BETA

946 Amendments of Carl SCHLYTER

Amendment 1 #

2014/2010(ACI)

Proposal for a decision
Recital E (new)
E. whereas unregulated and untransparent lobbyism is a significant threat to policy-making and the public interest;
2014/02/27
Committee: AFCO
Amendment 30 #

2014/2010(ACI)

Proposal for a decision
Paragraph 12 – point b
(b) to restrict access to European Parliament premises for non-registered organisations or individuals and to make sure the access badges to lobbyists are distributed fairly between NGOs, SMEs, bigger enterprises (including their organisations), researches and other parts of civil society to end the current over- representation of large companies at the expense of other interests;
2014/02/27
Committee: AFCO
Amendment 38 #

2014/2010(ACI)

Proposal for a decision
Paragraph 13 a (new)
13a. Invites its Bureau to create a compulsory register, electronically available to the public, of incoming documents to which lobbyists must send a copy of all documents they send to Members of the European Parliament or staff of the European Parliament;
2014/02/27
Committee: AFCO
Amendment 42 #

2014/2010(ACI)

Proposal for a decision
Paragraph 13 b (new)
13b. Invites its Bureau to introduce contractual or legal arrangements that make it possible for the European Parliament to introduce proportional, dissuasive fines for lobbyists that violate the code of conduct, the current sanctions being not deterrent enough;
2014/02/27
Committee: AFCO
Amendment 15 #

2013/2188(INI)

Motion for a resolution
Recital A a (new)
Aa. whereas, given that the EU's core aim is to promote freedom of the individual, security measures, including counterterrorism measures, must be pursued through the rule of law and must be subject to fundamental rights obligations, including those relating to privacy and data protection;
2014/01/24
Committee: LIBE
Amendment 101 #

2013/2188(INI)

Motion for a resolution
Recital BA a (new)
BAa. whereas US intelligence agencies have a policy of systematically undermining cryptographic protocols and products in order to be able to intercept even encrypted communication; whereas the US National Security Agency has collected vast numbers of so called "zero- day exploits" – IT security vulnerabilities that are not yet known to the public or the product vendor; whereas such activities massively undermine global efforts to improve IT security;
2014/01/24
Committee: LIBE
Amendment 210 #

2013/2188(INI)

Motion for a resolution
Paragraph 20 d (new)
20d. Calls on Sweden to revise the internet laws which authorised the National Defence Radio Establishment (FRA) to monitor communications traffic into and out of Sweden, cable bound as well as in the ether (radio and satellite), including emails, text messages and telephone calls and Act on signals intelligence which allows for the bulk transfer of data to other states if authorised by the Government, in order to specify the means and the scope of the surveillance and to improve the foreseeability of law which would enable an individual to foresee whether their communication or data about their communication is collected by FRA; recommends further to reinforce the system of checks and balances in oversight of the signals intelligence by including at the composition of the Inspection for Defence Intelligence Operations the parliamentarians in office;
2014/01/24
Committee: LIBE
Amendment 255 #

2013/2188(INI)

Motion for a resolution
Paragraph 46
46. Calls on the European Commission to react to concerns that three of the four major computerised reservation systems used by airlines worldwide are based in the US and that PNR data are saved in cloud systems operating on US soil under US law, which lacks data protection adequacy; states that this undermines the legitimacy and effectiveness of the PNR agreement; calls for termination of the EU US PNR agreement;
2014/01/24
Committee: LIBE
Amendment 292 #

2013/2188(INI)

Motion for a resolution
Paragraph 59
59. Strongly emphasises, given the importance of the digital economy in the relationship and in the cause of rebuilding EU-US trust, that the European Parliament will only consent tosee to it that the final TTIP agreement provided the agreement, among other criteria, fully respects fundamental rights recognised by the EU Charter, and that the protection of the privacy of individuals in relation to the processing and dissemination of personal data must continue to be governed by Article XIV of the GATSshall remain governed by Article XIV of the GATS before consenting to it; stresses that EU data protection legislation cannot be deemed an "arbitrary or unjustifiable discrimination" in the application of Article XIV of the GATS; stresses furthermore that the European Parliament shall not consent to any final TTIP agreement as long as the blanket mass surveillance activities and bulk processing of personal data as well as the interception of communications in EU institutions and diplomatic representations are not fully stopped;
2014/01/24
Committee: LIBE
Amendment 107 #

2013/0307(COD)

Proposal for a regulation
Article 2 – paragraph 2 – point b
(b) genetically modified organisms as defined in Article 2 of Directive 2001/18/EC;deleted
2014/01/13
Committee: ENVI
Amendment 188 #

2013/0307(COD)

Proposal for a regulation
Article 7 – paragraph 1 – point c
(c) transported, except for the transportation of species to facilities for eradicationdestruction, or in the case of vertebrates, humane euthanasia;
2014/01/13
Committee: ENVI
Amendment 208 #

2013/0307(COD)

Proposal for a regulation
Article 8 – paragraph 3 – point b
(b) their removal from the facilities or disposal or destruction, or in the case of vertebrates, humane euthanasia, is done in such way as to exclude propagation or reproduction outside of the facilities.
2014/01/13
Committee: ENVI
Amendment 270 #

2013/0307(COD)

Proposal for a regulation
Article 16 – paragraph 2 – point c a (new)
(ca) eradication methods undertaken thus far are considered to be inhumane or ineffective, and the use of these methods would cause pain, distress or suffering to target or non-target animals.
2014/01/13
Committee: ENVI
Amendment 39 #

2013/0305(COD)

Proposal for a regulation
Recital 23 a (new)
(23a) Since it is common practise to avoid regulations by slightly modifying existing substances the Commission should make a proposal for delegated act in order to classify groups of substances with the same mode of action even if they are not identical.
2014/01/29
Committee: LIBE
Amendment 77 #

2013/0305(COD)

Proposal for a regulation
Article 7 – paragraph 6 – subparagraph 1 (new)
The Commission shall within [18 months after the adoption of this Regulation] adopt delegated act concerning the evaluation, classification and regulation of substances in groups based on active end-points.
2014/01/29
Committee: LIBE
Amendment 124 #

2013/0305(COD)

Proposal for a regulation
Article 21 – paragraph 1 a (new)
The Commission shall [three years after entry into force of this Regulation] present a report and if relevant followed by a proposal for closing any identified loop-holes between 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)1a, Directive 2001/83/EC of the European Parliament and of the Council, Regulation (EC) No 726/2004 of the European Parliament and of the Council and this Regulation in order to make sure that psychotropic substances are properly regulated. __________________ 1a 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), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
2014/01/29
Committee: LIBE
Amendment 190 #

2013/0136(COD)

Proposal for a regulation
Paragraph 1
1. Adopts its position at first reading hereinafter set outRejects the Commission proposal;
2013/11/28
Committee: ENVI
Amendment 191 #

2013/0136(COD)

Proposal for a regulation
Paragraph 2
2. Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another textwithdraw its proposal and present an improved proposal;
2013/11/28
Committee: ENVI
Amendment 224 #

2013/0136(COD)

Proposal for a regulation
Recital 139 a (new)
(139a) Directive 2008/120/EC lays down minimum standards for the protection of pigs32a, Directive 1999/74/EC lays down minimum standards for the protection of laying hens32b, and Directive 2007/43/EC lays down minimum rules for the protection of chickens kept for meat production32c. However, specific legislation laying down minimum standards for the protection of dairy cows and beef cattle does not yet exist. In order to take account of the clear correlations between animal health and welfare, the Commission will present proposals on this regard before the entry into force of this regulation. __________________ 32 a OJ L 47, 18.2.2009, p.5 32b OJ L 203, 3.8.1999, p.53 32c OJ L 182, 12.7.2007, p.19
2013/11/28
Committee: ENVI
Amendment 123 #

2013/0027(COD)

Proposal for a directive
Article 14 – paragraph 2 point a (new)
(a) Commercial software producers shall be held responsible despite non liability clauses in users' agreement in case of gross negligence regarding safety and security.
2014/01/07
Committee: LIBE
Amendment 30 #

2012/2066(INI)

Motion for a resolution
Recital E
E. whereas EU legislation contains nolegal provisions concerning endocrine disrupters, but lacks criteria for determining whether a substance should be regarded as having endocrine-disrupting properties, which undermines proper application of the legal provisions;
2012/11/27
Committee: ENVI
Amendment 37 #

2012/2066(INI)

Motion for a resolution
Recital G
G. whereas the standard data requirements in EU chemicals legislation do not contain any information onare insufficient to adequately identify endocrine-disrupting properties;
2012/11/27
Committee: ENVI
Amendment 42 #

2012/2066(INI)

Motion for a resolution
Paragraph 1
1. Considers, on the basis of an overall assessment of the state of knowledge, that the p on the major adverse and irreversible effects that are cautionary principlesed, likely to be caused and possible to be caused by endocrine disrupters, that there is solid scientific ground not only to requires us as legislators to take measures to reduce human exposure to endocrine disruptors to a minimum, but to do so urgently;
2012/11/27
Committee: ENVI
Amendment 54 #

2012/2066(INI)

Motion for a resolution
Paragraph 2
2. Takes the view that the fearedknown, probable and potential effects of endocrine disruptors are so serious that the absence of precise knowledge, including exact knowledge of causal links, should not prevent us from taking measures to protect humans and animals;
2012/11/27
Committee: ENVI
Amendment 58 #

2012/2066(INI)

Motion for a resolution
Paragraph 2 a (new)
2 a. Considers that calls for full scientific proof of causality before taking any action in the name of "sound science" are in fact motivated by vested interests to delay any action against endocrine disrupters and have nothing to do with good science as they ignore the complexities and irreducible uncertainties referred to in paragraph D;
2012/11/27
Committee: ENVI
Amendment 59 #

2012/2066(INI)

Motion for a resolution
Paragraph 3
3. Calls, therefore, on the Commission to submit as soon as possible proposals for overarching criteria together with for known, probable and potesnting and information requirements for chemicals on the commercial market, and for EU legislation to make clear what is regarded as a substance with endocrine- disrupting properties; advocates considering the introduction of ‘endocrine disruptor’ as a regulatory hazard class; al endocrine disrupters, and to adapt the testing requirements for chemicals including pesticides and biocides accordingly, to ensure that endocrine disrupters on the commercial market can effectively be identified, so that EU legislation can address them adequately; advocates the introduction of ‘endocrine disruptor’ as a regulatory hazard class, with different categories based on the strength of evidence as also applied for CMR substances;
2012/11/27
Committee: ENVI
Amendment 75 #

2012/2066(INI)

Motion for a resolution
Paragraph 5
5. Takes the view that the criteria for defining endocrine disruptors should be based on criteria for defining ‘adverse effect’ and ‘endocrine mode of action’; considers that both these criteria must be weighed up in parallel in order to carry out a comprehensive assessment; considers that proven effects should be assumed to be harmful as long as there is no scientific data to indicate the opposite, unless the opposite can clearly be shown; considers that hormone-related action should be assumed as soon as interaction with the hormone system can be assumed with reasonable certainty; stresses that any possible combination effects should be taken into consideration;
2012/11/27
Committee: ENVI
Amendment 82 #

2012/2066(INI)

Motion for a resolution
Paragraph 6 a (new)
6 a. Strongly disagrees with the attempts to introduce the criterion of 'potency' as a cut-off for the definition of endocrine disrupters, as this would unduly limit the definition of endocrine disrupters, would be scientifically flawed and not coherent with the classification of CMR substances which is based on strength of evidence;
2012/11/27
Committee: ENVI
Amendment 86 #

2012/2066(INI)

Motion for a resolution
Paragraph 7
7. Takes the view that all peer-reviewed scientific studies, including non-GLP studies, should be taken into account, subject to their strengths and weaknesses, in assessing whether a substance does or does not have endocrine- disrupting properties; further considers it important to take account of modern methods and up-to- date research;
2012/11/27
Committee: ENVI
Amendment 88 #

2012/2066(INI)

Motion for a resolution
Paragraph 8
8. Calls on the Commission to introduce in all relevant EU legislation appropriate testing requirements for the identification of substances with endocrine-disrupting properties; considers that the validated and internationally recognised testing methods that have been developed in (for example) the OECD, in EURL ECVAM or under the US EPA Endocrine Disruptor Screening Program must be implemented; notes that the OECD programme of testing methods covers sex hormones and thyroid hormones as well as steroidogenesis; points out, on the other hand, that there are no tests for many other areas of the endocrine system, e.g. insulin and growth hormones; considers that testing methods and guidance documents should be developed so as to take better account of endocrine disruptors, possible low-dose effects and non- monotonic dose-response relationships, in particular with regard to critical windows of exposure during development;
2012/11/27
Committee: ENVI
Amendment 100 #

2012/2066(INI)

Motion for a resolution
Paragraph 10
10. Calls on the Commission, in its review of to revise its EU strategy on endocrine disruptors, to so that it delivers effective protection of human health by placeing greater emphasis on the precautionary principle and work towardsthe need to take preventive action to reducinge human exposure to endocrine disruptors;
2012/11/27
Committee: ENVI
Amendment 110 #

2012/2066(INI)

Motion for a resolution
Paragraph 10 a (new)
10 a. Calls on the Commission to put forward a concrete timetable for applying the future criteria and modified testing requirements for endocrine disrupters in relevant legislation, including reviews of the approval of active substances used in pesticides and biocides, and a roadmap with specific actions and targets to reduce exposure to endocrine disrupters;
2012/11/27
Committee: ENVI
Amendment 135 #

2012/2066(INI)

Motion for a resolution
Paragraph 14
14. Stresses that endocrine disruptors should be regarded as substances for which it is not possible to set a limit value atbelow which effects maydo not occur (‘non-threshold’ substances) and that any exposure to such substances may entail a risk; in the context of REACH, endocrine disrupters should therefore fall under Article 60(4) pursuant to which an authorisation may only be granted if it is shown that socio- economic benefits outweigh the risk to human health or the environment arising from the use of the substances and if there are no suitable alternative substances or technologies;
2012/11/27
Committee: ENVI
Amendment 137 #

2012/2066(INI)

Motion for a resolution
Paragraph 14 a (new)
14 a. Calls on the Commission to review relevant legislation to ensure that relevant combination effects of endocrine disruptors are effectively addressed;
2012/11/27
Committee: ENVI
Amendment 141 #

2012/2066(INI)

Motion for a resolution
Paragraph 15
15. Calls on the Commission to support targeted research projects on endocrine disruptors, including the development of new testing and analysis methods as well as supporting a paradigm shift towards testing of pathways of toxicity;
2012/11/27
Committee: ENVI
Amendment 143 #

2012/2066(INI)

Motion for a resolution
Paragraph 15 a (new)
15 a. Calls on the Commission to establish a financial instrument to finance independent research on endocrine disrupters;
2012/11/27
Committee: ENVI
Amendment 153 #

2012/2066(INI)

Motion for a resolution
Paragraph 17
17. Calls on the Commission to ensure that the criteria for identifying known, probable and potential endocrine disruptors are applied horizontally to all relevant current and future legislation so as to achieve a high level of protection, respectively;
2012/11/27
Committee: ENVI
Amendment 157 #

2012/2066(INI)

Motion for a resolution
Paragraph 17 a (new)
17 a. Stresses that while this resolution is limited to addressing the protection of human health from endocrine disrupters, it is equally important to take decisive action on endocrine disrupters to protect wildlife and the environment;
2012/11/27
Committee: ENVI
Amendment 27 #

2012/2031(INI)

Draft opinion
Paragraph 5
5. Recalls that Article 32 of the Regulation states that the Commission report shall take into account ‘scientific evidence on the welfare needs of animals’, and may be accompanied if necessary by appropriate legislative proposals concerning long journeys; calls on the Commission and the Council, therefore, to review Regulation 1/2005 in order to, inter alia, establish a maximum 8- hour limit for the journeys of animals transported for the purpose of being slaughtered, increase space allowances, and tighten the rules on the transport of pregnant and/or wounded animals;
2012/03/30
Committee: ENVI
Amendment 163 #

2012/2031(INI)

Motion for a resolution
Paragraph 9
9. Insists on a reconsideration of the issue of limiting the transport time of animals destined for slaughter to eight hours, with some exceptions based on geographic conditions, and the option of longer transport of some animal species confirmed by scientific research results, provided that the rules on animal welfare are complied with;Calls on the Commission to come forward with proposals to limit the transport of farmed animals to 8 hours
2012/06/05
Committee: AGRI
Amendment 228 #

2012/2031(INI)

Motion for a resolution
Paragraph 13 a (new)
13 a. Calls on the Commission and the Council to review Regulation 1/2005 to inter alia increase space allowances, and tighten the rules on the transport of pregnant and/or wounded animals;
2012/06/05
Committee: AGRI
Amendment 231 #

2012/2031(INI)

Motion for a resolution
Paragraph 13 b (new)
13 b. Notes that the provisions in the Regulation on transport time, resting time and space allowance are not based on a scientific opinion of SCAHAW or EFSA, but have been taken from the previous Directive; notes with regret that, despite clear conclusions from EFSA, parts of the Regulation are not in line with current scientific knowledge, especially as regards transport of horses, space allowance and internal height of compartments, and that the report is not accompanied by any proposal;
2012/06/05
Committee: AGRI
Amendment 80 #

2012/0366(COD)

Proposal for a directive
Recital 10 a (new)
(10 a) Polonium 210 has been shown to be a significant carcinogen in tobacco. Its presence in cigarettes could be eliminated almost completely by a combination of simple measures. It is thus appropriate to set a maximum yield for Polonium 210 that would result in a reduction of 95% of the current average content of Polonium 210 in cigarettes. An ISO standard to measure Polonium 210 in tobacco should be developed.
2013/05/29
Committee: ENVI
Amendment 101 #

2012/0366(COD)

Proposal for a directive
Recital 15
(15) The likelihood of diverging regulation is further increased by concerns over tobacco products, including smokeless tobacco products, having a characterising having a flavour other than tobacco, which may facilitate uptake of tobacco consumption or affect consumption patterns. For example, in many countries, sales of mentholated products gradually increased even as smoking prevalence overall declined. A number of studies indicated that mentholated tobacco products can facilitate inhalation as well as smoking uptake among young people. Measures introducing unjustified differences of treatment between flavoured cigarettes (e.g. menthol and clove cigarettes) should be avoided . Sweden should be allowed to regulate flavours in snus at a national level. If Sweden fails to do so within a certain period of time, the provisions of this Directive should apply.
2013/05/29
Committee: ENVI
Amendment 156 #

2012/0366(COD)

Proposal for a directive
Recital 24
(24) Tobacco products for smoking, other than cigarettes and roll-your-own tobacco products, which are mainly consumed by older consumers, should be granted an exemption from certain labelling requirements as long as there is no substantial change of circumstances in terms of sales volumes or consumption patterns in relation to young people. The labelling of these other tobacco products should follow specific ruleshould be subject to the same labelling requirements as cigarettes and roll-your-own tobacco products. The visibility of the health warnings on smokeless tobacco products needs to be ensured. Warnings should therefore be placed on the two main surfaces of smokeless tobacco product packaging.
2013/05/14
Committee: ENVI
Amendment 168 #

2012/0366(COD)

Proposal for a directive
Recital 28
(28) In order to ensure independence and transparency, manufacturers of tobacco productMember States should conclude data storage contracts with independent third parties, under the auspices of an external auditor, who should be appointed by the Commission. The data related to the tracking and tracing system should be kept separate from other company related data and be under the control of and accessible at all times by the competent authorities from Member States and the Commission.
2013/05/14
Committee: ENVI
Amendment 179 #

2012/0366(COD)

Proposal for a directive
Recital 30
(30) Cross-border distanceInternet sales of tobacco facilitate access to tobacco products of young people and risk to undermine compliance with the requirements provided for by tobacco control legislation and in particular by this Directive. Common rules on a notification system are necessary to ensure that this Directive achieves its full potential. The provision on notification of cross-border distance sales of tobacco in this Directive should apply notwithstanding the notification procedure set out in Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services , and should therefore be prohibited, in line with the implementing guidelines of the Framework Convention on Tobacco Control. Business to consumer distance sale of tobacco products is further regulated by Directive 97/7/EC of the European Parliament and the Council of 20 May 1997 on the protection of consumers in respect of distance contracts, which will be replaced by Directive 2011/83/EU of the European Parliament and the Council of 25 October 2011 on consumer rights, as of 13 June 2014.
2013/05/14
Committee: ENVI
Amendment 200 #

2012/0366(COD)

Proposal for a directive
Recital 34
(34) 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 use provides a legal framework to assess the quality, safety and efficacy of medicinal products including nicotine containing products. A significant number of nicotine-containing products were already authorised under this regulatory regime. The authorisation takes into account the nicotine content of the product in question. Subjecting all nicotine- containing products, whose nicotine content equals or exceeds the content of aHowever, measuring nicotine delivery has proven to be difficult, as it depends on the products and how they are being used. Therefore, subjecting all nicotine -containing product previously authorised under Directive 2001/83/EC, to the same legal frameworks regardless of their nicotine content to Directive 2001/83/EC clarifies the legal situation, levels out differences between national legislations, ensures equal treatment of all nicotine containing products usable for smoking cessation purposes and creates incentives for research and innovation in smoking cessation. This should be without prejudice to the application of Directive 2001/83/EC to other products covered by this Directive if the conditions set by Directive 2001/83/EC are fulfilled.
2013/05/14
Committee: ENVI
Amendment 205 #

2012/0366(COD)

Proposal for a directive
Recital 35
(35) Labelling provisions should be introduced for nicotine containing products below the threshold set out in this Directive drawing the attention of consumers to potential health risks.deleted
2013/05/14
Committee: ENVI
Amendment 213 #

2012/0366(COD)

Proposal for a directive
Recital 37
(37) In order to ensure uniform conditions for the implementation of this Directive, in particular concerning the format of ingredients reporting, the determination of products with characterising flavours or with increased levels of toxicity and addictiveness and the methodology for determining whether a tobacco product has characterising flavour, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 .
2013/05/14
Committee: ENVI
Amendment 236 #

2012/0366(COD)

Proposal for a directive
Recital 41
(41) Member States should remain free to maintain or introduce national legislations applying to all products alike for aspects falling outside the scope of this Directive, provided they are compatible with the Treaty and do not jeopardise the full application of this Directive. Accordingly, Member States could, for instance, maintain or introduce provisions providing standardisation of packaging of tobacco products provided that those provisions are compatible with the Treaty, with WTO obligations and do not affect the full application of this Directive. A prior notification is required for technical regulations pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and on rules on Information Society services . (If corresponding amendments introducing standardised packaging are not adopted, this amendment should fall.)
2013/05/14
Committee: ENVI
Amendment 355 #

2012/0366(COD)

Proposal for a directive
Article 3 – paragraph 1 – point c a (new)
(ca) 0.002 picocuries of Polonium 210
2013/05/14
Committee: ENVI
Amendment 397 #

2012/0366(COD)

Proposal for a directive
Article 4 – paragraph 1 – subparagraph 2 a (new)
The Commission shall ask ISO to develop a standard to measure Polonium 210 in tobacco.
2013/05/14
Committee: ENVI
Amendment 451 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Member States shall prohibit the placing on the market of tobacco products with a characterising flavour. The use of additives in tobacco products other than those listed in Annex -I, or listed in that Annex but not used in accordance with the conditions laid down in that Annex, shall be prohibited. Annex -I shall only contain substances that do not meet the criteria for classification as hazardous in accordance with Regulation EC (No) 1272/2008, and that do not result in such substances upon combustion. Annex -I shall not contain flavours or substances that increase palatability. The Commission shall be empowered to adopt delegated acts in accordance with Article 22 to establish and modify Annex -I..
2013/05/14
Committee: ENVI
Amendment 479 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 1 – subparagraph 2
Member States shall not prohibit the use of aAdditives which are essential for the manufacture of tobacco products may be included in Annex -I, as long as the additives do not result in a product with a characterising flavourflavour and are not linked to attractiveness of tobacco products.
2013/05/14
Committee: ENVI
Amendment 483 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 1 – subparagraph 3
Member States shall notify the Commission of measures taken pursuant to this paragraph.deleted
2013/05/14
Committee: ENVI
Amendment 486 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 2
2. The Commission shall at the request of a Member State or may on its own initiative determine by means of implementing acts whether a tobacco product falls within the scope of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21. The Commission shall adopt by means of implementing acts uniform rules on the procedures for determining whether a tobacco product falls within the scope of paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21.deleted
2013/05/14
Committee: ENVI
Amendment 512 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 3
3. In case the experience gained in the application of paragraphs 1 and 2 shows that a certain additive or a combination thereof typically imparts a characterising flavourflavour or increases palatability only when it exceeds a certain level of presence or concentration the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to set maximum levels for those additives or combination of additives that cause the characterising flavourby modifying Annex -I accordingly.
2013/05/14
Committee: ENVI
Amendment 516 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 4 – introductory part
4. Member States shall prohibit the use ofAnnex -I shall not contain the following additives in tobacco products:
2013/05/14
Committee: ENVI
Amendment 532 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 5
5. Member States shall prohibit tThe use of flavourings in the components of tobacco products such as filters, papers, packages, capsules or any technical features allowing modification of flavour or smoke intensity shall be prohibited. Filters and capsules shall not contain tobacco.
2013/05/14
Committee: ENVI
Amendment 542 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 7 – subparagraph 1
Member States shallAnnex -I shall not contain, based on scientific evidence, prohibit the placing on the market of tobacco products with additives in quantities that increase in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product.
2013/05/14
Committee: ENVI
Amendment 548 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2
Member States shall notify to the Commission measures taken pursuant to this paragraph.deleted
2013/05/14
Committee: ENVI
Amendment 553 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 8
8. The Commission shall at the request of a Member State or may on its own initiative determine by means of an implementing act whether a tobacco product falls within the scope of paragraph 7. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21 and shall be based on the latest scientific evidence.deleted
2013/05/14
Committee: ENVI
Amendment 559 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 9
9. In case scientific evidence and the experience gained in the application of paragraphs 7 and 8 shows that a certain additive or a certain quantity thereof amplify in an appreciable manner at the stage of consumption the toxic or addictive effect of a tobacco product only when it exceeds a certain level of presence or concentration, including standard safety margins, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to set maximum levels for those additives by modifying Annex -I accordingly.
2013/05/14
Committee: ENVI
Amendment 570 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 10
10. Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco productsFlavours used in tobacco for oral use (snus) shall be exempted from the prohibitvisions laid down in paragraphs 1 and 5. T 1. If Sweden does not take measures on flavours based on the FCTC and its guidelines within four years from the entry into force of this Directive, the Commission shall be empowered to adopt delegated acts in accordance with Article 22 to withdraw this exemption if there is a substantial change of circumstances as established in a Commission report.
2013/05/14
Committee: ENVI
Amendment 583 #

2012/0366(COD)

Proposal for a directive
Article 6 – paragraph 10 a (new)
10 a. In order to obtain the entry of an ingredient in Annex -I, manufacturers and importers shall make an application to the Commission. The application shall be accompanied by the following particulars: (a) name or corporate name and permanent address of the applicant; (b) chemical name of the ingredient; (c) function of the ingredient and maximum quantity to be used per cigarette; and (d) clear evidence supported by scientific data that the ingredient does not fall under any of the exclusion criteria listed in this Article. The Commission may ask the relevant scientific committee whether the ingredient concerned falls under any of the exclusion criteria listed in this Article as such, or only as of a certain concentration. The Commission shall take a decision in accordance with the procedure laid down in paragraph 1 no later than one year after receiving the application.
2013/05/14
Committee: ENVI
Amendment 621 #

2012/0366(COD)

Proposal for a directive
Article 8 – paragraph 3
3. For cigarette packets the general warning and the information message shall be printed on the lateral sides of the unit packets. These warnings shall have a width of not less than 20 mm and a height of not less than 43 mm. For roll-your-own tobacco the information message shall be printed on the surface that becomes visible when opening the unit packet. Both the general warning and the information message shall cover 50% of the surface on which they are printed. For tobacco for smoking other than cigarettes and roll- your-own tobacco, the general warning and the information message shall be printed on the lateral sides of the unit packets. Both the general warning and the information message shall cover 50% of the surface on which they are printed.
2013/05/14
Committee: ENVI
Amendment 677 #

2012/0366(COD)

Proposal for a directive
Article 9 – paragraph 1 – point c
(c) cover 7580 % of the external area of both the front and back surface of the unit packet and any outside packaging;
2013/05/14
Committee: ENVI
Amendment 757 #
2013/05/21
Committee: ENVI
Amendment 897 #

2012/0366(COD)

Proposal for a directive
Article 13 – paragraph 2 a (new)
2a. All outer surfaces of the unit packet and any outside packaging of tobacco for smoking shall be standardised in the following way: (a) not contain any trade mark or any other mark, apart from the brand name and any variant name for the tobacco products; (b) be of a dark, unattractive colour set by the Commission; (c) the brand name, and any variant name shall: (i) not appear more than once on any one surface; (ii) appear horizontally below, and in the same orientation as, the combined health warning, in the centre of the space remaining on the front and back surfaces of the unit packet and any outside packaging; (iii) comply with any more detailed rules set out in paragraph 3.
2013/05/21
Committee: ENVI
Amendment 988 #

2012/0366(COD)

Proposal for a directive
Article 14 – paragraph 6
6. Member States shall ensure that manufacturers and importers of tobacco products conclude data storage contracts with an independent third party, which shall host the data storage facility for data relating to the manufacturers and importer concerneds of tobacco products under their jurisdiction. The data storage facility shall be physically located on the territory of the Union. The suitability of the third party, in particular its independence and technical capacities, as well as the contract, shall be approved and monitored by an external auditor, who is proposed and paid by the tobacco manufacturer and approvointed by the Commission. Member States shall ensure full transparency and accessibility of the data storage facilities for the competent authorities of the Member States, the Commission and the independent third party on a permanent basis. In duly justified cases Member States or the Commission can provide manufacturers or importers access to this information, provided commercially sensitive information remains adequately protected in conformity with the relevant national and Union legislations.
2013/05/14
Committee: ENVI
Amendment 1029 #

2012/0366(COD)

Proposal for a directive
Title 2 – chapter 4 – title
Cross-border distance sSales of tobacco products
2013/05/14
Committee: ENVI
Amendment 1031 #

2012/0366(COD)

Proposal for a directive
Article 16 – title
Cross-border distanceInternet sales of tobacco products
2013/05/14
Committee: ENVI
Amendment 1043 #

2012/0366(COD)

Proposal for a directive
Article 16 – paragraph 1 – introductory part
1. Member States shall oblige retail outlets intending to engage in cross-border distance sales to consumers located in the Union to register with the competent authorities in the Member State where the retail outlet is established and in the Member State where the actual or potential consumer is located. Retail outlets established outside the Union have to register with the competent authorities in the Member State where the actual or potential consumer is located. All retail outlets intending to engage in cross- border distance sales shall submit at least the following information to the competent authorities:prohibit the sale of tobacco products over the internet in their territory. (Should replace the whole article)
2013/05/14
Committee: ENVI
Amendment 1156 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 1 – introductory part
1. The following nNicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC: . (If adopted, paragraphs 1(a) - (c), 2 to 5 of this Article should be deemed to be deleted.)
2013/05/14
Committee: ENVI
Amendment 1173 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 1 – point a
(a) products with a nicotine level exceeding 2 mg per unit, ordeleted
2013/05/14
Committee: ENVI
Amendment 1185 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 1 – point b
(b) products with a nicotine concentration exceeding 4 mg per ml ordeleted
2013/05/14
Committee: ENVI
Amendment 1199 #

2012/0366(COD)

Proposal for a directive
Article 18 – paragraph 1 – point c
(c) products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml.deleted
2013/05/14
Committee: ENVI
Amendment 1309 #

2012/0366(COD)

Proposal for a directive
Article 23 – paragraph 3 a (new)
3 a. Member States shall report every two years to the Commission on the enforcement of the measures taken pursuant to Council Recommendation 2003/54/EC of 2 December 2002 on the prevention of smoking and on initiatives to improve tobacco control , in particular with regard to age limits set in national legislation, as well as their plans to increase the age limit to achieve the goal of a "smoke-free generation".
2013/05/14
Committee: ENVI
Amendment 1330 #

2012/0366(COD)

Proposal for a directive
Article 26 – paragraph 1 a (new)
Member States may allow nicotine containing products which are not in compliance with this Directive to be placed on the market until [Publications Office, please insert the exact date: entry into force + 48 months]:
2013/05/14
Committee: ENVI
Amendment 1332 #

2012/0366(COD)

Proposal for a directive
Article 26 – paragraph 1 – point b
(b) nicotine containing products below the threshold set out in Article 18(1);deleted
2013/05/14
Committee: ENVI
Amendment 1337 #

2012/0366(COD)

Proposal for a directive
Annex 1 a (new)
Annex -I Additives approved for use in tobacco products Chemical name of the additive - function - maximum level permitted
2013/05/14
Committee: ENVI
Amendment 295 #

2012/0192(COD)

Proposal for a regulation
Article 6 – paragraph 1 – point a – point i – indent 3
– the reliability and robustness of the data generated in the clinical trial, based on pre-determined primary outcome parameters, taking account of statistical approaches, design of the trial and methodology (including sample size and pre-determined sub-groups allowing for a stratified analysis by age and gender and randomisation, comparator and endpoints);
2013/03/06
Committee: ENVI
Amendment 13 #

2012/0191(COD)

Proposal for a regulation
Recital 1 a (new)
(1a) Light commercial vehicles are one of the fastest growing sources of transport greenhouse gas (GHG) emissions. Such emissions increased by 26% between 1995 and 2010 and now account for 8% of road transport emissions. Introducing a further target of 85 g/km in 2025 is needed to ensure – a predictable policy framework for vehicle manufacturers in the framework of the necessary continued fuel efficiency improvement of vehicles beyond 2020, and in line with the decarbonisation of the transport sector as part of the Union's climate objectives.
2013/02/28
Committee: ENVI
Amendment 16 #

2012/0191(COD)

Proposal for a regulation
Recital 2
(2) It is appropriate to clarify that for the purpose of verifying compliance with the 2020 target of 147 g CO2/km, CO2 emissions should continue to be measured in accordance with Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information and its implementing measures and innovative technologies. However, studies carried out by the Commission have demonstrated that the test procedures used to measure CO2 emissions under that Regulation have not prevented an increased utilisation of flexibilities by manufacturers which has resulted in alleged CO2 emissions reductions that are not attributed to technological improvements and cannot be achieved in real driving on the road. Therefore, Regulation (EC) No 715/2007 should be reviewed as a matter of urgency in order to ensure that test procedures reflect adequately the real CO2 emissions behaviour of vehicles. This review should, inter alia, address the flexibilities resulting from the use of default load terms and from an upper limit of inertia settings.
2013/02/28
Committee: ENVI
Amendment 21 #

2012/0191(COD)

Proposal for a regulation
Recital 3
(3) According to the technical analysis made for the impact assessment, the technologies to meet the target of 147 g CO2/km are available and the required reductions may be achieved at a lower cost than estimated in the previous analysis carried out previous to the adoption of Regulation (EU) No 510/2011. In addition, the distance between the current average specific emissions of CO2 from new light commercial vehicles and the target has also decreased. Therefore, the feasibility of the target of 147 g CO2/km to be reached by 2020 is confirmedechnical analysis shows that a more stringent target would be technologically feasible and cost-effective. Therefore, the target for 2020 should be set at 110 g CO2/km.
2013/02/28
Committee: ENVI
Amendment 28 #

2012/0191(COD)

Proposal for a regulation
Recital 3 a (new)
(3 a) In view of the high research and development and unit production costs of early generations of ultra-low carbon vehicles it is appropriate to accelerate and facilitate the process of introducing them on the Union market at their initial stages of commercialization through accounting electric and hydrogen fuelled vehicles as zero emissions until 2025. However, whilst the use of certain alternative fuels can offer significant CO2 reductions in a life-cycle perspective, it has been recognised that the CO2 emissions arising from the production of those alternative fuels can be higher than those of conventional fuels. The Commission should therefore introduce metrics that take into account upstream greenhouse gas emissions for the period beyond 2025.
2013/02/28
Committee: ENVI
Amendment 44 #

2012/0191(COD)

Proposal for a regulation
Recital 10 a (new)
(10a) The speed of road vehicles has a strong 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 powertrains and associated inefficiencies in slower operating conditions. It is therefore appropriate to extend the scope of Council Directive 92/6/EEC of 10 February 1992 on the installation and use of speed limitation devices for certain categories of motor vehicles in the Community1, with the aim of including light commercial vehicles covered in this Regulation. _______________ 1 OJ L 57, 2.3.1992, p. 27.
2013/02/28
Committee: ENVI
Amendment 45 #

2012/0191(COD)

Proposal for a regulation
Article 1 – point 1
Regulation (EU) No 510/2011
Article 1 – paragraph 2
2. From 2020, this Regulation sets a target of 14710 g CO2/km for the average emissions of new light commercial vehicles registered in the Union as measured in accordance with Regulation (EC) No 715/2007 and its implementing measures, and innovative technologies.
2013/02/28
Committee: ENVI
Amendment 54 #

2012/0191(COD)

Proposal for a regulation
Article 1 – point 1 a (new)
Regulation (EU) No 510/2011
Article 1 – paragraph 2a (new)
(1a) In Article 1, the following paragraph is added: "2a. From 2025, this Regulation sets a target of 85 g CO2/km as the average emissions of the new light commercial vehicle fleet as measured in accordance with Regulation (EC) No 715/2007 and its implementing measures and Annex XII to Regulation (EC) No 692/2008 ."
2013/02/28
Committee: ENVI
Amendment 63 #

2012/0191(COD)

Proposal for a regulation
Article 1 – point 2 a (new)
Regulation (EU) No 510/2011
Article 5
(2a) Article 5 is deleted.
2013/02/28
Committee: ENVI
Amendment 70 #

2012/0191(COD)

Proposal for a regulation
Article 1 – point 2 b (new)
Regulation (EU) No 510/2011
Article 8 – paragraph 4 a (new)
(2b) In Article 8, the following paragraph is inserted: "4a. Where as a result of the verification of the conformity of production, a Member State, in accordance with Article 12(3) of Directive 2007/46/EC, establishes that the CO2 emissions for a production vehicle deviate significantly from the approved type, that deviation shall be reported to the Commission together with the detailed data specified in Annex II to this Regulation. The specific emissions of CO2 for the vehicle type for which a deviation has been established shall be adjusted accordingly in the calculation of the average specific emissions of CO2 in the following calendar year."
2013/02/28
Committee: ENVI
Amendment 75 #

2012/0191(COD)

Proposal for a regulation
Article 1 – point 4 – point a
Regulation (EU) No 510/2011
Article 13 – paragraph 1
By 31 December 2014, the Commission shall review thecarry out a detailed study of the 85g CO2/km target for 2025, including specific emissions targets, modalities and other aspects of this Regulation in order to establish the CO2 emission targets for new light commercial vehicles forascertain whether the target proves to be appropriate or if a lower target is justified in light of the use of low-emission technologies and their uptake or changes in climate policy objectives. As part of that study, the Commission shall report on the utility parameter to differentiate the speriod beyond 2020cific emissions targets, and may, as appropriate, make proposals to replace weight by another more appropriate utility parameter.
2013/02/28
Committee: ENVI
Amendment 81 #

2012/0191(COD)

Proposal for a regulation
Article 1 – point 4 – point b – indent - 1 a (new)
Regulation (EU) No 510/2011
Article 13 – paragraph 6 – subparagraph 1 a (new)
- the following subparagraph 1a is inserted: "With a view to ensuring that real world emissions are adequately reflected and measured CO2 values are strictly comparable, the Commission shall, in accordance with Article 14(3) of Regulation (EC) No 715/2007, ensure that those elements in the testing procedure that have a significant influence on measured CO2 emissions are strictly defined in order to prevent the utilisation of test cycle flexibilities by manufacturers."
2013/02/28
Committee: ENVI
Amendment 82 #

2012/0191(COD)

Proposal for a regulation
Article 1 – point 4 – point b – indent - 1 b (new)
Regulation (EU) No 510/2011
Article 13 – paragraph 6 – subparagraph 1 b (new)
- the following subparagraph 1b is inserted "For the purpose of verifying that the CO2 emissions of production vehicles conform to the values of the approved type, it shall be ensured that the aerodynamic and rolling resistance values are obtained from the vehicle for which conformity of production is being verified."
2013/02/28
Committee: ENVI
Amendment 83 #

2012/0191(COD)

Proposal for a regulation
Article 1 – point 4 – point b – indent 1
Regulation (EU) No 510/2011
Article 13 – paragraph 6 – subparagraph 2
– the second subparagraph is deleted;
2013/02/28
Committee: ENVI
Amendment 85 #

2012/0191(COD)

Proposal for a regulation
Article 1 – point 5
Regulation (EU) No 510/2011
Annex I – point 1 – point c – formula
Indicative specific emissions of CO2 = 14710 + a × (M – M0)
2013/02/28
Committee: ENVI
Amendment 94 #

2012/0191(COD)

Proposal for a regulation
Article 1 – point 5 a (new)
Regulation (EU) No 510/2011
Annex I – point 1 – point ca (new)
(5a) In point 1 of Annex I, the following point is added: "(ca) From 2025: Specific emissions of CO2 = 85 + a × (M – M0) Where: M = mass of the vehicle in kilograms (kg) M 0 = the value adopted pursuant to Article 13(2) a = 0.093"
2013/02/28
Committee: ENVI
Amendment 96 #

2012/0191(COD)

Proposal for a regulation
Article 1 – point 5 b (new)
Directive 92/6/EEC
Articles 1 and 2
(5b) Amendment to Directive 92/6/EEC Council Directive 92/6/EEC1 is hereby amended, with effect from ...*, as follows: (a) Article 1 is replaced by the following: "For the purposes of this Directive, "motor vehicle" means any power-driven vehicle falling within category M2, M3, N1, N2 or N3, intended for use on the road and having at least four wheels and a maximum design speed exceeding 25 km/h. Categories M2, M3, N1, N2 and N3 shall be understood to be those defined in Annex II to Directive 70/156/EEC2." (b) In Article 2, the first paragraph is replaced by the following: "Member States shall take the necessary measures to ensure that motor vehicles of categories N1 (class 2 and 3), N2, M2 and M3 referred to in Article 1 may be used on the road only if equipped with a speed limitation device set in such a way that their speed cannot exceed 100 kilometres per hour." ____________ * OJ please insert the date: one year after the date of entry into force of this Regulation. 1 OJ L 57, 2.3.1992, p. 27. 2 OJ L 42, 23.2.1970, p. 1.
2013/02/28
Committee: ENVI
Amendment 17 #

2012/0179(COD)

Proposal for a regulation
Recital 2 a (new)
(2a) The Union notes in particular paragraphs 83(a) of UNGA Resolution 61/105 and paragraphs 119(a) and 120 of UNGA Resolution 64/72 calling on flag States to not authorize bottom fishing activities until these resolutions have been fully implemented, including the requirement to assess, on the basis of the best available scientific information, whether individual bottom fishing activities would have significant adverse impacts on vulnerable marine ecosystems.
2013/02/25
Committee: ENVI
Amendment 18 #

2012/0179(COD)

Proposal for a regulation
Recital 3 a (new)
(3a) The capacity of vessels with deep-sea fishing permits has been limited since 2002 to the aggregate capacity of all the vessels that caught more than 10 tonnes of any mixture of deep-sea species in any of the years 1998, 1999 or 2000. The Commission evaluation concluded that this capacity ceiling had no substantial positive effect. Given the past experience and the lack of accurate data in many deep-sea fisheries, it is inadequate to manage these fisheries by means of effort limits only.
2013/02/25
Committee: ENVI
Amendment 19 #

2012/0179(COD)

Proposal for a regulation
Recital 11
(11) Vessels targeting deep-sea species with other bottom gear should not extend their range of operation according to their authorisation within Union waters, unless expansion can be assessed as not carrying a significant risk of negative impact on vulnerable marine ecosystems. Impact assessments carried out to that effect must conform to the requirements referred to in paragraph 47 of the 2008 FAO Guidelines for the Management of Deep-Sea Fisheries.
2013/02/25
Committee: ENVI
Amendment 21 #

2012/0179(COD)

Proposal for a regulation
Recital 12 a (new)
(12a) Given the mixed nature of most deep-sea fisheries, fishing opportunities for deep-sea fishing should be established in a way that ensures the long-term conservation of the most vulnerable species caught in the fisheries involved.
2013/02/25
Committee: ENVI
Amendment 22 #

2012/0179(COD)

Proposal for a regulation
Recital 13
(13) Scientific advice further indicates that fishing effort limits are an appropriate instrumentGiven the lack of accurate data in most deep-sea fisheries and the mixed nature of most of them, fishing effort limits should only be used in combination with catch limits for fixing fishing opportunities for deep-sea fisheries. In view of the large variety of gears and fishing patterns present in deep-sea fisheries, and the need to develop accompanying measures tackling the environmentally weak points of the fisheries individually, fishing effort limits should only replace catch limits when it can be ensured that they arneed to be adapted to specific fisheries.
2013/02/25
Committee: ENVI
Amendment 23 #

2012/0179(COD)

Proposal for a regulation
Recital 15 a (new)
(15a) A high number of species are caught in deep-sea fisheries, including vulnerable species of deep-sea sharks. An obligation to land all catches of fish and non-fish species should be introduced in deep-sea fisheries. Such an obligation could greatly contribute to fill the existing data gaps in these fisheries and to better understand their impact on the wide range of species caught.
2013/02/25
Committee: ENVI
Amendment 24 #

2012/0179(COD)

Proposal for a regulation
Recital 17
(17) Holders of a fishing authorisation allowing for the catch of deep-sea species should lose their authorisation as far as the catching of deep-sea species is concerned if they do not comply with relevant conservamanagement, conservation and data collection measures.
2013/02/25
Committee: ENVI
Amendment 25 #

2012/0179(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point a
(a) to ensure the sustainable management and exploitation of deep-sea specfisheries while minimising the impact of deep-sea fishing activities on the marine environment;
2013/02/25
Committee: ENVI
Amendment 26 #

2012/0179(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point a a (new)
(aa) to prevent significant adverse impacts on vulnerable marine ecosystems and ensure the long-term conservation of deep-sea fish stocks;
2013/02/25
Committee: ENVI
Amendment 27 #

2012/0179(COD)

Proposal for a regulation
Article 3 – paragraph 2 – point e
(e) ‘most vulnerable species’ means the deep- sea species indicathighly susceptible to depletion which shall be included in the third column ‘Most vulnerable (x)’ of the table in Annex I;. All species of deep-sea sharks shall fall under this category.
2013/02/25
Committee: ENVI
Amendment 28 #

2012/0179(COD)

Proposal for a regulation
Article 5 – paragraph 1 a (new)
Member States shall conduct annual capacity assessments of their fleet targeting deep-sea species and transmit the results to the Commission by 30 May of each year. Capacity assessments shall include an analysis of the total fleet capacity and its impact on stocks and the wider marine ecosystem. They shall also include an analysis of the long-term profitability of the fleet. To ensure a common approach to such assessments across all Member States, assessments shall be carried out in accordance with the Commission’s guidelines for an improved analysis of the balance between fleet capacity and fishing opportunities. The assessments shall be made publicly available.
2013/02/25
Committee: ENVI
Amendment 29 #

2012/0179(COD)

Proposal for a regulation
Article 6 – paragraph 1
Each application for a fishing authorisation allowing for the catch of deep-sea species whether as target or by- catch species, and for its renewal shall be accompanied by a description of the area where it is intended to conduct fishing activities, the typeincluding its boundaries, the type and quantity of gears, the depth range at which the activities will be deployed, and of the individual species targeted.
2013/02/25
Committee: ENVI
Amendment 30 #

2012/0179(COD)

Proposal for a regulation
Article 6 – paragraph 1 a (new)
From 1 January 2015 no fishing authorisation shall be issued for deep-sea species in an area which has not been subject to a prior impact assessment in accordance with the criteria laid down in Annex IIa to this Regulation. The impact assessments should be made publicly available and reviewed by a scientific advisory body.
2013/02/25
Committee: ENVI
Amendment 31 #

2012/0179(COD)

Proposal for a regulation
Article 7 – paragraph 1 – point b a (new)
(ba) Prior to granting an application Member States shall verify through the VMS record of such vessels that the information submitted following paragraph (b) is accurate. If the information provided under paragraph (b) does not match that in the VMS record the application shall not be granted.
2013/02/25
Committee: ENVI
Amendment 32 #

2012/0179(COD)

Proposal for a regulation
Article 7 – paragraph 2
2. Any fishing authorisation issued on the basis of an application made in accordance with paragraph 1 shall specify the bottom gear to be used and limit the fishing activities authorised to the area in which the intended fishing activity, as set out in paragraph 1(a), and the existing fishing activity, as set out in paragraph 1(b), overlap. However, tThe area of the intended fishing activity can be extended beyond the area of the existing fishing activity only if the Member State has assessed and documented, baconducted an impact assessment following the requirements sedt on scientific advice,ut in Annex IIa, which demonstrates that such extension would not have significant adverse impacts on vulnerable marine ecosystems.
2013/02/25
Committee: ENVI
Amendment 33 #

2012/0179(COD)

Proposal for a regulation
Article 10 a (new)
Article 10a Obligation to land all deep-sea catches All catches of fish and non-fish species made by a fishing vessel holding an authorisation to catch deep-sea species shall be brought and retained on board the fishing vessels, recorded in the logbook and landed.
2013/02/25
Committee: ENVI
Amendment 34 #

2012/0179(COD)

Proposal for a regulation
Article 10 – paragraph 1
1. Fishing opportunities shall be fixed at a rate of exploitation of the deep-sea species concerned that is consistent withensures that populations of deep-sea species are maintained or restored above levels which can produce maximum sustainable yield.
2013/02/25
Committee: ENVI
Amendment 35 #

2012/0179(COD)

Proposal for a regulation
Article 10 – paragraph 2 a (new)
2a. Fishing opportunities set for deep-sea species shall take into account the probable composition of the catch in these fisheries and shall ensure the long-term sustainability of all harvested species.
2013/02/25
Committee: ENVI
Amendment 37 #

2012/0179(COD)

Proposal for a regulation
Chapter 3 – section 2 – title
Management by fFishing effort limits and accompanying measures
2013/02/25
Committee: ENVI
Amendment 38 #

2012/0179(COD)

Proposal for a regulation
Article 11 – title
Fishing opportunities by means of fishing effort limits only
2013/02/25
Committee: ENVI
Amendment 39 #

2012/0179(COD)

Proposal for a regulation
Article 11 – paragraph 1
1. The Council, acting in accordance with the Treaty, may decide to switch from the fixing offix annual fishing opportunities for deep-sea species in terms of both fishing effort limits and catch limits to the fixing of only fishing effort limits for specific fisheries.
2013/02/25
Committee: ENVI
Amendment 40 #

2012/0179(COD)

Proposal for a regulation
Article 11 – paragraph 2
2. For the purposes of paragraph 1, the fishing effort levels for each deep-sea métier that shall be used as a baseline for any adjustments required in order to follow the principles set out in Article 10 shall be the fishing effort levels assessed, based on scientific information, as consistent with the cratches made by the relevant deep-sea métiers during the previous two calendar yearsof exploitation established in accordance with Article 10.
2013/02/25
Committee: ENVI
Amendment 41 #

2012/0179(COD)

Proposal for a regulation
Article 11 – paragraph 3 – point a
(a) the specific deep-sea métier to which the fishing effort limit applies by reference to the regulated gear, the specietype and amount of gear allowed, the species and specific stocks targeted and the ICES zones or CECAF areas within which the allowed effort may be deployed; and
2013/02/25
Committee: ENVI
Amendment 42 #

2012/0179(COD)

Proposal for a regulation
Article 11 – paragraph 3 – point b
(b) the fishing effort unit or combination of units to be used for management.
2013/02/25
Committee: ENVI
Amendment 43 #

2012/0179(COD)

Proposal for a regulation
Article 11 – paragraph 3 – point b a (new)
(ba) methods and protocols for the monitoring and reporting of effort levels during a management period.
2013/02/25
Committee: ENVI
Amendment 44 #

2012/0179(COD)

Proposal for a regulation
Article 12 – paragraph 1 – introductory part
1. Where annual fishing effort limits have replaced catch limits in accordance with Article 11(1), Member States shall maintain or put in place, in respect of their flagged vessels the following accompanying measures:
2013/02/25
Committee: ENVI
Amendment 45 #

2012/0179(COD)

Proposal for a regulation
Article 12 – paragraph 1 – point a
(a) measures to avoid an increase of the overall catching capacity of the vessels concerned by the effort limits established following Article 11.
2013/02/25
Committee: ENVI
Amendment 46 #

2012/0179(COD)

Proposal for a regulation
Article 12 – paragraph 1 – point b
(b) measures to avoid an increase inminimize by- catches in deep-sea fisheries, of most vulnerable species in particular; and
2013/02/25
Committee: ENVI
Amendment 47 #

2012/0179(COD)

Proposal for a regulation
Article 12 – paragraph 3
3. The Commission shall assess the effectiveness of the accompanying measures adopted by Member States upon their adoption, as well as annually thereof.
2013/02/25
Committee: ENVI
Amendment 49 #

2012/0179(COD)

Proposal for a regulation
Article 18 – paragraph 1 – point b
b) failure to comply with the data collection requirements, including the obligation to take on board a scientific observer or to allow sampling of catches for scientific purposes as specified in Article 19 of this Regulation.
2013/02/25
Committee: ENVI
Amendment 17 #

2012/0066(COD)

Proposal for a directive
Title 1
Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of [...] amending Directive 2006/66/EC on batteries and accumulators and waste batteries and accumulators as regards the placing on the market of portable batteries and accumulators containing cadmium intended for use in cordless power tools, of button cells with low mercury content, and on ready removability of batteries and accumulators
2012/12/11
Committee: ENVI
Amendment 19 #

2012/0066(COD)

Proposal for a directive
Recital 4
(4) The existing exemption for that use should continue to apply until 31 December 2015 in order to enable industry to further adapt the relevant technologiesno longer apply after 30 June 2014.
2012/12/11
Committee: ENVI
Amendment 23 #

2012/0066(COD)

Proposal for a directive
Recital 4 a (new)
(4 a) The definition of 'placing on the market' should be aligned with the definition used in Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.
2012/12/11
Committee: ENVI
Amendment 26 #

2012/0066(COD)

Proposal for a directive
Article 1 – point -1 (new)
Directive 2006/66/EC
Article 3 – point 13 a (new)
-1. In Article 3 the following point (13a) is inserted: '(13a)'making available on the market' means any supply of a battery or an accumulator for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;'
2012/12/11
Committee: ENVI
Amendment 27 #

2012/0066(COD)

Proposal for a directive
Article 1 – point -1a (new)
Directive 2006/66/EC
Article 3 – point 14
-1a. In Article 3 point (14) of is replaced by the following: 'placing on the market' means making available an EEE on the Union market for the first time;'
2012/12/11
Committee: ENVI
Amendment 28 #

2012/0066(COD)

Proposal for a directive
Article 1 – point - 1b (new)
Directive 2006/66/EC
Article 4 – paragraph 2
-1b. Article 4(2) is replaced by the following: '2. The prohibition set out in paragraph 1(a) shall not apply to button cells with a mercury content of no more than 2% by weight until 30 June 2014.'
2012/12/11
Committee: ENVI
Amendment 33 #

2012/0066(COD)

Proposal for a directive
Article 1 – point 1
(c) cordless power tools, until 31 December0 June 20154.
2012/12/11
Committee: ENVI
Amendment 37 #

2012/0066(COD)

Proposal for a directive
Article 1 – point 1 a (new)
1a. Article 6(2) is replaced by the following: '2. Member States shall take the necessary measures to ensure that batteries or accumulators which do not meet the requirements of this Directive are not placed on the market. Member States shall take the necessary measures to ensure that batteries or accumulators which do not meet the requirements of this Directive are no longer made available on the market one year after the respective phase-out date. Batteries and accumulators which do not meet the requirements of this Directive and which are placed on the market after the respective phase-out dates shall be withdrawn from the market.
2012/12/11
Committee: ENVI
Amendment 44 #

2012/0066(COD)

Proposal for a directive
Article 1 – point 2 a (new)
Directive 2006/66/EC
Article 11
2a. Article 11 is replaced by the following: 'Removal of waste batteries and accumulators Member States shall ensure that manufacturers design appliances in such a way that waste batteries and accumulators can be readily removed by the end-user. Appliances into which batteries and accumulators are incorporated shall be accompanied by instructions showing how they can be removed safely by the end-user and, where appropriate, informing the end- user of the type of the incorporated batteries and accumulators. These provisions shall not apply where, for safety, performance, medical or data integrity reasons, continuity of power supply is necessary and requires a permanent connection between the appliance and the battery or accumulator.'
2012/12/11
Committee: ENVI
Amendment 46 #

2012/0066(COD)

Proposal for a directive
Article 2 – paragraph 1
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1(1) of this Directive by 182 months after entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions.
2012/12/11
Committee: ENVI
Amendment 1 #

2011/2308(INI)

Motion for a resolution
Citation 6 a (new)
- having regard to Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds,[1][1] OJ L 020 26.01.2010, p. 7
2012/05/29
Committee: ENVI
Amendment 2 #

2011/2308(INI)

Motion for a resolution
Citation 7
– having regard to Directive 2008/110/75/ECU of the European Parliament and of the Council of 15 January 2008 concerning 24 November 2010 on industrial emissions (integrated pollution prevention and control (IPPC Directive)7 )[1][1] OJ L 334 17.12.2010, p. 17,
2012/05/29
Committee: ENVI
Amendment 4 #

2011/2308(INI)

Motion for a resolution
Citation 10 a (new)
- having regard to Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading (as amended)[1]; and Decision 406/2009/EC of the European Parliament and of the Council of 23 April2009 on the effort of Member States to reduce their greenhouse gas emissions to meet the Community's greenhouse gas emission reduction commitments up to 2020[2],[1] OJ L 338 13.11.2004, p. 18-23 [2] OJ L 140 05.06.2009, p. 136
2012/05/29
Committee: ENVI
Amendment 5 #

2011/2308(INI)

Motion for a resolution
Citation 11 a (new)
- having regard to 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 (aligning existing EU legislation to the United Nations Globally Harmonised System (GHS))[1][1] OJ L 353, 31.12.2008, p.1
2012/05/29
Committee: ENVI
Amendment 6 #

2011/2308(INI)

Motion for a resolution
Citation 17 a (new)
- having regard to Petitions 886/2011 (on extraction of shale gas in Poland) and 1378/2011(on the risks associated with shale gas exploration and extraction in Bulgaria) of the Committee on Petition.
2012/05/29
Committee: ENVI
Amendment 8 #

2011/2308(INI)

Motion for a resolution
Citation 18
– having regard to Articles 4, 11, 191, 192, 193 and 194 of the Treaty on the Functioning of European Union,
2012/05/29
Committee: ENVI
Amendment 10 #

2011/2308(INI)

Motion for a resolution
Recital A
A. whereas recent technological advancements have already spurred a rapid, commercial-scale extraction of unconventional fossil fuels (UFF) in certain parts of the world, significantlyperceived as increasing energy security, strengthening the overall economy and increasing employment, competitiveness and innovativeness, however resulting also in significant negative impacts on the environment and public health;
2012/05/29
Committee: ENVI
Amendment 13 #

2011/2308(INI)

Motion for a resolution
Recital A a (new)
Aa. whereas hydraulic fracturing and extraction of unconventional fossil fuels contradict EU climate objectives, risk delaying the necessary economic transition away from fossil fuels and have negative impacts on employment, competitiveness and innovation in other economic sectors, in particular agriculture, tourism, and other activities dependent on water and ecosystem services;
2012/05/29
Committee: ENVI
Amendment 19 #

2011/2308(INI)

Motion for a resolution
Recital B
B. whereas the Energy Roadmap 2050 indentifies that gas willcould be critical for the transformation of the energy system by helping to reduce emissions; whereas the EP resolution on Low Carbon Roadmap 2050 acknowledges that power sector needs to practically decarbonise by 2050; whereas the Commission notes that shale gas and other UFF willcould become a verypotential important new source of supply in or around Europe;
2012/05/29
Committee: ENVI
Amendment 28 #

2011/2308(INI)

Motion for a resolution
Recital C
C. whereas the two maincombination of two techniques deployed in unleashing the UFF potential of shale gas and coal bed methane, horizontal drilling and hydraulic fracturing, have been used for decades; should not be mistaken for well stimulation techniques used for the extraction of conventional fossil fuels due to the combination of these two techniques and the scale of intervention involved;
2012/05/29
Committee: ENVI
Amendment 33 #

2011/2308(INI)

Motion for a resolution
Recital D
D. whereas important analysis is still ongoing and there is a growing need for further and continuous research; whereas the existence and transparency of data, sampling and tests is paramount to high- quality research in support of proper regulation that will protect public health and the environment;
2012/05/29
Committee: ENVI
Amendment 35 #

2011/2308(INI)

Motion for a resolution
Recital E
E. whereas any type of fossil fuel and mineral extraction involves potential risks for the environmenthuman health and the environment, including those triggered by climate change; whereas it is essential that a precautionary principle be applied to any future decisions about the development of fossil fuel resources in Europe in order to minimise such risks via , taking into accountinuous research, proper management, regulation and monitoring at potential impacts from all stages of the exploration and exploitation process;
2012/05/29
Committee: ENVI
Amendment 42 #

2011/2308(INI)

Motion for a resolution
Recital E a (new)
E a. whereas many governments in Europe, such as France, Bulgaria, North Rhine Westphalia in Germany, Fribourg and Vaud in Switzerland, as well as a number of US states (North Carolina, New York, New Jersey, and Vermont and more than 100 local governments) and other countries around the world (South Africa, Quebec in Canada, New South Wales in Australia) currently have a ban or moratorium in place on the use of hydraulic fracturing for the extraction of oil and gas from shale or other 'tight' rock formations;
2012/05/29
Committee: ENVI
Amendment 43 #

2011/2308(INI)

Motion for a resolution
Recital E b (new)
E b. whereas a number of Member States, such as the Czech Republic, Romania and Germany, are currently considering a moratorium on the exploration and extraction of oil and gas from shale or other 'tight' rock formations;
2012/05/29
Committee: ENVI
Amendment 48 #

2011/2308(INI)

Motion for a resolution
Paragraph 1 a (new)
1 a. Urges Member States to not allow further shale gas, shale oil and coal bed methane activities to proceed given the serious environmental and health risks involved in hydraulic fracturing to extract shale gas;
2012/05/29
Committee: ENVI
Amendment 54 #

2011/2308(INI)

Motion for a resolution
Paragraph 1 b (new)
1 b. Points out that full utilisation of current discovered carbon resources would already be completely incompatible with maintaining climate change to any safe limits, therefore considers that UFF are over-evaluated and have significant investments insecurity as it is will not be possible to exploit them;
2012/05/29
Committee: ENVI
Amendment 56 #

2011/2308(INI)

Motion for a resolution
Paragraph 2
2. Believes that, given the relative novelty of UFF to the general public, a thorough assessment should be conductedhydraulic fracking and UFF must be subject to a thorough human health and environmental impact assessment on the basis of the European regulatory framework and improvement measures taken, where necessary, in line with Treaty principles;
2012/05/29
Committee: ENVI
Amendment 61 #

2011/2308(INI)

Motion for a resolution
Paragraph 3
3. Stresses that prevailing expert opinion indicates thatWhile some of the inherent risks of UFF extraction, most of which are are partly common to conventional fossil fuel extraction, and could be contained through pre-emptive measures, including proper planning, testing, use of new technologies, best practices and continuous data collection, monitoring and reporting; considers that as a minimum it is necessary to require measuring for baseline levels of naturally occurring methane and chemicals in groundwater in aquifers, and current air quality levels at potential drilling sites, before the beginning of new hydraulic fracturing or other UFF exploration or extraction;
2012/05/29
Committee: ENVI
Amendment 65 #

2011/2308(INI)

Motion for a resolution
Paragraph 4
4. Welcomes the Commission's preliminary assessment on the EU environmental legal framework applicable to UFFhydraulic fracturing; urges the Commission to use its powers regarding proper transposition and application of key EU environmental acts in all Member States, and issue without delay guidance on the establishment of baseline water monitoring data necessary for environmental impact assessment of shale gas exploration and extraction, as well as criteria to be used for assessing impacts of hydraulic fracturing to groundwater reservoirs in different geological formations, including potential leakage, and cumulative impacts;
2012/05/29
Committee: ENVI
Amendment 67 #

2011/2308(INI)

Motion for a resolution
Paragraph 4 a (new)
4 a. Calls on the Commission introduce an EU-wide risk management framework for unconventional fossil fuels exploration or extraction, in view of ensuring that harmonised provisions for the protection of human health and the environment apply across all Member States;
2012/05/29
Committee: ENVI
Amendment 68 #

2011/2308(INI)

Motion for a resolution
Paragraph 4 b (new)
4 b. Notes that methane is a powerful greenhouse gas, the emissions of which must be fully accounted for under either Directive 2003/87 (ETS) or Decision 406/2009 (the 'effort sharing decision');
2012/05/29
Committee: ENVI
Amendment 71 #

2011/2308(INI)

Motion for a resolution
Paragraph 6
6. Stresses that proper regulation of UFF exploration and extraction ultimately depends on the competence and resources of the relevant national authorities; calls on Member States, therefore, to ensure proper training and international exchafull compliance with existing EU legislation, sufficient human and technical capacities for monitoring, inspection and enforcement of permitted activities, includinge programmesper training for the staff of the competent national authorities, and to establish a coordinating platform to oversee the UFF responsibilities of the various competent authorities;
2012/05/29
Committee: ENVI
Amendment 75 #

2011/2308(INI)

Motion for a resolution
Paragraph 7
7. Notes the importance of the work undertaken by reputable institutions, notably the International Energy Agency (IEA), to prepare a comprehensive Best Available Techniques (BAT) reference document on hydraulic fracturing; calls on the Commission to cooperate with the Member States, the IEA and industry associations to this endguidance on best practice regarding regulations for unconventional gas and hydraulic fracturing;
2012/05/29
Committee: ENVI
Amendment 79 #

2011/2308(INI)

Motion for a resolution
Paragraph 7 a (new)
7 a. Calls on the Commission to include shale gas extraction under the Industrial Emissions Directive and requirements regarding Best Available Techniques, in addition to the waste treatment requirements under Mining Waste Directive;
2012/05/29
Committee: ENVI
Amendment 82 #

2011/2308(INI)

Motion for a resolution
Paragraph 9
9. Recognises that industry bears primary responsibility for preventing and reacting to accidents and calls for Member States to require from operators sufficient compulsory financial guarantees for environmental and civil liability for responding to any accidents or unintended negative impacts, at all stages of exploration, exploitation and dismantling; welcomes the progress made by the industry in setting high environmental and safety standards, but notes that strong concerns about the sufficiency of such standards still exists; stresses the importance of monitoring the industry's compliance by means of regular inspections carried out by trained and independent specialists;
2012/05/29
Committee: ENVI
Amendment 84 #

2011/2308(INI)

Motion for a resolution
Paragraph 10
10. Calls on the Commission to introduce opportunities for funding research projects in environmentally ameliorative UFF technologies within the framework of EU research and development (R&D) programmes such as Horizon 2020 and the European Strategic Energy Technology Plan (SET)energy companies active in the field of UFF extraction to invest in research in improving the environmental performance of UFF technologies; urges EU-based undertakings and academic institutions to develop relevant cooperative R&D programmes leading to greater safety inunderstanding about the safety and risks in UFF exploration and production (E&P) operations;
2012/05/29
Committee: ENVI
Amendment 87 #

2011/2308(INI)

Motion for a resolution
Paragraph 10 a (new)
10 a. Recalls the G20 commitment to phase out fossil fuels subsidies; concludes consequently that exploration and exploitation of fossil fuels sources, including unconventional sources, must not be subsidised from public funds;
2012/05/29
Committee: ENVI
Amendment 88 #

2011/2308(INI)

Motion for a resolution
Paragraph 10 b (new)
10 b. Considers that mutual non- disclosure agreements regarding damage to environmental, human and animal health, that have been practiced between landowners in the vicinity of shale gas wells and shale gas operators in the US would not be in line with Union and Member State obligations under the Aarhus convention, the Access to Information directive (2003/04/EC) and the Environmental Liability Directive;
2012/05/29
Committee: ENVI
Amendment 89 #

2011/2308(INI)

Motion for a resolution
Paragraph 11
11. Acknowledges that the types of rocks present in each individual region determine the design and method of extraction activities; calls for mandatory pre- authorisation precedingbaseline analysis of groundwater and geological analysis of the deep and shallow geology of a prospective shale play prior to authorisation, including reports on any past or present mining activities in the region;
2012/05/29
Committee: ENVI
Amendment 92 #

2011/2308(INI)

Motion for a resolution
Paragraph 11 a (new)
11 a. Calls on the Commission to bring forward proposals to ensure Environmental Impact Assessment Directive provisions adequately cover the specificities of shale gas, shale oil, and coal bed methane exploration and extraction; insists that prior environmental impact assessment include full life cycle impacts on air quality, soil quality, water quality, geological stability, land use and noise pollution;
2012/05/29
Committee: ENVI
Amendment 95 #

2011/2308(INI)

Motion for a resolution
Paragraph 11 b (new)
11 b. Calls on the Commission to include hydraulic fracturing in Annex III of the Environmental Liability Directive and to require compulsory financial security or insurance in case of environmental damage;
2012/05/29
Committee: ENVI
Amendment 96 #

2011/2308(INI)

Motion for a resolution
Paragraph 11 c (new)
11 c. Considers it appropriate, in context of liability, considers it appropriate to provide for the reversal of the burden of proof for shale gas operators, where, in view of the nature of the disturbance and its adverse effects, other possible causes and any other circumstances, the balance of probability indicates that shale gas operations were the cause of the environmental damage;
2012/05/29
Committee: ENVI
Amendment 97 #

2011/2308(INI)

Motion for a resolution
Paragraph 11 d (new)
11 d. Calls on the Commission to bring forward proposals to explicitly include fracking fluids as 'hazardous waste' under Annex III of the European Waste Directive (2008/98/EC);
2012/05/29
Committee: ENVI
Amendment 98 #

2011/2308(INI)

Motion for a resolution
Paragraph 12
12. Recognises the relatively high water volumes involved in hydraulic fracturing; points out, however, that such volumes are not as significant in comparison to the needs of other industrial activities; highlights the need for advance water provision plans based on local hydrology; highlights the need for advance water provision plans based on local hydrology taking into account other competing water users, to inform the integrated environment and health impact assessment;
2012/05/29
Committee: ENVI
Amendment 106 #

2011/2308(INI)

Motion for a resolution
Paragraph 12 a (new)
12 a. Recalls that Water Framework Directive requires Member States to implement the measures necessary to prevent the deterioration of the status of all bodies of groundwater, including from point sources such as hydrocarbon exploration and extraction;
2012/05/29
Committee: ENVI
Amendment 109 #

2011/2308(INI)

Motion for a resolution
Paragraph 13
13. Believes that, given the depth (over 3km) at which hydraulic fracturing takes place, the main immediate concern regarding groundwater contamination is often well integrity and; the quality of casing and cementing, including its ability to resist the high pressure of the liquid injected and the generated earth tremors, in addition to the concern related to the release and travel of hazardous chemicals and naturally occurring radioactive substances to water reservoirs;
2012/05/29
Committee: ENVI
Amendment 113 #

2011/2308(INI)

Motion for a resolution
Paragraph 13 a (new)
13 a. Concurs with the Commission analysis that Article 11 (3)(j) of the Water Framework Directive does not allow the injection of flow back water for disposal into geological formations;
2012/05/29
Committee: ENVI
Amendment 117 #

2011/2308(INI)

Motion for a resolution
Paragraph 14
14. Stresses that effective prevention requires consistent monitoring of strict adherence to the established highest standards and practices in well-bore construction; underlines that both industry and competent authorities should ensure regular quality control for casing and cement integrity; points out that this requires significant human resources and technical expertise taking into account also the very high well density of such operations;
2012/05/29
Committee: ENVI
Amendment 122 #

2011/2308(INI)

Motion for a resolution
Paragraph 16
16. Believes that on-site closed-loop water recycling, using steel storage tanks, offers the most environmentally sound way of treating flow-back water by minimising water volumes, the potential for surface spills and costs/traffic/road damage relating to water treatment transportation; rejects injection of flow back waste waters for disposal;
2012/05/29
Committee: ENVI
Amendment 133 #

2011/2308(INI)

Motion for a resolution
Paragraph 18
18. Considers that there should be a mandatory obligation to declare the chemical content of fracturing fluidby any operator to disclose the information referred to in REACH Article 119(1) and (2) about all the chemicals to be used in fracturing fluid and to make publicly available the exposure scenarios and proposed risk reduction measures; maintains that full transparency and disclosure should be required of operators prior to any drilling ;
2012/05/29
Committee: ENVI
Amendment 136 #

2011/2308(INI)

Motion for a resolution
Paragraph 18 a (new)
18 a. Calls on the Commission to request the European Chemicals Agency to conduct a manual analysis of registration dossiers, their updates and the notifications submitted by downstream user companies with regard to chemicals likely to be used in hydraulic fracturing for natural gas, oil or coal bed methane, so as to check whether the related exposure scenarios and risk management measures are adequate, within the times required by the REACH law, and report by end of 2012;
2012/05/29
Committee: ENVI
Amendment 140 #

2011/2308(INI)

Motion for a resolution
Paragraph 19
19. Notes that multi-horizontal-well drilling pads minimise land use and landscape disturbance over a larger area, but intensifies the impacts at the point of drilling over a longer period of time;
2012/05/29
Committee: ENVI
Amendment 143 #

2011/2308(INI)

Motion for a resolution
Paragraph 19 a (new)
19 a. Notes that the production volumes of shale gas wells in the United States are characterized by a sharp decline after the first two years, which leads to a high intensity of continuous drilling for new wells, notes that the storage tanks, compressor stations and pipeline infrastructure further add to the land use impact of the shale gas activities;
2012/05/29
Committee: ENVI
Amendment 148 #

2011/2308(INI)

Motion for a resolution
Paragraph 19 b (new)
19 b. Points out that any favourable comparison of lifecycle ghg balance of shale gas compared to coal is dependent on a one-hundred year atmospheric lifetime assumption; considers that the necessity to peak global emissions by 2020 would warrant examination over a shorter period, e.g. 20 years as more appropriate; calls for further scientific research to fugitive methane emissions to improve accounting for such emissions under member states annual inventories and targets under Effort Sharing Decision;
2012/05/29
Committee: ENVI
Amendment 152 #

2011/2308(INI)

Motion for a resolution
Paragraph 19 c (new)
19 c. Urges the Commission to bring forward legislative proposals to make the use of a completion combustion device, i.e. 'green completions' mandatory for all shale gas wells in the EU, to limit flaring only in case of concerns about safety and to forbid venting of all shale gas wells completely, in an effort to reduce the fugitive methane emissions and volatile organic compounds linked to shale gas;
2012/05/29
Committee: ENVI
Amendment 156 #

2011/2308(INI)

Motion for a resolution
Paragraph 20
20. Recognises that drilling activities could temporarilyan worsen living conditions and calls, therefore, for all the necessary measures to be taken, in particular by the industry through the implementation of best available techniques and by the public authorities through the application of strict regulations, to minimise the adverse consequences of such activities;
2012/05/29
Committee: ENVI
Amendment 158 #

2011/2308(INI)

Motion for a resolution
Paragraph 20 a (new)
20 a. Calls on all Member States, taking into account the negative environmental, health and land use impacts and where it is not possible to guarantee no deterioration of water resources from hydraulic fracturing, to suspend on-going shale gas or other UFF activities, and to refrain from further permits for any new projects, whether exploration or exploitation;
2012/05/29
Committee: ENVI
Amendment 162 #

2011/2308(INI)

Motion for a resolution
Paragraph 21
21. Believes that public participation should be ensured through adequate public information campaigns before exploration and through public consultation before theeach stage of exploitation stagesand exploration; calls for greater outreach and public education in UFF activititransparency of impacts, of chemicals and technologies used, as well as of all inspections and control measures in order to ensure public understanding, acceptance and confidence in the regulation of these activities;
2012/05/29
Committee: ENVI
Amendment 166 #

2011/2308(INI)

Motion for a resolution
Paragraph 22
22. Welcomes in this regard the 2012 EU budget appropriation for such a public dialogue and encourages the Member States to make use of this funding so as to ensure that citizens living in potential UFF development areas are better informed; and can effectively participate in decision making in their local and national governance structures;
2012/05/29
Committee: ENVI
Amendment 1 #

2011/2148(INI)

Draft opinion
Paragraph 1 a (new)
1a. Considers that EU space policy must not promote militarisation of space; in this context finds that any military use of GALILEO or GMES must be financed from Member States military budgets and in any case not from EU budget;
2011/10/06
Committee: ENVI
Amendment 4 #

2011/2148(INI)

Draft opinion
Paragraph 3
3. Reaffirms the importance of GMES, the Earth observation system which can provide easily accessible information at the global level, acquiring and analysing information and extracting precise and useful data for observing the environment and assisting in environmental policy design, as well as those involved in civil protection following earthquakes, tsunamis or environmental disasters; observes that, in light of the ‘Europe 2020’ objectives, GMES is an essential resource in combating climate change at the global level;
2011/10/06
Committee: ENVI
Amendment 67 #

2011/2012(INI)

Motion for a resolution
Recital F a (new)
Fa. whereas a reduction target of 40% for 2020 for the EU compared to 1990 would be more in line with science and maintaining climate change to 2°C;
2011/03/31
Committee: ENVI
Amendment 94 #

2011/2012(INI)

Motion for a resolution
Paragraph 2
2. Calls for the Commission to come forward with proposals to move to a domestic 30% greenhouse gas reduction target for 2020 as soon as possible, and at the latest by the end of 2011;
2011/03/31
Committee: ENVI
Amendment 62 #

2011/0438(COD)

Proposal for a directive
Recital 1
(1) The award of public contracts by or on behalf of Member States authorities has to comply with the principles of the Treaty on European Union and the Treaty on the Functioning of the European Union (TFEU), and in particular the free movement of goods, freedom of establishment and the freedom to provide services as well as the principles deriving therefrom, such as equal treatment, non- discrimination, mutual recognition, proportionality and transparency and with the distribution of competencies as enshrined in Article 14 TFEU and in Protocol No 26 on services of general interest. The Directive on public procurement should respect the wide discretion of public authorities in carrying out their public service tasks. However, for public contracts above a certain value, provisions should be drawn up coordinating national procurement procedures so as to ensure that these principles are given practical effect and public procurement is opened up to competition.
2012/06/14
Committee: ENVI
Amendment 63 #

2011/0438(COD)

Proposal for a directive
Recital 2
(2) Public procurement plays a key role in the Europe 2020 strategy as one of the market-based instruments to be used to achieve a smart, sustainable and inclusive growth while ensuring the most efficient use of public funds. For that purpose, the current public procurement rules adopted pursuant to Directive 2004/17/EC of the European Parliament and of the Council of 31 March 2004 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors and Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts have to be revised and modernised in order to enable procurers to make better use of public procurement in support of sustainable development and other common societal goals, thereby increaseing the efficiency of public spending, ensuring best value for money, and facilitating in particular the participation of small and medium-sized enterprises in public procurement and toencouraging local procurement. as well as enableing procurers to make better use of public procurement in support of common societal goals. There is also a need to simplify the Directives and to clarify basic notions and concepts to ensure better legal certainty and to incorporate certain aspects of related well-established case-law of the Court of Justice of the European Union. This Directive provides legislation on how to buy, what to buy is up to the contracting authorities. Contracting authorities are encouraged to set demands that are stricter or go further than current EU legislation in specific areas, in order to reach the common objectives.
2012/06/14
Committee: ENVI
Amendment 65 #

2011/0438(COD)

Proposal for a directive
Recital 3
(3) The increasingly diverse forms of public action have made it necessary to define more clearly the notion of procurement itself. The Union rules on public procurement are not intended to cover all forms of disbursement of public money, but only those aimed at the acquisition of works, supplies or services for consideration. The notion of acquisition should be understood broadly in the sense of obtaining the benefits of the works, supplies or services in question, not necessarily requiring a transfer of ownership to the contracting authorities. Furthermore, the mere financing of an activity, which is frequently linked to the obligation to reimburse the amounts received where they are not used for the purposes intended, does not usually fall under the public procurement rules. Contracts awarded to controlled entities or cooperation for the joint execution of the public service tasks of the participating contracting authorities are not subject of the public procurement rules if the conditions set out in this Directive are fulfilled.
2012/06/14
Committee: ENVI
Amendment 68 #

2011/0438(COD)

Proposal for a directive
Recital 5
(5) Under Articles 9, 10 and 11 of the Treaty on the Functioning of the European Union, environmental protection requirements and social considerations must be integrated into the definition and implementation of the Union policies and activities, in particular with a view to promoting sustainable development. This Directive clarifies how the contracting authorities may contribute to the protection of the environment and the promotion of sustainable development, whilst ensuring that and how they can use their discretionary power to select technical specifications and award criteria with the aim of achieving sustainable public procurement, whilst ensuring the link to the subject matter of they contract and obtaining the best value for money for their contracts.
2012/06/14
Committee: ENVI
Amendment 70 #

2011/0438(COD)

Proposal for a directive
Recital 5 b (new)
(5b) Contracting authorities have broad discretion to choose the technical specifications that define the supplies, services, or works they seek to procure. Further, they have broad discretion to use both technical specifications and award criteria to achieve a contracting authority's objectives, including specifications and criteria designed to achieve more sustainable public procurement. Technical specifications and award criteria, including those relating to sustainability objectives, must be linked to the subject matter of the procurement contract. Provided that the link to the subject matter rule is satisfied, this Directive is not intended to further constrain the types of concerns that a contracting authority can address through technical specifications or award criteria.
2012/06/14
Committee: ENVI
Amendment 71 #

2011/0438(COD)

Proposal for a directive
Recital 5 c (new)
(5c) Technical specifications, award criteria, and conditions for contract performance are distinguished by the role they play in the procurement process, and not by the content of the specifications or criteria. Through technical specifications, the contracting authority defines absolute requirements for the procurement; ability to meet the technical specifications is a prerequisite for being considered a candidate for the contract and only products or services meeting the specifications can be considered. In contrast, award criteria enable the contracting authority to compare the relative advantages of different combinations of criteria. The award criteria are weighted and each tender is scored on the extent of its satisfaction of each criterion, but ability to satisfy all the award criteria is not a prerequisite. Finally, contract performance clauses may be included in the contract to indicate how the contract must be performed. A contracting authority has broad discretion to incorporate its sustainability objectives into any stage of the procurement process – through technical specifications, award criteria, and contract performance conditions.
2012/06/14
Committee: ENVI
Amendment 79 #

2011/0438(COD)

Proposal for a directive
Recital 37
(37) Contracts should be awarded on the basis of objective criteria that ensure compliance with the principles of transparency, non-discriminaTo ensure the efficient use of public funds and enable contracting authorities to obtain best value for money, the award procedure should result in the procurement of high-quality works, supplies and services that are optimally suited to contracting authorities' functional and equal treatment. These criteriasustainability objectives. The award procedure should also guarantee that tenders are assessed in conditions of effective competition, also where contracting authorities require high- quality works, supplies and services that are optimally suited to their needs, for instance where the chosen award criteria include factors linked to the production process. As a resultwith contracts awarded on the basis of objective criteria that ensure compliance with the principles of transparency, non- discrimination and equal treatment. Accordingly, contracting authorities should be allowed to adopt as award criteria either ‘the most economically advantageous tender’ or ‘the lowest cost’, taking into account that in the latter case they are free to set adequateformulated to assess the contracting authority's sustainability concerns including, for example, factors linked to the production process and other life cycle characteristics. It should also be noted that contracting authorities are also free to set adequate sustainability and other quality standards by using technical specifications or contract performance conditions.
2012/06/14
Committee: ENVI
Amendment 82 #

2011/0438(COD)

Proposal for a directive
Recital 38
(38) Where cContracting authorities choose to award a contract to the most economically advantageous tender, they must determine the award criteria on the basis of which they will assess tenders in order to identify which one offers the best value for money. The determination of these criteria depends on the subject- matter of the contract since they must allow the level of performance offered by each tender to be assessed in the light ofo identify the tender representing best value, contracting authorities should use objective criteria that are linked to the subject- matter of the contract, as defined in the technical specifications, and the value for money of each tender to be measured. Furthermore, the chosen award criteria should not confer an unrestricted freedom of choice on the contracting authority and they should ensure the possibility of effective competition and be accompanied by requirements that allow. The chosen award criteria should not confer an unrestricted freedom of choice on the contracting authority, however. Rather, the award procedure should guarantee effective competition through strict compliance with the principles of transparency, non-discrimination and equal treatment. These principles require, among other things, that the information provided by the tenderers to be effectively and transparently verified.
2012/06/14
Committee: ENVI
Amendment 84 #

2011/0438(COD)

Proposal for a directive
Recital 39
(39) It is of utmost importance to fully exploit the potential of public procurement to achieve the objectives of the Europe 2020 Strategy for sustainable growth. In view of the important differences between individual sectors and markets, it would however not be appropriate to set general mandatory requirements for environmental, social and innovation procurement. The Union legislature has already set mandatory procurement requirements for obtaining specific goals in the sectors of road transport vehicles (Directive 2009/33/EC of the European Parliament and the Council of 23 April 2009 on the promotion of clean and energy-efficient road transport vehicles) and office equipment (Regulation (EC) No 106/2008 of the European Parliament and the Council of 15 January 2008 on a Community energy-efficiency labelling programme for office equipment). In addition, the definition of common methodologies for life cycle costing hascontinues to advance significantly, advancnd sector-specific applications of life-cycle costing continue to be developed, tested, and refined. It therefore appears appropriate to continue on that path, leaving it toto use sector- specific legislation to set mandatory objectives and targets in functionthe context of the particular policies and conditions prevailing in the relevant sector and to promote the development and use of European approaches toto further the use of public procurement in support of sustainable growth. These efforts should incorporate sector-appropriate applications of sound methodologies for life- cycle costing as a further underpinning for the use of public procurement in support of sustainable growth. . In accordance with other provisions of this Directive, mandatory procurement criteria adopted through sector-specific legislation may also include technical specifications and award criteria that incorporate sustainability considerations relating to generalised social and environmental benefits or harms, even where these have not been or cannot be monetised, provided that they are linked with the subject matter of the contract and strictly adhere to the principles of transparency, non- discrimination, and equal protection.
2012/06/14
Committee: ENVI
Amendment 86 #

2011/0438(COD)

Proposal for a directive
Recital 40
(40) These sector-specific measures must be complemented by an adaptation of the public procurement Directives empowering contracting authorities to pursue the objectives of the Europe 2020 Strategy in their purchasing strategies. It should hence be made clear that contracting authorities can determinshall seek to achieve the mobest economically advantageous tender and the lowesvalue for money when awarding public contracts. Consideration of what const using a life-cycle costing approach, provided that the methodology to be used is established in an objective and non- discriminatory manner and accessibleitutes 'best value for money' should include sustainability considerations, in accordance with Article 11 of the Treaty on the Functioning of the European Union, which calls for environmental protection requirements to allbe interesgrated parties. The notion of life-cycle costing includes all costs over the life cycle of works, supplies or services, both their internal costs (such as development, production, use, maintenance and end-of- life disposal costs) and their external costs, provided they can be monetised and monitored. Common methodologies should be developed at the level of the Union for the calculation of life-cycle costs for specific categories of supplies or services; whenever such a methodology is developed its use should be made compulsoryinto the definition and implementation of Union policies and activities, in particular with a view to promoting sustainable development. When using life cycle costing approaches to determine best value for money, such methodologies must be applied in an objective and non- discriminatory manner and accessible to all interested parties, in accordance with the general principles of transparency, non- discrimination, and equal protection affirmed herein.
2012/06/14
Committee: ENVI
Amendment 88 #

2011/0438(COD)

Proposal for a directive
Recital 41
(41) Furthermore, in technical specifications and in award criteria, contracting authorities should be allowed to refer to a specific production process, a specific mode of provision of services, or a specific process for any other stage of the life cycle of a product or service, provided that they are linked to the subject-matter of the public contract. In order to better integrate social considerations in public procurement, procurers may also be allowed to include, in the award criterion of the most economically advantageous tender, characteristics related to the working conditions of the persons directly participating in the process of production or provision in question. Those characteristics may only concern among others the protection of health of the staff involved in the production process or the favouring of social integration of disadvantaged persons or members of vulnerable groups amongst the persons assigned to performing the contract, including accessibility for persons with disabilities. Any award criteria which include those characteristics should in any event remain limited to characteristics that have immediate consequences on staff members in their working environment. They should be applied in accordance with Directive 96/71/EC of the European Parliament and of the Council of 16 December 1996 concerning the posting of workers in the framework of the provision of services and in a way that does not discriminate directly or indirectly against economic operators from other Member States or from third countries parties to the Agreement or to Free Trade Agreements to which the Union is party. For service contracts and for contracts involving the design of works, contracting authorities should also be allowed to use as an award criterion the organisation, qualification and experience of the staff assigned to performing the contract in question, as this may affect the quality of contract performance and, as a result, the economic value of the tender. Contracting authorities may include social considerations (i.a. ILO core conventions) in the technical specifications when this is relevant and linked to the subject matter of the contract.
2012/06/14
Committee: ENVI
Amendment 100 #

2011/0438(COD)

Proposal for a directive
Article 4 – paragraph 1 – point d
(d) EUR 51 000 000 for public contracts for social and other specific services listed in Annex XVI.
2012/06/14
Committee: ENVI
Amendment 103 #

2011/0438(COD)

Proposal for a directive
Article 10 – paragraph 1 – introductory part
This Directive shall not apply to public service contracts awarded by a contracting authority to another contracting authority or to an association of contracting authorities on the basis of an exclusive right which they enjoy pursuant to a published law, regulation or administrative provision which is compatible with the Treaty. This Directive shall also not apply to public service contracts for:
2012/06/14
Committee: ENVI
Amendment 106 #

2011/0438(COD)

Proposal for a directive
Article 11 – paragraph 5 a (new)
5 a. However transferring tasks between public sector organisations is a matter for the Member States' internal administrative organisation and is not subject to procurement rules.
2012/06/14
Committee: ENVI
Amendment 107 #

2011/0438(COD)

Proposal for a directive
Article 11 – paragraph 5 b (new)
5b. This directive shall further not apply to contracts for the supply of goods or the provision services which are subject by law to a fixed price and in relation to which a public procurement procedure ipso facto holds no value.
2012/06/14
Committee: ENVI
Amendment 111 #

2011/0438(COD)

Proposal for a directive
Article 24 – paragraph 1 – subparagraph 5
Member States may decide not to transpose into their national law the competitive procedure with negotiation, the competitive dialogue and the innovation partnership procedures.deleted
2012/06/14
Committee: ENVI
Amendment 112 #

2011/0438(COD)

Proposal for a directive
Article 27 – paragraph 1 – subparagraph 2
In the contract notice or in the invitation to confirm interest contracting authorities shall describe the procurement and the minimum requirements to be met and specify the award criteria so as to enable economic operators to identify the nature and scope of the procurement and decide whether to request to participate in the negotiations. In the technical specifications, contracting authorities shall specify which parts thereof define the minimum requirements.
2012/06/14
Committee: ENVI
Amendment 113 #

2011/0438(COD)

Proposal for a directive
Article 27 – paragraph 1 – subparagraph 3
The minimum time limit for receipt of requests to participate shall be 30 dayssufficient from the date on which the contract notice or, where a prior information notice is used as a means of calling for competition, the invitation to confirm interest is sent; the minimum time limit for the receipt of tenders shall be 30 dayssufficient from the date on which the invitation is sent. Article 26 (3) to (6) shall apply.
2012/06/14
Committee: ENVI
Amendment 114 #

2011/0438(COD)

Proposal for a directive
Article 27 – paragraph 3 – subparagraph 1
Contracting authorities shall negotiate with tenderers the tenders submitted by them to improve the content of the offers in order to better correspond to the award criteria and minimum requirements referred to in the second subparagraph of paragraph 1. The negotiation may focus on the legal, technical and financial components of the tender as well as on the variants and the correction of material errors.
2012/06/14
Committee: ENVI
Amendment 115 #

2011/0438(COD)

Proposal for a directive
Article 27 – paragraph 3 – subparagraph 2 – point b
(b) the part of the technical specifications which define the minimum requirements;deleted
2012/06/14
Committee: ENVI
Amendment 116 #

2011/0438(COD)

Proposal for a directive
Article 27 – paragraph 3 – subparagraph 2 – point c
(c) the main award criteria.
2012/06/14
Committee: ENVI
Amendment 128 #

2011/0438(COD)

Proposal for a directive
Article 40 – paragraph 4
4. UnlessWhen justified by the subject-matter of the contract, technical specifications shall notmay refer to a specific make or source, or a particular process, or to trade marks, patents, types or a specific origin or production with the effect of favouring or eliminating certain undertakings or certain products. Such reference shall be permitted on an exceptional basis, where a sufficiently precise and intelligible description of the subject-matter of the contract pursuant to paragraph 3 is not possible. Such reference shall be accompanied by the words "or equivalent".
2012/06/14
Committee: ENVI
Amendment 155 #

2011/0438(COD)

Proposal for a directive
Article 66 – paragraph 1 – subparagraph 1 – introductory part
Without prejudice to national laws, regulations or administrative provisions concerning the remuneration of certain services, the criteria on which contracting authorities shall base the award of public contracts shall be one of the following: the most economically, socially and environmentally advantageous tender. Or. en (If adopted, sub-paragraphs a) and b) as well as paragraph 3 of the same article will consequently fall.)
2012/06/14
Committee: ENVI
Amendment 162 #

2011/0438(COD)

Proposal for a directive
Article 66 – paragraph 1 – subparagraph 1 – point b
(b) the lowest cost.deleted
2012/06/14
Committee: ENVI
Amendment 166 #

2011/0438(COD)

Proposal for a directive
Article 66 – paragraph 2 – introductory part
2. The most economically, socially and environmentally advantageous tender referred to in point (a) of paragraph 1 from the point of view of the contracting authorityaragraph 1 shall be identified on the basis of criteria linked to the subject-matter of the public contract in question. Those criteria shall include, in addition to the price or costs referred to in point (b) of paragraph 1, other criteria linked to the subject-matter of the public contract in question, such as:
2012/06/14
Committee: ENVI
Amendment 168 #

2011/0438(COD)

Proposal for a directive
Article 66 – paragraph 2 – point a
(a) quality, including technical merit, aesthetic and functional characteristics, accessibility, design for all users, environmental characteristics, social and innovative characteristics, as well as proximity where relevant;
2012/06/14
Committee: ENVI
Amendment 171 #

2011/0438(COD)

Proposal for a directive
Article 66 – paragraph 4
4. Award criteria shall not confer an unrestricted freedom of choice on the contracting authority. They shall ensure the possibility of effective competition and shall be accompanied by requirements that allow the information provided by the tenderers to be effectively verified. Contracting authorities shall verify effectively, on the basis of the information and proof provided by the tenderers, whether the tenders meet the award criteriabe accompanied by requirements that allow the information provided by the tenderers to be effectively verified.
2012/06/14
Committee: ENVI
Amendment 174 #

2011/0438(COD)

Proposal for a directive
Article 67 – paragraph 2 – subparagraph 1 – point b
(b) it has been established for repeated or continuous application;deleted
2012/06/14
Committee: ENVI
Amendment 177 #

2011/0438(COD)

Proposal for a directive
Article 67 – paragraph 3 – subparagraph 1
Whenever aAny common methodology for the calculation of life-cycle costs is adopted as part of a legislative act of the Union, including by delegated acts pursuant to sector specific legislation, it shall be applied where life-cycle costing isor as part of a European technical specification shall be deemed to meet the criteria as set out in Paragraph 2 and may be included in the award criteria referred to in Article 66(1).
2012/06/14
Committee: ENVI
Amendment 183 #

2011/0438(COD)

Proposal for a directive
Article 74 – paragraph 1
Contracts for social and other specific services listed in Annex XVI shall be awarded in accordance with this Chapter, where thewith a value of the contracts is equal to or greater than the threshold indicated in Article 4 (d) shall be awarded in accordance with this Chapter, and subject solely to Articles 40, 48 and 49.
2012/06/14
Committee: ENVI
Amendment 199 #

2011/0438(COD)

Proposal for a directive
Annex XVI – row 2 – column 2
Health and social services, including ambulance services
2012/06/14
Committee: ENVI
Amendment 30 #

2011/0429(COD)

Proposal for a directive
Recital 1 a (new)
(1a) As set out in second sentence of Article 191(2) of the Treaty on the Functioning of the European Union, Union policy on the environment is to be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should, as a priority, be rectified at source and that the polluter should pay.
2012/11/13
Committee: ENVI
Amendment 33 #

2011/0429(COD)

Proposal for a directive
Recital 2
(2) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy lays down a strategy against the pollution of water and requires further specific measures for pollution control. That strategy involves the identification of priority substances among those causing a significant risk to or via the aquatic environment at Union level. Decision No 2455/2001/EC of the European Parliament and of the Council of 20 November 2001 establishing the list of priority substances in the field of water policy set out the first list of 33 substances or groups of substances that were prioritised at Union level and that are currently included in Annex X to Directive 2000/60/EC.
2012/11/13
Committee: ENVI
Amendment 39 #

2011/0429(COD)

Proposal for a directive
Recital 6
(6) Numerous Union acts have been adopted since the adoption of Directive 2000/60/EC, which constitute emission control measures in accordance with Article 16 of that Directive for individual priority substances. Moreover, many environmental protection measures fall under the scope of other existing Union legislation. Therefore, priority should be given to implementing and revising existing instruments rather than establishing new controls. The inclusion of a substance in Annex X to Directive 2000/60/EC is without prejudice to the application of the provisions of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection produc, fully applying and, where necessary, revising the provisions of existing sectorial instruments governing priority substances rather than establishing new controls in the context of Directive 2000/60/EC. However, this requires that the actions necessary to achieve the objectives laid down in Article 16(1) of Directive 2000/60/EC be effectively taken in the context of those other existing Union instruments. The inclusion of a substance in Annex X to Directive 2000/60/EC, or monitoring data showing that additional EU-level measures are necessary, should therefore trigger appropriate follow-up action under the corresponding Union instruments onby the market and repealing Council Directives 79/117/EEC and 91/414/EECCommission and Member States, without prejudice to the application of the provisions of those instruments.
2012/11/13
Committee: ENVI
Amendment 54 #

2011/0429(COD)

Proposal for a directive
Recital 9
(9) The derivation of EQS for priority hazardous substances usually involves higher levels of uncertainty than is the case for priority substances but the EQS still establishes a benchmark to assess compliance with the objective of good surface water chemical status, as defined in Article 2(24) and points (ii) and (iii) of Article 4(1)(a) of Directive 2000/60/EC. However, in order to ensure an adequate level of protection for the environment and human health, the ultimate aim for the priority hazardous substances is the cessation or phase out of emissions, discharges and losses, as established in Article 4(1)(a)(iv) of Directive 2000/60/EC. In accordance with Article 16(6) of Directive 2000/60/EC, the timetable to achieve the cessation or phasing-out of discharges, emissions and losses of priority hazardous substances should not exceed 20 years after the designation of a substance as a priority hazardous substance.
2012/11/13
Committee: ENVI
Amendment 55 #

2011/0429(COD)

Proposal for a directive
Recital 10 a (new)
(10a) In recent years there has been an increasing focus on the effects on human health and on the environment arising from exposure to many different chemicals. Discharges to the environment during the production, transport, use or disposal often contain a large number of chemicals. The requirements of Directive 2000/60/EC for water bodies to achieve a good chemical status require a focus not only on the concentration of individual chemicals but also on their effects in combination. It is therefore appropriate to reflect this in the derivation of the EQS.
2012/11/13
Committee: ENVI
Amendment 69 #

2011/0429(COD)

Proposal for a directive
Recital 24
(24) Since the objective of this Directive, namely that of achieving good surface water chemical status by laying down EQS for priority substances and certain other pollutants, cannot be sufficiently achieved by the Member States and can therefore, by reason of maintaining the same level of protection of surface water throughout the Union, be better achieved at Union level, the Union mayshould adopt measures, where necessary, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.
2012/11/13
Committee: ENVI
Amendment 79 #

2011/0429(COD)

Proposal for a directive
Article 2 – point 2
Directive 2008/105/EC
Article 3 – paragraph 6 – subparagraph 1
Member States shall arrange for the long- term trend analysis of concentrations of those priority substances listed in Part A of Annex I that tend to accumulate in sediment and/or biota, giving particular consideration to the substances numbered 2, 5, 6, 7, 12, 15, 16, 17, 18, 20, 21, 26, 28, 30, 34, 35, 36, 37, 43 and 44, on the basis of the monitoring of water status carried out in accordance with Article 8 of Directive 2000/60/EC. They shall take measures aimed at ensuring, subject to Article 4 of Directive 2000/60/EC that such concentrations do not significantly increaseare progressively reduced in sediment and/or relevant biota.
2012/11/13
Committee: ENVI
Amendment 83 #

2011/0429(COD)

Proposal for a directive
Article 2 – point 3 a (new)
Directive 2008/105/EC
Article 5 a (new)
3a. The following Article 5a is inserted: ‘Article 5a Controlling priority substances that are industrial chemicals 1. For all priority substances and priority hazardous substances which fall within the scope of Regulation (EC) No 1907/2006 (REACH) and which in the Commission's opinion meet the criteria in Article 57 of that Regulation, the Commission shall ask the European Chemicals Agency (ECHA) by [OJ to insert date: one year after the entry into force of the directive] to prepare dossiers pursuant to Article 59(2) or Article 69(1) of that Regulation, if this has not already been done. 2. For those substances which in the Commission's opinion do not meet the criteria in Article 57 of that Regulation, the Commission shall ask ECHA by [OJ to insert date: one year after the entry into force of the directive] to prepare dossiers pursuant to Article 69(1) of that Regulation, if this has not already been done. 3. When monitoring data show that additional EU-level measures are necessary for an existing priority or priority hazardous substance to ensure compliance with Directive 2000/60/EC, the Commission shall take action in accordance with paragraphs 1 and 2 of this Article, or review an authorisation granted pursuant Article 61(2) of Regulation (EC) No 1907/2006, or review a restriction pursuant to Article 68(1) of Regulation (EC) No 1907/2006, whatever is applicable.’
2012/11/13
Committee: ENVI
Amendment 84 #

2011/0429(COD)

Proposal for a directive
Article 2 – point 3 b (new)
Directive 2008/105/EC
Article 5 b (new)
3b. The following Article 5b is inserted: ‘Article 5b Controlling priority substances that are plant protection products 1. Member States shall review by [OJ to insert date: one year after the entry into force of the directive] all product authorisations based on Regulation (EC) No 1107/2009 for plant protection products containing priority substances pursuant to Article 44 of that Regulation to ensure that they are consistent with the objectives of Directive 2000/60/EC . 2. Member States shall review the relevant authorisations granted for plant protection products containing an existing priority substance based on Regulation (EC) No 1107/2009 pursuant to Article 48 of that Regulation when monitoring data show that additional EU-level measures are necessary for consistency with the objectives of Directive 2000/60/EC within one year after the publication of the monitoring data. 3. Priority hazardous substances shall be deemed not to satify the criteria under points 3.6.2, 3.6.3, 3.6.4, 3.6.5, 3.7.2 or 3.8.2 of Annex II of that Regulation. 4. Exceedance of the EQS shall be deemed to be an unacceptable effect on the environment pursuant to Article 4(3)(e)(i) of that Regulation.’
2012/11/13
Committee: ENVI
Amendment 85 #

2011/0429(COD)

Proposal for a directive
Article 2 – point 3 c (new)
Directive 2008/105/EC
Article 5 c (new)
3c. The following Article 5c is inserted: ‘Article 5c Controlling priority substances that are biocidal products 1. Member States, or in the case of a Union authorisation, the Commission, shall review by [OJ to insert date: one year after the entry into force of the directive] all authorisations granted based on Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products1, pursuant to Article 48 of that Regulation for biocidal products containing priority substances to ensure that they are consistent with the objectives of Directive 2000/60/EC. 2. Member States, or in the case of a Union authorisation, the Commission, shall review the relevant authorisations granted for an existing priority substance based on Regulation (EC) No 528/2012 pursuant to Article 48 of that Regulation when monitoring data show that additional EU-level measures are necessary for consistency with the objectives of Directive 2000/60/EC within one year after the publication of the monitoring data. 3. Priority hazardous substances shall be deemed to meet one of the exclusion criteria defined in Article 5(1) of that Regulation. 4. Exceedance of the EQS shall be deemed to be an unacceptable effect on the environment pursuant to Article 19(1)(b)(iv) of that Regulation.’ ____________________ 1 OJ L 167, 27.6.2012, p. 1
2012/11/13
Committee: ENVI
Amendment 86 #

2011/0429(COD)

Proposal for a directive
Article 2 – point 3 d (new)
Directive 2008/105/EC
Article 5 d (new)
3d. The following Article 5d is inserted: ‘Article 5d Controlling priority substances in industrial emissions For priority substances falling under the scope of Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control)1, for which Article 10 of Directive 2000/60/EC foresees the application of emission limit values and emissions controls based on best available techniques, the Commission shall include consideration of the monitoring data obtained under Directive 2000/60/EC in its regular review of the adequacy of those values and techniques. Where improvements are necessary, appropriate legislative action should be taken pursuant to Article 73(1) of that Directive.’ ___________________ 1 OJ L 334, 17.12.2010, p. 17
2012/11/13
Committee: ENVI
Amendment 87 #

2011/0429(COD)

Proposal for a directive
Article 2 – point 3 e (new)
Directive 2008/105/EC
Article 5 e (new)
3e. The following Article 5e is inserted: ‘Article 5e Controlling priority substances that are used as pharmaceuticals 1. For priority substances falling under the scope of 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 use1, Member States shall assess within one year after entry into force of this Directive whether the summary of product characteristics as well as the patient information leaflet will raise awareness sufficently to contribute effectively to achieving the objectives of this Directive. For priority substances falling under the scope of 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 Agency2 , the Commission, based on an opinion from the European Medicines Agency, shall assess within one year after entry into force of this Directive whether the summary of product characteristics as well as the patient information leaflet will raise awareness sufficently to contribute effectively to achieving the objectives of this Directive. To ensure transparency, the environmental risk assessments of priority substances shall be made publicly available in the context of pharmaceutical legislation. 2. Member States or, in the case of a Union authorisation, the Commission shall review the relevant authorisations granted for pharmaceutical substances or products containing an existing priority substance when monitoring data show that additional EU-level measures are necessary for consistency with the objectives of Directive 2000/60/EC within one year after the publication of the monitoring data. 3. For priority substances falling under the scope of Directive 2001/83/EC or Regulation (EC) No 726/2004, the Commission shall encourage Member States to consider making pharmaceutical products containing them subject to prescription. 4. Member States shall report to the Commission within one year after entry into force of this Directive that appropriate collection systems are in place for medicinal products that are unused or have expired pursuant to Article 127b of Directive 2001/83/EC.’ ______________ 1 OJ L 311, 28.11.2001, p. 67 2 OJ L 136, 30.4.2004, p. 1
2012/11/13
Committee: ENVI
Amendment 95 #

2011/0429(COD)

Proposal for a directive
Article 2 – point 4
Directive 2008/105/EC
Article 8
The Commission shall report to the European Parliament and to the Council the outcome of the regular review of Annex X to Directive 2000/60/EC provided for in Article 16(4) of that Directive. It shall accompany the report, if appropriate, with relevant proposals, in particular proposals to identify new priority substances or priority hazardous substances or to identify certain priority substances as priority hazardous substances and to set corresponding EQS for surface water, sediment or biota, as appropriate. When setting the EQS, the Commission shall take into account combination effects.
2012/11/13
Committee: ENVI
Amendment 101 #

2011/0429(COD)

Proposal for a directive
Article 2 – point 5
Directive 2008/105/EC
Article 8 a – paragraph 1 – point a
(a) present the chemical status information separately from that forof these substances as well as those of the rest of the substances separately 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
2012/11/13
Committee: ENVI
Amendment 112 #

2011/0429(COD)

Proposal for a directive
Article 2 – point 6
Directive 2008/105/EC
Article 8 b – paragraph 1 – subparagraph 2
The watch list shall contain no more thanat least 25 substances or groups of substances at any given time and shall indicate the monitoring matrix for each substance. The substances shall be selected from among those for which the available information indicates that they may pose a significant risk at Union level to or via the aquatic environment. In selecting the substances for the watch list the Commission shall take into account all available information including research projects, Member States' characterisation and monitoring programmes under Articles 5 and 8 of Directive 2000/60/EC and information on physico-chemical and toxicological properties, particle size, production volumes, use patterns, concentrations in the environment and effects, including that gathered in accordance with Directives 98/8/EC, 2001/82/EC and 2001/83/EC of the European Parliament and of the Council, and with Regulation (EC) No 1907/2006 and Regulation (EC) No 1107/2009 of the European Parliament and of the Council.
2012/11/13
Committee: ENVI
Amendment 139 #

2011/0429(COD)

Proposal for a directive
Article 2 – point 6
Directive 2008/105/EC
Article 8 b – paragraph 4 – subparagraph 2
Each Member State shall select at least one station per, on average, 15for every 40000 km2 geographical area, with a minimum of oneor alternatively, at least one station for every 2.0 million inhabitants, whichever is the higher, with a minimum of two stations. Member States may choose to limit the number of stations to 30 per Member State.
2012/11/13
Committee: ENVI
Amendment 142 #

2011/0429(COD)

Proposal for a directive
Article 2 – point 6
Directive 2008/105/EC
Article 8 b – paragraph 4 – subparagraph 3
In selecting the representative stations, the monitoring frequency and timing for each substance, Member States shall take into account the use patterns of the substance. The frequency of monitoring shall not be less than once per yearthree months.
2012/11/13
Committee: ENVI
Amendment 160 #

2011/0429(COD)

Proposal for a directive
Article 3 – paragraph 1 – subparagraph 2 a (new)
Notwithstanding the first subparagraph, following the date of entry into force of this Directive, Member States shall include the revised list of priority substances and their EQS into their first update of the river basin management plan pursuant to Article 13 of Directive 2000/60/EC.
2012/11/13
Committee: ENVI
Amendment 167 #

2011/0429(COD)

Proposal for a directive
Annex I – table – row 25
Directive 2000/60/EC
Annex I – table – row 25
(25) not applicable not applicable Octylphenols X
2012/11/13
Committee: ENVI
Amendment 192 #

2011/0429(COD)

Proposal for a directive
Annex I – table – row 48 a (new)
Directive 2000/60/EC
Annex X – table – row 48 a (new)
(48a) 15687-27-1 239-784-6 Ibuprofen
2012/11/13
Committee: ENVI
Amendment 201 #

2011/0429(COD)

Proposal for a directive
Annex I – footnote 4
Directive 2000/60/EC
Annex X – footnote 4
4 Only Tetra, Penta, Hexa and Heptabromodiphenylether (CAS-numbers 93703-48-1, 32534-81-9, 36483-60-0, 68928-80-3, respectively).deleted
2012/11/13
Committee: ENVI
Amendment 221 #

2011/0429(COD)

Proposal for a directive
Annex II – footnote 5
Directive 2008/105/EC
Annex I – Part A – footnote 5
5 For the group of priority substances covered by brominated diphenylethers (No 5), the EQS should be compared with the sum of the concentrations of congener numbers 28, 47, 99, 100, 153 and 154. At the next review of the list of priority substances, the Commission shall review the EQS for brominated diphenylethers based on all relevant congeners of brominated diphenylethers.
2012/11/13
Committee: ENVI
Amendment 146 #

2011/0402(CNS)

Proposal for a decision
Annex 1 – part III – point 1 – point 1.11 – paragraph 1
There is a need to support the development of scientific tools, methods and statistics for rapid, accurate and predictive assessment of the safety, efficacy and quality of health technologies including new drugs, biologics, advanced therapies and medical devices. This is particularly relevant for new developments in domains including those concerning vaccines, cell/tissue and gene therapies, organs and transplantation, specialist manufacturing, bio banks, new medical devices, diagnostic/treatment procedures, genetic testing, interoperability and e-health, including privacy aspects. Similarly, support for improvemodern hazard and risk assessment methodologies, testing approaches and strategies relating to assess chemicals with regard to their effects on the environment and health are required. There is also a need to support the development of relevant methods for assisting the assessment of ethical aspects of the above domains.
2012/06/26
Committee: ENVI
Amendment 125 #

2011/0401(COD)

Proposal for a regulation
Article 16 – paragraph 3 – point c a (new)
(ca) research classified as causing severe suffering to vertebrate animals;
2012/06/25
Committee: ENVI
Amendment 127 #

2011/0401(COD)

Proposal for a regulation
Article 16 – paragraph 3 – point c b (new)
(cb) involving wild-caught or F1 non- human primates;
2012/06/25
Committee: ENVI
Amendment 128 #

2011/0401(COD)

Proposal for a regulation
Article 16 – paragraph 3 – point c c (new)
(cc) research on mammals or birds involving deliberate maternal deprivation;
2012/06/25
Committee: ENVI
Amendment 136 #

2011/0401(COD)

Proposal for a regulation
Article 16 – paragraph 4 a (new)
4a. Research on animal testing falling within the scope of Directive 2010/63/EU on the protection of animals used for scientific purposes shall be subject to a rigorous and transparent ethical and scientific merit review process, including full substantiation of claims regarding the relevance of animal models to the human situation.
2012/06/25
Committee: ENVI
Amendment 169 #

2011/0401(COD)

Proposal for a regulation
Annex I – part I – point 2.3 – paragraph 2 – point a
(a) By fostering novel ideas (‘FET Open’), FET shall support embryonicerging science and technology research exploring new foundations for radically new future technologies by challenging current paradigms, such as the use of animal models in biomedical research or for the testing of chemicals for adverse effects on human health, and venturing into unknown areas. A bottom-up selection process widely open to any research ideas shall build up a diverse portfolio of targeted projects. Early detection of promising new areas, developments and trends, along with attracting new and high- potential research and innovation players, will be key.
2012/06/25
Committee: ENVI
Amendment 183 #

2011/0401(COD)

Proposal for a regulation
Annex I – part II – point 1.2.1. – introductory paragraph
The specific objective of nanotechnologies research and innovation is to secure Union leadership in this high growth global market, by stimulating investment in safe and responsible nanotechnologies and their uptake in high added-value, competitive products and services across a range of applications and sectors.
2012/06/25
Committee: ENVI
Amendment 193 #

2011/0401(COD)

Proposal for a regulation
Annex I – part II – point 1.2.3. – point b – paragraph 1
Advancing scientific knowledge of the potential impact of nanotechnologies and nanosystems on health or on the environment, and providing fit-for purpose non-animal tools for risk assessment and management along the entire life cycle.
2012/06/25
Committee: ENVI
Amendment 260 #

2011/0401(COD)

Proposal for a regulation
Annex I – part III – point 1.1 – paragraph 6
Meanwhile, drug and vaccine development processes are becoming more expensive and less effective, and the validity of the underlying animal tests for humans more and more challenged. Their regulatory science needs to be improved. Persistent health inequalities must be addressed, and access to effective and competent health systems must be ensured for all Europeans.
2012/06/25
Committee: ENVI
Amendment 8 #

2011/0197(COD)

Proposal for a directive
Article 5
The provisions of this Directive shall not prevent Member States from adopting provisions concerning navigation on certaintheir waters for the purpose of protection of the environment, including from noise pollution, the fabric of waterways, and ensuring safety of waterways, provided that those provisions do not require modification to watercraft conforming to this Directive.
2012/03/27
Committee: ENVI
Amendment 9 #

2011/0197(COD)

Proposal for a directive
Article 5 – paragraph 1 a (new)
(1a) Member States may restrict the use of personal watercraft to certain areas and hours of day in order to safeguard other competing public interests.
2012/03/27
Committee: ENVI
Amendment 14 #

2011/0197(COD)

Proposal for a directive
Annex I – part C – point 1 – point 1.1 – table
Rated Engine Power Maximum Sound Pressure (single engine) Level = LpASmax In kW In dB PN ≤ 10 67 10 < PN ≤ 40 72 PN > 410 675
2012/03/27
Committee: ENVI
Amendment 45 #

2011/0167(NLE)

Draft opinion
Paragraph 15 a (new)
15a. Calls on the Committee of International Trade, as the committee responsible, to recommend that Parliament declines to consent, pursuant to Article 218(6) TFEU, to the conclusion of ACTA;
2012/05/21
Committee: LIBE
Amendment 81 #

2011/0156(COD)

Proposal for a regulation
Recital 17 a (new)
(17a) With the exception of products authorised in accordance with Article 16 (1) of Regulation 834/2007, pesticides and other toxic substances should not be used for the production of food referred to in Article 1(1).
2012/01/26
Committee: ENVI
Amendment 85 #

2011/0156(COD)

Proposal for a regulation
Recital 17 b (new)
(17b) The use of genetically modified organisms pursuant to Regulation (EC) No 1829/2003 as well as products produced from animals that have been fed with genetically modified feedingstuffs should be prohibited in the production of food referred to in Article 1(1).
2012/01/26
Committee: ENVI
Amendment 91 #

2011/0156(COD)

Proposal for a regulation
Recital 19
(19) This Regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC. In order to adapt the definitions of infant formula, follow- on formula, processed cereal-based food and baby food, and food for special medical purposes laid down in this Regulation taking into account technical and scientific progress and relevant developments at international level, to lay down the specific compositional and information requirements with respect to the categories of food covered by this Regulation, including for additional labelling requirements to, or derogations from, the provisions of Directive 2000/13/EC and for the authorisation of nutrition and health claimslay down the specific compositional and information requirements with respect to the categories of food covered by this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
2012/01/26
Committee: ENVI
Amendment 104 #

2011/0156(COD)

Proposal for a regulation
Recital 20
(20) It is appropriate to establish and update a Union list of vitamins, minerals, amino acids and other substances that may be added to infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, subject to certain criteria laid down in this Regulation. Given the fact that the adoption of the list implies the application of criteria set out in this Regulation, implementing powers should be conferredand updating of the list is a measure of general application to supplement or amend certain non- essential elements onf the Commission in that respect. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament andlegislative act, the power to adopt acts in accordance with Article 290 of the Treaty ofn the CoFuncil 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 powerstioning of the European Union should be delegated to the Commission in that respect. The Commission should adopt immediately applicable implementingdelegated acts updating the Union list, where, in duly justified cases relating to public health, imperative grounds of urgency so require.
2012/01/26
Committee: ENVI
Amendment 106 #

2011/0156(COD)

Proposal for a regulation
Recital 21
(21) At present, pursuant to the Opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the risk assessment of products of nanotechnologies, dated 19 January 2009, there is inadequate information on the risks associated with engineered nanomaterials and existing test methods may not be sufficient to address all of the issues arising in relation to engineered nanomaterials. Therefore, engineered nanomaterials should not be included in the Union list for the categories of food covered by this Regulation, until an evaluation by the Authoraking account of this scientific opinion and in view of the particular sensitivity of the categories for which foods for particular uses are intended, engineered nanomaterials should not be included in the Union list for the categories of food covered by this Regulation as long as their safety, based on adequate and sufficient test methods, their nutritional value and their suitability for the persons to whom ity is carried outintended have not been demonstrated by the Authority.
2012/01/26
Committee: ENVI
Amendment 147 #

2011/0156(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point d a (new)
(da) the definition of 'engineered nanomaterial' set out in point (t) of Article 2(2) of Regulation (EU) No 1169/2011.
2012/01/26
Committee: ENVI
Amendment 175 #

2011/0156(COD)

Proposal for a regulation
Article 3
Food referred to in Article 1(1) may be placed on the market only if it complies with the provisions of this Regulation. "Milks" or similar products shall not be marketed by making reference to special suitability for infants or young children.
2012/01/26
Committee: ENVI
Amendment 190 #

2011/0156(COD)

Proposal for a regulation
Article 9 – paragraph 2 a (new)
2a. With the exception of products authorised in accordance with Article 16 (1) of Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products, pesticides and other toxic substances shall not be used for the production of food referred to in Article 1(1).
2012/01/26
Committee: ENVI
Amendment 191 #

2011/0156(COD)

Proposal for a regulation
Article 9 – paragraph 2 b (new)
2b. Foods referred to in Article 1(1) shall not contain residues of pesticides above the level of detection.
2012/01/26
Committee: ENVI
Amendment 192 #

2011/0156(COD)

Proposal for a regulation
Article 9 – paragraph 2 c (new)
2c. Genetically modified organisms as defined under Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed and products produced from animals that have been fed with genetically modified feeding stuffs shall not be used in the production of food referred to in Article 1(1).
2012/01/26
Committee: ENVI
Amendment 194 #

2011/0156(COD)

Proposal for a regulation
Article 9 – paragraph 3 a (new)
3a. The labelling of infant formulae and follow-on formulae as well as all other foods intended for infants or young children shall not include pictures of infants or young children, nor shall it include other pictures or text which may idealise the use of the product.
2012/01/26
Committee: ENVI
Amendment 195 #

2011/0156(COD)

Proposal for a regulation
Article 9 – paragraph 3 b (new)
3b. The labelling of infant formulae and follow-on formulae as well as all other foods intended for infants or young children may bear nutrition and health claims only in the cases listed in Annex IV of Directive 2006/141/EC and in accordance with the conditions set out therein.
2012/01/26
Committee: ENVI
Amendment 196 #

2011/0156(COD)

Proposal for a regulation
Article 9 – paragraph 3 c (new)
3c. Advertising of infant formulae, follow- on formulae and of any other kind of food intended for infants or young children shall be prohibited. This includes advertisements in publications, point-of- sale advertising, giving samples or any other promotional device to induce sales directly to the consumer.
2012/01/26
Committee: ENVI
Amendment 225 #

2011/0156(COD)

Proposal for a regulation
Article 10 – paragraph 2 – point f a (new)
(fa) a requirement for post-market monitoring in order to ensure that the specific legislative requirements e.g. regarding pesticides, contaminants, labelling and advertising are met.
2012/01/26
Committee: ENVI
Amendment 245 #

2011/0156(COD)

Proposal for a regulation
Article 11 – paragraph 1 – point b a (new)
(ba) they show an added benefit to the consumer.
2012/01/26
Committee: ENVI
Amendment 248 #

2011/0156(COD)

Proposal for a regulation
Article 11 – paragraph 2
2. No later than [2 years after the date of the entry into force of this Regulation], the Commission shall establish and subsequently update a Union list of permitted substances that meet the conditions of paragraph 1, by means of implementing Regulationdelegated acts. The entry of a substance in the Union list shall include a specification of the substance, and, where appropriate, specify the conditions of use and the applicable purity criteria. Those implementing Regulationdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 14(2)5. On duly justified grounds of extreme urgency relating to emerging health risks, the Commission shall adopt immediately applicable implementingdelegated acts updating the Union list in accordance with Article 14(3)6.
2012/01/26
Committee: ENVI
Amendment 250 #

2011/0156(COD)

Proposal for a regulation
Article 11 – paragraph 3 a (new)
3a. For substances referred to in paragraph 1 that are engineered nanomaterials, the following additional conditions shall apply: (a) the requirement of point (a) of paragraph 1 has been demonstrated on the basis of adequate and sufficient test methods; and (b) their nutritional value and the suitability for the persons to whom it is intended has been shown.
2012/01/26
Committee: ENVI
Amendment 254 #

2011/0156(COD)

Proposal for a regulation
Article 11 – paragraph 5
5. When a substance is already included in the Union list and there is a significant change in the production methods, or there is a change in particle size, for example through nanotechnology, the substance prepared by those new methods or with a change in particle size shall be considered as different substance and the Union list shall be modified accordingly before it can be placed on the Union marketwhich is not included in the list and which shall require a separate application.
2012/01/26
Committee: ENVI
Amendment 256 #

2011/0156(COD)

Proposal for a regulation
Article 11 – paragraph 5 a (new)
5a. The presence of substances included in the Union list shall not be used to advertise the benefits of a product.
2012/01/26
Committee: ENVI
Amendment 259 #

2011/0156(COD)

Proposal for a regulation
Chapter 5 – title
CONFIDENTIALITTRANSPARENCY
2012/01/26
Committee: ENVI
Amendment 260 #

2011/0156(COD)

Proposal for a regulation
Article 13 – title
General confidentialittransparency clause
2012/01/26
Committee: ENVI
Amendment 261 #

2011/0156(COD)

Proposal for a regulation
Article 13
The Commission, the Authority and the Member States shall, in accordance with Regulation (EC) No 1049/2001, take the necessary measures to ensure appropriate confidentiality oftransparency regarding the information received by them under this Regulation, except for information which must be made public if circumstanc.g. in order to protect human health, animal health or the environment. Measures sto require in order to protect human health, animal health or the environmentensure confidentiality of the information received can be taken in the exceptional cases laid down in Regulation (EC) No 1049/2001.
2012/01/26
Committee: ENVI
Amendment 263 #

2011/0156(COD)

Proposal for a regulation
Article 15 – paragraph 2
2. The delegation of power referred to in Articles 2(3)10 and 101 of this Regulation shall be conferred for an indeterminate period of time from the (*) [(*) Date of entry into force of the basic legislative act or from any other date set by the legislator.]
2012/01/26
Committee: ENVI
Amendment 265 #

2011/0156(COD)

Proposal for a regulation
Article 15 – paragraph 3
3. The delegation of powers referred to in Articles 2(3)10 and 101 of this Regulation may be revoked at any time by the European Parliament or by the Council. A decision of revocation 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.
2012/01/26
Committee: ENVI
Amendment 267 #

2011/0156(COD)

Proposal for a regulation
Article 15 – paragraph 5
5. A delegated act adopted pursuant to Articles 2(3)10 and 101 of this Regulation shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 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 2 months at the initiative of the European Parliament or the Council.
2012/01/26
Committee: ENVI
Amendment 13 #

2011/0137(COD)

Proposal for a regulation
Recital 16
(16) Taking into account the provisional and preventive character of the measures adopted by the customs authorities in this field and the conflicting interests of the parties affected by the measures, some aspects of the procedures should be adapted to ensure a smooth application of the Regulation, whilst respecting the rights of the concerned parties. Thus, with respect to the various notifications envisaged by this Regulation, the customs authorities should notify the most appropriate person, on the basis of the documents concerning the customs treatment or of the situation in which the goods are placed. The periods laid down in this Regulation for the required notifications should be counted from the time those are sent by the customs authorities in order to align all periods of notifications sent to the concerned parties. The period allowing for a right to be heard before an adverse decision is taken should be three working days, given that the holders of decisions granting applications for action have voluntarily requested the customs authorities to take action and that the declarants or holders of the goods must be aware of the particular situation of their goods when placed under customs supervisionfive working days. In the case of the specific procedure for small consignments, where consumers are likely to be directly concerned and cannot be expected to have the same level of diligence as other economic operators usually involved in the accomplishment of customs formalities, that period should be significantly extended.
2012/01/10
Committee: INTA
Amendment 14 #

2011/0137(COD)

Proposal for a regulation
Recital 17
(17) Under the ‘Declaration on the TRIPS Agreement and Public Health’ adopted by the Doha WTO Ministerial Conference on 14 November 2001, the TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all. In particular with regard to medicines the passage of which across this territory of the European Union, with or without transshipment, warehousing, breaking bulk, or changes in the mode or means of transport, is only a portion of a complete journey beginning and terminating beyond the territory of the Union, customs authorities should, when assessing a risk of infringement of intellectual property rights, take account of any substantial likelihood of diversion of these goods onto the market of the Union ensure that any measures taken by them are in line with the EU's international commitments and do not prevent access to medicines.
2012/01/10
Committee: INTA
Amendment 19 #

2011/0137(COD)

Proposal for a regulation
Article 2 – point 1 – point e
(e) a patent as provided for by the legislation of a Member State;deleted
2012/01/10
Committee: INTA
Amendment 20 #

2011/0137(COD)

Proposal for a regulation
Article 2 – point 1 – point f
(f) a supplementary protection certificate for medicinal products as provided for in Regulation (EC) No 469/2009 of the European Parliament and of the Council;deleted
2012/01/10
Committee: INTA
Amendment 21 #

2011/0137(COD)

Proposal for a regulation
Article 2 – point 1 – point g
(g) a supplementary protection certificate for plant protection products as provided for in Regulation (EC) No 1610/96 of the European Parliament and of the Council;deleted
2012/01/10
Committee: INTA
Amendment 22 #

2011/0137(COD)

Proposal for a regulation
Article 2 – point 1 – point h
(h) a Community plant variety right as provided for in Council Regulation (EC) No 2100/94;deleted
2012/01/10
Committee: INTA
Amendment 23 #

2011/0137(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 1 – point i
(i) a plant variety right as provided for by the legislation of a Member State;deleted
2012/01/10
Committee: INTA
Amendment 27 #

2011/0137(COD)

Proposal for a regulation
Article 6 – paragraph 4 a (new)
4a. The application and all information relevant to the identification of the goods by customs authorities as well as for the analysis and assessment of the risk of infringement of the intellectual property right(s) concerned, as defined in points (g), (h) and (i) of paragraph 3, shall be made publicly accessible through a website.
2012/01/10
Committee: INTA
Amendment 28 #

2011/0137(COD)

Proposal for a regulation
Article 10 – paragraph 3
3. Where an intellectual property right ceases to have effect or where the applicant ceases for other reasons to be the person entitled to submit an application, nothe applicant shall notify the customs authorities thereof and no further action shall be taken by the customs authorities. The decision granting the application shall be revoked or amended accordingly by the customs authorities that granted the decision.
2012/01/10
Committee: INTA
Amendment 29 #

2011/0137(COD)

Proposal for a regulation
Article 11 – paragraph 5 – subparagraph 2
Where an intellectual property right ceases to have effect or where the applicant ceases for other reasons to be the person entitled to submit an application, nothe applicant shall notify the customs authorities thereof and no further action shall be taken by the customs authorities. The decision granting the extension shall be revoked or amended accordingly by the customs authorities that granted the decision.
2012/01/10
Committee: INTA
Amendment 30 #

2011/0137(COD)

Proposal for a regulation
Article 13 – paragraph 3
3. Once the central database of the Commission referred to in Article 31(3) is in place, all exchanges of data on decisions concerning applications for action, accompanying documents and notifications between the customs authorities of the Member States shall be made publicly available via that database.
2012/01/10
Committee: INTA
Amendment 31 #

2011/0137(COD)

Proposal for a regulation
Article 14 – introductory wording
The holder of the decision granting the application shall notify within five working days the competent customs department that adopted that decision of any of the following:
2012/01/10
Committee: INTA
Amendment 32 #

2011/0137(COD)

Proposal for a regulation
Article 16 – paragraph 3
3. Before adopting the decision of suspension of release or detention of the goods, the customs authorities shall, communicate their intention to the declarant or, in cases where goods are to be detained, the holder of the goods. The declarant or the holder of the goods shall be given the opportunity to express his/her views within threfive working days ,of dispatch of that communication.
2012/01/10
Committee: INTA
Amendment 33 #

2011/0137(COD)

Proposal for a regulation
Article 17 – paragraph 3
3. Before adopting a decision to suspend the release of the goods or to detain them, the customs authorities shall communicate their intention to the declarant or, in cases where goods are to be detained, to the holder of the goods. The declarant or the holder of the goods shall be given the opportunity to express his/her views within threfive working days of dispatch of that communication.
2012/01/10
Committee: INTA
Amendment 34 #

2011/0137(COD)

Proposal for a regulation
Article 21 – paragraph 1 – subparagraph 1
Where the customs authorities have been notified of the initiation of proceedings to determine whether a design, patent, or utility model or plant variety right has been infringed and the period provided for in Article 20 has expired, the declarant or holder of the goods may request the customs authorities to release the goods or put an end to their detention.
2012/01/10
Committee: INTA
Amendment 36 #

2011/0137(COD)

Proposal for a regulation
Article 28 a (new)
Article 28a Penalties on applicants Applicants who repeatedly submit applications concerning the alleged intellectual property rights violations that prove to be false in the majority of cases over a period of two years shall lose the right to submit applications for a fixed period and may face penalties.
2012/01/10
Committee: INTA
Amendment 39 #

2011/0105(COD)

Proposal for a regulation
Article 14 – paragraph 7 – subparagraph 2
When deciding on the export of chemicals listed in Part 3 of Annex I, the designated national authority in consultation with the Commission assisted by the Agency shall document that it considered the possible impact on human health or the environment of the use of the chemical in the importing Party or other country. Or. en (Linked to the amendment by the same author to Art. 14(9))
2011/11/18
Committee: ENVI
Amendment 41 #

2011/0105(COD)

Proposal for a regulation
Article 14 – paragraph 9
9. The Agency shall register all requests for explicit consent, responses obtained and waivers granted, including the documentation pursuant to the second subparagraph of paragraph 7, in its Database. Each explicit consent obtained or waived shall be assigned a reference identification number and shall be listed with all relevant information concerning any conditions attached, such as validity dates. The non- confidential information shall be made publicly available on the Agency's Database . . Or. en (Linked to the amendment to Article 14(7) by the same author.)
2011/11/18
Committee: ENVI
Amendment 43 #

2011/0105(COD)

Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 2
By way of derogation from point (b) of Article 1(2) of Regulation (EC) No 1272/2008, chemicals that are intended for export and subject to customs supervision which do not undergo any treatment or processing and are in temporary storage or in a free zone or free warehouse with a view to re-exportation, shall be subject to the measures on classification, packaging and labelling established in, or pursuant to, Regulation (EC) No 1272/2008.
2011/11/18
Committee: ENVI
Amendment 43 #

2010/2203(INI)

Motion for a resolution
Paragraph 3
3. WelcomesNotes that the Commission's Communication ‘Towards a comprehensive European international investment policy’ but stresses that, whilefocuses extensively focusing on investor protection, while it should betterequally address the need to protect the public capacity to regulate;
2011/02/09
Committee: INTA
Amendment 47 #

2010/2203(INI)

Motion for a resolution
Paragraph 4 a (new)
4a. Reminds that increased volumes and new types of inward investments pose new challenges to the EU which are not reflected in most of the existing BITs of the EU Member States; welcomes the new approach exercised in the bilateral investment treaty policy of the USA and Canada regarding a stronger focus on the right to regulate in matters of public policy interests; calls on the Commission to enter into a transatlantic dialogue in order to draw lessons from these experiences and to report policy recommendations resulting from such consultations to Parliament before any new EU international investment treaty is negotiated with any partner country;
2011/02/09
Committee: INTA
Amendment 48 #

2010/2203(INI)

Motion for a resolution
Paragraph 4 b (new)
4b. Takes note of South Africa's wish to incorporate the possibility of discrimination resulting from its Black Empowerment Program into its existing BITs; recommends a positive approach in negotiations with South Africa regarding a change of existing BITs of EU Member States with this country;
2011/02/09
Committee: INTA
Amendment 54 #

2010/2203(INI)

Motion for a resolution
Paragraph 5
5. Considers that the same high level of protection should not be granted to all kinds of investments and that, for example, portfolio investment and intellectual property rights should be excluded from the scope of future international investment agreements signed by the EU; is therefore concerned that the Commission's recommendation for a negotiating directive on investment with India includes intellectual property rights; cautions that this could have a negative impact on the production of generic medicines and on public health;
2011/02/09
Committee: INTA
Amendment 60 #

2010/2203(INI)

Motion for a resolution
Paragraph 6
6. Notes with concern that negotiating a broad variety of investments would lead to mixing exclusive and shared competences; is concerned that if the Member States give the Commission a mandate to negotiate on all matterstypes of investment this could lead to substantial European concessions in the field of investment, given that the EU's already open economy means that it has few other levers in international negotiations;
2011/02/09
Committee: INTA
Amendment 79 #

2010/2203(INI)

Motion for a resolution
Paragraph 9
9. Doubts whetherRejects the request expressed by the Council in its conclusions on the Communication – that the new European legal framework should not negatively affect"at least" guarantee investor protection and guarantees t the level enjoyed under the existing agreements – constitutes an achievable objective; considers that with such a broad and undefined criterion any new agreement could be opposedmost investor friendly of any of the existing agreements of EU Member States, because it would undermine the necessary attempt to better balance investor protection - in an era of increased inward investment into the EU – with the widening of policy space to regulate in the field of public interest; warns that with such a criterion any new international EU investment agreement could be opposed; retains that such a criterion might even create legal uncertainty regarding which of two competing BITs should be considered as more investor-friendly;
2011/02/09
Committee: INTA
Amendment 110 #

2010/2203(INI)

Motion for a resolution
Paragraph 14
14. Stresses that future investment agreements concluded by the EU must be based on the general principles set out in the TEU, in particular its Articles 3(5) and 6(1), and in the TFEU, in particular its Title II of Part I, and protect the capacity for public intervention;
2011/02/09
Committee: INTA
Amendment 111 #

2010/2203(INI)

Motion for a resolution
Paragraph 15
15. Expresses its deep concern regarding the decision by somelevel of discretion of international arbitrators to make a broad interpretation of investor protection clauses, thereby leading to the ruling out of legitimate public regulations; calls on the Commission to produce clear definitions of investor protection standards in order to avoid such problems;
2011/02/09
Committee: INTA
Amendment 121 #

2010/2203(INI)

Motion for a resolution
Paragraph 17
17. Underlines that the Commission shall establish a list of sectors not covered by future agreements, for example sensitive sectors such as culture, education and those sectors which are strategically important for national defence, and calls on the Commission to foresee safeguards to protect public health; notes that the EU should also be aware of the concerns of its developing partners and should not call for more liberalisation if the latter deem it necessary for their development to protect certain sectors, particularly public services;
2011/02/09
Committee: INTA
Amendment 153 #

2010/2203(INI)

Motion for a resolution
Paragraph 23 a (new)
23a. Is aware that the Commission as an institution will in present circumstances not have the faculty to become a new member of ICSID and UNCITRAL; calls on the Commission to include a chapter on Dispute Settlement in each new international EU investment treaty which, duly reflecting present rules under ICSID and UNCITRAL, enables transparency, provides for the set up of a college of arbitrators, and guarantees an appeal mechanism and the involvement of third parties at least on the level of amicus curiae briefs;
2011/02/09
Committee: INTA
Amendment 154 #

2010/2203(INI)

Motion for a resolution
Paragraph 23 b (new)
23b. Remains entirely unconvinced about investor-to-state arbitration in new EU international investment treaties if it is not embedded in a clear framework of investors social and environmental obligations, transparency requirements in litigation procedures, the possibility of third party involvement, and the set-up of an appeal mechanism; recommends to the Commission to engage during this legislature only in investment treaty negotiations with countries which have a functioning and impartial judicial system, guaranteeing investor protection and remedies under a state-to-state arbitration procedure;
2011/02/09
Committee: INTA
Amendment 163 #

2010/2203(INI)

Motion for a resolution
Paragraph 26
26. Endorses the principle that priority partners for future EU investment agreements shall be countries that have a functioning judicial system and great market potential but where foreign investments need better protection;
2011/02/09
Committee: INTA
Amendment 6 #

2010/2156(INI)

Draft opinion
Paragraph 2
2. Stresses that legislation cannot force creativity and innovation, which are best encouraged by giving maximum freedomproviding a favourable context for entrepreneurs and creators to pursue their business and exert their talent;
2010/12/10
Committee: INTA
Amendment 14 #

2010/2156(INI)

Draft opinion
Paragraph 4
4. Recalls that theffective protection of intellectual property rights is an issue central to securingrequires a careful balancing of the interests of right holders and of society at large to ensure the EU's leading role in the knowledge economy; believes that a satisfactory performance of the European cultural and creative industries andis depending on finding such a balance to maintain incentives for companies, artists and creators to innovate;
2010/12/10
Committee: INTA
Amendment 24 #

2010/2156(INI)

Draft opinion
Paragraph 5
5. Supports the development of mutually beneficial and voluntary cooperation between EU Member States in the field of CCI, notinges that when such cooperation is voluntary it does not presult in any extra regulatory burden or unnecessary and unwanted financial costclude international legislative efforts, such as spelled out in the copyright directive 2001/29;
2010/12/10
Committee: INTA
Amendment 27 #

2010/2156(INI)

Draft opinion
Paragraph 6
6. Notes that e-commerce andin the internet are developing at such a pace, with ‘generEU is sustained by an ambitious regulatory framework providing for a balanced enforcement of IPRs and the limitations’ of technology growing shorter geometrically, and therefore believes that attempts to regulate them will always be at least a generation behiintermediary liability and that legislative constraints on internet content are subject to ECHR, in particular articles 6, 8 and 10 thereof; therefore believes that any regulatory initiative relating to CCI must beforehand, and thus largely pointless and damagssess the impact on effective knowledge sharing toand the cultural and creative industries of EU Member States.development of the economy of the commons;
2010/12/10
Committee: INTA
Amendment 31 #

2010/2156(INI)

Draft opinion
Paragraph 6 a (new)
6a. Notes that the internet is developing organically with ever decreasing technology life cycles, and therefore believes that any initiative aimed at controlling infrastructure development without producing alternative business models will always be at least a generation behind and is likely to inhibit growth to the cultural and creative industries of the EU Member States,
2010/12/10
Committee: INTA
Amendment 3 #

2010/2154(INI)

Draft opinion
Paragraph 1
1. Suggests, as the most appropriate solution asConsiders passive scanners in the terahertz band (millimetre), which do not emit any radiation, and which do not provide an image to the operator, but instead a red or green light indicating faor as health is concerned, technology based on passive millimetre wave imaging systems, which do not emit any radiationmanual screening, to be the only acceptable technological solution from the point of view of health, passenger acceptance and respect for integrity;
2010/12/13
Committee: ENVI
Amendment 4 #

2010/2154(INI)

Draft opinion
Paragraph 1 a (new)
1a. Calls on the Commission to present a proposal using passive scanners accompanied by an impact assessment on the relative cost, efficacy and respect for integrity of using this technology as compared to other anti-terror measures;
2010/12/13
Committee: ENVI
Amendment 9 #

2010/2154(INI)

Draft opinion
Paragraph 1 b (new)
1b. Calls for proportionate measures in relation to the risks, bearing in mind similar risks to passengers travelling with other means of transport; furthermore insists that any costs incurred should be paid by the aviation sector and reflected in airline ticket prices;
2010/12/13
Committee: ENVI
Amendment 16 #

2010/2154(INI)

Draft opinion
Paragraph 2
2. Proposes, as the most suitable solution,Recommends to avoid active millimetre wave imaging systems using non-ionising radiation, which is not considered harmful ifeven when exposure remains below the limit values laid down in existing legislation; they may only be used when passengers are given adequate warning and are entitled to opt-out;
2010/12/13
Committee: ENVI
Amendment 23 #

2010/2154(INI)

Draft opinion
Paragraph 3
3. Points out that the technology based on backscatter x-ray scanning emits a low dose of X-rays. Clearly, any exposure to ionising radiation, however low, may have long-term effects on health due to the cumulative effect of radiation. It is therefore proposed that we avoid this technology, or at least ensure that allThis technology should therefore no longer be used, even when exposure is are asduced to the low asest possible for workers and passengerslevel;
2010/12/13
Committee: ENVI
Amendment 38 #

2010/2154(INI)

Draft opinion
Paragraph 5 a (new)
5a. Calls on the Commission to make an impact assessment evaluating the risk of spill-over effects of terrorism to other modes of transport and of the potential increase of cost of security on those means of transport as a consequence of proposed additional measures to passenger controls in the aviation sector;
2010/12/13
Committee: ENVI
Amendment 51 #

2010/2154(INI)

Draft opinion
Paragraph 6 a (new)
6a. Rejects any further control measures until all earlier anti-terror legislation has been evaluated on the basis of health, cost, efficacy and respect for fundamental human rights, especially integrity and anti-discrimination;
2010/12/13
Committee: ENVI
Amendment 1 #

2010/2088(INI)

Motion for a resolution
Citation 11a (new)
- having regard to the Economics of Ecosystems and Biodiversity (TEEB) global initiative endorsed by G8+5 leaders in June 2007 and its published results in 2009 and 2010;
2010/11/09
Committee: ENVI
Amendment 2 #

2010/2088(INI)

Motion for a resolution
Citation 11b (new)
- having regard to the EU's sustainable Consumption and Production Action Plan (COM (2008) 397);
2010/11/09
Committee: ENVI
Amendment 14 #

2010/2088(INI)

Motion for a resolution
Recital B
B. whereas the EU 2020 strategy should pave the way to a resource-efficient economy, serve economic growth and create jobs, in particular since the EU has recently suffered a drop in GDP and falling industrial production, and since millions of unemployed wosustainable development and men represents a human, societal and economic disastercreate jobs,
2010/11/09
Committee: ENVI
Amendment 24 #

2010/2088(INI)

Motion for a resolution
Paragraph 1
1. Stresses that GDP is an indicator of economic market activity only 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 beis misleading and at other times simply not provide enough information or sufficiently detailed information;
2010/11/09
Committee: ENVI
Amendment 25 #

2010/2088(INI)

Motion for a resolution
Paragraph 2
2. Emphasises that GDP is based on a clear methodology which allows comparisons to be made over time and between countries and regions; stresses that it was, however, not intended to be an accurate measure to inform policy debates on all issues; underlines that, critically, GDP does not measure environmental sustainability, resource efficiency, social inclusion , inequalities or well-being in general; underlines the need to base other indicators on a clear and valid methodology;
2010/11/09
Committee: ENVI
Amendment 36 #

2010/2088(INI)

Motion for a resolution
Paragraph 4
4. Considers that well-informed, sound, solid and coherent policies and strategies are fundamental to ensuring a fair and competitive market, citizens’ welfare and, effective protection of public health and education and a bettersustainable environment;
2010/11/09
Committee: ENVI
Amendment 40 #

2010/2088(INI)

Motion for a resolution
Paragraph 6 a (new)
6 a. Regrets that the tools currently used to assess and design policies do not accurately capture negative externalities or possible co-benefits to the society as a whole; points out that economic activities that effectively result in a negative net impact to society still contribute in positive light to indicators such as GDP;
2010/11/09
Committee: ENVI
Amendment 50 #

2010/2088(INI)

Motion for a resolution
Paragraph 8
8. Welcomes the growing international recognition of limits to GDP as an indicator for human well-being and sustainable development; acknowledges progress made in different fora, such as the UNDP, World Bank, OECD and by the Commission, among others on the development of indicators to measure and analyse progress in policy-making; takes note of indicators developed already for various policy areas; notes, however, that there seem to be many indicators already in use, sometimes even overlapping or competing where they should instead be coordinated or combined; emphasises that there are currently too many indicators and the challenge is to develop a clear and comprehensible policyset of indicators that isare at the same time theoretically consistent, politically relevant and empirically measurable; stresses the need for this work to be done in close cooperation with other relevant institutions and organisations;
2010/11/09
Committee: ENVI
Amendment 55 #

2010/2088(INI)

Motion for a resolution
Paragraph 9
9. Underlines the need to keep costs at a reasonablat the ldevel and to also weigh the potential gains of Beyond GDP against the cost associated with it; stresses the importance of budgetary constraints and the necessity of timely impact assessmentopment and implementation of such measures and tools receive adequate funding and follow a clear and transparent methodology;
2010/11/09
Committee: ENVI
Amendment 58 #

2010/2088(INI)

Motion for a resolution
Paragraph 11
11. Takes note of the proposed measures, such as the complementing of GDP with environmental and social indicators, near real-time information for decision-making, more accurate reporting on distribution and inequalities, the development of a European Sustainable Development Scoreboard, the extension of national accounts to environmental and social issues and the proposed report on the implementation and outcomes of the actions to be put forward by 2012 at the latest; insists on having these action implemented by 2012 in order for the new indicators to serve concrete policy-making in the near future and to ensure comprehensive sustainable policies for the next programming period;
2010/11/09
Committee: ENVI
Amendment 65 #

2010/2088(INI)

Motion for a resolution
Paragraph 12
12. Criticises, however, the lack, in the Commission Communication, of a clear overall strategy on the application of the Beyond GDP approach in practice; stresses a certain lack of coordination and coherence with existing measures and tools which also aim to contribute to policy analysis, assessments and debates; criticises, furthermore, the proposed measures as partially vague or unclear so that the added value of the proposed action compared to the current situation is difficult to assess; points out that there is in particular no path set out to integrate the proposed measures into the current system of measures and tools for better policy- and law-making;
2010/11/09
Committee: ENVI
Amendment 84 #

2010/2088(INI)

Motion for a resolution
Paragraph 14 a (new)
14 a. Believes that in the short and medium term it is important that GDP be complemented and corrected by other indicators in EU policy and decision making; is convinced, however, that in the long term GDP will need to be replaced as an indicator for human well being and development;
2010/11/09
Committee: ENVI
Amendment 85 #

2010/2088(INI)

Motion for a resolution
Paragraph 14 b (new)
14 b. Suggests that the five actions planned by the Commission should result in the definition of a limited set of synthetic indicators to be used as complement for GDP in policy making; recommends that these indicators embody complementary perspectives on the environment via a monetarised indicator (e.g. Adjusted Net Savings) and a physical one (e.g. Ecological Footprint, Carbon Footprint or Decoupling Indicators, as suggested by the Joint Research Centre), an assessment of inequalities (such as GINI Index) as well as a broader indicator of social inclusion and human well-being (e.g. Human Poverty Index or Index of Social Health); recommends that Eurostat works in close cooperation with other research centres and organisations that have developed such indicators in order to make them more accurate and implementable;
2010/11/09
Committee: ENVI
Amendment 86 #

2010/2088(INI)

Motion for a resolution
Paragraph 14 c (new)
14 c. Calls on the Commission, in close cooperation with Eurostat, to make proposals for new indicators in time for the next financial perspectives and new programming period, together with measures to ensure standards for harmonised collection of data;
2010/11/09
Committee: ENVI
Amendment 1 #

2010/2085(INI)

Draft opinion
Paragraph 1
1. Points out that globalisation, increased outsourcing and the growth in international trade mean that more products are being traded on markets across the world; considers that close cooperation between global regulators and other stakeholders in the area of consumer product safety is key for addressing the challenges posed by complex supply chains and the higher volume of trade; expects that the revision of the GPSD proposes market surveillance provisions adequate to the task to hold companies effectively accountable for the entire supply chain of their products;
2010/11/09
Committee: INTA
Amendment 2 #

2010/2085(INI)

Draft opinion
Paragraph 3
3. Stresses that a single EU control system for all products, under the condition that its standards are at least equal to the highest standards in any one of the EU Member States, is essential for our trading partners and producers from third countries who place their products on the EU market; is of the opinion that when preparing a proposal on the revision of the General Product Safety Directive the Commission should seriously consider the possibility of including the market surveillance provisions of the GPSD in the New Legislative Framework;
2010/11/09
Committee: INTA
Amendment 51 #

2010/0377(COD)

Proposal for a directive
Recital 3
(3) Directive 96/82/EC has been instrumental in reducing the likelihood and consequences of such accidents thereby leading to better protection levels throughout the Union. A review of the Directive has confirmed that overall the existing provisions are fit for purpose and that no major changes are required. However,the rate of major accidents has remained stable. While overall the existing provisions are fit for purpose, several changes are required in order to further strengthen the level of protection, in particular with regard to the prevention of major accidents. At the same time the system established by Directive 96/82/EC should be adapted to changes to the Union system of classification of dangerous substances to which it refers. In addition, a number of other provisions should be clarified and updated.
2011/06/28
Committee: ENVI
Amendment 54 #

2010/0377(COD)

Proposal for a directive
Recital 8
(8) Certain industrial activities should be excluded from the scope of this Directive due to their specific characteristics. These activities, provided they are subject to other legislation at Union or national level providing an equivalent level of safety. The Commission should however continue to ensure that there are no significant gaps in the existing regulatory framework, in particular as regards new and emerging risks from other activities as well as from specific dangerous substances that do not yet fall within the scope of this Directive, and take appropriate action where necessary.
2011/06/28
Committee: ENVI
Amendment 56 #

2010/0377(COD)

Proposal for a directive
Recital 9
(9) Annex I to Directive 96/82/EC lists the dangerous substances falling within its scope, inter alia by reference to certain provisions of Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances6 as well as Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations7 . Those Directives have been replaced by 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 mixtures8 , which implements within the Union the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) that has been adopted at the international level, within the structure of the United Nations. That Regulation introduces new hazard classes and categories only partially corresponding to those used under the previous arrangements. At the same time, it lacks certain important hazard classes, as they are not part of the Globally Harmonised System of Classification and Labelling of Chemicals. Annex I to Directive 96/82/EC therefore needs to be amended to align it to that Regulation while maintainingand to address gaps in that Regulation to maintain and further increase the existing levels of protection of that Directive.
2011/06/28
Committee: ENVI
Amendment 59 #

2010/0377(COD)

Proposal for a directive
Recital 10
(10) Flexibility is needed in order to be able to amend Annex I to deal with any unwanted effects from the alignment to Regulation (EC) No 1272/2008 and subsequent adaptations to that Regulation having an impact on the classification of dangerous substances. On the basis of harmonised criteria to be developed, derogations could be granted where notwithstanding their hazard classification, substances do not present a major accident hazard. There should also be a corresponding correction mechanism to deal with substances that need to be included within the scope of this Directive because of their major accident hazard potential. Or. en (Amendment of the recital corresponding to amendments 10 and 48 of the rapporteur.)
2011/06/28
Committee: ENVI
Amendment 60 #

2010/0377(COD)

Proposal for a directive
Recital 15
(15) In order to provide greater protection for residential areas, areas of substantial public use and the environment, including areas of particular natural interest or sensitivity, it is necessary for land-use or other relevant policies applied in the Member States to take account of the need, in the long term, to keep a suitablensure that an adequate distance between such areas and establishments presenting such hazards is maintained and, where existing establishments are concerned, to take account ofimplement additional technical measures so that the risk to persons is not indecreased to an acceptable level. Sufficient information about the risks and technical advice on these risks should be taken into account when decisions are taken. Where possible, to reduce administrative burdens, procedures should be integrated with those under other Union legislation.
2011/06/28
Committee: ENVI
Amendment 65 #

2010/0377(COD)

Proposal for a directive
Recital 20 a (new)
(20a) In order to provide for incentives to prevent major accidents which involve dangerous substances and to cover the costs for competent authorities arising from the implementation of this Directive, Member States should set up a fund. The fund should be financed by the operators and be proportionate to the quantities of dangerous substances present at the establishment.
2011/06/28
Committee: ENVI
Amendment 68 #

2010/0377(COD)

Proposal for a directive
Recital 23
(23) The Commission should be emIn order to adapt this Directive to technical and scientific progress, the powered to adopt delegated acts in accordance with Article 290 of the Treaty in respect of the adoption of criteria for derogations and amendments to the Annexes of this Directiveon the Functioning of the European Union should be delegated to the Commission in respect of amendments to part 3 of Annex I, and the Annexes II, III, IV and VI of this Directive. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
2011/06/28
Committee: ENVI
Amendment 73 #

2010/0377(COD)

Proposal for a directive
Article 2 – paragraph 2 – point c
(c) the transport of dangerous substances and intermediate temporary storage, unless occurring on a regular basis or for periods exceeding 24 hours on working days or 72 hours when including a weekend, by road, rail, internal waterways, sea or air, outside the establishments covered by this Directive, including loading and unloading and transport to and from another means of transport at docks, wharves or marshalling yards;
2011/06/28
Committee: ENVI
Amendment 79 #

2010/0377(COD)

Proposal for a directive
Article 2 – paragraph 2 – point d
(d) the transport of dangerous substances in pipelines, including pumping stations, outside establishments covered by this Directive, where the annual throughput of dangerous substances is below the quantities listed in Parts 1 or 2 of Annex I;
2011/06/28
Committee: ENVI
Amendment 82 #

2010/0377(COD)

Proposal for a directive
Article 2 – paragraph 2 – point e
(e) the exploitation (exploration, extraction and processing) of minerals, including hydrocarbons, in mines, quarries, or by means of boreholes, with the exception of underground gas storage in natural strata and disused mines and of chemical and thermal processing operations, including hydraulic fracturing of hydrocarbons, and storage related to those operations which involve dangerous substances, as defined in Annex I;
2011/06/28
Committee: ENVI
Amendment 86 #

2010/0377(COD)

Proposal for a directive
Article 2 – paragraph 2 – point f
(f) the offshore exploration and exploitation of minerals, including hydrocarbons;deleted
2011/06/28
Committee: ENVI
Amendment 90 #

2010/0377(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 2
2. ‘lower-tier establishment’ means an establishment where dangerous substances are present in quantities equal to or in excess of the quantities listed in column 2 of Part 1 of Annex I andor column 2 of Part 2 of Annex I, where relevant, but less than the quantities listed in column 3 of Part 1 of Annex I, and column 3 of Part 2 of Annex I;
2011/06/28
Committee: ENVI
Amendment 91 #

2010/0377(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 3
3. ‘upper-tier establishment’ means an establishment where dangerous substances are present in quantities equal to or in excess of the quantities listed in column 3 of Part 1 of Annex I, and or column 3 of Part 2 of Annex I, where relevant;
2011/06/28
Committee: ENVI
Amendment 95 #

2010/0377(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 4
4. ‘new establishment’ means an establishment that is newly constructed or has yet to enter into operationafter 1 June 2015 or will enter into operation after 1 June 2017, or that due to modifications to its installations, activities or to its inventory of dangerous substances after 1 June 2015 falls within the scope of this Directive;
2011/06/28
Committee: ENVI
Amendment 98 #

2010/0377(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 7
7. ‘installation’ means a technical unit within an establishment in which dangerous substances are produced, used, handled or stored, including underground, and includes all the equipment, structures, pipework, machinery, tools, private railway sidings, docks, unloading quays serving the installation, jetties, warehouses or similar structures, floating or otherwise, necessary for the operation of the installation;
2011/06/28
Committee: ENVI
Amendment 99 #

2010/0377(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 8
8. ‘operator’ means any natural or legal person who operates or controls an establishment or installation or, where this is provided for by national legislation, to whom decisive economic power over the technical functioning of the establishment or installation has been delegated;
2011/06/28
Committee: ENVI
Amendment 105 #

2010/0377(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 11
11. ‘presence of dangerous substances’ means the actual or anticipated presence of dangerous substances in the establishment, or the presence of dangerous substances which it is believed may be generated during loss of control of any industrial chemical processstallation within the establishment, in quantities equal to or in excess of the thresholds set out in Parts 1 and 2 of Annex I.
2011/06/28
Committee: ENVI
Amendment 116 #

2010/0377(COD)

Proposal for a directive
Article 4 – paragraph 2 – subparagraph 2
The Commission shall informconsult the forum referred to in Article 17(2) of such notifications. (Linked to the amendment to Article 17(2) that seeks to include stakeholders into the forum)prior to listing substances in Part 3 of Annex I and about notifications made pursuant to the first subparagraph of this paragraph. Or. en
2011/06/28
Committee: ENVI
Amendment 117 #

2010/0377(COD)

Proposal for a directive
Article 4 – paragraph 3
3. Where it is demonstrated to the satisfaction of a competent authority, on the basis of the criteria referred to in paragraph 4 of this Article, that particular substances present at an individual establishment or any part thereof and listed in Parts 1 or 2 of Annex I are incapable of creating a major accident hazard, due to the specific conditions pertaining in the establishment such as the nature of the packaging and containment of the substance or the location and quantities involved, the Member State of the competent authority may decide not to apply the requirements set out in Articles 7 to 19 of this Directive to the establishment concerned. In the cases referred to in the first subparagraph the Member State concerned shall provide to the Commission a list of the establishments concerned, including the inventory of dangerous substances concerned. The Member State concerned shall give reasons for the exclusion. The Commission shall forward annually the lists referred to in the second subparagraph of this paragraph to the forum referred to in Article 17(2) for information.deleted
2011/06/28
Committee: ENVI
Amendment 121 #

2010/0377(COD)

Proposal for a directive
Article 4 – paragraph 5 – subparagraph 1
Where a Member State considers that a dangerous substance not listed in Parts 1 or 2 of Annex I, presents a major-accident hazard, or that a threshold is too high, it may take appropriate measures and shall notify the Commission.
2011/06/28
Committee: ENVI
Amendment 122 #

2010/0377(COD)

Proposal for a directive
Article 4 – paragraph 5 – subparagraph 2
The Commission shall informconsult the forum referred to in Article 17(2) of notifications made pursuant to the first subparagraph of this paragraph.
2011/06/28
Committee: ENVI
Amendment 123 #

2010/0377(COD)

Proposal for a directive
Article 4 – paragraph 5 – subparagraph 3 a (new)
Where appropriate, the Commission may adopt delegated acts in accordance with Article 24 in order to lower the threshold of the substances referred to in the first subparagraph of this paragraph in Part 1 or Part 2 of Annex I.
2011/06/28
Committee: ENVI
Amendment 124 #

2010/0377(COD)

Proposal for a directive
Article 5 – paragraph 1
1. Member States shall ensure that the operator is obliged to take all measures necessary to prevent major accidents and to limit their consequences for human health and the environment. This shall include the obligation to perform independent safety studies at least every two years.
2011/06/28
Committee: ENVI
Amendment 125 #

2010/0377(COD)

Proposal for a directive
Article 5 – paragraph 1 a (new)
1a. Member States shall ensure that the establishment operates according to best available techniques, in particular in relation to safety aspects, pursuant to Directive 2010/75/EU of the European Parliament and of the Council of 14 November 2010 on industrial emissions (integrated pollution prevention and control)1, without any derogations. _____________ 1 OJ L 334, 17.12.2010, p. 17.
2011/06/28
Committee: ENVI
Amendment 129 #

2010/0377(COD)

Proposal for a directive
Article 6 – paragraph 1 – point g
(g) the immediate environment of the establishment, elements liable to cause a major accident or to aggravate the consequences thereof, including details of neighbouring establishments, whether or not those are covered by this Directivere available to the operator, as well as other sites, areas and developments that could be the source of, or increase, the risk or consequences of a major accident and of domino effects.
2011/06/28
Committee: ENVI
Amendment 138 #

2010/0377(COD)

Proposal for a directive
Article 7 – paragraph 1
1. Member States shall require the operator to draw up a document setting out the major-accident prevention policy (hereinafter: "MAPP") and to ensure that it is properly implemented. The MAPP shall be established in writing. It shall be designed to guarantee a high level of protection for human health and the environment. It shall be proportionate to the major-accident hazards. It shall include the operator's overall aims and principles of action, timetable and measures for the attainment of these objectives, periodic assessment of progress made towards achieving these objectives, the role and responsibility of management and shall address safety culture with respect to the control and the commitment towards continuously improving the prevention of major- accident hazards. It shall be implemented by appropriate means, structures and management systems and shall include the safety management system for implementing it in accordance with Annex III.
2011/06/28
Committee: ENVI
Amendment 148 #

2010/0377(COD)

Proposal for a directive
Article 7 – paragraph 4 a (new)
4a. The MAPP shall be implemented by appropriate means, structures and management systems. For upper-tier establishments, it shall be implemented by safety management systems in accordance with Annex III. Member States shall require lower-tier establishments to implement the MAPP by means of a safety management system proportionate to the major-accident hazards, and to the complexity of the organisation or activities of the establishment.
2011/06/28
Committee: ENVI
Amendment 151 #

2010/0377(COD)

Proposal for a directive
Article 8 – paragraph 1
1. Member States shall ensure that the competent authority, using the information received from the operators in compliance with Articles 6 and, Article 8(1a) and Article 9 or through inspections pursuant to Article 19, identifies all lower-tier and upper-tier establishments or groups of establishments where the likelihood and the possibility or consequences of a major accident may be increased because of the location and the proximity of such establishments, and their inventories of dangerous substances, or the proximity of other sites.
2011/06/28
Committee: ENVI
Amendment 155 #

2010/0377(COD)

Proposal for a directive
Article 9 – paragraph 1 – point b
(b) demonstrating that major-accident hazards and possibleall major-accident scenarios have been identified and that the necessary measures have been taken to prevent such accidents and to limit their consequences for human health and the environment;
2011/06/28
Committee: ENVI
Amendment 157 #

2010/0377(COD)

Proposal for a directive
Article 9 – paragraph 1 – point d
(d) demonstrating that internal emergency plans have been drawn up in close consultation with workers and supplying information to enable the external emergency plan to be drawn up;
2011/06/28
Committee: ENVI
Amendment 172 #

2010/0377(COD)

Proposal for a directive
Article 12 – paragraph 1 – introductory part
Member States shall ensure that the objectives of preventing major accidents and limiting the consequences of such accidents for human health and the environment are taken into accountimplemented in their land- use policies or other relevant policies. They shall pursue those objectives through controls on:
2011/06/28
Committee: ENVI
Amendment 173 #

2010/0377(COD)

Proposal for a directive
Article 12 – paragraph 1 – point c
(c) new developments including transport links, locations frequented by the public and residential areas in the vicinity of existing establishments, where the siting or developments may be the source of or increase the risk or consequences of a major accident.
2011/06/28
Committee: ENVI
Amendment 174 #

2010/0377(COD)

Proposal for a directive
Article 12 – paragraph 2 – introductory part
Member States shall ensure by 1 June 2018 that their land- use or other relevant policies and the procedures for implementing those policies take account of the need, in the long termdeliver the following:
2011/06/28
Committee: ENVI
Amendment 187 #

2010/0377(COD)

Proposal for a directive
Article 13 – paragraph 2 – introductory part
For upper-tierall establishments, Member States shall also ensure that as a minimum:
2011/06/28
Committee: ENVI
Amendment 191 #

2010/0377(COD)

Proposal for a directive
Article 13 – paragraph 2 – point b
b) the safety report is made available to the public upon request subject to Article 21(3); where Article 21(3) applies, an amended report in the form of a non- technical summary, which shall include at least general information on major- accident hazards, potential effects and the requisite behaviour in the event of an accident, shall be made available; (Linked to the amendment by the same authors inserting a non-technical summary of theOr. en safety report to Part 1 of Annex V (needs to be voted together).)
2011/06/28
Committee: ENVI
Amendment 194 #

2010/0377(COD)

Proposal for a directive
Article 13 – paragraph 2 – point c
c) the inventory of dangerous substances is made available to the public concerned upon request subject to Article 21(3).
2011/06/28
Committee: ENVI
Amendment 195 #

2010/0377(COD)

Proposal for a directive
Article 13 – paragraph 2 – subparagraph 2
The information to be supplied under point (a) of this paragraph shall include at least the information referred to in Annex V. That information shall likewise be supplied to all establishmentntities serving the public, including schools and hospitals, and to all neighbouring establishments in the case of establishmentor sites covered by Article 8. Member States shall ensure that the information is supplied and that it is periodically reviewed and updated at least every five years.
2011/06/28
Committee: ENVI
Amendment 196 #

2010/0377(COD)

Proposal for a directive
Article 13 – paragraph 3
3. Requests for access to the information referred to in paragraph 2(a), (b) and (c) shall be handled in accordance with Articles 3 and 5 of Directive 2003/4/EC of the European Parliament and of the Council.deleted
2011/06/28
Committee: ENVI
Amendment 202 #

2010/0377(COD)

Proposal for a directive
Article 14 – paragraph 1 – introductory part
1. Member States shall ensure that the public is able to give its opinion ogiven early and effective opportunities to participate in the following matters and procedures:
2011/06/30
Committee: ENVI
Amendment 216 #

2010/0377(COD)

Proposal for a directive
Article 15 – title
Information to be supplied by the operator and actions to be taken following a major accident
2011/06/30
Committee: ENVI
Amendment 218 #

2010/0377(COD)

Proposal for a directive
Article 17 – title
Competent authority and forum Or. en (Linked to the amendment to Article 17(2) by the same authors.)
2011/06/30
Committee: ENVI
Amendment 221 #

2010/0377(COD)

Proposal for a directive
Article 17 – paragraph 2
2. The Commission shall regularly convene a forum composed of representatives of the competent authorities of the Member States. The competent authorities and the Commission shall cooperate in activities in support of implemen, representatives of industry, workers and non-governmental organisations promoting the protection of human health and/or the environment in support of the application, implementation and technical adaptation of this Directive.
2011/06/30
Committee: ENVI
Amendment 224 #

2010/0377(COD)

Proposal for a directive
Article 18 – paragraph 1 – subparagraph 1
Member States shall prohibit the use or bringing into use of any establishment, installation or storage facility, or any part thereof where the measures taken by the operator for the prevention and mitigation of major accidents are seriously deficientclearly deficient, including where the operator has not taken the necessary actions identified in the inspection report and within the deadline set pursuant to Art 19(7).
2011/06/30
Committee: ENVI
Amendment 225 #

2010/0377(COD)

Proposal for a directive
Article 18 – paragraph 1 – subparagraph 2
Member States mayshall prohibit the use or bringing into use of any establishment, installation or storage facility, or any part thereof if the operator has not submitted the notification, reports or other information required by this Directive within the specified period.
2011/06/30
Committee: ENVI
Amendment 230 #

2010/0377(COD)

Proposal for a directive
Article 19 – paragraph 4 – subparagraph 2
The period between two site visits shall be based on a systematic appraisal of the major-accident hazards of the establishments concerned and shall not exceed one year for upper-tier establishments and threewo years for lower- tier establishments. If an inspection has identified an important case of non- compliance with this Directive, an additional site visit shall be carried out within six months.
2011/06/30
Committee: ENVI
Amendment 232 #

2010/0377(COD)

Proposal for a directive
Article 19 – paragraph 6
6. Non-routine inspections shall be carried out once a year for upper-tier establishments and once every two years for lower-tier establishments, and to investigate serious complaints, serious accidents and near-misses, incidents and occurrences of non- compliance as soon as possible.
2011/06/30
Committee: ENVI
Amendment 241 #

2010/0377(COD)

Proposal for a directive
Article 21 – paragraph 3 – subparagraph 1
AWithout prejudice to Article 4(2) second subparagraph of Directive 2003/4/EC, access to the complete information referred to in Article 13(2)(b) and (c) obtained by the competent authorities may be refused if the operator has requested not to disclose certain parts of the safety report or the inventory of dangerous substances for the reasons provided for in points (b), (d), (e) or (f) of Article 4(2) of Directive 2003/4/EC.
2011/06/30
Committee: ENVI
Amendment 244 #

2010/0377(COD)

Proposal for a directive
Article 21 – paragraph 3 – subparagraph 2
The competent authority may also decide for the same reasons that certain parts of the report or inventory shall not be disclosed. In such cases, and on approval of the competent authority, the operator shall supply to the authority, and make available to the public, an amended report or inventory excluding those parts.
2011/06/30
Committee: ENVI
Amendment 255 #

2010/0377(COD)

Proposal for a directive
Article 27 a (new)
Article 27 a Review By [*], the Commission shall review whether further substances meeting the criteria for classification as carcinogenic, mutagenic or toxic to reproduction category 1A or 1B pursuant to Regulation (EC) No 1272/2008 and mixtures containing such substances shall be added to Annex I, and if necessary, make a legislative proposal to the European Parliament and to the Council, accordingly. By [*], the Commission shall review whether certain nanomaterials shall be added to Annex I, and if necessary, make a legislative proposal to the European Parliament and to the Council, accordingly.
2011/06/30
Committee: ENVI
Amendment 256 #

2010/0377(COD)

Proposal for a directive
Article 27 a (new)
Article 27 a Fund 1. Each Member State shall establish by [*] a fund to provide for the prevention of major accidents involving dangerous substances, and to cover costs of competent authorities arising from the implementation of this Directive. 2. The contributions to the national fund should be borne by the operators, and be proportional to the quantities of dangerous substances present at the establishment. It shall take account of the work required by the competent authorities in relation to this Directive and shall ensure that the revenue derived is sufficient to cover the cost of the services delivered. The exact amount shall be specified in a Commission Regulation adopted in accordance with the procedure referred to in Article 24. * OJ: please insert 3 years after entry into force of this Directive.
2011/06/30
Committee: ENVI
Amendment 263 #

2010/0377(COD)

Proposal for a directive
Annex I – Part 1 – Table – Section 'H' – row H3a (new)
H3a Substances or mixtures that are corrosive to the skin or irritating to the skin corrosion, Category 20000 20000 1 with hazard statement EUH314
2011/06/30
Committee: ENVI
Amendment 275 #

2010/0377(COD)

Proposal for a directive
Annex I – Part 1 – Table – Section 'O'– row O3a (new)
O3a Substances meeting the criteria for classification as persistent, bioaccumulative and toxic in accordance with the criteria set out in 0,5 2 Annex XIII of Regulation (EC) No 1907/2007 [*] *OJ L 396, 30.12.2006, p. 1
2011/06/30
Committee: ENVI
Amendment 276 #

2010/0377(COD)

Proposal for a directive
Annex I – Part 1 – Table – Section 'O'– row O3b (new)
O3b Substances meeting the criteria for classification as very persistent or very bioaccumulative in accordance with the criteria set out in 0,5 2 Annex XIII of Regulation (EC) No 1907/2007 [*] *OJ L 396, 30.12.2006, p. 1
2011/06/30
Committee: ENVI
Amendment 278 #

2010/0377(COD)

Proposal for a directive
Annex I – Part 2 – Table – row 32 – Column 3
Polychlorodibenzofurans and 0,000000001 (=1mg) polychlorodibenzodioxins (including 0,001 TCDD), calculated in TCDD equivalent (note 19) in combination with TCDD), calculated in TCDD equivalent a concentration (note 19) threshold of 1ppb
2011/06/30
Committee: ENVI
Amendment 280 #

2010/0377(COD)

Proposal for a directive
Annex I – Part 2 – Table – row 37 a (new)
Carbon dioxide 124-38-9 20 1000
2011/06/30
Committee: ENVI
Amendment 291 #

2010/0377(COD)

Proposal for a directive
Notes to Annex I – paragraph 3 - subparagraph 2
The quantities to be considered for the application of the relevant Articles are the maximum quantities which are present or are likely to be present at any one time. Dangerous substances present at an establishment only in quantities equal to or less than 21 % of the relevant qualifying quantity shall be ignored for the purposes of calculating the total quantity present if their location within an establishment is such that it cannot act as an initiator of a major accident elsewhere on the site.
2011/06/30
Committee: ENVI
Amendment 302 #

2010/0377(COD)

Proposal for a directive
Annex II – paragraph 2 – point c
(c) identification of neighbouring establishments, as well as other sites, areas and developments that could be the source of, or increase the risk or consequences of a major accident and of domino effects;
2011/06/30
Committee: ENVI
Amendment 303 #

2010/0377(COD)

Proposal for a directive
Annex II – paragraph 3 – point b
(b) description of processes, in particular the operating methods according to Best Available Techniques pursuant to Directive 2010/75/EU on industrial emissions;
2011/06/30
Committee: ENVI
Amendment 305 #

2010/0377(COD)

Proposal for a directive
Annex II – paragraph 4 – point a – subpoint ii
(ii) external risks and hazard sources, from domino effects and from other sites, areas and developments that could be the source of, or increase the risk or consequences of a major accident;
2011/06/30
Committee: ENVI
Amendment 311 #

2010/0377(COD)

Proposal for a directive
Annex V – Part 1 – point 5 a (new)
5a. Non-technical summaries of the safety report
2011/06/30
Committee: ENVI
Amendment 312 #

2010/0377(COD)

Proposal for a directive
Annex V – Part 1 – point 5 b (new)
5b. External emergency plans Or. en (Linked to the deletion of Point 5 of Part 2 of Annex V (to be voted together))
2011/06/30
Committee: ENVI
Amendment 313 #

2010/0377(COD)

Proposal for a directive
Annex V – Part 1 – point 5 c (new)
(Linked to the deletion of the same provisions in Part 2 of Annex V (to be voted together).)5c. Adequate information on how the population concerned will be warned and kept informed in the event of a major accident. Or. en
2011/06/30
Committee: ENVI
Amendment 314 #

2010/0377(COD)

Proposal for a directive
Annex V – Part 1 – point 5 d (new)
(Linked to the deletion of the same provision in Poi5d. Adequate information on the actions the population concerned should take, and on the behaviour they should adopt, in the event 3 of Part 2 of this Annex (to be voteda major accident. Or. en together))
2011/06/30
Committee: ENVI
Amendment 320 #

2010/0377(COD)

Proposal for a directive
Annex V – Part 2 – point 2
2. Adequate information on how the population concerned will be warned and kept informed in the event of a major accident. deleted Or. en (Linked to the new amendment to Part 1 of Annex V by the same authors.)
2011/06/30
Committee: ENVI
Amendment 321 #

2010/0377(COD)

Proposal for a directive
Annex V – Part 2 – point 3
3. Adequate information on the actions the population concerned should take, and on the behaviour they should adopt, in the event of a major accident. deleted Or. en (Linked to the new amendment to Part 1 of Annex V by the same authors.)
2011/06/30
Committee: ENVI
Amendment 322 #

2010/0377(COD)

Proposal for a directive
Annex V – Part 1 – point 5
5. Appropriate information from the external emergency plan drawn up to cope with any off-site effects from an accident. This should include advice to cooperate with any instructions or requests from the emergency services atdeleted Or. en (Linked to the new amendment to Part 1 of Annex V by the tisame of an accident. authors.)
2011/06/30
Committee: ENVI
Amendment 13 #

2010/0298(COD)

Proposal for a regulation – amending act
Recital 2
(2) Efficient alternatives to phosphates- based household laundry detergents currently require small amounts of other phosphorous compounds, namely phosphonates which if used in increasing quantitie, or other co-builders such as polycarboxylates. Those substances are not readily biodegradable. In its opinion of 29 May 2007 entitled "Non surfactant Organic Ingredients and Zeolite-based Detergents", the Scientific Committee on Health and Environmental Risks found that the available information is not sufficient to exclude a potential risk due to those substances and recommended that additional information be provided for a more thorough and complete risk assessment. If those substances were used in increasing quantities as a result of the limitation on the use of phosphates, this might be of concern for the environment.
2011/05/19
Committee: ENVI
Amendment 29 #

2010/0298(COD)

Proposal for a regulation – amending act
Article 1 – point 8
Regulation (EC) No 648/2004
Article 16 - paragraph -1 (new)
By December 2013, the Commission shall evaluate, submit a report to the European Parliament and to the Council on the use of phosphonates and polycarboxylates in detergents and, if justified, present a legislative proposal with a view to their gradual phase-out or restriction to specific applications.
2011/05/19
Committee: ENVI
Amendment 30 #

2010/0298(COD)

Proposal for a regulation – amending act
Article 1 – point 8
Regulation (EC) No 648/2004
Article 16
By 31 December 20146, the Commission shall evaluate, submit a report to the European Parliament and to the Council on the use of phosphates and other phosphorous compounds in household automatic dishwasherindustrial and institutional detergents and, if justified, present a legislative proposal with a view to their gradual phase-out or restriction to specific applications.
2011/05/19
Committee: ENVI
Amendment 36 #

2010/0298(COD)

Proposal for a regulation – amending act
Annex
Regulation (EC) No 648/2004
Annex VIa
Annex VIa LIMITATIONS ON THE CONTENT OF PHOSPHATES AND OF OTHER PHOSPHORUS COMPOUNDS Detergent Limitations Date as of which the limitation applies Household laundry Shall not be placed on the 1 January 2013 detergents market if the total content of phosphorus is equal to or greater than 0.5 % by4% by weight or equal to or greater than 0.4 grams by standard washing machine load as defined in section B of Annex VII, whichever is lower Household automatic Shall not be placed on the 1 January 2014 dishwasher detergents market if the total content of phosphorus is equal to or greater than 0.5 % by weight
2011/05/19
Committee: ENVI
Amendment 16 #

2010/0254(COD)

Proposal for a directive - amending act
Recital 1
(1) In order to enhance the free movement of fruit juices and certain similar products within the European Union, Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption4 has laid down specific provisions regarding production, composition and labelling of the products concerned. Those rules should be adapted to technical progress and should take account of developments in relevant international standards, in particular the Codex Standard for fruit juices and nectars (Codex Stan 247-2005) which was adopted by the Codex Alimentarius Commission during its 28th session on 4- 9 July 2005 and the Code of Practice of the European Fruit Juice Association (AIJN).
2011/04/26
Committee: ENVI
Amendment 19 #

2010/0254(COD)

Proposal for a directive - amending act
Recital 2
(2) The above Codex Standard establishes in particular quality factors and labelling requirements for fruit juices and similar products. The AIJN Code of Practice also establishes quality factors for fruit juice from concentrate and is internationally used as a reference standard for self- regulation in the fruit juice industry. Directive 2001/112/EC should be brought into line, as far as possible, with those standards.deleted
2011/04/26
Committee: ENVI
Amendment 23 #

2010/0254(COD)

Proposal for a directive - amending act
Article 1 – point 1
Directive 2001/112/EC
Article 3 - paragraph 3
3. For products manufactured from two or more fruits, except where lemon and lime juice are used under the conditions laid down in Part II.2 of Annex I, the product names shall be supplemented by a list of the fruits used, in descending order of the volume of the fruit juices or purées included. However, in the case of products manufactured from three or more fruits, the indication of the fruits used may be replaced by the words “several fruits” or a similar wording, or by the number of fruits used. In any event, all fruits used must be indicated in the ingredients list in descending order of volume, and followed by the quantity, expressed as a percentage, in accordance with Regulation (EU) No […] of the European Parliament and of the Council on the provision of food information to consumers. If any fruit is mentioned in the product name, the principal name of the product must correspond to the dominating fruit.
2011/04/26
Committee: ENVI
Amendment 24 #

2010/0254(COD)

Proposal for a directive - amending act
Article 1 – point 1
Directive 2001/112/EC
Article 3 - paragraph 3 a (new)
3a. Pictorial representations on the package must not mislead the consumer as to the actual composition of the juice.
2011/04/26
Committee: ENVI
Amendment 25 #

2010/0254(COD)

Proposal for a directive - amending act
Article 1 – point 1
Directive 2001/112/EC
Article 3 - paragraph 3 b (new)
3b. The use of fruit purée and/or concentrated fruit purée shall be indicated in the list of ingredients.
2011/04/26
Committee: ENVI
Amendment 30 #

2010/0254(COD)

Proposal for a directive - amending act
Article 1 – point 1
Directive 2001/112/EC
Article 3 - paragraph 4
4. Nectars and specific products of Annex III may be sweetened by the addition of sugars or honey. The sales name shall include the word “sweetened” or “with added sugar”, followed by an indication of the maximum quantity of sugar added, calculated as dry matter and expressed in grams per litre. If only honey has been added, the sales name may include the words "with added honey" instead of "sweetened".
2011/04/26
Committee: ENVI
Amendment 40 #

2010/0254(COD)

Proposal for a directive - amending act
Article 1 – point 1
Directive 2001/112/EC
Article 3 - paragraph 5
5. If treatments have been carried out or substances have been used in accordance with Part II.3 of Annex I, this shall be indicated on the labelling. The addition to fruit juice of extra pulp or cells as defined in Annex II shall be indicated on the labelling.
2011/04/26
Committee: ENVI
Amendment 48 #

2010/0254(COD)

Proposal for a directive - amending act
Annex
Directive 2001/112/EC
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 same juice.
2011/04/26
Committee: ENVI
Amendment 50 #

2010/0254(COD)

Proposal for a directive - amending act
Annex
Directive 2001/112/EC
Annex I – part I – point 1 – point a – paragraph 5
The mixing of fruit juice with fruit purée is authorised in the production of the fruit juice.deleted
2011/04/26
Committee: ENVI
Amendment 52 #

2010/0254(COD)

Proposal for a directive - amending act
Annex
Directive 2001/112/EC
Annex I – part I – point 1 – point b – paragraph 1
The product obtained by reconstituting 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 the quality of water intended for human consumption* and displays appropriate characteristics, particularly from the chemical, microbiological and organoleptic viewpoints, in such a way as to guarantee the essential qualities of the juice.
2011/04/26
Committee: ENVI
Amendment 61 #

2010/0254(COD)

Proposal for a directive - amending act
Annex
Directive 2001/112/EC
Annex I – part II – point 2 – indent 2
– Flavour, pulp and cells restored to fruit juice, nectars, defined in Part I.1(a) must have been separated from that juice during processing, whereas flavour, pulp and cells restored to fruit juices from concentrate, nectars and concentrated fruit juices may be recovered from the same species of fruitalso be from fruit juice of the same kind.
2011/04/26
Committee: ENVI
Amendment 62 #

2010/0254(COD)

Proposal for a directive - amending act
Annex
Directive 2001/112/EC
Annex I – part II – point 2 – indent 4
– The addition of sugars and/or honey is authorised only in nectars (up to 20% of the total weight of the finished products) and in some specific products of Annex III. The addition of sugars is authorised: - for regulating acidic taste; the quantity of sugars added, expressed as dry matter, may not exceed 15 g per litre of juice, - for sweetening purposes; the quantity of sugars added, expressed as dry matter, may not exceed 150 g per litre of juice provided that the total amount of sugar added for both regulating acidic taste and sweetening purposes may not exceed 150 g per litre.
2011/04/26
Committee: ENVI
Amendment 64 #

2010/0254(COD)

Proposal for a directive - amending act
Annex
Directive 2001/112/EC
Annex I – part II – point 2 – paragraph 2
The addition of both sugars and lemon or lime juice, whether concentrated or not, or acidifying agents as permitted by Regulation (EC) No 1333/2008 to the same product is prohibited for specific products covered by Annex III.
2011/04/26
Committee: ENVI
Amendment 19 #

2010/0208(COD)

Proposal for a regulation - amending act
Recital 2 a (new)
(2a) In line with the conclusions of the Environmental Council of 4 December 2008, the Commission should, as a priority, ensure the proper implementation of the provisions of Directive 2001/18/EC, particularly the requirements of Annex II on the environmental risk assessment. Until the risk assessment provisions are properly implemented, no new GMO variety should be authorised.
2011/03/17
Committee: ENVI
Amendment 26 #

2010/0208(COD)

Proposal for a regulation - amending act
Recital 5
(5) Experience has shown that cultivation of GMOs is an issue which is more thoroughly addressed by Member States, either at central or at regional and local level. Contrary to issues related to the placing on the market and the import of GMOs, which should remain regulated at EU level to preserve the internal market, cultivation has been acknowledged as an issue with a strong local/regional dimension. Moreover, the harmonised environmental and health risks assessment might not address all possible impacts of GMO cultivation in different regions and ecosystems. In accordance with Article 2(2) TFEU Member States should therefore be entitled to have a possibility to adopt rules concerning the effective cultivation of GMOs in their territory after the GMO has been legally authorised to be placed on the EU market.
2011/03/17
Committee: ENVI
Amendment 31 #

2010/0208(COD)

Proposal for a regulation - amending act
Recital 6
(6) In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more freedom to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are entitlrequired to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products.
2011/03/17
Committee: ENVI
Amendment 36 #

2010/0208(COD)

Proposal for a regulation - amending act
Recital 7
(7) Member States should therefore be authorised to adopt measures restricting or prohibiting the cultivation of all or particular GMOs in all or part of their territory, and respectively amend those measures as they deem appropriate, at all stages of the authorisation, re-authorisation or withdrawal from the market of the concerned GMOs. ThiCultivation is in fact closely linked to land use and the conservation of fauna and flora, areas in which the Member States retain significant powers. National territories are characterised by an ample diversity of ecosystems. Any impacts on these ecosystems, in particular by possible changes of agricultural practices, may also have health implications. The possibility of adopting these measures should apply as well to genetically modified varieties of seed and plant propagating material which are placed on the market in accordance with relevant legislation on the marketing of seeds and plant propagating material and, in particular, in accordance with Directives 2002/53/EC and 2002/55/EC. Measures should refer to the cultivation of GMOs only and not to the free circulation and import of genetically modified seeds and plant propagating material, as or in products, and of the products of their harvest. Similarly they should not affect the cultivation of non genetically modified varieties of seed and plant propagating material in which adventitious or technically unavoidable traces of EU authorised GMOs are found.
2011/03/17
Committee: ENVI
Amendment 37 #

2010/0208(COD)

Proposal for a regulation - amending act
Recital 8
(8) According to the legal framework for the authorisation of GMOs, the level of protection of human/animal health and of the environment chosen in the EU cannot be revised by a Member State and this situation must not be altered. However Member States may adopt measures restricting or prohibiting the cultivation of all or particular GMOs in all or part of their territory on the basis of grounds relating to the public interest other than those already addressed by the harmonised set of EU rules which already provide for procedures to take into account the risks that a GMO for cultivation may pose on health and the environment. The grounds given by the Member States may include consideration of environmental or health impacts complementary to those already covered by the risk assessment provided for in Part C of Directive 2001/18/EC, and may thus, at least partially, include the consideration of scientific data relating to the central, local or regional environmental impact on receiving environments or relate to the persistence of scientific uncertainty regarding environmental or health impacts examined during the risk assessment process, or the absence or lack of sufficient data on potential negative impacts. Those grounds may also depend on factors that are not directly connected with the risk assessment, but are linked to risk management or other national policies. The grounds given by the Member States may also include, inter alia, the risk of resistance development in weeds or in the target organisms, the invasive potential of the plant, the prevention of negative environmental or health impacts of unsustainable farming practices or to the protection and maintenance of agricultural practices that preserve the sustainability of ecosystems. They may also, inter alia, include socio- economic considerations such as the practicality and cost of the measures laid down in Article 26a of Directive 2001/18/EC for avoiding the unintended presence of GMOs in other products, fragmentation of the territory, changes in agricultural practices linked to intellectual property regimes, or social policy objectives such as the conservation of diversity or distinctive agricultural practices. Those measures should furthermore be in conformity with the Treaties, in particular as regards the principle of non discrimination between national and non national products and Articles 34 and 36 of the Treaty on the Functioning of the European Union, as well as with the relevant international obligations of the Union, notably in the context of the World Trade Organisation. .
2011/03/17
Committee: ENVI
Amendment 50 #

2010/0208(COD)

Proposal for a regulation - amending act
Recital 9
(9) On the basis of the subsidiarity principle, the purpose of this Regulation is not to harmonize the conditions of cultivation in Member States but to grant freedom to Member States to invoke other grounds thancomplementary to, or differing from, the scientific assessment of health and environmental risks to ban cultivation of GMOs on their territory or which have not been addressed properly in the risk assessment. In addition one of the purposes of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations which is to allow the Commission to consider the adoption of binding acts at EU level would not be served by the systematic notification of Member States’ measures under that Directive. Moreover, since measures which Member States can adopt under this Regulation cannot have as a subject the placing of the market of GMOs and thus does not modify the conditions of placing on the market of GMOs authorised under the existing legislation, the notification procedure under Directive 98/34/EC does not appear the most appropriate information channel for the Commission. Therefore, by derogation, Directive 98/34/EC should not be applicable. A simpler notification system of the national measures prior to their adoption appears to be a more proportionate tool for the Commission to be aware of these measures. Measures which Member States intend to adopt should thus be communicated together with their reasons to the Commission and to the other Member States one month prior to their adoption for information purposes.
2011/03/17
Committee: ENVI
Amendment 55 #

2010/0208(COD)

Proposal for a regulation – amending act
Article 1 – point -1 (new)
Directive 2001/18/EC
Article 22
Directive 2001/18/EC shall be amended as follows: (-1) Article 22 shall be replaced by the following: ‘Article 22 Free circulation Without prejudice to Article 23 or Article 26b, Member States may not prohibit, restrict or impede the placing on the market of GMOs, as or in products, which comply with the requirements of this Directive.’
2011/03/17
Committee: ENVI
Amendment 56 #

2010/0208(COD)

Proposal for a regulation – amending act
Article 1 – point -1 a (new)
Directive 2001/18/EC
Article 25 – paragraph 4 a (new)
Directive 2001/18/EC shall be amended as follows: (-1a) In Article 25, the following paragraph shall be inserted: ‘4a. Without undue prejudice to the protection of intellectual property rights, the access to material necessary for independent research on potential risks of GMOs, such as seed material, shall not be restricted or impeded.’
2011/03/17
Committee: ENVI
Amendment 57 #

2010/0208(COD)

Proposal for a regulation – amending act
Article 1 – point -1 b (new)
Directive 2001/18/EC
Article 26 a – paragraph 1
Directive 2001/18/EC shall be amended as follows: (-1b) Article 26a(1) shall be replaced by the following: ‘1. Member States shall take all appropriate measures to avoid the unintended presence of GMOs in other products on their territory and on the territory of other Member States.’
2011/03/17
Committee: ENVI
Amendment 67 #

2010/0208(COD)

Proposal for a regulation - amending act
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a – introductory part
(a) those measures are based on grounds other than those related to the assessment of the adverse effect on health and environment which might arise from the deliberate release or the placing on the market of GMOs;
2011/03/17
Committee: ENVI
Amendment 68 #

2010/0208(COD)

Proposal for a regulation - amending act
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 1 – point a – point i (new)
(i) grounds relating to environmental or health impacts which might arise from the deliberate release or the placing on the market of GMOs, and which are complementary to the environmental or health impacts examined during the risk assessment process conducted under Part C of this Directive or have not been sufficiently dealt with as part of this assessment; or
2011/03/17
Committee: ENVI
Amendment 69 #

2010/0208(COD)

Proposal for a regulation - amending act
Article 1 – point 1
(ii) the persistence of scientific uncertainty regarding environmental and health impacts examined during the risk assessment process conducted under Part C of this Directive; or
2011/03/17
Committee: ENVI
Amendment 70 #

2010/0208(COD)

Proposal for a regulation - amending act
Article 1 – point 1
Directive 2001/18/EC
Article 26 b paragraph 1 – point a – point iii (new)
(iii) the absence or lack of data on the potential negative impacts of the release of GMOs on the territory, biodiversity or population of the Member State; or
2011/03/17
Committee: ENVI
Amendment 71 #

2010/0208(COD)

Proposal for a regulation - amending act
Article 1 – point 1
Directive 2001/18/EC
Article 26 b paragraph 1 – point a – point iv (new)
(iv) grounds relating to the prevention of the development of pesticide resistance amongst weeds and pests; or
2011/03/17
Committee: ENVI
Amendment 72 #

2010/0208(COD)

Proposal for a regulation - amending act
Article 1 – point 1
Directive 2001/18/EC
Article 26 b paragraph 1 – point a – point v (new)
(v) grounds relating to the invasiveness or persistence of a GM-variety, or to the possibility of interbreeding with domestic cultivated or wild plants; or
2011/03/17
Committee: ENVI
Amendment 73 #

2010/0208(COD)

Proposal for a regulation - amending act
Article 1 – point 1
Directive 2001/18/EC
Article 26 b paragraph 1 – point a – point vi (new)
(vi) grounds relating to the prevention of negative environmental and health impacts of unsustainable farming practices; or
2011/03/17
Committee: ENVI
Amendment 74 #

2010/0208(COD)

Proposal for a regulation - amending act
Article 1 – point 1
Directive 2001/18/EC
Article 26 b paragraph 1 – point a – point vii (new)
( vii) grounds relating to the protection and maintenance of agricultural practices that preserve the sustainability of ecosystems, the maintenance of certain habitats and ecosystems, or certain types of natural and landscape features; or
2011/03/17
Committee: ENVI
Amendment 75 #

2010/0208(COD)

Proposal for a regulation - amending act
Article 1 – point 1
Directive 2001/18/EC
Article 26 b paragraph 1 – point a – point viii (new)
(viii) other grounds that may include, inter alia, changes in agricultural practices, land use, town and country planning, socio-economic impacts, or other legitimate factors;
2011/03/17
Committee: ENVI
Amendment 111 #

2010/0208(COD)

Proposal for a regulation - amending act
Article 1 – point 1
Directive 2001/18/EC
Article 26 b – paragraph 2
By way of derogation to Directive 98/34/EC, Member States that intend to adopt reasoned measures under this Article shall communicate them to the other Member States and to the Commission, one month prior to their adoption for information purposes.
2011/03/17
Committee: ENVI
Amendment 114 #

2010/0208(COD)

Proposal for a regulation - amending act
Article 1 – point 1 a (new)
Directive 2001/18/EC
Article 26 b a (new)
(1a) The following Article shall be inserted: ‘Article 26 ba Liability requirements Member States shall establish a general mandatory system of financial liability and financial guarantees, for example through insurance, which applies to all business operators and which ensures that the polluter pays for unintended effects or damages that might occur due to the deliberate release or the placing on the market of GMOs.’
2011/03/17
Committee: ENVI
Amendment 113 #

2009/2214(INI)

Motion for a resolution
Paragraph 14
14. Takes note ofWelcomes the rdecent legal developments regarding the EU's ban on seal products, in particularision by the European Court of Justice (ECJ) to rescind the suspension of Regulation (EC) No 1007/20096 on the trade in seal products by the European Court of Justice (ECJ) in several cases; notes the consultation procedure under the auspices of the World Trade Organisation (WTO) requested by Canada and Norway, joined by Iceland according to Annex 2 to the WTO Agreement; expresses its hope that disagreements between the parties can be overcome and that they will come to a common interpretation of the exception in the regulation for the Inuit population following the rulings of the ECJ and the WTO;
2010/11/16
Committee: AFET
Amendment 25 #

2009/0173(COD)

Proposal for a regulation
Recital 10
(10) In recognition of the very high research and development and unit production costs of early generations of very low carbon vehicle technologies to be introduced into the marketplace following its entry into force, this Regulation seeks to accelerate and facilitate, on an interim basis, the process of introducing into the Community market ultra low carbon vehicles at their initial stages of commercialisation.deleted
2010/05/21
Committee: ENVI
Amendment 54 #

2009/0173(COD)

Proposal for a regulation
Recital 24
(24) The speed of road vehicles has a strong 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 powertrains and associated inefficiencies in slower operating conditions. It is therefore appropriate to investigate the feasibility of extending 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, with the aim of to includinge light commercial vehicles covered in this Regulation.
2010/05/21
Committee: ENVI
Amendment 59 #

2009/0173(COD)

Proposal for a regulation
Article 1 – paragraph 1
1. This Regulation establishes CO2 emissions performance requirements for new light commercial vehicles. This Regulation sets the average CO2 emissions for new light commercial vehicles at 1765 g CO2/km, by means of improvements in vehicle technology, as measured in accordance with Regulation (EC) No 715/2007 and its implementing measures, and innovative technologies.
2010/05/21
Committee: ENVI
Amendment 66 #

2009/0173(COD)

Proposal for a regulation
Article 1 – paragraph 2
2. From 2020, this Regulation sets a target of 135 g CO2/km for the average CO2 emissions ofat 125 g CO2/km, for new light commercial vehicles registered in the Community, by means of improvements in vehicle technology, as measured in accordance with Regulation (EC) No 715/2007 and its implementing measures.
2010/05/21
Committee: ENVI
Amendment 75 #

2009/0173(COD)

Proposal for a regulation
Article 1 – paragraph 2 a (new)
2a. In order to promote low emission vehicles Member States are encouraged to introduce further complementary measures, and in particular to differentiate vehicle taxes, charges and fees based on emission performance.
2010/05/21
Committee: ENVI
Amendment 80 #

2009/0173(COD)

Proposal for a regulation
Article 2 – paragraph 1
1. This Regulation shall apply to motor vehicles of category N1M2, N1, and N2 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 ('light commercial vehicles') which are registered in the Community for the first time and which have not previously been registered outside the Community ('new light commercial vehicles').
2010/05/21
Committee: ENVI
Amendment 106 #

2009/0173(COD)

Proposal for a regulation
Article 4 – paragraph 2
For the purpose of determinassessing each manufacturer's specific emissions of CO2, the following percenrformance under Article 7 for the years 2012 and 2013, a non- binding average CO2 emission targest of each manufacturer's175 g CO2/km for new light commercial vehicles registered in the relevant year shall be taken into account: – 75% in 2014, – 80% in 2015, – 100% from 2016 onwardsshall be used.
2010/05/21
Committee: ENVI
Amendment 109 #

2009/0173(COD)

Proposal for a regulation
Article 4 – paragraph 2 – indent 1
– 75% in 2014,deleted
2010/05/21
Committee: ENVI
Amendment 119 #

2009/0173(COD)

Proposal for a regulation
Article 4 – paragraph 2 – indent 2
– 80% in 2015,deleted
2010/05/21
Committee: ENVI
Amendment 130 #

2009/0173(COD)

Proposal for a regulation
Article 4 – paragraph 2 – indent 3
– 100 % from 2016 onwards.deleted
2010/05/21
Committee: ENVI
Amendment 151 #

2009/0173(COD)

Proposal for a regulation
Article 5
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, – 1 light commercial vehicle from 2016.Article 5 deleted Super-credits
2010/05/21
Committee: ENVI
Amendment 203 #

2009/0173(COD)

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point a – introductory part
(a) From 2014 until 2018
2010/05/21
Committee: ENVI
Amendment 206 #

2009/0173(COD)

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point a – subpoint i
(i) For excess emissions of more than 3 g CO2/km: ((Excess emissions – 3) × €120 + 45 €) × number of new light commercial vehicles).
2010/05/21
Committee: ENVI
Amendment 208 #

2009/0173(COD)

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point a – subpoint i – indent 1
((Excess emissions – 3) × €120 + 45 €) × number of new light commercial vehicles.deleted
2010/05/21
Committee: ENVI
Amendment 213 #

2009/0173(COD)

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point a – subpoint ii – indent 1
((Excess emissions – 2) × 25 € + 20 €) × number of new light commercial vehicles.deleted
2010/05/21
Committee: ENVI
Amendment 217 #

2009/0173(COD)

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point a – subpoint iii
(iii) For excess emissions of more than 1 but no more than 2 g CO2/km: ((Excess emissions – 1) × 15 € + 5 €) × number of new light commercial vehicles.deleted
2010/05/21
Committee: ENVI
Amendment 221 #

2009/0173(COD)

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point a – subpoint iv
(iv) For excess emissions of no more than 1 g CO2/km: Excess emissions × 5 € × number of new light commercial vehicles.deleted
2010/05/21
Committee: ENVI
Amendment 222 #

2009/0173(COD)

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point a – subpoint iv
(iv) For excess emissions of no more than 1 g CO2/km: Excess emissions × 5 € × number of new light commercial vehicles.deleted
2010/05/21
Committee: ENVI
Amendment 241 #

2009/0173(COD)

Proposal for a regulation
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.deleted
2010/05/21
Committee: ENVI
Amendment 253 #

2009/0173(COD)

Proposal for a regulation
Article 12 – paragraph 4 – subparagraph 1 – introductory part
By 1 January 2013, the Commission shall complete a reviewevaluate the implementation of the specific emissions targets in Annex I and of the derogations in Article 10, with the aim of defining:
2010/05/21
Committee: ENVI
Amendment 261 #

2009/0173(COD)

Proposal for a regulation
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 2020, a long-term target of 1325 g CO2/km in a cost-effective manner; and
2010/05/21
Committee: ENVI
Amendment 266 #

2009/0173(COD)

Proposal for a regulation
Article 12 – paragraph 4 – subparagraph 2 – introductory part
On the basis of such a reviewthe evaluation and its impact assessment, which includes an overall assessment of the impact on the car industry and its dependent industries, the Commission shall, if appropriate,
2010/05/21
Committee: ENVI
Amendment 271 #

2009/0173(COD)

Proposal for a regulation
Article 12 – paragraph 4 – subparagraph 2 – indent 1
make a proposal to amend this adopt detailed rules on the modalities for implementing the requirements of this Regulation in a way which is as neutral as possible from the point of view of competition, and which is socially equitable and sustainable,
2010/05/21
Committee: ENVI
Amendment 277 #

2009/0173(COD)

Proposal for a regulation
Article 12 – paragraph 4 – subparagraph 3
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 13(3)2), insofar as the procedure remains compatible with the amended Treaties.
2010/05/21
Committee: ENVI
Amendment 290 #

2009/0173(COD)

Proposal for a regulation
Article 12 a (new)
Article 12a Amendment to Directive 92/6/EEC The Council Directive 92/6/EEC1 is hereby amended, with effect from …*, as follows: (1) Article 1 shall be replaced by the following: "For the purposes of this Directive, “motor vehicle” means any power-driven vehicle falling within category M2, M3, N1, N2 or N3, intended for use on the road and having at least four wheels and a maximum design speed exceeding 25 km/h." Categories M2, M3, N1, N2 and N3 shall be understood to be those defined in Annex II to Directive 70/156/EEC (*)." (2) Article 2 first subparagraph shall be replaced by the following: "Member States shall take the necessary measures to ensure that motor vehicles of categories N1, N2, M2 and M3 referred to in Article 1 may be used on the road only if equipped with a speed limitation device set in such a way that their speed cannot exceed 100 kilometres per hour.". ____________ *OJ: one year after the date of entry into force of this Regulation. ____________ 1 OJ L 57, 2.3.1992, p. 27.
2010/05/21
Committee: ENVI
Amendment 294 #

2009/0173(COD)

Proposal for a regulation
Annex 1 – point 1 – subpoint a – line 2
Indicative specific emissions of CO2 = 1765 + a × (M – M0)
2010/05/21
Committee: ENVI
Amendment 299 #

2009/0173(COD)

Proposal for a regulation
Annex 1 – point 1 – subpoint b a (new)
(b a) From 2020: Indicative specific emission of CO2 = 125 + a × (M – M0) Where: M = mass of the vehicle in kilograms (kg), or another utility parameter adopted pursuant to Article 12(4) M0 = the value adopted pursuant to Article 12(1) a = the value adopted pursuant to Article 12 (4)
2010/05/21
Committee: ENVI
Amendment 21 #

2008/2208(INI)

Motion for a resolution
Recital F a (new)
Fa. whereas the lack of clarity about the actual use of nanomaterials in consumer products is unlikely to change, unless their are clear notification requirements on the use of nanomaterials, as well as full enforcement of Directive 2006/114/EC concerning misleading and comparative advertising,
2009/03/03
Committee: ENVI
Amendment 29 #

2008/2208(INI)

Motion for a resolution
Recital H a (new)
Ha. whereas SCENIHR identified some specific health hazards as well as toxic effects on environmental organisms for some nanomaterials, and considered that these observations indicate potential hazards which should be taken into consideration,
2009/03/03
Committee: ENVI
Amendment 30 #

2008/2208(INI)

Motion for a resolution
Recital H b (new)
Hb. whereas SCENIHR furthermore found a general lack of high quality exposure data both for humans and the environment and expects risk assessment procedures to remain under development until there is sufficient scientific information available to characterise the possible harmful effects on humans and the environment, thus concluding that the knowledge on the methodology for both exposure estimates and hazard identification needs to be further developed, validated and standardised,
2009/03/03
Committee: ENVI
Amendment 31 #

2008/2208(INI)

Motion for a resolution
Recital H c (new)
Hc. whereas the combination of evidence of hazards for certain nanomaterials and the overall lack of methods to properly assess the risks of nanomaterials is a reason for concern,
2009/03/03
Committee: ENVI
Amendment 32 #

2008/2208(INI)

Motion for a resolution
Recital H d (new)
Hd. whereas current funding into the environmental, health and safety aspects of nanomaterials in the Seventh Framework Programme for Research (FP7) is far too low; whereas moreover the evaluation criteria for granting research projects to assess the safety of nanomaterials under FP7 are too restrictive (i.e. they have a narrow innovation bias), and thus do not sufficiently promote the urgent development of scientific methods to assess nanomaterials,
2009/03/03
Committee: ENVI
Amendment 34 #

2008/2208(INI)

Motion for a resolution
Recital H e (new)
He. whereas the knowledge about potential health and environmental impacts lags significantly behind the pace of market developments, thus raising fundamental questions about the ability of the current governance model to deal with emerging technologies in "real time",
2009/03/03
Committee: ENVI
Amendment 41 #

2008/2208(INI)

Motion for a resolution
Recital L a (new)
La. whereas a closer look at REACH reveals many deficiencies to deal with nanomaterials, for example: - the one tonne threshold excludes nanomaterials produced in low quantities, even though such nanomaterials are present in consumer articles, - an exposure assessment only becomes mandatory for substances produced by a manufacturer above 10 tonnes/year and if they have been found to meet the criteria for classification as dangerous in accordance with Directive 67/548/EEC; however, given the current difficulties with hazard identification, an exposure assessment may well not be provided due to non-identification of hazards on the basis of existing methodology, even though an exposure assessment is crucial for a proper risk assessment of nanomaterials, - the REACH notification requirements for substances in articles only concern substances of very high concern that are on the candidate list and when they are present in concentrations above 0.1% by weight in the article and in a total quantity of over one tonne in those articles per producer per year; however, as not a single nanomaterial is currently on the candidate list, such listing will be difficult in light of the problems with hazard identification of nanomaterials, and even if those problems could be overcome, the nanomaterials would most likely not exceed the tonnage and concentration thresholds, so that it is highly unlikely that REACH in its current form will lead to notification of nanomaterials in articles,
2009/03/03
Committee: ENVI
Amendment 43 #

2008/2208(INI)

Motion for a resolution
Recital L b (new)
Lb. whereas waste legislation in the absence of nano-specific provisions may not apply correctly, for example: - adequate waste treatment depends inter alia on the hazardousness of a waste (e.g. acceptance criteria for different wastes in a landfill), but will not apply for nanomaterials as long as there is no agreed method for hazard identification, thus leading to non-specific treatment of nanomaterials depending on the general nature of the waste they end up in (anything from municipal solid waste to hazardous waste), - emission limit values for waste incineration only apply to certain known pollutants and not for nanomaterials, even though some might have to be classified as pollutants, or might have special requirements (e.g. carbon nanotubes, which can present asbestos- like properties, are stable until very high temperatures),
2009/03/03
Committee: ENVI
Amendment 44 #

2008/2208(INI)

Motion for a resolution
Recital L c (new)
Lc. whereas air and water legislation are blind to nano-specific challenges, as existing limits or quality standards are mass-based, but nanomaterials require different metrics to adequately assess them (e.g. number of particles or total surface area),
2009/03/03
Committee: ENVI
Amendment 45 #

2008/2208(INI)

Motion for a resolution
Recital L d (new)
Ld. whereas legislation on integrated pollution prevention and control (IPPC) will not adequately cover the potential risks of nanomaterials: - manufacture of certain nanomaterials may not be covered adequately, as they do not fit into any category of traditional chemical nomenclature (e.g. fullerenes - they are not organic substances, and they are very different from inorganic bulk carbon), - processing after manufacturing may not be covered (e.g. the processing of carbon nanotubes into articles), - it is difficult to see how best available techniques reference documents (BREFs) can be established for the various nanomaterials, given the need for a case- by-case approach to nanomaterials,
2009/03/03
Committee: ENVI
Amendment 46 #

2008/2208(INI)

Motion for a resolution
Recital L e (new)
Le. whereas there are fundamental problems with regard to the effectiveness of key provisions of worker protection legislation in relation to nanomaterials: - the obligation on employers to conduct a risk assessment as a basis for risk management measures such as substitution or occupational exposure limits is undermined by the absence of adequate and agreed risk assessment methodologies for nanomaterials and even provisions, - existing instruments often fail to adequately detect nanomaterials, thus making it difficult to control exposure,
2009/03/03
Committee: ENVI
Amendment 47 #

2008/2208(INI)

Motion for a resolution
Recital L f (new)
Lf. whereas the significant amendments concerning nanomaterials currently negotiated between the Council and the European Parliament in the context of the recast of the cosmetics directive and the review of the regulation on novel food, respectively, highlight the clear need to amend Community legislation to address nanomaterials adequately,
2009/03/03
Committee: ENVI
Amendment 48 #

2008/2208(INI)

Motion for a resolution
Recital L g (new)
Lg. whereas the current debate about regulatory aspects of nanomaterials is largely limited to expert circles, even though nanomaterials have the potential to bring about far-ranging societal change, which requires wide-ranging public consultation and full public participation in decision-making,
2009/03/03
Committee: ENVI
Amendment 69 #

2008/2208(INI)

Motion for a resolution
Paragraph 5 a (new)
5a. Calls on the Commission to fundamentally rethink its approach to regulating nanomaterials, and to urgently revise all relevant legislation so as to establish an adaptive management system with early warnings and risk categories, before the technology is so established that its development can no longer be steered without major disruptions;
2009/03/03
Committee: ENVI
Amendment 74 #

2008/2208(INI)

Motion for a resolution
Paragraph 7 a (new)
7a. Calls for the introduction of a comprehensive science-based definition of nanomaterials in Community legislation as a prerequisite for nano-specific amendments to relevant horizontal and sectoral legislation;
2009/03/03
Committee: ENVI
Amendment 77 #

2008/2208(INI)

Motion for a resolution
Paragraph 7 b (new)
7b. Calls specifically for amendments to REACH that ensure the following not later than 18 months after entry into force: - simplified registration for nanomaterials manufactured or imported (with a threshold based on e.g. surface activity instead of tonnage), providing core data on physico-chemical properties as well as toxicological and ecotoxicological effects, - a chemical safety report with exposure assessment for all registered nanomaterials irrespective of hazard identification, - notification requirements for all nanomaterials placed on the market on their own, in preparations or in articles irrespective of tonnage and concentration thresholds;
2009/03/03
Committee: ENVI
Amendment 78 #

2008/2208(INI)

Motion for a resolution
Paragraph 7 c (new)
7c. Calls for the application of a "Duty of Care" for manufacturers that wish to place nanomaterials onto the market;
2009/03/03
Committee: ENVI
Amendment 79 #

2008/2208(INI)

Motion for a resolution
Paragraph 7 d (new)
7d. Calls specifically for amendments to waste legislation to adequately address nanomaterials, such as: - a separate entry for nanomaterials in the list of waste established by Decision 2000/532/EC, - a revision of the waste acceptance criteria in landfills in Decision 2003/33/EC, - a revision of relevant emission limit values for waste incineration to supplement the mass-based measurements by metrics based on particle number and/or surface;
2009/03/03
Committee: ENVI
Amendment 80 #

2008/2208(INI)

Motion for a resolution
Paragraph 7 e (new)
7e. Calls specifically for a revision of emission limit values and environmental quality standards in air and water legislation to supplement the mass-based measurements by metrics based on particle number and/or surface to adequately address nanomaterials;
2009/03/03
Committee: ENVI
Amendment 81 #

2008/2208(INI)

Motion for a resolution
Paragraph 7 f (new)
7f. Calls specifically for amendments of the IPPC directive to ensure for all relevant nanomaterials that: - manufacture and processing are covered, - BREFs are newly established or adapted;
2009/03/03
Committee: ENVI
Amendment 82 #

2008/2208(INI)

Motion for a resolution
Paragraph 7 g (new)
7g. Calls specifically for amendments to worker protection legislation to ensure that nanomaterials are only used in closed systems as long as it is not possible to reliably detect and control exposure;
2009/03/03
Committee: ENVI
Amendment 87 #

2008/2208(INI)

Motion for a resolution
Paragraph 8 a (new)
8a. Calls for full enforcement of Directive 2006/114/EC concerning misleading and comparative advertising to ensure that that there is no misleading advertising with nanomaterials;
2009/03/03
Committee: ENVI
Amendment 92 #

2008/2208(INI)

Motion for a resolution
Paragraph 9 a (new)
9a. Calls for a major stepping up of the funding of research into the environmental, health and safety aspects of nanomaterials over their life cycle; calls specifically on the Commission to revise the evaluation criteria under FP7 so that FP7 attracts and funds significantly more research to improve the scientific methodology to assess nanomaterials;
2009/03/03
Committee: ENVI
Amendment 93 #

2008/2208(INI)

Motion for a resolution
Paragraph 9 b (new)
9b. Calls on the Commission to promote coordination and exchange between Member States on research and development, risk assessment, guidance development and regulation of nanomaterials by using existing mechanisms (e.g. REACH Competent Authorities Subgroup on Nanomaterials) or by creating additional ones, if appropriate;
2009/03/03
Committee: ENVI
Amendment 94 #

2008/2208(INI)

Motion for a resolution
Paragraph 9 c (new)
9c. Calls on the Commission to make an impact assessment on the costs and benefits of creating a European institute on nanomaterials;
2009/03/03
Committee: ENVI
Amendment 95 #

2008/2208(INI)

Motion for a resolution
Paragraph 9 d (new)
9d. Calls on the Commission to promote an EU-wide public debate in the Member States on regulatory aspects of nanomaterials;
2009/03/03
Committee: ENVI
Amendment 98 #

2008/2208(INI)

Motion for a resolution
Paragraph 9 e (new)
9e. Calls on the Commission to ensure full public participation in all decision- making related to nanomaterials;
2009/03/03
Committee: ENVI
Amendment 14 #

2008/2204(INI)

Motion for a resolution
Recital E
E. whereas electronic commerce is taking place in an environment which was primarily developed for educational reasons and thus was for many years an open and unsecured network,
2008/12/10
Committee: INTA
Amendment 15 #

2008/2204(INI)

Motion for a resolution
Recital F
F. whereas the further development of the new "digitalised" commercial environment has already and will continue to provide new opportunities for traditional and modern trade transactions, to enhance the consumer's position in the commercial chain and to contribute to the improvement of living standards for people all over the worldlead to entirely novel business models in consumer-producer relations,
2008/12/10
Committee: INTA
Amendment 16 #

2008/2204(INI)

Motion for a resolution
Recital G
G. whereas the Internet offers consumers the possibility to make better commercialinformed decisions in terms of quality and choprice compared to traditional means of purchase,
2008/12/10
Committee: INTA
Amendment 29 #

2008/2204(INI)

Motion for a resolution
Paragraph 3 a (new)
3a. Acknowledges that Internet trade poses problems with regard to the guarantee of product quality and safety due to the lack of the usual control practices at the distribution stage, which must be addressed in novel ways, such as consumer ratings of vendors and consumer-to-consumer peer review;
2008/12/10
Committee: INTA
Amendment 43 #

2008/2204(INI)

Motion for a resolution
Paragraph 11
11. Considers that the discussion for the current and future challenges of global internet trade should take place in a mutually supportive and structured cooperative framework based on institutionalised rules systems amongst interdependent actors; notes that the current modes of Internet governance are characterised by their hybrid nature lacking functional and regulatory hierarchical steering instruments;
2008/12/10
Committee: INTA
Amendment 56 #

2008/2204(INI)

Motion for a resolution
Paragraph 17 a (new)
17a. Calls on the Commission to improve legal interoperability of Internet services through the development of model licenses and other legal solutions compatible with jurisdictions where private law has not been harmonised, in particular for voluntary patent indemnification of international online standards, and to propagate existing European deliverables for legal interoperability as a means to reduce transaction costs and legal uncertainty of online providers;
2008/12/10
Committee: INTA
Amendment 4 #

2008/2133(INI)

Motion for a resolution
Recital C
C. whereas serious infringements of intellectual property rights (IPR) are non- , if ignored systemically by trade partners, constitute de facto non-tariff trade barriers which make access to third-country markets more difficult and costly, especially for small and medium- sized enterprises (SMEs) of limited resources and means,
2008/09/11
Committee: INTA
Amendment 7 #

2008/2133(INI)

Motion for a resolution
Recital F a (new)
Fa. whereas a considerable share of counterfeit and pirated goods originates within the European Union,
2008/09/11
Committee: INTA
Amendment 8 #

2008/2133(INI)

Motion for a resolution
Recital G
G. whereas counterfeiting and piracy has alarming consequences for the EU economy and, whenever prevalent in specific sectors without being effectively tackled, lead to highly damaging effects for the Community social and economic system as a whole, with regard to reducing incentives to innovate, curbing foreign direct investment (FDI), eliminating skilled jobs from industry and laying the groundwork for the development of a hidden economic system, running parallel to the legal one and controlled by organised crime,
2008/09/11
Committee: INTA
Amendment 10 #

2008/2133(INI)

Motion for a resolution
Recital H
H. whereas counterfeiting causes serious damage to the environment, both because of the inadequacy of the quality standards of counterfeit goods and the high costs of disposing of and destroying themdestruction of seized goods,
2008/09/11
Committee: INTA
Amendment 12 #

2008/2133(INI)

Motion for a resolution
Recital I
I. whereas the single market ensures that European consumers can choose freely, transparently and safely which products to buy, and counterfeiting, unless appropriately curbed, can not only undermine the principle of confidence on which the entire system is based but can also pose serious risks to safety, and health, and in extreme cases, the very lives of consumers and it is thus necessary to better protect their rightst is thus necessary to better protect consumer rights and to listen to consumer associations in the fight against counterfeiting,
2008/09/11
Committee: INTA
Amendment 13 #

2008/2133(INI)

Motion for a resolution
Recital I a (new)
Ia. whereas appropriate consumer education in the target countries of counterfeit goods about their health and safety risks is the single most important measure to curb the phenomenon, whereas public campaigns against drug and nicotine use exemplify the need for public financial resources to be used in order to achieve this aim,
2008/09/11
Committee: INTA
Amendment 16 #

2008/2133(INI)

Motion for a resolution
Recital J
J. whereas the ongoexisting differences between the laws of the Member States on IPRs, particularly with regard to the criminal measures aimed at ensuring that they are respected, weaken the European Union’s negotiating position and may undermine the efforts hitherto made to suppress counterfeiting more effectively internationally,
2008/09/11
Committee: INTA
Amendment 28 #

2008/2133(INI)

Motion for a resolution
Paragraph 1
1. Takes the view that the WTO system has ensured that IPRs are more widely recognised internationally, providing for minimuman agreed level of standards of protection through the Trade-Related Aspects of Intellectual Property Rights (TRIPS), dialogue between member states and with other institutions such as the World Intellectual Property Organization (WIPO) and the World Customs Organization (WCO), as well as a dispute prevention and settlement mechanism;
2008/09/11
Committee: INTA
Amendment 30 #

2008/2133(INI)

Motion for a resolution
Paragraph 2
2. Calls on the Commission to persevere in the TRIPS Council to ensure that the minimum rules incorporated into national law are accompanied by effective enforcement measures and measures to prevent infringements, while preserving the legitimate use of TRIPS flexibilities to ensure access to medicines in developing countries;
2008/09/11
Committee: INTA
Amendment 33 #

2008/2133(INI)

Motion for a resolution
Paragraph 3
3. Calls on the Commission to makesupport every effort to strengthen and broaden the scope of the TRIPS agreement in order to extend it to export, transit and transhipment operations, as well as to all IPRs which have so far been excluded from the agreementat WTO level to review the TRIPS agreement which, among others, could have the effect of strengthening and broadening its scope in order to extend it to export, transit and transhipment operations, constantly bearing in mind the level of development of the parties involved and distinguishing between countries which produce counterfeit and pirated products, those which use them, and those through which the products transit;
2008/09/11
Committee: INTA
Amendment 35 #

2008/2133(INI)

Motion for a resolution
Paragraph 4
4. Calls on the Commission and the Member States to develop specific measures, backed up by appropriate financial coverage, in favour of more widespread consumer education in Europe and also in developing countries, in order to avert the risks relating to potentially dangerous counterfeit products, to the deterrent effect on FDI and to criminal and terrorist activities in those countries;
2008/09/11
Committee: INTA
Amendment 39 #

2008/2133(INI)

Motion for a resolution
Paragraph 5
5. Points out that in several emerging economies, the production of counterfeit and pirated goods has reached alarming levels; whilst welcoming the cooperation initiatives hitherto implemented, is of the view that special measures are required in order to strengthen coordination between customs, judicial and police authorities, and to encourage the harmonisation of the laws of these countries with those of the European Un, especially, between consumer awareness organisations;
2008/09/11
Committee: INTA
Amendment 45 #

2008/2133(INI)

Motion for a resolution
Paragraph 6 a (new)
6a. Reaffirms that any harmonisation of substantive law must respect national sovereignty and international treaties in this area, and that any such harmonisation is therefore beyond the mandate of trade negotiations and agreements, which have as their sole objective contributing to a mutually- beneficial reduction of tariff and non- tariff barriers to international trade;
2008/09/11
Committee: INTA
Amendment 46 #

2008/2133(INI)

Motion for a resolution
Paragraph 7
7. Calls on the Commission to continue its fight against counterfeiting and piracy, in parallel with the multilateral negotiations, the appropriate multilateral forums, such as the TRIPS Council, the WIPO and the WCO, and also by means of bilateral, regional and multilateral agreementsinitiatives, with a view to approximating and enforcing laws, also by providing for the establishment of efficient dispute settlement systems and penalties in case of failure to comply with the obligations underwritten; underlines that any new agreement, such as ACTA, must aim at consolidating the existing multilateral framework rather then creating overlapping competences, contradictory standards or exclusive areas of competence;
2008/09/11
Committee: INTA
Amendment 49 #

2008/2133(INI)

Motion for a resolution
Paragraph 7 a (new)
7a. Believes that international cooperation in actively promoting awareness and education of the general public on intellectual property rights policies should be the key focus for a successful fight against counterfeiting and piracy, with the goal to identify key audiences and create communication programmes to increase consumer and media awareness on the impact of intellectual property violations, including the risk to health and safety and the connection to organised crime;
2008/09/11
Committee: INTA
Amendment 50 #

2008/2133(INI)

Motion for a resolution
Paragraph 7 b (new)
7b. Remains unconvinced about a strong emphasis on criminal sanctions, as envisioned in the ACTA negotiations, given the demand-side structure of counterfeit and piracy markets, which are inversely proportional to variations in consumer spending power; regards raising consumer awareness, the bolstering of spending power and the fight against corporate manipulation of price setting as far more effective tools in combating the root causes of counterfeiting and piracy;
2008/09/11
Committee: INTA
Amendment 51 #

2008/2133(INI)

Motion for a resolution
Paragraph 8
8. Calls on the Commission and the Member States to make all appropriate efforts to achieve a swift andnegotiate ACTA under conditions of the utmost transparency towards the EU citizens, especially with regard to the definitions of the terms "counterfeiting" and "piracy" and the measures of criminal sanctions foreseen, in order to achieve a satisfactory conclusion to the ACTA agreement; takes the view that not only is the entry into force of the agreement an essential international benchmark, but that it can ensure that counterfeiting is suppressed more effectively and provide an important tool for putting pressure on non-signatory third countri, if the criminal sanctions therein contained make full use of the common denominator of existing EU Member State legislation and respect the limited Community competence with regard to criminal measures;
2008/09/11
Committee: INTA
Amendment 54 #

2008/2133(INI)

Motion for a resolution
Paragraph 8 a (new)
8a. Expresses its concern that the European legislative process could be undermined through negotiations by the Commission with third countries nominally but not substantially falling under the heading of trade, such as ACTA, and thus compromise the legislative competences of the European Parliament and the Council;
2008/09/11
Committee: INTA
Amendment 55 #

2008/2133(INI)

Motion for a resolution
Paragraph 8 b (new)
8b. Stresses that in all envisaged IP enforcement agreements the personal use that is not for profit must be distinguished from the fraudulent and intentional marketing of counterfeit and pirated goods;
2008/09/11
Committee: INTA
Amendment 59 #

2008/2133(INI)

Motion for a resolution
Paragraph 9
9. Welcomes the growing interest shown by a number of WTO member countries in the ACTA and hopes that the agreement can be signed also bysuggests extending the period envisaged for negotiating ACTA, in order to allow China and other emerging countries, the economies of which are more directly concerned by counterfeiting, to decide to take full part in the negotiations of the agreement;
2008/09/11
Committee: INTA
Amendment 62 #

2008/2133(INI)

Motion for a resolution
Paragraph 9 a (new)
9a. Expects the Commission to inform the Parliament regularly about the progress in ACTA negotiations, to forward to Parliament the proposals of participating countries and to consult Parliament before signing any final agreement;
2008/09/11
Committee: INTA
Amendment 70 #

2008/2133(INI)

Motion for a resolution
Paragraph 10
10. Recommends that an effective monitoring mechanism be introduced with regard to possible infringements of IPRs that are protected under the various agreements, coupled with trade incentive tools as part of a specific commitment to the fight against counterfeiting and piracy, such as including developing countries in the Generalised System of Preferences (GSP) or granting special treatment to emerging countries in the application of trade defence measuresfacilitation of custom procedures for trustworthy trade;
2008/09/11
Committee: INTA
Amendment 77 #

2008/2133(INI)

Motion for a resolution
Paragraph 12
12. Is of the view that the TBR can provide important assistance to European companies suffering from problems of third-country market access in relation to alleged intellectual property rights (IPR) infringements and of discriminatory enforcement of their rights under the respective jurisdictions, and calls on the Commission to encourage and facilitate its use, especially for SMEs;
2008/09/11
Committee: INTA
Amendment 79 #

2008/2133(INI)

Motion for a resolution
Paragraph 13
13. Calls on the Commission to redefine without delay its priorities regarding the human resources assigned to European Union delegations, with the aim of ensuring that a sufficient number of officials are specifically involved in the fight against counterfeiting; these resources, ideally to be incorporated into a ‘market access team’, should, in association with the diplomatic missions of the Member States, be responsible for projecting Community anti-counterfeiting measures more effectively and improving contact with the relevant local authorities, as well as beingmake the ‘market access team’ in the EU delegations a tangible point of reference for Community companies (in particular SMEs) complaining of IP infringements;
2008/09/11
Committee: INTA
Amendment 80 #

2008/2133(INI)

Motion for a resolution
Paragraph 14
14. Notes the Commission’s commitment to combating counterfeiting and consolidating IP law in the European Union and calls for greater commitment in the suppress, in particular in relation tof counterfeiting and the harmonisation of existing laws in the Member Statepyright, Community trademarks and geographic indications;
2008/09/11
Committee: INTA
Amendment 102 #

2008/2133(INI)

Motion for a resolution
Paragraph 20
20. Calls on the Commission, in association with the Council and the Member States, to frame a policy that is clear, structured and ambitious, which, alongside internal customs and criminal measuresonsumer education, should coordinate and guide the ‘external’ actions of the European Union and its Member States in the fight against counterfeiting and piracy;
2008/09/11
Committee: INTA
Amendment 105 #

2008/2133(INI)

Motion for a resolution
Paragraph 21
21. Stresses the need for Parliament henceforth to be given a more central role in the fight against counterfeiting; considers it particularly advisable for its political presence to be promoted in specialist international meetings such as the Global Anti-counterfeiting and Piracy Congress, and in the international organisations involved in IP protection;
2008/09/11
Committee: INTA
Amendment 7 #

2008/2101(INI)

Motion for a resolution
Recital F
F. whereas the situation of various typecertain stocks of whale has improved since the introduction of the moratorium, though others have not,
2008/11/18
Committee: PECH
Amendment 9 #

2008/2101(INI)

Motion for a resolution
Recital G
G. whereas the moratorium was originally intended to last only until an adequate management scheme was put in place and to allow adequate time for depleted stocks to recover,
2008/11/18
Committee: PECH
Amendment 11 #

2008/2101(INI)

Motion for a resolution
Recital J
J. whereas the number of whales killed under Special Permit has actually increased since the introduction of the moratorium,
2008/11/18
Committee: PECH
Amendment 15 #

2008/2101(INI)

Motion for a resolution
Paragraph 2
2. Believes that the conservation of whales and other cetaceans depends ultimately on the development of measures that are the subject of universal agreementsufficiently broad agreement to be implemented effectively;
2008/11/18
Committee: PECH
Amendment 18 #

2008/2101(INI)

Motion for a resolution
Paragraph 6
6. Respects the need for a limited amount of hunting to be done by those traditionally engaged in it for the purposes of food supplyallowed by the IWC to meet documented subsistence needs, but calls for much greater emphasis on research into and the employment of humane killing methods, and does not support the expansion of the hunts with respect to species or numbers taken;
2008/11/18
Committee: PECH
Amendment 21 #

2008/2101(INI)

Motion for a resolution
Paragraph 7
7. Calls for any such hunting to take place only with clear quotas based on sthe advice of the IWC Scientific advicCommittee, under strict controls and with full recording;
2008/11/18
Committee: PECH
Amendment 25 #

2008/2101(INI)

Motion for a resolution
Paragraph 9
9. Calls also for threats to the cetacean population arising from climate change, pollution, ship strikes, fishing gear, sonarunderwater noise (including sonar, seismic surveys and vessel noise) and other hazards to be tackled outside such protected areas;
2008/11/18
Committee: PECH
Amendment 2 #

2008/2004(INI)

Motion for a resolution
Recital A
A. whereas the European Union is the most competitive actor regarding trade in services; whereas the Union is the world's largest exporter and the biggest service provider with more than 28% of the world total export and therefore has a strong interest in ensuring that new markets for goods, services and investments are opeexisting market openness is maintained,
2008/06/04
Committee: INTA
Amendment 10 #

2008/2004(INI)

Motion for a resolution
Recital D
D. whereas services are only partly tradable and therefore cannot be compared to trade in goods; whereas trade in services so far onlhowever already amount to 25% of world trade; whereas the sector has a huge potential and a lot to be gained from liberalised trade in services; whereas more jobs are created in this sector than in any other sector of the economy,
2008/06/04
Committee: INTA
Amendment 14 #

2008/2004(INI)

Motion for a resolution
Recital D a (new)
Da. whereas services, especially in sectors such as health, education and business support, contribute decisively to the basic functioning and the social fabric of a society; whereas, with information technology advancing rapidly, an increasing percentage of service jobs not requiring personal presence becomes subject to offshore outsourcing; whereas the liberalisation of trade in services therefore is a sensitive issue in most countries,
2008/06/04
Committee: INTA
Amendment 16 #

2008/2004(INI)

Motion for a resolution
Recital E
E. whereas the multilateral trading system, embodied in the World Trade Organization (WTO), remains the most effective framework for achieving fair and equitable trade in goods on a global basis, by developing appropriate rules and ensuring compliance with those rules; whereas the role of the WTO with regard to the General Agreement on Trade in Services (GATS) has to take into account the different nature of the services sector which does not lend itself to quantitative measurements of its degree of liberalisation or remaining barriers to trade,
2008/06/04
Committee: INTA
Amendment 20 #

2008/2004(INI)

Motion for a resolution
Recital F
F. whereas GATS is and must be the multilateral framework for the regulation of trade in services; whereas this does not prohibit states and notably the EU from negotiating bilateral agreements which have further reaching schedules of specific commitments, taking however into account that bilateral agreements may impact negatively on the advancement and importance of the multilateral framework,
2008/06/04
Committee: INTA
Amendment 26 #

2008/2004(INI)

Motion for a resolution
Recital G
G. whereas an efficient services infrastructure is a precondition for economic suceconomic development is a precondition for the development of efficient servicess; whereas access to world-class services helps exporters and producers of goods and services in developing countries to capitalise on their competitive strength; whereas a number of developing countries have also been able, building on foreign investment and expertise, to advance in international services markets; whereas services liberalisation has thus become a key element of manyn option in development strategies,
2008/06/04
Committee: INTA
Amendment 30 #

2008/2004(INI)

Motion for a resolution
Recital H
H. whereas the WTO's agreements on Technical Barriers to Trade (TBT) and Non-Tariff Barriers (NTBs) are frameworks setting out the conditions for trade in goods; whereas obstacles to trade and behind- the-border barriers not only damage trade in goods but also significantly affect trade in services and public procurementin the services sector are principally dealt with in the framework of the GATS Article VI on Domestic Regulation, relating especially to disciplines with regard to service standards and licensing requirements, and GATS Article XVI on market access, relating especially to quantitative and qualitative measures,
2008/06/04
Committee: INTA
Amendment 48 #

2008/2004(INI)

Motion for a resolution
Paragraph 4
4. Emphasises that developed countries and trade blocs such as the EU cannot and should not impose a one-size-fits-all model on other countrihow to precisely regulate their domestic service sectors on other countries, given that services have different meanings in different cultures and serve different national development objectives at different times;
2008/06/04
Committee: INTA
Amendment 52 #

2008/2004(INI)

Motion for a resolution
Paragraph 5 a (new)
5a. Is concerned, in this regard, about the draft on new domestic disciplines proposed by the Chair of the WTO Working Party on Domestic Regulation in January 2008 which proposes to move non-discriminatory domestic regulation from its current green light status under the GATS Article VI to "yellow light" status, thus creating legal uncertainty in an area that is already a difficult environment for national regulation;
2008/06/04
Committee: INTA
Amendment 54 #

2008/2004(INI)

Motion for a resolution
Paragraph 5 b (new)
5b. Is alarmed by some of the proposed new disciplines in the draft of January 2008 that would weaken the regulatory authority of governments, particularly sub-national governments, and subject regulatory autonomy to rules aimed at minimising trade restrictive effects, thus creating new grounds on which non- discriminatory regulations might be challenged;
2008/06/04
Committee: INTA
Amendment 55 #

2008/2004(INI)

Motion for a resolution
Paragraph 5 c (new)
5c. Calls on the Commission to not support the proposed deletion of the recognition of the right to regulate in order to meet sub-national as well as national objectives, the proposed imposition of ever more onerous requirements to submit to the WTO “detailed information” on regulations, and the proposed narrowing of requirements to only consult “service suppliers” instead of all “interested persons” on regulations, which could have the effect of excluding all but commercial interests from reviewing new regulations;
2008/06/04
Committee: INTA
Amendment 56 #

2008/2004(INI)

Motion for a resolution
Paragraph 5 d (new)
5d. Warns that the right to regulate and to introduce new regulations, and in general the degree of regulatory diversity that is needed globally, would inevitably be curtailed by new disciplines requiring WTO members to ensure that licensing and qualification procedures are “as simple as possible”, that those wishing to supply services can only be required to approach “one competent authority”, and that international standards are to be taken into account when formulating national or sub-national technical standards;
2008/06/04
Committee: INTA
Amendment 57 #

2008/2004(INI)

Motion for a resolution
Paragraph 5 e (new)
5e. Is aware that the newly proposed disciplines on domestic regulation would be added in the form of an annex to the GATS requiring an amendment to the agreement; calls on the Commission to keep the Parliament informed about the proceedings of the GATS Working Party on Domestic Regulation and to submit any decision about an amendment to the GATS Agreement to Parliament under the codecision procedure;
2008/06/04
Committee: INTA
Amendment 62 #

2008/2004(INI)

Motion for a resolution
Paragraph 6
6. Suggests that the efficiency gains that could be obtained thanks to opening markets to services competition wcould allow less developed countries to provide services in areas that would otherwise be out of reach for the state due to its limited resources; considers that in this regard as much emphasis should be placed on government failure as is put on market failurethe universality of service delivery, its affordability for the poorer sections of populations and its sustainability over time which might outweigh efficiency gains through market opening;
2008/06/04
Committee: INTA
Amendment 70 #

2008/2004(INI)

Motion for a resolution
Paragraph 9
9. Recalls Article XIX of the GATS stating that members shall enter into successive rounds of negotiations, beginning not later than five years from the date of entry into force of the WTO Agreement and periodically thereafter, with a view to achieving a progressively higher level of liberalisation; recalls that such negotiations shall be directed to the reduction or elimination of the adverse effects on trade in services of measures as a mtake place in the frame of the single undertaking principle and therefore have to be balanced against interests put forward in other areans of providing effective market accesnegotiations;
2008/06/04
Committee: INTA
Amendment 81 #

2008/2004(INI)

Motion for a resolution
Paragraph 14
14. Takes note of the pressure frominterest of developing countries ondirected especially towards the EU and US to improve offers in Mode 4; considers it necessary to find the right balance in order to satisfy both sides;
2008/06/04
Committee: INTA
Amendment 84 #

2008/2004(INI)

Motion for a resolution
Paragraph 16
16. SupportsTakes note of the results achieved in the Economic Partnership Agreement (EPA) with the Caribbean Forum of ACP States (CARIFORUM); encourages the Commission to negotiate a similar ambitious chapter on services with the African regions and the Pacific region as envisaged in the interim agreements; believes that trade in services is a vehicle for development in these regions too; stresses the importance for the EU to cooperate and provide aid by establishing instruments andbelieves that trade in services is a vehicle for development subject to the condition that sound and transparent domestic regulations to govern services are in place;
2008/06/04
Committee: INTA
Amendment 86 #

2008/2004(INI)

Motion for a resolution
Paragraph 16 a (new)
16a. Calls seriously into question the fact that the CARIFORUM EPA applies to the regulation of services and investments at all levels of decision making, including village councils and non-governmental bodies exercising delegated powers, while the GATS only requires states to take ‘reasonable steps to ensure compliance’ at lower levels;
2008/06/04
Committee: INTA
Amendment 87 #

2008/2004(INI)

Motion for a resolution
Paragraph 16 b (new)
16b. Is concerned that in the CARIFORUM EPA the EC has narrowed the ‘right to regulate’ further than the GATS requires, by determining that regulation has to meet 'legitimate policy objectives’, though ‘legitimate’ is not defined and might exclude social or public service objectives; is equally concerned that the EPA does not contain safeguard provisions which would allow states to suspend their commitments if their domestic services or providers were threatened by a sudden influx from the EU;
2008/06/04
Committee: INTA
Amendment 88 #

2008/2004(INI)

Motion for a resolution
Paragraph 16 c (new)
16c. Notes that Title II of the CARIFORUM EPA combines investments in services and non-services activities, and thus extends GATS-style rules of ‘national treatment’ and ‘market access’ to foreign investment in non-services activities; is concerned that foreign investors are only required to consult local communities ‘where appropriate’ and when doing so does not impair their expected benefits from commitments made under the agreement, while there is no comparable concern for human rights, despite numerous reports from the UN Commission on Human Rights that agreements on trade in services have serious potential to undermine fundamental human rights;
2008/06/04
Committee: INTA
Amendment 91 #

2008/2004(INI)

Motion for a resolution
Paragraph 19
19. Is concernedaware with regards to the negotiation of the EU-Korea FTA about the difficulties that foreign firms face in gaining access to the Korean market for services including banking, insurance, telecommunications, news agencies and legal advice; urges the Commission to take into account growing concerns also in the EU about the crisis-prone effects of a banking and insurance sector whose pace of liberalisation was not accompanied by sound and transparent domestic regulation when addressing this issue in the negotiations on the FTA;
2008/06/04
Committee: INTA
Amendment 93 #

2008/2004(INI)

Motion for a resolution
Paragraph 20
20. Stresses with regards to the negotiation of the EU-India FTA the importance of our partnership with India and the need to get increased accto a balanced agreement, recognising India Government interests to the Indian marketwith regard to Mode 4 openings and EU interests in areas such as financial services, telecommunications, distribution, postal and courier, and legal services;
2008/06/04
Committee: INTA
Amendment 95 #

2008/2004(INI)

Motion for a resolution
Paragraph 20 a (new)
20a. Is concerned about the Commission's far reaching demands on India with regard to the opening of its financial service sector in the context of the bilateral requests in the GATS negotiations, including a request that money reserves for lending do not need to be located in the country itself by foreign owned bank branches; recalls from past experience, especially the financial crisis in Argentina in 2001, that there is no guarantee that parent banks transfer the necessary financial reserves in times of financial crisis in a country in which they do not hold reserves; reminds the Commission to follow the recommendations of the Financial Stability Forum ("Enhancing market and institutional resilience", April 2008) with regard to capital requirements and cross- border liquidity;
2008/06/04
Committee: INTA
Amendment 96 #

2008/2004(INI)

Motion for a resolution
Paragraph 20 b (new)
20b. Is aware that India has banned futures trading in key agricultural commodities over concerns that speculation has caused sharp increases in the price of food staples; reminds the Indian negotiators that this ban could be challenged under the FTA or the GATS dispute settlement procedures once India has made commitments on these financial services;
2008/06/04
Committee: INTA
Amendment 98 #

2008/2004(INI)

Motion for a resolution
Paragraph 21
21. Takes note of the latest study by the World Bank showing that in some countries, such as Ethiopia, Nigeria, Kenya and Uganda more than 40 % of people in the lowest economic quintile receive their health care from private, for profit providers; underlines the necessity of investments being made in this sector in order to meet these needs; stresses furthermore that problems with inconsistent levels of care, inefficiency, and unethical business practthe EU should support the development of sound domestic rules for the service sectors in these countries in order to enable them to open up their services must be addressed adequately; arkets at a later stage;
2008/06/04
Committee: INTA
Amendment 101 #

2008/2004(INI)

Motion for a resolution
Paragraph 22
22. Notes that no WTO member has yet made any commitments on the water distribution sector due to the utmost sensitive nature of the issue; recognises that most if not all examples of water provision through foreign private providers have failed to live up to required access, price and quality criteria; recalls nonetheless, that any state is free to do so should it consider itself unable to provide the service which its citizens need; stresses that should a such commitment be made it does not prohibit the state fromrequires prior established domestic rules setting levels of quality, safety, price or other policy objectives as they see fsuch as universalit,y and the same regulations would apply to foreign suppliers as to local supplierrequirements for foreign providers to invest also in water distribution infrastructure in more distant and rural areas;
2008/06/04
Committee: INTA
Amendment 108 #

2008/2004(INI)

Motion for a resolution
Paragraph 25
25. Believes that, on the basis of prior established sound and transparent domestic regulation, a cautious and phased opening up of the market in financial services in developing countries may offers citizens and entrepreneurs access to funds in order to create local jobs and alleviate poverty since they are no longer forced to rely on state monopolies or institutions with links to ruling elites;
2008/06/04
Committee: INTA
Amendment 109 #

2008/2004(INI)

Motion for a resolution
Paragraph 25 a (new)
25a. Is aware, however, that the premature opening of the financial services markets worldwide before sound national and international regulatory supervision was in place has contributed to the spreading of the current US financial crisis, and that therefore the Commission should not press for new commitments in this sector in the frame of the DDA until the Financial Stability Forum (FSF) and the Basel Committee on Banking Supervision have made precise recommendations and countries have implemented these recommendations;
2008/06/04
Committee: INTA
Amendment 110 #

2008/2004(INI)

Motion for a resolution
Paragraph 25 b (new)
25b. Calls on the Commission, in the light of the current financial crisis, to withdraw its request to Brazil, Chile and India and other countries to liberalise according to the far-reaching GATS' Understanding on Commitments in Financial Services' which requires that foreign financial service providers be given permission to introduce any kind of new financial service, until the FSF has made precise recommendations about the required regulatory supervision;
2008/06/04
Committee: INTA
Amendment 111 #

2008/2004(INI)

Motion for a resolution
Paragraph 25 c (new)
25c. Calls on the "Friends of Financial Services" led by Canada to withdraw, in the light of the current financial crisis, their request on various developing countries to permanently open their markets for trade in "derivative products including, but not limited to, futures and options", as well as investment banking and asset management, given that these products are not yet adequately regulated, thereby contributing to financial instability;
2008/06/04
Committee: INTA
Amendment 112 #

2008/2004(INI)

Motion for a resolution
Paragraph 25 d (new)
25d. Calls especially on raw materials producing developing countries to not engage in new commitments in financial services which would prevent them from intervening in their domestic financial markets to curb speculative activities and financial products, including derivative trading in commodities and food in times of crises and rising prices;
2008/06/04
Committee: INTA
Amendment 113 #

2008/2004(INI)

Motion for a resolution
Paragraph 25 e (new)
25e. Warns against the further weakening of prudential measures in the financial service sector through proposed language in the GATS Working Party on Domestic Regulation requiring service regulations to be made "as simple as possible”, thus increasing the uncertainty on whether measures that are introduced to avoid a financial crisis and adapt a country to changing circumstances might be considered as restrictions to trade;
2008/06/04
Committee: INTA
Amendment 29 #

2008/0256(COD)

The European Parliament rejects the Commission proposal.
2010/05/25
Committee: ENVI
Amendment 31 #

2008/0256(COD)

Proposal for a directive - amending act
Recital 1
(1) 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 use establishes harmonised rules on the advertising of medicinal products for human use. In particular, it prohibits the advertising to the general public of medicinal products subject to medical prescription in order to protect human health.
2010/05/25
Committee: ENVI
Amendment 37 #

2008/0256(COD)

Proposal for a directive - amending act
Recital 3 a (new)
(3a) For scientific information, transparency obligations for competent authorities have been established by Directive 2001/83/EC. However, evidence has shown that competent authorities restrict access to information for the general public due to a wide interpretation of commercial confidentiality. To avoid such divergent practices, the obligations of competent authorities to provide access to information for the general public need to be clarified.
2010/05/25
Committee: ENVI
Amendment 61 #

2008/0256(COD)

Proposal for a directive - amending act
Recital 10
(10) Provisions should be established to ensure that only high-quality non- promotionofficial information about the benefits and the risks of authorised medicinal products subject to medical prescription may be dissemmade available, notably through the Community database referred to in Articles 57(1)(l) and 57(2) of Regulation (EC) No 726/2004 (hereinaftedr ‘the Eudrapharm database’). 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 criteria.
2010/05/25
Committee: ENVI
Amendment 66 #

2008/0256(COD)

Proposal for a directive - amending act
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminate only high-quality information and to distinguish non-promotional information from advertising, the types of information which may be disseminated should be defined. Ivalidated statutory information, it is appropriate to allow marketing authorisation holders to disseminate the contents ofmake available the approved summaries of product characteristics and the approved package leaflet, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product- related information.
2010/05/25
Committee: ENVI
Amendment 79 #

2008/0256(COD)

Proposal for a directive - amending act
Recital 14
(14) Monitoring of information on prescription-only medicinal products should ensure that marketing authorisation holders only disseminate informationmake available material which is in compliance with Title VIIIa of Directive 2001/83/EC. Member States should adopt rules establishing effective independent 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 the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring.
2010/05/25
Committee: ENVI
Amendment 83 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point – 1 a (new)
Directive 2001/83/EC
Article 86 – paragraph 1
(-1a) Article 86(1) shall be replaced by the following: “1. For the purposes of this Title, ‘advertising of medicinal products’ shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular: - the advertising of medicinal products to the general public, including posts on blogs and websites, social media (so called ‘buzz marketing’) by the marketing authorisation holders either directly or indirectly through a third party; - advertising of medicinal products to persons qualified to prescribe or supply them, - visits by medical sales representatives to persons qualified to prescribe medicinal products, - the supply of samples, - the provision of inducements to prescribe, […]supply or, for citizens, patients and their carers, use medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal, - drawing the general public's attention to a specific medicinal product or to a therapeutic class of medicinal products using therapeutic indications or signs and symptoms, - sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products, - sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.”
2010/05/25
Committee: ENVI
Amendment 89 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 1
Directive 2001/83/EC
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;
2010/05/25
Committee: ENVI
Amendment 90 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 2
- factual, informative announcements and reference material relating, for example, to availability, pack changes, adverse- reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claimsinformation on the environmental risk of the medicinal product and information relating to the disposal of unused medicinal product or waste derived from medicinal products as well as reference to any collection system in place, provided they include no product claims and they do not induce to or promote the consumption of the medicinal product;
2010/05/25
Committee: ENVI
Amendment 93 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 3
- information relating to human health or diseases, provided that it is based on scientific evidence and that there is no reference, even indirect, to medicinal products;
2010/05/25
Committee: ENVI
Amendment 96 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 4
- informationofficially approved documents by the marketing authorisation holder to the general public on medicinal products subject to medical prescription, which is subject to the provisions of Title VIIIa.
2010/05/25
Committee: ENVI
Amendment 102 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 1 a (new)
Directive 2001/83/EC
Article 88 – paragraph 2
(1a) Article 88(2) is replaced by the following: "2. Medicinal products may be advertised to the general public, except on television, which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary."
2010/05/25
Committee: ENVI
Amendment 103 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 2
Directive 2001/83/EC
Article 88 – paragraph 4
(2) Article 88(4) is replaced by the following: “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.”;deleted.
2010/05/25
Committee: ENVI
Amendment 110 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point – 4 a (new)
Directive 2001/83/EC
Article 94 – paragraph 1
(4a) Article 94(1) shall be replaced by the following: "1. Where medicinal products are being promoted directly or indirectly by a marketing authorisation holder or a third party acting on its behalf or following its instructions to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons […]."
2010/05/25
Committee: ENVI
Amendment 113 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 1
1. Member States shall allow the marketing authorisation holder to disseminate, either directly or indirectly through a third party, information to the general public or members thereofto make available on their website official documents on authorised medicinal products subject to medical prescription provided that it is in the official languages of the Member States where they are authorised. Member States shall also allow the marketing accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIIIuthorisation holder to make available on their websites information on authorised medicinal products subject to medical prescription as listed in Article 86(2). When such information is made available, the marketing authorisation holder and any third party acting on behalf of the marketing authorisation holder shall be clearly identified.
2010/05/25
Committee: ENVI
Amendment 119 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 1 a (new)
1a. Health professionals who deliver information on pharmaceutical products or medical devices during a public event, in print and/or broadcast media shall declare publicly their interests, i.e. any financial ties with marketing authorisation holders or with third parties working on their behalf. This also includes the provision of consulting services and technical advice about the product(s) in question.
2010/05/25
Committee: ENVI
Amendment 121 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 2 – point a
a) information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products;deleted
2010/05/25
Committee: ENVI
Amendment 125 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 a – paragraph 2 – point b
b) material provided by the marketing authorisation holder to healthcare professionals for distribution to patients.
2010/05/25
Committee: ENVI
Amendment 131 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – introductory part
The following types of informationdocuments on authorised medicinal products subject to medical prescription may be disseminatedmade available by the marketing authorisation holder to the general public or members thereof:.
2010/05/25
Committee: ENVI
Amendment 136 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point a
a) the most recent summary of product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities, and the publicly accessible version of the assessment report drawn up by the competent authorities;
2010/05/25
Committee: ENVI
Amendment 139 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
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;deleted
2010/05/25
Committee: ENVI
Amendment 149 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
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;deleted
2010/05/25
Committee: ENVI
Amendment 157 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point d
d) medicinal product-related information about non-interventional scientific studies, or accompanying measures to prevention and medical treatment, or information which presents the medicinal product in the context of the condition to be prevented or treated.eleted
2010/05/25
Committee: ENVI
Amendment 167 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 c
InformationDocuments on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio. It shall only be made available through the following channels: a) health-related publications as defined by the Member State of publication, to the exclusion of unsolicited material actively distributed to the general public or members thereof; b) internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof; c) written answers to requests for information of a member of the general publicshall only be made available by the marketing authorisation holder to the general public via their website.
2010/05/25
Committee: ENVI
Amendment 172 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point a
a) health-related publications as defined by the Member State of publication, to the exclusion of unsolicited material actively distributed to the general public or members thereof;deleted
2010/05/25
Committee: ENVI
Amendment 188 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 1
1. The content and presentation of information on authorised medicinal products subject to medical prescription disseminated by the marketing authorisation holder to the general public or members thereof shall fulfil the following conditions: a) it must be objective and unbiased; in this regard, if the information refers to the benefits of a medicinal product, its risks shall also be stated; b) it must take into account the general needs and expectations of patients; c) it must be based on evidence, be verifiable and include a statement on the level of evidence; d) it must be up-to-date and include the date of publication or last revision of the information; e) it must be reliable, factually correct and not misleading; f) it must be understandable for the general public or members thereof; g) it must clearly state the source of the information indicating its author and giving references to any documentation that the information is based on; h) it must not contradict the summary of product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities.deleted
2010/05/25
Committee: ENVI
Amendment 198 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 2 – point d a (new)
da) a mail address or e-mail address allowing members of the general public to send comments to the national competent authorities;
2010/05/25
Committee: ENVI
Amendment 202 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100d – paragraph 2 – point d b (new)
"db) A statement indicating that members of the general public should report all suspected adverse reactions to their doctor, pharmacist, healthcare professional or to the national competent authority."
2010/05/25
Committee: ENVI
Amendment 205 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 3 – point a
a) comparisons between medicinal products;deleted
2010/05/25
Committee: ENVI
Amendment 214 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 e – paragraph 1
1. Member States shall ensure that marketing authorisation holders' Internet websites for the dissemination of informationmaking available of documents on medicinal products subject to medical prescription faithfully reproduce the summary of product characteristics and the package leaflet of the medicinal products concerned in the official languages of the Member States where they are authorised.
2010/05/25
Committee: ENVI
Amendment 216 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 e – paragraph 1 a (new)
1a. Member States shall ensure that each webpage from marketing authorisation holders referring to a medicinal product subject to medical prescription contains a prominent link to the corresponding webpage of the Community database referred to in Articles 57(1)(l) and 57(2) of Regulation (EC) No 726/2004 (hereinafter ‘the Eudrapharm database’).
2010/05/25
Committee: ENVI
Amendment 221 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5 (new)
Directive 2001/83/EC
Article 100 e – paragraph 1 b (new)
1 b. Member States shall make available on the website of the national competent authorities the approved and updated version of the summary of product characteristics, labelling and package leaflet of the medicinal product, the publicly accessible version of the assessment report and its summary where applicable. The relevant websites of the national competent authorities shall include a link to the Eudrapharm web site.
2010/05/25
Committee: ENVI
Amendment 227 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/ec
Article 100 e – paragraph 2
2. Member States shall ensure that requests for information to a marketing authorisation holder on a medicinal product subject to medical prescription by a member of the general public may be drafted in any of the official languages of the Community which are official languages in the Member States where the medicinal product is authorised. The reply shall be drafted in the language of the request. The request and the reply shall be kept by the marketing authorisation holder for 10 years following the request and be made available to the competent authorities upon their request.
2010/05/25
Committee: ENVI
Amendment 235 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100g – paragraph 1 – subparagraph 2 – indent 1
- the content of the informationdocuments hasve already been approved by the competent authorities; or.
2010/05/25
Committee: ENVI
Amendment 236 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 g – paragraph 1 – subparagraph 2 – indent 2
- an equivalent level of adequate and effective monitoring is ensured through a different mechanism.deleted
2010/05/25
Committee: ENVI
Amendment 240 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 g – paragraph 1 – subparagraph 3
The methods may include the voluntary control of information on medicinal products by self-regulatory or co- regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings available in the Member States.deleted
2010/05/25
Committee: ENVI
Amendment 250 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 1 – subparagraph 2
After registration of the Internet website, the information on a medicinal product contained therein may be provided by the marketing authorisation holder on other Internet websites throughout the Community if the contents are identical.deleted
2010/05/25
Committee: ENVI
Amendment 254 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
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.
2010/05/25
Committee: ENVI
Amendment 258 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 – subparagraph 1
2. Internet websites registered in accordance with paragraph 1 shall not contain links to other marketing authorisation holder websites unless they have also been registered in accordance with that paragraph. Those websites shall identify the competent authority which granted the marketing authorisation and its website address.
2010/05/25
Committee: ENVI
Amendment 263 #

2008/0256(COD)

Proposal for a directive - amending act
Article 1 – point 5
Directive 2001/83/EC
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, web-radio, pod casts, video streaming or any other digital information format not strictly authorised in accordance with this Directive.
2010/05/25
Committee: ENVI
Amendment 269 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
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 that website. marketing authorisation holder shall send the new contents and changes referred to in paragraph 1 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. The marketing authorisation holder shall remain fully responsible and liable for all the information it disseminates to the general public.
2010/05/25
Committee: ENVI
Amendment 283 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 5 a (new)
5a. Member States shall require marketing authorization holder to add the following statements to the registered web site: - [the name of the marketing authorisation holder] is responsible for the information provided in this web site. - “If you believe that the information provided is not in compliance with the law, please contact the national competent authority”. - “You are encouraged to report negative side effects of prescription drugs to your doctor, pharmacist, health care professional or to the national competent authorities”. - “You can find information on prescription medicines authorised in the community on the following web site: [link to Eudrapharm]."
2010/05/25
Committee: ENVI
Amendment 289 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 j – point c
c) supplyprovide the authorities or bodies responsible for monitoring information on medicinal products with the information, the financial resources and assistance they require to carry out their responsibilities;
2010/05/25
Committee: ENVI
Amendment 291 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5 (new)
Directive 2001/83/EC
Article 100 j – point c a (new)
ca) put in place complaint-handling systems and efficient redress mechanisms to deal with consumer complaints and to ensure fair compensation of victims.
2010/05/25
Committee: ENVI
Amendment 292 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5 (new)
Directive 2001/83/EC
Article 100 j – subparagraph 1 a (new)
Member States shall provide for the possibility to publish the name of a marketing authorisation holder responsible for disseminating non- compliant information on a medicinal product.
2010/05/25
Committee: ENVI
Amendment 294 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 k
Information on homeopathic and herbal medicinal products referred to in Article 14(1) that have been classified as prescription-only shall be subject to the provisions of this Title.
2010/05/25
Committee: ENVI
Amendment 296 #

2008/0256(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2001/83/EC
Article 100 l – paragraph 1 a (new)
Within 12 months following the entry into force of this Directive, the Commission shall, following a public consultation, involving patient and consumer organisations, doctors' and pharmacists' organisations, 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 a data analysis and a systematic review of evidence, the Commission shall, if appropriate, put forward proposals to improve the layout and content of the summaries of product characteristics and of the package leaflet to ensure they are a valuable source of information for the general public and for healthcare professionals.
2010/05/25
Committee: ENVI
Amendment 3 #

2008/0225(COD)

Proposal for a regulation – amending act
The European Parliament rejects the Commission proposal.
2010/05/04
Committee: ENVI
Amendment 6 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point -1 a (new)
Regulation (EC) No 726/2004
Article 9 – paragraph 4 – point a
(-1a) In Article 9(4), point (a) is 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;"
2010/05/04
Committee: ENVI
Amendment 8 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point -1 b (new)
Regulation (EC) No 726/2004
Article 9 – paragraph 4 – point e
(-1b) In Article 9(4), point (e) is 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";
2010/05/04
Committee: ENVI
Amendment 10 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point -1 c (new) Regulation (EC) No 726/2004

Article 9 – paragraph 4 – point e a (new)
(-1c) In Article 9(4), the following point is added: "(ea) the public summary of the assessment report referred to in Article 13(3)".
2010/05/04
Committee: ENVI
Amendment 12 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point -1 d (new)
Regulation (EC) No 726/2004
Article 10 – paragraph 6
(-1d) Article 10(6) is replaced by the following: "6. The Agency shall disseminate and make publicly available the documents referred to in Articles 9(4)(a), (b), (c), (d), (e) and (ea)."
2010/05/04
Committee: ENVI
Amendment 13 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point -1 e (new)
(-1e) In Article 13(3), the second subparagraph is 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."
2010/05/04
Committee: ENVI
Amendment 16 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 3
3. The Agency may object to the information submitted or parts thereof on grounds related to non-compliance with the provisions of Title VIIIa of Directive 2001/83/EC within 6120 days after receipt of the notification. If the Agency does not object within 6120 days, the information shall be deemed accepted and may be published. The marketing authorisation holder remains fully liable and responsible for the information provided in all cases.
2010/05/04
Committee: ENVI
Amendment 18 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 1
Regulation (EC) No 726/2004
Article 20b – paragraph 3 a (new)
3a. If the Agency has to make comments or objections to the documents submitted by the marketing authorisation holder, the Agency shall charge the marketing authorisation holder double the fee referred to in paragraph 4.
2010/05/04
Committee: ENVI
Amendment 19 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point - 1 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – point d
(-1a) In Article 57(1), point (d) is replaced by the following: "d. ensuring the dissemination of information on adverse reactions to medicinal products authorised in the Union, by means of a database permanently accessible to all Member States, health-care professionals, marketing authorisation holders and the public, [...] with personal data protection being guaranteed;"
2010/05/04
Committee: ENVI
Amendment 21 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 2 a (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 1 – point u a (new)
(2a) In Article 57(1), the following point is added: “(ua) promoting existing sources of independent reliable health information.”
2010/05/04
Committee: ENVI
Amendment 22 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 2 b (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 2
(2b) In Article 57, paragraph 2 shall be replaced by the following: "2. The database provided for in paragraph 1(l) shall include the most recent version of: - the summaries of product characteristics, - the patient or user package leaflet, - the information shown on the labelling, which shall always at least specify the International Non-proprietary Name, - the mock-ups of the secondary and primary packaging as well as of any other devices included in the package, - the conditions for authorisations granted subject to specific obligations as referred to in Articles 14(7) and 14(8), together with the deadline for their fulfilment and where appropriate a link to the results of the post-authorisation studies or risk management plans, once completed; - the European Public Assessment Reports (EPARs), including their summaries written in user-friendly language for the public, as referred to in Article 13(3); - for updates of European public assessment reports (EPARs) (variations or ‘steps taken after authorisation’) related to safety issues, the complete reports from the Committee for Medicinal Products for Human Use (CHMP); - the Public Assessment Reports (PARs) and, where available, summaries of them written in user-friendly language for the public; - the periodic safety update reports (PSURs), assessment reports and, where available, summaries of them written in user-friendly language to the public. It shall also include the date on which the marketing authorisation was awarded, and the procedure through which it was granted (centralised, decentralised or by mutual recognition). The database shall be developed in a stepwise way, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and of Directive 2001/82/EC respectively. The database shall subsequently be extended to include all the medicinal products authorised into the market within the European Union. This shall be achieved by ... *. This database shall be actively promoted to European citizens. To this end, each webpage from a marketing authorisation holder that refers to a medicinal product subject to medical prescription shall include a prominent link to the corresponding webpage of the Eudrapharm database. The database shall also include references to data on clinical trials being carried out, and those abandoned, or already completed, as contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC (hereinafter the ‘EudraCT database’)." * OJ: Please insert the date 5 years after the entry into force of this Regulation.
2010/05/04
Committee: ENVI
Amendment 23 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 2 c (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 2 a (new)
(2c) In Article 57, the following paragraph is added: "2a. The EudraCT database shall make publicly available: - the study protocols and subsequent variations of the study protocols; - a model of the informed consent form distributed to the patients; - a statement to the effect that clinical trials carried out outside the European Union meet the ethical requirements of Directive 2001/20/EC referred to in Article 6(1); - deadlines for the study completion; - detailed study results, to be made available not later than one year after the end of the study."
2010/05/04
Committee: ENVI
Amendment 24 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 2 d (new)
Regulation (EC) No 726/2004
Article 57 – paragraph 2 b (new)
(2d) In Article 57, the following paragraph is added: "2b. All clinical trials run by a marketing authorisation holder based in Europe or by a third party acting on its behalf shall be registered in the EudraCT database regardless of whether the clinical trials take place in Europe or in third countries."
2010/05/04
Committee: ENVI
Amendment 25 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 2 e (new)
Regulation (EC) No 726/2004
Article 59 – paragraph 4
(2e) In Article 59, paragraph 4 is replaced by the following: "4. Save as otherwise provided in this Regulation, in Directive 2001/83/EC or in Directive 2001/82/EC, where there is a fundamental conflict over scientific recommendations and decisions and the body concerned is a Member State institution, the Agency and the national body concerned shall work together to resolve the conflict, or to prepare a joint document duly clarifying the scientific points of conflict. This document shall be published and made publicly available immediately after its adoption."
2010/05/04
Committee: ENVI
Amendment 26 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 2 f (new)
Regulation (EC) No 726/2004
Article 62 – paragraph 2 – subparagraph 1
(2f) In Article 62(2), the first subparagraph is replaced by the following: "2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products who would be available to serve on working parties or scientific advisory groups of the Committee for Medicinal Products for Human Use, the Committee on Herbal Medicinal Products or the Committee for Medicinal Products for Veterinary Use, together with an indication of their qualifications, specific areas of expertise and declaration of interests."
2010/05/04
Committee: ENVI
Amendment 27 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 2 g (new)
Regulation (EC) No 726/2004
Article 62 – paragraph 2 a (new)
(2g) In Article 62, the following paragraph is inserted: "2a. Marketing authorisation holders shall provide the Agency and national competent authorities with a comprehensive list of payments and sponsorships to any patients' organisation, consumer organisation, healthcare professionals' organisation, learned society, individual health professional, political party and opinion leader in excess of 10 EUR. This list shall be made publicly available."
2010/05/04
Committee: ENVI
Amendment 28 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 2 h (new)
Regulation (EC) No 726/2004
Article 63 – paragraph 2
(2h) In Article 63, paragraph 2 is replaced by the following: "Members of the Management Board, members of the committees, rapporteurs and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to this industry shall be entered in a register held by the Agency which is accessible to the public on its website."
2010/05/04
Committee: ENVI
Amendment 29 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 2 i (new)
Regulation (EC) No 726/2004
Article 63 – paragraph 2 a (new)
(2i) In Article 63, the following paragraph is added: "2a. The Agency shall make publicly accessible: - the detailed agendas for the meetings of its committees and working parties, at the latest by the day before the meetings take place, - the records of these meetings, including the list of all experts attending and of experts not allowed to participate due to conflicts of interests, as well as a description of decisions taken, details of votes and explanations of votes, including minority opinions."
2010/05/04
Committee: ENVI
Amendment 30 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 2 j (new)
Regulation (EC) No 726/2004
Article 63 – paragraph 2 b (new)
(2j) In Article 63, the following paragraph is added: "2b. The Agency’s committees shall meet in public. Meetings shall be announced through the European Medicines Agency's website. The announcement shall include information on how the public can participate. Access to background documents shall be granted to all participants in the meeting."
2010/05/04
Committee: ENVI
Amendment 31 #

2008/0225(COD)

Proposal for a regulation – amending act
Article 1 – point 2 k (new)
Regulation (EC) No 726/2004
Article 80 – paragraph 2 a (new)
(2k) In Article 80, the following paragraph is added: "Commercial confidentiality may only be granted if it has been clearly shown by the applicant that the disclosure of the information would cause an unreasonable degree of prejudice to the commercial interests of the marketing authorisation holder. Commercial confidentiality may not be applied to an entire document or certain type of documents, but shall be restricted to the removal of specific elements of data, provided that there is no overriding public interest in disclosure."
2010/05/04
Committee: ENVI
Amendment 32 #

2008/0160(COD)

Proposal for a regulation
Recital 10
(10) The various prohibitions provided for by this Regulation should respond to the animal welfare concerns expressed by members of the public as to the placing on the Community market, including further to imports from third countries, of seal products obtained from seals that might not have been killed and skinned without causing avoidable pain, distress and other forms of suffering.
2008/12/10
Committee: ENVI
Amendment 34 #

2008/0160(COD)

Proposal for a regulation
Recital 13
(13) The fundamental economic and social interests of Inuit communities traditionally engaged in the hunting of seals as a means to ensure their subsistence shouldwill not be adversely affected. The hunt is an integrated part of the culture and the identity of the members of the Inuit society. It represents a source of income and contributes to the subsistence of the hunter. Therefore, s by this Regulation because subsistence hunting involves personal or family consumption only (and therefore not Community trade). Seal products deriving from hunts traditionally conducted by Inuit communities and which contribute to their subsistencefor subsistence purposes which enter the EU market only for cultural exchange purposes such as education or ceremony should not be covered by the prohibitions provided for in this Regulation.
2008/12/10
Committee: ENVI
Amendment 36 #

2008/0160(COD)

Proposal for a regulation
Recital 16
(16) In particular, the Commission should be empowered to adopt all measures necessary to ensure that procedures are in place allowing applications for derogation to the trade prohibitions set out in this Regulation to be lodged and handled in an efficient manner, as well as to ensure the proper implementation of the provisions of this Regulation concerning certification schemes and labelling and marking. Since those measures are of a general scope and are designed to amend non-essential elements of this Regulation by supplementing it, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. The Commission should also be empowered to decide on derogations to trade prohibitions under this Regulation, suspension or revocation thereof. Since those measures are adopted to ensure the management of the scheme provided for in this Regulation and apply it in individual cases, they must be adopted in accordance with the management procedure provided for in Article 4 of Decision 1999/468/EC.deleted
2008/12/10
Committee: ENVI
Amendment 43 #

2008/0160(COD)

Proposal for a regulation
Article 2 – paragraph 2
2. 'seal product' means all products, either processed or unprocessed, deriving or obtained from seals, including meat, oil, blubber, organs and raw fur skins and fur skins, tanned or dressed, including fur skins assembled in plates, crosses and similar forms as well as articles made from seal fur skins; with the exception of seal products derived from hunts conducted by Inuit communities that are traded as part of a non-commercial exchange between Inuit communities for cultural, educational, and/or ceremonial purposes.
2008/12/10
Committee: ENVI
Amendment 45 #

2008/0160(COD)

Proposal for a regulation
Article 2 – paragraph 7 a (new)
7a. 'subsistence purposes' means the customary and traditional uses by Inuit communities of seal products for direct personal or family consumption as food, shelter, fuel, clothing, tools; for the making and domestic selling of handicraft articles out of non-edible by-products taken from seals for personal or family consumption; and for the exchange of seals or their parts if the exchange is of a limited and non-commercial nature, or for sharing for personal or family consumption.
2008/12/10
Committee: ENVI
Amendment 2 #

2008/0108(CNS)

Proposal for a regulation – amending act
Recital 5
(5) The exclusive reference to cold treatment in the definition of ‘poultrymeat’ is too restrictive in view of technological developments. That definition should therefore be adapted.deleted
2009/02/11
Committee: ENVI
Amendment 3 #

2008/0108(CNS)

Proposal for a regulation – amending act
Annex – part 2 – point 1
Regulation (EC) No 1234/2007
Annex XIV– Part B – Part II
1. ‘poultrymeat’ means the edible parts of farmed birds falling within CN code 0105 suitable for human consumption, which have not undergone any treatment other than cold treatment.
2009/02/11
Committee: ENVI
Amendment 4 #

2008/0108(CNS)

Proposal for a regulation – amending act
Annex – part 3 a (new)
Regulation (EC) No 1234/2007
Annex XIV– Part B – Part III a (new)
3a. The following Part IIIa is added: "IIIa. Compulsory information on the label The name of the food in the labelling of any poultrymeat product shall include an indication of: (a) any added ingredient of a different animal origin to the rest of the meat; and (b) any added water making up more than 5 % of the weight of the product"
2009/02/11
Committee: ENVI
Amendment 5 #

2008/0108(CNS)

Proposal for a regulation – amending act
Annex – part 3 b (new)
Regulation (EC) No 1234/2007
Annex XIV– Part B – Part III b (new)
3a. The following Part IIIb is added: "IIIb. Indication of price The price per kilogram of the food shall be based solely on the drained net weight."
2009/02/11
Committee: ENVI
Amendment 16 #

2008/0063(CNS)

Proposal for a regulation – amending act
Recital 5 a (new)
(5a) Member States should exercise their power to allocate access to fishing for cod stocks so as to encourage their fishermen to fish in ways that result in more selective fishing and are less harmful to the environment.
2008/07/22
Committee: PECH
Amendment 19 #

2008/0063(CNS)

Proposal for a regulation – amending act
Article 1
Regulation (EC) No 423/2004
Article 6 - paragraph 1- point a
(a) if the size of the stock in the year prior to the year of application of the TAC is below the minimum level established in Article 5, the fishing mortality rate shall be reduced by 250% in the year of application of the TAC as compared with the fishing mortality rate in the prior year;
2008/07/22
Committee: PECH
Amendment 20 #

2008/0063(CNS)

Proposal for a regulation – amending act
Article 1
Regulation (EC) No 423/2004
Article 6 - paragraph 1- point b
(b) if the size of the stock in the year prior to the year of application of the TAC is below the precautionary level set out in Article 5 and above or equal to the minimum level established in Article 5, the fishing mortality rate shall be reduced by 125% in the year of application of the TAC as compared with the fishing mortality rate in the prior year; and
2008/07/22
Committee: PECH
Amendment 21 #

2008/0063(CNS)

Proposal for a regulation – amending act
Article 1
Regulation (EC) No 423/2004
Article 6 - paragraph 4
4. Notwithstanding paragraph 1(b) and (c) and paragraph 2, the Council shall not set the TAC at a level that is more than 125% below or 15% above the TAC established in the previous year.
2008/07/22
Committee: PECH
Amendment 25 #

2008/0045(COD)

Proposal for a directive – amending act
Article 2 – point 1 a (new)
Directive 2001/83/EC
Article 23 c (new)
(1a) The following Article 23c is inserted: The appropriate arrangements adopted by the Commission must take the following considerations into account: – For practical reasons of efficiency, the possibility should be extended to all the categories of change of submitting a single application for one or more identical changes made to the terms of a number of marketing authorisations; – Without prejudice to the global marketing authorisation referred to in Article 6(1), in the framework of extensions of marketing authorisations, the possibility should be provided, on the basis of arguments in justification, of submitting a complete, separate application for authorisation for a medicinal product that has already been authorised under another name and with a different product characteristic summary.”
2008/07/18
Committee: ENVI
Amendment 25 #

2008/0033(COD)

Proposal for a decision – amending act
Recital 9
(9) The number of fatalities and non-fatal accidents registered during industrial activities is an indication of inadequate enforcement of the workplace legislation. The exposure to DCM remains high and further risk reduction measures should apply to workers in industrial installations. Preventive measures such as good ventilation of the workplace that meets occupational exposure limits or respiratory protective equipment with an independent air supply, separate ventilated areas for the drying of stripped articles, appropriate personal protective equipment and additional modification of tanks should be adopted.
2008/07/17
Committee: ENVI
Amendment 26 #

2008/0033(COD)

Proposal for a decision – amending act
Recital 9 a (new)
(9a) In November 2007, the Scientific Committee on Occupational Exposure Limits recommended limit values for an eight hours Time Weighted Average and for a 15 minute Short Term Exposure Level. It is appropriate to establish these levels as maximum limits that are to be achieved by effective exhaust ventilation for industrial use, without prejudice to any lower levels set pursuant to national legislation.
2008/07/17
Committee: ENVI
Amendment 33 #

2008/0033(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point (xx) – column 2 – point 4 − point a
(a) operation of effective exhaust ventilation orproven to ensure full compliance with national occupational exposure limits that shall not exceed 100 ppm (353 mg/m3) for an eight hours Time Weighted Average or 200 ppm (706 mg/m3) for a 15 minute Short Term Exposure Level, or proven use of respiratory protective equipment with an independent air supply,
2008/07/17
Committee: ENVI
Amendment 115 #

2008/0028(COD)

Proposal for a regulation
Recital 30
(30) However, the Commission should produce a report within five years of the entry into force of this Regulation on whether someany categories of alcoholic beverages should be exempted, in particular, from providing the information on the energy value, and stating the reasons justifying possible exemptions, taking into account the need to ensure coherence with other relevant Union policies. The Commission mayshould also propose, if necessaryappropriate, specific requirements in the context of this Regulation.
2011/03/23
Committee: ENVI
Amendment 123 #

2008/0028(COD)

Proposal for a regulation
Recital 33
(33) The indication of origin is currently mandatory for beef and beef products15 in the Union following the bovine spongiform encephalopathy crisis and it has created consumer expectations. The impact assessment of the Commission confirms that the origin of meat appears to be consumers’ prime concern. There are other meats widely consumed in the Union, such as swine, sheep, goats and poultry. It is therefore appropriate to impose a mandatory declaration of origin for those products, and for those products when used in processed foods. For meat and poultry, the country or place of provenance may be given as a single place for animals only where the animals have been born, reared and slaughtered in the same country or place. In other cases information on each of the different places of birth, rearing and slaughter shall be given. The specific origin requirements could differ from one type of meat to another according to the characteristics of the animal species. It is appropriate to provide for the establishment through implementing rules of mandatory requirements that could vary from one type of meat to another taking into account the principle of proportionality and the administrative burden for food business operators and enforcement authorities.
2011/03/23
Committee: ENVI
Amendment 131 #

2008/0028(COD)

Proposal for a regulation
Recital 42
(42) To appeal to the average consumer and to serve the informative purpose for which it is introduced, and given the current level of knowledge on the subject of nutrition, the nutrition information provided should be simple and easily understood. To have the nutrition information partly on the ‘front of pack’ and partly the ‘back of pack’ might confuse consumers. Therefore, the nutrition declaration should be in the same field of vision. In addition, on a voluntary basis, some of the information may be repeated for example on the ‘front of pack’. A free choice as to the information that could be repeated might confuse consumers. Therefore it is necessary to clarify which information may be repeated tohe most important elements of the nutrition information should be placed on the ‘front of pack’, with the complete nutrition information placed on the ‘back of pack’. This will ensure that consumers can readily see the essential nutrition information when purchasing foods.
2011/03/23
Committee: ENVI
Amendment 140 #

2008/0028(COD)

Proposal for a regulation
Article 2 – paragraph 2 – point g
(g) ‘place of provenance’ means anythe place where a food is indicated to com, country or region where the fprom, and that is not the ‘country of origin’ as determducts or agricultural ingredients are wholly obtained, in accordance with Articles 23 to 26(2) of Regulation (EEC) No 2913/92;
2011/03/23
Committee: ENVI
Amendment 152 #

2008/0028(COD)

Proposal for a regulation
Article 7 – paragraph 1 – point b a (new)
(ba) by suggesting in the description or pictorial representations on the packaging the presence of a particular product or an ingredient although in reality the product which the packaging contains is an imitation food or contains a substitute for an ingredient normally used in a product. In such cases, the packaging must prominently bear the marking ‘imitation’ or ‘produced with (designation of the substitute ingredient) instead of (designation of the ingredient replaced)’;
2011/03/23
Committee: ENVI
Amendment 153 #

2008/0028(COD)

Proposal for a regulation
Article 7 – paragraph 1 – point b b (new)
(bb) for milk, by denoting milk as ‘fresh’ when its use-by-date is more than seven days after the filling date.
2011/03/23
Committee: ENVI
Amendment 163 #

2008/0028(COD)

Proposal for a regulation
Recital 27
(27) With a view to provide consumers with food information that is necessary to make an informed choice, alcoholic mixed beverages should also provide information on their ingredients.
2009/01/28
Committee: ENVI
Amendment 166 #

2008/0028(COD)

Proposal for a regulation
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.deleted
2009/01/28
Committee: ENVI
Amendment 173 #

2008/0028(COD)

Proposal for a regulation
Recital 29
(29) The indication of the country of origin or of the place of provenance of a food should be provided for foods consisting of a single ingredient and for the significant ingredient and the characterising ingredient(s) in multi-ingredient food products; also whenever its absence is likely to mislead consumers as to the true country of origin or place of provenance of that product. In other cases, the provision of the indication of country of origin or place of provenance is left to the appreciation of food business operators. In all cases, the indication of country of origin or place of provenance should be provided in a manner which does not deceive the consumer and on the basis of clearly defined criteria which ensure a level playing field for the industry and improve consumers’ understanding of the information related to the country of origin or place of provenance of a food. Such criteria should not apply to indications related to the name or address of the food business operator.
2009/01/28
Committee: ENVI
Amendment 175 #

2008/0028(COD)

Proposal for a regulation
Recital 31
(31) The European Community’s non- preferential rules of origin are laid down in Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code and its implementing provisions in Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code. Determination of the country of origin of foods will be based on these rules, which are well known to trade operators and administrations and should ease its implementation. For meat and foods containing meat, more differentiated rules shall apply, taking into account the places of birth, rearing, and slaughter.
2009/01/28
Committee: ENVI
Amendment 179 #

2008/0028(COD)

Proposal for a regulation
Recital 34
(34) In general, consumers are not aware of the potential contribution of alcoholic beverages to their overall diet. Therefore, it is appropriate to ensure that information on the nutrient content of in particular mixed alcoholic beverages is provided.
2009/01/28
Committee: ENVI
Amendment 194 #

2008/0028(COD)

Proposal for a regulation
Article 16 – paragraph 4 – subparagraph 2
By …36 , the Commission shall produce a report concerning the application of Article 18 and Article 29(1) to the products referred to in this paragraph, and addressing whether someany categories of alcoholic beverages should be exempted, in particular, from the requirement to provide the information on the energy value, and the reasons justifying possible exemptions, taking into account the need to ensure coherence with other relevant Union policies. __________________ 36 * OJ: Please insert the date: fivetwo years from the entry into force of this Regulation.
2011/03/23
Committee: ENVI
Amendment 195 #

2008/0028(COD)

Proposal for a regulation
Article 16 – paragraph 4 – subparagraph 3
The Commission mayshall accompany this report by a legislative proposal, if appropriate, determining the rules for a list of ingredients or a mandatory nutrition declaration for those products.
2011/03/23
Committee: ENVI
Amendment 209 #

2008/0028(COD)

Proposal for a regulation
Recital 27
(27) With a view to provide consumers with food information that is necessary to make an informed choice, alcoholic mixed beverages should also provide information on their ingredients.
2009/12/22
Committee: ENVI
Amendment 213 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 2 – introductory part
2. Indication of the country of origin or place of provenance shall be mandatory:
2011/03/23
Committee: ENVI
Amendment 213 #

2008/0028(COD)

Proposal for a regulation
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 wine1 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 1576/892, 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.deleted
2009/12/22
Committee: ENVI
Amendment 215 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 2 – subparagraph 1 (new)
For meat and poultry, the country or place of provenance may be given as a single place for animals only where the animals have been born, reared and slaughtered in the same country or place. In other cases information on each of the different places of birth, rearing and slaughter shall be given.
2011/03/23
Committee: ENVI
Amendment 217 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 2 – subparagraph 2 (new)
Where there are reasons which would make it impractical to label the country or place of provenance, the following statement may be given instead: ‘Of unspecified origin’.
2011/03/23
Committee: ENVI
Amendment 219 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 2 – point a
(a) where failure to indicate this might mislead the consumer as to the true country of origin or place of provenanceorigin of the food, in particular if the information accompanying the food or the label as a whole would otherwise imply that the food has a different country of origin or place of provenance;
2011/03/23
Committee: ENVI
Amendment 221 #

2008/0028(COD)

Proposal for a regulation
Recital 29
(29) The indication of the country of origin or of the place of provenance of a food should be provided for foods consisting of a single ingredient and for the significant ingredient and the characterising ingredient(s) in multi-ingredient food products. Such indication should also be provided whenever its absence is likely to mislead consumers as to the true country of origin or place of provenance of that product. In other cases, the provision of the indication of country of origin or place of provenance is left to the appreciation of food business operators. In all cases, the indication of country of origin or place of provenance should be provided in a manner which does not deceive the consumer and on the basis of clearly defined criteria which ensure a level playing field for the industry and improve consumers' understanding of the information related to the country of origin or place of provenance of a food. Such criteria should not apply to indications related to the name or address of the food business operator.
2009/12/22
Committee: ENVI
Amendment 223 #

2008/0028(COD)

Proposal for a regulation
Recital 31
(31) The European Community's non- preferential rules of origin are laid down in Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code1 and its implementing provisions in Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code2. Determination of the country of origin of foods will be based on these rules, which are well known to trade operators and administrations and should ease its implementation. For meat and foods containing meat, more differentiated rules should apply, taking into account the places of birth, rearing, and slaughter.
2009/12/22
Committee: ENVI
Amendment 227 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 2 – point b a (new)
(ba) for meat, poultry and fish when used as an ingredient in processed foods.
2011/03/23
Committee: ENVI
Amendment 227 #

2008/0028(COD)

Proposal for a regulation
Recital 34
(34) In general, consumers are not aware of the potential contribution of alcoholic beverages to their overall diet. Therefore, it is appropriate to ensure that information on the nutrient content of in particular mixed alcoholic beverages is provided.
2009/12/22
Committee: ENVI
Amendment 229 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 2 – point b a (new)
(ba) for dairy products;
2011/03/23
Committee: ENVI
Amendment 230 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 2 – point b b (new)
(bb) for fresh fruit and vegetables;
2011/03/23
Committee: ENVI
Amendment 231 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 2 – point b c (new)
(bc) for other single-ingredient-products;
2011/03/23
Committee: ENVI
Amendment 232 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 2 – point b d (new)
(bd) for meat, poultry and fish when used as an ingredient in processed foods.
2011/03/23
Committee: ENVI
Amendment 236 #

2008/0028(COD)

Proposal for a regulation
Recital 38
(38) Recent developments in the expression of the nutrition declaration, other than per 100g/100ml/portion, by some Member States and organisations in the food sector suggest that consumers like such schemes with an interpretative elemesnt as they can help them make informspeedy choices quickly. However, there is not evidence across all the Community on how the average consumer understands and uses the alternative expressiAs consumer research has shown, the use of a multiple colour system in highly processed products is most appreciated and best understood by consumers. To facilitate comparisons of the information. Therefore, it is appropriate to allow for different schemes to be developed and to allow research on consumer understanding in different Member States to continue so that, if appropriate, harmonised schemes may be introducedproducts in differing package sizes, it is appropriate to retain the mandatory stipulation that the nutrition declaration should refer to 100 g/100 ml amounts. If the food is prepacked as an individual portion, a nutrition declaration per portion should, in addition, be compulsory.
2009/12/22
Committee: ENVI
Amendment 241 #

2008/0028(COD)

Proposal for a regulation
Article 2 – paragraph 3
3. For the purposes of this Regulation the country of origin of a food shall refer to the origin of a food as determined in accordance with Articles 23 to 26 of Council Regulation (EEC) No 2913/92. For meat and foods containing meat, the origin of the foodstuff or the respective ingredient shall be defined as the country in which the animal was born, reared for most of its life, and slaughtered. If different, all three places have to be given when reference is made to the ‘country of origin’.
2009/01/28
Committee: ENVI
Amendment 244 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 3 – subparagraph 1 – introductory part
Where the country of origin or ther place of provenance of a food is given and where it is not the same as that of its primary ingredient:
2011/03/23
Committee: ENVI
Amendment 245 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 3 – subparagraph 1 – point a
(a) the country of origin or place of provenance of the primary ingredient in question shall also be given; or
2011/03/23
Committee: ENVI
Amendment 247 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 3 – subparagraph 1 – point b
(b) the country of origin or place of provenance of the primary ingredient shall be indicated as being different to that of the food.
2011/03/23
Committee: ENVI
Amendment 255 #

2008/0028(COD)

Proposal for a regulation
Article 25 – paragraph 5 – subparagraph 1 – introductory part
By …39 , the Commission shall submit reports to the European Parliament and the Council regarding the mandatory indication of the country of origin or place of provenance for: __________________ 39. * OJ: Please insert the date: three years from the entry into force of this Regulation.
2011/03/23
Committee: ENVI
Amendment 257 #

2008/0028(COD)

Proposal for a regulation
Article 7 – paragraph 1 – point c a (new)
(ca) by exhibiting pictures suggesting that the food is made of certain ingredients when it is not;
2009/01/28
Committee: ENVI
Amendment 258 #

2008/0028(COD)

Proposal for a regulation
Article 7 – paragraph 1 – point c b (new)
(cb) by suggesting that the flavour of the food comes from natural ingredients when it essentially comes from flavourings.
2009/01/28
Committee: ENVI
Amendment 262 #

2008/0028(COD)

Proposal for a regulation
Article 2 – paragraph 3
3. For the purposes of this Regulation the country of origin of a food shall refer to the origin of a food as determined in accordance with Articles 23 to 26 of Council Regulation (EEC) No 2913/92. With regard to Member States, the country of origin shall always refer to the respective Member State.
2009/12/22
Committee: ENVI
Amendment 263 #

2008/0028(COD)

Proposal for a regulation
Article 2 – paragraph 3 – subparagraph 2 (new)
For meat and foods containing meat, the origin shall be defined as the country in which the animal was born, reared for most of its life, and slaughtered. If different, all three places shall be given when reference is made to the 'country of origin'.
2009/12/22
Committee: ENVI
Amendment 270 #

2008/0028(COD)

Proposal for a regulation
Article 7 – paragraph 1 – point a a (new)
(aa) by pictorial representations that might mislead the consumer as to the origin of the food or its ingredients;
2009/12/22
Committee: ENVI
Amendment 270 #

2008/0028(COD)

Proposal for a regulation
Article 8 – paragraph 5
5. Food business operators within the business under their control shall ensure that information relating to non-prepacked food shall be transmitted to the operator receiving the food in order to enable, where appropriate, the provision of the mandatory food information specified in Article 9(1) points (a) to (c) and (f) to the final consumer.
2009/01/28
Committee: ENVI
Amendment 271 #

2008/0028(COD)

Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 1 – point b
(b) the amounts of fat, saturates, carbohydrate, sugars, proteinsugars, and salt.;
2011/03/23
Committee: ENVI
Amendment 273 #

2008/0028(COD)

Proposal for a regulation
Article 7 – paragraph 1 – point c a (new)
(ca) by suggesting that the flavour of the food comes from natural ingredients when it essentially comes from flavourings.
2009/12/22
Committee: ENVI
Amendment 274 #

2008/0028(COD)

Proposal for a regulation
Article 7 – paragraph 1 – point c b (new)
(cb) for foods containing fruits: (i) by exhibiting disproportionately large pictures of fruits which are not the dominant fruits in the food. The dominant fruit(s) must be the one(s) dominating the picture; (ii) by using a fruit's name in the name of the food, when this fruit is not present in amounts reasonably expected by the consumer.
2009/12/22
Committee: ENVI
Amendment 275 #

2008/0028(COD)

Proposal for a regulation
Article 7 – paragraph 1 – point c c (new)
(cc) for milk: by denoting milk as 'fresh' when its use-by-date is more than seven days after the date on which the milk packaging is filled.
2009/12/22
Committee: ENVI
Amendment 276 #

2008/0028(COD)

Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 1 – point b a (new)
(ba) the amounts of protein, carbohydrates, and transfats.
2011/03/23
Committee: ENVI
Amendment 278 #

2008/0028(COD)

Proposal for a regulation
Article 29 – paragraph 2 – point a
(a) trans fats;deleted
2011/03/23
Committee: ENVI
Amendment 284 #

2008/0028(COD)

Proposal for a regulation
Article 9 – paragraph 1 – point i
(i) the country of origin or place of provenance of foods consisting of a single ingredient and of the significant ingredient and the characterising ingredient(s) in multi-ingredient food products; the country of origin or place of provenance where failure to indicate this might mislead the consumer to a material degree as to the true country of origin or place of provenance of the food, in particular if the information accompanying the food or the label as a whole would otherwise imply that the food has a different country of origin or place of provenance; in such cases the indication shall be in accordance with the rules laid down in Article 35(3) and (4) and those established in accordance with Article 35(5);
2009/01/28
Committee: ENVI
Amendment 285 #

2008/0028(COD)

Proposal for a regulation
Article 8 – paragraph 5
5. Food business operators within the business under their control shall ensure that information relating to non-prepacked food shall be transmitted to the operator receiving the food for further sale or further processing in order to enable, where appropriate, the provision of the mandatory food information specified in Article 9(1) points (a) to (c) and (f) to the final consumer.
2009/12/22
Committee: ENVI
Amendment 290 #

2008/0028(COD)

Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 2
Notwithstanding subparagraph 1, food business operators shall ensure that the particulars referred to in Article 9(1) (a), (f(e), (f), (g) and (h) also appear on the external packaging in which the food is presented for marketing.
2009/12/22
Committee: ENVI
Amendment 291 #

2008/0028(COD)

Proposal for a regulation
Article 33 – paragraph 1
1. The particulars referred to in Article 29(1)(a) and (21)(b) shall be includpresented ion the same field of visionfront of pack and shall include the amount of energy in kcal as set out in Article 29(1)(a) and the mandatory nutrients in Article 29(1)(b) in grams. They shall be presented together in a clear format and, where appropriate, in the order of presentation provided for in Annex XV.
2011/03/23
Committee: ENVI
Amendment 293 #

2008/0028(COD)

Proposal for a regulation
Article 33 – paragraph 2
2. The particulars referred to in Article 29(1) and (2) shall be presented on the back of pack in tabular format, if space permits, in tabular format with the numbers aligned. Where space does not permit, the declaration shall appear in linear format and, where appropriate, in the order of presentation provided for in Annex XV.
2011/03/23
Committee: ENVI
Amendment 296 #

2008/0028(COD)

Proposal for a regulation
Article 9 – paragraph 1 – point h
(h) the name or business name and address of the manufacturer or, the packager, orand, when applicable, of athe seller established within the Community;
2009/12/22
Committee: ENVI
Amendment 296 #

2008/0028(COD)

Proposal for a regulation
Article 9 – paragraph 1 – point l a (new)
(la) the extent to which (expressed in %) the food business operator whose name is indicated on the label guarantees the absence of the following practices in the supply chain of the food: (1) child labour, as defined in Article 2 of ILO covenant 138; (2) forced labour, as defined in Article 2 of ILO covenant 29; (3) discrimination, as defined in Article 1 of ILO covenant 111; (4) violation of the freedom of association, as defined in Article 2 of ILO covenant 87.
2009/01/28
Committee: ENVI
Amendment 302 #

2008/0028(COD)

Proposal for a regulation
Article 9 – paragraph 2
2. The particulars referred to in paragraph 1 shall be indicated with words and numbers unless the consumers are informed, as regards one or more particulars, by other forms of expression established by implementing measures adopted by the Commission. Those measures designed to amend non- essential elements of this Regulation by supplementing it, shall be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 49(3)or numbers.
2009/01/28
Committee: ENVI
Amendment 303 #

2008/0028(COD)

Proposal for a regulation
Article 9 – paragraph 3
3. The Commission may amend the list of mandatory particulars laid down in paragraph 1. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).deleted
2009/01/28
Committee: ENVI
Amendment 306 #

2008/0028(COD)

Proposal for a regulation
Article 9 – paragraph 1 – point i
(i) the country of origin or place of provenance of foods consisting of a single ingredient and of the significant ingredient and the characterising ingredient(s) in multi-ingredient food products; the country of origin or place of provenance where failure to indicate this might mislead the consumer to a material degree as to the true country of origin or place of provenance of the food, in particular if the information accompanying the food or the label as a whole would otherwise imply that the food has a different country of origin or place of provenance; in such cases the indication shall be in accordance with the rules laid down in Article 35(3) and (4) and those established in accordance with Article 35(5);
2009/12/22
Committee: ENVI
Amendment 311 #

2008/0028(COD)

Proposal for a regulation
Article 9 – paragraph 1 – point i a (new)
(ia) with respect to meat and foods containing meat, the places of birth, rearing, and slaughter in accordance with Article 2(3)
2009/12/22
Committee: ENVI
Amendment 314 #

2008/0028(COD)

Proposal for a regulation
Article 34 – paragraph 1 a (new)
1a. Notwithstanding Article 4(1) of Regulation (EC) No 1924/2006, interpretive elements may be used, for the purpose of the present Regulation, for the expression or presentation of information on energy value and the amounts of fat, saturates, sugars and salt.
2011/03/23
Committee: ENVI
Amendment 315 #

2008/0028(COD)

Proposal for a regulation
Article 34 – paragraph 1 – point a
(a) they are based on sound, independent consumer research and do not mislead the consumer as referred to in Article 7;
2011/03/23
Committee: ENVI
Amendment 316 #

2008/0028(COD)

Proposal for a regulation
Article 34 – paragraph 1 – point a a (new)
(aa) their development is the result of extensive consultation with all stakeholder groups;
2011/03/23
Committee: ENVI
Amendment 316 #

2008/0028(COD)

Proposal for a regulation
Article 9 – paragraph 1 – point l a (new)
(la) the extent to which (expressed in percentage terms) the food business operator whose name is indicated on the label guarantees the absence of the following practices in the supply chain of the food: (1) child labour, as defined in Article 2 of ILO Convention 138; (2) forced labour, as defined in Article 2 of ILO Convention 29; (3) discrimination, as defined in Article 1 of ILO Convention 111; (4) violation of the freedom of association, as defined in Article 2 of ILO Convention 87.
2009/12/22
Committee: ENVI
Amendment 317 #

2008/0028(COD)

Proposal for a regulation
Article 34 – paragraph 1 – point c
(c) they are supported by independent evidence of understanding of such forms of expression or presentation by the average consumers; and
2011/03/23
Committee: ENVI
Amendment 318 #

2008/0028(COD)

Proposal for a regulation
Article 9 a (new)
Article 9a Derogations for micro-enterprises Handcrafted products produced by micro- enterprises shall be exempted from the requirement laid down in Article 9(1)(l). They may also be exempted from the information requirements laid down in Article 9(1)(a) to (k) if the products are sold on site of production and the sales staff is able to provide the information on request. Alternatively, the information may be given via labels on the shelves.
2009/12/22
Committee: ENVI
Amendment 318 #

2008/0028(COD)

Proposal for a regulation
Article 11
For specific types or categories of foods, the Commission may provide for derogations, in exceptional cases,Handcrafted products produced by micro- enterprises shall be exempted from the requirements laid down in Article 9(1) (b) and (f), provided that such derogations do not result in the final consumer and mass caterers being inadequately informed. Those measures designed to amend the non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure wi(l) if the products are sold on the site of production and the sales staff are able to provide the nutrition information. Alternatively, the information can be given via labels on the scrutiny referred to in Article 49(3)helves.
2009/01/23
Committee: ENVI
Amendment 321 #

2008/0028(COD)

Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 2
To facilitate the monitoring of the use and impact of such additional forms of expression or presentation, Member States mayshall require food business operators placing on the market in their territory foods bearing such information to notify the competent authority of the use of an additional form of expression or presentation and to provide them with the relevant justifications regarding the fulfilment of the requirements laid down in points (a) to (d) of paragraph 1. In such cases, information on the discontinuation of the use of such additional forms of expression or presentation mayshall also be required.
2011/03/23
Committee: ENVI
Amendment 322 #

2008/0028(COD)

Proposal for a regulation
Article 34 – paragraph 5 – footnote 44
____________________________ 44 * . OJ: Please insert the date: eightthree years from the entry into forcedate of application of this Regulation.
2011/03/23
Committee: ENVI
Amendment 322 #

2008/0028(COD)

Proposal for a regulation
Article 13 - paragraph 3
3. The availability of certain mandatory particulars by means other than on the package or on the label may be established by the Commission provided the general principles and requirements laid down in Chapter II of this Regulation are met. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).deleted
2009/01/23
Committee: ENVI
Amendment 324 #

2008/0028(COD)

Proposal for a regulation
Article 35 – paragraph 2 a (new)
2a. The term ‘vegetarian’ shall not be applied to foods that are, or are made from or with the aid of products derived from animals that have died, have been slaughtered, or animals that die as a result of being eaten. The term ‘vegan’ shall not be applied to foods that are, or are made from or with the aid of, animals or animal products, including products from living animals.
2011/03/23
Committee: ENVI
Amendment 347 #

2008/0028(COD)

Proposal for a regulation
Article 15 – paragraph 1 – point b
(b) the particulars provided in Article 9(1) points (d), (f), (g), (h) and (k (f) shall be mandatory only at the moment of delivery.
2009/12/22
Committee: ENVI
Amendment 348 #

2008/0028(COD)

Proposal for a regulation
Article 54 – paragraph 1 – subparagraph 2
Foods placed on the market or labelled prior to …54 ** which do not comply with the requirement laid down in point (l) of Article 9(1) may be marketed until the stocks of the foods are exhausted. __________________ 54. *** OJ: Please insert the date: the first day of the month five years after the entry into force of this Regulation.deleted
2011/03/23
Committee: ENVI
Amendment 349 #

2008/0028(COD)

Proposal for a regulation
Article 54 – paragraph 2
2. Between …55 and …56 , where the nutrition declaration is provided on a voluntary basis, it shall comply with Articles 29 to 34. __________________ 55. OJ: Please insert the date: the first day of the month three years after the entry into force of this Regulation. 56. OJ: Please insert the date: the first day of the month five years after the entry into force of this Regulation.deleted
2011/03/23
Committee: ENVI
Amendment 350 #

2008/0028(COD)

Proposal for a regulation
Article 55 – paragraph 2
It shall apply from …*, with the exception of point (l) of Article 9(1), which shall apply from …**. ________________________ * OJ: Please insert the date: the first day of the month three years after the entry into force of this Regulation. ** of the month five years after the entry into force of this Regulation. Three years is a sufficient period of time and there is no need for foreseeing a longer period for the requirement of a nutrition declarOJ: Please insert the date: the first day Or. en Justification.
2011/03/23
Committee: ENVI
Amendment 353 #

2008/0028(COD)

Proposal for a regulation
Article 17 – paragraph 2
2. In the case of packaging or containers the largest surface of which has an area of less than 10 cm2 only the particulars listed in Article 9(1) (a), (c), (e) and (f) and Article 29(1)(a) shall be mandatory on the package or on the label. The particulars referred to in Article 9(1)(b) shall be provided through other means orHowever, the provision of all particulars in accordance with Article 9(1) via the Internet shall be mandatory and the information shall be available at the request of the consumerpoint of purchase.
2009/12/22
Committee: ENVI
Amendment 356 #

2008/0028(COD)

Proposal for a regulation
Annex III – table – point 3a (new)
3a. FOODS CONTAINING GLUTAMIC ACIDS OR ITS SALTS 3a.1 Foods containing one or ‘contains appetite- more of the food additives enhancing E620, E621, E622, E623, ingredients’ E624 and E625
2011/03/23
Committee: ENVI
Amendment 357 #

2008/0028(COD)

Proposal for a regulation
Article 17 – paragraph 2 a (new)
2a. In the case of food in packaging or containers the largest surface of which has an area of less than 25 cm2, the nutrition declaration in accordance with Article 9(1)(l) shall not be mandatory on the package or on the label. However, the provision of this information via the Internet shall be mandatory and the information shall be available at the point of purchase.
2009/12/22
Committee: ENVI
Amendment 358 #

2008/0028(COD)

Proposal for a regulation
Article 17 – paragraph 3 – subparagraph 1 a (new)
The particulars listed in Articles 9 and 29 shall not be mandatory for foods provided by mass caterers within the meaning of Article 2(2)(d). However, the particulars referred to in Article 9(1)(a), (b), (c) and (i) shall be made available on request.
2009/12/22
Committee: ENVI
Amendment 360 #

2008/0028(COD)

Proposal for a regulation
Article 17 – paragraph 3 – subparagraph 1 b (new)
Food chains serving standardised food shall indicate the particulars referred to in Article 9(1)(a), (b), (c), (i) and (l) on the package of the food.
2009/12/22
Committee: ENVI
Amendment 361 #

2008/0028(COD)

Proposal for a regulation
Article 19 – paragraph 1 a (new)
1a. For products produced from animals that have been fed with genetically modified feedingstuffs pursuant to Regulation (EC) No 1829/2003, the words 'from animals fed with genetically modified feedingstuffs' shall appear in the list of ingredients referred to in Article 19 immediately following the ingredient(s) concerned. Where there is no list of ingredients, the words 'produced from animals fed with genetically modified feedingstuffs' shall appear clearly on the labelling.
2009/12/22
Committee: ENVI
Amendment 362 #

2008/0028(COD)

Proposal for a regulation
Article 19 – paragraph 1b (new)
1b. For products containing eggs or egg products, the terms referred to in Annex I to Commission Regulation (EC) No 557/2007 shall be added in brackets after the respective ingredient in the ingredient list, in accordance with the farming method used for the production of the eggs. For eggs from organic production, the respective ingredient may be labelled in accordance with Council Regulation (EC) No 834/2007, Article 23 (4) (b).
2009/12/22
Committee: ENVI
Amendment 372 #

2008/0028(COD)

Proposal for a regulation
Article 15 - point (b)
(b) the particulars provided in Article 9(1) points (d), (f), (g), (h) and (k (f) shall be mandatory only at the moment of delivery.
2009/01/23
Committee: ENVI
Amendment 377 #

2008/0028(COD)

Proposal for a regulation
Article 17 - paragraph 1
1. In the case of glass bottles intended for reuse which are indelibly marked and which therefore bear no label, ring or collar only the particulars listed in Article 9(1) (a), (c), (e), (f) and (l) shall be mandatory.deleted
2009/01/23
Committee: ENVI
Amendment 381 #

2008/0028(COD)

Proposal for a regulation
Article 29 – paragraph 1 - point b
(b) the amounts of fat, saturates, carbohydrates with specific reference to sugars, and saltsugars, salt, carbohydrates, protein, and artificial and natural trans fats.
2009/12/22
Committee: ENVI
Amendment 383 #

2008/0028(COD)

Proposal for a regulation
Annex VI – point 4 a (new)
4a. The name of the food shall indicate any added ingredients from a different animal origin to the primary animal, for meat products that have the appearance of a cut, joint, slice, portion or carcase and for fish products.
2011/03/23
Committee: ENVI
Amendment 384 #

2008/0028(COD)

Proposal for a regulation
Annex VI – point 4 b (new)
4b. The name of the food in the labelling of any meat product which has the appearance of a cut, joint, slice, portion or carcase of meat, or of cured meat shall include an indication of: (a) any added ingredient of a different animal origin to the rest of the meat; and (b) any added water in the following circumstances: – in the case of cooked and uncooked meat, or cooked cured meat, any added water making up more than 5 % of the weight of the product, – in the case of uncooked cured meat, any added water making up more than 10 % of the weight of the product.
2011/03/23
Committee: ENVI
Amendment 385 #

2008/0028(COD)

Proposal for a regulation
Annex VI – point 4 c (new)
4c. The name of the food in the labelling of any fish product which has the appearance of a cut, fillet, slice, or portion of fish shall include an indication of: (a) any added ingredient of vegetable origin, and of an animal origin other than fish; and (b) any added water making up more than 5 % of the weight of the product.
2011/03/23
Committee: ENVI
Amendment 387 #

2008/0028(COD)

Proposal for a regulation
Annex VII – Part B – table –point 1 – right-hand-column –first paragraph
‘Oil’, together with - either the adjective ‘vegetableanimal(or ‘animal’the indication of their specific animal origin) or, as appropriate, or - an indication of their specific vegetable or animal originigin. In cases where certain vegetable oils cannot be guaranteed not to be present, the use of ‘May contain...’ is required.
2011/03/23
Committee: ENVI
Amendment 389 #

2008/0028(COD)

Proposal for a regulation
Annex VII – Part B – table –point 1 – right-hand-column –second paragraph
The adjective fully or partly hydrogenated, as appropriate, must accompany the indication of a hydrogenated oil unless the amount of saturates and trans fats are included in the nutrition declaration.
2011/03/23
Committee: ENVI
Amendment 390 #

2008/0028(COD)

Proposal for a regulation
Article 17 - paragraph 2
2. In the case of packaging or containers the largest surface of which has an area of less than 10 cm2 only the particulars listed in Article 9(1) (a), (b), (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.
2009/01/23
Committee: ENVI
Amendment 391 #

2008/0028(COD)

Proposal for a regulation
Annex VII – Part B – table – point 2 – right-hand-column –first paragraph
‘Fat’, together with – either the adjective ‘vegetable’ or ‘animal’, as appropriate, or – an indication of their specific vegetable or animal origin. EP first reading posiOr. en Justification.
2011/03/23
Committee: ENVI
Amendment 391 #

2008/0028(COD)

Proposal for a regulation
Article 17 - paragraph 2
2. In the case of packaging or containers the largest surface of which has an area of less than 10 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 orHowever, the provision of all particulars according to Article 9(1) via the Internet shall be mandatory and the information shall be available at the request of the consumerpoint of purchase.
2009/01/23
Committee: ENVI
Amendment 393 #

2008/0028(COD)

Proposal for a regulation
Article 17 - paragraph 2 a (new)
2a. In the case of food in packaging or containers the largest surface of which has an area of less than 25 cm2, the nutrition declaration according to Article 9(1) (l) shall not be mandatory on the package or on the label. However, the provision of this information via the Internet shall be mandatory and the information shall be available at the point of purchase.
2009/01/23
Committee: ENVI
Amendment 394 #

2008/0028(COD)

Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 2
This paragraph shall not apply to wine as defined in Council Regulation (EC) No 1493/1999, beer, and spirits as defined in Article 2(1) of Regulation (EC) No. […] of […] of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89. The Commission shall produce a report after [five years of the entry into force of this Regulation] concerning the application of this paragraph on these products and may accompany this report by specific measures determining the rules for a mandatory nutrition declaration for these products. Those measures designed to amend non-essential elements of this Regulation, by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).deleted
2009/12/22
Committee: ENVI
Amendment 400 #

2008/0028(COD)

Proposal for a regulation
Article 20 - point (e)
(e) wine as defined in Council Regulation (EC) No 1493/1999, beer, and spirits as defined in Article 2(1) of Regulation (EC) No. […] of […] of the European Parliament and the Council on the definitions, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89. The Commission shall produce a report [five years of the entry into force of this Regulation] concerning the application of Article 19 on these products and may accompany this report by specific measures determining the rules for labelling ingredients. Those measures designed to amend non- essential elements of this Regulation, by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3);deleted
2009/01/23
Committee: ENVI
Amendment 404 #

2008/0028(COD)

Proposal for a regulation
Article 29 - paragraph 2
2. The nutrition declaration may also include the amounts of one or more of the following: (a) trans fats; (b) mono-unsaturates; (c) polyunsaturates; (d) polyols; (e) starch; (f) fibre; (g) protein; (h) any of the minerals or vitamins listed in point 1 of Part A of Annex XI, and present in significant amounts as defined in point 2 of Part A of Annex XI.
2009/12/22
Committee: ENVI
Amendment 414 #

2008/0028(COD)

Proposal for a regulation
Article 30 – paragraph 4 – subparagraph 2
The rules for implementing the declaration of energy and nutrients with regard to the precision of the declared values such as the differences between the declared values and those established in the course of official checks may be decided upon in accordance with the procedure laid downregulatory procedure with scrutiny as referred to in Article 49(23).
2009/12/22
Committee: ENVI
Amendment 423 #

2008/0028(COD)

Proposal for a regulation
Article 31 – paragraph 2
2. The amount of energy and nutrients referred to in paragraph 1 shall be expressed per 100 g or per 100 ml or, subject to Article 32(2) and (3), perand per portion, if the food is prepacked as an individual portion.
2009/12/22
Committee: ENVI
Amendment 430 #

2008/0028(COD)

Proposal for a regulation
Article 25 - paragraph 2
2. The appropriate date shall be expressed in accordance with Annex IX. It must not be hidden and shall be indicated in a clearly visible way.
2009/01/23
Committee: ENVI
Amendment 434 #

2008/0028(COD)

Proposal for a regulation
Article 31 – paragraph 3
3. The mandatory nutrition declaration shall also be expressed, as appropriate, as a percentage of the reference intakes set out in Part B of Annex XI in relation to per 100 g or per 100 ml or perand per portion, if the food is prepacked as an individual 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.
2009/12/22
Committee: ENVI
Amendment 440 #

2008/0028(COD)

Proposal for a regulation
Article 31 – paragraph 3 a (new)
3a. Within 6 months after the entry into force of this Regulation, and taking into account recommendations by the European Food Safety Authority as well as independent research, the Commission shall establish reference intake values for energy and selected nutrients other than vitamins and minerals to be added in Annex XI, Part B. Those measures, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).
2009/12/22
Committee: ENVI
Amendment 442 #

2008/0028(COD)

Proposal for a regulation
Article 31 – paragraph 4
4. The declaration of polyols and/or starch and the declaration of type of fatty acids, other than the mandatory declaration of saturates and trans fats referred to in Article 29(1) (b), shall be presented in accordance with Annex XIII Part B.
2009/12/22
Committee: ENVI
Amendment 459 #

2008/0028(COD)

Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 1 – point b
(b) the amounts of fat, saturates, carbohydrates with specific reference to sugars, and saltsugars, salt, carbohydrates, protein, and artificial and natural transfats.
2009/01/23
Committee: ENVI
Amendment 463 #

2008/0028(COD)

Proposal for a regulation
Article 34 – paragraph 1
1. The following particulars referred to Article 31(2) related to the mandatory nutrition declaration shall be included in the principal field of vision: energy value, amounts of fat, saturates, sugars, and salt. They shall be presented, where appropriate, together in a clear format in the following order: energy, fat, saturates, carbohydrates with specific reference to sugars, and saltorder specified above.
2009/12/22
Committee: ENVI
Amendment 467 #

2008/0028(COD)

Proposal for a regulation
Article 34 – paragraph 1 a (new)
1a. The following particulars referred to in Article 31(2) related to the mandatory nutrition declaration shall be provided on the back of the package: carbohydrates, protein, and artificial and natural trans fats. They shall be presented together in a clear format in the order specified above.
2009/12/22
Committee: ENVI
Amendment 469 #

2008/0028(COD)

Proposal for a regulation
Article 29 – paragraph 1 – subparagraph 2
This paragraph shall not apply to wine as defined in Council Regulation (EC) No 1493/1999, beer, and spirits as defined in Article 2(1) of Regulation (EC) No. […] of […] of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89. The Commission shall produce a report after [five years of the entry into force of this Regulation] concerning the application of this paragraph on these products and may accompany this report by specific measures determining the rules for a mandatory nutrition declaration for these products. Those measures designed to amend non-essential elements of this Regulation, by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).deleted
2009/01/23
Committee: ENVI
Amendment 470 #

2008/0028(COD)

Proposal for a regulation
Article 34 – paragraph 1 b (new)
1b. Annex XIIIa lays down product categories for which the presentation of the nutrition declaration through a multiple colour coding system is compulsory. For products that fall under one of these categories, the levels of nutrients on the front of pack nutrition declaration referred to in paragraph 1 shall be indicated through a multiple colour coding system. The colours green, yellow and red shall, referring to the content per 100g or 100 ml, indicate whether a food is low, medium or high in those nutrients. To this end, before the date of application of Articles 29-34 and based on an opinion of the European Food Safety Authority, reference levels will be determined that indicate a high, medium and low level of those nutrients. Those measures designed to amend non- essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).
2009/12/22
Committee: ENVI
Amendment 472 #

2008/0028(COD)

Proposal for a regulation
Article 29 – paragraph 2
2. The nutrition declaration may also include the amounts of one or more of the following: (a) trans fats; (b) mono-unsaturates; (cb) polyunsaturates; (dc) polyols; (ed) starch; (fe) fibre; (gf) (h)any of the minerals or vitamins listed in point 1 of Part A of Annex XI, and present in significant amounts as defined in point 2 of Part A of Annex XI. protein; any of the minerals or vitamins
2009/01/23
Committee: ENVI
Amendment 478 #

2008/0028(COD)

Proposal for a regulation
Article 34 – paragraph 6 a (new)
6a. Five years after entry into force of this Regulation, the Commission shall present an evaluation report on the form of presentation described in paragraphs 1-6.
2009/12/22
Committee: ENVI
Amendment 482 #

2008/0028(COD)

Proposal for a regulation
Article 35 – paragraph 1
1. Where food information covered by this Regulation is provided on a voluntary basis, such information shall comply with the relevant specific requirements laid down in this Regulation, particularly with the requirements of Article 7.
2009/12/22
Committee: ENVI
Amendment 485 #

2008/0028(COD)

Proposal for a regulation
Article 35 – paragraph 1 a (new)
1a. All relevant information regarding voluntary food information schemes, such as the underlying criteria and scientific studies, must be made available to the public.
2009/12/22
Committee: ENVI
Amendment 491 #

2008/0028(COD)

Proposal for a regulation
Article 30 - paragraph 2
2. Conversion factors for the vitamins and minerals mentioned in point 1 of Part A of Annex XI, in order to calculate more precisely their content in foods, mayshall be set and included in Annex XII by the Commission. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).
2009/01/23
Committee: ENVI
Amendment 493 #

2008/0028(COD)

Proposal for a regulation
Article 30 - paragraph 4 - subparagraph 2
The rules for implementing the declaration of energy and nutrients with regard to the precision of the declared values such as the differences between the declared values and those established in the course of official checks may be decided upon in accordance with the procedure laid downregulatory procedure with scrutiny as referred to in Article 49(23).
2009/01/23
Committee: ENVI
Amendment 495 #

2008/0028(COD)

Proposal for a regulation
Article 35 – paragraph 6
6. Implementing rules concerning the conditions and criteria of use of particulars voluntarily provided in accordance with paragraphs 1-5 may be established by the Commission. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).
2009/12/22
Committee: ENVI
Amendment 496 #

2008/0028(COD)

Proposal for a regulation
Article 35 – paragraph 6 a (new)
6a. The term ‘vegetarian’ should not be applied to foods that are, or are made from or with the aid of products derived from animals that have died, have been slaughtered, or animals that die as a result of being eaten. The term ‘vegan’ should not be applied to foods that are, or are made from or with the aid of animals or animal products (including products from living animals).
2009/12/22
Committee: ENVI
Amendment 497 #

2008/0028(COD)

Proposal for a regulation
Article 35 – paragraph 6 b (new)
6b. In accordance with Article 3(1), it shall be admissible to provide information on environmental, social and ethical considerations regarding foodstuffs. In order not to encourage arbitrary commitments and to ensure comparability, the Commission shall, within [12 months from the entry into force of this regulation] present a legislative proposal on such criteria with regard to foods.
2009/12/22
Committee: ENVI
Amendment 502 #

2008/0028(COD)

Proposal for a regulation
Article 31 - paragraph 2
2. The amount of energy and nutrients referred to in paragraph 1 shall be expressed per 100 g or per 100 ml or, subject to Article 32(2) and (3), perand per portion, in case the food is prepacked as an individual portion.
2009/01/23
Committee: ENVI
Amendment 505 #

2008/0028(COD)

Proposal for a regulation
Article 38 – paragraph 2
2. By means of paragraph 1, Member States may introduce measures concerning the mandatory indication of the country of origin or place of provenance of foods only where there is a proven link between certain qualities of the food and its origin or provenance. When notifying such measures to the Commission, Member States shall provide evidence that the majority of consumers attach significant value to the provision of this information.deleted
2009/12/22
Committee: ENVI
Amendment 507 #

2008/0028(COD)

Proposal for a regulation
Article 38 a (new)
Article 38a National provisions on specific forms of presentation In addition to the requirements laid down in Article 34, Member States may decide to introduce a mandatory scheme which provides for an additional presentation of the nutrition information using colour and textual means. Such national schemes shall be developed in compliance with the general principles and requirements laid down in Chapter II and III of this Regulation, and must take into account the results of independent consumer research and of extensive stakeholder consultations. The Commission shall encourage and facilitate the exchange of information between Member States and between itself and Member States on matters relating to the adoption and implementation of the national schemes and shall encourage the participation of stakeholders in this process. On (the first day of the month 5 years after the entry into force of this Regulation), the Commission shall conduct an evaluation of the evidence gathered on consumers' use and understanding of the various national schemes in order to determine which scheme performs best and is most useful for European consumers. Based on the outcomes of this evaluation, the Commission shall come forward with a proposal for a harmonised European front-of-pack labelling scheme.
2009/12/22
Committee: ENVI
Amendment 511 #

2008/0028(COD)

Proposal for a regulation
Article 40 a (new)
Article 40a 40a. Member States may adopt or maintain national measures that set additional binding provisions for operators who choose to voluntarily label specific characteristics of foodstuffs.
2009/12/22
Committee: ENVI
Amendment 512 #

2008/0028(COD)

Proposal for a regulation
Article 31 - paragraph 3
3. The mandatory nutrition declaration shall also be expressed, as appropriate, as a percentage of the reference intakes set out in Part B of Annex XI in relation to per 100 g or per 100 ml or perand per portion, in case the food is prepacked as an individual 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.
2009/01/23
Committee: ENVI
Amendment 518 #

2008/0028(COD)

Proposal for a regulation
Article 41 – paragraph 2
2. 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 Articles 9(1) (c) and 10, provided that the consumer or mass caterer still receives sufficient information.
2009/12/22
Committee: ENVI
Amendment 521 #

2008/0028(COD)

Proposal for a regulation
Article 31 - paragraph 3 a (new)
3a. Within 6 months after the entry into force of this Regulation, and taking into account recommendations by the European Food Safety Authority, the Commission shall establish reference intake values for energy and selected nutrients other than vitamins and minerals to be added in Annex XI, Part B. Those measures designed to amend non- essential elements of this Regulation by supplementing it shall be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).
2009/01/23
Committee: ENVI
Amendment 522 #

2008/0028(COD)

Proposal for a regulation
Article 43
Detailed rules for the application of this Chapter may be adopted by the Commission. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the procedureregulatory procedure with scrutiny referred to in Article 49(23).
2009/12/22
Committee: ENVI
Amendment 524 #

2008/0028(COD)

Proposal for a regulation
Article 44 – paragraph 5
5. Member States shall provide the Commission with the details of the national schemes referred to in paragraph 1, such as the underlying criteria and scientific studies, including an identifier for foods that are labelled in compliance with that national scheme. The Commission shall make those details available to the public, in particular through a dedicated page on the Internet.
2009/12/22
Committee: ENVI
Amendment 524 #

2008/0028(COD)

Proposal for a regulation
Article 31 - paragraph 4
4. The declaration of polyols and/or starch and the declaration of type of fatty acids, other than the mandatory declaration of saturates and trans fats referred to in Article 29(1)(b), shall be presented in accordance with Annex XIII Part B.
2009/01/23
Committee: ENVI
Amendment 526 #

2008/0028(COD)

Proposal for a regulation
Article 51 a (new)
Article 51a Amendments to Regulation (EC) 104/2000 In Article 4 of Regulation (EC) No 104/2000, the following point is added: "(d) whether the fish comes from a stock that is subject to a recovery plan adopted by the EU.".
2009/12/22
Committee: ENVI
Amendment 528 #

2008/0028(COD)

Proposal for a regulation
Article 32
1. In addition to the nutrition declaration per 100g or per 100ml referred to in Article 31(2), the information may be expressed per portion as quantified on the label, provided that the number of portions contained in the package is stated. 2. The nutrition declaration may be expressed on a per portion basis alone if the food is prepacked as an individual portion. 3. The expression on a per portion basis alone for foods presented in packages containing multiple portions of the food, that have not been prepacked as individual portions, shall be established by the Commission. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted, in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).deleted
2009/01/23
Committee: ENVI
Amendment 536 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 1.1 a (new)
1.1a. Foods which packaging contains nanomaterials ‘packaging using nanomaterials’ this statement shall accompany the name of the food.
2009/12/22
Committee: ENVI
Amendment 537 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 2.1
2.1 Foods containing a sweetener or sweeteners authorised pursuant to Directive 89/107/EEC ‘with sweetener(s)’ this statement shall accompany the name of the food in the principal field of vision.
2009/12/22
Committee: ENVI
Amendment 538 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 2.2
2.2 Foods containing both an added sugar or sugars and a sweetener or sweeteners authorised pursuant to Directive 89/107/EEC ‘with sugar(s) and sweetener(s)’ this statement shall accompany the name of the food in the principal field of vision.
2009/12/22
Committee: ENVI
Amendment 539 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 2.3
2.3 Foods containing aspartame or neotame authorised pursuant to Directive 89/107/EECRegulation (EC) No 1333/2008 ‘contains a source of phenylalanine’
2009/12/22
Committee: ENVI
Amendment 546 #

2008/0028(COD)

Proposal for a regulation
Article 34 - paragraph 1
1. The following particulars referred to in Article 31(2) related to the mandatory nutrition declaration shall be included in the principal field of vision: energy value, amounts of fat, saturates, sugars, and salt. They shall be presented, where appropriate, together in a clear format in the following order: energy, fat, saturates, carbohydrates with specific reference to sugars, and saltorder specified above.
2009/02/24
Committee: ENVI
Amendment 549 #

2008/0028(COD)

Proposal for a regulation
Annex IV – point 16
- food in packaging or containers the largest surface of which has an area of less than 25 cm2;deleted
2009/12/22
Committee: ENVI
Amendment 555 #

2008/0028(COD)

Proposal for a regulation
Annex V – part B – paragraph 2 a (new)
2a. The name of the food in the labelling of any meat product which has the appearance of a cut, joint, slice, portion or carcase of meat, or of cured meat shall include an indication of: (a) any added ingredient of a different animal origin to the rest of the meat; and (b) any added water in the following circumstances: - in the case of cooked and uncooked meat, or cooked cured meat, any added water making up more than 5 % of the weight of the product - in the case of uncooked cured meat, any added water making up more than 10 % of the weight of the product.
2009/12/22
Committee: ENVI
Amendment 556 #

2008/0028(COD)

Proposal for a regulation
Annex V – part B – paragraph 2 b (new)
2b. The name of the food in the labelling of any fish product which has the appearance of a cut, fillet, slice, or portion of fish shall include an indication of: (a) any added ingredient of vegetable origin and, of an animal origin other than fish; and (b) any added water making up more than 5 % of the weight of the product.
2009/12/22
Committee: ENVI
Amendment 558 #

2008/0028(COD)

Proposal for a regulation
Annex VI – part B – row 17
Definition of category of food Designation 17. Skeletal muscles1 of mammalian and bird species ‘… meat’ and the name(s)2 of the recognised as fit for human consumption with naturally animal species from which it included or adherent tissue, where the total fat and meat constitutes comes connective tissue content does not exceed the values indicated below and where the meat constitutes an , followed by the words 'of an ingredient of another food. The products covered by the definition of ‘mechanically separated meat’ are excluded from this definition. Maximum fat and connective tissue contents for ingredients designated by the term ‘… meat’ Species Fat (%) Connective tissue3 (%) Mammals (other than 25 25 rabbits and porcines) and mixtures of species with mammals predominating Porcines 30 25 Birds and rabbits 15 10 If these maximum limits are exceeded, but all other criteria for the definition of ‘meat’ are satisfied, the ‘… meat’ content must be adjusted downwards accordingly and the list of ingredients must mention, in addition to the term ‘… meat’, the presence of fat which' and the share in total fat the definition of ‘mechanically separated meat’ are and/or connective tissue. 1 The diaphragm and the masseters are part of the skeletal muscles, while the heart, tongue, the muscles of the head (other than the masseters), the muscles of the carpus, the tarsus and the tail are excluded. 2 For labelling in English, this designation may be replaced by the generic name of the ingredient for the animal species concerned. 3 The connective tissue content is calculated on the basis of the ratio between collagen content and meat protein content. The collagen content means the hydroxyproline content multiplied by a factor of 8. (in %) excluded from this definition.
2009/12/22
Committee: ENVI
Amendment 562 #

2008/0028(COD)

Proposal for a regulation
Annex VI – part B – row 18 – right column
‘mechanically separated meat’ and the name(s) (3) of the animal species from which it comes, followed by words 'of which' and the share in total fat and connective tissue (in %)
2009/12/22
Committee: ENVI
Amendment 568 #

2008/0028(COD)

Proposal for a regulation
Annex VIII – paragraph 5 – subparagraph 1
5. Where a solid food is presented in a liquid medium, the drained net weight of the food shall also be indicated. The price per kilogram referring to the respective food shall be based solely on the drained net weight.
2009/12/22
Committee: ENVI
Amendment 568 #

2008/0028(COD)

Proposal for a regulation
Article 34 - paragraph 1 a (new)
1a. In accordance with the regulatory procedure with scrutiny referred to in Article 49 (3), based on an opinion of the European Food Safety Authority, and before the date of application of Articles 29-34, reference levels will be determined that indicate a high amount of the respective nutrient per 100g or per 100 ml. If these reference levels are exceeded in a foodstuff, the nutrition information on the respective nutrient shall be highlighted by a red mark.
2009/02/24
Committee: ENVI
Amendment 569 #

2008/0028(COD)

Proposal for a regulation
Article 34 - paragraph 1 a (new)
1a. The following particulars referred to in Article 31(2) related to the mandatory nutrition declaration shall be provided on the back of the package: carbohydrates, protein, and artificial and natural transfats. They shall be presented together in a clear format in the order specified above.
2009/02/24
Committee: ENVI
Amendment 573 #

2008/0028(COD)

Proposal for a regulation
Annex XI – part B
Energy or Reference nutrient nutrient Intake1 Energy 8400 kJ (2000kcal) Total fat 70 g Saturates 20 g Carbohydrate 230 g Sugars 90 g Salt 6gSalt 1 Values to be established in reference to Article 31( 3a)
2009/12/22
Committee: ENVI
Amendment 575 #

2008/0028(COD)

Proposal for a regulation
Annex XIII a (new)
ANNEX XIIIa CATEGORIES OF FOOD As referred to in Article 34(1b) For food falling under the following categories of food, the presentation through a multiple colour coding system is compulsory. - Ready to eat meals - Prepared products of animal origin - Pre-packaged snacks - Breakfast cereals - Drinks except fruit juices as defined in Council Directive 2001/112/EC of 20 December 2001.
2009/12/22
Committee: ENVI
Amendment 584 #

2008/0028(COD)

Proposal for a regulation
Article 34 - paragraph 6 a (new)
6a. The Commission shall present an evaluation report on the form of presentation described in the previous paragraphs five years after entry into force of this Regulation.
2009/02/24
Committee: ENVI
Amendment 594 #

2008/0028(COD)

Proposal for a regulation
Article 35 - paragraph 1
1. Where food information covered by this Regulation is provided on a voluntary basis, such information shall comply with the relevant specific requirements laid down in this Regulation, particularly with the requirements of Article 7.
2009/02/24
Committee: ENVI
Amendment 595 #

2008/0028(COD)

Proposal for a regulation
Article 35 - paragraph 1 a (new)
1a. All relevant information regarding voluntary food information schemes, such as the underlying criteria and scientific studies, must be made available to the public.
2009/02/24
Committee: ENVI
Amendment 598 #

2008/0028(COD)

Proposal for a regulation
Article 35 - paragraph 2
2. Without prejudice to labelling in accordance with specific Community legislation and in addition to the requirements of Article 9(1)(i), paragraphs 3 and 4 shall apply where the country of origin or the place of provenance of a food is voluntarily indicated to inform consumers that a food originates or comes from the European Community or a given country orf place.
2009/02/24
Committee: ENVI
Amendment 605 #

2008/0028(COD)

Proposal for a regulation
Article 35 - paragraph 6
6. Implementing rules concerning the conditions and criteria of use of particulars voluntarily provided according to the previous paragraphs may be established by the Commission. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 49(3).
2009/02/24
Committee: ENVI
Amendment 606 #

2008/0028(COD)

Proposal for a regulation
Article 35 - paragraph 6 a (new)
6a. The term ‘vegetarian’ should not be applied to foods that are, or are made from or with the aid of products derived from animals that have died, have been slaughtered, or animals that die as a result of being eaten. The term ‘vegan’ should not be applied to foods that are, or are made from or with the aid of animals or animal products (including products from living animals).
2009/02/24
Committee: ENVI
Amendment 607 #

2008/0028(COD)

Proposal for a regulation
Article 35 - paragraph 6 b (new)
6b. In line with Article 3 (1), it shall be admissible to provide information on environmental, social and ethical considerations regarding foodstuffs. In order not to encourage arbitrarily commitments and to ensure comparability, the Commission shall, within [12 months from the entry into force of this regulation] present a legislative proposal on such criteria with regard to foods.
2009/02/24
Committee: ENVI
Amendment 617 #

2008/0028(COD)

Proposal for a regulation
Article 38 – paragraph 2
2. By means of paragraph 1, Member States may introduce measures concerning the mandatory indication of the country of origin or place of provenance of foods only where there is a proven link between certain qualities of the food and its origin or provenance. When notifying such measures to the Commission, Member States shall provide evidence that the majority of consumers attach significant value to the provision of this information.deleted
2009/02/24
Committee: ENVI
Amendment 623 #

2008/0028(COD)

Proposal for a regulation
Article 40
Member States may, pending the adoption of the Community provisions referred to in Article 20(e), maintain national rules as regard the listing of ingredients in the case of beverages containing more than 1,2 % by volume of alcohol.Article 40 deleted Alcoholic beverages
2009/02/24
Committee: ENVI
Amendment 630 #

2008/0028(COD)

Proposal for a regulation
Article 41 – paragraph 2
2. 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) and 10, provided that the consumer or mass caterer still receives sufficient information.
2009/02/24
Committee: ENVI
Amendment 634 #

2008/0028(COD)

Proposal for a regulation
Article 43
Detailed rules for the application of this Chapter may be adopted by the Commission. Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the procedureregulatory procedure with scrutiny referred to in Article 49(23).
2009/02/24
Committee: ENVI
Amendment 643 #

2008/0028(COD)

Proposal for a regulation
Article 44 - paragraph 5
5. Member States shall provide the Commission with the details of the national schemes referred to in paragraph 1, such as the underlying criteria and scientific studies, including an identifier for foods that are labelled in compliance with that national scheme. The Commission shall make those details available to the public, in particular through a dedicated page on the Internet.
2009/02/24
Committee: ENVI
Amendment 644 #

2008/0028(COD)

Proposal for a regulation
Article 51 a (new)
Article 51a Amendments to Regulation (EC) 104/2000 In Article 4 of Regulation (EC) 104/2000, the following subparagraph is added: (d) whether the fish comes from a stock that is subject to a recovery plan adopted by the EU.
2009/02/24
Committee: ENVI
Amendment 664 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 2.1
2.1 Foods ‘with containing a sweetener(s)’ this sweetener or statement shall sweeteners accompany the authorised name of the food. pursuant to in the principal Directive 89/107/ field of vision. EEC
2009/03/02
Committee: ENVI
Amendment 667 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 2.2
2.2 Foods ‘with sugar(s) and containing both sweetener(s)’ this an added sugar or statement shall sugars and a accompany the sweetener or name of the food. sweeteners authorisedin the principal authorised field of vision. pursuant to Directive 89/107/ EEC
2009/03/02
Committee: ENVI
Amendment 670 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 3 a (new)
3a. FOODS CONTAINING GLUTAMIC ACIDS OR ITS SALTS 3a.1 Foods containing 'contains one or more of the appetite- food additives E620, E enhancing 621, E622, E623, E624 ingredients' and E 625
2009/03/02
Committee: ENVI
Amendment 673 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 5 a (new)
5a. OTHER FOODS
2009/03/02
Committee: ENVI
Amendment 674 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 5a.1 (new)
Commission 5a.1 Foods produced 'produced from from animals fed animals fed with with genetically genetically modified modified feedingstuffs' feedingstuffs Where food consists of pursuant to more than one Regulation (EC) No ingredient, whereof 1829/2003 one or more are produced from animals fed with genetically modified feedingstuffs pursuant to Regulation (EC) No 1829/2003, the words 'from animals fed with genetically modified feedingstuffs' shall appear in the list of ingredients referred to in Article 19 immediately following the ingredient(s) concerned. Where there is no list of ingredients, the words 'produced from animals fed with genetically modified feedingstuffs' shall appear clearly on the labelling.
2009/03/02
Committee: ENVI
Amendment 675 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 5a.2 (new)
Commission 5a.2 Products 'produced with the aid of produced with the nanotechnologies' aid of Where food consists of nanotechnologies more than one ingredient, whereof one or more are produced with the aid of nanotechnologies, the words 'produced with the aid of nanotechnologies' shall appear in the list of ingredients referred to in Article 19 immediately following the ingredient(s) concerned. Where there is no list of ingredients, the words 'produced with the aid of nanotechnologies' shall appear clearly on the labelling.
2009/03/02
Committee: ENVI
Amendment 676 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 5a.3 (new)
Commission 5a.3 Foodstuffs (1) ‘Free range eggs’, containing eggs or (2) ‘Barn eggs’ or egg products (3) ‘Eggs from caged hens’ shall be added in brackets after the respective ingredient in the ingredient list - according to the farming method the contained eggs were produced with. Concerning eggs from organic production, the respective ingredient may be labelled in accordance with Council Regulation (EC) No 834/2007, Article 23 (4) (b).
2009/03/02
Committee: ENVI
Amendment 677 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 5a.4 (new)
Commission 5a.4 Meat of large 'contains predatory fish methylmercury- not species as specified recommended for in Commission pregnant or Regulation breastfeeding women, 466/2001, Annex I, women who might point 3.3.1.1. or become pregnant, and foodstuffs children' shall be added containing meat immediately after the list from these fish of ingredients. In species absence of a list of ingredients, the statement shall accompany the name of the food.
2009/03/02
Committee: ENVI
Amendment 678 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 5a.5 (new)
Commission 5a.5 Meat derived 'Meat derived from from animals that animals that have not have not been stunned been stunned prior to prior to slaughter slaughter'
2009/03/02
Committee: ENVI
Amendment 679 #

2008/0028(COD)

Proposal for a regulation
Annex III – point 5a.6 (new)
Commission 5a.6 Whole nuts in 'Do not eat nuts that packages look bad or taste bad as they may contain high levels of Aflatoxins' this statement shall appear clearly on the labelling.
2009/03/02
Committee: ENVI
Amendment 692 #

2008/0028(COD)

Proposal for a regulation
Annex IV – indent 16
- food in packaging or containers the largest surface of which has an area of less than 25 cm2;deleted
2009/03/02
Committee: ENVI
Amendment 699 #

2008/0028(COD)

Proposal for a regulation
Annex V – part B – paragraph 2 a (new)
2a. The name of the food in the labelling of any meat product which has the appearance of a cut, joint, slice, portion or carcase of meat, or of cured meat shall include an indication of: (a) any added ingredient of a different animal origin to the rest of the meat; and (b) any added water in the following circumstances: - in the case of cooked and uncooked meat, or cooked cured meat, any added water making up more than 5% of the weight of the product - in the case of uncooked cured meat, any added water making up more than 10% of the weight of the product.
2009/03/02
Committee: ENVI
Amendment 700 #

2008/0028(COD)

Proposal for a regulation
Annex V – part B – paragraph 2 b (new)
2b. The name of the food in the labelling of any fish product which has the appearance of a cut, fillet, slice, or portion of fish shall include an indication of: (a) any added ingredient of vegetable origin and, of an animal origin other than fish; and (b) any added water making up more than 5% of the weight of the product.
2009/03/02
Committee: ENVI
Amendment 705 #

2008/0028(COD)

Proposal for a regulation
Annex VI – part B – point 17
17. Skeletal muscles12 of mammalian and bird ‘… meat’ and the name(s)23 of species recognised as fit for human consumption with the animal species from which it naturally included or adherent tissue, where the totalmeat comes fat and connective tissue content does not exceed the values indicated below and where the meat 1 The diaphragm and the masseters are part of the skeletal muscles, while the heart, tongue, the muscles of the head (other than the masseters), the muscles of the carpus, the tarsus and the tail are excluded. 2 For labelling in English, this designation may be replaced by the generic name of the ingredient for the animal species concerned. constitutes an ingredient of another food. The products covered by the definition of ‘mechanically separated meat’ are excluded from this definition. Maximum fat and connective tissue contents for ingredients designated by the term ‘… meat’ Species Fat Connectiv (%) e tissue1 (%) Mammals (other than 25 25 rabbits and porcines) and mixtures of species with mammals predominating Porcines 30 25 Birds and rabbits 15 10 If these maximum limits are exceeded, but all other criteria for the definition of ‘meat’ are satisfied, the ‘… meat’ content must be adjusted downwards accordingly and the list of ingredients must mention, in addition to the term ‘… meat’, the presence of fat and/or connective tissue. , followed by the words 'of constitutes an ingredient of another food. The which' and the share in total fat products covered by the definition of ‘mechanically and connective tissue (in %) separated meat’ are excluded from this definition.
2009/03/02
Committee: ENVI
Amendment 706 #

2008/0028(COD)

Proposal for a regulation
Annex VI – part B – point 18
18. All types ‘mechanically of products separated meat’ covered by the and the name(s) definition of (3) of the animal ‘mechanically species from separated meat’. which it comes, followed by words 'of which' and the share in total fat and connective tissue (in %)
2009/03/02
Committee: ENVI
Amendment 717 #

2008/0028(COD)

Proposal for a regulation
Annex VIII – paragraph 5 – subparagraph 1
5. Where a solid food is presented in a liquid medium, the drained net weight of the food shall also be indicated. The price per kilogram referring to the respective food shall be based solely on the drained net weight.
2009/03/02
Committee: ENVI
Amendment 736 #

2008/0028(COD)

Proposal for a regulation
Annex XI – part B – table
Energy or Reference nutrient Intake nutrient Intake* Energy 84(2000 kJ cal) Total fat 70 g Saturates 20 g Carbohydrate 230 g Sugars 90 g Salt 6gSugars Salt _______ * Values to be established in reference to Article 31, paragraph 3a (new)
2009/03/02
Committee: ENVI
Amendment 14 #

2008/0016(COD)

Proposal for a directive
Recital 4
(4) The Renewable Energy Roadmap demonstrated that at least a 20% target for the overall share of energy from renewable sources and a 10% target for renewable energy in transport would be appropriate andwould be achievable, as an objectives, and that a framework that includes mandatory targets should provide the business community with the long term stability it needs to make rational investment decisions in the renewable energy sectorove towards a renewable energies based economy.
2008/06/02
Committee: INTA
Amendment 15 #

2008/0016(COD)

Proposal for a directive
Recital 8
(8) In the light of the positions taken by the Commission, the Council and the European Parliament, it is appropriate to establish mandatory targets for an overall 20% share of renewable energy and a 1 minimum interim shares and an overall 20% share of renewable energy in transport in the European Union's final consumption in 2020.
2008/06/02
Committee: INTA
Amendment 16 #

2008/0016(COD)

Proposal for a directive
Recital 10
(10) By contrast, it is appropriate for the 10% target for renewable energy in transport to be set at the same level for each Member State in order to ensure consistency in transport fuel specifications and availability. Because transport fuels are traded easily, Member States with low endowments of the relevant resources will easily be able to obtain renewable transport fuels from elsewhere. While it would technically be possible for the Community to meet its biofuel target solely from domestic production, it is both likely and desirable that theWhile it is likely that the renewable energy targets will in fact be met through a combination of domestic production and imports. To, in this endcontext, the Commission should monitor the supply of the Community market for biofuels, and should, as appropriate, propose relevant measures to achieve a balanced approach between domestic production and importsrenewable energies, including biomass for energy, taking into account the development of multilateral and bilateral trade negotiations as well as environmental, and social costs, energy security and other considerations.
2008/06/02
Committee: INTA
Amendment 18 #

2008/0016(COD)

Proposal for a directive
Recital 48
(48) In order to permit the achievement of a 10% share of biofuels, it is necessary to ensure the placing on the market of higher blends of biodiesel in diesel than those envisaged by standard EN590/2004.deleted
2008/06/02
Committee: INTA
Amendment 19 #

2008/0016(COD)

Proposal for a directive
Recital 57
(57) Since the general objectives of achieving a 20% share of renewable energies in the Community's overall energy consumption and a 10% share of biofuels in each Member State's transport petrol and diesel consumption by 2020, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve thoseat objectives.
2008/06/02
Committee: INTA
Amendment 21 #

2008/0016(COD)

Proposal for a directive
Article 3 - paragraph 3
3. Each Member State shall ensure that the share of energy from renewable sources in transport in 2020 is at least 10% of final consumption of energy in transport in that Member State. In calculating total energy consumed in transport for the purposes of the first subparagraph, petroleum products other than petrol and diesel shall not be taken into account.deleted
2008/06/02
Committee: INTA
Amendment 70 #

2008/0014(COD)

Proposal for a decision
Recital 16 a (new)
(16a) Recent scientific findings show that in order to avert dangerous anthropogenic interference with the climate system concentration of carbon dioxide must be reduced to below 350 parts per million, which translates to a domestic Community greenhouse gas emission reduction target of 40% by 2020 and 60% by 2030 compared to 1990 levels. This target and the corresponding Community commitments should be pursued in the international negotiations for post-2012 climate agreement.
2008/07/09
Committee: ENVI
Amendment 82 #

2008/0014(COD)

Proposal for a decision
Article 3 – paragraph -1 (new)
-1. The Community shall, by 2020, limit its domestic greenhouse gas emissions by at least 40% compared to 1990 levels. Greenhouse gas emissions from sources not covered under Directive 2003/87/EC should undertake one third of the emission reduction effort required to meet this target, using 2005 emissions as the baseline. The corresponding greenhouse gas emission limits and amounts in tonnes of CO2 equivalent per Member State for sources not covered under Directive 2003/87/EC, shall be calculated by the Commission.
2008/07/09
Committee: ENVI
Amendment 87 #

2008/0014(COD)

Proposal for a decision
Article 3 – paragraph 1
1. Until a future international agreement on climate change has been concluded by the Community leading to emission reductions exceeding those required pursuant to this Article, eEach Member State shall, by 2020, limit its domestic greenhouse gas emissions from sources not covered under Directive 2003/87/EC at a minimum by the percentage set for that Member State in the Annex to this Decision in relation to its emissions in the year 2005.
2008/07/09
Committee: ENVI
Amendment 93 #

2008/0014(COD)

Proposal for a decision
Article 3 – paragraph 1 a (new)
1a. No credits from project activities may be used for the implementation of obligations under this article, unless at least an overall 40% reduction in the Community’s domestic greenhouse gas emissions is guaranteed.
2008/07/09
Committee: ENVI
Amendment 155 #

2008/0014(COD)

Proposal for a decision
Article 4 a (new)
Article 4a Helping developing countries adapt to the negative consequences of climate change 1. Upon the conclusion of an international agreement on climate change, the Community shall, as from the beginning of 2013, commit to binding to provide grant-based financial assistance for developing countries, in particular for communities and countries most at risk from climate change and current climate variability, with the aim of supporting them in their adaptation to the negative consequences of climate change. These investments are in addition to those mentioned under Article 4. 2. The assistance referred to in paragraph 1 shall increase annually in a linear manner and reach EUR 11 billion in 2020. The assistance effort for 2013 is set at EUR 5 billion. This finance must not be counted towards meeting the UN-agreed target of 0,7 per cent for aid. 3. The assistance effort for the Community referred to in paragraph 2 shall be distributed among Member States in accordance with the regulatory procedure with scrutiny referred to in Article 9(2). The committee shall decide on the distribution of the assistance effort according to the following criteria: (a) the share of Member States' efforts shall be a linear relation to the GDP per capita of this Member State in 2005; (b) Member States which are not required to reduce their greenhouse gas emissions compared to 2005 in Kyoto Protocol parties listed in the United Nations Convention on Climate Change Annex I shall not contribute to the Community investment effort referred to in paragraphs 1 and 2. 4. Member States may use the revenues from auctioning under the implementation of Directive 2003/87/EC as amended for the purpose of meeting the obligations of this Article. 5. Each Member State shall report annually to the Commission and the European Parliament. This report shall contain information on the Member States' compliance with paragraphs 1 to 4. The Commission shall draw up a reporting format to be used by Member States for the reporting under this Article, before the end of 2010. 6. The 2020 assistance budget mentioned in paragraph 2 shall be reviewed by the Commission no later than 2015. This review shall be based on the latest scientific evidence of that time.
2008/07/09
Committee: ENVI
Amendment 42 #

2008/0013(COD)

Proposal for a directive – amending act
Recital 2
(2) The ultimate objective of the United Nations Framework Convention on Climate Change, which was approved on behalf of the European Community by Council Decision 94/69/EC of 15 December 1993 concerning the conclusion of the United Nations Framework Convention on Climate Change (UNFCCC), is to stabilise greenhouse gas concentrations in the atmosphere at a level that would prevent dangerous anthropogenic interference with the climate system. In order to meet that objective, the overall global annual mean surface temperature increase should not exceed 2°C above pre-industrial levels. The latest Intergovernmental Panel on Climate Change Assessment (IPCC) report shows that, in order to reach that objective, global emissions of greenhouse gases must peak by 2020. Recent scientific findings show that atmospheric concentration of carbon dioxide must be reduced to below 350 parts per million, which means a Community greenhouse gas emission reduction target of 60% by 2030. This implies the increasing of efforts by the Community and the quick involvement of developed countries and encouraging the participation of developing countries in the emission reduction process.
2008/07/08
Committee: ENVI
Amendment 48 #

2008/0013(COD)

Proposal for a directive – amending act
Recital 4
(4) In order to contribute to achieving those long- term objectives, it is appropriate to set out a predictable path according to which the emissions of installations covered by the Community scheme should be reduced. To achieve cost-effectively the commitment of the Community to at least a 240% reduction in greenhouse gas emissions below 1990 levels, emission allowances allocated in respect of those installations should be 21% below adjusted accordingly with the sectors covered by the Community scheme undertaking two-their 2005ds of the emission levels by 2020reduction effort, with verified emissions in 2005 being the year from which effort is determined.
2008/07/08
Committee: ENVI
Amendment 54 #

2008/0013(COD)

Proposal for a directive – amending act
Recital 5
(5) In order to enhance the certainty and predictability of the Community scheme, provisions should be specified to increase the level of contribution of the Community scheme to achieving an overall reduction of more than 240%, in particular in view of the objective of the European Council for a 30% reduction by 2020 twith a view to reaching what is considered scientifically necessary to avoid dangerous climate change.
2008/07/08
Committee: ENVI
Amendment 60 #

2008/0013(COD)

Proposal for a directive – amending act
Recital 5 a (new)
(5a) Recent scientific findings show that, in order to avert dangerous anthropogenic interference with the climate system, concentration of carbon dioxide must be reduced to below 350 parts per million, which translates to a domestic Community greenhouse gas emission reduction target of 40% by 2020 and 60% by 2030. This target and commitment should be pursued in the negotiations for a future international agreement.
2008/07/08
Committee: ENVI
Amendment 78 #

2008/0013(COD)

Proposal for a directive – amending act
Recital 11
(11) The Community-wide quantity of allowances should decrease in a linear manner calculated from the mid-point of the period 2008 to 2012, ensuring that the emissions trading system delivers gradual and predictable reductions of emissions over time. The annual decrease of allowances should be equal to 1.74% of thequantity should decrease by a linear factor compared to the average annual total quantity of allowances issued by Member States pursuant to Commission Decisions on Member States' national allocation plans for the period 2008 to 2012, so that the Community scheme contributes cost- effectively to achieving the commitment of the Community to an overall reduction in emissions of at least 240% by 2020.
2008/07/08
Committee: ENVI
Amendment 82 #

2008/0013(COD)

Proposal for a directive – amending act
Recital 12
(12) This contribution is equivalent to a reduction of emissions in 2020 in the Community scheme of 2140% below reported 2005 levels1990 levels by 2020, with the sectors covered by the Community scheme undertaking two- thirds of this emission reduction effort and verified emissions in 2005 being the year from which effort is determined, including the effect of the increased scope from the period 2005 to 2007 to the period 2008 to 2012 and the 2005 emission figures for the trading sector used for the assessment of the Bulgarian and Romanian national allocation plan for the period 2008 to 2012, leading to an issue of a maximum of 1 720 million allowances in the year 2020. Exact quantities of emissions will be calculated once Member States have issued allowances pursuant to Commission Decisions on their national allocation plans for the period 2008 to 2012, as the approval of allocations to some installations was contingent upon their emissions having been substantiated and verified. Once the issue of allowances for the period 2008 to 2012 has taken place, the Commission will publish the Community-wide quantity. Adjustments should be made to the Community-wide quantity in relation to installations which are included in the Community scheme during the period 2008 to 2012 or from 2013 onwards.
2008/07/08
Committee: ENVI
Amendment 195 #

2008/0013(COD)

Proposal for a directive – amending act
Recital 22
(22) In order to provide predictability, operators should be given certainty about their potential after 2012 to use CERs and ERUs up toup to 50% of the remainder of the level which they were allowed to use in the period 2008 to 2012, from project types which are Gold Standard certified and were accepted by all Member States in the Community scheme during the period 2008 to 2012. As carry-over by Member States of CERs and ERUs held by operators between commitments periods under international agreements (‘banking’ of CERs and ERUs) cannot take place before 2015, and only if Member States choose to allow the banking of those CERs and ERUs within the context of limited rights to bank such credits, this certainty should be given by requiring Member States to allow operators to exchange such CERs and ERUs issued in respect of emission reductions before 2012 for allowances valid from 2013 onwards. However, as Member States should not be obliged to accept CERs and ERUs which it is not certain they will be able to use towards their existing international commitments, this requirement should not extend beyond 31 December 2014. Operators should be given the same certainty concerning such CERs issued from projects that have been established before 2013 in respect of emission reductions from 2013 onwards.
2008/07/08
Committee: ENVI
Amendment 272 #

2008/0013(COD)

Proposal for a directive – amending act
Article 1 – point 5
Directive 2003/87/EC
Article 9
The Community-wide quantity of allowances issued each year starting in 2013 shall decrease in a linear manner beginning from the mid-point of the period 2008 to 2012. The quantity shall decrease by a linear factor of 1.74% compared to the average annual total quantity of allowances issued by Member States in accordance with the Commission Decisions on their national allocation plans for the period 2008 to 2012. The linear factor shall correspond to meeting a Community wide greenhouse gas emission reduction target of a minimum of 40% below 1990 by 2020, with the sectors covered by the Community scheme undertaking two- thirds of this emission reduction effort, Verified emissions in 2005 shall be the year from which effort is determined. The Commission shall publish the linear factor by 30 June 2010. The Commission shall, by 30 June 2010, publish the absolute quantity of allowances for 2013, based on the total quantities of allowances issued by the Member States in accordance with the Commission Decisions on their national allocation plans for the period 2008 to 2012. The Commission shall review the linear factor no later than 202515 in order to ensure that the EU is acting in conformity with sustainable emission levels according to latest scientific findings.
2008/07/10
Committee: ENVI
Amendment 625 #

2008/0013(COD)

Proposal for a directive – amending act
Article 1 - point 9
Directive 2003/87/EC
Article 11a
Use of CERs and only Gold Standard certified CERUs from project activities in the Community scheme before the entry into force of a future international agreement on climate changein case no future international agreement on climate change comes into force before the end of 2012 Wherever referred to in this Directive, CERs shall only be allowed if they apply the methodologies and standards consistent with those developed by the Gold Standard Foundation. 2. Operators may request the competent authority, to the extent that the levels of CER/ERU use allowed to them by Member States for the period 2008 to 2012 have not been used up, to issue allowances to them valid from 2013 onwards in exchange for CERs and only Gold Standard certified CERUs issued in respect of emission reductions up until 2012 from project types which were accepted by all Member States in the Community scheme during the period 2008 to 2012. The amount of allowances issued, including allowances issued under paragraphs 3, 4 and 5, may not exceed 50% of the volume of the external credits as referred to above that have not been used up. Until 31 December 2014, the competent authority shall make such an exchange on request. 3. To the extent that the levels of CER/ERU use allowed to operators by Member States for the period 2008 to 2012 have not been used up, competent authorities shall allow operators to exchange only Gold Standard certified CERs from projects that were established before 2013 issued in respect of emission reductions from 2013 onwards for allowances valid from 2013 onwards. The amount of allowances issued, including allowances issued under paragraphs 2, 4 and 5, may not exceed 50% of the volume of the external credits as referred to above that have not been used up. The first subparagraph shall apply for all Gold Standard certified project types which were accepted by all Member States in the Community scheme during the period 2008 to 2012. 4. To the extent that the levels of CER/ERU use allowed to operators by Member States for the period 2008 to 2012 have not been used up, competent authorities shall allow operators to exchange only Gold Standard certified CERs issued in respect of emission reductions from 2013 onwards for allowances from new projects started from 2013 onwards in Least Developed Countries. The first subparagraph shall apply to CERs for all project types which were accepted by all Member States in the Community scheme during the period 2008 to 2012, until those countries have ratified an agreement with the Community or until 2020, whichever is the earlier. The amount of allowances issued, including allowances issued under paragraphs 2, 3 and 5, may not exceed 50% of the volume of the external credits as referred to above that have not been used up. 5. To the extent that the levels of CER/ERU use allowed to operators by Member States for the period 2008 to 2012 have not been used up and in the event that the conclusion of an international agreement on climate change is delayed, credits from projects or other emission reducing activities may be used in the Community scheme in accordance with agreements concluded with third countries, specifying levels of use. In accordance with such agreements, operators shall be able to use credits from project activities in those third countries, as long as they are Gold Standard certified, to comply with their obligations under the Community scheme. The amount of allowances issued, including allowances issued under paragraphs 2, 3 and 4, may not exceed 50% of the external credits as referred to above that have not been used up. 6. Any agreements referred to in paragraph 5 shall provide for the use of Gold Standard certified credits in the Community scheme from renewable energy or energy efficiency technologies which promote technological transfer, sustainable development. Any such agreement may also provide for the use of credits from projects where the baseline used is below the level of free allocation under the measures referred to in Article 10a or below the levels required by Community legislation. 7. Once an international agreement on climate change has been reached, only Gold Standard certified CERs from third countries which have ratified that agreement shall be accepted in the Community scheme." , up to 10% of the additional reduction effort taking place in accordance with Articles 9 and 28.
2008/07/15
Committee: ENVI
Amendment 695 #

2008/0013(COD)

Proposal for a regulation – amending act
Article 1 - point 19
Directive 2003/87/EC
Article 24 a
(19) The following Article 24a is inserted: Harmonised rules for projects that reduce 1. In addition to the inclusions provided for in Article 24, the Commission may adopt implementing measures for issuing allowances in respect of projects administered by Member States that reduce greenhouse gas emissions outside of the Community scheme. 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)]. Any such measures shall not result in the double-counting of emissions reductions and impede the undertaking of other policy measures to reduce emissions not covered by the Community scheme. Provisions shall only be adopted where inclusion is not possible in accordance with Article 24, and the next review of the Community scheme shall consider harmonising the coverage of those emissions across the Community. 2. The Commission may adopt implementing measures that set out the details for crediting Community-level projects referred to in paragraph 1. 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)]."deleted "Article 24a emissions
2008/07/17
Committee: ENVI
Amendment 740 #

2008/0013(COD)

Proposal for a directive – amending act
Article 1 - point 21
Directive 2003/87/EC
Article 28 - paragraphs 1 to 3
1. Upon the conclusion by the Community of an international agreement on climate change leading, by 2020, to mandatory reductions of greenhouse gas emissions exceeding the minimum reduction levels agreed upon by the European Councilunder Article 9, paragraphs 2, 3 and 4 of this Article shall apply. 2. From the year following the conclusion of the international agreement referred to in paragraph 1, the linear factor shall increase so that the Community quantity of allowances in 2020 is lower than that established pursuant to Article 9, by a quantity of allowances equivalent to the overall reduction of greenhouse gas emissions by the Community below 240% to which the international agreement commits the Community, multiplied by the share of overall greenhouse gas emission reductions in 2020 which the Community scheme is contributing pursuant to Articles 9 and 9a. 3. Operators may use CERs, ERUs or other credits approved in accordance with paragraph 4 from third countries which have concluded the international agreement, up to half10% of the reduction taking place in accordance with paragraph 2.
2008/07/17
Committee: ENVI
Amendment 14 #

2007/2198(INI)

Motion for a resolution
Recital C
C. whereas the absence of internationally agreed upon competition rules in the WTO currently leaves no alternative but TDIs to, under current rules in the WTO, TDIs are the only suitable solution for dealing with unfair trade practices, underlining the importance of their effective functioning,
2008/03/26
Committee: INTA
Amendment 26 #

2007/2198(INI)

Motion for a resolution
Recital E
E. whereas, anti-dumping is, a very specific andt present, a narrowly focused instrument tackling anticompetitive practices; whereas antidumping is not designed to tackl solely with regard to the pricing of the clabour and environmental standards and to apply such standards that would hardly be in line with current WTO regulassical factor costs of production,
2008/03/26
Committee: INTA
Amendment 28 #

2007/2198(INI)

Motion for a resolution
Recital E a (new)
Ea. whereas antidumping rules may need to be conceptually redesigned in order to allow for the inclusion of a set of quantifiable and comparable production cost factors deriving from international obligations, legal norms and labour and environmental standards,
2008/03/26
Committee: INTA
Amendment 29 #

2007/2198(INI)

Motion for a resolution
Recital E b (new)
Eb. whereas production cost factors deriving from international obligations, legal norms and labour and environmental standards should in any case be included in reformed anti-subsidy rules, in order to prevent national governments from undercutting globally cost-effective international endeavours, such as curbing climate change,
2008/03/26
Committee: INTA
Amendment 34 #

2007/2198(INI)

Motion for a resolution
Recital F a (new)
Fa. whereas EU companies adapting to the social and environmental challenges of globalisation will be strengthened by a reform adapting the TDIs to current real cost calculation, including especially developments in international law that are cost-effective,
2008/03/26
Committee: INTA
Amendment 60 #

2007/2198(INI)

Motion for a resolution
Paragraph 2 a (new)
2a. Reiterates its belief that, in order to offset the potentially disruptive impact of free trade, multilateral trade rules must be based on principles of equity, inclusion and social justice, on their subordination to international social and environmental standards, and on the respect of national sovereignty with regard to the setting of economic development goals;
2008/03/26
Committee: INTA
Amendment 61 #

2007/2198(INI)

Motion for a resolution
Paragraph 2 b (new)
2b. Believes that the unsustainable trade imbalances that have built up in the last decade among leading trade powers cannot be corrected through TDIs or any kind of national sector-based protectionism but that they hint instead to the need of novel global economic governance mechanisms that are entrusted with the mitigation of unbalanced trade flows through policy, finance and currency measures, in order to preserve the global trading system from implosion;
2008/03/26
Committee: INTA
Amendment 74 #

2007/2198(INI)

Motion for a resolution
Paragraph 4 a (new)
4a. Acknowledges that TDI rules also have to reflect the interest of European firms that have retained production capacity within the EU as well as of those firms who have relocated parts of their production processes to third countries; points out, however, that also under a reformed TDI system the very definition of injury positively entails preferential treatment for local producers and that, systematically in practice, special consideration of the interests of relocated firms cannot be justified;
2008/03/26
Committee: INTA
Amendment 92 #

2007/2198(INI)

Motion for a resolution
Paragraph 8 a (new)
8a. Takes the view that a reformed EU anti-subsidy and countervailing measures system should address all trade behaviour by third countries that deliberately aims to undermine EU policy coherence with regard to the Lisbon and Goteborg principles of preserving sustainable and competitive employment, or systematically infringes international social and environmental standards and norms;
2008/03/26
Committee: INTA
Amendment 97 #

2007/2198(INI)

Motion for a resolution
Paragraph 9 a (new)
9a. While asking the Comission to maintain its strict criteria with regard to the initiation procedure for TDI investigations, sees room to reduce the initial complexity and expenditure for the complainant, which at present heavily discriminates against smaller firms, and regards it as important that complainants are assured about effective remedies, including a reduction of the current 9- or 15- month waiting time for provisional measures, the retention of the current period of 5 years for enacted measures, and provisions against the circumvention of measures through culprits' relocation of production to third countries;
2008/03/26
Committee: INTA
Amendment 98 #

2007/2198(INI)

Motion for a resolution
Paragraph 9 b (new)
9b. Considers it important that the initiationof a TDI investigation can result from a complaint by a single firm or on the Commission's own initiative, and that trade unions can also become complainants if, in the follow-up to the Council's position on "decent work" and its integration into trade policy, the anti- dumping claim is based on proven systemicatic violation of ILO core labour standards;
2008/03/26
Committee: INTA
Amendment 115 #

2007/2198(INI)

Motion for a resolution
Paragraph 13 a (new)
13a. Calls on the Commission to systematically take into consideration not only the position of European producers, but also of all interest groups in the chain from production to consumption, including trade unions, social and environmental interest groups, affected local administrations, consumer groups, importers, wholesalers and retailers in TDI investigations;
2008/03/26
Committee: INTA
Amendment 192 #

2007/2198(INI)

Motion for a resolution
Paragraph 35 a (new)
35a. Stresses that the guiding principle in defining the "community interest" must be the maintenance of a high level of EU policy coherence, especially with regard to the values in human rights, and social and environmental standards underlying the employment and competition policies of the Union as formulated in Lisbon and Gothenborg, which must also be upheld in the EU's foreign trade policy;
2008/03/26
Committee: INTA
Amendment 9 #

2007/2184(INI)

Motion for a resolution
Recital B
B. whereas the EU is well-advised to attaches the utmost importance to safeguarding what has so far been achieved by the multilateral trade system and remains firmly committed to the success of the Doha Round,
2008/03/03
Committee: INTA
Amendment 20 #

2007/2184(INI)

Motion for a resolution
Paragraph 3
3. Calls on the Commission to present, as soon as possible, a strongn initiative in Geneva with a view to relaunching this debate; calls on the Commission to make contact informally, in this regard, with other WTO members likely to support such an initiative and with the Director- General of that organisation, and to report to him, by the end of 2008, on the outcome of these consult, aimed at a WTO reform increasing both the democratic legitimacy and the efficiency of the organisations;
2008/03/03
Committee: INTA
Amendment 21 #

2007/2184(INI)

Motion for a resolution
Paragraph 3 a (new)
3a. Points out that the WTO is the only global organisation with rule-setting functions that is not part of the family of UN organisations, which has negative consequences on the coherence of global trade rules with other globally decided policies, and thus greatly impedes WTO rule-setting that restricts itself to the remit of simple trade policy; calls on the Commission to put this structural dilemma high on the agenda of WTO reform;
2008/03/03
Committee: INTA
Amendment 27 #

2007/2184(INI)

Motion for a resolution
Paragraph 4 a (new)
4a. Is of the opinion that the single most challenging requirement for consistency between the UN system and the WTO will be the need for the latter to ensure trade rules fully respect human rights law and social and environmental standards;
2008/03/03
Committee: INTA
Amendment 33 #

2007/2184(INI)

Motion for a resolution
Paragraph 5 a (new)
5a. Regards, in the light of tariffs reduced to historic minimum levels, the maintenance of multilateral rules through the dispute settlement mechanism as probably the main function of the WTO in the future on which the efficiency and democratic legitimacy of the WTO will be measured; perceives this function of the WTO less as an arbiter in infringements of the rules, but as a means to mitigate fairly between different interests and values; regards it as necessary, in this light, that a standing body of elected judges including experts from the UN specialised agencies be appointed to the DSU, that proceedings are open to the public, and that financial and technical support is made available to all members to file cases for dispute settlement;
2008/03/03
Committee: INTA
Amendment 35 #

2007/2184(INI)

Motion for a resolution
Paragraph 7
7. Suggests that the relevance and applicability of the multilateral trade rules in force should be subject to regular revision with a view to abolishing those which appear to be in conflict with evolving international human rights law, which are obsolete or inapplicable and those which do not meet, or no longer meet, the objectives governing their adoption;
2008/03/03
Committee: INTA
Amendment 36 #

2007/2184(INI)

Motion for a resolution
Paragraph 9
9. Stresses the importance of the parliamentary dimension of the WTO in order to enhance the democratic legitimacy and transparency of WTO negotiations; stresses the importance of the work done by the Parliamentary Conference on the WTO, which is organised jointly by the European Parliament and the Inter- Parliamentary Union, whose activities could be stepped upunderlines, however, that, ultimately, the legitimacy of the WTO can only derive from statutory changes that make the organisation part of the family of UN- agencies and subject its rule-setting to the basic rights as embodied in the UN Charters;
2008/03/03
Committee: INTA
Amendment 44 #

2007/2184(INI)

Motion for a resolution
Paragraph 13
13. Considers that the recurrent question of the establishment of a kind of WTO ‘restricted Council’ or ‘Steering Committee’ to prepare and facilitate consensus-based decisions in the General Council should be looked into more closely; stresses that there is a strong need for such a body to be representative, accountable to the entire WTO membership and internally transparent;
2008/03/03
Committee: INTA
Amendment 47 #

2007/2184(INI)

Motion for a resolution
Paragraph 14
14. Wishes to see the issue of the role of the WTO Secretariat and Director-General carefully considered; queries the limits of an excessively stringent application of, while upholding the principles of the management of the system by the governments of the member countries (the member-driven organisation concept);
2008/03/03
Committee: INTA
Amendment 8 #

2007/0200(COD)

Proposal for a decision – amending act
Recital 8
(8) The risk assessment for MDI has shown that there is a need to limit the risks during consumer applications of preparations containing MDI due to concerns from inhalation and dermal exposure. To prevent and eliminate these risks, the placing on the market for supply to the general public of preparations containing MDI should be permitted only under certain conditions such as the mandatory supply of polyethylenappropriate gloves toin the packaging and additional instructions ton the packaging. As the provision of the protective equipment and the printing of relevant instructions will require specific efforts by producers, a longer period of transition should be provided.
2008/03/05
Committee: ENVI
Amendment 11 #

2007/0200(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point 53 – column 2
Shall not be placedmade available on the market after [186 months after the entry into force of the Decision], for supply to the general public, as a constituent in paints and in paint strippers in concentrations equal to or higher than 0.1% by mass.
2008/03/05
Committee: ENVI
Amendment 13 #

2007/0200(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point 54 – column 2 – point 1
(1) Shall not be placed on the market for the first time after [182 months after the entry into force of the Decision], for supply to the general public, as a constituent of spray paints in concentrations equal to or higher than 3% by mass.
2008/03/05
Committee: ENVI
Amendment 15 #

2007/0200(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point 54 – column 2 – point 2
(2) Paints not conforming to the concentration limit in point (1) shall not be placed on the market for supplymade available to the general public after [2415 months after the entry into force of the Decision].
2008/03/05
Committee: ENVI
Amendment 17 #

2007/0200(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point 54 – column 2 – point 3
(3) Without prejudice to other Community legislation concerning the classification, packaging and labelling of dangerous substances and preparations, paints other than spray paints containing more than 3% by mass of DEGBE that are placed on the marketmade available for supply to the general public shall be legibly and indelibly marked by [2415 months after the entry into force of the Decision] as follows: “Do not use in paint spraying equipment".
2008/03/05
Committee: ENVI
Amendment 19 #

2007/0200(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point 55 – column 2 – point 4
(4) Shall not be placed on the marketmade available after [124 months after the entry into force of the Decision], as a constituent of preparations in concentrations equal to or higher than 0.1% by mass for supply to the general public, unless the packaging:
2008/03/05
Committee: ENVI
Amendment 20 #

2007/0200(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point 55 – column 2 – point 4 – point (a)
(a) contains polyethylene gloves. appropriate gloves. For the sake of harmonisation, the nature of the appropriate gloves shall be adopted in accordance with the procedure referred to in Article 2a of this Directive.
2008/03/05
Committee: ENVI
Amendment 22 #

2007/0200(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point 55 – column 2 – point 6
(6) Natural or legal persons placing on the market for the first time preparations containing MDI shall, within 3 years from the date of implementation of the restrictions set forth in paragraph (1), collect data on possible cases of persons suffering from respiratory allergy during the use of preparations containing MDI and make those data available to the Commission with a view to assessing whether Article 69(1) and (3) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council shall be applied. Data shall be collected in accordance with a study protocol that shall involve specialised centres and shall be agreed by the Commission.
2008/03/05
Committee: ENVI
Amendment 23 #

2007/0200(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point 56 – column 2 – point 8
(8) Shall not be placed on the market for the first time after [182 months after the entry into force of the Decision], for supply to the general public, as a constituent of neoprene based adhesives in concentrations equal to or higher than 0.1% by mass in package sizes greater than 6350 g.
2008/03/05
Committee: ENVI
Amendment 24 #

2007/0200(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point 56 – column 2 – point 9
(9) Neoprene based adhesives containing cyclohexane and not conforming to (1) shall not be placed on the marketmade available for supply to the general public after [2415 months after the entry into force of the Decision].
2008/03/05
Committee: ENVI
Amendment 25 #

2007/0200(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point 56 – column 2 – point 10
(10) Without prejudice to other Community legislation concerning the classification, packaging and labelling of dangerous substances and preparations, neoprene based adhesives containing cyclohexane in concentrations equal to or higher than 0.1% by mass that are placed on the marketmade available for supply to the general public after [2415 months after the entry into force of the Decision] shall be legibly and indelibly marked as follows: - “Do not use under conditions of poor ventilation. - Do not use for carpet laying.”
2008/03/05
Committee: ENVI
Amendment 26 #

2007/0200(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point 57 – column 2 – point 1
(1) Shall not be placed on the market for the first time after [182 months after the entry into force of the Decision] as a substance, or in preparations that contain more than 28% by mass of nitrogen in relation to ammonium nitrate, for use as a solid fertiliser, straight or compound, unless the fertiliser complies with the technical provisions for ammonium nitrate fertilisers of high nitrogen content set out in Annex III to Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers.
2008/03/05
Committee: ENVI
Amendment 27 #

2007/0200(COD)

Proposal for a decision – amending act
Annex
Directive 76/769/EEC
Annex I – point 57 – column 2 – point 2
(2) Shall not be placed on the marketmade available for supply to the general public after [185 months after the entry into force of the Decision] as a substance, or in preparations that contain 20% or more by mass of nitrogen in relation to ammonium nitrate.
2008/03/05
Committee: ENVI
Amendment 45 #

2007/0121(COD)

Proposal for a regulation – amending act
Recital 8
(8) Therefore it is essential to harmonise the provisions for the classification and labelling of substances and mixtures within the Community, taking into full account the classification criteria and labelling rules of the GHS, but also by building on the 40 years of experience obtained through implementation of existing Community chemicals legislation and maintaining the level of protection achieved through the system of harmonisation of classification and labelling, through Community hazard classes not yet part of the GHS as well as through current labelling and packaging rules.
2008/02/26
Committee: ENVI
Amendment 50 #

2007/0121(COD)

Proposal for a regulation – amending act
Recital 24 a (new)
(24a) When conducting or overseeing validation studies to assess non-animal tests, or methods that reduce the number of animals used or the suffering experienced by test animals, account should be taken of the need to classify and label substances according to this Regulation and legislation implementing the GHS.
2008/02/26
Committee: ENVI
Amendment 51 #

2007/0121(COD)

Proposal for a regulation – amending act
Recital 24 b (new)
(24b) In the event that non-animal tests, or animal tests that have been refined to reduce the number of animals used or the suffering experienced by test animals, generate data that are not directly compatible with certain classification and labelling criteria under this Regulation, but in all respects satisfy the requirements of scientific validation for the purpose of protection of human health and the environment, this Regulation should be adapted, where there is adequate scientific justification, to ensure that classification and labelling criteria do not become a barrier to use of such test methods.
2008/02/26
Committee: ENVI
Amendment 57 #

2007/0121(COD)

Proposal for a regulation – amending act
Recital 37
(37) It is essential that the substances and mixtures placed on the market be well identified,; however, the Agency should allow enterprises, where necessary, to describe the chemical identity of certain substances in a way that does not put the confidential nature of their businesses at risk.
2008/02/26
Committee: ENVI
Amendment 67 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 3 - paragraph 2 - point (b)
(b) hazard classes 3.1 other than category 5, 3.2 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
2008/02/26
Committee: ENVI
Amendment 73 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 7 - paragraph 2 a (new)
2a. Validation studies to assess non- animal tests, or methods that reduce the number of animals used or the suffering experienced by test animals, shall be designed to ensure that new test methods take account of the requirements contained in this Regulation and similar legislation implementing the Globally Harmonised System of Classification and Labelling of Chemicals in other jurisdictions so that classification and labelling requirements do not become a barrier to the replacement, reduction and refinement of animal testing.
2008/02/26
Committee: ENVI
Amendment 74 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 7 - paragraph 2 b (new)
2b. Where there is sufficient scientific justification, and in order to minimise animal testing, the Commission shall adapt this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 54(3) to ensure that classification and labelling requirements do not become a barrier to the use of test methods that replace, reduce or refine animal testing.
2008/02/26
Committee: ENVI
Amendment 82 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 14 - paragraph 1
1. The classification of a mixture shall not be affected where the evaluation of the information indicates any of the following: (a) that the substances in the mixture react slowly with atmospheric gases, in particular oxygen, carbon dioxide, water vapour, to form different substances; (b) that the substances in the mixture react very slowly with other substances in the mixture to form different substances; (c) that the substances in the mixture may self-polymerize to form oligomers or polymers.
2008/02/26
Committee: ENVI
Amendment 86 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 17 - paragraph 1 - points (d) to (h)
(d) where appropriate, hazard pictograms in accordance with Article 19; (e) where appropriate, signal words in accordance with Article 20; (f) where appropriate, hazard statements in accordance with Article 21; (g) where appropriate, precautionary statements in accordance with Article 22; (h) where appropriate, a section for supplemental information in accordance with Article 27.
2008/02/26
Committee: ENVI
Amendment 91 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 19 - paragraph 3
3. The hazard pictogram relevant for each specific classification is set out in the tables indicating the label elements required for each hazard class in parts 2, 3 and 4 of Annex I.
2008/02/26
Committee: ENVI
Amendment 93 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 21 - paragraph 1
1. The label shall include the relevant hazard statements describing the nature of the hazards of a hazardous substance or mixture, including, where appropriatlicable, the degree of hazard.
2008/02/26
Committee: ENVI
Amendment 95 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 23
Where a substance or mixture is classified in accordance with part 5 of Annex I the following shall apply: (a) a hazard pictogram shall not be included on the label; (b) the signal words, hazard statements and precautionary statlabelling elements shall be placed in the supplemental information section as referred to in Article 27.
2008/02/26
Committee: ENVI
Amendment 99 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 26 - paragraph 1 a (new)
1a. Paragraph 1 shall not apply to substances that have been identified as meeting the criteria referred to in Article 57 of Regulation (EC) No 1907/2006.
2008/02/26
Committee: ENVI
Amendment 104 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 30 - paragraph 2 - subparagraph 1
2. Where the substance or mixture is sold to the general public, one precautionary statement addressing the disposal of that substance or mixture shall appear on the label, where appropriate.
2008/02/26
Committee: ENVI
Amendment 105 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 31 - paragraph 1
1. For packaging containing 125 ml or less, hazard and precautionary statements need not be indicated on the label, if the substance or mixture is classified as: (a) Flammable Gas of category 2; (b) Flammable Liquid of category 2 or 3; (c) Flammable Solid of category 1 or 2; (d) Substances which in contact with water emit Flammable Gases of categories 2 or 3; (e) Oxidising Liquid of category 2 or 3; (f) Oxidising Solid of category 2 or 3; (g) Acutely Toxic of category 4, if the substances or mixtures are not supplied to the general public; (h) Skin Irritant of category 2; (i) Eye Irritant of category 2; (j) Acutely Aquatic Hazardous of category 1; (k) Chronically Aquatic Hazardous of category 1, 2, 3 and 4.deleted
2008/02/26
Committee: ENVI
Amendment 111 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 31 - paragraph 2 - point (a)
(a) where the packaging is either too small or otherwise unsuitable for affixing the label, the conditions for applying the label elements onto a separate sheet that accompanies the packaging;
2008/02/26
Committee: ENVI
Amendment 112 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 31 - paragraph 2 - point (b)
(b) where packaging contains a quantity other than 125 ml which does not entail a risk to workers or human health or the environment, the quantities and the appropriate exemptions from the labelling requirements for substances and mixtures classified as follows: (i) Flammable Gases; (ii) Oxidising Gases; (iii) Flammable Liquids; (iv) Flammable Solids; (v) Substances which in contact with water emit Flammable Gases; (vi) Oxidising Liquids; (vii) Oxidising Solids; (viii) Acutely Toxic of category 4; (ix) Skin Irritant of category 2; (x) Eye Irritant of category 2; (xi) Hazardous to the Environment.deleted
2008/02/26
Committee: ENVI
Amendment 115 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 32
Packaging destined for the general public on which it is physically impossible to apply a label in accordance with Article 34, shall be exempted from the obligation to bear a label, provided that such packaging is accompanied by precise and clear instructions for use, including, where appropriate, instructions for its disposal, and provided that it contains substances or mixtures classified in accordance with the following hazard classes and categories in Annex I: (a) Section 3.1, acute toxicity category 1, 2 or 3; (b) Section 3.2, skin corrosion category 1; (c) Section 3.8, specific target organ toxicity (STOT) – single exposure category 1; (d) Section 3.9, specific target organ toxicity (STOT) – repeated exposure category 1a separate datasheet with the labelling information and precise and clear instructions for use, including, where relevant, instructions for its disposal.
2008/02/26
Committee: ENVI
Amendment 128 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 41 - paragraph 1 - point (c a) (new)
(ca) where the classification is different from the classification already included in the classification and labelling inventory, the reasons for it;
2008/02/26
Committee: ENVI
Amendment 130 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 43 - paragraph 3 – introductory part
3. In addition to the information referred to in paragraph 1, the Agency shall, where appropriatlicable, include the following information in each entry:
2008/02/26
Committee: ENVI
Amendment 135 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 49 - paragraph 1 - subparagraph 1
1. Any supplier of a substance or mixture shall assemble and keep available all the information required for the purposes of classification and labelling under this Regulation for a period of at least 130 years after he last supplied the substance or the mixture.
2008/02/26
Committee: ENVI
Amendment 138 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 53
The Commission may adjust and adapt Articles 12, 14, 23, 27 to 320 and 37 (2) second and third subparagraph and Annexes I to VII to technical progress. 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 54 (3). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 54 (4).
2008/02/26
Committee: ENVI
Amendment 139 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 53 - paragraph 1 a (new)
The Commission shall adapt Annexes I to VII, where relevant, to incorporate the hazard class persistence, bioaccumulation and toxicity, the hazard class very persistent and very bioaccumulative, and acute toxicity hazard category 5 by ...*. 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 54 (3). * Twelve months after entry into force of this Regulation.
2008/02/26
Committee: ENVI
Amendment 141 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 58
1. Until 1 December 2010, substances shall be classified, labelled and packaged in accordance with Directive 67/548/EEC. Until 1 JuneDecember 20153, mixtures shall be classified, labelled and packaged in accordance with Directive 1999/45/EC. 2. By way of derogation from Article 60 and from paragraph 1 of this Article, the substances and mixtures classified in accordance with paragraph 1 may, as regards the period before 1 December 2010 and 1 JuneDecember 20153 respectively, be classified and labelled in accordance with this Regulation. In that case, the provisions on labelling in Directives 67/548/EEC and 1999/45/EC shall not apply. 3. From 1 December 2010 until 1 JuneDecember 20153, substances shall be classified in accordance with both Directive 67/548/EEC and this Regulation. They shall be labelled and packaged in accordance with this Regulation. 4. Substances and mixtures that have been classified and placed on the market before 1 December 2010 and 1 JuneDecember 20153 respectively shall not be required to be labelled and packaged in accordance with this Regulation.
2008/02/26
Committee: ENVI
Amendment 143 #

2007/0121(COD)

Proposal for a regulation – amending act
Article 60 - paragraph 2
Titles II, III and IV shall apply in respect of substances from 1 December 2010 and in respect of mixtures from 1 June 2015 December 2013. Or. en (Linked to the amendment by the same author to Article 58)
2008/02/26
Committee: ENVI
Amendment 146 #

2007/0121(COD)

Proposal for a regulation – amending act
Annex I - part 3.1. - paragraph 3.1.2.1. and table 3.1.1. – rows 1 and 2
3.1.2.1. Substances can be allocated to one of fourive toxicity categories based on acute toxicity by the oral, route and to one of four toxicity categories based on acute toxicity by the dermal or inhalation route according to the numeric criteria shown in Table 3.1.1 Table 3.1.1 below. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). Explanatory notes are notes are shown following Table 3.1.1. Table 3.1.1 Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories Exposure Category 1 Category 2 Category 3 Category 4 Route Category 5 Route Oral (mg/kg 2000 < ATE < bodyweight) 5 < ATE < 50 < ATE < 300 < ATE < 5000 ATE < 5 50 5 300 300 2000 See Note (a) 2000 See Note (a) See Note (ca) Note: (ca) Criteria for Category 5 are intended to enable the identification of substances which are of relatively low acute toxicity hazard but which under certain circumstances may present a danger to vulnerable populations. These substances are anticipated to have an oral LD50 in the range of 2000-5000 mg/kg bodyweight. The specific criteria for Category 5 are: (i) The substance is classified in this Category if reliable evidence is already available that indicates the LD50 to be in the range of Category 5 values or other animal studies or toxic effects in humans indicate a concern for human health of an acute nature. (ii) The substance is classified in this Category, through extrapolation, estimation or measurement of data, if assignment to a more hazardous category is not warranted, and: - reliable information is available indicating significant toxic effects in humans; or - any mortality is observed when tested up to Category 4 values by the oral, inhalation or dermal routes; or - where expert judgement confirms significant clinical signs of toxicity, when tested up to Category 4 values, except for diarrhoea, piloerection or an ungroomed appearance; or - where expert judgement confirms reliable information indicating the potential for significant acute effects from other animal studies. Recognising the need to protect animal welfare, testing in animals in Category 5 ranges is discouraged and should only be considered when there is a strong likelihood that results of such a test would be of direct relevance for the protection of human health.
2008/02/26
Committee: ENVI
Amendment 148 #

2007/0121(COD)

Proposal for a regulation – amending act
Annex I - part 3.1. - paragraph 3.1.2.2.1a (new)
3.1.2.2.1a. Category 5 is for chemicals which are of relatively low acute toxicity but which, under certain circumstances, may pose a hazard to vulnerable populations. Criteria for identifying substances in Category 5 are provided in addition to the table. These substances are anticipated to have an oral LD50 value in the range 2000 - 5000 mg/kg bodyweight. In light of animal welfare considerations, testing in animals in Category 5 ranges is discouraged and should only be considered when there is a strong likelihood that results of such testing would be of direct relevance for the protection of human health.
2008/02/26
Committee: ENVI
Amendment 150 #

2007/0121(COD)

Proposal for a regulation – amending act
Annex I - part 3.1. - paragraph 3.1.3.6.2.3 - table 3.1.2. - row 2
Table 3.1.2. Conversion from experimentally obtained acute toxicity range values (or acute toxicity hazard categories) to acute toxicity point estimates for classification for the respective routes of exposure Converted Acute Classification Category or experimentally Exposure routes Toxicity point estimate obtained acute toxicity range estimate (see Note 1) 0 < Category 1 ≤ 5 0.5 5 < Category 2 ≤ 50 5 Oral 5 50 < Category 235300 100 5 (mg/kg bodyweight) 5 300 < Category 3432000 1500 32000 < Category 45 25000 (see Note 1a) 2500 Note 1: These values are designed to be used in the calculation of the ATE for classification of a mixture based on its components and do not represent test results. Note 1a: Category 5 is for mixtures which are of relatively low acute toxicity but which under certain circumstances may pose a hazard to vulnerable populations. These mixtures are anticipated to have an oral LD50 value in the range of 2000-5000 mg/kg bodyweight. In light of animal welfare considerations, testing in animals in Category 5 ranges is discouraged and should only be considered when there is a strong likelihood that results of such testing would be of direct relevance for the protection of human health.
2008/02/26
Committee: ENVI
Amendment 152 #

2007/0121(COD)

Proposal for a regulation – amending act
Annex I - paragraph 3.1.4.1. - table 3.1.3. - rows 1 to 4 and 8
Table 3.1.3. Acute toxicity label elements Category 5 Classification Category 1 Category 2 Category 3 Category 4 GHS Pictograms (see Note 2a) No GHS Pictograms pictogram Signal word Danger Danger Danger Warning Hazard H300:Warning Warning H303: H300: H300: H301: H302: Hazard statement: Fatal if May be Fatal if Fatal if Toxic if Harmful if Oral harmful if swallowed swallowed swallowed swallowed swallowed Precautionary P301 + P310 P301 + P310 P301 + P310 statement P301 + P312 statement P321 P321 P321 P321 response P312 P330 response (oral) P330 P330 P330 (oral) P330 P330 Note 2a: The label elements for Category 5 in Table 3.1.3 shall be used for substances and mixtures available to the general public. Regarding substances and mixtures in Category 5 which are intended for professional users only, the supplier shall provide the information on classification to downstream users and distributors by means of the safety data sheet.
2008/02/26
Committee: ENVI
Amendment 155 #

2007/0121(COD)

Proposal for a regulation – amending act
Annex I - paragraph 5.1a (new)
5.1a. Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) 5.1a.1. Classification criteria for substances 5.1a.1.1. A substance shall be classified as PBT or vPvB if it is: (i) identified as PBT or vPvB by a manufacturer or an importer pursuant to Article 14 of Regulation (EC) No 1907/2006, or (ii) included as PBT or vPvB in the list pursuant to Article 59(1) of Regulation (EC) No 1907/2006, or (iii) included as PBT or vPvB in Annex XIV of Regulation (EC) No 1907/2006. 5.1a.2. Classification criteria for Mixtures 5.1a.2.1. Mixtures shall be classified as PBT or vPvB on the basis of the individual concentration of the substance(s) contained therein that are also classified as PBT or vPvB, in accordance with Table 5.2a. 5.1a.3. Hazard Communication 5.1a.3.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 5.2b.
2008/02/26
Committee: ENVI
Amendment 22 #

2007/0064(COD)

Proposal for a regulation
Recital 20
(20) The Community contributes in the context of the Codex Alimentarius to the development of international standards on maximum residue limits, while ensuring that the high level of human health protection adopted in the Community is not reduced. The Community should therefore take over without a further risk assessment those Codex maximum residue limits it has supported in the relevant Codex Alimentarius Commission meeting. Consistency between international standards and Community legislation on residue limits in food will thereby be further enhanced. , subject to a review of substances not authorised in the EU and of specific synergetic and cumulative effects of specific substances that may harm human health. Consistency between international standards and Community legislation on residue limits in food will thereby be further enhanced, without jeopardising the level of protection required for authorisation in the Community. The Commission must involve the European Parliament formally before agreement is reached.
2008/02/28
Committee: ENVI
Amendment 30 #

2007/0064(COD)

Proposal for a regulation
Article 1 — paragraph 1 — subparagraph 1 a (new)
This includes, as appropriate, provisions on the use and placing on the market of pharmacologically active substances.
2008/02/28
Committee: ENVI
Amendment 37 #

2007/0064(COD)

Proposal for a regulation
Article 5
WIn line with the objective of ensuring a high level of health protection and with the principles laid down in Article 6, the Committee shall, with a view to ensuring the availability of authorised veterinary medicinal products for conditions affecting food—producing species, the Committee shall, when carrying out scientific risk assessments and when drawing up risk management recommendations, consider using maximum residue limits established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or in one or more species for other species. In the event of extrapolation between different animal species, a safety factor of at least 10 should be applied when setting maximum residue limits.
2008/02/28
Committee: ENVI
Amendment 41 #

2007/0064(COD)

Proposal for a regulation
Article 6 — paragraph 1
1. The scientific risk assessment shall consider the metabolism and depletion of pharmacologically active substances in relevant animal species and the type of residues, and the amount thereof, that may be ingested by human beings over a lifetime without an appreciable health risk, expressed in terms of acceptable daily intake (ADI). Alternative approaches to ADI may be used, if they have been laid down by the Commission as provided for in Article 12(1), paying particular attention to the synergetic and cumulative effects of different pharmacologically active substances and to effects on vulnerable categories of people. Alternative approaches to ADI may be used, if they have been laid down by the Commission as provided for in Article 12(1). The risk assessment should comply with the principles for assessing the safety of foodstuffs laid down in Regulation (EC) No 178/2002.
2008/02/28
Committee: ENVI
Amendment 47 #

2007/0064(COD)

Proposal for a regulation
Article 7 — point (b)
(b) other legitimate factors such as the technological aspects of food production, the feasibility of controls, conditions of use and application of the substances in veterinary medicinal products and the likelihood of misuse or illegal use; misuse includes the prophylactic use of veterinary medicinal products when diseases can be managed by making proportionate and reasonable changes to the conditions in which animals are kept;
2008/02/28
Committee: ENVI
Amendment 54 #

2007/0064(COD)

Proposal for a regulation
Article 9 — paragraph 1 — subparagraph 1
1. For substances not intended for use in veterinary medicinal products to be placed on the market in the Community and where no application for such substances has been made in accordance with Article 3, the Commission or, Member States or a third party pursuing legitimate interests may forward to the Agency requests for an opinion on maximum residue limits. Paragraph 3 suggests that third parties may also forward requests, although this possibility isOr. en Justification not included in paragraph 1. Systematic clarification.
2008/02/28
Committee: ENVI
Amendment 56 #

2007/0064(COD)

Proposal for a regulation
Article 9 — paragraph 3 a (new)
3a. Paragraphs 1 to 3 shall apply mutatis mutandis to authorised pharmacologically active substances for which the cost of the procedure for the establishment of residue limits is disproportionate in relation to the economic revenue from the substance on account of the limited distribution of the animal species or their minor economic significance (‘minor uses’). In the event of extrapolation between different animal species, a safety factor of at least 10 shall be applied when setting maximum residue limits. The Commission may, in accordance with the regulatory procedure with scrutiny referred to in Article 20(3), establish more precise requirements for the application of this paragraph.
2008/02/28
Committee: ENVI
Amendment 59 #

2007/0064(COD)

Proposal for a regulation
Article 12 — paragraph 1 — introductory part
1. In accordance with the regulatory procedure referred to in Article 20(2), tThe Commission shall, in consultation with the Agency, adopt the followingrules on:
2008/02/28
Committee: ENVI
Amendment 60 #

2007/0064(COD)

Proposal for a regulation
Article 12 — paragraph 1 — subparagraph 1 a (new)
Decisions shall be made, in the case of point (a), in accordance with the regulatory procedure referred to in Article 21(2) and, in the case of point (b), in accordance with the regulatory procedure with scrutiny referred to in Article 21(3).
2008/02/28
Committee: ENVI
Amendment 69 #

2007/0064(COD)

Proposal for a regulation
Article 13 — paragraph 3
3. A maximum residue limit shall be laid down where it appears necessary for the protection of human health pursuant to an opinion of the Agency in accordance with Articles 4, 9 or 10 or pursuant to a vote by the Community in favour of the establishment of a maximum residue limit. Maximum residue limits agreed by the Community for a pharmacologically active substance intended for use in a veterinary medicinal product in the Codex Alimentarius. In the latter case an additional assessment by the Agency is not required must be of equal value to the Community health protection provisions in force. An additional assessment by the Agency in the interests of health protection as regards at least the synergetic and cumulative effects of different pharmacologically active substances shall be required when the Agency or relevant Member State authorities have concerns as regards health protection.
2008/02/28
Committee: ENVI
Amendment 70 #

2007/0064(COD)

Proposal for a regulation
Article 13 — paragraph 3 a (new)
3a. Before the Commission agrees to maximum residue limits in the Codex Alimentarius, the procedure referred to in Article 21(3) shall apply. The Commission may approve the maximum residue limits in the Codex Alimentarius only if they guarantee an equal level of safety for human health as Community legislation. Article 13(e) of Regulation (EC) No 178/2002 must be taken into account.
2008/02/28
Committee: ENVI
Amendment 71 #

2007/0064(COD)

Proposal for a regulation
Article 13 — paragraph 4
4. A provisional maximum residue limit may be established for a pharmacologically active substance in cases where scientific data are incomplete, provided that there are no grounds for supposing that residues of the substance concerned at the level proposed present a hazard for humarisk to human health. The decision on risk must be based on thealth principles referred to in Article 6 and the rules laid down in Article 12. The provisional maximum residue limit shall apply for a defined period of time, which shall not exceed fivthree years. That period may be extended once for a period not exceeding two years where it is demonstrated that such an extension would allow scientific studies in progress to be completed.
2008/02/28
Committee: ENVI
Amendment 79 #

2007/0064(COD)

Proposal for a regulation
Article 14 — paragraph 2
2. The Regulation referred to in paragraph 1 shall be adopted by the Commission in accordance with, and within 390 days after the end of, the regulatory procedure with scrutiny referred to in Article 20(23).
2008/02/28
Committee: ENVI
Amendment 87 #

2007/0064(COD)

Proposal for a regulation
Article 16 a (new)
Article 16a Use of unclassified substances Administering veterinary medicinal products that contain pharmacologically active substances not included in the Annex to food—producing animals shall be prohibited. Clinical trials authorised by the appropriate national authorities upon notification or approval pursuant to the relevant legislation shall be exempt, provided that the food from the animals used in such trials contains no residues harmful to human health.
2008/02/28
Committee: ENVI
Amendment 89 #

2007/0064(COD)

Proposal for a regulation
Article 17 — paragraph 1 — subparagraph 1 a (new)
The principles of risk assessment pursuant to Articles 4 to 8 shall be applied in order to guarantee a high level of health protection.
2008/02/28
Committee: ENVI
Amendment 94 #

2007/0064(COD)

Proposal for a regulation
Article 17 — paragraph 1 — subparagraph 3 a (new)
Foodstuffs of animal origin containing pharmacologically active substances for which no maximum residue limits have been set may not be placed on the market. This prohibition shall apply also where special detection limits are set in respect of such substances under other Community provisions and those detection limits are exceeded.
2008/02/28
Committee: ENVI
Amendment 102 #

2007/0064(COD)

Proposal for a regulation
Article 19 a (new)
Article 19a Placing on the market If the maximum residue limits or reference quantities established under this Regulation are exceeded, the product shall not be placed on the market as a foodstuff, transformed into foodstuffs or mixed with foodstuffs.
2008/02/28
Committee: ENVI
Amendment 104 #

2007/0064(COD)

Proposal for a regulation
Article 22
Within [690] days after the entry into force of this Regulation, the Commission shall adopt, in accordance with the regulatory procedure referred to in Article 20(23), a Regulation containing the pharmacologically active substances and their classification regarding maximum residues limits in accordance with Annexes I to IV of Regulation (EEC) No 2377/90.
2008/02/28
Committee: ENVI
Amendment 106 #

2007/0064(COD)

Proposal for a regulation
Article 23 — paragraph 1 — subparagraph 3 a (new)
Commission Decisions 2002/657/EC and 2005/34/EC shall expire within three years of the entry into force of this Regulation. Any new regulations adopted shall comply with the risk assessment criteria of this Regulation.
2008/02/28
Committee: ENVI
Amendment 28 #

2006/0147(COD)


Article 3 - paragraph 2 - point (j a) (new)
(ja) "produced by GMOs" shall mean derived by using a GMO as the last living organism in the production process, but not containing or consisting of GMOs nor produced from GMOs;
2008/04/07
Committee: ENVI
Amendment 44 #

2006/0147(COD)


Article 29
Directive 2000/13/EC
Annex III - paragraph 2 a (new)
2a. For flavourings produced from a source material falling within the scope of Regulation (EC) No 1829/2003, the indication "produced from GMOs" shall appear on the label. For flavourings produced by an organism falling within the scope of Regulation (EC) No 1829/2003, no specific labelling shall be required.
2008/04/07
Committee: ENVI
Amendment 21 #

2006/0145(COD)


Article 2 – paragraph 2 – point b
(b) substances used for the protection of plants and plant products in accordanceconformity with Community rules relating to plant health, with the exception of post-harvest plant protection products used as preserving agents;
2008/04/09
Committee: ENVI
Amendment 25 #

2006/0145(COD)


Article 12
12. A food additive produced from, with or by GMOs or falling within the scope of Regulation (EC) No 1829/2003 may be included in the Community lists in Annexes II and III in accordance with this Regulation only when it is covered by an authorisation in accordance with Regulation (EC) No 1829/2003. It shall be clearly labelled, displaying the words "produced by GMOs" or "produced from GMOs" next to its name or E Number.
2008/04/09
Committee: ENVI
Amendment 8 #

2006/0144(COD)


Recital 6
(6) Food enzymes should be approved and used only if they fulfil the criteria laid down in this Regulation. Food enzymes must be safe when used, there must be a technological need for their use and, their use must not mislead the consumer and their use should be of benefit to the consumer. Misleading the consumer includes, but is not limited to, issues related to the nature, freshness, quality of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product. The approval of food enzymes should also take into account other factors relevant to the matter under consideration including societal, economic, traditional, ethical and environmental factors and the feasibility of controls.
2008/04/03
Committee: ENVI
Amendment 9 #

2006/0144(COD)


Recital 8
(8) Food enzymes the use of which is permitted within the Community should appear in a Community list that should clearly describe the enzymes and specify any conditions governing their use, including where necessary information on their function in the final food. This list should be supplemented by specifications, in particular on their origin, including where relevant information about allergenic properties, and purity criteria. Where the food enzyme is produced with or by a genetically modified organism (“GMO”) within the meaning of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms1, the unique identifier assigned to the GMO under that Regulation should also be included in the specifications. 1 OJ L 268, 18.10.2003, p. 24.
2008/04/03
Committee: ENVI
Amendment 10 #

2006/0144(COD)


Recital 9
(9) In order to ensure harmonisation, the risk assessment of food enzymes and their inclusion in the Community list should be carried out in accordance with the precautionary principle and with the procedure laid down in Regulation (EC) No …/… of the European Parliament and of the Council of … establishing a common authorisation procedure for food additives, food enzymes and food flavourings.
2008/04/03
Committee: ENVI
Amendment 12 #

2006/0144(COD)


Recital 14
(14) In order to ensure fair and equal conditions for all applicants, the Community list should be drawn up in a single step. That list should be established after completion of the risk assessment of all food enzymes for which sufficient information has been submitted during the initial two-year period. However, the opinions of the Authority should be published as soon as the scientific assessment is completed.
2008/04/03
Committee: ENVI
Amendment 13 #

2006/0144(COD)


Article 6 - point (a)
(a) it does not, on the basis of the scientific evidence available and the precautionary principle, pose a safety concern to the health of the consumer at the level of use proposed and;
2008/04/03
Committee: ENVI
Amendment 15 #

2006/0144(COD)


Article 6 - point (c a) (new)
(ca) its use has a clear benefit for the consumer.
2008/04/03
Committee: ENVI
Amendment 16 #

2006/0144(COD)


Article 7 - paragraph 2 - point (f)
(f) where necessary, specific requirements in respect of the labelling of food in which the food enzymes have been used in order to ensure that the final consumer is informed of the physical condition of the food or the specific treatment it has undergone.
2008/04/03
Committee: ENVI
Amendment 25 #

2006/0144(COD)


Article 21 - point 2
Directive 2000/13/EC
Article 6 - paragraph 6
2) In Article 6(6), the following indent shall be added to Article 6(6): "− enzymes other than as referred to in paragraph 4(c)(ii)present in the food product shall be designated by the name of one of the categories of ingredients listed in Annex II, followed by their specific name,". and an indication of whether they are still active in the final product or not; for enzymes produced from GMOs the indication “produced from GMOs” shall be given on the label,”.
2008/04/03
Committee: ENVI
Amendment 17 #

2006/0143(COD)


Article 6 – paragraph 1
1. In duly justified cases wWhere the Authority requests additional information from applicants, the period referred to in Article 5(1) may be extended. After consulting the applicant, the Authority shall lay down a period within which this information can be provided and shall inform the Commission of the additional period needed. If the Commission does not object within eight working days of being informed by the Authority, the period referred to in Article 5(1) shall be automatically extended by the additional period. The Commission shall inform the Member States of the extension.
2008/04/09
Committee: ENVI
Amendment 44 #

2005/0254(COD)

Proposal for a regulation
Recital 7
(7) The introduction of an origin mark can contribute to make demanding Community standards work in favour of the Community industry, especially small and medium enterprises which often put a genuine effort into the quality of their products and which also preserve traditional and artisanal jobs and methods of production, but which are also greatly exposed to global competition which lacks rules to distinguish between production methods. It will also help to prevent the reputation of the Community industry being tainted by inaccurate claims of origin. Improved transparency and consumer information about the origin of goods will thus contribute to the objectives of the Lisbon agenda and those of the EU 2020 Strategy.
2010/09/02
Committee: INTA