Applications pursuant to Directive 2001/18/EC

Applications for the placing on the market of GMOs which are not intended for use as food or feed must be submitted to the competent authority of the EU Member State in which the GMO will be placed on the market for the first time (Article 13 (1) of Directive 2001/18/EC). The BVL is the competent authority in Germany.

The requirements for application documents are governed by Article 13 (2) of the Directive in conjunction with Annexes II, III, IV and VII.

Risk assessments for applications pursuant to Directive 2001/18/EC are carried out by the authority to which the application has been submitted..

Applications pursuant to Regulation (EC) No. 1829/2003

Applications for approving the placing on the market of food and feed which either consists of GMOs, contains GMOs or was manufactured from GMOs must be submitted to the competent authority of an EU Member State. The BVL is the competent authority in Germany.

The requirements for application documents are governed by Article 5 (3) and Article 17 (3) of Regulation (EC) No. 1829/2003. In addition, the documents referred to in Article 5 (5) and Article 17 (5) of the regulation must be attached to applications for GMOs or food and/or feed that either contain or consist of GMOs.

Approval for the cultivation of genetically modified plants intended for the purposes of food or feed can also be the subject of applications pursuant to Regulation (EC) No. 1829/2003.

Risk assessments for applications pursuant to Regulation (EC) No. 1829/2003 are carried out by the European Food Safety Authority (EFSA).

European Food Safety Authority (EFSA) Guidelines

The European Food Safety Authority (EFSA) has numerous guidance documents which give recommendations as to the structure and content of applications for approval for placing on the market.

• „Guidance document for the risk assessment of genetically modified plants and derived food and feed by the Scientific Panel on Genetically Modified Organisms (GMO)“
• „Guidance on the environmental risk assessment of genetically modified plants“
• „Guidance Document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants containing stacked transformation events”
• „Guidance document for the risk assessment of genetically modified microorganisms and their derived products intended for food and feed use by the Scientific Panel on Genetically Modified Organisms (GMO)”