Scientific Opinion on the re-evaluation of 4-hexylresorcinol (E 586) as a food additive

The Panel on Additives and Nutrient Sources added to Food (ANS) delivers an opinion re-evaluating the safety of an antioxidant 4-hexylresorcinol (4-HR) (E 586). The SCF in 2003 and the JECFA in 1996 recognised that available database was not sufficient to establish an ADI but considered 4-HR toxicologically acceptable for prevention of melanosis in shrimps provided residues in crustacean meat did not exceed 2 mg/kg (SCF) or 1 mg/kg (JECFA). The Panel was not provided with a newly submitted dossier and no new toxicological or biological information was submitted for the present re-evaluation following a public call for data and based its evaluation on previous evaluations and additional literature that became available since then. The Panel agreed with the SCF that the database did not allow the establishment of an ADI. The Panel considered nephropathy in mice as the most sensitive endpoint for 4-HR toxicity. The lowest BMDL10 for nephropathy in carcinogenicity study in mice (4 mg/kg bw/day) and the highest exposure estimate (3.3 µg/kg bw/day, adults, 95th percentile of consumers only) provided the MoS considered by the Panel as sufficient given the conservative nature of exposure estimates and limited uses. The Panel concluded that 4-HR was toxicologically acceptable for prevention of melanosis in shrimps and related crustaceans provided that residues in crustacean meat do not exceed 2 mg/kg. The Panel concluded that any increase in the permitted use would require additional reproductive toxicity studies. As the information on actual residual levels in crustaceans was limited the Panel recommended monitoring of these levels in the European market.