In the case of silicon dioxide (E 551), two restrictions apply to this food category: For this reason, in addition to food categories listed in Table, EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), I have read and accept the Wiley Online Library Terms and Conditions of Use, AOAC Official Method 920.08. The authors concluded that most of the silica particles were organised in aggregates or agglomerates of sizes larger than 100 nm; the food integrator showed a more heterogeneous population of aggregates than the cappuccino mixture. Part 2: general principles, Use of the EFSA Comprehensive European Food Consumption Database in Exposure Assessment, Evaluation of the FoodEx, the food classification system applied to the development of the EFSA Comprehensive European Food Consumption Database, Calcium silicate and silicon dioxide/silicic acid gel added for nutritional purposes to food supplements, Statement on a conceptual framework for the risk assessment of certain food additives re‐evaluated under Commission Regulation (EU) No 257/2010, Statement on the safety assessment of the substance silicon dioxide, silanated, FCM Substance No 87 for use in food contact materials, Scientific Opinion on the risk for public health related to the presence of mercury and methylmercury in food, Scientific Opinion on dietary exposure to inorganic arsenic in the European population, Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to the Tolerable Upper Intake Level of Silicon, Scientific Opinion on the substantiation of health claims related to silicon and stimulating macrophages and increasing circulating lymphocytes (ID 358) pursuant to Article 13(1) of Regulation (EC) No 1924/2006, Scientific opinion on the substantiation of health claims related to silicon and protection against aluminium accumulation in the brain (ID 290), “cardiovascular health” (ID 289), forming a protective coat on the mucous membrane of the stomach (ID 345), neutralisation of gastric acid (ID 345), contribution to normal formation of collagen and connective tissue (ID 287, 288, 333, 334, 335, 1405, 1652, 1718, 1719, 1945), maintenance of normal bone (ID 287, 335, 1652, 1718, 1945), maintenance of normal joints (ID 1405, 1652, 1945), maintenance of normal appearance and elasticity of the skin (ID 288, 333), and contribution to normal formation of hair and nails (ID 334, 1652, 1719) pursuant to Article 13(1) of Regulation (EC) No 1924/2006, Guidance of the Scientific Committee on Transparency in the Scientific Aspects of Risk Assessments carried out by EFSA. silicon dioxide appears to be poorly absorbed; however, silicon containing material (in some cases presumed to be silicon dioxide) was found in some tissues. The Panel noted that the experimental data, which were used to estimate the model parameters, i.e. The silica concentration in tissues was apparently not influenced by the silica concentration in the diet. According to the authors, these results indicated that silica nanoparticles can be absorbed through the intestine and that particle diameter and surface properties are major determinants of the degree of absorption. Available online: http://www.gnpd.com/sinatra/home/ accessed on 28/7/2017. (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). CEFIC‐LRI N1 Project: GENOTOXICITY OF A SYNTHETIC AMORPHOUS SILICA (SAS) IN RATS (Poster). 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. Results are expressed as a mass percentage of nanosized silica (5–200 nm) relative to the total amount of silica in or added to the food item. Food Additive and Color Additive Petitions Under Review or Held in Abeyance Code of Federal Regulations Citations for Color Additives, Food Ingredients … Doses of 10, 12.6, 15.8 or 20 g/kg bw were tested. Once ultrasonicated then suspended in culture medium the two SAS materials formed aggregates with mean diameters of 147 and 127 nm. Finally, according to Annex III, Part 5, Section B of Regulation (EC) No 1333/2008, silicon dioxide (E 551) is also authorised as a food additive added in nutrients intended to be used in foods for infants and young children in dry powdered nutrient preparations at the maximum level of 10,000 mg/kg. E 551 does not raise a concern with respect to genotoxicity. Toxicologic evaluation of synthetic amorphous silica particles, final report IITRI‐L8034‐1. An anticaking agent is an additive placed in powdered or granulated materials, such as table salt or confectioneries, to prevent the formation of lumps and for easing packaging, transport, flowability, and consumption. No particular findings were found at necropsy. The most common methods for sensitive silicon analysis are inductively coupled plasma atomic absorption spectrometry (ICP‐AES) and flameless atomic absorption spectrometry (AAS) (Carlisle, 1997). However, because nanoparticles of silicon dioxide are present in the food additive E 551 (see Table 2), studies performed with specifically designed engineered nanoparticles of SAS have also been included in this assessment in order to assess any toxicity associated with nanoparticles present in the food additive, provided they were prepared using amorphous silicon dioxide. Maximum levels of silicon dioxide (E 551) have been defined in Annex II to Regulation (EC) No 1333/20081414 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. Is a food additive dangerous or not? Become a Vegan Easy Supporter and receive an Animal Liberation Victoria membership card with a handy reference of additives to avoid. Silicon dioxide (E 551) as a food additive did not raise a concern with respect to genotoxicity. Therefore, eating occasions belonging to these FCs were also reclassified under food categories in accordance with their main component. 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). Untersuchungsbericht über den Einfluss polymerer Kieselsäuren auf die renale SiO. 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. 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. The code indicates an ingredient which is some type of food additive. Attempts were made at retrieving relevant original study reports on which previous evaluations or reviews were based; however, not always these were available to the Panel. They extrapolated the model to humans using allometric scaling to all the constants including distribution constants, to estimate the silicon concentration in liver in humans for average‐to‐worst‐case dietary exposure at steady state. 1574. According to Annex III, Part 1, silicon dioxide (E 551) is authorised as a carrier in emulsifiers and colours at QS. Bellmann et al. SAS materials used in the available biological and toxicological studies were different in their physicochemical properties; their characteristics were not always described in sufficient detail. Hepatotoxicity induced by nanomaterials: mechanisms and in vitro models. For SAS used as a food additive, in cosmetics or in pharmaceuticals, 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. Crystalline silicon dioxide is the common name for the additive. Lang K, 1966. In the information provided by interested parties (CEFIC, 2016b, 2017 (Documentation provided to EFSA n. 15, 17)), the production process of pyrogenic (fumed) SAS was summarised as being produced by hydrolysis of volatile chlorosilanes (e.g. Taken together, these results indicated that nano‐silica particles can induce allergen‐specific Th2‐type allergic immune responses in vivo. 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. Ten animals received via gavage one of the two test substances in corn oil at dose levels up to 3,160 mg/kg bw. By using specifically engineered nano‐silica, and employing various routes of administration, it was shown that most of the material was excreted in the faeces but that a small proportion of material measured as silicon could be found in the liver, kidney, spleen and lung indicating limited absorption. Food additives and nanotechnologies. Inhaling finely divided crystalline silica is toxic and can lead to severe inflammation of … Monopoli et al. However, these materials are, in fact, aggregates and/or agglomerates of primary particles, and not primary particles per se. No reproductive toxicity was noted after treatment with SAS; however, the validity of these results was limited since only one dose of 500 mg/kg bw per day was tested and the group size of pregnant rats was small. 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