
Article 1 
The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘binders’ and ‘anticaking agents’, is authorised as an additive in animal nutrition, subject to the conditions laid down in the Annex.
Article 2 
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, 3 January 2019.
For the Commission
The President
Jean-Claude JUNCKER
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 
Preparation of a natural mixture of illite- montmorillonite-kaolinite, having a minimum content of:


— 40 % of illite
— 10 % of montmorillonite
— 8 % of kaolinite

Illite:


 CAS number 106958-53-6
 K(Al,Fe)2AlSi3O10(OH)2 · H2O

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

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 fatteningPigs 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 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 
Preparation of a natural mixture of illite- montmorillonite-kaolinite, having a minimum content of:


— 40 % of illite
— 10 % of montmorillonite
— 8 % of kaolinite

Illite:


 CAS number 106958-53-6
 K(Al,Fe)2AlSi3O10(OH)2 · H2O

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

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 fatteningPigs 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 simultaneous oral use with macrolides shall be avoided’.
 24 January 2029
All other animal species and categories — 5 000 20 000
