ANNEXSupplementary provisions
ANNEX Identification number of the additive 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 feedingstuff with a moisture content of 12 % Technological additives: binders 1g599 Illite-montmorillonite-kaolinite Additive composition Preparation of a natural mixture of illite- montmorillonite-kaolinite, having a minimum content of: — 40 % of illite — 10 % of montmorillonite — 8 % of kaolinite Characterisation of the active substance Illite: CAS number 106958-53-6 K(Al,Fe) 2 AlSi 3 O 10 (OH) 2 · H 2 O Montmorillonite: CAS number 1318-93-0 Nax[(Al2-xMgx)Si4O10) (OH)2] Kaolinite: CAS number 1318-74-7 Al2(OH)4(SiO5) Iron (structural) 10 % average Free of asbestos Analytical method ( 1 ) Characterisation of the feed additive: — X-ray diffraction (XRD) together with — X-ray fluorescence (XRF). Chickens for fattening and minor poultry species for fattening. Cattle for fattening and minor ruminants for fattening Pigs for fattening and weaned piglets — 5 000 50 000 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 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, including breathing protection. 3. In the labelling of the additive and premixtures containing it, the following shall be indicated: ‘The additive illite-montmorillonite-kaolinite is rich in (inert) iron’. 4. The total amount of different uses of illite-montmorillonite-kaolinite in complete feedingstuff shall not exceed the permitted maximum level for the relevant species or category of animals. 5. The instructions for use shall indicate the following: — ‘The simultaneous oral use with macrolides shall be avoided’. 24 January 2029 All other animal species and categories — 5 000 20 000 Technological additives: anticaking agents 1g599 Illite-montmorillonite-kaolinite Additive composition Preparation of a natural mixture of illite- montmorillonite-kaolinite, having a minimum content of: — 40 % of illite — 10 % of montmorillonite — 8 % of kaolinite Characterisation of the active substance Illite: CAS number 106958-53-6 K(Al,Fe) 2 AlSi 3 O 10 (OH) 2 · H 2 O Montmorillonite: CAS number 1318-93-0 Nax[(Al2-xMgx)Si4O10) (OH)2] Kaolinite: CAS number 1318-74-7 Al2(OH)4(SiO5) Iron (structural) 10 % average Free of asbestos Analytical method ( 1 ) Characterisation of the feed additive: — X-ray diffraction (XRD) together with — X-ray fluorescence (XRF). Chickens for fattening and minor poultry species for fattening. Cattle for fattening and minor ruminants for fattening Pigs for fattening and weaned piglets — 5 000 50 000 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 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, including breathing protection. 3. In the labelling of the additive and premixtures containing it, the following shall be indicated: ‘The additive illite-montmorillonite-kaolinite is rich in (inert) iron’. 4. The total amount of different uses of illite-montmorillonite-kaolinite in complete feedingstuff shall not exceed the permitted maximum level for the relevant species or category of animals. 5. The instructions for use shall indicate the following: — ‘The simultaneous oral use with macrolides shall be avoided’. 24 January 2029 All other animal species and categories — 5 000 20 000 ( 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