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National regulations

In Germany, basically these legal regulations apply in the area of genetic engineering.

Genetic Engineering Act
In Germany, genetic engineering is stipulated in the Genetic Engineering Act It aims both to protect against potential risks arising from the application of genetic engineering as well as to facilitate exploitation of and exploration into genetic engineering.. Essentially, it regulates activities of development and application of genetically modified organisms, in laboratories for example, and also governs deliberate releases of genetically modified organisms into the environment.
Act on the implementation of European Community or European Union regulations in the field of genetic engineering and on labelling for foodstuffs made without genetically modified methods (EGGenTDurchfG)
This act stipulates the interface between European provisions and their implementation in national law. It also specifies the use of the term “non GMO” may be used in food labelling.
Ordinance on consultation procedures in accordance with the Genetic Engineering Act (Genetic Engineering Public Consultation Ordinance - GenTAnhV)
This ordinance specifies the details of public consultation with regard to, for example, the deliberate release of GMOs into the environment or the construction of genetic engineering facilities. This allows the affected community to be made aware of the respective projects. Citizens can raise their objections within a specified time-limit, and, if applicable, they will be discussed at a public hearing.
Ordinance on the documents for application and notification and on the procedure for authorisation and notification, in accordance with the Genetic Engineering Act (Genetic Engineering Procedural Regulation - GenTVfV)
This ordinance stipulates in detail which documents the applicant must submit to the competent authority in the authorisation procedure based on genetic engineering legislation. In conjunction with European regulations, this ordinance also stipulates that, within the scope of deliberate releases of GMOs into the environment, so called simplified procedures for the additional notification of sites can take effect.
German federal ordinance on costs relating to the Genetic Engineering Act (BGenTGKostV)
This ordinance stipulates the amount charged by the Federal Office of Consumer Protection and Food Safety (BVL) for official acts and in which cases they are applicable, in accordance with the Genetic Engineering Act.
Gentechnik-Beteiligungsverordnung (GenTBetV)
This ordinance stipulates the participation of the Council, the Commission and the authorities of the Member States of the EU and of the Agreement on the European Economic Area as regards the authorising procedure for releasing GMOs into the environment and placing them on the market, as well as the procedure for subsequent measures in accordance with the Genetic Engineering Act.
Ordinance on the preparation of external emergency plans and on informing, reporting and notification requirements in accordance with the Genetic Engineering Act (Genetic Engineering Emergency Regulations - GenTNotfV)
This ordinance stipulates when an emergency plan must be prepared by the competent authority. Should such an incident occur, the operator must notify this to the competent authority immediately as per the ordinance. The competent authority then orders the necessary measures.
Ordinance on genetically modified plant production from 7 April 2008 (GenTPflEV)
This ordinance stipulates the principles of good practice pursuant to Section 16b, Paragraph. 3 of the Genetic Engineering Act with regard to the commercial production of genetically modified crops.
Ordinance on the security levels and safety measures for genetic engineering operations in genetic engineering facilities (Genetic Engineering Safety Ordinance - GenTSV)
This ordinance stipulates the safety requirements for genetic engineering operations in genetic engineering facilities and standardises safety requirements when releasing GMOs into the environment.
Gentechnik-Aufzeichnungsverordnung - GenTAufzV
This ordinance stipulates how to keep adequate records during genetic engineering work and release of GMOs into the environment and made them available to the competent authority on request.

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