What EU GMO Deliberate Release Directive 2001/18/EC - Environmental Risk Assessment and Market Authorisation requires
Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms (GMOs) establishes the regulatory framework for the controlled and uncontrolled environmental release of GMOs in the EU. Part B covers deliberate release for research and development purposes, requiring prior written consent from the competent authority after a case-by-case environmental risk assessment (ERA). Part C covers market authorisation for GMOs as or in products, implemented through the centralised EFSA assessment procedure and Commission decision. Article 4 establishes the general obligations including a precautionary approach and step-by-step assessment. Annex II prescribes the mandatory ERA methodology. The Directive requires post-market monitoring, public consultation, and mandatory labelling. Authorisations are granted for a maximum of 10 years and are renewable. The Directive does not cover contained use of GMOs, which is governed by Directive 2009/41/EC.
Pillar: Biotech & Genomics · Authority: European Food Safety Authority (EFSA); European Commission (DG SANTE); Member State competent authorities · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32001L0018
SHA-256 integrity: a1a10f4caa631a1f31a58c2ceb729867ced11891cb131f86bc9478463ba238bf
Primary Citations — 7 traced to source
- Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms - OJ L 106/1, 17.4.2001; Part B (R&D releases), Part C (market authorisation), Annex II (ERA), Annex IV (labelling)
- Directive 2001/18/EC Article 4 - general obligations: precautionary principle; case-by-case ERA; step-by-step release approach
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