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

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

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

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

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 re-evaluation of aspartame (E 951) as a food additive

The EFSA ANS Panel provides a scientific opinion on the safety of aspartame (E 951). Aspartame is a sweetener authorised as a food additive in the EU. In previous evaluations by JECFA and the SCF, an ADI of 40 mg/kg bw/day was established based on chronic toxicity in animals. Original reports, previous evaluations, additional literature and data made available following a public call were evaluated. Aspartame is rapidly and completely hydrolysed in the gastrointestinal tract to phenylalanine, aspartic acid and methanol. Chronic and developmental toxicities were relevant endpoints in the animal database. From chronic toxicity studies in animals, a NOAEL of 4000 mg/kg bw/day was identified. The possibility of developmental toxicity occurring at lower doses than 4000 mg/kg in animals could not be excluded. Based on MoA and weight-of-evidence analysis, the Panel concluded that developmental toxicity in animals was attributable to phenylalanine. Phenylalanine at high plasma levels is known to cause developmental toxicity in humans. The Panel concluded that human data on developmental toxicity were more appropriate for the risk assessment. Concentration-response modelling was used to determine the effects of aspartame administration on plasma phenylalanine using human data after phenylalanine administration to normal, PKU heterozygote or PKU homozygote individuals. In normal and PKU heterozygotes, aspartame intakes up to the ADI of 40 mg/kg bw/day, in addition to dietary phenylalanine, would not lead to peak plasma phenylalanine concentrations above the current clinical guideline for the prevention of adverse effects in fetuses. The Panel concluded that aspartame was not of safety concern at the current aspartame exposure estimates or at the ADI of 40 mg/kg bw/day. Therefore, there was no reason to revise the ADI of aspartame. Current exposures to aspartame - and its degradation product DKP - were below their respective ADIs. The ADI is not applicable to PKU patients

A study on video game review summarization

Game reviews have constituted a unique means of interaction between players and companies for many years. The dynamics appearing through online publishing have significantly grown the number of comments per game, giving rise to very interesting communities. The growth has, in turn, led to a difficulty in dealing with the volume and varying quality of the comments as a source of information. This work studies whether and how game reviews can be summarized, based on the notions pre-existing in aspect-based summarization and sentiment analysis. The work provides suggested pipeline of analysis, also offering preliminary findings on whether aspects detected in a set of comments can be consistently evaluated by human users.peer-reviewe