. Camphor in flavourings and other food ingredients with flavouring properties Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission

The European Food Safety Authority (EFSA) 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 of human health. In particular, EFSA is asked to advise the Commission on the implications for human health of the presence of d-camphor in the diet. Dietary exposure to camphor arises from the consumption of foods flavoured by using either herbs (e.g. basil, coriander, marjoram, rosemary, sage), their essential oils or the chemically defined flavouring substance d-camphor. Camphor is easily absorbed in the gastrointestinal tract. The major metabolic pathway is the oxidation to 5- and 3-hydroxycamphor, followed by conjugation and excretion. Camphor did not show mutagenic activity in Salmonella typhimurium strains and did not induce chromosome aberrations in vitro with and without metabolic activation. There was no evidence of reproductive and developmental toxicity after oral administration to rats and rabbits. The available data on toxicity of camphor are limited and thus a TDI cannot be derived. However, based on the available toxicity data and the Panel's conservative estimate of chronic exposure (15 mg/day equivalent to 250 mu g/kg body weight (bw)/day) calculated using the maximum limits suggested by the Council of Europe, the Panel considered that there would be no safety concern regarding chronic toxicity. The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (Panel) considered that safety aspects of d-camphor in terms of acute toxicity needed to be addressed. The reported acute toxicity data on adults and children arise mostly from accidental ingestion of camphor-containing medications. The probable lethal oral bolus dose has been reported to be in the range of 50 to 500 mg/kg bw. No acute toxicity was reported after doses lower than 2 mg/kg bw and clinically insignificant signs of toxicity may be seen in sensitive individuals at doses of 5 mg/kg bw and higher, whereas clinically manifest toxicity in sensitive persons would require doses higher than 30 mg/kg bw. Potential acute exposure related to the consumption of large amounts of certain foods on a single day was estimated by the Panel for several age groups. It was lowest in adults (from 0.14 to 0.34 mg/kg bw according to the food commodity) and highest in children under 6 (from 0.41 to 0.83 mg/kg bw according to the food commodity). The commodity leading to the highest potential acute exposure was fresh cheese in all age groups. The acute exposure estimates for children and adults are about 60-120 times and 150-360 times, respectively, lower than the probable lowest lethal oral bolus dose of 50 mg/kg bw. The acute exposure estimates for children and adults are about 2-5 times and 6-14 times, respectively, lower than the dose of 2 mg/kg bw below which no acute effects have been reported in human case studies. Although these margins might appear to be low, the large number of cases describing the dose-response relationship suggests that the data sufficiently cover inter-individual variability in sensitivity. Therefore, the Panel concluded that it is unlikely that acute effects may occur in relation to consumption of foods providing less than 2 mg/kg bw in one large portion. The acute exposure estimates considered by the Panel are based on observed high consumption in only one Member State and on maximum limits suggested by the Council of Europe. However, maximum permitted levels for d-camphor are not currently set in the EU legislation and there is uncertainty on its actual upper use levels in foods and beverages currently on the market and on the high consumption of food flavoured with d-camphor all over Europe. The Panel therefore suggests that maximum limits should be set to ensure that exposure to camphor does not exceed 2 mg/kg bw on a single day in any age group.