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Document 02019R0893-20200224
Commission Implementing Regulation (EU) 2019/893 of 28 May 2019 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) (Text with EEA relevance)Text with EEA relevance
Consolidated text: Commission Implementing Regulation (EU) 2019/893 of 28 May 2019 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) (Text with EEA relevance)Text with EEA relevance
Commission Implementing Regulation (EU) 2019/893 of 28 May 2019 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) (Text with EEA relevance)Text with EEA relevance
No longer in force
02019R0893 — EN — 24.02.2020 — 001.001
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COMMISSION IMPLEMENTING REGULATION (EU) 2019/893 of 28 May 2019 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation ►M1 Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U. ◄ ) (OJ L 142 29.5.2019, p. 60) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING REGULATION (EU) 2020/146 of 3 February 2020 |
L 31 |
3 |
4.2.2020 |
COMMISSION IMPLEMENTING REGULATION (EU) 2019/893
of 28 May 2019
concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation ►M1 Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U. ◄ )
(Text with EEA relevance)
Article 1
The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.
Article 2
Regulation (EC) No 1444/2006 is repealed.
Article 3
This Regulation shall enter into force on the twentieth day following that of 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 % |
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Category of zootechnical additives. Functional group: gut flora stabilisers |
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4b1820 |
►M1 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 × 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 (EN 15784:2009) Identification: pulsed-field gel electrophoresis (PFGE). |
Chickens for fattening |
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►M1 3 × 108 ◄ |
— |
1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. The use is permitted in feed containing one of the following authorised coccidiostats: monensin sodium, salinomycin sodium, seduramycin sodium, lasalocid sodium, maduramycin ammonium, narasin/nicarbazin, diclazuril. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eye and breathing protection. |
18 June 2029 |
(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports |