Elaboration of scientific opinions on applications for the release and placing on the market of GMO
According to the Gene Technology Act (GenTG) the release of GMO and the commercialisation of products which contain, or consist of, GMO are subject to authorisation. The authorisation has to be granted when all safety measures according to the state of the art of science and technology are taken, and no harmful effects on the legally protected rights mentioned in §1 No. 1 (see below) which are not justified by the purpose of the release or placing on the market are to be expected. A decision on such applications has to be taken within 90 days.
The decision of the responsible federal authority (= BVL; Federal Office of Consumer Protection and Food Safety) is issued after agreement with the Federal Agency for Nature Conservation (BfN), with the Robert Koch-Institute (RKI) and the Federal Institute for Risk Assessment (BfR); also the opinions of the Central Commission for Biological Safety (ZKBS), of the Julius Kühn-Institute (JKI) and, in so far as GM vertebrates or GM microorganisms for application on vertebrates are concerned, the opinions of the Friedrich-Loeffler-Institute (FLI) and of the Paul-Ehrlich-Institute (PEI) have to be taken into account. Before the final authorisation for release into the environment is issued the responsible federal state authority must give its comment, and the public must be involved.
§ 1 GenTG
The objective of the GenTG is
- in consideration of ethical values, to protect the life and health of human beings, the environment with its interactions, animals, plants and goods from harmful effects of gene technological processes and products, and to take precautions against such harmful effects;
- to make sure that goods, especially food and feed products, can be produced and placed on the market either by conventional or by ecological methods, or by the use of GM organisms;
- to establish the legal frame for research, development, use, and promotion of the scientific, technical, and economic chances offered by gene technology.