Proposed policy update on foods derived from somatic cell nuclear transfer (SCNT) clones and their offspring
Health Canada, in collaboration with other departments, applied a rigorous process in reviewing the scientific literature of foods made from cloned cattle and swine. This is summarized in the Scientific Opinion. The science underpins Health Canada's conclusion that food products made from these animals and their progeny are as safe and nutritious as foods from traditionally bred animals. This is consistent with the interpretation of other trusted jurisdictions.
The Government of Canada has received significant input from both consumers and industry about the implications of this potential policy update. The Department has therefore indefinitely paused the policy update to provide time for further discussions and consideration.
Until the policy is updated, foods made from cloned cattle and swine will remain subject to the novel food assessment. There are currently no approved foods from cloned products on the market in Canada.
Background
In 2003, Health Canada put in place an interim policy on foods derived from somatic cell nuclear transfer (SCNT) clones and their offspring. The interim policy stated that until more was known about the products of this technology, Health Canada would consider these foods to be captured under the definition of "novel food" in the Food and Drug Regulations. As such, these foods were subject to:
- the regulations in Division 28, Part B, of the Food and Drug Regulations
- a mandatory pre-market safety assessment before being sold
This was done at that time because SCNT technology was still in the research and development stage. It was unclear whether there was an impact on the safety and nutritional quality of foods derived from animals generated by SCNT.
Since the publication of the interim policy, Health Canada has worked with Agriculture and Agri-Food Canada (AAFC), the Canadian Food Inspection Agency (CFIA) and Environment and Climate Change Canada (ECCC) to gather and evaluate scientific evidence about the safety of SCNT cattle and swine clones. This work resulted in the development of the Scientific Opinion on the Impact of Somatic Cell Nuclear Transfer (SCNT) Cloning of Cattle and Swine on Food and Feed Safety, Animal Health and the Environment (2023). The scientific opinion is based on the availability of data.
After a review of all available information, the scientific opinion concludes that foods derived from healthy cattle and swine clones and their offspring are as safe as foods from traditionally bred animals. The Canadian scientific opinion agrees with those published by the:
- United States Food and Drug Administration(2008)
- European Food Safety Authority (2008)
- Japan Food Safety Commission (2009)
- New Zealand Food Safety Authority (2010)
Proposed revised policy on foods derived from SCNT cloned cattle and swine and their offspring
Based on the conclusions of the scientific opinion, Health Canada's Food and Nutrition Directorate is proposing that these foods should be regulated in the same manner as those from traditionally bred animals. Foods derived from SCNT clones of other animals such as goat, sheep, etc., (that is, not cattle or swine) would continue to be novel and require a mandatory pre-market safety assessment.
Consequently, foods derived from SCNT cloned cattle and swine and their offspring would no longer be considered novel foods and as such would no longer be subject to pre-market notification under Division 28, Part B of the Food and Drug Regulations. Manufacturers, producers and importers of foods derived from these animals would remain responsible for ensuring these products comply with all applicable legislation including the: