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 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition,

“ Regulation 429/2008” means Commission Regulation (EC) No 429/2008on detailed rules for the implementation of Regulation (EC) No 1831/2003of 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( 4),

“ Regulation 767/2009” means Regulation (EC) No 767/2009of 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 1831/2003and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/ECand 96/25/ECand Commission Decision 2004/217/EC( 5).

(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 ofBacillus velezensis(DSM 15544) (identification number 4b1820)

4.—(1) Commission Implementing Regulation (EU) 2016/897concerning the authorisation of a preparation ofBacillus 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( 6) 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 × 10⁸”.

5.—(1) In Commission Implementing Regulation (EU) 2017/2312concerning the authorisation of a new use of the preparation ofBacillus subtilisC-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.)( 7), 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 subtilisC-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) 2018/1081concerning the authorisation of the preparation ofBacillus subtilisC-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.)( 8), 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 subtilisC-3102”, in each place it occurs, substitute “Bacillus velezensis”.

Modification of authorisation for selenised yeast produced fromSaccharomyces cerevisiaeCNCM I-3060 (identification number 3b810)

7.—(1) In Commission Implementing Regulation (EU) 2019/804concerning the renewal of the authorisation of organic form of selenium produced bySaccharomyces cerevisiaeCNCM I-3060 and of selenomethionine produced bySaccharomyces cerevisiaeNCYC R397 as feed additives for all animal species(( 9), 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—

(3) In the ninth column (other provisions), after point 4, insert—

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) No887/2011concerning the authorisation of a preparation ofEnterococcus faeciumCECT 4515 as feed additive for chickens for fattening (holder of the authorisation Evonik Nutrition & Care GmbH)( 10) 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) 2017/961concerning the authorisation of a preparation ofEnterococcus faeciumCECT 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 2036/2005and Regulation (EU) No887/2011(holder of authorisation Evonik Nutrition & Care GmbH)( 11) 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) 2020/1395concerning the renewal of the authorisation ofBacillus amyloliquefaciensCECT 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)( 12) 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) 2020/354establishing a list of intended uses of feed intended for particular nutritional purposes( 13), 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) (formerlyBacillus subtilisC-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 ofBacillus velezensis(DSM 15544) (formerlyBacillus subtilisC-3102), with the identification number 4b1820, authorised under the prior authorisations;

“ prior authorisations” means the authorisations contained in—

Transitional provision: Selenised yeast produced fromSaccharomyces 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) 2019/804concerning 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( 18).

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 fromKomagataella phaffii(formerlyKomagataella 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) No98/2012concerning the authorisation of 6-phytase (EC 3.1.3.26) produced byPichia 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)( 19).

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 349/2010concerning the authorisation of copper chelate of hydroxy analogue of methionine as a feed additive for all animal species( 20).

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 350/2010concerning the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species( 21).

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 335/2010concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species( 22).

PART 5 Revocations

Amendment of Commission Implementing Regulation (EU) 2016/1095

20.  In Commission Implementing Regulation (EU) 2016/1095concerning 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( 23), omit Article 4 (Amendment to Regulation (EU) No335/2010).

Amendment of Commission Implementing Regulation (EU) 2018/1039

21.  In Commission Implementing Regulation (EU) 2018/1039concerning 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( 24), 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.

SCHEDULES

Regulation 3(1)

SCHEDULE 1 Authorisation of a preparation of chromium chelate of DL-methionine (identification number GB4d0001) as a feed additive for dairy cows

Authorisation

1.  The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “other zootechnical”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 2 Renewal of authorisation of a preparation ofSaccharomyces cerevisiae(MUCL 39885) (identification number 4b1710) as a feed additive for weaned piglets, and its authorisation as a feed additive extending existing uses to cover all Suidaeother than sows and suckling piglets, and cats and dogs

Authorisation

1.  The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “gut flora stabilisers”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table( 28).

Regulation 3(1)

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

Authorisation

1.  The preparation specified in the table, belonging to the additive category “technological additives” and to the functional groups “acidity regulators” and “hygiene condition enhancers”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 4 Renewal of authorisation (with modification) of a preparation of monensin sodium (produced fromStreptomyces cinnamonensis28682 (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 as a feed additive extending existing uses to cover turkeys reared for breeding

Authorisation

1.  The preparation specified in the table, belonging to the additive category “coccidiostats and histomonostats”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table( 35).

Regulation 3(1)

SCHEDULE 5 Renewal of authorisation (with modification) of a preparation of monensin sodium (produced fromStreptomyces cinnamonensis28682 (NBIMCC 3419)) (carrier: perlite, wheat bran) (identification number 51701) as a feed additive for chickens for fattening, and turkeys for fattening, and its authorisation as a feed additive extending existing uses to cover chickens reared for laying, and turkeys reared for breeding

Authorisation

1.  The preparation specified in the table, belonging to the additive category “coccidiostats and histomonostats”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table( 39).

Regulation 3(1)

SCHEDULE 6 Renewal of authorisation (with modification) of a preparation of 6-phytase (EC 3.1.3.26) produced fromKomagataella phaffii(formerlyKomagataella 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 as a feed additive extending existing uses to cover all avian species and all porcine species

Authorisation

1.  The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “digestibility enhancers”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table( 43).

Regulation 3(1)

SCHEDULE 7 Renewal of authorisation (with modification) of a preparation ofBacillus velezensis(formerlyBacillus 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 and its authorisation as a feed additive extending and consolidating existing authorised uses to cover all avian species

Authorisation

1.  The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “gut flora stabilisers”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table( 48).

Regulation 3(1)

SCHEDULE 8 Authorisation of a preparation of L-histidine monohydrochloride monohydrate (produced fromEscherichia coliK-12 (KCCM 80212)) (identification number 3c352i) as a feed additive for all animal species

Authorisation

1.  The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 9 Authorisation of a preparation of L-tryptophan (produced fromEscherichia coli(KCCM 80210)) (identification number 3c440i) as a feed additive for all animal species

Authorisation

1.  The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 10 Authorisation of a preparation of L-lysine sulphate (produced fromCorynebacterium glutamicum(KCCM 80227)) (identification number 3c324i) as a feed additive for all animal species

Authorisation

1.  The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Regulation 3(1)

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

Authorisation

1.  The substance specified in the table, belonging to the additive category “technological additives” and to the functional group “antioxidants”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 12 Authorisation of a preparation of L-lysine base (liquid) (produced fromCorynebacterium glutamicum(KCCM 80183)) (identification number 3c320) as a feed additive for all animal species

Authorisation

1.  The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 13 Authorisation of the substance L-lysine monohydrochloride (technically pure) (produced fromCorynebacterium glutamicum(KCCM 80183)) (identification number 3c322ii) as a feed additive for all animal species

Authorisation

1.  The substance specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 14 Authorisation of the substance disodium 5’-guanylate (GMP) (produced fromCorynebacterium stationis(KCCM 10530) andEscherichia coliK-12 (KFCC 11067)) (identification number 2b627i) as a feed additive for all animal species

Authorisation

1.  The substance specified in the table, belonging to the additive category “sensory additives” and to the functional group “flavouring compounds”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 15 Authorisation of a preparation of muramidase (produced by fermentation withTrichoderma reesei(DSM 32338)) (identification number 4d16) as a feed additive for weaned piglets

Authorisation

1.  The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “other zootechnical additives”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 16 Authorisation of the substance vitamin K₁or Phytomenadione (identification number 3a712) as a feed additive for horses

Authorisation

1.  The substance specified in the table, belonging to the additive category “nutritional additives” and to the functional group “vitamins, pro-vitamins and chemically well-defined substances having a similar effect”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Regulation 3(1)

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

Authorisation

1.  The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “compounds of trace elements”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table( 99).

Regulation 3(1)

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

Authorisation

1.  The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “compounds of trace elements”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table( 107).

Regulation 3(1)

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

Authorisation

1.  The preparation specified in the table, belonging to the additive category “nutritional additives” and to the functional group “compounds of trace elements”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table( 112).

Regulation 3(1)

SCHEDULE 20 Authorisation of a preparation of fumonisin esterase (EC 3.1.1.87) produced by fermentation withKomagataella phaffi(DSM 32159) (identification number 1m03i) as a feed additive for all animal species, for use only in maize-based silages

Authorisation

1.  The preparation specified in the table, belonging to the additive category “technological additives” and to the functional group “substances for reduction of the contamination of feed by mycotoxins”, is authorised as an additive in animal nutrition, subject to the conditions set out in the table.

Regulation 22

SCHEDULE 21 Revocations

1.   Commission Regulation (EC) No 109/2007concerning the authorisation of monensin sodium (Coxidin) as a feed additive( 124).

2.   Commission Regulation (EU) No 333/2010concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)( 125).

3.   Commission Regulation (EU) No 335/2010concerning the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species( 126).

4.   Commission Regulation (EU) No 349/2010concerning the authorisation of copper chelate of hydroxy analogue of methionine as a feed additive for all animal species( 127).

5.   Commission Regulation (EU) No 350/2010concerning the authorisation of manganese chelate of hydroxy analogue of methionine as a feed additive for all animal species( 128).

6.   Commission Regulation (EU) No 170/2011concerning the authorisation ofSaccharomyces cerevisiaeMUCL 39885 as a feed additive for piglets (weaned) and amending Regulation (EC) No 1200/2005(holder of authorisation Prosol SpA)( 129).

7.   Commission Regulation (EU) No 184/2011concerning 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 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)( 130).

8.  Commission Implementing Regulation (EU) No98/2012concerning the authorisation of 6-phytase (EC 3.1.3.26) produced byPichia 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)( 131).

9.  Commission Implementing Regulation (EU) No140/2012concerning the authorisation of monensin sodium as a feed additive for chickens reared for laying (holder of authorisation Huvepharma NV Belgium)( 132).

10.  Commission Implementing Regulation (EU) 2019/893concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006(holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)( 133).

11.  Commission Implementing Regulation (EU) 2020/146amending Regulation (EU) No333/2010, Implementing Regulation (EU) 2017/2312, Implementing Regulation (EU) 2018/1081, Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2019/893and Regulation (EU) No184/2011concerning the authorisations of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive( 134).

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations make provision regarding the authorisation of feed additives under Regulation (EC) No 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition (“EUR 2003/1831”) and regarding use of feed for a particular nutritional purpose, in Scotland.

Regulation 3(1) and schedules 1 to 20 provide for the authorisation of 20 feed additives.

Regulation 3(2) provides that the authorisations are valid for a period of 10 years, in accordance with Article 9(7) of EUR 2003/1831. This is subject to Article 14(4) of that Regulation, which provides for an extension of the authorisation period in certain circumstances following the submission of an application for renewal.

Regulations 4 to 6 amend certain specified Commission Implementing Regulations which make provision concerning the feed additiveBacillus velezensis(DSM 15544).

Regulation 7 amends Commission Implementing Regulation (EU) 2019/804which makes provision concerning the authorisation of the feed additive selenised yeast produced by fermentation withSaccharomyces cerevisiaeCNCM I-3060.

Regulation 8 makes provision to remove the authorisation in relation to Butylated hydroxyanisole as a feed additive for cats as an ‘existing product’ under Article 10 of EUR 2003/1831. In order to remain on the market the feed additive for cats must meet the conditions of the authorisation contained in schedule 11 of these Regulations. Regulation 15 makes transitional provision whereby in certain specified circumstances existing products can be placed on the market and used until stocks are exhausted.

Regulations 9 to 11 amend certain specified Commission Implementing Regulations which make provision concerning the authorisation of a preparation ofEnterococcus faeciumCECT 4515 and the authorisation ofBacillus amyloliquefaciensCECT 5940.

Part 3 (regulation 12) amends Commission Regulation (EU) 2020/354establishing a list of intended uses of feed intended for particular nutritional purposes. The amendment relates to an essential nutritional characteristic regarding feed intended for use to reduce the risk of milk fever and subclinical hypocalcaemia.

Part 4 (regulations 13 to 19) contains transitional provisions made in relation to authorisations of feed additives which are modified or renewed by these Regulations. The provisions allow the continued production and labelling of products, for specified limited time periods, under the conditions of the prior authorisation and the labelling requirements applicable immediately before the coming into force of these Regulations. Products produced within the transitional periods may be marketed and sold until stocks are exhausted.

Part 5 (regulations 20 to 22) makes revocation provision. Regulations 20 and 21 make minor consequential amendments. Regulation 22 and schedule 21 revoke spent assimilated direct legislation, including those which contain authorisations which are now renewed by these Regulations.

Schedule 1 contains a new authorisation, for a preparation of chromium chelate of DL-methionine (identification number GB4d0001).

Schedule 2 contains a renewal of the authorisation of a preparation ofSaccharomyces cerevisiae(MUCL 39885) (identification number 4b1710). The authorisation extends authorised uses to cover additional species/categories of animal.

Schedule 3 contains a new authorisation, for a preparation ofPediococcus acidilactici(CNCM I-4622) (identification number 4d1712).

Schedules 4 and 5 contain a renewal (with modification) of an authorisation of preparations of monensin sodium produced by fermentation withStreptomyces cinnamonensis28682 (NBIMCC 3419) (carriers: perlite and (respectively) calcium carbonate or wheat bran) (identification number 51701), and new authorisation extending authorised uses to cover an additional category of animal. The modifications on renewal are—

• a correction to the description of an animal species/category (turkey) covered,

• the removal of the requirement for a 1-day (before slaughter) withdrawal period.

Schedule 6 contains a renewal (with modification) of an authorisation of a preparation of 6-phytase (EC 3.1.3.26) produced by fermentation withKomagataella phaffii(DSM 23036) (identification number 4a16), and new authorisation extending authorised uses to cover additional species/categories of animals. See regulation 16 for transitional provision. The modifications on renewal are—

• the name of the bacterial strain is updated toKomagataella phaffii(formerlyKomagataella pastoris),

• a requirement as to use listed under “ other provisions” (relating to phosphorus content in feed) is removed.

Schedule 7 contains a renewal of the authorisation (with modification) of a preparation ofBacillus velezensis(DSM 15544) (identification number 4b1820), and new authorisation extending and consolidating authorised uses to cover additional species of animal. See regulation 13 for transitional provision. The modifications on renewal are—

• the name of the authorisation holder is updated,

• the name of the bacterial strain is updated toBacillus velezensis(formerlyBacillus subtilis),

• the minimum content requirement for chickens reared for laying is reduced (from 5 × 108 to 3 × 108 CFU/kg) to align with the minimum content requirement for other avian species/categories.

Schedule 8 contains a new authorisation, for a preparation of L-histidine monohydrochloride monohydrate produced by fermentation withEscherichia coliK-12 (KCCM 80212) (identification number 3c352i).

Schedule 9 contains a new authorisation, for a preparation of L-tryptophan produced by fermentation withEscherichia coli(KCCM 80210) (identification number 3c440i).

Schedule 10 contains a new authorisation, for a preparation of L-lysine sulphate produced by fermentation with by fermentation withCorynebacterium glutamicum(KCCM 80227) (identification number 3c324i).

Schedule 11 contains a new authorisation, of the substance butylated hydroxyanisole (identification number 1b320).

Schedule 12 contains a new authorisation, for a preparation of L-lysine base (liquid) produced fromCorynebacterium glutamicum(KCCM 80183) (identification number 3c320).

Schedule 13 contains a new authorisation, of the substance L-lysine monohydrochloride (technically pure) (produced fromCorynebacterium glutamicum(KCCM 80183) (identification number 3c322ii).

Schedule 14 contains a new authorisation, of the substance disodium 5’-guanylate (GMP) produced fromCorynebacterium stationis(KCCM 10530) andEscherichia coliK-12 (KFCC 11067) (identification number 2b627i).

Schedule 15 contains a new authorisation, for a preparation of muramidase produced by fermentation withTrichoderma reesei(DSM 32338) (identification number 4d16).

Schedule 16 contains a new authorisation, of the substance vitamin K₁or Phytomenadione (identification number 3a712).

Schedule 17 contains a renewal of the authorisation (with modification) of a preparation of copper chelate of hydroxy analogue of methionine (identification number 3b410i). See regulation 17 for transitional provision. The modifications on renewal are—

• the identification number is changed from 3b4.10 to 3b410i,

• there are changes to the specification of the authorised preparation,

• a maximum level for nickel (20 ppm) is added,

• the analytical methods have been updated.

Schedule 18 contains a renewal of the authorisation (with modification) of a preparation of manganese chelate of hydroxy analogue of methionine (identification number 3b510). See regulation 18 for transitional provision. The modifications on renewal are—

• the identification number is changed from 3b5.10 to 3b510,

• there are changes to the specification of the authorised preparation,

• a maximum level for nickel (170 ppm) is added,

• the analytical methods have been updated.

Schedule 19 contains a renewal of the authorisation (with modification) of a preparation of zinc chelate of hydroxy analogue of methionine (identification number 3b610). See regulation 19 for transitional provision. The modifications on renewal are—

• the identification number is changed from 3b6.10 to 3b610,

• there are changes to the specification of the authorised preparation,

• a maximum level for nickel (1.7 ppm) is added,

• the analytical methods have been updated.

Schedule 20 contains a new authorisation, for a preparation of fumonisin esterase produced by fermentation withKomagataella phaffi(DSM 32159) (EC 3.1.1.87) (identification number 1m03i).

A Policy Note has been published alongside this instrument atwww.legislation.gov.uk.