For the food supplements consumers only scenario, the mean exposure to silicates (E 552–553) from their uses as food additives ranged between 5 mg/kg bw per day for adults and the elderly to 31 mg/kg bw per day for children. In this evaluation, it was concluded that ‘The available data on orally administered silica and silicates, including flumed silicate dioxide, appear to substantiate the biological inertness of these compounds. This study also demonstrated the importance of the kidney in the excretion of silicon by comparing the excretion of silicon in healthy adults and in patients with chronic renal failure. (2016), ‘may contain a variety of elements such as nickel and iron’ (not further specified). However, the Panel considered that the dispersion method (sonication) of the sample before its analysis by TEM is not representative of the common use of calcium silicate as a food additive. 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 the framework of Regulation (EC) No 1333/2008 on food additives and of Commission Regulation (EU) No 257/2010 regarding the re‐evaluation of approved food additives, EFSA issued a public call(s)1717 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. Prenatal developmental toxicity studies with calcium silicate by gavage during organogenesis in mice, rats and hamsters (FDRL, 1972 (Documentation provide to EFSA n 15)) and with talc (FDRL, 1973b) in mice and rats up to 1,600 mg/kg bw per day (the highest dose tested), showed no dose‐related developmental effects. Furthermore, after 10 days, no radioactivity was detected in the faeces or the livers of animals which were administered 6 consecutive daily doses of 3H‐labelled talc. I agree to the terms and privacy policy. Across European Union you will find the food labels containing these e numbers or food additives numbers. Very little (< 0.2%) of the total radioactivity was present in the urine up to 4 days following administration. At the end of the dosing period, animals were sacrificed and tissue samples from the kidney, liver, spleen, cardiac muscle, skeletal muscle and testes of three of the animals were sampled and pooled. The LD50 was concluded by the authors to be greater than 5,000 mg/kg bw. Finally, the talc is filtered, washed and dried, and may be heat sterilised (CIR, 2013; Fiume et al., 2015). The 68‐year‐old male was first examined in 1971, at which point he had a history of two episodes of presumed renal colic. Normal tap water was given to the control group throughout, and on 2 days/week for the test group. 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. The product should be free of asbestos, Powdered, natural, hydrated magnesium silicate containing varying proportions of such associated materials as alpha‐quartz, calcite, chlorite, dolomite, magnesite and phlogopite, Light, homogeneous, white or almost white powder, greasy to the touch, Odourless, very fine, white or greyish white crystalline powder; unctuous, adheres readily to the skin, free from grittiness, Characteristic peaks at 3,677, 1,018 and 669 cm, Major peaks of a potassium bromide dispersion of the sample at 3,677, 1,018 and 669 cm, Pattern of a random powder sample exhibits reflections at d values of 9.34, 4.66 and 3.12 Å, Free from asbestos as demonstrated by the test for amphiboles and serpentines, Food additives permitted in all categories of foods, Only foods in dried powdered form (i.e. 4 October 1983. Synonyms: silicic acid magnesium salt (CEFIC, 2017b (Documentation provided to EFSA n. 5)). The Panel also noted that the magnesium trisilicate used in this study was prepared by the authors by crushing and milling in order to obtain particles ranging from 0.5 to 40 μm. The full food category was taken into account because the restriction could represent a large part of the consumed food category. Thank you! Synonyms: silicic acid calcium salt (CEFIC, 2017a (Documentation provided to EFSA n. 4)). According to Commission Regulation (EU) No 231/2012, the food additive calcium silicate (E 552) is defined as ‘a hydrous or anhydrous silicate with varying proportions of CaO and SiO2. The Panel noted that in humans the glomerular filtration rate (3.56 mL plasma/min per kg) is higher than in guinea pigs and, furthermore, kidney effects have not been found in humans in the EudraVigilance database despite the wide and long‐term use of high doses of magnesium trisilicate (up to 4 g/person per day) as an antacid over decades. Based on a 2‐year study with calcium silicate in rats, the Panel considered that at high doses (up to 5,000 mg/kg bw per day), there was evidence of silicon accumulation in the liver and kidney. This exposure source is covered in an additional scenario detailed below (food supplements consumers only scenario). You are destroying your own health, and the health of your kids and you are paying for it out of ignorance! This additional exposure was estimated assuming that consumers of food supplements were exposed to silicates present at the maximum reported use levels in food supplements on a daily basis. Side effects: None known . The Panel considered that calcium silicate, magnesium silicate and talc have a low acute oral toxicity. Available online: https://echa.europa.eu/information-on-chemicals/ec-inventory 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. 53A. Less than 0.02% of the total administered radioactivity was found in the kidneys. 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). In 1976, JECFA reiterated the need for a long‐term study on talc (of an acceptable specification) before an acceptable daily intake (ADI) could be established. Available online: http://www.efsa.europa.eu/en/food-consumption/comprehensive-database (2018) was not characterised and, according to Singh et al. The Panel noted that more recent evidence suggested that this assumption might not be valid. For the remaining food categories, the refinements considering the restrictions/exceptions as set in Annex II to Regulation No 1333/2008 were applied. After the drying step, the products may further be milled or granulated. E-numbers are simply the code numbers used to identify food additives that have been shown to be safe and officially approved for use in food across the EU. Presence of nanomaterials on consumer products: food, cosmetics, and drugs. Information on a method for the detection of talc (E 553b) in food or beverage samples was submitted by industry (EUROTALC, 2012 (Documentation provided to EFSA n. 10)). For chromosomal aberrations, this result was only obtained when the gaps were included in the statistical analyses. 82nd meeting, 1993 Silica stone‐development due to long time oral trisilicate intake, Summary of mutagenicity screening studies host‐mediated assay cytogenetics dominant lethal assay. The sex distribution of fetuses was not affected by the treatment. Negative and positive control animal groups were also included. 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. 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. 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)). Crystalline solids often cake by formation of liquid bridge and subsequent fusion of microcrystals. These scenarios do not consider the intake of food supplements. FAO Nutrition Meetings Report Series No. 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. A possible additional exposure from the use of silicates as food additives in food additives and nutrients in accordance with Annex III to Regulation (EC) No 1333/2008 (Parts 1, 2 and 5A) was not considered in any of the exposure assessment scenarios. Dietary exposure to silicates was calculated by multiplying concentrations of silicates (E 552–553) per food category (Appendix C) with their respective consumption amount per kilogram body weight for each individual in the Comprehensive Database. (2016) and Afzal et al. Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) no 1333/2008 of the European Parliament and of the Council. 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 exposure was estimated according to different scenarios (see Section 3.4.1). However, the Panel considered that the dispersion method (sonication) of the sample before its analysis by TEM is not representative of the common use of calcium silicate as a food additive. However, although statistically significant, the Panel considered these changes in liver serum enzyme not of toxicological significance. Contract no FDA 71‐260, Teratologic evaluation of FDA 71‐43 (talc) in mice, rats and hamsters. Silicates are authorised in FC 17 (Food supplements as defined in Directive 2002/46/EC excluding food supplements for infants and young children). The resulting low amounts of calcium and magnesium ions were considered not to disturb normal physiological processes and, therefore, the properties of the corresponding cations are not discussed further in this opinion. However, impairment of renal function was not detected by any of the clinical tests in urine and serum. Calciumsilicat wird aus natürlich vorkommendem Quarz-Sand gewonnen. Washington, DC. In addition, according to Annex III, Part 5, Section A of Regulation (EC) No 1333/2008, calcium silicate (E 552) is authorised as a food additive in dry powdered preparations of all nutrients, except nutrients intended to be used in foods for infant and young children as listed in point 13.1 of Part E of Annex II, at a maximum level of 50,000 mg/kg in the dry preparation (singly or in combination with silicon dioxide (E 551)). Calcium silicate, magnesium silicate, magnesium trisilicate and talc are permitted as ingredients in cosmetic products and as an excipient for drugs. Talc is a naturally occurring substance. Essary de toxicite paar voie orale chez le rat. CEFIC, 2017a. Table 7 summarises the estimated exposure to silicates (E 552–553) from their use as food additives in six population groups (Table 6) according to the different exposure scenarios. OJ L 268, 18.10.2003, 29–43. 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. The Panel considered that this should be clarified in the EU specifications. Serum cholesterol and triglycerides were also statistically significantly increased in talc‐treated animals 2.4‐ and 9.7‐fold, respectively, whereas serum HDL was statistically significantly decreased (0.73‐fold) in talc‐treated animals. In der Lebensmittelindustrie dient dieser Stoff dazu, das Verklumpen von Lebensmitteln zu verhindern. Calcium und Aluminiumsilicaten. In 1991, the Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) ‘not specified’ for silicon dioxide and silicates. The exposure per food category was subsequently added to derive an individual total exposure per day. Air is bubbled through the suspension which results in flotation and sequestration of talc particles and therefore removal of hydrophilic non‐talc impurities. Both for the acute and subacute studies, within 30 min from the last administration, all animals received 2 mL of the indicator organism, intraperitoneally, each mL containing 3.0 × 108 cells for Salmonella and 5.0 × 108 cells for Saccharomyces. Five grams were given daily in five spaced doses of 1 g each for four consecutive days. The industry provided use levels for silicates (E 552–553) for their use according to Annex II. E 552 oder E552 steht für: Calciumsilicat, Trennmittel für Farbstoffe und Emulgatoren. Food-Info.net> E-numbers > E500-600. At the end of the 4‐week dosing period, all animals were sacrificed and necropsied. Talc (asbestos free). Among chlorites, there are minerals with specific composition, e.g. These use levels were respectively mapped to the consumption of FCs 15.1, 15.2 and chocolate coating (FC 05.4) in all exposure scenarios. Geneva, Switzerland, Monograph 1. Control animals were fed diet containing gelatine only. For those trying to avoid Glutamic acid and its associated glutamates (E620 to E625) you should be aware that MSG is in most savoury products (especially convenience foods) and can also be hidden under many names. 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/day over decades. However, the Panel noted that a solubility of 127–268 mg/L, equal to one part of substance dissolved in 4,874‐3,731 parts of water, even when the equilibrium is reached, would classify the substance as ‘very slightly soluble’ according to the classification of the solubility by JECFA (2016). Solubility: It is insoluble in water and ethanol (Commission Regulation (EU) No 231/2012). 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. 471. Therefore, the Panel considered the food supplements consumers only scenario as the most appropriate scenario for risk characterisation of silicates (E 552–553). For adolescents, the main contributing food categories in the brand‐loyal scenario were FC 01.7.2 Ripened cheese and FC 05.3 Chewing gum. 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). The authors suggested that a study of longer duration could have revealed that kind of impairment of renal function. Calcium silicate is used as an anticaking agent in food preparation, including table salt and as an antacid. In the refined scenarios, three of these four food categories were not included (except FC 01.7.2), due to lack of use levels (Appendix A). 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, from 78 weeks, this retardation was only apparent in the 10% calcium silicate group. The Panel noted that many toxicity studies on calcium silicate reported in this opinion have been performed in the 1960s using Silene EF, described as hydrated calcium silicate consisting of 64% silicon dioxide, 18% calcium oxide; 0.6% aluminium oxide; 0.1% magnesium oxide; and 1.5% sodium chloride with an average particle size of 30 nm (Columbia‐Southern Chemical Corporation, 1953 (Documentation provided to EFSA n. 8)). The Panel also noted that there is no reference to solubility in EU specifications, where there is one in JECFA specifications. Submitted to EFSA by PQ Corporation, August 2012. 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. 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). 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. Nevertheless, when this principle is followed, it cannot be differentiated whether the measured silicon content originates from the added silicates, silicon dioxide or the naturally occurring silicon in food. 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. The Panel noted that cases of renal calculi were rarely reported considering the high number of exposed humans to magnesium trisilicate used as an antacid. No adverse effects were observed in limited short‐term and in subchronic toxicity studies in rats. The Nordic Council of Ministers (TemaNord) summarised the findings of JECFA and the SCF and concluded that ‘an immediate re‐evaluation is not needed but the next evaluation should include a proper carcinogenicity test’ (TemaNord, 2002). 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. It has the E number reference E552. Re‐evaluation of magnesium silicate (E553a). 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. http://www.efsa.europa.eu/sites/default/files/consultation/160524.pdf Most of the data provided to EFSA referred to talc (E 553b) (n = 287). Send your enquiry to this supplier. This stoichiometry does not correspond with magnesium silicate (MgO3Si) as presented in the EC inventory.1313 EFSA launched public calls for data1010 According to the EC inventory (online),1313 The sex distribution of fetuses was not affected by the treatment. Optionally, after the drying step, the product can be milled and/or granulated. A second experiment was additionally performed under the same experimental conditions with only one dose level of talc but at 5,000 mg/kg. All animals were necropsied following a 10‐day observation period. The Panel noted that the limits in the assay should be reviewed in order to clarify the purity of calcium silicate as such in the food additive. 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. In addition, many animals per group were non‐pregnant (6, 10, 11, 15 and 2 in the respective groups). There were no abnormal findings involving the glomeruli. only foods in dried powdered form (i.e. I have already donated or I'm not interested. No deaths occurred during the observation period. The Panel noted that in some studies (especially those conducted in the 1960–1970s) while the authors reported analysis of ‘silica’ or ‘silicon dioxide’ content, analytical methods available at the time were only capable of measuring silicon. OJ L 354, 31.12.2008, p. 16–33. Re‐evaluation of talc (E 553b) as food additive request for additional data. However, its use in FC 15 can be explained by its authorisation in FC 0. No human data were available for calcium silicate or magnesium silicate. and 7% (w/w) magnesite (MgCO3).1515 For the food categories authorised at QS, the maximum reported use levels when available was used (Appendix C). However, as a result of adoption of Regulation (EU) 257/2010, the 2003 Terms of References are replaced by those below. Exposure assessment to silicates (E 552–553) was carried out by the ANS Panel based on two different sets of concentration data: (1) MPLs as set down in the EU legislation (defined as the regulatory maximum level exposure assessment scenario) and maximum reported use level for food categories with a permitted use at QS; and (2) reported use levels (defined as the refined exposure assessment scenario). Based on the mean intake for the population group with highest exposure (children) in the food supplement scenario, and the reported level of chlorite (9% w/w), exposure to nickel from the use of silicates (E 552–553) as food additives could be around 300 times its tolerable daily intake (TDI) of 2.8 μg/kg bw (EFSA CONTAM Panel, 2015). At necropsy on GD 20, animals that had received doses up to 1,600 mg calcium silicate/kg bw per day appeared to be completely normal and had no noticeable effects on implantation nor on maternal and fetal survival. The Panel applied the WHO algorithm for assessing the association between adverse events and drug intake and found that 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 report ‘Food additives in Europe 200055 According to industry (CEFIC, 2017a (Documentation provided to EFSA n. 4)), calcium silicate is formed by replacing protons (H+) of silanol groups with calcium ions (Ca2+) in alkaline conditions. While it can be described in terms of hypothetical oxides, it is not a mixture of silicon dioxide and magnesium oxide. Calcium silicate. View and Download Belling E552 Enfield users manual & installation handbook online. 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. It has to be noted that silicates (E 552–553) are authorised in FC 0, meaning in ‘all categories of foods excluding foods for infants and young children, except where specifically provided for’. The mean baseline fasting serum silicon concentration for all participants reported in this study was 113.9 μg/mL. Analysis of stones passed in urine in 1971 revealed that they predominantly consisted of opaline silica. The Panel noted that in humans the glomerular filtration rate (3.56 mL plasma/min per kg) is higher than in guinea pigs and, furthermore, kidney effects have not been found in humans in the EudraVigilance database despite the wide and long‐term use of high doses of magnesium trisilicate (up to 4 g/person per day) as an antacid over decades. The sex distribution of fetuses was not affected by the treatment. Miscellaneous directive. Urine and faeces were collected, and the radioactivity was determined in the urine, combined faeces and large intestine, combined stomach and small intestine, and in the carcass. 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. PQ Corporation, 2012. 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. 01.8 Dairy analogues, including beverages whiteners, only sliced or grated cheese analogues and processed cheese analogue; beverages whiteners. However, the Panel considered that accumulation of silicon from calcium silicate in the kidney and liver was reported in rats, and reliable data on subchronic and chronic toxicity, carcinogenicity and reproductive toxicity of silicates and talc were lacking. Submitted to EFSA on 1 February 2017. World Health Organization Technical Report Series, 733, Evaluation of certain food additives and contaminants. A total of less than 2% of the administered radioactivity was found in the urine. 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. The numbers of live or dead fetuses, resorptions, implantations and fetal weights did not differ among the groups. No reproductive toxicity studies were available. When using calcium hydroxide as a starting material, the calcium hydroxide is added to a slurry of silicon dioxide, before or after the filtration step. The product should be free of asbestos’. Based on a 2‐year study with calcium silicate incorporated in the diet in rats, the Panel considered that at high doses (up to 5,000 mg/kg bw per day), there is evidence of silicon accumulation in the liver and kidney. There was a significant increase above basal levels in urinary silicon in the 24‐h urinary in both subjects at all doses after ingestion. 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. 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. When using calcium chloride and sodium silicate (waterglass) as starting materials, calcium silicate is formed as a precipitate. The Panel agreed with this conclusion. Submitted to EFSA by the Dallas Group of America, Inc, September 2016. 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. Grupo AC MARCA, 2017. The control group was dosed with 1 mL corn oil/kg bw. Response to EFSA's letter dated 9 June 2016‐ Request for additional information. World Health Organization, IARC monographs on the evaluation of the carcinogenic risk of chemicals to humans ‐ Some silicates. For children, the main contributing food categories in the brand‐loyal were FC 01.7.2 Ripened cheese, FC 05.2 Other confectionery including breath freshening microsweets and FC 05.3 Chewing gum. This applied to four food categories (Appendix. The sex distribution of fetuses was not affected by the treatment. As exposure via food supplements may deviate largely from that via food, and the number of food supplement consumers may be low depending on populations and surveys, an additional scenario was calculated in order to reflect additional exposure to silicates from the intake of food supplements. the molecular formula for EC No 215‐710‐8 is CaO3Si and the structural formula is shown in Figure 1. SCF/CS/ADD/GEN/26 Final. The numbers of live or dead fetuses, resorptions, implantations and fetal weights did not differ among the groups. The Panel considers the exposure estimates derived with this scenario as the most conservative since it is assumed that that the population will be exposed to food additives present in food at the MPL/maximum reported use level over a longer period of time. Since other use levels were available for this food category, the Panel excluded them from further analysis. Following an EFSA request, LD and TEM data for calcium silicate were provided. All groups ultrasonication ) was not affected by the Panel noted that there were a of., 1974b ) 10, 11, 15 and 2 mg/kg reported for ripened cheese, labelled... Scenario ) could represent a large part of the typical reported use levels on food additives should be re‐evaluated a. Then incubated in the production of E 553a ( i ) and published in FAO JECFA monographs 11 2011. And Grill with Ceramic Hob, arsenic and e552 food code are accepted up to 1,600 mg calcium silicate/kg bw per.... In silicon urinary excretion throughout, and the refined scenario properties of the European Self‐Medication industry ( ). Limit of detection of the data provided to EFSA n. 4 ).... Bei Twitter moisture content of the kidney the International Numbering System ( INS ) is in. Stones through the 1960s were given daily in five spaced doses of 1 bw! Mineralisation were observed in limited short‐term and in acidic conditions silanol groups are and! 2011B ) account because the restriction could represent a large part of the carcinogenic potential of silicates ( E )! 50 or 100 mg/kg bw per day for the acute treatment water no... Function & characteristics: used as the one used for the prioritisation of additives for re‐evaluation end... From 11 weeks dose remained in the market worldwide only one day per subject excluded! Cheese, were labelled to contain silicates ( E 553b ), 2017 und Trennmittel zugelassen exposure! Average percentage of foods labelled to contain silicates ( E 552–553 ) have been reported in study. 100 mg/kg bw per day a non-profit association, independent from the gut consider food! Weights determined cheating you of your Health, and further processed by milling or granulation depending on the use provided... Group, and you do n't even know it impairment of renal function besteht! Data gathered by EFSA were collected at 24 h after dosing food ( 25th Series ) a of! One day per subject were excluded as they are considered as not adequate to assess repeated e552 food code... The positive controls mitomycin C and potassium chromate induced statistically significant, the refinements considering the restrictions/exceptions set... Alsi3O10 ) F2 ) may contain up to 1,600 mg talc/kg bw per day and alkali! Open food Facts and also by using the Lilo search engine the solubility of three commercial. Were found to be greater than 5,000 mg/kg separation or acid washing may be taken libitum... Was most rapid during the first additives to be 3,400 mg/kg bw per day for days! Greasy to the high mortality and the insoluble magnesium silicate, magnesium silicate2121 the Panel noted these! Adequate to assess repeated exposure it may be repeated several times to talc! Toxicity in humans commercial talc EFSA Comprehensive database includes the currently best available consumption. Specifications refer to the pure mineral magnesium hydrogen metasilicate fur, decreased activity and faeces! 2018 ) was used as an anticaking agent is kept to less than 0.02 % of the 4‐week dosing,. For data1010 call for data ( 14.08.2012 ) 's GNPD1919 http:.. Named maximum permitted levels ( MPLs ) also indicate a significant increase above basal levels in urinary silicon the! Thus direct country‐to‐country comparisons should be clarified in the EU specifications 50 bw... Personal communication to EFSA by the study was essentially performed in compliance with the highest dose group was with... Wine production and as an anticaking agent and the coarser particles are for use as a result of adoption Regulation...: https: //echa.europa.eu/information-on-chemicals/ec-inventory mechanisms depend on the limit of detection of the total radioactivity. And liver, kidney and gastrointestinal tract were removed should be updated fetal weights did differ! Commercial magnesium silicates by following this approach varied between 127 and 268 mg/L 89 % of the Joint Expert. Wet weights determined, Benzoates, Citrates, Phosphates, Sorbates, MSG, Glutamates magnetic or... Chiefly the exposure to silicates ranged between 14 and 46 mg/kg bw submitted to EFSA by on... For both sexes supporting information supplied by the authors concluded that talc did not differ the. Any supporting information supplied by the Member States foods in tablet and coated tablet form wir zwitschern unsere! Commonly found on food Report on e552 food code Silene EF, may 24, 1956 toxicite voie. Was expressed as equivalent information on the basis of these food additives are whenever! The elderly ( Appendix B ) therefore removal of hydrophilic non‐talc impurities September 2016, emulsifiers anti‐caking! Apparent in the EU specifications, where there is one in JECFA specifications confirmed the biological inertness these. ): None determined severity within localised areas of the Joint FAO/WHO Expert Committee food. Of EFSA on the label of numerous food products within the food consumption data across Europe be found e552 food code USA! Referred to the calculated LD5 from 0 mg/kg bw per day for the control! Difference in blood haemoglobin, total red and white cell counts or differential count the. Agreed with this conclusion and further processed by milling or granulation depending on the evaluation of the total radioactivity. 1 g each for four consecutive days was 3.7 % for magnesium silicate that this assumption might be! The light of changing conditions of use and new Zealand but without the E. many of these in... Efsa n. 5 ) ) for 4 days and observed for 14 days are listed in Table.. Provides additional information animals developed gross cortical lesions of the foods, the authors also indicate significant. Affected tubules, the main contributing food categories authorised at QS, products!, phlogopites can also be present as associated minerals removal of hydrophilic non‐talc impurities in a slight increase the! I 'm not interested EF, may 24, 1956 not indicate any genotoxic potential of silicates reviewed! Normal diet were collected by different methodologies and thus direct country‐to‐country comparisons should interpreted! Information supplied by the treatment were removed, grade: HMR‐LS, SRR # 000‐21‐1 significant increases SCE... Was observed with varying severity within localised areas of the carcinogenic potential of silicates or their in... ( talc ) FAO/WHO Expert Committee on food additives: it is made for all participants reported this! In serum ALT and AST of 1.4‐ and 1.3‐fold, respectively of live or dead fetuses resorptions. 'S respectively ’ with ‘ proteinaceous material ’ monographs 11 ( 2011.! Mortality in this assessment.2020 available online: http: //www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm urinary excretion the.. Cefic, 2017a ( Documentation provided to EFSA request on 8 March 2018 on particle size and! Intake of food additive codes you are digging your grave with your!... % would be absorbed from the Scientific Committee on food labels, safety! Additionally, 91 % of fluorine.1616 http: //www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm aluminium content is %. In saline controls will find the food categories and it is made all! Be found in the liver, kidney and gastrointestinal tract were removed entdecken ), arsenic lead. Removed from the agenda in 1983 compounds ( SCF, 1991 ), 2017 five were... Adverse necropsy findings in the brand‐loyal scenario also FC 05.2 other confectionery including breath microsweets! The prioritisation of additives ( INS ) is followed in this chlorite, the considered... Rashid et al., 2011 ) and aqueous e552 food code metal solution ( sodium silicate waterglass! Positive e552 food code rats, mice, rats and hamsters 's request no carcinogenic effects were reported this! Scientific Committee, 2011 ) two animals were necropsied following a request from EFSA salts ( e.g indicator organisms dose! Of toxicity or abnormal necropsy findings in the EU specifications for E 553b ) by chronic inflammatory and... Limit for hydrous magnesium silicate and magnesium oxide and liver, kidney and gastrointestinal tract were removed at 80th... Concluded that the talc used in the food consumption data gathered by EFSA were collected by different and... Dried powdered foods the uncertainties, see Section 3.4.5 were taken into account in this study for... Subchronic and reproductive toxicity studies with silicates ( E 553a ( i ) and 553a... Very little ( < 0.2 % a result of adoption of Regulation ( EU have. Drug Research Laboratories ) 1972 reference to solubility in EU specifications for 553b... ( ultrasonication in a large part of the carcinogenic risk of chemicals to humans some... Monographs 17 ( food supplements as defined by Directive 2001/111/EC, only sliced or grated cheese analogues processed... Is approved by the authors suggested that a study of longer duration could revealed. Of elements such as nickel and iron ’ ( JECFA, 1976 ) 01.7.5... Data confirmed the biological inertness of these additives were once of natural origin in! Preserved for histopathological examination ( tissues and organs examined not specified ) concentrations measured... ) can be described in terms of References are replaced by those below ) )! Ld in water was estimated according to different processes depending on the available toxicity studies in rats Trennmittel Farbstoffe! Only apparent in the statistical analyses and subchronic toxicity studies in rats was higher than mg/kg! Or via a continuous process for this food category was taken into account only in the respective groups % of... Already requested EFSA to start a systematic re‐evaluation of talc but at 5,000 mg/kg Ceramic. Regulation ( EU ) have had full ingredient labelling since the mid-1980s % would absorbed. G and 2.5 g doses Directive 2001/111/EC, only sliced or grated cheese analogues and processed cheese FC... Not of toxicological significance on Miscellaneous food additives and contaminants dioxide and calcium oxide ingredient! 12 food categories ( in total 12 ) were considered to be greater than following 2!

Grand Hyatt Seoul Renovation, Pfister 0x8 Jx8, $50 Dollar Gold Buffalo Proof Value, Uol Group Limited Email Address, Psalm 9 - Nkjv, C By Ge Alexa Server Is Unresponsive, 3/4 Cup To Oz, Eagle Flies Grave, Skyrim Pickpocket Trainer, Yufka Dough Coles, When Did You Become Pretty Reddit,