The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Miscellaneous Amendment) (Scotland) Regulations 2024

Made: 6th November 2024

Laid before the Scottish Parliament: 8th November 2024

Coming into force: 20th December 2024

There has been consultation as required by Article 9 of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety³.

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 additives⁴,

• “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/EC⁵.

• (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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Modification of authorisations for a preparation of Bacillus velezensis (DSM 15544) (identification number 4b1820)

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Modification of authorisation for selenised yeast produced from Saccharomyces cerevisiae CNCM I-3060 (identification number 3b810)

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 purposes⁶, 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 piglets⁷, 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 birds⁸, 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 fish⁹, Commission Implementing Regulation (EU) 2019/893 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening¹⁰.

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 species¹¹.

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)¹².

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 species¹³.

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 species¹⁴.

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 species¹⁵.

PART 5 — Revocations

Amendment of Commission Implementing Regulation (EU) 2016/1095

20

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Amendment of Commission Implementing Regulation (EU) 2018/1039

21

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Revocations

22

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 as a feed additive extending existing uses to cover allSuidae other than sows and suckling piglets,and catsanddogs

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 5 — Renewal of authorisation (with modification) of a preparation of monensin sodium (produced from Streptomyces cinnamonensis 28682 (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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 6 — Renewal of authorisation (with modification) of a preparation of 6-phytase (EC 3.1.3.26) produced from 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 as a feed additive extending existing uses to cover all avian species andallporcinespecies

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 and its authorisation as a feed additive extending and consolidating existing authorised uses tocoverallavianspecies

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 9 — Authorisation of a preparation of L-tryptophan (produced from Escherichia coli (KCCM 80210)) (identification number 3c440i) as a feed additive forallanimalspecies

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 14 — Authorisation of the substance disodium 5’-guanylate (GMP) (produced from Corynebacterium stationis (KCCM 10530) and Escherichia coli K-12 (KFCC11067)) (identification number 2b627i) as a feed additive forallanimalspecies

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 16 — Authorisation of the substance vitamin K₁ or Phytomenadione (identification number 3a712) as a feed additive for horses

Authorisation

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Authorisation

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SCHEDULE 21 — Revocations

1

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Signed

JENNI MINTO — Authorised to sign by the Scottish Ministers — 6th November 2024

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

These Regulations make provision regarding the authorisation of feed additives under Regulation (EC) No 1831/2003 of 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 additive Bacillus velezensis (DSM 15544).

Regulation 7 amends Commission Implementing Regulation (EU) 2019/804 which makes provision concerning the authorisation of the feed additive selenised yeast produced by fermentation with Saccharomyces cerevisiae CNCM 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 of Enterococcus faecium CECT 4515 and the authorisation of Bacillus amyloliquefaciens CECT 5940.

Part 3 (regulation 12) amends Commission Regulation (EU) 2020/354 establishing 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 of Saccharomyces 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 of Pediococcus 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 with Streptomyces cinnamonensis 28682 (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 with Komagataella 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 to Komagataella phaffii (formerly Komagataella 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 of Bacillus 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 to Bacillus velezensis (formerly Bacillus 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 with Escherichia coli K-12 (KCCM 80212) (identification number 3c352i).

Schedule 9 contains a new authorisation, for a preparation of L-tryptophan produced by fermentation with Escherichia 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 with Corynebacterium 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 from Corynebacterium glutamicum (KCCM 80183) (identification number 3c320).

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

Schedule 14 contains a new authorisation, of the substance disodium 5’-guanylate (GMP) produced from Corynebacterium stationis(KCCM 10530) and Escherichia coli K-12 (KFCC 11067) (identification number 2b627i).

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

Schedule 16 contains a new authorisation, of the substance vitamin K₁ or 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 with Komagataella phaffi (DSM 32159) (EC 3.1.1.87) (identification number 1m03i).

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

Footnotes

Editorial notes