Documents considered by the Committee on 24 November - European Scrutiny Committee Contents

1 Animal cloning for food production



COM(10) 585

Commission Report on animal cloning for food production

Legal base
Document originated19 October 2010
Deposited in Parliament22 October 2010
DepartmentEnvironment, Food & Rural Affairs
Basis of considerationEM of 18 November 2010
Previous Committee ReportNone
To be discussed in CouncilNo date set
Committee's assessmentPolitically important
Committee's decisionFor debate in European Committee A


1.1 The Commission observes that cloning[1] is a relatively new breeding technique which allows for the asexual reproduction of animals which have shown good productivity, low incidence of disease and the ability to cope with the production environment. It says that the aim of this report is to assess the technology as it applies to food production, looking at such aspects as food safety and the health and welfare of the animals, as well as the ethical and trade implications and the rights of consumers.

The current document


1.2 The Commission notes that opinions produced by the European Food Standards Authority (EFSA) over the last two years or so suggest that, although no differences had been found in the food safety of milk and meat from clones and their offspring as compared with that from conventionally bred animals, cloning presents a number of welfare problems. First, a large number of cloned embryos fail to develop to term, and a significant proportion of those which do die during (or shortly after) birth from cardiovascular failure, respiratory problems, liver or kidney failure, immuno-deficiencies or musculoskeletal abnormalities, with the mortality rate being considerably higher than in sexually produced animals. It says that the overall success rate for cloning procedures is less than 10% in bovine animals and between 5 and 17% in pigs, though it adds that studies outside Europe show that the survival of the progeny of clones (around 85%) does not differ to any significant extent from conventionally bred animals.

1.3 The Commission adds that the EFSA has also highlighted important welfare issues for surrogate cattle dams which suffer from late gestational losses and more difficult delivery. In addition, clones may be unusually large, giving rise to "large offspring syndrome" (LOS), which is a common problem in cattle and sheep clones (but not in pigs), and some abnormalities may not show up until later in life, whilst other underlying frailties may not do so until the animal is stressed in some manner. The Commission suggests that, in order to assess correctly the impact of cloning on animal welfare, it is important to consider how the technique is likely to be used within the livestock sector: thus, whilst the cloning of the fastest growing and high yielding animals may lead to a higher proportion suffering from health and welfare problems, the cloning of conventionally bred animals which are resistant to certain diseases or which can easily adapt to difficult environmental conditions, may have some possible welfare benefits.


1.4 The Commission notes that the European Group on Ethics in Science and New Technologies (EGE) published in 2008 a report on the ethical aspects of animal cloning for food production, which expressed doubts on its justification, given the current level of suffering and health problems of surrogate dams and animal clones, and said that further research was also needed in relation to the progeny of clones. It observes that the basic issue raised by the EGE concerns the moral status attributed to animals, which are seen by society either as mere possessions or to be given respect in varying degree, such attitudes being influenced strongly by cultural and religious traditions.

1.5 The Commission suggests that, in the case of moral subjects, actions which affect health or welfare are seen as difficult to accept, the view being that animals should be used only under specific conditions where pain is minimised and authorised in well-justified circumstances, based on the 3Rs (reduction, refinement and replacement) principle and on the five freedoms defined by the Farm Animal Welfare Council (freedom from hunger, thirst and malnutrition, from fear and distress, from physical and thermal discomfort, from pain, injury and disease, and from constraints on normal patterns of behaviour). It adds that there is an even stricter line which arises where animals are given a moral value in themselves, and (like humans) are regarded as moral entities because of their sentient capacities, those subscribing to it concluding that they should not be used for human purposes at all.


1.6 The Commission says that imports, trade and use of products from clones (food, semen and embryos) are covered by general EU legislation, but, as this does not include any notification obligations (apart from a pre-market authorisation for meat and milk under the Novel Foods Regulation (258/97)), it is not possible to gain a complete picture of the overall situation. It says that, apart from Denmark (which has imposed a ban on cloning for commercial purposes), no other Member State has any specific legislation on the use of cloning, though some have provisions relating to possible pain and suffering associated with reproduction techniques. However, a number of Member States — including the UK — use cloning technology for research purposes only.


1.7 The Commission says that the United States is the most advanced country as regards the cloning of animals for food production, though a voluntary moratorium on the marketing of meat and milk from cloned animals (but not on that from their offspring, or from semen and embryos from clones) is in place there. It adds that the situation is evolving in other countries, such as Argentina, Brazil and Japan, and that China has expressed an interest in the technique. Based upon information provided by the three major US companies selling clones to farmers, the Commission observes that, although precise figures are not available, products from the offspring of clones have entered the food chain in the US and elsewhere, and that, although there is an economic incentive for farmers not to introduce clones into the food chain, the fact that tracing of clones is not mandatory means that there can be no guarantee that their milk does not enter the food chain (although it is unlikely that it would be used for food purposes). Against this background, the Commission says that it will strengthen the dialogue with the EU's trading partners in order to explore whether common ground can be found on cloning.


1.8 The Commission says that an opinion poll it carried out in 2008 showed that a majority had a "broadly negative" perception of the use of cloning for food production, many being concerned about the lack of information on the long-term consequences and about the ethical considerations. There was also a feeling that cloning for food production would not benefit the consumer, and that this would not be more efficient in the long run or lower the cost for consumers. However, 44% thought that cloning can be justified in certain circumstances, such as improving resistance to disease or preserving rare species. The Commission also notes that animal rights groups have campaigned strongly against cloning for food production in the EU, and have stressed the need to apply strict measures to products from the offspring of clones, even if such animals are produced through conventional breeding techniques, and for them to be included in the EU's approach to cloning for food.

1.9 The Commission says that it has discussed the use of cloning with the agri-food sector, including the possibility of a voluntary moratorium for a limited period on the use of clones and their offspring, in order to prevent future regulatory options being compromised by their appearance on the market. However, the Association of European farmers and agri-cooperatives (COPA-COGECA) takes the view that this would not be appropriate, because there are currently no means, nor controls, to ensure full traceability of imported products, or to legally pursue those who break the moratorium. Also, the European meat processing industry believes that products from cloned animals and/or their offspring are being sold within the EU, and that a traceability scheme would be very costly.

1.10 The Commission observes that both the European Parliament and the Council expect it to work on a separate proposal on all aspects of cloning. In the meantime, the Council has extended pre-market approval under the Novel Foods Regulation to food from the offspring of clones, whilst the Parliament has reiterated its request for a total ban on animal cloning, on imports of live clones and their offspring, and on the import of semen and embryos from clones.


1.11 The Commission notes that breeding of the European bovine herd takes place mainly through artificial insemination, and that about 2.5% of bovine semen used is imported, almost all from the US and Canada. On the basis of the information available, it estimates that about 600,000 (or approximately 2%) of the calves born in the EU in 2010 are progeny of US or Canadian bulls, and it also points out that 747 consignments of bovine embryos were imported in 2009 (though imports of live animals were much less common).

1.12 The Commission points out that live animals, animal products and food are covered by multilateral agreements under the World Trade Organisation (WTO), notably the General Agreement on Tariffs and Trade (GATT), the Agreement on Sanitary and Phytosanitary Measures (SPS) and the Agreement on Technical Barriers to Trade (TBT). It says that the relevance of each of these provisions would depend upon the justification and nature of any legislation drafted, but that it would in any case be necessary to avoid any measures involving less favourable treatment of imports or which ran counter to the requirement to eliminate quantitative restrictions. It adds that, although exemptions are allowed in line with international standards or based on scientific evidence, there is no such evidence which could justify on health grounds restrictions on food from clones and their offspring, and that the most relevant exemptions would be those relating to animal welfare. However, it stresses that WTO exemptions are subject to strict requirements, including proof that they are needed to attain the objective in question: this would involve showing there is no less restrictive way of doing so ,and the measure being applied in a non-discriminatory, non-arbitrary and non-trade-restrictive manner.


1.13 The Commission points out that the applicable EU veterinary and zootechnical law does not distinguish between animals produced by different reproduction technologies, as from a genetic perspective this does not affect the genome or susceptibility to infectious diseases: and certificates accompanying traded animals and animal products do not contain information about the technology by which the animal was produced. On the other hand, the relevant Council Directive (98/58/EC) on the protection of farmed animals does enable cloning to be examined from a welfare perspective, as does the corresponding European Convention, whilst the Treaty on the Functioning of the EU states that animal welfare needs must be fully taken into account in implementing EU policies in a number of areas, including agriculture. Other EU legislation relating to clones includes the traceability requirements for food producing animals and the Novel Foods Regulation, whilst, in the case of organic farming, forms of artificial reproduction (apart from artificial insemination) must not be used.


1.14 The Commission concludes that, whilst it is scientifically accepted that there are no food safety concerns about food produced from clones or their offspring, the animal welfare risks provide a solid basis for it to initiate legislation. After identifying a range of options — including preserving the legal status quo; a total prohibition on the cloning of farm animals for food on EU territory, on the use of clones and on the placing on the market of food from them, including imports; on the placing on the market of the offspring of clones and food arising from such offspring, and on the use of reproductive material from clones — it says that it will propose to:

  • 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;
  • establish the traceability of imports of semen and embryos to allow farmers and industry to set up data banks of offspring in the EU.

It adds that the measure would be based on the appropriate legal basis, with a review clause after five years, and that cloning would remain possible for all purposes other than food production (such as research, the production of pharmaceuticals, and the conservation of endangered species or breeds). Also, it will during the review period monitor the scientific and technical development of cloning in order to assess whether, when and under which conditions these provisional conditions could be removed.

The Government's view

1.15 In his Explanatory Memorandum of 18 November 2010, the Minister of State at the Department for Environment, Food & Rural Affairs (Mr Jim Paice) says that the Government's general view is that all regulation should be proportionate and enforceable, safeguarding the principles of food safety and consumer choice and guided by the principles of better regulation and evidence-based decision-making. He adds that it recognises that cloning is not a traditional breeding technique, and that approval therefore needs to be sought under the Novel Foods Regulation before food from clones themselves can be marketed, but it agrees that controls should not apply to immediate offspring or later generations where these are conceived by traditional breeding techniques. Also, whilst recognising that cloning is a relatively new technique, requiring the welfare of clones and their surrogate dams to be protected, it believes that existing EU legislation is sufficient to deal with welfare issues.

1.16 The Minister suggests that a ban, or temporary prohibition, on cloning, the use of clones and the marketing of food from clones is disproportionate in terms of food safety and animal welfare, and he says that the UK will oppose the proposed temporary suspension because insufficient evidence has been produced to justify it, adding that the UK would need to see an Impact Assessment which demonstrates the need for, and benefit of, a new regulation. He also notes that the proposed traceability system would require semen and embryos from cloned animals imported from third countries to be identified as such on import certificates, and that the cloned status of the parent would need to be included on the import certificate. However, he suggests that the value of any subsequent information system is open to question because it would not deal either with offspring of clones already present within the EU or with imported food derived from animals with clones in their ancestry. He also points out that, if confined to providing additional information on import certificates, implementation would be relatively straightforward, but that adding information to pedigree certificates would need amending legislation.

1.17 The Minister concludes by saying that an Impact Assessment will be prepared when the Commission makes a formal legislative proposal, but that a temporary ban on the use of cloning techniques within the EU would have little impact in the UK, as there are no companies here currently offering a commercial cloning service. However, he adds that it is important not to deny to UK industry technology which is available elsewhere in the world, and which could be useful in bringing about more rapid access to desirable traits, including resistance to disease. He also notes that, although indicating on import certificates whether semen or embryos derive from cloned animals would involve negligible cost, if would be very expensive is this led to pressure to amend official traceability schemes.


1.18 Compared with many similar documents, this is a well presented report, which deals in a balanced and sensible manner with a range of issues arising on this subject, and which suggests that, although food safety may not be an issue in relation to the cloning of animals for food production, this can give rise to a number of welfare and ethical concerns. It also concludes by saying that the Commission intends to put forward certain legislative proposals, including a temporary suspension of cloning 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.

1.19 This is evidently a topic of undoubted public interest, and we note the Government's reservations about aspects of the immediate course of action proposed by the Commission. In view of this, we think this would be good opportunity for the House to explore these issues further, and we are therefore recommending that the report be debated in European Committee A.

1   Cloning is defined as replication by somatic cell nuclear transfer to create genetic replicas. The report does not cover embryo splitting or any form of genetic modification. Back

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