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 dried aerial parts of Hoodia parviflora as a novel food (NF) pursuant to Regulation (EC) No 258/97. The assessment follows the methodology set in Commission Recommendation 97/618/EC. The assessment is based on the data supplied in the original application, the initial assessment by the competent authority of Ireland, the concerns and objections of a scientific nature of the other Member States and the responses of the applicant.
The NF is the whole dried aerial parts of Hoodia parviflora, which is a succulent cactus-like milkweed plant native to southern Africa. The raw material, which is harvested from plants of more than 3 years, is sanitised, freeze-dried and ground into a fine powder.
The information provided on the composition, the specifications, batch-to-batch variability, the production process 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, with a recommended daily dose of up to 40 mg/day. The target population proposed by the applicant is adults.
When estimating intakes of the NF from the foods intended to be fortified, the highest intakes were found for elderly (≥ 65 years) individuals, with mean and high (95th percentile) intakes of 0.3 and 1.0 mg/kg body weight (bw) per day, respectively.
Based on the genotoxicity tests provided, the Panel concludes that there are no concerns regarding genotoxicity of the NF.
No conclusions could be drawn from the two human studies provided, owing to methodological weaknesses.
The risk of allergic reactions to the NF is low.
One 90-day repeated dose oral toxicity study was provided with the NF, which was administered to rodents at dosages of 100, 250 and 350 mg/kg bw per day. When the data from the study were subjected to benchmark dose (BMD) modelling, a BMD lower confidence limit (BMDL05) of 53.5 mg/kg bw per day (for the endpoint body weight) was derived, which is considered by the Panel as the reference point.
Considering the BMDL05 of 53.5 mg/kg bw per day, and the estimated high intakes of the NF from fortified foods of 1.0 mg/kg bw per day, the resulting margin of exposure (MoE) is 53.5. With regard to food supplements and the proposed maximum daily intake of the NF, the resulting MoE is 94. The Panel considers these MoEs for fortified foods and food supplements as insufficient.
Considering the BMDL05 of 53.5 mg/kg bw per day and by applying an uncertainty factor of 400 (composed of a factor of 100 to account for inter- and intra-species variability plus a factor of 4 to account for uncertainty for the content of the hoodigosides tested in the subchronic toxicity study), the Panel considers an intake of 0.134 mg/kg bw per day of the NF in the form of food supplements as safe. In adults (i.e. the target population) with a default body weight of 70 kg, this intake level corresponds to a maximum daily dose of 9.4 mg.
The Panel concludes that the addition of the NF, dried aerial parts of Hoodia parviflora, 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 daily dose of 9.4 mg. The target population is adults.