Re-evaluation of oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (E 479b) as a food additive

Acknowledgements: The Panel wishes to thank the Working Group on the re-evaluation of food additives other than gums and colours of the former EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) for the preparatory work on this scientific output, in particular Pasquale Mosesso and Rudolf Antonius Woutersen. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.Publisher PD

Appropriateness to set a group health based guidance value for nivalenol and its modified forms

The Panel wishes to thank the members of the Working Group on HBGV for mycotoxins and their modified forms: Jan Alexander, Chiara Dall'Asta, Arno Gutleb, Manfred Metzler, Isabelle P Oswald and Dominique Parent‐Massin for the preparatory work on this scientific output, and the EFSA staff members: Marco Binaglia and Hans Steinkellner for the support provided to this scientific output. Adopted: 15 March 2017Peer reviewedPublisher PD

Re‐evaluation of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) as food additives

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) when used as food additives. In 1991, the Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) ‘not specified’ for the fatty acids (myristic‐, stearic‐, palmitic‐ and oleic acid) and their salts. The sodium, potassium, calcium and magnesium salts of fatty acids are expected to dissociate in the gastrointestinal tract to fatty acid carboxylates and their corresponding cations. There were no data on subchronic toxicity, chronic toxicity, reproductive and developmental toxicity of the salts of fatty acids. There was no concern for mutagenicity of calcium caprylate, potassium oleate and magnesium stearate. From a carcinogenicity study with sodium oleate, a no observed adverse effect level (NOAEL) could not be identified but the substance was considered not to present a carcinogenic potential. Palmitic‐ and stearic acid which are the main fatty acids in E 470a and E 470b were already considered of no safety concern in the re‐evaluation of the food additive E 570. The fatty acid moieties of E 470a and E 470b contributed maximally for 5% to the overall intake of saturated fatty acids from all dietary sources. Overall, the Panel concluded that there was no need for a numerical ADI and that the food additives sodium, potassium, calcium and magnesium salts of fatty acids (E 470a and E 470b) were of no safety concern at the reported uses and use levels

Appropriateness to set a group health based guidance value for T2 and HT2 toxin and its modified forms

Acknowledgements: The Panel wishes to thank the members of the Working Group on HBGV for mycotoxins and their modified forms: Jan Alexander, Chiara Dall'Asta, Arno Gutleb, Manfred Metzler, Isabelle Oswald and Dominique Parent-Massin for the preparatory work on this scientific opinion, and the EFSA staff members: Marco Binaglia and Hans Steinkellner for the support provided to this scientific opinion.Peer reviewedPublisher PD

Re‐evaluation of propane‐1,2‐diol (E 1520) as a food additive

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol (E 1520) when used as a food additive. In 1996, the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day for propane‐1,2‐diol. Propane‐1,2‐diol is readily absorbed from the gastrointestinal and is expected to be widely distributed to organs and tissues. The major route of metabolism is oxidation to lactic acid and pyruvic acid. At high concentrations, free propane‐1,2‐diol is excreted in the urine. No treatment‐related effects were observed in subchronic toxicity studies. The available data did not raise concern with respect to genotoxicity. Haematological changes suggestive of an increased red blood cell destruction with a compensatory increased rate of haematopoiesis were observed at the highest dose level (5,000 mg/kg bw per day) in a 2‐year study in dogs. No adverse effects were reported in a 2‐year chronic study in rats with propane‐1,2‐diol (up to 2,500 mg/kg bw per day). The SCF used this study to derive the ADI. No adverse effects were observed in the available reproductive and developmental toxicity studies. Propane‐1,2‐diol (E 1520) is authorised according to Annex III in some food additives, food flavourings, enzymes and nutrients and it is then carried over to the final food. Dietary exposure to E 1520 was assessed based on the use levels and analytical data. The Panel considered that for the food categories for which information was available, the exposure was likely to be overestimated. Considering the toxicity database, the Panel concluded that there was no reason to revise the current ADI of 25 mg/kg bw per day. The Panel also concluded that the mean and the high exposure levels (P95) of the brand‐loyal refined exposure scenario did not exceed the ADI in any of the population groups from the use of propane‐1,2‐diol (E 1520) at the reported use levels and analytical results

Risks to human and animal health related to the presence of deoxynivalenol and its acetylated and modified forms in food and feed

Peer reviewedPublisher PD

Évaluation du risque pour le consommateur de l exposition de la population beyrouthine aux mycotoxines par voie alimentaire

Les mycotoxines sont des métabolites secondaires toxiques produits par des moisissures appartenant principalement aux genres Aspergillus, Pénicillum, Fusarium, naturellement présentes dans l air ambiant et le sol. Parmi elles, certaines (les aflatoxines, l ochratoxine A, le désoxynivalenol...) présentent des risques importants (activités mutagènes, cancérigènes, tératogènes et immuno-toxinogènes) pour la santé publique et des organismes internationaux ont fixé des valeurs toxicologiques de références (DJT, DHTP) représentant la quantité que le consommateur peut consommer tous les jours de sa vie sans courir de risque pour sa santé. Pour caractériser le risque, il est nécessaire de connaître outre les valeurs toxicologiques de références, les quantités auxquelles le consommateur est exposé. Cette étude permet de mesurer pour la première fois au Liban, l exposition du consommateur (Beyrouthin, Adulte 25-54 ans) à trois familles de mycotoxines, les ochratoxines, les trichothécènes et les aflatoxines par une approche de la distribution simple à partir de la méthode de la ration totale, basée sur le panier de la ménagère. Les résultats obtenus montrent que les mycotoxines sont présents, d une façon générale dans les aliments consommés par les sous groupes de la population libanaise étudiée, à des taux conformes aux normes nationales et européennes en vigueur. Cependant, des cas de dépassement des limites maximales de certaines mycotoxines (Aflatoxine Mi, DON, OTA) dans respectivement certains aliments analysés (lait et boissons à base de lait, pains et biscottes et biscuits et viennoiseries) ont été observés. Compte tenu du niveau d exposition à OTA et au DON, il y a risque de dépassement des Doses Journalières Tolérables respectives. De plus, il semble nécessaire que soit portée une attention particulière à l exposition aux aflatoxines de certains groupes de populations tels que les forts consommateurs pour lesquels le risque d être exposés à un niveau d aflatoxine Bi et Mi n est pas nul. Le café, les produits céréaliers (pains et biscottes, biscuits et viennoiseries) et les boissons alcoolisées sont parmi les principaux contributeurs de l exposition à IOTA, le lait et les boissons à base de lait et le yaourt pour l AFM1, les produits céréaliers (pains et biscottes) pour l AFB1 et les produits céréaliers (pains et biscottes et riz et produits à base de riz) pour le DON. Ceci souligne la nécessité de l établissement des plans de contrôle et de surveillance pour ces substances dans les différentes denrées alimentaires afin de protéger la santé des consommateurs.Mycotoxins are toxic secondary metabolites produced by fungi belonging mainly to the genera Aspergillus, Penicillium, Fusarium, naturally present in ambient air and soil. Some of them (aflatoxins, ochratoxin A, deoxynivalenol ....) pose significant risks (activities mutagenic, carcinogenic, teratogenic and immuno-toxigenic) to public health. International agencies have set reference toxicological values (TDI, PTWI) representing the amount of food that consumers can eat all the days of his life without running any risk to their health. To characterize the risk, it is also necessary to know the toxicological reference values, the quantities which the consumer is exposed. This study provides a measure for the first time in Lebanon, consumer exposure (for Beirut consumer, Adults 25-54) to three families of mycotoxins, ochratoxin, trichothecenes and aflatoxins by a simple distribution approach of total diet study, based on household basket. The results show that mycotoxins are present, generally in food consumed by subgroups of the Lebanese population studied, at levels consistent with national and European regulations. However, an exceeding of maximum limits of certain mycotoxins (Aflatoxin M1, DON, OTA) respectively in certain analyzed foods (milk and milk-based beverages, breads and crackers, cookies and pastries) were observed. Given the level of exposure to OTA and DON, there is a risk of exceeding the tolerable daily intake respectively. Moreover, it seems necessary that special attention must be paid to exposure to aflatoxins in certain population groups such as high consumers for whom the risk of being exposed to a level of aflatoxin B1 and M1 is not zero. Coffee, wheat based products (breads, crackers, cookies and pastries) and alcoholic beverages are among the main contributors to OTA exposure, milk and milk beverages and yogurt to AFM1, wheat based products (breads and crackers) to AFB1 and wheat based products (breads, crackers and rice products and rice) to DON. This underlines the need for establishing control and surveillance plans for these substances in different foodstuffs to protect consumers health.BREST-BU Droit-Sciences-Sports (290192103) / SudocSudocFranceF

Evaluation in vitro des effets toxiques de contaminants alimentaires sur les cellules dendritiques

Les trichothécènes, mycotoxines produites par différentes espèces de moisissures, sont à l'origine d'intoxications alimentaires graves qui touchent aussi bien l'animal d'élevage que l'homme. Les intoxications alimentaires humaines dues aux mycotoxines sont en général accidentelles. Les maladies décrites à la suite d'intoxications aux trichothécènes sont principalement l'Aleucie Toxique Alimentaire (ATA) rencontrée dans les pays d'Europe de l'Est et les pays en voie de développement, la Stachybotryotoxicose, rencontrée en Europe de l'Ouest et en Amérique du Nord, et " l'Akakabio disease " rencontrée dans le Sud-Est asiatique. L'origine de ses troubles est hématologique. En effet, les trichothécènes sont connues pour leur hématoxicité mais également pour leur immunotoxicité. Une cellule fait le lien entre ces deux toxicités : la cellule dendritique. Les cellules immunitaires sont produites par des cellules souches, au sein de la moelle osseuse. Parmi ces cellules, la cellule dendritique apparaît comme la cellule initiatrice de la réponse immunitaire primaire, capable de stimuler la prolifération des lymphocytes T naïfs. Le but de ce travail est de développer un modèle humain utilisant les cellules dendritiques générées in vitro à partir de monocytes. Ce modèle permettant d'étudier les effets de xénobiotiques sur la maturation des cellules dendritiques. Pour réaliser cette étude, il s'est avéré nécessaire de choisir un modèle cellulaire pertinent et d'optimiser ce modèle pour l'adapter à l'étude des effets immunotoxiques de contaminants de l'alimentation. Ce travail montre l'importance des études réalisées in vitro sur les cellules dendritiques humaines dans la compréhension des effets immunotoxiques de contaminants alimentaires. Il paraît pertinent de proposer que ces études soient réalisées très en amont au cours de l'exploration d'un effet immunotoxique.The trichothecenes, mycotoxins produced by various species of moulds, are at the origin of serious food poisonings which touch as well the livestock as the man. The human food poisonings due to the mycotoxins are in general accidental. The diseases described following intoxications with trichothecenes are mainly Aleucie Toxique Food (ATA) met in the countries of Eastern Europe and the countries in the process of development, Stachybotryotoxicose, met in Western Europe and North America, and Akakabio disease met in the South-East Asia. The origin of its disorders is hematologic. Indeed, the trichothecenes are known for their hematoxicity but also for their immunotoxicity. A cell establishes the link between these two toxicities: the dendritic cell. The immunizing cells are produced by cells stocks, within osseous marrow. Among these cells, the dendritic cell seems the initiating cell of the immunizing answer primary, able to stimulate the proliferation of the lymphocytes T naive. Taking into account the immunotoxicity of the mycotoxins, primarily on the lymphocytes T, it seemed relevant to study the effects of these molecules on the dendritic cells. To make this study, it proved to be necessary to choose a relevant cellular model and to optimize this model to adapt to the study of the adverse effects of contaminants of the food. The model using the CD34+ involves the majority formation of cells of Langerhans (dentritic cells of the skin). These last are implied in the cutaneous reactions, without interest for the study of the effects of food contaminants. This is why the choice was made on dendritic cultures of cells deriving from monocytes, rather than of cells CD34+. The aim of this work is to develop a human model using the dendritic cells generated in vitro from monocytes. This model allowing to study the effects of xenobiotic on maturation of the dendritic cells. This work shows the importance of the studies carried out in vitro on the human dendritic cells in the comprehension of the immunotoxic effects of food contaminants. It appears relevant to propose that these studies are carried out very upstream during the exploration of a immunotoxic effect.BREST-BU Droit-Sciences-Sports (290192103) / SudocSudocFranceF

Hematopoïèse et toxicologie (optimisation et développement des méthodes in vitro pour étudier les effets des toxiques sur l'hématopoïèse humaine et murine)

Due à son " turn-over " rapide, le système hématopoïétique est une cible privilégiée pour la toxicité des xénobiotiques. Le but de ce travail a été l'optimisation des protocoles de tests in vitro d'étude en l'hématotoxicité et myélotoxicité, afin de les rendre plus fiables, reproductibles, et peu onéreux et, en même temps, de réduire l'utilisation des animaux de laboratoire. Les protocoles des tests clonogéniques in vitro ont d'abord été perfectionnés chez l'homme, transférés chez la souris et miniaturisés pour réduire les coûts . On a utilisé les cultures long-terme de moelle osseuse qui ont permis de mieux comprendre le rôle du microenvironnement. La caractérisation approfondie de la moelle osseuse humaine a permis d'aboutir à la définition de nouveaux end-points pour étudier l'hématotoxicité et deux nouvelles lignées cellulaires, dérivant de souris transgéniques, ont été utilisées comme modèle pertinent pour clarifier le rôle des cytokines dans les désordres lymphoprolifératifs.Due to its rapid turnover, the hemopoietic tissue is a sensitive target for xenobiotic toxicity. The aim of the work presented, was protocol optimisation of in vitro tests for hematotoxicity and myelotoxicity, in order to make them more reliable, reproductible and less costly, and to reduce the use of animals. In vitro clonogenic assays were first optimised using human models, then transferred to the murine model and miniaturised for cost reducing. Bone marrow long-term cultures were used to better understand the microenvironnment role. Moreover, human bone marrow characterisation gave rise to new end-points for evaluating hematotoxicity, such as telomerase activity. The study of in vitro model for hematopoietic system is still undergoing development. Two new cellular lines, from transgenic mouse lineage were employed as a useful model for clarifying cytokine role in lymphoproliferative disorders.BREST-BU Droit-Sciences-Sports (290192103) / SudocPARIS-BIUP (751062107) / SudocSudocFranceF

Distribution du déoxynivalénol (DON) dans les grains de blé dur : Effet des procédés de transformation et de la cuisson des pâtes alimentaires sur le niveau d’exposition des consommateurs au DON

National audienceThis project has been performed in order to know DON becoming from durum wheat grain to cooked pasta as consumed and the evaluation of pasta consumer exposition to DON. DON dosage by HPLC has been validated on the various matrices (durum wheat grains, fractions resulting from pasta process, raw and cooked pasta). Four durum wheat samples, including one very contaminated by DON (> 4000 μg/kg) and three less (≤ 2000 μg/kg), were the subject of DON analyses all along the pasta process. The results show that the process of semolina industry decreases the DON contamination of 25 %. Cooking eliminates from 40 to 60 % of DON in raw pasta and the ultimate consumer is exposed to 14 % of DON quantity present in the durum wheat grains at harvest for the more contaminated wheat (7000 μg/kg). The exposure of the consumer of pasta contaminated by 500 μg/kg of DON is weak for the average of consumers, since the maximum value, which is found in the children from 3 to 5 years, is equal to 14 % of TDI (Tolerable Daily Intake).Ce projet a porté sur le devenir du DON du grain de blé dur à la pâte alimentaire cuite, telle que consommée et l'évaluation de l'exposition du consommateur de pâtes alimentaires à DON. Il a permis de valider le dosage par HPLC de DON sur les différentes matrices concernées (grains de blé dur, fractions issus du process pastier, pâtes crues et cuites). Quatre lots de blé dur, dont un très contaminé par DON (> 4000 μg/kg) et trois moins (≤ 2000 μg/kg) ont fait l'objet d'analyses de DON tout le long du process pastier. Les résultats ont montré que les opérations de semoulerie diminuent la contamination en DON de 25 %. La cuisson élimine de 40 à 60 % du DON présent dans les pâtes crues et le consommateur final est exposé à 14 % de la quantité de DON présent sur les grains de blé dur à la récolte pour le lot le plus contaminé (7000 μg/kg). L'exposition du consommateur de pâtes alimentaires contaminées par DON à un niveau de l'ordre de 500 μg/kg est faible pour la moyenne des consommateurs puisque la valeur maximale qui est retrouvée chez les enfants de 3 à 5 ans est égale à 14 % de la DJT