The Feed Additives (Authorisations) (Scotland) Regulations 2023

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations make provision regarding the authorisation of feed additives under Regulation (EC) No 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition (“Regulation (EC) 1831/2003”) in Scotland.

Regulation 3(1) and schedules 1 to 13 provide for the authorisation of 13 feed additives.

Schedule 1 contains a renewal of the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced from Trichoderma reesei (CBS 143953) (identification number 4a11). The authorisation has been modified as follows:—

• the strain identification number for Trichoderma reesei is updated from “ATCC PTA 5588” to “CBS 142953”,

• the minimum content of the feed additive for turkeys for fattening is reduced from 1,250 to 625 units of activity per kilogram of complete feed (U/kg), to provide that the minimum content is 625 U/kg for all poultry species.

Schedule 2 contains a new authorisation, for a preparation of Lacticaseibacillus rhamnosus (formerly Lactobacillus 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 (formerly Lactobacillus plantarum) (IMI 507026) IMI 507026) (identification number 1k21601).

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

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

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

Schedule 9 contains a renewal of the authorisation of a preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced from Trichoderma reesei (CBS 114044) (identification number 4a8i). The authorisation has been modified as follows:—

• the identification number of the feed additive is changed from “4a8” to “4a8i”,

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

Schedule 10 contains a renewal of the authorisation of a preparation of 6-phytase (EC 3.1.3.26) produced from Trichoderma reesei (CBS 122001) (identification number 4a12). The authorisation has been modified as follows:—

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

Schedule 11 contains a new authorisation, for L-lysine (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 a preparation of 3-nitrooxypropanol (identification number 4c1).

Regulation 3(2) provides that the authorisations are valid for a period of 10 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 following the submission of an application for renewal.

Regulation 4 makes transitional provision in relation to the feed additive endo-1,4-beta-xylanase (EC 3.2.1.8) the authorisation of which is renewed under schedule 9. Under the renewal of the authorisation the identification number of the feed additive is changed. 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 by removing from the Annex the authorisations for cobalt (II) acetate tetrahydrate, cobalt (II) carbonate, cobalt (II) carbonate hydroxide (2:3) monohydrate and cobalt (II) sulphate heptahydrate. This is consequential to the Feed Additives (Form of Provisional Authorisations) (Cobalt (II) Compounds) (Scotland) Regulations 2023 (S.S.I. 2023/170) which provisionally authorised these feed additives.

Regulation 6 amends Commission Implementing Regulation (EU) 2019/221 by revoking articles which amend Commission Regulation (EU) No 9/2010 and Commission Implementing Regulations (EU) No 528/2011 and 1021/2012. Those Regulations are revoked by regulation 7 and schedule 14.

Regulation 7 and schedule 14 revoke retained direct EU legislation that contains previous authorisations for the feed additives now authorised by schedules 1, 9 and 10.

A business and regulatory impact assessment has not been produced for this instrument as no significant impact on the private or voluntary sector is foreseen.