Commission Implementing Regulation (EU) 2020/1032 of 15 July 2020 concerning the authorisation of the preparation of Bacillus subtilis DSM 28343 as a feed additive for calves for rearing and pigs for fattening (holder of authorisation Lactosan GmbH & Co. KG) (Text with EEA relevance)
Data as of 2026-07-04 Β· Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Β· Read the official text β
Authorisation
The preparation specified in the Annex, belonging to the additive category βzootechnical additivesβ and to the functional group βgut flora stabilisersβ, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
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.
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 Γ 10 10 CFU/g of additive Solid form βββββββββββββββ Characterisation of the active substance Viable spores of Bacillus subtilis DSM 28343 βββββββββββββββ Analytical method Β ( 1 ) For identification of Bacillus subtilis DSM 28343 in the feed additive, premixtures and feedingstuffs: Pulsed Field Gel Electrophoresis (PFGE) For enumeration of Bacillus subtilis DSM 28343 in the feed additive, premixtures and feedingstuffs: Spread plate method using tryptone soya agar β EN 15784 Calves for rearing Pigs for fattening - - 1 Γ 10 9 2 Γ 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 use in calves for rearing shall be restricted to milk replacers. 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. 5 August 2030 ( 1 ) Β Β 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
Source: EUR-Lex (Publications Office of the EU), Β© European Union, reuse permitted under Commission Decision 2011/833/EU.