The Feed Additives (Authorisations) (Wales) Regulations 2023

EXPLANATORY NOTE

(This note is not part of the Regulations)

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 (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 from Trichoderma 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 for Trichodema reesei is 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 of Lacticaseibacillus rhamnosus (IMI 507023) (identification number 1k21701).

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

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

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

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

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

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

Schedule 9 contains a renewal (with modification) of an authorisation of endo-1,4-beta-xylanase produced from Trichoderma 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 from Trichoderma 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 from Corynebacterium glutamicum (KCCM 80216 or KCTC 12307BP) (identification number 3c326).

Schedule 12 contains a new authorisation, for L‐lysine monohydrochloride produced from Corynebacterium 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) No601/2013 concerning 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^th Floor, Welsh Government Building, Cathays Park, Cardiff, CF10 3NQ or by writing to [e-mail].

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.