Propyl gallate (1b310) as an antioxidant in feed for all species until 5 March 2035: spectrophotometry at 275 nm in the additive (Ph. Eur. 1039), RP-HPLC-UV-DAD at 285 nm in premixtures and feed (LOQ 6 mg/kg); limits from 15 mg/kg for chickens to 100 mg/kg for ornamental fish, no use in drinking water
Commission Implementing Regulation (EU) 2025/281, published on 13 February 2025, following a re-evaluation authorises propyl gallate as a technological additive in the antioxidants group for all animal species; it had previously been authorised without a time limit under Directive 70/524/EEC. The request for use in drinking water was not granted, because Regulation (EC) No 1831/2003 does not provide for this for technological additives. In 2020 EFSA could not assess safety for cats and consumers; in its 2024 opinion it found 71 mg/kg safe for cats and the additive safe for consumers. A corrigendum of 27 November 2025 added the expiry date of the authorisation: 5 March 2035.
- Annex: propyl gallate ≥ 97 %, solid form; sulphated ash < 0.1 %, gallic acid < 0.5 %, chlorinated organic compounds < 100 mg/kg; C₁₀H₁₂O₅, CAS 121-79-9, produced by esterification of gallic acid from gallnuts. Methods: determination in the additive — spectrophotometry at 275 nm (European Pharmacopoeia monograph 1039); in premixtures and compound feed — RP-HPLC with UV diode-array detection at 285 nm. Directions for use must state storage conditions and stability to heat treatment; where procedures are not sufficient, skin, eye and respiratory protection.
- Maximum contents (mg/kg complete feed with 12 % moisture): 40 — cattle, sheep, goats, cervids, camelids, sows, equines, salmonids and minor fish species; 100 — ornamental fish; 15 — chickens for fattening, minor poultry species for fattening or reared for laying or reproduction, ornamental birds; 20 — turkeys for fattening, laying hens, minor poultry species reared for laying or reproduction, leporids; 27 — piglets and pigs for fattening and breeding; 71 — dogs and cats; 15 — all other species.
- Methods according to the EU reference laboratory (EFSA opinion of 2020): the RP-HPLC-UV(DAD) method for premixtures (5–120 g/kg) and feed (35–226 mg/kg) — RSDr 1.7–7 %, RSDR 3.0–12 %, recovery 84.4–112 %, LOQ 6 mg/kg; no performance characteristics were given for the Ph. Eur. spectrophotometric method, but the laboratory considered it suitable for official control. Seven batches from three producers: ≥ 98.6 %; solvents (n-propanol, benzene, toluene, cyclohexane) below the LOD of 1 mg/kg; dusting potential of one batch 1.36 g/m³.
- Safety (EFSA): propyl gallate is neither genotoxic nor carcinogenic; it is a skin and eye irritant and a dermal sensitiser, and inhalation exposure was considered a hazard. In feed with 5 % vegetable oil recoveries after 3 months were 45 % and 38 % (at 27 and 100 mg/kg), in the other feeds no losses. ADI set by the ANS Panel in 2014 — 0.5 mg/kg bw per day. Transitional period: premixtures produced before 5 September 2025, feed for food-producing animals — before 5 March 2026, for others — before 5 March 2027.