EFSA’s Scientific Committee (SC)[3], which includes the chairs of all of EFSA’s Panels, has led this work as it is a multi-disciplinary issue relevant to a number of the Panels’ respective areas of expertise. They have been assisted by a Working Group of scientists with relevant expertise to consider the different aspects of the Commission’s request.

Some of the key conclusions of the draft opinion include:

• Although death and disease rates of clones are significantly higher than those observed in conventionally reproduced animals, healthy clones and their offspring indicate that somatic cell nucleus transfer (SCNT)[4] can be successfully used as a reproductive technique in cattle and pigs. Based on a number of parameters including physiological and clinical ones, healthy clones and healthy offspring do not show any significant differences from their conventional counterparts.
• The health and welfare of a significant proportion of clones have been found to be adversely affected. The proportion of unhealthy clones is likely to decrease as the technology improves.
• Food products obtained from healthy cattle and pig clones and their offspring, i.e., meat and milk, are within the normal range with respect to the compositionand nutritional valueof similar products obtained from conventionally bred animals. In view of these findings, and assuming that unhealthy clones are removed from entering the food chain as is the case with conventionally bred animals, it is very unlikely that any difference exists in terms of food safety between food products originating from clones and their progeny compared with those derived from conventionally bred animals.
• No environmental impact is foreseen as a result of animal cloning, but there is only limited data available.

This draft opinion acknowledges that SCNT is a relatively new technology and the available data for risk assessment are limited. Most studies have been of small sample size and the currently available data only allow for an assessment of cattle and pig clones and their progeny. In addition, as SCNT is a developing technology, information on animals reared and remaining alive for considerable periods of time is limited. Also, the current welfare assessment is largely based on interpretation of limited data.

EFSA is launching a consultation on its draft opinion. Comments can be submitted until 25 February 2008. Contributions to the consultation can be made via the EFSA website. EFSA will also hold a stakeholder meeting in February and engage in consultation with EU Member States (MS) through its Advisory Forum.

The Working Group and the SC will consider the comments and contributions made during the consultation. It is likely that the SC will be able to then consider a revised draft of the opinion for possible adoption at its April meeting and subsequent publication in May 2008.

The EC has also asked for an opinion from the European Group on Ethics in Science and New Technologies which will address ethical issues around this issue. This will complement EFSA’s work as EFSA does not have a mandate to consider ethical, moral or other societal issues beyond its scientific remit.

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