CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter and scope
Article 2
Definitions
Article 3
Reference samples
Article 4
Fees
Article 5
Evaluation reports by the reference laboratory
CHAPTER II
NATIONAL REFERENCE LABORATORIES
Article 6
... Reference laboratories
Article 7
Rapporteur laboratories
Article 8
Duties and tasks of rapporteur laboratories
Article 9
Duties and tasks of scientific experts or official laboratories assisting the reference laboratory
CHAPTER III
TESTING AND VALIDATION OF METHODS OF ANALYSIS, REPORTING AND GUIDANCE
Article 10
Testing of methods of analysis and validation of methods of analysis
Article 11
Reporting
Article 12
Guidance
CHAPTER IV
FINAL PROVISIONS
Article 13
Amendments to Regulation (EC) No 1831/2003
Article 14
Entry into force
ANNEX I
Requirements for participating scientific experts and official laboratories, as referred to in Article 6
Scientific experts or official laboratories assisting the reference laboratory must...
... have suitable qualified staff that are adequately trained in...
ANNEX II
Community reference laboratory and consortium of national reference laboratories, as referred to in Article 6(2)
COMMUNITY REFERENCE LABORATORY
NATIONAL REFERENCE LABORATORIES OF THE MEMBER STATES
Belgique/België
Česká republika
Danmark
Deutschland
Eesti
España
France
Éire/Ireland
Ελλάδα
Italia
Kypros
Latvija
Lietuva
Luxembourg
Magyarország
Nederland
Österreich
Polska
Portugal
Slovenija
Slovensko
Suomi/Finland
Sverige
United Kingdom
NATIONAL REFERENCE LABORATORIES OF EFTA COUNTRIES
Norway
ANNEX III
Text replacing paragraphs 2 and 3 of Annex II to Regulation (EC) No 1831/2003
ANNEX IV
RATES FOR FEES AS REFERRED TO IN ARTICLE 4(1)
Composition of the fee
Rates according to the type of application for authorisations of...
1.
Authorisation of a new feed additive (Article 4(1) of Regulation...
2.
Authorisation of a new use of a feed additive (Article...
3.
Authorisation of an already authorised feed additive (Article 10(2) of...
4.
Applications for changing the terms of an existing authorisation (Article...
5....
Commission Regulation (EC) No 378/2005
of 4 March 2005
on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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 nutrition , and in particular the first subparagraph of Article 7(4) and the third subparagraph of Article 21 thereof,
Whereas:
(1)
Regulation (EC) No 1831/2003 lays down rules for the placing on the market and use of feed additives in animal nutrition. It provides that any person seeking an authorisation for a feed additive or a new use of a feed additive is to submit an application for authorisation to the Commission in accordance with that Regulation (the application).
(2)
Regulation (EC) No 1831/2003 provides for a Community reference laboratory (the CRL) to carry out certain duties and tasks set out in Annex II to that Regulation. It also provides that the Joint Research Centre of the Commission is to be the CRL and that it may be assisted by a consortium of national reference laboratories to perform the duties and tasks set out in that Annex.
(3)
In accordance with Regulation (EC) No 1831/2003, it is necessary to adopt detailed rules for implementing Annex II to that Regulation, including practical conditions for the duties and tasks of the CRL and to amend that Annex accordingly.
(4)
In addition, the samples to be provided in the application, in accordance with Regulation (EC) No 1831/2003, should meet specific requirements in view of the duties and tasks of the CRL.
(5)
It is necessary to establish a precise timing for the delivery of the evaluation report from the CRL to the European Food Safety Authority (the Authority) in order to ensure that the procedures provided for in Regulation (EC) No 1831/2003 can be met.
(6)
The CRL should be authorised to charge a fee to applicants towards the costs of supporting the duties and tasks of the CRL and the consortium of national reference laboratories.
(7)
National reference laboratories should be part of the consortium of laboratories assisting the CRL only if they meet specific requirements in order to properly perform the duties and tasks laid down in Regulation (EC) No 1831/2003. Member States should be permitted to apply to the Commission for the designation of such laboratories.
(8)
In order to ensure the effective functioning of the consortium, it is necessary to appoint a rapporteur laboratory to carry out an initial assessment of the method(s) of analysis of each individual application and to establish clearly the duties and tasks of the rapporteur laboratories and the other laboratories participating in the consortium.
(9)
It is necessary to establish special procedures for the cases where the data in the application are insufficient concerning testing or validation of the method(s) of analysis.
(10)
In the interests of stability and efficacy and also in order to make the consortium operational, it is necessary to appoint the national reference laboratories participating in the consortium.
(11)
The relations between the members of the consortium should be defined by contract between them. In this context the CRL may develop guidance for applicants and for the laboratories participating in the consortium.
(12)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
OJ L 268, 18.10.2003, p. 29.