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 active substance/kg of complete feedingstuff with a moisture content of 12 % Category of technological additives. Functional group: binders 1m558i Bentonite Additive composition Bentonite: ≥ 50 % smectite Characterisation of active substance Bentonite: ≥ 50 % smectite Analytical method ( 1 ) For the determination in feed additive: X-ray diffraction (XRD) All animal species — 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 use with coccidiostats other than robenidine is contraindicated with level of bentonite above 5 000 mg/kg of complete feed. 3. The total amount of bentonite must not exceed the permitted maximum level in complete feedingstuff of 20 000 mg/kg of complete feedingstuff. 4. For safety: breathing protection, glasses and gloves shall be used during handling. 19 November 2023 Category of technological additives. Functional group: anticaking agents 1m558i Bentonite Additive composition Bentonite: ≥ 50 % smectite Characterisation of active substance Bentonite: ≥ 50 % smectite Analytical method ( 1 ) For the determination in feed additive: X-ray diffraction (XRD) All animal species — 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 use with coccidiostats other than robenidine is contraindicated with level of bentonite above 5 000 mg/kg of complete feed. 3. The total amount of bentonite must not exceed the permitted maximum level in complete feedingstuff of 20 000 mg/kg of complete feedingstuff. 4. For safety: breathing protection, glasses and gloves shall be used during handling. 19 November 2023 Category of technological additives. Functional group: substances for control of radionuclide contamination ( 134/137 Cs) 1m558i Bentonite Additive composition Bentonite: ≥ 50 % smectite Characterisation of active substance Bentonite: ≥ 50 % smectite Analytical method ( 1 ) For the determination in feed additive: X-ray diffraction (XRD) All animal species — — 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 use with coccidiostats other than robenidine is contraindicated with level of bentonite above 5 000 mg/kg of complete feed. 3. The mixture of different sources of bentonite must not exceed the permitted maximum level in complete feedingstuff of 20 000 mg/kg of complete feedingstuff. 4. The additive may be used where feed is contaminated by radiocaesium to control it in animals and their products. 5. For safety: breathing protection, glasses and gloves shall be used during handling. 19 November 2023 ( 1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx