Welsh Statutory Instruments
Agriculture, Wales
Made
27 November 2024
Laid before Senedd Cymru
29 November 2024
Coming into force
20 December 2024
The Welsh Ministers make these Regulations in exercise of the powers conferred by Articles 9(1), 10(5) and 18A(3) of Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition, and section 74A(1)(a) and (b) of the Agriculture Act 1970.
There has been consultation as required by Article 9 of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
Textual Amendments
F1Regulations revoked (except for regs. 8, 12-17 and regs. 1, 2 so far as they relate to regs. 8, 12-17) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 2 (i) (with reg. 23)
1.—(1) The title of these Regulations is the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (Wales) Regulations 2024.
(2) These Regulations—
(a)extend to England and Wales;
(b)apply in relation to Wales;
(c)come into force on 20 December 2024.
Commencement Information
I1Reg. 1 in force at 20.12.2024, see reg. 1(2)(c)
2.—(1) Expressions used in these Regulations and in Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition or [F2Regulation (EC) No 767/2009] of the European Parliament and of the Council on the placing on the market and use of feed(1) have the same meaning as in Regulation (EC) No 1831/2003 or Regulation (EC) No 767/2009, respectively.
(2) In Schedules 1 to 20, expressions used to refer to species or categories of animals that are also used in Annex 4 (categories and definitions of target animals etc.) to Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives(2) have the same meaning as in that Annex.
Textual Amendments
F2Words in reg. 2(1) substituted (31.3.2025) by The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (Wales) (Amendment) Regulations 2025 (S.I. 2025/384), regs. 1, 2(2)
Commencement Information
I2Reg. 2 in force at 20.12.2024, see reg. 1(2)(c)
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Textual Amendments
F1Regulations revoked (except for regs. 8, 12-17 and regs. 1, 2 so far as they relate to regs. 8, 12-17) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 2 (i) (with reg. 23)
F14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regulations revoked (except for regs. 8, 12-17 and regs. 1, 2 so far as they relate to regs. 8, 12-17) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 2 (i) (with reg. 23)
F15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regulations revoked (except for regs. 8, 12-17 and regs. 1, 2 so far as they relate to regs. 8, 12-17) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 2 (i) (with reg. 23)
F16. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regulations revoked (except for regs. 8, 12-17 and regs. 1, 2 so far as they relate to regs. 8, 12-17) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 2 (i) (with reg. 23)
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Textual Amendments
F1Regulations revoked (except for regs. 8, 12-17 and regs. 1, 2 so far as they relate to regs. 8, 12-17) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 2 (i) (with reg. 23)
8. Butylated hydroxyanisole (E 320) may no longer be placed on the market or used as a feed additive for cats under Article 10 of Regulation (EC) No 1831/2003(3).
Commencement Information
I3Reg. 8 in force at 20.12.2024, see reg. 1(2)(c)
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Textual Amendments
F1Regulations revoked (except for regs. 8, 12-17 and regs. 1, 2 so far as they relate to regs. 8, 12-17) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 2 (i) (with reg. 23)
F110. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regulations revoked (except for regs. 8, 12-17 and regs. 1, 2 so far as they relate to regs. 8, 12-17) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 2 (i) (with reg. 23)
F111. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Regulations revoked (except for regs. 8, 12-17 and regs. 1, 2 so far as they relate to regs. 8, 12-17) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 2 (i) (with reg. 23)
12.—(1) The relevant feed additive and premixtures, compound feed or feed materials containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2) In paragraph (1), the reference to the “relevant feed additive” is a reference to the feed additive 6-phytase (EC 3.1.3.26) (identification number 4a16)(4) as authorised immediately before 20 December 2024 under Commission Implementing Regulation (EU) No98/2012 concerning the authorisation of 6-phytase (EC 3.1.3.26) produced by Pichia pastoris (DSM 23036) as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows(5).
Commencement Information
I4Reg. 12 in force at 20.12.2024, see reg. 1(2)(c)
13.—(1) Any substance or product labelled “Bacillus subtilis C-3102” or as containing “Bacillus subtilis C-3102”, but otherwise produced and labelled in accordance with an authorisation contained in an instrument mentioned in regulations 4 to 6 of these Regulations, may continue to be placed on the market and used under that authorisation.
(2) The relevant feed additive and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(3) Compound feed and feed materials containing the relevant feed additive and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(4) Compound feed and feed materials containing the relevant feed additive and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(5) In this regulation, references to the “relevant feed additive” are references to the feed additive Bacillus velezensis (formerly Bacillus subtilis C-3102) (DSM 15544), with the identification number 4b1820(6), as authorised immediately before 20 December 2024 under—
(a)Commission Regulation (EU) No 333/2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets(7);
(b)Commission Regulation (EU) No 184/2011 concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds(8);
(c)Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish(9);
(d)Commission Implementing Regulation (EU) 2019/893 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening(10).
Commencement Information
I5Reg. 13 in force at 20.12.2024, see reg. 1(2)(c)
14.—(1) The relevant feed additive and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2) Compound feed and feed materials containing the relevant feed additive and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(3) Compound feed and feed materials containing the relevant feed additive and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(4) In this regulation, references to the “relevant feed additive” are references to the feed additive selenised yeast produced by fermentation with Saccharomyces cerevisiae CNCM I-3060, inactivated, with the identification number 3b810, as authorised immediately before 20 December 2024 under Commission Implementing Regulation (EU) 2019/804(11).
Commencement Information
I6Reg. 14 in force at 20.12.2024, see reg. 1(2)(c)
15.—(1) Butylated hydroxyanisole as a feed additive for cats and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2) Compound feed and feed materials containing butylated hydroxyanisole intended for cats, which are produced and labelled before the end of 19 December 2026 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
Commencement Information
I7Reg. 15 in force at 20.12.2024, see reg. 1(2)(c)
16.—(1) A relevant feed additive and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(2) Compound feed and feed materials containing a relevant feed additive and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(3) Compound feed and feed materials containing a relevant feed additive and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.
(4) In this regulation, references to a “relevant feed additive” are references to each of the following feed additives.
(a)The feed additive copper chelate of hydroxy analogue of methionine, with the identification number 3b410i (formerly 3b4.10)(12) as authorised immediately before 20 December 2024 under Commission Regulation (EU) No 349/2010 concerning the authorisation of copper chelate of hydroxy analogue of methionine as a feed additive for all animal species(13).
(b)The feed additive manganese chelate of hydroxy analogue of methionine, with the identification number 3b510 (formerly 3b5.10)(14) as authorised immediately before 20 December 2024 under Commission Regulation (EU) No 350/2010 concerning the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species(15).
(c)The feed additive zinc chelate of hydroxy analogue of methionine, with the identification number 3b610 (formerly 3b6.10)(16) as authorised immediately before 20 December 2024 under Commission Regulation (EU) No 335/2010 concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species(17).
Commencement Information
I8Reg. 16 in force at 20.12.2024, see reg. 1(2)(c)
17.—(1) In Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes(18), in the Annex, in Part B (list of intended uses), the table is amended as follows.
(2) In entry 60 (reduction of the risk of milk fever and subclinical hypocalcaemia), in column number 2 (essential nutritional characteristics), in the section of the entry starting “Low cations/anions ratio”, for “Objective: 0 < DCADs (mEq/kg dry matter) < 100” substitute “Objective: Range from -200 mEq/kg dry matter DCAD s to <100 mEq/kg dry matter DCAD”.
Commencement Information
I9Reg. 17 in force at 20.12.2024, see reg. 1(2)(c)
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Sarah Murphy
Minister for Mental Health and Wellbeing, under the authority of the Cabinet Secretary for Health and Social Care, one of the Welsh Ministers
27 November 2024
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Regulation 20
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EUR 2009/767, amended by S.I. 2019/654, 2022/1351. S.I. 2019/654 was amended by S.I. 2020/1504.
EUR 2008/429, to which there are amendments not relevant to these Regulations.
But see regulation 15 of these Regulations for transitional provision. See Schedule 11 to these Regulations for the new authorisation of butylated hydroxyanisole as a feed additive for cats.
See Schedule 6 to these Regulations for relevant renewed authorisation of this feed additive.
EUR 2012/98, amended prior to implementation period completion day by Commission Implementing Regulation (EU) 2016/348 (EUR 2016/348). EUR 2012/98 is revoked by regulation 20 of, and Schedule 21 to, these Regulations.
See Schedule 7 to these Regulations for relevant renewed and consolidated authorisation of this feed additive.
EUR 2010/333, amended prior to implementation period completion day by Commission Implementing Regulation (EU) 2020/146 (EUR 2020/146). EUR 2010/333 and 2020/146 are revoked by regulation 20 of, and Schedule 21 to, these Regulations
EUR 2011/184, amended prior to implementation period completion day by Commission Implementing Regulation (EU) 2020/146 (EUR 2020/146). EUR 2011/184 and 2020/146 are revoked by regulation 20 of, and Schedule 21 to, these Regulations
See regulation 4 of these Regulations for amendments to EUR 2016/897.
EUR 2019/893, amended prior to implementation period completion day by Commission Implementing Regulation (EU) 2020/146 (EUR 2020/146). EUR 2019/893 and 2020/146 are revoked by regulation 20 of, and Schedule 21 to, these Regulations.
See regulation 7 of these Regulations for amendments to EUR 2019/804.
See Schedule 17 to these Regulations for the renewed authorisation of this feed additive.
EUR 2010/349, amended prior to implementation period completion day by Commission Implementing Regulation (EU) 2018/1039 (EUR 2018/1039). EUR 2010/349 is revoked by regulation 20 of, and Schedule 21 to, these Regulations.
See Schedule 18 to these Regulations for the renewed authorisation of this feed additive.
EUR 2010/350. EUR 2010/350 is revoked by regulation 20 of, and Schedule 21 to, these Regulations.
See Schedule 19 to these Regulations for the renewed authorisation of this feed additive.
EUR 2010/335, amended prior to implementation period completion day by Commission Implementing Regulation (EU) 2016/1095 (EUR 2016/1095). EUR 2010/335 is revoked by regulation 20 of, and Schedule 21 to, these Regulations.
EUR 2020/354, to which there are amendments not relevant to these Regulations.