The Feed Additives (Authorisations) (Scotland) Regulations 2022

Regulation 3(2)

SCHEDULE 7 Authorisation of a preparation of Bacillus licheniformis DSM 28710 (identification number 4b1828) as a feed additive for laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds

Authorisation

1.  The preparation specified in the table in this schedule, 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 in this schedule.

Table

Column 1		Column 2
Additive		Bacillus licheniformis DSM 28710
Identification number of the additive		4b1828
Authorisation holder		HuvePharma NV
Additive category		Zootechnical additives
Functional group		Gut flora stabilisers
Additive composition		Solid form preparation of Bacillus licheniformis DSM 28710 containing a minimum of 3.2 x 109 CFU/g of additive
Characterisation of the active substance(s)		Viable spores of Bacillus licheniformis DSM 28710
Analytical methods(1)		1. For enumeration (colony count) in the additive, premixture and feed:
		Spread plate method in accordance with European standard EN 15784:2021 entitled “Animal feeding stuffs: Methods of sampling and analysis – Detection and enumeration of Bacillus spp. used as feed additive”(2)
		2. For identification of bacterial strain:
		Pulsed field gel electrophoresis (PFGE)
Species or category of animal		Laying hens, minor poultry species for laying, poultry species for breeding and ornamental birds
Maximum age		Not applicable
Content of Bacillus licheniformis DSM 28710 in CFU/kg of complete feed with a moisture content of 12%	Minimum content	1.6 x 109 CFU/kg
	Maximum content	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. Where Bacillus licheniformis DSM 28710 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:
		Diclazuril Lasalocid A sodium

(1)

Details of the analytical methods are set out in the document referenced “Ares(2015)4524025 – 23/10/2015” and last updated on 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2015-0016.

(2)

This standard was approved by the European Committee for Standardization (CEN) on 2 August 2021. Under reference BS EN 15784:2021, it was published as a UK standard by the British Standards Institution on 30 November 2021 (ISBN 978 0 580 99829 4).