Substantial equivalence
The concept of substantial equivalence or the material equivalent serves to assess the risk of new foods, especially genetically modified foods . It was first introduced into a broader discussion in 1993 by the OECD in connection with the evaluation of foods made from genetically modified organisms (GMOs) and subsequently established in numerous countries as the basis for the safety evaluation of such foods and food ingredients.
Scientific aspects
The principle of substantial equivalence assumes that a newly developed food is just as safe as an existing one if it has the same composition and therefore does not require any further safety tests. This is based on the empirically founded assumption that the process of genetic modification does not result in any further changes in the genetic make-up and that the entire change only consists of the newly introduced genes. This approach is criticized by environmentalists because, in their opinion, essential aspects of the change in the plant genetic makeup are not examined.
When assessing the possible health risks of foods from genetically modified organisms (GMOs), toxicological and allergological aspects are in the foreground. Toxic or anti-nutritional effects could arise from both new proteins formed in the GMO itself and from effects of genetic modification on the genome.
Legal framework in the EU
Foods made from GMOs (GM foods) that are placed on the EU market must (as of March 2003) go through an approval procedure within the framework of Regulation 258/97 for novel foods and food ingredients (Novel Food Regulation), in which possible health risks are examined. Toxicological and allergological aspects are not explicitly mentioned in the regulation, but are implicitly a focus of these tests.
Individual evidence
- ↑ Novel Food, Concept of Substantial Equivalence ( Memento of the original from October 1, 2005 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
- ↑ Risk assessment of genetically modified products
- ^ Substantial equivalence: Its uses and abuses Henry I. Miller, Hoover Institution Nature Biotechnology 17, 1042-1043 (1999)
- ↑ The work of these scientists is scandalous! ( Page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice.
- ↑ Toxicology and Allergology of GMOs (PDF; 334 kB)
- ↑ Summary Toxicology and Allergology of GMOs ( page no longer available , search in web archives ) Info: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice.
- ↑ Summary Toxicology and Allergology of GMOs (PDF; 24 kB)
- ↑ EU Novel Food Regulation ( Memento of the original dated May 4, 2009 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
