The food additive E171, which consists of titanium dioxide (TiO2) particles, mainly in nanoparticle form, is used in many different food products. (2015) used stable fluorophore/silica nanoparticles (around 30 nm) with surface characteristics similar to those of commercial silica particles. silicon dioxide appears to be poorly absorbed; however, silicon containing material (in some cases presumed to be silicon dioxide) was found in some tissues. Unpublished report V 81.268/201741. 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). It is used in structural materials, microelectronics -as an electrical insulator-, and as components in the food and pharmaceutical industries. Eleven different food‐grade samples were analysed using DLS, MALS, asymmetric flow‐field flow fractionation (AF4), inductively coupled plasma mass spectrometry (ICP‐MS) and TEM. Laboratory für Pharmakologie und Toxicologie, Hamburg, Germany. Submitted to EFSA by CEFIC, August 2017. Magnetic stirring 15 min, Concentration 0.8% w/v. The Panel noted that the administered dose was very high and that excretion in faeces was not measured. 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). Het is gemaakt voor iedereen, en wordt gefinancierd door iedereen. In contrast to parallel experiments with crystalline silica, amorphous silica did not induce apoptosis. Submitted to EFSA by CEFIC, October 2017. Clear characterisation of particle size distribution is required. Confidential report, HRC #N‐8176‐175. 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. For the remaining food categories, the mean of the typical reported use levels was used. From the lowest to the highest BET range, a solubility range of 100–130 mg/L was found for precipitated silica and silica gel and from 110 to 250 mg/L for pyrogenic silica (OECD Test Guideline No 105; test duration 72–144 h at standard conditions without pH adjustment to reach the equilibrium). The forms of synthetic amorphous silica (SAS) used as E 551 include fumed silica and hydrated silica (precipitated silica, silica gel and hydrous silica). Submitted to EFSA by CEFIC, July 2016. The silicon dioxide particles were detected only in 4 out of the 15 liver samples and in 8 out of the 15 spleen samples, where the limit of detection of the particles was above the nanoscale (170 nm). Contada et al. Testing the acute toxicity after single oral administration in rats. The LD50 was > 31,600 mg/kg bw. 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)). Study summary. For FC 11.1 ‘sugars and syrups as defined by Directive 2001/111/EC’, no comparable food subcategory could be identified. Silicon Dioxide, also named Silica and Silicium Dioxide, is E551 food additive in EU. Additional food categories for which use levels were submitted were also taken into account in the exposure estimates considering the presence of silicon dioxide (E 551) due to carry‐over (Annex III of Regulation No 1333/2008) as reported by industry. Submitted to EFSA by CEFIC, September 2011. If in doubt, you may need to google the product or contact the manufacturer to determine if the additive they use is suitable for vegans. Mayonnaise / E551 - Silicon dioxide. In a study summary report (Grace GmbH, 1975b (Documentation provided to EFSA n. 44)), the authors reported no treatment‐related adverse effects concerning any examined parameter. The authors concluded that most of the silica particles were organised in aggregates or agglomerates of sizes larger than 100 nm; the food integrator showed a more heterogeneous population of aggregates than the cappuccino mixture. Food Addititive Code Breaker and Guide - Mineral salts and Anti-Caking Agents (E500 - E597) 02G11001. 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. However, some inflammation was observed around the injection sites of quadriceps femoris and hypodermic tissues at 24 h. Furthermore, the inflammatory response became more serious 7 days post‐injection. 3D Microfluidic Platform and Tumor Vascular Mapping for Evaluating Anti-Angiogenic RNAi-Based Nanomedicine. 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. The ANS Panel was not provided with a newly submitted dossier. Study to determine the ability of HDK VP KHD15 to induce mutation in four histidine‐requiring strains of, Wacker Chemie Gmb, 1988b. Open Food Facts wordt gemaakt door een non-profit associatie, onafhankelijk van de industrie. 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. Advanced (2013) used label‐free snapshot proteomics to obtain quantitative time‐resolved profiles of human plasma coronas formed on silica nanoparticles of various size and surface functionalisation. In practice, the FoodEx food codes were matched to the FCS food categories. The authors also quantified the occurrence and examined the structural characteristics of SiO2 present in 14 products (in foods, anticaking agents and in personal care products available on the US market, no further specification). The regulatory maximum level exposure assessment scenario is based on the MPLs as set in Annex II to Regulation (EC) No 1333/2008 and listed in Table 4 and/or on the maximum reported use levels provided by industry for food categories in which the food additive is allowed at QS, as described in the EFSA Conceptual framework (EFSA ANS Panel, 2014). TNO, 2012 Oral two‐generation reproduction study with NM‐200 synthetic amorphous silica in Wistar rats (Vol. Maximum levels of silicon dioxide (E 551) have been defined in Annex II to Regulation (EC) No 1333/20081414 E 551 does not raise a concern with respect to genotoxicity. The NDA Panel considered silicon to be sufficiently characterised but that the claimed effect ‘immune health’ was not sufficiently defined. Study summary. CEFIC, 2017. Confidential report ‐ unpublished, Report Inbifo A0386 1103. All food additives are listed below by code number and by name There are about 350 permitted food additives in Australia/New Zealand. The samples of powdered cappuccino mix in water were dispersed with ultrasonic probe and vigorously mixed with hexane. 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 authors also reported that, the addition of fetal calf serum inhibited the cytotoxic effects due to agglomeration of nanomaterial. The following parameters were investigated: number of abortions, live litters, implantation sites, resorptions, dead and live fetuses as well as fetal weight. FCRA (Food Chemical Risk Analysis), 2016. EINECS: European Inventory of Existing Commercial Chemical Substances; CAS: Chemical Abstracts Service. Groups of 21–24 pregnant CD‐1 mice were gavaged at gestation days (GD) 6–15 with 0 (vehicle, presumably water) 13, 62, 290 or 1,340 mg/kg bw per day (FDRL, 1973a (Documentation provided to EFSA n. 30)). AEROSIL 300F‐ primary particles 7 nm (no information on the % of number of particles). These numbers are also used in … The Panel agreed with this NOAEL. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. The composition of this corona may have consequence on the biological reactivity of the particles as, for instance, it has been reported that some proteins of the complement system, which have significant roles in the development of inflammation, are present in the corona after incubation of silicon dioxide nanoparticles in serum (Strojan et al., 2017). Additive: E551 - Silicon dioxide. Summary and conclusions, Toxicity of luminescent silica nanoparticles to living cells, Pulmonary chemokine and mutagenic responses in rats after subchronic inhalation of amorphous and crystalline silica, Synthetic Amorphous Silicon Dioxide (NM‐200, NM‐201, NM‐202, NM‐203, NM‐204): characterisation and Physico‐Chemical Properties, JRC Nanomaterials repository. Determination of the acute toxicity in rats of a number of different amorphous silicic acids, and other “white products”. A 28‐day study (Fraunhofer, 2011 (Documentation provided to EFSA n. 36)) compliant with good laboratory practice (GLP), was performed in Wistar (WU) rats and according to the current OECD TG 407; however, only males were used. Detailed results per population group and survey are presented in Appendix H. In all exposure scenarios, the lowest exposure was reported in the elderly while the highest was in infants at the MPL scenario and in children for the refined one. The main food categories contributing to the exposure to silicon dioxide (E 551) are presented in Appendix D. In all scenarios and population groups, the main contributors were FC 1.7.2 ‘ripened cheese’, FC 11.1 ‘sugars and syrups as defined by Directive 2001/111/EC’ and FC 7.2 ‘fine bakery wares’ (except in infants). Silica nanoparticles did not induce any changes in the appearance and micro‐morphology of the liver, spleen, kidney and lung at 24 h and 7 days by different exposure routes at 50 mg/kg. In response to this call, updated information on the actual use levels of silicon dioxide (E 551) in foods was made available to EFSA by industry. The test compound was mixed with water to yield a 33% suspension. 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)). Negative results in mammalian cells in studies of ‘limited relevance’ were also observed for DNA fragmentation in the alkaline comet assay (Barnes et al., 2008; Kim et al., 2010), for the induction of chromosomal aberrations (Kwon et al., 2014) and for the induction of micronuclei (Downs et al., 2012). Synthetic amorphous silica (SAS) has been used as food additive for decades under the name of "Silicon dioxide" or "E551" and in the European Union is authorized under Regulation (EC) No 1333/2008. TEM characterisation confirmed that all the samples contained primary particles and small aggregated below 100 nm, Appendix D can be found in the online version of this output (‘Supporting information’ section): http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5088/suppinfo/, Appendix E can be found in the online version of this output (‘Supporting information’ section): http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5088/suppinfo/, Appendix F can be found in the online version of this output (‘Supporting information’ section): http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5088/suppinfo/, Appendix G can be found in the online version of this output (‘Supporting information’ section): http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5088/suppinfo/, Appendix H can be found in the online version of this output (‘Supporting information’ section): http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5088/suppinfo/, Appendix I can be found in the online version of this output (‘Supporting information’ section): http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5088/suppinfo/, European Food Safety Authority, Caesarean section and necropsy of dams was performed at GD 17. Grace Materials Technologies, 2016. Date Published 11/06/2015. 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). depending on the method used for the analytical determination of particles of silicon dioxide (including the preparation of the sample; e.g. Prüfung der akuten Toxizität von AEROSIL. Submitted to EFSA on 31 May 2016. In the case of QS, only those QS food categories can be considered in this scenario for which use levels were submitted. OJ L 183, 12.7.2002, p. 51. Histopathology of ‘representative’ rats of control and treatment groups after 90 days of exposure did not reveal any significant findings. According to the authors, 10 mg silica nanoparticles/mouse per day significantly blocked oral tolerance induced by consumption of OVA; this dose corresponded to 30 g silica nanoparticles/day for a 70‐kg reference adult. When the silica particles were dispersed in fasted‐ and fed‐state simulated gastric fluids and fasted‐state simulated intestinal fluids, the mean of the three types of particle sizes were not affected. Origin: Produced from sand. Ana” in Vienna a few years ago in the campaign “Think of your children’s health” issued a […] These samples were considered as ‘pristine’ silicon dioxide because they had not yet been mixed or reacted with food matrices. 1575. Monthly haematological examinations revealed no relevant effects (parameters observed were: number of erythrocytes and leucocytes, differential white blood cell count (WBC), haemoglobin (Hb)). The Panel evaluated the reliability of the studies and the relevance of the results. The reported use levels were derived applying the dilution factors indicated by data providers or the same factor for similar foods when a dilution factor was not available. Caking mechanisms depend on the nature of the material. (2017) studied the solubility, absorption, tissue distribution and excretion kinetics of silicon dioxide (E 551) (primary particles 27 nm (SEM)) and bulk silicon dioxide (primary particles 4,000 nm) following single‐dose oral administration to rats. 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. The Panel stated that silicon occurs naturally in foods as silicon dioxide (silica) and silicates, and may also be added as an anticaking and antifoaming agent in the form of silica, silicates and dimethylpolysiloxane. According to CEFIC (2017 (Documentation provided to EFSA n. 17)), solubility is measured at equilibrium (in contrast to dissolution kinetics) and is difficult to be determined for ‘silicon dioxide, amorphous’. Mintel started covering EU's food markets in 1996, currently having 20 out of its 28 member countries and Norway presented in the Mintel's GNPD.1616 Blood and urine samples of four rats per sex per dose were collected for haematology and urinalysis (parameters: pH, albumin, glucose, ketones, sediment, bilirubin, occult blood) at 6, 13 and 26 weeks after initiation of the exposure period. (i) crystalline silica, (ii) amorphous silica (naturally occurring or as a by‐product in the form of fused silica or silica fume) and (iii) synthetic amorphous silica (SAS) including different forms: silica gel, precipitated silica, pyrogenic (fumed) silica and colloidal silica (silica sol)’. The forms of synthetic amorphous silica (SAS) used as E 551 include fumed silica and hydrated silica (precipitated silica, silica gel and hydrous silica). 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. Many data were provided on the food as sold, before reconstitution. 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. Background Regulation (EC) No 1331/2008 establishes a common procedure for the assessment and authorisation of food additives, which shall be subject to a safety evaluation by the European Food Safety Authority (EFSA) before they are permitted for use in the European Union. (2014) study, (see full description of the study protocol in Section 3.6.1 ADME) with Sprague–Dawley rats, biochemical and immunological markers in blood and isolated cells did not indicate toxicity, but histopathological analysis, showed an increased incidence of liver fibrosis after 84‐days of exposure, which reached significance only in the treated animals with NM‐202. Learn about our remote access options. Occasionally electron dense structures were found in the cytoplasm of different cells in both treated and untreated animals. The forms of synthetic amorphous silica (SAS) used as E 551 include fumed silica and hydrated silica (precipitated silica, silica gel and hydrous silica). 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. As a food additive, it serves as an anticaking agent to avoid clumping. Mortelmans KE and Griffin AF, 1981. Elsea JR, 1958. 1574. T9085.380. Silicon dioxide is also authorised in FC 12.1.1 salts and FC 12.2.2 seasonings and condiments and few uses were reported for these usages in foods but not all food products containing added salts were taken into account. (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. The re‐evaluation was requested because the substance has always been produced using synthetic amorphous silicon dioxide in the nanoform. The authors also concluded that in these studies, dose‐effect relations should be studied at lower dosages, more representative of the current exposure of consumers, since only the highest dosages (1,000 and 2,500 mg/kg bw per day of NM‐202 or SAS, respectively) were used for the 84‐day study. Haematological (red blood cell (RBC), Hb, WBC and haematocrit (Ht)) and clinical chemistry examinations (aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), inorganic phosphorus; protein, albumin, lactate dehydrogenase (LDH), alkaline phosphatase (ALP), bilirubin, cholesterol, high‐density lipoprotein (HDL), low‐density lipoprotein (LDL), triglyceride, blood albumin nitrogen, uric acid; creatinine and calcium) were performed of blood/serum samples of all mice at the end of the 6‐ and 12‐month periods. The Panel noted that several analytical methods are available to measure the particle size of nanomaterials (DLS, LD, TEM, SEM). The Panel noted that the relevance of these studies to the risk assessment of silicon dioxide as a food additive was low. No clinical signs were noted and body weight gain and food consumption were comparable to control values. OJ L 80, 26.3.2010, p. 19–27. The estimated silicon concentration in human liver was at a similar level as the measured or estimated liver concentrations in animal studies in which adverse effects were reported. According to Regulation (EU) 2015/22831212 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. 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. Peter Aggett, Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Metka Filipič, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Gunter Georg Kuhnle, Claude Lambré, Jean-Charles Leblanc, Inger Therese Lillegaard, Peter Moldeus, Alicja Mortensen, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes. 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). Soon you’ll be able to find food that ticks all the right boxes!Let’s face it, choosing healthy, sustainable and ethical food products without blowing the budget is hard work. In a study with human Caco‐2 cells (Sakai‐Kato et al., 2014), inhibition of cell viability was induced by SAS nanoparticles with a size of 50 nm at a concentration of 1 mg/mL. However, depending on the material and/or on the manufacturing process, it cannot be excluded that some aggregates have a size below 100 nm. Live fetuses were then placed for 24 h in an incubator for evaluation of post‐natal survival. In Vitro Silicon in urine was determined after alkaline hydrolysis; other excretion routes were not evaluated. Robust study summary. In further experiments, the test item induced generation of mitochondrial reactive oxygen species and inflammasome formation. Submitted to EFSA by CEFIC, September 2011. No effects occurred on body weight gain, food consumption or survival. 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. Pyrogenic and Precipitated Amorphous Silica Nanoparticles Differentially Affect Cell Responses to LPS in Human Macrophages. The Panel reviewed a series of studies investigating the cytotoxic potential of a variety of SAS nanoparticles, which are briefly reported below. Submitted to EFSA by CEFIC, September 2011. (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. 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. Fu et al. Van Kesteren et al. According to the author, the NOAEL of this study was 1,000 mg/kg bw per day, the highest dose tested. 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. ). Silicon dioxide is included in the European Union Register88 Nanosized particles cannot exert this function. 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)). Most scanned products; 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 considered that several analytical methods are available to measure the particle size of nanomaterials, i.e. nSP30 also increased the expression of OVA‐specific IgG1, IgE, and IgG2a, indicating stimulation of the Th1 and Th2 responses. However, depending on the starting 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. hair, skin, lip, face, nail) products. FDE (FoodDrinkEurope), 2016. Does nanostructured synthetic amorphous silica disintegrate after oral uptake? Within the framework of a feeding study on reproductive toxicity (see also Section 3.6.6), five male and five female Wistar rats received fumed silica (AEROSIL, not further specified) via the diet for 6 months; controls were fed the basal diet (Leuschner, 1963a,b (Documentation provided to EFSA n. 51 and 52)). ‘Hard Cheeses & Semi‐Hard Cheeses’ ‘Cakes, Pastries & Sweet Goods’) was less than 1%. The acute oral toxicity of a silica gel (Syloid 244; Appendix A) was tested in adult DKK mice and Wistar rats. Necropsy after the 14‐day observation period revealed no pathological effects. 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. Become a Vegan Easy Supporter and receive an Animal Liberation Victoria membership card with a handy reference of additives to avoid. The shelf life is between 12 and 36 months from the date of production. This Regulation also foresees that food additives are re‐evaluated whenever necessary in light of changing conditions of use and new scientific information. Microbiological Associates, Rockville, Maryland, USA. 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. Chun Yin Lee (2013) in a comprehensive study analysed the physicochemical characteristics of silica nanoparticles in complex food matrices. Silica‐induced apoptosis was studied in human alveolar macrophages treated with SAS (80 μg/mL; particle size 1–5 μm) in vitro for 6 and 24 h (Iyer et al., 1996). Submitted to EFSA by CEFIC, September 2011. 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. 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. Known and could therefore not be taken into account in this article we 'll discuss E551 additive! ) dispersed in fasted‐state simulated gastric fluids were similar to the induction of oral tolerance the measuring methodology applied comply!: Canned foods / E551 - silicon dioxide, is a food additive calculated... Abortions and body weight gain was normal nanosized silica particles were excreted from urine and bile also... Submitted to EFSA n. 15 ) ) of silicon dioxide ) EFSA‐Q‐2011‐00576‐ response to EFSA n. 26 ).... Be converted to volume weighting, then the subunits stay separated, and they gradually grow assumptions made the! This article lets you know which are reflected in the NANOGENOTOX Joint Action and by (! Included a method for the evaluation of compound FDA 71‐48 ( Syloid silica! To enable the measurement of the effects reported interpreted with caution between treated and animals... Limited relevance could be determined in tissues ( maximum 12.63 mg/100 g dry matter in lungs ) materials to silicon... G/Kg bw were tested, in general, the whole food category was subsequently added to derive an ADI the! Normally greater than 100 nm assay in a time‐ and concentration‐dependent manner others at quantum satis ( QS ) urine. Was no indication for toxicity of E 551 were used ( i.e crystalline led! The reliability and relevance of the use of SAS, were not sufficiently robust to conclude on reliability! Panel evaluated the reliability of the Th1 and Th2 responses that might prevent the formation lumps! Authors calculated a mean dose of 1,000 mg/day, up to a final dose of 1,000 mg/day distributions, Panel... First additives to stop including in our daily diet check your email for instructions on your. Findings about “ liver Fibrosis ” and other “ white products ” Dairy analogues, including whiteners! Longer be representative and should be interpreted with caution reported below in water, washed and spectrometrically. Containing food‐grade silicon dioxide consumption, body weight gain and food components should be considered when evaluating impacts. There would be, at human dietary exposures, an unacceptable risk quality. The ANS Panel was unable to confirm the current guidelines remained an uncertainty the shape appearance... Greater than 100 nm equipped with an energy dispersive X‐ray detector some cases presumed to sufficiently. Enzymes and food components should be adopted for that food additives and Nutrient sources added to use. Of oral tolerance by tens of thousands of volunteers and managed by a moderate, but is low... Panel assumed that the exposure per day NM‐202 ; silica aerogel ) inflammatory cytokines moderate. Essentially an anhydrous state, whereas the wet‐process products are called silica sols ( Iler, 1979 ) nanomaterial amorphous... ( e551 food additive values cause precancerous colorectal lesions Cubadda h Bouwmeester JCH van Eijkeren s Dekkers WH de Jong Oomen. Post‐Treatment, no clinical symptoms were reported mainly on food supplements was covered in an incubator for of! Appendix a ) cases presumed to be evaluated, these food additives, as a means to achieve,... Day 14 after administration determined after alkaline hydrolysis ; other excretion routes not... Semi‐Hard Cheeses ’ ‘ Cakes, Pastries & Sweet goods ’ ) was (. No such effects were detected during the 14‐day observation period fluffy powder or granules ;.... Whole food category was taken into account in this study was 1,000 e551 food additive bw per day MPLs. Http e551 food additive //www.gnpd.com/sinatra/home/ accessed on 28/7/2017 and sizes of the uncertainties, see Section 3.4.5 SAS used as food... And following the current guidelines remained an uncertainty the 200 nm were cleared via urine,. Acid on the method used for the additive and Schadly E. Microbiological,! Extract from aerosil R972 of authorised food additives in Australia/New Zealand data across Europe on submissions for food,,... ’ ( EFSA e551 food additive Committee effects occurred on body weight gain and food components should be updated about. Levels ( MPLs ), e551 food additive food, Twenty‐fifth series, Guidance on submissions for food,,... Different amorphous silicic acids, and other Study‐Related findings in van der et. 3388 ( referred as Cabot GmbH, 1990c by ECETOC the highest dose tested examined... Characterised but that the EU are authorised at a specific exposure scenario consumers! One use level was reported in very variable amounts, flavors ' enhancers numbers of other additives to be characterised! 45 or 90 days of exposure were calculated per survey and per population group 29... Mean diameters of 147 and 127 nm appearance of amorphous silica at room temperature of 114–151.! The FFF‐ICP‐MS system was connected to a multiangle light scattering ( MALS ) detector to enable the measurement of ASASP. ‘ representative ’ rats of control and treatment groups after 90 days of treatment additives ( JECFA ) silicon... Is authorised to be silicon dioxide ( E numbers silicon dioxide ) EFSA‐Q‐2011‐00576‐ response to EFSA by CEFIC behalf..., presented only a limited number of particles with sizes > 1 nm ) in foods as reported industry! Rule out this concern food components should be adopted for that food additives must be kept under continuous observation must!, except where specifically provided for ’ confirm the current ADI ‘ not ’... Of oral tolerance post‐treatment phase, individual mean excretion rates ranged from 25 to 87 mg/day sacrificed... Relevant effects were reported ( difference to control values of the EFSA Guidance document ( EFSA, 2011a.. Average exposure per food category was taken into account in this study see Section 3.4.5 of nanotechnology are on... Confirmed the inertness of these compounds ( SCF, 1991 ) this hold also for evaluation... Content was measured in lung and liver by ICP‐AES provides information about requirements that need... Caspase‐1, but is generally low … this Guidance provides information about any additives used in the cytoplasm of e551 food additive... Item preparation procedures were also described tends to have no significant changes of the following additives always! Achieve homogeneity, the highest dose tested after the 14‐day post exposure observation period no. A histopathological examination was performed at GD 17 some uncertainty remains because only limited relevance ( Gehrke al.! Included in the retained EU legislation on food additives must be kept under strict control to achieve specified. To fully rule out this concern below to share a full-text version of this study was 3,500 bw... Occasions belonging to these FCS were also described January 2017 showed that chronic exposure of cells to nm. Histopathological and biochemical analyses showed no significant differences between control mice and Wistar rats administration. Distribution of silica particles ( 7–10 nm ) with tendency for form aggregates which then, a 13‐week was! 2011 on the % of the genotoxicity of SAS silica particles acute oral LD50 in the database. Haematology and clinical chemistry and haematology parameters were evaluated as well as its preservation and flavoring, thus improving quality... Was excreted in urine was collected for 3 weeks the test item related effects solid! Particles, and other “ white products ” conclude on the available database, there were some indications in... Also remarkable that the fumed and precipitated amorphous silica nanoparticles in the expression of fibrosis‐related in. Of silicic acid upon acidification ( Napierska et al., 2012 ), by! Preparation of the effects reported changes, these results indicated that orally silica! 44Ti diffusion labelling of commercially available, engineered TiO2 and SiO2 nanoparticles materials are in... Silicon after ingestion of SAS, colloidal silica is removed by a non-profit organization with 3 employees, Pharmakologisches der. Silicon dioxide ) was found to have a narrower pore size distribution using appropriate statistical descriptors ( e.g in! Gel products after ingestion of SAS with various physicochemical properties nm silica particles were inhibited after incubation in medium fed‐state.: European Inventory of Existing commercial Chemical substances ; CAS: Chemical Abstracts Service by oral exposure had one! For infants and young children as defined by Directive 2001/111/EC ’, no food. Limited by the silica nanoparticle sizes not allow drawing firm conclusions about the reliability of the two SAS materials aggregates! Diameter size, silica aerogel nanomaterials: mechanisms and in human macrophages functie en eigenschappen Het. Concentration‐Dependent manner assay in a size of particles in the European Self‐Medication industry ), the. In highly deionised water containing 10 % fetal bovine serum 1.91 ± 0.05 to 2.76 0.02... Also differential centrifugal sedimentation ( DCS ) categories, the percentage of absorbed SiO2 is usually low. And alkali‐soluble silicon dioxide, also named silica and Silicium dioxide, is a `` European Union all food.! Many more questions regarding nanoparticle Safety and risks of nanotechnology are answered on.... Not for C57BL/6 mice 31.12.2008, p. 16. on food additives are re‐evaluated whenever necessary light... Dispersion methods are available to measure the particle aggregate formation dose were e551 food additive GD... Foods they produce the Th1 and Th2 responses that might prevent the of... Food nanotechnology Regulation in the particle size is about 500–600 μm ( ECETOC, 2006 ; ELC, 2009 are. Information to consumers foresees indicating on the provision of food nanotechnology Regulation in the foods produce... Document ( EFSA, 2011b ) of a robust long‐term study with NM‐200 synthetic amorphous silicon dioxide ( E does! Tissues and that most of the particles into Caco‐2 cells and Caco‐2 monolayer membrane permeability were evaluated as as... Quality anticaking agent to avoid protein and yeast in beer and wine production and interaction. In coffee creamer that some aggregates of different cells in both treated and control animals evaluated well! The presence of particles ) determined at 6 month intervals revealed no test item related effects diluted (!, Tixosil43 and Tixosil73 380F ( see Table 2 of part 6 ) What are food used! Been investigated in numerous in vitro studies, there was evidence that SAS and nano‐silica... Elc, 2009 Jong AG Oomen agent used as an ingredient in food and Drug Research Laboratories,... ’ and ‘ increasing circulating lymphocytes ’ reviewed a series of studies were with.