ANNEXSupplementary provisions
ANNEX Identification number of the additive Name of the 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 mg of additive/kg of complete feed with a moisture content of 12 % Category: technological additives. Functional group: anticaking agents 1i567 Clinoptilolite of volcanic origin Additive composition Clinoptilolite of volcanic origin containing: clinoptilolite ≥ 85,0 % Solid form. Characterisation of the active substance Clinoptilolite of volcanic origin (calcium hydrated aluminosilicate): Clinoptilolite ≥ 85,0 %, Feldspar, micas and clays ≤ 15,0 % CAS number 1318-02-1 EC number 215-283-8 Chemical formula: (Na,K,Ca) 2 –3Al 3 (Al,Si) 2 Si 13 O 36 •12H 2 O Impurities: Nickel ≤ 0,1 mg/kg Respirable crystalline silica ≤ 0,1 % Free of asbestos ( 1 ) Analytical method ( 2 ) For the characterisation of the feed additive: — X-ray diffraction (XRD) spectrometry (EN 13925) and — X-ray fluorescence (XRF) spectrometry (EN ISO 12677) Poultry for fattening Poultry reared for laying or reproduction Ornamental birds Piglets Pigs for fattening - - 20 000 1. In the directions for use of the additive and premixtures, the storage conditions shall be indicated. 2. The total quantity of clinoptilolite from all sources shall not exceed the maximum content of 20 000 mg/kg complete feed. 3. 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 by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin and breathing protection. Particular attention shall be given to compliance with Union legislation on the protection of workers from the inhalation risks related to exposure to crystalline silica and nickel. 11.10.2036 ( 1 ) Transmission Electron Microscopy (TEM). ( 2 ) 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 .