The Feed Additives (Authorisations) (England) Regulations 2022

Regulation 3

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 of Bacillus velezensis (ATCC PTA-6737), belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table(1).

(1) Details of the analytical methods set out in the document referenced “D08/FSQ/CVH/SY/Ares(2009)61627” and last updated 6th 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 at concentrations below the minimum content level in feed materials and compound feed.
(3) Content of Bacillus velezensis (ATCC PTA-6737): 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 × 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(2): Spread plate method using tryptone soya agar with pre-heat treatment of feed samples.
	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, sporting and game birds
Maximum age	Not applicable
Minimum content(3)	1 x 10 7 CFU/kg
Maximum content(3)	No maximum
Other provisions	1) In the directions for use of the 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, and in accordance with their individual authorisation criteria for: lasalocid A sodium, maduramicin ammonium, monensin sodium, narasin, narasin/nicarbazin (as combined use only) salinomycin sodium, decoquinate, robenidine hydrochloride or diclazuril.

(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 11 of these Regulations but see the transitional provision in regulation 8. This feed additive is separately authorised for use in feed for specified other species or categories of animals by Commission Implementing Regulations (EU) No. 306/2013, 787/2013, 2015/1020 and 2017/2276.