Annexes to COM(2010)585 - Animal cloning for food production - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2010)585 - Animal cloning for food production. |
|---|---|
| document | COM(2010)585  |
| date | October 19, 2010 |
Any measure adopted would have to honour the principle of "National Treatment", which prohibits less favourable treatment of like products imported (Article III:4 GATT), and the requirement to eliminate quantitative restrictions (Article XI GATT). Exemptions from these general rules can be justified under Article XX of GATT (General Exemptions) and/or the TBT or SPS agreement. The two latter would allow exemptions in line with international standards or based on scientific evidence. The potentially relevant international standard setting bodies for food safety (Codex Alimentarius) and animal health (World Organisation for Animal Health (OIE)) have not set relevant standards on cloning.
There is no scientific evidence which could justify restrictions on food from clones and food from offspring of clones based on human health concerns. EFSA has however expressed concerns which are related to the welfare of clones.
The most relevant exemptions from Article III and XI of GATT would thus be the exception on "public morals" which could include animal welfare (paragraph a GATT XX) or the protection of life and health. The WTO exemptions are subject to strict requirements, amongst others, proof of the necessity of the measure to obtain the objective in question, which implies that it has to be investigated whether there is not a less trade restrictive way to obtain the same objective, as well as proof of application in a non-discriminatory, non-arbitrary, non-trade restrictive manner.
8.Legal aspects to be taken into acount in the risk management
Animal Health and Zootechnics
The applicable law, both veterinary and zootechnical, is based on Article 43 of the Treaty of the Functioning of the European Union. The rules do not distinguish between animals produced by different reproduction technologies (e.g. artificial insemination, embryo transfer, embryo splitting, in-vitro-fertilisation or cloning) as from a genetic perspective none of these practices affects the genome or susceptibility to infectious diseases.
The basic aim of EU animal health legislation is to control infectious diseases. This legislation harmonises animal health conditions governing EU trade and imports from third countries. Animals and their products are traded with veterinary certificates. The certificates do not contain information about the reproduction technology by which the animal or (for semen, ova and embryos) the donor animal was produced.
The basic aim of EU zootechnical legislation is to improve livestock performance by rules to ensure free trade and harmonised conditions for imports of 'pure-bred' breeding animals and their genetic material. Pure bred breeding animals are traded with pedigree certificates containing the parentage of the animal. This legislation does not however affect the trade, imports or breeding of non pure-bred animals (representing some 95% of pigs, sheep and goats, 90% of beef cattle and 50% of dairy cattle).
EU zootechnical legislation establishes that pedigree certificates are issued by approved breeders’ organisations or associations to ensure the ancestry, performance and genetic value of pure-bred breeding animals (bovine, swine, equine, sheep and goats) and their semen, ova and embryos that are traded within the EU or imported from third countries. These certificates do not foresee that information is given if the animals in question are clones/offspring of clones or if they are conventionally bred.
Animal welfare
Cloning could be examined in the light of the provisions of Council Directive 98/58/EC concerning the protection of animals kept for farming purposes. Paragraph 20 of the Annex to the Directive states that: “Natural or artificial breeding or breeding procedures which cause or are likely to cause suffering or injury to any of the animals concerned must not be practised.” The same text is included in the European Convention for the protection of animals kept for farming purposes, which gives principles for the keeping, care and housing of animals, in particular in intensive breeding systems. Member States are responsible for the implementation of EU legislation on their territory. Furthermore, Article 13 of the Treaty of the Functioning of the EU clearly states that animals welfare needs must be fully taken into account when drafting and implementing EU policies on agriculture, fisheries, transport, internal market, research and development and space.
Traceability of animals
In the EU, food producing animals are subject to traceability requirements which also apply to clones. Individual traceability has been in place for bovine animals since 1997. For sheep and goats, individual traceability began in 2010. Pigs have been traceable on a batch basis since 1992. The current rules do not foresee a need to record on the documents any reference to reproduction technology.
Novel Foods issues
Food from clones is covered by Regulation (EC) 258/97 on Novel foods, since such food is derived from animals that are obtained by non-traditional breeding techniques. This means that these food products cannot be put on the market without a safety assessment and a specific authorising legal act. To date, no application has been made by any company seeking to put food from clones on the market.
Legislation on organic farming
Since 1991, the EU has in place a legislative framework relating to the practice of organic farming. At first the organic Regulation only regulated plant products. Additional provisions for the production of animal products were later introduced. These rules included animal feed, prevention of illness, veterinary treatment, animal protection, livestock breeding in general and the use of livestock manure14.
With regard to breeding, the Regulation states that reproduction shall take place using natural methods. However artificial insemination is allowed, but any other form of artificial reproduction, such as cloning and embryo transfer, shall not be used. The use of inducing treatments with hormones or similar substances is forbidden, unless in the form of therapeutic treatment for an individual animal.
The EU framework on organic farming provides for the guarantee that food is obtained from animals bred without the use of any "non-traditional breeding method" such as cloning or embryo transfer.
9.Options
The assessment of the situation shows that it is scientifically accepted that there are no food safety concerns about food produced from clones or their offspring. The risks for animal welfare are however a solid basis for the Commission to initiate a legislative process. To address the concern that people perceive the cloning of animals as morally wrong could be seen as another factor to be taken into account under EU law.
The options are therefore:
(1) Legal status quo
Cloning would continue not to be specifically regulated at EU level. Clones and their reproductive materials (semen, ova and embryos) would continue to be marketed in the EU under the general rules. Food from clones would still be subject to a pre-market authorisation under the Novel foods Regulation. Food from the offspring of clones would continue to be covered by generic rules, which ensure the safety of those products and the functioning of the single market15.
(2) Total prohibition
Prohibition of the cloning of farm animals for food production: This would address the key issue pertaining to cloning, namely the welfare concerns. Cloning would not be allowed on EU territory for food production purposes.
A ban in the EU on the use of clones and of the placing on the market of food from clones: This measure, which would also apply to imports would ensure coherence with the ban of the cloning technique in the EU.
A ban of the placing on the market of offspring of clones and food from the offspring of clones: This measure would not be justified on grounds of protecting animal welfare, animal health or public health in so far as there are no welfare concerns for the offspring of clones as they are produced by normal reproduction techniques, nor safety concerns for food derived from offspring of clones, as indicated by EFSA. As food from the offspring of clones cannot be distinguished from food from other animals, a complete traceability system would be needed. This would be extremely burdensome to put in place as it would imply detailed tracing of all generations of offspring, for the species used for food production. Furthermore, such prohibition would lead to a ban of imports of any food of animal origin (meat, milk and processed products), from third countries which may have imported reproductive material from clones. A total ban on the import of food from the offspring of clones would have a considerable and disproportionate economic impact on EU agriculture production and trade. In addition, there are no welfare or health or food safety concerns to justify such action.
A ban on the use of reproductive material from clones: There are no health or food safety concerns linked to the use of conventional breeding techniques, therefore a ban on imports of reproductive material from clones is difficult to justify.
(3) Mix of measures
The Commission considers that a mix of measures would meet the concerns raised on the issue of cloning. These measures could include:
A temporary suspension of the cloning technique of farm animals for food purposes: This option addresses the welfare issues linked to the use of the cloning technique for food production in the EU. As the technique may mature and alleviate partially or fully these concerns, the prohibition should be revisited after a certain period.
A temporary suspension of the use of cloned farm animals: This is a limited measure since imports of live clones are rare and no commercial cloning occurs in the EU. This would ensure coherence with the suspension of the cloning technique.
A temporary suspension of placing on the market of food from clones: This suspension which would apply also to imports would ensure coherence with the ban of the technique in the EU.
Traceability of reproductive material: This would allow farmers and the food industry to develop information schemes. In order to distinguish between (i) semen and embryos from clones and (ii) semen and embryos originating from conventionally bred-animals it would be necessary to amend certain certification requirements laid down in the zootechnical and animal health legislation. As operators would be required to mention in existing certificates whether or not the reproductive material derives from a clone, the administrative burden is limited. Such information is not difficult to retrieve as the genetic value is usually requested by the purchaser. Further, some trading partners using the cloning technique for food production purposes have already established - or envisage to do so - a specific system of compulsory registration of clones, which facilitates further the traceability of reproductive material.
10.conclusions
In view of the issues outlined above, and in particular the need to address the welfare concerns linked to the use of the cloning technique and the appropriateness to allow market information, the Commission will propose to:
(i) Suspend temporarily the use of the technique in the EU for the reproduction of all food producing animals; the use of clones of these animals; and the marketing of food from clones.
(ii) Establish the traceability of imports of semen and embryos to allow farmers and industry to set up data bank(s) of offspring in the EU.
With a review clause after 5 years, the proposed legislative measure will be based on the appropriate legal basis taking into account its content and objective. Cloning would however remain possible for all other purposes than food production such as research16, production of pharmaceuticals or the conservation of endangered species or breeds. During the five year period, the Commission will monitor the scientific and technological development of cloning in order to asses whether, when and under which conditions these provisional measures could be removed. No legal measures are proposed in relation to food from the offspring of clones. However, the establishment of the traceability system under (ii) above makes information schemes possible.
The future scenarios can be summarised as follows:
| Clones | Offspring | |||||
| Clone itself | Embryo/semen | Food products | Offspring itself | Embryo/semen | Food products | |
| Produced in the EU | Temporary suspension of the technique for food production | No measure As long as the technique is suspended there will be no products (embryos, semen, food) of clones produced in the EU and of their offspring | ||||
| Imported in the EU | Temporary suspension of imports of clones | Traceability requirements on exporters to EU | Temporary suspension of placing on the market. | No measure |
The Commission invites the Parliament and the Council to consider the contents and conclusions of this report and to express their positions in due course.
1For the purposes of this report (and in common with EFSA and EGE Opinions) “cloning” refers to replication by somatic cell nuclear transfer (SCNT) to create genetic replicas (clones) from adult animals that share the same nuclear gene set as another organism. This report does not cover embryo splitting or any form of genetic modification.
2http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902019540.htm
3http://www.efsa.europa.eu/cs/BlobServer/Statm_of_Efsa/sc_statementej_RN319_en.pdf?ssbinary=true
4"Epigenetics" seeks to describe the inheritance of information on the basis of gene expression. Epigenetic changes in reprogramming of the donor’s nucleus in SCNT have been implicated in causing many of the observed anomalies.
5Dr. Shinya Watanabe, National Institute of Livestock and Grassland Science, Japan.
6Wells DN. 2005. Animal cloning: problems and prospects. Revue Scientifique et Technique (International Office of Epizootics) 24(1):251-64.
7http://ec.europa.eu/european_group_ethics/activities/docs/opinion23_en.pdf
8Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients.
9European attitudes towards animal cloning: http://ec.europa.eu/public_opinion/flash/fl_238_en.pdf
10http://www.copa-cogeca.be/Main.aspx?page=search&lang=en
11http://www.clitravi.eu/
12Reference COM (2007) 872 of 7 January 2008
13Switzerland is not considered here, as in accordance with an agreement in place on veterinary issue, it is bound to apply EU legislation. Therefore trade in live animals with Switzerland takes place in accordance with the rules applying amongst Member States.
14Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91.
15Treaty of the Functioning of the EU, Art. 34 – 36, General food law Regulation (EC) No 178/2002 on the general principles and requirements of food law, Regulation (EC) No 852/2004 on the hygiene of foodstuffs, Regulation (EC) No 853/2004 on the specific hygiene rules for food of animal origin.
16The use of clones in research must be in compliance with the Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes.
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