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

EXPLANATORY NOTE

(This note is not part of the Regulations)

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