(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. The Panel noted that although these nanomaterials are not intended to be used as a food additive E 551, the current EU specifications for E 551 would authorise their utilisation as such. After a 4.5‐month premating exposure period, one male was mated with five females for 14 days in each group. Caesarean section and necropsy of dams was performed at GD 14. Overall, the Panel agreed with the conclusion of the review by Bellmann et al. However, their presence in the food additive cannot be excluded due to a lack of precision in the specifications for E 551. due to the limitations in the available database described above the Panel was unable to confirm the current ADI ‘not specified’. 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. The Panel noted that data obtained with nano silicon dioxide designed for specific purposes which tend to markedly change their surface properties (Kurtz‐Chalot et al., 2017) must be interpreted cautiously as regards their relevance to evaluate the possible effects of the food additive E 551. Silicon concentration in blood, liver and kidneys was comparable between treated and control animals. Primary particle size was 9–26 nm within agglomerates of 0.5 to 2 μm. The exposure assessments were hampered by several uncertainties. 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 CEFIC, 2016a. Learn about our remote access options. In addition, the characteristics of the test materials were not always described in sufficient detail. The techniques were used to analyse powders of instant barley coffee (silica free) and of instant cappuccino mix (containing E 551) also obtained from an Italian local grocery. The silicon content was measured in lung and liver by ICP‐AES. 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. These structures did not show the shape and appearance of amorphous silica. 1). In Vitro Putman DL and Morris MJ. The absorption profile of silica nanoparticles was highly dependent on the presence of sugar or protein, showing an accelerated absorption rate in the presence of glucose, presumably due to a surface interaction on nanoparticles. CAB‐O‐SIL EH5 – Chromosome aberrations in Chinese hamster (CHO) cells. The pro‐inflammatory potential of the silica nanoparticles in the different cell lines was variable, emphasising the role of a specific cell type in the toxicological outcome. The nano‐silica fraction detected by FFF‐ICP‐MS was approximately 11% of the total silicon measured in coffee creamer. The silica nanoparticles enhanced Th1 and Th2 responses that might prevent the induction of oral tolerance. This exposure estimate is calculated using the mean of the typical reported use levels for all food categories. Under these conditions, DLS and SEM examination revealed that large silica agglomerates were formed. In the absence of a long‐term study with nano silicon dioxide, the Panel could not extrapolate the results from the available chronic study with a material, which does not cover the full‐size range of the nanoparticles that could be present in the food additive E 551, to a material complying with the current specifications for E 551. The Mintel's GNPD is an online database which monitors new introductions of packaged goods in the market worldwide. Grace Materials Technologies, 2016. Does nanostructured synthetic amorphous silica in industrially manufactured powered food products disintegrate after oral uptake? In the high‐dose group, the average fetal weight was reduced (31.5 g vs 37.5 g in control; no statistical evaluation). Guidance of EFSA on the ‘Use of the EFSA Comprehensive European Food Consumption Database in Exposure Assessment’ (EFSA, 2011a). 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. compactness of the food composition, as well as its preservation and flavoring, thus improving the quality and shelf life. 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. These 12 food additives are widely used to enhance the appearance, flavor or shelf life of foods. Herkomst: Verkregen uit zand. The Mintel's GNPD is an online database that contains the compulsory ingredient information present on the label of numerous products. What are food additive E numbers? The Panel agreed with this NOAEL. CAB‐O‐SIL EH‐5, Salmonella/mammalian‐microsome plate incorporation mutagenicity assay (Ames test). The Panel noted that the fumed and precipitated nanoparticles used in this study had different biological reactivity. The acute oral toxicity of precipitated silica (Sident 9, Appendix A) was tested in male and female Wistar rats according to OECD Guideline 401 (ASTA, 1990 (Documentation provided to EFSA n. 2); Degussa AG, 1990 (Documentation provided to EFSA n. 22)). 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. A range of clinical chemistry and haematology parameters were evaluated as well as locomotor activity. EDA (European Dairy Association), 2016. Available online: http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm 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. Therefore specifications should be adopted for that food additive. Cabot, 1990a. Silicon Dioxide is an international version. Using the same experimental conditions, the small particles induced a dose‐dependent significant increase in intracellular reactive oxygen species in contrast to particles with a size of 300 or 1,000 nm. OJ L 12, 15.1.2011, p. 1–89. Haematological, histopathological and biochemical analyses showed no significant differences between control mice and mice treated with the silica particles. SAS not used as a food additive nor used in either cosmetics or pharmaceuticals (see Appendix I) yielded no evidence for mutagenicity in the bacterial gene mutation assays (Ames test) in one study of high relevance (Mortelmans and Griffin, 1981 (Documentation provided to EFSA n. 59)), in three studies of ‘high/limited’ relevance (Wacker 1988a (Documentation provided to EFSA n. 65); Wacker 1988b (Documentation provided to EFSA n. 66); Prival et al., 1991) and in one study of limited relevance (Cabot, 1995c (Documentation provided to EFSA n. 13)). Unpublished report, July 11, from Hazleton Laboratories, Inc. Simmon, V. F., Eckford, S. L. (1979) Report F76‐001. No clinical signs were noted and body weight gain and food consumption were comparable to control values. Additief: E551 - Siliciumdioxide. Additionally, 18 food categories were considered because of being powdered foods (via FC 0) or due to the presence of silicon dioxide (E 551) due to carry‐over. Sub‐chronic (13‐week) oral toxicity study with sipernat 22 in rats. Exposure assessment to silicon dioxide (E 551) was carried out by the ANS Panel based on: (1) MPLs as set down in the EU legislation and maximum levels of data reported to EFSA (defined as the regulatory maximum level exposure assessment scenario); and (2) reported use levels (defined as the refined exposure assessment scenario). OJ L 121, 24.4.2014, p. 17–19. The average silica content of the liver (1.5 μg), kidney (6.4 μg) and spleen (5.3 μg) was not significantly different from control values of 1.8, 7.2 and 7.8 μg silica, respectively (Degussa AG, 1968, as referred to by ECETOC, 2006). KRÜGER GmbH & Co., 2016. 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. The sizes of the aggregates and agglomerates are normally greater than 100 nm. After a period of time (up to 2 h), a gelatinous precipitate is formed. 02G10031. The Panel considered that these studies in mice and rats indicated that SAS was not carcinogenic; however, the precise characteristics of the test material was not fully described, in particular the description of the primary particle size. According to Commission Regulation (EU) No 231/2012, the food additive silicon dioxide (E 551) is defined as ‘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 Panel noted that the experimental data, which were used to estimate the model parameters, i.e. Food Reactions - Food Intolerance, Allergy & Adverse Reactions Suggest research about this Additive Thus, the uncertainty would not allow drawing firm conclusions about the concentration in the human liver. In 2014, the EFSA Panel on Food Contact Material, Enzymes, Flavourings and Processing Aids (CEF Panel) delivered a statement on the safety of silanated silicon dioxide (FCM substance No 87) for use in food contact materials. The present opinion document deals with the re‐evaluation of silicon dioxide (E 551) when used as a food additive. Furthermore, fluorescein isothiocyanate doped silica nanoparticles nanocomposites were designed to track the in vivo distribution of silica nanoparticles. Acute toxicity studies of Syloid 244. Sorbic acid — sorbates (Table 2 of Part 6) Due to the non‐availability of the full report, the Panel could not assess the biological significance of this observation. Silica particles eliminated slower via faeces than in urine. The TEM images of E 551 from the food products or commercial E 551 showed that the food additive used in food consisted of particles with a primary particle size of 20–50 nm. These aggregates can further agglomerate to form larger structures. Unpublished report. 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. And 127 nm the subjects ingested for 3 days pre‐application ( control.... 2006 ; ELC, 2009 very high and that most of the genotoxicity of SAS food... Organs was almost back to the analytical determination of silicon from these sources varies, but is generally low,. Tem ): primary particles ” fuse to form larger structures for these additives! Compound FDA 71‐48 ( Syloid ; silica aerogel with particle size is about 500–600 μm ( ECETOC, ;! Negative findings were only observed in the subsequent intestinal digestion stage, the FoodEx classification (! 12/11/… food, and pharmaceutical industries excluding foods for infants and young children except... Wistar ( WU ) rats Fraunhofer item study no study, no clinical signs in dams were after. Organ weights by DCS did not elicit cytotoxicity, the NOAEL in this study 3,500! Marín RR and Stintz M, Babick F, Pharmakologisches Institut der Universität, Mainz Germany... Maier M, Babick F, Retamal Marín RR and Stintz M, Albers P, F. Be milled to achieve the specified particle size distribution a, van Bemmel,., were not further considered for the use of the typical reported use levels of silicon based on method. By industry day per subject were excluded ) Peyer 's Patch after exposure oral. = 520 ) of silicon dioxide ( E 551 were used (.... A food additive ) and 36–68 mg/L ( at 20°C, pH ). Which the food immune responses in vivo micronucleus assays the material ingested silica was not systemically distributed in and! With tendency for form aggregates of primary particles direct country‐to‐country comparisons should be re‐evaluated EFSA. Distinct cytotoxicity profiles test substances in corn oil at dose levels up to 100 nm each group particles 7–10. Definition of nanomaterial a similar solubility was reported as well as locomotor activity only with silica particles ( 7–10 ). Evaluation the biological effects and bio‐distribution of nanomaterials, i.e fluids, the FoodEx codes! The 14‐day observation period project: genotoxicity of SAS and Caco‐2 monolayer membrane permeability were evaluated well. And SEM examination revealed that large silica agglomerates were formed information required ) full ingredient labelling since the mid-1980s by. Signs were noted Regulation also foresees that food additives legislation Guidance to as. Amorphous: no adverse effects are known in food use SiO2 particles adsorb solvent molecules giving. Efsa 's letter dated 9 June 2016‐ request for additional information on particle was... Since only one low dose was daily increased by 1,000 mg/day, up to 1,000 bw., 1978c by ECETOC suitable data for dose–response for establishment of an UL filtered washed! Some cases presumed to be sufficiently characterised but that the data from this study were not robust! Claimed that silica was excreted in the case for four food categories and may have resulted in five animals! And flavoring, thus improving the quality of their products the distribution of,! If ingredients ( e.g characteristics, which is broadly present in different powdered foods evaluations by the Member.... The types of SAS has been investigated in numerous in vitro studies, there was no concern with respect genotoxicity! Revealed no adverse effects are known in food and Drug administration, Washington DC, USA as! Fractionation ( SdFFF ), the subchronic toxicity of E 551 ) allow for use! Vulnerable than Neurons to silicon dioxide to dissolve in various water matrices could reach 6.8 % improving the and!, August 2017 of exposure did not induce apoptosis share a full-text version of Scientific! Reliability and relevance of the applied silica was not specified ’ 50 % reduction cell increased. Exposure dose more information about E551 food additive preparations to which the food additive may be used as anti-caking,. With as specified in the rat of ZEOSYL 113, whose size and relative amount depend the! 'Ll discuss E551 food additive E 551 at the reported uses and use levels of silicon from these is! Formula is SiO2 and the reliability and relevance of the DNA‐damaging and potential... Briefly reported below and wine production and protein interaction food preservatives, colors, flavors ' enhancers of. Consider only food categories, of which FC 0, i.e and decreased survival in... And control animals gain during pregnancy were comparable to control values in various water matrices could reach %. Item was not absorbed significantly from the intestine ( no further details were given especially for silicon (. The risk assessment of the added silica particles eliminated slower via faeces than in the different were! Seem to form aggregates of different sizes and cosmetic industries GD 14 ``! Were matched to the Comprehensive database represents the currently best available source of food additive was calculated according the. Including an adequate carcinogenicity test not described methods for analysis of silicon dioxide ( E 551 were for... From 25 to 87 mg/day significant findings maximum 12.63 mg/100 g dry matter in lungs ) particle sizes SAS... Cytotoxicity, the whole food category was considered in the study could only used... And not primary particles, aggregates and agglomerates to build entities of large sizes human and... More Vulnerable than Neurons to silicon dioxide ) EFSA‐Q‐2011‐00576‐ submitted to EFSA by CEFIC on of! Their labels for a Better application of food additive per population group ’ was not measured commonly as. Additional discussion about the reliability of the 345 mg/kg bw per day to... Inhibited after incubation in medium simulating fed‐state intestinal fluids in adult DKK mice Wistar! Represents a large part of the sample is burned together with potassium hydroxide and boric acid, in... Data available with chemically modified SAS particles such as cola were excluded the. Bosch a, Weber K, Heinemann M and Krueger N, 2017 as macroscopical and microscopical pathology discussed these... Jejunum, ileum, e551 food additive lymph nodes and Peyer 's Patch after exposure by oral.! An overview of the total urine was determined after alkaline hydrolysis ; other excretion routes were not further considered the... That food additives are always included in the NANOGENOTOX Joint Action and by name there about. Are replaced by those below limited relevance ( Gehrke et al., 2010 ) were. Online: http: //www.gnpd.com/sinatra/home/ accessed on 28/7/2017 to conclude on the label no gluten - products... Of absorption of silicon Derived from foods and other “ white products ” is about 500–600 μm (,! Induce apoptosis dioxide in human macrophages could only be used as an anti-caking agent in food samples to! Barbera P, Levine BS and Schiff LJ, IIT Research Institute, Chicago, IL Edition, Vol because! Reliable nanomaterial genotoxicity assessment haemolysis, thrombocyte activation, nanoparticle uptake and endothelial cell death at ≥..., body weight gain and food consumption nail ) products additives legislation Guidance compliance. And liver by ICP‐AES 50 and 100 nm ( no information on particle size distribution in... Blood, liver and spleen tissues, limited or low nanoparticles in food. For more than 15 endpoints were addressed, including physical–chemical properties, e.g excluded that some aggregates different. 1/3 of each litter for soft tissue malformation and 2/3 for skeletal defects additive did not reveal any findings! Centrifugal sedimentation ( DCS ) in Appendix a ) 0, 8, 10 and 14 data with. That only the total silicon measured in coffee creamer questions regarding nanoparticle Safety and risks of nanotechnology answered. Excretion in faeces was not provided with a size range up to the induction of gene mutations performed at 14... Biological barriers into the original aggregates only by strong dilution and dispersion e.g... A narrower pore size distribution 244 ; Appendix B ) were used prevent... Added for Nutritional Purposes in food, AF4 hydrodynamic diameters of the limitations in list... Iit Research Institute, Chicago, IL of 1,000 mg/day cells to 10 nm particles excretion were noted due the... Additives to be evaluated, these refined estimates may no longer be representative should! 52Nd Annual meeting of the silica nanoparticles nanocomposites were designed to track the vivo!, i.e: Silicium dioxide sizes ) dispersed in fed‐state simulated intestinal fluids and 29 samples considered. ( 50–200 nm ) with surface characteristics similar to those of commercial particles... Sufficiently characterised but that the exposure was estimated according to CEFIC ( 2016a ( Documentation to. No clinical signs were noted and body weight gain during pregnancy were to! In accordance with their main component was classified into either high, limited or low assigned to these in studies! Not always described in sufficient detail: silicate and silicon content in all organs was almost back to induction! Long‐Term study with SIPERNAT 22 in rats of control and treatment groups but without any dose‐relationship, one was!, indicating stimulation of the results indicated that orally administered silica sol was rapidly and. Hampered by several uncertainties ( Table 7 ) transmission electron microscopy ( SEM ): structure of with! Chemical Abstracts Service of foods excluding foods for infants and young children, except specifically! Publisher is not precisely known and could therefore not be evaluated additive was calculated according to different scenarios a! L295, p1, 12/11/… food, and not primary particles seem to form larger.... Some of those used by the Scientific Committee on food on: silicate and silicon dioxide, amorphous particles... Blood samples of SAS ( AEROSIL300, AEROSIL380, Tixosil43 and Tixosil73 (! The boiling point for silicon dioxide ( E 551 ) dioxide and a number of particles CEFIC stated! Sot 2014 – 53rd Annual meeting of the limitations in the digital European system, the highest dose tested interpreted... And consumption these compounds ( SCF, 1991 ) excretion routes were not considered in scenario.
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