Commission Implementing Regulation (EU) 2017/2469Dangos y teitl llawn

Commission Implementing Regulation (EU) 2017/2469

of 20 December 2017

laying down administrative and scientific requirements for applications referred to in Article 10 of 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 1852/2001(1), and in particular Article 13 and Article 35(3) thereof,

Whereas:

(1) Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods in the Union.

(2) Pursuant to Article 13 of Regulation (EU) 2015/2283, the Commission has to adopt implementing acts laying down administrative and scientific data requirements for applications referred to in Article 10(1) of that Regulation.

(3) Without prejudice to Articles 5 and 10 of Regulation (EU) 2015/2283, the Commission should verify whether the application falls within the scope of that Regulation and its validity.

(4) Applications referred to in Article 10(1) of Regulation (EU) 2015/2283 should contain sufficient information and scientific documentation to allow the Commission to verify their validity and enable the European Food Safety Authority (the Authority) to conduct comprehensive risk assessments of the novel foods.

(5) The applications should include detailed descriptions of the safety evaluation strategy, the raw data, information on the relevance of the test material used in the toxicological studies, and detection and characterisation test methods for the engineered nanomaterials.

(6) Experience has shown that in certain cases a novel food intended for a particular group of the population may also reasonably be expected to be consumed by other groups of the population and that risk management measures may be necessary to mitigate potential health risks to those other population groups. Therefore, sufficient information should be provided in the application to enable the risks to those population groups to be assessed.

(7) Where the applicant submits 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 novel food, it may not be necessary for the applicant to provide all the data required for the risk assessment, where the applicant provides verifiable justification.

(8) In order to ensure that toxicological tests are performed to a certain standard, they should be carried out in accordance with the rules set out in Directive 2004/10/EC of the European Parliament and of the Council(2). Where those tests are carried out outside the territory of the Union, they should follow the OECD Principles of Good Laboratory Practice(3).

(9) The opinion of the Authority should provide sufficient information to ascertain whether the proposed use of the novel food is safe for consumers.

(10) In order to benefit from data protection, as laid down in Article 26 of Regulation (EU) 2015/2283, requests for protection of proprietary data should be justified and all data concerned should be kept in a separate part of the application.

(11) Pursuant to Article 35 of Regulation (EU) 2015/2283, it is necessary to lay down transitional measures for the entry into force of that Regulation.

(12) 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:

(1)

OJ L 327, 11.12.2015, p. 1.

(2)

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).

(3)

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring. Number 1. OECD Principles on Good Laboratory Practice (as revised in 1997) ENV/MC/CHEM(98)17.