The authors concluded that the changes in silicon excretions were within the range of normal physiological variation, and there was little indication of absorption of silica after ingestion (Degussa AG, 1966 (Documentation provided to EFSA n. 18); Lang, 1966 (Documentation provided to EFSA n. 50); Langendorf and Lang, 1967). 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. The Panel noted that among the three types of silicon dioxide, SAS is the only one to be authorised as a food additive (E 551). Submitted to EFSA by CEFIC, July 2016. Silicon dioxide (PM Ref. The ANS Panel was not provided with a newly submitted dossier. Kiezelzuur, kwarts, silica . These aggregates can further agglomerate to form larger structures. In 2004, the EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to derive an UL for the intake of silicon from food that is unlikely to pose a risk of adverse health effects. However, the Panel noted that their presence in the food additive cannot be excluded due to a lack of precision in the specifications for E 551. If current practice changes, these refined estimates may no longer be representative and should be updated. Lee et al. No clinical signs were noted and body weight gain and food consumption were comparable to control values. Recently modified products. The exposure via the intake of food supplements was covered in an additional exposure scenario described below. However, in most of the toxicological studies, the consequence of the potential interaction between nanoparticles and food components in real life was ignored. 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. 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. Leuschner F, 1963a. 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. The hydrodynamic diameters of the agglomerates in samples were in the range of 1,223 ± 468 to 1,579 ± 88 nm. The product is then bagged, filled into containers, or loaded into silo cars. Function & Characteristics: Used as anti-caking agent, to remove protein and yeast in beer and wine production and as anti-foaming agent. In addition, the restrictions which apply to the use of silicon dioxide (E 551) for the FCs 17.1, 17.2 and FC 17.3 (Food supplements, in solid, liquid and syrup‐type or chewable form) could not be taken into account, and therefore, the whole food category (FC 17) was considered in the specific exposure scenario including food supplements (Section 3.4.3). Robust study summary. However, depending on the starting Most of the primary particles seem to form larger aggregated and/IR agglomerates. The Panel evaluated the reliability of the studies and the relevance of the results. 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. Ana” in Vienna a few years ago in the campaign “Think of your children’s health” issued a […] 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. 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’. Fraunhofer, 2014b. These scenarios did not consider the exposure to silicon dioxide (E 551) via the intake of food supplements or consumption of foods for special medical purposes (FSMP). Til HP, Hollanders VMH and Beems RB, 1981. Cabot, 1990b. This hold also for the increased food consumption accompanied by decreased food efficiency at the high‐dose level. Advanced E 551 does not raise a concern with respect to genotoxicity. The Panel agreed with the authors (for additional discussion about the reliability of this study see Section 3.6.3). However, silicon‐containing material (in some cases presumed to be silicon dioxide) was found in some tissues. According to the EU specifications for silicon dioxide (E 551), the forms of SAS used as a food additive E 551 includes fumed (pyrogenic) silica and hydrated silica (precipitated silica, silica gel and hydrous silica) depending on the process (thermal or wet) used for their manufacture. Cabot, Tuscola, Illinois, USA. In a study using a protocol comparable to OECD Guideline 401, five male and five female SD/N BR rats per group were orally gavaged with precipitated silica (Zeosyl 113; Appendix A). No clinical signs were noted during the 28‐day observation period following administration. 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). 14‐Day Nose‐Only Inhalation Toxicity Study of NM‐200 (Synthetic Amorphous Silica) in Wistar WU Rats Fraunhofer ITEM Study No. Regulation (EC) No 1831/2003 of the European Parliament and the Council of 22 September 2003 on additives for use in animal nutrition. Yang et al. The LD50 of this test compound was > 20,000 mg/kg bw (JM Huber Corporation, 1978 (Documentation provided to EFSA n. 48)). Doses of 10, 12.6, 15.8 or 20 g/kg bw were tested. Negative findings were only observed in the alkaline comet assay in a study of limited relevance (Gehrke et al., 2012). Crystalline silicon dioxide is the common name for the additive. Yun et al. 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. An overview of methods for analysis of silicon in environmental and biological media is given in ECETOC (2006). This exposure estimate is calculated as follows: The non‐brand‐loyal consumer scenario: It was assumed that a consumer is exposed long‐term to silicon dioxide (E 551) present at the mean reported use level in food. The author reported that no gross changes were found at necropsy and organ weights did not show ‘certain differences’ between control and treatment groups (no statistical evaluation performed). 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. In particular, they looked at the cytokines release by different cell types: human epithelial A549, human THP‐1 and mouse J774A.1 macrophage cells. No particular findings were found at necropsy. 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. The sizes and the intracellular transport of the particles into Caco‐2 cells and Caco‐2 monolayer membrane permeability were evaluated. In the post‐treatment phase, individual mean excretion rates ranged from 32 to 61 mg/day. Overall, the Panel noted that there was evidence that SAS and engineered nano‐silica had a low acute toxicity after oral administration. Contado et al. The other 145 reported use levels related to foods in which silicon dioxide (E 551) could be present due to its authorisation in FC 0 or as carry‐over. Report PB 223808. Summary and conclusions, Toxicity of luminescent silica nanoparticles to living cells, Pulmonary chemokine and mutagenic responses in rats after subchronic inhalation of amorphous and crystalline silica, Synthetic Amorphous Silicon Dioxide (NM‐200, NM‐201, NM‐202, NM‐203, NM‐204): characterisation and Physico‐Chemical Properties, JRC Nanomaterials repository. The total urine was collected for 3 days pre‐application (control values) and for 4 days post‐application. In the subsequent intestinal digestion stage, the nanosized silica particles reappeared again. Microbial mutagenesis testing of substances compound report: F76‐037, Silica—silicon G‐910 SCM Glidden Pigments, Lot #14‐J‐2 CAS #7631869 Prepared for: FDA, U. S. Food and Drug Administration; NTIS, National Technical Information Service, U.S. Department of Commerce, Springfield, VA, USA, PB89‐187066. 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 Panel considered that no evidence was provided that ‘stimulating macrophages’ and ‘increasing circulating lymphocytes’ were beneficial to the health of subjects with normal immune function and concluded that no cause and effect relationship was established between the consumption of silicon and ‘stimulating macrophages’ and ‘increasing circulating lymphocytes’ (EFSA NDA Panel, 2009. Each dose contained 1,250 mg of the test substance. The authors claimed that silica particles of 50, 100 and 200 nm were cleared via urine and bile. 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. At 12 h, 50 nm nanoparticles reached the highest concentration in urine, and 100 nm particles had a peak concentration at 24 h. All three sized silica particles were detected in urine only 1 week after injection. The animals (5 weeks old at initiation) received for 93 weeks a diet containing 0%, 1.25%, 2.5% or 5 % of the test item (equivalent to 0, 1,875, 3,750 and 7,500 mg/kg bw per day). Ana” in Vienna a few years ago in the campaign “Think of your children’s health” issued a […] The Panel agreed with this conclusion. depending on the method used for the analytical determination of particles of silicon dioxide (including the preparation of the sample; e.g. The results for more than 15 endpoints were addressed, including physical–chemical properties, e.g. Guidance of EFSA on the ‘Use of the EFSA Comprehensive European Food Consumption Database in Exposure Assessment’ (EFSA, 2011a). Submitted to EFSA by CEFIC, July 2016. We will understand. 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. The results were based on studies by European laboratories participating to the NANOGENOTOX Joint Action and by JRC (JRC, 2013). The Panel reviewed a series of studies investigating the cytotoxic potential of a variety of SAS nanoparticles, which are briefly reported below. 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. As white, fluffy powder or granules ; hygroscopic was tested in a size up! Well as its preservation and flavoring, thus improving the quality of their products ; such... 54Th Annual meeting of the food additive in environmental and biological media ECETOC! Identification number 3388 ( referred as Cabot GmbH, 1989a by ECETOC is between 12 and 36 months the! ≥ 10 μg/mL in a Comprehensive study analysed the physicochemical characteristics of silica gel products iedereen... 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