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)
In forceLast amended 2026-02-15
Data as of 2026-11-02 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
Transitional measures
1. The substance specified in the Annex and premixtures containing that substance, which are intended for dairy ruminants, weaned and fattening Suidae , salmonids and chickens for fattening and are produced and labelled before 28 August 2023 in accordance with the rules applicable before 28 February 2023 may continue to be placed on the market and used until the existing stocks are exhausted. 2. Compound feed and feed materials containing the substance specified in the Annex, which are intended for dairy ruminants, weaned and fattening Suidae , salmonids and chickens for fattening and are produced and labelled before 28 February 2024 in accordance with the rules applicable before 28 February 2023 may continue to be placed on the market and used until the existing stocks are exhausted.
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.
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: Mg 4 Si 6 O 15 (OH) 2 ·6H 2 O. Illite (potassium and iron aluminium silicate): ≥ 25 % CAS number: 12173-60-3 Einecs number: 601-803-4 Chemical formula: (K,H 3 O)(Al,Mg,Fe) 2 (Si,Al) 4 O 10 [(OH) 2 ·(H 2 O)] 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: Mg 4 Si 6 O 15 (OH) 2 ·6H 2 O. Illite (potassium and iron aluminium silicate): ≥ 25 % CAS number: 12173-60-3 Einecs number: 601-803-4 Chemical formula: (K,H 3 O)(Al,Mg,Fe) 2 (Si,Al) 4 O 10 [(OH) 2 ·(H 2 O)] 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.
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