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Commission Implementing Regulation (EU) 2016/897Show full title
Commission Implementing Regulation (EU) 2016/897 of 8 June 2016 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) and amending Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 as regards the holder of the authorisation (Text with EEA relevance)
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ANNEXU.K.
| a Details of the analytical methods are available at the following address of the Reference Laboratory: www.irmm.jrc.ec.europa.eu/crl-feed-additives | |||||||||
| 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 | [F1Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.] | Bacillus subtilis C-3102 (DSM 15544) | Additive compositionBacillus subtilis C-3102 (DSM 15544) with minimum of 1,0 × 1010 CFU/g Characterisation of the active substanceViable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544) Analytical method aEnumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009) Identification: pulsed-field gel electrophoresis (PFGE). | Laying hens | — | 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 shall be indicated.2.For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eyes contact. Where the dermal, inhalator or eyes exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment. | 29 June 2026 |
| Ornamental fish | 1 × 1010 | ||||||||
Textual Amendments
F1 Substituted by Commission Implementing Regulation (EU) 2020/146 of 3 February 2020 amending Regulation (EU) No 333/2010, Implementing Regulation (EU) 2017/2312, Implementing Regulation (EU) 2018/1081, Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2019/893 and Regulation (EU) No 184/2011 concerning the authorisations of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive (Text with EEA relevance).
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