Cloning Food Dossier • Policy Report

Cloning Food Dossier • Policy Report

Positions and objectives with which Sustainable Economy Europe agrees:

1.     To avoid the commercial use of cloned meat in the EU and to propose a solution that can be sustainable for the European farmers, for the animal health and for the environment.

2.     To protect farmers and in general small and medium enterprises from a possible new unfair high-tech concurrence in the meat production industry.

3.      To protect particularly the high quality Italian food producers, (DOP and IGP) against incorrect concurrence.

4.     To protect human health and food chain sustainability: until now research studies have not been done on the long term effects in humans eating meat from cloned animals neither scientific epigenetic study of heritable changes in gene expression. Moreover EFSA (European Food Authority Agency) has stressed that the scientific database on this subject is very limited, and in its 2008 opinion 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.”

 

SUMMARY

Cloning is a process that produces genetically identical individuals without genetic modification. Scientists have developed methods to clone animals, by using the genetic material contained in mature body cells to produce exact genetic copies of animals. This reproductive technology is known as somatic cell nuclear transfer (SCNT) and can be used to duplicate animals.

Presently, food from clones falls under the scope of the “Novel Food Regulation” as a novel production technique and is subject to authorization. The European Commission was invited to prepare a legislative proposal on cloning in food production based on an impact assessment which falls outside the Novel Food Regulation. The Commission has thus presented two proposals for directives:

  1. 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 (Cloning Technique Proposal)
  2. Proposal for a Council Directive on the placing on the market of food from clones (COM 2013 893 final) adopted on 18 December 2013. (Cloning Food Proposal).

RESULTS

The 8thof September 2015 the European Parliament confirmed its strict opposition to the production and import of food from cloned animals or their descendants with the following votes on a total of 706 members:

  • 529 in favour
  • 120 against
  • 57 abstention

The Parliament voted the following amendments to the Commission proposal:
I. Choice of legal instrument: a regulation would be more appropriate than a directive (which was proposed by the Commission).
II. Objective and scope: the Parliament disapproves of animal cloning for food production purposes because it jeopardises the defining characteristics of the European farming model, which is based on product quality, consumer health, animal welfare and environmentally sound methods.
III. The prohibition on cloning should be permanent instead of provisional, and should not only involve animal and embryo clones, but also their descendants, their germinal products and their use for food or feed.
IV. These rules should not only apply to animals of the bovine, porcine, ovine, caprine and equine species, but to all species of animals kept and reproduced for farming purposes.
V. Third countries should not be allowed to export animals to the EU unless these animals are accompanied by import certificates showing that they are not clones or descendants of clones.
VI. Traceability systems should be established for animal clones, their descendants and their germinal products through delegated acts adopted by the Commission.

Ever since Dolly (the cloned sheep) emerged from the lab in 1997, Europeans have been sceptical on this topic. With the vote of the EP the majority of MEPs were with them, beefing up a partial cloning ban to cover all farm animals, their offspring and imported cloned food and feed.

 

MAIN POSITIVE AMENDMENTS PRESENTED BY POLITICAL GROUPS:

Amendment  1

Proposal for a directive

Title

Text proposed by the CommissionAmendment
Proposal for a Directive of the European Parliament and the Council on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purposesProposal for a Regulation of the European Parliament and the Council on the cloning of animals kept and reproduced for farming purpose

Amendment 1: Regulation instead of Directive.

Amendment  4

Proposal for a directive

Recital 2

Text proposed by the CommissionAmendment
(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 miscarriages15with 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.

 

Amendment 4: this amendment remarked an official EFSA’s Opinion missing in the Original Text from the Commission. In this Opinion of  2008, the European Food Safety Agency stated 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”, and that 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.

Amendment  11

Proposal for a directive

Recital 2 g (new)

Text proposed by the CommissionAmendment
(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 CommissionAmendment
(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  14

Proposal for a directive

Recital 4

Text proposed by the CommissionAmendment
(4) Currently animals of bovine, porcine, ovine, caprine and equine species are likely to be cloned for farming purposes. The scope of this Directive should therefore be limited to the use of cloning for farming purposes of those five species.deleted

 

Amendment  18

Proposal for a directive

Recital 4 d (new)

Text proposed by the CommissionAmendment
(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  37

Proposal for a directive

Article 3 – paragraph 1 – introductory part

Text proposed by the CommissionAmendment
Member States shall provisionally prohibit:The following shall be prohibited:

 

Amendment  39

Proposal for a directive

Article 3 a (new)

Text proposed by the CommissionAmendment
Article 3a
Import conditions
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.
Germinal products and food and feed of animal origin shall not be imported from third countries unless the accompanying import certificates show that they are not derived from 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 Article 48 or Article 49 of Regulation (EC) No 882/2004 of the European Parliament and of the Council by …* and shall, if necessary, present a proposal to amend other legislation in the field of animal health or zootechnical and genealogical conditions for imports.