Commission Implementing Regulation (EU) 2018/1079 of 30 July 2018 concerning the authorisation of a preparation of Bacillus subtilis DSM 28343 as a feed additive for weaned piglets (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 ↗
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
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 4b1825 Lactosan GmbH & Co. KG Bacillus subtilis DSM 28343 Additive composition Preparation of Bacillus subtilis DSM 28343 containing a minimum of 1 × 10 10 CFU/g of additive Solid form Characterisation of the active substance Viable spores of Bacillus subtilis DSM 28343 Analytical method ( 1 ) For identification of Bacillus subtilis DSM 28343 in the feed additive, premixtures and feedingstuffs: — Identification: Pulsed Field Gel Electrophoresis (PFGE) For enumeration of Bacillus subtilis DSM 28343 in the feed additive, premixtures and feedingstuffs: — Enumeration: Spread plate method using tryptone soya agar — EN 15784 Piglets (weaned) — 1 × 10 9 — 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. For use in weaned piglets up to 35 kg of body weight. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks 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. 20.8.2028 ( 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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