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Commission Implementing Regulation (EU) 2017/2468Dangos y teitl llawn

Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with 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 a notification

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

  6. Article 5.Administrative data to be provided in a notification or an application

  7. Article 6.Scientific data to be provided in a notification or an application

  8. Article 7.Verification of the validity of a notification

  9. Article 8.Verification of the validity of an application

  10. Article 9.Duly reasoned safety objections

  11. Article 10.Information to be included in the opinion of the Authority

  12. Article 11.Transitional measures

  13. Article 12.Entry into force and application

  14. Signature

    1. ANNEX I

      Template cover letter accompanying a notification for traditional food from a third country following the requirements of Article 14 of Regulation (EU) 2015/2283

      1. EUROPEAN COMMISSION

      2. Directorate General

      3. Directorate

      4. Unit

      5. Date: …

      6. Subject: Notification for authorisation of a traditional food from a...

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

      8. Notification for an authorisation of a new traditional food. Notification...

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

      10. (name(s), address(es)…)

      11. …

      12. …

      13. …

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

      15. Identity of the traditional food:

      16. …

      17. …

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

      19. Yes No

      20. Food categories, conditions of use and labelling requirements

      21. Yours sincerely,

      22. Signature …

      23. Enclosures:

      24. Complete technical dossier Summary of the dossier List of the...

    2. ANNEX II

      Template cover letter accompanying an application for traditional food from a third country following the requirements of Article 16 of Regulation (EU) 2015/2283

      1. EUROPEAN COMMISSION

      2. Directorate General

      3. Directorate

      4. Unit

      5. Date: …

      6. Subject: Application for authorisation of a traditional food from a...

      7. The Applicant(s) or their Representative(s) within the European Union

      8. (name(s), address(es)…)

      9. …

      10. …

      11. …

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

      13. Identity of the traditional food:

      14. …

      15. …

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

      17. Yes No

      18. Food categories, conditions of use and labelling requirements

    3. ANNEX III

      Justification for confidential information

      1. This Annex shall be updated during the notification or application...

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

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