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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(1), and in particular the first subparagraph of Article 7(4) and the third subparagraph of Article 21 thereof,

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

[F1Article 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.F1]

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) [F2 ; 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. F3]

[F2Article 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 [F4 to the reference laboratory, upon request,F4] in a form in which the feed additive is intended to be placed on the market by the applicant.

In addition, [F5 and upon request,F5] the applicant shall provide to the [F6 reference laboratoryF6] :

(a)reference standards of the pure active agents in the case of feed additives:

(b)where the application concerns a feed additive consisting of or containing micro-organisms, an authorisation to the [F6 reference laboratoryF6] 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 [F6 reference laboratoryF6] .

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 [F10 forF10] the authorisation of the feed additive by supplying new reference samples to the [F6 reference laboratoryF6] to replace [F11 any that expireF11] .

The applicant shall supply additional reference samples, reference standards, feed and/or food test materials, as defined in Article 2, if requested by the [F6 reference laboratoryF6] . Upon justified request of the [F12 scientific experts or official laboratories working on behalf of the reference laboratoryF12] and without prejudice [F13 to Regulation (EU) 2017/625F13] , the [F6 reference laboratoryF6] 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 [F6 reference laboratoryF6] 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 [F6 reference laboratoryF6] as reference sample of the feed additive concerned.F2]

Article 4 Fees

[F2 1. The [F14 reference laboratory F14] shall charge the applicant a fee in accordance with the rates set out in Annex IV (‘the fee’). F2]

2.The [F14reference laboratoryF14] 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.

[F15 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.F15]

[F16 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.

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.F16]

Article 5 Evaluation reports by the [F17reference laboratoryF17]

[F2 1.The [F17 reference laboratoryF17] shall submit a full evaluation report to the [F18 Food Safety AuthorityF18] 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 [F17 reference laboratoryF17] considers the application to be very complex, it may extend that period by an additional month. The [F17 reference laboratoryF17] shall inform the [F19 appropriate authorityF19] , the [F20 Food Safety AuthorityF20] , 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 [F20 Food Safety AuthorityF20] , whenever the [F17 reference laboratoryF17] requests supplementary information which cannot be provided by the applicant and/or cannot be evaluated by the [F17 reference laboratoryF17] within those time limits.

However, the time limit for the [F17 reference laboratoryF17] to submit the evaluation report to the [F20 Food Safety AuthorityF20] shall not exceed the time limit for [F20 Food Safety AuthorityF20] to provide its opinion, as provided for in Article 8(1) of Regulation (EC) No 1831/2003.F2]

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.

[F3 3.The evaluation report provided for in paragraph 1 may be amended by the [F17 reference laboratoryF17] at the request of the [F19 appropriate authorityF19] or the [F20 Food Safety AuthorityF20] 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 [F20 Food Safety AuthorityF20] .

[F21 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 [F17 reference laboratoryF17] ;

(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 [F17 reference laboratoryF17] ;

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

Notwithstanding paragraph 4, the [F19 appropriate authorityF19] , the [F17 reference laboratoryF17] or the [F20 Food Safety AuthorityF20] 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 [F17 reference laboratoryF17] .F21,F3]]

CHAPTER II F23...REFERENCE LABORATORIES

Article 6 F24... Reference laboratories

[F25 1.The reference laboratory is to be assisted by [F26 scientific experts or officialF26] laboratories for the duties and tasks set out in 2.2, 2.4 and 3 of Annex 2 to Regulation (EC) No. 1831/2003.F25]

[F27 2.For the purposes of paragraph 1, scientific experts or official laboratories must comply with the requirements set out in Annex I.F27]

3.F31The [F28scientific experts or official laboratoriesF28] , including the [F29reference laboratoryF29] , shall enter into a contract to define the relations between them, particularly in financial matters. In particular, the contract may provide that the [F29reference laboratoryF29] is to distribute a share of the fees it receives to the [F30scientific experts or official laboratoriesF30] . Subject to this contract, the [F29reference laboratoryF29] may issue guidance ... as provided for in Article 12.

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

F33Article 7 Rapporteur laboratories

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

F34Article 8 Duties and tasks of rapporteur laboratories

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

[F35Article 9 Duties and tasks of [F36scientific experts or official laboratories assisting the reference laboratoryF36]

1.[F37 Scientific experts or official laboratories, who are assisting the reference laboratory,F37] 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.[F38 A scientific expert or official laboratory, who, or which, is assisting the reference laboratory,F38] must communicate to the reference laboratory by 30 January each year an estimate of the number of applications for which the [F39 scientific expert or officialF39] laboratory considers itself able to carry out the tasks for that year. The reference laboratory must make available annually to all the [F40 scientific experts or officialF40] laboratories a compilation of the estimates provided.F35]

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 [F41reference laboratoryF41] shall indicate in its evaluation report to the [F42Food Safety AuthorityF42] , as provided for in Article 5(2), and shall inform the applicant and the [F43appropriate authorityF43] , 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 laboratoryF41] shall provide the applicant with a document describing the work to be carried out through [F44scientific experts or official laboratoriesF44] including a time schedule and an estimate of a special fee to be paid by the applicant. The applicant shall inform the [F41reference laboratoryF41] about his agreement to the document within 15 days of receipt of the communication.

2.The [F41reference laboratoryF41] shall supplement the report to the [F42Food Safety AuthorityF42] , 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 laboratoryF41] of the results of the testing and validation work.

Article 11 Reporting

The [F45reference laboratoryF45] 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 authorityF46] . The [F47scientific experts or official laboratoriesF47] shall contribute to this annual report.

The [F45reference laboratoryF45] may also organise an annual meeting with the [F47scientific experts or official laboratoriesF47] , in view of the establishment of the annual report.

Article 12 Guidance

1.The [F48reference laboratoryF48] 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;F2]

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

2.The [F48reference laboratoryF48] shall establish detailed guidance for [F49scientific experts or official laboratories, including criteria for appointing scientific experts or official laboratoriesF49] .

CHAPTER IV FINAL PROVISIONS

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

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

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.

F51 ...

ANNEX I [F52Requirements for participating scientific experts and official laboratories, as referred to in Article 6F52]

[F53 Scientific experts or official laboratories assisting the reference laboratoryF53] must satisfy the following minimum requirements:

(a)

F54 ...

(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)

F55 have sufficient data-processing capacity to produce technical reports and to enable rapid communication ...;

(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.

F56ANNEX II Community reference laboratory and consortium of national reference laboratories, as referred to in Article 6(2)

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

F57ANNEX III Text replacing paragraphs 2 and 3 of Annex II to Regulation (EC) No 1831/2003

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

[F3ANNEX 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 [F58 reference laboratoryF58] administrative costs and the costs related to the handling of the reference samples. This first component amounts to EUR 2 000.

2.

The second component is intended to support the costs of the [F59 laboratory which performsF59] the scientific evaluation and preparation of the evaluation report. This second component amounts to EUR 4 000.

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):

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

4. Applications for changing the terms of an existing authorisation (Article 13(3) of Regulation (EC) No 1831/2003):

5. F60. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(1)

OJ L 268, 18.10.2003, p. 29.

(2)

[ F2 OJ L 133, 22.5.2008, p. 1 .F2]

(1)

OJ L 268, 18.10.2003, p. 29.

(2)

[F2 OJ L 133, 22.5.2008, p. 1 .]

Textual Amendments

Status: There are currently no known outstanding effects by UK legislation for Commission Regulation (EC) No 378/2005.
Commission Regulation(EC) No 378/2005 ()
Version from: 1 April 2025

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Status of this instrument

in force Provision is in force
in force* In force only for specified purposes (see footnote)
not in force Not in force in England (may be in force in other geographies, see footnotes)
defined term Defined term
dfn Defined term (alternative style)
footnote commentary transitional and savings in force status related provisions geo extent insert/omit source count in force adj
F1 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) substituted
F2 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).
F2 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).
F2 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).
F2 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).
F2 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).
F2 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).
F3 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).
F3 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).
F3 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).
F4 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) inserted: England, Wales and Scotland inserted
F5 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) inserted: England, Wales and Scotland inserted
F6 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) substituted
F7 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) substituted
F8 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 substituted
F9 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) omitted: England, Wales and Scotland omitted
F10 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) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F11 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) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F12 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) substituted: England, Wales and Scotland substituted
F13 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) substituted: England, Wales and Scotland substituted
F14 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) substituted
F15 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) substituted
F16 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) inserted
F17 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) substituted
F18 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) substituted
F19 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) substituted
F20 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) substituted
F21 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).
F22 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) this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary. omitted
F23 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) omitted
F24 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) omitted
F25 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) substituted
F26 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) substituted: England, Wales and Scotland substituted
F27 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) substituted: England, Wales and Scotland substituted
F28 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) substituted: England, Wales and Scotland substituted
F29 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) substituted
F30 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) substituted: England, Wales and Scotland substituted
F31 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) omitted: England, Wales and Scotland omitted
F32 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) omitted
F33 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) omitted
F34 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) omitted
F35 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) substituted
F36 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) substituted: England, Wales and Scotland substituted
F37 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) substituted: England, Wales and Scotland substituted
F38 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) substituted: England, Wales and Scotland substituted
F39 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) inserted: England, Wales and Scotland inserted
F40 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) inserted: England, Wales and Scotland inserted
F41 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) substituted
F42 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) substituted
F43 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) substituted
F44 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) substituted: England, Wales and Scotland substituted
F45 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) substituted
F46 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) substituted
F47 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) substituted: England, Wales and Scotland substituted
F48 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) substituted
F49 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) substituted: England, Wales and Scotland substituted
F50 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) omitted: England, Wales and Scotland omitted
F51 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) omitted
F52 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) substituted: England, Wales and Scotland substituted
F53 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) substituted: England, Wales and Scotland substituted
F54 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) omitted
F55 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) omitted: England, Wales and Scotland omitted
F56 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) omitted
F57 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) omitted: England, Wales and Scotland omitted
F58 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) substituted
F59 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) substituted
F60 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) this amendment (text omitted) should be read in conjunction with other related provisions, see the commentary. omitted
Defined Term Section/Article ID Scope of Application
EUR art. Article 4 of CHAPTER I def_40c697bd30
evaluation of the method of analysis art. Article 2 of CHAPTER I def_0f4e0af31b
feed test material art. Article 2 of CHAPTER I def_381c1b7257
food test material art. Article 2 of CHAPTER I def_ff683f68f0
GBP art. Article 4 of CHAPTER I def_d70dec2349
method of analysis art. Article 2 of CHAPTER I def_c23bd2f4b8
multi-analyte methods art. Article 2 of CHAPTER I def_613c5d67e9
reference sample art. Article 2 of CHAPTER I def_5882dcfff4
reference standard art. Article 2 of CHAPTER I def_5dec207461
testing of a method of analysis art. Article 2 of CHAPTER I def_72bf27b35f
the fee art. Article 4 of CHAPTER I def_3da88fd28f
validation of a method of analysis art. Article 2 of CHAPTER I def_861ad02173

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