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

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 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

Refined exposure assessment of Brown HT (E 155)

The European Food Safety Authority (EFSA) carried out an exposure assessment of Brown HT (E 155) taking into account additional information on its use in foods as consumed. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Brown HT and concluded that dietary exposure in both adults and 1-10 year old children at the high level may exceed the Acceptable Daily Intake (ADI) for Brown HT of 1.5 mg/kg body weight (bw)/day at the upper end of the range. Following this conclusion, the European Commission requested EFSA to perform a refined exposure assessment for this food colour. Data on the presence of Brown HT in foods were requested from relevant stakeholders through a call for usage and concentration data. Usage levels were provided to EFSA for six out of 37 food categories in which Brown HT is authorised. A limited number of analytical results were also reported to EFSA, all below the limit of detection (LOD) or limit of quantification (LOQ). Exposure assessment was performed using the EFSA Comprehensive Food Consumption Database. Three different scenarios were considered, including i) exposure estimates based on Maximum Permitted Levels (MPLs), ii) a combination of MPLs and reported maximum use levels and iii) reported maximum use levels only. Considering the first two scenarios, high exposure levels (95th percentile) exceeded the ADI for all age groups, with exception for the elderly. In comparison to the previous assessment, for both children and adults, the current mean exposure estimates are of the same order of magnitude, while the 95th percentile exposure is lower, particularly in adults. The mean and high level exposure estimates of Brown HT are below the ADI for all population groups when considering the reported use levels only

Statement on the safety of iodized ethyl esters of poppy seed oil as a source of iodine added for nutritional purposes to foodstuffs

Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver an opinion on the safety of “iodized ethyl esters of poppy seed oil” (ethyl esters of iodinated fatty acids of poppy seed oil, EEIFAPSO) and the bioavailability of the iodine from this source when used for the fortification of vegetable oils with iodine. The safety of iodine itself, in terms of amounts that may be consumed, is outside the remit of this Panel. EEIFAPSO are described as a mixture of ethyl palmitate, ethyl stearate, ethyl monoiodostearates, ethyl diiodostearates and ethyl triiodostearates. The iodine content of EEIFAPSO is 37-39 % (w/w) and the source is intended to be added at the concentration of 2.76-3.05 mg of EEIFAPSO per kg of vegetable oil. The Panel noted that kinetic data referring to exposure conditions of fortification are limited and that available results are indicating that a possible bioaccumulation of EEIFAPSO and/or their metabolites may occur. Furthermore the available data did not allow a quantitative assessment of the bioavailability of iodine from EEIFAPSO. No data are available on short-term, subchronic and chronic toxicity, carcinogenicity and reproductive toxicity of EEIFAPSO. Overall the Panel could not conclude on the safety of EEIFAPSO as a source of iodine in food fortification and on the bioavailability of iodine from this source due to data gaps in the kinetic and the dynamic properties of the different iodinated compounds in EEIFAPSO

Statement on two reports published after the closing date of the public consultation of the draft Scientific Opinion on the re‐evaluation of aspartame (E 951) as a food additive

Abstract Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) of the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the re‐evaluation of aspartame (E 951) as a food additive. After the end of the public consultation on the draft opinion on the re‐evaluation of aspartame (E951) (15th February 2013, the cut‐off date for the inclusion of new literature in the assessment), two papers were brought to the attention of EFSA as relevant for the evaluation of aspartame. One was the evaluation by Gift et al. (2013) of several studies carried out by the European Ramazzini Foundation (ERF) and the second was the Toxicological Review of Methanol (Noncancer) by the US‐EPA. The Panel noted that the Gift et al. (2013) review of the ERF studies is consistent with EFSA's conclusions on the lack of carcinogenic activity of aspartame. The Panel also analysed US‐EPA's Toxicological Review of Methanol (Noncancer) in the context of the safety assessment of aspartame. The Panel noted that the combination of the endpoint used, a benchmark dose response (BMR) of 5% and the uncertainty factors applied, resulted in a Reference Dose (RfD) for exogenous methanol of 2 mg/kg bw/day that was overly conservative. This RfD was by definition in addition to dietary intakes of methanol which were included in the background exposure estimates used by the US EPA. Taking all these factors into consideration, the Panel concluded that the toxicological review of methanol by US‐EPA and the review by Gift et al. (2013) do not alter the conclusions on the risk assessment of aspartame performed by EFSA. EFSA confirmed the Acceptable Daily Intake (ADI) for aspartame of 40 mg/kg bw/day