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concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation ►M2 Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U. ◄ )

The preparation specified in the Annex, 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 laid down in that Annex.

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Identification number of the additive	Name of the holder of authorisation	Additive	Composition, chemical formula, description, analytical method	Species or category of animal	Maximum age	Minimum content	Maximum content	Other provisions	End of period of authorisation
						CFU/kg of complete feedingstuff with a moisture content of 12 %
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1820	►M2 Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U. ◄	Bacillus subtilis C-3102 (DSM 15544)	Additive composition: Bacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/g Characterisation of the active substance: Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544) Analytical method (1): Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15874:2009) Identification: pulsed-field gel electrophoresis (PFGE).	Piglets (weaned)	—	3 × 108	—	1. In the directions for use of the additive, premixture and compound feedingstuff indicate the storage temperature, storage life and stability to pelleting 2. For use in weaned piglets up to approximately 35 kg. 3. For safety: breathing protection, glasses and gloves shall be used during handling.	13 May 2020
(1) Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.ec.europa.eu/crl-feed-additives

		Official Journal
		No	page	date
M1	COMMISSION IMPLEMENTING REGULATION (EU) 2016/897 of 8 June 2016	L 152	7	9.6.2016
►M2	COMMISSION IMPLEMENTING REGULATION (EU) 2020/146 of 3 February 2020	L 31	3	4.2.2020