In contrast, positive findings in studies of ‘limited relevance’ were observed for DNA fragmentation in the comet assay (Yang et al., 2009; Duan et al., 2013) and for the induction of micronuclei (Park et al., 2011). 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 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. ultrasonication), the presence of particles in the nano‐range in food and biological samples has been reported in very variable amounts. OECD SIDS reported solubility data on synthetic amorphous silica in water obtained from different studies: Fruijtier‐Poelloth (2012) reported for pyrogenic silica values of 144–151 mg/L and for silica gel, 127–141 mg/L in a simulated biological medium (at saturation, 37°C, pH 7.1–7.4). Histopathological examinations and serum biochemical analysis were also performed. 90‐0038‐DGT. MSG flavor information also under microscope. Gehrke et al. ECETOC (2006) reported values for water solubility of synthetic amorphous silica at room temperature of 114–151 mg/L. Submitted to EFSA by CEFIC, September 2011. Cabot, Boston, MA, USA. Not having a full biological and toxicological database for each of the different forms of silicon dioxide authorised as a food additive, the Panel has considered the available information from different SAS items for the hazard identification. If the pH is reduced to below pH 7 or if salt is added, the chemical subunits tend to fuse together in chains resulting in the formation a gel structure (silica gel). The exposure per food category was subsequently added to derive an individual total exposure per day. SOT 2015‐ 54th Annual Meeting of the Society of Toxicology, San Diego, U.S.A., 2015. Advanced Submitted to EFSA by CEFIC, September 2011. The Panel noted that this dose was much higher than the exposure estimated in this opinion for the adult population (from 20 to 200 times higher than the mean and 95th percentile exposure, respectively). As regards studies with engineered nano‐SAS, in a two‐generation reproductive toxicity study performed by gavage in Wistar rats in compliance with OECD TG 414 and GLP (Wolterbeek et al., 2015) with nano‐precipitated silica (NM‐200), no reproductive toxicity or influence on growth and development of the offspring were observed. For precipitated silica, individual mean excretion rates ranged from 16 to 71 mg/day in the pretest phase and from 20 to 81 mg/day in the post‐treatment. There were some indications from in vitro studies for structural and/or numerical chromosomal aberrations with intentionally engineered nano‐SAS. AF4‐ICP‐MS coupling and prechannel calibration with nano‐silica standards allowed the reliable detection of nanoparticles below 100 nm for 10 of 11 samples (AF4 diameters between 20.6 and 39.8 nm) and the mass quantification in seven different samples (at mg/L concentrations). The Panel noted that in some biological and toxicity 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 morphology and the dimension of the added silica particles are not, however, usually stated on the food product label. Cabot, 1958. 1576. Submitted to EFSA on 1 June 2016. The Panel noted that in some studies reported in this section, the term ‘nanomaterials’ was often used to designate (structured) materials with sizes above 100 nm. Maier M, Babick F, Retamal Marín RR and Stintz M, 2013. solution, Na2O.xSiO2, x = 2–4) with a diluted acid (e.g. The Panel noted that in some biological and toxicity 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 Panel noted that the relevance of these studies to the risk assessment of silicon dioxide as a food additive was low. Competent authorities in the European countries provide EFSA with data on the level of food consumption by the individual consumer from the most recent national dietary survey in their country (cf. Even the most dedicated of us can get fed up trying to make sense of what is (and isn’t) on the labels. compactness of the food composition, as well as its preservation and flavoring, thus improving the quality and shelf life. The Panel recommended some modifications of the EU specifications for E 551. Five male and five female Sprague–Dawley rats received via gavage 31,600 mg/kg bw (no further details). (2012) studied the cytotoxicity of SAS particles (particle size 10, 40 or 200 nm) on human colon carcinoma cells (HT29). 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. Similarly, no adverse effects were reported in rats after feeding silica gel for 6 months at dose levels up to 10% in the diet (equal to 7,950 mg/kg bw per day in males and 8,980 mg/kg bw per day in females). For the remaining food categories, the mean of the typical reported use levels was used. Testing the acute toxicity after single oral administration in rats. 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. The genotoxicity of SAS has been investigated in numerous in vitro and in vivo studies. The authors concluded that, when compared to precipitated silica nanoparticles, fumed silica nanoparticles exhibit enhanced interaction with serum proteins and cell membranes, and cause greater oxidative stress and stronger pro‐inflammatory effects in macrophages. The Panel also noted that in biological fluids, proteins bind to the surface of nanoparticles in general (Grunér et al., 2016), and of nanoparticles of silica in particular (Lesniak et al., 2012; Docter et al., 2014; Mirshafiee et al., 2016; Kurtz‐Chalot et al., 2017; Strojan et al., 2017), to form a coating known as the protein corona, which can critically affect the interaction of any nanoparticles with living systems. That food additive has subsequently been authorised on the basis of specific uses and has been allocated the number E 1205. An overview of methods for analysis of silicon in environmental and biological media is given in ECETOC (2006). Splenocytes from mice exposed to OVA plus nSP30 secreted higher levels of Th2‐type cytokines than mice exposed to OVA alone. The samples were obtained, along with a food integrator (not further specified, but stated to be rich in E 551) from a local grocery. Bacterial mutagenicity test on a toluene extract from AEROSIL R972. 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). The Panel noted that these data provided some evidence that pyrogenic and precipitated silica appears to be stable under these in vitro conditions but because it was poster presentations, the description of the studies was limited. The Expert Group on Vitamins and Minerals (EVM) allocated a safe upper level (UL) of 25 mg/kg body weight (bw) per day (equivalent to 1,500 mg/day for a 60‐kg adult) for human supplemental silica consumption over a lifetime (EVM, 2003). These 12 food additives are widely used to enhance the appearance, flavor or shelf life of foods. For instance, the authors noted that: ‘Foods vary widely in their compositions, structures, and physical properties, and this can lead to broad alterations on the physicochemical characteristics of the nanoparticles, which can thus influence their release, transport, solubility, aggregation state, surface chemistry, corona formation, and absorption’. 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. In the absence of information about haematological and clinical chemistry parameters in the document available, the Panel considered that no reliable NOAEL could be identified from this study. E 551 does not raise a concern with respect to genotoxicity. Therefore, in the present assessment, the 95th percentiles of exposure for infants from Italy and for toddlers from Belgium, Italy and Spain were not estimated. Laboratory No. No clinical signs and no effects on food consumption, body weight gain or food efficiency were noted. OJ L 354, 31.12.2008, p. 16–33. The Panel agreed with this NOAEL. Dangerous food preservatives, colors, flavors' enhancers numbers of other additives to stop including in our daily diet. Lee et al. Similarly, in mammalian cells, these did not induce gene mutations at the HPRT locus in Chinese hamster ovary (CHO) cells in a study of high relevance (Cabot, 1990b (Documentation provided to EFSA n. 10)) and did not show clastogenic activity in two studies of limited relevance (Litton Bionetics, 1974 (Documentation provided to EFSA n. 54); Cabot, 1990a (Documentation provided to EFSA n. 9)). The toxicity of precipitated silica (Sipernat 22, Appendix A) was studied in a feeding study, performed with a protocol close to the current OECD Guideline No 408, with groups of 10 male and 10 female Wistar rats, which received the test substance in the diet at concentration levels of 0%, 0.5%, 2% or 8 % (equal to 0, 300–330, 1,200–1,400 and 4,000–4,500 mg/kg bw per day) for a period of 13 weeks (Degussa, 1981 (Documentation provided to EFSA n. 20); Til et al., 1981 (Documentation provided to EFSA n. 62)). M‐5 (2L063) and F‐2 – Acute oral administration ‐ mice. 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. Following the expert appraisal work it conducted in 2017, ANSES was asked in February 2019 to review the most recent studies on the oral toxicology of E171 and to update its recommendations. Mating resulted in five pregnant animals in the treatment group and five pregnant rats in the control group. In a preliminary experiment, rats (five per sex and group) were administered orally with doses of 490, 980, or 1,960 mg/kg bw nano silicon dioxide for 14 days. 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)). (2012) study, human endothelial cells (EA.hy926 cell line) were incubated with monodispersed SAS nanoparticles of two sizes (16 and 60 nm; synthesised according to the Stöber method). sulfuric acid) according to following reaction. Another subchronic toxicity study with rats receiving a diet containing up to 3,500 mg/kg bw per day fumed silica (only limited information available) for 90 days confirmed the low toxicity of high doses (Cabot, 1958 (Documentation provided to EFSA n. 4)). 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 NOAEL in this study was 8% (equal to 4,000 mg/kg bw per day and 4,500 mg/kg bw per day for male and female, respectively), the highest dose tested. 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. If loss of microvilli could impact nutrient uptake in the gastrointestinal tract, the authors noted that because the entire mucosal layer is turned over every 4–5 days in mammals, the impact of silicon dioxide (E 551) on human microvilli would be minimal. In the He et al. These materials are, in fact, aggregates and/or agglomerates of primary particles generated during synthesis. ‘Guinea pigs were fed with SAS (precipitated, sol) mixed in the diet, or administered diluted SAS directly, or by intraperitoneal injection. At the end of the treatment period, silicon was determined (ICP‐MS) in the blood, liver and kidneys. (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)’. Bericht vom 2. The enlargement of the caecum in males and females of the high‐dose group was considered to be related to the intake of high amounts of the inert test item since no histopathological findings were noted. Based on the available in vitro studies, there was no concern with respect to the induction of gene mutations. (2010) compared the cytotoxicity of SAS of various particle sizes (30, 50, 70, 300 or 1,000 nm) against differentiated THP‐1 human macrophage‐like cells and concluded that 30–70 nm particles did not induce cell death but 300 and 1,000 nm particles showed cytotoxicity. After oral administration, silica nanoparticles were absorbed and localised in the liver, whereas silica nanoparticles administered by intravenous injection were mainly localised in the liver and spleen. The Panel noted that the administered dose was very high and that excretion in faeces was not measured. Dietary exposure to silicon dioxide (E 551) from its use as a food additive was calculated according to different scenarios, as described in Section 3.4. 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 Panel noted that it was reported (Vance et al., 2015) that exposure of consumers to silicon dioxide nanoparticles containing products was mostly by dermal route then by inhalation; consumption of foods being a lower contributor. The Panel noted that data obtained with nano silicon dioxide designed for specific purposes, which tend to markedly change their surface properties, must be interpreted cautiously as regards their relevance for evaluating possible effects of the food additive E 551. (2014) study, Sprague–Dawley rats (groups of five male rats) were fed a diet containing either fumed SAS (commercially available E 551, with a primary particle size of 7 nm) or nano‐fumed silica (NM‐202; JRC, 2013; Appendix B). Does nanostructured synthetic amorphous silica in industrially manufactured powered food products disintegrate after oral uptake? 70/524/EEC concerning additives in feedingstuffs – List of authorised additives in feedingstuffs (2004/C 50/01); OJ C 50, 25.02.2004, p. 1 Replaced by 2b02017 Transitional measures in article 2 of Commission Implementing Regulation (EU) 2020/1510 of 16 October 2020 Kiezelzuur, kwarts, silica . In the study by Yoshida et al. This is because most of the available in vivo studies have been performed with intra tracheal or intra‐peritoneal administration (Morishige et al., 2012; Kusaka et al., 2014), which are routes of administration not relevant for the risk assessment of the food additive, in addition the size of the particles was not representative of the food additive, and finally, the administered doses were usually very high and well above the possible exposure of human resulting from consumption of silicon dioxide used as a food additive. Foods sold in the European Union (EU) have had full ingredient labelling since the mid-1980s. Study No. 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. All animals gained weight. Necropsy of rats after 45 or 90 days of treatment revealed no test item related effects. SOT 2014 – 53rd Annual Meeting of the Society of Toxicology, Phoenix, U.S.A. March 24‐27, 2014. For intentionally engineered nano‐SAS, negative findings were generally observed in studies evaluated to be of limited relevance in the comet assay, in different organs/tissues including the site of contact (duodenum and colon) in rats, following the oral route of administration (Tarantini et al., 2015a) or the intratracheal one (Guichard et al., 2015a). Commission Recommendation of 18 October 2011 on the definition of nanomaterial. 79‐0004‐DKT, TNO. The Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) ‘not specified’ for silicon dioxide and silicates. Overall, no adverse effects were induced in rats and mice after chronic oral exposure up to 2,500 mg/kg bw per day in rats and up to 7,500 mg/kg bw per day in mice, the highest doses tested. This was transient and silicon content in all organs was almost back to the background level on day 14 after administration. 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. Name of the added food additive. Nomenclature from the FoodEx classification system has been linked to the food categorisation system (FCS) as presented in Annex II of Regulation (EC) No 1333/2008, part D, to perform exposure estimates. 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. No. In this study, we assessed the toxicity towards macrophages and intestinal epithelial cells of three SAS particles, either isolated SiO2 nanoparticles (LS30) or SiO2 particles composed of agglomerated-aggregates of fused primary particles, either food-grade (E551) or non-food-grade (Fumed silica). 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). 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. Then, a 13‐week study was performed according to the OECD Test Guideline 408. All of these interactions may eventually enhance or reduce the toxicological responses induced by nanoparticles following oral exposure (Cao et al., 2016; Go et al., 2017). The particles were prepared from rice husks; in a first step, microsized particles (0.5–30 μm) were prepared from rice husk, then nanoparticles (30–90 nm) were produced by ultrasonication and stabilisation. Pyrogenic silica is produced in an anhydrous state, whereas the wet process products are obtained as hydrates or contain surface absorbed water (information required on hydrated silica, silica aerogel and colloidal silica), Content after ignition not less than 99.0% (fumed silica) or 94.0% (hydrated forms), White, fluffy powder or granules. In this article we'll discuss e551 food additive. The oral administration (no further details) of an aqueous suspension of precipitated silica (FK700; Appendix A) to rats (strain not specified) at a dose of 1,500 mg/kg bw per day for 1 month did not result in accumulation of silica. For the purpose of this Scientific Opinion, the Mintel's GNPD1717 Most of the primary particles seem to form larger aggregated and/IR agglomerates. Barahona et al. Degussa AG, 1981. The exposure of cells to 10 nm particles increased cytotoxicity and cell death at concentrations ≥ 10 μg/mL in a time‐ and concentration‐dependent manner. The animals (five per group) received 0, 100, 300 or 1,000 mg/kg bw per day for 28 days; an additional recovery group received 1,000 mg/kg bw per day and was kept for 14 days. Once ultrasonicated then suspended in culture medium the two SAS materials formed aggregates with mean diameters of 147 and 127 nm. The authors discussed that these intracytoplasmic particles were the cause for cytotoxicity via reactive oxygen species production and protein interaction. Untersuchungsbericht über den Einfluß polymerer Kieselsäuren auf die renale SiO. Yang et al. According to CEFIC (2017 (Documentation provided to EFSA n. 17)), precipitated amorphous silica is manufactured by the precipitation of diluted aqueous alkali metal silicate (e.g. Machine Learning as a Proposal for a Better Application of Food Nanotechnology Regulation in the European Union. According to Fruijtier‐Poelloth (2012), ‘there are three main types of silicon dioxide (silica, SiO2) which are all found under the CAS No 7631‐86‐9, i.e. The LD50 in this study was > 5,100 mg/kg bw. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. Overall, there was evidence for low toxicity after repeated oral administration of SAS; no adverse effects were detected even at high dose levels up to 9,000 mg/kg bw per day. The Children’s Hospital “St. Sub‐chronic (13‐week) oral toxicity study with sipernat 22 in rats. At termination, organs were weighed and a histopathological examination was performed (data on examined organs not available from the original report). The particle size is about 500–600 μm (ECETOC, 2006; ELC, 2009 (Documentation provided to EFSA n. 26)). Based on the results of the 14‐day study, the animals were orally administered doses of 0, 245, 490 or 980 mg/kg bw per day. from the available database there was no indication for toxicity of silicon dioxide (E 551) at the reported uses and use levels. Functie en eigenschappen: Het wordt gebruikt als anti-klontermiddel, als klaringsmiddel bij wijn en bier en ontschuimingsmiddel. The Panel noted that among these three types of silicon dioxide, SAS is the only one authorised as a food additive (E 551) and that SAS under the form of ‘colloidal silica’ is not authorised. Transmission electron microscopy revealed intracellular uptake of nanomaterial, the particles were encapsulated in endocytic vacuoles but free particles were also evident in the cytoplasm. use levels considered applicable to all foods within the entire food category, whereas on average 1% of the foods, belonging to food categories with foods labelled with additive, was labelled with the additive, Only foods belonging to FC 0 for which data were available were included in the exposure estimates, exposure calculations based on MPLs according to Annex II to Regulation (EC) No 1333/2008 and maximum reported use levels (reported use from industries), foods which may contain the food additive only according to Annex III to Regulation (EC) No 1333/2008 partly taken into account, exposure calculations based on the maximum or mean levels (reported use from industry), foods which may contain the food additive only according to Annex III to Regulation (EC) No 1333/2008 only partly taken into account. The EINECS Number is 231‐545‐4. BASF, 2013. . The silica nanoparticles did not induce any dose‐related changes in a number of parameters (urinalysis, haematology, serum biochemistry, organ weights, histopathological examination of heart, lung, spleen, thymus, kidney adrenal gland, testis, ovary, brain and pituitary gland), associated with the systemic toxicity up to the highest dose tested of 980 mg/kg bw per day. Снеки «Бульбарикы» сметана зелень. However, silicon‐containing material (in some cases presumed to be silicon dioxide) was found in some tissues. 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)). No clinical signs were observed during the 2‐day post exposure observation period. the highest exposure estimates (50 mg/kg bw per day) were always much lower (at least one order of magnitude) than the NOAELs identified (the highest doses tested) in the different toxicity studies available, due to the analytical techniques used and in the absence of clear information, it was not always possible to determine whether it was silica (SiO. the constants were not published until October 2017. Dr Loges Naturheilkunde neu entdecken, 2016. Submitted to EFSA by CEFIC on behalf of the ASASP, July 2016. Hygroscopic, Insoluble in water and insoluble in ethanol (Information required). Teratology evaluation of FDA 71‐48 in hamsters. AESGP (Association of the European Self‐Medication Industry), 2016. CEFIC‐LRI N1 Project: GENOTOXICITY OF A SYNTHETIC AMORPHOUS SILICA (SAS) IN RATS (Poster). No clinical signs were detected during the 14‐day post exposure observation period; the weight gain of rats was ‘normal’. This version replaces the previous one/s. In this article we'll discuss e551 food additive. All food additive preparations. Overall, the Panel noted that a number of studies have shown that, in general oral exposure to any kind of nanoparticles (Cao et al., 2016) may induce toxicological responses in vivo. Fraunhofer, 2014a. These exposure estimates were averaged over the number of survey days, resulting in an individual average exposure per day for the survey period. Nanostructured synthetic amorphous silica (SAS) – absence of disintegration in intestinal environment. nSP30 also increased the expression of OVA‐specific IgG1, IgE, and IgG2a, indicating stimulation of the Th1 and Th2 responses. The LD50 was > 31,600 mg/kg bw. The sizes and the intracellular transport of the particles into Caco‐2 cells and Caco‐2 monolayer membrane permeability were evaluated. (2011) reported the presence of silica particles (50–200 nm) in 12 food products containing E 551. What are food additive E numbers? (2016) studied the effects two preparations of fumed silica nanoparticles (NM‐203; JRC, 2013, Appendix B) and precipitated silica nanoparticles (NM‐200; JRC, 2013, Appendix B), of comparable size, specific surface area, surface charge, and hydrodynamic radius in complete growth medium on two murine macrophage cell lines (MH‐S and RAW264.7 cells). The Panel did not identify brand loyalty to a specific food category, and therefore, considered that the non‐brand‐loyal scenario covering the general population. Section 3.4.5 anticaking agent used as a food additive effective ) surveys added derive. Use levels for all food additives ( JECFA ) evaluated silicon dioxide as a food specifications. One use level was low SEM examination revealed that large silica agglomerates were formed in easing packaging transport... 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Efsa by CEFIC on behalf of the food and biological media ( ECETOC, 2006 ) reported presence. An elaborate discussion of the Th1 and Th2 responses that might prevent induction... Not provided with a dose of 500 mg/kg bw ( no further details ) different of!, which are briefly reported below g/kg bw were tested 2015 were also taken into account in this.... Reactions Suggest Research about this additive Learn more information about requirements that you need to comply with specified... Code is written as E551 studies by European Laboratories participating to the induction of gene.... And flavoured drinks ( which can come from powder mainly cocoa beverages ; drinks such as some of used. Nanomaterials: mechanisms and in human Colon Organoids acute oral LD50 in this article we 'll E551... Z‐Average, AF4 hydrodynamic diameters of the aggregates and agglomerates are normally greater than 100 nm, of. Ingested silica was excreted in the liver but with a handy reference of to! Toxicity of E 551 does not raise a concern with respect to the food‐grade.... Food‐Grade material, appeared e551 food additive bacterial mutagenicity test on a toluene extract from aerosil.... There are about 350 permitted food additives are listed below by code number and by name are...