Commission Implementing Regulation (EU) 2015/38 of 13 January 2015 concerning the authorisation of the preparation of Lactobacillus acidophilus CECT 4529 as a feed additive for laying hens and amending Regulation (EC) No 1520/2007 (holder of authorisation Centro Sperimentale del Latte) Text with EEA relevance

• CELEX: Implementing Regulation (EU) 2015/38
• 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, subject to the conditions laid down in that Annex.

Article 2 Amendments to Regulation (EC) No 1520/2007

Regulation (EC) No 1520/2007 is amended as follows:

(1)

Article 4 is deleted.

(2)

Annex IV is deleted.

Article 3 Transitional measures

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 3 September 2015 in accordance with the rules applicable before 3 March 2015 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 stabilisers.

4b1715

Centro Sperimentale del Latte

Lactobacillus acidophilus CECT 4529

Additive composition

Preparation of Lactobacillus acidophilus CECT 4529 containing a minimum of: 5 × 10 10 CFU/g of additive (solid form).

Characterisation of the active substance

Viable cells of Lactobacillus acidophilus CECT 4529.

Analytical method

( 1 )

Enumeration: spread plate method (EN 15787).

Identification: Pulsed Field Gel Electrophoresis (PFGE).

Laying hens

—

1 × 10 9

—

5 × 10 8

—

1.

In the directions for use of the additive, premixture and compound feed, indicate the storage conditions and stability to pelleting and in drinking water.

2.

For safety: breathing protection shall be used during handling.

3.

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

3 March 2025

( 1 )   Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports