In the European Union all food additives are identified by an E number. SAS not used as a food additive nor used in either cosmetics or pharmaceuticals (see Appendix I) yielded no evidence for mutagenicity in the bacterial gene mutation assays (Ames test) in one study of high relevance (Mortelmans and Griffin, 1981 (Documentation provided to EFSA n. 59)), in three studies of ‘high/limited’ relevance (Wacker 1988a (Documentation provided to EFSA n. 65); Wacker 1988b (Documentation provided to EFSA n. 66); Prival et al., 1991) and in one study of limited relevance (Cabot, 1995c (Documentation provided to EFSA n. 13)). Unpublished study report. AF4‐ICP‐MS coupling and prechannel calibration with nano‐silica standards allowed the reliable detection of nanoparticles below 100 nm for 10 of 11 samples (AF4 diameters between 20.6 and 39.8 nm) and the mass quantification in seven different samples (at mg/L concentrations). When SiO2 nanoparticles were administered intravenously with the same total dose, silicon content in organs was much higher than after oral dosing, with silicon mainly in the liver where it persisted up to 90 days after administration. In a subchronic study comparable to OECD Guideline 408, no adverse effects were detected in rats after feeding a diet containing up to 8% precipitated SAS for a period of 13 weeks. The morphology and the dimension of the added silica particles are not, however, usually stated on the food product label. The authors tested 42 substances including different precipitated and fumed silica (e.g. SP513 (referred as Degussa AG, 1983d by ECETOC. The Panel is aware that the specifications for ‘silicon dioxide, amorphous’ were discussed at the 84th JECFA meeting (JECFA, 2017). The Panel considered that this should be considered in the interpretation of the biological data. Overall, there was evidence for low toxicity after repeated oral administration of SAS; no adverse effects were detected even at high dose levels up to 9,000 mg/kg bw per day. Doses of 10, 12.6, 15.8 or 20 g/kg bw were tested. Amorphous silica nanoparticles, as well as crystalline silica led to an up regulation of MHC‐II, CD80 and CD86 on dendritic cells. Date Published 11/06/2015. Available online: http://www.gnpd.com/sinatra/home/ accessed on 28/7/2017. The prolonged ingestion of a SAS‐containing diet did not result in any storage of silica’ (Sauer et al., 1959a,b; as referred to by ECETOC, 2006). This was the case for four food categories and may have resulted in an underestimation of the exposure. Guidance of EFSA on the ‘Use of the EFSA Comprehensive European Food Consumption Database in Exposure Assessment’ (EFSA, 2011a). Given the absence of information about the particle size distribution for silicon dioxide (E 551) in the current EU specifications, the Panel considered that no SAS preparation used in any single study might be fully representative of the food additive E 551. BASF, 2013. Determination of the acute toxicity in rats of a number of different amorphous silicic acids, and other “white products”. Report PB 223808. In addition, the characteristics of the test materials were not always described in sufficient detail. For the remaining food categories, the mean of the typical reported use levels was used. Overig Open Access Nee. The Panel noted that there were a number of approaches which could decrease these limitations which included but were not limited to a chronic toxicity study conducted according to a recognised guideline and with an adequately characterised material representative of SAS used as a food additive E 551. The results for more than 15 endpoints were addressed, including physical–chemical properties, e.g. the highest exposure estimates (50 mg/kg bw per day) were always much lower (at least one order of magnitude) than the NOAELs identified (the highest doses tested) in the different toxicity studies available, due to the analytical techniques used and in the absence of clear information, it was not always possible to determine whether it was silica (SiO. Zane et al. According to industry (CEFIC, 2017 (Documentation provided to EFSA n. 17)), colloidal silica preparations are ‘stabilized colloidal suspensions’ of silica nanoparticles in liquids, usually water, and manufactured by different processes (ion exchange process with resins). Cappuccino mix contains particles and/or aggregates of sizes spanning between 30 nm to 2 m. DLS: hydrodynamic diameter range 152.3–202 nm for fumed SASs and 284.9–644.6 nm for the other samples. 01.8 Dairy analogues, including beverages whiteners, only sliced or grated cheese analogues and processed cheese analogue; beverages whiteners. Acute oral LD50 in the rat of ZEOSYL 113. Monthly haematological examinations revealed no relevant effects (parameters observed were: number of erythrocytes and leucocytes, differential white blood cell count (WBC), haemoglobin (Hb)). They were excluded from the exposure assessment when other usage levels were available for these food categories. Recently modified products. At autopsy gross and microscopic examination (only hyperplastic and neoplastic lesions were reported) was performed of lungs, bronchi, heart, kidneys, liver, spleen, brain, stomach, colon, intestines, pancreas, adrenal glands, pituitary, thyroid, salivary glands, thymus, testes, prostate, bladder, ovaries, uterus, oviducts, femoral bones, mammary glands, skin and subcutis. Positive findings were also observed for the induction of DNA fragmentation in the alkaline comet assay in different rodent and human cell lines in two studies of limited relevance (Zhong et al., 1997; Gerloff et al., 2009). CEFIC further stated that: ‘silicon dioxide (E 551) is characterised by primary structures (“primary particles”). After drying the precipitated silica can be milled to achieve the specified particle size distribution. The Panel considered that it would be possible to derive an ADI should the limitations in the toxicological database be reduced. An overview of amorphous silica commercially available as a food additive E 551 and measured by different analytical techniques is given in Table 2 (CEFIC, 2016b, 2017, (Documentation provided to EFSA n. 16, 17)). Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. The Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) ‘not specified’ for silicon dioxide and silicates. Updated information on the actual use levels of silicon dioxide (E 551) in foods was made available to EFSA by Food Chemical Risk Analysis (FCRA), European Dairy Association (EDA), KRÜGER GmbH & Co., Food Drink Europe (FDE), International Chewing Gum Association (ICGA), Grace Materials Technologies, Dr Loges Naturheilkunde neu entdecken, Specialised Nutrition Europe (SNE), European Federation of Associations of Health Products Manufacturers (EHPM), Association of the European Self‐Medication Industry (AESGP) and Food Supplements Europe (FSE). To achieve homogeneity, the suspension was continuously stirred. The NDA Panel assumed that the claimed effect referred to aspects of ‘stimulating macrophages’ and ‘increasing circulating lymphocytes’. 1576. These numbers are also used in … The authors discussed that these intracytoplasmic particles were the cause for cytotoxicity via reactive oxygen species production and protein interaction. There were some indications for induction of structural and/or numerical chromosomal aberrations in vitro for SAS not used as a food additive nor used in either cosmetics or pharmaceuticals. The available in vivo studies were not adequate to fully rule out this concern because the negative results observed in comet assays and in micronucleus assays are were of ‘limited relevance’ only. As exposure via food supplements may deviate largely from that via food, and the number of food supplement consumers may be low depending on populations and surveys, the exposure to silicon dioxide (E 551) was calculated according to an additional scenario in order to reflect additional exposure to food additives from the intake of food supplements. Dossier supporting the re‐evaluation of silicon dioxide (E 551) as a food additive according to Regulation (EU) No 257/2010 (Dossier prepared in accordance with the EFSA “Guidance for submission for food additive evaluations” published on 16 August 2012). Food additives are always included in the ingredient lists of foods in which they are used. Ana” in Vienna a few years ago in the campaign “Think of your children’s health” issued a […] The silica nanoparticles enhanced Th1 and Th2 responses that might prevent the induction of oral tolerance. 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. In the He et al. No other developmental abnormalities were observed. Study summary. Chun Yin Lee (2013) in a comprehensive study analysed the physicochemical characteristics of silica nanoparticles in complex food matrices. Silicon dioxide appears to be poorly absorbed. Huntingdon Research Center. There were no dose‐related changes in mortality, clinical observations, body weight, haematology, serum biochemistry and organ weights. No clinical signs were noted and body weight gain and food consumption were comparable to control values. SIDENT 9 – Testing the acute toxicity after single oral administration. The NOAEL identified by the Panel from this study was 5% in the diet, equivalent to 7,500 mg/kg bw per day, the highest dose tested. Winkler et al. As regards subchronic toxicity with nano‐silica, the reported effects in animals (increase absolute and relative weights of some organs mainly the liver and lung with no indication of histopathological changes) were limited, even when using doses up to 2,000 mg/kg per day. Overall, the basis for the evaluation was not specified. Project No. despite the limitations in the subchronic, reproductive and developmental toxicological studies, including studies with nano silicon dioxide, there was no indication of adverse effects. In the framework of Regulation (EC) No 1333/2008 on food additives and of Commission Regulation (EU) No 257/2010 regarding the re‐evaluation of approved food additives, EFSA issued a public call1515 A further subchronic feeding study with rats receiving a diet containing up to 5% (equal to 3,500 mg/kg bw per day) fumed silica for 90 days supported the low subchronic toxicity of SAS. It is also remarkable that the increased ALT was only found for Balb/c mice and not for C57BL/6 mice. OECD SIDS reported solubility data on synthetic amorphous silica in water obtained from different studies: Fruijtier‐Poelloth (2012) reported for pyrogenic silica values of 144–151 mg/L and for silica gel, 127–141 mg/L in a simulated biological medium (at saturation, 37°C, pH 7.1–7.4). However, depending on the starting material and/or on the manufacturing process, it cannot be totally excluded that some aggregates of primary particles could be smaller than 100 nm in size. In this document, these levels are named maximum permitted levels (MPLs). 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). The Panel considered that in the absence of statistical evaluation the biological relevance of the reported changes cannot be evaluated. The mean diameter of synthetic amorphous silica is typically in the micrometre range’. Consumption records were codified according to the FoodEx classification system (EFSA, 2011b). Leuschner F, 1977. The absolute level was low in all tissues (maximum 12.63 mg/100 g dry matter in lungs). These facts were taken into consideration by the Panel when evaluating the safety of silicon dioxide (E 551) used as a food additive. The food additive, silicon dioxide (E 551), is a material comprised of aggregated nanosized primary particles. Submitted to EFSA by CEFIC, September 2011. depending on the method used for the analytical determination of particles of silicon dioxide (including the preparation of the sample; e.g. Agglomerates can be separated into the original aggregates only by strong dilution and dispersion (e.g. In contrast, no cytotoxicity was observed for particles with a size of 100 or 200 nm even at a concentration of 10 mg/mL. According to the authors, the NOAEL in this study was 1,000 mg/kg bw per day, the highest dose tested. ‘Hydrated’ silica is synonym for the ‘water‐based production process’ for precipitated silica and silica gel where the surface is covered by sylanol groups. Finally, the Panel noted that, as already noted by others (Fruijtier‐Poelloth, 2012), the test material was amorphous silica of biogenic origin and may include impurities of crystalline silica. Working off-campus? ), on the initial content of nanoparticles in the sample added to the food, and on the form of the food. In particular, they looked at the cytokines release by different cell types: human epithelial A549, human THP‐1 and mouse J774A.1 macrophage cells. While exposure to SAS or NM‐202 did not result in clearly elevated tissue ‘silica’ concentration after 28 days of exposure, after 84 days ‘silica’ accumulation was reported in the spleen of animals exposed to SAS, but not to NM‐202. Emulsifiers are additives used in food industry as a means to achieve the emulsion, i.e. ). FDRL (Food and Drug Research Laboratories), 1973c. Clinical signs were recorded daily and maternal body weighed data at GD 0, 8, 10 and 14. The LD50 of all tested substances was > 10,000 mg/kg bw (Spanjers and Til, 1979 (Documentation provided to EFSA n. 61)). Wacker Chemie GmbH, 1988a. The pellet was redispersed in ethanol for TEM analysis, Suspension was sonicated (30 min) in a water bath sonicator, Suspension was sonicated (30 min) in a water bath sonicator. ICGA (International Chewing Gum Association), 2016. 90‐0038‐DGT. 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. These include standard codes (E numbers) that accurately describe additives used in the production of food. Furthermore, it was stated that silicon dioxide is a rather inert substance and that no degradation products under normal conditions are known (Holleman, 2007; EFSA ANS Panel, 2009). The samples of powdered cappuccino mix in water were dispersed with ultrasonic probe and vigorously mixed with hexane. Bericht vom 2. This Regulation also foresees that food additives are re‐evaluated whenever necessary in light of changing conditions of use and new scientific information. If the pH is reduced to below pH 7 or if salt is added, the chemical subunits tend to fuse together in chains resulting in the formation a gel structure (silica gel). The Panel noted that due to methodological difficulties, in particular, during processing of the samples used for the determination of the presence of nanoparticles, it is often difficult to conclude on the actual quantity of nanoparticles that can be present in various organs. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Members States relating to food supplements. Food products labelled with silicon dioxide (E 551) belonged mainly to the following food subcategories of the Mintel's GNPD: Instant Noodles, Creamers, Malt & Other Hot Beverages, and Meal Replacements & Other Drinks. Microbiological Associates, Rockville Maryland, USA. However, because nanoparticles of silicon dioxide are present in the food additive E 551 (see Table 2), studies performed with specifically designed engineered nanoparticles of SAS have also been included in this assessment in order to assess any toxicity associated with nanoparticles present in the food additive, provided they were prepared using amorphous silicon dioxide. The Panel noted that, according to information provided by industry, the size of primary particles for precipitate SAS used as a food additive E 551 range from 5 to 15 nm (measured by TEM) (Appendix A). Laboratory No. That food additive has subsequently been authorised on the basis of specific uses and has been allocated the number E 1205. 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). TEM: transmission electron microscopy; HDC: hydrodynamic chromatography; ICP‐MS: inductively coupled plasma mass spectrometry; FFF: field flow fractionation; SdFFF: sedimentation field flow fractionation; SEM: scanning electron microscopy; DLS: dynamic light scattering; AF4: asymmetric flow‐field flow fractionation; MALS: multiangle light scattering. An overview of the characteristics of the samples used in the biological and toxicological studies is given in Appendices A and B. Since 2010, the EFSA Comprehensive European Food Consumption Database (Comprehensive Database) has been populated with national data on food consumption at a detailed level. Table 6 summarises the estimated exposure to silicon dioxide (E 551) from its use as a food additive in six population groups (Table 5) according to the different exposure scenarios. This allocation was based on a chronic feeding study in mice and rats (Takizawa et al., 1988) with amorphous silica (Syloid 244). Food Additives in Europe 2000 ‐ Status of safety assessments of food additives presently permitted in the EU, 535‐539, Rapid formation of plasma protein corona critically affects nanoparticle pathophysiology. EFSA launched public calls for data to collect information from interested parties. EDA (European Dairy Association), 2016. At the doses of 1 and 10 mg/mouse per day, silica nanoparticles increased the levels of OVA‐specific IgG in OVA‐tolerised mice and induced (dose related) the proliferation of OVA‐immunised splenocytes in response to OVA. Unpublished report, Sident 9. The author reported that no gross changes were found at necropsy and organ weights did not show ‘certain differences’ between control and treatment groups (no statistical evaluation performed). (2014) studied the relationship between the particle size of silica (from Micromod Partikeltechnologie GmbH; 30, 1,000, 3,000, and 10,000 nm) and phagocytosis, inflammasome activation, IL‐1β secretion, cell death in mouse bone marrow‐derived macrophages cells in vitro. Cabot, 1989b. The LD50 was > 31,600 mg/kg bw. A380 (SEM): structure of aggregates with clusters of 50–200 nm. (2009), a fluorescent dye‐labelled silica particle suspension of 50, 100 and 200 nm sizes was intravenously injected to groups of BALB/c mice (n = 5 males) to identify their tissue distribution and excretion. E number of the added food additive. sonication), the presence of particles in the nano‐range in food and biological samples has been reported in very variable amounts. The Panel noted that the analysis of silicon cannot distinguish between silicon from the food additive E 551, natural presence of silicon, or silicon from other sources of silicon dioxide. Submitted to EFSA by CEFIC, October 2017. Negative results were observed for the induction of micronuclei in the bone marrow of mice following oral gavage (but no proof of bone marrow exposure) (Kwon et al., 2014), or following intratracheal administration to rats (Maser et al., 2015). Cabot, 1958. Foods sold in the European Union (EU) have had full ingredient labelling since the mid-1980s. For the three different particles of silica, the observed effects were mainly hepatocellular necrosis and increased serum aminotransferase and inflammatory cytokines. However, their presence in the food additive cannot be excluded due to a lack of precision in the specifications for E 551. due to the limitations in the available database described above the Panel was unable to confirm the current ADI ‘not specified’. The food industry has adapted nanotechnology using engineered nanoparticles to improve the quality of their products. For: FDA, U. S. Food and Drug Administration; NTIS, National Technical Information Service, U. S. Department of Commerce, USA. No adverse clinical effects were induced at doses up to 20,000 mg/kg bw. Silicon dioxide (E 551) is authorised as a food additive in the European Union (EU) in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008 on food additives and specific purity criteria are defined in the Commission Regulation (EU) No 231/2012. Breznan et al. Because nanoparticles of silicon dioxide are present in the food additive E 551, studies performed with specifically designed engineered nano silicon dioxide have also been included in this assessment in order to assess any toxicity associated with nanoparticles present in the food additive, provided they were prepared using amorphous silicon dioxide. 02G11001. Necropsy and histopathology showed no evidence for pathologic and carcinogenic effects (no reporting of non‐neoplastic lesions and only 20 males and 20 females per group were examined after 24 months). In further experiments, the test item induced generation of mitochondrial reactive oxygen species and inflammasome formation. Silica particles with a diameter 30–1,000 nm induced lysosomal destabilisation, cell death and IL‐1β secretion at markedly higher levels than did 3,000‐10,000 nm silica particles. Re‐evaluation of E551 (silicon dioxide) EFSA‐Q‐2011‐00576‐ Submitted to EFSA by CEFIC on behalf of the ASASP, August 2017. Submitted to EFSA by CEFIC, September 2011. Information on the particles size of silicon dioxide (E 551) as reported in the literature is presented in Appendix C. The specifications for silicon dioxide (E 551) as defined in the Commission Regulation (EU) No 231/2012 and by JECFA (2015) are listed in Table 3. Currently, silicon dioxide (E 551) is an authorised food additive in the EU in 22 food categories as listed in Table 4. Number of times cited according to CrossRef: Food Powders Properties and Characterization. (2015) observed that after incubation at a concentration of 100 mg/cm2, stable fluorophore/silica nanoparticles (30 nm) were visible in the cytoplasm but not in the nucleus of cells from the mouse macrophage cell line MH‐S, and of C2BBe1 (derived from Caco‐2) cells. He et al. from the available database there was no indication for toxicity of silicon dioxide (E 551) at the reported uses and use levels. Available online: http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm 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. Rabolli et al. The authors calculated a mean dose of 500 mg/kg bw per day in the treatment groups. The acute oral toxicity of two fumed silica (CAB‐O‐SIL M‐5 or F‐2; Appendix A) was also tested in male Swiss mice (Cabot, 1964 (Documentation provided to EFSA n. 5)). The Panel noted that the highest exposure estimates were always much lower (at least one order of magnitude) than the NOAELs identified (the highest doses tested) in the different toxicity studies available. Additief: E551 - Siliciumdioxide. Nanostructured synthetic amorphous silica (SAS) – absence of disintegration in intestinal environment. Some food categories or their restrictions/exceptions are not referenced in the EFSA Comprehensive Database and could therefore not be taken into account in the present estimate. 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). The full food category was taken into account because the restriction represents a large part of the whole food category. Clinical signs were recorded daily and maternal body weighed data at GD 0, 6, 12, 18 and 29. Based on the available in vitro studies, there was no concern with respect to the induction of gene mutations. Teratology evaluation of FDA 71‐48 in rabbits. BET: Brunauer–Emmett–Teller; TEM: transmission electron microscopy. Despite the limitations in the subchronic, reproductive and developmental toxicological studies, including studies with nano silicon dioxide, there was no indication of adverse effects. Submitted to EFSA by CEFIC, October 2017. Furthermore, these particles activated the inflammasome, leading to significant interleukin (IL)‐1β‐secretion by (dendritic) cells isolated from wild‐type (WT) but not from caspase‐1‐ or from NLRP3‐deficient mice. Fumed silica is produced in essentially an anhydrous state, whereas the wet‐process products are obtained as hydrates or contain surface absorbed water’. Athinarayanan et al. The observed liver effects appeared to be mild and were not accompanied by changes in biochemical markers in blood, but supported by mild changes in transcriptome analysis data from the liver’. Yun et al. The Panel noted that there are no limits for the particle size of silicon dioxide (E 551) in the EU specifications (Commission Regulation (EU) No 231/2012). No findings were reported at necropsy. (2015) developed a kinetic model based on blood and tissue concentrations in time of two different engineered SAS types (NM‐200 and NM‐203; Appendix B) that were orally and intravenously administered, for rats. For an elaborate discussion of the uncertainties, see Section 3.4.5. Technical hearing follow‐up. The Commission asks the EFSA to re‐evaluate the safety of food additives already permitted in the Union before 2009 and to issue scientific opinions on these additives, taking especially into account the priorities, procedures and deadlines that are enshrined in the Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re‐evaluation of approved food additives in accordance with the Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. For SAS used as a food additive, in cosmetics or in pharmaceuticals, the available in vitro and in vivo study results, although of ‘limited relevance’ did not indicate any potential for genotoxicity, and overall the Panel considered that SAS used as a food additive did not raise a concern with respect to genotoxicity. These effects were, however, not considered for hazard identification because the route of administration was not relevant for the use of SAS as a food additive. JECFA (2015) included a method for the determination of silicon based on ICP‐AES. A fraction of the silica nanoparticles administered by intramuscular and sub‐cutaneous injections crossed biological barriers into the liver but with a low absorption rate. Van der Lee M, Undas A, van Bemmel G, van Polanen Ab. Salmonella/Mammalian‐Microsome plate incorporation mutagenicity assay ( Ames test ) ( food and pharmaceutical applications food information to consumers indicating. 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