The Feed Additives (Authorisations) (Wales) Regulations 2022

Made: 31 October 2022

Laid before Senedd Cymru: 2 November 2022

Coming into force: 24 November 2022

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[^f00002].

Title, extent, application and commencement

1

• (1) The title of these Regulations is the Feed Additives (Authorisations) (Wales) Regulations 2022.

• (2) These Regulations—

• (a) extend to England and Wales;

• (b) apply in relation to Wales;

• (c) come into force on 24 November 2022.

Interpretation

2

• (1) In these Regulations—

• “Regulation 1831/2003” (“Rheoliad 1831/2003”) means Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition;

• “Regulation 767/2009” (“Rheoliad 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[^f00003].

• (2) Any expression used both in these Regulations and in Regulation 1831/2003 or Regulation 767/2009 has the same meaning as it has in Regulation 1831/2003 or Regulation 767/2009, respectively.

Authorisations

3

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Amendment of existing Bacillus velezensis ATCC PTA-6737 authorisations

4

• (1) Commission Implementing Regulation (EU) No 306/2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) for weaned piglets and weaned Suidae other than Sus scrofa domesticus[^f00004] is amended as follows.

• (2) In the Annex, in the table, in columns 3 (additive) and 4 (composition, chemical formula, description, analytical method), for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.

5

• (1) Commission Implementing Regulation (EU) No 787/2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for turkeys for fattening and turkeys reared for breeding[^f00005] is amended as follows.

• (2) In the Annex, in the table, in columns 3 (additive) and 4 (composition, chemical formula, description, analytical method), for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.

6

• (1) Commission Implementing Regulation (EU) 2015/1020 concerning the authorisation of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for laying hens and minor poultry species for laying[^f00006] is amended as follows.

• (2) In the Annex, in the table, in columns 3 (additive) and 4 (composition, chemical formula, description, analytical method), for “Bacillus subtilis” in each place it occurs substitute “Bacillus velezensis”.

7

• (1) Commission Implementing Regulation (EU) 2017/2276 concerning the authorisation of a new use of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for sows[^f00007] is amended as follows.

• (2) In the Annex, in the table, in columns 3 (additive) and 4 (composition, chemical formula, description, analytical method), for “Bacillus subtilis”, in each place it occurs, substitute “Bacillus velezensis”.

Revocations

8

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Transitional provisions: Saccharomyces cerevisiae CNCM I-4407 (formerly Saccharomyces cerevisiae NCYC Sc 47) (identification number 4b1702)

9

• (1) The relevant feed additive and premixtures containing it, which are produced and labelled before the end of 23 May 2023 in accordance with the conditions of the prior authorisation may continue to be placed on the market and used until the existing 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 23 November 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.

• (3) In this regulation—

• “relevant feed additive” (“chwanegyn bwyd anifeiliaid perthnasol”) refers to the feed additive Saccharomyces cerevisiae CNCM I-4407, or as formerly designated, Saccharomyces cerevisiaeNCYC Sc 47, with the identification number 4b1702, which was previously authorised under the prior authorisation;

• “the prior authorisation” (“yr awdurdodiad ymlaen llaw”) refers to the authorisation contained in Commission Regulation (EU) Regulation No 883/2010 concerning the authorisation of a new use of Saccharomyces cerevisiae NCYC Sc 47 as a feed additive for calves for rearing[^f00008].

Transitional provisions: Bacillus velezensis ATCC PTA-6737 (formerly Bacillus subtilis ATCC PTA-6737) (identification number 4b1823)

10

• (1) Any substance or product labelled “Bacillus subtilis ATCC PTA-6737” or as containing “Bacillus subtilis ATCC PTA-6737”, but otherwise produced and labelled in accordance with an authorisation contained in an instrument mentioned in regulations 4 to 7, 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 23 May 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing 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 23 November 2023 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing 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 23 November 2024 in accordance with the conditions of the prior authorisation, may continue to be placed on the market and used until the existing stocks are exhausted.

• (5) In this regulation—

• “relevant feed additive” (“ychwanegyn bwyd anifeiliaid perthnasol”) refers to the feed additive Bacillus velezensis ATCC PTA-6737 or, as formerly designated, Bacillus subtilis ATCC PTA-6737, with the identification number 4b1823, which was previously authorised under the prior authorisation;

• “the prior authorisation” (“yr awdurdodiad ymlaen llaw”) refers to an authorisation contained in—Commission Regulation (EU) No 107/2010 concerning the authorisation of Bacillus subtilis ATCC PTA-6737 as a feed additive for chickens for fattening [^f00009], orCommission Implementing Regulation (EU) No 885/2011 concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches[^f00010].

Transitional provision: Decoquinate (Deccox®) (identification number 51756i (formerly E756))

11

• (1) The relevant feed additive and feed containing it, which are produced and labelled before the end of 23 May 2023 in accordance with the conditions of the prior authorisation may, continue to be placed on the market and used until the existing stocks are exhausted.

• (2) In this regulation—

• “relevant feed additive” (“ychwanegyn bwyd anifeiliaid perthnasol”) refers to the feed additive Decoquinate (Deccox®)which was previously authorised under the prior authorisation with the identification number E756;

• “the prior authorisation” (“yr awdurdodiad ymlaen llaw”) refers to the authorisation contained in Commission Regulation (EC) No 1289/2004 concerning the authorisation for 10 years of the additive Deccox® in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances[^f00011].

SCHEDULE 1 — Authorisation of a preparation of manganese chelate of lysine and glutamic acid (identification number 3b509) as a feed additive for all animal species

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SCHEDULE 2 — Authorisation of a preparation of Lactobacillus buchneriDSM 29026 (identification number 1k20759) as a feed additive for all animal species

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SCHEDULE 3 — Authorisation of a preparation of serine protease (EC 3.4.21.-) produced by Bacillus licheniformis DSM 19670 (identification number 4a13) as a feed additive for chickens for fattening

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SCHEDULE 4 — Renewal of authorisation of pyridoxine hydrochloride (vitamin B₆) (identification number 3a831) as a feed additive for all animal species

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SCHEDULE 5 — Renewal of authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 (formerly Saccharomyces cerevisiae NCYC Sc 47) (identification number 4b1702) as a feed additive for calves for rearing

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

SCHEDULE 6 — Renewal of authorisation (with modification) of a preparation of Bacillus velezensis ATCC PTA-6737 (formerly Bacillus Subtilis ATCC PTA-6737) (identification number 4b1823) as a feed additive for chickens for fattening, chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches, and its authorisation as a feed additive extending existing uses to cover all minor poultry species (except for laying), ornamental birds, sporting birds and game birds

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

SCHEDULE 7 — Authorisation of a preparation of Bacillus licheniformis DSM 28710 (identification number 4b1828) as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds

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SCHEDULE 8 — Renewal of authorisation of a preparation of Clostridium butyricum FERM BP-2789 (identification number 4b1830) as a feed additive for chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species, and its authorisation as a feed additive for chickens for fattening, suckling piglets and suckling minor porcine species

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SCHEDULE 9 — Authorisation of a preparation of 6-phytase (EC 3.1.3.26) (identification number 4a32) as a feed additive for all poultry species, ornamental birds, piglets, pigs for fattening, sows, minor porcine species for fattening or reproduction

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SCHEDULE 10 — Authorisation of decoquinate (Deccox®) (identification number 51756i) as a feed additive for chickens for fattening

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

SCHEDULE 11 — Authorisation of decoquinate (Avi-Deccox® 60G) (identification number 51756ii) as a feed additive for chickens for fattening

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SCHEDULE 12 — Revocation of retained direct EU legislation

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Signed

Lynne Neagle — Deputy Minister for Mental Health and Wellbeing, under the authority of the Minister for Health and Social Services, one of the Welsh Ministers — 31 October 2022

Explanatory note

(This note is not part of the Regulations)

EXPLANATORY NOTE

The Welsh Ministers make these Regulations pursuant to Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition (“Regulation 1831/2003”). These Regulations make provision for the authorisation of eleven feed additives.

Regulation 3 and Schedules 1 to 11 provide for the authorisation of the following feed additives—

• Schedule 1 is a new authorisation, for a preparation of Manganese chelate of lysine and glutamic acid (identification number 3b509);

• Schedule 2 is a new authorisation, for a preparation of Lactobacillus buchneriDSM 29026 (identification number 1k20759);

• Schedule 3 is a new authorisation, for a preparation of Serine protease (EC 3.4.21.-) produced by Bacillus licheniformis (DSM 19670) (identification number 4a13);

• Schedule 4 is a renewal of the authorisation of Pyridoxine hydrochloride (vitamin B₆) (identification number 3a831);

• Schedule 5 is a renewal of the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 (identification number 4b1702). The name of the bacterial strain is changed from “ Saccharomyces cerevisiae NCYC Sc 47” to “Saccharomyces cerevisiae CNCM I-4407”;

• Schedule 6 is a renewal of the authorisation of a preparation of Bacillus velezensis (ATCC PTA-6737) (identification number 4b1823), and an extension of existing authorised uses to cover all minor poultry species (except for laying), ornamental birds, sporting birds and game birds. The authorisation has been modified as follows: the bacterial strain name is changed from “Bacillus subtilis” to “Bacillus velezensis”; the minimum content of the feed additive in the preparation is increased from 1x10¹⁰ to 8x10¹⁰ colony forming units per gram (CFU/g);

• Schedule 7 is a new authorisation of a preparation of Bacillus licheniformis DSM 28710 (identification number 4b1828);

• Schedule 8 is a renewal of the authorisations of a preparation of Clostridium butyricum (FERM BP-2789) (identification number 4b1830) and authorises it for a new use in feed for chickens for fattening, suckling piglets and minor porcine species (suckling);

• Schedule 9 is a new authoristion, for a preparation of 6-phytase produced by Komagataella phaffii DSM 32854 (identification number 4a32);

• Schedule 10 authorises a new formulation of decoquinate (Deccox®) (identification number E756) as decoquinate (Deccox®) (identification number 51756i);

• Schedule 11 authorises a modifed form of decoquinate (Deccox®) (identification number E756) as decoquinate (Avi-Deccox® 60G) (identification number 51756ii). This feed additive differs from decoquinate (Deccox®) in physical form and in the dilutant used being calcium sulphate dihydrate.

Regulation 3(2) provides that authorisations granted by these Regulations are valid for a period of ten years in accordance with Article 9(7) of Regulation 1831/2003. 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.

Regulations 4 to 7 amend four retained EU Regulations that authorise the feed additive Bacillus subtilis ATCC PTA-6737 for differing poultry and pig sub-groups. The name of the bacterial strain is updated from “Bacillus subtilis” to “Bacillus velezensis”. Regulation 10(1) contains a transitional provision that allows products labelled using the name “Bacillus subtilis” to continue to be marketed and used under the relevant authorisations despite the change to the name.

Regulation 8 and Schedule 12 revoke, in relation to Wales, retained EU Regulations that contain prior authorisations for the feed additives now authorised by Schedules 3, 4, 5, 6, 8 and 10.

Regulations 9, 10(2) to (5) and 11 contain transitional provisions that allow the continued production and labelling of products, for limited time periods, under the conditions of prior authorisations of the relevant feed additives. Those feed additives are now authorised by Schedules 5, 6 and 10 respectively.

Further information, including in relation to any documentation referenced in the Schedules, can be obtained from the Food Standards Agency, 11th Floor, Southgate House, Cardiff, CF10 1EW or by writing toregulated.products.wales@food.gov.uk.

The Welsh Ministers’ Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result, it was not considered necessary to carry out a regulatory impact assessment as to the likely costs and benefits of complying with these Regulations.

Footnotes

[^f00001]: EUR 2003/1831, amended by S.I. 2019/654 and 2022/377. S.I. 2019/654 was amended by S.I. 2020/1504. The terms “prescribe” and “appropriate authority” are defined in Article 2 of EUR 2003/1831.

[^f00002]: EUR 2002/178, amended by S.I. 2019/641. S.I. 2019/641 was amended by S.I 2020/1504.

[^f00003]: EUR 2009/767, amended by S.I. 2019/654. S.I 2019/654 was amended by S.I. 2020/1504.

[^f00004]: EUR 2013/306.

[^f00005]: EUR 2013/787.

[^f00006]: EUR 2015/1020.

[^f00007]: EUR 2017/2276.