Safety of dried aerial parts of Hoodia parviflora as a novel food pursuant to Regulation (EC) No258/97.

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 dried aerial parts of Hoodia parviflora as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97. The information provided on the composition, the specifications, the production process, the batch‐to‐batch variability and the stability of the NF is sufficient and does not raise safety concerns. The applicant intends to use the NF in a number of energy‐reduced/sugar‐free/no‐added‐sugar foods in quantities of up to 15 mg per serving. The applicant also proposes to provide the NF as a food supplement. The target population proposed by the applicant is adults. The highest intake estimates were found in the group of elderly (≥ 65 years) individuals, with a high intake of 1.0 mg/kg body weight (bw) per day. One 90‐day toxicity study in rodents was provided from which a benchmark dose lower confidence limit (BMDL 05) of 53.5 mg/kg bw per day was derived for effects of the NF on bodyweight. The Panel concludes that the addition of the NF to foods as a food ingredient at the uses and use levels as proposed by the applicant would exceed intake levels considered safe in humans. The Panel considers that the NF is safe to be used as a food supplement at a maximum dose of 9.4 mg/day. The target population is adults.