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Placing on the market of genetically modified organisms

Placing on the market - Marketing authorisation for genetically modified food and feed

“Placing on the market” refers to the sale of GMOs or products containing GMOs to third parties. Approval is required before GMOs can be placed on the market. Decisions relating to the placing on the market of GMOs are reached during an EU-wide approval procedure and are applicable to all EU Member States.

The competent authorities of all Member States participate in the approval procedure. The competent authority for Germany is the BVL. The BVL delivers opinions relating to applications for GMOs to be placed on the market in consultation with the Federal Agency for Nature Conservation (BfN), the Federal Institute for Risk Assessment (BfR) and the Robert Koch Institute (RKI). The Julius Kühn Institute - Federal Research Institute for Cultivated Plants (JKI) delivers its opinion to the BVL.

Decisions as to whether the GMO is to be used as a food or feed (Regulation (EC) No. 1829/2003) or not (Directive 2001/18/EC) are made in the process of the approval procedure. Approval is not required for the marketing of products manufactured from GMOs if these are not intended for use as food or feed and do not contain any organisms capable of replication (e.g. cotton shirt). Marketing authorisations are issued for specific purposes, such as for importation into the EU or for the cultivation of crops in the EU.

Whereas experimental releases are restricted in terms of time and location, the agricultural cultivation of genetically modified plants is not restricted to specific locations or particular trial years. Marketing authorisations are initially issued for a maximum of ten years.

The federal states are responsible for inspections and control measures with respect to the placing on the market of GMOs and products manufactured from GMOs.

Strict regulations for the approval and labelling of genetically modified food and feed have been applicable in the EU since 2004. The European Food Safety Authority (EFSA) is responsible for carrying out scientific safety assessments. Genetically modified food and feed which had been on the market before 2004 may still be placed on the market provided that the manufacturers have presented safety assessment information to the EU Commission corresponding to the new, stricter regulations. In addition, a standardised detection procedure for the respective GMO must be available.

The BVL provides information on GMOs and products made from GMOs which are either under application or have been approved in the EU Member States.

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