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Commission Regulation (EC) No 641/2004Dangos y teitl llawn
Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation (Text with EEA relevance)
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Changes over time for: Article 2
Changes to legislation:
There are currently no known outstanding effects by UK legislation for Commission Regulation (EC) No 641/2004, Article 2.
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Article 2U.K.
1.Without prejudice to Article 5(3) and (5) and Article 17(3) and (5) of Regulation (EC) No 1829/2003, and taking into account the guidance of the [F1Food Safety Authority] provided for in Articles 5(8) and 17(8) of that Regulation, applications for authorisation submitted in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (the applications) shall comply with the requirements of paragraphs 1 to 4 of this Article and with Articles 3 and 4 of this Regulation.
2.In supplying the information required under Article 5(3)(b) and Article 17(3)(b) of Regulation (EC) No 1829/2003, the application shall clearly identify the products covered by it in accordance with Articles 3(1) and 15(1) of that Regulation. Where the application is limited to either food or feed use, it shall contain a verifiable justification explaining why the authorisation should not cover both uses in accordance with Article 27 of Regulation (EC) No 1829/2003.
3.The application shall clearly state which parts of the application are considered to be confidential, together with a verifiable justification in accordance with Article 30 of Regulation (EC) No 1829/2003. Confidential parts shall be submitted in separate documents.
4.The application shall specify, in supplying the information required under Article 5(3)(c) and Article 17(3)(c) of Regulation (EC) No 1829/2003, whether the information included in the application may be notified as such to the biosafety clearing house under the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Cartagena Protocol) approved by Council Decision 2002/628/EC(1).
If the application may not be notified as such, it shall include the information which complies with Annex II to the Cartagena Protocol and which may be notified to the biosafety clearing house by the [F2appropriate authority] as provided in Article 44 of Regulation (EC) No 1829/2003 in a separate and clearly identified document.
5.Paragraph 4 shall not apply to applications concerning only food and feed produced from genetically modified organisms (GMOs) or containing ingredients produced from GMOs.
Textual Amendments
F1Words in Art. 2(1) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 43(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 2(4) substituted (31.12.2020) by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 43(b); 2020 c. 1, Sch. 5 para. 1(1)
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