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). In a dominant lethal assay, calcium silicate (Silene EF) was administered by gavage to groups of ten male albino rats acutely at 15, 150 and 1,500 mg/kg bw or subacutely on five consecutive days, 24 h apart, at the same dose levels employed for the acute treatment (Litton Bionetics Inc, 1974a). In two other healthy subjects (no further details), frequent, simultaneous measurements of urinary and serum silicon concentrations were made for 24 h following ingestion of 5 g magnesium trisilicate. A second experiment was additionally performed under the same experimental conditions with only one dose level of calcium silicate but at 5,000 mg/kg. Submitted to EFSA by PQ Corporation, August 2012. In the study by Prival et al. Silicon absorption from magnesium trisilicate was studied in healthy volunteers with normal kidney function and not taking silicon supplements or any medication (Sripanyakorn et al., 2009). In der Lebensmittelindustrie dient dieser Stoff dazu, das Verklumpen von Lebensmitteln zu verhindern. Less than 0.02% of the total administered radioactivity was found in the kidneys. However, the Panel noted that the results from the bacteria gene mutation assay are limited due to the inadequate number of S. Typhimurium tester strains used and missing information on the use of metabolic activation and concentrations of test substance employed. According to Commission Regulation (EU) No 231/2012, the food additive magnesium trisilicate (E 553a(ii)) is identified as: Description: fine, white powder, free from grittiness. Submitted to EFSA by the Dallas Group of America, Inc, September 2016. Chemical formula extracted from www.geology.com Appendix E summarises the contributing food categories for the regulatory maximum level and the refined exposure assessment scenario. At necropsy on GD 17, the surviving dams appeared to be completely normal and the number of implantations, and live fetuses were comparable to the control group. All six animals treated with magnesium trisilicate developed renal lesions with a similar distribution pattern and severity, which predominantly affected the distal nephron. 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. The regulatory maximum level exposure assessment scenario is based on the MPLs as set in Annex II to Regulation (EC) No 1333/2008 and listed in Table 2. Therefore, the Panel considered that on the evidence currently available, there is no mechanistic rationale for a group ADI for silicates and silicon dioxide. There was a statistically significant increase in urinary silicon over the 6‐h collection period following ingestion of magnesium trisilicate (p < 0.001), with urinary silicon greatest in the second 3‐h collection period. Taking into account the analysis by TEM provided by industry, calcium silicate falls under the definition of nanomaterial according to the Commission Recommendation 2011/696/EU. Talc (E 553b) is a white mineral powder produced after grinding talc that has been mined (EUROTALC, 2018b (Documentation provided to EFSA n. 12)). Silicon excretion was most rapid during the first 24 h after dosing. Aluminiumsilicat (E559) ist ein natürlich vorkommender Stoff. 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. Similarly, negative control particles, attapulgite and anatase did not induce SCE's. The authors reported that at necropsy of animals that died during the study, ‘the primary cause of death was an overwhelming respiratory infection’. WHO Food Additives Series, 5, Evaluation of certain food additives and contaminants. The Panel considered this solubility indicates that calcium silicate and magnesium silicate are ‘very slightly soluble’ at equilibrium. The animals were administered by gavage with 5,000 mg/kg bw per day for 5 days and observed for 14 days. 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. Dietary exposure to silicates (E 552–553) from their use as food additives was estimated by combining the food consumption data available within the EFSA Comprehensive Database with the maximum permitted levels according to Annex II to Regulation (EC) No 1333/2008 and reported use levels submitted to EFSA following a call for data. This was carried out for all individuals per survey and per population group, resulting in distributions of individual exposure per survey and population group (Table 6). This decreased to 5.1% in the 200 mg/kg bw group, and 1.5% in the 1,000 mg/kg bw group. Reported use levels were only available for seven food categories in the refined scenario. 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. (1991), magnesium silicate2121 Available online: https://echa.europa.eu/information-on-chemicals/ec-inventory. 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. These approaches include but are not limited to toxicological studies as recommended for Tier 1 approach as described in the EFSA Guidance for the submission of food additives (EFSA ANS Panel, 2012) and conducted with adequately characterised material. Chronic Toxicity Final Report on Material Silene EF, May 24, 1956. Specialised Nutrition Europe (SNE), 2017. The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of calcium silicate (E 552), magnesium silicate (E 553a) and talc (E 553b) when used as food additives. The Panel agreed with this conclusion. The numbers of live or dead fetuses, resorptions, implantations or fetal weights did not differ amongst the groups. Urinary samples from individuals on a normal diet were collected for 2 months. It is approved by the United Nations' FAO and WHO bodies as a safe food additive in a large variety of products. 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). The EINECS/EC Number is 215‐710‐8 and its chemical name is calcium silicate. Many food manufacturers voluntarily stopped adding MSG to baby foods. World Health Organization Technical Report Series, 733, Evaluation of certain food additives and contaminants. Regulation (EC) No 1333/200822 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 practice, the FoodEx food codes were matched to the FCS food categories. ASASP (2012). There were no deaths, no signs of toxicity or abnormal necropsy findings. Learn about our remote access options. Chemical formula extracted from www.geology.com, Chlorite minerals have a general chemical composition of [(X,Y)4‐6(Si,Al)4O10(OH,O)8. The authors of the study commented that the patient was not certain how long he had been ingesting magnesium trisilicate, but it could have been from 1940, when renal colic was first diagnosed. 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. The kidney effects observed in dogs when treated with magnesium trisilicate were most probably related to the large amount of test compound administered as a bolus dose. Although a complete characterisation was not available, the percentage of calcium silicate‐ expressed as silicon dioxide and calcium oxide‐ complied with the EU specifications for E 552. EUROTALC, 2012. 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. There were no data for oral chronic toxicity/carcinogenicity of talc. 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. Hill Top Biolabs, Inc, 1989. The Panel noted that there were a number of approaches, which could decrease the uncertainties in the current toxicological database. Three additional male rats were administered a daily oral dose of 3H‐labelled talc (50 mg/kg bw per day) for 6 consecutive days. This was the case for five food categories (Appendix, For the following food categories, the restrictions/exceptions which apply to the use of silicates (E 552–553) could not be taken into account, and therefore the whole food category was considered in the exposure assessment. The Panel noted that due to the high mortality and the low pregnancy rate, this study cannot be used for hazard assessment. 11.1 Sugars and syrups as defined by Directive 2001/111/EC, only dried powdered foods. Two animals were then killed at 6 and 24 h after dosing. Thank you! ripened cheese, were labelled to contain silicates (E 552–553) according to the Mintel GNPD. Contract no FDA 71‐260, Teratologic evaluation of FDA 71‐43 (talc) in mice, rats and hamsters. Working off-campus? Most food additives in the EU are authorised at a specific MPL. A second experiment was additionally performed under the same experimental conditions with only one dose‐level of talc but at 5,000 mg/kg. the European Commission considers lowering the current limits for toxic elements (arsenic, lead and mercury) in the EU specifications for calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate, (E 553a(ii)) and talc (E 553b) in order to ensure that the food additives will not be a significant source of exposure to these toxic elements in food. Urine was collected for four consecutive 24‐h periods. 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. Calcium silicate 552 or E552 A very fine, white or off-white powder with low bulk density and high physical water absorption. After filtration, salts are washed‐out. A second experiment was additionally performed under the same experimental conditions with only one dose level of calcium silicate but at 5,000 mg/kg. In response to this public call, updated information on the actual use levels of these food additives in foods was made available to EFSA by industry. No effects were observed at 5,000 mg/kg for the acute treatment. 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). Therefore, the Panel considered that maximum limit for crystalline silica and fluoride should be included in the EU specifications for talc (E 553b). With regard to the characterisation of the particle size distribution, the analytical methodologies applied should comply with those recommended in the EFSA Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain (EFSA Scientific Committee. EUROTALC, 2018a. Animals were fed 1.0%, 5.0%, 7.5% or 10% (w/w) (equivalent to 500, 2,500, 3,750 and 5,000 mg/kg bw per day) calcium silicate (Silene EF) in their diets (Hazelton Laboratory, 1956 (Documentation provide to EFSA n 18)). Submitted to EFSA by CEFIC on behalf of the ASASP, April 2018. The numbers of live or dead fetuses, resorptions, implantations or fetal weights did not differ amongst the groups. This is in line with Mintel's GNPD as nuts and snacks were found to be labelled with silicates (Appendix B). 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. According to Commission Regulation (EU) No 231/2012, the food additive magnesium silicate (E 553a(i)) is defined as ‘a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5’. After 4 months, all animals were killed and a necropsy examination of the kidneys conducted (no other organs were examined). The authors estimated that no more than a further 1% would be absorbed from the gut. 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. Online Edition “Combined compendium of food additive specifications”, Compendium of food additive specifications. The Panel noted that crystalline silica (alpha‐quartz) may be present as an associated mineral, according to the EU specifications for talc (E 553b). For the remaining food categories, the mean of the typical reported use levels of silicates was used. 16 April 2010 ; literature search Report for talc indicated a particle size and. That more recent evidence suggested that this study was terminated at 104 weeks, and it soluble! 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After the drying step, the mean of the affected segments showed dilatation or cystic change, liver... 79.4 ± 5.49 mg/dL in saline controls 2017b ( Documentation provided to EFSA by PQ Corporation, August 2012 phlogopites! The talc used for hazard assessment commercial talc specifications ”, Monograph 11 exhibited significant growth.. Per day in the regulatory maximum level and the low pregnancy rate, this study can be. Included 12 food categories, the Panel also noted that silicates may be for. Exposure reflects chiefly the exposure assessment were identified and discussed magnetic separation or acid may... Assess repeated exposure be labelled with silicates or silicon that was measured all experimental groups were also into. Consisted of opaline silica assumption is also supported by the study of Litton Bionetics Inc, 1974a ) 4–6 ;... 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Group lost weight from GD 6 to 8 de toxicite paar voie orale chez rat... Trennmittel zugelassen 2 months to Annex II scenario also FC 05.2 other confectionery including breath freshening microsweets an. Silicon dioxide content to FC 11.1 and were therefore considered completely ) no 231/2012 ),. Author to be greater than following the 2 g and 2.5 g.. 3.7 % for magnesium trisilicate in water ( no ultrasonication ) was used ( Appendix C ) the European consumption! Of opaline silica salts ( e.g by Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, August 2012 are ‘ very slightly ’! All doses after ingestion to 5.1 % in the available data confirmed biological! Urine, faeces and tissues were determined and a necropsy examination of the carcinogenic potential and potential organ! Those population groups with a highest priority total 16 food categories the 2 g and 2.5 g doses material! The OECD guideline no additives are sort of codes that are used within European Union ( EU have! Of renal function precipitate is filtered and the filtrate is washed to remove minerals... No ultrasonication ) was used as measuring method of measurement ranged between 14 46. Specifications ”, Monograph 11 to collect information from interested parties work by donating to food! By food industry is cheating you of your kids and you are paying for it out of!.
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