Updated information on the actual use levels of silicates (E 552–553) in foods was made available to EFSA by Dr Loges Naturheilkunde neu entdecken, Grupo AC MARCA, European Snacks Association/SNACMA (ESA), Association of the European Self‐Medication Industry (AESGP), Specialised Nutrition Europe (SNE), Food Drink Europe (FDE), Food Supplements Europe (FSE), International Chewing Gum Association (ICGA) and EUROTALC. The numbers of live or dead fetuses, resorptions, implantations and fetal weights did not differ amongst the groups. Online Edition “Combined compendium of food additive specifications”, Monograph 17. In accordance with the guidance provided in the EFSA opinion related to uncertainties in dietary exposure assessment (EFSA, 2007), the following sources of uncertainties have been considered and summarised in Table 8. more data on the actual usage and use levels of silicates (E 552, E 553a(i)), E 553a(ii)) should be provided because most of the data submitted were for talc (E 553b). The resulting amounts of calcium and magnesium ions released were considered too low to disturb normal physiological processes and therefore, the consequence of ingesting them from the use of the food additives E 552, E 553a and E 553b are not discussed further in this opinion. The Panel considered that calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) dissociate to a limited extent in the gastrointestinal tract into silicates and their corresponding cations. The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of silicon dioxide (E 551) when used as a food additive. The Mintel's GNPD is an online database which monitors new introductions of packaged goods in the market worldwide. Products with the emb code UNKNOWN - Products that contain the ingredient E552. Additionally, 91% of the reported use levels were related to the use of silicates in food supplements. Food Additives in Europe 2000 ‐ Status of safety assessments of food additives presently permitted in the EU, 668‐670, Bilateral urinary calculi after treatment with a silicate‐containing milk thickener. Response to EFSA request on 8 March 2018 on particle size distribution for magnesium silicate and magnesium trisilicate. There were no kidney lesions in control animals. The Panel considered that limited data in humans indicated that the silicate anion from magnesium trisilicate is absorbed to a limited extent, then excreted in the urine (as determined from urinary silicon measurements). However, a food additive may be used at a lower level than the MPL. Available online: http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm. The numbers of live or dead fetuses, resorptions, implantations or fetal weights did not differ amongst the groups. Industry provided EFSA with data on use levels (n = 292) of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) in foods for 7 out of the 28 food categories in which these food additives are authorised. There was no effect on mortality. The Panel concluded that on the available toxicological database for silicates it was not possible to establish ADIs for calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b). Prepared for Bureau of Foods. Man findet ihn unter anderem in Trockenlebensmitteln in Pulverform, Würzmitteln, Nahrungsergänzungsmitteln, Käse, in Scheiben oder gerieben und Kochsalz oder Kochsalzersatz. World Health Organization Technical Report Series, 733, Evaluation of certain food additives and contaminants. Following treatment, the males were sequentially mated to two females per week for 8 weeks (7 weeks in the subacute study) and housed separately until sacrifice. Particularly, only 15 animals per sex per group were used, no reliable clinical chemistry and haematological evaluation was conducted and animals had respiratory infection. Side effects: None known . World Health Organization, IARC monographs on the evaluation of the carcinogenic risk of chemicals to humans ‐ Carbon black, titanium dioxide, and talc. Solubility: It is insoluble in water and in ethanol (JECFA, 2015) by following the solubility test described in Volume 4 (JECFA), which foresees a waiting time of 5 min. No data were available for magnesium silicate. Data on usage levels of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) 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 (2017). Across European Union you will find the food labels containing these e numbers or food additives numbers. Negative and positive control animal groups were also included. E.552 steht für: FS E.552, italienische Lokomotivbaureihe. This new evaluation concluded that the ADI for silicon dioxide and certain silicates, except magnesium silicate and talc, to be ‘not limited’, whereas for magnesium and talc concluded an ADI ‘temporarily not limited’. However, the authors also reported that stone analysis in hospitals was limited, so the composition of the stones might not be accurate. Why pork is haram in Islam (Research) From the Research of the 10th World Conference of Scientific Miracles in the Quran and Sunnah in Turkey 1432 H – 2011 To be completed / E552. There were no data for oral chronic toxicity/carcinogenicity of talc. They are mostly found in adults but they have also been described in rare cases in children (Tasdemir et al., 2017), where they were associated with consumption of milk thickener containing 5.5% silicates in one case of a 6‐month‐old boy (Ulinski et al., 2004), or milk powder dissolved in silicate‐rich mineral water (water containing 172 mg silicate/L; estimated daily intake of about 200 mg silicate) in a 10 month old boy (Nishizono et al., 2004). No analytical data on the concentration of these additives in foods were made available by the Member States. On the other hand, some foods in which the use of silicates (E 552–553) is authorised but for which no data were submitted, were labelled to contain silicates (E 552–553) according to the Mintel's GNPD (e.g. This scenario included 12 food categories (Appendix C). 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. General methods for the analysis of silicates are available but they relate mainly to the analysis of aqueous samples. For talc (E 553b), arsenic and lead are accepted up to concentrations of 10 and 2 mg/kg. The Panel applied the WHO algorithm for assessing the association between adverse events and drug intake (Edwards and Biriell, 1994) 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. According to the authors, the excretion of silicon from magnesium trisilicate was limited, suggesting that either the process of absorption or excretion became saturated. The solubility of three non‐food‐grade commercial magnesium silicates by following this approach varied between 127 and 268 mg/L. Furthermore, the Mintel's GNPD showed that the maximum percentage of foods per food subcategory labelled to contain silicates (E 552–553) was 8.4% for ‘Vitamins & Dietary Supplements’. There were no deaths or adverse necropsy findings in the groups that received 50 or 100 mg/kg bw. Origin: Produced from chalk and special sand. OJ L 83, 22.3.2012, p. 1. Submitted to EFSA by CEFIC, August 2012. For the induction of SCE's, samples of talc were treated at 2, 5, 10 or 15 μg/mL and incubated for 48 h at 37°C in the dark. The Panel considered that it was unclear how talc (E 553b), which is known to be hardly absorbed, could induce such a significant increase in body weight and diabetes in rats, and particularly at such low doses. All of the animals died within 24 h. At necropsy, impacted stomach, patchy liver and bloody fluid in the stomach and intestine were reported (Litton Bionetics Inc, 1974b). CEFIC, 2017b. The animals were administered by gavage with 5,000 mg/kg bw per day for 5 days and observed for 14 days. The numbers of live or dead fetuses, resorptions, implantations or fetal weights did not differ amongst the groups. Working off-campus? A single tablet of ‘magnesium trisilicate mixture’ (250 mg magnesium trisilicate, 250 mg magnesium carbonate, 250 mg sodium hydrogen carbonate) may be taken as a single dose up to 1,000 mg magnesium trisilicate (14.3 mg/kg bw per dose). In practice, the FoodEx food codes were matched to the FCS food categories. However, the Panel noted that no carcinogenic effects were reported in this study. Teratologic evaluation of FDA 71‐41 (hydrated calcium silicate). The effects on the kidney reported in guinea pigs treated with magnesium trisilicate could be due to higher concentrations in the primary urine as a consequence of lower glomerular filtration‐rates in guinea pigs (2.29 mL plasma/min per kg; Neiberger, 1992) as compared to rats (4.63 mL plasma/min per kg; Pestel et al., 2007). It contains information of over 2.5 million food and beverage products of which more than 900,000 are or have been available on the European food market. and 7% (w/w) magnesite (MgCO3).1515 It was shown that in healthy individuals, serum silicon concentrations are maintained within a narrow range, but that hypersilicaemia can develop in individuals with kidney disease. Chronic Toxicity Final Report on Material Silene EF, May 24, 1956. PQ Corporation, 2012. The numbers of live or dead fetuses, resorptions, implantations and fetal weights did not differ amongst the groups. 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. 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 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 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. OJ L 268, 18.10.2003, 29–43. 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). Wir zwitschern Ihnen unsere Neuigkeiten: Folgen Sie uns bei Twitter. 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