Novel Foods Regulation
Articles
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