What Regulation (EC) No 1829/2003 on genetically modified food and feed - authorisation and labelling requires
Regulation (EC) No 1829/2003 establishes a harmonised Community procedure for the authorisation, supervision, and labelling of genetically modified (GM) food and feed. The regulation applies to GMOs for food use; food containing or consisting of GMOs; food produced from or containing ingredients produced from GMOs; and feed containing, consisting of, or produced from GMOs. No person may place such products on the market unless covered by an authorisation granted under the regulation. Authorisation requires a scientific safety assessment by the European Food Safety Authority (EFSA), which must verify that the food or feed does not have adverse effects on human health, animal health, or the environment; does not mislead the consumer; and does not differ from its conventional counterpart to an extent that normal consumption would be nutritionally disadvantageous. Applications must be submitted to a national competent authority and include a dossier with the applicant's name, product specification, transformation event(s), method of production, safety studies, detection and sampling methods, control samples, and, where applicable, a post-market monitoring plan and an environmental risk assessment conforming to Directive 2001/18/EC. EFSA has six months to issue an opinion. The Commission then has three months to submit a draft decision to the Regulatory Committee. Authorisation is valid for 10 years throughout the Community and is renewable. Labelling requirements apply to foods delivered to final consumers or mass caterers that contain, consist of, or are produced from GMOs, with a 0.9% threshold for adventitious or technically unavoidable presence. The regulation also covers the status of existing products lawfully on the market before its application date, requiring notification and re-application within specified periods.
Pillar: Agriculture & Agritech · Authority: European Commission (DG SANTE) · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32003R1829
SHA-256 integrity: 93215635a822c14ed4f81002f5a0ca3c678272097da7a56219fa9412c34e0367
Primary Citations — 7 traced to source
- Regulation (EC) No 1829/2003, 2003 (European Union) - Article 4(1): Requirements for GM food and feed - safety, consumer misleading, nutritional disadvantage.
- Regulation (EC) No 1829/2003, 2003 (European Union) - Article 5: Application for authorisation - submission to national competent authority, dossier content including detection methods and control samples.
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