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. Among chlorites, there are minerals with specific composition, e.g. In practice, the FoodEx food codes were matched to the FCS food categories. The Panel considered that this should be clarified in the EU specifications. In the regions of the affected tubules, the interstitium was expanded by chronic inflammatory infiltrate and an excess of collagen fibres. Food ‐ science and techniques, Guidance on submissions for food additive evaluations by the Scientific Committee on Food. According to Annex III, Part 1, calcium silicate (E 552) is authorised as a carrier in emulsifiers and colours at QS, and talc (E 553b) is authorised as a carrier in colours at a maximum level of 50 mg/kg in the colour preparation. Calcium silicate is included in the European Union Register77 Therefore, the Panel concluded that the safety of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) when used as food additives cannot be assessed. 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). You are destroying your own health, and the health of your kids and you are paying for it out of ignorance! Control animals (4–6 animals; 240–260 g) were administered water. Nomenclature from the FoodEx classification system has been linked to the food categorisation system (FCS) as presented in Annex II of Regulation (EC) No 1333/2008, part D, to perform exposure estimates. Specifications prepared at the 80th JECFA (2015) and published in FAO JECFA monographs 17 (2015). All animals were examined daily and weighed weekly. The Panel noted that the EINECS Number reported in EU specifications corresponds to the CAS Number 14987‐04‐3 (anhydrous form), while the chemical formula given in the EU specifications refers to an hydrated form. No studies were available for magnesium trisilicate. Results obtained indicated that talc 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. Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, 2012. The Panel applied the WHO algorithm for assessing the association between adverse events and drug intake, and found that the association between silicate antacid use and renal calculi was ‘possible’ but not ‘definite’, which does not exclude that the occurrence of renal calculi and intake of silicates would be a chance finding. 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% talc was systemically available, with low levels seldom found in the liver. This assumption is also supported by the literature (Rashid et al., 2011). The Panel noted that more recent evidence suggested that this assumption might not be valid. However, the authors also reported that stone analysis in hospitals was limited, so the composition of the stones might not be accurate. Pregnant Wistar rats (20–22 animals/group) were treated with calcium silicate (Silene EF) by gavage once daily from 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)). Negative and positive control animal groups were also included. Volume 42. This stoichiometry does not correspond with magnesium silicate (MgO3Si) as presented in the EC inventory.1313 There was a dose‐related increase of ‘silicon dioxide’ in the liver (5% concentration: males, 2‐fold background; females, no or slight increase; 10% concentration: males and females, 3‐fold background), and in the kidney (5% concentration: males, 3‐fold background; females, no or slight increase; 10% concentration: males, 20‐fold background; females, 15‐fold background), but not in the other organs tested. The brand‐loyal consumer scenario: It was assumed that a consumer is exposed long‐term to silicates (E 552–553) present at the maximum reported use level for one food category. Herkunft. In the non‐brand‐loyal, the main contributing food categories were FC 01.7.2 Ripened cheese, FC 01.7.5 Processed cheese and FC 05.3 Chewing gum. Twentieth Report of the Joint FAO/WHO Expert Committee on Food Additives. On this basis, the results were considered to be of low relevance. The number of abnormalities seen in either soft tissues or skeletons at fetal pathological examination of the calcium silicate‐treated groups, did not differ from the number in vehicle‐treated dams of the control group. In addition, biological relevance of SCEs is unclear and the test for induction of sister chromatid exchanges does not belong to the assays recommended for regulatory purposes (EFSA Scientific Committee, 2011). E552 : Calcium silicate . Sprague–Dawley CD rats (5 males/group, average weight 250 g) were administered a single oral dose of talc (0, 50, 100, 500, 1,000, 2,000 or 3,000 mg/kg bw) suspended in saline by gavage. 98% of the reported use levels referred to the use of talc (E 553b). Furthermore, the Panel noted that no foods belonging to an important contributing food category in all population groups, i.e. CEFIC, 2017b. E numbers for food additives are sort of codes that are used within European Union. A second experiment was additionally performed under the same experimental conditions with only one dose level of talc but at 5,000 mg/kg. Results obtained indicated that all three samples induced significant increases of both aberrant cells and SCE's at the two higher concentrations of 10 and 100 μg/mL compared with the concurrent untreated controls. These samples showed that there are minor daily fluctuations in silicon urinary excretion. only foods in dried powdered form (i.e. Fertility index, total implants (live fetuses plus early and late fetal deaths), total dead (early and late fetal deaths), dead implants per total implants and preimplantation loss (calculated as the difference between the total corpora lutea and total implant counts) were evaluated and according to the authors, the results did not raise concern with respect to genotoxicity. Products with the emb code UNKNOWN - Products that contain the ingredient E552. According to information provided (CEFIC, 2017b (Documentation provided to EFSA n. 5)), both magnesium silicate (E 553a(i) and magnesium trisilicate E 553a(ii) are manufactured either batchwise or via a continuous process. CEFIC, 2018a. Therefore, the use of these substances as food additives was ‘not limited except for good manufacturing practice’ (JECFA, 1969). In this document, these levels are named maximum permitted levels (MPLs). No data were available for magnesium silicate. OJ L 354, 31.12.2008, p. 16–33. Submitted to EFSA by the Dallas Group of America, Inc, September 2016. Solubility: It is insoluble in water and ethanol (Commission Regulation (EU) No 231/2012). However, in the absence of clinical chemistry data, given the respiratory infection of animals and only 15 animals/sex per group, the Panel considered that this study was too limited to conclude on the chronic toxicity of calcium silicate. The International Numbering System (INS) is followed in this e numbering scheme. donbassite, Al13(Al3Si9O30)(OH)24, or nimite (Ni,Mg,Al)6(Si,Al)4O10(OH)8.1515 Industry (EUROTALC, 2012 (Documentation provided to EFSA n. 10)) provided information on the particle size distribution of two lots of talc (E 553b). for calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b). This Regulation also foresees that food additives are re‐evaluated whenever necessary in the light of changing conditions of use and new scientific information. 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. There were no data for oral chronic toxicity/carcinogenicity of talc. According to the EC inventory (online),1313 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). The amounts excreted after a 5 g dose were greater than following the 2 g and 2.5 g doses. Silicates (E 552‐553) are authorised in 28 food categories, including FC 0, according to Annex II to Regulation (EC) No 1333/2008. The 24‐h urinary excretion of silicon was determined by atomic absorption spectroscopy in a healthy adult male and healthy adult female on a normal diet, in four consecutive urine collections (Dobbie and Smith, 1982). However, although statistically significant, the Panel considered these changes in liver serum enzyme not of toxicological significance. Origin: Produced from chalk and special sand. 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