AGRICULTURE, ENGLAND Part 1 Introductory Citation, commencement, extent and application 1 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 2 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 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 4 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<DCAD s (mEq/kg dry matter) < 100” substitute “Objective: range from -200 mEq/kg dry matter DCAD s 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) 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Modification of authorisation: selenised yeast Saccharomyces cerevisiae (CNCM I-3060), inactivated (identification number 3b810) 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Changes of authorisation holder: amendment of Commission Implementing Regulation (EU) No887/2011 and Commission Implementing Regulations (EU) 2017/961 and 2020/1395 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amendment of Commission Implementing Regulation (EU) 2016/1095 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amendment of Commission Implementing Regulation (EU) 2018/1039 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Part 5 Transitional Provisions Transitional provision: a preparation of Bacillus velezensis (DSM 15544) (identification number 4b1820) 10 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) 11 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) 12 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) 13 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) 14 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) 15 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) 16 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 17 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Andrew Gwynne Parliamentary Under-Secretary of State, Department of Health and Social Care 4th November 2024