2010R0333 — EN — 29.06.2016 — 001.001

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►B COMMISSION REGULATION (EU) No 333/2010 of 22 April 2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets ( ►M1 holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office ◄ ) (Text with EEA relevance) (OJ L 102 23.4.2010, p. 19)

Amended by:









▼B

COMMISSION REGULATION (EU) No 333/2010

of 22 April 2010

concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets ( ►M1 holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office ◄ )

(Text with EEA relevance)







Article 1

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.

Article 2

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.









ANNEX







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 ►M1 Asahi Calpis Wellness Co. Ltd, represented in the European Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office ◄ 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