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Commission Implementing Regulation (EU) 2019/11Show full title
Commission Implementing Regulation (EU) 2019/11 of 3 January 2019 concerning the authorisation of the preparation of Enterococcus faecium NCIMB 10415 as a feed additive for sows, suckling piglets, weaned piglets, pigs for fattening, and amending Regulations (EC) No 252/2006, (EC) No 943/2005 and (EC) No 1200/2005 (holder of authorisation DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o.) (Text with EEA relevance)
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ANNEX
| a 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 | |||||||||
| 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 of zootechnical additives. Functional group: gut flora stabilisers. | |||||||||
| 4b1705 | DSM Nutritional products Ltd, represented by DSM Nutritional Products Sp. z o.o. | Enterococcus faecium NCIMB 10415 | Additive compositionPreparation of Enterococcus faecium NCIMB 10415 containing a minimum of:
Characterisation of the active substanceViable cells of Enterococcus faecium NCIMB 10415 Analytical method aEnumeration: spread plate method using bile esculin azide agar (EN 15788) Identification: Pulsed- Field Gel Electrophoresis (PFGE) | Sows | — | 7 × 108 | — | 1.In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.2.The additive shall be administered to pregnant and lactating sows and simultaneously to the suckling piglets3.For use in weaned piglets until approximately 35 kg.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. | 24 January 2029 |
| Suckling piglets | 1 × 109 | — | |||||||
| Weaned piglets Pigs for fattening | 3,5 × 108 | — | |||||||
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