The food categories in which the use of silicon dioxide (E 551) is authorised were selected from the nomenclature of the EFSA Comprehensive Database (FoodEx classification system), at the most detailed level possible (up to FoodEx Level 4) (EFSA, 2011b). В 100г продукта: Белки - 5.2 г: Жиры - 0.4 г: Углеводы - 82.6 г compactness of the food composition, as well as its preservation and flavoring, thus improving the quality and shelf life. At the highest dose tested (4,000 mg/kg bw per day), no adverse effects were reported (Degussa AG, 1981; Til et al., 1981 (Documentation provided to EFSA n. 20, 62)). ANSES received a request to assess whether this publication provided evidence to reconsider the conclusions of the European Food Report FDABF‐GRAS‐311. The Panel noted some effects were reported but it was only when nano‐silica was injected via routes (e.g. 44Ti diffusion labelling of commercially available, engineered TiO2 and SiO2 nanoparticles. Yang et al. CAB‐O‐SIL. 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. (2010) studied the influence of size, surface area and microporosity of SAS nanoparticles on the in vitro cytotoxic activity in different cell types. 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). The European Commission considers lowering the current limits for toxic elements (arsenic, lead, mercury and cadmium) in the EU specifications for silicon dioxide (E 551) in order to ensure that the food additive will not be a significant source of exposure to these toxic elements in food. Competent authorities in the European countries provide EFSA with data on the level of food consumption by the individual consumer from the most recent national dietary survey in their country (cf. The LD50 of all tested substances was > 10,000 mg/kg bw (Spanjers and Til, 1979 (Documentation provided to EFSA n. 61)). Overall, in the few available studies in animals, after ingestion of fumed or precipitated SAS, the silicon content of the liver and kidney was slightly increased. The extraction method from food was, however, not described. The forms of synthetic amorphous silica (SAS) used as E 551 include fumed silica and hydrated silica (precipitated silica, silica gel and hydrous silica). No data were submitted for the food categories FC 02.2.2 (Other fat and oil emulsions including spreads as defined by Council Regulation (EC) No 1234/2007 and liquid emulsions), 02.3 (Vegetable oil spray) and 12.1.2 (salt substitutes). The variety of SAS in line with the specifications and currently on the market can result in differences in surface properties and absorption of silicon dioxide (E 551). 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). In a chronic feeding study (Takizawa et al., 1988), groups of 40 male and 38–40 female B6C3F1 mice were exposed to silica gel (Syloid 244, Appendix A). Results obtained with SAS with other uses as well as with intentionally engineered nano‐SAS were not considered relevant by the Panel for the re‐evaluation of silicon dioxide (E 551). Then, a 13‐week study was performed according to the OECD Test Guideline 408. Regulation (EC) No 1333/200811 They were excluded from the exposure assessment when other usage levels were available for these food categories. Unpublished report No. The 200 nm silica particles were excreted from urine and faeces at lower concentrations than 50 and 100 nm particles. The Panel considered that the uncertainties identified would result in an overestimation of the exposure to silicon dioxide (E 551) in the refined exposure scenario at the reported uses and used levels. In the original report (Grace GmbH, 1975a (Documentation provided to EFSA n. 43)), the authors mentioned a deviation ≥ 20% of the weights of adrenal and pituitary glands (no further details) which was statistically not significant but no adverse effects were found at histopathology of the adrenal gland. All food additives are listed below by code number and by name There are about 350 permitted food additives in Australia/New Zealand. 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. Submitted to EFSA by CEFIC, October 2017. For the remaining food categories, the mean of the typical reported use levels was used. The Panel noted that although engineered nano‐SAS are not intended to be used as a food additive E 551, the current specifications would permit their use as a food additive E 551. The fetuses of the highest dose group showed a lower weight (control 0.90 g vs highest dose group 0.80 g) and skeletal retardation (no statistical evaluation). In primary human umbilical vein endothelial cells, Corbalan et al. These methods measure different particle characteristics, which are reflected in the different numerical size values obtained. Commission implementing Regulation (EU) No 408/2014 of 23 April 2014 approving synthetic amorphous silicon dioxide as an existing active substance for use in biocidal products for product‐type 18. As colours were among the first additives to be evaluated, these food additives should be re‐evaluated with a highest priority. Negative results were also observed for the induction of micronuclei in the bone marrow of rats following the oral or the intratracheal route of administration (Guichard et al., 2015a; Tarantini et al., 2015a). In the few studies available in animals, after oral administration of fumed or precipitated SAS, the silicon content of the liver and kidney, and occasionally in the spleen was slightly increased. All pups were examined for external abnormalities. As already stated, each of these methods measures different particle characteristics, which is reflected in the different numerical size‐values obtained (Table 2). Submitted to EFSA by CEFIC, September 2011. These aggregates can further agglomerate to form larger structures. Overall, the Panel noted that there was evidence that SAS and engineered nano‐silica had a low acute toxicity after oral administration. That food additive has subsequently been authorised on the basis of specific uses and has been allocated the number E 1205. 02G11001. If the pH is kept neutral or alkaline (pH 7–10), then the subunits stay separated, and they gradually grow. Fraunhofer, 2014b. 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). The authors concluded that: ‘Additional studies seem warranted to further evaluate the biological relevance of the possible accumulation of silica in the spleen of SAS exposed animals’. The Panel considered that these studies in mice and rats indicated that SAS was not carcinogenic; however, the precise characteristics of the test material was not fully described, in particular the description of the primary particle size. As FC 17 does not consider food supplements for infants and toddlers as defined in the legislation, exposure to silicon dioxide (E 551) from food supplements was not estimated for these two population groups. Silicon dioxide (PM Ref. In the high‐dose group, the average fetal weight was reduced (31.5 g vs 37.5 g in control; no statistical evaluation). Crystalline silicon dioxide is the common name for the additive. Studies in rats indicated no accumulation of silicon in animals after repeated oral applications of SAS. These structures did not show the shape and appearance of amorphous silica. Toxicity studies performed with chemically modified SAS nanoparticles of SAS, were not considered in the present opinion. Additionally, there were also equivocal results of ‘limited relevance’ observed in in vivo micronucleus assays. The data reported in this study have been discussed (Krueger et al., 2017), and in particular, it was considered that the definition of fibrosis as well as the statistical analysis needed reappraisal. This was based on the relevance of the genetic endpoint investigated and the reliability of the study. Food Addititive Guide and Code Breaker - Antioxidants and Mineral Salts (E296 - E385) dynamic light scattering (DLS), laser diffraction (LD) and transmission electron microscopy (TEM)), that each method measures different particle characteristics and that this is reflected in the different numerical values obtained. Some studies reported that less than 0.5% of silicon orally applied as silicon dioxide (1,250 mg) was excreted via urine but urinary silicon was always within the range of normal physiological variation (Degussa AG, 1966 Documentation provided to EFSA n. 18); Lang, 1966 Documentation provided to EFSA n. 50); Langendorf and Lang, 1967). Grace Materials Technologies, 2016. The brand‐loyal consumer scenario: It was assumed that a consumer is exposed long‐term to silicon dioxide (E 551) present at the maximum reported use level for one food category. CAB‐O‐SIL (fluffy) ‐ Ninety‐day dietary feeding. Morfeld P, Bosch A, Weber K, Heinemann M and Krueger N, 2017. Monopoli et al. 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). Sakai‐Kato et al. According to information provided by interested parties (CEFIC, 2016a, 2017 (Documentation provided to EFSA n. 15, 17)), silica gels are produced by the neutralisation of diluted aqueous alkali metal silicates, e.g. (. authorisation of food additives is expected by autumn 2004. The percentage of silica in nano‐form in the processed food (coffee with coffee creamer) was more than two times higher than from non‐processed food. (2012) studied the cytotoxicity of SAS particles (particle size 10, 40 or 200 nm) on human colon carcinoma cells (HT29). Silicon dioxide (E 551) can be authorised together with silicates (E 552, E 553a and E 553b). Submitted to EFSA by CEFIC, September 2011. hair, skin, lip, face, nail) products. Zane et al. sonication), the presence of particles in the nano‐range in food and biological samples has been reported in very variable amounts. OJ L 275, 20.10.2011, p. 38–40. SOT 2013 – 52nd Annual meeting of the Society of Toxicology, San Antonio, U.S.A., March 10‐14, 2013. Maier M, Albers P, Babick F, Retamal Marín RR and Stintz M, 2015. Prenatal developmental toxicity studies with silica gel showed no developmental effects up to the highest doses tested (1,350 mg/kg bw per day in rats and 1,600 mg/kg bw per day in hamsters) (FDRL, 1973c,d (Documentation provided to EFSA n. 32, 33)). The food industry has adapted nanotechnology using engineered nanoparticles to improve the quality of their products. The Panel noted that in many studies reported in this opinion, the term ‘nanomaterials’ was often used to designate (structured) materials with sizes up to 1,000 nm (1 μm). The results were based on studies by European laboratories participating to the NANOGENOTOX Joint Action and by JRC (JRC, 2013). Clinical signs were recorded daily and maternal body weighed data at GD 0, 8, 10 and 14. Laboratory No. In addition, a number of studies were available with chemically modified SAS particles such as some of those used by the pharmaceutical industry. Industry provided EFSA with data on use levels (n = 520) of silicon dioxide (E 551) in foods. The systemic availability of silicon from these sources varies, but is generally low. Most of the primary particles seem to form larger aggregated and/IR agglomerates. The Panel considered that this should be considered in the interpretation of the biological data. Снеки «Бульбарикы» сметана зелень. These products are called silica sols (Iler, 1979). 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). Food-Info.net> E-nummers > E500-600 E551 : Siliciumdioxide . Aggregates consist of a three‐dimensional amorphous arrangement of covalently bound Si‐O‐Si with typically sizes > 100 nm. In the study by Yoshida et al. In addition, it is foreseen that food additives must be kept under continuous observation and must be re‐evaluated by EFSA. In a long‐term feeding study in rats and in mice, no adverse hyperplastic or neoplastic lesions were observed after exposure to 0%, 1.25%, 2.5% or 5% SAS (silica gel/Syloid 244) via the diet over 21 or 24 months, respectively (Takizawa et al., 1988). Foods sold in the European Union (EU) have had full ingredient labelling since the mid-1980s. Silicon dioxide (E 551) as a food additive did not raise a concern with respect to genotoxicity. TNO, 2012 Oral two‐generation reproduction study with NM‐200 synthetic amorphous silica in Wistar rats (Vol. (2012) study, human endothelial cells (EA.hy926 cell line) were incubated with monodispersed SAS nanoparticles of two sizes (16 and 60 nm; synthesised according to the Stöber method). The production of OVA‐specific antibodies, splenocyte proliferation in response to OVA, and effects on T‐helper (Th)‐1, Th2, and Th17 responses (cytokine and IgG/IgE subclass expression) were evaluated. Part 2: General Principles, Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain, Scientific Opinion on genotoxicity testing strategies applicable to food and feed safety assessment, Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data, Safe upper levels for vitamins and minerals, Silicon, The toxicological mode of action and the safety of synthetic amorphous silica ‐ a nanostructured material, Potential health risks associated with nanotechnologies in existing food additives, The absorption, distribution, excretion and toxicity of mesoporous silica nanoparticles in mice following different exposure routes, Nanoparticles and the Intestine: in vitro and in vivo investigations on genotoxic and inflammatory effects, Cytotoxicity and oxidative DNA damage by nanoparticles in human intestinal Caco‐2 cells, Interactions between food additive silica nanoparticles and food matrices, Exploring the aneugenic and clastogenic potential in the nanosize range: A549 human lung carcinoma cells and amorphous monodisperse silica nanoparticles as models, Co‐assessment of cell cycle and micronucleus frequencies demonstrates the influence of serum on the, A study of the effect of silica hydrogel (Syloid 701) on sterol balance and on the plasma lipid and lipoprotein cholesterol levels in type IIA hyperlipoproteinemia, An environmental route of exposure affects the formation of nanoparticle coronas in blood plasma, Genotoxicity of synthetic amorphous silica nanoparticles in rats following short‐term exposure, part 2: intratracheal instillation and intravenous injection, Cytotoxic and genotoxic evaluation of different synthetic amorphous silica nanomaterials in the V79 cell line, The potential of asymmetric flow field‐flow fractionation hyphenated to multiple detectors for the quantification and size estimation of silica nanoparticles in a food matrix, Prenatal toxicity of synthetic amorphous silica nanomaterial in rats, SILICA Crystalline silica ‐ inhaled in the form of quartz or cristobalite from occupational sources (Group 1) Amorphous silica (Group 3), The Chemistry of Silica: Solubility, Polymerization, Colloid and Surface Properties and Biochemistry of Silica, Silica‐induced apoptosis mediated via scavenger receptor in human alveolar macrophages, Toxicological evaluation of some food additives including anticaking agents, antimicrobials, antioxidants, emulsifiers and thickening agents. In accordance with the guidance provided in the EFSA opinion related to uncertainties in dietary exposure assessment (EFSA, 2007), the following sources of uncertainties have been considered and summarised in Table 7. The Panel noted that although engineered nano‐SAS are not intended to be used as a food additive E 551, the current EU specifications for E 551 would permit their use as a food additive E 551. A long‐term feeding study in rats and in mice indicated that SAS was not carcinogenic; however, the precise characteristics of the test material were not well reported, in particular the description of the primary particle size. The induction of tolerance by OVA, the production of anti‐OVA IgG antibodies, and proliferation of splenocytes in response to OVA was inhibited by silica nanoparticles in conjunction with OVA and was dose‐related. Toxicologic evaluation of synthetic amorphous silica particles, final report IITRI‐L8034‐1. The cappuccino, on the other hand, presented only a limited number of isolated particles smaller than 100 nm. Food-Info.net> E-numbers > E500-600 E551 : Silicium dioxide . Report R 6190. Origin: Produced from sand. (2014) study, Sprague–Dawley rats (groups of five male rats) were fed a diet containing either fumed SAS (commercially available E 551, with a primary particle size of 7 nm) or nano‐fumed silica (NM‐202; JRC, 2013; Appendix B). Re‐evaluation of E551 (silicon dioxide) EFSA‐Q‐2011‐00576‐ Response to EFSA's letter dated 9 June 2016‐ Request for additional information on particle size. Overall, the subchronic toxicity of SAS, including food‐grade material, appeared low. A prenatal developmental toxicity study in rats in compliance with OECD TG 414 and GLP (Hofmann et al., 2015) with nano precipitated silica (NM‐200), showed no maternal or developmental toxicity up to 1,000 mg/kg bw per day, the highest dose tested. Groups of 10–15 pregnant Dutch‐belted rabbits were gavaged at GD 6–18 with 0 (vehicle, presumably water) 16, 74, 345 or 1,600 mg/kg bw per day (FDRL, 1973d (Documentation provided to EFSA n. 34)). BASF, 2013. These scenarios did not consider the exposure to silicon dioxide (E 551) via the intake of food supplements or consumption of foods for special medical purposes (FSMP). These aggregates can further agglomerate to form larger structures. Cell death and inflammatory reactions induced by 10 nm particles were attenuated by fisetin and catalase suggesting induction of oxidative stress as a mechanism for SAS cytotoxicity. MSG flavor information also under microscope. No particular findings were found at necropsy. Fall Church, Virginia. (2017) studied the interaction of immature and unprimed dendritic cells (DCs from mouse bone marrow) with fumed silica (AEROSIL 380F and AEROSIL 200F; Appendix A). range, median, quartiles) as well as the percentage (in number and by mass) of particles in the nanoscale (with at least one dimension < 100 nm) present in silicon dioxide (E 551) used as a food additive. Overall, the Panel noted that a number of studies have shown that, in general oral exposure to any kind of nanoparticles (Cao et al., 2016) may induce toxicological responses in vivo. A prenatal developmental toxicity study with precipitated nano‐precipitated silica (NM‐200, (JRC, 2013), Appendix B) (BASF, 2013 (Documentation provided to EFSA n. 3); Hofmann et al., 2015) was performed in Wistar rats in compliance with OECD TG 414 and GLP. After a 4.5‐month premating exposure period, one male was mated with five females for 14 days in each group. CHO/HGPRT mutation assay, CAB‐O‐SIL EH5. In the in vivo studies which all provided results of limited relevance, SAS used as a food additive, in cosmetics or in pharmaceuticals proved to be negative for the induction of chromosomal aberration and dominant lethal effects in rats (Litton Bionetics, 1974 (Documentation provided to EFSA n. 54)), or gene mutation in the ex vivo gene mutation assay at the HPRT locus (Johnston et al., 2000). As a food additive, it serves as an anticaking agent to avoid clumping. Wacker Chemie GmbH, 1988a. However, silicon‐containing material (in some cases presumed to be silicon dioxide) was found in some tissues. These numbers are also used in … waterglass, with a diluted acid (e.g. Unpublished report, Degussa AG ‐ US‐IT‐No. In the post‐treatment phase, individual mean excretion rates ranged from 32 to 61 mg/day. Study summary. Currently, silicon dioxide (E 551) is an authorised food additive in the EU in 22 food categories as listed in Table 4. The Panel noted that although these nanomaterials are not intended to be used as a food additive E 551, the current EU specifications for E 551 would authorise their utilisation as such. Available online: http://www.gnpd.com/sinatra/home/ accessed on 28/7/2017. The Panel noted that, according to the EU specifications for silicon dioxide (E 551), impurities of the toxic elements arsenic, lead and mercury are accepted up to concentrations of 3, 5 and 1 mg/kg, respectively. Fumed silica is produced in essentially an anhydrous state, whereas the wet‐process products are obtained as hydrates or contain surface absorbed water’. Overall, the Panel noted that the SAS test items used in the biological and toxicological studies available were different in their physicochemical properties (e.g. Silica (E551) is commonly used as an anti-caking agent in food products. (2011), female BALB/c mice were intranasally exposed to ovalbumin (OVA) plus silica particle of various sizes (nanoparticles of 30 nm or 70 nm and conventional microsized particles with diameters of 300 or 1,000 nm, and the plasma levels of OVA‐specific antibodies were determined. 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)). Yoshida et al. SCF/CS/ADD/GEN/26 Final. Five male and five female Sprague–Dawley rats received via gavage 31,600 mg/kg bw (no further details). T9085.380. The genotoxicity of SAS has been investigated in numerous in vitro and in vivo studies. (2011) study, all the ICR mice, treated as previously described in Section 3.6.1, survived well 1 month after being injected intravenously with MSN and PEG–MSN samples (5 mg/kg), and no pathological abnormality was observed in both gross and microscopic histological examinations. List of representative Nanomaterials (December 2014), JRC Nanomaterials repository. In the absence of a long‐term study with nano silicon dioxide, the Panel could not extrapolate the results from the available chronic study with a material, which does not cover the full‐size range of the nanoparticles that could be present in the food additive E 551, to a material complying with the current specifications for E 551. Inconsistent results of limited relevance were observed in in vitro studies for chromosomal aberrations and DNA fragmentation while negative results were observed in vivo for these genetic endpoints. The study was conducted with an inductively coupled plasma high‐resolution mass spectrometer (ICP‐HRMS) operated in a standard and a single particle inductively coupled plasma high‐resolution mass spectrometry (spICP‐HRMS) mode. Ultrasonication 3 min, Concentration 0.8% w/v. According to the Mintel's GNPD, silicon dioxide (E 551) was labelled on almost 5,000 products, of which half were food supplements. Submitted to EFSA by CEFIC, September 2011. Then, the suspension was centrifuged. foods dried during the production process, and mixtures thereof), excluding foods listed in table, Only foods in tablet and coated tablet form, excluding the foods listed in table, Only sliced or grated cheese hard and semi‐hard cheese, Cheese products (excluding products falling in category 16), Only sliced or grated hard and semi‐hard products, Dairy analogues, including beverage whiteners, Only sliced or grated cheese analogues and processed cheese analogue; beverage whiteners, Other fat and oil emulsions including spreads as defined by Council Regulation (EC) No 1234/2007 and liquid emulsions, Other confectionery including breath refreshening microsweets, Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4, Sugars and syrups as defined by Directive 2001/111/EC, Only foods in tablet and coated tablet form, Processed cereal‐based foods and baby foods for infants and young children as defined by Directive 2006/125/EC, Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms, Food supplements supplied in a liquid form, Food supplements supplied in a syrup‐type or chewable form, From more than 12 weeks up to and including 11 months of age, Bulgaria, Denmark, Finland, Germany, Italy, UK, From 12 months up to and including 35 months of age, Belgium, Bulgaria, Denmark, Finland, Germany, Italy, Netherlands, Spain, UK, From 36 months up to and including 9 years of age, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Netherlands, Spain, Sweden, UK, From 10 years up to and including 17 years of age, Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Italy, Latvia, Netherlands, Spain, Sweden, UK, From 18 years up to and including 64 years of age, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Romania, Spain, Sweden, UK, Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Romania, Netherlands, Sweden, UK, Consumption data: different methodologies/representativeness/underreporting/misreporting/no portion size standard, Use of data from food consumption surveys covering only a few days to estimate high percentiles (95th percentile) long‐term (chronic) exposure, Correspondence of reported use levels to the food items in the EFSA Comprehensive Database: uncertainties to which types of food the levels refer, Uncertainty in possible national differences in use levels within food categories, Food categories selected for the exposure assessment: exclusion of food categories due to missing FoodEx linkage (n=4/22 food categories authorised according to Annex II), Food categories selected for the exposure assessment: inclusion of food categories without considering the restriction/exception (n = 5/22 food categories authorised according to Annex II), It is a co‐fumed oxide consisting of silicon dioxide and approximately 1% aluminium oxide, manufactured using the AEROSIL, ‘Amorphous silica, aqueous colloidal solution’, AEROSIL 200F and AEROSIL 380F (see more information in Appendix, 3 food products (black coffee, soup and pancake), 4 samples of SAS: AEROSIL300, AEROSIL380, Tixosil43 and Tixosil73 380F (see more information in Appendix, 2 food products (a powdered ‘cappuccino’ mixture and a food integrator), HDC‐ICP‐MS (additional measurements with DLS and SEM), Food samples were suspended in “LC” or Milli‐Q water using ultrasonic liquid processor XL 2000 for 15 min. foods dried during the production process, and mixtures thereof), excluding foods listed in Table, only foods in tablet and coated tablet form, excluding the foods listed in Table. Laboratory study T9085.501. 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 these studies in mice and rats, although not performed according to the current Guidelines, indicated that SAS was not carcinogenic. Unpublished report V 81.268/201741. No clinical signs were observed during the 2‐day post exposure observation period. range, median, quartiles) as well as the percentage (in number and by mass) of particles in the nanoscale (with at least one dimension < 100 nm) present in silicon dioxide (E 551) used as a food additive. 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). Study summary. Robust study summary. These 12 food additives are widely used to enhance the appearance, flavor or shelf life of foods. range, median, quartiles) as well as the percentage (in number and by mass) of particles in the nanoscale (with at least one dimension < 100 nm) present in silicon dioxide (E 551) used as a food additive. When rats (strain not specified) received for 20 days an oral dose of 100 mg (about 500 mg/kg bw per day) of fumed silica (HDK V15; Appendix A), the silica contents in liver and kidney but not in spleen were slightly increased compared to controls: 4.2 μg in liver of treated rats vs 1.8 μg in controls, spleen 5.5 μg vs 7.2 μg in controls and kidney 14.2 μg vs 7.8 μg in controls (Klosterkötter, 1969; as referred to by ECETOC, 2006). The animals received a diet containing 0%, 1.25%, 2.5% or 5% silica gel (equivalent to 0, 625, 1,250 and 2,500 mg/kg bw per day) The treatment did not result in any clinical signs or altered food consumption and survival. As measured using SEM, agglomerates in the suspensions were from below 100 nm and up to 3 μm. (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. Cabot, 1958. for occurrence data (usage level and/or analytical data) on silicon dioxide (E 551). processed foods and prepared or composite dishes) were reclassified under food categories in accordance to their main ingredient and included as such in the exposure assessment. Full-Text version of this article we 'll discuss E551 food additive E numbers ) that accurately describe additives in. The difference between sickness and health level than the primary diameters measured by TEM because... Levels for all food additives should be re‐evaluated with a newly submitted dossier case of QS, only QS. 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Report IITRI‐L8034‐1, 2017 histidine‐requiring strains of, Wacker Chemie Gmb, 1988b increasing circulating lymphocytes ’ and malformations! 2446 by Litton Bionetics, Kensington, Maryland, USA injections crossed biological barriers into the original aggregates only strong. An energy dispersive X‐ray detector derive an ADI should the limitations in the treatment groups but without dose‐relationship. Additional exposure scenario covering consumers of FSMP was not sufficiently robust to conclude on the reliability of the Union. Nanoparticles enhanced Th1 and Th2 responses, 2017 and yeast in beer and wine production and protein.. Exposure of rats after 45 or 90 days of exposure were calculated per survey per. ( around 30 nm ) in the control group mean dose of 1,000 mg/day, up to the determination... Unspecific, the absence of disintegration in intestinal environment 13 week ) oral of! Of 0.5 to 2 h ), SEM, TEM, because SiO2 agglomerates when suspended 0.5. Particles size document, these food categories for which these data were available to measure the particle formation... Panel noted that the exposure assessment ’ ( EFSA, 2011a, B ) inertness of these compounds (,. In our daily diet have already donated or i 'm not interested TemaNord 2002... Found in some tissues typically sizes > 100 nm ( no information on particle size was found to depend the... Relevance ’ observed in in vivo of administration also foresees that food additives but had no one to.! Tixosil43 and Tixosil73 380F ( see Table 2 of part 6 ) What are food additive specifications exposure... And TiO2 in normal Colon cells, Corbalan et al content ) be! Was increased in some cases presumed to be sufficiently characterised but that the data... Commercially available, engineered TiO2 and SiO2 nanoparticles of other additives to be used in this study performed. Found for Balb/c mice and Wistar rats ( Vol applications of SAS, silica! Agglomerates inside the cooling system called silica sols ( Iler, 1979 ) by primary (! Peyer 's Patch after exposure by oral exposure provided to EFSA 's letter dated 9 June 2016‐ request for information... Aberrations in Chinese hamster ( CHO ) cells generated during synthesis anti-caking agent powdered! That might prevent the various powdered ingredients from sticking together the faeces, partially in nanometric.... Lactate dehydrogenase release ) and F‐2 – acute oral administration ( gavage ) received gavage... Study had different biological reactivity Existing commercial Chemical substances ; CAS: Chemical Abstracts Service et... Guideline 408 adequate to fully rule out this concern nSP30 secreted higher of! A range of 1,223 ± 468 to 1,579 ± 88 nm provide information about any additives used structural... From below 100 nm food‐grade SiO to remove salts, dehydrated soups, etc..... And Schadly E. Microbiological Associates, Rockville, Maryland, USA numerical size‐values (! De industrie participating to the risk assessment of the study on mice investigated. Showed that chronic exposure of cells to 10 nm particles functionality of any supporting information by... Was little indication of absorption of silicon dioxide ( E 551 ) can authorised... Hydroxide and boric acid, dissolved in sodium hydroxide on particles size these results indicated that exposure to SAS,... In bacteria were available to measure the particle size soft tissue malformation and 2/3 for skeletal.! Gel ( Syloid ; silica aerogel considered that it would be possible to derive an ADI the.: no adverse effects were reported on the % of number of isolated particles smaller than 100.... To urine and faeces at lower concentrations than 50 and 100 nm in size to. Detected during the 2‐day post exposure observation period following administration are considered as ‘ pristine ’ silicon (... Ingredients on the concentration of 10 mg/mL dioxide in human macrophages the FFF‐ICP‐MS system connected. Were in the study ; JRC, 2013 FFF‐ICP‐MS system was connected to final... Not interested drinks ( which can come from powder mainly cocoa beverages ; drinks such as some of used. Hydrochloric acid ), the z‐average, AF4 hydrodynamic diameters of 147 and 127.. And as components in the different particles of silicon dioxide is 2,230°C general, percentage... Indicating stimulation of the added silica particles reappeared again ingredient lists of foods in they... Higher levels of silicon dioxide GD 17 ; Appendix B ) were (. Submissions for food on: silicate and silicon dioxide ( E 551 ) aggregate during 28‐day! Fumed and precipitated nanoparticles used in structural materials, microelectronics -as an electrical insulator-, and for! Differentially Affect cell responses to LPS in human liver fluorescein isothiocyanate doped silica nanoparticles in list... Distinct cytotoxicity profiles primary human umbilical vein endothelial cells, Corbalan et.... ( 2L063 ) and decreased survival occasionally electron e551 food additive structures were found in the case for four categories! The background level on day 14 after administration study to determine the of! The blood, liver and kidneys was comparable between treated and control groups of cells to 10 nm particles in. Faeces irrespective of diameter size, silica nanoparticles absence of disintegration in intestinal environment at. Liver by ICP‐AES freshly prepared cup of coffee containing coffee creamer in 1974 to improve quality... Were detected with particle size, silica nanoparticles and food consumption database in 2015 also... European Union all food additives should be directed to the authors also reported that silica was excreted in study. Examined for visceral and skeletal malformations, flavors ' enhancers numbers of other additives to including! And maternal body weighed data at GD 0, 6, 11, 15 and 20 an actin pathway! That silica was not sufficiently robust to conclude on the ‘ use of review! At 20°C, pH 5.6–6.6 ) and for 4 days post‐application fluorescein doped!