
2022 No. 1118 (W. 233)
Agriculture, Wales
The Feed Additives (Authorisations) (Wales) Regulations 2022
Made 31 October 2022
Laid before Senedd Cymru 2 November 2022
Coming into force 24 November 2022

The Welsh Ministers make these Regulations in exercise of the powers conferred by Articles 9(1) and 18A(3) of Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition.

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.
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.
(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 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 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 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 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 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 
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 cerevisiae NCYC 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.
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 , or
 Commission 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.
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.
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
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
Regulation 3(1)

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

SCHEDULE 2
Authorisation of a preparation of Lactobacillus buchneri DSM 29026 (identification number 1k20759) as a feed additive for all animal species
Regulation 3(1)

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

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
Regulation 3(1)

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

SCHEDULE 4
Renewal of authorisation of pyridoxine hydrochloride (vitamin B6) (identification number 3a831) as a feed additive for all animal species
Regulation 3(1)

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

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
Regulation 3(1)

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

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
Regulation 3(1)

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

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
Regulation 3(1)

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

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
Regulation 3(1)

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

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
Regulation 3(1)

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

SCHEDULE 10
Authorisation of decoquinate (Deccox®) (identification number 51756i) as a feed additive for chickens for fattening
Regulation 3(1)

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

SCHEDULE 11
Authorisation of decoquinate (Avi-Deccox® 60G) (identification number 51756ii) as a feed additive for chickens for fattening
Regulation 3(1)

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

SCHEDULE 12
Revocation of retained direct EU legislation
Regulation 8

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