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)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(1), and in particular Articles 5(7), 8(8), 17(7), 20(8) and 47(4) thereof,
After consulting the European Food Safety Authority in accordance with Articles 5(7) and 17(7) of Regulation (EC) No 1829/2003,
Whereas:
(1) Regulation (EC) No 1829/2003 lays down Community procedures for the authorisation and supervision of genetically modified food and feed and for the labelling of such food and feed.
(2) It is necessary to provide detailed rules concerning applications for authorisations submitted in accordance with Regulation (EC) No 1829/2003.
(3) In addition, Regulation (EC) No 1829/2003 provides that the European Food Safety Authority (the Authority) is to publish detailed guidance to assist the applicant in the preparation and the presentation of the application, concerning notably the information and data to be provided in order to demonstrate that the product complies with the criteria referred to in Articles 4(1) and 16(1) of that Regulation.
(4) In order to ensure a smooth transition to the regime provided by Regulation (EC) No 1829/2003 transitional measures laid down in that Regulation as regards requests and notifications of products falling within the scope of other Community legislation, should be subject to implementing rules.
(5) It is also necessary to provide detailed rules on the preparation and presentation of notifications of existing products submitted to the Commission under Regulation (EC) No 1829/2003 as regards products placed on the market in the Community before 18 April 2004.
(6) Such rules should facilitate the task of operators, in preparing applications for authorisations and in the preparation of notifications of existing products, and the Authority in evaluating such applications and verifying such notifications.
(7) The scope of Regulation (EC) No 1829/2003 includes food which consists of, contains or is produced from genetically modified organisms (GMOs) such as genetically modified plants and micro-organisms. Therefore, in the interests of consistency of Community legislation, the scope of the present Regulation should also cover existing food consisting of, containing or produced from genetically modified plants and micro-organisms.
(8) The scope of Regulation (EC) No 1829/2003 covers feed, including feed additives as defined in Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs(2) consisting of, containing or produced from GMOs such as genetically modified plants and micro-organisms. Therefore, the scope of the present Regulation should also cover existing feed, including feed additives consisting of, containing or produced from genetically modified plants and micro-organisms.
(9) The scope of Regulation (EC) No 1829/2003 does not cover processing aids, including enzymes used as processing aids. Therefore, the scope of the present Regulation similarly should not cover existing processing aids.
(10) Regulation (EC) No 1829/2003 provides that detailed rules are to be adopted for implementing the transitional measures for the adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation. In the interests of consistency of Community legislation those rules should in particular clarify which genetically modified material is covered by such transitional measures and how the 0,5 % threshold is to be applied.
(11) It is necessary for this Regulation to apply as a matter of urgency as Regulation (EC) No 1829/2003 applies from 18 April 2004.
(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
CHAPTER I Applications for authorisation
Article 1
This chapter provides detailed rules concerning applications for authorisation submitted in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, including applications submitted under other Community legislation which are transformed or supplemented in accordance with Article 46 of that Regulation.
SECTION 1 Requirements for applications for authorisation of genetically modified food and feed
Article 2
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(3).
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
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(4);
(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(5);
(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(6);
(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
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.
SECTION 2 Transformation of requests and notifications into applications in accordance with Regulation (EC) No 1829/2003
Article 5
1. Where a request submitted under Article 4 of Regulation (EC) No 258/97 of the European Parliament and of the Council(7) is transformed into an application under Regulation (EC) No 1829/2003, in accordance with Article 46(1) of that Regulation, the national competent authority of the Member State in which the request was submitted shall, without delay, ask the applicant to submit a complete dossier in accordance with Article 5 of Regulation (EC) No 1829/2003.
2. The national competent authority shall:
(a) acknowledge receipt of the information supplied by the applicant in accordance with paragraph 1 within 14 days of the date of its receipt. The acknowledgement shall state the date of receipt: of the information;
(b) inform the Authority without delay;
(c) make the request and the information supplied by the applicant in accordance with paragraph 1 available to the Authority;
(d) where applicable, make available to the Authority the initial assessment report provided for in Article 6(3) of Regulation (EC) No 258/97, as well as any comments or objections which may have been made by Member States or the Commission under Article 6(4) of that Regulation.
3. The Authority shall:
(a) inform the other Member States and the Commission without delay that the request under Article 4 of Regulation (EC) No 258/97 has been transformed into an application under Regulation (EC) No 1829/2003 and make the application and any supplementary information supplied by the applicant available to them;
(b) make the summary of the dossier referred to in Article 5(3)(l) of Regulation (EC) No 1829/2003 available to the public.
4. The date of receipt of the application for the purpose of Article 6(1) of Regulation (EC) No 1829/2003 shall be the date of receipt by the Authority of the information referred to in points (c) and (d) of paragraph 2 of this Article.
5. The transformed application shall further be processed as any other application under Article 5 of Regulation (EC) No 1829/2003.
Article 6
1. Where a notification concerning a product including its use as feed submitted under Article 13 of Directive 2001/18/EC is transformed into an application under Regulation (EC) No 1829/2003, in accordance with Article 46(3) of that Regulation, the national competent authority, within the meaning of Directive 2001/18/EC, of the Member State in which the notification was submitted shall ask without delay the notifier to submit a complete dossier in accordance with Article 17 of Regulation (EC) No 1829/2003.
2. The national competent authority shall:
(a) acknowledge receipt of the information supplied by the notifier in accordance with paragraph 1 within 14 days of the date of its receipt; the acknowledgement shall state the date of receipt of the information;
(b) inform the Authority without delay;
(c) make the notification and the information supplied by the notifier in accordance with paragraph 1 available to the Authority;
(d) where applicable, make available to the Authority the assessment report provided for in Article 14(2) of Directive 2001/18/EC.
3. The Authority shall:
(a) inform the other Member States and the Commission without delay that the notification under Article 13 of Directive 2001/18/EC has been transformed into an application under Regulation (EC) No 1829/2003 and shall make the application and any supplementary information supplied by the notifier available to them;
(b) make the summary of the dossier referred to in Article 17(3)(l) of Regulation (EC) No 1829/2003 available to the public.
4. The date of receipt of the application for the purpose of Article 18(1) of Regulation (EC) No 1829/2003 shall be the date of receipt by the Authority of the information referred to in points (c) and (d) of paragraph 2 of this Article.
5. The transformed application shall further be processed as any other application under Article 17 of Regulation (EC) No 1829/2003.
Article 7
1. Where a request submitted under Article 7 of Council Directive 82/471/EEC(8), concerning products produced from GMOs, is transformed into an application under Regulation (EC) No 1829/2003, in accordance with Article 46(4) of that Regulation, the Commission shall ask the applicant without delay to submit a complete dossier in accordance with Article 17 of Regulation (EC) No 1829/2003.
The applicant shall send the complete dossier to the Member States and to the Commission.
2. The Commission shall:
(a) acknowledge receipt of the information supplied by the applicant in accordance with paragraph 1 within 14 days of the date of its receipt; the acknowledgement shall state the date of receipt of the information;
(b) inform the Authority without delay;
(c) make the request and the information supplied by the applicant in accordance with paragraph 1 available to the Authority;
(d) where applicable, make available to the Authority the dossier provided for in Article 7(1) of Directive 82/471/EEC.
3. The Authority shall make:
(a) any supplementary information supplied by the applicant available to the Member States and the Commission;
(b) the summary of the dossier referred to in Article 17(3)(l) of Regulation (EC) No 1829/2003 available to the public.
4. The date of receipt of the application for the purpose of Article 18(1) of Regulation (EC) No 1829/2003 shall be the date of receipt by the Authority of the information referred to in points (c) and (d) of paragraph 2 of this Article.
5. The transformed application shall further be processed as any other application under Article 17 of Regulation (EC) No 1829/2003.
SECTION 3 Supplementation of requests under Directive 70/524/EEC by an application under Regulation (EC) No 1829/2003
Article 8
1. Where a request submitted under Article 4 of Directive 70/524/EEC, concerning products referred to in Article 15(1) of Regulation (EC) No 1829/2003, is supplemented by an application under Regulation (EC) No 1829/2003, in accordance with Article 46(5) of that Regulation, the Member State acting as rapporteur shall ask the applicant without delay to submit a separate application for authorisation in accordance with Article 17 of Regulation (EC) No 1829/2003.
2. The application shall further be processed as any other application under Article 17 of Regulation (EC) No 1829/2003.
CHAPTER II Notification of existing products
Article 9
This chapter provides the requirements concerning the preparation and presentation of notifications of existing products submitted to the Commission in accordance with Articles 8 and 20 of Regulation (EC) No 1829/2003 and applies to existing products covered by the scope of that Regulation and placed on the market in the Community prior to 18 April 2004.
SECTION 1 General requirements for notifications of certain products placed on the market before 18 April 2004
Article 10
1. Notifications submitted in accordance with Articles 8(1) and 20(1) of Regulation (EC) No 1829/2003 shall:
(a) clearly identify the products covered by the notification, taking account of Articles 3(1) and 15(1) of Regulation (EC) No 1829/2003;
(b) include relevant information and studies, including, where available, independent and peer-reviewed studies, which demonstrate that the product complies with the requirements provided for in Articles 4(1) or 16(1) of Regulation (EC) No 1829/2003;
(c) clearly indicate which parts of the notification are considered to be confidential, together with a verifiable justification, and those parts shall be submitted in separate documents;
(d) include a method(s) of detection, sampling and identification of the transformation event in accordance with Annex I to this Regulation;
(e) in accordance with Articles 5(3)(j) and 17(3)(j) of Regulation (EC) No 1829/2003 provide:
(i) samples of the food and feed and their control samples in accordance with Annex I to this Regulation;
(ii) information as to the place where the reference material, which shall be developed in accordance with Annex II to this Regulation, may be found.
2. The notifications referred to in paragraph 1 shall be submitted to the Commission before 18 October 2004.
SECTION 2 Additional requirements for notifications of certain products placed on the market before 18 April 2004
Article 11
1. In addition to the requirements of Article 10, notifications of GMOs which have been placed on the market in accordance with part C of Council Directive 90/220/EEC(9) or part C of Directive 2001/18/EC shall include a copy of the relevant consent granted under those directives.
2. The date of publication in the Official Journal of the European Union of the Decision to grant consent under Directive 90/220/EEC or Directive 2001/18/EC shall be considered to be the date on which the product was first placed on the market, unless the notifier provides verifiable proof that it was first placed on the market at a later date
Article 12
1. In addition to the requirements of Article 10, notifications of food produced from GMOs which have been placed on the market in accordance with Article 5 of Regulation (EC) No 258/97 shall include a copy of the original notification letter to the Commission.
2. The date of the letter from the Commission forwarding the original notification to the Member States shall be considered to be the date on which the product was first placed on the market, unless the notifier provides verifiable proof that it was first placed on the market at a later date.
Article 13
1. In addition to the requirements of Article 10, notifications of genetically modified food which have been placed on the market in accordance with Articles 6 and 7 of Regulation (EC) No 258/97 shall include a copy of the authorisation of that food.
2. The date the authorisation of the product took effect under Regulation No (EC) 258/97 shall be considered to be the date on which it was first placed on the market, unless the notifier provides verifiable proof that the product was first placed on the market at a later date.
Article 14
1. In addition to the requirements of Article 10, notifications of feed produced from GMOs which have been placed on the market in accordance with Articles 3 and 4 of Directive 82/471/EEC shall include a copy of the authorisation at Community level or, where applicable, the authorisation granted by a Member State.
2. The date the authorisation of the product took effect in accordance with Directive 82/471/EEC shall be considered to be the date on which it was first placed on the market, unless the notifier provides verifiable proof that the product was first placed on the market at a later date.
Article 15
1. In addition to the requirements of Article 10, notifications of feed containing, consisting of or produced from GMOs which have been authorised in accordance with Directive 70/524/EEC shall include:
(a) the identification of the feed additive(s) to be covered by the number or the EC number, where applicable, as laid down in Article 9(l) of Directive 70/524/EEC;
(b) a copy of the authorisation.
2. The date the authorisation of the product took effect under Directive 70/524/EEC shall be considered to be the date on which it was first placed on the market, unless the notifier provides verifiable proof that the product was first placed on the market at a later date.
Article 16
In addition to the requirements of Article 10, notifications of feed produced from GMOs which have been lawfully placed on the market in the Community, which are not covered by Articles 11, 14 and 15, and for which the GMO(s) has been notified for authorisation for use as animal feed under part C of Directive 2001/18/EC shall:
(a) contain a reference to the notification under evaluation submitted according to Article 13 of Directive 2001/18/EC;
(b) include a declaration that the product was placed on the market before 18 April 2004.
Article 17
In addition to the requirements of Article 10, notifications of food and feed produced from GMOs which have been lawfully placed on the market in the Community and which are not covered by Articles 11 to 16 shall include a declaration that the product was placed on the market before 18 April 2004.
CHAPTER III Transitional measures for adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation
Article 18
1. For the purpose of implementing Article 47 of Regulation (EC) No 1829/2003, the Commission shall, on 18 April 2004, publish a list of the genetically modified material that has benefited from a favourable opinion from the Community Scientific Committee(s) or the Authority before that date and for which an application for authorisation has not been rejected in accordance with the relevant Community legislation.
2. This list shall distinguish between:
(a) material in respect of which the Commission has been informed, by any interested party, that a detection method is publicly available; an indication of where the detection method has been made available shall be included;
(b) material in respect of which the Commission has not yet been informed that a detection method is publicly available.
Any interested party may, at any time, inform the Commission that a detection method for material referred to in point (b) of the first subparagraph is publicly available, with an indication of where the detection method is available.
3. The list referred to in paragraph 1 shall be maintained by the Commission. Amendments to the list may result, in particular, from:
(a) the granting of an authorisation or the rejection of an application for authorisation for material included in the list, in accordance with the relevant Community legislation;
(b) notifications to the Commission, in accordance with Articles 8 or 20 of Regulation (EC) No 1829/2003, that material included in the list has been lawfully placed on the market in the Community before 18 April 2004, or adoption by the Commission of a measure in accordance with Article 8(6) or 20(6) of Regulation (EC) No 1829/2003;
(c) information received by the Commission that a detection method in respect of material included in the list is publicly available.
Information about amendments brought to the list shall be compiled in an Annex to the list.
Article 19
1. The 0,5 % threshold provided for in Article 47(1) of Regulation (EC) No 1829/2003 shall apply to genetically modified material included in part (a) of the list referred to in Article 18(2) of the present Regulation. Where a lower threshold has been established in accordance with Article 47(3) of Regulation (EC) No 1829/2003, it shall be specified in that list.
2. The thresholds provided for in Article 47 of Regulation (EC) No 1829/2003 shall apply to food ingredients considered individually or food consisting of a single ingredient and to feed and each feed of which it is composed.
CHAPTER IV Final provision
Article 20
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.
Done at Brussels, 6 April 2004.