Synthetic Amorphous Silica in Food: Findings about “Liver Fibrosis” and Other Study‐Related Findings in Van der Zande et al. Koop Antiklontermiddel E551 online bij Natural Spices. Civo Institutes TNO, Zeist NL. 81‐0016‐DKT. After filtration, silicon is precipitated with HCl, dried and weighed. Most of the primary particles seem to form larger aggregated and/IR agglomerates. Inhaling finely divided crystalline silica is toxic and can lead to severe inflammation of … The Panel noted that the fumed and precipitated nanoparticles used in this study had different biological reactivity. The silicon content in the liver, kidney, spleen, blood, and urine of high dose rats treated for a period of 45 or 90 days was not increased compared to both control groups (no further information available). For an elaborate discussion of the uncertainties, see Section 3.4.5. The committee stated that the available data on orally administered silicon dioxide and silicates ‘appear to substantiate the biological inertness of these compounds’. Report PB 223808. Degussa, Frankfurt am Main, Germany. Overall, the Panel considered that these in vitro data, although potentially informative on some mechanisms of cytotoxicity of SAS nanoparticles, were of limited relevance for the risk assessment of silicon dioxide (E 551) used as a food additive. Maier et al. Gehrke et al. Together they form a unique fingerprint. Barahona et al. (2015) identified several significant knowledge gaps such as: physical forces, osmotic concentration, pH, digestive enzymes, and commensal microbes, inherent properties of NMs of different chemical makeup in the determination of their percent absorption through mucus and epithelial cells. The Panel noted that the relevance of these studies to the risk assessment of silicon dioxide as a food additive was low. The total urine was collected for 3 days pre‐application (control values) and for 4 days post‐application. Prior to dosing, NM‐200 was suspended in 0.5% v/v of methylhydroxypropylcellulose in ultrapure water as a vehicle. According to CEFIC (2016a (Documentation provided to EFSA n. 15)), the boiling point for silicon dioxide is 2,230°C. Study summary. The food industry has adapted nanotechnology using engineered nanoparticles to improve the quality of their products. These include standard codes (E numbers) that accurately describe additives used in the production of food. The precipitate is then filtered, washed to remove salts, dehydrated and milled. The authors also reported that silica was not systemically distributed in tissues and that most of the ingested silica was excreted in the faeces. Additionally, 18 food categories were considered because of being powdered foods (via FC 0) or due to the presence of silicon dioxide (E 551) due to carry‐over. Testing Strategies and Models of the Intestine for Nanosafety Research Regulation (EC) No 1333/200811 The Panel considered that the food additive silicon dioxide (E 551) to be a nanosized material composed of aggregated ‘primary particles’. They should include characterisation of particle size distribution using appropriate statistical descriptors (e.g. To address this knowledge gap, we investigated the effects of two widely used, partly nanoscale, engineered particulate food additives, TiO 2 (E171) and SiO 2 (E551), on the cytotoxicity and cellular uptake and translocation of the pesticide boscalid. Submitted to EFSA on 31 May 2016. The authors reported data on number of abortions, live litters, corpora lutea, implantation sites, early and late resorptions, dead and live fetuses as well as fetal weight and sex ratio. Unpublished report, No. diﬀerent techniques for the assessment of the presence of nanoparticles (NPs) in food-grade synthetic amorphous silica (SAS), usually coded as food additive E551. Category: Canned foods Additive: E551 - Silicon dioxide. The sizes of the aggregates and agglomerates are normally greater than 100 nm. Estimation of the Uncertainties Related to the Measurement of the Size and Quantities of Individual Silver Nanoparticles in Confectionery, http://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=search.simple, http://ec.europa.eu/food/food/animalnutrition/feedadditives/comm_register_feed_additives_1831-03.pdf, http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm, http://www.efsa.europa.eu/sites/default/files/consultation/151012.pdf, https://doi.org/10.1371/journal.pone.0062087, http://www.food.gov.uk/multimedia/pdfs/vitmin2003.pdf, https://ec.europa.eu/jrc/sites/jrcsh/files/JRC%20Nanomaterials%20Repository%20-%20List%20of%20Representative%20Nanomaterials.pdf, https://ec.europa.eu/jrc/sites/jrcsh/files/JRC-Nanomaterials-Repository-List-of-Representative-Nanomaterials.pdf, https://webcache.googleusercontent.com/search?q=cache:YzdAr2XEPM0J:https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/328992/Physicochemical_characterisation_of_silica_nanoparticles_in_complex_matrices.pdf+&cd=1&hl=en&ct=clnk&gl=in, https://www.anses.fr/fr/system/files/ANSES-Ft-Nanogenotox_FinalReport.pdf, https://doi.org/10.1371/journal.pone.0169552, http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5088/suppinfo/, Silica, amorphous, fumed; crystalline‐free, Synthetic amorphous silica, precipitated; crystalline‐free, Ultrasonication 7 min; (Misonix XL2020 at amplitude 9). Bellmann et al. It is made for all, ... Canned foods / E551 - Silicon dioxide. the EU specifications for silicon dioxide (E 551) allow for the use of SAS with various physicochemical properties. Study to determine the ability of HDK VP KHD50 to induce mutation in four histidine‐requiring strains of, absorption, distribution, metabolism and excretion, Association of the European Self‐Medication Industry, EFSA Panel on Food Additives and Nutrient Sources added to Food, Association of Official Agricultural Chemists, Association of Synthetic Amorphous Silica Producers, EFSA Panel on Food Contact Material, Enzymes, Flavourings and Processing Aids, European Centre for Ecotoxicology and Toxicology of Chemicals, European Federation of Associations of Health Products Manufacturers, Federation of European Food Additives, Food Enzymes and Food Cultures Industries, European Inventory of Existing Commercial Chemical Substances, field flow fractionation‐inductively coupled plasma mass spectrometry, hydrodynamic chromatography with inductively coupled plasma mass spectrometry, hypoxanthine‐guanine phosphoribosyl transferase, International Agency for Research on Cancer, inductively coupled plasma atomic absorption spectrometry, inductively coupled plasma high‐resolution mass spectrometry, inductively coupled plasma mass spectrometry, inductively coupled plasma‐optical emission spectrometry, International Organization for Standardization, Joint FAO/WHO Expert Committee on Food Additives, lethal dose, 50%, i.e. (2014), mice were orally administered for 28 days with amorphous silica particles with particle sizes of 70, 300 and 1,000 nm (nSP70, mSP300, and mSP1000, respectively) (see Section 3.6.1 for description of the experimental material used). After a period of time (up to 2 h), a gelatinous precipitate is formed. During the gastric stage, nanosized silica was no longer present in the food matrices of coffee and instant soup, while small amounts were found in pancake. silica gel tends to have a narrower pore size distribution than precipitated silica). Unscheduled DNA synthesis in rat primary hepatocytes. Cytotoxic effects of small size particles were inhibited after incubation in medium simulating fed‐state intestinal fluids. According to CEFIC (2016a (Documentation provided to EFSA n. 15)), depending on the environmental conditions, SAS is either partially or completely soluble in water, and dissolves (depolymerises) in water generating orthosilicic acid (H4SiO4). Both in vitro and in vivo, nanoparticles of amorphous silicon dioxide have been reported to have several immunomodulatory effects including an adjuvant and/or carrier effect for allergens; particles above the nanosize range being less effective. It has been reported that nanosized particles of silicon dioxide can be present in different powdered foods. For the present assessment, food consumption data were available from 33 different dietary surveys carried out in 19 European countries (Table 5). The Panel based its assessment on information submitted to EFSA following the public calls for data, information from previous evaluations and additional available literature up to November 2017. CAB‐O‐SIL. However, silicon‐containing material (in some cases presumed to be silicon dioxide) was found in some tissues. Cabot, 1995b. Novel insights into the risk assessment of the nanomaterial synthetic amorphous silica, additive E551, in food. Toxicologic evaluation of synthetic amorphous silica particles, final report IITRI‐L8034‐1. The code indicates an ingredient which is some type of food additive. View Food additives legislation guidance to compliance as PDF (191.49 KB) Important. for occurrence data (usage level and/or analytical data) on silicon dioxide (E 551). It was shown that, in general, the z‐average, AF4 hydrodynamic diameters and root mean square radii were in good agreement. The food categories which were not taken into account are (in ascending order of the FCS codes): For the following food categories, the restrictions/exceptions which apply to the use of silicon dioxide (E 551) were also not referenced. The authors reported that silica was not systemically distributed in tissues and that most of the ingested silica was excreted in the faeces. No marked adverse side effects were observed and the substance did not markedly enhance bile acid excretion (no further information available) (Grace, 1982, as referred to by ECETOC, 2006). The highest exposure estimates were at least one order of magnitude lower than the no observed adverse effect levels (NOAELs) identified (the highest doses tested). In 1991, the SCF established a group acceptable daily intake (ADI) ‘not specified’ for sodium silicate (E 550), silicon dioxide (E 551), calcium silicate (E 552), magnesium silicate (E 553) and potassium silicate (E 560). In the post‐treatment phase, individual mean excretion rates ranged from 32 to 61 mg/day. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. The test substance was administered by gavage (dose volume 10 mL) at dose levels of 10, 30 or 100 mg NM‐200/mL (equal to 100, 300 and 1,000 mg/kg bw per day) for two generations. Commission Regulation (EU) No 238/2010 of 22 March 2010 amending Annex V to Regulation (EC) No 1333/2008 of the European Parliament and of the Council with regard to the labelling requirement for beverages with more than 1,2 % by volume of alcohol and containing certain food colours 2. The results demonstrated that absorption of nanoparticles (3.94 ± 0.38%) was greater than that of bulk materials (2.95 ± 0.37%), possibly due to intestinal transport by microfold (M) cells. Measurement of the DNA‐damaging and cytotoxic potential of synthetic amorphous silica (NM‐200) in cultured primary rat alveolar macrophages. Data on usage levels of silicon dioxide (E 551) in foods in response to the EFSA call for food additives usage level and/or concentration data in food and beverages intended for human consumption (2016). Food additives are always included in the ingredient lists of foods in which they are used. The mean diameter of all primary particles (TEM analysis) were < 100 nm with mean primary particle sizes in a range of 9 ± 6 to 26 ± 8 nm. For the remaining food categories, the mean of the typical reported use levels was used. Hide the banner. Functie en eigenschappen: Het wordt gebruikt als anti-klontermiddel, als klaringsmiddel bij wijn en bier en ontschuimingsmiddel. No effects were observed at doses equivalent to 6,500 mg/kg bw per day in mice and 2,500 mg/kg bw per day in rats, the highest doses tested. The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) evaluated calcium silicate and silicon dioxide/silicic acid gel added for nutritional purposes to food supplements and concluded that the use of silicon dioxide up to 1,500 mg SiO2/day added to food supplements is of no safety concern (EFSA ANS Panel, 2009). The Panel considered that while this was expressed as silica by the authors, it was not possible to determine whether it was silica or silicon that was measured. In the information provided by interested parties (CEFIC, 2016b, 2017 (Documentation provided to EFSA n. 15, 17)), the production process of pyrogenic (fumed) SAS was summarised as being produced by hydrolysis of volatile chlorosilanes (e.g. For an elaborate discussion of the uncertainties, see Section 3.4.5. Food additives and nanotechnologies. Study No. Submitted to EFSA by CEFIC, September 2011. In practice, the FoodEx food codes were matched to the FCS food categories. Huntingdon Research Center. Suspensions of fumed silica (AEROSIL 200; Appendix A) in water (containing 1% methyl‐hydoxyethyl cellulose 300 P) were given via gavage to groups of 10 male and 10 female Sprague–Dawley rats at dose levels of 2,000 or 3,300 mg/kg bw (Leuschner, 1977 (Documentation provided to EFSA n. 53)). In contrast, positive findings in studies of ‘limited relevance’ were observed for DNA fragmentation in the comet assay (Yang et al., 2009; Duan et al., 2013) and for the induction of micronuclei (Park et al., 2011). engineered nanomaterials (ENMs)) of insoluble inorganic food additives including amorphous silica (E 551). The biodistribution percentages of MSNs and PEG–MSNs of the particle sizes of 80 and 120 nm in liver and spleen firstly decreased, then increased, and finally decreased again; however, those of 200 and 360 nm decreased continuously in the time period from 30 min to 1 month after injection. Learn about our remote access options. ). Breznan et al. Monopoli et al. No effects of toxicological relevance on body weight were reported (difference to control < 10%). SCF/CS/ADD/GEN/26 Final. The Panel considered that it would be possible to derive an ADI should the limitations in the toxicological database be reduced. Table 1 quantum satis. on Food Additives and Nutrient Sources added to Food (ANS), published in 2017, also concludes in the absence of toxic e ﬀ ects of E551 at the currently used levels, although silica was found to be Suspension filtrated prior measurement. Necropsy and histopathology showed no evidence for pathological and carcinogenic effects (no reporting of non‐neoplastic lesions and only 20 males and 20 females per group were examined after 24 months). Unpublished report 2446 by Litton Bionetics, Kensington, Maryland, USA. On completion of this expert appraisal, Report PB 223808. 2016 The investigation of silicon and silicon dioxide in human liver and spleen tissues. 4 samples of SAS (AEROSIL300, AEROSIL380, Tixosil43 and Tixosil73 380F (see more information in Appendix A). An uncertainty was, however, due to the fact that all study results on the induction of chromosomal aberrations were of ‘limited relevance’. Test article CAB‐O‐SIL EH‐5. A table on the available in vitro and in vivo genotoxicity studies with indication of their reliability and relevance is presented in Appendix I. SAS used as a food additive, in cosmetics or in pharmaceuticals (see Appendix I) yielded no evidence for mutagenicity in bacterial gene mutation assays (Ames test) in studies which provided results of limited relevance (Degussa, 1983 (Documentation provided to EFSA n. 21); Cabot, 1989a (Documentation provided to EFSA n. 7); Cabot, 1994a (Documentation provided to EFSA n. 11); Cabot 1994b (Documentation provided to EFSA n. 12)). Available online: http://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=search.simple Learn more information about e551 food additive. Added to that, according to Annex III, Part 2 of Regulation (EC) No 1333/2008, silicon dioxide (E 551) is also authorised as a food additive other than carrier in foods additives, in E 1209 polyvinyl alcohol‐polyethylene glycol‐graft‐co‐polymer at the maximum level of 5,000 mg/kg in the preparation; in dry powdered extracts of rosemary (E 392) at the maximum level of 30,000 mg/kg in the preparation; in potassium nitrate (E 252) at the maximum level of 10,000 mg/kg in the preparation. Therefore, information on actual use levels is required for performing a more realistic exposure assessment, especially for those food additives for which no MPL is set and which are authorised according to QS. Resulted in an oxygen ( air ) /hydrogen gas flame reactor structure of aggregates clusters... By nanomaterials: mechanisms and in vivo studies dispersion methods occasions belonging to this food category subsequently... Noted some effects were induced at doses of 50 μg/mL n. 15 )... 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