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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).]
Textual Amendments
For the purposes of this Regulation, the following definitions shall apply:
‘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;
‘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;
‘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;
‘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;
‘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;
‘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;
‘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)[F1;]
[F2‘ 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;
‘ reference standard ’ is a sample of a pure active agent used for calibration purposes.]
Textual Amendments
1. Any person submitting an application for an authorisation for a feed additive or for a new use of a feed additive, as provided for in Article 4(1) of Regulation (EC) No 1831/2003, shall send three reference samples in a form in which the feed additive is intended to be placed on the market by the applicant.
In addition, the applicant shall provide to the CRL:
(a) reference standards of the pure active agents in the case of feed additives:
(a) 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.
2. The three reference samples of the feed additive shall be accompanied by a written statement by the applicant that the fee provided for in Article 4(1) has been paid.
3. The applicant shall maintain the reference samples valid for the entire period of the authorisation of the feed additive by supplying new reference samples to the CRL to replace those expired.
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.
4. 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.]
Textual Amendments
[F11. The CRL shall charge the applicant a fee in accordance with the rates set out in Annex IV ( ‘ the fee ’ ).]
2.The CRL shall use the fees towards supporting the costs of the duties and tasks as set out in Annex II to Regulation (EC) No 1831/2003, and in particular those referred to in 2.1, 2.2 and 2.3 of that Annex.
3.The amount of the fee mentioned in paragraph 1 may be adapted once a year in accordance with the procedure referred to in Article 22(2) of Regulation (EC) No 1831/2003. The adaptation shall take into account the experience gained during the operation of this Regulation and in particular the possibility of fixing different fees for different types of applications.
Textual Amendments
[F11. The CRL shall submit a full evaluation report to the European Food Safety Authority (the Authority) for each application, or for each group of applications, within three months from the date of receipt of a valid application as referred to in Article 8(1) of Regulation (EC) No 1831/2003 and the payment of the fee.
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.]
2.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;
(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.
[F23. 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.
[F34. 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, consider that a new evaluation of the methods of analysis is necessary. In such cases the applicant shall be informed by the CRL.] ]
Textual Amendments
F1 Substituted by Commission 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).
1.The CRL shall be assisted by a consortium of national reference laboratories (the consortium) for the duties and tasks set out in 2.2, 2.4 and 3 of Annex II to Regulation (EC) No 1831/2003.
2.The consortium is open to national reference laboratories which comply with the requirements set out in Annex I. The laboratories listed in Annex II are hereby appointed national reference laboratories to take part in the consortium.
3.The members of the consortium, including the CRL, shall enter into a contract to define the relations between them, particularly in financial matters. In particular, the contract may provide that the CRL is to distribute a share of the fees it receives to the other members of the consortium. Subject to this contract, the CRL may issue guidance to the members of the consortium as provided for in Article 12.
4.Any Member State may submit requests to the Commission for the designation of further national reference laboratories to take part in the consortium. If it considers that such laboratories comply with the requirements set out in Annex I, the Commission shall amend the list in Annex II in accordance with the procedure referred to in Article 22(2) of Regulation (EC) No 1831/2003. The same procedure shall apply if a Member State wishes to withdraw one of its national reference laboratories from the consortium. The contractual arrangements between the members of the consortium shall be adjusted to reflect any changes to the consortium.
1.The CRL shall appoint one laboratory to act as rapporteur laboratory for each application (the rapporteur laboratory).
However, the CRL may also act as rapporteur laboratory for applications.
2.When appointing a rapporteur laboratory, the CRL shall take into account the expertise, experience and workload of the laboratory.
3.The laboratories shall send comments to the rapporteur laboratory within 20 days from the date of receipt of the initial evaluation report provided for in Article 8(a).
The rapporteur laboratories shall be responsible for:
drafting an initial evaluation report concerning the data submitted in each application and submitting it for comments to the other laboratories;
compiling the comments received from the other laboratories and preparing a revised evaluation report;
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)[F1;]
[F2if 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.]
Textual Amendments
1.The laboratories participating in the consortium shall be responsible for contributing to the initial evaluation report prepared by the rapporteur laboratory by sending comments to the rapporteur laboratory within 20 days of the reception of the initial report.
2.Each laboratory shall communicate to the CRL by 30 January each year an estimate of the number of applications for which the laboratory considers itself able to carry out the tasks of rapporteur laboratory for that year. The CRL shall make available annually to all the laboratories a compilation of the estimates provided.
1.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.
2.The CRL shall supplement the report to the Authority, as provided for in Article 5(1), with an addendum concerning the outcome of the application of the procedure foreseen in paragraph 1 within 30 days of the availability to the CRL of the results of the testing and validation work.
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.
1.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[F1;]
[F2(d) requirements concerning methods of analysis submitted in accordance with paragraph 2.6. of Annex II to Regulation (EC) No 429/2008.]
2.The CRL shall establish detailed guidance for laboratories, including criteria for appointing rapporteur laboratories.
Textual Amendments
Paragraphs 2 and 3 of Annex II to Regulation (EC) No 1831/2003 are replaced by the text in Annex III to this Regulation.
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.