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Document 02019R0893-20200224

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

ELI: http://data.europa.eu/eli/reg_impl/2019/893/2020-02-24

02019R0893 — EN — 24.02.2020 — 001.001


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B

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)

(OJ L 142 29.5.2019, p. 60)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION IMPLEMENTING REGULATION (EU) 2020/146 of 3 February 2020

  L 31

3

4.2.2020




▼B

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Regulation (EC) No 1444/2006 is repealed.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 %

Category of zootechnical additives. Functional group: gut flora stabilisers

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

►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

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