The food additive, silicon dioxide (E 551), is a material comprised of aggregated nanosized primary particles. 02G11001. Oesch F, Pharmakologisches Institut der Universität, Mainz, Germany. 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)). The animals (5 weeks old at initiation) received for 93 weeks a diet containing 0%, 1.25%, 2.5% or 5 % of the test item (equivalent to 0, 1,875, 3,750 and 7,500 mg/kg bw per day). Putman DL and Morris MJ. Based on the available in vitro studies, there was no concern with respect to the induction of gene mutations. Even the most dedicated of us can get fed up trying to make sense of what is (and isn’t) on the labels. CEFIC, 2016a. Overall, there was evidence for a low acute oral toxicity of SAS. The Panel estimated the chronic dietary exposure to silicon dioxide (E 551) for the following population groups: infants, toddlers, children, adolescents, adults and the elderly. 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. This applied to five food categories and may have resulted in an overestimation of the exposure: The following two sugars and syrups categories represent most of foods under FC 11.1 thus whole food category was included in the assessment: It has to be noted that silicon dioxide (E 551) is authorised in FC 0, meaning in ‘all categories of foods excluding foods for infants and young children, except where specifically provided for’. (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). 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. Products that have the label No gluten - 10 products. The Panel evaluated the reliability of the studies and the relevance of the results. it is ‘permitted in all categories of foods excluding foods for infants and young children, except where specifically provided for’. Submitted to EFSA by CEFIC, September 2011. The Panel agreed with this NOAEL. Fraunhofer ITEM Study No. They are marked in RED bold with “AVOID” Other Additives in According to these authors, studies using nanoparticles for oral exposure may lead to misinterpretation and underestimation or overestimation of toxicity of nanoparticles, and it is necessary to assess the synergistic effects of nanoparticles in a complex system when considering the safety of nanoparticles used in food. TNO, Zeist. Therefore, eating occasions belonging to these FCs were also reclassified under food categories in accordance with their main component. Clear characterisation of particle size distribution is required. The Panel noted that the administered dose was very high and that excretion in faeces was not measured. 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. However, the absence of a robust long‐term study with a well‐characterised food additive and following the current guidelines remained an uncertainty. No clinical signs and no effects on food consumption, body weight gain or food efficiency were noted. Prüfung der akuten Toxizität von AEROSIL. Teratologic Evaluation of FDA 71‐48 (Syloid; silica aerogel). The effect of the presence of food components, such as sugar and protein, on the absorption of nanoparticles was also evaluated by measuring silicon urinary excretion. 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. Intranasal exposure to OVA plus smaller nano‐silica particles tended to induce a higher level of OVA‐specific immunoglobulin (Ig) E, IgG and IgG1 antibodies than did exposure to OVA plus larger silica particles. Robust study summary. These specifications do not exclude the presence of nanoparticles. Use the link below to share a full-text version of this article with your friends and colleagues. 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. (2013) analysed an instant barley coffee (stated to be silica free) and an instant cappuccino (containing E 551) both in powder form. Accordingly, no adverse effects were reported in rats fed for 6 months a diet with silica gel at doses up to 8,980 mg/kg bw per day in females (Grace, 1975a, 1975b (Documentation provided to EFSA n. 43, 44)). The exposure assessments were hampered by several uncertainties. Official Methods of Analysis of AOAC International, 17th Edition, Vol. Clinical signs were recorded daily and maternal body weighed data at GD 0, 8, 10 and 14. The Panel noted that because of their specific physicochemical properties, engineered nanoparticles of SAS are not representative of silicon dioxide used as a food additive (E 551). Hide the banner. (2015) that ‘in vitro and in silico fluid incubation data provided some evidence of changes in particle stability, aggregation, and surface properties following interaction with luminal factors present in the GI tract. 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. Using the same experimental conditions, the small particles induced a dose‐dependent significant increase in intracellular reactive oxygen species in contrast to particles with a size of 300 or 1,000 nm. In Vitro According to Annex III, Part 4, silicon dioxide (E 551) is authorised as a food additive including carriers in food flavourings, at the maximum level of 50,000 mg/kg in all flavourings. Nevertheless, despite the limitations of the toxicological database available with SAS samples closely related to the food additive E 551, there was no indication of adverse effects. The ANS Panel was not provided with a newly submitted dossier. Pellet was re‐suspended in water, Suspension were mixed on a vortex (30 s) and then: stirred using magnetic bar (15 min); or sonicated 120 s; or sonicated in water bath for 15 min, Ultrasonic probe used as dispersing technique, Primary particles (20–50 nm) were aggregated, All samples contained agglomerates (0.5–2 m); the mean diameters of all primary particles below 100 nm with mean primary particle sizes of 9–26 nm (no quantification), Nanoparticles of SAS observed in 10 out of the 13 samples (no quantification). The samples were obtained, along with a food integrator (not further specified, but stated to be rich in E 551) from a local grocery. These methods measure different particle characteristics, which are reflected in the different numerical size‐values obtained (see Table 2). Missing Bulgaria, Cyprus, Estonia, Latvia, Lithuania, Luxembourg, Malta and Slovenia. Gentle sonication in a water bath was applied to facilitate the particle distribution. The authors used hydrodynamic chromatography with inductively coupled plasma mass spectrometry (HDC‐ICP‐MS) to determine the particle size and determine the concentration of silicon and derive the silica content in the selected foods. TEM characterisation included the determination of the minimum detectable size and subsequent measurement of the equivalent circle diameter of primary particles and small aggregates, which were between 10.3 and 20.3 nm. Silicon dioxide particles were identified by scanning electron microscopy equipped with an energy dispersive X‐ray detector. Equivocal results for the induction of micronuclei were observed for fumed silica (NM‐203) in the rat bone marrow, following the intravenous route of administration (Guichard et al., 2015b), or in the colon of rats for fumed silica (NM‐202 and NM‐203) following oral administration (Tarantini et al., 2015a). That food additive has subsequently been authorised on the basis of specific uses and has been allocated the number E 1205. Silicon dioxide (E 551) is authorised to be used in 22 food categories, of which FC 0, i.e. demonstration of the presence of particles with sizes > 1 nm). Novel insights into the risk assessment of the nanomaterial synthetic amorphous silica, additive E551, in food 11.1 Sugars and syrups as defined by Directive 2001/111/EC, only dried powdered foods, 11.1 Sugars and syrups as defined by Directive 2001/111/EC, only foods in tablet and coated tablet form. only foods in dried powdered form (i.e. Available online: http://www.gnpd.com/sinatra/home/ accessed on 28/7/2017. Based on the available database, there was no indication for toxicity of E 551 at the reported uses and use levels. 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). Available online: http://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=search.simple Please check your email for instructions on resetting your password. No relevant effects were reported on body weight gain and food consumption. Submitted to EFSA by CEFIC, September 2011. Silica (E551) is commonly used as an anti-caking agent in food products. 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). During the 4 days post‐treatment, no significant changes of the renal silicon excretion were noted compared with pre‐application values. Data were also submitted for the FCs 13.2, 13.3 and 18 in which silicon dioxide (E 551) is not authorised as such but could be present as for FC 0 or from carry‐over. Submitted to EFSA on 30 May 2016. Monopoli et al. The most common methods for sensitive silicon analysis are inductively coupled plasma atomic absorption spectrometry (ICP‐AES) and flameless atomic absorption spectrometry (AAS) (Carlisle, 1997). Degussa, Hanau, Germany. No reproductive toxicity was noted but the study was limited since only one low dose was tested in a small group of pregnant rats. No clinical signs of toxicity were noted during the exposure period. 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). Report FDABF‐GRAS‐311. The cytotoxic effect was found to depend on the concentration and the size of particles. 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. 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). 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). After drying the precipitated silica can be milled to achieve the specified particle size distribution. Silica gel (Syloid 244, Appendix A) was tested in a study on acute oral toxicity (Grace, 1976 (Documentation provided to EFSA n. 45)). Oxidative stress markers gave positive results at cytotoxic concentrations. The exposure was estimated according to different scenarios (see Section 3.4). There was no significant difference in total and dissolved silica levels excreted in urine (analysed colorimetrically). CAB‐O‐SIL EH‐5, Salmonella/mammalian‐microsome plate incorporation mutagenicity assay (Ames test). 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). 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. Food additives and nanotechnologies. 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’. Takizawa et al. Fumed silica is produced in essentially an anhydrous state, whereas the wet‐process products are obtained as hydrates or contain surface absorbed water’. AEROSIL 200F‐ primary particles 12 nm (no information on the % of number of particles). Recently modified products. The Panel noted that the authors did not use TEM to demonstrate the presence of nanoparticles in the tissues; however, the authors concluded that, by combining confocal fluorescence microscopy with ICP‐MS, they could demonstrate the presence of nanoparticles, rather than their dissolved form, was established mainly in liver tissues. The number of pups per litter was not different from the control group as well as pup weight and postnatal survival at day 7 and 21. The animals received 0, 100, 1,000 or 2,500 mg/kg bw per day of fumed SAS, or 100, 500 or 1,000 mg/kg bw per day of NM‐202. These methods measure different particle characteristics, which are reflected in the different numerical size values obtained. in the absence of a long‐term study with nano silicon dioxide, the Panel was unable to extrapolate these results to a material complying with the current specifications for E 551, potentially containing nanoparticles. Submitted to EFSA by CEFIC, September 2011. For this purpose, a programme for the re‐evaluation of food additives that were already permitted in the European Union before 20 January 2009 has been set up under the Regulation (EU) No 257/201022 by filtering. Offspring did not show clinical signs or external malformations; post‐natal body weight gain was normal. Open Food Facts is a collaborative project built by tens of thousands of volunteers and managed by a non-profit organization with 3 employees. The full food category was taken into account because the restriction represents a large part of the whole food category. . For SAS used as a food additive, 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. In contrast, in mammalian cells, SAS not used as a food additive nor used in either cosmetics or pharmaceuticals induced micronuclei in a study of high relevance (Liu et al., 1996) and equivocal results for the same end point in a study of limited relevance (Decan et al., 2016). These include standard codes (E numbers) that accurately describe additives used in the production of food. The total urine was collected for 3 days pre‐application (control values) and for 4 days post‐application. OJ L 80, 26.3.2010, p. 19–27. 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. However, when the different particles were dispersed in fed‐state simulated intestinal fluids, the amounts of intracellular particles significantly decreased compared to control. 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. Nanosized particles cannot exert this function. Available online: http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm. Technical dossier, Volume I of VIII Date of submission: 18 July 2016, Submitted by: The Association of Synthetic Amorphous Silica Producers (ASASP), Belgium. The committee stated that the available data on orally administered silicon dioxide and silicates ‘appear to substantiate the biological inertness of these compounds’. I have already donated or I'm not interested. Gehrke et al. Open Food Facts wordt gemaakt door een non-profit associatie, onafhankelijk van de industrie. Advanced 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 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.