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)

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 F2to the reference laboratory, upon request, in a form in which the feed additive is intended to be placed on the market by the applicant.

In addition, F3and upon request, the applicant shall provide to the F4reference laboratory:

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 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.

The applicant shall maintain the reference samples F8for the authorisation of the feed additive by supplying new reference samples to the reference laboratory to replace F9any that expire.

The applicant shall supply additional reference samples, reference standards, feed and/or food test materials, as defined in Article 2, if requested by the reference laboratory. Upon justified request of the F10scientific experts or official laboratories working on behalf of the reference laboratory and without prejudice F11to Regulation (EU) 2017/625, the reference laboratory may request to the applicant additional reference samples, reference standards, feed and/or food test materials.

Reference samples shall not be required for:

The F2reference laboratory shall charge the applicant a fee in accordance with the rates set out in Annex IV (‘the fee’).

The reference laboratory 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.

The appropriate authority may, once a year, prescribe adaptations in the amount of the fee mentioned in paragraph 1. 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.

In this Regulation, any rates, fees or charges denominated in euro (“EUR”) are to be read as converted into pounds sterling (“GBP”) using an exchange rate of GBP1 = EUR1.1413.

Any power to make regulations under this Article—

For regulations made under this Article by the Scottish Ministers, see also section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010 (Scottish statutory instruments).

Any power to make regulations under this Article includes power—

Any statutory instrument or Scottish statutory instrument containing regulations made under this Article is subject to annulment in pursuance of a resolution—

In this Article, any power—

The reference laboratory shall submit a full evaluation report to the F3Food Safety 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 reference laboratory considers the application to be very complex, it may extend that period by an additional month. The reference laboratory shall inform the F4appropriate authority, the F5Food Safety 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 Food Safety Authority, whenever the reference laboratory requests supplementary information which cannot be provided by the applicant and/or cannot be evaluated by the reference laboratory within those time limits.

However, the time limit for the reference laboratory to submit the evaluation report to the Food Safety Authority shall not exceed the time limit for Food Safety 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:

The evaluation report provided for in paragraph 1 may be amended by the reference laboratory at the request of the appropriate authority or the Food Safety Authority where:

An evaluation report shall not be required for:

Notwithstanding paragraph 4, the appropriate authority, the reference laboratory or the Food Safety 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 reference laboratory.

The reference laboratory is to be assisted by F2scientific experts or official laboratories for the duties and tasks set out in 2.2, 2.4 and 3 of Annex 2 to Regulation (EC) No. 1831/2003.

For the purposes of paragraph 1, scientific experts or official laboratories must comply with the requirements set out in Annex I.

The F4scientific experts or official laboratories, including the F5reference laboratory, shall enter into a contract to define the relations between them, particularly in financial matters. In particular, the contract may provide that the reference laboratory is to distribute a share of the fees it receives to the F6scientific experts or official laboratories. Subject to this contract, the reference laboratory may issue guidance F7... as provided for in Article 12.

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F2Scientific experts or official laboratories, who are assisting the reference laboratory, are responsible for assisting the reference laboratory in the preparation of evaluation reports by sending comments to the reference laboratory within 20 days of the reception of the initial report.

F3A scientific expert or official laboratory, who, or which, is assisting the reference laboratory, must communicate to the reference laboratory by 30 January each year an estimate of the number of applications for which the F4scientific expert or official laboratory considers itself able to carry out the tasks for that year. The reference laboratory must make available annually to all the F5scientific experts or official laboratories a compilation of the estimates provided.

The F1reference laboratory shall indicate in its evaluation report to the F2Food Safety Authority, as provided for in Article 5(2), and shall inform the applicant and the F3appropriate authority, if it considers that the following are necessary:

In doing so, the reference laboratory shall provide the applicant with a document describing the work to be carried out through F4scientific experts or official laboratories including a time schedule and an estimate of a special fee to be paid by the applicant. The applicant shall inform the reference laboratory about his agreement to the document within 15 days of receipt of the communication.

The reference laboratory shall supplement the report to the Food Safety 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 reference laboratory of the results of the testing and validation work.

The F1reference laboratory may establish detailed guidance for applicants concerning:

The reference laboratory shall establish detailed guidance for F4scientific experts or official laboratories, including criteria for appointing scientific experts or official laboratories.