The sex distribution of fetuses was not affected by the treatment. According to industry (CEFIC, 2017b (Documentation provided to EFSA n. 5)), magnesium silicate (E 553(i)) – CAS 1343‐88‐0 and an EINECS number 215‐681‐1 – has the name ‘Synthetic amorphous magnesium silicate, with molar ratio (SiO2:MgO) range of 1.4‐4’. Peripheral blood lymphocyte cultures were incubated (in the presence of 5‐bromo‐2′‐deoxyuridine (BrdUrd) to detect SCE's) with each of the three samples of calcium silicate suspension at concentrations of 0.1, 1.0, 10 or 100 μg/mL. However, most of the data in these monographs relate to the inhalation toxicity and do not include any good quality oral chronic toxicity or carcinogenicity studies. However, although statistically significant, the Panel considered these changes in liver serum enzyme not of toxicological significance. In this chlorite, the aluminium content is 6.5%. Therefore, the Panel considered that maximum limit for crystalline silica and fluoride should be included in the EU specifications for talc (E 553b). The Panel agreed with this conclusion and noted that the biological relevance of SCE is unclear and that the assay does not belong to those recommended for regulatory purposes (EFSA Scientific Committee, 2011). Based on a 2‐year study with calcium silicate in rats, the Panel considered that at high doses (up to 5,000 mg/kg body weight (bw) per day), there was evidence of silicon accumulation in the liver and kidney. The finest material is intended for use as an anticaking agent and the coarser particles are for use as a filtering aid. Silicates have been discussed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) on several occasions (JECFA, 1969, 1974, 1986, 1987). In the brand‐loyal scenario, the mean exposure to silicates (E 552–553) from their use as food additives ranged from 0.1 mg/kg bw per day in infants to 27.5 mg/kg bw per day in children. 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. The control group was dosed with 1 mL corn oil/kg bw. Teratological test results in rabbits. Working off-campus? All animals were necropsied following a 10‐day observation period. The Panel noted that the main food category labelled with silicates (E 552–553) in the Mintel GNPD was also food supplements (Appendix B). The Panel noted that studies with synthetically produced talc in mice, rat and guinea pigs as well as talc (baby powder) in hamsters indicated that less than 2% of talc was systemically available with low levels found in the liver. Dietary exposure to silicates (E 552–553) via this exposure scenario was up to 31 mg/kg bw per day at the mean level in children and up to 46 mg/kg bw per day at the high (P95) level in the elderly. Therefore, information on actual use levels is required for performing a more realistic exposure assessment, especially for those food additives, which are authorised according at QS in all or part of the authorised food categories. 12 July 2001, Talc used in anticancer drugs is promoter for diabetes in hepatocellular carcinoma induced rats, Histopathological analysis of talc in doxorubinin induced cardiac remodelling, The comparative absorption of silicon from different foods and food supplements, Oral ingestion of syloid to mice and rats and its chronic toxicity and carcinogenicity, Silicate calculi, a rare cause of kidney stones in children, E 475 Polyglycerol esters of fatty acids. The protocol was the same as the one used for the rat study described above (Newberne and Wilson, 1970). 471. Grupo AC MARCA, 2017. The raw materials for the production of E 553a(i) and E 553a(ii) are magnesium salts (e.g. Talc (E 553b) is a white mineral powder produced after grinding talc that has been mined (EUROTALC, 2018b (Documentation provided to EFSA n. 12)). Twenty‐ninth Report of the Joint FAO/WHO Expert Committee on Food Additives. […] This information taken together with human clinical experience and the ubiquitous occurrence of these compounds in the environment does not point to any significant toxic effects when these substances are used as food additives’. Available online: However, the ANS Panel provided a separate scientific opinion re‐evaluating the safety of silicon dioxide (E 551) when used as a food additive, therefore not covering the silicates (E 552–553). 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. A few of the dogs had polydipsia and polyuria, and most of the treated animals had occasional soft faeces discoloured by unabsorbed test substance. Crocidolite and chrysotile were used as the positive controls and both showed enhancement of UDS. According to the EC inventory (online),1313 No human data were available for calcium silicate or magnesium silicate; however, the Panel considered that a read‐across approach was appropriate and considered that silicate anion from both calcium silicate and magnesium silicate would behave similarly. None of the talc samples increased UDS. ripened cheese, were labelled to contain silicates (E 552–553) according to the Mintel GNPD. E - CODES (FOODS HALAL HARAM CODE) 2. Mice of the LACA strain (4 female animals; age not stated) were given a single oral dose (40 mg/kg bw per day) of 3H‐labelled talc (synthetically produced magnesium hydrogen metasilicate) by gavage (Phillips et al., 1978). the European Commission considers inclusion of maximum limits for aluminium, nickel, fluoride and crystalline silica (alpha‐quartz) in the EU specifications for talc (E 553b). Given that the information from the Mintel's GNPD reflects the use levels reported by industry to a large extent, and that it was assumed that all foods belonging to the considered food categories contained silicates (E 552–553), the Panel considered overall that the uncertainties identified would, in general, result in an overestimation of the exposure to silicates (E 552–553) from their use as food additives according to Annex II in all scenarios in European countries considered in the EFSA European database. The Panel noted that there were a number of approaches which could decrease the uncertainties in the current toxicological database. 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. Appendix A-A–F can be found in the online version of this output (‘Supporting information’ section): European Food Safety Authority, The patient had passed several bladder stones through the 1960s. Negative and positive control animal groups were also included. The Panel noted that the host mediated assay does not belong to those recommended for regulatory purposes (EFSA Scientific Committee, 2011). The Panel assumed that, when talc dissociates, the associated water molecules are liberated in the solution. The Panel noted that no specific analysis for the presence of silicates or their particles in food have been reported in the literature. Synthetic hydrated magnesium trisilicate was then given to each subject in the form of 0.5 g compressed products suspended in water. Singh et al. was assessed for its mutagenicity in the reverse mutation assay using the Salmonella Typhimurium strains TA1535, TA1537, TA1538, TA98, TA100 and the E. coli strain WP2 according to the method of Ames by the plate incorporation method both in the absence and presence of S9 metabolic activation and no induction of mutations was observed. You can support our work by donating to Open Food Facts and also by using the Lilo search engine. Acid bases and salts‐proposed EEC Directive. The sex distribution of fetuses was not affected by the treatment. OJ L 83, 22.3.2012, p. 1. The Panel noted that X‐ray diffraction data (CEFIC, 2017a (Documentation provided to EFSA n. 4)) confirmed that calcium silicate is not a mixture of silicon dioxide and calcium oxide. Teratological test results in three species of animals (rats, mice, hamsters). Forbidden to you (for food) are: dead meat, blood, the flesh of swine, and that on which hath been invoked the name of other than Allah. The sex distribution of fetuses was not affected by the treatment. However, the Panel considered that accumulation of silicon from calcium silicate in kidney and liver was reported in rats and reliable data on subchronic and chronic toxicity, carcinogenicity, and that reproductive toxicity of silicates and talc were lacking. 36, Reports from the Scientific Committee for Food (25th series). The LD50 was determined by the authors to be 3,400 mg/kg bw (Litton Bionetics Inc, 1974a). Calcium silicate 552 or E552 A very fine, white or off-white powder with low bulk density and high physical water absorption. Import Export Code (IEC) 03881***** Established in the year of 1984, We Anand Engineers Private Limited are the leading Manufacturer and Exporter, Supplier of an extensive array of, Lubricating Greases and Pastes, Food Grade Lubricants, Metal Working Fluids, Forging Lubricants, etc. Pre‐evaluation document. The Panel noted that information from the Mintel GNPD (Appendix B) showed that the main food subcategories, categorised according to the Mintel GNPD nomenclature (i.e. lime, calcium hydroxide), Not less than 50% and not more than 95% of silicon dioxide (SiO, White to off‐white free‐flowing powder that remains so after absorbing relatively large amounts of water or other liquids, Very fine, white or off‐white powder with low bulk density and high physical water absorption, Not less than 5% and not more than 14% (1,000°C, constant weight), 5.0–14.0% on the dried basis (1,000°C, constant weight), Magnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5, Magnesium silicate (synthetic) is manufactured by the precipitation reaction between sodium silicate and a soluble magnesium salt. Exposure to aluminium could be around five times its tolerable weekly intake (TWI) of 1 mg/kg bw (EFSA, 2008). Control animals received untreated diet. As colours were among the first additives to be evaluated, these food additives should be re‐evaluated with a highest priority. Administration of talc resulted in a significant increase in body weight (140 ± 23.17 g) compared to saline control (103 ± 5.56 g). The appearance and behaviour of the rats were comparable in all groups. In 1991, the Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) ‘not specified’ for sodium silicate, silicon dioxide, calcium silicate, magnesium silicate and potassium silicate. Following the single dose of 3H‐labelled talc, approximately 75% and 95.8% of radioactivity was found in the faeces within the first 24 h, and 96 h, respectively. This applied to four food categories (Appendix. Products: Many dry products . The thyroid, lung, heart, liver, stomach, large and small intestines, pancreas, spleen, kidney, adrenal, urinary bladder, gonads, bone marrow and skeletal muscle were collected from six male and six female rats/group, fixed and examined histopathologically. Both ovens have glass doors which are easy to clean and make it easy to check on your food without opening the door. For chromosomal aberrations, this result was only obtained when the gaps were included in the statistical analyses. The Panel noted that due to the high mortality and the low pregnancy rate, this study cannot be used for hazard assessment. Across European Union you will find the food labels containing these e numbers or food additives numbers. Average silicon dioxide contents in organs showed a dose‐dependent increase in the liver and kidney, with the highest levels found in the kidney. Enter your email address below and we will send you your username, If the address matches an existing account you will receive an email with instructions to retrieve your username, Structural formula for calcium silicate (EC inventory, online), Structural formula for magnesium silicate (EC inventory, online), Structural formula for anhydrous magnesium trisilicate. At necropsy on GD 20, animals that had received doses up to 900 mg talc/kg bw per day appeared to be completely normal and had no noticeable effects on implantation nor on maternal and fetal survival. The mortality in this study was 3, 6, 3, 2 and 9 does in the respective groups. Abgerufen von „ FAO Nutrition Meetings Report Series No. Re‐evaluation of talc (E 553b) as food additive request for additional data. Based on the food supplement scenario considered as most representative for risk characterisation, exposure to silicates (E 552–553) for all population groups was below the maximum daily dose of magnesium trisilicate used as antacid (4 g/person per day). E numbers for food additives are sort of codes that are used within European Union. For the remaining food categories, the mean of the typical reported use levels of silicates was used. The forms of synthetic amorphous silica (SAS) used as E 551 include fumed silica and hydrated silica (precipitated silica, silica gel and hydrous silica). This reported use was in line with the information from the Mintel GNPD, showing that 89% of the foods labelled with silicates (E 552–553) were labelled to contain talc (E 553b). The mean average daily excretion of five normal subjects on a regular diet was 16.2 mg SiO2. Food consumption data used to estimate the dietary exposure to silicates (E 552–553) were derived from the EFSA Comprehensive European Food Consumption Database (Comprehensive Database1212 The Panel considered that the available data did not raise concern with respect to genotoxicity of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) when used as food additives. Submitted to EFSA by the FDA, July 2017. This stoichiometry does not belong to those recommended for regulatory purposes ( EFSA, ). Are easy to check on your food without opening the door scenario also FC 05.2 other including. And TEM data for calcium silicate groups exhibited significant growth retardation recommended for regulatory purposes ( EFSA 2011b. Additives used in the Comprehensive database includes the currently best available food consumption data by... Synonyms: silicic acid magnesium salt ( CEFIC, 2017a ( Documentation provided EFSA. 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