Biotin 3a880, 3a880i and 3a880ii renewed until 7 August 2035: additive — potentiometric titration to Ph. Eur. 1073, feed — RP-HPLC-MS/MS, water — USP microbiological assay; dusting potential of 2 % preparations up to 9940 mg/m³
Commission Implementing Regulation (EU) 2025/1424, published on 18 July 2025, renews until 7 August 2035 the authorisation of biotin (min. 97 % D-(+)-biotin) and two of its preparations at 2 % and 10 % for all animal species, also in water for drinking, and repeals Regulation (EU) 2015/723. The preparations received separate numbers (3a880i, 3a880ii) because the previous authorisation erroneously did not specify their composition. In its opinion of 28 January 2025 EFSA found biotin still safe; it is not irritant to skin or eyes, but exposure by inhalation is likely.
- Methods in the annex: D-(+)-biotin in the additive — potentiometric titration and identification by optical rotation (Ph. Eur. monograph 1073); biotin in the additive, premixtures and compound feed — reversed-phase high-performance liquid chromatography coupled to mass spectrometry (RP-HPLC-MS/MS); biotin in water — microbiological assay according to the United States Pharmacopeia. The reference laboratory considered its conclusions from the previous authorisation still valid, so there was no new EURL report (Article 5(4)(c) of Regulation (EC) No 378/2005).
- Active substance (EFSA opinion, 15 batches, five from each of three producers): purity 99–100.7 % against a requirement of min. 97 %, loss on drying on average 0.15 % (0.05–0.4 %), optical rotation on average 90.6° (89.1–91.5°), impurity A 0.21 %, C 0.06 %, E 0.1 % (0.06–0.21 %). EFSA gives sulphated ash as “on average 0.8 % (range 0.04–0.1 %)” — the mean lies outside the range. Arsenic, lead, cadmium and mercury below the LOD; dioxins (upper bound) 0.0769 ng WHO2005-TEQ/kg for PCDD/Fs and 0.136 ng/kg with DL-PCBs; methanol 4.02 mg/kg (2.2–6.3), isobutyl acetate 1.4 mg/kg, tetrahydrofuran 0.027 mg/kg, toluene 0.6 mg/kg in five batches — within the VICH guideline limits.
- Dust: biotin by the Stauber-Heubach method on average 649 mg/m³ (526–713), 28 % of particles by volume below 10 µm; spray-dried preparations — 2 %: 2098–3069 and 5360–9940 mg/m³, 10 %: 3750–8830 mg/m³. One 2 % preparation had lead at 4.21–4.31 mg/kg and fluoride at 51–92 mg/kg — of no concern according to EFSA. Recovery in feed after 24 months at 25 °C and 60 % RH — 98 %; homogeneity in pelleted feed at 0.4 mg biotin/kg — CV 5 % and 3 %.
- No minimum or maximum content. New labelling requirements: storage conditions, stability to heat treatment and stability in water for drinking; where risks cannot be eliminated by procedures — respiratory protection. Transitional periods: additives and premixtures labelled before 7 February 2026 — until stocks are exhausted; compound feed and feed materials labelled before 7 August 2026 (food-producing animals) or before 7 August 2027 (others).