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

Effects of two different blends of naturally mycotoxin-contaminated maize meal on growth and metabolic profile in replacement heifers

The aim of this trial was to assess the effects of the administration of different combinations of mycotoxins in naturally contaminated maize grains on dairy heifer growth, blood measurements and puberty onset. A total of 35 Friesian female heifers were randomly allotted to three experimental groups from 18-21 to 42-45 weeks of age. During the 24-week experimental period (EP), heifers were fed the same diet, but with maize meal derived from three differently contaminated lots: very low contamination, as control (C); medium-low aflatoxin-contaminated (A); and mixed aflatoxin-fumonisin contaminated (A-F). At the end of the EP, they returned to a common diet without contaminated maize, and they were monitored for an additional period of 12 weeks (post-experimental period, PEP). BW, wither height, hip height, body length and heart girth were measured every 4 weeks from the beginning of EP to the end of PEP. At the same time, body condition score was evaluated and blood samples were taken from the jugular vein to be analysed for haematological, serum protein and metabolic profiles. Age at puberty was assessed by measuring weekly plasma progesterone levels from 40 to 52 weeks of age. Body growth measurements were processed both by ANOVA of average daily gain of EP and PEP separately, and by the analysis of growth curve parameters. Haematological, serum protein and metabolic profile were evaluated using a mixed model, taking into account the repeated measurements in time on each animal. Heifers' growth was delayed both in A and A-F groups during EP, as evidenced by the different linear coefficients of the BW growth curve in the three groups. Differently contaminated diets did not affect the haematological profile, so that it can be concluded that these levels of mycotoxin contamination do not determine any specific effect on haematopoiesis and immunity in growing heifers. The main blood marker of mycotoxin chronic toxicity was the γ-glutamyl transferase activity level in plasma, which appeared to be altered even after the removal of mycotoxins. During EP, plasma glucose was lower in the groups fed contaminated diet compared with C. The joint actions of an altered nutritional status and a long-lasting liver damage were probably the causes of the delay in puberty attainment in A and, particularly, in the A-F group. The results from this trial evidenced that a chronic aflatoxin-fumonisin contamination in diets of dairy heifers can determine an important delay in the reproductive career of these animals

Deoxynivalenol-Induced Proinflammatory Gene Expression: Mechanisms and Pathological Sequelae

The trichothecene mycotoxin deoxynivalenol (DON) is commonly encountered in human cereal foods throughout the world as a result of infestation of grains in the field and in storage by the fungus Fusarium. Significant questions remain regarding the risks posed to humans from acute and chronic DON ingestion, and how to manage these risks without imperiling access to nutritionally important food commodities. Modulation of the innate immune system appears particularly critical to DON’s toxic effects. Specifically, DON induces activation of mitogen-activated protein kinases (MAPKs) in macrophages and monocytes, which mediate robust induction of proinflammatory gene expression—effects that can be recapitulated in intact animals. The initiating mechanisms for DON-induced ribotoxic stress response appear to involve the (1) activation of constitutive protein kinases on the damaged ribosome and (2) autophagy of the chaperone GRP78 with consequent activation of the ER stress response. Pathological sequelae resulting from chronic low dose exposure include anorexia, impaired weight gain, growth hormone dysregulation and aberrant IgA production whereas acute high dose exposure evokes gastroenteritis, emesis and a shock-like syndrome. Taken together, the capacity of DON to evoke ribotoxic stress in mononuclear phagocytes contributes significantly to its acute and chronic toxic effects in vivo. It is anticipated that these investigations will enable the identification of robust biomarkers of effect that will be applicable to epidemiological studies of the human health effects of this common mycotoxin

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

Deoxynivalenol (DON) is a mycotoxin primarily produced by Fusarium fungi, occurring predominantly in cereal grains. Following the request of the European Commission, the CONTAM Panel assessed the risk to animal and human health related to DON, 3-acetyl-DON (3-Ac-DON), 15-acetyl-DON (15-Ac-DON) and DON-3-glucoside in food and feed. A total of 27,537, 13,892, 7,270 and 2,266 analytical data for DON, 3-Ac-DON, 15-Ac-DON and DON-3-glucoside, respectively, in food, feed and unprocessed grains collected from 2007 to 2014 were used. For human exposure, grains and grain-based products were main sources, whereas in farm and companion animals, cereal grains, cereal by-products and forage maize contributed most. DON is rapidly absorbed, distributed, and excreted. Since 3-Ac-DON and 15-Ac-DON are largely deacetylated and DON-3-glucoside cleaved in the intestines the same toxic effects as DON can be expected. The TDI of 1 μg/kg bw per day, that was established for DON based on reduced body weight gain in mice, was therefore used as a group-TDI for the sum of DON, 3-Ac-DON, 15-Ac-DON and DON-3-glucoside. In order to assess acute human health risk, epidemiological data from mycotoxicoses were assessed and a group-ARfD of 8 μg/kg bw per eating occasion was calculated. Estimates of acute dietary exposures were below this dose and did not raise a health concern in humans. The estimated mean chronic dietary exposure was above the group-TDI in infants, toddlers and other children, and at high exposure also in adolescents and adults, indicating a potential health concern. Based on estimated mean dietary concentrations in ruminants, poultry, rabbits, dogs and cats, most farmed fish species and horses, adverse effects are not expected. At the high dietary concentrations, there is a potential risk for chronic adverse effects in pigs and fish and for acute adverse effects in cats and farmed mink