BETA


2013/0433(COD) Cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes
Next event: Proposal withdrawn by Commission 2020/09/29 more...

Progress: Procedure lapsed or withdrawn

RoleCommitteeRapporteurShadows
Joint Responsible Committee ['ENVI', 'AGRI']
Former Responsible Committee AGRI
Committee Opinion IMCO
Committee Opinion INTA
Committee Opinion ITRE
Former Committee Opinion IMCO
Former Committee Opinion INTA Santiago FISAS AYXELÀ (icon: PPE PPE), Eleonora FORENZA (icon: GUE/NGL GUE/NGL), Emma McCLARKIN (icon: ECR ECR)
Former Committee Opinion ITRE
Former Committee Opinion ENVI
Committee Legal Basis Opinion JURI
Lead committee dossier:
Legal Basis:
RoP 58, TFEU 043-p2

Events

2020/09/29
   EC - Proposal withdrawn by Commission
2015/10/22
   EC - Commission response to text adopted in plenary
Documents
2015/09/08
   EP - Results of vote in Parliament
2015/09/08
   EP - Debate in Parliament
2015/09/08
   EP - Decision by Parliament, 1st reading
Details

The European Parliament adopted by 529 votes to 120, with 157 abstentions, a 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.

Parliament’s position adopted at first reading following the ordinary legislative procedure amended the Commission proposal as follows:

Choice of legal instrument : Parliament voted to use a Regulation as the appropriate legal instrument (as opposed to a Directive as proposed by the Commission).

Objective and scope : Parliament recalled that 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.

In this regard, 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.

Members recalled that the majority of Union citizens disapprove of cloning for farming purposes due to, inter alia, animal welfare and general ethical concerns.

Provisional or permanent prohibitions : although the proposal qualifies the prohibitions on the use of cloning as “provisional”, Parliament favoured a pure and simple prohibition .

Thus, the Regulation shall prohibit the placing on the market of:

animal clones, embryo clones,

and the import of :

animal clones, embryo clones descendants of animal clones, germinal products of animal clones and of their descendants (meaning semen, oocytes and embryos collected or produced from animals for the purpose of reproduction), food and feed from animal clones and their descendants.

The Regulation shall apply to all species of animals kept and reproduced for farming purposes and not only animals of the bovine, porcine, ovine, caprine and equine species as was proposed by the Commission.

Import conditions : Members stated that animals shall not be imported from third countries unless the accompanying import certificates show that they are not animal clones or descendants of animal clones.

In order to ensure that import certificates accompanying animals and germinal products and food and feed of animal origin indicate whether they are, or are derived from, animal clones or descendants of animal clones, the Commission shall adopt specific import conditions under Regulation (EC) No 882/2004 of the European Parliament and of the Council by 6 months from the entry into force of this Regulation and shall, if necessary, present a proposal to amend other legislation in the field of animal health or zootechnical and genealogical conditions for imports.

Traceability : Parliament noted that traceability systems shall be established for animal clones; descendants of animal clones; germinal products of animal clones and of their descendants. The Commission shall be empowered to adopt delegated acts to establish detailed rules for such systems. The power to adopt delegated acts shall be conferred on the Commission for a period of five years (tacitly extended for periods of an identical duration) from the entry into force of the Regulation.

Penalties : the penalties provided for shall be effective, proportionate, dissuasive and shall ensure a level playing field .

Reports and reviews : by 6 years from the entry into force of this Regulation, the Member States shall report to the Commission on the experience gained by them on the application of this Regulation, scientific and technical progress, the evolution of consumer perceptions, and international developments, in particular trade flows and the Union's trade relations as well as ethical issues relating to animal cloning.

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.

The Regulation shall apply from 1 year from the entry into force of this Regulation.

Documents
2015/06/25
   EP - Committee report tabled for plenary, 1st reading
Details

The Committee on the Environment, Public Health and Food Safety and the Committee on Agriculture and Rural Development jointly adopted the report by Renate SOMMER (EPP, DE) 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.

The committee recommended that the European Parliament’s position adopted at first reading following the ordinary legislative procedure should amend the commission proposal as follows:

Choice of legal instrument : while the Commission considers that a Directive is the most appropriate instrument for this legislation, Members proposed using a Regulation as the legal instrument as this would enhance legal certainty and ensure the rationality and consistency of the enforcement, while respecting the subsidiarity and proportionality principles.

Purpose and scope : Members considered that the Regulation should establish rules concerning 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 (meaning semen, oocytes and embryos collected or produced from animals for the purpose of reproduction), food and feed from animal clones and their descendants.

It shall apply to all species of animals kept and reproduced for farming purposes and not only animals of the bovine, porcine, ovine, caprine and equine species as was proposed by the Commission.

Moreover, 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. It has been clearly and consistently shown by consumer research, the majority of Union citizens disapprove of cloning for farming purposes due to, inter alia, animal welfare and general ethical concerns.

Provisional or permanent prohibitions : although the proposal qualifies the prohibitions on the use of cloning as “provisional”, referring to a “suspension” of the use of the technique, Members suggested a pure and simple prohibition .

Import conditions : Members stated that animals shall not be imported from third countries unless the accompanying import certificates show that they are not animal clones or descendants of animal clones.

In order to ensure that import certificates accompanying animals and germinal products and food and feed of animal origin indicate whether they are, or are derived from, animal clones or descendants of animal clones, the Commission shall adopt specific import conditions under Regulation (EC) No 882/2004 of the European Parliament and of the Council by 6 months from the entry into force of this Regulation and shall, if necessary, present a proposal to amend other legislation in the field of animal health or zootechnical and genealogical conditions for imports.

Traceability : the report noted that traceability systems shall be established for animal clones; descendants of animal clones; germinal products of animal clones and of their descendants. The Commission shall be empowered to adopt delegated acts to establish detailed rules for such systems.

Reports and reviews : this Regulation shall be reviewed within a reasonable time, taking into account the experience gained by the Member States in its application, scientific and technical progress, the evolution of consumer perceptions, and international developments, in particular trade flows and the Union's trade relations.

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.

Documents
2015/06/17
   EP - Vote in committee, 1st reading
2015/05/28
   EP - Committee opinion
Documents
2015/04/28
   EP - Amendments tabled in committee
Documents
2015/03/23
   EP - Committee draft report
Documents
2014/12/17
   EP - Referral to joint committee announced in Parliament
2014/10/20
   EP - Committee referral announced in Parliament, 1st reading
2014/02/26
   ES_PARLIAMENT - Contribution
Documents
2014/02/23
   IT_SENATE - Contribution
Documents
2014/02/19
   AT_BUNDESRAT - Contribution
Documents
2014/02/10
   PT_PARLIAMENT - Contribution
Documents
2014/01/16
   EP - Committee referral announced in Parliament, 1st reading
2013/12/18
   EC - Document attached to the procedure
2013/12/18
   EC - Document attached to the procedure
2013/12/18
   EC - Legislative proposal published
Details

PURPOSE: to suspend the use of the technique and the marketing of animal clones for farming purposes ensures that all Union farmers and breeders are subject to the same conditions while adequately protecting animal welfare.

PROPOSED ACT: Directive of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: Directive 98/58/EC on the protection of animals kept for farming purposes sets very general minimum animal welfare standards for animals used in agriculture. It does not refer explicitly to cloning, but calls on Member States to avoid unnecessary pain, suffering or injury in farm animals. If cloning causes unnecessary pain, suffering or injury Member States have to act at national level to avoid it.

In 2008, the Commission presented a proposal to streamline the approval process in Regulation (EC) N° 258/97 on novel foods. In the legislative procedure, lawmakers aimed to amend the proposal to introduce specific rules on cloning. Yet no agreement was reached on the scope and features of these insertions so that the proposal was abandoned after a failed Conciliation in March 2011.

As a result, the Commission was asked to prepare a legislative proposal on cloning in food production based on an impact assessment outside the Novel Food Regulation.

The European Parliament resolution of 6 July 2011 on the Commission Work Programme 2012 requested a legislative proposal to prohibit food from clones, offspring and descendants.

The European Food Safety Authority (EFSA) views cloning primarily as an animal welfare hazard related to the low efficiency of the technique. It up-dated its opinion on cloning of animals in 2012 concluding that scientific knowledge available on cloning has increased but that nevertheless its efficiency remains low compared to other reproduction techniques.

Union citizens , on the other hand, held a broadly negative perception of the use of the cloning technique for the production of animals for farming purposes.

IMPACT ASSESSMENT: the option calling for a temporary suspension of the technique and of imports of live clones was retained as the basis of the present proposal.

CONTENT: the proposal envisages a suspension on Union territory of:

the use of the technique for food production purposes; the marketing of live clones (animal clones).

These provisional prohibitions will confine a production technique causing distress to animals to areas where it appears to have particular benefit.

The provisional prohibitions are kept under review given the development of knowledge on the technique and progress in the application of the technique in areas outside farming.

This proposal excludes cloning carried out in research, for the preservation of rare breeds or endangered species and for the production of medicinal products and medical devices.

Documents

Activities

AmendmentsDossier
187 2013/0433(COD)
2015/04/21 INTA 51 amendments...
source: 554.861
2015/04/28 ENVI, AGRI 136 amendments...
source: 554.978

History

(these mark the time of scraping, not the official date of the change)

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              • date: 2014-01-16T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP shadows: group: EPP name: AYUSO Pilar group: S&D name: AGUILERA GARCÍA Clara Eugenia group: S&D name: SÂRBU Daciana Octavia group: ECR name: NICHOLSON James group: ECR name: WOJCIECHOWSKI Janusz group: ALDE name: FEDERLEY Fredrick group: ALDE name: MÜLLER Ulrike group: GUE/NGL name: ECK Stefan group: GUE/NGL name: HAZEKAMP Anja group: Verts/ALE name: BOVÉ José group: Verts/ALE name: STAES Bart responsible: True committee: AGRI date: 2014-07-14T00:00:00 2014-07-14T00:00:00 committee_full: Agriculture and Rural Development rapporteur: group: EPP name: SOMMER Renate group: EFD name: MOI Giulia body: EP responsible: True committee_full: Agriculture and Rural Development committee: AGRI body: EP shadows: group: EPP name: AYUSO Pilar group: S&D name: AGUILERA GARCÍA Clara Eugenia group: S&D name: SÂRBU Daciana Octavia group: ECR name: NICHOLSON James group: ECR name: WOJCIECHOWSKI Janusz group: ALDE name: FEDERLEY Fredrick group: ALDE name: MÜLLER Ulrike group: GUE/NGL name: ECK Stefan group: GUE/NGL name: HAZEKAMP Anja group: Verts/ALE name: BOVÉ José group: Verts/ALE name: STAES Bart responsible: True committee: ENVI date: 2014-07-14T00:00:00 2014-07-14T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: EPP name: SOMMER Renate group: EFD name: MOI Giulia body: EP responsible: False committee: ENVI date: 2014-03-20T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE name: MAZEJ KUKOVIČ Zofija body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: False committee: INTA date: 2014-09-03T00:00:00 committee_full: International Trade rapporteur: group: S&D name: KIRTON-DARLING Jude body: EP responsible: False committee: INTA date: 2014-01-20T00:00:00 committee_full: International Trade rapporteur: group: S&D name: PIRILLO Mario body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE body: EP responsible: None committee_full: Legal Affairs committee: JURI
              • date: 2014-10-20T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP shadows: group: EPP name: AYUSO Pilar group: S&D name: AGUILERA GARCÍA Clara Eugenia group: S&D name: SÂRBU Daciana Octavia group: ECR name: NICHOLSON James group: ECR name: WOJCIECHOWSKI Janusz group: ALDE name: FEDERLEY Fredrick group: ALDE name: MÜLLER Ulrike group: GUE/NGL name: ECK Stefan group: GUE/NGL name: HAZEKAMP Anja group: Verts/ALE name: BOVÉ José group: Verts/ALE name: STAES Bart responsible: True committee: AGRI date: 2014-07-14T00:00:00 2014-07-14T00:00:00 committee_full: Agriculture and Rural Development rapporteur: group: EPP name: SOMMER Renate group: EFD name: MOI Giulia body: EP responsible: True committee_full: Agriculture and Rural Development committee: AGRI body: EP shadows: group: EPP name: AYUSO Pilar group: S&D name: AGUILERA GARCÍA Clara Eugenia group: S&D name: SÂRBU Daciana Octavia group: ECR name: NICHOLSON James group: ECR name: WOJCIECHOWSKI Janusz group: ALDE name: FEDERLEY Fredrick group: ALDE name: MÜLLER Ulrike group: GUE/NGL name: ECK Stefan group: GUE/NGL name: HAZEKAMP Anja group: Verts/ALE name: BOVÉ José group: Verts/ALE name: STAES Bart responsible: True committee: ENVI date: 2014-07-14T00:00:00 2014-07-14T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: EPP name: SOMMER Renate group: EFD name: MOI Giulia body: EP responsible: False committee: ENVI date: 2014-03-20T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: PPE name: MAZEJ KUKOVIČ Zofija body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO body: EP responsible: False committee: INTA date: 2014-09-03T00:00:00 committee_full: International Trade rapporteur: group: S&D name: KIRTON-DARLING Jude body: EP responsible: False committee: INTA date: 2014-01-20T00:00:00 committee_full: International Trade rapporteur: group: S&D name: PIRILLO Mario body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE body: EP responsible: None committee_full: Legal Affairs committee: JURI
              • date: 2014-12-17T00:00:00 body: EP type: Referral to joint committee announced in Parliament
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              • date: 2013-12-18T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2013:0519:FIN:EN:PDF title: EUR-Lex title: SWD(2013)0519 type: Document attached to the procedure body: EC
              • date: 2013-12-18T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2013:0520:FIN:EN:PDF title: EUR-Lex title: SWD(2013)0520 type: Document attached to the procedure body: EC
              • date: 2015-03-23T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE551.999 title: PE551.999 type: Committee draft report body: EP
              • date: 2015-04-28T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE554.978 title: PE554.978 type: Amendments tabled in committee body: EP
              • date: 2015-05-28T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE551.983&secondRef=02 title: PE551.983 committee: INTA type: Committee opinion body: EP
              • date: 2015-06-09T00:00:00 docs: title: PE560.690 type: Amendments tabled in committee body: EP
              • date: 2015-10-22T00:00:00 docs: url: /oeil/spdoc.do?i=25934&j=0&l=en title: SP(2015)649 type: Commission response to text adopted in plenary
              • date: 2014-02-20T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2013)0892 title: COM(2013)0892 type: Contribution body: AT_BUNDESRAT
              • date: 2014-02-27T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2013)0892 title: COM(2013)0892 type: Contribution body: ES_PARLIAMENT
              • date: 2014-02-24T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2013)0892 title: COM(2013)0892 type: Contribution body: IT_SENATE
              • date: 2014-02-11T00:00:00 docs: url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2013)0892 title: COM(2013)0892 type: Contribution body: PT_PARLIAMENT
              events
              • date: 2013-12-18T00:00:00 type: Legislative proposal published body: EC docs: url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2013&nu_doc=0892 title: EUR-Lex title: COM(2013)0892 summary: PURPOSE: to suspend the use of the technique and the marketing of animal clones for farming purposes ensures that all Union farmers and breeders are subject to the same conditions while adequately protecting animal welfare. PROPOSED ACT: Directive of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: Directive 98/58/EC on the protection of animals kept for farming purposes sets very general minimum animal welfare standards for animals used in agriculture. It does not refer explicitly to cloning, but calls on Member States to avoid unnecessary pain, suffering or injury in farm animals. If cloning causes unnecessary pain, suffering or injury Member States have to act at national level to avoid it. In 2008, the Commission presented a proposal to streamline the approval process in Regulation (EC) N° 258/97 on novel foods. In the legislative procedure, lawmakers aimed to amend the proposal to introduce specific rules on cloning. Yet no agreement was reached on the scope and features of these insertions so that the proposal was abandoned after a failed Conciliation in March 2011. As a result, the Commission was asked to prepare a legislative proposal on cloning in food production based on an impact assessment outside the Novel Food Regulation. The European Parliament resolution of 6 July 2011 on the Commission Work Programme 2012 requested a legislative proposal to prohibit food from clones, offspring and descendants. The European Food Safety Authority (EFSA) views cloning primarily as an animal welfare hazard related to the low efficiency of the technique. It up-dated its opinion on cloning of animals in 2012 concluding that scientific knowledge available on cloning has increased but that nevertheless its efficiency remains low compared to other reproduction techniques. Union citizens , on the other hand, held a broadly negative perception of the use of the cloning technique for the production of animals for farming purposes. IMPACT ASSESSMENT: the option calling for a temporary suspension of the technique and of imports of live clones was retained as the basis of the present proposal. CONTENT: the proposal envisages a suspension on Union territory of: the use of the technique for food production purposes; the marketing of live clones (animal clones). These provisional prohibitions will confine a production technique causing distress to animals to areas where it appears to have particular benefit. The provisional prohibitions are kept under review given the development of knowledge on the technique and progress in the application of the technique in areas outside farming. This proposal excludes cloning carried out in research, for the preservation of rare breeds or endangered species and for the production of medicinal products and medical devices.
              • date: 2014-01-16T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
              • date: 2014-10-20T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
              • date: 2014-12-17T00:00:00 type: Referral to joint committee announced in Parliament body: EP
              • date: 2015-06-17T00:00:00 type: Vote in committee, 1st reading/single reading body: EP
              • date: 2015-06-25T00:00:00 type: Committee report tabled for plenary, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A8-2015-0216&language=EN title: A8-0216/2015 summary: The Committee on the Environment, Public Health and Food Safety and the Committee on Agriculture and Rural Development jointly adopted the report by Renate SOMMER (EPP, DE) 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. The committee recommended that the European Parliament’s position adopted at first reading following the ordinary legislative procedure should amend the commission proposal as follows: Choice of legal instrument : while the Commission considers that a Directive is the most appropriate instrument for this legislation, Members proposed using a Regulation as the legal instrument as this would enhance legal certainty and ensure the rationality and consistency of the enforcement, while respecting the subsidiarity and proportionality principles. Purpose and scope : Members considered that the Regulation should establish rules concerning 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 (meaning semen, oocytes and embryos collected or produced from animals for the purpose of reproduction), food and feed from animal clones and their descendants. It shall apply to all species of animals kept and reproduced for farming purposes and not only animals of the bovine, porcine, ovine, caprine and equine species as was proposed by the Commission. Moreover, 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. It has been clearly and consistently shown by consumer research, the majority of Union citizens disapprove of cloning for farming purposes due to, inter alia, animal welfare and general ethical concerns. Provisional or permanent prohibitions : although the proposal qualifies the prohibitions on the use of cloning as “provisional”, referring to a “suspension” of the use of the technique, Members suggested a pure and simple prohibition . Import conditions : Members stated that animals shall not be imported from third countries unless the accompanying import certificates show that they are not animal clones or descendants of animal clones. In order to ensure that import certificates accompanying animals and germinal products and food and feed of animal origin indicate whether they are, or are derived from, animal clones or descendants of animal clones, the Commission shall adopt specific import conditions under Regulation (EC) No 882/2004 of the European Parliament and of the Council by 6 months from the entry into force of this Regulation and shall, if necessary, present a proposal to amend other legislation in the field of animal health or zootechnical and genealogical conditions for imports. Traceability : the report noted that traceability systems shall be established for animal clones; descendants of animal clones; germinal products of animal clones and of their descendants. The Commission shall be empowered to adopt delegated acts to establish detailed rules for such systems. Reports and reviews : this Regulation shall be reviewed within a reasonable time, taking into account the experience gained by the Member States in its application, scientific and technical progress, the evolution of consumer perceptions, and international developments, in particular trade flows and the Union's trade relations. 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.
              • date: 2015-09-08T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=25934&l=en title: Results of vote in Parliament
              • date: 2015-09-08T00:00:00 type: Debate in Parliament body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20150908&type=CRE title: Debate in Parliament
              • date: 2015-09-08T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2015-0285 title: T8-0285/2015 summary: The European Parliament adopted by 529 votes to 120, with 157 abstentions, a 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. Parliament’s position adopted at first reading following the ordinary legislative procedure amended the Commission proposal as follows: Choice of legal instrument : Parliament voted to use a Regulation as the appropriate legal instrument (as opposed to a Directive as proposed by the Commission). Objective and scope : Parliament recalled that 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. In this regard, 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. Members recalled that the majority of Union citizens disapprove of cloning for farming purposes due to, inter alia, animal welfare and general ethical concerns. Provisional or permanent prohibitions : although the proposal qualifies the prohibitions on the use of cloning as “provisional”, Parliament favoured a pure and simple prohibition . Thus, the Regulation shall prohibit the placing on the market of: animal clones, embryo clones, and the import of : animal clones, embryo clones descendants of animal clones, germinal products of animal clones and of their descendants (meaning semen, oocytes and embryos collected or produced from animals for the purpose of reproduction), food and feed from animal clones and their descendants. The Regulation shall apply to all species of animals kept and reproduced for farming purposes and not only animals of the bovine, porcine, ovine, caprine and equine species as was proposed by the Commission. Import conditions : Members stated that animals shall not be imported from third countries unless the accompanying import certificates show that they are not animal clones or descendants of animal clones. In order to ensure that import certificates accompanying animals and germinal products and food and feed of animal origin indicate whether they are, or are derived from, animal clones or descendants of animal clones, the Commission shall adopt specific import conditions under Regulation (EC) No 882/2004 of the European Parliament and of the Council by 6 months from the entry into force of this Regulation and shall, if necessary, present a proposal to amend other legislation in the field of animal health or zootechnical and genealogical conditions for imports. Traceability : Parliament noted that traceability systems shall be established for animal clones; descendants of animal clones; germinal products of animal clones and of their descendants. The Commission shall be empowered to adopt delegated acts to establish detailed rules for such systems. The power to adopt delegated acts shall be conferred on the Commission for a period of five years (tacitly extended for periods of an identical duration) from the entry into force of the Regulation. Penalties : the penalties provided for shall be effective, proportionate, dissuasive and shall ensure a level playing field . Reports and reviews : by 6 years from the entry into force of this Regulation, the Member States shall report to the Commission on the experience gained by them on the application of this Regulation, scientific and technical progress, the evolution of consumer perceptions, and international developments, in particular trade flows and the Union's trade relations as well as ethical issues relating to animal cloning. 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. The Regulation shall apply from 1 year from the entry into force of this Regulation.
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              • body: EC dg: url: http://ec.europa.eu/info/departments/agriculture-and-rural-development_en title: Agriculture and Rural Development commissioner: HOGAN Phil
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              • url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2015-0285 type: Decision by Parliament, 1st reading/single reading title: T8-0285/2015
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              • The Committee on the Environment, Public Health and Food Safety and the Committee on Agriculture and Rural Development jointly adopted the report by Renate SOMMER (EPP, DE) 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.

                The committee recommended that the European Parliament’s position adopted at first reading following the ordinary legislative procedure should amend the commission proposal as follows:

                Choice of legal instrument: while the Commission considers that a Directive is the most appropriate instrument for this legislation, Members proposed using a Regulation as the legal instrument as this would enhance legal certainty and ensure the rationality and consistency of the enforcement, while respecting the subsidiarity and proportionality principles.

                Purpose and scope: Members considered that the Regulation should establish rules concerning 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 (meaning semen, oocytes and embryos collected or produced from animals for the purpose of reproduction),
                • food and feed from animal clones and their descendants.

                It shall apply to all species of animals kept and reproduced for farming purposes and not only animals of the bovine, porcine, ovine, caprine and equine species as was proposed by the Commission.

                Moreover, 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. It has been clearly and consistently shown by consumer research, the majority of Union citizens disapprove of cloning for farming purposes due to, inter alia, animal welfare and general ethical concerns.

                Provisional or permanent prohibitions: although the proposal qualifies the prohibitions on the use of cloning as “provisional”, referring to a “suspension” of the use of the technique, Members suggested a pure and simple prohibition.

                Import conditions: Members stated that animals shall not be imported from third countries unless the accompanying import certificates show that they are not animal clones or descendants of animal clones.

                In order to ensure that import certificates accompanying animals and germinal products and food and feed of animal origin indicate whether they are, or are derived from, animal clones or descendants of animal clones, the Commission shall adopt specific import conditions under Regulation (EC) No 882/2004 of the European Parliament and of the Council by 6 months from the entry into force of this Regulation and shall, if necessary, present a proposal to amend other legislation in the field of animal health or zootechnical and genealogical conditions for imports.

                Traceability: the report noted that traceability systems shall be established for animal clones; descendants of animal clones; germinal products of animal clones and of their descendants. The Commission shall be empowered to adopt delegated acts to establish detailed rules for such systems.

                Reports and reviews: this Regulation shall be reviewed within a reasonable time, taking into account the experience gained by the Member States in its application, scientific and technical progress, the evolution of consumer perceptions, and international developments, in particular trade flows and the Union's trade relations.

                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.

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              http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2013&nu_doc=0892
              New
              http://old.eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2013&nu_doc=0892
              activities/1/committees/1/date
              2014-03-20T00:00:00
              activities/1/committees/1/rapporteur
              • group: EPP name: MAZEJ KUKOVIČ Zofija
              committees/1/date
              2014-03-20T00:00:00
              committees/1/rapporteur
              • group: EPP name: MAZEJ KUKOVIČ Zofija
              activities/1/committees/3/date
              2014-01-20T00:00:00
              activities/1/committees/3/rapporteur
              • group: S&D name: PIRILLO Mario
              committees/3/date
              2014-01-20T00:00:00
              committees/3/rapporteur
              • group: S&D name: PIRILLO Mario
              procedure/subject/0
              Old
              3.10.03 Marketing and trade of agricultural products, in general
              New
              3.10.03 Marketing and trade of agricultural products and livestock
              activities/0/docs/0/text
              • PURPOSE: to suspend the use of the technique and the marketing of animal clones for farming purposes ensures that all Union farmers and breeders are subject to the same conditions while adequately protecting animal welfare.

                PROPOSED ACT: Directive of the European Parliament and of the Council.

                ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

                BACKGROUND: Directive 98/58/EC on the protection of animals kept for farming purposes sets very general minimum animal welfare standards for animals used in agriculture. It does not refer explicitly to cloning, but calls on Member States to avoid unnecessary pain, suffering or injury in farm animals. If cloning causes unnecessary pain, suffering or injury Member States have to act at national level to avoid it.

                In 2008, the Commission presented a proposal to streamline the approval process in Regulation (EC) N° 258/97 on novel foods. In the legislative procedure, lawmakers aimed to amend the proposal to introduce specific rules on cloning. Yet no agreement was reached on the scope and features of these insertions so that the proposal was abandoned after a failed Conciliation in March 2011.

                As a result, the Commission was asked to prepare a legislative proposal on cloning in food production based on an impact assessment outside the Novel Food Regulation.

                The European Parliament resolution of 6 July 2011 on the Commission Work Programme 2012 requested a legislative proposal to prohibit food from clones, offspring and descendants.

                The European Food Safety Authority (EFSA) views cloning primarily as an animal welfare hazard related to the low efficiency of the technique. It up-dated its opinion on cloning of animals in 2012 concluding that scientific knowledge available on cloning has increased but that nevertheless its efficiency remains low compared to other reproduction techniques.

                Union citizens, on the other hand, held a broadly negative perception of the use of the cloning technique for the production of animals for farming purposes.

                IMPACT ASSESSMENT: the option calling for a temporary suspension of the technique and of imports of live clones was retained as the basis of the present proposal.

                CONTENT: the proposal envisages a suspension on Union territory of:

                • the use of the technique for food production purposes;
                • the marketing of live clones (animal clones).

                These provisional prohibitions will confine a production technique causing distress to animals to areas where it appears to have particular benefit.

                The provisional prohibitions are kept under review given the development of knowledge on the technique and progress in the application of the technique in areas outside farming.

                This proposal excludes cloning carried out in research, for the preservation of rare breeds or endangered species and for the production of medicinal products and medical devices.

              activities/1
              date
              2014-01-16T00:00:00
              body
              EP
              type
              Committee referral announced in Parliament, 1st reading/single reading
              committees
              procedure/dossier_of_the_committee
              AGRI/7/14954
              procedure/stage_reached
              Old
              Preparatory phase in Parliament
              New
              Awaiting committee decision
              activities
              • date: 2013-12-18T00:00:00 docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2013&nu_doc=0892 celexid: CELEX:52013PC0892:EN type: Legislative proposal published title: COM(2013)0892 type: Legislative proposal published body: EC commission: DG: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers Commissioner: BORG Tonio
              committees
              • body: EP responsible: True committee_full: Agriculture and Rural Development committee: AGRI
              • body: EP responsible: False committee_full: Environment, Public Health and Food Safety committee: ENVI
              • body: EP responsible: False committee_full: Internal Market and Consumer Protection committee: IMCO
              • body: EP responsible: False committee_full: International Trade committee: INTA
              • body: EP responsible: False committee_full: Industry, Research and Energy committee: ITRE
              links
              European Commission
              other
              • body: EC dg: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers commissioner: BORG Tonio
              procedure
              reference
              2013/0433(COD)
              Mandatory consultation of other institutions
              Economic and Social Committee
              instrument
              Directive
              legal_basis
              Treaty on the Functioning of the EU TFEU 043-p2
              stage_reached
              Preparatory phase in Parliament
              subtype
              Legislation
              title
              Cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposes
              type
              COD - Ordinary legislative procedure (ex-codecision procedure)
              subject