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
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.
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.
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.
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 .
Supplementary provisions
ANNEXSupplementary provisions
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
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.