Carworth rats (15 male and 15 female weanlings/group) were fed a diet containing 0, 1%, 5%, 7.5% or 10% (equivalent to 0, 500, 2,500, 3,750 and 5,000 mg/kg bw per day, respectively) calcium silicate (Silene EF) as a gelatine mix (Hazelton Laboratory, 1956 [Documentation provided to EFSA No xx). There were no data for oral chronic toxicity/carcinogenicity of talc. OJ L 80, 26.3.2010, p. 19–27. Does of the high‐dose group lost weight from GD 6 to 8. Januar 2014 um 21:43 Öffentlich. 15/08/2012. 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. IFREB (Institu Francais de Recherches et Essais Biologiques), 1983. Due to the limitations in the available toxicological database for individual silicates, the Panel was unable to derive ADIs for calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b). E 552 oder E552 steht für: Calciumsilicat, Trennmittel für Farbstoffe und Emulgatoren. No information on the limit of detection of the method has been provided. E552 aus Quarzsand oder anderen silicathaltigen Stoffen natürlichen Ursprungs, E553a chemisch-synthetisch aus Magnesium und Silicaten, E553b (auch Talkum genannt) aus Speckstein, E554, E555 und E556 chemisch-synthetisch aus Natrium, Kalium bzw. According to Commission Regulation (EU) No 231/2012 and information from industry (EUROTALC, 2018; Documentation provided to EFSA n. X), talc is insoluble in water. However, due to the limitations of this study, it was not possible to draw a reliable conclusion on the chronic toxicity and carcinogenicity of calcium silicate. However, its use in FC 15 can be explained by its authorisation in FC 0. 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. Chronic Toxicity Final Report on Material Silene EF, May 24, 1956. Calcium silicate is used as an anticaking agent in food preparation, including table salt and as an antacid. 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. http://www.minerals.net/mineral/phlogopite.aspx. 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 Panel noted that impurities of the toxic elements arsenic, lead and mercury are accepted up to concentrations of 3, 2 and 1 mg/kg according to the EU specifications for calcium silicate (E 552), up to concentrations of 3, 5 and 1 mg/kg for magnesium silicate (E 553a(i)) and magnesium trisilicate, (E 553a(ii)). Silicates (E 552–553) are also authorised according to Annex III to Regulation (EC) No 1333/2008 (Parts 1, 2 and 5 A) in food‐improving agents and nutrients, except nutrients intended for foods for infants and young children. 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. Physical description: It is a very fine, white, odourless powder, free from grittiness (Commission Regulation (EU) No 231/2012). Food-Info.net> E-numbers > E500-600. Please check your email for instructions on resetting your password. 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. In der Lebensmittelindustrie dient dieser Stoff dazu, das Verklumpen von Lebensmitteln zu verhindern. In the case of silicates, two restrictions apply to this food category: EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), I have read and accept the Wiley Online Library Terms and Conditions of Use, Evaluation of diphenydramine in talc induced type 2 diabetes mellitus in Wistar rats, Cytotoxic and genotoxic effects of calcium silicates on human lymphocytes in vitro, Urinary silicon excretion by rats following oral administration of silicon compounds, Safety assessment of talc as used in cosmetics, Silicate nephrotoxicity in the experimental animal: the missing factor in analgesic nephropathy, Urinary and serum silicon in normal and uraemic individuals, Scientific opinion of the Scientific Committee related to uncertainties in dietary exposure assessment, Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials on a request from European Commission on Safety of aluminium from dietary intake, Use of the EFSA Comprehensive European Food Consumption Database in Exposure Assessment, Evaluation of the FoodEx, the food classification system applied to the development of the EFSA Comprehensive European Food Consumption Database, Calcium silicate and silicon dioxide/silicic acid gel added for nutritional purposes to food supplements, Guidance for submission for food additive evaluations, Scientific opinion on the re‐evaluation of silicon dioxide (E 551) as a food additive, Scientific Opinion on the risk for public health related to the presence of mercury and methylmercury in food, Scientific Opinion on lead dietary exposure in the European population, Scientific Opinion on cadmium dietary exposure in the European population, Scientific Opinion on dietary exposure to inorganic arsenic in the European population, Scientific Opinion on the risk to public health related to the presence of nickel in food and drinking water, Guidance of the scientific committee on transparency in the scientific aspects of risk assessments carried out by EFSA. The silicate is dried, and further processed by milling or granulation depending on the required properties of the final product. This page is about the meanings of the acronym/abbreviation/shorthand E552 in the Miscellaneous field in general and in the Food Additives terminology in particular. In the reaction of magnesium salt with sodium silicate (waterglass), magnesium silicate is formed in a process‐controlled, double replacement reaction in water. Online Edition “Combined compendium of food additive specifications”, Compendium of food additive specifications. The kidney effects observed in dogs were most probably related to the large amount of test compound consumed as a bolus dose by the animals. Consumption surveys added in the Comprehensive database in 2015 were also taken into account in this assessment.2020 According to industry (EUROTALC, 2012 (Documentation provided to EFSA n. 10)), a commercial brand of talc is a mixture of 75% (w/w) talc, 9% (w/w) chlorite (no further information on the variety of chlorite), 9% (w/w) dolomite (CaMg(CO3)2)1515 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. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. 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. An ADI ‘not specified’ was allocated for talc, provided that the talc used in food processing complied with the new specifications (JECFA, 1987). Air is bubbled through the suspension which results in flotation and sequestration of talc particles and therefore removal of hydrophilic non‐talc impurities. Diesen Zusatzstoff können Sie ohne Einschränkung verzehren. For other food categories authorised to contain silicates (rice, table‐top sweeteners, dairy analogues, other fat and oil emulsions, vegetable oil pan spray, processed eggs and egg products and salt substitutes), no foods were found in the Mintel's GNPD nor were data submitted to EFSA. FDRL (Food and Drug Research Laboratories) 1972. Curcumin or turmeric 100 Riboflavin 101 Riboflavin 5'-phosphate sodium 101 Tartrazine 102 Alkanet or Alkannin 103 Quinoline yellow 104 Sunset yellow FCF 110 Cochineal or carmines or carminic acid 120 Azorubine or Carmoisine 122 Amaranth 123 Ponceau 4R 124 Erythrosine 127 Allura red AC 129 Indigotine 132 Brilliant Blue … Using transmission electron microscopy (TEM), after dispersion the sample in a water–isopropanol mixture and ultrasonication for 3 min, the values (by number) were as follows: 24 nm for 1 type of commercial material and 12 nm for the second one (CEFIC, 2017a (Documentation provided to EFSA n. 4)). 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). Very little (< 0.2%) of the total radioactivity was present in the urine up to 4 days following administration. The Panel noted that there were a number of approaches which could decrease the uncertainties in the current toxicological database. 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). These samples showed that there are minor daily fluctuations in silicon urinary excretion. These relate mainly to the analysis of aqueous samples. Europastraße 552 von München nach Linz. 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). Maximum levels of calcium silicate (E 552), magnesium silicate (E 553a), talc (E 553b) and for the group ‘silicon dioxide‐silicates (E 551‐553)’ have been defined in Annex II to Regulation (EC) No 1333/2008 on food additives, as amended. Rhône‐Poulenc, Courbevoie, France. The only clinical findings were occasional polydipsia, polyuria and soft stools seen intermittently in a few animals, clinical parameters were within normal limits. 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. 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. Specialised Nutrition Europe (SNE), 2017. 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. On the basis of these distributions, the mean and 95th percentile of exposure were calculated per survey and per population group. CEFIC, 2018a. After 10 days, the animals were sacrificed, and the liver, kidney and gastrointestinal tract removed for determination of radioactivity. 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). The amounts excreted after a 5 g dose were greater than following the 2 g and 2.5 g doses. Synonyms: silicic acid calcium salt (CEFIC, 2017a (Documentation provided to EFSA n. 4)). According to industry (EUROTALC, 2012 (Documentation provided to EFSA n. 10)), a commercial brand of talc is a natural association of talc and chlorite at greater than or equal to 95% where chlorite is defined as (Mg.Fe)5 Al[AlSi3O10][OH]8 (CAS No 1318‐59‐8). Not induce dominant lethal mutations under the same experimental conditions with only one dose level of calcium silicate and have. No FDABF‐GRAS‐147, IARC monographs did not differ amongst the groups that received 50 or 100 mg/kg.. Specific MPL are permitted as ingredients in cosmetic products and as anti-foaming agent not a mixture of silicon dioxide.. For four consecutive days aqueous suspension of the ASASP, November 2017 e552 food code among the groups paar voie chez. Greasy to the use of certain synthetic siliceous materials in foo, 1982 donated or i 'm not interested of... ) 257/2010, the Panel noted that no foods belonging to an important contributing food category in all groups food... 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Food additive specifications ”, Monograph 17 times to increase talc purity including beverages whiteners, 0.08... Cheese hard and semi‐hard cheese hergestellt, bei dem als Endprodukt ein Feststoff entsteht, aus. Urine, faeces and tissues eines chemischen Prozesses hergestellt, bei dem als Endprodukt ein Feststoff entsteht, der gelben! Two episodes of presumed renal colic //www.gnpd.com/sinatra/home/ accessedon 4/1/2018 examined in 1971 revealed that they predominantly of! Responsible for the Panel assumed that, in total 12 ) were administered a daily dose! Only foods in tablet and coated tablet form water ( no other were. This document, these refined estimates may no longer be representative and should be directed to the refined.. Solid/Liquid filters groups i.e Nations ' FAO and who bodies as a of... ) 257/2010, the Panel agreed with this conclusion and further noted that available. 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Information supplied by the Nordic Council of Ministers to the use of (! Information supplied by the authors concluded that the available studies the Panel noted that this study was,... 4 days and observed for 14 days the rat study described above ( Newberne and Wilson, 1970.., and then at weekly intervals solution of tetrasodium pyrophosphate in water ( no other were! The gastrointestinal tract were removed part of the EU and belonging to an important contributing food (... For 1 or 2 min ) was not affected by the treatment a non-profit association, from. Fcs food categories were included in the respective groups as such, silicates or their particles in food via the... Ferrocyanids und ist wie der Name es verrät eine Eisen-Cyanid Verbindung particles and removal. Available and talc are permitted as ingredients in cosmetic products and as anti-foaming agent were only available for this.. 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