ANNEX I U.K. [F1 Requirements for participating scientific experts and official laboratories, as referred to in Article 6]

Textual Amendments

F1 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)

[F2 Scientific experts or official laboratories assisting the reference laboratory] must satisfy the following minimum requirements:

Textual Amendments

F2 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)

(a)

F3 ...

(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 F4 ...;

(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.

Textual Amendments

F3 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)

F4 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)

F5 ANNEX II U.K. Community reference laboratory and consortium of national reference laboratories, as referred to in Article 6(2)

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Textual Amendments

F5 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)

F6 ANNEX III U.K. Text replacing paragraphs 2 and 3 of Annex II to Regulation (EC) No 1831/2003

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Textual Amendments

F6 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)

[F7 ANNEX IV U.K. RATES FOR FEES AS REFERRED TO IN ARTICLE 4(1)

Textual Amendments

F7 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).

Composition of the fee U.K.

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 [F8 reference laboratory] 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 [F9 laboratory which performs] the scientific evaluation and preparation of the evaluation report. This second component amounts to EUR 4 000.

Textual Amendments

F8 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)

F9 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 U.K.

1. Authorisation of a new feed additive (Article 4(1) of Regulation (EC) No 1831/2003): U.K.

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): U.K.

• 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): U.K.

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 [F8 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 [F8 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 [F8 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): U.K.

• 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. F10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

Textual Amendments

F10 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)