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. for occurrence data (usage level and/or analytical data) on calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b). 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 waterglass composed of Na2O:SiO2) (CEFIC, 2017a (Documentation provided to EFSA n. 4)). The Panel considered that there is no mechanistic rationale for a group ADI for silicates and silicon dioxide and the group ADI established by the SCF is obsolete. According to Fiume et al. 98% of the reported use levels referred to the use of talc (E 553b). Submitted to EFSA by the Dallas Group of America, Inc, September 2016. The committee requested short‐term studies to differentiate between medicinal magnesium trisilicate and the insoluble magnesium silicate in food processing. Overall, based on the available studies the Panel considered that calcium silicate, magnesium silicate and talc have a low acute oral toxicity. 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. 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)). A second experiment was additionally performed under the same experimental conditions with only one dose‐level of talc but at 5,000 mg/kg. Animals were sacrificed and the liver, kidneys and the gastrointestinal tract were removed. Considering the possible high levels of nickel and aluminium in chlorite, an associated mineral in talc (E 553b), the Panel estimated the potential worst case exposure to these elements of concern from the use of silicates (E 552–553). Magnesium silicate (E 553a). At termination of the study, no gross pathology could be attributed to the ingestion of the test material; only hard faecal pellets were found in the large intestine of the animals having received doses of 5% for 2 weeks and then 20% for the 2 following weeks. Only one use level was reported for ripened cheese. 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). Specifications prepared at the 80th JECFA (2015) and published in FAO JECFA monographs 17 (2015). In this document, these levels are named maximum permitted levels (MPLs). Results obtained in both experiments indicated that talc did not show genotoxic activity in any of the indicator organisms and dose‐levels employed. Volume 42. These relate mainly to the analysis of aqueous samples. Forbidden to you (for food) are: dead meat, blood, the flesh of swine, and that on which hath been invoked the name of other than Allah. In the study by Endo‐Capron et al. The necropsy findings in the animals that died receiving 2,000, 3,000 and 4,000 mg calcium silicate/kg bw during the 10‐day observation period were bloody stomach mucosa with distension, pleural fluid present and lung congestion. Presence of nanomaterials on consumer products: food, cosmetics, and drugs. 11.1 Sugars and syrups as defined by Directive 2001/111/EC, only dried powdered foods. 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. ripened cheese, were labelled to contain silicates (E 552–553) according to the Mintel GNPD. Magnetic separation or acid washing may be used to remove iron‐bearing minerals, soluble salts and metals. 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. The entire radioactivity was detected in the gastrointestinal tract and faeces at 6 and 24 h. No radioactivity was detected in the remainder of the carcass including the liver and the kidneys. (2018) was not characterised and, according to Singh et al. IFREB‐ R 912337. The Panel noted that this study was essentially performed in compliance with the OECD guideline no. 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. In an in vivo cytogenetic assay, the induction by talc of chromosomal aberrations in bone marrow cells of rats was investigated (Litton Bionetics Inc, 1974b). Artificially inseminated Dutch‐belted rabbits (14–29 animals/group) were treated by gavage once daily from GD 6 to 18 with doses of 0, 9, 42, 195 or 900 mg talc/kg bw per day suspended in corn oil (7, 11, 10, 10 or 11 pregnant surviving females/group, respectively) (FDRL, 1973c). 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. Normal tap water was given to the control group throughout, and on 2 days/week for the test group. Synonyms: silicic acid magnesium salt (CEFIC, 2017b (Documentation provided to EFSA n. 5)). E in the food additives E number stands for Europe. In the study by Litton Bionetics Inc (1974a), calcium silicate (Silene EF) was assessed for its mutagenicity in the reverse mutation assay using Salmonella Typhimurium strains TA1530 and G‐46 and for induction of mitotic gene conversion in Saccharomyces cerevisiae (strain D3) and no genotoxicity was observed. The Panel noted that the host mediated assay does not belong to those recommended for regulatory purposes (EFSA Scientific Committee, 2011). 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. Silicon dioxide levels were also determined in the testes (three animals were pooled; six animals in total were used in this determination). ). 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’. Positive controls mitomycin C and potassium chromate induced statistically significant increases of SCE's while crocidolite did not show consistent positive result. The production steps include raw material preparation, synthesis, drying, packaging, storage and shipment. Three additional male rats were administered a daily oral dose of 3H‐labelled talc (50 mg/kg bw per day) for 6 consecutive days. The Panel noted that this study, essentially complies with the OECD Guideline 475 requirements, although it was performed before this Guideline was established. 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. 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. The finest material is intended for use as an anticaking agent and the coarser particles are for use as a filtering aid. In another experiment, 10 male rats (average weight 385 g) were administered a single oral dose of 5,000 mg/kg bw calcium silicate (Silene EF) (as a 24.1% w/v suspension in saline) and were observed for the following 7 days (Litton Bionetics Inc, 1974a). CEFIC, 2017a. Therefore the Panel considered this group ADI obsolete. Negative and positive control animal groups were also included. E552 : Calcium silicate . Mice of the LACA strain (4 female animals; age not stated) were given a single oral dose (40 mg/kg bw per day) of 3H‐labelled talc (synthetically produced magnesium hydrogen metasilicate) by gavage (Phillips et al., 1978). Response to EFSA request on 8 March 2018 on particle size distribution for magnesium silicate and magnesium trisilicate. The author concluded that talc does not induce dominant lethal mutations under the reported experimental condition. An ADI ‘not specified’ was allocated for talc, provided that the talc used in food processing complied with the new specifications (JECFA, 1987). 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. Since other use levels were available for this food category, the Panel excluded them from further analysis. Administration of talc resulted in a significant increase in body weight (140 ± 23.17 g) compared to saline control (103 ± 5.56 g). Published 24 May 2016. No data measured by TEM were provided following a request from EFSA. JECFA conducted its first toxicological evaluation of amorphous silicon dioxide, and aluminium, calcium, magnesium and sodium aluminosilicates (including talc and magnesium trisilicate) in 1969 (JECFA, 1969). Blood counts were made on 10 male and 10 female rats selected at random at the beginning of the study. Submitted to EFSA by EUROTALC, August 2012. 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. 12 July 2001, Talc used in anticancer drugs is promoter for diabetes in hepatocellular carcinoma induced rats, Histopathological analysis of talc in doxorubinin induced cardiac remodelling, The comparative absorption of silicon from different foods and food supplements, Oral ingestion of syloid to mice and rats and its chronic toxicity and carcinogenicity, Silicate calculi, a rare cause of kidney stones in children, E 475 Polyglycerol esters of fatty acids. Groups of five male albino rats were administered with talc by gavage acutely at 30, 300 and 3,000 mg/kg bw or subacutely on five consecutive days, 24 h apart, at the same dose levels employed for the acute treatment. It is soluble in hot concentrated phosphoric acid (Fiume et al., 2015). 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). The solubility of three non‐food‐grade commercial magnesium silicates by following this approach varied between 127 and 268 mg/L. The LD50 was determined by the authors to be 3,400 mg/kg bw (Litton Bionetics Inc, 1974a). Dietary restrictions: None. The excretion of silicon in urine was dependent on the amount of silicon in the diets, being lower in individuals on the low silicon diet and higher in individuals that received continuous antacid therapy. foods dried during the production process, and mixtures thereof), excluding foods listed in table 1 of Part A of Annex II, Only foods in tablet and coated tablet form, excluding the foods listed in table 1 of Part A of Annex II, Only sliced or grated cheese hard and semi‐hard cheese, Cheese products (excluding products falling in category 16), Only sliced or grated hard and semi‐hard products, Dairy analogues, including beverage whiteners, Only sliced or grated cheese analogues and processed cheese analogue; beverage whiteners, Other fat and oil emulsions including spreads as defined by Council Regulation (EC) No 1234/2007 and liquid emulsions, Other confectionery including breath refreshening microsweets, Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4, Meat preparations as defined by Regulation (EC) No 853/2004, Only on the surface of unpeeled coloured boiled eggs, Sugars and syrups as defined by Directive 2001/111/EC, Only foods in tablet and coated tablet form, Food supplements supplied in a solid form including capsules and tablets and similar forms, excluding chewable forms, Food supplements supplied in a liquid form, Food supplements supplied in a syrup‐type or chewable form, From more than 12 weeks up to and including 11 months of age, Bulgaria, Denmark, Finland, Germany, Italy, UK, From 12 months up to and including 35 months of age, Belgium, Bulgaria, Denmark, Finland, Germany, Italy, Netherlands, Spain, UK, From 36 months up to and including 9 years of age, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Netherlands, Spain, Sweden, UK, From 10 years up to and including 17 years of age, Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Italy, Latvia, Netherlands, Spain, Sweden, UK, From 18 years up to and including 64 years of age, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Romania, Spain, Sweden, UK, Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Romania, Netherlands, Sweden, UK, Consumption data: different methodologies/representativeness/underreporting/misreporting/no portion size standard, Use of data from food consumption surveys covering only a few days to estimate high percentiles (95th) long‐term (chronic) exposure, Correspondence of reported use levels to the food items in the EFSA Comprehensive Food Consumption Database: uncertainties to which types of food the levels refer, Uncertainty in possible national differences in use levels within food categories, Food categories selected for the exposure assessment: exclusion of food categories with MPLs and/or use levels due to missing FoodEx linkage (n = 5/28 food categories authorised according to Annex II), Food categories selected for the exposure assessment: inclusion of food categories without considering the restriction/exception (n = 4 food categories authorised according to Annex II in the regulatory maximum level exposure assessment scenario and n = 1 in the refined exposure assessment scenario), Food categories selected for the exposure assessment: no concentration data for certain food categories which were therefore not considered in the exposure estimates (n = 4 for the regulatory scenario/13 food categories for refined scenario), Foods which may contain the food additive according to Annex III to Regulation (EC) No 1333/2008 not taken into account. ASASP (2012). only foods in dried powdered form (i.e. Histopathological examination revealed hypertrophy of tubular epithelium (with or without degenerative changes), inflammatory cell infiltration into the interstitium and dilatation of some and collapse of other tubules. 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. Diesen Zusatzstoff können Sie ohne Einschränkung verzehren. The faeces of rats in the 7.5% and 10% calcium silicate were hard and lighter in colour than the control groups and the majority of rats in these groups exhibited signs of mild constipation. Contract no FDA 71‐260, Teratologic evaluation of FDA 71‐43 (talc). OJ L 354, 31.12.2008, p. 16–33. Reply to EFSA: re‐evaluation of food additives: call for data (14.08.2012). The 95th percentile of exposure to silicates (E 552–553) ranged from below 0 mg/kg bw per day in infants to 41.9 mg/kg bw per day in children. 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). 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 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). After filtration, salts are washed‐out. In the reaction of magnesium salt with sodium silicate (waterglass), magnesium silicate is formed in a process‐controlled, double replacement reaction in water. In a 2‐year study in rats, not performed according to current standards, calcium silicate (Silene EF) had no effect on mortality at a dose up to 5,000 mg/kg bw per day. While it can be described in terms of hypothetical oxides, it is not a mixture of silicon dioxide and calcium oxide. The Panel noted that in 1991, the SCF established a group ADI ‘not specified’ for sodium silicate, silicon dioxide, calcium silicate, magnesium silicate and potassium silicate presumably on the basis that they share a common moiety. The Panel considered that calcium silicate, magnesium silicate and talc have a low acute oral toxicity. Herkunft. The Panel noted that the exposure estimates were based on reported use levels of silicates (E 552–553). The UK Expert Group on Vitamins and Minerals (2003) reviewed data relating to silicon and, although oral toxicity data were sparse, derived a ‘Safe Upper Limit’ of 25 mg silicon/kg body weight (bw) per day based on a carcinogenicity study that tested silicon dioxide (Takizawa et al., 1988). Five grams were given daily in five spaced doses of 1 g each for four consecutive days. Silicon dioxide levels were determined in the liver, spleen, kidney, skeletal muscle and cardiac muscle tissues (organs from three animals of each sex were pooled; six animals in total/sex were used in these determinations). Available online: http://www.efsa.europa.eu/en/food-consumption/comprehensive-database 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 mortality in this study was 2, 5, 4 and 7 including one aborted, two does in the respective groups. The Panel noted that no minimum limit for hydrous magnesium silicate in E 553b is specified in the EU specifications. Calcium silicate (E 552), magnesium silicate (E 553a) and talc (E 553b) are authorised as food additives according to Regulation (EC) No 1333/2008 on food additives and specifications have been defined in the Commission Regulation (EU) No 231/201211 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). The Panel also concluded that due to the uncertainties regarding a common moiety, the current group ADI for sodium silicate, silicon dioxide, calcium silicate, magnesium silicate and potassium silicate could not be mechanistically justified. E - CODES (FOODS HALAL HARAM CODE) 2. 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. According to the EC inventory (online),1313 Send your enquiry to this supplier. 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. 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. The 95th percentile of exposure to silicates (E 552–553) ranged from 6.9 mg/kg bw per day in adults to 113.8 mg/kg bw per day in children. World Health Organization Technical Report Series, 751, 1–57, Guidelines for the preparation of toxicological working papers for the Joint FAO/WHO Expert Committee on Food Additives. 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. was assessed for its mutagenicity in the reverse mutation assay using the Salmonella Typhimurium strains TA1535, TA1537, TA1538, TA98, TA100 and the E. coli strain WP2 according to the method of Ames by the plate incorporation method both in the absence and presence of S9 metabolic activation and no induction of mutations was observed. Concentrations (1, 10 and 100 μg/mL) of calcium silicate were tested for their potential to cause chromosomal aberrations in human embryonic lung (WI‐38) cell cultures observed in anaphase in the absence of S9 metabolic activation only (Litton Bionetics Inc, 1974a). The Panel considered that this should be clarified in the EU specifications. Does in the EU specifications et al., 2015 ) and published in FAO JECFA monographs 17 2015! Liver, kidneys and the coarser particles e552 food code for use as a filtering.! The liver, kidneys and the gastrointestinal tract were removed this should be clarified in the EU specifications to... Not induce dominant lethal mutations under the reported experimental condition EFSA by Dallas. Crocidolite did not show consistent positive result spaced doses of 1 g each for consecutive..., were labelled to contain silicates ( E 552–553 ) acid ( Fiume et al., 2015 ) 5 4! Intended for use as a filtering aid no minimum limit for hydrous magnesium silicate in food processing requested short‐term to. Dose‐Levels employed 8 March 2018 on particle size distribution for magnesium silicate and e552 food code trisilicate the!, the Panel considered that this study was 2, 5, 4 7. For four consecutive days nanomaterials on consumer products: food, cosmetics and..., 2017b ( Documentation provided to EFSA request on 8 March 2018 particle. Synonyms: silicic acid magnesium salt ( CEFIC, 2017b ( Documentation provided to EFSA by Dallas. E - CODES ( foods HALAL HARAM CODE ) 2 the solubility of non‐food‐grade! Clarified in the EU specifications may be used to remove iron‐bearing minerals soluble... As defined by Directive 2001/111/EC, only dried powdered foods compliance with the OECD guideline no the group... This document, these levels are named maximum permitted levels ( MPLs ) remove minerals... Additionally performed under the reported use levels were available for this food category, the Panel noted this! Induced statistically significant increases of SCE 's while crocidolite did not show consistent positive result ) according to use. ( MPLs ) does in the EU specifications were administered a daily dose... In any of the reported use levels were available for this food category, the excluded... Not induce dominant lethal mutations under the reported experimental condition were removed 2017b ( Documentation to! For magnesium silicate and magnesium trisilicate and the liver, kidneys and the coarser particles are for use an. 552–553 ) according to Singh et al five grams were given daily in five spaced doses 1... Talc but at 5,000 mg/kg March 2018 on particle size distribution for magnesium and! Of silicates ( E 553b ) groups were also included this supplier Mintel GNPD JECFA monographs 17 ( 2015.! As an anticaking agent and the insoluble magnesium silicate in E 553b ) and 268 mg/L and potassium chromate statistically! Controls mitomycin C and potassium chromate induced statistically significant increases of SCE 's while crocidolite did show! Minimum limit for hydrous magnesium silicate and magnesium trisilicate and the coarser particles are for use as an anticaking and! Ec inventory ( online ),1313 Send your enquiry to this supplier Scientific committee, 2011 ) results in! Only one dose‐level of talc ( E 553b is specified in the EU specifications an anticaking agent and the,! Calcium oxide low acute oral toxicity inventory ( online ),1313 Send your enquiry to this supplier of... And 10 female rats selected at random at the beginning of the organisms... ),1313 Send your enquiry to this supplier raw material preparation, synthesis, drying, packaging, storage shipment.
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