Transcription-coupled and global genome repair differentially influence UV-B-induced acute skin effects and syste

Exposure to UV-B radiation impairs immune responses in mammals by inhibiting especially Th1-mediated contact hypersensitivity and delayed-type hypersensitivity. Immunomodulation is not restricted to the exposed skin, but is also observed at distant sites, indicating the existence of mediating factors such as products from exposed skin cells or photoactivated factors present in the superficial layers. DNA damage appears to play a key role, because enhanced nucleotide excision repair (NER) strongly counteracts immunosuppression. To determine the effects of the type and genomic location of UV-induced DNA damage on immunosuppression and acute skin reactions (edema and erythema) four congenic mouse strains carrying different defects in NER were compared: CSB and XPC mice lacking transcription-coupled or global genome NER, respectively, as well as XPA and TTD/XPD mice carrying complete or partial defects in both NER subpathways, respectively. The major conclusions are that 1) transcription-coupled DNA repair is the dominant determinant in protection against acute skin effects; 2) systemic immunomodulation is only affected when both NER subpathways are compromised; and 3) sunburn is not related to UV-B-induced immunosuppression

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

L-carnitine and contribution to normal lipid metabolism:evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 via the Competent Authority of Germany, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to L-carnitine and normal lipid metabolism. The food that is proposed as the subject of the health claim is L-carnitine. The Panelconsiders that L-carnitine is sufficiently characterised. The claimed effect proposed by the applicant is normal lipid metabolism'. The target population proposed by the applicant is the general population. The Panelconsiders that contribution to normal lipid metabolism is a beneficial physiological effect. The applicant proposes that the claim submitted with this application is based on the essentiality of a nutrient. The Panelconsiders that the evidence provided does not establish that dietary L-carnitine is required to maintain normal lipid metabolism in the target population, for which the claim is intended. The Panelconcludes that a cause and effect relationship has not been established between the consumption of L-carnitine and contribution to normal lipid metabolism in the target population

Scientific Opinion related to a notification from DuPont Nutrition Biosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certain emulsifiers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 – for permanent exemption from labelling

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition andAllergies (NDA) was asked to deliver a scienti\ufb01c opinion related to a noti\ufb01cation from DuPont NutritionBiosciences Aps on behenic acid from mustard seeds to be used in the manufacturing of certainemulsi\ufb01ers pursuant to Article 21(2) of Regulation (EU) No 1169/2011 \u2013 for permanent exemptionfrom labelling. Behenic acid is produced from rapeseed\u2013mustard seed variants prevalent in India,namely Brassica juncea (L.) Czern. (oriental mustard), Brassica rapa (L.) (brown/yellow Sarson orToria), Brassica napus (L.) (rapeseed) and Brassica nigra (L.) W.D.J.Koch (black mustard). No humanor animal allergenicity data were provided by the applic ant for either behenic acid or the emulsi\ufb01ersmanufactured from beheni c acid. Based on enzyme-linke d immunosorbent assay (ELISA) data, thePanel considers that proteins and peptides may not be carried over into behenic acid after the twodistillation steps reported in the manufacturing process in amounts beyond 1 mg/kg. The Panel notesthat the maximum amount of mustard protein that could be consumed from emulsi\ufb01ers manufacturedfrom behenic acid (E 470a, E 471 and E 477) on a single occasion by an adult under the proposedconditions of use would be around 0.00119 mg, which is about 1,000 times lower than the proteindoses repo rted to trigger allergic reactions in mustard-allergic individuals (around 1 mg). On the basisof the data presented, the Panel concludes that oral consumption of emulsi\ufb01ers manufactured usingbehenic acid from mustard seeds (E 470a, E 471 and E 477) are unli kely to trigger an allergic reactionin susceptible individuals (i.e. mustard-allergic individuals) under the proposed conditions of use

L-carnitine and contribution to normal lipid metabolism : evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No1924/2006 via the Competent Authority of Germany, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to L-carnitine and normal lipid metabolism. The food that is proposed as the subject of the health claim is L-carnitine. The Panelconsiders that L-carnitine is sufficiently characterised. The claimed effect proposed by the applicant is normal lipid metabolism'. The target population proposed by the applicant is the general population. The Panelconsiders that contribution to normal lipid metabolism is a beneficial physiological effect. The applicant proposes that the claim submitted with this application is based on the essentiality of a nutrient. The Panelconsiders that the evidence provided does not establish that dietary L-carnitine is required to maintain normal lipid metabolism in the target population, for which the claim is intended. The Panelconcludes that a cause and effect relationship has not been established between the consumption of L-carnitine and contribution to normal lipid metabolism in the target 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

Symbiosal((R)) and lowering of blood pressure and reduced risk of hypertension : evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Following an application from Flan-Biotech GmbH, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, 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 Symbiosal((R)), lowering of blood pressure and reduced risk of hypertension. The Panel considers that the food, Symbiosal((R)), which is the subject of the health claim, and the food, table salt, which Symbiosal((R)) should replace, are sufficiently characterised. Lowering of blood pressure is a beneficial physiological effect. Increased blood pressure is a risk factor for hypertension. In weighing the evidence, the Panel took into account that one human study with some methodological limitations showed an effect of Symbiosal((R)) on blood pressure in the context of a self-selected diet with a maximum of 3 g/day added salt. The Panel also took into account that no other human studies in which these results have been replicated were provided, that the animal studies did not support the results of the human study, that no evidence was provided in support of a mechanism by which Symbiosal((R)) could induce a decrease in blood pressure upon oral consumption as compared to table salt in vivo in humans, and the low biological plausibility of the effect observed in the human intervention study. The Panel concludes that a cause and effect relationship has not been established between the consumption of Symbiosal((R)) and lowering of blood pressure. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe

NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk and reduction of the loss of vision : evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Newtricious R&D B.V., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panelon Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to NWT-02 and a reduction of the loss of vision. The food proposed by the applicant as the subject of the health claim is NWT-02. NWT-02 is standardised by its content in lutein (>= 1.10 mg), zeaxanthin (>= 0.20 mg) and docosahexaenoic acid (DHA) (>= 170 mg). The Panel considers that the food/constituent that is the subject of the health claim, NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, is sufficiently characterised. The claimed effect proposed by the applicant is 'reduces loss of vision'. The target population proposed by the applicant is 'healthy adults over 50 years of age'. The Panel considers that a reduction of the loss of vision is a beneficial physiological effect. The applicant provided two human intervention studies for the scientific substantiation of the claim. The Panel considers that the only study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of NWT-02 on vision. The Panel concludes that a cause and effect relationship has not been established between the consumption of NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, and a reduction of the loss of vision. (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Peer reviewe