
Article 1 
The preparation specified in the Annex I, belonging to the additive category ‘technological additives’ and to the functional group ‘anti-caking agents’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2 
The preparation specified in the Annex II, belonging to the additive category ‘technological additives’ and to the functional groups ‘anti-caking agents’ and ‘binders’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 9 November 2016.
For the Commission
The President
Jean-Claude JUNCKER
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 additive/kg of complete feedingstuff with a moisture content of 12 %
Technological additives: anti-caking agents
1g598 Dolomite-Magnesite 
Preparation of natural mixture of:

dolomite and magnesite ≥ 40 % (having a minimum content of: carbonates 24 %).

Dolomite:


 CAS number 16389-88-1
 (CaMg)(CO3)2

Magnesite:


 CAS number 546-93-0
 MgCO3

Talc (hydrated silicates of magnesium):


 CAS number 14807-96-6
 Mg3Si4O10(OH)2
 Talc ≥ 35 %

Chlorite (aluminium–magnesium):


 CAS number 1318-59-8
 (Mg,Fe,Al)6(Si, Al)4O10(OH)8
 Iron (structural) 6 % (average)
 Chlorite ≥ 16 %
 Free of quartz and asbestos

Characterisation of the feed additive:


— X-ray diffraction (XRD), together with
— atomic absorption spectrophotometry (AAS).
 Dairy cows and other ruminants for dairy productionWeaned pigletsPigs for fattening — 5 000 20 000 
1.. For use in weaned piglets until 35 kg.
2.. In the labelling of the additive and premixtures containing it, the following shall be indicated: ‘The additive dolomite-magnesite is rich in (inert) iron’.
3.. 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. 30 November 2026

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 
Preparation of montmorillonite-illite mixed layer clay mineral: phyllosilicates ≥ 75 %.

Phyllosilicates ≥ 75 %:


 ≥ 35 % montmorillonite-illite (swellable)
 ≥ 30 % illite/muscovite
 ≤ 15 % kaolinite(non-swellable)

Quartz ≤ 20 %

Iron (structural) 3,6 % (average)

Free of asbestos

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 
Preparation of montmorillonite-illite mixed layer clay mineral: phyllosilicates ≥ 75 %

Phyllosilicates ≥ 75 %:


 ≥ 35 % montmorillonite/illite (swellable)
 ≥ 30 % illite/muscovite
 ≤ 15 % kaolinite (non-swellable)

Quartz ≤ 20 %

Iron (structural) 3,6 % (average)

Free of asbestos

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
