Commission Regulation (EC) No 378/2005Show full title

[F1 Article 3 U.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 [F2 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, [F3 and upon request,] the applicant shall provide to the [F4 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 [F5 [F6 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 F7 ... 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 [F4 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(1), if requested by the [F4 reference 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 [F8 for] the authorisation of the feed additive by supplying new reference samples to the [F4 reference laboratory] to replace [F9 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 [F4 reference laboratory]. Upon justified request of the [F10 scientific experts or official laboratories working on behalf of the reference laboratory] and without prejudice [F11 to Regulation (EU) 2017/625], the [F4 reference 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 [F4 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 [F4 reference laboratory] as reference sample of the feed additive concerned.]

Textual Amendments

F1 Substituted by Commission Regulation (EC) No 885/2009 of 25 September 2009 amending Regulation (EC) No 378/2005 as regards reference samples, fees and the laboratories listed in Annex II (Text with EEA relevance).

F2 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)

F3 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)

F4 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)

F5 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)

F6 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

F7 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)

F8 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)

F9 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)

F10 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)

F11 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)

(1)

[F1 OJ L 133, 22.5.2008, p. 1 .]

Textual Amendments

F1 Substituted by Commission Regulation (EC) No 885/2009 of 25 September 2009 amending Regulation (EC) No 378/2005 as regards reference samples, fees and the laboratories listed in Annex II (Text with EEA relevance).