As a member of the EU the European legislation on genetically modified organisms (GMOs), which has been in place since the early 1990s, is either directly applicable in Germany or has been implemented into German law. The EC has created a comprehensive legal framework and introduced specific legislation on GMOs. Therefore, the comprehensive information given in the report of the EU also partly covers the situation in Germany. Germany has fully implemented existing EC-legislation into national law through the German Gentechnikgesetz [Genetic Engineering Act] and the EG-Gentechnik-Durchführungsgesetz [EC Genetic Engineering Implementation Act]. These legal documents are publicly available on the homepage of the German Competent National Authority (BVL) which also hosts the German BCH-homepage: https://www.bvl.bund.de/DE/06_Gentechnik/gentechnik_node.html and http://www.biosafety-bch.de. In addition to European legislation German law foresees administrative fines and penalties to ensure compliance with relevant provisions. The Articles 38 and 39 of the German Gentechnikgesetz [Genetic Engineering Act] as well as the §§ 6 and 7 of the German EG-Gentechnik-Durchführungsgesetz [EC Genetic Engineering Implementation Act] include penal provisions that serve to enforce the aims and provisions of the Cartagena Protocol. These provisions penalize actions that can contravene the goals of the Cartagena Protocol, for example the deliberate release of a GMO into the environment or the placing on the market of a GMO without the necessary authorization. Moreover, § 6, 2nd paragraph of the German EG-Gentechnik-Durchführungsgesetz [EC Genetic Engineering Implementation Act] penalizes the transboundary movement of living modified organisms carried out in contravention of the relevant German and European laws. Further details see report of the EC.

See report of the EC.

See report of the EC.

See report of the EC. To the German experience, applications/notifications regarding the transboundary movement of LMOs for intentional introduction into the (German) environment refer to applications regarding the (commercial) use of LMOs. In the EU, decisions regarding applications with this objective are taken at the EU level among the EU member states, but not by a single EU member state. Information to questions 29-37 regarding the EU level will be delivered from the EU NFP.

See report of the EC. In the EU, decisions on LMOs-FFP are taken at the EU level among the EU member states, but not in a single EU member state. Information to questions 41-43 regarding the EU level will be delivered from the EU NFP. The EU has developed a comprehensive legal framework on GMOs, which also addresses the import of GMOs intended for direct use for food or feed, or for processing. The EU has declared, with reference to Article 14.4 of the Cartagena Protocol that it relies on its existing legal framework for intentional movements of GMOs within the EU and for imports of GMOs into the EU.

In 2009, Germany decided to suspend an existing EU-authorisation for the intentional introduction of a LMO into the environment for cultivation at the national level.

See report of the EC.

See report of the EC.

See report of the EC.

See report of the EC.

See report of the EC. Regulation (EC) No. 1946/2003 and other relevant EU regulations are implemented into national laws where appropriate, e.g. EG-Gentechnik-Durchführungsgesetz.

See report of the EC.

c) Bilateral, multilateral and regional agreements and arrangements Not applicable, no such agreements or arrangements in Germany. e) Transit: Not applicable; transit of LMO through Germany does not require LMO-specific decision. f) Contained use: According to national law, the import of LMO for contained use does not require a specific import authorisation processes under the Genetic Engineering Act. However, handling of these LMO is regulated in the contained use legal framework. g) UTM: Not applicable, no release of LMOs in Germany in the current period. h) ITM: In most cases of ITM, trace amounts of unauthorised LMO were detected in the affected lots. Measures were successfully taken to prevent these products from entering the market, or these products were successfully withdrawn from the market. The affected countries were informed about the incidents. i) Import for introduction into the environment: In the current reporting period, no applications on decisions regarding the importation of LMOs for intentional introduction into the environment were presented in Germany. For this period the answer is: not applicable, no corresponding application. For the previous periods Germany abstained from entering redundant information on (confined) field trial risk assessments and decisions due to priority considerations. Here the answer is: Information available but only partially available in the BCH (see q) below) k) Domestic use as food or feed, or for processing: In the EU these decisions are taken at the EU level. EU competent authority informs the Parties through the BCH. m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6): Not applicable n) Review and change of decisions: Not applicable, no revision of decisions undertaken. p) LMOs with exemption status: Not applicable; no such LMOs q) Summaries of risk assessments: In the case of repeated environmental releases of (almost) identical LMOs, only the decision and risk assessment on the most recent release is published in the BCH in order to avoid duplication (see i) above).

See report of the EC.

See report of the EC.

See report of the EC.

See report of the EC.

See report of the EC.

See report of the EC.

See report of the EC.

In Germany, the EU-directive 2004/35/CE on environmental liability has been transposed into national law by enactment of the Umweltschadensgesetz (USchadG).