General scientific guidance for stakeholders on health claim applications

The European Food Safety Authority (EFSA) asked the Panel on Dietetic Products Nutrition and Allergies (NDA) to update the General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims published in March 2011. Since then, the NDA Panel has completed the evaluation of Article 13.1 claims except for claims put on hold by the European Commission, and has evaluated additional health claim applications submitted pursuant to Articles 13.5, 14 and also 19. In addition, comments received from stakeholders indicate that general issues that are common to all health claims need to be further clarified and addressed. This guidance document aims to explain the general scientific principles applied by the NDA Panel for the evaluation of all health claims and outlines a series of steps for the compilation of applications. The general guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims, and it may be further updated, as appropriate, when additional issues are addressed

Vitamin C and contribution to the normal function of the immune system: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to vitamin C and ‘helps to support a healthy immune system’. The Panel considers that vitamin C is sufficiently characterised, and that contribution to the normal function of the immune system is a beneficial physiological effect. The Panel has previously assessed a claim on vitamin C and its contribution to the normal function of the immune system with a favourable outcome. The target population was the general population. The Panel considers that the role of vitamin C in the functioning of the immune system applies to all ages, including infants and young children (from birth to three years of age). The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin C and contribution to the normal function of the immune system. The following wording reflects the scientific evidence: ‘Vitamin C contributes to the normal function of the immune system.’ The target population is infants and young children up to three years of age

A fixed carbohydrate: protein ratio <= 1.8 on an energy basis consumed in the context of an energy-restricted diet and reduction of body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Following an application from Marks and Spencer PLC, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a CHO:P ratio &lt;= 1.8 on an energy basis in the context of an energy-restricted diet and body weight. The Panel considers that the food/constituent that is the subject of the health claim is sufficiently characterised. The Panel also considers that reduction of body weight in the context of an energy-restricted diet is a beneficial physiological effect. The target population proposed by the applicant is 'adults between the ages of 18 and 70 years with excess body weight'. No conclusions could be drawn from two unpublished studies investigating the effect of ready-to-eat meals with a CHO: P ratio &lt;= 1.8 on body weight. The remaining 14 human intervention studies investigated the effect of diets targeting a CHO: P ratio &lt;= 1.8 as compared to diets targeting a CHO: P ratio &gt;= 3.0 on overweight and obese adults in the context of energy restriction. Four out of seven studies lasting &lt; 12 weeks reported an effect of a CHO: P ratio &lt;= 1.8 on body weight in overweight/obese subjects, whereas no significant effect was observed in six out of the seven studies lasting 12 weeks or more. The Panel considers that these studies do not provide evidence for a sustained effect of the food/constituent on body weight. The Panel concludes that a cause and effect relationship has not been established between the consumption of a fixed CHO: P ratio &lt;= 1.8 on an energy basis consumed in the context of an energy-restricted diet and reduction of body weight. (C) 2017 European Food Safety Authority

Safety of betaine 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 betaine as a novel food (NF) pursuant to Regulation (EC) No 258/97. The information provided on the composition, the specifications, the batch-to-batch variability, stability and production process of the NF is sufficient and does not raise concerns about the safety of the NF. The NF is proposed to be used in foods intended to meet additional requirements for intense muscular effort with a maximum intake of 2.5 g/day of betaine for sports people above 10 years of age. Based on the lowest BMDL05, which was derived from a chronic toxicity study in rats in which a dose-related increase in platelet counts was observed, and the anticipated daily intake of the NF in the target population, the Margins of Exposure are 3.6 and 5, which are generally regarded as not sufficient. However, the total exposure to betaine from the diet (about 830 mg/day) is not known to be associated with adverse effects. Moreover, no adverse effects on platelet counts were noted in human intervention studies with exposure levels of 4 g/day of betaine for up to 6 months. A significant increase in total and low-density lipoprotein (LDL)-cholesterol concentrations was noted at intakes of 4 g/day of betaine in overweight subjects with metabolic syndrome but not in healthy subjects, nor at intakes of 3 g/day. Thus, considering 4 g/day of betaine as a reference point and applying an uncertainty factor of 10 to account for interindividual variability, an amount of 400 mg/day of betaine in addition to the background exposure is considered as safe. The Panelconsiders that the NF is safe to be used at maximum intake of 400 mg/day in the target population

Safety of iron milk proteinate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of iron from this source in the context of Directive 2002/46/EC

Following a request from the European Commission, the EFSA Panel&nbsp;on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on iron milk proteinate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of iron from this source in the context of Directive 2002/46/EC. The NF is a complex of iron, casein and phosphate, which is produced from iron salts (i.e. ferric chloride or ferric sulfate), sodium caseinate and potassium orthophosphate. The NF is proposed by the applicant to be used as a source of iron, of which the NF contains 2–4%. The applicant intends to market the NF as an ingredient in a number of food categories; in food supplements, in total diet replacement for weight control and in foods for special medical purposes. The Panel&nbsp;considers that, taking into account the composition of the NF and the proposed conditions of use, consumption of the NF is not nutritionally disadvantageous. The studies provided for ADME and bioavailability indicate that iron from the NF is bioavailable. Overall, the evidence indicates that upon ingestion the NF undergoes digestion into small peptides to yield iron-bound caseinophosphopeptides that are normal constituents of the human diet, and that the iron from the NF does not bypass the homeostatic control of iron as a nutrient. The Panel&nbsp;concludes that the NF, iron milk proteinate, is safe under the proposed conditions of use. The Panel&nbsp;also concludes that the NF is a source from which iron is bioavailable

Statement on the safety of taxifolin-rich extract from Dahurian Larch (Larix gmelinii)

Following a request from the European Commission, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to carry out a supplementary safety assessment for taxifolin by considering also those population groups which were originally excluded at the request of the applicant (i.e. infants, young children and children up to 9 years) for the food categories set out in the application, and by taking into the extension of use of taxifolin from yogurt to a wider range of dairy products. In 2016, the EFSA NDA Paneladopted the Scientific Opinion on the safety of taxifolin-rich extract from Dahurian Larch (Larix gmelinii) as a novel food ingredient in non-alcoholic beverages, yogurts, chocolate confectionery and food supplements pursuant to Regulation (EC) No 258/97. In order to address the present mandate, an intake assessment was carried out by taking into account all population groups (including now also children below 9years of age) and by considering the food intended categories for which the applicant provided maximum use levels of taxifolin. Intakes were estimated for all age groups of the general population. The highest 95 th percentile intakes per kg bw per day among all population groups are 0.94 and 1.54 mg, respectively, derived for toddlers. Noting that the no-observed-adverse effect level (NOAEL) of the subchronic study was 1,500 mg/kg body weight (bw), the resulting margin of exposure (MOE) would be almost 1,000. For adults weighing 70 kg, the MOE to the combined intake from fortified foods and food supplements would be about 772. For adolescents, taking into account a default mean body weight of 61 kg, the MOE to the combined intake (including 100 mg from food supplements) would be about 627. The Panelconsiders that these MOEs are sufficient. The Panelconcludes that the NF food, taxifolin-rich extract from Dahurian Larch, is safe under the proposed conditions of use

Safety of Ecklonia cava phlorotannins 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 a scientific opinion on the safety of Ecklonia cava phlorotannins (marketed as SeaPolynol) as a novel food submitted pursuant to Regulation (EC) No258/97. The novel food is a phlorotannin-rich alcohol extract of Ecklonia cava, which is an edible marine brown alga species. The information provided on the composition, the specifications, the production process and the batch-to-batch variability of the novel food is sufficient and does not raise safety concerns. The intention is to market the novel food as a food supplement for healthy individuals over the age of 12years. A subchronic repeated dose oral toxicity study in rodents tested the novel food at daily doses of 0, 375, 750 and 1,500mg/kg body weight (bw). The Panelconsiders the mid-dose as the no-observed-adverse-effect-level (NOAEL) of the study. Taking into account this NOAEL of 750mg/kg bw per day and by applying an uncertainty factor of 200, the Panelconsiders an intake level of 3.75mg/kg bw per day as safe. The Panelconcludes that the novel food, Ecklonia cava phlorotannins, is safe for the use in food supplements at a maximum daily intake level of 163mg/day for adolescents from 12 to 14years of age, 230mg/day for adolescents above 14years of age and 263mg/day for adults. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority