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

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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  1. Introductory Text

  2. CHAPTER I Applications for authorisation

    1. Article 1.This chapter provides detailed rules concerning applications for authorisation submitted...

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

      1. Article 2.(1) Without prejudice to Article 5(3) and (5) and Article...

      2. Article 3.(1) The application shall include the following:

      3. Article 4.(1) Samples of the food and feed and their control...

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

      1. Article 5.. . . . . . . . . ....

      2. Article 6.. . . . . . . . . ....

      3. Article 7.. . . . . . . . . ....

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

      1. Article 8.. . . . . . . . . ....

  3. CHAPTER II Notification of existing products

    1. Article 9.. . . . . . . . . ....

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

      1. Article 10.. . . . . . . . . ....

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

      1. Article 11.. . . . . . . . . ....

      2. Article 12.. . . . . . . . . ....

      3. Article 13.. . . . . . . . . ....

      4. Article 14.. . . . . . . . . ....

      5. Article 15.. . . . . . . . . ....

      6. Article 16.. . . . . . . . . ....

      7. Article 17.. . . . . . . . . ....

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

    1. Article 18.. . . . . . . . . ....

    2. Article 19.. . . . . . . . . ....

  5. CHAPTER IV Final provision

    1. Article 20.This Regulation shall enter into force on the day of...

  6. Signature

    1. ANNEX I

      METHOD VALIDATION

      1. 1. INTRODUCTION

        1. A. For the purpose of implementing Articles 5(3)(i) and 17(3)(i) of...

        2. B. The method acceptance criteria and method performance requirements are set...

        3. C. The RL, ... will evaluate the provided information for its...

        4. D. If the information provided about the method is considered adequate...

        5. E. The validation process will be carried out by the RL...

        6. F. The RL... shall provide further information about the operational procedures...

        7. G. The RL... shall evaluate the results obtained in the validation...

      2. 2. INFORMATION ABOUT THE METHOD

        1. A. The method shall refer to all the methodological steps needed...

        2. B. As described in the document referred to under 1(B), RL...

        3. C. The applicant shall demonstrate that the method fulfils the following...

        4. D. For the purpose of implementing Articles 5(3)(i) and 17(3)(i) of...

        5. E. The applicant shall provide a complete and detailed description of...

      3. 3. INFORMATION ABOUT THE METHOD TESTING CARRIED OUT BY THE APPLICANT...

        1. A. The applicant shall provide all the available and relevant data...

        2. B. The information provided shall demonstrate the robustness of the method...

        3. C. Information required about the method development and the method optimisation:...

        4. D. Testing report. Besides the values obtained for the performance indices,...

      4. 4. SAMPLES OF THE FOOD AND FEED AND THEIR CONTROL SAMPLES...

    2. ANNEX II

      REFERENCE MATERIAL

      1. The reference material as referred to in Articles 5(3)(j) and...

      2. For verification and value assignment, a method that has been...

      3. A. Terminology:

      4. B. GM RM containers:

      5. C. Homogeneity testing:

      6. D. Stability testing:

      7. E. Batch characterisation:

      8. F. Final storage:

      9. G. Establishment of a certificate for CRMs:

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