Clinoptilolite of sedimentary origin (1g568) renewed until 16 February 2036: XRD in the annex, in the EFSA opinion also ICP-AES and TEM — 83–85 % of particles (by number) below 500 nm; nickel at 0.6–1.8 mg/kg makes the additive a sensitiser, dusting potential up to 4305 mg/m³
Commission Implementing Regulation (EU) 2026/167, published on 27 January 2026, renews until 16 February 2036 the authorisation of clinoptilolite of sedimentary origin as a binder and anticaking agent for all animal species, up to 10 000 mg/kg complete feed, and repeals Regulation (EU) No 651/2013. In its opinion of 19 March 2025 EFSA found the additive still safe; in new studies it did not irritate skin or eyes and did not sensitise the skin, but because of nickel it must be treated as a skin and respiratory sensitiser. Following EFSA’s recommendation the 10 000 mg/kg limit now applies to clinoptilolite from all sources combined, not only the sedimentary one.
- Method in the annex: clinoptilolite content in the additive — X-ray diffraction (XRD). Specification: clinoptilolite ≥ 80 % and clay minerals ≤ 20 %, free of fibres and quartz; CAS 12173-10-3, EC No 687-562-6. The act describes clinoptilolite as a hydrated sodium calcium aluminosilicate, the EFSA opinion as a hydrated calcium aluminosilicate. EFSA recommended correcting the old provision “10 000 mg” without a reference unit to mg/kg complete feed — which is how the new annex reads.
- Analyses (EFSA): XRD in 10 batches — clinoptilolite 84.4 % on average (82 – ≥ 90), clay minerals ≤ 5 %; ICP-AES (as oxides) — SiO₂ 69.8 %, Al₂O₃ 12.2 %, CaO and K₂O 3.2 % each, Fe₂O₃ 1.7 %, Na₂O 1.2 %; loss on ignition 7.5 %. Lead 9.99–11.05, arsenic 1.27–1.48, cadmium 0.027–0.033, mercury 0.008–0.010, nickel 0.6–1.8 mg/kg, fluorine < 8.8 mg/kg. Stauber-Heubach dusting potential 4035–4305 mg/m³; in the dust 73.4–75.3 % of particles below 10 µm.
- TEM under the EFSA guidance on small particles: 85, 83 and 85 % of particles (by number) have at least one dimension below 500 nm, and 67–71 % below 250 nm, so the additive contains a nano fraction. Genotoxicity: Ames test (OECD TG 471, five strains, up to 5000 µg/plate) and micronucleus test in TK6 cells (OECD TG 487, up to 125 µg/ml) — negative; EFSA notes that this concerns the soluble part of the material. Literature search 2010–2022: 412 articles, 59 eligible, no new hazards.
- User: intracutaneous test in rabbits (ISO 10993-10) and OECD TG 405 — no irritation; two OECD TG 406 tests in guinea pigs — no skin sensitisation. Even so EFSA considered the additive a sensitiser because of nickel (Directive (EU) 2022/431: occupational exposure limit of 0.01 mg/m³ for the respirable and 0.05 mg/m³ for the inhalable fraction; carcinogen category 1A). The act requires particular attention to the rules protecting workers against inhalation of nickel, and skin and respiratory protection.