Commission Implementing Regulation (EU) 2022/1417 of 22 August 2022 concerning the authorisation of a preparation of Lactobacillus acidophilus CECT 4529 as a feed additive for all poultry species and categories, other than laying hens and chickens for fattening, and for ornamental birds and amending Implementing Regulation (EU) 2017/2275 (holder of authorisation: Centro Sperimentale del Latte S.r.l.) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/1417
• Articles: 5

Article 1

The preparation specified in the Annex I, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as a feed additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

The Annex to Implementing Regulation (EU) 2017/2275 is replaced by Annex II to this Regulation.

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.

Schedules & Appendices

ANNEX I

ANNEX I

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 S.r.l.

Lactobacillus acidophilus CECT 4529

Additive composition

Preparation of Lactobacillus acidophilus CECT 4529 containing a minimum of 5 × 10 10 CFU/g

Solid form

All poultry species and categories except laying hens and chickens for fattening

-

1 × 10 9

-

5 × 10 8

-

1.

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

2.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes, skin and breathing protection.

12.9.2032

Characterisation of the active substance

Viable cells of Lactobacillus acidophilus CECT 4529

Ornamental birds

Analytical method

( 1 )

Enumeration:

—

spread plate method using MRS agar (EN 15787)

Identification:

—

Pulsed Field Gel Electrophoresis (PFGE) or DNA sequencing methods

( 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

ANNEX II

ANNEX II

‘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

Solid form

Chickens for fattening

-

1 × 10 9

-

-

-

1.

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

2.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes, skin and breathing protection.

29.12.2027

Characterisation of the active substance

Viable cells of Lactobacillus acidophilus CECT 4529

Chickens for fattening

-

-

-

5 × 10 8

-

12.9.2032

Analytical method

( 1 )

Enumeration:

—

spread plate method using MRS agar (EN 15787)

Identification:

—

Pulsed Field Gel Electrophoresis (PFGE). or DNA sequencing methods

( 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’