Thujone : European Union
Opinion of the Scientific Committee on Food on Thujone
(expressed on 2 December 2002)
Terms of Reference
The Committee is asked to advise the Commission on substances used as flavouring substances or present in flavourings or present in other food ingredients with flavouring properties for which existing toxicological data indicate that restrictions of use or presence might be necessary to ensure safety for human health. In particular the Committee is asked to advise the Commission on the implications for human health of thujone in the diet.
Thujone occurs in nature as a mixture of a-(-)- and b-(+)-diastereoisomers, the proportions varying with the source (Micali & Lanuza, 1995; Pinto-Sconamiglio, 1967). Synthetic a-thujone is also available commercially. Data on both isomers, or mixtures, are considered in this opinion.
Council of Europe (CoE):
Thujone has been evaluated by the CoE which allocated a TDI of 10 mg/kg bw/d based on a NOEL for convulsions of 5 mg/kg bw in the female rat, dosed by gavage on 6 days per week for 14 weeks, to which a safety factor of 500 was applied (Council of Europe, 1999).
Current Regulatory Status
Annex II of Directive 88/388/EEC (EEC, 1988) on flavourings sets the following maximum levels for thujone (a and b) in foodstuffs and beverages to which flavourings or other food ingredients with flavouring properties have been added: 0.5 mg/kg in foodstuffs and beverages with the exception of
5 mg/kg in alcoholic beverages with not more than 25% volume of alcohol
10 mg/kg in alcoholic beverages with more than 25% volume of alcohol
25 mg/kg in foodstuffs containing preparations based on sage
35 mg/kg in bitters.
Thujone may not be added as such to food.
United States of America:
Thujone is not authorized for use as a flavouring substance in the USA.
In 1979, the Codex Committee on Food Additives recommended restricting the use of a- and b-
thujone to the following maximum levels in final products for consumption:
0.5 mg/kg in food and beverages
5 mg/kg in alcoholic beverages containing < 25% alcohol
10 mg/kg in alcoholic beverages containing > 25% alcohol
35 mg/kg in bitters (Codex Alimentarius Commission 1979)