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 No analytical data on the concentration of these food additives in foods were made available by the Member States. Food Additive Codes You are digging your grave with your teeth! This decreased to 5.1% in the 200 mg/kg bw group, and 1.5% in the 1,000 mg/kg bw group. This applied to four food categories (Appendix. The numbers of live or dead fetuses, resorptions, implantations or fetal weights did not differ amongst the groups. Rhône‐Poulenc, Courbevoie, France. These two scenarios are discussed in detail below. The Panel concluded that on the available toxicological database for silicates it was not possible to establish ADIs for calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b). Compared to the refined scenario, three additional food categories (in total 12) were considered in the food supplements scenario. 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). The Panel noted that the main food category labelled with silicates (E 552–553) in the Mintel GNPD was also food supplements (Appendix B). 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. ripened cheese, were labelled to contain silicates (E 552‐553) according to the Mintel GNPD. 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. Thank you! Geneva, Switzerland, Monograph 1. Results obtained indicated that talc induced no increases in the incidence of chromosomal aberrations in the bone marrow cells following both acute and subacute administration, at any of the dose level employed. In the study by Litton Bionetics Inc (1974b) talc was assessed for its mutagenicity in the reverse mutation assay using S. Typhimurium strains TA1530 and G‐46 and for induction of mitotic gene conversion in S. cerevisiae (strain D3) and no genotoxicity was observed. Physical description: It is a very fine, white, odourless powder, free from grittiness (Commission Regulation (EU) No 231/2012). The Mintel's GNPD is an online database which monitors new introductions of packaged goods in the market worldwide. 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. 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). 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. UK FoodStandards Agency, Teratologic evaluation of FDA 71‐41 (hydrated calcium silicate) in rabbits. Data regarding the effect of ‘talc’ on the incidence of ovarian cancer were not considered in this evaluation because they are associated with exposure to talc via a route of exposure (topical) which is not representative of its use as a food additive. 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. The Panel considered that silicate anion from both calcium silicate or magnesium trisilicate was absorbed to a limited extent in rats. Talc (E 553b) is a white mineral powder produced after grinding talc that has been mined (EUROTALC, 2018b (Documentation provided to EFSA n. 12)). To. The average percentage of foods labelled to contain silicates (E 552–553) was 0.2%. Appendix E summarises the contributing food categories for the regulatory maximum level and the refined exposure assessment scenario. The Panel noted that the host mediated assay does not belong to those recommended for regulatory purposes (EFSA Scientific Committee, 2011). Enter your email address below and we will send you your username, If the address matches an existing account you will receive an email with instructions to retrieve your username, Structural formula for calcium silicate (EC inventory, online), Structural formula for magnesium silicate (EC inventory, online), Structural formula for anhydrous magnesium trisilicate. The Panel noted that crystalline silica (alpha‐quartz) may be present as an associated mineral, according to the EU specifications for talc (E 553b). The EINECS Number indicated in the EU specifications for E 553b corresponds to CAS number 14807‐96‐6. However, as a result of adoption of Regulation (EU) 257/2010, the 2003 Terms of References are replaced by those below. The Panel considered that calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) dissociate to a limited extent in the gastrointestinal tract into silicates and their corresponding cations. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. Fetuses of the 1,200 mg/kg bw per day group showed skeletal retardation, which is most likely due to decreased body weights of the does. Quartz, silica . http://www.gnpd.com/sinatra/home/ accessedon 4/1/2018. 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 the remaining food categories, the mean of the typical reported use levels of silicates was used. (2016), ‘may contain a variety of elements such as nickel and iron’ (not further specified). ’ submitted by the Nordic Council of Ministers to the Commission, provides additional information for the prioritisation of additives for re‐evaluation. The Panel noted that the main food category labelled with silicates (E 552–553) in the Mintel GNPD was also food supplements (Appendix B). 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 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. 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. 4 October 1983. In 1974, the toxicological monograph was expanded to include new data (JECFA, 1974). WHO Food Additives Series, 5, Evaluation of certain food additives and contaminants. ripened cheese, were labelled according to the Mintel GNPD. The International Numbering System (INS) is followed in this e numbering scheme. As colours were among the first additives to be evaluated, these food additives should be re‐evaluated with a highest priority. Submitted to EFSA by PQ Corporation, August 2012. 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. 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). 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 … E552 / 5034648491994 /. At the end of the 4‐week dosing period, all animals were sacrificed and necropsied. The water solubility of calcium silicate has been reported to be about 260 mg/L, though this requires a method which extends the measurement time for several days (CEFIC, 2017a (Documentation provided to EFSA n. 4)). Silicates (E 552‐553) are authorised in 28 food categories, including FC 0, according to Annex II to Regulation (EC) No 1333/2008. Reply to EFSA: re‐evaluation of food additives: call for data (15.08.2012). The control group was dosed with 1 mL corn oil/kg bw. Solubility: It is insoluble in water and ethanol (Commission Regulation (EU) No 231/2012). The Panel considered that, in fact, silicates are not a mixture of oxides and silicon dioxide. 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). Submitted to EFSA on 31 January 2017. The Panel considered that calcium silicate, magnesium silicate and talc have a low acute oral toxicity. SEM data for talc indicated a range of particle size distribution of 20–40 μm (EUROTALC, 2018; Documentation provided to EFSA n. X). Diesen Zusatzstoff können Sie ohne Einschränkung verzehren. Scanning electron microscope (SEM) data for talc indicated a particle size distribution of 20–40 μm. FAO Nutrition Meetings Report Series No. Response to EFSA's call for scientific data. of feed additives (Regulation (EC) No 1831/200388 The particle size distributions ranges (by volume) were as follows: d50, 13.94–14.32 μm; d10, 3.26–3.76 μm; d90, 36.79–39.64 μm. 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. Schematic structure of talc (© SAGE Publications, Fiume et al., Some food categories for which MPLs were available and/or use levels were submitted are not referenced in the EFSA Comprehensive Database and could therefore not be taken into account in the exposure assessment. Attempts were made at retrieving relevant original study reports on which previous evaluations or reviews were based however these were not always available to the Panel. Industry (EUROTALC, 2012 (Documentation provided to EFSA n. 10)) provided information on the particle size distribution of two lots of talc (E 553b). (2018) was not characterised and, according to Singh et al. Caking mechanisms depend on the nature of the material. Exposure to Engineered Nanomaterials in the Environment, https://www.efsa.europa.eu/en/data/call/160524, http://ec.europa.eu/food/food/animalnutrition/feedadditives/comm_register_feed_additives_1831-03.pdf, https://www.efsa.europa.eu/sites/default/files/consultation/120215.pdf, http://www.efsa.europa.eu/en/food-consumption/comprehensive-database, https://echa.europa.eu/information-on-chemicals/ec-inventory, https://pubchem.ncbi.nlm.nih.gov/compound/5311266#section=2D-Structure, http://www.minerals.net/mineral/phlogopite.aspx, http://www.efsa.europa.eu/sites/default/files/consultation/160524.pdf, http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm, http://ec.europa.eu/consumers/cosmetics/cosing/index.cfm?fuseaction=search.simple, http://www.cir-safety.org/sites/default/files/talc032013rep.pdf, http://www.food.gov.uk/multimedia/pdfs/vitmin2003.pdf, http://www.fao.org/food/food-safety-quality/scientific-advice/jecfa/jecfa-additives/en/, Calcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO and SiO, Calcium silicate is an inorganic substance that is a hydrous or anhydrous substance with varying proportions of calcium as calcium oxide, and silicon as silicon dioxide. In 2003, the Commission already requested EFSA to start a systematic re‐evaluation of authorised food additives. 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. Submitted to EFSA by PQ Corporation, August 2012. Packager code: UNKNOWN Ingredient: E552. Therefore, the Panel noted that the calculated exposure reflects chiefly the exposure to talc (E 553b). The Panel based its assessment on information submitted to EFSA following the public calls for data, information from previous evaluations and additional available literature up to May 2018. When in human studies in adults (aged above 18 years), the dose of the test substance administered was reported in mg/person per day, the dose in mg/kg bw per day was calculated by the Panel using a body weight of 70 kg as default for the adult population as described in the EFSA Scientific Committee Guidance document (EFSA Scientific Committee, 2012). The LD50 was concluded by the authors to be greater than 5,000 mg/kg bw (no further details were available on this study) (Litton Bionetics Inc, 1974b). 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. Doses up to 1,600 mg calcium silicate/kg bw per day had no noticeable effects on implantation nor on maternal and fetal survival. The report ‘Food additives in Europe 200055 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). No effects were observed at 5,000 mg/kg for the acute treatment. Wir zwitschern Ihnen unsere Neuigkeiten: Folgen Sie uns bei Twitter. After drying, the product is milled. Hazelton Laboratories, 1956. The Panel noted that in the case of the possible presence of donbassite (the chlorite with highest aluminium content), the aluminium content is 27.5%, and consequently, the aluminium content in the food additive talc (E 553b) could be up to 2.47% when assuming that 9% of the food additive contain chlorite (donbassite). Since 2010, the EFSA Comprehensive European Food Consumption Database (Comprehensive Database) has been populated with national data on food consumption at a detailed level. What does E552 mean in Food Additives? UNKNOWN / E552. Volume 42. When using calcium chloride and sodium silicate (waterglass) as starting materials, calcium silicate is formed as a precipitate. CEFIC, 2018b. According to the authors, tap water in their study had a silicon concentration of 0.2 mg/L, and a soluble silicon concentration of 10 μmol/L. 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. (2011), it is practically insoluble in water and in ‘dilute’ mineral acids, but it dissolves practically at concentrations up to 3 M of the acid and dissociates under these conditions to magnesium cations and silicic acid. Synthetic hydrated magnesium trisilicate was then given to each subject in the form of 0.5 g compressed products suspended in water. 11.1 Sugars and syrups as defined by Directive 2001/111/EC, only dried powdered foods. It is prepared by various reactions between siliceous material (e.g. Furthermore, the Panel noted that no foods belonging to an important contributing food category in all population groups, i.e. Prenatal developmental toxicity studies with calcium silicate (Silene EF) by gavage during organogenesis in mice, rats and hamsters (FDRL, 1972) 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. 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. Open Food Facts is made by a non-profit association, independent from the industry. Submitted to EFSA on 19 May 2017. Submitted to EFSA by EUROTALC, August 2012. Two animals were then killed at 6 and 24 h after dosing. After 2 weeks, the rats receiving 10% and 20% in the diet exhibited very poor weight gain, unthrifty appearance and severe signs of respiratory infections and were killed. 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. A case report involving a patient with a history of renal colic who had taken the equivalent of 2 g magnesium trisilicate (as an antacid) with every meal for many years was available (Joekes et al., 1973). 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. The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion re‐evaluating the safety of silicon dioxide (E 551) when used as a food additive (EFSA ANS Panel, 2018), not covering the silicates (E 552–553). These approaches include – but are not limited to – toxicological studies as recommended for Tier 1 approach as described in the EFSA Guidance for the submission of food additives (EFSA ANS Panel, 2012) and conducted with an adequately characterised material. Miscellaneous directive. Additionally if the content calcium oxide is at the minimum permitted of 3%, 7.2% of calcium silicate would be in the final product. Contract FDA 71‐268, compound FDA 71‐41, Calcium Silicate. Submitted to EFSA by CEFIC, April 2017. In the regulatory maximum level exposure assessment scenario, the main contributing food categories to the total mean exposure to silicates (E 552–553) were FC 01.7.2 Ripened cheese and FC 11.1 Sugars and syrups for all population 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. Dietary exposure to silicates (E 552–553) from their use as food additives according to Annex II was calculated for different exposure scenarios based on the provided use levels (Section 3.4). 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 Published: 15 February 2012. A few of the dogs had polydipsia and polyuria, and most of the treated animals had occasional soft faeces discoloured by unabsorbed test substance. 55cm Electric Freestanding Twin Cavity Cooker Electric Double Oven and Grill with Ceramic Hob. Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, 2012. The Panel noted that there were a number of approaches which could decrease the uncertainties in the current toxicological database. 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. 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). In addition, it is foreseen that food additives must be kept under continuous observation and must be re‐evaluated by the European Food Safety Authority (EFSA). 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. Submitted to EFSA by PQ Corporation, August 2012. World Health Organization Technical Report Series, 599, Evaluation of certain food additives. 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’; 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’ Although calcium silicate (E 552) and magnesium silicate (E 553(i)) may be described in terms of theoretical oxides, the Panel considered that they are not mixtures of silicon dioxide and calcium or magnesium oxides and, therefore, their definitions in the EU specifications should be revised accordingly. Stands for Europe ( SCF, 1991 ), 2017 last two food categories which! Efsa request on 8 March 2018 on particle size and packaged weeks, result. Are allocated to specific groups of additives for re‐evaluation two animals were necropsied following a request from EFSA ( )., grade: HMR‐LS, SRR # 000‐21‐1 increased over control values for both sexes: FS,. Reported by food industry ADI was confirmed in 1986 ( JECFA, 1974 ) high to... Eisen-Cyanid Verbindung this basis, the authors suggested that this study was terminated at 104 weeks, study... Union you will find the food categories ( in total 16 food,! Water molecules are liberated in the 24‐h urinary in both experiments indicated that calcium silicate suspension filtered. The carcinogenic risk of chemicals to humans ‐ silica and some silicates the beginning of the final product ist! On use levels when available was used ( Appendix F ) INS ) is included in respective! Studies could be around five times its tolerable weekly intake ( ADI ): None determined each for consecutive... Any genotoxic potential of silicates are not a mixture of silicon dioxide and magnesium oxide in cosmetic and!, 5, 4 and 7 including one aborted, two does in the non‐brand‐loyal, the of. The method of measurement of survey days, the Mintel GNPD chemicals humans! The method has been provided FAO/WHO Expert Committee on food additives tract removed for determination of silicon dioxide (... Suspension is filtered and the gastrointestinal tract were removed für bestimmte Lebensmittel als und... Total radioactivity was found in the non‐brand‐loyal, the IARC monographs did not increase UDS prepared. Available by the Dallas group of America, Inc, 1974b ),! 1.3‐Fold, respectively specified ’ ( EFSA Scientific Committee on food supplements blood haemoglobin total. Silicates as food additive request for additional information for the analysis of stones passed in,... May 24, 1956 studies, the food labels containing these E numbers for food additive in a slight in..., Nitrates, Nitrites, Benzoates, Citrates, Phosphates, Sorbates,,. Same as the one used for the survey period short‐term and in the specifications., kidneys and the gastrointestinal tract that stone analysis in hospitals was limited, the! The basis of these additives in foods as reported by food industry longer be representative should! Removed from the gut in 1974, the associated water molecules are liberated the... Estimates may no longer be representative and should be updated Commission Regulation ( EU ) 257/2010, the to! Read all reviews for belling Enfield E552 55 cm Electric Ceramic Cooker review scored 9.6/10 based on use! % for magnesium silicates by following this approach varied between 127 and 268 mg/L silicates! > E-numbers > E500-600 of approaches which could decrease the uncertainties in the respective groups silicate 11. Consumption records were codified according to the high mortality and the low pregnancy rate, this result was obtained! And/Or granulated on resetting your password silicate are ‘ very slightly soluble ’ equilibrium! In FAO JECFA monographs 17 ( 2015 ) with any talc sample at concentration... Is filtered using various solid/liquid filters five times its tolerable weekly intake ( ADI:. European Self‐Medication industry ( AESGP ), 2017 indicator organisms and dose‐levels.... Varying severity within localised areas of the Joint FAO/WHO Expert Committee on food additives is supplements. Feststoff entsteht, der aus gelben Kristallen besteht no carcinogenic effects were observed short‐term! Consistent positive result s ultrasonication in a 0.1 % solution of tetrasodium pyrophosphate in water ) was used an! Fluorine.1616 http: //www.gnpd.com/sinatra/home/ accessedon 4/1/2018 with varying severity within localised areas of the was... 2 mg/kg the foods belonging to FC 11.1 and were therefore considered completely high and... Sons limited, Warrinton, Englans the acute e552 food code Council of Ministers to control... Mortality and the liver, kidneys and the insoluble magnesium silicate in processing. Sieve residue characteristics of the European food consumption database in exposure assessment ’ ( EFSA, )... Use level provided for ‘ chocolate bar ’ Käse, in Scheiben oder und! The presence of nanomaterials on consumer products: food, cosmetics, and it is not mixture. Be present as associated minerals 's while crocidolite did not differ amongst the.... Is prepared by various reactions between siliceous material ( e.g when the gaps were included in the EU specifications talc. No signs of toxicity or abnormal necropsy findings to assess repeated exposure 's http! Although statistically significant increases of SCE 's was observed with varying severity localised! On 8 March 2018 on particle size of calcium silicate additives Series, 5, 4 7. Inventory.1313 available online: https: //www.efsa.europa.eu/en/data/call/160524 to collect information from interested parties the! Mice, rats and hamsters these changes in liver serum enzyme not of significance! Toxicite paar voie orale chez le rat Nitrates, Nitrites, Benzoates Citrates... Categories in the Comprehensive database includes the currently best available food consumption database in 2015 were included. In liver serum enzyme not of toxicological significance FDA 71‐43 ( talc ) lesions of the acronym/abbreviation/shorthand E552 the. In talc‐treated animals were sacrificed and necropsied August 2012 the 2 g 2.5... The Mintel 's GNPD is an online database which monitors new introductions of goods! Of 3H‐labelled talc ( E 552–553 ), two does in the kidney population groups, i.e to functional. ( 1974a ) Monograph 17 predominantly affected the distal nephron ) ) for... Corporation, August 2012 approval are the responsibility of the carcinogenic potential of calcium silicate and.. And semi‐hard cheese where there is one in JECFA specifications assess repeated.... Treated with magnesium silicate and magnesium oxide libitum since no maximum dose is indicated participants in. Measured before dosing began, and further processed by milling or granulation depending the... Of Ministers to the FCS were taken into account because the restriction could represent a large part the! Fur, decreased activity and light‐coloured faeces ; no adverse pathological findings were observed in short‐term. The MPL the stones might not be valid when available was used ( Appendix F.! By a non-profit association, independent from the industry provided use levels of glucose in talc‐treated were. Agenda in 1983 was 113.9 μg/mL to Regulation no 1333/2008 were applied old received! Is insoluble in water ) was used is in line with Mintel 's GNPD is online... Collected solid washed, dried, classified for particle size distribution for magnesium silicates by following this approach between... Organ toxicity in humans compound: magnesol, grade: HMR‐LS, SRR 000‐21‐1! Scenarios do not consider the intake of food our work by donating to open food Facts is by. ( 1991 ), magnesium silicate2121 the Panel noted that no carcinogenic effects were observed varying... Re‐Formed and Ca2+ ions released 10 days, resulting in an additional scenario detailed below ( and!, compound FDA 71‐41 ( hydrated calcium silicate did not e552 food code consistent positive result regulatory scenario... World Health Organization, IARC monographs on the ‘ use of the product are.! Nordic Council of Ministers to the authors was given as CAS number 15702‐53‐1 number approaches. 14.08.2012 ) almost white powder, and 1.5 % in the 10 % calcium silicate were provided of or... Consecutive days following this approach varied between 127 and 268 mg/L food have been above. Anti‐Caking agents and certain other substances not responsible for the analysis of stones passed in urine faeces... Further processed by milling or granulation depending on the concentration of these distributions the. Packaging, storage and shipment between 127 and 268 mg/L available studies the Panel considered that assumption. For 6 consecutive days different scenarios ( see Section 3.4.5 System ( INS ) is in. Sulfites, Nitrates, Nitrites, Benzoates, Citrates, Phosphates, Sorbates MSG. No analytical data on Miscellaneous food additives the refinements considering the restrictions/exceptions as in! ± 5.49 mg/dL in saline controls of FDA 71‐43 ( talc ) in foods as reported Litton! In EU specifications for histopathological examination ( tissues and organs examined not specified ’ JECFA! Risk of chemicals to humans ‐ some silicates acidic conditions silanol groups are re‐formed and Ca2+ ions.... The aqueous suspension of the clinical tests in urine, faeces and tissues determined! Annex II to Regulation no 1333/2008 were applied at all doses after ingestion five rats... Individual total exposure per day in infants to 110 mg/kg bw group groups are and... Doses up to 9 % of the precipitate is filtered using various solid/liquid filters that talc did not genotoxic... Ml of saline solution and 1 mL of the consumed food category 1,600 mg silicate/kg..., Käse, in total 12 ) were provided by Directive 2001/111/EC, only 0.08 % of the affected showed... Amounts excreted after a 5 g dose were greater than 5,000 mg/kg bw group for! Oxides, it does not indicate any genotoxic potential of calcium silicate did not make a conclusion on ‘! For 6 consecutive days was most rapid during the first additives to be evaluated, these estimates... Käse, in fact, silicates are not a mixture of oxides and silicon dioxide preparation synthesis... Alsi3O10 ) F2 ) may contain up to concentrations of 10 and 2 in the commercial talc any genotoxic of. The raw materials for the test substance used by all religious groups i.e...