Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority

The European Food Safety Authority (EFSA) has been involved in the risk assessment of novel foods since 2003. The implementation of the current novel food regulation in 2018 rendered EFSA the sole entity of the European Union responsible for such safety evaluations. The risk assessment is based on the data submitted by applicants in line with the scientific requirements described in the respective EFSA guidance document. The present work aims to elaborate on the rationale behind the scientific questions raised during the risk assessment of novel foods, with a focus on complex mixtures and whole foods. Novel foods received by EFSA in 2003-2019 were screened and clustered by nature and complexity. The requests for additional or supplementary information raised by EFSA during all risk assessments were analyzed for identifying reoccurring issues. In brief, it is shown that applications concern mainly novel foods derived from plants, microorganisms, fungi, algae, and animals. A plethora of requests relates to the production process, the compositional characterization of the novel food, and the evaluation of the product's toxicological profile. Recurring issues related to specific novel food categories were noted. The heterogeneous nature and the variable complexity of novel foods emphasize the challenge to tailor aspects of the evaluation approach to the characteristics of each individual product. Importantly, the scientific requirements for novel food applications set by EFSA are interrelated, and only a rigorous and cross-cutting approach adopted by the applicants when preparing the respective application dossiers can lead to scientifically sound dossiers. This is the first time that an in-depth analysis of the experience gained by EFSA in the risk assessment of novel foods and of the reasoning behind the most frequent scientific requests by EFSA to applicants is made

Ouvrir plus, ouvrir mieux

L’Agence régionale du livre PACA et l’enssib proposent une journée professionnelle consacrée à l’amélioration de la facilité d’accès aux bibliothèques. Ce thème anime la profession depuis une dizaine d’années et est étayé par des études montrant la mutation du rapport de l’usager à la bibliothèque. Ce changement de comportement individuel peut s’observer sous les angles de la gestion du temps social et l’aménagement des temps urbains

A targeted next-generation sequencing assay for the molecular diagnosis of genetic disorders with orodental involvement.

BACKGROUND: Orodental diseases include several clinically and genetically heterogeneous disorders that can present in isolation or as part of a genetic syndrome. Due to the vast number of genes implicated in these disorders, establishing a molecular diagnosis can be challenging. We aimed to develop a targeted next-generation sequencing (NGS) assay to diagnose mutations and potentially identify novel genes mutated in this group of disorders. METHODS: We designed an NGS gene panel that targets 585 known and candidate genes in orodental disease. We screened a cohort of 101 unrelated patients without a molecular diagnosis referred to the Reference Centre for Oro-Dental Manifestations of Rare Diseases, Strasbourg, France, for a variety of orodental disorders including isolated and syndromic amelogenesis imperfecta (AI), isolated and syndromic selective tooth agenesis (STHAG), isolated and syndromic dentinogenesis imperfecta, isolated dentin dysplasia, otodental dysplasia and primary failure of tooth eruption. RESULTS: We discovered 21 novel pathogenic variants and identified the causative mutation in 39 unrelated patients in known genes (overall diagnostic rate: 39%). Among the largest subcohorts of patients with isolated AI (50 unrelated patients) and isolated STHAG (21 unrelated patients), we had a definitive diagnosis in 14 (27%) and 15 cases (71%), respectively. Surprisingly, COL17A1 mutations accounted for the majority of autosomal-dominant AI cases. CONCLUSIONS: We have developed a novel targeted NGS assay for the efficient molecular diagnosis of a wide variety of orodental diseases. Furthermore, our panel will contribute to better understanding the contribution of these genes to orodental disease. TRIAL REGISTRATION NUMBERS: NCT01746121 and NCT02397824.journal articleresearch support, non-u.s. gov't2016 Feb2015 10 26importe

Entre transition médicale et passage à l’âge adulte, un possible conflit de temporalité pour les jeunes atteints d’une maladie chronique

International audienceLes progrès thérapeutiques ont augmenté la survie des enfants et adolescents atteints de maladies chroniques. Pour ces jeunes patients, le passage de la pédiatrie vers les services pour adultes peut entraîner une rupture de soins, car il implique un bouleversement de leur relation au système de soins : transformation d’une prise en charge familiale, centrée sur l’adolescent et ses parents, en une prise en charge individuelle et éclatée entre différents services ou établissements avec des règles et des usages différents de ceux de la pédiatrie. L’objet de cet article est de restituer les enjeux sociaux de ce passage, et de montrer les tensions pouvant exister entre les temporalités des transitions médicale et sociale. La transition médicale, parce qu’elle est implicitement organisée autour de l’âge de 18 ans et de la majorité juridique, tend à entrer en conflit avec la temporalité des autres transitions qui jalonnent, dans nos sociétés contemporaines, le passage à l’âge adulte

Alcool et grossesse : population à risque, perception des risques

International audienc

Tabac, grossesse et allaitement : Exposition, connaissances et perceptions des risques

National audienceIntroduction – Smoking during pregnancy is a major public health issue, especially considering the damages for the unborn child's health. In France, statistics on smoking during pregnancy are available, but little is known about smokers' awareness and perceptions, about exposure to secondhand tobacco or about breastfeeding smokers. Method – A telephone study was conducted in 2012 with a national sample of 3,603 pregnant women or mothers who had recently given birth.Results – Daily tobacco use in the previous month was reported by 16.1% of pregnant women and 13.4% of breastfeeding mothers. A total of 10.2% women reported being exposed to secondhand smoke in the workplace. Nearly half of these women (49.4%) benefitted from flexible work arrangements during pregnancy. The first kind of risks cited spontaneously by women, whether they smoked or not, were " breathing problems " for the child. The " stress " caused by smoking cessation was seen as more harmful for the unborn child than moderate smoking by 78.2% of smokers. More than half of the smokers (53.8%) believed that nicotine replacement therapy (NRT) is not recommended during pregnancy. Conclusion – The results highlight the need to improve women's awareness on the tobacco-related risks and on cessation support services during pregnancy.Introduction – La consommation de tabac pendant la grossesse représente un enjeu de santé publique important en raison des risques pour la santé de l'enfant à naître. Si la prévalence du tabagisme gravidique est bien connue, on sait peu de choses sur les connaissances et les perceptions des fumeuses vis-à-vis des risques qu'elles encourent, sur l'importance du tabagisme pendant l'allaitement ou sur l'exposition des femmes enceintes au tabagisme passif. Méthode – Une étude a été menée en 2012 par téléphone auprès d'un échantillon national de 3 603 femmes enceintes ou ayant récemment accouché. Résultats – L'usage quotidien de tabac au cours du mois écoulé concernait 16,1% des femmes enceintes et 13,4% des mères allaitantes. Parmi les femmes professionnellement actives, 10,2% ont déclaré être exposées à la fumée des autres sur leur lieu de travail. Un peu moins de la moitié des femmes concernées (49,4%) a bénéficié d'un aménagement de poste au cours de la grossesse. Lorsqu'elles étaient interrogées sur la nature des risques encourus, fumeuses et non-fumeuses évoquaient d'abord, de manière spontanée, de possibles « problèmes respiratoires » pour l'enfant. Pour 78,2% des fumeuses, le « stress » provoqué par le sevrage tabagique serait plus nocif pour l'enfant qu'une consommation modérée de tabac. Pour plus de la moitié des fumeuses (53,8%), les traitements de substitution nicotinique (TSN) seraient déconseillés pendant la grossesse. Conclusion – Les résultats soulignent la nécessité d'améliorer les connaissances des femmes sur les risques liés au tabagisme et sur les possibilités d'aide au sevrage pendant leur grossesse