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Commission Regulation (EC) No 378/2005Dangos y teitl llawn

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)

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CHAPTER IU.K.GENERAL PROVISIONS

[F1Article 1U.K. 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 reference laboratory.]

Textual Amendments

Article 2U.K.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)[F2;]

(h)

[F3‘ 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.]

Textual Amendments

[F2Article 3U.K.Reference samples

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 [F4to 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, [F5and upon request,] the applicant shall provide to the [F6reference laboratory]:

(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 [F7[F8assimilated] law] relating to the marketing of products consisting of, containing or produced from genetically modified organisms (GMOs);

  • for which Maximum Residue Limits have been established F9... 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 [F6reference laboratory] 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(1), if requested by the [F6reference 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.

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 [F10for] the authorisation of the feed additive by supplying new reference samples to the [F6reference laboratory] to replace [F11any 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 [F6reference laboratory]. Upon justified request of the [F12scientific experts or official laboratories working on behalf of the reference laboratory] and without prejudice [F13to Regulation (EU) 2017/625], the [F6reference laboratory] 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 [F6reference laboratory] 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 [F6reference laboratory] as reference sample of the feed additive concerned.]

Textual Amendments

Article 4U.K.Fees

[F21.The [F14reference laboratory] shall charge the applicant a fee in accordance with the rates set out in Annex IV (‘the fee’).]

2.The [F14reference 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.

[F153.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.]

[F164.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.

5.Any power to make regulations under this Article—

(a)so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;

(b)so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument.

6.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).

7.Any power to make regulations under this Article includes power—

(a)to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business); and

(b)to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.

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

(a)in the case of England, of either House of Parliament;

(b)in the case of Wales, of Senedd Cymru;

(c)in the case of Scotland, of the Scottish Parliament.

9.In this Article, any power—

(a)of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;

(b)of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;

(c)of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only.]

Textual Amendments

Article 5U.K.Evaluation reports by the [F17reference laboratory]

[F21.The [F17reference laboratory] shall submit a full evaluation report to the [F18Food 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 [F17reference laboratory] considers the application to be very complex, it may extend that period by an additional month. The [F17reference laboratory] shall inform the [F19appropriate authority], the [F20Food 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 [F20Food Safety Authority], whenever the [F17reference laboratory] requests supplementary information which cannot be provided by the applicant and/or cannot be evaluated by the [F17reference laboratory] within those time limits.

However, the time limit for the [F17reference laboratory] to submit the evaluation report to the [F20Food Safety Authority] shall not exceed the time limit for [F20Food Safety 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.

[F33.The evaluation report provided for in paragraph 1 may be amended by the [F17reference laboratory] at the request of the [F19appropriate authority] or the [F20Food Safety 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 [F20Food Safety Authority].

[F214.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 [F17reference laboratory];

(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 [F17reference laboratory];

F22(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Notwithstanding paragraph 4, the [F19appropriate authority], the [F17reference laboratory] or the [F20Food 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 [F17reference laboratory].]]

Textual Amendments

CHAPTER IIU.K.F23...REFERENCE LABORATORIES

Article 6U.K.F24... Reference laboratories

[F251.The reference laboratory is to be assisted by [F26scientific 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.]

[F272.For the purposes of paragraph 1, scientific experts or official laboratories must comply with the requirements set out in Annex I.]

3.The [F28scientific experts or official laboratories], including the [F29reference laboratory], shall enter into a contract to define the relations between them, particularly in financial matters. In particular, the contract may provide that the [F29reference laboratory] is to distribute a share of the fees it receives to the [F30scientific experts or official laboratories]. Subject to this contract, the [F29reference laboratory] may issue guidance F31... as provided for in Article 12.

F324.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F33Article 7U.K.Rapporteur laboratories

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F34Article 8U.K.Duties and tasks of rapporteur laboratories

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F35Article 9U.K.Duties and tasks of [F36scientific experts or official laboratories assisting the reference laboratory]

1.[F37Scientific 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.

2.[F38A 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 [F39scientific 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 [F40scientific experts or official] laboratories a compilation of the estimates provided.]

Textual Amendments

Textual Amendments

CHAPTER IIIU.K.TESTING AND VALIDATION OF METHODS OF ANALYSIS, REPORTING AND GUIDANCE

Article 10U.K.Testing of methods of analysis and validation of methods of analysis

1.The [F41reference laboratory] shall indicate in its evaluation report to the [F42Food Safety Authority], as provided for in Article 5(2), and shall inform the applicant and the [F43appropriate authority], if it considers that the following are necessary:

(a)testing of methods of analysis;

(b)validation of methods of analysis.

In doing so, the [F41reference laboratory] shall provide the applicant with a document describing the work to be carried out through [F44scientific 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 [F41reference laboratory] about his agreement to the document within 15 days of receipt of the communication.

2.The [F41reference laboratory] shall supplement the report to the [F42Food 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 [F41reference laboratory] of the results of the testing and validation work.

Textual Amendments

Article 11U.K.Reporting

The [F45reference laboratory] 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 [F46appropriate authority]. The [F47scientific experts or official laboratories] shall contribute to this annual report.

The [F45reference laboratory] may also organise an annual meeting with the [F47scientific experts or official laboratories], in view of the establishment of the annual report.

Textual Amendments

Article 12U.K.Guidance

1.The [F48reference laboratory] 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[F2;]

[F3(d)requirements concerning methods of analysis submitted in accordance with paragraph 2.6. of Annex II to Regulation (EC) No 429/2008.]

2.The [F48reference laboratory] shall establish detailed guidance for [F49scientific experts or official laboratories, including criteria for appointing scientific experts or official laboratories].

Textual Amendments

CHAPTER IVU.K.FINAL PROVISIONS

F50Article 13U.K.Amendments to Regulation (EC) No 1831/2003

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 14U.K.Entry into force

This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

F51...

Textual Amendments

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