Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive:Question No EFSA-Q-2008-223

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Quinoline Yellow (E 104). Quinoline Yellow has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1975, 1978 and 1984, and the EU Scientific Committee for Food (SCF) in 1984. Both committees established an Acceptable Daily Intake (ADI) of 0-10 mg/kg body weight (bw). Studies not evaluated by JECFA and the SCF included a chronic toxicity and carcinogenicity study with a reproductive toxicity phase in rats and a study on behaviour in children by McCann et al. from 2007. The latter study concluded that exposure to a mixture of colours including Quinoline Yellow resulted in increased hyperactivity in 8- to 9-years old children. The Panel concurs with the conclusion from a previous EFSA opinion on the McCann et al. study that the findings of the study cannot be used as a basis for altering the ADI. The Panel notes that Quinoline Yellow was negative in in vitro genotoxicity as well as in long term carcinogenicity studies. The Panel concludes that the currently available database on semi-chronic, reproductive, developmental and long-term toxicity of Quinoline Yellow, including a study in rats not apparently taken into consideration by JECFA or the SCF, provides a rationale for re-definition of the ADI. Using the NOAEL of 50 mg/kg bw/day provided by the chronic toxicity and carcinogenicity study with a reproductive toxicity phase carried out in rats and applying an uncertainty factor of 100 to this NOAEL, the Panel establishes an ADI of 0.5 mg/kg bw/day. The Panel notes that at the maximum levels of use of Quinoline Yellow, refined intake estimates are generally well over the ADI of 0.5 mg/kg bw/day

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Scientific Opinion on Flavouring Group Evaluation 213, Revision 1 (FGE.213Rev1): Consideration of genotoxic potential for α , β -Unsaturated Alicyclic ketones and precursors from chemical subgroup 2.7 of FGE.19. EFS

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 26 flavouring substances from subgroup 2.7 of FGE.19 in the Flavouring Group Evaluation 213. In the first version of FGE.213 the Panel concluded based on available genotoxicity data that a concern regarding genotoxicity could be ruled out for [FL-no: 07.047, 07.056, 07.057, 07.075, 07.076, 07.080, 07.117, 07.118, 07.119, 07.120 and 07.168], but for the remaining 15 substances in subgroup 2.7 further genotoxicity data were required. Based on new submitted genotoxicity data, the Panel concluded in FGE.213Rev1 that the concern regarding genotoxicity could be ruled out for 13 substances in subgroup 2.7 [FL-no: 02.106, 07.008, 07.010, 07.041, 07.083, 07.089, 07.108, 07.109, 07.127, 07.136, 07.200, 07.224 and 09.305] but not for maltol [FL-no: 07.014] and maltyl isobutyrate [FL-no: 09.525]

Scientific Opinion on the revised exposure assessment of steviol glycosides (E 960) for the proposed uses as a food additive

Following a request from the European Commission, the European Food Safety Authority (EFSA) carried out an exposure assessment of steviol glycosides (E 960) from its use as a food additive, taking into account the proposed extension of uses. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of steviol glycosides (E 960) and established an Acceptable Daily Intake (ADI) of 4 mg/kg body weight (bw) per day. Conservative estimates of exposure, both in adults and children, suggested that it is likely that the ADI would be exceeded at the maximum proposed use level. In 2011, EFSA carried out a revised exposure assessment for steviol glycosides based on revised proposed uses and concluded that high level dietary exposure in children may still exceed the ADI. The current refined exposure estimates are based on the currently authorised uses, the proposed extension, and the EFSA Comprehensive Food Consumption Database. The mean dietary exposure to steviol glycosides ranges from 0.1 mg/kg bw/day in adults and the elderly, to 2.4 mg/kg bw/day in toddlers. Estimates at the 95th percentile of exposure range from 0.3 to 4.3 mg/kg bw/day in the elderly and toddlers, respectively. The Panel concluded that dietary exposure to steviol glycosides is considerably lower than that in the previous exposure assessment. Overall, the revised exposure estimates for all age groups remain below the ADI, except for toddlers at the upper range of the high level (95th percentile) estimates, in one country. Moreover, the Panel noted that table top sweeteners may represent an important source of exposure and therefore a MPL with a numerical value, rather than quantum satis, would be preferable, to allow for a more precise estimation of the potential maximum level of exposure from table top sweeteners

EFSA CEF Penal (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2014. Scientific Opinion on Flavouring Group Evaluation 212, Revision 2 (FGE.212Rev2): α,β-Unsaturated alicyclic ketones and precursors from chemical subgroup 2.6 of FGE.19

International audienc

Schistosoma haematobium infection levels determine the effect of praziquantel treatment on anti-schistosome and anti-mite antibodies

Field studies show an association between schistosome infection and atopy, but the effects of anti-helminthic treatment on this association have not yet been investigated in human populations with different schistosome endemicity levels. This study aimed to compare the effects of anti-helminthic treatment on responses directed against the house dust mite Dermatophagoides pteronyssinus (Derp1) and Schistosoma haematobium in Zimbabwean populations living in high and low schistosome infection areas. Derp1- and schistosome-specific IgE and IgG4 antibodies were quantified by ELISA before and 6 weeks after anti-helminthic treatment. Following treatment, there were changes in the immune responses, which varied with place of residence. After allowing for the effects of sex, age and baseline infection intensity, there was no significant treatment effect on the change in anti-schistosome IgE and IgG4 in the high infection area. However, the anti-schistosome IgE/IgG4 ratio increased significantly, while anti-Derp1 IgE responses decreased as a result of treatment. In the low infection area, treatment resulted in a significant increase in anti-worm IgE levels, but there was no significant treatment effect on anti-schistosome or anti-Derp1 IgE/IgG4 ratios. Thus, the study shows that the level of schistosome endemicity affects the host responses to schistosome and mite antigens following anti-helminthic treatment

EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 93, Revision 1 (FGE.93Rev1)

International audienc

Can somatostatin control acute bleeding from oesophageal varices in Schistosoma mansoni patients?[ISRCTN63456799]

BACKGROUND: Management of patients with bleeding oesophageal varices comprises of mainly diagnostic endoscopy, sclerotherapy and band ligation. One of the major problems to do any of the above is the active bleeding which makes any intervention difficult. The neuropeptide hormone somatostatin administered exogenously has caused a reduction in portal hypertension and variceal bleeding in patients suffering from liver cirrhosis. We believe that the symptomatic use of somatostatin for variceal bleeding in Schistosoma mansoni infected subjects can reduce bleeding, thereby alleviating the pathology caused by schistosomiasis. METHODS/DESIGN: We herein present a study protocol for establishing this neuropeptide as a potential therapeutic agent in schistosomiasis. Adolescent subjects, age range varying from 12–17 years will be selected, based on several inclusion criteria, most important being infection with Schistosoma mansoni with bleeding from oesophageal varices in the last 24 hours. One group of schistosomiasis patients will be treated with somatostatin and praziquantel, the other with propanolol and praziquantel. Survival graphs will be set up to correlate somatostatin administration with survival time. A two part questionnaire will be set up to control treatment outcomes. The pre-treatment part of the clinical questionnaire will identify inclusion criteria questions, the post-treatment part of the questionnaire will identify treatment outcomes. DISCUSSION: We expect that the administration of somatostatin as a bolus followed by a 24 hour long infusion, will stop bleeding immediately, delay rebleeding as compared to the control study group and delay mortality in the somatostatin treated subjects