Mutagenicity testing with transgenic mice. Part II: Comparison with the mouse spot test

The mouse spot test, an in vivo mutation assay, has been used to assess a number of chemicals. It is at present the only in vivo mammalian test system capable of detecting somatic gene mutations according to OECD guidelines (OECD guideline 484). It is however rather insensitive, animal consuming and expensive type of test. More recently several assays using transgenic animals have been developed. From data in the literature, the present study compares the results of in vivo testing of over twenty chemicals using the mouse spot test and compares them with results from the two transgenic mouse models with the best data base available, the lacI model (commercially available as the Big Blue(® )mouse), and the lacZ model (commercially available as the Muta™ Mouse). There was agreement in the results from the majority of substances. No differences were found in the predictability of the transgenic animal assays and the mouse spot test for carcinogenicity. However, from the limited data available, it seems that the transgenic mouse assay has several advantages over the mouse spot test and may be a suitable test system replacing the mouse spot test for detection of gene but not chromosome mutations in vivo

Green kiwifruit (lat. Actinidia deliciosa var. Hayward) and maintenance of normal defecation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Zespri International Limited, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to green kiwifruit (lat. Actinidia deliciosa var. Hayward) and maintenance of normal defecation. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is green kiwifruit. The Panel considers that green kiwifruit (Actinidia deliciosa var. Hayward) is sufficiently characterised. The claimed effect proposed by the applicant is 'maintenance of normal defecation'. Maintenance of normal defecation is a beneficial physiological effect provided that it does not result in diarrhoea. All human intervention studies submitted had different limitations and could not be used on their own for the scientific substantiation of the claim. However, the results of six pertinent human intervention studies are consistent with respect to an effect of consuming daily between two and four green kiwifruits var. Hayward on an increase in stool frequency. Two out of four studies in which a validated instrument was used to assess stool consistency showed an effect also on stool consistency. There is evidence for a plausible mechanism by which kiwifruit could exert an effect on normal defecation. The consumption of kiwifruit in the studies did not result in diarrhoea. A cause and effect relationship has been established between the consumption of green kiwifruit (Actinidia deliciosa var. Hayward) and maintenance of normal defecation. The following wordings reflect the scientific evidence: 'consumption of kiwifruit contributes to the maintenance of normal defecation'. In order to obtain the claimed effect, two large green kiwifruits (i.e. around 200 g of kiwi flesh) should be consumed

Scientific advice related to nutrient profiling for the development of harmonised mandatory front-of-pack nutrition labelling and the setting of nutrient profiles for restricting nutrition and health claims on foods

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver scientific advice related to nutrient profiling for the development of harmonised mandatory front‐of‐pack nutrition labelling and the setting of nutrient profiles for restricting nutrition and health claims on foods. This Opinion is based on systematic reviews and meta‐analyses of human studies on nutritionally adequate diets, data from the Global Burden of Disease framework, clinical practice guidelines, previous EFSA opinions and the priorities set by EU Member States in the context of their Food‐Based Dietary Guidelines and associated nutrient/food intake recommendations. Relevant publications were retrieved through comprehensive searches in PubMed. The nutrients included in the assessment are those likely to be consumed in excess or in inadequate amounts in a majority of European countries. Food groups with important roles in European diets have been considered. The Panel concludes that dietary intakes of saturated fatty acids (SFA), sodium and added/free sugars are above, and intakes of dietary fibre and potassium below, current dietary recommendations in a majority of European populations. As excess intakes of SFAs, sodium and added/free sugars and inadequate intakes of dietary fibre and potassium are associated with adverse health effects, they could be included in nutrient profiling models. Energy could be included because a reduction in energy intake is of public health importance for European populations. In food group/category‐based nutrient profiling models, total fat could replace energy in most food groups owing to its high‐energy density, while the energy density of food groups with low or no fat content may be well accounted for by the inclusion of (added/free) sugars. Some nutrients may be included in nutrient profiling models for reasons other than their public health importance, e.g. as a proxy for other nutrients of public health importance, or to allow for a better discrimination of foods within the same food category

Joselito® and lowering of LDL-cholesterol concentration, blood pressure, and reduction of coronary heart disease risk: Evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

AbstractFollowing an application from Cárnicas Joselito S.A. pursuant to Article 14 ofRegulation (EC) No 1924/2006 via the Competent Authority of Spain, the Panel onNutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinionon the scientific substantiation of a health claim related to ‘Joselito ham increasesantioxidant substances in the body, reduces blood pressure and plasma triglycerides,decreases oxidative stress and prevents effect in diseases related to the cardiovascularand intestinal systems’. The scope of the application was proposed to fall under ahealth claim referring to disease risk reduction. The food constituent that is thesubject of the health claim is Joselito, an Iberian ham characterised by a high con-tent of oleic acid. The Panel considers that the food is sufficiently characterised.The Panel considers that lowering of LDL-cholesterol concentration and bloodpressure is a beneficial effect by decreasing the risk of coronary heart disease.Upon a request from EFSA, the applicant identified one human intervention studyas being pertinent to the claim. However, due to methodological limitations, thePanel considers that no conclusions can be drawn from this study for the scientificsubstantiation of the claim. The Panel notes that no human intervention studiesfrom which conclusions could be drawn for the scientific substantiation of theclaim were provided by the applicant. The Panel concludes that a cause and effectrelationship has not been established between the intake of Joselito® ham and thereduction of LDL-cholesterol concentration or blood pressure

‘Citicoline’ and support of the memory function: Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

AbstractFollowing an application from Egde Pharma Sp. z o.o, submitted for authorisa-tion of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006via the Competent Authority of Poland, the EFSA Panel on Nutrition, Novel Foodsand Food Allergens (NDA) was asked to deliver an opinion on the scientific sub-stantiation of a health claim related to citicoline and memory. The Panel considersthat the food, citicoline (cytidine 5-diphosphocholine, CDP- Choline) inner salt, issufficiently characterised. Improvement, maintenance or reduced loss of memoryis a beneficial physiological effect for middle-aged or elderly adults encounter-ing age-associated subjective memory impairment. The applicant identified threepertinent human intervention studies in healthy individuals that investigated theeffect of citicoline on memory. In weighing the evidence, the Panel took into ac-count that only one randomised controlled trial in healthy participants showed abeneficial effect of citicoline on episodic memory when consumed at doses of 500mg/day for 12 weeks, whereas this effect has not been observed in another studyusing citicoline at doses of 1 g/day for 3 months or supported by data obtainedin patients with dementia using doses of 1 g/day for 12 weeks and 12 months. Noconvincing evidence of a plausible mechanism by which citicoline or any of itscomponents (in addition to their endogenous synthesis) could exert an effect onmemory in humans has been provided. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of citico-line (CDP- Choline) inner salt and improvement, maintenance or reduced loss ofmemory in middle-aged or elderly adults encountering age-associated subjectivememory impairment

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

Statement on additional scientific evidence in relation to the essential composition of total diet replacement for weight control

Acknowledgements: The Panel wishes to thank the following EFSA staff members for the support provided to this scientific output: Oceane Albert, Fabio Alfieri, Carsten Behring, Janusz Ciok, Ester Artau Cortacans, Jose Cortin~as Abrahantes, Ionut Craciun, Celine Dumas, Lucia Fabiani, Estefania Noriega Fernandez, Irene Mun~oz Guajardo, Tilemachos Goumperis, Leonard Matijevic, Charlotte Salgaard Nielsen, Gabriela Precup and Ruth Roldan.Peer reviewedPublisher PD

Efficacy of an infant formula manufactured from a specific protein hydrolysate derived from whey protein isolate and concentrate produced by Société des Produits Nestlé S.A. in reducing the risk of developing atopic dermatitis

The European Commission asked EFSA to evaluate the efficacy of an infant formula, containing a specific protein hydrolysate derived from whey protein isolate and concentrate and manufactured by Société des Produits Nestlé S.A., in reducing the risk of developing atopic dermatitis in infants with a family history of allergy. This was following the submission of a dossier by Société des Produits Nestlé S.A. to the European Commission, in the context of Regulation (EU) 2016/127. The protein hydrolysate from which the infant formula is produced is included in Annex I and II of Commission delegated Regulation (EU) 2016/127 as suitable protein source for the manufacture of infant and follow-on formulae. This opinion does not cover the assessment of the nutritional safety and suitability of the infant formula or the safety of the food enzymes used in the manufacture of the protein hydrolysate. The Panel considers that, in relation to the effect that is claimed, the infant formula under evaluation is not sufficiently characterised with respect to the molecular weight distribution of peptides. From the human intervention studies submitted, no conclusions could be drawn on the efficacy of the infant formula in reducing the risk of developing atopic dermatitis. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of the infant formula under evaluation and the reduction in the risk of developing atopic dermatitis in infants with a family history of allergy

Scientific Opinion on the energy conversion factor of d‐tagatose for labelling purposes

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutritionand Allergies (NDA) was asked to deliver a scienti\ufb01c opinion on the energy conversion factor ofD-tagatose to be used for calculating the energy value of foods to be declared in nutrition labelling.Energy conversion factors for nutrients for the purpose of nutrition labelling have been set based onthe concept of metabolisable energy (ME). The same methodology has been applied to calculate theenergy conversion factor forD-taga tose in this opinion. The assessment is based on a dossier preparedfor Nutrilab NV and submitted by Bioresco Ltd. At present, data are insuf\ufb01cient to derive an accurateME value forD-tagatose. Relying on the human data indicating a mean absorption rate of 80% (range69\u201388%) and a urinary excretion of either 1% or 5%, the corresponding energy values forD-tagatosewould be 2.8 kcal/g (11.8 kJ/g) and 2.96 kcal/g (12.4 kJ/g), respectively. Taking into account that theremaining 20% ofD-tagatose which is not absorbed in the sma ll intestine is fermented in the colonand may deliver at least some energy, e.g. in form of short-chain fatty acids, the Panel concludes thata rounded estimate of the energy conversion factor forD-tagatose based on the available data andcalculated as ME would be 3 kcal/g (12.5 kJ/g). The Panel considers that additional data on theabsorption, distribution, metabolism and excretion ofD-tagatose in humans w ould help in thecalculation of a more accurate energy conversion factor forD-tagatose based on the concept of ME

Scientific opinion on the relationship between intake of alpha-lipoic acid (thioctic acid) and the risk of insulin autoimmune syndrome

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the relationship between alpha-lipoic acid (ALA) and the risk of insulin autoimmune syndrome (IAS). The Panel was also asked to advise on the dose below which ALA added to foods is not expected to cause IAS. A review of all possible adverse effects associated with consumption of ALA was not requested. This mandate refers to the procedure under Article 8(2) of Regulation (EC) No 1925/2006 on addition of vitamins, minerals and certain other substances to foods. No pre-established rule exists for the evaluation of the safety of foods when classical toxicity tests cannot be used, e.g. for autoimmune diseases. Published scientific evidence was retrieved through comprehensive literature searches, particularly 49 case reports in which IAS developed following ALA consumption. In all cases, IAS resolved after a few weeks to months when ALA was discontinued. No publication linking the intake of ALA naturally occurring in foods to IAS was identified. The Panel concludes that the consumption of ALA added to foods, including food supplements, is likely to increase the risk of developing IAS in individuals with certain genetic polymorphisms, who cannot be readily identified without genetic testing. The plausible mechanism of such an effect has not yet been fully elucidated. The incidence of IAS in Europe is low and likely lower than in Japan where it has been estimated to be 0.017 per 100,000 inhabitants in 2017-2018. Considering the limited data available, the risk associated with the development of IAS following ALA consumption cannot be quantified precisely. An ALA dose below which IAS is not expected to occur is likely to vary between individuals and cannot be determined from the available data. (c) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority