Navigation and service

European law

The European Union’s legally binding means of action are directives, regulations and decisions. The EU institutions can also make recommendations and offer opinions:

EU directives set a legal framework which is effective throughout the EU. They must be transposed into the national law of the individual EU Member States. For example, the Directive 2009/41/EC on contained use of genetically modified micro-organisms and the Directive 2001/18/EC on deliberate release of GMOs into the environment have been transposed into German law by the Genetic Engineering Act (GenTG).

EU regulations are directly applicable in the EU Member States. Implementation into national law is not required. However, it is possible to address national responsibilities in national ordinances. For example, tasks derived from the Regulation (EC) No 1829/2003 on genetically modified food and feed are assigned to the Federal Office of Consumer Protection and Food Safety (BVL) under German law.

With EU decisions, however, only the issues addressed in the decision are binding for the authorities concerned. In this respect, they are similar to the so-called “Verwaltungsakte” (administrative acts) in German law. For example, pursuant to the Directive on the deliberate release of genetically modified organisms, the EU has decided on the organisation of documents which must accompany an application for authorisation of deliberate release of GMOs into the environment or placing them on the market.

EU recommendations and opinions are not legally binding in contrast to acts and regulations. However, they frequently provide a basis for the harmonised interpretation and implementation of European regulations throughout the EU.

Directive 2001/18/EC on the deliberate release of GMOs into the environment in conjunction with the Directive 2009/41/EC on contained use forms the legislative framework for the European law on genetic engineering. The Directive on contained use regulates the handling of genetically modified organisms and micro-organisms in genetic engineering facilities such as laboratories with special equipment. The Directive on the deliberate release of GMOs into the environment covers all kinds of organisms and micro-organisms, also including animals and plants and establishes, among other things, the legal conditions for field trials and certain forms of placing on the market.

In 2015, the Directive 2015/412/EU modified the Directive 2001/18/EC on the deliberate release of GMOs allowing EU member states to restrict or prohibit the cultivation of genetically modified plants on their territory under certain conditions.

Further central regulations which govern the implementation of GMOs include the Regulation 1829/2003/EC on genetically modified food and feed (placing on the market), the Regulation 1830/2003/EC on traceability and labelling and the Regulation 1946/2003/EC on transboundary movements of genetically modified organisms,.

Directives

Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC


Regulations

Commission Regulation (EU) No 619/2011 of 24 June 2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired
Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91
Commission Regulation (EC) No 1981/2006 of 22 December 2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms
Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation
Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms
Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety


Decisions

Commission Implementing Decision 2011/884/EC of 22 December 2011 on emergency measures regarding unauthorised genetically modified rice in rice products originating from China and repealing Decision 2008/289/EC
Commission Decision 2010/315/EC of 8 June 2010 repealing Decision 2006/601/EC on emergency measures regarding the non-authorised genetically modified organism ‘LL RICE 601’ in rice products, and providing for random testing for the absence of that organism in rice products
Commission Decision 2004/204/EC of 23 February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council
Commission Decision 2003/701/EC of 29 September 2003 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market
Council Decision 2002/813/EC of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market
Council Decision 2002/812/EC of 3 October 2002 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products
Council Decision 2002/811/EC of 3 October 2002 establishing guidance notes supplementing AnnexVII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
Commission Decision 2002/623/EC of 24 July 2002 establishing guidance notes supplementing AnnexII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
Commission Decision 94/730/EC of 4 November 1994 establishing simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6 (5) of Council Directive 90/220/EEC
Commission Decision 93/584/EEC of 22 October 1993 establishing the criteria for simplified procedures concerning the deliberate release into the environment of genetically modified plants pursuant to Article 6 (5) of Council Directive 90/220/EEC


Recommendations of the Commission

Commission Recommendation 2010/C 200/01 of 13 July 2010 on guidelines for the development of national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops
Commission Recommendation 2004/787/EC of 4 October 2004 on technical guidance for sampling and detection of genetically modified organisms and material produced from genetically modified organisms as or in products in the context of Regulation (EC) No 1830/2003

Two clicks for more safety: The element will be activated only after operating the slide control. Data protection information: By activating this external link you will leave the BVL website. We have no influence on the contents of the following website, in particular not on the protection of your personal data. For more information please see our data protection declaration, which you can find here.


© 2018 Federal Office of Consumer Protection and Food Safety