LegalizeCommission Implementing Regulation (EU) No 1061/2013 of 29 October 2013 concerning the authorisation of a preparation of Enterococcus faecium NCIMB 10415 as a feed additive for calves, kids, cats and dogs and amending Regulation (EC) No 1288/2004 (holder of the authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o) Text with EEA relevance
Article 1
Authorisation
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional groups ‘gut flora stabilisers’ and ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Repeal of Regulation (EC) No 102/2009
Regulation (EC) No 102/2009 is repealed.
Article 3
Amendment to Regulation (EC) No 1288/2004
In Annex I to Regulation (EC) No 1288/2004 the entry on E 1705, Enterococcus faecium NCIMB 10415 is deleted.
Article 4
Transitional measures
The preparation specified in Annex as far as its use for calves is concerned, and feed containing that preparation, which are produced and labelled before 19 May 2014 in accordance with the rules applicable before 19 November 2013 may continue to be placed on the market and used until the existing stocks are exhausted.
The preparation specified in Annex as far as its use for cats and dogs is concerned, and feed containing that preparation, which are produced and labelled before 19 November 2015 in accordance with the rules applicable before 19 November 2013 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 5
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | CFU/kg of complete feedingstuff with a moisture content of 12 % | CFU/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation | ||||||
| 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 | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers | Category of zootechnical additives. Functional group: gut flora stabilisers |
| 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 | ————— | ————— | ————— | ————— | ————— | ————— | ————— | ————— | ————— | ————— |
| 4b1705 | DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o | Enterococcus faecium NCIMB 10415 | Additive composition Preparation of Enterococcus faecium NCIMB 10415 containing a minimum of: 5 × 109 CFU/g of additive; Microencapsulated forms (shellac). Characterisation of the active substance Viable cells of Enterococcus faecium NCIMB 10415 Analytical method [^E0001] Enumeration: spread plate method using bile esculin azide agar (EN 15788) Identification: Pulsed-Field Gel Electrophoresis (PFGE) | Cats | — | 7 × 109 | — | Other provisions | End of period of authorisation | In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting. | 19 November 2023 | ||||
| Category of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions) | Category of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions) | Category of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions) | Category of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions) | Category of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions) | Category of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions) | Category of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions) | Category of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions) | Category of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions) | Category of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions) | ||||||
| 4b1705 | DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o | Enterococcus faecium NCIMB 10415 | Additive composition Preparation of Enterococcus faecium NCIMB 10415 containing a minimum of 5 × 109 CFU/g of additive. Microencapsulated forms (shellac). Characterisation of the active substance Viable cells of Enterococcus faecium NCIMB 10415 Analytical method [^E0001] Enumeration: spread plate method using bile esculin azide agar (EN 15788) Identification: Pulsed-Field Gel Electrophoresis (PFGE) | Dogs | — | 2,5 × 109 | Other provisions | End of period of authorisation | In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting. | 19 November 2023 |
Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
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