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The European Food Safety Agency’s opinion follows a request from the European Commission to EFSA for advice on this issue in February 2007 and public consultation on a draft opinion earlier this year. Prof. Vittorio Silano, chair of EFSA’s Scientific Committee, when presenting the opinion said:

"It is clear there are significant animal health and welfare issues for surrogate mothers and clones that can be more frequent and severe than for conventionally bred animals. For cattle and pigs, food safety concerns are considered unlikely.

No clear evidence has emerged to suggest any differences between food products from clones or their offspring, in terms of food safety, compared to products from conventionally bred animals.

But we must acknowledge that the evidence base, while growing and showing consistent findings, is still small. That has been one of the challenges throughout this work."

EFSA’s drew several conclusions in its opinion statement.

- 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 were available.
- The health and welfare of a significant proportion of clones, mainly within the juvenile period for cattle and perinatal period for pigs, have been found to be adversely affected, often severely and with a fatal outcome.
- Somatic Cell Nucleus Transfer (SCNT) (the most common technique used to clone animals) has resulted in the production of 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. However, such a conclusion is based on the assumption that meat and milk are derived from healthy animals which are subject to relevant food safety regulations and controls.
- No environmental impact is foreseen but there are only limited data available.

Prof. Silano added:

"EFSA cannot always offer simple answers or reassurances. Complex and evolving science and technology, where data can be limited, do not offer such neat solutions. Our advice is guided by the science and will help inform consideration of any future EU measures in relation to animal clones and products obtained from these animals and their offspring."

EFSA made several recommendations in its opinion statement:

- The health and welfare of clones should be monitored during their production life and natural life span.
- As food animals other than cattle and pig have also been produced via SCNT, risk assessments should be performed on these species when relevant data become available.
- Investigate further the causes of pathologies and mortality observed in clones during the gestational and postnatal periods and those observed at a lower frequency in adulthood.
-  Further investigate the immunocompetence and the susceptibility of clones and their offspring to diseases and transmissible agents when reared and kept under conventional husbandry conditions.
- Perform studies on animal welfare, including behavioural studies, in healthy clones under normal husbandry conditions.

EPHA’s opinion

- EPHA believes the EFSA opinion on the implications of animal cloning on food safety, animal health and welfare and the environment finally brings some clarity to this issue for the whole European Union.

- EPHA is pleased that EFSA acknowledged the need for more scientific data on the potential risks of animal cloning to human health.

- The recommendations made in the EFSA opinion are welcomed as they aim to understand the full repercussions of cloning.

- EPHA understands the difficult role of EFSA as an risk assessor but would like to call for a clearer stance from both EFSA and the Commission rather than ’sitting on the fence’ as it has up until now.

Commission’s opinion

The Commission released a ’very preliminary response’ to this opinion acknowledging the increased concerns about animal health and welfare expressed in the opinion.

The Commission also stated that they had launched a Eurobarometer survey to gauge public opinion on the subject.

This opinion comes just ahead of the World Organisation for Animal Health (OIE) meeting on animal welfare in Panama City on August 19-20. The recent opinion could have some baring on this meeting that is financially backed by the European Commission


For more information

- Click here to read the Commission’s response in full

- EFSA’s scientific opinion

- Summary of EFSA’s scientific opinion

- Website of the European Group on Ethics in Science and New Technology

EPHA related articles

- **UPDATED** EFSA’s consultation and opinion on animal cloning

- European Food Safety Authority (EFSA) Work Plan 2008

- An international informal debate on ethics and science

- **Update** EFSA calls for Scientific data on applications of Nanotechnology and Nanomaterials used in Food and Feed, February 2008

Last modified on July 25 2008.

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