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Regulation (EU) 2015/2283 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (Text with EEA relevance)

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  1. Introductory Text

  2. CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS

    1. Article 1.Subject matter and purpose

    2. Article 2.Scope

    3. Article 3.Definitions

    4. Article 4.Procedure for determination of novel food status

    5. Article 5.Implementing power concerning the definition of novel food

  3. CHAPTER II REQUIREMENTS FOR PLACING NOVEL FOODS ON THE MARKET WITHIN THE UNION

    1. Article 6.Union list of authorised novel foods

    2. Article 7.General conditions for inclusion of novel foods in the Union list

    3. Article 8.Initial establishment of the Union list

    4. Article 9.Content and updating of the Union list

  4. CHAPTER III AUTHORISATION PROCEDURES FOR A NOVEL FOOD

    1. SECTION I General rules

      1. Article 10.Procedure for authorising the placing on the market within the Union of a novel food and updating the Union list

      2. Article 11.Opinion of the Authority

      3. Article 12.Authorisation of a novel food and updates of the Union list

      4. Article 13.Implementing acts laying down administrative and scientific requirements for applications

    2. SECTION II Specific rules for traditional foods from third countries

      1. Article 14.Notification of a traditional food from a third country

      2. Article 15.Procedure for notifying the placing on the market within the Union of a traditional food from a third country

      3. Article 16.Application for the authorisation of a traditional food from a third country

      4. Article 17.Opinion of the Authority on a traditional food from a third country

      5. Article 18.Authorisation of a traditional food from a third country and updates of the Union list

      6. Article 19.Updates to the Union list as regards authorised traditional foods from third countries

      7. Article 20.Implementing acts laying down administrative and scientific requirements concerning traditional foods from third countries

  5. CHAPTER IV ADDITIONAL PROCEDURAL RULES AND OTHER REQUIREMENTS

    1. Article 21.Additional information concerning risk management

    2. Article 22.Ad hoc extension of time periods

    3. Article 23.Confidentiality of applications for updates of the Union list

    4. Article 24.Post-market monitoring requirements

    5. Article 25.Additional information requirements

  6. CHAPTER V DATA PROTECTION

    1. Article 26.Authorisation procedure in case of data protection

    2. Article 27.Authorisation of a novel food and inclusion in the Union list based on protected proprietary scientific evidence or scientific data

    3. Article 28.Authorisation procedure in case of a parallel application for the authorisation of a health claim

  7. CHAPTER VI PENALTIES AND GENERAL PROVISIONS

    1. Article 29.Penalties

    2. Article 30.Committee procedure

    3. Article 31.Delegated acts

    4. Article 32.Exercise of the delegation

  8. CHAPTER VII TRANSITIONAL MEASURES AND FINAL PROVISIONS

    1. Article 33.Amendments to Regulation (EU) No 1169/2011

    2. Article 34.Repeal

    3. Article 35.Transitional measures

    4. Article 36.Entry into force

  9. Signature

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