Risk assessment of "other substances" – Coenzyme Q10. Opinion of the Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics of the Norwegian Scientific Committee for Food Safety

Abstract

The Norwegian Scientific Committee for Food Safety (VKM) has, at the request of the Norwegian Food Safety Authority, assessed the risk of intake of 100 mg/day of coenzyme Q10 in food supplements. For the risk characterization, the values used for comparison with the estimated exposure are 900 mg/day (corresponding to 12.9 mg/kg bw per day in a 70 kg adult) based on human studies (4 weeks) and the NOAEL of 1200 mg/kg bw per day based on a long-term toxicity study in rats (52 weeks). No specific studies on children (10 to <14 years) and adolescents (14 to <18 years) were identified. Based on the included literature there was no evidence indicating that age affects tolerance for CoQ10. Therefore, a tolerance as for adults, based on body weight, was assumed for children and adolescents, in the comparison with human data. VKM concludes that it is unlikely that a daily dose of 100 mg of CoQ10 from food supplements causes adverse health effects in children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).