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Who does what?

In Germany

Federal Office of Consumer Protection and Food Safety (BVL)

The Central Committee on Biological Safety (ZKBS) administrative office is located at the BVL. It receives enquiries to the ZKBS regarding the safety of genetic engineering as well as applications for the authorisation of genetic engineering facilities and operations, along with applications for micro-organisms to be classified as donor or recipient organisms for genetic engineering operations. Applications for the authorisation of genetic engineering operations and facilities are checked here. Additionally, the administrative office prepares responses and opinions from the ZKBS and coordinates the decision-making procedures.

The BVL is also the approval authority for the deliberate release of genetically modified organisms (GMOs) for scientific trials. If applications for the marketing authorisation of GMOs are made to the EU (for placing on the market), either for cultivation or for the use of GMOs as food or feed, the BVL as the national competent authority delivers its opinion on these applications as part of the EU Community approval procedure. As the competent authority in Germany, the BVL may be requested by the European Food Safety Authority (EFSA) to perform an environmental risk assessment for the cultivation of a new genetically modified plant.

GMOs that have been cultivated or released are registered at the GMO location register, which is maintained at the BVL. The BVL also coordinates activities aimed at safeguarding coexistence and environmental monitoring (GMO monitoring) in Germany.

The BVL is the competent authority for the Biosafety Clearing-House (BCH) in Germany. It is responsible for posting information on genetic engineering on the BCH Central Portal, thus making this information available to Contracting States and the public worldwide. The BVL is also the responsible contact point for notifications of the unintended transboundary movement of GMOs in cases affecting Germany.

If GMOs are exported from Germany and either released or cultivated outside the EU, this must be communicated to the BVL prior to exportation.

Furthermore, the BVL maintains databases on genetic engineering operations and facilities as well as on micro-organisms, oncogenes, Escherichia coli recipient strains, vectors and cell lines in order to guarantee nationally consistent standards.

The monitoring activities carried out by the federal states are supported through other tasks performed by the BVL. For example, the BVL publishes the “Amtliche Sammlung von Untersuchungsverfahren” (Official Collection of Methods of Analysis), hosts the national reference laboratory for GMOs and takes on a coordinating role in the event of the detection of unauthorised GMOs.

Central Committee on Biological Safety (ZKBS)

As a voluntary expert panel, the ZKBS advises the federal government and the federal states on issues relating to the safety of genetic engineering. It carries out risk assessments for micro-organisms and containment level assignments for genetic engineering operations and recommends suitable technical and organisational safety measures for these operations. Moreover, the ZKBS evaluates possible risks for humans, animals and the environment associated with deliberate release or placing on the market of GMOs.

Advisory authorities: The Robert Koch Institute (RKI), the Federal Institute for Risk Assessment (BfR), the Federal Agency for Nature Conservation (BfN), the Julius Kühn Institute (JKI), the Friedrich Loeffler Institute (FLI) and the Paul Ehrlich Institute (PEI)

The BVL reaches decisions regarding the deliberate release of GMOs in consultation with the BfN, the BfR and the RKI. The JKI, the ZKBS and the competent authority of the federal state concerned deliver opinions on the planned release. The involvement of the PEI and the FLI is required in cases of deliberate release of genetically modified vertebrates or GMOs that are to be used with vertebrates.

The BVL also delivers opinions on applications for marketing authorisation for GMOs in the EU with the involvement of the advisory authorities.

Federal states

The federal states are responsible for monitoring genetic engineering facilities, deliberate releases into the environment and placing on the market of GMOs and products made from GMOs. As part of the official food and feed monitoring, the responsible federal state authorities carry out regular testing of samples taken from the manufacturer or the trade for this purpose. Genetic engineering operations and facilities and seed stocks are also subjected to regular controls.

Federal Ministry of Food, Agriculture and Consumer Protection (BMEL)

The BMEL prepares the Genetic Engineering Act legislative procedure and its related regulations and represents Germany in the “Standing Committee on the Food Chain and Animal Health” in Brussels. Agreements regarding marketing authorisations for GMOs either for the purposes of cultivation or as food or feed are reached in this committee.

Members of the ZKBS and their deputies are appointed by the BMEL in agreement with the respective federal ministries of education and research, economics and technology, labour and social affairs, health, and the ministry for the environment, nature conservation and nuclear safety.

As the national contact point, the BMEL represents Germany in panels for the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.

In Europe

European Commission

The European Commission is responsible for granting authorisation for placing on the market of GMOs and genetically modified food and feed in a joint EU Community procedure.

The European Commission also maintains the European Reference Laboratory for Genetically Modified Food and Feed (EURL-GMFF) in Ispra (Italy), which is situated in the Joint Research Centre of the European Commission. Testing and validation of the official detection methods for GMOs are coordinated by the EURL. The EURL works in close cooperation with the European Network of GMO Laboratories (ENGL), in which the BVL is represented as well.

European Food Safety Authority (EFSA)

Risk assessments for food and feed safety in the EU are carried out by the EFSA. It works in close cooperation with the national authorities of the Member States and delivers scientific opinions and recommendations, which are used as the basis for risk management decisions made by the European Commission, the European Parliament and the EU Member States. Each of the subject areas has its own specialist panel. The GMO panel carries out risk assessments for GMO safety. During the application process for placing on the market of GMOs scientific information and data are monitored and, taking into account the national opinions of the EU Member States, recommendations are delivered. Based on these recommendations, the European Commission decides whether the approval will be granted for use as food or feed or for cultivation.

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