L-tyrosine from hydrolysis of poultry feather keratin (3c401) renewed until 12 May 2035 for all species: min. 95 %, optical rotation and titration in the additive according to Ph. Eur. 1161, IEC-VIS in premixtures and feed according to Regulation 152/2009; EFSA — dusting potential up to 8417 mg/m³, half of the particle volume below 10 µm
Commission Implementing Regulation (EU) 2025/752, published on 22 April 2025, renews for 10 years the authorisation of L-tyrosine as a nutritional additive in the amino acids group for all animal species and repeals Regulation (EU) No 101/2014. According to the EFSA opinion of 4 June 2024 the additive remains safe for animals, consumers and the environment; it is not irritant to skin or eyes, but EFSA could not conclude whether it is a skin sensitiser, and inhalation exposure is likely. The EU reference laboratory considered its earlier evaluation of the methods still valid, so no new report was drawn up. A corrigendum of 27 April 2026 was published only in the Portuguese version.
- Annex: powder with a minimum L-tyrosine content of 95 %, produced by hydrolysis of keratin from poultry feathers; CAS 60-18-4, C₉H₁₁NO₃. Methods: identification in the additive — specific optical rotation, determination in the additive — titration (both according to European Pharmacopoeia monograph 1161); determination in premixtures and compound feed — ion-exchange chromatography with post-column derivatisation and optical detection (IEC-VIS) according to Regulation (EC) No 152/2009. No maximum contents; the instructions recommend not exceeding 5 g/kg feed for food-producing animals and 15 g/kg for others.
- EFSA data (five batches): tyrosine 96.4–98.5 % (average 97.7 %), loss on drying 0.1–0.2 %, sulphated ash 0.3–2.1 %; residues of L-cystine 0.1–0.2 % and L-phenylalanine 1.2–2 %. Ten batches: cadmium and arsenic below the LOQ, lead on average 0.15 mg/kg, mercury 0.016 mg/kg. Microbiology: total aerobic count < 400–14 000 CFU/g, Enterobacteriaceae and anaerobic sulphate-reducing bacteria < 10 CFU/g, Salmonella absent in 100 g. Since the first authorisation the producer has slightly changed the duration of some steps and increased the hydrochloric acid concentration — according to EFSA without significance for the product.
- Physical properties (EFSA): dusting potential of three batches by the Heubach method 3900–8417 mg/m³; laser diffraction — 50 % of the particle volume below 10 µm, 10 % below 4 µm; BET specific surface area 0.06 m²/g (approx. 0.1 m²/cm³); solubility in water at 25 °C 0.45 g/L. SEM images were taken at too low a magnification to assess small particles, but because solubility increases at pH < 2 and > 8 EFSA did not require further characterisation of nanoparticles.
- User safety: studies were submitted for L-tyrosine of different origin with a purity of 99.9 % — the EpiDerm human skin model (OECD TG 439) and the BCOP test on bovine cornea (OECD TG 437), both without irritant effects; no data on sensitisation. The act requires procedures and organisational measures and, where they are not sufficient, skin and respiratory protection. Transitional period: additive and premixtures produced before 12 November 2025, feed for food-producing animals — before 12 May 2026, for others — before 12 May 2027.