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The EU regulatory framework on genetically modified organisms (GMOs).
Transgenic Res 2019; 28(Suppl 2):169-174TR

Abstract

The European Union (EU) legislation on genetically modified organisms (GMOs) aims to ensure a high level of protection for human, animal and environmental health and a well-functioning EU internal market. The framework regulates the release of GMOs into the environment and their use as, or in, food and feed. It has three main pillars: pre-market authorisation based on a prior risk assessment, traceability and labelling. Within this legal framework, the EU has authorised the placing on the market of 118 GMOs so far. These have been obtained through long-standing techniques of genetic modification, namely transgenesis. Following the adoption of the GMO legislation, new techniques of genetic modification, including new mutagenesis techniques, have been developed, which have raised questions regarding the applicability of the GMO legislation and attracted a lot of attention from stakeholders and the general public. This article provides an overview of EU GMO legislation and implementation of the EU Court of Justice ruling on organisms obtained by mutagenesis techniques, issued in July 2018. It also updates on the recent initiatives by the European Commission and EU Member States on new developments in biotechnology. The manuscript is based on the author's contribution at the OECD Conference on Genome Editing, Applications in Agriculture, Implications for Health, Environment and Regulation held in Paris on 28-29 June 2018. It is complemented with updated information.

Authors+Show Affiliations

Directorate General Health and Food Safety, European Commission, 1049, Brussels, Belgium. chantal.bruetschy@ec.europa.eu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31321701

Citation

Bruetschy, Chantal. "The EU Regulatory Framework On Genetically Modified Organisms (GMOs)." Transgenic Research, vol. 28, no. Suppl 2, 2019, pp. 169-174.
Bruetschy C. The EU regulatory framework on genetically modified organisms (GMOs). Transgenic Res. 2019;28(Suppl 2):169-174.
Bruetschy, C. (2019). The EU regulatory framework on genetically modified organisms (GMOs). Transgenic Research, 28(Suppl 2), pp. 169-174. doi:10.1007/s11248-019-00149-y.
Bruetschy C. The EU Regulatory Framework On Genetically Modified Organisms (GMOs). Transgenic Res. 2019;28(Suppl 2):169-174. PubMed PMID: 31321701.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The EU regulatory framework on genetically modified organisms (GMOs). A1 - Bruetschy,Chantal, PY - 2019/7/20/entrez PY - 2019/7/20/pubmed PY - 2019/7/20/medline KW - European Union KW - Gene drive KW - Genetically modified organisms KW - Mutagenesis KW - Regulatory framework KW - Synthetic biology SP - 169 EP - 174 JF - Transgenic research JO - Transgenic Res. VL - 28 IS - Suppl 2 N2 - The European Union (EU) legislation on genetically modified organisms (GMOs) aims to ensure a high level of protection for human, animal and environmental health and a well-functioning EU internal market. The framework regulates the release of GMOs into the environment and their use as, or in, food and feed. It has three main pillars: pre-market authorisation based on a prior risk assessment, traceability and labelling. Within this legal framework, the EU has authorised the placing on the market of 118 GMOs so far. These have been obtained through long-standing techniques of genetic modification, namely transgenesis. Following the adoption of the GMO legislation, new techniques of genetic modification, including new mutagenesis techniques, have been developed, which have raised questions regarding the applicability of the GMO legislation and attracted a lot of attention from stakeholders and the general public. This article provides an overview of EU GMO legislation and implementation of the EU Court of Justice ruling on organisms obtained by mutagenesis techniques, issued in July 2018. It also updates on the recent initiatives by the European Commission and EU Member States on new developments in biotechnology. The manuscript is based on the author's contribution at the OECD Conference on Genome Editing, Applications in Agriculture, Implications for Health, Environment and Regulation held in Paris on 28-29 June 2018. It is complemented with updated information. SN - 1573-9368 UR - https://www.unboundmedicine.com/medline/citation/31321701/The_EU_regulatory_framework_on_genetically_modified_organisms_(GMOs) L2 - https://doi.org/10.1007/s11248-019-00149-y DB - PRIME DP - Unbound Medicine ER -
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