Re-evaluation of 4-hexylresorcinol (E 586) as a food additive

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Article
4-hexylresorcinol, E586, 4-hexyl-1,3benzenediol, 4-hexyl-1,3-dihydroxybenzene, CAS Registry Number 136-77-6, food antioxidant, food additive
First published in the EFSA Journal
24 April 2014
Adopted
2 April 2014
Type
Scientific Opinion
Abstract

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.

Panel members at the time of adoption
Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Pasquale Mosesso, Rose Martin, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright
Panel on Food Additives and Nutrient Sources Added to Food
Contact
ans [at] efsa.europa.eu
doi
10.2903/j.efsa.2014.3643
EFSA Journal 2014;12(4):3643 [35 pp.].
Question Number
On request from
European Commission
Print on demand
Number of Pages
35