Article 1
The Annex to Implementing Regulation (EU) 2021/422 is replaced by the Annex to this Regulation.
Commission Implementing Regulation (EU) 2021/1414 of 27 August 2021 correcting Implementing Regulation (EU) 2021/422 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for laying hens (holder of authorisation: Lactosan GmbH & Co KG) (Text with EEA relevance)
Commission Implementing Regulation (EU) 2021/1414 of 27 August 2021 correcting Implementing Regulation (EU) 2021/422 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for laying hens (holder of authorisation: Lactosan GmbH & Co KG) (Text with EEA relevance)
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 2
1. The preparation specified in the Annex and premixtures containing that substance, which are produced and labelled before 1 December 2021 in accordance with the rules applicable before 31 August 2021 may continue to be placed on the market until the existing stocks are exhausted. 2. Feed materials and compound feed containing the preparation and premixtures referred to in paragraph 1 which are produced and labelled before 31 August 2022 in accordance with the rules applicable before 31 August 2021 may continue to be placed on the market until the existing stocks are exhausted.
Article 3
This Regulation shall enter into force on the 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 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 4b1841 Lactosan GmbH & Co KG Enterococcus faecium DSM 7134 Additive composition Preparation of Enterococcus faecium DSM 7134 containing a minimum of: Powder: 1x10 10 CFU/g of additive Granules (microencapsulated): 1x10 10 CFU/g of additive Laying hens - 1 x 10 9 - 5 x 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. The additive may be used via water for drinking. 3. For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured. 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 appropriate personal protective equipment, including breathing and skin protection.’ 30.3.2031 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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