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The German Biosafety Clearing-House

Legal framework

There are several layers of legal framework in the area of gene technology. All aim at protecting humans, animals, and the environment from adverse effects caused by the application of gene technology or products derived thereof.

International treaties and agreements

International treaties and contracts are the instruments for intergovernmental relations.

Directives, Regulations and Decisions, as well as Opinions and Recommendations issued by the European Union  

Legally binding instruments at the level of the European Union (EU) are Directives, Regulations and Decisions. EU institutions may issue Recommendations and Opinions, too. The most important regulations regarding GMOs are Directives 2001/18/EC and 2009/41/EC and Regulation (EC) No 1829/2003. Commission Regulation (EC) No 1946/2003 implements the contents of the Cartagena Protocol at EU level.

EU Directives set a legal frame that is binding within the EU. They need to be implemented into national law in each Member State. EU Regulations, however, are applicable directly in the Member States, an implementation is not necessary. EU Decisions, however, are applicable to the referred issue and the specific applicant only. They resemble so-called administrative decisions (Verwaltungsakt) in Germany.

Legal regulations in Germany  

In order to find German entries in the database of the Biosafety Clearing-House (BCH) Central Portal concerning legal regulations, guidelines and opinions of the Central Committee on Biological Safety (ZKBS) please check here in the German country profile of the BCH.


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