Citation, commencement, extent, and application

1.—(1) These Regulations may be cited as the Feed Additives (Authorisations) (England) Regulations 2023 and come into force on 22nd December 2023.

(2) These Regulations extend to England and Wales but apply in relation to England only.

Interpretation

2.—(1) In these Regulations—

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

(b) “ Regulation (EC) 429/2008” means Commission Regulation (EC) No. 429/2008on detailed rules for the implementation of Regulation (EC) 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);

(c) “ Regulation (EC) 152/2009” means Commission Regulation (EC) No. 152/2009laying down the methods of sampling and analysis for the official control of feed( 4).

(2) Any expression used both in these Regulations and in Regulation (EC) 1831/2003or Regulation (EC) No. 767/2009of the European Parliament and of the Council on the placing on the market and use of feed, etc( 5) has the same meaning as it has in those Regulations.

(3) In Schedules 1 to 13, in the tables, in the row relating to “Species or category of animal”, expressions used that are also used in Annex 4 of Regulation (EC) 429/2008(categories and definitions of target animals etc.) have the same meaning as in that Annex.

Authorisation of various feed additives

3.  Schedules 1 to 13 have effect.

Amendment of Commission Implementing Regulation (EU) No.601/2013

4.  In the Annex to Commission Implementing Regulation (EU) No.601/2013concerning 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( 6) omit—

(a) the entry for cobalt(II) acetate tetrahydrate;

(b) the entry for cobalt(II) carbonate;

(c) the entry for cobalt(II) carbonate hydroxide (2:3) monohydrate;

(d) the entry for cobalt(II) sulphate heptahydrate.

Amendment of Commission Implementing Regulation (EU) 2019/221

5.—(1) Commission Implementing Regulation (EU) 2019/221( 7) is amended as follows.

(2) Omit Article 4 (Amendment to Commission Regulation (EU) No 9/2010).

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

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

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

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

(2) Stocks of feed materials and compound feed containing the relevant feed additive, intended for food-producing animals, which are produced and labelled before the end of 21st December 2024 in accordance with the conditions of the prior authorisation and the labelling requirements applicable before 22nd December 2023, may continue to be placed on the market and used until they are exhausted.

(3) In this regulation—

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

“ prior authorisation” 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)( 8).

Revocation of retained direct EU legislation

7.—(1) The instruments in Part 1 of Schedule 14 are revoked.

(2) The instrument in Part 2 of Schedule 14 is revoked subject to regulation 6.

Regulation 3

SCHEDULE 1 Renewal of authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced fromTrichoderma reesei(CBS 143953, formerly 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 extending to the use for 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), belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, in accordance with the specifications in the following table( 9).

Regulation 3

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), belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table.

Regulation 3

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

The preparation ofPediococcus pentosaceus(IMI 507024), belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table.

Regulation 3

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), belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table.

Regulation 3

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), belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table.

Regulation 3

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), belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table.

Regulation 3

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), belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table.

Regulation 3

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), belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table.

Regulation 3

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), belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table( 10).

Regulation 3

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), belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table( 11).

Regulation 3

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 for all animal species

The substance of L‐lysine base (liquid), 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 in accordance with the specifications in the following table.

Regulation 3

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), 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 in accordance with the specifications in the following table.

Regulation 3

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

The preparation of 3-nitrooxypropanol 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, in accordance with the specifications in the following table.

Regulation 7

SCHEDULE 14 Revocation of retained direct EU legislation

PART 1 Revocation of retained direct EU legislation in accordance with regulation 7(1)

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.)( 12).

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)( 13).

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)( 14).

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.)( 15).

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)( 16).

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)( 17).

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.)( 18).

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)( 19).

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)( 20).

PART 2 Revocation of retained direct EU legislation in accordance with regulation 7(2)

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)( 21).

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations authorise the placing on the market of specific feed additives in England.

Regulation 3 and Schedules 1 – 13 contain the following authorisations—

• Schedule 1 renews the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced fromTrichoderma reesei(CBS 143953) (identification number 4a11) and authorises it for a new use to be used in feed by extending to all poultry species and to suckling piglets and minor porcine species;

• Schedule 2 authorises a new preparation ofLacticaseibacillus rhamnosus(IMI 507023) (identification number 1k21701);

• Schedule 3 authorises a new preparation ofPediococcus pentosaceus(IMI 507024) (identification number 1k21016);

• Schedule 4 authorises a new preparation ofPediococcus pentosaceus(IMI 507025) (identification number 1k21017);

• Schedule 5 authorises a new preparation ofLactiplantibacillus plantarum(IMI 507026) (identification number 1k21601);

• Schedule 6 authorises a new preparation ofLactiplantibacillus plantarum (IMI 507027) (identification number 1k21602);

• Schedule 7 authorises a new preparation ofLactiplantibacillus plantarum (IMI 507028) (identification number 1k21603);

• Schedule 8 authorises a new preparation ofLactiplantibacillus plantarum(DSM 26571) (identification number 1k1604);

• Schedule 9 renews the authorisation for a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced fromTrichoderma reesei(CBS 114044) (identification number 4a8i);

• Schedule 10 renews the authorisation for a preparation of 6-phytase (EC 3.1.3.26) produced fromTrichoderma reesei(CBS 122001) (identification number 4a12);

• Schedule 11 authorises a new feed additive L‐lysine base produced fromCorynebacterium glutamicum(KCCM 80216 or KCTC 12307BP) (identification number 3c326);

• Schedule 12 authorises a new feed additive L‐lysine monohydrochloride produced fromCorynebacterium glutamicum(KCCM 80216 or KCTC 12307BP) (identification number 3c327);

• Schedule 13 authorises a new preparation of 3-nitrooxypropanol (identification number 4c1).

Authorisations granted by these Regulations are valid for a period of ten years in accordance with Article 9(7) of Regulation (EC) 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.

Regulation 4 amends Regulation (EU) No.601/2013by removing authorisation of cobalt(II) acetate tetrahydrate, cobalt(II) carbonate, cobalt(II) carbonate hydroxide (2:3) monohydrate and cobalt(II) sulphate heptahydrate. These feed additives have been provisionally authorised by the Feed Additives (Form of Provisional Authorisations) (Cobalt(II) Compounds) (England) Regulations 2023 ( S.I. 2023/689).

Regulation 5 revokes minor amendment provisions relating to instruments that are revoked by regulation 7 and Schedule 14.

Regulation 6 is a transitional provision that enables the continued production and labelling of endo-1,4-beta-xylanase (EC 3.2.1.8) produced fromTrichoderma reesei(CBS 114044), for limited periods, under the conditions of its previous authorisation. Endo-1,4-beta-xylanase (EC 3.2.1.8) is now authorised under Schedule 9.

Regulation 7 and Schedule 14 revoke, in relation to England, retained EU Regulations that contain previous authorisations for feed additives now authorised by Schedules 1, 9 and 10.

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[email protected].

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.