Agriculture PART 1 Introduction Citation, commencement and extent 1 1 These Regulations may be cited as the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Miscellaneous Amendment) (Scotland) Regulations 2024 and come into force on 20 December 2024. 2 These Regulations extend to Scotland only. Interpretation 2 1 In these Regulations— “ Regulation 1831/2003 ” means Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition, “ Regulation 429/2008 ” means 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 , “ Regulation 767/2009 ” means Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC , Commission Directive 80/511/EEC , Council Directives 82/471/EEC , 83/228/EEC , 93/74/EEC , 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC . 2 Expressions used in these Regulations and in Regulation 1831/2003 or Regulation 767/2009 have the same meaning as in Regulation 1831/2003 or Regulation 767/2009, respectively. 3 In schedules 1 to 20— a expressions used to refer to species or categories of animals that are also used in Annex 4 (categories and definitions of target animals and indication of the minimum duration of efficacy studies) of Regulation 429/2008 have the same meaning as in that Annex, b any reference to a minor species is to be read in accordance with the definition of “minor species” in Article 1 (definitions) of Regulation 429/2008. PART 2 Feed Additive Authorisations 3 1 Schedules 1 to 20 have effect. 2 Subject to Article 14(4) (renewal of authorisation) of Regulation 1831/2003, the authorisations set out in schedules 1 to 20 cease to have effect at the end of 19 December 2034. Modification of authorisations for a preparation of Bacillus velezensis (DSM 15544) (identification number 4b1820) 4 1 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 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) and amending Regulations (EC) No 1444/2006 , (EU) No 333/2010 and (EU) No 184/2011 is amended as follows. 2 Omit Articles 2 to 4. 3 In the Annex, in the table— a in the second column (name of the holder of authorisation), for “Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office” substitute “Asahi Biocycle Co., Ltd, (represented by Pen & Tec Consulting S.L.U., now trading as Argenta)” , b in the third column (additive) and the fourth column (composition, chemical formula, description, analytical method), for “ Bacillus subtilis C-3102”, in each place it occurs, substitute “ Bacillus velezensis ” , c in the fifth column (species or category of animal), omit “Laying hens”, d in the sixth column (minimum content), omit “3 × 10 8 ”. 5 1 In 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 (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) , in the Annex, the table is amended as follows. 2 In the second column (name of the holder of authorisation), for “Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.” substitute “Asahi Biocycle Co., Ltd (represented by Pen & Tec Consulting S.L.U., now trading as Argenta)” . 3 In the third column (additive), for “ Bacillus subtilis ” substitute “ Bacillus velezensis ” . 4 In the fourth column (composition, chemical formula, description, analytical method)— a in the section headed “ Additive composition ”, for “ Bacillus subtilis C-3102” substitute “ Bacillus velezensis ” , b in the section headed “ Characterisation of the active substance ”, for “ Bacillus subtilis ” substitute “ Bacillus velezensis ” . 6 1 In 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 (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) , in the Annex, the table is amended as follows. 2 In the second column (name of the holder of authorisation), for “Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.” substitute “Asahi Biocycle Co., Ltd (represented by Pen & Tec Consulting S.L.U., now trading as Argenta)” . 3 In the third column (additive) and the fourth column (composition, chemical formula, description, analytical method), for “ Bacillus subtilis C-3102”, in each place it occurs, substitute “ Bacillus velezensis ” . Modification of authorisation for selenised yeast produced from Saccharomyces cerevisiae CNCM I-3060 (identification number 3b810) 7 1 In Commission Implementing Regulation (EU) 2019/804 concerning the renewal of the authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 and of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 as feed additives for all animal species( , in the Annex, the entry for “3b810” is amended as follows. 2 In the third column (composition, chemical formula, description, analytical method), for the section headed “ Additive composition ”, substitute— Additive composition Preparation of organic selenium (Se) produced by Saccharomyces cerevisiae (CNCM I-3060) containing 2000 to 3500 mg Se/kg with the below components: Organic selenium: 97% minimum of total selenium Selenomethionine: 63% minimum of total selenium . 3 In the ninth column (other provisions), after point 4, insert— 5. The dusting potential of the additive must ensure a maximum selenium exposure of 0.2 mg Se/m 3 . Removal of authorisation of Butylated hydroxyanisole as an existing product for the purposes of Article 10 of Regulation 1831/2003 (identification number 1b320) 8 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 of these Regulations. Changes of authorisation holder: amendment of Commission Implementing Regulations (EU) 887/2011, 2017/961 and 2020/1395 9 1 Commission Implementing Regulation (EU) No887/2011 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive for chickens for fattening (holder of the authorisation Evonik Nutrition & Care GmbH) is amended as follows. 2 In the Annex, in the second column of both tables (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH)”, in each place it occurs, substitute “Evonik Operations GmbH” . 10 1 Commission Implementing Regulation (EU) 2017/961 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as a feed additive for weaned piglets, and a new use in water for drinking for weaned piglets and chickens for fattening, and amending Regulation (EC) No 2036/2005 and Regulation (EU) No887/2011 (holder of authorisation Evonik Nutrition & Care GmbH) is amended as follows. 2 In Annex 1, in the table, in the second column (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH)” substitute “Evonik Operations GmbH” . 11 1 Commission Implementing Regulation (EU) 2020/1395 concerning the renewal of the authorisation of Bacillus amyloliquefaciens CECT 5940 as a feed additive for chickens for fattening, its authorisation for chickens reared for laying, and repealing Regulation (EC) No 1292/2008 (holder of authorisation Evonik Nutrition & Care GmbH) is amended as follows. 2 In the Annex, in the table, in the second column (name of the holder of authorisation), for “Evonik Nutrition & Care GmbH” substitute “Evonik Operations GmbH” . 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 12 1 In Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes , 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 DCADs to <100 mEq/kg dry matter DCAD” . PART 4 Transitional provisions Transitional provision: Bacillus velezensis (DSM 15544) (formerly Bacillus subtilis C-3102) (identification number 4b1820) 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 assimilated direct legislation mentioned in regulations 4 to 6, 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 accordance with the conditions of the prior authorisations and the labelling requirements applicable 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 accordance with the conditions of the prior authorisations and the labelling requirements applicable 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 accordance with the conditions of the prior authorisations and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted. 5 In this regulation— “ relevant feed additive ” means the feed additive of a preparation of Bacillus velezensis (DSM 15544) (formerly Bacillus subtilis C-3102), with the identification number 4b1820, authorised under the prior authorisations; “ prior authorisations ” means the authorisations contained in— 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 , 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 , Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillis subtilis C-3102 (DSM 15544) as a feed additive for laying hens and ornamental fish , 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 . Transitional provision: Selenised yeast produced from Saccharomyces cerevisiae (CNCM I-3060), inactivated (identification number 3b810) 14 1 The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable 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 accordance with the conditions of the prior authorisation and the labelling requirements applicable 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 accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted. 4 In this regulation— “ relevant feed additive ” means the feed additive selenised yeast Saccharomyces cerevisiae (CNCM 1-3060), 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 as a feed additive for cats (identification number 1b320) 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 accordance with the conditions of authorisation and the labelling requirements applicable 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 accordance with the conditions of authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted. Transitional provision: 6-phytase (EC 3.1.3.26) produced from Komagataella phaffii (formerly Komagataella pastoris ) (DSM 23036) (identification number 4a16) 16 1 The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable 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 June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks 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 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) (formerly 3b4.10) 17 1 The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable 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 accordance with the conditions of the prior authorisation and the labelling requirements applicable 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 accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks 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 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) 18 1 The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable 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 accordance with the conditions of the prior authorisation and the labelling requirements applicable 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 accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks 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 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) (formerly 3b6.10) 19 1 The relevant feed additive, and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in accordance with the conditions of the prior authorisation and the labelling requirements applicable 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 accordance with the conditions of the prior authorisation and the labelling requirements applicable 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 accordance with the conditions of the prior authorisation and the labelling requirements applicable before 20 December 2024, may continue to be placed on the market and used until stocks 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 concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species . PART 5 Revocations Amendment of Commission Implementing Regulation (EU) 2016/1095 20 In Commission Implementing Regulation (EU) 2016/1095 concerning the authorisation of Zinc acetate dihydrate, Zinc chloride anhydrous, Zinc oxide, Zinc sulphate heptahydrate, Zinc sulphate monohydrate, Zinc chelate of amino acids hydrate, Zinc chelate of protein hydrolysates, Zinc chelate of glycine hydrate (solid) and Zinc chelate of glycine hydrate (liquid) as feed additives for all animal species , omit Article 4 (Amendment to Regulation (EU) No335/2010 ). Amendment of Commission Implementing Regulation (EU) 2018/1039 21 In Commission Implementing Regulation (EU) 2018/1039 concerning the authorisation of Copper(II) diacetate monohydrate, Copper(II) carbonate dihydroxy monohydrate, Copper(II) chloride dihydrate, Copper(II) oxide, Copper(II) sulphate pentahydrate, Copper(II) chelate of amino acids hydrate, Copper(II) chelate of protein hydrolysates, Copper(II) chelate of glycine hydrate (solid) and Copper(II) chelate of glycine hydrate (liquid) as feed additives for all animal species , omit Article 5 (Amendment to Regulation (EU) No349/2010 ). Revocations 22 1 The instruments listed in paragraphs 2, 3, 4, 5, 7, 8 and 10 of schedule 21 are revoked subject to Part 4. 2 The instruments listed in paragraphs 1, 6, 9 and 11 of schedule 21 are revoked. JENNI MINTO Authorised to sign by the Scottish Ministers St Andrew’s House, Edinburgh 6th November 2024