ANNEX IISupplementary provisions
ANNEX II Identification number of the feed additive Name of the holder of authorisation Name of the 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 feed with a moisture content of 12 % CFU/l of water for drinking Category: zootechnical additives. Functional group: gut flora stabilisers. 4b1894 Chr. Hansen A/S Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 Additive composition Preparation of Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 containing a minimum of 3,2 × 10 9 CFU/g additive (1,6 × 10 9 CFU B. subtilis DSM 32324/g; 1,0 × 10 9 CFU B. subtilis DSM 32325/g and 0,6 × 10 9 CFU B. amyloliquefaciens DSM 25840/g) (ratio 1.6:1.0:0.6) Solid forms Characterisation of the active substance Viable spores of cells of Bacillus subtilis DSM 32324 , Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840. Analytical method ( 1 ) Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) (CEN/TS 17697) Enumeration in the feed additive, premixtures, compound feed and water for drinking: Spread plate method on tryptone soya agar (EN 15784). All poultry species for fattening or reared for laying or reared for breeding - 1,6 × 10 9 - 5,4 × 10 8 - 1. The additive may be used via water for drinking. 2. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated. 3. The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: diclazuril, decoquinate, halofuginone, monensin, salinomycin, narasin, a combination of nicarbazin and narasin, or lasalocid. 4. 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 protection, glasses and gloves. 16.12.2030 ( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en