LegalizeCommission Regulation (EC) No 885/2009 of 25 September 2009 amending Regulation (EC) No 378/2005 as regards reference samples, fees and the laboratories listed in Annex II (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 (1), and in particular the first subparagraph of Article 7(4) and the third paragraph of Article 21 thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 of the European Parliament and of the Council establishes a Community 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 378/2005 (2) 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) It provides that any person making an application is to send reference samples in a form in which the feed additive is intended to be placed on the market by the applicant or that are suitable to be converted easily in a form in which the feed additive is intended to be placed on the market by the applicant.
(4) Regulation (EC) No 378/2005 also provides that the CRL is to charge applicants a fee of EUR 6 000 for each application. In addition, Annex II to that Regulation sets out a list of the consortium of national reference laboratories assisting the CRL in its duties and tasks.
(5) The experience gained during the operation of Regulation (EC) No 378/2005 shows that it is desirable to clarify certain details of the existing requirements for the reference samples to be submitted by applicants in some cases and to simplify them in the cases of a) applications for new uses of already authorised additives and b) applications for changing the terms of authorisations when the proposed change is not related to the characteristics of the feed additive previously sent to the CRL as reference sample of the feed additive concerned.
(6) Experience has shown that different rates should be established for the fee depending on the different types of applications, in particular taking into account the need for new reference samples and new evaluations of the method of analysis for feed additives already authorised.
(7) In addition, there are multi-analyte methods based on a defined principle applicable for the single or simultaneous determination of one or more substance(s)/agent(s) in the specific matrices defined in the scope of the method. Experience has shown that it is possible to carry out the evaluations of the methods of analysis for similar feed additives in groups when the methods of analysis are similar and particularly in the case of these multi-analyte methods.
(8) A number of already authorised feed additives subject to the re-evaluation process provided for in Article 10(2) of Regulation (EC) No 1831/2003 may be subject to applications submitted simultaneously in homogeneous groups when they belong to the same category of feed additives, functional group and sub classification, if applicable, and when the methods of analysis used for them are of the type multi-analyte methods.
(9) The substances classified in the group ‘chemically defined flavourings’ appearing in the Community Register of Feed Additives, belonging to the category sensory additives and allocated within the functional group flavouring compounds, are a group of feed additives representing nearly two thirds of the entries of the Community Register of Feed Additives at present. Those chemically defined flavourings are subject to the re-evaluation process provided for in Article 10(2) of Regulation (EC) No 1831/2003 and therefore may represent a significant workload in the process. These chemically defined flavourings also represent an homogeneous group of feed additives in terms of their conditions of authorisation and their safety assessment to be carried out following the specific requirements for them laid down in Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (3). The methods of analysis used for many of these chemically defined flavourings may be of the type of multi-analyte methods.
(10) It is therefore appropriate to establish a system of reduced fees for groups of applications for authorisations concerning already authorised feed additives such as the chemically defined flavourings when the applications are submitted simultaneously and contain similar methods of analysis, particularly of the type multi-analyte methods.
(11) For the purpose of the calculation of the different fees, the fee is considered to be composed of two components. The first component is intended to support the CRL administrative costs and the costs related to the handling of the reference samples. The second component is intended to support the costs of the Rapporteur Laboratory for the scientific evaluation and preparation of the evaluation report.
(12) It is also appropriate to adapt the scope of the guidance to applicants prepared by the CRL following the adoption of Regulation (EC) No 429/2008 and also to introduce other minor amendments to Regulation (EC) No 378/2005, taking into account the experience gained.
(13) Belgium has submitted a request to the Commission for the designation of Centre wallon de recherches agronomiques (CRA-W) in Gembloux, as a new national reference laboratory to take part in the consortium. Since that laboratory complies with the requirements set out in Annex I to Regulation (EC) No 378/2005 it should be inserted in the list of laboratories set out in Annex II to that Regulation. Lithuania has informed the Commission that it wishes to withdraw Klaipėdos apskrities VMVT laboratorija, in Klaipėda, from the consortium of national reference laboratories. That laboratory should therefore be deleted from that list of laboratories. In addition several Member States have informed the Commission that certain details of their national reference laboratories taking part in the consortium have changed. The list in Annex II to Regulation (EC) No 378/2005 should be amended accordingly. In the interests of clarity of Community legislation, it should be replaced in its entirety by the list in the Annex I to this Regulation.
(14) Regulation (EC) No 378/2005 should therefore be amended accordingly.
(15) 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:
Article 1
Regulation (EC) No 378/2005 is amended as follows:
Article 1 is replaced by the following:
‘Article 1 Subject matter and scope This Regulation lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the duties and tasks of the Community Reference Laboratory (the CRL).’
In Article 4, paragraph 1 is replaced by the following:
‘1. The CRL shall charge the applicant a fee in accordance with the rates set out in Annex IV (“the fee”).’
Annex II is replaced by the text in Annex I to this Regulation.
A new Annex IV, the text of which is set out in Annex II to the present Regulation, is added.
Article 2
This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 September 2009.
For the Commission Androulla VASSILIOU Member of the Commission
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