TY - JOUR

T1 - Safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97

T2 - (Scientific Opinion)

AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

AU - Sjödin, Anders Mikael

N1 - EFSA 2017 4777

PY - 2017/5/12

Y1 - 2017/5/12

N2 - 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) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council. TheNF contains about 55–60% proanthocyanidins (PACs). 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 retain the phenolic components. 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 beverages and yogurts to provide 80 mg PACs per serving. The target population is the adult general population. The mean and 95th percentile estimates for the all-user intakes from all proposed foodusesare 68 and 192 mg/day, respectively, for female adults, and 74 mg/day and 219 mg/day, respectively, for male adults. 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. Considering the composition, manufacturing process, intake, history of consumption of the source and human data, the Panel considers that the data provided do not give reasons for safety concerns. The Panel concludes that the cranberry extractpowder is safe as a food ingredient at the proposed uses and use levels.

AB - 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) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council. TheNF contains about 55–60% proanthocyanidins (PACs). 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 retain the phenolic components. 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 beverages and yogurts to provide 80 mg PACs per serving. The target population is the adult general population. The mean and 95th percentile estimates for the all-user intakes from all proposed foodusesare 68 and 192 mg/day, respectively, for female adults, and 74 mg/day and 219 mg/day, respectively, for male adults. 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. Considering the composition, manufacturing process, intake, history of consumption of the source and human data, the Panel considers that the data provided do not give reasons for safety concerns. The Panel concludes that the cranberry extractpowder is safe as a food ingredient at the proposed uses and use levels.

KW - Faculty of Science

KW - Cranberry extract powder

KW - Proanthocyanidins

KW - Novel food

KW - Ingredient

KW - Safety

U2 - 10.2903/j.efsa.2017.4777

DO - 10.2903/j.efsa.2017.4777

M3 - Journal article

VL - 15

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 5

M1 - 4777

ER -