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)

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, and in particular the first subparagraph of Article 7(4) and the third subparagraph of Article 21 thereof,
OJ L 268, 18.10.2003, p. 29.
Whereas:
(1) Regulation (EC) No 1831/2003 lays down rules for the placing on the market and use of feed additives in animal nutrition. It provides that any person seeking an authorisation for a feed additive or a new use of a feed additive is to submit an application for authorisation to the Commission in accordance with that Regulation (the application).
(2) Regulation (EC) No 1831/2003 provides for a Community reference laboratory (the CRL) to carry out certain duties and tasks set out in Annex II to that Regulation. It also provides that the Joint Research Centre of the Commission is to be the CRL and that it may be assisted by a consortium of national reference laboratories to perform the duties and tasks set out in that Annex.
(3) In accordance with Regulation (EC) No 1831/2003, it is necessary to adopt detailed rules for implementing Annex II to that Regulation, including practical conditions for the duties and tasks of the CRL and to amend that Annex accordingly.
(4) In addition, the samples to be provided in the application, in accordance with Regulation (EC) No 1831/2003, should meet specific requirements in view of the duties and tasks of the CRL.
(5) It is necessary to establish a precise timing for the delivery of the evaluation report from the CRL to the European Food Safety Authority (the Authority) in order to ensure that the procedures provided for in Regulation (EC) No 1831/2003 can be met.
(6) The CRL should be authorised to charge a fee to applicants towards the costs of supporting the duties and tasks of the CRL and the consortium of national reference laboratories.
(7) National reference laboratories should be part of the consortium of laboratories assisting the CRL only if they meet specific requirements in order to properly perform the duties and tasks laid down in Regulation (EC) No 1831/2003. Member States should be permitted to apply to the Commission for the designation of such laboratories.
(8) In order to ensure the effective functioning of the consortium, it is necessary to appoint a rapporteur laboratory to carry out an initial assessment of the method(s) of analysis of each individual application and to establish clearly the duties and tasks of the rapporteur laboratories and the other laboratories participating in the consortium.
(9) It is necessary to establish special procedures for the cases where the data in the application are insufficient concerning testing or validation of the method(s) of analysis.
(10) In the interests of stability and efficacy and also in order to make the consortium operational, it is necessary to appoint the national reference laboratories participating in the consortium.
(11) The relations between the members of the consortium should be defined by contract between them. In this context the CRL may develop guidance for applicants and for the laboratories participating in the consortium.
(12) 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:

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 reference laboratory.
Art. 1 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 64; 2020 c. 1, Sch. 5 para. 1(1)

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

Article 3 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 to 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, and upon request, the applicant shall provide to the reference 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 assimilated 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 ... or following Regulation (EC) No 1831/2003.
Words in Art. 3(1)(a) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 65(b); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 3(1)(a) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 10
Words in Art. 3(1)(a) omitted (E.W.S.) (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(2)(a)(ii)(bb)
(b) where the application concerns a feed additive consisting of or containing micro-organisms, an authorisation to the reference 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, if requested by the reference laboratory.
OJ L 133, 22.5.2008, p. 1 .
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.
Words in Art. 3(1) inserted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(2)(a)(i)
Words in Art. 3(1) inserted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(2)(a)(ii)(aa)
Words in Art. 3 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 65(a); 2020 c. 1, Sch. 5 para. 1(1)
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 for the authorisation of the feed additive by supplying new reference samples to the reference laboratory to replace any 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 scientific experts or official laboratories working on behalf of the reference laboratory and without prejudice to Regulation (EU) 2017/625, the reference laboratory may request to the applicant additional reference samples, reference standards, feed and/or food test materials.
Word in Art. 3(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 4(2)(a) (with regs. 23, 24)
Words in Art. 3(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 4(2)(b) (with regs. 23, 24)
Words in Art. 3(3) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(2)(b)(i)
Words in Art. 3(3) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(2)(b)(ii)
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 reference 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 reference laboratory as reference sample of the feed additive concerned.

Article 4 Fees
1. The reference laboratory shall charge the applicant a fee in accordance with the rates set out in Annex IV (‘the fee’).
Words in Art. 4 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 66(a); 2020 c. 1, Sch. 5 para. 1(1)
2. 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.
3. 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.
Art. 4(3) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 66(b); 2020 c. 1, Sch. 5 para. 1(1)
4. 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.
Art. 4(4)-(9) inserted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 66(c) (as amended by S.I. 2020/1504, regs. 1(2), 12(14)); 2020 c. 1, Sch. 5 para. 1(1)
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.

Article 5 Evaluation reports by the reference laboratory
1. The reference laboratory shall submit a full evaluation report to the Food 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 appropriate authority, the Food 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.
Words in Art. 5(1) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 67(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 5 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 67(d); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 5 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 67(c); 2020 c. 1, Sch. 5 para. 1(1)
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.
3. 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:
(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 Food Safety Authority.
4. 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 reference 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 reference laboratory;
(c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 5(4)(c) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 4(3) (with regs. 23, 24)
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.
Substituted by Commission Implementing Regulation (EU) 2015/1761 of 1 October 2015 amending Commission Regulation (EC) No 378/2005 as regards the Community Reference Laboratory reports, fees and the laboratories listed in Annex II thereto (Text with EEA relevance).
Words in Art. 5 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 67(a); 2020 c. 1, Sch. 5 para. 1(1)

CHAPTER II ...REFERENCE LABORATORIES

Article 6 ... Reference laboratories
1. The reference laboratory is to be assisted by scientific 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.
Art. 6(1) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 69(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 6(1) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(3)(a)
2. For the purposes of paragraph 1, scientific experts or official laboratories must comply with the requirements set out in Annex I.
Art. 6(2) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(3)(b)
3. The scientific experts or official laboratories, including the reference 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 scientific experts or official laboratories. Subject to this contract, the reference laboratory may issue guidance ... as provided for in Article 12.
Words in Art. 6(3) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(3)(c)(i)
Words in Art. 6 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 69(d); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 6(3) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(3)(c)(ii)
Words in Art. 6(3) omitted (E.W.S.) (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(3)(c)(iii)
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 6(4) omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 69(e); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 6 heading omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 69(a); 2020 c. 1, Sch. 5 para. 1(1)

Article 7 Rapporteur laboratories
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 7 omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 70; 2020 c. 1, Sch. 5 para. 1(1)

Article 8 Duties and tasks of rapporteur laboratories
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 8 omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 70; 2020 c. 1, Sch. 5 para. 1(1)

Article 9 Duties and tasks of scientific experts or official laboratories assisting the reference laboratory
1. Scientific 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.
Words in Art. 9(1) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(4)(b)
2. A 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 scientific 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 scientific experts or official laboratories a compilation of the estimates provided.
Words in Art. 9(2) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(4)(c)(i)
Words in Art. 9(2) inserted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(4)(c)(ii)
Words in Art. 9(2) inserted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(4)(c)(iii)
Art. 9 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 71; 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 9 heading substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(4)(a)
Word in Ch. 2 heading omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 68; 2020 c. 1, Sch. 5 para. 1(1)

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
1. The reference laboratory shall indicate in its evaluation report to the Food Safety Authority, as provided for in Article 5(2), and shall inform the applicant and the appropriate 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 reference laboratory shall provide the applicant with a document describing the work to be carried out through scientific 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.
Words in Art. 10 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 72(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 10 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 72(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 10(1) substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 72(c); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 10(1) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(5)
2. 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.

Article 11 Reporting
The reference 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 appropriate authority. The scientific experts or official laboratories shall contribute to this annual report.
The reference laboratory may also organise an annual meeting with the scientific experts or official laboratories, in view of the establishment of the annual report.
Words in Art. 11 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 73(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 11 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 73(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 11 substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(6)

Article 12 Guidance
1. The reference 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;
(d) requirements concerning methods of analysis submitted in accordance with paragraph 2.6. of Annex II to Regulation (EC) No 429/2008.
Words in Art. 12 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 74; 2020 c. 1, Sch. 5 para. 1(1)
2. The reference laboratory shall establish detailed guidance for scientific experts or official laboratories, including criteria for appointing scientific experts or official laboratories.
Words in Art. 12(2) substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(7)

CHAPTER IV FINAL PROVISIONS

Article 13 Amendments to Regulation (EC) No 1831/2003
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 13 omitted (E.W.S.) (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(8)

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.
...
Words in Signature omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 75; 2020 c. 1, Sch. 5 para. 1(1)

ANNEX I Requirements for participating scientific experts and official laboratories, as referred to in Article 6
Scientific experts or official laboratories assisting the reference laboratory must satisfy the following minimum requirements:
(a) ...
Annex 1 point (a) omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 76; 2020 c. 1, Sch. 5 para. 1(1)
(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 ...;
Words in Annex 1 point (e) omitted (E.W.S.) (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(9)(c)
(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 1 heading substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(9)(a)
Words in Annex 1 substituted (E.W.S.) (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(9)(b)

ANNEX II Community reference laboratory and consortium of national reference laboratories, as referred to in Article 6(2)

COMMUNITY REFERENCE LABORATORY
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NATIONAL REFERENCE LABORATORIES OF THE MEMBER STATES

Belgique/België
Federaal Laboratorium voor de Voedselveiligheid Tervuren (FLVVT –FAVV);
Vlaamse Instelling voor Technologisch Onderzoek (VITO), Mol;
Centre wallon de Recherches agronomiques (CRA-W), Gembloux.

Česká republika
Ústřední kontrolní a zkušební ústav zemědělský (ÚKZÚZ), Praha.

Danmark
Fødevarestyrelsens Laboratorie Aarhus (kemisk);
Fødevarestyrelsens Laboratorie Ringsted (kemisk og mikrobiologisk).

Deutschland
Sachgebiet Futtermittel des Bayrischen Landesamtes für Gesundheit und Lebensmittelsicherheit (LGL), Oberschleißheim;
Landwirtschaftliche Untersuchungs- und Forschungsanstalt (LUFA), Speyer;
Staatliche Betriebsgesellschaft für Umwelt und Landwirtschaft. Geschäftsbereich 6 — Labore Landwirtschaft, Nossen;
Thüringer Landesanstalt für Landwirtschaft (TLL). Abteilung Untersuchungswesen. Jena.

Eesti
Põllumajandusuuringute Keskus (PMK). Jääkide ja saasteainete labor, Saku, Harjumaa;
Põllumajandusuuringute Keskus (PMK), Taimse materjali labor, Saku, Harjumaa.

España
Laboratorio Arbitral Agroalimentario. Ministerio de Agricultura, Alimentación y Medio Ambiente, Madrid;
Laboratori Agroalimentari, Departament d'Agricultura, Ramaderia, PESCA, Alimentació i Medi Natural. Generalitat de Catalunya, Cabrils.

France
Laboratoire de Rennes (SCL L35), Service Commun des Laboratoires DGCCRF et DGDDI, Rennes.

Éire/Ireland
The State Laboratory, Kildare.

Ελλάδα
Εργαστήριο Ελέγχου Κυκλοφορίας Ζωοτροφών Θεσσαλονίκης.

Italia
Istituto Superiore di Sanità. Dipartimento di Sanità Pubblica Veterinaria e Sicurezza Alimentare, Roma;
Centro di referenza nazionale per la sorveglienza ed il controllo degli alimenti per gli animali (CReAA), Torino.

Kypros
Feedingstuffs Analytical Laboratory, Department of Agriculture, Nicosia.

Latvija
Pārtikas drošības, dzīvnieku veselības un vides zinātniskais institūts BIOR, Rīga.

Lietuva
Nacionalinis maisto ir veterinarijos rizikos vertinimo institutas, Vilnius.

Luxembourg
Laboratoire de Contrôle et d'essais — ASTA, Ettelbruck.

Magyarország
Nemzeti Élelmiszerlánc-biztonsági Hivatal, Élelmiszer- és Takarmánybiztonsági Igazgatóság, Takarmányvizsgáló Nemzeti Referencia Laboratórium, Budapest.

Nederland
RIKILT Wageningen UR, Wageningen.

Österreich
Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES), Wien.

Polska
Instytut Zootechniki — Państwowy Instytut Badawczy, Krajowe Laboratorium Pasz, Lublin;
Państwowy Instytut Weterynaryjny, Pulawy.

Portugal
Instituto Nacional de Investigação Agrária e Veterinária, I.P. (INIAV,IP), Lisboa.

Slovenija
Univerza v Ljubljani. Veterinarska fakulteta. Nacionalni veterinarski inštitut. Enota za patologijo prehrane in higieno okolja, Ljubljana;
Kmetijski inštitut Slovenije, Ljubljana.

Slovensko
Skúšobné laboratórium analýzy krmív, Ústredný kontrolný a skúšobný ústav poľnohospodársky, Bratislava.

Suomi/Finland
Elintarviketurvallisuusvirasto/Livsmedelssäkerhetsverket (Evira), Helsinki/Helsingfors.

Sverige
Avdelningen för kemi, miljö och fodersäkerhet, Statens Veterinärmedicinska Anstalt (SVA), Uppsala.

United Kingdom
LGC Ltd, Teddington.

NATIONAL REFERENCE LABORATORIES OF EFTA COUNTRIES

Norway
The National Institute of Nutrition and Seafood Research (NIFES), Bergen.
Annex 2 omitted (31.12.2020) by virtue of The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 77; 2020 c. 1, Sch. 5 para. 1(1)

ANNEX III Text replacing paragraphs 2 and 3 of Annex II to Regulation (EC) No 1831/2003
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Annex 3 omitted (E.W.S.) (31.12.2022) by virtue of The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 10(10)

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:
1. The first component is intended to support the reference laboratory administrative costs and the costs related to the handling of the reference samples. This first component amounts to EUR 2 000.
Words in Annex 4 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 78(a); 2020 c. 1, Sch. 5 para. 1(1)
2. The second component is intended to support the costs of the laboratory which performs the scientific evaluation and preparation of the evaluation report. This second component amounts to EUR 4 000.
Words in Annex 4 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 78(b); 2020 c. 1, Sch. 5 para. 1(1)
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 reference laboratory:
Component 2 = (EUR 4 000 × m) = M
The fee shall be the sum of the two components:
Fee = N + M
For groups of applications concerning more than one chemically defined flavouring submitted simultaneously 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 reference samples, as specified in Article 3 paragraph 1, submitted to the reference laboratory:
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 reference laboratory:
Component 2 = (EUR 4 000 × m) = M
The fee shall be the sum of the two components:
Fee = N + M

4. Applications for changing the terms of an existing authorisation (Article 13(3) of Regulation (EC) No 1831/2003):
when Article 3(4)(b) and Article 5(4)(b) apply:
Fee = EUR 0
when only Article 3(4)(b) applies, only Component 2 applies:
Fee = EUR 4 000

5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annex 4 para. 5 omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 4(4) (with regs. 23, 24)