Six cellulose derivatives in feed after re-evaluation — 25 authorisations until 19 February 2035 (emulsifiers, stabilisers, thickeners, gelling agents, binders): microcrystalline cellulose ≥ 97 %, methyl cellulose 25–33 % methoxyl groups, ethyl cellulose 44–50 % ethoxyl, HPC, HPMC and sodium carboxymethyl cellulose ≥ 99.5 %; identification under Regulation 231/2012, JECFA monographs and the European Pharmacopoeia
Commission Implementing Regulation (EU) 2025/157, published on 30 January 2025, completes the re-evaluation of six cellulose derivatives authorised without time limit under Directive 70/524/EEC and lists them as technological additives for all animal species, without content limits. Microcrystalline cellulose, methyl cellulose, hydroxypropyl methyl cellulose and sodium carboxymethyl cellulose additionally obtain the new functional group ‘binders’. EFSA (opinions of 2 July 2020 and 31 January 2024) found them safe for animals, consumers and the environment; it could not conclude on user safety for lack of data.
- Authorisations by functional group: microcrystalline cellulose 1c460i, methyl cellulose 1c461, hydroxypropyl methyl cellulose 1c464 and sodium carboxymethyl cellulose 1c466 — emulsifiers, stabilisers, thickeners, gelling agents and binders (5 entries each); hydroxypropyl cellulose 1c463 — without binders (4 entries); ethyl cellulose 1d462 — stabiliser only. Methods: identification and characterisation in the additive under Regulation 231/2012 (food additive specifications), the FAO JECFA monographs and Volume 4 of the JECFA compendium, for methyl, ethyl, hydroxypropyl and hydroxypropyl methyl cellulose also the European Pharmacopoeia (monographs 0345, 0822, 0337, 0348).
- Specifications (selected): microcrystalline cellulose ≥ 97 % cellulose on the anhydrous basis, from wood pulp partially depolymerised with hot mineral acid, loss on drying ≤ 7 %, water-soluble matter ≤ 0.24 %, sulfated ash ≤ 0.5 %, carboxyl groups ≤ 1 %, ≤ 10 % of particles below 5 µm; methyl cellulose 25–33 % -OCH₃ groups and ≤ 5 % hydroxyethoxyl; ethyl cellulose 44–50 % ethoxyl groups (up to 2.6 per anhydroglucose unit), loss on drying ≤ 3 %.
- Further specifications: hydroxypropyl cellulose ≤ 80.5 % hydroxypropoxyl groups (up to 4.6 per anhydroglucose unit), propylene chlorohydrins ≤ 0.1 mg/kg; hydroxypropyl methyl cellulose 19–30 % methoxyl and 3–12 % hydroxypropoxyl groups, sulfated ash ≤ 1.5 % (viscosity ≥ 50 mPa·s) or ≤ 3 % (below 50 mPa·s), propylene chlorohydrins ≤ 0.1 mg/kg; sodium carboxymethyl cellulose ≥ 99.5 %, 0.2–1.5 carboxymethyl groups per anhydroglucose unit, total glycolate ≤ 0.4 % (as sodium glycolate), sodium ≤ 12.4 %.
- Background of the assessment (EFSA 2024): in the 2020 opinions the FEEDAP Panel could not confirm proper identification and characterisation of microcrystalline cellulose and carboxymethyl cellulose or assess toxic impurities; new data showed compliance with the food additive specifications, so the safety conclusions apply to them. Efficacy was not studied — all are authorised food additives. Users: risk-reducing procedures and, where that is not possible, skin, eye and respiratory protection. Transitional provisions: additives and premixtures under the old rules until 19 August 2025, feed for food-producing animals until 19 February 2026, other feed until 19 February 2027.