The European Union has established a legal framework to ensure that the development of modern biotechnology, and more specifically of GMOs, takes place in safe conditions.
The legal framework aims to:
Protect human and animal health and the environment by introducing a safety assessment of the highest possible standards at EU level before any GMO is placed on the market.
Put in place harmonised procedures for risk assessment and authorisation of GMOs that are efficient, time-limited and transparent.
Ensure clear labelling of GMOs placed on the market in order to enable consumers as well as professionals (e.g. farmers, and food feed chain operators) to make an informed choice.
Ensure the traceability of GMOs placed on the market
The building blocks of the GMO legislation are:
Directive 2001/18/EC on the deliberate release of GMOs into the environment
Regulation (EC) 1829/2003 on genetically modified food and feed
Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory
Regulation (EC) 1830/2003 concerning the traceabilityand labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms
Directive 2009/41/EC on contained use of genetically modified micro-organisms. Regulation (EC) 1946/2003 on transboundary movements of GMOs
These main pieces of legislation are supplemented by a number of implementing rules or by recommendations and guidelines on more specific aspects.
Reports on the implementation of the GMO legislation can be found here.
Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain (Transparency Regulation)
The Transparency Regulation amended among others Regulation (EC) No 178/2002, Regulation (EC) 1829/2003 and Directive 2001/18/EC. Further information on the implementation of the Transparency Regulation can be found on a dedicated page of DG SANTE’s website.
Directive 2001/18/EC does not provide for the involvement of the European Food Safety Authority (EFSA) on notifications under its Part B (deliberate release of GMOs for any other purpose than for placing on the market).Conversely, this directive requires EFSA to provide scientific output on notifications under Part C of the directive (placing on the market of GMOs as or in products) in certain cases. Therefore, certain provisions of the Transparency Regulation are applicable to the approval procedures of these notifications.
The Commission adopted Notice 2021/C 80/01 to facilitate a smooth and harmonised application of the Transparency Regulation as regards Directive 2001/18/EC. This Notice provides guidance both to business operators that intend to submit notifications under Part C of Directive 2001/18/EC and to the competent authorities of the Member States that receive such notifications.
Publication of Commission Directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC, concerning the environmental risk assessment (ERA) of GMOs.
The Commission Directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms was published on 9 March 2018. This measure brings the requirements on ERA up to date with developments in scientific knowledge and technical progress, while building on the EFSA Guidance Document for the ERA of plants. The measure enters into force on 29 March 2018. EU countries shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 September 2019 at the latest.
Publication of Commission Implementing Decision (EU) 2018/1790 of 16 November 2018, repealing Decision 2002/623/EC, establishing guidance notes on the environmental risk assessment of genetically modified organisms.
The Commission Implementing Decision (EU) 2018/1790 of 16 November 2018 repealing Decision 2002/623/EC was published in the Official Journal of the EU, on 20 November 2018. This measure repeals the Guidance Notes of 2002, which have become obsolete. The repeal reduces the number of guidance documents that operators and competent authorities need to take into account, when carrying out an environmental risk assessment under Annex II to Directive 2001/18/EC.
- Directive 2001/18/EC
- Regulation (EC) 1829/2003 on genetically modified food and feed
- Regulation (EC) 1830/2003 traceability and labelling of GMOs
- Directive 2009/41/EC
- Directive (EU) 2015/412