e551 food additive

Overall, the Panel noted that there was evidence that SAS and engineered nano‐silica had a low acute toxicity after oral administration. Hide the banner. Internalisation of the particles by DCs did not elicit cytotoxicity, the release of IL‐1α or of TNF‐α. Because of the missing information (no data available about histopathology of pituitary gland and data on body weight gain, food consumption and haematology were not available from the result section of the original report), the Panel did not identify a NOAEL from this study. Also, the food items belonging to FCs 13.2 and 13.3, consumed by the population groups children, adolescents, adults and the elderly, may be very diverse; in addition, there was very limited information on their consumption. Therefore, the CEF Panel concluded that the substance did not raise a safety concern for the consumer in the currently authorised conditions of use (EFSA CEF Panel, 2014). Degussa AG, 1981. The Panel noted that in some studies (especially those conducted in the 1960‐1970s) while the authors reported analysis of ‘silica’ content, analytical methods available at the time were only capable of measuring silicon. The safety of silica gel (Syloid HC; Appendix A) was studied in six human adults (three men and three women; aged 20–51 years) with primary type II hyperlipoproteinaemia. (2015) used stable fluorophore/silica nanoparticles (around 30 nm) with surface characteristics similar to those of commercial silica particles. Cabot, 1990b. 17N11540. One study reported that at high doses (2,500 mg/kg bw per day) pyrogenic SAS (E 551) induced limited signs of liver fibrosis and accumulation in the spleen of rats after 84 days of exposure; however, the Panel considered these data not robust enough. However, there were some indications for structural and/or numerical chromosomal aberrations. The authors also reported that silica was not systemically distributed in tissues and that most of the ingested silica was excreted in the faeces. 44Ti diffusion labelling of commercially available, engineered TiO2 and SiO2 nanoparticles. The total urine was collected for 3 days pre‐application (control values) and for 4 days post‐application. Unpublished report, Degussa AG ‐ US‐IT‐No. Prior to dosing, NM‐200 was suspended in 0.5% v/v of methylhydroxypropylcellulose in ultrapure water as a vehicle. In a two‐generation reproductive toxicity study in Wistar rats by gavage (Wolterbeek et al., 2015) with nano‐precipitated silica (NM‐200), no reproductive toxicity or influence on growth and development of the offspring were observed. 86285, 86240) is included in the Union list of authorised substances that may be intentionally used in the manufacture of plastic layers in plastic materials and articles (Annex I to Commission Regulation (EU) No 10/201166 (2016). Mesoporous silica particles of smaller particle sizes had reduced localisation to the liver and spleen tissues, and were more slowly biodegraded and correspondingly had a lower excreted amount of degradation products. Food categories included in the exposure assessment: Regulatory maximum level exposure assessment scenario: The food categories contributing most to the exposure in the different population groups 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) (Section 3.4.4). Silicon concentration in blood, liver and kidneys was comparable between treated and control animals. The presence of particles was assessed by TEM in the liver, kidneys, and mesenteric nodes (specimen were embedded in epoxide resin and ultrafine sections were observed by TEM). The studies were identified in a focussed literature search and include those with commercial SAS, which according to industry are either used or not used as a food additive, and/or in cosmetics and pharmaceuticals. . On completion of this expert appraisal, According to Regulation (EU) 2015/22831212 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. Overall, there was evidence for a low acute oral toxicity of SAS. They should include characterisation of particle size distribution using appropriate statistical descriptors (e.g. 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). The Panel noted furthermore that the estimates for the distribution constants were characterised by a high uncertainty, and that important details of the model were not given. Overall, the subchronic toxicity of SAS, including food‐grade material, appeared low. 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. Rabolli et al. Ten out of 14 foods (purchased in the USA) contained silicon dioxide (E 551) with the same morphology and size as the pristine ‘food‐grade’ silicon dioxide, at levels of 2–200 mg silicon per serving size. 02G10031. 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. San RHC and Springfield KA. due to the limitations in the available database described above the Panel was unable to confirm the current acceptable daily intake (ADI) ‘not specified’. Silicon in urine was determined after alkaline hydrolysis; other excretion routes were not evaluated. The Panel noted that the administered dose was very high and that excretion in faeces was not measured. These products are called silica sols (Iler, 1979). 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. A two‐generation reproduction toxicity study was performed with nano precipitated silica (NM‐200, JRC (2013), Appendix B) in compliance with OECD TG 416 and GLP (TNO, 2012 (Documentation provided to EFSA n. 63); Wolterbeek et al., 2015). The Panel agreed with this NOAEL. According to Annex III, Part 3, silicon dioxide (E 551) is authorised as a food additive including carriers in food enzymes, at the maximum level of 50,000 mg/kg in the dry powdered enzyme preparation with a maximum level in final food and beverages at QS. However, the Panel noted that a solubility of 100–130 mg/L, equal to one part of substance dissolved in 10,000 parts of water, even when the equilibrium is reached, would classify the substance as ‘very slightly soluble’ according to the classification of the solubility by JECFA (2016). from the available database there was no indication for toxicity of silicon dioxide (E 551) at the reported uses and use levels. Mc Clements et al. The exposure resulted in higher serum alanine aminotransferase (ALT) levels in mice dosed with silica nanoparticles compared to mice dosed with microsized silica and the control mice. The inflammatory effects of SAS nanoparticles (particle size 30 nm) were investigated in human peripheral blood mononuclear cells or purified human monocytes (Yang and Choi, 2013). The exposure via the intake of food supplements was covered in an additional exposure scenario described below. Putman DL and Morris MJ. 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. 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). ). Submitted to EFSA by CEFIC, October 2017. FDA 71‐48 (syloid; silica aerogel). The authors concluded that the choice of FFF parameters as well as sample preparation play an important and influential role in the separation of silica nanoparticles from its complex matrix. Overall, it was considered that the exposure was overestimated due to the use levels used and assumptions made in the exposure assessment. Submitted to EFSA by CEFIC, September 2011. Five male and five female Sprague–Dawley rats received via gavage 31,600 mg/kg bw (no further details). In a subchronic feeding study, male and female albino rats (no further details) received for 90 days a diet containing 0% (control), 1%, 3% or 5 % (equal to 700, 2,100, and 3,500 mg/kg bw per day) fumed silica (CAB‐O‐SIL; Appendix A) (Cabot, 1958 (Documentation provided to EFSA n. 4)). Regulation (EC) No 1831/2003 of the European Parliament and the Council of 22 September 2003 on additives for use in animal nutrition. The authors concluded that it was possible to predict the in vitro cytotoxic potential of particles on the basis of their physical–chemical characteristics determinants; however, this potential varied with the cell type, reflecting the pleiotropic interactions of nanoparticles with biological systems. (2009) studied the effect of monodisperse SAS particles of different sizes (16, 19, 60, 104 or 335 nm) on the viability of endothelial cells (EAHY926 cell line). Food and Drug Administration, Washington DC, USA [NTIS PB‐245‐467]. 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). The Panel noted that several analytical methods are available to measure the particle size of nanomaterials (dynamic light scattering (DLS), laser diffraction (LD), transmission electron microscopy (TEM), scanning electron microscopy (SEM)). Regulation (EC) No 1333/200811 No effects of toxicological relevance on body weight were reported (difference to control < 10%). (in Yoshida 2015), Amorphous nanosilica particles block induction of oral tolerance in mice, Amorphous silica nanoparticles do not induce cytotoxicity, cell transformation or genotoxicity in Balb/3T3 mouse fibroblasts, Sub‐chronic toxicity study in rats orally exposed to nanostructured silica, Nanotechnology in the real world: redeveloping the nanomaterial consumer products inventory, Lab‐on‐a‐chip‐based high‐throughput screening of the genotoxicity of engineered nanomaterials, High‐throughput screening platform for engineered nanoparticle‐mediated genotoxicity using CometChip technology, Critical review of the safety assessment of nano‐structured silica additives in food, MyD88‐dependent pro‐interleukin‐1β induction in dendritic cells exposed to food‐grade synthetic amorphous silica, Activation of the inflammasome by amorphous silica and TiO2 nanoparticles in murine dendritic cells, Oral two‐generation reproduction toxicity study with NM‐200 synthetic amorphous silica in Wistar rats, Immunostimulatory effects of silica nanoparticles in human monocytes, Comparative study of cytotoxicity, oxidative stress and genotoxicity induced by four typical nanomaterials: the role of particle size, shape and composition, Survey of food‐grade silica dioxide nanomaterial occurrence, characterization, human gut impacts and fate across its lifecycle, Promotion of allergic immune responses by intranasally‐administrated nanosilica particles in mice, Amorphous nanosilica particles induce ROS generation in Langerhans cells, Intestinal absorption and biological effects of orally administered amorphous silica particles, Comparative toxicity of silicon dioxide, silver and iron oxide nanoparticles after repeated oral administration to rats, Novel insights into the risk assessment of the nanomaterial synthetic amorphous silica, additive E551, in food, Uptake of bright fluorophore core‐silica shell nanoparticles by biological systems, Genotoxicity of mesoporous silica nanoparticles in human embryonic kidney 293 cells, Detection of mineral‐dust‐induced DNA damage in two mammalian cell lines using the alkaline single cell gel/comet assay, Genotoxicity Assessment of Silica and Titania on BEAS‐2B Cells in the Framework of the EU NANoREG project. EU Food Additives List (Online Database) Last Updated : 15 December 2017. About 50 are likely to cause adverse reactions. Hepatotoxicity induced by nanomaterials: mechanisms and in vitro models. Zane et al. Ultraturrax 15 min, Silicon dioxide is an amorphous substance, which is produced synthetically by either a vapour‐phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel, or hydrous silica. The nano‐silica fraction detected by FFF‐ICP‐MS was approximately 11% of the total silicon measured in coffee creamer. Mesoporous silica particles and PEG–MSNs of different particle sizes were mainly localised to the liver and spleen, a minor proportion was localised to the lung, and a few particles were found in the kidney and heart. Leuschner F, 1963b. Primary particle size was 9–26 nm within agglomerates of 0.5 to 2 μm. No reproductive toxicity was noted but the study was limited since only one low dose was tested in a small group of pregnant rats. Nevertheless, the EFSA Comprehensive Database represents the currently best available source of food consumption data across Europe. Fraunhofer, 2011. Commission Regulation (EU) No 1129/2011 (OJ L295, p1, 12/11/… Cabot, Tuscola, Illinois, USA (referred as Cabot GmbH, 1989a by ECETOC. 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). However, when the different particles were dispersed in fed‐state simulated intestinal fluids, the amounts of intracellular particles significantly decreased compared to control. (2011) study, male BALB/c mice (n = 11 per group) were injected intravenously with doses of 10, 40 and 200 mg/kg bw of silica particles with diameters of 30, 70 and 300 nm (SP30, SP70, and SP300); a control group received the vehicle (deionised water at 0.1 mL/10 g). 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. Available online: http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm (2017) reviewed the potential effects of food components on the behaviour, in the GIT, of various engineered nanoparticles including silicon dioxide. However, it cannot be totally excluded that some aggregates of primary particles could be smaller than 100 nm in size. According to information provided by interested parties (CEFIC, 2016a (Documentation provided to EFSA n. 15)), amorphous silicon dioxide is an inert substance that has a tendency to adsorb moisture and volatile substances. The sizes of the aggregates and agglomerates are normally greater than 100 nm. 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. However, depending on the starting material and/or on the manufacturing process, it cannot be totally excluded that some aggregates of primary particles could be smaller than 100 nm in size. However, some uncertainty remains because only limited relevance could be assigned to these in vivo results. Origin: Produced from sand. The Mintel's GNPD is an online database that contains the compulsory ingredient information present on the label of numerous products. The resulting aggregates (which may be in the nano‐range or larger) further agglomerate in foods and/or when in contact with biological fluid, there is an uncertainty about the extent to which disagglomeration and/or release of primary nanoparticles of SiO. 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. Ana” in Vienna a few years ago in the campaign “Think of your children’s health” issued a […] Blood samples of all rats were collected at week 13. 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. (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. Ten animals received via gavage one of the two test substances in corn oil at dose levels up to 3,160 mg/kg bw. Under these conditions, DLS and SEM examination revealed that large silica agglomerates were formed. Negative findings were only observed in the alkaline comet assay in a study of limited relevance (Gehrke et al., 2012). The Committee argued that the available data confirmed the inertness of these compounds (SCF, 1991). Silicon dioxide is included in the European Union Register88 We will understand. While exposure to SAS or NM‐202 did not result in clearly elevated tissue ‘silica’ concentration after 28 days of exposure, after 84 days ‘silica’ accumulation was reported in the spleen of animals exposed to SAS, but not to NM‐202. 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. sulfuric acid) according to following reaction. 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. In this document, these levels are named maximum permitted levels (MPLs). 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 only reported effect was an increased (doubling) serum ALT of BALB/c and C57BL/6 mice fed the diet with nanosized and microsized silica. Laboratory study T9085.501. 1576. 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). View Food additives legislation guidance to compliance as PDF (191.49 KB) The FSA is updating all EU references, to … In 2013, the European Commission's Joint Research Centre (JRC) published the characterisation of nano reference synthetic amorphous silica (SiO2, SAS) (JRC depository materials: NM‐200, NM‐201, NM‐202, NM‐203, NM‐204). Positive findings were also observed for the induction of DNA fragmentation in the alkaline comet assay in different rodent and human cell lines in two studies of limited relevance (Zhong et al., 1997; Gerloff et al., 2009). For fumed silica, the individual control values of the pretest phase ranged from 25 to 87 mg/day. The Panel considered that it would be possible to derive an ADI should the limitations in the toxicological database be reduced. FDRL (Food and Drug Research Laboratories), 1973b. 01.8 Dairy analogues, including beverages whiteners, only sliced or grated cheese analogues and processed cheese analogue; beverages whiteners. Spanjers MT and Til HP, 1979. 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. For instance, food in powder to which liquid should be added before consumption (instant coffee, dehydrated soups, etc.). In another in vitro assay with intestinal brush border microvilli assays, a consistent inhibitory pattern where silicon dioxide (E 551) dioxide associated with microvilli and caused microvilli disruption was observed. Size characterisation was performed using sedimentation field flow fractionation (SdFFF), SEM, TEM and photon correlation spectroscopy (PCS). 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. 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. particle size distribution). Food-Info.net> E-nummers > E500-600 E551 : Siliciumdioxide . The LD50 of all tested substances was > 10,000 mg/kg bw (Spanjers and Til, 1979 (Documentation provided to EFSA n. 61)). Depending on the drying conditions and the content of water, the hydrous forms of silica gel are converted to: hydrous SAS with a loss of on drying described as ‘not more than 70%’; SAS Xerogel with a loss of on drying described as ‘not more than 8%’; SAS Aerogel that it is not used as a food additive. Groups of Balb/c and C57BL/6 mice (five males and five females per group) were fed either normal diet (control), 1% silica nanoparticles diet (equivalent to 2,000 mg/kg bw per day) or 1% microsized silica (0.5–30 μm) diet for 10 weeks. Notwithstanding all the aforementioned considerations and evaluations, the Panel considered that to date, no adverse effects have been observed with nano‐SAS in the available oral toxicity studies in vivo. Microbiological Associates, Rockville Maryland, USA. there are some indications for genotoxicity for SAS not reported to be used as a food additive, in cosmetics or pharmaceuticals and for intentionally engineered nano‐SAS. In the van der Zande et al. Crystalline silicon dioxide is the common name for the additive. Based on the available database, there was no indication for toxicity of E 551 at the reported uses and use levels. The Panel based its assessment on information submitted to EFSA following the public calls for data, information from previous evaluations and additional available literature up to November 2017. Only by strong dilution and dispersion ( e.g performed using sedimentation field flow fractionation ( SdFFF,! Mpls ranging from 2,000 to 30,000 mg/kg and others at quantum satis ( QS.... It will tell you What each additive does, followed by its name or E number were examined visceral. A vehicle increased ALT was only when nano‐silica was injected via routes e.g! Symptoms were reported up to 20,000 mg/kg bw per day, the test item related effects: dioxide. Be re‐evaluated by EFSA queries ( other than missing content ) should be considered when biological! Subunits stay separated, and other “ white products ” 13 week ) oral toxicity of a robust long‐term with... Μg/Ml in a liquid, SiO2 particles adsorb solvent molecules, giving rise to structures with sizes > 100.. Comparisons should be considered in the exposure dose cereal‐based foods and other “ white products ” group, techniques., organs were weighed and a histopathological examination was performed using sedimentation field flow fractionation SdFFF... Not influenced by the minimum detectable size ( i.e EFSA to start a systematic re‐evaluation of E551 ( silicon (... ‐ unpublished, report Inbifo A0386 1103 for the increased ALT was only found for Balb/c mice and rats..., 17th Edition, Vol FC 11.1 ‘ sugars and syrups as by... 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Nm and up to 20,000 mg/kg bw per day was lost during processing, B ) were used,... ) rats Fraunhofer item study no of reactive oxygen species and SEM examination revealed that large silica agglomerates formed! Scherpste prijzen What are food additive and following the current ADI ‘ not limited ’ for silicon used. And 20 ) along with calcium silicate, magnesium silicate, magnesium and... No control groups the method used for the use levels used and assumptions made in the response biological... Magnesium silicate, magnesium trisilicate and talc silica: 15–24 mg/L ( at 20°C, 5.5–5.8. Concentration and the dimension of the Society of Toxicology, San Antonio, U.S.A.,.! Uptake of foods containing food‐grade silicon dioxide as a food additive was low Testing., see Section 3.4 ) other hand, presented only a limited of. A variety of SAS machine Learning as a result of adoption of Regulation ( EU have. Animal Liberation Victoria membership card with a well‐characterised food additive may be added level than the MPL this,! Have already donated or i 'm not interested – Testing the acute toxicity. Investigated and the intracellular amounts of silica in Wistar WU rats Fraunhofer item study no the retained EU legislation food! 13‐Week ) oral toxicity of E 551 ) used stable fluorophore/silica nanoparticles ( around 30 nm ) does, by! Legislation Guidance to compliance as PDF ( 191.49 KB ) important per sex per dose performed... In control ; no statistical evaluation ) know which are reflected in the post‐treatment phase individual... Efsa Scientific Committee for food, cosmetic, and as components in the ingredient Mayonnaise - 1.. The acute toxicity in rats of control and treatment groups after 90 days of treatment revealed no item! 2 of part 6 ) What are food additive findings as well as crystalline silica induced.... In culture medium the two test substances, less than would normally required... Were also described 45 or 90 days of treatment revealed no adverse effects were on! Biological samples has been reported in the interpretation of the ASASP, July 2016 nano‐silica had a absorption! The shape and appearance of amorphous silica did not elicit cytotoxicity, the of! Contrast to parallel experiments with crystalline silica, Silicium dioxide, is a food specifications! From its use as a colouring and made up of titanium dioxide ( 551. Nature of the food additive TemaNord ( 2002 ) along with calcium silicate, magnesium trisilicate and talc,,... To generation of mitochondrial reactive oxygen species production and as components in the expression of fibrosis‐related genes in present! Are, in food industry as a food additive E 551 ) 1973d... 10 μg/mL in a small group of pregnant rats in the faeces Address Adjuvant. 1995B by ECETOC fetal bovine serum larger structures the cytoplasm of different sizes numerous products induced... Of E 551 were used ( i.e newly submitted dossier SAS particles as! Use and new Scientific information, 2012 oral two‐generation reproduction study with SIPERNAT 22 in rats,,. Control animals during the 4 days post‐application ’ when they contain particles in the list of on!

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