Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 Nov... (32015R2283)
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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)
- 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)
- CHAPTER I
- SUBJECT MATTER, SCOPE AND DEFINITIONS
- Article 1
- Subject matter and purpose
- Article 2
- Scope
- Article 3
- Definitions
- Article 4
- Procedure for determination of novel food status
- Article 5
- Implementing power concerning the definition of novel food
- CHAPTER II
- REQUIREMENTS FOR PLACING NOVEL FOODS ON THE MARKET WITHIN THE UNION
- Article 6
- Union list of authorised novel foods
- Article 7
- General conditions for inclusion of novel foods in the Union list
- Article 8
- Initial establishment of the Union list
- Article 9
- Content and updating of the Union list
- CHAPTER III
- AUTHORISATION PROCEDURES FOR A NOVEL FOOD
- SECTION I
- General rules
- Article 10
- Procedure for authorising the placing on the market within the Union of a novel food and updating the Union list
- Article 11
- Opinion of the Authority
- Article 12
- Authorisation of a novel food and updates of the Union list
- Article 13
- Implementing acts laying down administrative and scientific requirements for applications
- SECTION II
- Specific rules for traditional foods from third countries
- Article 14
- Notification of a traditional food from a third country
- Article 15
- Procedure for notifying the placing on the market within the Union of a traditional food from a third country
- Article 16
- Application for the authorisation of a traditional food from a third country
- Article 17
- Opinion of the Authority on a traditional food from a third country
- Article 18
- Authorisation of a traditional food from a third country and updates of the Union list
- Article 19
- Updates to the Union list as regards authorised traditional foods from third countries
- Article 20
- Implementing acts laying down administrative and scientific requirements concerning traditional foods from third countries
- CHAPTER IV
- ADDITIONAL PROCEDURAL RULES AND OTHER REQUIREMENTS
- Article 21
- Additional information concerning risk management
- Article 22
- Ad hoc extension of time periods
- Article 23
- Confidentiality of applications for updates of the Union list
- Article 24
- Post-market monitoring requirements
- Article 25
- Additional information requirements
- CHAPTER V
- DATA PROTECTION
- Article 26
- Authorisation procedure in case of data protection
- Article 27
- Authorisation of a novel food and inclusion in the Union list based on protected proprietary scientific evidence or scientific data
- Article 28
- Authorisation procedure in case of a parallel application for the authorisation of a health claim
- CHAPTER VI
- PENALTIES AND GENERAL PROVISIONS
- Article 29
- Penalties
- Article 30
- Committee procedure
- Article 31
- Delegated acts
- Article 32
- Exercise of the delegation
- CHAPTER VII
- TRANSITIONAL MEASURES AND FINAL PROVISIONS
- Article 33
- Amendments to Regulation (EU) No 1169/2011
- Article 34
- Repeal
- Article 35
- Transitional measures
- Article 36
- Entry into force
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