EU regulatory framework on biosafety: Genetically modified food and feed

Related:

European Commission report, 2011 (PDF file): Evaluation of the EU legislative framework in the field of cultivation and placing on the market of GMOs (Directive 2001/18/EC and Regulation (EC) No 1829/2003)

Graph: Evolution of the European regulatory framework for the deliberate release and the placing on the market of GMO's

Historical steps toward the development of the EU regulatory framework on GMOs

Until 1997, the placing on the market of GMOs or products derived from GMOs intended for use as food or feed was regulated by Directive 90/220/EEC. From 1997, food containing or consisting of GMOs was regulated by Regulation (EC) No. 258/97 on novel foods. These provisions on GM foods and derived products were replaced in September 2003 by Regulation (EC) No. 1829/2003. The scope of this Regulation extends not only to GMOs for use as food but also to those for use as feed. Furthermore, in contrast to Directive 2001/18/EC which related solely to living GMOs, it also covers the placing on the market of food and feed derived from, but no longer containing GMOs. It establishes the principle of a single "one door – one key" authorisation. The applicant submits a single application for food and feed uses and for cultivation. For GM Food/Feed that are likely to be released into the environment, an environmental risk assessment shall be undertaken in accordance with the principles laid down in Directive 2001/18/EC. The authorisation procedure is centralised at EU level, the European Food Safety Authority (EFSA) playing a central role in the risk assessment process and in contacts with the Member States and applicants.

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

Since 2003, the placing on the market of GMOs and foodstuffs containing these, whether they are intended for consumption by humans or animals, is regulated by a specific Regulation, also referred to as the "GM Food/Feed Regulation".

REGULATION (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed. (OJ L 268, 18.10.2003, p.1)

Detailed rules for the implementation of the GM Food/Feed Regulation have been established in 2004, with regards to the information to be provided in applications and the scientific requirements for the risk assessment. These rules have been amended in 2013 as regards GM plants for food or feed uses, food or feed containing or consisting of GM plants and food or feed produced from GM plants.

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. (OJ L 102, 7.4.2004, p.14)
COMMISSION IMPLEMENTING REGULATION (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006. (OJ L 157, 08.06.2013, p.1)

Products consisting of or containing GMOs and food products obtained from GMOs which have been authorised for commercialisation are subject to traceability and labelling requirements pursuant to Regulations (EC) Nos 1829/2003 and 1830/2003. Labelling provides information for consumers and users of the product and allows them to make an informed choice.

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. (OJ L 268, 18.10.2003, p. 24)

To assist in the implementation of some provisions of Regulation (EC) 1829/2003 (in particular those related to the detection and identification of GMOs), a Community Reference Laboratory (CRL-GMO) has been established and a set of technical guidance adopted.

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. (OJ L 368, 23.12.2006, p.99)
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. (OJ L 348, 24.11.2004, p.18)
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. (OJ L 166, 25.6.2011, p. 9)

Other EU legislation relevant to the production and labelling of GM Food and Feed

COUNCIL REGULATION (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication of the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC (OJ L 159, 03/06/1998, p. 4)
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 (OJ L 189, 20.07.2007, p.1)

Other EU legislation relevant to the implementation of Regulation (EC) No 1829/2003

REGULATION (EC) No 298/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) No 1829/2003 on genetically modified food and feed, as regards the implementing powers conferred on the Commission (OJ L 97, 9.4.2008, p. 64)

The European Food Safety Authority (EFSA) has been established in 2002. EFSA’s role is to assess and communicate on all risks associated with the food chain. It is therefore a key actor in the implementation of the GM Food/Feed Regulation.

REGULATION (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (OJ L 231, 6.9.2019, p.1–28)
REGULATION (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 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. (OJ L 31, 1.2.2002, p. 1)
COMMISSION REGULATION (EC) No 1304/2003 of 11 July 2003 on the procedure applied by the European Food Safety Authority to requests for scientific opinions referred to it. (OJ L 185, 24.7.2003, p.6)
REGULATION (EC) No 1642/2003 of the European Parliament and of the Council of 22 July 2003 amending Regulation (EC) No 178/2002 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. (OJ L 102, 7.4.2004, p.14)
COMMISSION REGULATION (EC) No 2230/2004 of 23 December 2004 laying down detailed rules for the implementation of European Parliament and Council Regulation (EC) No 178/2002 with regard to the network of organisations operating in the fields within the European Food Safety Authority’s mission. (OJ L 379, 24.12.2004, p.64)

Previous EU legislation

REGULATION (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997, concerning novel foods and novel food ingredients. (OJ L 43, 14.2.1997, p.1)
COMMISSION RECOMMENDATION 97/618/EC of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council. (OJ L 253, 16.9.1997, p.1)