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Commission Implementing Regulation (EU) 2021/1424 of 31 August 2021 concerning the renewal of the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for chickens for fattening, and repealing Regulation (EU) No 998/2010 (holder of authorisation Lactosan GmbH & Co KG) (Text with EEA relevance)

Commission Implementing Regulation (EU) 2021/1424 of 31 August 2021 concerning the renewal of the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for chickens for fattening, and repealing Regulation (EU) No 998/2010 (holder of authorisation Lactosan GmbH & Co KG) (Text with EEA relevance)

Implementing Regulation (EU) 2021/1424 · Regulation · 4 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.

Article 2

Regulation (EU) No 998/2010 is repealed.

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.

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 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 4b1841 Lactosan GmbH & Co KG Enterococcus faecium DSM 7134 Additive composition Preparation of Enterococcus faecium DSM 7134 containing a minimum of: Powder: 1 × 10 10 CFU/g of additive Granules (microencapsulated): 1x10 10 CFU/g of additive Chickens for fattening - 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. May be used in feed containing the following permitted coccidiostats: robenidine hydrochloride, maduramicin ammonium, diclazuril, decoquinate, halofuginone hydrobromide, monensin sodium and lasalocid A sodium. 3. 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 breathing and skin protection. 21 September 2031 Characterisation of the active substance Viable cells of Enterococcus faecium DSM 7134 Analytical method  ( 1 ) For enumeration: Spread plate method using bile esculin azid agar (EN 15788). For identification: Pulsed Field Gel Electrophoresis (PFGE). ( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

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

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