Commission Implementing Regulation (EU) No 1060/2013 of 29 October 2013 concerning the authorisation of bentonite as a feed additive for all animal species Text with EEA relevance
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Bentonite specified in the Annexes, belonging to the additive category ‘technological additives’ and to the functional groups ‘substances for reduction of the contamination of feed by mycotoxins’, ‘binders’, ‘anticaking agents’ and ‘substances for control of radionuclide contamination’ is authorised as an additive in animal nutrition, subject to the conditions laid down in those Annexes.
The additive specified in Annex II belonging to the functional groups ‘binders’ and ‘anticaking agents’ and feed containing that additive, which are produced and labelled before 19 November 2015 in accordance with the rules applicable before 19 November 2013 may continue to be placed on the market and used until the existing stocks are exhausted.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEX I 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: substances for reduction of the contamination of feed by mycotoxins: aflatoxin B1 1m558 Bentonite Additive composition Bentonite: ≥ 70 % smectite (dioctahedral montmorillonite) Characterisation of active substance Bentonite: ≥ 70 % smectite (dioctahedral montmorillonite) < 10 % opal and feldspar < 4 % quartz and calcite AfB 1 -binding capacity (BC AfB1 ) above 90 % Analytical method ( 1 ) For the determination of bentonite in feed additive: X-ray diffraction (XRD) For the determination of BC AfB1 of the additive: adsorption test carried out in a buffer solution at pH 5,0 with a concentration of 4 mg/l for AfB 1 and 0,02 % (w/v) for the feed additive. Ruminants Poultry Pigs — 20 000 1. Indicate in the instructions for use: — ‘The simultaneous oral use with macrolides shall be avoided’; — for 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. The use of the additive is allowed in feedingstuffs complying with the European Union legislation on undesirable substances in animal feed. 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
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
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