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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to 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 1852/20011, and in particular Article 20 and Article 35(3) thereof,
Whereas:
Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods in the Union.
Pursuant to Article 20 of Regulation (EU) 2015/2283 the Commission has to adopt implementing acts laying down administrative and scientific requirements concerning traditional foods from third countries.
Without prejudice to Articles 5, 15 and 16 of Regulation (EU) 2015/2283, the Commission should verify whether the notification falls within the scope of that Regulation and the validity of the notification or the application.
Notifications referred to in Article 14 of Regulation (EU) 2015/2283 should contain sufficient information and scientific documentation to allow the Commission to verify the validity and enable Member States and the Authority to evaluate the history of safe use of the traditional food from a third country.
Applications referred to in Article 16 of Regulation (EU) 2015/2283 should contain sufficient information and scientific documentation to allow the Commission to verify the validity and enable the Authority to conduct comprehensive risk assessments.
Where the applicant submits a notification or an application to add, remove or change the conditions of use, the specifications, additional specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required for the safety assessment where the applicant provides adequate verifiable justification.
The exchange of information between the Commission, the Member States and the Authority should allow that duly reasoned safety objections are submitted to the Commission where necessary.
The opinion of the Authority should provide sufficient information to ascertain whether the proposed use of the traditional food from a third country is safe for consumers.
Pursuant to Article 35(3) of Regulation (EU) 2015/2283 the Commission has to adopt implementing acts laying down the requirements referred to in Article 20 of that Regulation.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION: