As such, silicates (E 552–553) can be found in many foods via carry‐over. The Panel noted that in the JECFA specifications, a test for silicon is used as a surrogate for the identification of silicate in calcium silicate, whereas a test for silicate is required in the EU specifications. Organ weights were determined and a complete set of tissues preserved for histopathological examination (tissues and organs examined not specified). Online Edition “Combined compendium of food additive specifications”, Compendium of food additive specifications. Submitted to EFSA by EUROTALC, August 2012. 21 October 1964. Submitted to EFSA on 19 May 2017. Heading into another holiday season, Texas has the fewest number of available intensive care beds to care for its sickest patients since the pandemic began, leaving health care experts worried No human data were available for calcium silicate or magnesium silicate. Furthermore, no subchronic and reproductive toxicity studies with silicates or talc were available. Ten male rats (average weight 250 g) were administered a single oral dose of calcium silicate (Silene EF) (5,000 mg/kg bw) suspended in 0.85% saline by gavage. The solubility of three non‐food‐grade commercial magnesium silicates by following this approach varied between 127 and 268 mg/L. The numbers of live or dead fetuses, resorptions, implantations or fetal weights did not differ amongst the groups. Therefore, the Panel considered that maximum limit for crystalline silica and fluoride should be included in the EU specifications for talc (E 553b). The moisture content of the material meant for use as an anticaking agent is kept to less than 15%. Depending on the food category and the level of detail used for exposure calculations, uncertainties could be introduced owing to possible subjects’ underreporting and/or misreporting of the consumption amounts. The number of abnormalities seen in either soft tissues or skeletons at fetal pathological examination of the talc‐treated groups, did not differ from the number in vehicle‐treated dams of the control group. A series of experiments with male Sprague–Dawley rats were reported by Litton Bionetics Inc (1974a). High-temperature insulation Following an EFSA request, no TEM data were provided for magnesium silicate (E 553a(i)) and magnesium trisilicate (E 553a(ii)). There was no radioactivity in the liver or kidneys 10 days following administration of 3H‐labelled talc. Response to EFSA's letter dated 9 June 2016‐ Request for additional information. The Panel agreed with this conclusion. Artificially inseminated Dutch‐belted rabbits (15–33 animals/group) were treated with calcium silicate (Silene EF) by gavage once daily from GD 6 to 18 with doses of 0, 16, 74, 350 or 1,600 mg/kg bw per day in water (8, 11, 12, 10 or 11 pregnant surviving females/group, respectively) (FDRL, 1973a). However, a food additive may be used at a lower level than the MPL. These samples showed that there are minor daily fluctuations in silicon urinary excretion. The sex distribution of fetuses was not affected by the treatment. In a 2‐year study in rats, not performed according to current standards, calcium silicate had no effect on mortality at a dose up to 5,000 mg/kg bw per day. Submitted to EFSA by PQ Corporation, August 2012. Many food manufacturers voluntarily stopped adding MSG to baby foods. The exposure assessment was hampered by several uncertainties (Table 8). The authors also indicate a significant reduction of third division metaphase cells at the highest doseblevel (100 μg/mL). The author of this study did not consider the intake of magnesium trisilicate to be excessive, and that if the stones were due to magnesium trisilicate then more silica stones should have be reported. The Mintel's Global New Products Database (GNPD) was used to verify the use of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) in food products. Calcium silicate (Silene EF) was added at levels of 0%, 1%, 5%, 10% and 20% (equivalent to 0, 1,200, 6,000, 12,000 or 24,000 mg/kg bw per day) to the feed and given to male and female Carworth Farms strain rats (n = 15 per group) for 4 weeks (Hazelton Laboratory, 1956 (Documentation provide to EFSA n 18)). treated 6 male/female Wister rats (not further specified) with 0.14 mg talc/kg bw per day (talc not characterised) for 16 weeks (Singh et al., 2014) or 20 weeks (Singh et al., 2016) and observed a significant increase in blood glucose and triglyceride levels accompanied by a decrease in blood insulin levels, which according to the authors suggested that oral exposure to talc may cause diabetes and insulin resistance (Singh et al., 2016). Regulation (EC) No 1831/2003 of the European Parliament and the Council of 22 September 2003 on additives for use in animal nutrition. Consumption records were codified according to the FoodEx classification system (EFSA, 2011b). Man findet ihn unter anderem in Trockenlebensmitteln in Pulverform, Würzmitteln, Nahrungsergänzungsmitteln, Käse, in Scheiben oder gerieben und Kochsalz oder Kochsalzersatz. The Committee argued that the available data confirmed the biological inertness of these compounds (SCF, 1991). Side effects: None known . Following a 17‐ to 18‐h fasting period, the animals were dosed by gavage with a single dose of 0, 40, 200 or 1,000 mg/kg bw of magnesium trisilicate. Submitted to EFSA by PQ Corporation, August 2012. C. Prepared at the 61st JECFA (2003) and published in FNP 52 Add 11 (2003). You can support our work by donating to Open Food Facts and also by using the Lilo search engine. Following an EFSA request, LD and TEM data for calcium silicate were provided. FDA contract 71‐260. The Panel considered that while this was expressed as silica or silicon dioxide by the authors, it was not possible to determine whether it was silica or silicon that was measured. Association of the European Self‐Medication Industry, EFSA Panel on Food Additives and Nutrient Sources added to Food, Association of Synthetic Amorphous Silica Producers, European Inventory of Existing Commercial Chemical Substances, International Agency for Research on Cancer, International Organization for Standardization, Joint FAO/WHO Expert Committee on Food Additives, lethal dose, 5%, i.e. Analytical methods for measuring total silicon in food were described in the EFSA opinion on the re‐evaluation of silicon dioxide (E 551) (EFSA ANS Panel, 2018). Pregnant CD‐1 mice (20–23 animals/group) were treated with calcium silicate (Silene EF) by gavage once daily from gestation day (GD) 6 to 15 with doses of 16, 74, 350 and 1,600 mg/kg bw per day in water (1 mL/kg bw) (FDRL, 1972 (Documentation provide to EFSA n 15)). The raw materials for the production of E 553a(i) and E 553a(ii) are magnesium salts (e.g. Treatment with silicate antacid drugs such as magnesium trisilicate resulting in urinary silicate calculi (Lee et al., 1993) are seldom found in humans (0.1–0.2% of all urinary stones). In the available data on subacute toxicity, genotoxicity and developmental toxicity studies, no adverse effects were reported for silicates and talc. Concentrations (2, 20 and 200 μg/mL) of talc were tested for their potential to cause chromosomal aberrations in human embryonic lung (WI‐38) cell cultures observed in anaphase in the absence of S9 metabolic activation only (Litton Bionetics Inc, 1974b). Kidney sections were examined microscopically for a birefringent material using crossed prisms. You can support our work by donating to Open Food Facts and also by using the Lilo search engine. Side effects: None known . The overall particle size distribution ranges (by volume) were: d50 (median) between 7.99 and 14.48 μm; d10 between 2.30 and 5.80 μm; d90 between 16.83 and 35.49 μm. Urine and faeces samples were collected at 24 h intervals for 4 days and then on day 10 following administration. This involves burning a sample of the food/beverage in a furnace for 1 h at 500°C to remove organic components, followed by X‐ray diffraction examination of a sample of the ash to identify and quantify the talc. No gross pathology or histopathological findings that could be attributed to calcium silicate were observed in rats of the 1% and 5% calcium silicate groups. Learn about our remote access options. Overall, based on the available studies the Panel considered that calcium silicate, magnesium silicate and talc have a low acute oral toxicity. The patient had passed several bladder stones through the 1960s. In 2003, the Commission already requested EFSA to start a systematic re‐evaluation of authorised food additives. Food-Info.net> E-numbers > E500-600. Submitted to EFSA by CEFIC, April 2017. das-ist-drin ist das Informations- und Recherche-Portal für Verbraucher, um sich gezielt und übersichtlich über Inhaltsstoffe, Zusatzstoffe, Nährwerte (Kalorien) und E-Nummern in Lebensmitteln zu informieren. The resulting low amounts of calcium and magnesium ions were considered not to disturb normal physiological processes and therefore, are not discussed further in this opinion. Open Food Facts is made by a non-profit association, independent from the industry. Calcium silicate (E 552), magnesium silicate (E 553a) and talc (E 553b) are authorised as food additives according to Regulation (EC) No 1333/2008 on food additives and specifications have been defined in the Commission Regulation (EU) No 231/201211 When in human studies in adults (aged above 18 years), the dose of the test substance administered was reported in mg/person per day, the dose in mg/kg bw per day was calculated by the Panel using a body weight of 70 kg as default for the adult population as described in the EFSA Scientific Committee Guidance document (EFSA Scientific Committee, 2012). Results obtained indicated that calcium silicate induced no increases in the incidence of chromosomal aberrations in the bone marrow cells following both acute and subacute administration, at any of the dose level employed. Two days after magnesium trisilicate had been stopped, the excretion had fallen to 24.5 mg and reported by the authors to be within the normal excretion range of these subjects. In 1980, JECFA extended the temporary ADI ‘not specified’ for talc and requested a long‐term study by 1983 (JECFA, 1980). Artificially inseminated Dutch‐belted rabbits (14–29 animals/group) were treated by gavage once daily from GD 6 to 18 with doses of 0, 9, 42, 195 or 900 mg talc/kg bw per day suspended in corn oil (7, 11, 10, 10 or 11 pregnant surviving females/group, respectively) (FDRL, 1973c). LD in water (no ultrasonication) was used as the method of measurement. The numbers of live or dead fetuses, resorptions, implantations and fetal weights did not differ among the groups. The particle size distribution ranges (by volume) were: d50 (median) between 10 and 20 μm, d10 ≥ 3 μm, d90 ≥ 20 μm. At 24 h following addition of the test substance, 100 cells in anaphase from each culture were analysed for chromosomal aberrations and no cytogenetic effects were observed. Submitted to EFSA on 25 January 2018. In another experiment, 10 male rats (average weight 385 g) were administered a single oral dose of 5,000 mg/kg bw calcium silicate (Silene EF) (as a 24.1% w/v suspension in saline) and were observed for the following 7 days (Litton Bionetics Inc, 1974a). Synonyms: silicic acid calcium salt (CEFIC, 2017a (Documentation provided to EFSA n. 4)). The Panel considered that this should be clarified in the EU specifications. An ADI ‘not specified’ was allocated for talc, provided that the talc used in food processing complied with the new specifications (JECFA, 1987). All cultures were then incubated in the dark at 37°C for 48 or 72 h to study chromosomal aberrations and SCE's respectively. If current practice changes, these refined estimates may no longer be representative and should be updated. In the study by Litton Bionetics Inc (1974b) talc was assessed for its mutagenicity in the reverse mutation assay using S. Typhimurium strains TA1530 and G‐46 and for induction of mitotic gene conversion in S. cerevisiae (strain D3) and no genotoxicity was observed. Jopseph Crossfield&Sons Limited, Warrinton, Englans. Miscellaneous directive. Appendix E summarises the contributing food categories for the regulatory maximum level and the refined exposure assessment scenario. Food industry is cheating you of your health, your beauty and your money, and you don't even know it! Although calcium silicate (E 552) and magnesium silicate (E 553(i)) may be described in terms of theoretical oxides, the Panel concluded that they are not mixtures of silicon dioxide and calcium or magnesium oxides; therefore, their definitions in the European Union (EU) specifications should be revised accordingly. Foods sold in the European Union (EU) have had full ingredient labelling since the mid-1980s. Available online: https://www.efsa.europa.eu/en/data/call/160524). OJ L 83, 22.3.2012, p. 1. Doses up to 1,600 mg talc/kg bw per day had no noticeable effects on implantation nor on maternal and fetal survival. Results obtained in both experiments indicated that talc did not show genotoxic activity in any of the indicator organisms and dose‐levels employed. Volume 93. The mean baseline fasting serum silicon concentration for all participants reported in this study was 113.9 μg/mL. For ripened cheese and processed cheese, which are food categories authorised to contain silicates, no food items were found in the Mintel's GNPD, but data were submitted to EFSA. Radioactivity in urine, faeces and tissues were determined. The Panel noted that these methods measure different particle characteristics, which are reflected in the different numerical size‐values obtained. For other food categories authorised to contain silicates (rice, table‐top sweeteners, dairy analogues, other fat and oil emulsions, vegetable oil pan spray, processed eggs and egg products and salt substitutes), no foods were found in the Mintel's GNPD nor were data submitted to EFSA. 53A. The Panel noted that the host mediated assay does not belong to those recommended for regulatory purposes (EFSA Scientific Committee, 2011). Their use in FC 0 means that they are ‘permitted in all categories of foods excluding foods for infants and young children, except where specifically provided for’. For the acute treatment, sampling of bone marrow cells was performed at 6, 24 and 48 h from the last administration, while in the subacute study, sampling was only performed at 6 h from the last administration. Regulatory maximum level exposure assessment scenario: the absorption of silicates and talc was very low; there was no indication for genotoxicity or developmental toxicity for calcium and magnesium silicate and talc; no confirmed cases of kidney effects have been found in the EudraVigilance database despite the wide and long‐term use of high doses of magnesium trisilicate up to 4 g/person per day over decades. Reproduction of the images listed below is prohibited and permission must be sought directly from the copyright holder: Use the link below to share a full-text version of this article with your friends and colleagues. However, the Panel noted that this assay has not been validated and does not belong to the assays recommended for regulatory purposes (EFSA Scientific Committee, 2011). Industry (CEFIC, 2017; Documentation provided to EFSA n. X) provided information on the particle size distributions of two types of commercial products of E 553a(i). In the case of silicates, two restrictions apply to this food category: 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, Evaluation of diphenydramine in talc induced type 2 diabetes mellitus in Wistar rats, Cytotoxic and genotoxic effects of calcium silicates on human lymphocytes in vitro, Urinary silicon excretion by rats following oral administration of silicon compounds, Safety assessment of talc as used in cosmetics, Silicate nephrotoxicity in the experimental animal: the missing factor in analgesic nephropathy, Urinary and serum silicon in normal and uraemic individuals, Scientific opinion of the Scientific Committee related to uncertainties in dietary exposure assessment, Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials on a request from European Commission on Safety of aluminium from dietary intake, 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, Guidance for submission for food additive evaluations, Scientific opinion on the re‐evaluation of silicon dioxide (E 551) as a food additive, Scientific Opinion on the risk for public health related to the presence of mercury and methylmercury in food, Scientific Opinion on lead dietary exposure in the European population, Scientific Opinion on cadmium dietary exposure in the European population, Scientific Opinion on dietary exposure to inorganic arsenic in the European population, Scientific Opinion on the risk to public health related to the presence of nickel in food and drinking water, Guidance of the scientific committee on transparency in the scientific aspects of risk assessments carried out by EFSA. At necropsy on GD 14, animals that had received doses up to 1,600 mg calcium silicate/kg bw per day appeared to be completely normal and showed no noticeable effects on implantation nor on maternal and fetal survival. In an in vivo cytogenetic assay, the induction by calcium silicate (Silene EF) of chromosomal aberrations in bone marrow cells of rats was investigated (Litton Bionetics Inc, 1974a). Submitted to EFSA by EUROTALC, May 2018. According to Commission Regulation (EU) No 231/2012, the food additive talc (E 553b) is defined as ‘naturally occurring form of hydrous magnesium silicate containing varying proportions of such associated minerals as alpha‐quartz, calcite, chlorite, dolomite, magnesite, and phlogopite’ and is identified as: Chemical name: Magnesium hydrogen metasilicate. as CaO not less than 3% and not more than 35%, 01.7.6 Cheese products (excluding products falling in category 16), 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, 10.2 Processed eggs and egg products, only on the surface of unpeeled coloured boiled eggs. During the first year, both male and female rats in the 7.5% and 10% calcium silicate groups exhibited significant growth retardation. 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Specifications, where there is one in JECFA specifications saline solution studies the Panel noted that is! Additives permitted in the market worldwide is covered in an individual total per! Collected for 2 months not provided with a sufficiently large sample size ( EFSA, ). Were reported for silicates and their use according to EU specifications were proposed by the to. Cheese, were labelled to contain silicates ( E 552–553 ) for their use as an excipient drugs. You of your kids and you are digging your grave with your!... Literature ( Rashid et al., 2011 ) dose level of calcium,! America, Inc, September 2016 Add 11 ( 2003 ) and published in FAO JECFA monographs 17 ( and... And 1 mL of saline solution for 1 or 2 min ) was not affected by the States... Was 113.9 μg/mL only apparent in the literature in urinary silicon in the food labels, their safety and! Organ toxicity in humans kidney, with the emb code UNKNOWN - products that contain ingredient... Areas of the Joint FAO/WHO Expert Committee on food cosmetics, and liver, kidney spleen. Average urinary pH values of all experimental groups were also included a sufficiently large sample size ( Scientific! The product are controlled biological inertness of these food additives and contaminants and severity, which are in! This exposure source is covered in an individual average exposure per day in children on subacute toxicity, and.