Commission Implementing Regulation (EU) 2020/2120 of 16 December 2020 amending Implementing Regulation (EU) 2016/1964 as regards the authorisation of a preparation of montmorillonite-illite as feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/2120
• Articles: 3

Article 1

The Annex to Implementing Regulation (EU) 2016/1964 is amended in accordance with the Annex to this Regulation.

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

In the Annex to Implementing Regulation (EU) 2016/1964, the entry concerning the additive montmorillonite-illite with the identification number 1g557 is replaced by the following:

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 %

Category of technological additives. Functional group: 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

≤ 15 % kaolinite (non-swellable)

Quartz ≤ 20 %

Iron (structural) 3,6 % (average)

Free of asbestos

All animal 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.

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’

Analytical method

( 1 )

For the determination in feed additive:

—

X-ray diffraction (XRD)

—

Inductively coupled plasma atomic emission spectroscopy (ICP-AES)

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 %

Category of technological additives. Functional group: 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)

≥ 30 % illite/muscovite

≤ 15 % kaolinite (non-swellable)

Quartz ≤ 20 %

Iron (structural) 3,6 % (average)

Free of asbestos

All animal species

-

-

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.

The additive shall be used at a minimum level of:

—

10 000 mg/kg when it is used as anti-caking agent directly in complementary feedingstuffs,

—

20 000 mg/kg when it is used as anti-caking agent in complete feedingstuffs.

3.

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

4.

In the labelling of feed additive and premixtures containing it, the following shall be indicated: “The additive, montmorillonite-illite, is rich in (inert) iron”.

5.

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

6.

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’

Analytical method

( 2 )

For the determination in feed additive:

—

X-ray diffraction (XRD)

—

Inductively coupled plasma atomic emission spectroscopy (ICP-AES)

( 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

( 2 )   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