Scientific Opinion on dihydrocapsiate

Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of a synthetic dihydrocapsiate (DHC) as a food ingredient in the context of Regulation (EC) No 258/97 taking into account the comments and objections of a scientific nature raised by Member States. Dihydrocapsiate belongs to a group known as capsinoids which have been shown to occur naturally in a number of chilli and sweet peppers. The applicant intends to market DHC to food manufacturers as an ingredient for incorporation into foods of various categories at concentration levels varying from 8 to 2050 mg per kg. Considering the proposed uses the mean intake of synthetic DHC was estimated to be around 12–13 mg/day (8.1 mg/day for pre-school children); the 97.5th percentile intakes of adults and the elderly were estimated to be around 34 mg/day (18.5 mg/day for pre-school children). Calculations based on body weights resulted in the highest intakes being for pre-school children (mean: 0.6 mg/kg bw/day; 97.5th percentile: 1.3 mg/kg bw/day). The applicant has provided a range of toxicological studies with DHC. The Panel concludes that it has no safety concerns regarding genotoxicity. Studies on developmental toxicity in rats and rabbits using commercial grade DHC did not show adverse effects on pregnant animals or on foetal growth and development. The no-observed adverse effect level (NOAEL) of three subchronic oral toxicity studies in rats was consistently at 300 mg DHC/kg bw/day. The Panel is of the opinion that the margin of safety (MOS) in relation to the NOAEL of 300 mg/kg bw/day is sufficient, including the highest estimated intake of 1.3 mg/kg bw/day for preschool children. The Panel concludes that the novel food ingredient, DHC, is safe under the proposed uses and use levels.