
2024 No. 1101
AGRICULTURE, ENGLAND
The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (England) Regulations 2024
Made 4th November 2024
Laid before Parliament 5th November 2024
Coming into force 20th December 2024
The Secretary of State makes 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 sections 74A(1)(a) and (b) of the Agriculture Act 1970.There has been open and transparent public consultation during the preparation and evaluation of 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.
Part 1 Introductory
Citation, commencement, extent and application
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(1) These Regulations may be cited as the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (England) Regulations 2024 and come into force on 20th December 2024.
(2) These Regulations extend to England and Wales but apply in relation to England only.
Interpretation
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(1) In these Regulations —
 “Regulation (EC) 152/2009” means Commission Regulation (EC) No 152/2009 laying down the methods of sampling and analysis for the official control of feed.
(2) Any expression used both 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 Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, etc. has the same meaning as it has in those Regulations.
(3) In Schedules 1 to 20, in the tables, in the row relating to “Species or category of animal”, expressions used that are also used in Annex 4 of Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) 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 (categories and definitions of target animals etc.) have the same meaning as in that Annex.
Part 2 Feed additive authorisations
Authorisation of various feed additives
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Part 3 Uses of feed intended for particular nutritional purposes
Modification of an essential nutritional characteristic for feed intended to reduce the risk of milk fever and subclinical hypocalcaemia
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In Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes, etc., in the Annex, in Part B (list of intended uses), 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 DCADs to < 100 mEq/kg dry matter DCAD”.
Part 4 Amendment of assimilated direct legislation
Modification of authorisation: a preparation of Bacillus velezensis (DSM 15544), (identification number 4b1820)
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Modification of authorisation: selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated (identification number 3b810)
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Changes of authorisation holder: amendment of Commission Implementing Regulation (EU) No887/2011 and Commission Implementing Regulations (EU) 2017/961 and 2020/1395
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Amendment of Commission Implementing Regulation (EU) 2016/1095
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Amendment of Commission Implementing Regulation (EU) 2018/1039
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Part 5 Transitional Provisions
Transitional provision: a preparation of Bacillus velezensis (DSM 15544) (identification number 4b1820)
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(1) Any substance or product labelled “Bacillus subtilis C-3102 (DSM 15544)” or as containing “Bacillus subtilis C-3102 (DSM 15544)”, but otherwise produced and labelled in accordance with an authorisation contained in an instrument mentioned in regulation 5, may continue to be placed on the market and used under that authorisation.
(2) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(4) Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(5) In this regulation—
 “relevant feed additive” means the feed additive of a preparation of Bacillus velezensis (DSM 15544), with the identification number 4b1820 authorised under the prior authorisation;
 “prior authorisation” means the authorisations contained in Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 1544) as a feed additive for laying hens and ornamental fish, etc., Commission Implementing Regulation (EU) 2017/2312 concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs, etc., and Commission Implementing Regulation (EU) 2018/1081 concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening, etc., as the Regulations had effect immediately before 20th December 2024.
Transitional provision: selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated (identification number 3b810)
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(1) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(2) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3) Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(4) In this regulation—
 “relevant feed additive” means the feed additive selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated, with the identification number 3b810 authorised under the prior authorisation;
 “prior authorisation” means the authorisation contained in Commission Implementing Regulation (EU) 2019/804 concerning the renewal of the authorisation of organic form selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species.
Transitional provision: butylated hydroxyanisole (identification number 1b320)
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(1) Butylated hydroxyanisole (E 320) is authorised to be placed on the market, processed or used as a feed additive for cats only to the extent that it is covered by and meets the conditions of the authorisation contained in Schedule 11 to these Regulations, and in consequence of that authorisation butylated hydroxyanisole (E 320) shall no longer be treated as an existing product under, and for the purposes of, Article 10 of Regulation (EC) No 1831/2003.
(2) Stocks of butylated hydroxyanisole as a feed additive for cats, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in compliance with the conditions of the authorisation and the labelling requirements applicable before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3) Stocks of feed materials and compound feed containing butylated hydroxyanisole, intended for cats, which are produced and labelled before the end of 19th December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
Transitional provision: 6-phytase (EC 3.1.3.26) (identification number 4a16)
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(1) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(2) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3) In this regulation—
 “relevant feed additive” means the feed additive 6-phytase (EC 3.1.3.26), with the identification number 4a16 authorised under the prior authorisation;
 “prior authorisation” means the authorisation contained in Commission Implementing Regulation (EU) No98/2012, as it had effect immediately before 20th December 2024, 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 (holder of authorisation Huvepharma AD).
Transitional provision: copper chelate of hydroxy analogue of methionine (identification number 3b410i)
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(1) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(2) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3) Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(4) In this regulation—
 “relevant feed additive” means copper chelate of hydroxy analogue of methionine, with the identification number 3b410i authorised under the prior authorisation;
 “prior authorisation” means the authorisation contained in Commission Regulation (EU) No 349/2010, as it had effect immediately before 20th December 2024, concerning the authorisation of copper chelate of hydroxy analogue of methionine as a feed additive for all animal species.
Transitional provision: manganese chelate of hydroxy analogue of methionine (identification number 3b510)
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(1) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(2) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3) Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(4) In this regulation—
 “relevant feed additive” means manganese chelate of hydroxy analogue of methionine, with the identification number 3b510 authorised under the prior authorisation;
 “prior authorisation” means the authorisation contained in Commission Regulation (EU) No 350/2010, as it had effect immediately before 20th December 2024, concerning the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species.
Transitional provision: zinc chelate of hydroxy analogue of methionine (identification number 3b610)
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(1) Stocks of the relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19th June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(2) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 19th December 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(3) Stocks of feed materials and compound feed containing the relevant feed additive, intended for non-food-producing animals, which are produced and labelled before the end of 19th December 2026 in accordance with the conditions of the prior authorisation and the labelling requirements applicable immediately before 20th December 2024, may continue to be placed on the market and used until they are exhausted.
(4) In this regulation—
 “relevant feed additive” means zinc chelate of hydroxy analogue of methionine, with the identification number 3b610 authorised under the prior authorisation;
 “prior authorisation” means the authorisation contained in Commission Regulation (EU) No 335/2010, as it had effect immediately before 20th December 2024, concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species.
Part 6 Revocation of assimilated direct legislation
Revocation of assimilated direct legislation
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Andrew Gwynne
Parliamentary Under-Secretary of State,
Department of Health and Social Care
4th November 2024
Schedule 1
Authorisation of a preparation of chromium chelate of DL-methionine (identification number GB4d0001) as a feed additive for dairy cows
Regulation 3

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Schedule 2
Renewal of authorisation of a preparation of Saccharomyces cerevisiae (MUCL 39885) (identification number 4b1710) as a feed additive for weaned piglets, and its authorisation extending to the use for cats, dogs and all Suidae other than sows and suckling piglets
Regulation 3

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Schedule 3
Authorisation of a preparation of Pediococcus acidilactici (CNCM I-4622) (identification number 4d1712) as a feed additive for all animal species
Regulation 3

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Schedule 4
Renewal of authorisation (with modification) of a preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) (carrier: perlite, calcium carbonate) (identification number 51701) as a feed additive for chickens for fattening, chickens reared for laying and turkeys for fattening, and its authorisation extending to the use for turkeys reared for breeding
Regulation 3

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Schedule 5
Renewal of authorisation (with modification) of a preparation of monensin sodium produced by fermentation with Streptomyces cinnamonensis 28682 (NBIMCC 3419) (carrier: perlite, wheat bran) (identification number 51701) as a feed additive for chickens for fattening, turkeys for fattening and its authorisation extending to the use for chickens reared for laying and turkeys reared for breeding
Regulation 3

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Schedule 6
Renewal of authorisation (with modification) of a preparation of 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (formerly Komagataella pastoris) (DSM 23036) (identification number 4a16) as a feed additive for chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding, other avian species for fattening and laying, sows, pigs for fattening and weaned piglets, and its authorisation extending to the use for all avian species and all Suidae
Regulation 3

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Schedule 7
Renewal of authorisation (with modification) of a preparation of Bacillus velezensis (formerly Bacillus subtilis) (DSM 15544) (identification number 4b1820) as a feed additive for weaned piglets, chickens reared for laying, turkeys, minor avian species, ornamental birds and game birds; consolidation of existing authorised uses for laying hens and chickens for fattening; and its authorisation as a feed additive extending existing authorised uses to cover all other avian species
Regulation 3

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Schedule 8
Authorisation of a preparation of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli K-12 (KCCM 80212) (identification number 3c352i) as a feed additive for all animal species
Regulation 3

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Schedule 9
Authorisation of a preparation of L-tryptophan produced by fermentation with Escherichia coli (KCCM 80210) (identification number 3c440i) as a feed additive for all animal species
Regulation 3

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Schedule 10
Authorisation of a preparation of L-lysine sulphate produced by fermentation with Corynebacterium glutamicum (KCCM 80227) (identification number 3c324i) as a feed additive for all animal species
Regulation 3

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Schedule 11
Authorisation of the substance butylated hydroxyanisole (identification number 1b320) as a feed additive for cats
Regulation 3

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Schedule 12
Authorisation of a preparation of L-lysine base (liquid) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) (identification number 3c320) as a feed additive for all animal species
Regulation 3

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Schedule 13
Authorisation of the substance L-lysine monohydrochloride (technically pure) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) (identification number 3c322ii) as a feed additive for all animal species
Regulation 3

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Schedule 14
Authorisation of the substance disodium 5’ -guanylate (GMP) produced by fermentation with Corynebacterium stationis (KCCM 10530) and Escherichia coli K-12 (KFCC 11067) (identification number 2b627i) as a feed additive for all animal species
Regulation 3

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Schedule 15
Authorisation of a preparation of muramidase (EC 3.2.1.17) produced by fermentation with Trichoderma reesei (DSM 32338) (identification number 4d16) as a feed additive for weaned piglets
Regulation 3

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Schedule 16
Authorisation of the substance of phytomenadione (Vitamin K1) (identification number 3a712) as a feed additive for horses
Regulation 3

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Schedule 17
Renewal of authorisation (with modification) of a preparation of copper chelate of hydroxy analogue of methionine (identification number 3b410i (formerly 3b4.10)) as a feed additive for all animal species
Regulation 3

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Schedule 18
Renewal of authorisation (with modification) of a preparation of manganese chelate of hydroxy analogue of methionine (identification number 3b510 (formerly 3b5.10)) as a feed additive for all animal species
Regulation 3

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Schedule 19
Renewal of authorisation (with modification) of a preparation of zinc chelate of hydroxy analogue of methionine (identification number 3b610 (formerly 3b6.10)) as a feed additive for all animal species
Regulation 3

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Schedule 20
Authorisation of a preparation of fumonisin esterase (EC 3.1.1.87) produced by fermentation with Komagataella phaffii (DSM 32159) (identification number 1m03i) as a feed additive for all animal species, for use only in maize-based silages
Regulation 3

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Schedule 21
Revocation of assimilated direct legislation
Regulation 17

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