Substantial equivalence

The concept of substantial equivalence, or equivalent material is used for risk assessment of new foods, particularly genetically modified foods. It was the first time in 1993 by the OECD in connection with the assessment of foods derived from genetically modified organisms (GMOs ) into a broader discussion and established as a result in many countries as a basis for assessing the safety of such foods and food ingredients.

Scientific aspects

The principle of substantial equivalence assumes that a newly developed food is as safe as an existing, if it has the same composition, and therefore needs no further security checks. This is based on the empirical evidence to suggest that there is no further change in the genetic material through the process of genetic modification and the total change is only in the newly introduced genes. This approach is criticized by environmentalists because in their opinion essential aspects of the change in the plant genome are not investigated.

In estimating the potential health risks of foods derived from genetically modified organisms ( GMOs) and toxicological aspects of allergy in the foreground. Toxic or anti-nutritional effects could come from both new proteins formed in the GMO itself and effects of genetic modification on the genome ..

The legal framework in the EU

Food from GMOs ( GM foods ) that are placed on the market within the EU must ( with as of March 2003) through an authorization process under Regulation 258/97 on novel foods and food ingredients ( Novel Food Regulation ), in which possible health risks are reviewed. Toxicological and allergy aspects are not explicitly mentioned in the Regulation, are implicit, however, a focus of these tests.