Inositol for fish and crustaceans renewed until 2036: it is quantified in the additive, premixtures and feed by a microbiological activity assay, and identified according to Ph. Eur. monograph 1805
Commission Implementing Regulation (EU) 2026/1151, published on 29 May 2026, renews until 18 June 2036 the authorisation of inositol (purity at least 97 %) as a nutritional additive in the group of vitamins and substances having a similar effect for fish and crustaceans — both food-producing and ornamental — without a minimum or maximum content; it repeals Regulation 1249/2014. EFSA confirmed that the additive on the market complies with the existing conditions and that the production process has not changed.
- Methods in the annex: qualitative analysis of inositol in the additive — liquid chromatography and infrared absorption spectrophotometry according to European Pharmacopoeia monograph 1805; quantitative determination in the additive, premixtures and compound feed — a microbiological activity assay. Details of the methods are published by the EU reference laboratory for feed additives (EURL-FA).
- Data from the EFSA opinion (e9701): 5 batches contained 99.6–99.9 % inositol against a specification of ≥ 97 %, loss on drying 0.02–0.04 %; in 3 batches lead < 0.04 mg/kg, arsenic < 0.01, mercury < 0.01, cadmium < 0.003, fluorine 4.5–4.8 mg/kg, and dioxins PCDD/F 0.054–0.085 ng WHO-TEQ/kg (upper bound).
- The description of origin differs between the sources: the annex to the regulation describes inositol as “produced by chemical synthesis”, while the EFSA opinion states that it is obtained by hydrolysis of natural phytic acid. The substance is myo-inositol (cyclohexane-1,2,3,4,5,6-hexol), CAS 87-89-8, C6H12O6.
- EFSA concluded that the additive remains safe for fish, crustaceans, consumers and the environment, is not a skin or eye irritant and not a skin sensitiser; efficacy was not assessed in the renewal procedure. The label states storage conditions and stability to heat treatment. Additive and premixtures made under the old rules before 18 December 2026, feed for food-producing animals before 18 June 2027 and other feed before 18 June 2028 may be used until stocks are exhausted.