Sepiolitic clay authorised up to 20 000 mg/kg for all species: XRD with XRF or AAS for characterisation, absence of asbestos confirmed by XRD and SEM-EDX, nickel ≤ 20.3 mg/kg, and the content in trial feeds was checked via SiO₂, MgO and Al₂O₃
Commission Implementing Regulation (EU) 2026/154, published on 26 January 2026, authorises until 15 February 2036 sepiolitic clay (a hydrated magnesium silicate of sedimentary origin, ≥ 40 % sepiolite and ≥ 25 % illite) as a binder and anticaking agent for all animal species for which it was not yet authorised, and in the 2023 authorisation raises the maximum content for salmonids from 17 600 and for chickens for fattening from 10 000 to 20 000 mg/kg feed. It rests on two new tolerance studies assessed by EFSA on 20 March 2025.
- Specification: sepiolite (Mg4Si6O15(OH)2·6H2O) ≥ 40 %, illite ≥ 25 %, carbonates (dolomite, calcium magnesium carbonate) ≤ 35 %, nickel ≤ 20.3 mg/kg, free of asbestos — as confirmed by X-ray diffraction and scanning electron microscopy with point energy-dispersive X-ray analysis (SEM-EDX). Characterisation of the additive: X-ray diffraction (XRD) and X-ray fluorescence (XRF) or atomic absorption spectrometry (AAS).
- Chicken study (EFSA opinion e9365): 960 day-old male Ross 308 chicks in 48 pens, 35 days, feed with 0, 20 000 and 40 000 mg/kg; the additive content in feed was confirmed by analysis of SiO₂, MgO and Al₂O₃. At the double dose the availability of protein, retinol, zinc and riboflavin was unchanged and there was no interaction with narasin; dry matter retention fell, but without an effect on growth.
- Rainbow trout study: 540 juvenile fish in 18 tanks of 500 L, 93 days; intended 20 000 and 40 000 mg/kg, with 16 792 and 34 465 mg/kg calculated from SiO₂, Al₂O₃ and MgO analysis. No effect on growth, blood or histopathology — EFSA considered 20 000 mg/kg safe for all species. New SEM particle size data did not allow the fraction of small particles to be assessed: the dispersion protocol departed from EFSA guidance and the image resolution was too poor.
- The additive is a respiratory and skin sensitiser and, because of dusting and its silica content, poses a risk by inhalation; the conditions of authorisation call for particular attention to the rules on protecting workers from crystalline silica and nickel. For the species of Regulation 2023/263 the authorisation runs until 28 February 2033; additive and premixtures for salmonids and chickens made under the old rules before 15 August 2026, and feed before 15 February 2027, may be used until stocks are exhausted.