European Union and International issues

Implementation of Directive 2001/18/EC on the Deliberate Release of Genetically Modified Organisms into the Environment

In February 2001, the EU adopted new legislation - Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms. The UK and other EU Member States were required to transpose the new Directive into national legislation by October 17 2002.

In the UK, Defra and the devolved administrations are responsible for implementing the Directive in England, Scotland, Wales and Northern Ireland respectively.

In England, the Genetically Modified Organisms (Deliberate Release) Regulations 2002 were placed before Parliament on 26 September 2002 and entered into force on 17 October 2002. Similar regulations for Scotland and Wales came into force in December 2002. Regulations for Northern Ireland are expected to enter into force in April 2003.

In England, we adopted an implementation strategy involving two public consultations. The first of these asked for public comments on general issues raised by the new Directive (and the results of this exercise were used to inform the drafting of implementing regulations). The second consultation asked the public for views on the regulations in draft. Copies of both consultation papers, and analysis of responses received can be found below.

Practical guidance on the legislation controlling the deliberate release of genetically modified organisms (GMOs) in England has also been produced.

See:

• Control of GM products in the EU, and the possibility of "GM-free" zones under Article 19 of Directive 2001/18/EC (21 February 2003)
• Deliberate Release of Genetically Modified Organisms - A Guide
• Strengthened GMO safety legislation for England (News Release, 17 October 2002)
• Implementing Directive 2001/18/EC: Regulatory Impact Assessment (Adobe Acrobat format, 610 KB)
• Analysis of responses to the 2^nd Consultation (Adobe Acrobat format, 60 KB)
• 2^nd Consultation paper (Adobe Acrobat format, 210 KB)
• Summary of responses to the 1^st Consultation (Adobe Acrobat format, 60 KB)
• 1^st Consultation paper (Adobe Acrobat format, 190 KB)
• The Genetically Modified Organisms (Deliberate Release) Regulations 2002 (Statutory Instrument 2002/2443) are available at www.hmso.gov.uk/si/si2002/20022443.htm (on the HMSO web site)
• For EU Directive 2001/18/EC see
  http://europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_106/l_10620010417en00010038.pdf
  (If the document cannot be located via this link, European Union legal documents can be accessed at this site)

EU and International Agreements

We deal with the negotiation and implementation of international legislation and treaties relating to GMOs, such as the Cartagena Protocol, the EU proposal on the transboundary movement of GMOs and the EU proposal on the traceability and labelling of GMOs.

Transboundary movement of GMOs

The Cartagena Protocol on Biosafety is a UN multinational environment agreement designed to secure an adequate level of environmental protection against any cross-border movements of GMOs. It also helps to provide a safety net for the protection of biodiversity in developing countries which do not have the necessary systems and capacity in place to control trade in GMOs. The Government are working with the European Union to develop a regulation on the transboundary movement of GMOs to implement in the EU those aspects of the Cartagena Protocol not covered by existing legislation. Please see our Cartagena page for more information on this area.

Traceability and Labelling

Under current EU legislation, GMOs must be labelled, as must GM food ingredients and non-GM ingredients that have a more than 1% incidental GM presence. The Government are working with the European Union to develop further regulations on the authorisation, traceability and labeling of GMOs. The traceability and labelling regulation will provide harmonized EU rules on the documentation required to account for and identify GM products throughout the supply chain. The Government supports labeling rules that are practical, proportionate and enforceable and in line with our international obligations.

Other international initiatives

We deal with other international initiatives concerned with GMOs, including for example work undertaken by the Organisation for Economic Cooperation and Development (OECD) on biotechnology and work on biosafety undertaken by the United Nations Environment Programme (UNEP).

Links

Legal Framework
www.defra.gov.uk/environment/gm/background/legal/index.htm

Directive 2001/18EEC
http://europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_106/l_10620010417en00010038.pdf

Draft Legislation on Traceability and Labelling
(amending Directive 2001/18/EC)
http://www.europa.eu.int/eur-lex/en/com/pdf/2001/en_501PC0182.pdf

Draft Legislation on Transboundary Movements
(implementing the Cartagena Protocol on Biosafety)
www.defra.gov.uk/corporate/consult/cartagena/index.htm
(consultation closed 25 October 2002)

Organisation for Economic Corporation and Development (OECD) www.oecd.org/EN/home/0,,EN-home-0-nodirectorate-no-no-no-0,FF.html
carries out work on biotechnology and biosafety under the UN Environment programme.

United Nations Environment Programme (UNEP)
www.unep.org
encourages sustainable development through sound environmental practice.
Specific information on biosafety can be found at www.unep.org/unep/program/natres/biodiv/irb/welcome.htm

Aarhus Convention
See www.sustainable-development.gov.uk/what_is_sd/transparency.htm