Safety of cranberry extract powder as a novel food ingredient

Safety of cranberry extract powder as a novel food ingredient

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on cranberry extract powder as a novel food (NF) ingredient submitted pursuant to Regulation (EC) No 258/971 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. The assessment, which follows the methodology set in Commission Recommendation 97/618/EC is based on the data supplied in the original application, the initial assessment by the competent authority of France, the concerns and objections of the other Member States and the responses of the applicant.

The NF cranberry extract powder is prepared from the juice concentrate of sound, mature berries of the cranberry cultivar (Vaccinium macrocarpon). According to the specification, the NF contains 55–60% proanthocyanidins (PACs) as measured by OSC-DMAC (colorimetric analysis using dimethylaminocinnamaldehyde (DMAC) with isolated cranberry PACs as a standard compound). Other main constituents of the NF are anthocyanins, other phenolic compounds such as flavonols, sugars and organic acids. The Panel considers that the information provided on the composition, the specifications, batch-to-batch variability and stability of the NF is sufficient and does not raise safety concerns.

Cranberry extract powder is produced from cranberry juice concentrate through an ethanolic extraction using an adsorptive resin column to remove sugars and organic acids and to retain the phenolic components which are eluted, concentrated and spray-dried to yield the powder. Silicon dioxide is added as a flow agent and maltodextrin as a carrier. The manufacturing process is performed according to good manufacturing practice (GMP). About 66 mL of pure (7.5 Brix) cranberry juice is needed to produce 145 mg of cranberry extract containing 33–36 mg PACs (about 80 mg measured by OSC-DMAC) and this amount approximately corresponds to a 240 mL serving of Ocean Spray’s 27% ‘cranberry juice classic’ currently on the market. The Panel considers that the production process is sufficiently described and does not raise concerns about the safety of the novel food.

The NF is intended to be added to fruit-flavoured drinks (regular and low calorie), isotonic drinks (including electrolyte types), tea drinks (ready-to-drink, iced), vitamin enhanced waters, yogurts and yogurt drinks with the intention to provide 80 mg PACs per serving (based on OSC-DMAC method). According to the applicant, the target population is the adult general population and the NF is not intended to be marketed to children.

When assuming that 240 mL of 27% cranberry juice contains on the average 156 mg PACs, the mean and 95th percentile of an adult female consumer is about 200 and 1,200 mL, respectively, cranberry juice per day. The corresponding mean and 95th percentile intakes of PACs from cranberry juice would be about 130 and 780 mg PACs per day for adult females, and 108 and 246 mg for adult males. For female adults, the mean and 95th percentile estimates for the all-user intakes of PACs from all proposed food-uses of the NF were 68 mg/day and 192 mg/day, respectively. The mean and 95th percentile estimates for the all-user intakes for male adults of PACs from all proposed food-uses also were 74 and 219 mg/day, respectively.

Taking into account the composition of the novel food and the intended use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous.

While no animal toxicological studies have been conducted on the NF, a number of human clinical studies have been conducted with cranberry products other than the NF. None of these studies have indicated adverse effects caused by cranberry consumption. In addition, three clinical studies have been conducted with the NF. The Panel notes that the PACs dose of these clinical studies is high as compared to the conditions of use of the NF. The Panel considers these studies do not raise safety concerns of the NF.

Based on the data provided, and considering the composition, manufacturing process, anticipated intake, history of consumption of the source and human studies, the Panel considers that the consumption of the cranberry extract powder under the proposed conditions of use does not raise safety concerns.

The Panel concludes that the cranberry extract powder is safe as a food ingredient at the proposed uses and use levels.

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