Commission Implementing Regulation (EU) 2025/757 of 16 April 2025 concerning the authorisation of sepiolite as a feed additive for all animal species

• CELEX: Implementing Regulation (EU) 2025/757
• Articles: 4

Article 1 Authorisation

The substance specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional groups ‘binders’ and ‘anticaking agents’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Transitional measures

1.   The feed additive sepiolite, as authorised pursuant to Directive 70/524/EEC, and premixtures containing this additive, which are produced and labelled before 12 November 2025 in accordance with the rules applicable before 12 May 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.

2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 12 May 2026 in accordance with the rules applicable before 12 May 2025 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 12 May 2027 in accordance with the rules applicable before 12 May 2025 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals.

Article 3 Entry into force

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 feed 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: technological additives. Functional group: binders

1g562

Sepiolite

Additive composition

Hydrated magnesium silicate of sedimentary origin, containing ≥ 60 % sepiolite, ≤ 30 % montmorillonite, free of asbestos  ( 1 )

Solid form

———————————————

Characterisation of the active substance

Sepiolite (hydrous magnesium silicate): ≥ 60 %

CAS number: 63800-37-3

Chemical formula: Mg 4 Si 6 O 15 (OH) 2 ·6H 2 O

Montmorillonite: ≤ 30 %

———————————————

Analytical method

( 2 )

For the characterisation of the feed additive:

– X-ray diffraction (XRD) and

– X-ray fluorescence (XRF) or atomic absorption spectrometry (AAS)

All animal species

-

-

20 000

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 by such procedures and measures, the additive and premixtures shall be used with personal skin and breathing protective equipment.

12 May 2035

Identification number of the feed 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: technological additives. Functional group: anticaking agents

1g562

Sepiolite

Additive composition

Hydrated magnesium silicate of sedimentary origin, containing ≥ 60 % sepiolite, ≤ 30 % montmorillonite, free of asbestos  ( 3 )

Solid form

———————————————

Characterisation of the active substance

Sepiolite (hydrous magnesium silicate): ≥ 60 %

CAS number: 63800-37-3

Chemical formula: Mg 4 Si 6 O 15 (OH) 2 ·6H 2 O

Montmorillonite: ≤ 30 %

———————————————

Analytical method

( 4 )

For the characterisation of the feed additive:

—

X-ray diffraction (XRD) and

—

X-ray fluorescence (XRF) or atomic absorption spectrometry (AAS)

All animal species

-

-

20 000

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 by such procedures and measures, the additive and premixtures shall be used with personal skin and breathing protective equipment.

12 May 2035

( 1 )   Method employed: Transmission Electron Microscopy (TEM).

( 2 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .

( 3 )   Method employed: Transmission Electron Microscopy (TEM).

( 4 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en .