EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on establishing Food-Based Dietary Guidelines

This Opinion of the EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA) provides guidance on the translation of nutrient based dietary advice into guidance, intended for the European population as a whole, on the contribution of different foods or food groups to an overall diet that would help to maintain good health through optimal nutrition (food-based dietary guidelines). The main focus of this Opinion is put on the scientific process of developing food-based dietary guidelines (FBDG) for the diverse European populations, following a stepwise approach which should ideally consist of: 1) Identification of diet-health relationships, 2) Identification of country specific diet-related health problems, 3) Identification of nutrients of public health importance, 4) Identification of foods relevant for FBDG, 5) Identification of food consumption patterns, 6) Testing and optimising FBDG and 7) Graphical representations of FBDG. FBDG should focus on the diet-disease relationships of particular relevance to the specific population and should be developed using a multi-disciplinary approach. The early involvement of stakeholders is recommended to promote the acceptance of the outcome. FBDG should be consistent with other public policies that have an impact on food availability and be integrated with other policies related to health promotion. Once established, FBDG should be implemented and their impact monitored and evaluate

Scientific Opinion on the substantiation of a health claim related to fermented milk containing Lactobacillus casei DN-114 001 plus yoghurt symbiosis (Actimel\uae), and reduction of Clostridium difficile toxins in the gut of patients receiving antibiotics and reduced risk of acute diarrhoea in patients receiving antibiotics pursuant to Article 14 of Regulation (EC) No 1924/2006

Following an application from Danone Produits Frais France submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to a fermented milk drink Actimel\uae containing Lactobacillus casei (Lc) DN-114 001 and reduction of the presence of Clostridium difficile toxins in the gut which reduces the incidence of acute diarrhoea. The Panel considers that the food constituent, Actimel\uae, which is the subject of the health claim, is sufficiently characterised. The Panel considers that reducing the risk of Clostridium difficile diarrhoea by reducing the presence of C. difficile toxins is a beneficial physiological effect. In total the applicant indicated seven publications on human studies, three unpublished human studies, eight published and one unpublished non-human studies to be pertinent for the claimed effect. In weighing the evidence, the Panel took into account that human and animal studies showed partial survival of Lc DN-114 001 during its gastrointestinal passage, that one human intervention study with Actimel\uae which showed a statistically significant risk reduction for CDAD had considerable limitations, that there were only limited data on the effect of Actimel\uae on the reduction C. difficile toxins (the risk factor) in humans, that one study which showed an inhibitory effect of Lc DN-114 001 on the growth of C. difficile in vitro does not predict the occurrence of an effect against C. difficile in humans, that five further human studies do not support the proposed mechanisms by which Actimel\uae could exert the claimed effect, and that the evidence provided from a further two animal and three in vitro studies does not establish that effects of Actimel\uae or Lc DN-114 001 in these model systems related to immune function and infection can predict the occurrence of such effects in humans. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of Actimel\uae and a reduction of the risk of C. difficile diarrhoea by reducing the presence of C. difficile toxins

Scientific opinion on the substantiation of health claims related to olive oil and maintenance of normal blood LDL-cholesterol concentrations (ID 1316, 1332), maintenance of normal (fasting) blood concentrations of triglycerides (ID 1316, 1332), maintenance of normal blood HDL-cholesterol concentrations (ID 1316, 1332) and maintenance of normal blood glucose concentrations (ID 4244) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to olive oil and maintenance of normal blood LDL-cholesterol concentrations, maintenance of normal (fasting) blood concentrations of triglycerides, maintenance of normal blood HDL-cholesterol concentrations and maintenance of normal blood glucose concentrations. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food that is the subject of the health claims is olive oil. The Panel considers that olive oil is sufficiently characterised in relation to the claimed effect

Scientific opinion on the substantiation of health claims related to maize oil and maintenance of normal blood LDL-cholesterol concentrations (ID 3086) pursuant to article 13(1) of regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to maize oil and maintenance of normal blood LDL-cholesterol concentrations. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food that is the subject of the health claim is maize oil. The Panel considers that maize oil is sufficiently characterised in relation to the claimed effect. The claimed effect is \u201ccorn oil with a guaranteed polyunsaturated fatty acids content (56 % of total fatty acids), supplemented with vitamin E\u201d. The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effect refers to maintenance of normal LDL-blood cholesterol concentrations. The Panel considers that maintenance of normal blood LDL-cholesterol concentrations is a beneficial physiological effect. No studies that investigated whether maize oil had a cholesterol-lowering effect beyond what could be expected from the fatty acid composition of maize oil have been provided. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of maize oil and maintenance of normal blood LDL-cholesterol concentrations beyond what could be expected from the fatty acid composition of maize oil. A claim on the replacement of mixtures of SFAs with cis-MUFAs and/or cis-PUFAs in foods or diets and maintenance of normal blood LDL-cholesterol concentrations has already been assessed with a favourable outcome. A claim on linoleic acid and maintenance of normal blood cholesterol concentrations has also already been assessed with a favourable outcome

Nutritional safety and suitability of a specific protein hydrolysate derived from a whey protein concentrate and used in an infant formula and follow-on formula manufactured from hydrolysed protein by FrieslandCampina Nederland B.V

The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from a whey protein concentrate and used in an infant and follow-on formula manufactured by FrieslandCampina Nederland B.V., which submitted a dossier to the European Commission to request an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in the manufacture of infant and/or follow-on formula. The protein hydrolysate under evaluation is sufficiently characterised with respect to the fraction of the hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 2.4 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to a growth equivalent to a formula manufactured from intact cow's milk protein with a protein content of 2.1 g/100 kcal. Data on gastrointestinal tolerance of the formula did not raise any concerns. No experimental data have been provided on the nutritional safety and suitability of this protein source in follow-on formula. Given that it is consumed with complementary foods and the protein source is nutritionally safe and suitable in an infant formula that is the sole source of nutrition of infants, the Panel considers that the protein hydrolysate is also a nutritionally safe and suitable protein source for use in follow-on formula. The Panel concludes that the protein hydrolysate under evaluation is a nutritionally safe and suitable protein source for use in infant and follow-on formula, as long as the formula in which it is used contains a minimum of 2.4 g/100 kcal protein and complies with the compositional criteria of Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA

Nutritional safety and suitability of a specific protein hydrolysate derived from whey protein concentrate and used in an infant and follow-on formula manufactured from hydrolysed protein by HIPP-Werk Georg Hipp OHG (dossier submitted by meyer.science GmbH)

The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from whey protein concentrate and used in infant and follow-on formula by HIPP-Werk Georg Hipp OHG. The dossier that was submitted to the European Commission aimed at requesting an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in infant and/or follow-on formula. This opinion does not cover the assessment of the safety of the food enzymes used in the manufacture of the protein hydrolysate. The protein hydrolysate under evaluation is sufficiently characterised with respect to the fraction of the hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 1.9 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to growth equivalent to a formula manufactured from intact cow’s milk protein with the same protein content. No experimental data have been provided on the nutritional safety and suitability of this protein source in follow-on formula. However, given that it is consumed with complementary foods and the protein source is considered nutritionally safe and suitable in an infant formula that is the sole source of nutrition of infants, the Panel considers that the protein hydrolysate is also a nutritionally safe and suitable protein source for use in follow-on formula. The Panel concludes that the protein hydrolysate under evaluation is a nutritionally safe and suitable protein source for use in infant and follow-on formula, as long as the formula in which it is used contains a minimum of 1.9 g/100 kcal protein and complies with the compositional criteria of Commission Delegated Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA

Nutritional safety and suitability of a specific protein hydrolysate derived from whey protein concentrate and used in an infant and follow-on formula manufactured from hydrolysed protein by Danone Trading ELN B.V

The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from whey protein concentrate and used in an infant and follow-on formula by Danone Trading ELN B.V, which submitted a dossier to the European Commission to request an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in the manufacture of infant and/or follow-on formula. This opinion does not cover the assessment of the safety of the food enzymes used in the manufacture of the protein hydrolysate. The protein hydrolysate under evaluation is sufficiently characterised with respect to the fraction of the hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 2.3 g/100 kcal and consumed as the sole source of nutrition by infants for 3.5 months led to growth equivalent to a formula manufactured from intact cow's milk protein (2 g protein/100 kcal). No experimental data have been provided on the nutritional safety and suitability of this protein source in follow-on formula. However, given that it is consumed with complementary foods and the protein source is considered nutritionally safe and suitable in an infant formula that is the sole source of nutrition of infants, the Panel considers that the protein hydrolysate is also a nutritionally safe and suitable protein source for use in follow-on formula. The Panel concludes that the protein hydrolysate under evaluation is a nutritionally safe and suitable protein source for use in infant and follow-on formula, as long as the formula in which it is used contains a minimum of 2.3 g/100 kcal protein and complies with the compositional criteria of Commission Delegated Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA

Scientific Opinion on the substantiation of health claims related to iron and formation of red blood cells and haemoglobin (ID 374, 2889), oxygen transport (ID 255), contribution to normal energy-yielding metabolism (ID 255), reduction of tiredness and fatigue (ID 255, 374, 2889), biotransformation of xenobiotic substances (ID 258), and activity of heart, liver and muscles (ID 397) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to iron and formation of red blood cells and haemoglobin, oxygen transport, contribution to normal energy-yielding metabolism, reduction of tiredness and fatigue, biotransformation of xenobiotic substances and \u201cactivity of heart, liver and muscles\u201d. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claims is iron. The Panel considers that iron is sufficiently characterised

Appropriate age range for introduction of complementary feeding into an infant's diet

Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) revised its 2009 Opinion on the appropriate age for introduction of complementary feeding of infants. This age has been evaluated considering the effects on health outcomes, nutritional aspects and infant development, and depends on the individual’s characteristics and development. As long as foods have an age-appropriate texture, are nutritionally appropriate and prepared following good hygiene practices, there is no convincing evidence that at any age investigated in the included studies (< 1 to < 6 months), the introduction of complementary foods (CFs) is associated with adverse health effects or benefits (except for infants at risk of iron depletion). For nutritional reasons, the majority of infants need CFs from around 6 months of age. Infants at risk of iron depletion (exclusively breastfed infants born to mothers with low iron status, or with early umbilical cord clamping (< 1 min after birth), or born preterm, or born small-for-gestational age or with high growth velocity) may benefit from earlier introduction of CFs that are a source of iron. The earliest developmental skills relevant for consuming pureed CFs can be observed between 3 and 4 months of age. Skills for consuming finger foods can be observed in some infants at 4 months, but more commonly at 5–7 months. The fact that an infant may be ready from a neurodevelopmental perspective to progress to a more diversified diet before 6 months of age does not imply that there is a need to introduce CFs. There is no reason to postpone the introduction of potentially allergenic foods (egg, cereals, fish and peanut) to a later age than that of other CFs as far as the risk of developing atopic diseases is concerned. Regarding the risk of coeliac disease, gluten can be introduced with other CFs

Dietary Reference Values for riboflavin

Following a request from the European Commission, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) derives dietary reference values (DRVs) for riboflavin. The Panelconsiders that the inflection point in the urinary riboflavin excretion curve in relation to riboflavin intake reflects body saturation and can be used as a biomarker of adequate riboflavin status. The Panelalso considers that erythrocyte glutathione reductase activation coefficient is a useful biomarker, but has limitations. For adults, the Panelconsiders that average requirements (ARs) and population reference intakes (PRIs) can be determined from the weighted mean of riboflavin intake associated with the inflection point in the urinary riboflavin excretion curve reported in four intervention studies. PRIs are derived for adults and children assuming a coefficient of variation of 10%, in the absence of information on the variability in the requirement and to account for the potential effect of physical activity and the methylenetetrahydrofolate reductase 677TT genotype. For adults, the AR and PRI are set at 1.3and 1.6mg/day. For infants aged 7-11months, an adequate intake of 0.4mg/day is set by upward extrapolation from the riboflavin intake of exclusively breastfed infants aged 0-6months. For children, ARs are derived by downward extrapolation from the adult AR, applying allometric scaling and growth factors and considering differences in reference body weight. For children of both sexes aged 1-17years, ARs range between 0.5 and 1.4mg/day, and PRIs between 0.6 and 1.6mg/day. For pregnant or lactating women, additional requirements are considered, to account for fetal uptake and riboflavin accretion in the placenta during pregnancy or the losses through breast milk, and PRIs of 1.9 and 2.0mg/day, respectively, are derived