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Dokumentum 02020R1760-20220225

Egységes szerkezetbe foglalt szöveg: Commission Implementing Regulation (EU) 2020/1760 of 25 November 2020 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance)Text with EEA relevance

ELI: http://data.europa.eu/eli/reg_impl/2020/1760/2022-02-25

02020R1760 — EN — 25.02.2022 — 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) 2020/1760

of 25 November 2020

concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S)

(Text with EEA relevance)

(OJ L 397 26.11.2020, p. 6)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION IMPLEMENTING REGULATION (EU) 2022/271 of 23 February 2022

  L 43

10

24.2.2022




▼B

COMMISSION IMPLEMENTING REGULATION (EU) 2020/1760

of 25 November 2020

concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S)

(Text with EEA relevance)



Article 1

Authorisation

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

Entry into force

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.

▼M1




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

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of complete feedingstuff with a moisture content of 12 %

CFU/l of water for drinking

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1902

Chr. Hansen A/S

Bacillus subtilis

DSM 25841

Additive composition

Preparation of Bacillus subtilis DSM 25841 containing a minimum of 1,25 × 1010 CFU/g of additive

Solid form

Characterisation of the active substance

Viable spores of Bacillus subtilis DSM 25841

Analytical method (1)

For identification of Bacillus subtilis DSM 25841: Identification: Pulsed Field Gel Electrophoresis (PFGE)

For enumeration of Bacillus subtilis DSM 25841 in the feed additive, premixtures and feedingstuffs: Spread plate method using tryptone soya agar – EN 15784

All porcine species, including sows,

other than lactating sows in order to have a benefit in suckling piglets

-

5 × 108

-

1,7 × 108

-

1.  In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.  The additive may be used in water for drinking.

3.  For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured.

4.  For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use: a potential respiratory sensitiser, potential skin irritant and potential eyes or dermal sensitiser. 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.

16.12.2030

(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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