Following a request from the European Commission, an exposure assessment was carried out based on the maximum permitted levels (MPLs) authorised in Annex II of Regulation (EC) No 1333/2008 for thaumatin (E 957) and the proposed increase in its use level in flavoured drinks and proposed extension of use in several food categories at the levels proposed by the applicant. The safety of thaumatin as a food additive was previously evaluated by the EU Scientific Committee on Food (SCF) in 1984 and 1988 and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1989. Following these assessments, thaumatin was considered acceptable for use, and the ADI was established as 'not specified'. In these evaluations it was, moreover, noted that thaumatin, being a protein, undergoes digestion to normal food components. In providing a scientific opinion on the safety of the proposed extensions of use and use levels, the ANS Panel has decided that a comparison of the exposure resulting from the current uses and use levels with the exposure resulting from these additional proposed uses would be sufficient to address the safety of thaumatin. The Panel calculated that a maximum daily intake of 1.03 mg/kg bw/day of thaumatin, resulting from the exposure assessment at the current proposed uses, or 1.10 mg/kg bw/day, at the proposed new Maximum Permitted Levels (MPLs), would represent 0.12 % or 0.13 %, respectively, of the total daily protein intake for an adult. These percentages would be even lower for children of all ages. The Panel concluded, based on the existing toxicological evaluations, that the proposed extension of uses and changes to use levels would result in a margin of safety of approximately 1 300 which would not represent a safety concern.

Chlorophylls (E 140(i)) were previously evaluated by Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1969 and the Scientific Committee on Food (SCF) in 1975 and 1983 and, in relation to special medical purposes, for young children in 1996. Neither of the Committees established a numerical Acceptable Daily Intake (ADI). Specifications should be updated to adequately cover chlorophylls (E 140(i)), as currently up to 90 % of the extract is unidentified and chlorophylls (E 140(i)) may be obtained from sources that could not be regarded as regular edible plant materials or foods (grass, lucerne, nettle) for humans. Based on the origin of chlorophylls (E 140(i)), the Panel also concluded that data on pesticides, mycotoxins and other components with biological activity (e.g. phytoestrogens, phytotoxins and allergens) should be included in the specification and kept as low as possible to avoid any potential adverse effects (allergenicity, endocrinal effects). The few biological data available indicate that chlorophylls are poorly absorbed by humans and are not metabolised to chlorophyllins (the dephytylated form of chlorophylls). The Panel considered that the few toxicological studies available for chlorophylls were limited and did not comply with the Organisation of Economic Co‐operation and Development (OECD) guidelines or current regulatory requirements, and therefore did not allow for an ADI to be established. The Panel concluded that the available database for chlorophylls was inadequate for risk assessment. However, chlorophylls are natural dietary constituents, which are present at relatively high concentrations in a number of foods. In addition, the exposure resulting from the use of chlorophylls (E 140(i)) as food additives is lower than the exposure to chlorophylls from the regular diet. Therefore, the Panel concluded that, at the reported use levels, chlorophylls (E 140(i)) are not of safety concern as regards their current use as food additives.

Following a request by the European Commission the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to conclude on the possible link between the ingestion of β-carotene and cancer enhancement in heavy smokers. The safety of (synthetic) β-carotene [E 160a (ii)] has been evaluated previously by JECFA (1975) and by the SCF (2000a). In 2000, the SCF concluded that there were insufficient data to set a precise figure for a Tolerable Upper Intake Level (UL) of β-carotene (SCF, 2000b). Unexpectedly, two independent trials revealed that heavy smokers (at least 1 package/day for 36 years on average) receiving long-term β-carotene (20 mg/day) supplementation or β-carotene (30 mg/day) + retinol (25 000 International Unit (IU) vitamin A) supplementation, showed increased rather than decreased incidences of lung cancer. A meta-analysis of randomized controlled trials (RCT) demonstrated absence of any protective effect associated with β-carotene supplementation with regard to cancer risk. Epidemiological studies reported no increased lung cancer incidence in heavy smokers at supplemental dose levels of β-carotene varying from 6 -15 mg/day for about 5 up to 7 years. The Panel concluded that exposure to β-carotene from its use as food additive and as food supplement at a level below 15 mg/day do not give rise to concerns about adverse health effects in the general population, including heavy smokers.

Following a request from the European Commission, a refined exposure assessment was carried out based on the maximum permitted levels (MPLs) authorised in Annex II of Regulation (EC) No 1333/2008 for extracts of rosemary (E 392) and the extension of its use in fat‐based spreads at the levels proposed by the applicant of 30 mg/kg and 100 mg/kg. This was not covered by the previous re‐evaluation of the safety of extracts of rosemary (E 392) as a food additive performed by EFSA in 2008. In that previous opinion, it was noted that, whilst the data were insufficient to establish a numerical ADI, the margin of safety was high enough to conclude that dietary exposure resulting from the proposed uses and use levels was not of safety concern. In providing a scientific opinion on the safety of the proposed extensions of use, the ANS Panel has decided that a comparison of the exposure resulting from the current uses and use levels with the exposure resulting from these additional proposed uses would be sufficient to address the safety of extracts of rosemary. The Panel concluded that, since the two additional uses for rosemary extracts in fat‐based spreads would not change the estimated exposure to the food additive compared with the already approved permitted uses in any part of the population, the conclusions made by the AFC Panel in 2008 regarding safety remain valid. Therefore, the Panel considered that it is unlikely that there is a safety concern with the current permitted uses together with the additional proposed extension of uses compared with the current permitted uses alone. The Panel recommends that a refined exposure assessment is carried out to decrease the existing uncertainties arising from its conservative estimates based on current MPLs.

Potassium polyaspartate (A-5D K/SD) is proposed for use as a stabiliser in wine, with a maximum use level of 300 mg/L and typical levels in the range of 100-200 mg/L. The data provided in support of the current application were in accordance with the Tier 1 requirement of the Guidance for submission for food additive evaluations issued by the ANS Panel in 2012. In the in vitro tests provided by the applicant, potassium polyaspartate (A-5D K/SD) showed minimal proteolytic digestion and no absorption of the intact compound. Potassium polyaspartate (A-5D K/SD) tested negative in a bacterial reverse mutation assay performed in accordance with OECD TG 471 and in an in vitro mammalian cell micronucleus test performed in accordance with OECD TG 487. From a 90-day oral toxicity study in rats performed in accordance with OECD TG 408, a no observed adverse effect level (NOAEL) was set at 1,000 mg/kg bw per day, the highest dose tested. The Panel considered these data as fulfilling the requirements for the evaluation of the new food additive and did not request additional testing for chronic toxicity and carcinogenicity, nor for reprotoxicity and developmental toxicity. Exposure estimates to potassium polyaspartate (A-5D K/SD) from its proposed use were calculated for both typical and maximum use levels. In the worst case scenario of high-level intakes of potassium polyaspartate (A-5D K/SD) when used at the maximum proposed use level of 300 mg/L, the maximum estimated intake would be 1.8 mg/kg bw per day in the elderly and 1.4 mg/kg bw per day in adults, resulting in a margin of safety of approximately 550. The Panel concluded that there was no safety concern from the proposed use and use levels of potassium polyaspartate (A-5D K/SD). Acknowledgements:The Panel wishes to thank the members of the Working Group on Applications for the preparatory work on this scientific output and EFSA staff members: Paolo Colombo, Juho Lemmetyinen, Camilla Smeraldi and Alexandra Tard for the support provided to this scientific output.

Chlorophyllins (E 140(i)) are obtained by saponification of a solvent extract from sources, such as grass, lucerne, and nettle, that could not be regarded as edible plant material or food for humans. Chlorophyllins represent 90 % of the colouring matter in the food additive E 140(ii); the remaining part consists of other pigments, such as carotenoids, together with oils, fats and waxes derived from the source material. The Panel noted that the material used in many studies, identified as "chlorophyllins", was quite often, if not always, a copper complex of chlorophyllins (E 141(ii)). There are no data regarding the absorption, distribution, metabolism and excretion (ADME) and toxicity of chlorophyllins (E 140(ii)). Considering the available data on chlorophylls (E 140(i)), the Panel concluded that chlorophyllins are not metabolites of chlorophylls in humans and owing to their differences in physico-chemical properties, it was not possible to support read-across for toxicity data between these two compounds. The Panel considered that it is necessary to carefully review the definition and identity of E 140(ii) in order to adequately characterise the food additive E 140(ii)) as used in the market. This will also allow proper assessment of its safety when relevant studies of the compound to which consumers are actually exposed become available. Considering the absence of relevant ADME and toxicity data, and because chlorophyllins (E 140(ii)) are neither natural constituents of the regular diet nor metabolites of chlorophylls in humans, the Panel concluded that it was not possible to assess the safety of chlorophyllins (E 140(ii)) as food additives. © European Food Safety Authority, 2015 KEY WORDSChlorophyllins, chlorophyllin a, chlorophyllin b, chlorin e6, rhodin g7, E 140(ii), food colours SUMMARYFollowing a request from the European Commission (EC), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of chlorophyllins (E 140(ii)) when used as food additives.The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations and additional literature that has become available since then. No new toxicological or biological information was submitted to the Panel for the re-evaluation of chlorophyllins (E 140(ii)) following European Food Safety Authority (EFSA) public calls for data. The Panel noted that not all of the original studies on which previous evaluations were based were available for this re-evaluation.To assist in identifying any emerging issue or any information relevant for the risk assessment, EFSA outsourced a contract to deliver an updated literature review on toxicological endpoints, dietary exposure and occurrence levels of chlorophyllins (E 140(ii)), which covered the period up to the end of 2014.Chlorophyllins (E 140(ii) There are no data regarding the absorption, distribution, metabolism and excretion (ADME) and toxicity of chlorophyllins (E 140(ii)).From the availab...

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion reevaluating 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 single tablet provides 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. SUMMARYFollowing a request from the European Commission to the European Food Safety Authority (EFSA), the Panel on Food Additives and Nutrient Sources added to Food (ANS) has been asked to provide a scientific opinion on the safety of ChromoPrecise® cellular bound chromium yeast added for nutritional purposes as a source of chromium in food supplements and on the bioavailability of chromium from this source.ChromoPrecise® chromium yeast is a yeast preparation with an enriched trivalent chromium (chromium(III)) content, obtained by culture of Saccharomyces cerevisiae in the presence of chromium(III) chloride. A daily intake of 100 µg chromium (III) is provided in a single tablet Much of the chromium accumulated by the yeast cells from a trivalent source such as chromium chloride, as in the case of ChromoPrecise® chromium yeast, is bound to amino acids and peptides in the cell and hence is present in an organic form. The Panel noted the lack of data on the actual identity of the chromium species contained in chromium-enriched yeast and their toxicokine...

Following a request by the European Commission, the Panel of Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the safety of sodium stearoyl-2-lactylate (E 481, SSL) and calcium stearoyl-2-lactylate (E 482, CSL) when used as food additives. SSL and CSL are used as emulsifiers and stabilizers. An Acceptable Daily Intake (ADI) of 20 mg/kg bw/day for SSL and CSL (either singly or in combination) was established in 1974 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The Scientific Committee on Food (SCF) endorsed this ADI of 20 mg/kg bw/day in 1978. The biological fate of CSL is comparable in rodent and non-rodent species. The acute oral toxicity in rats is low. Subacute and subchronic oral toxicity studies with SSL and CSL in rats and dogs revealed a NOAEL of 5 % in the diet. Neither SSL and CSL nor their breakdown products stearic and lactic acid raise concern for genotoxicity. The NOAEL in a one-year oral toxicity study with SSL in rats was 2214 mg/kg bw/day for males and 2641 mg/kg bw/day for females. No data on reproductive toxicity and carcinogenicity were available. However, no reproductive or carcinogenic effects are expected since the products of hydrolysis, stearic and lactic acid are constituents of natural food and part of endogenous metabolism in mammals. The Panel concluded that based on the NOAEL of 2200 mg/kg bw/day derived from the one-year toxicity study in rats and an uncertainty factor of 100, an ADI of 22 mg/kg bw/day for sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) either singly or in combination can be established. The estimated exposure to SSL and CSL occurs mainly via the consumption of flavoured fermented milk products including heat treated products, bread and rolls and fine bakery wares and is below the ADI of 22 mg/kg bw/day for all the adult population including the elderly, but exceeds the ADI for other groups of the population at mean level and for all groups of the population at high level