Commission Implementing Regulation (EU) 2023/263 of 7 February 2023 concerning the authorisation of sepiolitic clay as a feed additive for dairy ruminants, weaned and fattening Suidae, salmonids and chickens for fattening (Text with EEA relevance)

Current text a fecha 2026-02-15

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

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

Identification number of the feed additive	Name of the 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 feed with a moisture content of 12 %
Category: technological additives. Functional group: binders
1g563	Sepiolitic clay	Additive composition Hydrated magnesium silicate of sedimentary origin, containing ≥ 40 % sepiolite and ≥ 25 % illite. Powder form. Characterisation of the active substance Sepiolite (hydrous magnesium silicate): ≥ 40 % CAS number: 63800-37-3 Einecs number: 264-465-3 Chemical formula: Mg4Si6O15(OH)2·6H2O. Illite (potassium and iron aluminium silicate): ≥ 25 % CAS number: 12173-60-3 Einecs number: 601-803-4 Chemical formula: (K,H3O)(Al,Mg,Fe)2(Si,Al)4O10[(OH)2·(H2O)] Carbonates (dolomite, calcium and magnesium carbonate): ≤ 35 % Free of asbestos (¹) Impurities: Nickel ≤ 20,3 mg/kg Analytical method (²) For the characterisation of the feed additive: — X-ray diffraction (XRD) and — X-ray fluorescence (XRF) or atomic absorption spectrometry (AAS).	— Ruminants for milk production or reproduction — Weaned piglets of porcine species — Porcine species for fattening — Salmonids — Chickens for fattening		-	20 000	1. In the directions for use of the additive and premixtures, the storage conditions 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 protective equipment, including skin and breathing protection. Particular attention shall be given to compliance with Union legislation on the protection of workers from the inhalation risks related to exposure to crystalline silica and nickel.	28 February 2033
(¹) The methods employed were: X-Ray diffraction and Scanning electron microscopy (SEM) with punctual Energy Dispersive X-Ray Analysis (EDAX). (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.
Identification number of the feed additive	Name of the 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 feed with a moisture content of 12 %
Category: technological additives. Functional group: anticaking agents
1g563	Sepiolitic clay	Additive composition Hydrated magnesium silicate of sedimentary origin, containing ≥ 40 % sepiolite and ≥ 25 % illite. Powder form. Characterisation of the active substance Sepiolite (hydrous magnesium silicate): ≥ 40 % CAS number: 63800-37-3 Einecs number: 264-465-3 Chemical formula: Mg4Si6O15(OH)2·6H2O. Illite (potassium and iron aluminium silicate): ≥ 25 % CAS number: 12173-60-3 Einecs number: 601-803-4 Chemical formula: (K,H3O)(Al,Mg,Fe)2(Si,Al)4O10[(OH)2·(H2O)] Carbonates (dolomite, calcium and magnesium carbonate): ≤ 35 % Free of asbestos (¹) Impurities: Nickel ≤ 20,3 mg/kg Analytical method (²) For the characterisation of the feed additive: — X-ray diffraction (XRD) and — X-ray fluorescence (XRF) or atomic absorption spectrometry (AAS).	— Ruminants for milk production or reproduction — Weaned piglets of porcine species — Porcine species for fattening — Salmonids — Chickens for fattening		-	20 000	1. In the directions for use of the additive and premixtures, the storage conditions 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 protective equipment, including skin and breathing protection. Particular attention shall be given to compliance with Union legislation on the protection of workers from the inhalation risks related to exposure to crystalline silica and nickel.	28 February 2033
(¹) The methods employed were: X-Ray diffraction and Scanning electron microscopy (SEM) with punctual Energy Dispersive X-Ray Analysis (EDAX). (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.