Commission Implementing Regulation (EU) 2023/256 of 6 February 2023 concerning the authorisation of a preparation of Limosilactobacillus reuteri DSM 32203 as a feed additive for dogs and a preparation of Limosilactobacillus reuteri DSM 32264 as a feed additive for cats (holder of authorisation: NBF Lanes s.r.l.) (Text with EEA relevance)

Article 1

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

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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
Other provisions
End of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %
Category: zootechnical additives. Functional group: gut flora stabilisers.
4b1850
NBF Lanes s.r.l.
Limosilactobacillus reuteri
DSM 32203
Additive composition
Preparation of Limosilactobacillus reuteri
DSM 32203 containing a minimum of 1 × 10 11 CFU/g
Solid form
Dogs
-
1 × 10 10
-
1.
Post-market monitoring is required on the effects of the additive on constipation for a long-term use.
2.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3.
On the label of the additive and premixtures, the following shall be indicated: “The decision to supplement dogs with Limosilactobacillus reuteri DSM 32203 for a period longer than five weeks should take into account the characteristics of the supplemented feed and diet, the breed of dog and the availability of water, in order to avoid constipation.”
4.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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.
27 February 2033
Characterisation of the active substance:
Viable cells of Limosilactobacillus reuteri
DSM 32203
Analytical method
( 1 )
Identification: DNA sequencing methods or pulsed Field Gel Electrophoresis (PFGE)
Enumeration in feed additive and compound feed: spread plate method on MRS agar (EN 15787)
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
Other provisions
End of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %
Category: zootechnical additives. Functional group: gut flora stabilisers.
4b1851
NBF Lanes s.r.l.
Limosilactobacillus reuteri DSM 32264
Additive composition
Preparation of Limosilactobacillus reuteri DSM 32264 containing a minimum of 1 × 10 11 CFU/g
Solid form
Cats
-
1 × 10 10
-
1.
Post-market monitoring is required on the effects of the additive on constipation for a long-term use.
2.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
3.
On the label of the additive and premixtures, the following shall be indicated: “The decision to supplement cats with Limosilactobacillus reuteri DSM 32264 for a period longer than five weeks should take into account the characteristics of the supplemented feed and diet, the breed of cat and the availability of water, in order to avoid constipation.”
4.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their 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.
27 February 2033
Characterisation of the active substance:
Viable cells of Limosilactobacillus reuteri DSM 32264
Analytical method
( 2 )
Identification: DNA sequencing methods or pulsed Field Gel Electrophoresis (PFGE)
Enumeration in feed additive and compound feed: spread plate method on MRS agar (EN 15787)
( 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
( 2 )   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

Schedules & Appendices

Cite this act