Calcium D-pantothenate and D-panthenol (vitamin B5) renewed until 2035: titration to Ph. Eur. 0470 and 0761, HPLC-MS and RP-HPLC-UV — in the D-panthenol purity criterion 3-aminopropanol has been replaced by 3-aminopropionic acid
Commission Implementing Regulation (EU) 2025/2171, published on 30 October 2025, renews until 19 November 2035 the authorisations of calcium D-pantothenate (3a841) for all animal species and D-panthenol (3a842) — only in water for drinking — and repeals Regulation (EU) No 669/2014. The common name “vitamin B5” has been added to the names of the additives and may be used on feed labels together with the identification number.
- Methods: calcium D-pantothenate in the additive — potentiometric titration with perchloric acid and identification by specific rotation (Ph. Eur. monograph 0470); in water, premixtures and feed — HPLC-MS. D-panthenol in the additive — titration with perchloric acid and potassium hydrogen phthalate, identification by optical rotation and infrared spectroscopy (Ph. Eur. monograph 0761); in water — RP-HPLC-UV. The EURL considered the conclusions of the previous method evaluation still valid, so no new report was required.
- Calcium pantothenate (EFSA opinion of 28 January 2025): five batches at 99.7–100.2 % on a dry matter basis, 3-aminopropionic acid 0.10–0.11 % (limit 0.5 %), loss on drying 2.14–2.49 %, rotation +26.4 to +26.6°, related impurities 0.84 % in total (applicant’s limit 1.2 %); in water a loss of 1.08 % after 48 h. In the opinion of 26 June 2024 dusting potential was 1630–4180 mg/m³ — inhalation exposure likely, low inhalation toxicity.
- D-panthenol (opinion of 28 January 2025): five batches at 99.6–100.4 % on an anhydrous basis, water 0.1 %, 3-aminopropanol 0.4–0.5 % (limit 0.5 %), dichloromethane < 0.7 mg/kg, methanol < 8 mg/kg. EFSA considered D-panthenol a skin and eye irritant and a dermal and respiratory sensitiser; calcium pantothenate is neither a skin irritant nor a skin sensitiser.
- Discrepancy: Regulation No 669/2014 and the 2025 EFSA opinion limit 3-aminopropanol (≤ 0.5 %) in D-panthenol, whereas the new act — in the Polish and English versions — gives for D-panthenol “max. 0.5 % 3-aminopropionic acid”, as for calcium pantothenate. Transition: additives and premixtures labelled before 19 May 2026, feed for food-producing animals before 19 November 2026, other feed before 19 November 2027.