Commission Regulation (EC) No 641/2004Show full title

CHAPTER I U.K. Applications for authorisation

[F1 Article 1 U.K.

This chapter provides detailed rules concerning applications for authorisation submitted in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 except for those applications covered by Commission Implementing Regulation (EU) No 503/2013 (1) .]

Textual Amendments

F1 Substituted by Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (Text with EEA relevance).

SECTION 1 U.K. Requirements for applications for authorisation of genetically modified food and feed

Article 2 U.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 European Food Safety Authority (the 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(2).

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 Commission 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.

Article 3 U.K.

1. The application shall include the following:

(a) the monitoring plan referred to in Article 5(5)(b) and Article 17(5)(b) of Regulation (EC) No 1829/2003, taking into account Council Decision 2002/811/EC(3);

(b) in supplying the information required under Article 5(5)(a) and Article 17(5)(a) of Regulation (EC) No 1829/2003, a proposal for labelling complying with the requirements of Annex IV to Directive 2001/18/EC of the European Parliament and of the Council(4);

(c) in supplying the information required under Article 5(5)(a) and Article 17(5)(a) of Regulation (EC) No 1829/2003, a proposal for a unique identifier for the GMO in question, developed in accordance with Commission Regulation (EC) No 65/2004(5);

(d) a proposal for labelling in all official Community languages, where a proposal for specific labelling is needed in accordance with Article 5(3)(f) and Article (g) and 17(3)(f) and (g) of Regulation (EC) No 1829/2003;

(e) a description of a method(s) of detection, sampling and event specific identification of the transformation event, as provided for in Article 5(3)(i) and Article 17(3)(i) of Regulation (EC) No 1829/2003, in accordance with Annex I to this Regulation;

(f) a proposal for post-market monitoring regarding the use of the food for human consumption or the feed for animal consumption, as provided for in Article 5(3)(k) and Article 17(3)(k) of Regulation (EC) No 1829/2003, and according to the characteristics of the products concerned, or a verifiable justification to the effect that a post-market monitoring is not necessary.

2. Points (a), (b) and (c) of paragraph 1 shall not apply to applications concerning only food and feed produced from GMOs or containing ingredients produced from GMOs.

Article 4 U.K.

1. Samples of the food and feed and their control samples which are to be submitted in accordance with Article 5(3)(j) and Article 17(3)(j) of Regulation (EC) No 1829/2003 shall be in accordance with the requirements set out in Annexes I and II to this Regulation.

The application shall be accompanied by information concerning the place where the reference material developed in accordance with Annex II may be found.

2. The summary to be provided in accordance with Article 5(3)(l) and Article 17(3)(l) of Regulation (EC) No 1829/2003 shall:

(a) be presented in an easily comprehensible and legible form;

(b) not contain parts which are considered to be confidential.

F2 SECTION 2 U.K. [F2 Transformation of requests and notifications into applications in accordance with Regulation (EC) No 1829/2003

F2 Article 5 U.K.

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F2 Article 6 U.K.

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F2 Article 7 U.K.

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Textual Amendments

F2 Deleted by Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (Text with EEA relevance).

F2 SECTION 3 U.K. Supplementation of requests under Directive 70/524/EEC by an application under Regulation (EC) No 1829/2003

F2 Article 8 U.K.

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F2 CHAPTER II U.K. Notification of existing products

F2 Article 9 U.K.

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F2 SECTION 1 U.K. General requirements for notifications of certain products placed on the market before 18 April 2004

F2 Article 10 U.K.

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F2 SECTION 2 U.K. Additional requirements for notifications of certain products placed on the market before 18 April 2004

F2 Article 11 U.K.

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F2 Article 12 U.K.

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F2 Article 13 U.K.

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F2 Article 14 U.K.

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F2 Article 15 U.K.

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F2 Article 16 U.K.

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F2 Article 17 U.K.

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F2 CHAPTER III U.K. Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation]

F2 Article 18 U.K.

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F2 Article 19 U.K.

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CHAPTER IV U.K. Final provision

Article 20 U.K.

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

It shall apply from 18 April 2004.

This Regulation shall be binding in its entirety and directly applicable in all Member States.