EU regulatory framework on biosafety: Other EU legislation pertaining to biosafety

(All the links provided below refer to Eur-lex, the electronic Official Journal of the EU - © European Union, 1998-2016)

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international Treaty which sets common rules for the transboundary movement of GMOs to ensure the protection of biodiversity taking also into account risks to human health. The Protocol has been approved on behalf of the European Community in 2002 (see Decision below). Regulation 1946/2003 has been adopted to complement the existing GMO regulatory framework in place in the EU (in particular Directive 2001/18/EC and Regulation (EC) 1829/2003) to ensure that all legal, administrative and other requirements of the Protocol are fulfilled.

  • COUNCIL DECISION 2002/628/EC of 25 June 2002 concerning the conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafety. (OJ L 201, 31.07.2002, p.48)
  • REGULATION (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms. (OJ L 287, 5.11.2003, p.1)

Coexistence refers to the ability of farmers to make a practical choice between conventional, organic and GM crop production, in compliance with the legal obligations for labelling and/or purity standards. Measures for co-existence should be developed and implemented by the Member States. Recommendation 2003/556/EC helps Member States to develop national legislative or other strategies for coexistence.

  • COMMISSION RECOMMENDATION of 23 July 2003 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming (notified under document number C(2003) 2624). (OJ L 189, 29.7.2003, p.36)

GM seeds and crops are also covered by the general EU legislation on agricultural plant and vegetable varieties, in particular EU Directives 2002/53/EC and 2002/55/EC. Additional information of the relevant rules in the EU is also available from the European Commission website.

The EU has established a framework on environmental liability based on the polluter pays principle to prevent and remedy environmental damage. It also applies to environmental damage caused by GMOs. This framework must also be considered in light of the Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety adopted in 2010.

  • DIRECTIVE 2004/35/CE of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage. (OJ L 143, 30.4.2004, p.56)

The European Commission has set out rules on public access to environmental information which ensure freedom of access to, and dissemination of, information on the environment held by public authorities as well as the basic terms and conditions under which such information should be made available.

  • DIRECTIVE 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC. (OJ L 158, 23.6.1990, p.56)

Most of the current GM crops approved for commercialisation are tolerant to herbicides or resistant to insects. Their use is therefore closely linked to the use of plant protection products. The risk assessment of GM plants for cultivation purposes covers the impacts on the environment of the specific management techniques used, including the change of herbicide practices. Moreover, some plant protection products may also contain GMOs. The EU has established strict rules on the use of plant protection products to ensure a high level of protection of both human and animal health and the environment and at the same time to safeguard the competitiveness of Community agriculture. The regulatory framework establishes a “dual” system: The Commission approves the active substances contained in the products; EU countries authorise the products on their territory and ensure compliance with EU rules.

  • REGULATION (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. (OJ L 309, 24.11.2009, p.1)
  • DIRECTIVE 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides. (OJ L 309, 24.11.2009, p.71)
  • REGULATION (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. (OJ L 70, 16.03.2005, p.1)