Statement on the safety of EstroG‐100™ as a novel food pursuant to Regulation (EC) No 258/97

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to update its scientific opinion on the safety of EstroG-100 (TM) as a novel food (NF) in the light of additional information submitted by the applicant. In its previous scientific opinion of 2016, the Panel concluded that EstroG-100 (TM), which is a hot-water extract of a mixture of three herbal roots, is safe for the use in food supplements at the maximum intake level of 175 mg/day in post-menopausal women, which is lower than the maximum intake level proposed by the applicant (514 mg/day). The Panel reached its conclusions based on the effects of EstroG-100 (TM) on liver and haematology as observed in several oral toxicity studies, the lack of information on liver and haematological parameters in human studies and the absence of chronic toxicity data. In view of the Panel's conclusion on the safety of EstroG-100 (TM), the applicant has now provided additional information on haematological and liver parameters for the human intervention study with EstroG-100 (TM) and historical control data related to the subchronic 90-day oral toxicity study with EstroG-100 (TM). After assessing the additional information provided by the applicant, the Panel considers that the conclusion of the scientific opinion on the safety of EstroG-100 (TM) does not need to be revised, and thus, the Panel reconfirms that the NF is safe for the use in food supplements at the maximum intake level of 175 mg/day in post-menopausal women. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority

Safety of pyrroloquinoline quinone disodium salt as a novel food pursuant to Regulation (EC)No 258/97

Following a request from the European Commission, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on pyrroloquinoline quinone disodium salt (PQQ), trade name BioPQQ, as a novel food pursuant to Regulation (EC) No 258/97. PQQ is produced by fermentation using Hyphomicrobiumdenitrificans CK-275 and purification process. PQQ has a minimum purity of 99.0%. The information provided on the composition, specifications, batch-to-batch variability, stability and production process of PQQ is sufficient and does not raise safety concerns. The applicant intends to market PQQ for use in food supplements for healthy adults, except pregnant and lactating women, at a maximum proposed level of consumption of 20 mg/day (corresponding to 0.29 mg/kg bw per day for a 70-kg person). The proposed level of consumption is at least 250 times higher than the estimated background intake of PQQ occurring naturally in foods. Information on the absorption, distribution, metabolism and excretion of PQQ in animals and humans is limited. Considering the no-observed-adverse-effect-level (NOAEL) of 100mg/kg bw per day from a 90-day repeated dose oral toxicity study with BioPQQ, and the maximum proposed level of consumption, the Panelconcludes that the margin of exposure (of 344) is sufficient. The Panelconcludes that the novel food, pyrroloquinoline quinone disodium salt (BioPQQ (TM)), is safe under the intended conditions of use as specified by the applicant

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

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. The NF 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 food-uses are 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 extract powder is safe as a food ingredient at the proposed uses and use levels. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority

Safety of egg membrane hydrolysate as a novel food pursuant to Regulation (EU) 2015/2283

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 egg membrane hydrolysate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a water-soluble hydrolysate of egg membrane, produced by alkaline treatment of the thin layer lining the shells of chicken eggs. The main constituents of the NF are elastin, collagen and glycosaminoglycans. The information provided on the production process, batch-to-batch variability, composition and specifications of the NF is sufficient and does not raise safety concerns. The NF is proposed to be used as a food supplement for adults, at a maximum daily amount of 450 mg. The consumption of the NF is not nutritionally disadvantageous. One human study, which was not designed for safety but included a number of endpoints pertaining to safety, did not raise safety concerns. The Panel considers that taking into account the information provided and considering the nature, the source and the production process of the NF, there are no safety concerns for the NF at the proposed conditions of use. The Panel concludes that the NF, egg membrane hydrolysate, is safe as a food supplement at a dose of 450 mg/day. The target population for the NF is the general adult population. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe

Safety of Whey basic protein isolates as a novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on whey basic protein isolate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is obtained by ion exchange chromatography of skimmed cow's milk. The applicant intends to market the NF in infant and follow-on formulae and meal replacement beverages, dietary foods for special medical purposes and as food supplements. The highest estimated intake of the NF based on the proposed uses and use levels would be 24.8 mg/kg body weight (bw) per day in infants and 27.8 in toddlers. The information provided on composition, specifications, production process and stability of the NF do not raise safety concerns. Taking into account the composition of the NF and the intended use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. The Panel considers that there is no concern with respect to genotoxicity. The no observed adverse effect level (NOAEL) of a subchronic 13-week rat study was 2000 mg/kg bw per day. Considering the source, the production process and nature of the NF, the Panel considers the margin of exposure (MOE) of 154 to be sufficient for the adult population (on a high-estimated intake of 13 mg/kg bw). For infants and toddlers, the MOE would be at least 81 and 72, respectively. Taking into account the composition of the NF, its source, the history of consumption of the main components of the NF, the production process and that the NOAEL in a subchronic rat study was the highest dose tested the Panel considers that also the MOE for infants and toddlers are sufficient. The Panel concludes that the novel food ingredient, whey basic protein isolate, is safe under the proposed uses and use levels. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe

Safety of Allanblackia seed oil for extended uses in vegetable oils and milk and in yellow fat and cream-based spreads up to 30% (w/w)

In 2007, the EFSA NDA Panel concluded that Allanblackia seed oil obtained from the seeds of Allanblackia trees is safe for human consumption under the proposed conditions of use. Due to its high contents of stearic-oleic-stearic and stearic-oleic-oleic triglycerides, which made the oil suitable as a ‘hardstock’ component, the applicant applied for its use as a novel food (NF) ingredient in yellow fat and cream-based spreads at a level of 20% (w/w). In this application, the applicant seeks (1) to increase the authorised maximum use level (i.e. 20% w/w) in yellow fat spreads and cream-based spreads to 30% (w/w) and (2) the use of this NF in mixes of vegetable oils and milk up to a maximum use level of 30% (w/w). (3) The applicant proposes also some changes in the specifications of the NF, although he noted that the oil is collected, extracted and refined using the same processes that are currently used for other edible vegetable oils and which have been evaluated in the original application assed by EFSA in 2007. According to the information provided by the applicant, the production process and the composition of the NF do not change. The Panel notes that the revised specification limits on trans-fatty acid (TFA), unsaponifiable matter, peroxide value are similar to those for other edible oils and fats. The applicant also indicated that he had performed an updated comprehensive literature search using several different databases, but no preclinical studies or human studies on Allanblackia seed oil were identified which have not been provided for the previous EFSA assessment in 2007. The Panel notes that the proposed extended uses would increase the potential intake of the NF, which is considered not to be nutritionally disadvantageous. The Panel concludes that Allanblackia seed oil is safe at the extended uses and use level

Safety of xylo-oligosaccharides (XOS) as a novel food pursuant to Regulation (EU) 2015/2283

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 a mixture of xylo-oligosaccharides (XOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is obtained from corncobs (Zea mays subsp. mays) via enzyme-catalysed hydrolysis and subsequent purification. The main components of the NF, the oligosaccharides, are resistant to human digestive enzymes and are fermented by colonic bacteria. The intention is to add the NF to a variety of foods such as bakery and dairy products, fruit jelly, chocolates and soy-drinks. The information provided on composition, specifications, production process and stability of the NF, does not raise safety concerns. There were effects observed in the animal studies with the NF or with other XOS which were considered by the Panel to be expected from the intake of non-digestible carbohydrates. The Panel notes that the acute and transient gastrointestinal observed in human intervention studies with the NF or with other XOS have also been associated with the consumption of other non-digestible carbohydrates. The Panel concludes that the NF, a mixture of XOS, is safe under the proposed uses and use levels. The target population is the general population. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe

Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on shrimp peptide concentrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a peptide mixture obtained by an enzymatic proteolysis from northern shrimp (Pandalus borealis) shells and heads. The information provided on the composition, specifications, batch-to-batch variability, stability and production process of the NF is sufficient and does not raise safety concerns. The intention of the applicant is to use this NF as an ingredient in food supplements and to market it to adult consumers at a maximum proposed level of intake of 1,200 mg/day (corresponding to 17 mg/kg body weight (bw) per day for a 70 kg person). There are no concerns with regard to genotoxicity. The available human data do not raise safety concerns. Considering the no observed adverse effect level (NOAEL) of 2,000 mg/kg bw per day from a 90-day repeated-dose oral toxicity study, the maximum proposed level of intake and the nature of the NF, the Panel concludes that the margin of exposure (of 117) is sufficient. The Panel concludes that the NF, shrimp peptide concentrate, is safe to be used as a food supplement at the proposed maximum dose of 1,200 mg/day. The target population is adults. The Panel considered that the conclusion on the safety of the NF could not have been reached without the data from the unpublished study report on repeated-dose 90-day oral toxicity and from the unpublished study reports on two human studies. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe