The Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (England) Regulations 2024

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Schedule 21 — Revocation of assimilated direct legislation

Part 1 — Revocation of assimilated direct legislation in accordance with regulation 17(1)

1

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 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)[^f00127].

2

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[^f00128].

3

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[^f00129].

4

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[^f00130].

5

Commission Regulation (EU) No 170/2011 concerning the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for piglets (weaned) and amending Regulation (EC) No 1200/2005 (holder of authorisation Prosol SpA)[^f00131].

6

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 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.)[^f00132].

7

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)[^f00133].

8

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 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.)[^f00134].

9

Commission Implementing Regulation (EU) 2020/146 amending Regulation (EU) No333/2010, Implementing Regulation (EU) 2017/2312, Implementing Regulation (EU) 2018/1081, Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2019/893 and Regulation (EU) No184/2011 concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive[^f00135].

Part 2 — Revocation of assimilated direct legislation in accordance with regulation 17(2)

10

Commission Regulation (EC) No 109/2007 concerning the authorisation of monensin sodium (Coxidin) as a feed additive[^f00136].

11

Commission Implementing Regulation (EU) No140/2012 concerning the authorisation of monensin sodium as a feed additive for chickens reared for laying (holder of authorisation Huvepharma NV Belgium)[^f00137].

Signed

Andrew Gwynne — Parliamentary Under-Secretary of State, — Department of Health and Social Care — 4th November 2024

Explanatory note

(This note is not part of the Regulations)

Explanatory Note

These Regulations make provision, in relation to England, in relation to animal feed additive authorisations, and in relation to a use of feed for a particular nutritional purpose.

Regulation 3 and Schedules 1 - 20 contain the following authorisations—

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

• Schedule 2 contains a renewal of an authorisation of a preparation of Saccharomyces cerevisiae (MUCL 39885) (identification number 4b1710, and new authorisation extending 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).

• Schedule 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 animals 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 13 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 authorisations (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 10 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 coliK-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 (BHA) (identification number 1b320) as a feed additive for cats. BHA as a feed additive for cats is separately an ‘existing product’ for the purpose of Article 10 of EUR 2003/1831 – see regulation 12 for removal of the existing product status.

• Schedule 12 contains a new authorisation of a preparation of L-lysine base (liquid) produced by fermentation with Corynebacterium glutamicum (KCCM 80183) (identification number 3c320).

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

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

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

• Schedule 16 contains a new authorisation of the substance phytomenadione (vitamin K1) (identification number 3a712).

• Schedule 17 contains a renewal of authorisation (with modification) of a preparation of copper chelate of hydroxy analogue of methionine (identification number 3b410i). See regulation 14 for transitional provision. The modifications on renewal are:the identification number is changed from 3b4.10 to 3b410i;there are changes to the composition of the authorised preparation;a maximum level of for nickel (20 ppm) is added;the analytical methods are updated.

• Schedule 18 contains a renewal of authorisation (with modification) of a preparation of manganese chelate of hydroxy analogue of methionine (identification number 3b510). See regulation 15 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 are updated.

• Schedule 19 contains a renewal of authorisation (with modification) of a preparation of zinc chelate of hydroxy analogue of methionine (identification number 3b610. See regulation 16 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 of a preparation of fumonisin esterase (EC 3.1.1.87) as a feed additive for all animal species, for use only in maize-based silages.

Authorisations granted by these Regulations are valid for a period of ten years in accordance with Article 9(7) of Regulation (EC) No 1831/2003 (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 where an application for renewal has been submitted.

Part 3 (regulation 4) is made in exercise of powers in the Agriculture Act 1970 (1970 c. 40). Regulation 4 amends Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes, etc. An amendment is made to an essential nutritional characteristic for the lawful marketing of feed intended for use for the reduction of the risk of milk fever and subclinical hypocalcemia.

Regulation 5 amends certain instruments containing authorisations for the feed additive Bacillus velezensis (DSM 15544). The authorisations are modified to update the name of the authorisation holder, and to update the name of the bacterial strain Bacillus velezensis(formerly Bacillus subtilis C-3102).

Regulation 5(1) amends Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillus subtilis(C-3102) (DSM 1544) as a feed additive for laying hens and ornamental fish, etc., to remove the authorisation for Bacillus velezensis (DSM 15544) in relation to laying hens. That authorisation is superseded by, and consolidated within, the authorisation contained in Schedule 7.

Regulation 6 amends 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, etc., which contains an authorisation for the feed additive selenised yeast produced by fermentation with Saccharomyces cerevisiae CNCM I-3060, inactivated, with the identification number 3b810. The authorisation is modified in relation to the permitted selenium content of the additive, and to introduce a requirement in relation to the dusting potential of the additive. See regulation 12 for transitional provision.

Regulation 7 amends a number a instruments to update the name of the authorisation holder.

Regulations 8 and 9 make minor consequential amendments.

Regulation 12 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. To remain on the market as feed additive for cats, the additive must comply with the conditions of the new authorisation contained in Schedule 11 to these Regulations. Regulation 12 makes transitional provision to allow existing products (that cannot comply with the new authorisation) produced and labelled within specified periods to continue to be markets and used until stocks are exhausted.

Part 5 (regulations 10 to 16) of these Regulations contains transitional provisions in relation to feed additive authorisations that are modified or renewed by the Regulations. The transitional provisions allow the continued production and labelling of specified feed additives and products containing them, for limited time periods, under the conditions of authorisation applicable immediately before these Regulations come into force. Products produced and labelled within the transitional periods may be marketed and used until stocks are exhausted.

Regulation 17 and Schedule 21 revoke, in relation to England, assimilated direct legislation that contain previous authorisations for feed additives now authorised by Schedules 2 to 7, 11, 18 and 19.

Hard copies of the documents in the Schedules are available for inspection at the Food Standards Agency, Food House, Kings Pool, 1-2 Peasholme Green, York YO1 7PR following a written request to that address or to FeedAdditives@food.gov.uk.

An impact assessment has not been produced for this instrument as no, or no significant, impact on the public, private or voluntary sector is foreseen.

Footnotes

[^f00001]: EUR 2003/1831, amended by S.I. 2019/654, 2022/377 and 1351. See Article 2 for the definitions of “appropriate authority” and “prescribe”.

[^f00002]: 1970 c. 40. Section 74A was inserted by paragraph 6 of Schedule 4 to the European Communities Act 1972 (c. 68) and amended by section 33(3) of the Agriculture Act 2020 (c. 21). There are other amendments, but these are not relevant for this instrument. type=start slip=2024-12-01 time=1734688523889type=end slip=2024-12-01 time=1734688523889The terms “the Minister”, “prescribed” and “regulations” are defined in section 66(1) of the Agriculture Act 1970.

[^f00003]: EUR 2002/178, amended by S.I. 2019/641.

[^f00006]: EUR 2020/354.

[^f00016]: EUR 2016/897, EUR 2017/2312, EUR 2018/1081.

[^f00017]: EUR 2019/804.

[^f00018]: Prior to the coming into force of these Regulations, butylated hydroxyanisole has been treated as an ‘existing product’ for the purposes of Article 10 of Regulation (EC) 1831/2003.

[^f00019]: EUR 2012/98.

[^f00020]: Save to the extent that its continued operation is needed for the operation of this transitional provision, this Regulation is revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

[^f00021]: EUR 2010/349.

[^f00022]: Save to the extent that its continued operation is needed for the operation of this transitional provision, this Regulation is revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

[^f00023]: EUR 2010/350.

[^f00024]: Save to the extent that its continued operation is needed for the operation of this transitional provision, this Regulation is revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

[^f00025]: EUR 2010/335.

[^f00026]: Save to the extent that its continued operation is needed for the operation of this transitional provision, this Regulation is revoked by regulation 17(1) of, and Part 1 of Schedule 21 to, these Regulations.

Editorial notes

[^key-f7762dcc763245d000c8ee23451e5969]: Reg. 4 in force at 20.12.2024, see reg. 1(1)

[^key-84219490276f9c2ceae49e4a692e1209]: Reg. 1 in force at 20.12.2024, see reg. 1(1)

[^key-9cd5593c4733adbb0db0a9e25454ec98]: Reg. 10 in force at 20.12.2024, see reg. 1(1)

[^key-ab26e24fd1b7871f1bd9d3f6ecac8bd3]: Reg. 11 in force at 20.12.2024, see reg. 1(1)

[^key-2b8c613114db67736dae5d79d6b32bb6]: Reg. 12 in force at 20.12.2024, see reg. 1(1)

[^key-cc7b77b95f7528b40ac5d931468f65ef]: Reg. 13 in force at 20.12.2024, see reg. 1(1)

[^key-a997fa8347b5c335a4828cb3afe7d9b4]: Reg. 14 in force at 20.12.2024, see reg. 1(1)

[^key-f708686aaadaaa20902228ad1d172650]: Reg. 15 in force at 20.12.2024, see reg. 1(1)

[^key-a2b1d2431b540e615ab0e379a0c3cbaf]: Reg. 16 in force at 20.12.2024, see reg. 1(1)

[^key-a1fb5a36a8280b5b6f13a984ba714da8]: Regulations revoked (except for regs. 4, 10-16 and regs. 1, 2 so far as they relate to regs. 4, 10-16) (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), reg. 1(2), Sch. 3 (j) (with reg. 23)

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