REPORT on the proposal for a directive of the European Parliament and of the Council on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes
25.6.2015 - (COM(2013)0892 – C7‑0002/2014 – 2013/0433(COD)) - ***I
Committee on the Environment, Public Health and Food Safety
Committee on Agriculture and Rural Development
Rapporteurs: Renate Sommer, Giulia Moi
(Joint committee meetings – Rule 55 of the Rules of Procedure)
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
on the proposal for a directive of the European Parliament and of the Council on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes
(COM(2013)0892 – C7‑0002/2014 – 2013/0433(COD))
(Ordinary legislative procedure: first reading)
The European Parliament,
– having regard to the Commission proposal to Parliament and the Council (COM(2013)0892),
– having regard to Article 294(2) and Article 43(2) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7‑0002/2014),
– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,
– having regard to its legislative resolution of 7 July 2010 on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on novel foods, amending Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001[1],
– having regard to the opinion of the European Economic and Social Committee of 30 April 2014[2],
– having regard to Rule 59 of its Rules of Procedure,
– having regard to the joint deliberations of the Committee on the Environment, Public Health and Food Safety and the Committee on Agriculture and Rural Development under Rule 55 of the Rules of Procedure,
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the Committee on Agriculture and Rural Development and the opinion of the Committee on International Trade (A8-0216/2015),
1. Adopts its position at first reading hereinafter set out;
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;
3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.
Amendment 1 Proposal for a directive Title | ||||||||||||||||||||||||||||||||||
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Amendment 2 Proposal for a directive Recital -1 (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(-1) In the implementation of Union policy and having regard to the Treaty on the Functioning of the European Union, a high level of protection of human health and consumer protection, as well as a high level of animal welfare and environmental protection, should be guaranteed. At all times, the precautionary principle as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council1a should be applied. | |||||||||||||||||||||||||||||||||
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1a Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). | |||||||||||||||||||||||||||||||||
Amendment 3 Proposal for a directive Recital 1 | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
(1) Council Directive 98/58/EC14 lays down general minimum welfare standards for animals bred or kept for farming purposes. It calls on Member States to avoid unnecessary pain, suffering or injury of farm animals. If cloning causes unnecessary pain, suffering or injury, Member States have to act at national level to avoid it. Different national approaches to animal cloning could lead to market distortion. It is thus necessary to ensure that the same conditions apply to all involved in the production and distribution of live animals throughout the Union. |
(1) The cloning of animals is not in line with Council Directive 98/58/EC14, which lays down general minimum welfare standards for animals bred or kept for farming purposes. Directive 98/58/EC calls on Member States to avoid unnecessary pain, suffering or injury of farm animals, and, more specifically, states in point 20 of its Annex that “natural or artificial breeding procedures which cause, or are likely to cause, suffering or injury to any of the animals concerned must not be practised”. Different national approaches to animal cloning or the use of products derived from animal cloning could lead to market distortion. It is thus necessary to ensure that the same conditions apply to all involved in the production and distribution of animals and of products derived from animals throughout the Union. | |||||||||||||||||||||||||||||||||
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14 Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23). |
14 Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23). | |||||||||||||||||||||||||||||||||
Amendment 4 Proposal for a directive Recital 2 | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
(2) The European Food Safety Authority (EFSA) has confirmed that surrogate dams used in cloning suffer in particular from placenta dysfunctions contributing to increased levels of miscarriages15. This contributes, amongst other things, to the low efficiency of the technique, 6 to 15 % for bovine and 6 % for porcine species, and the need to implant embryo clones into several dams to obtain one clone. In addition, clone abnormalities and unusually large offspring result in difficult births and neonatal deaths. |
(2) The European Food Safety Authority (EFSA) concluded, in its 2008 opinion on animal cloning14a, that “the health and welfare of a significant proportion of clones [...] have been found to be adversely affected, often severely and with a fatal outcome”. More specifically, EFSA has confirmed that surrogate dams used in cloning suffer in particular from placenta dysfunctions contributing to increased levels of miscarriages15, with possible adverse effects on their health This contributes, amongst other things, to the low efficiency of the technique, 6 to 15 % for bovine and 6 % for porcine species, and the need to implant embryo clones into several dams to obtain one clone. In addition, clone abnormalities and unusually large offspring result in difficult births and neonatal deaths. High mortality rates at all development stages are characteristic of the cloning technique15a. | |||||||||||||||||||||||||||||||||
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14a http://www.efsa.europa.eu/en/efsajournal/doc/767.pdf | |||||||||||||||||||||||||||||||||
15 Scientific Opinion of the Scientific Committee on Food Safety, Animal Health and Welfare and Environmental Impact of Animals derived from Cloning by Somatic Cell Nucleus Transfer (SCNT) and their Offspring and Products Obtained from those Animals http://www.efsa.europa.eu/en/topics/topic/cloning.htm?wtrl=01 |
15 Scientific Opinion of the Scientific Committee on Food Safety, Animal Health and Welfare and Environmental Impact of Animals derived from Cloning by Somatic Cell Nucleus Transfer (SCNT) and their Offspring and Products Obtained from those Animals http://www.efsa.europa.eu/en/topics/topic/cloning.htm?wtrl=01 | |||||||||||||||||||||||||||||||||
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15a http://www.efsa.europa.eu/en/efsajournal/doc/2794.pdf | |||||||||||||||||||||||||||||||||
Amendment 5 Proposal for a directive Recital 2 a (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(2a) As regards food safety, EFSA has stressed the importance of acknowledging that the data base is limited, and in its 2008 opinion on animal cloning concluded: “Uncertainties in the risk assessment arise due to the limited number of studies available, the small sample sizes investigated and, in general, the absence of a uniform approach that would allow all the issues relevant to this opinion to be more satisfactorily addressed.” For example, EFSA has stated that information is limited on the immunological competence of clones and recommended in that opinion that, if evidence of reduced immunocompetence of clones becomes available, the question should be investigated as to “whether, and if so, to what extent, consumption of meat and milk derived from clones or their offspring may lead to an increased human exposure to transmissible agents”. | |||||||||||||||||||||||||||||||||
Amendment 6 Proposal for a directive Recital 2 b (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(2b) As regards potential impacts on the environment, EFSA has stated that limited data is available and, with regard to potential impacts on genetic diversity, EFSA has drawn attention to the fact that there could be an indirect effect due to overuse of a limited number of animals in breeding programmes, and that increased homogeneity of a genotype within an animal population may increase the susceptibility of that population to infection and other risks. | |||||||||||||||||||||||||||||||||
Amendment 7 Proposal for a directive Recital 2 c (new) | ||||||||||||||||||||||||||||||||||
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Amendment 8 Proposal for a directive Recital 2 d (new) | ||||||||||||||||||||||||||||||||||
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Amendment 9 Proposal for a directive Recital 2 e (new) | ||||||||||||||||||||||||||||||||||
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Amendment 10 Proposal for a directive Recital 2 f (new) | ||||||||||||||||||||||||||||||||||
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Amendment 11 Proposal for a directive Recital 2 g (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(2g) Animal cloning for food production purposes jeopardises the defining characteristics of the European farming model, which is based on product quality, food safety, consumer health, strict animal welfare rules and the use of environmentally sound methods. | |||||||||||||||||||||||||||||||||
Amendment 12 Proposal for a directive Recital 3 | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
(3) Taking into account the objectives of the Union’s agricultural policy, the results of the recent scientific assessments of EFSA and the animal welfare requirement provided in Article 13 of the Treaty, it is prudent to provisionally prohibit the use of cloning in animal production for farm purposes of certain species. |
(3) Taking into account the objectives of the Union’s common agricultural policy, the results of the scientific assessments of EFSA based on the available studies, the animal welfare requirement provided in Article 13 TFEU and the citizens' concerns, it is appropriate to prohibit the use of cloning in animal production for farming purposes and the placing on the market of animals and products derived from the use of the cloning technique. . | |||||||||||||||||||||||||||||||||
Amendment 13 Proposal for a directive Recital 3 a (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(3a) Animal clones are not produced in order to serve for meat or milk production, but rather to use their germinal products for breeding purposes. It is the sexually reproduced descendants of animal clones which become the food-producing animals. Although animal welfare concerns might not be apparent in the case of descendants of cloned animals, as they are born by means of conventional sexual reproduction, in order for there even to be a descendant, a cloned animal progenitor is required, which entails significant animal welfare and ethical concerns. Measures aimed at addressing animal welfare concerns and consumers’ perceptions relating to the cloning technique should therefore include within their scope germinal products of animal clones, descendants of animal clones and products derived from descendants of animal clones. | |||||||||||||||||||||||||||||||||
Amendment 14 Proposal for a directive Recital 4 | ||||||||||||||||||||||||||||||||||
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Amendment 15 Proposal for a directive Recital 4 a (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(4a) With regard to the marketing of agricultural products, in connection with the ban on the use of cloning and in order to address consumer perceptions on cloning linked to, inter alia, animal welfare, the lack of adequate research and general ethical concerns, it is necessary to ensure that food from animal clones and their descendants does not enter the food chain. Less restrictive measures, such as food labelling, would not entirely address citizens’ concerns since the marketing of food produced with a technique that involves animal suffering would still be allowed. | |||||||||||||||||||||||||||||||||
Amendment 16 Proposal for a directive Recital 4 b (new) | ||||||||||||||||||||||||||||||||||
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Amendment 17 Proposal for a directive Recital 4 c (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(4c) Animal clones, embryo clones, descendants of animal clones, germinal products of animal clones and of their descendants, and food and feed from animal clones and their descendants cannot be considered like products to animals, embryos, germinal products, food and feed that do not derive from the use of the cloning technique within the meaning of Article III.4 of the General Agreement on Tariffs and Trade (GATT). Furthermore, the prohibition of the cloning of animals and of the placing on the market and import of animal clones, embryo clones, descendants of animal clones, germinal products of animal clones and of their descendants, and food and feed from animal clones and their descendants is a measure that is necessary to protect public morals and to protect animal health within the meaning of Article XX of the GATT. | |||||||||||||||||||||||||||||||||
Amendment 18 Proposal for a directive Recital 4 d (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(4d) Steps should be taken to ensure that trade agreements which are currently being negotiated do not encourage the authorisation of practices which may have an adverse effect on the health of consumers and farmers, on the environment or on animal welfare. | |||||||||||||||||||||||||||||||||
Amendment 19 Proposal for a directive Recital 4 e (new) | ||||||||||||||||||||||||||||||||||
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Amendment 20 Proposal for a directive Recital 4 f (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(4f) In its 2010 report to the European Parliament and the Council, the Commission stated that measures to establish the traceability of imports of semen and embryos in order to set up data banks of offspring in the Union were appropriate. The Commission should therefore act accordingly. | |||||||||||||||||||||||||||||||||
Amendment 21 Proposal for a directive Recital 4 g (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(4g) Consistent with the implementation of the ban on cloning which is laid down in this Regulation, targeted trade promotion measures adopted by the Commission should be applied in order to support high-quality meat production and animal husbandry in the Union. | |||||||||||||||||||||||||||||||||
Amendment 22 Proposal for a directive Recital 5 | ||||||||||||||||||||||||||||||||||
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Amendment 23 Proposal for a directive Recital 5 a (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(5a) According to the latest Eurobarometer survey, the majority of Europeans do not consider animal cloning in food production to be safe for their health or for that their family. Furthermore, when it comes to animal cloning, there are more countries in Europe expressing a clear preference for decisions to be taken primarily from the standpoint of moral and ethical issues, rather than on the basis of scientific evidence. Therefore, before this legislation is reviewed, the Commission should carry out an official EU-Survey to reassess consumers' perceptions. | |||||||||||||||||||||||||||||||||
Amendment 24 Proposal for a directive Recital 5 b (new) | ||||||||||||||||||||||||||||||||||
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Amendment 25 Proposal for a directive Recital 6 | ||||||||||||||||||||||||||||||||||
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Amendment 26 Proposal for a directive Recital 6 a (new) | ||||||||||||||||||||||||||||||||||
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Amendment 27 Proposal for a directive Article 1 – paragraph 1 – point b | ||||||||||||||||||||||||||||||||||
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Amendment 28 Proposal for a directive Article 1 – paragraph 2 | ||||||||||||||||||||||||||||||||||
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Amendment 29 Proposal for a directive Article 1 a (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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Article 1a | |||||||||||||||||||||||||||||||||
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Objective | |||||||||||||||||||||||||||||||||
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The objective of this Regulation is to address concerns relating to animal health and welfare and to consumers' perceptions and ethical considerations with regard to the cloning technique. | |||||||||||||||||||||||||||||||||
Amendment 30 Proposal for a directive Article 2 – paragraph 1 – point a | ||||||||||||||||||||||||||||||||||
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Amendment 31 Proposal for a directive Article 2 – paragraph 1 – point b | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
(b) “cloning” means asexual reproduction of animals with a technique whereby the nucleus of a cell of an individual animal is transferred into an oocyte from which the nucleus has been removed to create genetically identical individual embryos (“embryo clones”), that can subsequently be implanted into surrogate mothers in order to produce populations of genetically identical animals (“animal clone”); |
(b) “cloning” means asexual reproduction of animals to create, by inter alia using a technique whereby the nucleus of a cell of an individual animal is transferred into an oocyte from which the nucleus has been removed, genetically identical individual embryos (“embryo clones”), that can subsequently be implanted into surrogate mothers in order to produce populations of genetically identical animals (“animal clones”); | |||||||||||||||||||||||||||||||||
Amendment 32 Proposal for a directive Article 2 – paragraph 1 – point b a (new) | ||||||||||||||||||||||||||||||||||
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Amendment 33 Proposal for a directive Article 2 – paragraph 1 – point b b (new) | ||||||||||||||||||||||||||||||||||
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Amendment 34 Proposal for a directive Article 2 – paragraph 1 – point b c (new) | ||||||||||||||||||||||||||||||||||
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Amendment 35 Proposal for a directive Article 2 – paragraph 1 – point c a (new) | ||||||||||||||||||||||||||||||||||
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Amendment 36 Proposal for a directive Article 3 – title | ||||||||||||||||||||||||||||||||||
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Amendment 37 Proposal for a directive Article 3 – paragraph 1 – introductory part | ||||||||||||||||||||||||||||||||||
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Amendment 38 Proposal for a directive Article 3 – paragraph 1 – point b | ||||||||||||||||||||||||||||||||||
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Amendment 39 Proposal for a directive Article 3 a (new) | ||||||||||||||||||||||||||||||||||
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Amendment 40 Proposal for a directive Article 3 b (new) | ||||||||||||||||||||||||||||||||||
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Amendment 41 Proposal for a directive Article 4 – paragraph 1 | ||||||||||||||||||||||||||||||||||
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Amendment 42 Proposal for a directive Article 4 a (new) | ||||||||||||||||||||||||||||||||||
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Amendment 43 Proposal for a directive Article 5 – paragraph 1 | ||||||||||||||||||||||||||||||||||
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Amendment 44 Proposal for a directive Article 5 – paragraph 2 – point b | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
(b) scientific and technical progress, in particular relating to the animal welfare aspects of cloning; |
(b) all available scientific and technical evidence of progress, in particular relating to the animal welfare aspects of cloning and food safety issues, and the progress made in establishing reliable traceability systems for clones and the descendants of clones. | |||||||||||||||||||||||||||||||||
Amendment 45 Proposal for a directive Article 5 – paragraph 2 – point b a (new) | ||||||||||||||||||||||||||||||||||
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Amendment 46 Proposal for a directive Article 5 – paragraph 2 – point c a (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(ca) consumers' concerns in relation to public health and animal welfare; | |||||||||||||||||||||||||||||||||
Amendment 47 Proposal for a directive Article 5 – paragraph 2 – point c b (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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(cb) ethical issues relating to animal cloning. | |||||||||||||||||||||||||||||||||
Amendment 48 Proposal for a directive Article 5 – paragraph 2 a (new) | ||||||||||||||||||||||||||||||||||
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Amendment 49 Proposal for a directive Article 5 – paragraph 2 b (new) | ||||||||||||||||||||||||||||||||||
Text proposed by the Commission |
Amendment | |||||||||||||||||||||||||||||||||
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2b. By means of an official EU-Survey, the Commission shall launch a public consultation aimed at assessing any new trends regarding consumers' perceptions of food products from cloned animals. | |||||||||||||||||||||||||||||||||
Amendment 50 Proposal for a directive Article 6 | ||||||||||||||||||||||||||||||||||
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Amendment 51 Proposal for a directive Article 7 – title | ||||||||||||||||||||||||||||||||||
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Amendment 52 Proposal for a directive Article 7 – paragraph 1 a (new) | ||||||||||||||||||||||||||||||||||
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Amendment 53 Proposal for a directive Article 8 | ||||||||||||||||||||||||||||||||||
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Amendment 54 Proposal for a directive Ending part (new) | ||||||||||||||||||||||||||||||||||
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- [1] Texts adopted of that date, P7_TA(2010)0266.
- [2] OJ C311, 12.9.2014, p.73.
EXPLANATORY STATEMENT
Background
Cloning is a form of asexual reproduction performed in a laboratory where animals are generated by using the genetic material from a cell from another animal. The animal clone shares the same DNA as its genetic donor. In practice, the main technique used for cloning is “somatic cell nuclear transfer”, where the nucleus of a normal body cell is transferred into an egg (oocyte) from another animal from which the nucleus has been removed; the manipulated oocyte is implanted into a surrogate mother who will - if everything goes well - give birth to the clone.
At present, cloning is not used for farming purposes in the European Union. However, it is used in certain third countries, such as the USA, Canada, Argentina, Brazil and Australia. Cloning may for instance be used to multiply top-performing breeding animals. It may reduce the number of animals required for breeding programmes, as it allows the production of higher quantities of reproductive material with the genes of the elite animals. The high-value reproductive material from clones would then be used to breed animals through conventional reproduction techniques.
Scientific studies have demonstrated with overwhelming evidence that animal cloning is a hazard for animal welfare. The somatic cell nuclear transfer technique leads to placental and foetal abnormalities that result in poor welfare – and often substantial pain – to surrogate dams used for cloning and to their offspring. This naturally also leads to ethical issues related to the justification of the cloning technique.
Cloning is also an issue which is highly sensitive for European citizens: for instance, a Eurobarometer survey of 2010 showed that the European public sees animal cloning as not offering benefits, as unsafe, inequitable and worrying, with only 18% of respondents supporting the technique at all. The European Parliament has had a firm negative stance as regards the cloning of animals for farming purposes. Following up on Parliament’s resolution of 3 September 2008 on the cloning of animals for food supply, the first proposal adopted by Parliament to address the issue of cloning was put forward in the context of the 2008 proposal for a regulation on Novel Foods, and cloning is precisely the issue owing to which the dossier ultimately ended in a deadlock in Conciliation in March 2011. Since then, in several of its adopted positions, the Parliament has consistently strived to introduce into the Union’s legislation specific provisions on cloning to address the citizens’ concerns.
On 18 December 2013, the European Commission published two legislative proposals on the cloning of animals for food supply: the proposal under consideration, and an accompanying proposal for a Council Directive on the placing on the market of food from animal clones (2013/0434(APP)). The proposals suspend the use of the cloning technique in the EU for farm animals, the placing on the market of live animal clones and embryo clones, and the marketing of food, such as meat and milk, from animal clones.
The Rapporteurs’ position
The Rapporteurs are of the opinion that the negative effects of cloning, inter alia on animal welfare, greatly outweigh any possible positive effects. They therefore welcome the prohibition of the cloning technique put forward by the Commission, but believe that the proposal falls short of properly addressing the valid concerns that have been repeatedly expressed by the citizens and by the European Parliament. In particular, the Commission did not include any specific provisions on food from the descendants of cloned animals, nor any measures as regards the reproductive material from clones and their descendants. The Rapporteurs propose therefore a number of amendments to the Commission proposal, in order to strengthen it and increase its effectiveness, along the following lines.
Descendants and germinal products: cloning of animals for farming purposes is not currently taking place in the EU, and in any case the use of the cloning technique is so expensive, and its success rate so low, that its use for food production is not profitable. Hence, the prohibitions proposed by the Commission as regards the placing on the market of live animal clones and the marketing of food from animal clones just enforce the status quo and do not address the main concerns related to cloning, namely the production of germinal products (semen, oocytes and embryos) from clones to be used to breed animals (the descendants of clones) through conventional reproduction techniques.
The cloning technique is and will remain allowed in certain third countries. It would be incoherent to ban the cloning technique in the EU, on the basis of very significant scientific and ethical grounds, while still allowing imports of the main products for which that technique is mainly used, namely germinal products from clones and food from descendants of clones. In order to ensure the coherence of the legislation it is therefore necessary to also prohibit the import and the placing on the market of the descendants of animal clones, and of the germinal products and of the food coming from animal clones and their descendants. That prohibition would also address the worries of consumers as regards the possible long-term effects of the consumption of food (such as meat and milk) from the descendants of animal clones, on which scientific data is still sparse.
To enforce that prohibition, the Commission will have to adopt specific import conditions under the “Official controls” Regulation (EC) No 882/2004, before the proposed legislation starts to apply. Moreover, the Rapporteurs consider that mandatory traceability is a basic and feasible requirement in this context, as the application of the prohibition would be jeopardised if it is impossible to trace animal clones, their descendants and the corresponding products. The Commission, in its 2010 report on animal cloning for food production, had already promised to establish specific traceability requirements within the zootechnical legislation. While the traceability system would have no direct effect inside the Union, where the use of the cloning technique will be prohibited, live animals, germinal products and food imported into the Union from third countries should be subject to at least equivalent identification conditions and traceability requirements as those applicable in the Union. The Commission will have to adopt, by means of delegated acts prior to the date of application of the legislation, rules for the inclusion of traceability requirements into the certificates provided for in animal health and zootechnical legislation.
The Rapporteurs consider that the legal basis of the proposal, Article 43 of the Treaty on the Functioning of the European Union, is appropriate for the introduction of the above-described amendments. In fact, according to case-law of the Court of Justice, Article 43 is the appropriate legal basis for any legislation concerning the production and marketing of agricultural products which contributes to the achievement of one or more of the objectives of the common agricultural policy, and can also be used for the adoption of legislation addressing other objectives besides those of the common agricultural policy. Furthermore, measures taken in the context of the common agricultural policy may also affect the import of the products concerned.
Scope of the legislation: although not as substantial as the evidence concerning mammals, there is scientific evidence for poor welfare in dams and offspring due to cloning procedures in farmed fish and related germ cell transplantation procedures in poultry. It is therefore appropriate that the proposed measures apply to all farmed animals, and not only to animals of the bovine, porcine, ovine, caprine and equine species as proposed by the Commission.
Temporary or permanent prohibition: the proposal qualifies the prohibitions on the use of cloning as “provisional”, referring to a “suspension” of the use of the technique. However, such a qualification is not justified by any substantive element in the proposed act, and is therefore misleading and should be deleted. Moreover, it has to be kept in mind that the reported frequency of harms to cloned mothers and offspring has shown no substantial improvement for the past decade and that a more efficient methodology for cloning is neither currently available nor seems likely to be developed in the near future. However, the Rapporteurs fully agree with keeping a reporting and review clause, as proposed by the Commission, taking into account all relevant aspects, such as the scientific and technical progress in this area.
Choice of legal instrument: finally, while the Commission considers that a Directive is the most appropriate instrument for this legislation as it would allow Member States to employ existing control tools for the implementation, the core of the proposal is a simple prohibition on the use of cloning and the placing of the market of the corresponding products, and such a prohibition would better be enforced by a Regulation. Using a Regulation as the legal instrument would enhance legal certainty and ensure the rationality and consistency of the enforcement, while respecting the subsidiarity and proportionality principles.
In summary, the Rapporteurs believe that the Commission proposal should be strengthened by adopting a more comprehensive approach to all aspects related to the cloning of animals for farming purposes. The amendments proposed in this draft report aim at putting into place an effective and coherent Regulation that addresses the legitimate concerns of the farming sector and of the European citizens at large.
OPINION of the Committee on International Trade (28.5.2015)
for the Committee on the Environment, Public Health and Food Safety and the Committee on Agriculture and Rural Development
on the proposal for a directive of the European Parliament and of the Council on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes
(COM(2013)0892 – C7‑0002/2014 – 2013/0433(COD))
Rapporteur: Jude Kirton-Darling
SHORT JUSTIFICATION
Background
Animal cloning ("genetic copying") for farming purposes raises animal health and welfare, consumer choice and ethical issues and poses a long-term regulatory challenge. At present cloning is mostly used to produce breeding animals and the food potentially marketed in the EU would be derived from offspring of clones.
Currently in the EU the marketing of food from clones requires a pre-market approval based on a scientific food safety assessment by the European Food Safety Authority (EFSA), as governed under the "Novel Food Regulation" (EC) No 258/1997. Its current review excludes regulation of cloning from its scope and is dealt with in two separate Commission proposals of 18 December 2013. Until this legislation on food derived from cloned animals and their descendants enters into force, cloning remains under the existing "Novel Food Regulation" (EC) No 258/1997. So far, no business operator has applied for an authorisation to market food produced using the cloning technique in the EU.
Although animals are not cloned for food production in the EU, commercial agricultural cloning takes place in several countries, including Argentina, Australia, Brazil, Canada, and the US and may also be undertaken in Chile, China, New Zealand and Uruguay, where cloning companies operate.
As meat and milk from clone descendants and clones themselves start entering the food supply chain, it is imperative to ensure forward-looking regulation and a level-playing field in this domain. It is important to note that none of the third countries have established viable traceability and labelling systems or systems of identification and registration for imports of the offspring of clones or food derived from them.
Conclusions and recommendations of the European Food Safety Authority contained in its 2008 opinion and reconfirmed in its statements in 2009 and 2010 recognised animal health and welfare concerns due to mortality rates associated with the cloning technology. The proposed package on animal cloning takes into account animal welfare and ethical concerns, aiming to bring more legal certainty in the field by around 2016.
WTO compatibility
Your rapporteur deems it essential to ensure regulatory consistency with the WTO framework – the General Agreement on Tariffs and Trade (GATT), the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and the Agreement on Technical Barriers to Trade (TBT)) – and a level-playing field within the rules-based system.
Cloning technique currently does not stand up to the animal welfare standards, and concerns of EU citizens regarding cloning and animal welfare must be taken into account. There are no international SPS standards on cloning and no science-based evidence proving risks on food safety. As there are no direct food safety concerns related to the cloning technology, but rather animal health and welfare ones, current proposals must pass the test of the GATT and TBT Agreements.
Articles I and III of the GATT prohibit measures resulting in discrimination between the “like products”. If food derived from the clones and their offspring would be "likened" to conventional food, the consistency of the proposed measures with the WTO rules would be justifiable under Article XX GATT exceptions.
The proposals were notified by the EU under the Technical Barriers to Trade Agreement only as a precautionary measure, as prohibitions on placing on the market would not constitute "a technical regulation", in contrast to introduction of any labelling requirements.
As demonstrated by the Seals products dispute (DS400 and DS401), Article XX of GATT covers animal welfare protection and is justified for moral concerns, if it does not constitute “arbitrary and unjustifiable discrimination”.
Your rapporteur is convinced that provisional prohibition of marketing of animal clones, embryo clones and food for human consumption derived from animal clones and their offspring is a proportionate measure addressing justified concerns. Alternative measures such as prior authorisation and labelling would not entirely resolve ethical and animal welfare concerns in this case.
AMENDMENTS
The Committee on International Trade calls on the Committee on the Environment, Public Health and Food Safety and the Committee on Agriculture and Rural Development, as the committees responsible, to take into account the following amendments:
Amendment 1 Proposal for a directive Title | |
Text proposed by the Commission |
Amendment |
Proposal for a |
Proposal for a |
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL |
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL |
on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes |
on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes |
|
(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) |
Justification | |
Using a Regulation as the legal instrument enhances legal certainty and ensures consistency of enforcement, while respecting the subsidiarity and proportionality principles. | |
Amendment 2 Proposal for a directive Recital 3 | |
Text proposed by the Commission |
Amendment |
(3) Taking into account the objectives of the Union's agricultural policy, the results of the recent scientific assessments of EFSA and the animal welfare requirement provided in Article 13 of the Treaty, it is prudent to provisionally prohibit the use of cloning in animal production for farm purposes of certain species. |
(3) Taking into account the objectives of the Union's agricultural policy, the results of the recent scientific assessments of EFSA and the animal welfare requirement provided in Article 13 of the Treaty, it is prudent to prohibit the use of cloning in animal production for farm purposes of certain species. |
Amendment 3 Proposal for a directive Recital 3 a (new) | |
Text proposed by the Commission |
Amendment |
|
(3a) Traceability systems established for food from animal clones and germinal products could support the enforcement of the measures contained in this Regulation, in particular by providing competent authorities and economic operators with useful information. The Commission should therefore endeavour to obtain commitments in this regard from trading partners of the Union in which cloning of animals is carried out for farming purposes, within the framework of ongoing and future trade negotiations, at both bilateral and multilateral levels; |
Amendment 4 Proposal for a directive Recital 5 | |
Text proposed by the Commission |
Amendment |
(5) It is expected that the knowledge on the impact of the cloning technique on the welfare of the animals used will increase. The cloning technique is likely to improve over time. Consequently prohibitions should only apply provisionally. This Directive should therefore be reviewed within a reasonable time taking into account the experience gained by the Member States in its implementation, scientific and technical progress and international developments. |
(5) It is expected that knowledge of the impact of the cloning technique on the welfare of the animals used will increase. The cloning technique is likely to improve over time. Consequently, prohibitions could be reviewed and/or updated in the event of evident improvements in the said cloning technique. This Regulation should therefore be reviewed within a reasonable time, taking into account the experience gained by the Member States in its application, scientific and technical progress, changes in consumer perceptions, and international developments, in particular trade flows and the Union's trade relations. |
Amendment 5 Proposal for a directive Recital 5 a (new) | |
Text proposed by the Commission |
Amendment |
|
(5a) (5a) Embryo clones, animal clones, food from animal clones, germinal products of animal clones and food derived therefrom cannot be considered like products, within the meaning of Article III.4 of the GATT, to embryos, animals, food from animals, germinal products and food derived therefrom respectively. |
Amendment 6 Proposal for a directive Recital 5 b (new) | |
Text proposed by the Commission |
Amendment |
|
(5b) The prohibition of the cloning of animals, of the placing on the market of animal clones and embryo clones, and of the placing on the market of food from animal clones germinal products and food derived therefrom is a measure that is necessary in order to protect public morals and animal health, within the meaning of Article XX of the GATT. |
Amendment 7 Proposal for a directive Article 1 – paragraph 1 – point b | |
Text proposed by the Commission |
Amendment |
(b) the placing on the market of embryo clones and animal clones. |
(b) the placing on the market of embryo clones, animal clones and germinal products of animal clones. |
Amendment 8 Proposal for a directive Article 3 – title | |
Text proposed by the Commission |
Amendment |
Provisional prohibition |
Prohibition |
Amendment 9 Proposal for a directive Article 3 – introductory part | |
Text proposed by the Commission |
Amendment |
Member States shall provisionally prohibit: |
1. The following shall be prohibited: |
Amendment 10 Proposal for a directive Article 3 – point b a (new) | |
Text proposed by the Commission |
Amendment |
|
(ba) food derived from animal clones. |
Amendment 11 Proposal for a directive Article 3 – paragraph 1 a (new) | |
Text proposed by the Commission |
Amendment |
|
1a. In the case of food of animal origin imported from third countries where food from clones and germinal products and food derived therefrom can be legally placed on the market or exported, Member States shall ensure that such food is only placed on the market of the Union in accordance with any specific import conditions adopted under Articles 48 and 49 of Regulation (EC) No 882/2004 of the European Parliament and of the Council*. Member States shall further ensure that no food from animal clones or germinal products and food derived therefrom is exported to the Union from those third countries. |
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___________________________ |
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* Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1). |
Amendment 12 Proposal for a directive Article 3 – paragraph 1 b (new) | |
Text proposed by the Commission |
Amendment |
|
1b. Likewise, Member States shall ensure that neither animal clones or embryo clones, nor germinal products of animal clones are imported into the Union and that food imported from third countries where animal cloning is allowed for farming purposes complies with relevant requirements of Union food law or with conditions recognised by the Union to be a at least equivalent to those requirements. |
Amendment 13 Proposal for a directive Article 5 – paragraph 2 – point b | |
Text proposed by the Commission |
Amendment |
(b) scientific and technical progress, in particular relating to the animal welfare aspects of cloning; |
(b) scientific and technical progress, in particular relating to the animal welfare aspects of cloning and consumer perceptions; |
Amendment 14 Proposal for a directive Article 5 – paragraph 2 – point c | |
Text proposed by the Commission |
Amendment |
(c) international developments. |
(c) international developments, and in particular the impact of this Regulation on trade flows and on the Union's trade relations. |
Amendment 15 Proposal for a directive Article 6 | |
Text proposed by the Commission |
Amendment |
Article 6 |
deleted |
Transposition |
|
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [date = 12 month after the date of transposition of this Directive]. They shall forthwith communicate to the Commission the text of those provisions. |
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When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. |
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2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. |
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Amendment 16 Proposal for a directive Article 8 | |
Text proposed by the Commission |
Amendment |
Article 8 |
deleted |
Addressees |
|
This Directive is addressed to the Member States. |
|
Amendment 17 Proposal for a directive Article 8 a (new) | |
Text proposed by the Commission |
Amendment |
|
Article 8a |
|
This Regulation shall be binding in its entirety and directly applicable in all Member States. |
PROCEDURE
Title |
Cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes |
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References |
COM(2013)0892 – C7-0002/2014 – 2013/0433(COD) |
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Committees responsible Date announced in plenary |
ENVI 16.1.2014 |
AGRI 16.1.2014 |
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|
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Opinion by Date announced in plenary |
INTA 16.1.2014 |
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Rapporteur Date appointed |
Jude Kirton-Darling 3.9.2014 |
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Rule 55 – joint committee meetings Date announced in plenary |
17.12.2014 |
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Discussed in committee |
14.4.2015 |
6.5.2015 |
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|
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Date adopted |
28.5.2015 |
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|
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Result of final vote |
+: –: 0: |
34 6 1 |
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Members present for the final vote |
William (The Earl of) Dartmouth, Maria Arena, Tiziana Beghin, David Borrelli, Daniel Caspary, Marielle de Sarnez, Santiago Fisas Ayxelà, Christofer Fjellner, Eleonora Forenza, Yannick Jadot, Ska Keller, Jude Kirton-Darling, Bernd Lange, Jörg Leichtfried, David Martin, Emmanuel Maurel, Emma McClarkin, Anne-Marie Mineur, Alessia Maria Mosca, Franz Obermayr, Artis Pabriks, Franck Proust, Godelieve Quisthoudt-Rowohl, Inmaculada Rodríguez-Piñero Fernández, Tokia Saïfi, Matteo Salvini, Marietje Schaake, Helmut Scholz, Joachim Schuster, Joachim Starbatty, Adam Szejnfeld, Iuliu Winkler, Jan Zahradil |
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Substitutes present for the final vote |
Goffredo Maria Bettini, Dita Charanzová, Georgios Epitideios, Seán Kelly, Sander Loones, Frédérique Ries, Adina-Ioana Vălean, Jarosław Wałęsa |
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PROCEDURE
Title |
Cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes |
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References |
COM(2013)0892 – C7-0002/2014 – 2013/0433(COD) |
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Date submitted to Parliament |
18.12.2013 |
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|
|
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Committees responsible Date announced in plenary |
ENVI 16.1.2014 |
AGRI 16.1.2014 |
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|
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Committees asked for opinions Date announced in plenary |
INTA 16.1.2014 |
ITRE 16.1.2014 |
IMCO 16.1.2014 |
|
|
Not delivering opinions Date of decision |
ITRE 22.1.2014 |
IMCO 24.9.2014 |
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|
|
Rapporteurs Date appointed |
Renate Sommer 14.7.2014 |
Giulia Moi 14.7.2014 |
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|
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Rule 55 – joint committee meetings Date announced in plenary |
17.12.2014 |
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Discussed in committee |
16.4.2015 |
26.5.2015 |
|
|
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Date adopted |
17.6.2015 |
|
|
|
|
Result of final vote |
+: –: 0: |
82 8 8 |
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Members present for the final vote |
Marco Affronte, John Stuart Agnew, Clara Eugenia Aguilera García, Eric Andrieu, Pilar Ayuso, Zoltán Balczó, Ivo Belet, Lynn Boylan, Paul Brannen, Daniel Buda, Nicola Caputo, Nessa Childers, Alberto Cirio, Birgit Collin-Langen, Mireille D’Ornano, Miriam Dalli, Seb Dance, Viorica Dăncilă, Angélique Delahaye, Albert Deß, Diane Dodds, Jørn Dohrmann, Herbert Dorfmann, Ian Duncan, Stefan Eck, Bas Eickhout, Norbert Erdős, Eleonora Evi, José Inácio Faria, Edouard Ferrand, Luke Ming Flanagan, Karl-Heinz Florenz, Iratxe García Pérez, Elisabetta Gardini, Gerben-Jan Gerbrandy, Jens Gieseke, Julie Girling, Sylvie Goddyn, Beata Gosiewska, Matthias Groote, Françoise Grossetête, Andrzej Grzyb, Martin Häusling, Jan Huitema, Anneli Jäätteenmäki, Peter Jahr, Jean-François Jalkh, Benedek Jávor, Karin Kadenbach, Jarosław Kalinowski, Elisabeth Köstinger, Zbigniew Kuźmiuk, Giovanni La Via, Peter Liese, Norbert Lins, Philippe Loiseau, Mairead McGuinness, Susanne Melior, Miroslav Mikolášik, Giulia Moi, James Nicholson, Maria Noichl, Gilles Pargneaux, Marit Paulsen, Piernicola Pedicini, Marijana Petir, Pavel Poc, Marcus Pretzell, Laurenţiu Rebega, Frédérique Ries, Annie Schreijer-Pierik, Jordi Sebastià, Czesław Adam Siekierski, Davor Škrlec, Renate Sommer, Dubravka Šuica, Tibor Szanyi, Marc Tarabella, Glenis Willmott, Jadwiga Wiśniewska, Janusz Wojciechowski, Damiano Zoffoli, Marco Zullo |
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Substitutes present for the final vote |
Nikos Androulakis, Guillaume Balas, Renata Briano, Caterina Chinnici, Mark Demesmaeker, Peter Eriksson, Lampros Fountoulis, Emmanouil Glezos, Maria Heubuch, Andrey Kovatchev, Momchil Nekov, Sirpa Pietikäinen, Stanislav Polčák, Gabriele Preuß, Christel Schaldemose, Bart Staes, Hannu Takkula, Keith Taylor, Claude Turmes, Vladimir Urutchev, Tom Vandenkendelaere |
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Substitutes under Rule 200(2) present for the final vote |
Ángela Vallina |
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Date tabled |
25.6.2015 |
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