http://www.legislation.gov.uk/id/eur/2015/1761

Commission Implementing Regulation (EU) 2015/1761

of 1 October 2015

amending Commission Regulation (EC) No 378/2005 as regards the Community Reference Laboratory reports, fees and the laboratories listed in Annex II thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition1, and in particular the first subparagraph of Article 7(4) and the third paragraph of Article 21 thereof,

After consulting the European Food Safety Authority,

Whereas:

(1)

Regulation (EC) No 1831/2003 establishes the procedure for authorising the placing on the market and use of feed additives in animal nutrition. It provides that any person seeking authorisation for a feed additive or a new use of a feed additive is to submit an application for authorisation in accordance with that Regulation.

(2)

Commission Regulation (EC) No 378/20052 lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards applications for authorisation of a feed additive or for a new use of a feed additive and the duties and tasks of the Community Reference Laboratory (‘CRL’).

(3)

Article 5 of Regulation (EC) No 378/2005 provides that the CRL is to submit a full evaluation report to the European Food Safety Authority (‘the Authority’) for each application for authorisation of a feed additive. Exceptions to the requirement to submit an evaluation report are made for applications for a new use of a feed additive or applications for changing the terms of an existing authorisation, provided that the proposed conditions for the new use or for the change in the terms of the authorisation fall within the scope of the method of analysis previously submitted in accordance with the requirements laid down in Annex II to Commission Regulation (EC) No 429/20083 and already evaluated. Furthermore, Article 4 of that Regulation provides that the CRL is to charge applicants fees for submitting applications for authorisation. Exception is made where no samples are required and the CRL does not need to issue a report, as the method of analysis has already been evaluated. However, applications for renewal of authorisations of feed additives do not benefit from those exceptions.

(4)

Experience has shown that the exceptions to the requirements concerning evaluation reports and submission fees should also be extended to the applications for renewal of authorisations of feed additives. Article 5 of and Annex IV to Regulation (EC) No 378/2005 should therefore be amended accordingly.

(5)

Annex II to Regulation (EC) No 378/2005 sets out a list of national reference laboratories assisting the CRL in its duties and tasks. Several Member States have informed the Commission that their national reference laboratories taking part in the consortium have changed because other laboratories have been designated for that purpose or the name or address of the laboratories have changed. Annex II to Regulation (EC) No 378/2005 should therefore be adapted accordingly.

(6)

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: