# L_2016303EN.01000701.xml

| 10.11.2016 | EN | Official Journal of the European Union | L 303/7 |
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10.11.2016

EN

Official Journal of the European Union

L 303/7

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1964

of 9 November 2016

concerning the authorisations of a preparation of dolomite-magnesite for dairy cows and other ruminants for dairy production, weaned piglets and pigs for fattening and a preparation of montmorillonite-illite for all animal species as feed additives

(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 applications were submitted for the authorisations of a preparation of dolomite-magnesite and a preparation of montmorillonite-illite. Those applications were 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 applications were submitted for the authorisations of a preparation of dolomite-magnesite and a preparation of montmorillonite-illite. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | Those applications concern the authorisations of a preparation of dolomite-magnesite for dairy cows and other ruminants for dairy production, weaned piglets and pig for fattening and a preparation of montmorillonite-illite as feed additives for all animal species to be classified in the additive category ‘technological additives’. |
| --- | --- |

(3)

Those applications concern the authorisations of a preparation of dolomite-magnesite for dairy cows and other ruminants for dairy production, weaned piglets and pig for fattening and a preparation of montmorillonite-illite as feed additives for all animal species to be classified in the additive category ‘technological additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 1 December 2015 (2) that the preparation of dolomite-magnesite does not have an adverse effect on animal health, on the environment or on human health. The Authority has also concluded that it is efficacious as an anti-caking 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 opinion of 1 December 2015 (2) that the preparation of dolomite-magnesite does not have an adverse effect on animal health, on the environment or on human health. The Authority has also concluded that it is efficacious as an anti-caking 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) | Due to the physiological similarity of the dairy cows with all ruminants for dairy production, it is appropriate to extend the use of this additive to other ruminants for dairy production. |
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(5)

Due to the physiological similarity of the dairy cows with all ruminants for dairy production, it is appropriate to extend the use of this additive to other ruminants for dairy production.

| (6) | The Authority concluded in its opinions of 30 October 2014 and 10 September 2015 (3) that the preparation of montmorillonite-illite does not have an adverse effect on animal health, on the environment or on human health. The Authority has also concluded that it is efficacious as an anti-caking agent and as binder. 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. |
| --- | --- |

(6)

The Authority concluded in its opinions of 30 October 2014 and 10 September 2015 (3) that the preparation of montmorillonite-illite does not have an adverse effect on animal health, on the environment or on human health. The Authority has also concluded that it is efficacious as an anti-caking agent and as binder. 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.

| (7) | The assessment of the preparation of dolomite-magnesite and of the preparation of montmorillonite-illite shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annexes to this Regulation. |
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(7)

The assessment of the preparation of dolomite-magnesite and of the preparation of montmorillonite-illite shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annexes to this Regulation.

| (8) | 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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(8)

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 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

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

1

(2)  
  EFSA Journal 2016;14(1):4341

2

EFSA Journal

(3)  
  EFSA Journal 2014;12(11):3904 and EFSA Journal 2015;13(9):4237

3

EFSA Journal

EFSA Journal

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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 | Additive composition

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

  Characterisation of the active substance

  Dolomite: | CAS number 16389-88-1 |

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

Additive composition

Preparation of natural mixture of:

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

Characterisation of the active substance

Dolomite:

CAS number 16389-88-1

| | (CaMg)(CO3)2 |
| --- | --- |

(CaMg)(CO3)2

Magnesite:

| | CAS number 546-93-0 |
| --- | --- |

CAS number 546-93-0

| | MgCO3 |
| --- | --- |

MgCO3

Talc (hydrated silicates of magnesium):

| | CAS number 14807-96-6 |
| --- | --- |

CAS number 14807-96-6

| | Mg3Si4O10(OH)2 |
| --- | --- |

Mg3Si4O10(OH)2

| | Talc ≥ 35 % |
| --- | --- |

Talc ≥ 35 %

Chlorite (aluminium–magnesium):

| | CAS number 1318-59-8 |
| --- | --- |

CAS number 1318-59-8

| | (Mg,Fe,Al)6(Si, Al)4O10(OH)8 |
| --- | --- |

(Mg,Fe,Al)6(Si, Al)4O10(OH)8

| | Iron (structural) 6 % (average) |
| --- | --- |

Iron (structural) 6 % (average)

| | Chlorite ≥ 16 % |
| --- | --- |

Chlorite ≥ 16 %

| | Free of quartz and asbestos |
| --- | --- |

Free of quartz and asbestos

Analytical method
   (1)

Characterisation of the feed additive:

| — | X-ray diffraction (XRD), together with |
| --- | --- |

—

X-ray diffraction (XRD), together with

| — | atomic absorption spectrophotometry (AAS). |
| --- | --- |

—

atomic absorption spectrophotometry (AAS).

Dairy cows and other ruminants for dairy production

Weaned piglets

Pigs for fattening

—

5 000

20 000

| 1. | For use in weaned piglets until 35 kg. |
| --- | --- |

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’. |
| --- | --- |

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. |
| --- | --- |

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

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

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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 | Additive composition

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

  Characterisation of active substance

  Phyllosilicates ≥ 75 %: | ≥ 35 % montmorillonite-illite (swellable) |

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

Additive composition

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

Characterisation of active substance

Phyllosilicates ≥ 75 %:

≥ 35 % montmorillonite-illite (swellable)

| | ≥ 30 % illite/muscovite |
| --- | --- |

≥ 30 % illite/muscovite

| | ≤ 15 % kaolinite(non-swellable) |
| --- | --- |

≤ 15 % kaolinite(non-swellable)

Quartz ≤ 20 %

Iron (structural) 3,6 % (average)

Free of asbestos

Analytical method
   (1)

For the determination in feed additive:

| — | X-ray diffraction (XRD), |
| --- | --- |

—

X-ray diffraction (XRD),

| — | inductively coupled plasma atomic emission spectroscopy (ICP-AES) |
| --- | --- |

—

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’, |
| --- | --- | --- |

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’. |
| --- | --- |

—

‘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. |
| --- | --- |

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’. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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

Additive composition

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

Characterisation of active substance

Phyllosilicates ≥ 75 %:

| | ≥ 35 % montmorillonite/illite (swellable) |
| --- | --- |

≥ 35 % montmorillonite/illite (swellable)

| | ≥ 30 % illite/muscovite |
| --- | --- |

≥ 30 % illite/muscovite

| | ≤ 15 % kaolinite (non-swellable) |
| --- | --- |

≤ 15 % kaolinite (non-swellable)

Quartz ≤ 20 %

Iron (structural) 3,6 % (average)

Free of asbestos

Analytical method
   (1)

For the determination in feed additive:

| — | X-ray diffraction (XRD), |
| --- | --- |

—

X-ray diffraction (XRD),

| — | inductively coupled plasma atomic emission spectroscopy (ICP-AES). |
| --- | --- |

—

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’, |
| --- | --- | --- |

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’. |
| --- | --- |

—

in poultry: ‘The simultaneous use with robenidine shall be avoided’.

| 2. | For poultry: the simultaneous oral use with coccidiostats other than robenidine is contraindicated. |
| --- | --- |

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’. |
| --- | --- |

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. |
| --- | --- |

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. |
| --- | --- |

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

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

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