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Following an application from Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Cyprus, 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 organic foods and contribution to the protection of body cells and molecules (lipids and DNA) from oxidative damage. The scope of the application was proposed to fall under a health claim referring to children's development and health. The food proposed by the applicant as the subject of the health claim is 'organic foods'. The applicant claimed that organic foods are characterised by their lower level of pesticides residues compared with foods not labelled as organic. The Panel notes, however, that in the application and the human studies submitted the nutritional composition and the pesticide concentration in 'organic food' are not reported. The Panel considers that organic foods which are the subject of the health claim, and the foods that they are intended to replace are not sufficiently characterised. Therefore, the Panel concludes that a cause and effect relationship cannot be established between the consumption of organic foods and contribution to the protection of body cells and molecules (lipids and DNA) from oxidative damage. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

International audience; Following the submission of application EFSA-GMO-RX-009 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified soybean A2704-12, for food and feed uses, import and processing, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. In addition, the applicant provided sequence data on the soybean A2704-12 event using material from a commercial variety currently on the market and intended to be marketed in the coming years. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. The GMO Panel concludes that there is no evidence in the renewal application EFSA-GMORX-009 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean A2704-12.

Following the submission of application EFSA-GMO-RX-012 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified oilseed rape T45, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in oilseed rape T45 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in the renewal application EFSA-GMO-RX-012 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape T45.

Maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 89034, 1507, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the four single events and four of their subcombinations and did not identify safety concerns. No new data on the maize single events or their four subcombinations that could lead to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicates that the combination of the single maize events and of the newly expressed proteins in the four‐event stack maize does not give rise to food/feed safety and nutritional concerns. The GMO Panel concludes that the four‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested. In the case of accidental release of viable grains of the four‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the six maize subcombinations for which no experimental data were provided, and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the four‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the four‐event stack maize. No post‐market monitoring for food/feed is necessary. The GMO Panel concludes that the four‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.

Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in soybean MON 89788 considered for renewal is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐011 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean MON 89788.

Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. In addition, the applicant provided sequence data on the LLCotton25 event using the material from a commercial variety that, according to the applicant, may be imported into the EU at the time of this renewal application. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. The GMO Panel concludes that there is no evidence in the renewal application EFSA‐GMO‐RX‐010 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on LLCotton25.

The scope of application EFSA-GMO-DE-2016-133 is for food and feed uses, import and processing ofgenetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed toconfer tolerance to the herbicidal active substances glyphosate and glufosinate-ammonium. Themolecular characterisation data and bioinformatic analyses do not identify issues requiring food/feedsafety assessment. None of the identified differences in the agronomic/phenotypic and compositionalcharacteristics tested between maize MZHG0JG and its conventional counterpart needs furtherassessment, except for early stand count (pre-thinning). The GMO Panel does not identify safetyconcerns regarding the toxicity and allergenicity of the mEPSPS and PAT proteins as expressed inmaize MZHG0JG, andfinds no evidence that the genetic modification would change the overallallergenicity of maize MZHG0JG. The nutritional impact of food/feed derived from maize MZHG0JG isexpected to be the same as that of food/feed derived from the conventional counterpart andcommercial non-GM maize reference varieties. The GMO Panel concludes that maize MZHG0JG isnutritionally equivalent to and as safe as the conventional counterpart and non-GM maize referencevarieties tested, and no post-market monitoring of food/feed is considered necessary. In the case ofaccidental release of viable maize MZHG0JG grains into the environment, maize MZHG0JG would notraise environmental safety concerns. The post-market environmental monitoring plan and reportingintervals are in line with the intended uses of maize MZHG0JG. In conclusion, the GMO Panel considersthat maize MZHG0JG, as described in this application, is as safe as its conventional counterpart andthe tested non-GM maize reference varieties with respect to potential effects on human and animalhealth and the environment.

International audience; Lipids are an important source of energy for young children and play a major role in the development and functioning of nervous tissue. Essential fatty acids and their long-chain derivatives also fulfill multiple metabolic functions and play a role in the regulation of numerous genes. The Food and Agriculture Organization of the United Nations (FAO), the World Health Organization (WHO), and the French Agency for Food, Environmental and Occupational Health & Safety (Agence nationale de securite sanitaire de rahmentation, de l'environnement et du travail [ANSES]) have recently recommended a minimum daily intake in preformed long-chain polyunsaturated fatty acids (LC-PUFAs): arachidonic acid (ARA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). Mother's milk remains the only reference, but the large variability in its DHA content does not guarantee that breastfed children receive an optimal DHA intake if the mother's intake is insufficient. For children fed with infant formulas, ARA and DHA intake is often below the recommended intake because only one-third of infant formulas available on the market in France are enriched in LC-PUFAs. For all children, linoleic acid (LA) intake is on average higher than the minimal recommended values. The consequences of these differences between intake and recommended values are uncertain. A cautious attitude is to come close to the current recommendations and to advise sufficient consumption of DHA in breastfeeding women. For bottle-fed children, infant formulas enriched in LC-PUFAs and with moderate levels of LA should be preferred. LC-PUFA-rich fish should be consumed during breastfeeding, and adapted vegetable oils when complementary foods are introduced. (C) 2014 Elsevier Masson SAS. All rights reserved.

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.

Lipids are an important source of energy for young children and play a major role in the development and functioning of nervous tissue. Essential fatty acids and their long-chain derivatives also fulfill multiple metabolic functions and play a role in the regulation of numerous genes. The Food and Agriculture Organization of the United Nations (FAO), the World Health Organization (WHO), and the French Agency for Food, Environmental and Occupational Health & Safety (Agence nationale de securite sanitaire de rahmentation, de l'environnement et du travail [ANSES]) have recently recommended a minimum daily intake in preformed long-chain polyunsaturated fatty acids (LC-PUFAs): arachidonic acid (ARA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). Mother's milk remains the only reference, but the large variability in its DHA content does not guarantee that breastfed children receive an optimal DHA intake if the mother's intake is insufficient. For children fed with infant formulas, ARA and DHA intake is often below the recommended intake because only one-third of infant formulas available on the market in France are enriched in LC-PUFAs. For all children, linoleic acid (LA) intake is on average higher than the minimal recommended values. The consequences of these differences between intake and recommended values are uncertain. A cautious attitude is to come close to the current recommendations and to advise sufficient consumption of DHA in breastfeeding women. For bottle-fed children, infant formulas enriched in LC-PUFAs and with moderate levels of LA should be preferred. LC-PUFA-rich fish should be consumed during breastfeeding, and adapted vegetable oils when complementary foods are introduced.

Le lait de femme contient des hormones, des facteurs de croissance, des cytokines, des cellules immunocompétentes, etc., et possède de nombreuses propriétés biologiques. Sa composition varie en fonction de l'âge de l'enfant, de son terme, et du moment de la tétée. La prévalence de l'allaitement maternel en France est une des plus faibles des pays européens : 58 % des enfants nés en France en 2003 étaient allaités au sortir de la maternité, pour une durée médiane de l'ordre de 10 semaines. L'allaitement maternel exclusif permet une croissance normale au moins jusqu'à l'âge de 6 mois, et peut être poursuivi jusqu'à l'âge de 2 ans ou plus, à condition d'être complété par la diversification alimentaire à partir de 6 mois. L'allaitement maternel est associé à un bénéfice sur le plan cognitif, modeste, mais dont il serait dommage de ne pas faire bénéficier l'enfant. Si sa durée est supérieureà 3 mois, l'allaitement maternel exclusif diminue l'incidence et la gravité des infections digestives, ORL et respiratoires. S'il est prolongé idéalement 6 mois, l'allaitement maternel exclusif permet une réduction du risque allergique chez les nourrissons à risque (père, mère, frère ou s½ur allergique). Il participe également à la prévention ultérieure de l'obésité pendant l'enfance et l'adolescence. Parvenus à l'âge adulte, les enfants allaités ont une tension artérielle et une cholestérolémie inférieures à celles des enfants nourris au lait artificiel. L'infection maternelle par le virus de l'hépatite B ou de l'hépatite C ne constitue pas une contre-indication de l'allaitement, à l'inverse de l'infection maternelle par le VIH et de la galactosémie. Une supplémentation en vitamine D et en vitamine K est nécessaire chez le nourrisson au sein. Très peu de médicaments contre-indiquent de façon formelle la poursuite de l'allaitement maternel. Le prématuré peut être allaité par sa mère et/ou recevoir son lait, sous réserve qu'il reçoive une supplémentation en énergie, protéines et sels minéraux. La perte de poids de la mère est plus rapide dans les 6 premiers mois du post-partum. L'allaitement maternel diminue l'incidence des cancers du sein et de l'ovaire avant la ménopause, et supprime l'augmentation du risque d'ostéoporose lié à la ménopause.

La dénutrition protéino-énergétique (DPE) est l'état pathologique résultant d'une inadéquation entre les besoins et les apports protéino-énergétiques. Elle est délétère par ses conséquences fonctionnelles et structurelles (perte tissulaire) et peut entraîner une augmentation de la morbidité, voire de la mortalité d_une éventuelle pathologie sous-jacente. Le Comité de nutrition de la Société française de pédiatrie (SFP) recommande de peser et de mesurer tout enfant quel que soit le contexte de visite ou d_hospitalisation. En l'absence d_information sur la cinétique de la croissance, l'indice de masse corporelle (IMC) doit être calculé et interprété en fonction des courbes de référence figurant dans le carnet de santé. Pour tout IMC < 3e percentile pour l'âge et le sexe, il est recommandé d'examiner l'enfant à la recherche de signes cliniques de dénutrition ou de signes orientant vers son origine et de tracer l'évolution de la croissance staturopondérale (IMC et taille). Toute dénutrition, qu'elle soit identifiée en pédiatrie communautaire ou en milieu hospitalier, nécessite d'établir une stratégie nutritionnelle intégrée à la prise en charge globale de l'enfant. Elle suppose de définir le poids cible et d'adapter les apports protéino-énergétiques en termes de niveaux, de composition et de modalités d'administration (orale, entérale, parentérale). Dans tous les cas cette attitude sera évaluée et adaptée selon l'effet obtenu. Protein energy malnutrition (PEM) occurs when energy and protein intake do not meet requirements. It has a functional and structural impact and increases both morbidity and mortality of a given disease. The Nutrition Committee of the French Pediatric Society recommends weighing and measuring any child when hospitalized or seen in consultation. The body mass index (BMI) must be calculated and analyzed according to references any time growth kinetics cannot be analyzed. Any child with a BMI below the third centile or -2 standard deviations for age and sex needs to be examined looking for clinical signs of malnutrition and signs orienting toward an etiology and requires having his BMI and height dynamics plotted on a chart. PEM warrants drawing up a nutritional strategy along with the overall care plan. A target weight needs to be determined as well as the quantitative and qualitative nutritional care including its implementation. This plan must be evaluated afterwards in order to adapt the nutritional therapy.

New data on food allergy has recently changed the management of children with cow's milk protein allergy (CMPA). The diagnosis of CMPA first requires the elimination of cow's milk proteins and then an oral provocation test following a standard diagnostic procedure for food allergy, without which the elimination diet is unjustified and sometimes harmful. Once the diagnosis is made, the elimination diet is strict, at least until the age of 9-12 months. If the child is not breastfed or the mother cannot or no longer wishes to breastfeed, the first choice is a formula based on extensive hydrolyzate of cow's milk (eHF), provided that its effectiveness has been demonstrated. When eHF fails, a formula based on amino acids is warranted. eHF based on rice protein hydrolysates is an alternative to cow's milk eHF. Infant formulas based on soy protein can be used after the age of 6 months, after verification of good clinical tolerance to soy. Most commonly, CMPA disappears within 2 or 3 years of life. However, the age of recovery varies depending on the child and the type of CMPA, and whether or not it is IgE-mediated, the first being more sustainable. When the child grows, a hospital oral provocation test evaluates the development of tolerance and, if possible, authorizes continuing the reintroduction of milk proteins at home. Some children with CMPA will tolerate only a limited daily amount of cow's milk proteins. The current therapeutic options are designed to accelerate the acquisition of tolerance, which seems facilitated by regular exposure to cow's milk proteins.

BACKGROUND: We have previously observed associations of the T-allele of the exon 18 variant (ACC --> ACT; Thr759Thr) of the sulfonylurea receptor 1 (SUR1) gene with type 2 diabetes mellitus (T2DM). Here we assess beta-cell function and insulin sensitivity in carriers of different genotypes at this locus. METHODS: Pre-hepatic insulin secretion rates (ISR) derived by deconvolution of circulating C-peptide levels, and glucose clearance were assessed during graded infusions of intravenous glucose in CC-homozygous (n=6) and CT-heterozygous (n=6) nondiabetic relatives of CT-heterozygous type 2 diabetic subjects. RESULTS: Average ISR over the duration of the study, adjusted for sex, age, BMI and prevailing glucose levels, were lower in CT-heterozygous subjects as compared with CC-homozygous subjects (3.91 +/- 0.40 vs. 4.84 +/- 0.28 pmol/kg x min(-1); p=0.048). The correlation curves relating ISR to glucose levels were significantly different in the two groups (analyses of covariance p=0.029). Glucose clearance was similar in both groups. CONCLUSIONS: Insulin secretion rates, but not insulin sensitivity, assessed during graded infusion of glucose were mildly decreased in nondiabetic relatives of type 2 diabetic subjects, who carry the at risk T-allele of exon 18 variant of the SUR1 gene. These results suggest that the at-risk allele might have a small effect on pancreatic B-cell function and contribute to the development of T2DM in these families.