4-Hydroxy-2,5-dimethylfuran-3(2H)-one (furaneol) in feed for all species other than cats and dogs: recommended 10 mg/kg, determination by GC-MS with retention time locking, lowest safe concentration 22 mg/kg in chickens
Commission Implementing Regulation (EU) 2025/2498, published on 12 December 2025, authorises until 1 January 2036 4-hydroxy-2,5-dimethylfuran-3(2H)-one (FLAVIS 13.010, CAS 3658-77-3, chemical synthesis, purity 98 %) as a flavouring for all animal species except cats and dogs — without a maximum content, with a recommended maximum of 10 mg/kg on the label. For cats and dogs the substance is already authorised; EFSA lists the synonyms “furaneol” and “strawberry furanone”.
- Method in the annex: the additive in flavouring mixtures is determined by gas chromatography-mass spectrometry with retention time locking (GC-MS-RTL). The reference laboratory considered valid the method evaluation from an earlier application, verified by EFSA in its opinion of 23 July 2012, so no new report was required.
- EFSA data (opinion e9538): 15 batches contained 99.1–99.9 % of the substance against a specification of 98 %; lead, mercury, cadmium and arsenic below the limits in 3 batches; solubility 176 g/L at 20 °C and 315 g/L at 25 °C; Stauber-Heubach dusting potential 8–24 mg/m³; after 24 months at 22 °C the recovery was 99.8 % (1 batch).
- Safety: the reference point is a NOAEL of 200 mg/kg bw per day from a two-year rat carcinogenicity study (at 400 mg/kg bw males gained less weight and survived less); with an uncertainty factor of 100 EFSA calculated maximum safe concentrations: chickens for fattening 22, turkeys 30, laying hens 33, rabbits 35, piglets 40, pigs for fattening 48, dairy cows 57, lactating sows 58, cattle for fattening, sheep, goats and horses 88, veal calves 100, salmon 101, ornamental fish 391 mg/kg. The recommended 10 mg/kg lies below each of these values.
- For cats and dogs the recommended maximum has so far been 18 and 25 mg/kg; in its 2012 opinion EFSA considered 5 mg/kg safe for all species. The substance is a skin, eye and respiratory tract irritant and a skin and respiratory sensitiser — any user exposure is considered a risk. The additive only via a premixture; if the dose from a premixture would exceed 10 mg/kg, the premixture label states the functional group, identification number, name and amount of the substance.