946 Amendments of Carl SCHLYTER

Jan Philipp ALBRECHT, Judith SARGENTINI, Jean LAMBERT, Hélène FLAUTRE, Rui TAVARES, Raül ROMEVA i RUEDA, Carl SCHLYTER

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

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

2013/2188(INI)

Jan Philipp ALBRECHT, Judith SARGENTINI, Jean LAMBERT, Hélène FLAUTRE, Rui TAVARES, Raül ROMEVA i RUEDA, Carl SCHLYTER

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

2013/2188(INI)

Jan Philipp ALBRECHT, Christian ENGSTRÖM, Carl SCHLYTER, Judith SARGENTINI, Jean LAMBERT, Hélène FLAUTRE, Rui TAVARES, Raül ROMEVA i RUEDA

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

2013/2188(INI)

Jan Philipp ALBRECHT, Judith SARGENTINI, Jean LAMBERT, Hélène FLAUTRE, Rui TAVARES, Raül ROMEVA i RUEDA, Carl SCHLYTER

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

2013/2188(INI)

Jan Philipp ALBRECHT, Judith SARGENTINI, Jean LAMBERT, Hélène FLAUTRE, Rui TAVARES, Raül ROMEVA i RUEDA, Carl SCHLYTER

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 to~~see 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 GATS~~shall 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

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

2013/0307(COD)

Proposal for a regulation
Article 7 – paragraph 1 – point c

(c) transported, except for the transportation of species to facilities for ~~eradication~~destruction, or in the case of vertebrates, humane euthanasia;

2014/01/13
Committee: ENVI

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

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

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

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

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

2013/0136(COD)

Proposal for a regulation
Paragraph 1

1. ~~Adopts its position at first reading hereinafter set out~~Rejects the Commission proposal;

2013/11/28
Committee: ENVI

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 text~~withdraw its proposal and present an improved proposal;

2013/11/28
Committee: ENVI

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

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

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

2012/2066(INI)

Motion for a resolution
Recital G

G. whereas the standard data requirements in EU chemicals legislation ~~do not contain any information on~~are insufficient to adequately identify endocrine-disrupting properties;

2012/11/27
Committee: ENVI

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 cau~~tionary principle~~sed, 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

2012/2066(INI)

Motion for a resolution
Paragraph 2

2. Takes the view that the ~~feared~~known, 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

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

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

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

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

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

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

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 towards~~the need to take preventive action to reduc~~ing~~e human exposure to endocrine disruptors;

2012/11/27
Committee: ENVI

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

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 ~~may~~do 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

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

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

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

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

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

2012/2031(INI)

Bas EICKHOUT, Carl SCHLYTER

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

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

2012/2031(INI)

Bas EICKHOUT, Carl SCHLYTER

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

2012/2031(INI)

Bas EICKHOUT, Carl SCHLYTER

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

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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA

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

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

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA

Proposal for a directive
Recital 28

(28) In order to ensure independence and transparency, ~~manufacturers of tobacco product~~Member 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

2012/0366(COD)

Proposal for a directive
Recital 30

(30) ~~Cross-border distance~~Internet 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

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Kartika Tamara LIOTARD, Carl SCHLYTER, Catherine STIHLER, Antonyia PARVANOVA

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 a~~However, 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 framework~~s 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

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Kartika Tamara LIOTARD, Carl SCHLYTER, Catherine STIHLER, Antonyia PARVANOVA

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

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA

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

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

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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

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

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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

Proposal for a directive
Article 6 – paragraph 1 – subparagraph 2

~~Member States shall not prohibit the use of a~~Additives 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 flavour~~flavour and are not linked to attractiveness of tobacco products.

2013/05/14
Committee: ENVI

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

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 flavour~~flavour 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 flavour~~by modifying Annex -I accordingly.

2013/05/14
Committee: ENVI

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

Proposal for a directive
Article 6 – paragraph 4 – introductory part

4. ~~Member States shall prohibit the use of~~Annex -I shall not contain the following additives in tobacco products:

2013/05/14
Committee: ENVI

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

Proposal for a directive
Article 6 – paragraph 5

5. ~~Member States shall prohibit t~~The 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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

Proposal for a directive
Article 6 – paragraph 7 – subparagraph 1

~~Member States shall~~Annex -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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

Proposal for a directive
Article 6 – paragraph 10

10. ~~Tobacco products other than cigarettes, roll-your-own tobacco and smokeless tobacco products~~Flavours used in tobacco for oral use (snus) shall be exempted from the pro~~hibit~~visions laid down in paragraph~~s 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

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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA

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

2012/0366(COD)

Christel SCHALDEMOSE, Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA

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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA

Proposal for a directive
Article 10

~~[...]~~deleted

2013/05/21
Committee: ENVI

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA

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

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA

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 ~~concerned~~s 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 app~~rov~~ointed 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

2012/0366(COD)

Proposal for a directive
Title 2 – chapter 4 – title

~~Cross-border distance s~~Sales of tobacco products

2013/05/14
Committee: ENVI

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA

Proposal for a directive
Article 16 – title

~~Cross-border distance~~Internet sales of tobacco products

2013/05/14
Committee: ENVI

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA

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

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Kartika Tamara LIOTARD, Carl SCHLYTER, Catherine STIHLER, Antonyia PARVANOVA

Proposal for a directive
Article 18 – paragraph 1 – introductory part

1. ~~The following n~~Nicotine-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

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Kartika Tamara LIOTARD, Carl SCHLYTER, Catherine STIHLER, Antonyia PARVANOVA

Proposal for a directive
Article 18 – paragraph 1 – point a

~~(a) products with a nicotine level exceeding 2 mg per unit, or~~deleted

2013/05/14
Committee: ENVI

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Kartika Tamara LIOTARD, Carl SCHLYTER, Catherine STIHLER, Antonyia PARVANOVA

Proposal for a directive
Article 18 – paragraph 1 – point b

~~(b) products with a nicotine concentration exceeding 4 mg per ml or~~deleted

2013/05/14
Committee: ENVI

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Kartika Tamara LIOTARD, Carl SCHLYTER, Catherine STIHLER, Antonyia PARVANOVA

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

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Kartika Tamara LIOTARD, Carl SCHLYTER, Catherine STIHLER, Antonyia PARVANOVA

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

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

2012/0366(COD)

Andrés PERELLÓ RODRÍGUEZ, Kartika Tamara LIOTARD, Carl SCHLYTER, Catherine STIHLER, Antonyia PARVANOVA

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

2012/0366(COD)

Kartika Tamara LIOTARD, Carl SCHLYTER, Nessa CHILDERS, Catherine STIHLER, Antonyia PARVANOVA, Kathleen VAN BREMPT

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

2012/0192(COD)

Margrete AUKEN, Carl SCHLYTER

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

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

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

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. T~~herefore, the feasibility of the target of 147 g CO2/km to be reached by 2020 is confirmed~~echnical 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

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

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

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

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

2012/0066(COD)

Proposal for a directive
Article 1 – point 1

(c) cordless power tools, until 3~~1 December~~0 June 20154.

2012/12/11
Committee: ENVI

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

2012/0066(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

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

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

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

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

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 ~~improve~~modern 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

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

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

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

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

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 em~~bryonic~~erging 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

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

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

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

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 ~~certain~~their 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

2011/0197(COD)

Satu HASSI, Carl SCHLYTER

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

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 6~~7 10 < PN ≤ 40 7~~2 PN > 410 675

2012/03/27
Committee: ENVI

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

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

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

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

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 conferred~~and 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 and~~legislative act, the power to adopt acts in accordance with Article 290 of the Treaty ofn the CoFunc~~il of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers~~tioning of the European Union should be delegated to the Commission in that respect. The Commission should adopt immediately applicable ~~implementing~~delegated 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

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. T~~herefore, engineered nanomaterials should not be included in the Union list for the categories of food covered by this Regulation, until an evaluation by the Author~~aking 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 out~~intended have not been demonstrated by the Authority.

2012/01/26
Committee: ENVI

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

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

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

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

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

2011/0156(COD)

Carl SCHLYTER, Christel SCHALDEMOSE

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

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

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

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

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

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 Regulation~~delegated 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 Regulation~~delegated acts shall be adopted in accordance with the ~~examination~~ procedure referred to in Article 1~~4(2)~~5. On duly justified grounds of extreme urgency relating to emerging health risks, the Commission shall adopt immediately applicable ~~implementing~~delegated acts updating the Union list in accordance with Article 1~~4(3)~~6.

2012/01/26
Committee: ENVI

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

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 market~~which is not included in the list and which shall require a separate application.

2012/01/26
Committee: ENVI

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

2011/0156(COD)

Proposal for a regulation
Chapter 5 – title

~~CONFIDENTIALIT~~TRANSPARENCY

2012/01/26
Committee: ENVI

2011/0156(COD)

Proposal for a regulation
Article 13 – title

General ~~confidentialit~~transparency clause

2012/01/26
Committee: ENVI

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 of~~transparency regarding the information received by them under this Regulation, e~~xcept 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 environment~~ensure 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 ~~thre~~five working days ,of dispatch of that communication.

2012/01/10
Committee: INTA

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 ~~thre~~five working days of dispatch of that communication.

2012/01/10
Committee: INTA

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

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

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

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

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

2010/2203(INI)

Motion for a resolution
Paragraph 3

3. ~~Welcomes~~Notes that the Commission's Communication ‘Towards a comprehensive European international investment policy’ ~~but stresses that, while~~focuses extensively ~~focusing~~ on investor protection, while it should ~~better~~equally address the need to protect the public capacity to regulate;

2011/02/09
Committee: INTA

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

2010/2203(INI)

Niccolò RINALDI, Carl SCHLYTER, David MARTIN

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

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

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 ~~matters~~types 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

2010/2203(INI)

Motion for a resolution
Paragraph 9

9. ~~Doubts whether~~Rejects 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 a~~nd 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 opposed~~most 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

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

2010/2203(INI)

Niccolò RINALDI, Carl SCHLYTER, David MARTIN

Motion for a resolution
Paragraph 15

15. Expresses its deep concern regarding the ~~decision by some~~level 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

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

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

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

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

2010/2156(INI)

Draft opinion
Paragraph 2

2. Stresses that legislation cannot force creativity and innovation, which are best encouraged by ~~giving maximum freedom~~providing a favourable context for entrepreneurs and creators to pursue their business and exert their talent;

2010/12/10
Committee: INTA

2010/2156(INI)

Draft opinion
Paragraph 4

4. Recalls that theffective protection of intellectual property rights ~~is an issue central to securing~~requires 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 ~~and~~is depending on finding such a balance to maintain incentives for companies, artists and creators to innovate;

2010/12/10
Committee: INTA

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, not~~ing~~es that when such cooperation is voluntary it does not pre~~sult in any extra regulatory burden or unnecessary and unwanted financial cost~~clude international legislative efforts, such as spelled out in the copyright directive 2001/29;

2010/12/10
Committee: INTA

2010/2156(INI)

Draft opinion
Paragraph 6

6. Notes that e-commerce ~~and~~in the ~~internet are developing at such a pace, with ‘gener~~EU 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 behi~~intermediary 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, a~~nd thus largely pointless and damag~~ssess 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

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

2010/2154(INI)

Draft opinion
Paragraph 1

1. ~~Suggests, as the most appropriate solution as~~Considers 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 radiation~~manual 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

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

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

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 if~~even 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

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 all~~This technology should therefore no longer be used, even when exposure is are asduced to the low asest possible ~~for workers and passengers~~level;

2010/12/13
Committee: ENVI

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

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

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

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

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 wo~~sustainable development and ~~men represents a human, societal and economic disaster~~create jobs,

2010/11/09
Committee: ENVI

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 be~~is misleading and at other times simply not provide enough information or sufficiently detailed information;

2010/11/09
Committee: ENVI

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

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 ~~better~~sustainable environment;

2010/11/09
Committee: ENVI

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

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 ~~policy~~set 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

2010/2088(INI)

Motion for a resolution
Paragraph 9

9. Underlines th~~e need to keep costs at a reasonabl~~at 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 assessment~~opment and implementation of such measures and tools receive adequate funding and follow a clear and transparent methodology;

2010/11/09
Committee: ENVI

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

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

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

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

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

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

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

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

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

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 maintaining~~and to address gaps in that Regulation to maintain and further increase the existing levels of protection of that Directive.

2011/06/28
Committee: ENVI

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

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 suitabl~~ensure that an adequate distance between such areas and establishments presenting such hazards is maintained and, where existing establishments are concerned, to ~~take account of~~implement additional technical measures so that the risk to persons is ~~not in~~decreased 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

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

2010/0377(COD)

Proposal for a directive
Recital 23

(23) ~~The Commission should be em~~In 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 Directive~~on 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

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

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

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

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

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 ~~and~~or 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

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

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 operation~~after 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

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

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

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 in~~dustrial chemical process~~stallation 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

2010/0377(COD)

Proposal for a directive
Article 4 – paragraph 2 – subparagraph 2

The Commission shall ~~inform~~consult 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

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

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

2010/0377(COD)

Proposal for a directive
Article 4 – paragraph 5 – subparagraph 2

The Commission shall ~~inform~~consult the forum referred to in Article 17(2) of notifications made pursuant to the first subparagraph of this paragraph.

2011/06/28
Committee: ENVI

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

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

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

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, whe~~ther or not those are covered by this Directive~~re 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

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

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

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

2010/0377(COD)

Proposal for a directive
Article 9 – paragraph 1 – point b

(b) demonstrating that major-accident hazards and ~~possible~~all 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

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

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 account~~implemented in their land- use policies or other relevant policies. They shall pursue those objectives through controls on:

2011/06/28
Committee: ENVI

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

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 term~~deliver the following:

2011/06/28
Committee: ENVI

2010/0377(COD)

Proposal for a directive
Article 13 – paragraph 2 – introductory part

For ~~upper-tier~~all establishments, Member States shall also ensure that as a minimum:

2011/06/28
Committee: ENVI

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

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

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 e~~stablishment~~ntities serving the public, including schools and hospitals, and to all neighbouring establishments ~~in the case of establishment~~or 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

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

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 o~~given early and effective opportunities to participate in the following matters and procedures:

2011/06/30
Committee: ENVI

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

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

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

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 deficient~~clearly 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

2010/0377(COD)

Proposal for a directive
Article 18 – paragraph 1 – subparagraph 2

Member States ~~may~~shall 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

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 t~~hree~~wo 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

2010/0377(COD)

Proposal for a directive
Annex V – Part 1 – point 5 d (new)

~~(Linked to the deletion of the same provision in Poi~~5d. 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 voted~~a major accident. Or. en together))

2011/06/30
Committee: ENVI

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

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

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

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

Proposal for a regulation – amending act
–

The European Parliament rejects the Commission proposal.

2010/05/04
Committee: ENVI

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

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

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

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

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

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

2008/0033(COD)

Carl SCHLYTER, Bart STAES

2008/04/03
Committee: ENVI

2006/0143(COD)

Article 6 – paragraph 1

1. ~~In duly justified cases w~~Where 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

2005/0254(COD)