Commission Implementing Regulation (EU) 2023/2647 of 28 November 2023 concerning the authorisation of the preparation of Bacillus subtilis DSM 5750 and Bacillus paralicheniformis DSM 5749 as a feed additive for calves for fattening, lambs for rearing and for fattening and minor ruminant species for rearing and for fattening, and amending Implementing Regulation (EU) 2017/2308 as regards the terms of the authorisation of that preparation for suckling piglets (holder of authorisation: Chr. Hansen A/S)

• CELEX: Implementing Regulation (EU) 2023/2647
• Articles: 5

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 for calves for fattening, lambs for rearing and for fattening, and minor ruminant species for rearing and for fattening, subject to the conditions laid down in that Annex.

Article 2 Amendment to Implementing Regulation (EU) 2017/2308

In the Annex to Implementing Regulation (EU) 2017/2308, the provision number 4 in the column ‘other provisions’ is replaced by the following:

‘4.

Indicate in the instructions for use:

“It is recommended to feed the additive to lactating sows and suckling piglets simultaneously.”

’

Article 3 Transitional measures concerning the amendment to Implementing Regulation (EU) 2017/2308

1.   The preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) for use for suckling piglets and premixtures containing that preparation, which are produced and labelled before 19 June 2024 in accordance with the rules applicable before 19 December 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the preparation referred to in paragraph 1 for use for suckling piglets, which are produced and labelled before 19 December 2024 in accordance with the rules applicable before 19 December 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4 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.

Schedules & Appendices

ANNEX

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 stabiliser

4b1700i

Chr. Hansen A/S

Bacillus subtilis DSM 5750 and Bacillus

paralicheniformis DSM 5749

Additive composition

Preparation of

Bacillus subtilis DSM 5750 and Bacillus

paralicheniformis DSM 5749 containing a minimum of

3,2 × 10 10 CFU/g of additive

(1:1 ratio)

Solid form

Characterisation of the active substance

Viable spores of Bacillus subtilis

DSM 5750 and Bacillus paralicheniformis DSM 5749

Analytical method

( 1 )

Identification and enumeration of Bacillus subtilis DSM 5750 and Bacillus paralicheniformis DSM 5749 in the feed additive, premixtures, compound feed and water:

—

For the identification: Pulsed Field Gel Electrophoresis (PFGE) CEN/TS 17697 or DNA sequencing methods

—

For the enumeration: Spread plate method using tryptone soya agar EN 15784.

Calves for fattening

Lambs for rearing and for fattening

Minor ruminant species for rearing and for fattening

—

1,3 × 10 9

—

6,5 × 10 8

—

1.

In the directions for use of the additive and premixture, 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, a homogeneous 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. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.

19 December 2033

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en