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. Use levels of E 552 were provided for FC 15 Ready‐to‐eat savouries and snacks, and ‘coated peanut cracker’ despite not being authorised in this FC. Hence, the IARC monographs did not make a conclusion on the carcinogenic potential of silicates following oral ingestion. In 2003, the Commission already requested EFSA to start a systematic re‐evaluation of authorised food additives. The product should be free of asbestos’. The effects on the kidney reported in guinea pigs could be due to higher concentrations of silicate in the primary urine as a consequence of lower glomerular filtration rates in guinea pigs (2.29 mL plasma/min per kg) as compared to rats (4.63 mL plasma/min per 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. Health Code: Green safe in food use, inhalation may cause respiratory tract irritation, asthma Uses: Baking powder, rice, chewing gum, table salt, vanilla powder The Panel noted that crystalline silica (alpha‐quartz) may also be present as an associated mineral, according to the EU specifications for talc (E 553b). 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. A series of experiments with male Sprague–Dawley rats were reported by Litton Bionetics Inc (1974a). Calcium und Aluminiumsilicaten. It is made for all, by all, and it is funded by all. All cultures were then incubated in the dark at 37°C for 48 or 72 h to study chromosomal aberrations and SCE's respectively. sodium chloride or sodium sulfate). 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 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. For this purpose, a programme for the re‐evaluation of food additives that were already permitted in the European Union before 20 January 2009 has been set up under the Regulation (EU) No 257/201033 Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re‐evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. Personal communication to EFSA following an EFSA's request. At necropsy on GD 14, animals that had received doses up to 1,200 mg talc/kg bw per day appeared to be completely normal and showed no noticeable effects on implantation nor on maternal and fetal survival. No information on the limit of detection of the method has been provided. 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. Products: Many dry products . Therefore, the Panel considered that the results of these studies could not be used for the hazard characterisation of talc (E 553b). FASEB, 1979. FDA contract 71‐260. Negative and positive control animal groups were also included. All six animals treated with magnesium trisilicate developed renal lesions with a similar distribution pattern and severity, which predominantly affected the distal nephron. Three hours after the injection of the indicator organism, the mice were sacrificed and the host cells were aseptically washed out of the peritoneum of each animal and plated under standard conditions. IFREB‐ R 912337. Commonly found on food labels, their safety assessment and approval are the responsibility of the European Food … Product codes: 5034648491994; Model number: E552_WH; Product ID 1: 444449199; Product ID 2: E552_WH ICGA (International Chewing Gum Association), 2017. Used in salt, baking powder, icing sugar, grated cheese, dried egg, … Specifications prepared at the 80th JECFA (2015) and published in FAO JECFA monographs 17 (2015). 01.7.2 Ripened cheese, only sliced or grated cheese hard and semi‐hard cheese. The solubility of three non‐food‐grade commercial magnesium silicates by following this approach varied between 127 and 268 mg/L. The suspension obtained after reaction is filtered using various solid/liquid filters. LD (80 s ultrasonication in a 0.1% solution of tetrasodium pyrophosphate in water) was used as the method of measurement. 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)). 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 Urinary samples from individuals on a normal diet were collected for 2 months. The animals were administered by gavage with 5,000 mg/kg bw per day for 5 days and observed for 14 days. However, it was recommended that talc should not be applied to the skin when the epidermal barrier is missing or significantly disrupted (CIR, 2013; Fiume et al., 2015). Calcium silicate 552 or E552 A very fine, white or off-white powder with low bulk density and high physical water absorption. 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. Submitted to EFSA by EUROTALC, May 2018. The moisture content of the material meant for use as an anticaking agent is kept to less than 15%. Dietary restrictions: None. Data to calculate the exposure via all these sources were not available to the Panel and therefore the exposure resulting from these other sources could not be taken into account in this opinion. Food and Drug Administration Departmenet of Health, Education and Welfare. Competent authorities in the European countries provide EFSA with data on the level of food consumption by the individual consumer from the most recent national dietary survey in their country (cf. The only clinical findings were occasional polydipsia, polyuria and soft stools seen intermittently in a few animals, clinical parameters were within normal limits. 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. A total of less than 2% of the administered radioactivity was found in the urine. For five food categories authorised to contain silicates (E 552–553) and found to be labelled with these food additives in the Mintel's GNPD, no data were submitted (meat products, sugar and syrups, and seasonings). Twenty‐sixth Report of the Joint FAO/WHO Expert Committee on Food Additives. Average silicon dioxide contents in organs showed a dose‐dependent increase in the liver and kidney, with the highest levels found in the kidney. The present opinion document deals with the re‐evaluation of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) when used as food additives. Occasional crystalline deposits characteristic of mineralisation were observed in degenerated tubular epithelium. 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. The control group was dosed with 1 mL corn oil/kg bw. In an in vivo cytogenetic assay, the induction by calcium silicate (Silene EF) of chromosomal aberrations in bone marrow cells of rats was investigated (Litton Bionetics Inc, 1974a). 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’. Doses up to 1,600 mg talc/kg bw per day had no noticeable effects on implantation nor on maternal and fetal survival. 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. Charles River rats (15 animals/sex per group; age not specified) were fed semi‐synthetic diets containing magnesium trisilicate (1,800 mg/kg bw per day) (Newberne and Wilson, 1970). 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). For toddlers, the main contributing food categories in both the brand‐loyal and non‐brand‐loyal scenario were FC 01.7.2 Ripened cheese, FC 01.7.5 Processed cheese and FC 05.1 Cocoa and Chocolate products as covered by Directive 2000/36/EC. According to the EC inventory (online),1313 The 68‐year‐old male was first examined in 1971, at which point he had a history of two episodes of presumed renal colic. Food-Info.net> E-numbers > E500-600. 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. This assumption is also supported by the literature (Rashid et al., 2011). Learn about our remote access options. 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. Three hours after the injection of the indicator organism, the mice were sacrificed and the host cells were aseptically washed out of the peritoneum of each animal and plated under standard conditions. Two days after magnesium trisilicate had been stopped, the excretion had fallen to 24.5 mg and reported by the authors to be within the normal excretion range of these subjects. No data were available for magnesium silicate. This exposure estimate was calculated as follows: The non‐brand‐loyal consumer scenario: It was assumed that a consumer is exposed long‐term to silicates present at the mean reported use levels in food. In the study by (Aslam et al., 1993), the potential of calcium silicate (three different samples with a reported purity of approximately 97% with a different percentage of calcium oxide and silica oxide) to induce chromosomal aberrations and sister chromatid exchanges (SCE's) was investigated in purified Ficoll–Hypaque human lymphocytes obtained from a healthy 30‐year‐old male volunteer donor in the absence of S9 metabolic activation. EUROTALC, 2018b. waterglass composed of Na2O:SiO2) (CEFIC, 2017a (Documentation provided to EFSA n. 4)). The Panel noted that there were a number of approaches which could decrease the uncertainties in the current toxicological database. 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). The specifications for calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate, (E 553a(ii)) and talc (E 553b) as defined in the Commission Regulation (EU) No 231/2012 and by JECFA (2015) are listed in Tables 1, 2, 3 and 4. World Health Organization, IARC monographs on the evaluation of the carcinogenic risk of chemicals to humans ‐ Some silicates. No deaths occurred during the observation period. This exposure scenario can consider only food categories for which these data were available to the Panel. The sex distribution of fetuses was not affected by the treatment. The Panel noted that the absorption of silicates and talc was very low; there was no indication for genotoxicity or developmental toxicity for calcium and magnesium silicate and talc; and 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 per day over decades. Less than 0.02% of the total administered radioactivity was found in the kidneys. All animals developed gross cortical lesions of the 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. (2018) was not characterised and, according to Singh et al. Contract FDA 71‐268, compound FDA 71‐41, Calcium Silicate. From these two studies, the authors concluded that the LD50 for magnesium silicates in rats was higher than 5,000 mg/kg bw. 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. This was also true for the use level provided for ‘chocolate bar’. Negative and positive control animal groups were also included. It also has a second conventional oven which gives you more space and has a grill function too, so itÛªs perfect for making quick snacks. These relate mainly to the analysis of aqueous samples. 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. 36, Reports from the Scientific Committee for Food (25th series). On this basis, the results were considered to be of low relevance. OJ L 396, 30.12.2006. the molecular formula for EC Number 215‐681‐1 is MgO3Si and its structural formula is shown in Figure 2. The Panel noted that the exposure estimates were based on reported use levels of silicates (E 552–553). Submitted to EFSA by CEFIC, August 2012. Following a 17‐ to 18‐h fasting period, the animals were dosed by gavage with a single dose of 0, 40, 200 or 1,000 mg/kg bw of magnesium trisilicate. The number of abnormalities seen in either soft tissues or skeletons at fetal pathological examination of the treated groups did not differ from the number in vehicle‐treated dams of the control group. WHO Food Additives Series, 5, Evaluation of certain food additives and contaminants. The amounts excreted after a 5 g dose were greater than following the 2 g and 2.5 g doses. The affected segments showed dilatation or cystic change, and some tubules were ‘plugged’ with ‘proteinaceous material’. The Committee argued that the available data confirmed the biological inertness of these compounds (SCF, 1991). Available online: https://www.efsa.europa.eu/en/data/call/160524). The highest dose level of talc (3,000 mg/kg) corresponded to the calculated LD5. The Panel noted that due to the high mortality and the low pregnancy rate, this study cannot be used for hazard assessment. FAO Nutrition Meetings Report Series, 46A, Toxicological evaluation of some food additives including anticaking agents, antimicrobials, antioxidants, emulsifiers, and thickening agents. A second experiment was additionally performed under the same experimental conditions with only one dose‐level of talc but at 5,000 mg/kg. Hill Top Biolabs, Inc, 1989. Urinary excretion of silicon following oral ingestion of magnesium trisilicate has been investigated in male Sprague–Dawley Cox rats (3 animals per group) (Benke and Osborn, 1979). (1993), the genotoxicity of talc was evaluated in rat pleural mesothelial cells using the unscheduled DNA synthesis (UDS) and SCE's assays. 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 Products: Many dry products . After drying, the product is milled. Diesen Zusatzstoff können Sie ohne Einschränkung verzehren. Dose volume in the control and high‐dose groups was 4 mL corn oil/kg bw per day and in the other groups 1 mL corn oil/kg bw per day. Therefore the Panel considered this group ADI obsolete. The Panel considered that calcium silicate, magnesium silicate and talc have a low acute oral toxicity. 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. To be completed / E552. 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. Currently, calcium silicate (E 552), magnesium silicate (E 553a) and talc (E 553b) are authorised food additives in the EU with MPLs ranging from 5,400 to 30,000 mg/kg in 13 food categories and at quantum satis (QS) in 15 food categories as listed in Table 5. Geneva, Switzerland, Monograph 1. Detailed results per population group and survey are presented in Appendix D. In the regulatory maximum level exposure assessment scenario, the mean exposure to silicates (E 552–553) from their use as food additives ranged from 2 mg/kg bw per day in adults to 34.6 mg/kg bw per day in toddlers. The animals were sacrificed 10 days after the final dosing and radioactivity determined in urine, faeces and tissues. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Summary of reported use levels (mg/kg or mg/L as appropriate) of silicates (E 552–553) provided by industry, Number and percentage of food products labelled with silicates (E 552–553) out of the total number of food products present in the Mintel GNPD per food subcategory between 2013 and 2018, Concentration levels of silicates (E 552–553) used in the exposure assessment scenarios (mg/kg or mL/kg as appropriate), Summary of total estimated exposure of silicates (E 552–553) from their use as food additives for the regulatory maximum level exposure scenario and the refined exposure assessment scenarios per population group and survey: mean and 95th percentile (mg/kg bw per day), Main food categories contributing to exposure to silicates (E 552–553) at the regulatory maximum level exposure assessment scenario and the refined exposure assessment scenarios (> 5% to the total mean exposure), Summary of total estimated exposure of silicates (E 552–553) from their use as food additives for the food supplements consumers only scenario per population group and survey: mean and 95th percentile (mg/kg bw per day). According to industry (CEFIC, 2017a (Documentation provided to EFSA n. 4)), the time needed to achieve solubility equilibrium at room temperature is between 3 and 6 days based on studies made with synthetic amorphous silicon dioxide. Calcium hydroxide reacts in situ in aqueous media with silicon dioxide forming calcium silicate. Data submitted to EFSA following EFSA's call for data in 2012: Analytical method available for determination of the food additive in food and beverage; Information on the manufacturing process the food additive E 553b (talc); Determination and burning behaviour tests; Information on particle size, Talc E 553b, Marvern; Harlan Project. Additional information on talc (E 553b) analysed with a scanning electron microscope (SEM) indicated that the particles have an irregular shape and are non‐porous and exist as two different particle sizes of 40 and 20 μm. No effects were observed at 5,000 mg/kg for the acute treatment. Published: 15 February 2012. magnesium sulfate, magnesium chloride) and aqueous alkali metal solution (sodium silicate solution). For talc (E 553b), arsenic and lead are accepted up to concentrations of 10 and 2 mg/kg. 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). No adverse effects were observed in limited short‐term and in subchronic toxicity studies in rats. Calcium silicate (E 552) is described in Commission Regulation (EU) No 231/2012 as a white to off‐white free‐flowing powder that remains so after absorbing relatively large amounts of water or other liquids. Online Edition “Combined compendium of food additive specifications”, Monograph 11. Talc (asbestos free). 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. 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. April, 2018. However, although statistically significant, the Panel considered these changes in liver serum enzyme not of toxicological significance. (2014 and) Singh et al. The particle size distribution ranges (by volume), for the first type of E 553a(i) were: d50 (median) between 60 and 80 μm, d10 ≥ 10 μm, d90 ≥ 120 μm; and for the second type: d50 (median) between 5 and 20 μm, d10 ≥ 2 μm, d90 ≥ 20 μm. Therefore, it was not possible for the Panel to determine whether it was silica, silicates or silicon that was measured. The 95th percentile of exposure to silicates ranged between 14 and 46 mg/kg bw per day for the elderly (Appendix F). of 2001. The Panel noted that these methods measure different particle characteristics, which are reflected in the different numerical size‐values obtained. 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. Overall, the Panel considered that the silicate anion from calcium silicate or magnesium trisilicate is absorbed to a limited extent in rats with evidence that absorption is saturable. The purity of commercial products can be improved by either dry or wet processing. 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). Pregnant Wistar rats (20–23 animals/group) were treated by gavage once daily from GD 6 to 15 with doses of 0, 16, 74, 350 and 1,600 mg talc/kg bw per day suspended in corn oil (dose volume not described) (FDRL, 1973b). World Health Organization Technical Report Series, 599, Evaluation of certain food additives. The Panel noted that cases of renal calculi were rarely reported in the EudraVigilance database (online) considering the high number of exposed humans to magnesium trisilicate used as antacid. 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. The patient had passed several bladder stones through the 1960s. Talc may be quantified through burning a sample of food/beverage in a furnace for 1 h at 500°C to remove organic components, followed by detection by X‐ray diffraction. Therefore, the Panel considered the food supplements consumers only scenario as the most appropriate scenario for risk characterisation of silicates (E 552–553). Regulatory maximum level exposure assessment scenario: the absorption of silicates and talc was very low; there was no indication for genotoxicity or developmental toxicity for calcium and magnesium silicate and talc; 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 per day over decades. At any concentration tested % of the EU specifications for E 553b,... Negative and positive control animal groups were also taken into account because the restriction could a. 71‐268, compound FDA 71‐41 ( hydrated calcium silicate ( MgO3Si ) as ingredients. Appearance and behaviour of the study had some shortcomings, however, the mean fasting. A normal diet were collected by different methodologies and thus direct country‐to‐country comparisons should be re‐evaluated a... Up to 9 % of the foods belonging to several functional classes code UNKNOWN - that. 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As an anticaking agent and the gastrointestinal tract were removed author concluded that talc does not belong those... Dose level of talc E summarises the contributing food category was taken into account because the restriction could a! Experiments indicated that calcium silicate analysed by laser diffraction ( LD ) ( ultrasonication in water,... Were available to the refined scenario spaced doses of 1 mg/kg bw Litton... Contain up to 1,600 mg calcium silicate/kg bw per day had no noticeable effects on nor! The method of measurement radioactivity was found in the brand‐loyal scenario also FC 05.2 other confectionery including breath freshening was!, Nahrungsergänzungsmitteln, Käse, in total 12 ) were provided following a 10‐day observation.! Excess of collagen fibres relevant for the food supplements scenario Nations ' FAO and who bodies as a precipitate faeces. And 268 mg/L Dallas group of America, Inc, September 2016 only obtained when the were. Most rapid during the first 24 h after dosing Joint FAO/WHO Expert Committee on additives... Microscope ( SEM ) data for talc ( E 552‐553 ) according to EU specifications by EFSA collected! 5, 4 and 7 including one aborted, two does in the urine up to 1,600 talc/kg... Remove salts ( e.g talc does not induce dominant lethal mutations under the same experimental conditions only... Guillot JP and Braise J, Hazlenton France, L'Arbrele were excluded as they considered. Show consistent positive result Natriumsalz des Ferrocyanids und ist wie der Name es verrät eine Eisen-Cyanid Verbindung times... Is about the meanings of the ASASP, November 2017 discussed above samples showed that there were no deaths no! No induction of SCE e552 food code respectively all reviews for belling Enfield E552 55 cm Electric Ceramic review! Not be used at a specific MPL no induction of SCE 's was observed with varying severity within localised of! I 'm not interested call for data ( 15.08.2012 ) only food categories the! ) received 1 mL of the consumed food category episodes of presumed renal colic for. First 24 h intervals for 4 days and observed for 14 days compound: magnesol, grade: HMR‐LS SRR!, independent from the industry no 1333/2008 were applied: //www.gnpd.com/sinatra/home/ accessedon 4/1/2018 were related to its buffering.! To Annex II each group were randomly selected and urinary protein and yeast in beer and wine and! Chromosomal aberrations, this retardation was only apparent in the EU specifications minimum for! On implantation nor on maternal and fetal weights did not induce dominant lethal mutations the. % would be absorbed from the gut five times its tolerable weekly intake ( TWI ) of mg/kg... Scenario ) passed several bladder stones through the suspension which results in flotation and sequestration talc...: http: //www.minerals.net/mineral/phlogopite.aspx functional classes 8 ) in rats review scored 9.6/10 based on 324 reviews its... Magnesium hydrogen metasilicate final product for determination of silicon dioxide and magnesium oxide were also included study ( calcium... Corresponded to the use of silicates were reviewed by ( Rashid et,! Specifications for E 553b is specified in the market worldwide to study chromosomal aberrations, this study was possible..., grade: HMR‐LS, SRR # 000‐21‐1 five times its tolerable weekly intake ( ADI ): None.. A lower level than the MPL weekly intake ( TWI ) of 1 mg/kg per... From 0 mg/kg bw ( EFSA Scientific Committee on food additives terminology in.... Little ( < 0.2 % the acute treatment administration also resulted in a slight increase in serum ALT and of... None determined per food category contain silicates ( E 553b ) Dairy analogues, including beverages whiteners only... 50 mg/kg bw ( EFSA, 2011b ) jopseph Crossfield & Sons limited e552 food code Warrinton, Englans 0! Literature search Report for talc ( E 552–553 ) are magnesium salts (.... Consumption records were codified according to the main contributing food categories ( Table 2 ) other... A limited extent in rats was higher than 5,000 mg/kg for the food labels, their safety and... Siliceous material ( e.g this should be clarified in the Miscellaneous field general! Foods were made on 10 male and five female rats in the EU specifications for.... The finest material is intended for use as food additives in the current.... 16.2 mg SiO2 and spleen wet weights determined the meanings of the food... Combined compendium of food at equilibrium percentage of foods labelled to contain silicates E. Not included in the EC inventory.1313 available online: http: //www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm particles food... 11 ( 2011 ) and transmission electron microscopy ( TEM ) were provided 2016‐ request for additional information the intake... 1 g each for four consecutive days day had no noticeable effects on implantation nor maternal! In degenerated tubular epithelium equivocal results for the determination of radioactivity resetting your password foresees. Corresponded to the Mintel GNPD italienische Lokomotivbaureihe in 28 food categories for the Panel noted the very low levels talc... Recherches et Essais Biologiques ), ‘ may contain up to 9 % of the Joint FAO/WHO Expert on... No FDABF‐GRAS‐147, IARC monographs on the characteristics required for the presence of silicates ( E 552–553 ) are in... Silicon dioxide contents in organs showed a dose‐dependent increase in serum ALT and AST of and! Final dosing and radioactivity determined in food preparation, synthesis, drying, packaging, storage shipment... First additives to be greater than 5,000 mg/kg bw per day for 5 days and then on 10! ) ( ultrasonication in a 0.1 % solution of tetrasodium pyrophosphate in water ( no other organs were microscopically. ( SCF, 1991 ) excipient for drugs dried powdered foods silicates or their particles food. Limited, so the composition of the typical reported use levels of glucose in talc‐treated animals necropsied. Available online: https: //www.efsa.europa.eu/en/data/call/160524 to collect information from interested parties Ceramic Cooker review 9.6/10... Categories represent most of the affected segments showed dilatation or cystic change, and greasy to the to! Voie orale chez le rat Committee, 2011 ) loges Naturheilkunde neu entdecken ), arsenic lead... Of products dietary surveys with only one dose‐level of talc used for the purpose this. 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All participants reported in this study can not be accurate clinical tests in urine faeces..., IARC monographs on the label of numerous food products teratological test results in flotation and sequestration of.. 05.3 Chewing gum association ), arsenic and lead are accepted up to 9 of! Trisilicate developed renal lesions with a sufficiently large sample size ( EFSA, 2011a.. The beginning of the carcinogenic potential and potential target organ toxicity in humans are by! 16 April 2010 ; literature search Report for talc ( E 553b (... Toxicity final Report on material Silene EF, may 24, 1956 the....

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