Scientific Opinion on the reconsideration of the ADI and a refined exposure assessment of β-apo-8?-carotenal (E 160e)

The Panel on Food Additives and Nutrient Sources added to Food (ANS) has previously provided a scientific opinion re-evaluating the safety of β-apo-8′-carotenal (E 160e) as a food additive in the EU and establishing an acceptable daily intake (ADI) of 0.05 mg/kg body weight (bw)/day (EFSA ANS Panel, 2012). Following a request by the European Commission, the ANS Panel was asked to consider newly submitted information on the interpretation of the 13-week study in rats used as a basis to establish the ADI, to clarify its impact on that ADI and to carry out the refined exposure assessment of β-apo-8′-carotenal. The new information comprised an evaluation of all of the original kidney section slides from the 13-week toxicological study under improved visualisation conditions. The ANS Panel has considered that the supplementary information provided by the Commission and the present toxicological database on β-apo-8′-carotenal provides a basis to revise the established ADI and concluded that, based on the NOAEL of 30 mg/kg bw/day from the 13-week study in rats and an uncertainty factor of 100, a new ADI for β-apo-8′-carotenal of 0.3 mg/kg bw/day can be established. The Panel concluded that using data provided by the food industry, which are based only on a limited number of regulated categories, the reported uses and use levels of β-apo-8’-carotenal (E 160e) would not be of safety concern

Scientific Opinion on the re-evaluation of montan acid esters (E 912) as a food additive

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of montan acid esters (E 912) when used as a food additive. Montan acids are extracted from oxidised montan wax and esterified with ethylene glycol, 1,3-butanediol or triols, to form montan acid esters. Montan acid esters are authorised only for the surface treatment of fresh fruits. No data, specifically for montan acid esters, on toxicokinetics and reproductive and developmental toxicity were available. The available data on short-term and subchronic toxicity, genotoxicity and chronic toxicity and carcinogenicity were limited. Important deficiencies in the available studies on chronic toxicity and carcinogenicity were noticed. The data requested in the 1990s (i.e. chromosomal aberration in vitro, reproduction and teratogenicity studies, material characteristics, impurities, presence of PAHs) were not submitted. Furthermore no data were submitted following an EFSA public call for data in 2012. The Panel identified some summary data in the European Chemicals Agency database (ECHA) on registered substances that might have been relevant for the assessment of montan acid esters but the original study reports were not made available to EFSA. Based on these limitations in the toxicological database the Panel concluded that montan acid esters as a food additive could not be evaluated

Scientific Opinion on ChromoPrecise® cellular bound chromium yeast added for nutritional purposes as a source of chromium in food supplements and the bioavailability of chromium from this source

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of ChromoPrecise® cellular bound chromium yeast added for nutritional purposes as a source of chromium in food supplements and the bioavailability of chromium from this source. ChromoPrecise® is a yeast preparation with an enriched trivalent chromium content, obtained by culture of Saccharomyces cerevisiae in the presence of chromium chloride. A daily intake of 100 µg chromium(III). There are limited data on the nature and identity of the organic chromium(III) compounds contained in chromium-enriched yeast and on their toxicokinetic and toxicodynamic behaviour in the body. Overall, the Panel concluded that the bioavailability in man of chromium from chromium-enriched yeast is potentially up to approximately ten times higher than that of chromium from chromium chloride. A NOAEL of 2500 mg/kg bw/day ChromoPrecise® was identified in a 90-day feeding study in rats; no evidence of adverse effects of chromium yeasts were reported in other animal studies investigating the effects of dietary supplementation with chromium yeast. ChromoPrecise® chromium yeast was non-genotoxic in a range of in vitro genotoxicity studies. Although no information was available on the chronic toxicity, carcinogenicity or reproductive toxicity of ChromoPrecise® chromium yeast, the ANS Panel has previously concluded that trivalent chromium is not carcinogenic, and limited data on other chromium yeasts provide no evidence of an effect on reproductive endpoints. No adverse effects have been reported in clinical efficacy trials with chromium yeasts. The Panel concluded that the use of ChromoPrecise® chromium yeast in food supplements is not of concern, despite the lack of data on the nature and identity of the organic chromium(III) compounds contained in the product, provided that the intake does not exceed 250 μg/day, as recommended by the WHO

Statement on the exposure assessment of sodium stearoyl-2-lactylate and calcium stearoyl-2-lactylate including exposure resulting from extension of the authorisation of sodium stearoyl-2-lactylates

Following a request by the European Commission, the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) carried out an exposure assessment of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) as a food additive, including an extension of the uses to use the additives in emulsified cooked meat products (e.g. mortadella, paté). Reflecting the data on actual use levels provided by food industry, the combined exposure to sodium stearoyl-2-lactylate and calcium stearoyl-2-lactylate is in the range 6-55 mg/kg bw/day for toddlers, 14-54 mg/kg bw/day for children, 13-27 mg/kg bw/day for adolescents, 4-16 mg/kg bw/day for adults, and 3-13 mg/kg bw/day for the elderly at the mean level. For exposure at high levels, ranges of 22-109 mg/kg bw/day for toddlers, 28-107 mg/kg bw/day for children, 21-46 mg/kg bw/day for adolescents, 15-33 mg/kg bw/day for adults, and 9-30 mg/kg bw/day were calculated for the elderly. The extension of the authorisation for the use of sodium stearoyl-2-lactylate in emulsified cooked meat products (e.g. mortadella, paté) would not lead to an increase of exposure based on the approach taken for the exposure assessment for the two food additives

Statement on a refined dietary exposure assessment of erythritol (E 968) taking into account additional data provided

Following a request by the European Commission, the Scientific Panel on Food Additives and Nutrient Sources added to Foods (ANS) carried out an assessment of the dietary exposure to erythritol and concluded on the safety of the proposed use in beverages at a maximum use level of 2.5 %, taking into account additional exposure data provided to the Panel. Anticipated exposure to erythritol from its use as food additive including soft-drinks containing a mean concentration of 2.5 % erythritol would be in the range of 0.004-0.04 g/kg bw/day for toddlers, 0-0.05 g/kg bw/day for children, 0-0.08 g/kg bw/day for adolescents, 0-0.14 g/kg bw/day for adults, and 0-0.01 g/kg bw/day for the elderly. At high level, exposure estimates would be in the range of 0.29-0.48 g/kg bw/day (toddlers), 0.13-0.76 g/kg bw/day (children), 0.04-0.50 g/kg bw/day (adolescents), 0.05-0.43 g/kg bw/day (adults), and 0.01-0.25 g/kg bw/day (the elderly). The main categories contributing to the exposure to erythritol were table-top sweeteners and soft drinks for all age groups except toddlers where soft drinks were the only main contributor. The Panel concluded that based on the new data provided on use levels of erythritol in foods and on the basis of the extension of the authorisation for the use of erythritol to soft drinks at a use level of 2.5 % the Margin of Safety of 1.54 is too low to protect children adequately

From roses to bullets: the rise and decline of post-Soviet colour revolutions

The chapter explores the reasons for the colour revolutions’ successes and failures in the post-Soviet space. The article starts with an overview on the colour movement from the first stirrings to the present day. We then propose criteria that will be applied to our analysis, constructed on five variables. The factual analysis of individual countries that follows is built around these five variables

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

Medical Physics: forming and testing solutions to clinical problems

According to the European Federation of Organizations for Medical Physics (EFOMP) policy statement No. 13, “The rapid advance in the use of highly sophisticated equipment and procedures in the medical field increasingly depends on information and communication technology. In spite of the fact that the safety and quality of such technology is vigorously tested before it is placed on the market, it often turns out that the safety and quality is not sufficient when used under hospital working conditions. To improve safety and quality for patient and users, additional safeguards and related monitoring, as well as measures to enhance quality, are required. Furthermore a large number of accidents and incidents happen every year in hospitals and as a consequence a number of patients die or are injured. Medical Physicists are well positioned to contribute towards preventing these kinds of events”. The newest developments related to this increasingly important medical speciality were presented during the 8th European Conference of Medical Physics 2014 which was held in Athens, 11–13 September 2014 and hosted by the Hellenic Association of Medical Physicists (HAMP) in collaboration with the EFOMP and are summarized in this issue

Scientific opinion on the evaluation of authorised ferric sodium EDTA as an ingredient in the context of Regulation (EC) 258/97 on novel foods and Regulation (EU) 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control

The present opinion deals with the evaluation of the proposed increase of the currently authorised maximum amounts of ferric sodium ethylenediaminetetraacetic acid (EDTA) as a novel food ingredient used as a source of iron, and its extension of use in processed cereal‐based foods and baby foods. The applicant also provided information on two forms of ferric sodium EDTA, one previously assessed by EFSA and a new one of finer consistency. To support the proposed changes to the uses of ferric sodium EDTA, the applicant proposed a revision of the current acceptable daily intake (ADI) for EDTA, derived from that set for the food additive calcium disodium EDTA (E 385). The Panel confirmed that ferric sodium EDTA is a source from which iron is bioavailable. In assessing the safety of the proposed revision to the existing specifications for the novel food ingredient ferric sodium EDTA, the Panel noted that this would not discriminate between the previously evaluated substance and the one of finer consistency. In particular, the Panel noted that particle size was not one of the proposed parameters for the revised specifications. The Panel noted that it was not possible to determine whether particles of ferric sodium EDTA in the nano range were present in the product with finer consistency in the solid form. The toxicological data submitted did not add any new relevant information to the database on which the current ADI for EDTA is based. Consequently, the Panel concluded that there was no sound scientific justification to increase the ADI for EDTA and hence increase the use levels of ferric sodium EDTA or introduce additional uses as proposed by the applicant. The Panel recommended that additional toxicological data should be provided to address the shortcomings in the available toxicity database prior to the re‐evaluation of calcium disodium EDTA (E 385)