Navigation und Service

Safety assessment of genetically modified food and feed

By way of deviation from the procedures laid down in the Novel Foods Regulation whereby national authorities are responsible for safety assessment, Regulation (EC) No. 1829/2003 envisages a centralised procedure and assigns overall responsibility to the European Food Safety Authority (EFSA). It, in turn, can then delegate responsibility for the safety assessment of food and feed and the environmental impact assessment of genetically modified organisms (GMOs) to one of the competent authorities of the Member States. In Germany, according to the Genetic Engineering Implementing Act, the Federal Institute for Consumer Protection and Food Safety (BVL), in agreement with the Robert Koch Institute (RKI) and the Federal Institute for Risk Assessment (BfR), is responsible for the safety assessment of genetically modified food and feed. The environmental impact assessment is undertaken by BVL in agreement with the German Federal Agency for Nature Conservation (BfN) and RKI. BfR and the Federal Biological Research Centre for Agriculture and Forestry (BBA) draw up expert opinions.

Up-to-date guidelines for the safety assessment of genetically modified plants and derived food were published by the working group of the Scientific Committees for Food, Plants and Animal Nutrition (cf. Guidance Document for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed) and by the Codex Alimentarius Commission (CAC) responsible for international food standards in June 2003 (cf. Codex Principles and Guidelines on Foods Derived from Biotechnology).

The safety assessment is based on the principle of substantial equivalence which was described by an OECD working group in 1993 and further developed in the ensuing years by FAO and WHO. It is based on a comparison of the genetically modified organism with the non-modified starting organism (more information can be found in the document "The Concept of Substantial Equivalence").

Genetically modified food and feed may only receive marketing authorisation if it has been demonstrated in comprehensive studies that they are just as safe as comparable conventional products. Furthermore, in the case of GMO-containing food and feed it must also be shown that the GMOs do not constitute a threat to the environment.

The studies required for the testing of food safety encompass the characterisation of genetic modification and the resulting new proteins. Furthermore, comparative analyses are to be undertaken of the nutritive, anti-nutritive, toxic and allergenic ingredients of relevance for the respective organism. This is in order to be able to determine any unintended changes triggered by the genetic modification. If changes are observed, then - depending on the type and scale -a decision must be taken as to which more extensive studies are needed in order to prove the safety of the product.

If new findings are available indicating that a genetically modified food or feed, which has been legally placed on the market, probably constitutes a serious threat to the health of humans, animals or the environment, trade with the product may be suspended or subjected to specific requirements.

Up