Title, extent, application and coming into force

1.—(1) The title of these Regulations is the Feed Additives (Authorisations) (Wales) Regulations 2023.

(2) These Regulations—

(a) extend to England and Wales;

(b) apply in relation to Wales;

(c) come into force on 22 December 2023.

Interpretation

2.—(1) Expressions used in these Regulations and in Regulation 1831/2003 or Regulation 767/2009 have the same meaning as in Regulation 1831/2003 or Regulation 767/2009, respectively.

(2) In Schedules 1 to 13—

(a) 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 Regulation 429/2008 have the same meaning as in that Annex;

(b) any reference to a minor species is to be read in accordance with the definition of “minor species” in Article 1 of Regulation 429/2008.

(3) In this regulation—

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

“ Regulation 429/2008” (“ Rheoliad 429/2008”) means Commission Regulation (EC) No 429/2008on detailed rules for the implementation of Regulation (EC) No 1831/2003of 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( 3);

“ Regulation 767/2009” (“ Rheoliad 767/2009”) means Regulation (EC) No 767/2009of the European Parliament and of the Council on the placing on the market and use of feed( 4).

Authorisations

3.—(1) Schedules 1 to 13 contain authorisations of feed additives.

(2) Subject to Article 14(4) (renewal of authorisation) of Regulation 1831/2003, the authorisations set out in Schedules 1 to 13 cease to have effect at the end of 21 December 2033.

Transitional provision: Endo-1,4-beta-xylanase (EC 3.2.1.8) (identification number 4a8i (formerly 4a8))

4.—(1) The relevant feed additive and premixtures containing it, which are produced and labelled before the end of 21 June 2024 in compliance with the conditions of the prior authorisation and the labelling requirements applicable before 22 December 2023, 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 21 December 2024 in compliance with the conditions of the prior authorisation and the labelling requirements applicable before 22 December 2023, may continue to be placed on the market and used until stocks are exhausted.

(3) In this regulation—

“ relevant feed additive” (“ ychwanegyn bwyd anifeiliaid perthnasol”) means the feed additive endo-1,4-beta-xylanase (EC 3.2.1.8), with the identification number 4a8, authorised under the prior authorisation( 5);

“ prior authorisation” (“ awdurdodiad ymlaen llaw”) means the authorisation contained in Commission Regulation (EC) No 902/2009concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced byTrichoderma reesei (CBS 114044) as a feed additive for weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding (holder of authorisation Roal Oy)( 6).

Amendment of Commission Implementing Regulation (EU) No601/2013

5.—(1) Commission Implementing Regulation (EU) No601/2013concerning the authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate, cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate as feed additives( 7) is amended as follows.

(2) In the Annex, in the table, omit the entries for—

(a) cobalt(II) acetate tetrahydrate (identification number 3b301);

(b) cobalt(II) carbonate (identification number 3b302);

(c) cobalt(II) carbonate hydroxide (2:3) monohydrate (identification number 3b303);

(d) cobalt(II) sulphate heptahydrate (identification number 3b305).

Amendment of Commission Implementing Regulation (EU) 2019/221

6.—(1) Commission Implementing Regulation (EU) 2019/221amending Regulations (EC) No 785/2007, (EC) No 379/2009, (EC) No 1087/2009, (EU) No 9/2010, (EU) No 337/2011 and Implementing Regulations (EU) No 389/2011, (EU) No 528/2011, (EU) No 840/2012, (EU) No 1021/2012, (EU) 2016/899, (EU) 2016/997, (EU) 2017/440 and (EU) 2017/896 as regards the name of the holder of the authorisation and the representative of the holder of the authorisation for certain feed additives( 8) is amended as follows.

(2) Omit Article 4 (amendment to Regulation (EU) No9/2010).

(3) Omit Article 7 (amendment to Implementing Regulation (EU) No528/2011).

(4) Omit Article 9 (amendment to Implementing Regulation (EU) No1021/2012).

Revocations

7.  The instruments listed in Schedule 14 are revoked.

Regulation 3(1)

SCHEDULE 1 Renewal of authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced fromTrichoderma reesei(CBS 143953) (formerlyTrichoderma reesei(ATCC PTA 5588)) (identification number 4a11) as a feed additive for chickens for fattening, laying hens, turkeys for fattening, ducks, minor poultry species, weaned piglets, and piglets for fattening, and its authorisation as a feed additive extending existing uses to cover all poultry species, piglets (suckling and weaned), pigs for fattening, and minor porcine species

The preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “digestibility enhancers”, is authorised as an additive in animal nutrition subject to the conditions set out in the table( 9).

Regulation 3(1)

SCHEDULE 2 Authorisation of a preparation ofLacticaseibacillus rhamnosus(formerlyLactobacillus rhamnosus) (IMI 507023) (identification number 1k21701) as a feed additive for all animal species

The preparation ofLacticaseibacillus rhamnosus(IMI 507023) specified in the table, belonging to the additive category “technological additives” and to the functional group “silage additives”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 3 Authorisation of a preparation ofPediococcus pentosaceus(IMI 507024) (identification number 1k21016) as a feed additive for all animal species

The preparationPediococcus pentosaceus(IMI 507024) specified in the table, belonging to the additive category “technological additives” and to the functional group “silage additives”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 4 Authorisation of a preparation ofPediococcus pentosaceus(IMI 507025) (identification number 1k21017) as a feed additive for all animal species

The preparation ofPediococcus pentosaceus(IMI 507025) specified in the table, belonging to the additive category “technological additives” and to the functional group “silage additives”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 5 Authorisation of a preparation ofLactiplantibacillus plantarum(formerlyLactobacillus plantarum) (IMI 507026) (identification number 1k21601) as a feed additive for all animal species

The preparation ofLactiplantibacillus plantarum(IMI 507026) specified in the table, belonging to the additive category “technological additives” and to the functional group “silage additives”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 6 Authorisation of a preparation ofLactiplantibacillus plantarum(formerlyLactobacillus plantarum) (IMI 507027) (identification number 1k21602) as a feed additive for all animal species

The preparation ofLactiplantibacillus plantarum(IMI 507027) specified in the table, belonging to the additive category “technological additives” and to the functional group “silage additives”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 7 Authorisation of a preparation ofLactiplantibacillus plantarum (formerlyLactobacillus plantarum) (IMI 507028) (identification number 1k21603) as a feed additive for all animal species

The preparation ofLactiplantibacillus plantarum(IMI 507028) specified in the table, belonging to the additive category “technological additives” and to the functional group “silage additives”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 8 Authorisation of a preparation ofLactiplantibacillus plantarum(formerlyLactobacillus plantarum) (DSM 26571) (identification number 1k1604) as a feed additive for all animal species

The preparation ofLactiplantibacillus plantarum(DSM 26571) specified in the table, belonging to the additive category “technological additives” and to the functional group “silage additives”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 9 Renewal of authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced fromTrichoderma reesei(CBS 114044) (identification number 4a8i) as a feed additive for piglets (weaned), chickens for fattening, chickens reared for laying, turkeys for fattening, and turkeys reared for breeding

The preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “digestibility enhancers”, is authorised as an additive in animal nutrition subject to the conditions set out in the table( 10).

Regulation 3(1)

SCHEDULE 10 Renewal of authorisation of a preparation of 6-phytase (EC 3.1.3.26) produced fromTrichoderma reesei(CBS 122001) (identification number 4a12) as a feed additive for pigs, poultry for breeding, poultry for fattening, and poultry for laying

The preparation of 6-phytase (EC 3.1.3.26) specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “digestibility enhancers”, is authorised as an additive in animal nutrition subject to the conditions set out in the table( 11).

Regulation 3(1)

SCHEDULE 11 Authorisation of L‐lysine base (liquid) produced fromCorynebacterium glutamicum(KCCM 80216 or KCTC 12307BP) (identification number 3c326) as a feed additive for all animal species

The substance L‐lysine base (liquid) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 12 Authorisation of L‐lysine monohydrochloride (technically pure) produced fromCorynebacterium glutamicum(KCCM 80216 or KCTC 12307BP) (identification number 3c327) as a feed additive for all animal species

The substance L‐lysine monohydrochloride (technically pure) specified in the table, belonging to the additive category “nutritional additives” and to the functional group “amino acids, their salts and analogues”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.

Regulation 3(1)

SCHEDULE 13 Authorisation of a preparation of 3-nitrooxypropanol (identification number 4c1) as a feed additive for ruminants for milk production and ruminants for reproduction

The preparation of 3-nitrooxypropanol specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “substances which favourably affect the environment”, is authorised as an additive in animal nutrition subject to the conditions set out in the table.

Regulation 7

SCHEDULE 14 Revocations

Commission Regulation (EC) No 902/2009concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced byTrichoderma reesei (CBS 114044) as a feed additive for weaned piglets, chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding (holder of authorisation Roal Oy)( 13).

Commission Regulation (EU) No 9/2010concerning the authorisation of the endo-1,4-beta-xylanase produced byTrichoderma reesei(ATCC PTA 5588) as a feed additive for chickens for fattening, laying hens, ducks and turkeys for fattening (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.)( 14).

Commission Regulation (EU) No 277/2010concerning the authorisation of 6-phytase as a feed additive for poultry for fattening and breeding other than turkeys for fattening, for poultry for laying and for pigs other than sows (holder of authorisation Roal Oy)( 15).

Commission Regulation (EU) No 891/2010concerning the authorisation of a new use of 6-phytase as a feed additive for turkeys (holder of authorisation Roal Oy)( 16).

Commission Implementing Regulation (EU) No528/2011concerning the authorisation of endo-1,4-β-xylanase produced byTrichoderma reesei(ATCC PTA 5588) as a feed additive for weaned piglets and pigs for fattening (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.)( 17).

Commission Implementing Regulation (EU) No886/2011concerning the authorisation of 6-phytase (EC 3.1.3.26) produced byTrichoderma reesei(CBS 122001) as a feed additive for sows (holder of authorisation Roal Oy)( 18).

Commission Implementing Regulation (EU) No1110/2011concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced byTrichoderma reesei(CBS 114044) as a feed additive for laying hens, minor poultry species and pigs for fattening (holder of authorisation Roal Oy)( 19).

Commission Implementing Regulation (EU) No1021/2012concerning the authorisation of endo-1,4-beta-xylanase produced byTrichoderma reesei(ATCC PTA 5588) as a feed additive for minor poultry species other than ducks (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.)( 20).

Commission Implementing Regulation (EU) No1196/2012amending Regulation (EU) No9/2010as regards the minimum content of a preparation of endo-1,4-beta-xylanase produced byTrichoderma reesei(ATCC PTA 5588) as a feed additive in feed for laying hens (holder of authorisation Danisco Animal Nutrition)( 21).

Commission Implementing Regulation (EU) 2018/1569amending Implementing Regulation (EU) No1110/2011concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced byTrichoderma reesei (CBS 114044) as a feed additive for laying hens, minor poultry species and pigs for fattening (holder of authorisation Roal Oy)( 22).

EXPLANATORY NOTE

(This note is not part of the Regulations)

The Welsh Ministers make these Regulations pursuant to Regulation (EC) No 1831/2003of the European Parliament and of the Council on additives for use in animal nutrition (EUR 2003/1831). These Regulations make provision for the authorisation for the placing on the market, processing and use of 13 feed additives.

Regulation 3, and Schedules 1 to 13, provide for the authorisation of feed additives.

Schedule 1 contains a renewal (with modification) of an authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced fromTrichoderma reesei(CBS 143953) (identification number 4a11), and an extension of existing authorised uses to cover additional species/categories of animal. The modifications on renewal of the authorisation are—

• the strain identification number forTrichodema reeseiis updated to “ CBS 142953” (formerly “ATCC PTA 5588”);

• the minimum content of feed additive for turkeys for fattening is reduced from 1,250 to 625 U/kg of complete feed.

Schedule 2 contains a new authorisation, for a preparation ofLacticaseibacillus rhamnosus(IMI 507023) (identification number 1k21701).

Schedule 3 contains a new authorisation, for a preparation ofPediococcus pentosaceus(IMI 507024) (identification number 1k21016).

Schedule 4 contains a new authorisation, for a preparation ofPediococcus pentosaceus(IMI 507025) (identification number 1k21017).

Schedule 5 contains a new authorisation, for a preparation ofLactiplantibacillus plantarum(IMI 507026) (identification number 1k21601).

Schedule 6 contains a new authorisation, for a preparation ofLactiplantibacillus plantarum (IMI 507027) (identification number 1k21602).

Schedule 7 contains a new authorisation, for a preparation ofLactiplantibacillus plantarum (IMI 507028) (identification number 1k21603).

Schedule 8 contains a new authorisation, for a preparation ofLactiplantibacillus plantarum(DSM 26571) (identification number 1k1604).

Schedule 9 contains a renewal (with modification) of an authorisation of endo-1,4-beta-xylanase produced fromTrichoderma reesei(CBS 114044) (EC 3.2.1.8) (identification number 4a8i). The modifications on renewal of the authorisation are—

• the identification number of the additive is changed from 4a8 to 4a8i;

• the minimum level of stock enzyme activity is reduced to 160,000 BXU/g in both solid and liquid forms (from 4,000,000 BXU/g in the solid form and 400,000 BXU/g in the liquid form).

Schedule 10 contains a renewal (with modification) of an authorisation of 6-phytase (EC 3.1.3.26) produced fromTrichoderma reesei(CBS 122001) (identification number 4a12). The modification on renewal of the authorisation is—

• the minimum level of stock enzyme activity is reduced to 5,000 PPU/g in the liquid form (from 10,000 PPU/g).

Schedule 11 contains a new authorisation, for L‐lysine base (liquid) produced fromCorynebacterium glutamicum(KCCM 80216 or KCTC 12307BP) (identification number 3c326).

Schedule 12 contains a new authorisation, for L‐lysine monohydrochloride produced fromCorynebacterium glutamicum(KCCM 80216 or KCTC 12307BP) (identification number 3c327).

Schedule 13 contains a new authorisation, for 3-nitrooxypropanol (identification number 4c1).

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 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.

Regulation 4 contains transitional provision. The renewal of authorisation of the feed additive under Schedule 9 is subject to a change to the identification number of the additive (from “4a8” to “4a8i”). Regulation 4 allows the continued production and labelling of products, for the 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 used until stocks are exhausted.

Regulation 5 amends Commission Implementing Regulation (EU) No601/2013concerning the authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate, cobalt(II) sulphate heptahydrate and coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate as feed additives (EUR 2013/601), to remove spent entries relating to four feed additives. The authorisations for those feed additives expired at the end of 14 July 2014. Those four feed additives have now been provisionally authorised for a further 5 years, in relation to Wales, by administrative decision of the Welsh Ministers dated 20 June 2023, and made pursuant to Article 15 of EUR 2003/1831. The forms of authorisations for those feed additives were prescribed by the Feed Additives (Form of Provisional Authorisations) (Cobalt(II) Compounds) (Wales) Regulations 2023 ( S.I. 2023/678 (W. 100)).

Regulation 6 revokes, in relation to Wales, minor amendment provisions relating to instruments that are revoked by regulation 7 (and Schedule 14).

Regulation 7 and Schedule 14 revoke, in relation to Wales, spent instruments including the prior authorisations for the feed additives now authorised by Schedules 1, 9 and 10.

Further information, including in relation to any documentation referenced in the Schedules, can be obtained from the Food Standards Agency in Wales, 4^thFloor, Welsh Government Building, Cathays Park, Cardiff, CF10 3NQ or by writing to[email protected].

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.