(This note is not part of the Regulations)
These Regulations make provision as regards the authorisation of feed additives under Regulation (EC) 1831/2003 of the European Parliament and of the Council on additives for use in animal nutrition (“Regulation (EC) 1831/2003”).
Regulation 3 and schedules 1 to 11 prescribe the authorisation of 11 feed additives, in accordance with article 9(1) of Regulation (EC) 1831/2003.
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.-1) 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 (ACTISAF® Sc47) (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). The authorisation has been modified as follows:-
the bacterial strain name 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, for 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 to be used in feed for chickens for fattening, suckling piglets and minor porcine species (suckling).
Schedule 9 is a new authorisation, 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) following a re-evaluation requested by the holder.
Schedule 11 authorises a modified 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 dehydrate.
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. Relevant provision is made by regulation 3(3) of these Regulations.
Regulations 4 to 7 modify 4 retained EU Regulations that authorise the feed additive Bacillus subtilis ATCC PTA-6737 for differing poultry and pig sub-groups. The name of the feed additive is updated from “ Bacillus subtilis” to “Bacillus velezensis”. Regulation 9(1) is a transitional provision which allows products labelled using the name “Bacillus subtilis” to continue to be marketed and used under the relevant authorisations despite the name change.
Regulations 8, 9(2) to (5) and 10 make transitional provision to enable the continued production and labelling of products, for limited time periods, under the conditions of previous authorisations where authorisations are renewed under schedules 5, 6 and 10 respectively.
Regulation 11 and schedule 12 revoke retained direct EU legislation that contains previous authorisations for the feed additives now authorised by schedules 3, 4, 5, 6, 8 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.