The Feed Additives (Authorisations) (Wales) Regulations 2022

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 (“Regulation 1831/2003”). These Regulations make provision for the authorisation of eleven feed additives.

Regulation 3 and Schedules 1 to 11 provide for the authorisation of the following feed additives—

• Schedule 1 is a new authorisation, for a preparation of Manganese chelate of lysine and glutamic acid (identification number 3b509);

• Schedule 2 is a new authorisation, for a preparation of Lactobacillus buchneri DSM 29026 (identification number 1k20759);

• Schedule 3 is a new authorisation, for a preparation of Serine protease (EC 3.4.21.-) produced by Bacillus licheniformis (DSM 19670) (identification number 4a13);

• Schedule 4 is a renewal of the authorisation of Pyridoxine hydrochloride (vitamin B₆) (identification number 3a831);

• Schedule 5 is a renewal of the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 (identification number 4b1702). The name of the bacterial strain is changed from “ Saccharomyces cerevisiae NCYC Sc 47” to “Saccharomyces cerevisiae CNCM I-4407”;

• Schedule 6 is a renewal of the authorisation of a preparation of Bacillus velezensis (ATCC PTA-6737) (identification number 4b1823), and an extension of existing authorised uses to cover all minor poultry species (except for laying), ornamental birds, sporting birds and game birds. The authorisation has been modified as follows:

  • the bacterial strain name is changed from “Bacillus subtilis” to “Bacillus velezensis”;

  • the minimum content of the feed additive in the preparation is increased from 1x10¹⁰ to 8x10¹⁰ colony forming units per gram (CFU/g);

• Schedule 7 is a new authorisation of a preparation of Bacillus licheniformis DSM 28710 (identification number 4b1828);

• Schedule 8 is a renewal of the authorisations of a preparation of Clostridium butyricum (FERM BP-2789) (identification number 4b1830) and authorises it for a new use in feed for chickens for fattening, suckling piglets and minor porcine species (suckling);

• Schedule 9 is a new authoristion, for a preparation of 6-phytase produced by Komagataella phaffii DSM 32854 (identification number 4a32);

• Schedule 10 authorises a new formulation of decoquinate (Deccox^®) (identification number E756) as decoquinate (Deccox^®) (identification number 51756i);

• Schedule 11 authorises a modifed form of decoquinate (Deccox^®) (identification number E756) as decoquinate (Avi-Deccox^® 60G) (identification number 51756ii). This feed additive differs from decoquinate (Deccox^®) in physical form and in the dilutant used being calcium sulphate dihydrate.

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 Regulation 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.

Regulations 4 to 7 amend four retained EU Regulations that authorise the feed additive Bacillus subtilis ATCC PTA-6737 for differing poultry and pig sub-groups. The name of the bacterial strain is updated from “Bacillus subtilis” to “Bacillus velezensis”. Regulation 10(1) contains a transitional provision that allows products labelled using the name “Bacillus subtilis” to continue to be marketed and used under the relevant authorisations despite the change to the name.

Regulation 8 and Schedule 12 revoke, in relation to Wales, retained EU Regulations that contain prior authorisations for the feed additives now authorised by Schedules 3, 4, 5, 6, 8 and 10.

Regulations 9, 10(2) to (5) and 11 contain transitional provisions that allow the continued production and labelling of products, for limited time periods, under the conditions of prior authorisations of the relevant feed additives. Those feed additives are now authorised by Schedules 5, 6 and 10 respectively.

Further information, including in relation to any documentation referenced in the Schedules, can be obtained from the Food Standards Agency, 11th Floor, Southgate House, Cardiff, CF10 1EW 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.