# L_2019002EN.01001301.xml

| 4.1.2019 | EN | Official Journal of the European Union | L 2/13 |
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4.1.2019

EN

Official Journal of the European Union

L 2/13

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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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of a natural mixture of illite-montmorillonite-kaolinite. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of a natural mixture of illite-montmorillonite-kaolinite. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | That application concerns the authorisation of a preparation of a natural mixture of illite-montmorillonite-kaolinite as a feed additive for all animal species, to be classified in the additive category ‘technological additives’. |
| --- | --- |

(3)

That application concerns the authorisation of a preparation of a natural mixture of illite-montmorillonite-kaolinite as a feed additive for all animal species, to be classified in the additive category ‘technological additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 1 December 2015 (2), 5 July 2017 (3) and 5 July 2018 (4) that, under the proposed conditions of use, the preparation of a natural mixture of illite-montmorillonite-kaolinite does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that it is effective as a binder and anticaking agent. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 1 December 2015 (2), 5 July 2017 (3) and 5 July 2018 (4) that, under the proposed conditions of use, the preparation of a natural mixture of illite-montmorillonite-kaolinite does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that it is effective as a binder and anticaking agent. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of the preparation of a natural mixture of illite-montmorillonite-kaolinite shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. |
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(5)

The assessment of the preparation of a natural mixture of illite-montmorillonite-kaolinite shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

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

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(1)  
  OJ L 268, 18.10.2003, p. 29.

1

(2)  EFSA Journal 2016; 14(1):4342.

2

(3)  EFSA Journal 2017; 15(7):4940.

3

(4)  EFSA Journal 2018; 16(7):5387.

4

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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 |

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 |
| --- | --- |

—

10 % of montmorillonite

| — | 8 % of kaolinite |
| --- | --- |

—

8 % of kaolinite

Characterisation of the active substance

Illite:

| | CAS number 106958-53-6 |
| --- | --- |

CAS number 106958-53-6

| | K(Al,Fe)2AlSi3O10(OH)2 · H2O |
| --- | --- |

K(Al,Fe)2AlSi3O10(OH)2 · H2O

Montmorillonite:

| | CAS number 1318-93-0 |
| --- | --- |

CAS number 1318-93-0

| | Nax[(Al2-xMgx)Si4O10) (OH)2] |
| --- | --- |

Nax[(Al2-xMgx)Si4O10) (OH)2]

Kaolinite:

| | CAS number 1318-74-7 |
| --- | --- |

CAS number 1318-74-7

| | Al2(OH)4(SiO5) |
| --- | --- |

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 diffraction (XRD) together with

| — | X-ray fluorescence (XRF). |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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’. |
| --- | --- |

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. |
| --- | --- |

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’. |
| --- | --- | --- |

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 |
| --- | --- |

—

40 % of illite

| — | 10 % of montmorillonite |
| --- | --- |

—

10 % of montmorillonite

| — | 8 % of kaolinite |
| --- | --- |

—

8 % of kaolinite

Characterisation of the active substance

Illite:

| | CAS number 106958-53-6 |
| --- | --- |

CAS number 106958-53-6

| | K(Al,Fe)2AlSi3O10(OH)2 · H2O |
| --- | --- |

K(Al,Fe)2AlSi3O10(OH)2 · H2O

Montmorillonite:

| | CAS number 1318-93-0 |
| --- | --- |

CAS number 1318-93-0

| | Nax[(Al2-xMgx)Si4O10) (OH)2] |
| --- | --- |

Nax[(Al2-xMgx)Si4O10) (OH)2]

Kaolinite:

| | CAS number 1318-74-7 |
| --- | --- |

CAS number 1318-74-7

| | Al2(OH)4(SiO5) |
| --- | --- |

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 diffraction (XRD) together with

| — | X-ray fluorescence (XRF). |
| --- | --- |

—

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. |
| --- | --- |

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. |
| --- | --- |

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’. |
| --- | --- |

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. |
| --- | --- |

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’. |
| --- | --- | --- |

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

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(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

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