Commission Implementing Regulation (EU) 2019/10 of 3 January 2019 concerning the authorisation of a preparation of a natural mixture of illite- montmorillonite-kaolinite as a feed additive for all animal species (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2019/10
• Articles: 3

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 .

Schedules & Appendices

ANNEX

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

Additive composition

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

—

40 % of illite

—

10 % of montmorillonite

—

8 % of kaolinite

Characterisation of the active substance

Illite:

CAS number 106958-53-6

K(Al,Fe) 2 AlSi 3 O 10 (OH) 2 · H 2 O

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

Analytical method

( 1 )

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 fattening

Pigs 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 instructions for use shall indicate the following:

—

‘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

Additive composition

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

—

40 % of illite

—

10 % of montmorillonite

—

8 % of kaolinite

Characterisation of the active substance

Illite:

CAS number 106958-53-6

K(Al,Fe) 2 AlSi 3 O 10 (OH) 2 · H 2 O

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

Analytical method

( 1 )

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 fattening

Pigs 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 instructions for use shall indicate the following:

—

‘The simultaneous oral use with macrolides shall be avoided’.

24 January 2029

All other animal species and categories

—

5 000

20 000

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports