ANNEX IISupplementary provisions
ANNEX II Identification number of the additive Additive Chemical formula, description, methods of analysis 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 1g557 Montmorillonite-Illite Additive composition Preparation of montmorillonite-illite mixed layer clay mineral: phyllosilicates ≥ 75 %. Characterisation of active substance Phyllosilicates ≥ 75 %: ≥ 35 % montmorillonite-illite (swellable) ≥ 30 % illite/muscovite ≤ 15 % kaolinite(non-swellable) Quartz ≤ 20 % Iron (structural) 3,6 % (average) Free of asbestos Analytical method ( 1 ) For the determination in feed additive: — X-ray diffraction (XRD), — inductively coupled plasma atomic emission spectroscopy (ICP-AES) All animals species — 10 000 20 000 1. The instructions for use shall indicate the following: — ‘The simultaneous oral use with macrolides shall be avoided’, — ‘In addition, for poultry, the simultaneous use with robenidine shall be avoided’. 2. For poultry: the simultaneous oral use with coccidiostats other than robenidine is contraindicated with level of montmorillonite-illite above 10 000 mg/kg of complete feed. 3. In the labelling of feed additive and premixtures containing it, the following shall be indicated: ‘The additive, montmorillonite-illite, is rich in (inert) iron’. 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. 5. The total amount of different sources of montmorillonite-illite in complete feedingstuff shall not exceeded the permitted maximum level of 20 000 mg/kg of complete feedingstuff. 30 November 2026 Technological additives: anti-caking agent 1g557 Montmorillonite-Illite Additive composition Preparation of montmorillonite-illite mixed layer clay mineral: phyllosilicates ≥ 75 % Characterisation of active substance Phyllosilicates ≥ 75 %: ≥ 35 % montmorillonite/illite (swellable) ≥ 30 % illite/muscovite ≤ 15 % kaolinite (non-swellable) Quartz ≤ 20 % Iron (structural) 3,6 % (average) Free of asbestos Analytical method ( 1 ) For the determination in feed additive: — X-ray diffraction (XRD), — inductively coupled plasma atomic emission spectroscopy (ICP-AES). All animals species — 20 000 20 000 1. Indicate in the instructions for use: — ‘The simultaneous oral use with macrolides shall be avoided’, — in poultry: ‘The simultaneous use with robenidine shall be avoided’. 2. For poultry: the simultaneous oral use with coccidiostats other than robenidine is contraindicated. 3. In the labelling of feed additive and premixtures containing it, the following shall be indicated: ‘The additive, montmorillonite-illite, is rich in (inert) iron’. 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. 5. The total amount of different sources of montmorillonite-illite in complete feedingstuff shall not exceeded the permitted maximum level of 20 000 mg/kg of complete feedingstuff. 30 November 2026 ( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports