Scientific Committee On Food Research Articles

Safety of nisin (E234) as a food additive in the light of new toxicological data and the proposed extension of use.

The present scientific opinion deals with the evaluation of the safety of nisin (E 234) in the light of new toxicological data and with the proposed extension of use in unripened cheese and heat‐treated meat products. Nisin (E 234) is currently an authorised food additive in the EU under Annex II of Regulation (EC) 1333/2008 for use in several food categories. The safety of nisin (E 234) as a food additive has been evaluated in 2006 by the EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, where an acceptable daily intake (ADI) of 0.13 mg/kg body weight (bw) was confirmed as previously established by Scientific Committee on Food (SCF). In addition to the studies previously evaluated by EFSA in 2006, the Panel considered in the present opinion, data from a new subchronic toxicity study. No adverse effects were observed in a repeated dose oral toxicity study in which rats were administered nisin A for 90 days. A no observed adverse effect level (NOAEL) of 225 mg nisin A/kg bw per day, the highest dose tested, was identified for this study. Using this NOAEL, an ADI of 1 mg nisin A/kg bw per day for nisin (E 234) was calculated applying a default uncertainty factor of 200 for extrapolation of subchronic to chronic exposure and inter‐ and intra‐species variability. The Panel calculated exposure estimates for both the current and the proposed uses based on the data available in the EFSA Comprehensive Database. The Panel considered that the overall exposure estimate was below the new ADI for nisin A for all population groups. The Panel concluded that the proposed extension of use of nisin (E 234) as a food additive in unripened cheese (at maximum level of 12 mg/kg) and in heat‐treated meat products (at maximum level of 25 mg/kg) would not be of safety concern.

Safety of the proposed amendment of the specifications for the food additive polyvinyl alcohol-polyethylene glycol-graft-co-polymer (E1209).

The European Commission asked EFSA to provide a scientific opinion on the request for a modification of the EU specifications for polyvinyl alcohol‐polyethylene glycol‐graft‐co‐polymer (PVA‐PEG graft‐co‐polymer) (E 1209) and its possible impact on the safety. In accordance with Annex II to Regulation (EC) No 1333/2008, PVA‐PEG graft‐co‐polymer (E 1209) has a single authorisation for use as a food additive in the EU, in the food category food supplements in solid form. According to the current EU specifications, ethylene glycol and diethylene glycol can be present as impurities in other food additives authorised in the EU, namely in polysorbates (E 432–436) and polyethylene glycol (E 1521). The exposure to ethylene glycol and diethylene glycol from their presence in E 1209 and in the other food additives was estimated considering the maximum limit permitted according to the EU specifications and the new proposed maximum limit in E 1209 of 620 mg/kg for the ethylene glycol individually or in combination with diethylene glycol in E 1209. This proposed request would result in a total exposure from food additive uses below the group tolerable daily intake (TDI) of 0.5 mg/kg body weight (bw) per day allocated by the Scientific Committee on Food (SCF) for these contaminants. Therefore, the Panel concluded that the requested amendment of the EU specifications for E 1209 would not result in a safety concern. The Panel noted that the analytical results provided were consistently and considerably lower (up to 360 mg/kg) than the proposed level of 620 mg/kg for ethylene glycol individually or in combination with diethylene glycol in the EU specifications for E 1209.

Re-evaluation of fatty acids (E570) as a food additive.

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of fatty acids (E 570) when used as a food additive. The food additive includes caprylic‐ (C8), capric‐ (C10), lauric‐ (C12), myristic‐ (C14), palmitic‐ (C16), stearic‐ (C18) and oleic acid (C18:1), present alone or in combination. In 1991, the Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) ‘not specified’ for the fatty acids (myristic, stearic, palmitic and oleic acid). The fatty acids (E 570) are absorbed in the same way as the free fatty acids from the regular diet. They show low acute toxicity. The available studies on subchronic toxicity were limited but there was no evidence for toxic effects at doses up to 10% in the diet (equivalent to 9,000 mg lauric acid/kg body weight (bw) per day). The Panel considered that the fatty acids (E 570) did not raise a concern for genotoxicity. Data on chronic toxicity, reproductive toxicity and developmental toxicity were too limited to reach a conclusion on these endpoints. The Panel noted that the contribution of fatty acids (E 570) represented on average only 1% of the overall exposure to saturated fatty acids from all dietary sources (food additive and regular diet). Based on the approach described in the conceptual framework for the risk assessment of certain food additives re‐evaluated under Commission Regulation (EU) No 257/2010 and taking into account the considerations mentioned above, the Panel concluded that the food additive fatty acids (E 570) was of no safety concern at the reported uses and use levels.

Re-evaluation of sorbitan monostearate (E491), sorbitan tristearate (E492), sorbitan monolaurate (E493), sorbitan monooleate (E494) and sorbitan monopalmitate (E495) when used as food additives.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives. The Scientific Committee on Food (SCF) allocated an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day for E 491, E 492 and E 495 singly or in combination; and a separate group ADI for E 493 and E 494 singly or in combination of 5 mg/kg bw per day calculated as sorbitan monolaurate in 1974. The Panel noted that after oral administration sorbitan monostearate can be either hydrolysed to its fatty acid moiety and the corresponding anhydrides of sorbitol and excreted via urine or exhaled as CO 2 or excreted intact in the faeces. The Panel considered that sorbitan esters did not raise concern for genotoxicity. Based on the no observed adverse effect level (NOAEL) of 2,600 mg sorbitan monostearate/kg bw per day, taking into account the ratio between the molecular weight of sorbitan monostearate (430.62 g/mol) and sorbitan (164.16 g/mol), and applying an uncertainty factor of 100, the Panel derived a group ADI of 10 mg/kg bw per day expressed as sorbitan for sorbitan esters (E 491–495) singly or in combination. This group ADI of 10 mg sorbitan/kg bw per day is equivalent to 26 mg sorbitan monostearate/kg bw per day. The Panel concluded that the exposure at the mean and the 95th percentile level, using non‐brand‐loyal scenario, did not exceed the ADI in any of the population groups. The Panel on the request for an amendment of specifications regarding the removal of ‘congealing range’ concluded that it could be eventually replaced by another identification parameter such as melting point.

Re-evaluation of glycerol (E422) as a food additive.

The ANS Panel provides a scientific opinion re‐evaluating the safety of glycerol (E 422) used as a food additive. In 1981, the Scientific Committee on Food (SCF) endorsed the conclusion from the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1976 of ‘acceptable daily intake (ADI) for man not specified’. The Panel concluded that glycerol has low acute toxicity and that local irritating effects of glycerol in the gastrointestinal tract reported in some gavage studies was likely due to hygroscopic and osmotic effects of glycerol. Glycerol did not raise concern with respect to genotoxicity and was of no concern with regard to carcinogenicity. Reproductive and prenatal developmental studies were limited to conclude on reproductive toxicity but no dose‐related adverse effects were reported. None of the animal studies available identified an adverse effect for glycerol. The Panel conservatively estimated the lowest oral dose of glycerol required for therapeutic effect to be 125 mg/kg bw per hour and noted that infants and toddlers can be exposed to that dose by drinking less than the volume of one can (330 mL) of a flavoured drink. The Panel concluded that there is no need for a numerical ADI and no safety concern regarding the use of glycerol (E 422) as a food additive at the refined exposure assessment for the reported uses. The Panel also concluded that the manufacturing process of glycerol should not allow the production of a food additive, which contains genotoxic and carcinogenic residuals at a level which would result in a margin of exposure below 10,000. The Panel recommended modification of the EU specifications for E 422. The Panel also recommended that more information on uses and use levels and analytical data should be made available to the Panel.

Occurrence of polychlorinated dibenzo-p-dioxins (PCDDs), dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs) in eggs from free-range hens in Campania (southern Italy) and risk evaluation

ABSTRACTHens’ eggs collected in home-producing farms located in different areas of the Campania region of southern Italy were analysed for six NDL-polychlorobiphenyls (PCB indicators), 17 polychlorodibenzo-p-dioxins (PCDDs) and polychlorodibenzofurans (PCDFs), and 12 congeners of dioxin-like PCBs (DL-PCBs). In the investigated area, waste from civil, industrial and hospital activities was illegally dumped and in many cases burned, so the area is called the ‘Land of fire’. This illicit practice has been considered the main source of pollution in this territory and the cause of the persistent organic pollutants’ (POPs) contamination in the neighbouring lands intended for agricultural use and livestock. The results, which were obtained from the analysis of 56 samples of eggs, showed levels of contamination by dioxins and PCBs that have often exceeded the action levels set by European Union Recommendation 711/2013 and sometimes even exceeded the maximum levels set by Commission Regulation (EU) 1259/2011. The median PCDD/Fs was 0.41 pg TEQ g−1 fat (range = 0.01–6.18 pg TEQ g−1 fat) and the median concentration of DL-PCBs was 0.70 pg TEQ g−1 fat (range = 0.01–14.60 pg TEQ g−1 fat), whereas NDL-PCBs median was 7.35 ng g−1 fat (range = 0.48–67.55 ng g−1 fat). Nevertheless, the estimated weekly intake (EWI) calculated for consumers of eggs home produced in Campania is lower than the tolerable weekly intake (TWI) established by the European Union Scientific Committee on Food (SCF).

Safety of the proposed extension of use of acesulfame K (E 950) in foods for special medical purposes in young children

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 regarding the safety of the extension of use of the food additive acesulfame K (E 950) when added to dietary food for special medical purpose (FSMP) intended for young children aged 1–3 years. Acesulfame K was re-evaluated by the European Union (EU) Scientific Committee on Food (SCF) in 2000 who confirmed an acceptable daily intake (ADI) of 9 mg/kg body weight (bw). Acesulfame K is authorised in the EU for food use with exception for foods for young children. According to the applicant, the use of sweeteners is required to ensure palatable foods for the dietary management of patients whose compliance with the dietary regime (prescribed by healthcare professionals) is a key factor to their health. The exposure scenarios based on the proposed use by the applicant (4.1 or 5.9 mg acesulfame K/g protein) on the FSMPs and as specified in the mandate (9 mg acesulfame K/g protein, corresponding to 450 mg/kg (L)) indicated that if the daily protein intake (3 g protein/kg bw) is exclusively provided by the sweetened powdered product, the ADI would be exceeded. When the protein intake from the product is limited to either 10 or 20 g of protein/child at the concentration of 5.9 mg acesulfame K/g of protein, the ADI was exceeded in the 1 and 2 year age groups following consumption of 20 g protein/day. Considering the concentration of acesulfame K of 9 mg/kg day, only the 10 g protein scenario was below or close to the ADI. The ANS Panel concluded that the proposed extension of use of acesulfame K (E 950) at the level up to 9 mg/g protein while providing 10 g protein/day to 1- to 3- year-old children would not be of safety concern.

Report on the public consultation on the EFSA draft Scientific Opinion on Recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials

EFSA Supporting PublicationsVolume 13, Issue 1 988E Technical reportOpen Access Report on the public consultation on the EFSA draft Scientific Opinion on Recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 28 January 2016 https://doi.org/10.2903/sp.efsa.2016.EN-988 Published date: 28 January 2016 Question number: EFSA-Q-2015-00293 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat References Cramer GM, Ford RA, Hall RL, 1978. Estimation of toxic hazard - a decision tree approach. Food and Cosmetic Toxicology 16: 255– 276. EC (European Commission), 2001. Guidance of the Scientific Committee on Food (SCF) for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation. SCF/CS/PLEN/GEN/100 Final. 19 December 2001. EFSA (European Food Safety Authority), 2015. Public consultation on draft scientific opinion on "recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials" (closed on 7 October 2015). Available online. EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2016. Scientific opinion on recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials. EFSA Journal 2016; 14(1):4357, 28 pp. doi:10.2903/j.efsa.2016.4357. EFSA Scientific Committee, 2012a. Scientific Opinion on exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC). EFSA Journal 2012; 10(7):2750, 103 pp. EFSA Scientific Committee, 2012b. Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data. EFSA Journal 2012; 10(3):2579. [ 32 pp.] doi:10.2903/j.efsa.2012.2579. Available online. International Life Sciences Institute (ILSI), 2015. Guidance on best practices on the risk assessment of non-intentional added substances (NIAS) in food contact materials and articles. ILSI Europe Report Series 2015, ISBN: 9789078637424. DOI: D/2015/10.996/39. Koster S, Rennen M, Leeman W, Houben G, Muilwijk B, van Acker F and Krul L (2014). A novel safety assessment strategy for non-intentionally added substances (NIAS) in carton food contact materials. Food Addit. Contam. 2014, Part A 31(3), 422– 443. Munro IC, Ford RA, Kennepohl E, Sprenger JG, 1996. Correlation of structural class with no observed effect levels: a proposal for establishing a threshold of concern. Food and Chemical Toxicology, 34, 829– 867. Rennen M, Koster S, Krul C, Houben G. Application of the threshold of toxicological concern (TTC) concept to the safety assessment of chemically complex food matrices. Food and Chemical Toxicology 2011, 49: 933– 940. Volume13, Issue1January 2016988E ReferencesRelatedInformation

Safety of the proposed extension of use of sucralose (E 955) in foods for special medical purposes in young children

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion regarding the safety of the extension of use of the food additive sucralose (E 955) when added to dietary food for special medical purpose (FSMP) intended for young children aged from 1 to 3 years. Sucralose was evaluated by the EU Scientific Committee on Food (SCF) who established an acceptable daily intake (ADI) of 15 mg/kg body weight (bw). Sucralose is authorised in the EU for food use with exception for foods for young children. According to the applicant, the use of sweeteners is required to ensure palatable foods for the dietary management of patients whose compliance with the dietary regime (prescribed by healthcare professionals) is a key factor to their health. The exposure scenarios based on the proposed use by the applicant on the FSMP indicated that the total daily protein requirement (3 g protein/kg bw) could be covered by the product containing 400 mg sucralose/kg without exceeding the ADI. Also, exposure in other scenarios based on different assumptions was always below the ADI. Therefore, the ANS Panel concluded that the proposed extension of use of sucralose (E 955) in FSMP in young children aged from 1 to 3 years would not be of safety concern.

Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on Dietary Reference Values for vitamin E as ɑ‐tocopherol

Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on Dietary Reference Values for vitamin E as ɑ‐tocopherol

Scientific Opinion on the re‐evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives

The Panel on Food Additives and Nutrient Sources added to Food (ANS) re-evaluated the safety of polysorbate 20 (E 432), polysorbate 80 (E 433), polysorbate 40 (E 434), polysorbate 60 (E 435) and polysorbate 65 (E 436) as food additives. The Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) derived an Acceptable Daily Intake (ADI) of 25 mg/kg body weight (bw)/day (group ADI for polysorbates 20, 40, 60, 65 and 80) and the Scientific Committee on Food (SCF) derived a group ADI of 10 mg/kg bw/day. Small amounts of polyoxyethylene sorbitans are absorbed. Similar toxicokinetics would be expected for all polysorbates based on their similarities in structure and metabolic fate. The acute toxicity is very low. There is no concern regarding genotoxicity, carcinogenicity or developmental toxicity. From a limited number of studies, there is no indication of reproductive toxicity. The Panel considered the long-term carcinogenicity study in rats with a No Observed Adverse Effect Level (NOAEL) equivalent to 2 500 mg/kg bw/day – consistent with the NOAEL defined in subchronic studies – as the key study and allocated a group ADI of 25 mg/kg bw/day using an uncertainty factor of 100. The estimated exposure of toddlers at the highest level in non-brand loyal scenario remains very close to the ADI (24.5 mg/kg bw/day). The Panel is aware that for three food categories no reported uses have been obtained and that other dietary sources of exposure to polysorbates could not been considered in this opinion and therefore more data (usage and analytical data) are needed to decrease uncertainties in the refined exposure assessment scenario used.

Scientific Opinion on the re‐evaluation of chlorophylls (E 140(i)) as food additives

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.

Monitoring of trace elements in silverside (Odontesthes bonariensis) from pampasic ponds, Argentina

The presence of trace elements (Cr, Mn and Zn) in soft tissues (muscle, gills, scales, liver and gonads) of silverside (Odontesthes bonariensis), and its relation to the concentration of these elements, in water of the Pampasic ponds were studied. Based on the results, the risk of poisoning by consumption of silverside fish was calculated. Cr had a higher concentration in the fish scales of most ponds, the gill being the secondary target organ. The highest concentrations of manganese were found in gills, liver and fish scales. Gills and liver samples from Chascomús ponds had higher values of that metal than the rest of the ponds. In the ponds of Adela, Chis-Chis, and Barrancas these concentrations were lower, with 14–34μg/g in gills and 5–9μg/g in liver. In Tablilla ponds, Mn concentration in all organs of silverside was very variable. Zn was the metal with the highest concentration in all fish organs analyzed with respect to the other trace elements studied. Considering the limits set by the Scientific Committee on Food (SCF) for Cr at 0.03mg/kg, Mn at 0.07mg/kg and Zn at 1.57mg/kg, and given a balanced diet, with a consumption of twice a week, we could observe that in none of the cases the consumption of this species can be harmful to human health. Nevertheless, if we considered a daily consumption of this fish coming from Chascomús ponds, the limit of Mn could exceed the permitted levels and making it a human risk.

Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on Dietary Reference Values for folate

Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on Dietary Reference Values for folate

Exposure to polychlorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs), dioxin-like polychlorinated biphenyls (DL-PCBs) and polybrominated diphenyl ethers (PBDEs) through the consumption of prepared meals in Italy

Diet is a relevant source of exposure to environmental pollutants. Dietary intake of polychlorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs), dioxin-like polychlorinated biphenyls (DL-PCBs) and polybrominated diphenyl ethers (PBDEs) by the Italian population was assessed through a duplicate diet study on prepared meals. Baby food composite representative of the diet of toddlers aged 9–12 months and school canteen servings from four towns in Italy representing the diet of children aged 4–9 years were collected on a 5-day basis. Similarly, 5-day lunches from an office canteen, 7-day lunches from a hotel-school, three fast food meals, and eight duplicate 1-day meals of individuals (one vegetarian) were selected to represent the diet of adults aged above 18 years. Servings from each diet were then pooled to form a composite and analysed. Dietary intake was estimated from the resulting contaminant levels in composites combined with age-related food consumption data from national survey. The mean upper bound (UB) intakes for cumulative PCDDs, PCDFs, and DL-PCBs were 0.67, 0.63–0.92, and 0.27–0.63 pg WHO2005-TE kg−1 body weight (bw) day−1 for toddlers, children and adults, respectively. BDE-47 (UB) ng kg−1 bw day−1 estimates were 2.75 in toddlers, 0.08–0.16 in children and 0.03–0.09 in adults. Similarly, for BDE-99 higher UB intakes (ng kg−1 bw day−1) resulted in toddlers (1.26), than those in children (0.06–0.08) and adults (0.03–0.10), respectively. The above estimates fall below the tolerable weekly intake (TWI) (14 WHO2005-TE kg−1 bw day−1) established by the European Union Scientific Committee on Food (SCF) for PCDD/Fs and DL-PCBs. The margin of exposure (MOE = 3) of toddlers to BDE-99 clearly indicates this age group as target for a risk-oriented approach. This study is proposed as a first cost-effective screening in PCDD, PCDF, DL-PCB and PBDE intake assessment, with a focus also on time trends.

Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on Dietary Reference Values for molybdenum

EFSA Supporting PublicationsVolume 10, Issue 8 475E Technical reportOpen Access Outcome of a public consultation on the Draft Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on Dietary Reference Values for molybdenum European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this author First published: 08 August 2013 https://doi.org/10.2903/sp.efsa.2013.EN-475 Published date: 8 August 2013 Question number: EFSA-Q-2013-00320 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat References EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on Dietary Reference Values for molybdenum. EFSA Journal 2013; 11(8):3333, 35 pp. doi:10.2903/j.efsa.2013.3333 SCF (Scientific Committee on Food), 2000. Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of molybdenum. 15 pp. Volume10, Issue8August 2013475E ReferencesRelatedInformation

Scientific Opinion on the re‐evaluation of sodium stearoyl‐2‐lactylate (E 481) and calcium stearoyl‐2‐lactylate (E 482) as food additives

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.

Scientific Opinion on the re‐evaluation of microcrystalline wax (E 905) as a food additive

Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on microcrystalline wax (E 905) when used as a food additive. Microcrystalline wax (E 905) is authorised quantum satis as a surface treatment agent on non-chocolate confectionery, chewing gum and decorations, coatings and fillings, except fruit based fillings. It is also permitted as a surface treatment of melons, papaya, mango and avocado. The substance was evaluated by the Scientific Committee on Food (SCF) in 1990 and 1995 and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the latest in 1995. The JECFA established a group ADI of 20 mg/kg bw/day for mineral oils, paraffins and microcrystalline waxes. The Panel noted that all mineral oil products accumulated in tissues in a dose- and time-dependent manner with the exception of microcrystalline waxes. The Panel concluded that there is no concern for genotoxicity from microcrystalline wax (E 905). The Panel also considered that the available toxicity studies with mineral hydrocarbons, closely related from a chemical point of view with microcrystalline waxes, consistently reported no effects of concern associated with the intake of microcrystalline wax. The Panel further concluded that since no long-term toxicity and carcinogenicity studies with microcrystalline wax E 905 were available, no ADI could be established. The Panel also concluded that the conservative exposure estimates to microcrystalline wax (E 905) from its use at maximum permitted level (following quantum satis rules), resulted in a sufficient margin of safety compared to the NOAEL established by the Panel for the closely related high viscosity mineral oils, and therefore the use microcrystalline wax (E 905) as a food additive with the currently authorised uses would not be of safety concern.

Predicted dietary intake of selenium by the general adult population in Belgium

The total selenium content of about 800 food products purchased in Belgium was determined and combined with food records to determine the nutritional selenium status of Belgian people. The largest selenium concentrations (>1 mg kg−1) were found in Brazil nuts and offal, of which the consumption is limited. Usually consumed food groups with the highest selenium concentrations were fish and shellfish (0.2–0.9 mg kg−1), eggs, poultry meat, cheese, mushrooms and pasta (approximately 0.2 mg kg−1). The mean dietary selenium intake was calculated to be 60 µg day−1, which is at the lower end but within the range recommended by the Superior Health Council in Belgium (60–70 µg day−1), and adequate according to the 55 µg day−1 recommended by the Scientific Committee on Food (SCF) of the European Commission. The major sources of selenium intake are meat and meat products (31%), fish and shellfish (20%), pasta and rice (12%), and bread and breakfast cereals (11%).

Enrichment of iron and folic acid

Enrichment of iron and folic acid