to such installations in respect of the producHighly efficient combined heat and power plants (CHP) within the meaning of Directive 2004/8/EC shall be granted, without time limitation, free allowances for their power and heat generation ofn that heat shall be adjusted by the linear factor referred to in Article 9e basis of a benchmark.
Amendment 488 #
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
Amendment 505 #
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
Amendment 522 #
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 542 #
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 581 #
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
Amendment 617 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2003/87/EC
Article 11 - paragraph 1
Article 11 - paragraph 1
1. Each Member State shall publish and submit to the Commission, by 30 September 2011, the list of installations covered by this Directive in its territory and any free allocation to each installation in its territory calculated in accordance with the rules referred to in Article 10a(12).
Amendment 53 #
2008/0000(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that action plans should address, in particular, the need to reduce communicable and non-communicable diseaseand prevent epidemics and pandemics;
Amendment 57 #
2008/0000(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Proposes that the Commission set as a priority goal a reduction in health inequitsupporting the health sector, to which subsidiarity applies, between and within Member States as well as between different social groupsy means of measures from which European added value can be anticipated;
Amendment 28 #
2007/2285(INI)
Motion for a resolution
Recital E
Recital E
E. considering physical activity to be the primary prevention against overweight and noting with alarm that one in three Europeans do not exercise at all in their free time, while the average European spends over five hours a day sitting down,
Amendment 36 #
2007/2285(INI)
Motion for a resolution
Recital G
Recital G
G. considering that overweight and obesity should be tackled with a holistic approach acting across government policy areas and at different levels of government, especially at national and local level, with all due regard for subsidiarity,
Amendment 43 #
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 63 #
2007/2285(INI)
Motion for a resolution
Recital K
Recital K
Amendment 65 #
2007/2285(INI)
Motion for a resolution
Recital K a (new)
Recital K a (new)
Ka. whereas the action and conduct of the marketing sector to date are persistently in need of improvement and whereas modern marketing media such as cell phones, instant messaging, video games and interactive games on the Internet generally have a negative influence on children,
Amendment 91 #
2007/2285(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Recognises unreservedly the substantial role and effectiveness of self-regulation;
Amendment 97 #
2007/2285(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls, however, for more tangible measures especially targeted at children and at-risk groups such as elderly people, especially women, disabled persons, and poor and unemployed people;
Amendment 113 #
2007/2285(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
Amendment 119 #
2007/2285(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on local government bodies, when carrying out town planning, to make municipalities conducive to physical movement, which requires a sensible mixture of residential areas, commercial areas and shops, in which it should be possible to travel on foot but in which infrastructure must also be accessible for vehicles and evacuation routes must remain open to them;
Amendment 149 #
2007/2285(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Urges the Commission and Member States to proposet guidelines drawn up by experts on how to improve physical activity as early as the pre-school period and to promote nutritional education already at this early stage;
Amendment 156 #
2007/2285(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Calls on Member States to include dietetics, agriculture and cookery in the curriculum;
Amendment 172 #
2007/2285(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Further, asks Member States, local entities and school authorities to monitor and to improve the quality and nutritional standards of school meals and to review portion sizes; asks for a total ban on the sale of foods and beverages high in fat, salt or sugar in 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 187 #
2007/2285(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 194 #
2007/2285(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Considers it essential that, in general, no products should be marketed at schools;
Amendment 195 #
2007/2285(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Considers that sports organisations and teams should set an example with regard to exercise and healthy diet;
Amendment 201 #
2007/2285(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes the reform of the COM allowing the production of more fruit and vegetables to be served in schools, provided that the quality and chemical safety of these products is controlled; calls for morappropriate support for organic production;
Amendment 225 #
2007/2285(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls for a ban on, as a first step, for a reduction in non-natural trans-fatty acids and urges EU Member States to follow good practices in controlling the content of substances in food (e.g. salt content); nevertheless points out that special exemptions should be provided for PDO (protected designation of origin) and PGI (protected geographical indication) and traditional products in order to preserve original recipes;
Amendment 235 #
2007/2285(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
Amendment 239 #
2007/2285(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls on Member States, as part of social programmes, to ensure that even socially disadvantaged groups have access to high-quality food;
Amendment 246 #
2007/2285(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
Amendment 258 #
2007/2285(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls on the Commission to draft a Europe-wide programme, ‘Grow it yourself - cook it yourself - prepare it yourself’.
Amendment 264 #
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’ targeted at children in the media; urges holders of intellectual property rights not to license cartoon characters for advertising this kind of food;
Amendment 274 #
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 286 #
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; is convinced that the problem of hidden placement of products of poor nutritional value in films and cartoons should also be addressed at European level;
Amendment 294 #
2007/2285(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
Amendment 298 #
2007/2285(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Calls on the Council and Commission to conduct a Europe-wide general media campaign for healthy diet and exercise;
Amendment 307 #
2007/2285(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
Amendment 313 #
2007/2285(INI)
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Considers that practising doctors should be made aware of their leading role in the early identification of people at risk of overweight and the fact that they will be the main actors in the fight against the obesity epidemic;
Amendment 319 #
2007/2285(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Is convinced of the need for full recognition of the qualification of medical professionals as ‘clinical dietitians’ as well as ‘nutritionists’; urges Member States to promote the presence at school and in all workplaces of these kinds of doctoris;
Amendment 37 #
2007/0297(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) Directive 2007/46/EC provides that manufacturers are to issue a certificate of conformity which must accompany each new passenger car and that Member States are to permit the registration and entry into service of a new passenger car only if it is accompanied by a valid certificate of conformity. Data collected by Member States should be consistent with the certificate of conformity issued by the manufacturer for the passenger car. and should be based on this reference only. Should Member States, for justified reasons, not use the certificate of conformity to complete the process of registration and entry into service of a new passenger car, they should put the necessary measures in place to ensure adequate accuracy in the monitoring procedure. There should be a common European standard database for certificate of conformity data. It should be used as a single reference to enable Member States to more easily maintain their registration data when vehicles are newly registered. The Commission should ensure the use of electronic networks by the Member States, such as demonstrated in the REGNET project, that provide for further streamlining of the exchange of registration data, such as for CO2 emissions, for the purpose of accurate monitoring. Further, to enable manufacturers to respond to market developments, the Commission should, at the latest by 30 August for each monitoring year, make available an interim monitoring report to each manufacturer for that year.
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 54 #
2007/0297(COD)
Proposal for a regulation
Article 1
Article 1
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 of1a. The individual target must be achieved by 2012 for at least 25%, by 2013 for at least 50%, by 2014 for at least 75% and by 2015 for the entire new car fleet. If the individual CO2 emissions target to be determined using the calculation formula is to be achieved for the entire new car fleet by 2015, corresponding improvements 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. technology will be required. 1b. As part of of the Community's integrated approach, this Regulation shall introduce additional measures corresponding to at least 10 g CO2/km. 1c. CO2 emissions shall be measured in accordance with Regulation (EC) No 715/2007 and its implementing provisions. Additional Additional proven measures taken by automobile manufacturers and their component suppliers which lead to further reductions in greenhouse gas emissions shall be taken into account in connection with vehicle technology requirements, pursuant to Article 6 and Annex III.
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 70 #
2007/0297(COD)
Proposal for a regulation
Article 1 – subparagraph 1 a (new)
Article 1 – subparagraph 1 a (new)
In 2014 a target shall be set for 2020 which guarantees, on the basis of the aggregate impact of all relevant measures, a further reduction in average CO2 emissions of at least 20% by comparison with the individual target for the period 2012-2015. In that connection, due account shall be taken of climate protection developments at international level.
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 107 #
2007/0297(COD)
Proposal for a regulation
Article 3 – paragraph 2 – introductory part
Article 3 – paragraph 2 – introductory part
Amendment 109 #
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. For this purpose, the CO2 emissions, adjusted for CO2 emission reductions delivered by eco innovations, shall be balanced over three consecutive years, as under Article 7.
Amendment 112 #
2007/0297(COD)
Proposal for a regulation
Article 4
Article 4
For the calendar year commencing 1 January 2012 and each subsequent calendar year, each manufacturer of passenger cars shall ensure that itn 2012 25%, in 2013 50%, in 2014 75% and in 2015 and each subsequent calendar year 100% of the fleet’s average specific emissions of CO2 do not exceed itsthe specific emissions target for a manufacturer's fleet determined in accordance with Annex I or, where a manufacturer is granted a derogation under Article 9, in accordance with that derogation.
Amendment 125 #
2007/0297(COD)
Proposal for a regulation
Article 4 – subparagraph 1 a (new)
Article 4 – subparagraph 1 a (new)
For manufacturers which produce cars with specific CO2 emissions which are 20%, 30%, 40% and 50% lower than the target set in Annex I, when average specific CO2 emissions are calculated every new vehicle registered over the period to 2015 inclusive shall be counted as two, three, four or five, in keeping with the percentage by which emissions fall below the set target.
Amendment 138 #
2007/0297(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. For the year beginning 1 January 20102 and each subsequent year, each Member State shall record information for each new passenger car registered in its territory in accordance with Part A of Annex II.
Amendment 142 #
2007/0297(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. By 28 Februar31 July 20112 and each subsequent half year, the Member State shall determine and transfer to the Commission the information, verified by a certified auditor, listed in Part B of Annex II in respect of the preceding calendar year. The data shall be transmitted in accordance with the format specified in Part C of Annex II..
Amendment 150 #
2007/0297(COD)
Proposal for a regulation
Article 6 – paragraph 8 a (new)
Article 6 – paragraph 8 a (new)
8a. On a manufacturer’s request, eco- innovations shall be considered in the calculation of the average CO2 emissions of a manufacturer. The request shall include: (a) the calendar year; (b) concrete eco-innovations; (c) a definition of the vehicles which have been equipped with these eco-innovations; and (d) a certificate from an independent qualified institute. b. The Commission shall adopt the necessary implementing measures in accordance with the regulatory procedure with scrutiny referred to in Article 12.
Amendment 155 #
2007/0297(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. In respect of each calendar year from 2012 onwards for which a manufacturer's average specific emissions of CO2, adjusted for CO2 emission reductions delivered by eco-innovations and balanced over three consecutive years, exceed its specific emissions target in that year, the Commission shall impose an excess emissions premium on the manufacturer or, in the case of a pool, the pool manager.
Amendment 165 #
2007/0297(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The excess emissions premium shall be: (a) in relation to excess emissions similar to premiums paid in othe calendar year 2012, 20 euros; (b) in relation to excess emissions in the calendar year 2013, 35 euros; and (c) in relation to excess emissions in the calendar year 2014, 60 euros; and (d) in relation to excess emissions in the calendar year 2015 and subsequent calendar years, 95 eurosr sectors under the European Emission Trading Scheme.
Amendment 169 #
2007/0297(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The excess emissions premium pursuant to Article 1 shall be: (a) in relation to excess emissions in the calendar year 2012, 20 eurosEUR 10; (b) in relation to excess emissions in the calendar year 2013, 35 eurosEUR 20; (c) in relation to excess emissions in the calendar year 2014, 60 euros; andEUR 30; (d) in relation to excess emissions in the calendar year 2015 and subsequent calendar years, 95 eurosEUR 40.
Amendment 182 #
2007/0297(COD)
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. The amounts of the excess emissions premium shall be considerpaid into a fund which must be used asto revenue for the budget of the European Unionduce CO2 emissions in the road transport sector and for research into new, energy-efficient technologies.
Amendment 194 #
2007/0297(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) is responsible for less than 10,0000.1% of new passenger cars registeredrations in the Community per calendar year; and
Amendment 195 #
2007/0297(COD)
Proposal for a regulation
Article 9 – paragraph 1 a (new)
Article 9 – paragraph 1 a (new)
1a. On request, the Commission shall grant manufacturers of specific models total new registrations of which make up no more than 1% of annual EU-wide passenger car registrations an alternative emissions target of a 25% reduction in their average specific emissions by comparison with 2008, in place of the specific target calculated pursuant to Annex I.
Amendment 202 #
2007/0297(COD)
Proposal for a regulation
Article 9 a (new)
Article 9 a (new)
Amendment 203 #
2007/0297(COD)
Proposal for a regulation
Article 9 a (new)
Article 9 a (new)
Amendment 209 #
2007/0297(COD)
Proposal for a regulation
Article 10 − paragraph 3
Article 10 − paragraph 3
Amendment 218 #
2007/0297(COD)
Proposal for a regulation
Article 10 − paragraph 3 a (new)
Article 10 − paragraph 3 a (new)
3a. Whenever the Commission proposes new legislation affecting light duty vehicles and their fuels in a manner that leads directly or indirectly to an increase of CO2 emissions, the Commission shall indicate this fact clearly in its proposals to the European Parliament and the Council and reflect any adverse impact on manufacturers’ compliance with the specific CO2 emissions target set out in this Regulation.
Amendment 225 #
2007/0297(COD)
Proposal for a regulation
Article 11
Article 11
Amendment 226 #
2007/0297(COD)
Proposal for a regulation
Article 11
Article 11
Amendment 232 #
2007/0297(COD)
Proposal for a regulation
Article 11 a (new)
Article 11 a (new)
Article 11 a Implementing Measures The measures necessary for the implementation of Article 3(1)(fa), which are designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 12(3).
Amendment 265 #
2007/0297(COD)
Proposal for a regulation
Annex II a (new)
Annex II a (new)
Amendment 95 #
2007/0286(COD)
Council position
Article 10 – paragraph 1
Article 10 – paragraph 1
This Chapter shall apply to the activities set out in Annex I and, where applicable, reaching the capacity thresholds set out in that Annex. When calculating the total rated thermal input of installations referred to in point 1.1 of Annex I, each single combustion plant with a rated thermal input below 50 MW and operating no more than 500 hours per year shall not be included for the purposes of this calculation.
Amendment 166 #
2007/0286(COD)
Council position
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Member States shall take the necessary measures to ensure that the competent authority periodically reconsiders in accordance with paragraphs 2 to 5 all permit conditions and, where necessary to ensure compliance with this Directive, updates those conditions, taking consideration of investment cycles and avoiding disproportionately high costs for the affected plant operators.
Amendment 177 #
2007/0286(COD)
Council position
Article 21 – paragraph 4
Article 21 – paragraph 4
4. Where an installation is not covered by any of the BAT conclusions, the permit conditions shall be reconsidered and, if necessary, updated where developments in the best available techniques allow for the significant reduction of emissions without causing disproportionately high costs compared to the environmental benefits.
Amendment 225 #
2007/0286(COD)
Council position
Article 30 - paragraph 8 - point a
Article 30 - paragraph 8 - point a
(a) diesel engines and gas engines;
Amendment 238 #
2007/0286(COD)
Council position
Article 32 - paragraph 1 – subparagraph 1
Article 32 - paragraph 1 – subparagraph 1
1. During the period from 1 January 2016 to 31 December 2020, Member States may draw up and implement a transitional national plan covering combustion plants which were granted the first permit before 27 November 2002 or the operators of which had submitted a complete application for a permit before that date, provided that the plant was put into operation no later than 27 November 2003. For each of the combustion plants covered by the plan, the plan shall cover emissions of one or more of the following pollutants: nitrogen oxides, sulphur dioxide * and dust. For gas turbines and gas engines, only nitrogen oxides and carbon monoxide emissions shall be covered by the plan.
Amendment 240 #
2007/0286(COD)
Council position
Article 32 - paragraph 3 – subparagraph 2
Article 32 - paragraph 3 – subparagraph 2
The ceiling for the year 2016 shall be calculated on the basis of the relevant emission limit values set out in Annexes III to VII to Directive 2001/80/EC or, where applicable, on the basis of the rates of desulphurisation set out in Annex III to Directive 2001/80/EC. In the case of gas turbines and gas engines, the emission limit values for nitrogen oxides and carbon monoxide set out for such plants in Part B of Annex VI to Directive 2001/80/EC shall be used. The ceilings for the years 2019 and 2020 shall be calculated on the basis of the relevant emission limit values set out in Part 1 of Annex V to this Directive or, where applicable, the relevant rates of desulphurisation set out in Part 5 of Annex V to this Directive. The ceilings for the years 2017 and 2018 shall be set providing a linear decrease of the ceilings between 2016 and 2019.
Amendment 245 #
2007/0286(COD)
Council position
Article 32 a (new)
Article 32 a (new)
Article 32 a Higher annual operating hours than those provided for in Parts 1 and 2 of Annex V may be granted by the competent authority to combustion plants using solid fuels which were granted a permit before 27 November 2002 or the operators of which submitted a complete application for a permit before that date, provided that the plant was put into operation no later than 27 November 2003 and introduced or retrofitted technical measures to reduce SO2 emissions in line with the requirements of Directives 2001/80/EC and 2008/1/EC before …*. Such combustion plants may be exempted from compliance with the emission limit values for SO2 referred to in the tables in Parts 1 and 2 of Annex V. The emission limit values laid down in the permits of these combustion plants, pursuant in particular to the requirements of Directives 2001/80/EC and 2008/1/EC, should at least be maintained, but shall not exceed 400 mg/Nm³. _________ * OJ: Date of entry into force of this Directive.
Amendment 246 #
2007/0286(COD)
Council position
Article 32 a (new)
Article 32 a (new)
Article 32a Higher annual operating hours than those provided for in Parts 1, 2, 4 and 6 of Annex V may be granted by the competent authority to combustion plants which were granted a permit before 27 November 2002 or the operators of which submitted a complete application for a permit before that date, provided that the plant was put into operation no later than 27 November 2003 and provided that a stricter emission limit value is applied that leads to the equivalent environmental protection level for this pollutant on an annual basis.
Amendment 301 #
2007/0286(COD)
Council position
Annex V – Part 1 – section 2 – paragraph 1 a (new) (after the table)
Annex V – Part 1 – section 2 – paragraph 1 a (new) (after the table)
Combustion plants using solid fuels which were granted a permit before 27 November 2002 or the operators of which had submitted a complete application for a permit before that date, provided that the plant was put into operation no later than 27 November 2003 and introduced or retrofitted technical measures to reduce SO2 emissions in line with the requirements of Directives 2001/80/EC and 2008/1/EC before …* , may be exempted from compliance with the emission limit values for SO2 referred to in the preceding table. The emission limit values laid down in the permits of these combustion plants, pursuant in particular to the requirements of Directives 2001/80/EC and 2008/1/EC, should at least be maintained, but shall not exceed 400 mg/Nm³. * OJ: Date of entry into force of this Directive.
Amendment 316 #
2007/0286(COD)
Council position
Annex V – Part 1 – section 6 – table – heading
Annex V – Part 1 – section 6 – table – heading
Emission limit values (mg/Nm3) for NOx and CO for gas fired combustion plants
Amendment 317 #
2007/0286(COD)
Council position
Annex V – Part 1 – section 6 – table – column "CO"
Annex V – Part 1 – section 6 – table – column "CO"
Amendment 318 #
2007/0286(COD)
Council position
Annex V – Part 1 – section 6 – table
Annex V – Part 1 – section 6 – table
Amendment 321 #
2007/0286(COD)
Council position
Annex V – Part 1 – section 6 – paragraph 2 (after the notes)
Annex V – Part 1 – section 6 – paragraph 2 (after the notes)
For gas turbines (including CCGT), the NOx and CO emission limit values set out in this point apply only above 70 % load, at ISO base load conditions.
Amendment 322 #
2007/0286(COD)
Council position
Annex V – Part 1 – section 6 – paragraph 3 (after the notes)
Annex V – Part 1 – section 6 – paragraph 3 (after the notes)
For gas turbines (including CCGT)-fired combustion units which were granted a permit before 27 November 2002 or the operator of which had submitted a complete application for a permit before that date, provided that the plant was put into operation no later than 27 November 2003, and which do not operate more than 1 500 operating hours per year as a rolling average over a period of five years, the emission limit value for NOx is 150 mg/Nm³ when firing natural gas and 200 mg/Nm³ when firing other gases or liquid fuels.
Amendment 325 #
2007/0286(COD)
Council position
Annex V – Part 1 – section 6 – paragraph 5 (after the notes)
Annex V – Part 1 – section 6 – paragraph 5 (after the notes)
Gas turbines and gas engines for emergency use-fired combustion units that operate less than 500 operating hours per year are not covered by the emission limit values set out in this point. The operator of such plants shall record the used operating hours.
Amendment 329 #
2007/0286(COD)
Council position
Annex V – Part 2 – section 6 – table – heading and column "CO"
Annex V – Part 2 – section 6 – table – heading and column "CO"
6. Emission limit values (mg/Nm3) for NOx and CO for gas fired combustion plants CO 100 100 100
Amendment 330 #
2007/0286(COD)
Council position
Annex V – Part 2 – section 6 – table
Annex V – Part 2 – section 6 – table
NOx (1) NOx CO Combustion plants other than gas turbines and 100 100 gas engines with a total rated thermal 150 100 capacity not exceeding 300 MW, other than gas turbines and gas engines Combustion plants firing natural gas with a 100 100 total rated thermal capacity exceeding 300 MW, with the exception of gas turbines and gas engines Gas turbines (including CCGT) 50 (1) 100 Gas engines 75 200 1200 Note: (1) For single cycle gas turbines having an efficiency greater than 35 % – determined at ISO base load conditions – the emission limit value for NOx shall be 50xη/35 where η is the gas turbine efficiency at ISO base load conditions expressed as a percentage.
Amendment 331 #
2007/0286(COD)
Council position
Annex V – Part 2 – section 6 – paragraph 2
Annex V – Part 2 – section 6 – paragraph 2
For gas turbines (including CCGT), the NOx and CO emission limit values set out in this point apply only above 70 % load, at ISO base load conditions.
Amendment 332 #
2007/0286(COD)
Council position
Annex V – Part 2 – section 6 – paragraph 2
Annex V – Part 2 – section 6 – paragraph 2
For gas turbines (including CCGT), the NOx and CO emission limit values set out in this point apply only above 70 % load, at ISO base load conditions.
Amendment 333 #
2007/0286(COD)
Council position
Annex V – Part 2 – section 6 – paragraph 3
Annex V – Part 2 – section 6 – paragraph 3
Gas turbines and gas engines for emergency use-fired combustion units that operate less than 500 operating hours per year are not covered by the emission limit values set out in this point. The operator of such plants shall record the used operating hours.
Amendment 66 #
2006/0304(COD)
Article 1 - point 4
Directive 2003/87/EC
Article 3d - paragraph 2
Article 3d - paragraph 2
2. For subsequent periods, the percentage to be auctioned as referred to in paragraph 1 may be increased as part of the general review of this Directive, up to the maximum internationally agreed level of auctioning.
Amendment 71 #
2006/0304(COD)
Article 1 - point 8
Directive 2003/87/EC
Article 11a - paragraph 1a - subparagraph 1
Article 11a - paragraph 1a - subparagraph 1
“1a. Subject to paragraph 3, during each period referred to in Article 3c, Member States shall allow each aircraft operator to use CERs and ERUs from project activities. During the period referred to in Article 3c(1), aircraft operators may use CERs and ERUs, up to 150% of the number of allowances they are required to surrender pursuant to Article 12(2a).
Amendment 75 #
2006/0304(COD)
Article 1 - point 18
Directive 2003/87/EC
Article 25a - paragraph 2 a (new)
Article 25a - paragraph 2 a (new)
2a. If air transport operators from third countries who provide air transport services in a given geographical framework are not included in the European system, for reasons of equal treatment and in order to support an overall solution to combating emissions from aviation, air transport operators from the European Union serving comparable routes shall not be included in the system either.
Amendment 83 #
2006/0304(COD)
Annex I - point 1 - point (c)
Directive 2003/87/EC
Annex I - paragraph 2 - table - new category - point (j a) (new)
Annex I - paragraph 2 - table - new category - point (j a) (new)
(ja) Flights from third countries to the EU or from the EU to third countries where the third countries are not subject to the rules of the EU emissions trading system or of an equivalent system pursuant to Article 25 a.
Amendment 134 #
2005/0281(COD)
Article 7 – paragraph 1
Amendment 136 #
2005/0281(COD)
Article 7 – paragraph 1 a (new)
1a. In order to strengthen the prevention and recovery of waste, Member States may take legislative or non-legislative measures to ensure that any natural or legal person who professionally develops or imports products has extended producer responsibility.
Amendment 151 #
2005/0281(COD)
Article 8 a (new)
Amendment 37 #
2004/0209(COD)
Article 1 – point 2
Directive 2003/88/EC
Article 2a – subparagraph 1
Article 2a – subparagraph 1
The inacentivre parteriod of on-call time shall not be regarded as working time unless national law or, in accordance with national law and/or practice, a collective agreement or an agreement between the social partners provides otherwise, including the inactive parts, shall in principle be regarded as working time but by collective agreement or other agreement between the two sides of industry or by means of laws or regulations, inactive parts of on-call time shall be calculated in a specific manner in order to comply with the maximum weekly average working time laid down in Article 6, subject to compliance with the general principles relating to the protection of the safety and health of workers.
Amendment 38 #
2004/0209(COD)
Article 1 – point 2
Directive 2003/88/EC
Article 2a – subparagraph 2
Article 2a – subparagraph 2
The inactive part of on-call time mayshall be calculated on the basis of an average number of hours or a proportion of on-call time, taking account of experience in the sector concerned, by collective agreement or agreement between the social partners or by national legislation following consultation of the social partners.
Amendment 39 #
2004/0209(COD)
Article 1 – point 2
Directive 2003/88/EC
Article 2a – subparagraph 3
Article 2a – subparagraph 3
The inactive part of on-call time shall not be taken into account in calculating the daily or weekly rest periods laid down in Articles 3 and 5 respectively, unless otherwise provided for: (a) in a collective agreement or an agreement between the social partners; or (b) by means of national legislation following consultation of the social partners.
Amendment 60 #
2004/0209(COD)
Article 1 – point 6
Directive 2003/88/EC
Article 22 – paragraph 2 – point d
Article 22 – paragraph 2 – point d
(d) no worker who has given an agreement under this Article shall, over a period of seven days, work more than: (i) 60 hours, calculated as an average over a period of three months, unless otherwise provided for in a collective agreement or an agreement between the social partners and when the inactive part of on-call time is calculated in a specific manner in accordance with Article 2a.; or (ii) 65 hours, calculated as an average over a period of three months, in the absence of a collective agreement and when the inactive parts of on-call time is regarded as working time in accordance with Art. 2a without using the possibility of calculating it in a specific manner;