The Feed Additives (Authorisations) (Wales) Regulations 2022

Regulation 3(1)

SCHEDULE 6 Renewal of authorisation (with modification) of a preparation of Bacillus velezensis ATCC PTA-6737 (formerly Bacillus Subtilis ATCC PTA-6737) (identification number 4b1823) as a feed additive for chickens for fattening, chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches, and its authorisation as a feed additive extending existing uses to cover all minor poultry species (except for laying), ornamental birds, sporting birds and game birds

The preparation specified in the table, belonging to the additive category “zootechnical additives” and to the functional group “gut flora stabilisers”, is authorised as an additive in animal nutrition subject to the conditions set out in the table(1).

(1) Details of the analytical methods set out in the document referenced “D08/FSQ/CVH/SY/Ares(2009)61627” and last updated 6 June 2016. This document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2008-0039.
(2) This method is not suitable for the detection of Bacillus velezensis ATCC PTA-6737 in feed materials and compound feed at concentrations below the minimum content level.
(3) Content of Bacillus velezensis ATCC PTA-6737 in CFU/kg of complete feed with a moisture content of 12%.
Additive	Bacillus velezensis ATCC PTA-6737
Identification number of the additive	4b1823
Authorisation holder	Kemin Europa N.V.
Additive category	Zootechnical additives
Functional group	Gut flora stabilisers
Additive composition	Preparation of Bacillus velezensis ATCC PTA-6737 containing a minimum of 8 x 1010 CFU/g additive
Characterisation of the active substance(s)	Viable spores of Bacillus velezensis ATCC PTA-6737
Analytical methods(1)	For enumeration (colony count) in the feed additive, premixtures, feed materials and compound feed: Spread plate method using tryptone soya agar with pre-heat treatment of feed samples(2).
	For identification of bacterial strain: Pulsed-field gel electrophoresis (PFGE).
Species or category of animal	Chickens for fattening Chickens reared for laying Minor poultry species (except for laying) Ornamental birds Sporting birds Game birds
Maximum age	None
Minimum content(3)	1 x 107 CFU/kg
Maximum content(3)	None
Other provisions	1. In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.
	2. If Bacillus velezensis ATCC PTA-6737 is to be used in feed containing coccidiostats, this feed additive is authorised for use with the following coccidiostats only, and in accordance with their individual authorisation criteria: Decoquinate Diclazuril Lasalocid A sodium Maduramicin ammonium Monensin sodium Narasin Narasin/Nicarbazin (as combined use only) Robenidine hydrochloride Salinomycin sodium

(1)

This authorisation is a renewal of the authorisations granted under Commission Regulation (EU) No 107/2010 and Commission Implementing Regulation (EU) No 885/2011. Those Regulations are revoked by regulation 8 of these Regulations but see the transitional provision in regulation 10.