ANNEX IISupplementary provisions
ANNEX II ‘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 4b1715 Centro Sperimentale del Latte Lactobacillus acidophilus CECT 4529 Additive composition Preparation of Lactobacillus acidophilus CECT 4529 containing a minimum of 5 × 10 10 CFU/g Solid form Chickens for fattening - 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 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 eyes, skin and breathing protection. 29.12.2027 Characterisation of the active substance Viable cells of Lactobacillus acidophilus CECT 4529 Chickens for fattening - - - 5 × 10 8 - 12.9.2032 Analytical method ( 1 ) Enumeration: — spread plate method using MRS agar (EN 15787) Identification: — Pulsed Field Gel Electrophoresis (PFGE). or DNA sequencing methods ( 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’