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

Made: 27 November 2024

Laid before Senedd Cymru: 29 November 2024

Coming into force: 20 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 safety.

PART 1 — Introduction

Title, extent, application and coming into force

1

• (1) The title of these Regulations is the Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) (Wales) Regulations 2024.

• (2) These Regulations—

• (a) extend to England and Wales;

• (b) apply in relation to Wales;

• (c) come into force on 20 December 2024.

Interpretation

2

• (1) Expressions used in these Regulations and in Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition or Regulation (EC) No 767/2009 of the European Parliament and of the Council on the placing on the market and use of feed[^f00004] have the same meaning as in Regulation (EC) No 1831/2003 or Regulation (EC) No 767/2009, respectively.

• (2) In Schedules 1 to 20, expressions used to refer to species or categories of animals that are also used in Annex 4 (categories and definitions of target animals etc.) to Commission Regulation (EC) No 429/2008 on detailed rules for the implementation of Regulation (EC) No1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives[^f00005] have the same meaning as in that Annex.

PART 2 — Feed additive authorisations

Authorisations

3

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

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

4

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

5

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

6

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

Modification of authorisation: selenised yeast produced by fermentation with Saccharomyces cerevisiae CNCM I-3060, inactivated (identification number 3b810)

7

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

Removal of authorisation of butylated hydroxyanisole as an existing product for the purposes of Article 10 of Regulation (EC) No 1831/2003

8

Butylated hydroxyanisole (E 320) may no longer be placed on the market or used as a feed additive for cats under Article 10 of Regulation (EC) No 1831/2003[^f00010].

Changes of authorisation holder: amendment of Commission Implementing Regulation (EU) No887/2011 and Commission Implementing Regulations (EU) 2017/961 and 2020/1395

9

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

10

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

11

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

PART 3 — Transitional provisions

Transitional provision: 6-phytase (EC 3.1.3.26) produced by fermentation with Komagataella phaffii (formerly Komagataella pastoris) (DSM 23036) (identification number 4a16)

12

• (1) The relevant feed additive and premixtures, compound feed or feed materials containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.

• (2) In paragraph (1), the reference to the “relevant feed additive” is a reference to the feed additive 6-phytase (EC 3.1.3.26) (identification number 4a16)[^f00014] as authorised immediately before 20 December 2024 under 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[^f00015].

Transitional provision: Bacillus velezensis (formerly Bacillus subtilis C-3102) (DSM 15544) (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 an instrument mentioned in regulations 4 to 6 of these Regulations, 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 compliance with the conditions of authorisation and the labelling requirements applicable immediately 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 compliance with the conditions of authorisation and the labelling requirements applicable immediately 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 compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.

• (5) In this regulation, references to the “relevant feed additive” are references to the feed additive Bacillus velezensis (formerly Bacillus subtilis C-3102) (DSM 15544), with the identification number 4b1820[^f00016], as authorised immediately before 20 December 2024 under—

• (a) 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[^f00017];

• (b) 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[^f00018];

• (c) Commission Implementing Regulation (EU) 2016/897 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish[^f00019];

• (d) 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[^f00020].

Transitional provision: Selenised yeast produced by fermentation with 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 compliance with the conditions of authorisation and the labelling requirements applicable immediately 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 compliance with the conditions of authorisation and the labelling requirements applicable immediately 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 compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.

• (4) In this regulation, references to the “relevant feed additive” are references to the feed additive selenised yeast produced by fermentation with Saccharomyces cerevisiae CNCM I-3060, inactivated, with the identification number 3b810, as authorised immediately before 20 December 2024 under Commission Implementing Regulation (EU) 2019/804[^f00021].

Transitional provision: Butylated hydroxyanisole as a feed additive for cats

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 compliance with the conditions of authorisation and the labelling requirements applicable immediately 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 compliance with the conditions of authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.

Transitional provisions: Copper, manganese and zinc chelates of hydroxy analogue of methionine (identification numbers 3b410i, 3b510 and 3b610 respectively)

16

• (1) A relevant feed additive and premixtures containing it, which are produced and labelled before the end of 19 June 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately 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 a relevant feed additive and intended for food-producing animals, which are produced and labelled before the end of 19 December 2025 in compliance with the conditions of authorisation and the labelling requirements applicable immediately 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 a relevant feed additive and intended for non-food-producing animals, which are produced and labelled before the end of 19 December 2026 in compliance with the conditions of the authorisation and the labelling requirements applicable immediately before 20 December 2024, may continue to be placed on the market and used until stocks are exhausted.

• (4) In this regulation, references to a “relevant feed additive” are references to each of the following feed additives.

Copper chelate of hydroxy analogue of methionine a The feed additive copper chelate of hydroxy analogue of methionine, with the identification number 3b410i (formerly 3b4.10)[^f00022] as authorised immediately before 20 December 2024 under 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[^f00023].

Manganese chelate of hydroxy analogue of methionine b The feed additive manganese chelate of hydroxy analogue of methionine, with the identification number 3b510 (formerly 3b5.10)[^f00024] as authorised immediately before 20 December 2024 under 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[^f00025].

Zinc chelate of hydroxy analogue of methionine c The feed additive zinc chelate of hydroxy analogue of methionine, with the identification number 3b610 (formerly 3b6.10)[^f00026] as authorised immediately before 20 December 2024 under 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[^f00027].

PART 4 — 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

17

• (1) In Commission Regulation (EU) 2020/354 establishing a list of intended uses of feed intended for particular nutritional purposes[^f00028], 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 5 — Revocations

Amendment of Commission Implementing Regulation (EU) 2016/1095

18

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

Amendment of Commission Implementing Regulation (EU) 2018/1039

19

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

Revocations

20

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

SCHEDULE 1 — ...

The preparation of chromium chelate of DL-methionine 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.