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Commission Implementing Regulation (EU) 2017/2469Show full title

Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance)

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  1. Introductory Text

  2. Article 1.Scope and subject matter

  3. Article 2.Definitions

  4. Article 3.Structure, content and presentation of an application

  5. Article 4.Administrative data requirements

  6. Article 5.Scientific data requirements

  7. Article 6.Verification of the validity of an application

  8. Article 7.Information to be included in the opinion of the Authority

  9. Article 8.Transitional measures

  10. Article 9.Entry into force and application

  11. Signature

    1. ANNEX I

      Template cover letter accompanying an application for novel food

      1. EUROPEAN COMMISSION

      2. Directorate General

      3. Directorate

      4. Unit

      5. Date: …

      6. Subject: Application for authorisation of a novel food in accordance...

      7. (Please indicate clearly by ticking one of the boxes)

      8. Application for an authorisation of a new novel food. Application...

      9. The Applicant(s) or their Representative(s) in the Union

      10. (name(s), address(es)…)

      11. …

      12. …

      13. …

      14. submit(s) this application in order to update the Union list...

      15. Identity of the novel food (information on the identity of...

      16. …

      17. …

      18. Confidentiality. Where appropriate, state whether the application includes confidential data...

      19. Yes No

      20. Data Protection. Where appropriate, state whether the application includes a...

      21. Yes No

      22. Food categories, conditions of use and labelling requirements

      23. Yours sincerely,

      24. Signature …

      25. Enclosures:

      26. Complete dossier Summary of the dossier List of the parts...

    2. ANNEX II

      Justification for confidential information

      1. This Annex shall be updated during the application procedure each...

      2. Where the production process contains confidential data, a non-confidential summary...

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