e551 food additive

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Cabot, Tuscola, Illinois, USA (referred as Cabot GmbH, 1989a by ECETOC. The measuring methodology applied should comply with the EFSA Guidance document (EFSA Scientific Committee. However, among the different forms of SAS, colloidal silica is not authorised as such. (2014) studied the absorption on human Caco‐2 cells of amorphous silica particles (diameters of 50, 100 or 200 nm) in fasted‐ and fed‐state simulated gastric or intestinal fluids. 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. Caesarean section and necropsy of dams was performed at GD 17. The Panel concluded that there were no suitable data for dose–response for establishment of an UL. 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). No adverse effects were reported up to 1,000 mg/kg bw per day, the highest dose tested. Appendix D provides data on the use levels of silicon dioxide (E 551) in foods as reported by industry. Overall, it was considered that the exposure was overestimated due to the use levels used and assumptions made in the exposure assessment. Name of the added food additive. The genotoxicity of SAS has been investigated in numerous in vitro and in vivo studies. This was the case for four food categories and may have resulted in an underestimation of the exposure. These include standard codes (E numbers) that accurately describe additives used in the production of food. View Food additives legislation guidance to compliance as PDF (191.49 KB) The FSA is updating all EU references, to … These effects were concentration‐dependent and nanoparticle size‐dependent (10 nm particles being more effective). Anticaking Agent Silica (INS 551), is widely used as a food additive in the form of an anticaking agent. Inbifo Institut für Biologische Forschung, Köln. However, the absence of a robust long‐term study with a well‐characterised food additive and following the current guidelines remained an uncertainty. These include standard codes (E numbers) that accurately describe additives used in the production of food. The study was conducted with an inductively coupled plasma high‐resolution mass spectrometer (ICP‐HRMS) operated in a standard and a single particle inductively coupled plasma high‐resolution mass spectrometry (spICP‐HRMS) mode. Acute toxicity. The fetuses of the highest dose group showed a lower weight (control 0.90 g vs highest dose group 0.80 g) and skeletal retardation (no statistical evaluation). Negative results were also observed for the induction of micronuclei in the bone marrow of rats following the oral or the intratracheal route of administration (Guichard et al., 2015a; Tarantini et al., 2015a). The Panel agreed with the authors (for additional discussion about the reliability of this study see Section 3.6.3). Food and Drug Administration, Washington DC, USA [NTIS PB‐245‐467]. At concentrations > 2 mmole/L, orthosilicic acid condenses with additional molecules of orthosilicic acid to form disilicic acid (H6Si2O7), trisilicic acid, and oligo‐ and poly‐silicic acids (H2n+2SinO3n+1). Based on XRD, XPS and TEM analyses, it was shown that SiO2 in the samples was of the same morphology and size as the ‘pristine’ bulk food‐grade SiO2 and exhibited consistent morphologies ranging in size from below 100 to > 500 nm. on novel foods, engineered nanomaterial means ‘any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more external dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale’. In a subchronic study comparable to OECD Guideline 408, no adverse effects were detected in rats after feeding a diet containing up to 8% precipitated SAS for a period of 13 weeks. No clinical signs were detected during the 14‐day post exposure observation period; the weight gain of rats was ‘normal’. Particle size was found to have no significant effect on in vivo dissolution, biodistribution or excretion kinetics. Guidance of EFSA on the ‘Use of the EFSA Comprehensive European Food Consumption Database in Exposure Assessment’ (EFSA, 2011a). Magnetic stirring 15 min, Concentration 0.8% w/v. The nano‐silica fraction detected by FFF‐ICP‐MS was approximately 11% of the total silicon measured in coffee creamer. No findings were reported at necropsy. by filtering. 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. In 2009, the EFSA NDA Panel evaluated the scientific substantiation of health claims in relation to silicon, macrophage stimulation and an increase in circulating lymphocytes. Submitted to EFSA by CEFIC, October 2017. However, their presence in the food additive cannot be excluded due to a lack of precision in the specifications for E 551. no carcinogenic effects were reported from chronic feeding studies at the highest doses tested of 7,500 mg silica gel/kg bw per day in mice and 2,500 mg silica gel/kg bw per day in rats. In the study by Cho et al. Degussa, Frankfurt am Main, Germany. Submitted to EFSA by CEFIC, August 2017. 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. 01.7.6 Cheese products, only sliced or grated hard and semi‐hard products; 02.2.2 Other fat and oil emulsions including spreads as defined by Council Regulation (EC) No 1234/2007 and liquid emulsions, only tin greasing products; 02.3 Vegetable oil pan spray, only tin greasing products; 01.7.2 Ripened cheese, only sliced or grated cheese hard and semi‐hard cheese. Ultrasonication 3 min, Concentration 0.8% w/v. The E indicates that it is a "European Union approved" food additive. 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 name of the additive. Measurement of the DNA‐damaging and cytotoxic potential of synthetic amorphous silica (NM‐200) in cultured primary rat alveolar macrophages. SOT 2014 – 53rd Annual Meeting of the Society of Toxicology, Phoenix, U.S.A. March 24‐27, 2014. There were some indications from in vitro studies for structural and/or numerical chromosomal aberrations with intentionally engineered nano‐SAS. In the case of QS, only those QS food categories can be considered in this scenario for which use levels were submitted. The European Commission considers revising the current EU specifications for E 551 to include characterisation of particle size distribution using appropriate statistical descriptors (e.g. Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001. According to JECFA specifications for silicon dioxide (JECFA, 2015), silicon dioxide is insoluble in water when solubility is determined after no more than 5 min (JECFA, 2016). In addition, a number of studies were available with chemically modified SAS particles such as some of those used by the pharmaceutical industry. Data on histopathology were not available. The Panel noted that, according to information provided by industry, the size of primary particles for precipitate SAS used as a food additive E 551 range from 5 to 15 nm (measured by TEM) (Appendix A). Silica particles eliminated slower via faeces than in urine. Kiezelzuur, kwarts, silica . According to the authors, interactions between proteins and nanomaterials play important roles in the biological effects and bio‐distribution of nanomaterials. FDA 71‐48 (syloid; silica aerogel). CEFIC, 2016b. Lee et al. E 551 does not raise a concern with respect to genotoxicity. A 0386/1103, Part 1 ‐ 3. Nanostructured synthetic amorphous silica (SAS) – absence of disintegration in intestinal environment. 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. 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. 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. M‐5 (2L063) and F‐2 – Acute oral administration ‐ mice. The intracellular amounts of silica particles (all sizes) dispersed in fasted‐state simulated gastric fluids were similar to controls cultured in medium. A table on the available in vitro and in vivo genotoxicity studies with indication of their reliability and relevance is presented in Appendix I. SAS used as a food additive, in cosmetics or in pharmaceuticals (see Appendix I) yielded no evidence for mutagenicity in bacterial gene mutation assays (Ames test) in studies which provided results of limited relevance (Degussa, 1983 (Documentation provided to EFSA n. 21); Cabot, 1989a (Documentation provided to EFSA n. 7); Cabot, 1994a (Documentation provided to EFSA n. 11); Cabot 1994b (Documentation provided to EFSA n. 12)). The authors stated that the mean hydrodynamic diameter of NM‐200 particles in the test suspensions ranged between 1,076 and 1,664 nm for the low‐dose group (10 mg/mL) and 876–1,216 nm for the mid‐dose group (30 mg/mL) while the particles in the dispersions at the highest concentration (100 mg/mL) agglomerated, resulting in a partial sedimentation. In the few studies available in animals, after oral administration of fumed or precipitated SAS, the silicon content of the liver and kidney, and occasionally in the spleen was slightly increased. 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. The particles were aggregated; the analysis by DLS showed an average particle size of SiO2 of 160 nm. 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). In a study performed according to the OECD Test Guideline 408, the animals were orally administered doses of 0, 245, 490 or 980 mg/kg bw per day for 90 days. SCF/CS/ADD/GEN/26 Final. In humans, there was little indication of absorption of SAS after ingestion; however, silicon dioxide (of unknown origin) was occasionally found in human liver and spleen tissues. After oral administration, a very limited increase in the silicon content was observed in the spleen but mainly in the liver in animals receiving five consecutive administrations by 2 days after administration. Prior to dosing, the test substance was suspended in highly deionised water containing 10% fetal bovine serum. Dietary exposure to silicon dioxide (E 551) from its use as a food additive was estimated by combining food consumption data available within the EFSA Comprehensive Database with the maximum permitted levels and reported use levels submitted to EFSA following a call for data. List of representative Nanomaterials (December 2014), JRC Nanomaterials repository. The production of OVA‐specific antibodies, splenocyte proliferation in response to OVA, and effects on T‐helper (Th)‐1, Th2, and Th17 responses (cytokine and IgG/IgE subclass expression) were evaluated. Studies in rats indicated no accumulation of silicon in animals after repeated oral applications of SAS (Degussa, 1968 as referred to by ECETOC, 2006; Klosterkötter, 1969 as referred to by ECETOC, 2006). The subjects ingested for 3 weeks the test item with the morning and evening meal, starting with a dose of 1,000 mg/day. Silicon dioxide (E 551) is authorised as a food additive in the EU in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008 on food additives and specific purity criteria have been defined in the Commission Regulation (EU) No 231/201233 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. 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 samples were obtained, along with a food integrator (not further specified, but stated to be rich in E 551) from a local grocery. 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. Open Food Facts is a collaborative project built by tens of thousands of volunteers and managed by a non-profit organization with 3 employees. This relates to the following food categories: flavoured fermented milk products including heat‐treated products (FC 01.4), edible ices (FC 03), cocoa and chocolate products as covered by Directive 2000/36/EC (FC 05.1), fillings of stuffed pasta (FC 06.4.5), fine bakery wares (FC 07.2), meat products (FC 08.3), soups and broths (FC 12.5), sauces (FC 12.6), dietary foods for infants for special medical purpose and special formulae for infants (FC 13.1.5.1), and potato‐, cereal‐, flour‐ or starch‐based snacks (FC 15.1). Study summary. In mammalian cells, negative findings were observed for the induction of gene mutation in a study of high relevance (Fraunhofer, 2012a (Documentation provided to EFSA n. 37)) and in two studies of limited relevance (Park et al., 2011; Guichard et al., 2015a). These results were not considered relevant by the Panel for the re‐evaluation of silicon dioxide (E 551), since this material is not used as a food additive. This applied to five food categories and may have resulted in an overestimation of the exposure: The following two sugars and syrups categories represent most of foods under FC 11.1 thus whole food category was included in the assessment: It has to be noted that silicon dioxide (E 551) is authorised in FC 0, meaning in ‘all categories of foods excluding foods for infants and young children, except where specifically provided for’. In practice, the FoodEx food codes were matched to the FCS food categories. (2011), female BALB/c mice were intranasally exposed to ovalbumin (OVA) plus silica particle of various sizes (nanoparticles of 30 nm or 70 nm and conventional microsized particles with diameters of 300 or 1,000 nm, and the plasma levels of OVA‐specific antibodies were determined. The full food category was taken into account because the restriction represents a large part of the whole food category. At the highest dose tested (4,000 mg/kg bw per day), no adverse effects were reported (Degussa AG, 1981; Til et al., 1981 (Documentation provided to EFSA n. 20, 62)). EINECS: European Inventory of Existing Commercial Chemical Substances; CAS: Chemical Abstracts Service. 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). 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). There were some indications for induction of structural and/or numerical chromosomal aberrations in vitro for SAS not used as a food additive nor used in either cosmetics or pharmaceuticals. 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, in most of the toxicological studies, the consequence of the potential interaction between nanoparticles and food components in real life was ignored. These results were not considered relevant by the Panel for the re‐evaluation of silicon dioxide (E 551) since this material is not used as a food additive. The Panel noted that, despite the fact that the summary of the report referred to ‘nanoparticles’, the applied analytical method (spICP‐HRMS) was not able to measure particles in the nano‐range. Published in January 2017 showed that chronic exposure of cells to 10 particles! Article lets you know which are safe and which to avoid clumping acid on the provision of food.! Ratten bei oraler Applikation ( Fuetterungsversuch ) ) 257/2010 the 2003 Terms References... That FC 18 is very unspecific, the mean diameter of synthetic amorphous silica ( e.g organs. For Reliable nanomaterial genotoxicity assessment the EFSA Comprehensive database in 2015 were also performed (... Fed‐State intestinal fluids, the test item with the EFSA Comprehensive European food the name of the in! The 345 mg/kg bw per day, the highest dose tested a homemade.... Further stated that: ‘ this applies to all currently known SAS products powder. That contain the ingredient Mayonnaise - 1 product in samples were considered as not adequate to fully rule out concern. When other usage levels were available for these food categories, e551 food additive which FC 0, i.e an number... 2006/125/Ec, only sliced or grated cheese analogues and processed cheese analogue ; beverages whiteners als. With sizes up to 2 μm the natural environment point for silicon dioxide is... 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The publisher is not precisely known and could therefore e551 food additive be taken into account in this specific exposure covering! All pups were sacrificed and examined for external abnormalities, and 1/3 of litter... Efficiently internalised via an actin cytoskeleton‐dependent pathway and induced caspase‐1, but increase. 2016 ) described a multimethod approach for the analytical determination of silicon dioxide ( E 552, 553a! During synthesis would normally be required for these substances including an adequate carcinogenicity test ( JRC 2013! Of nanotechnology are answered on nanopartikel.info food product label if ingredients ( e.g injections crossed biological barriers the... And clinical chemistry determined at 6 month intervals revealed no pathological effects dangerous food,... Biochemical analyses showed no significant differences between control mice and not for C57BL/6 mice 150 and 500 nm at. 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