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 additivesText with EEA relevance

CHAPTER I

GENERAL PROVISIONS

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), which is the Joint Research Centre of the Commission located in Geel, Belgium.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a) ‘reference sample’ means a representative sample of the feed additive, as referred to in Article 7(3)(f) of Regulation (EC) No 1831/2003, which is the object of an application;

(b) ‘method of analysis’ means the procedure for the determination of the active substance(s) of the feed additive in feedingstuffs, and where appropriate, of its residue(s) or metabolite(s) in food, as referred to in Article 7(3)(c) of the Regulation (EC) No 1831/2003;

(c) ‘evaluation of the method of analysis’ means the thorough assessment of the protocol of the method of analysis as described in the application, including, if appropriate, literature research but not necessarily any experimental work;

(d) ‘testing of a method of analysis’ means the application of the method of analysis in a laboratory and comparison of results with those described in the application;

(e) ‘validation of a method of analysis’ means the process of proving that a method of analysis is fit for the intended purpose, by an intercomparison study according to ISO 5725-1 to 6 or other internationally harmonised guidelines for validation of methods by intercomparison study;

(f) ‘feed test material’ means a feedingstuff sample or premixture sample with or without the inclusion of the feed additive which is the object of the application, to be used for experimental studies on the method of analysis for the determination of the feed additive in feedingstuffs and/or premixtures;

(g) ‘food test material’ means a food sample derived from an animal that has been fed with feedingstuffs with or without the inclusion of the feed additive which is the object of the application, to be used for experimental studies on the method of analysis for the determination of the feed additive in the residue(s) or metabolite(s);

(h) ‘multi-analyte methods’ are 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;

(i) ‘reference standard’ is a sample of a pure active agent used for calibration purposes.

Article 3

Reference samples

In addition, the applicant shall provide to the CRL:

(a) reference standards of the pure active agents in the case of feed additives: — belonging to the category zootechnical additives referred to in Article 6(1)(d) of Regulation (EC) No 1831/2003, except feed additives consisting of or containing micro-organisms; — belonging to the category coccidiostats and histomonostats referred to in Article 6(1)(e) of Regulation (EC) No 1831/2003; — falling within the scope of Community legislation relating to the marketing of products consisting of, containing or produced from genetically modified organisms (GMOs); — for which Maximum Residue Limits have been established in Annex I or III of Council Regulation (EEC) No 2377/90 (¹) or following Regulation (EC) No 1831/2003.

(b) where the application concerns a feed additive consisting of or containing micro-organisms, an authorisation to the CRL to access the microbial strain deposited at the internationally recognised culture collection mentioned in point 2.2.1.2. of Annex II of Commission Regulation (EC) No 429/2008 (²), if requested by the CRL.

Where the application concerns a feed additive belonging to the category sensory additives and allocated within the functional group flavouring compounds referred to at point 2(b) of Annex I to Regulation (EC) No 1831/2003, subject to Article 10(2) of that Regulation, which forms part of a group of applications, the reference samples must be representative of all the compounds/substances in the group.

The applicant shall supply additional reference samples, reference standards, feed and/or food test materials, as defined in Article 2, if requested by the CRL. Upon justified request of the national reference laboratories of the consortium and without prejudice of Articles 11, 32 and 33 of Regulation (EC) No 882/2004, the CRL may request to the applicant additional reference samples, reference standards, feed and/or food test materials.

Unless the applicant is required to supply reference samples in accordance with paragraph 3, reference samples shall not be required for:

(a) an application for a new use of a feed additive, already authorised for another use, submitted in accordance with Article 4(1) of Regulation (EC) No 1831/2003, when reference samples have been previously sent to the CRL for that other use;

(b) an application for changing the terms of an existing authorisation submitted in accordance with Article 13(3) of Regulation (EC) No 1831/2003, 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;

(c) an application for renewal of an existing authorisation submitted in accordance with Article 14 of Regulation (EC) No 1831/2003, provided the reference samples held by the CRL in relation to the existing authorisation of the feed additive are in the form in which the feed additive is intended to be placed on the market.

Article 4

Fees

Article 5

Evaluation reports by the CRL

However, if the CRL considers the application to be very complex, it may extend that period by an additional month. The CRL shall inform the Commission, the Authority, and the applicant when the period is extended.

The time limits provided for in this paragraph may be further extended with the agreement of the Authority, whenever the CRL requests supplementary information which cannot be provided by the applicant and/or cannot be evaluated by the CRL within those time limits.

However, the time limit for the CRL to submit the evaluation report to the Authority shall not exceed the time limit for Authority to provide its opinion, as provided for in Article 8(1) of Regulation (EC) No 1831/2003.

The evaluation report provided for in paragraph 1 shall include in particular:

(a) an evaluation indicating if the methods of analysis in the data submitted in the application are suitable to be used for official controls;

(aa) an indication of which of the duties and tasks set out in Annex II to Regulation (EC) No 1831/2003 could not be carried out as a result of the disagreement notified by the applicant on additional fees as referred to in Article 4(4);

(b) an indication if testing of a method of analysis is considered necessary;

(c) an indication if a validation of a method of analysis by an intercomparison study is considered necessary.

The evaluation report provided for in paragraph 1 may be amended by the CRL at the request of the Commission or the Authority where:

(a) the conditions for placing the feed additive on the market resulting from the Authority's opinion in accordance with Article 8(3)(a) of Regulation (EC) No 1831/2003 differ from those originally proposed by the applicant;

(b) supplementary information relevant to the method of analysis have been provided by the applicant to the Authority.

An evaluation report shall not be required for:

(a) applications for a new use of a feed additive submitted in accordance with Article 4(1) of Regulation (EC) No 1831/2003, when the proposed conditions for placing the feed additive on the market for the new use fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL;

(b) applications for changing the terms of an existing authorisation submitted in accordance with Article 13(3) of Regulation (EC) No 1831/2003, when the proposed change or the new conditions for placing the feed additive on the market fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL;

(c) applications for renewal of an existing authorisation submitted in accordance with Article 14 of Regulation (EC) No 1831/2003, when the conditions for placing the feed additive on the market fall within the scope of the method of analysis previously submitted in accordance with paragraph 2.6 of Annex II to Regulation (EC) No 429/2008 and already evaluated by the CRL.

Notwithstanding paragraph 4, the Commission, the CRL or the Authority may, on the basis of legitimate factors relevant to the application, in particular the need to adapt the methods of analysis in the light of scientific and technological developments, consider that a new evaluation of the methods of analysis is necessary. In such cases the applicant shall be informed by the CRL and Article 4(4) shall apply.

CHAPTER II

NATIONAL REFERENCE LABORATORIES

Article 6

National reference laboratories

Article 7

Rapporteur laboratories

However, the CRL may also act as rapporteur laboratory for applications.

Article 8

Duties and tasks of rapporteur laboratories

The rapporteur laboratories shall be responsible for:

(a) drafting an initial evaluation report concerning the data submitted in each application and submitting it for comments to the other laboratories;

(b) compiling the comments received from the other laboratories and preparing a revised evaluation report;

(c) submitting the revised evaluation report to the CRL in sufficient time to allow the CRL to submit its full evaluation report to the Authority within the deadline referred to in Article 5(1);

(d) if requested by the CRL, submitting an amendment to the evaluation report concerning the supplementary data submitted by the applicant to the CRL or to the Authority.

Article 9

Duties and tasks of the laboratories participating in the consortium

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

The CRL shall indicate in its evaluation report to the Authority, as provided for in Article 5(2), and shall inform the applicant and the Commission, if it considers that the following are necessary:

(a) testing of methods of analysis;

(b) validation of methods of analysis.

In doing so, the CRL shall provide the applicant with a document describing the work to be carried out through the consortium including a time schedule and an estimate of a special fee to be paid by the applicant. The applicant shall inform the CRL about his agreement to the document within 15 days of receipt of the communication.

Article 11

Reporting

The CRL shall be responsible for preparing an annual report on each year’s activities carried out for the implementation of this Regulation and shall submit it to the Commission. The consortium shall contribute to this annual report.

The CRL may also organise an annual meeting with the consortium, in view of the establishment of the annual report.

Article 12

Guidance

The CRL may establish detailed guidance for applicants concerning:

(a) reference samples;

(b) the testing of methods of analysis, including in particular criteria about when such testing may be required;

(c) the validation of methods of analysis, including in particular criteria about when such validation may be required;

(d) requirements concerning methods of analysis submitted in accordance with paragraph 2.6. of Annex II to Regulation (EC) No 429/2008.

CHAPTER IV

FINAL PROVISIONS

Article 13

Amendments to Regulation (EC) No 1831/2003

Paragraphs 2 and 3 of Annex II to Regulation (EC) No 1831/2003 are replaced by the text in Annex III to this Regulation.

Article 14

Entry into force

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.

ANNEX I

Requirements for laboratories participating in the consortium of national reference laboratories, as referred to in Article 6(2)

Laboratories participating in the consortium must satisfy the following minimum requirements:

(a) have been designated as a national reference laboratory by a Member State for the purpose of taking part in the consortium referred to in Article 21 and Annex II to Regulation (EC) No 1831/2003;

(b) have suitable qualified staff that are adequately trained in analytical methods used for the feed additives on which they are involved;

(c) possess the equipment needed to carry out the analysis of feed additives, in particular the ones on which they are carrying tasks under this Regulation;

(d) have an adequate administrative infrastructure;

(e) have sufficient data-processing capacity to produce technical reports and to enable rapid communication with the other laboratories participating in the consortium;

(f) provide assurance that their staff respect the confidential aspects of issues, results or communications involved in the handling of applications for authorisation submitted in accordance with Regulation (EC) No 1831/2003 and in particular the information referred to in Article 18 of that Regulation;

(g) have sufficient knowledge of international standards and practices in laboratory work;

(h) must be accredited, or being in the process of accreditation according to international standards such as ISO 17025 .

ANNEX III

Text replacing paragraphs 2 and 3 of Annex II to Regulation (EC) No 1831/2003

‘2.For the duties and tasks set out in this Annex, the CRL may be assisted by a consortium of national reference laboratories.

The CRL shall be responsible for:

2.1. the reception, storage and maintenance of the samples of the feed additive sent by the applicant as provided for in Article 7(3)(f);

2.2. evaluating the method of analysis of the feed additive, and of other relevant methods of analysis related to it, on the basis of the data provided in the application for authorisation of the feed additive as regards its suitability for official control in accordance with the requirements of the implementing rules referred to in Article 7(4) and (5) and the guidance of the Authority referred to in Article 7(6);

2.3. submitting a full evaluation report to the Authority on the results of the duties and tasks referred to in this Annex;

2.4. where necessary, the testing of the method(s) of analysis.

3.The CRL shall be responsible for coordination of the validation of the method(s) of analysis of the additive, in accordance with the procedure provided for in Article 10 of Regulation (EC) No 378/2005 (^*1). This task may involve the preparation of food or feed test material.

4.The CRL shall provide scientific and technical assistance to the Commission, especially in cases where Member States contest the results of analyses related to the duties and tasks referred to in this Annex, without prejudice to any role defined for it under Articles 11 and 32 of Regulation (EC) No 882/2004 of the European Parliament and of the Council (^*2).

5.On request by the Commission, the CRL may also be responsible for conducting special analytical or other related studies in a manner similar to the duties and tasks referred to in point 2. This may be the case, in particular, for existing products notified under Article 10 and included in the Register and for the period until an application for authorisation under Article 10(2) is submitted in accordance with Article 10(2).

6.The CRL shall be responsible for the overall coordination of the consortium of national reference laboratories. The CRL shall ensure that the relevant data concerning the applications are made available to the laboratories.

7.Without prejudice to the responsibilities of the Community reference laboratories laid down in Article 32 of Regulation (EC) No 882/2004, the CRL may create and maintain a database of methods of analysis available for control of feed additives and make it available to official control laboratories from Member States and other interested parties.

ANNEX IV

RATES FOR FEES AS REFERRED TO IN ARTICLE 4(1)

Composition of the fee

For the purpose of the calculation of the fee, the fee is composed of the following two components:

The two components are applied as detailed below to calculate the fee rates.

Rates according to the type of application for authorisations of feed additives in accordance with Regulation (EC) No 1831/2003

1.Authorisation of a new feed additive (Article 4(1) of Regulation (EC) No 1831/2003):

Fee = Component 1 + Component 2 = EUR 6 000

2.Authorisation of a new use of a feed additive (Article 4(1) of Regulation (EC) No 1831/2003):

— when Article 3 (4)(a) and Article 5(4)(a) apply: Fee = EUR 0

— when only Article 3 (4)(a) applies, only Component 2 is applicable: Fee = EUR 4 000

3.Authorisation of an already authorised feed additive (Article 10(2) of Regulation (EC) No 1831/2003):

Fee = Component 1 + Component 2 = EUR 6 000

— For groups of applications concerning more than one feed additive submitted simultaneously belonging to the same category of feed additives, functional group and sub classification, if applicable, and other than chemically defined flavourings, zootechnical additives, coccidiostats and histomonostats, and when the methods of analysis used for these feed additives are of the multi-analyte type of methods of analysis, the fee shall be calculated as follows: The first component is multiplied by the number (n) of feed additives in the group: Component 1 = (EUR 2 000 × n) = N The second component is multiplied by the number (m) of methods of analysis to be evaluated by the CRL: Component 2 = (EUR 4 000 × m) = M The fee shall be the sum of the two components: Fee = N + M