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5.

Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (Text with EEA relevance) · European Union

In the case of GMOs or feed containing or consisting of GMOs, the application shall also be accompanied by: the complete technical dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC or, where the placing on the market of the GMOs has been authorised under part C of Directive 2001/18/EC, a copy of the authorisation decision; a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan; this duration may be different from the proposed period for the consent. In such case, Articles 13 to 24 of Directive 2001/18/EC shall not apply.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-04 · Text as adopted (Official Journal); later amendments are not incorporated in this text.