What is animal cloning?

Cloning is a form of reproduction. The most common technique used is known as Somatic Cell Nucleus Transfer (SCNT). A genetic copy of an animal is produced by replacing the nucleus of an unfertilised ovum with the nucleus of a body (somatic) cell from the animal to form an embryo. The embryo is then transferred to a surrogate dam where it then develops in the womb until birth.

What is EFSA’s role in this issue?

As cloning technology develops so does the possibility of food products from clones or their offspring becoming a commercial reality. This is why the European Commission (EC) has requested EFSA’s expert scientific opinion on the implications of animal cloning on food safety, animal health and welfare and the environment. EFSA provides scientific advice to the EC and other European risk managers, who are the decision makers on any future European Union (EU) measures in relation to animal clones and products obtained from these animals and their offspring.

Who else is involved

The EC also received an expert opinion from the European Group on Ethics in Science and New Technologies (EGE). This complements EFSA’s work because EFSA does not have a mandate to consider ethical, moral or other societal issues beyond its scientific remit .The EC will then consider whether any further action or measures are required. Other countries are also considering the same kind of issues at the moment, for example in the United States, where the US Food and Drug Administration (FDA) has also produced a risk assessment.

Are products from cloned animals on sale today?

At present cloning is not a commercial practice in Europe. There is no information suggesting that products from cloned animals would be on the market in other parts of the world. In the US there has been a voluntary moratorium on the sale of such products since July 2001.

What is EFSA’s opinion on animal cloning

Key conclusions in the opinion include:

  • 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. Only pigs and cattle are addressed in this opinion: the two species of animals where adequate data was available
  • The health and welfare of a significant proportion of clones, mainly within the juvenile period for bovines and perinatal period for pigs, have been found to be adversely affected, often severely and with a fatal outcome.
  • Somatic Cell Nucleus Transfer (the most common technique used to clone animals) has however also produced healthy cattle and pig clones, and healthy offspring, that are similar to their conventional counterparts based on parameters such as physiological characteristics, demeanour and clinical status.
  • There is no indication that differences exist in terms of food safety for meat and milk of clones and their progeny compared with those from conventionally bred animals. Such a conclusion is based on the assumption that meat and milk are derived from healthy animals which are subject to relevant food safety controls
  • No environmental impact is foreseen but there are only limited data available

In a statement adopted in June 2009, EFSA confirmed that the conclusions and recommendations contained in its 2008 opinion were still valid. It also pointed out that not enough data were available to say whether current knowledge on cattle and pigs could applied to the cloning of other species.

What happens next?

EFSA’s scientific advice and that of the EGE, will help inform consideration of any future measures by the EC, Member States and the European Parliament in relation to animal clones and products obtained from these animals and their offspring.