Data obtained with test samples that contained asbestos fibres were not considered in this evaluation because asbestos must not be present in the food additives (E 552, E 553b) according to the current EU specifications and therefore these data were considered not relevant. Irradiated (neutron‐activated) talc was suspended in physiological saline solution and 1 mL of the suspension was administered to the animals by gavage. Their use in FC 0 means that they are ‘permitted in all categories of foods excluding foods for infants and young children, except where specifically provided for’. For the acute treatment, sampling of bone marrow cells was performed at 6, 24 and 48 h from the last administration, while in the subacute study sampling was only performed at 6 h from the last administration. There were no abnormal findings involving the glomeruli. Radioactivity in urine, faeces and tissues were determined. Urine and faeces were collected at 24 h intervals for 4 days. The mortality in this study was 2, 5, 4 and 7 including one aborted, two does in the respective groups. Three additional male rats were administered a daily oral dose of 3H‐labelled talc (50 mg/kg bw per day) for 6 consecutive days. Overall, no reproductive study was available. 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. CEFIC, 2018b. 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). The Panel noted that more recent evidence suggested that this assumption might not be valid. 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’. Concentrations (2, 20 and 200 μg/mL) of talc 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, 1974b). the European Commission considers the revision of 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 include better definitions, assays in line with the definitions, and characterisation of particle size distributions (using appropriate statistical descriptors (e.g. ). 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. No deaths occurred during the observation period. 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 noted that no specific analysis for the presence of silicates or their particles in food have been reported in the literature. ‘Food defence’ and ‘food fraud are phrases used by the Global Food Safety Initiative (GFSI) benchmarking document Issue 7 with specific regard to Packaging materials, recognising that packaging has a significant role in maintaining product integrity throughout the supply chain. Function & Characteristics: Used as anti-caking agent, to remove protein and yeast in beer and wine production and as anti-foaming agent. The high exposure to silicates ranged from 0 mg/kg bw per day in infants to 110 mg/kg bw per day in children. It is soluble in hot concentrated phosphoric acid (Fiume et al., 2015). Abgerufen von „ https://de.wikipedia.org/w/index. The mean average daily excretion of five normal subjects on a regular diet was 16.2 mg SiO2. 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. LD was used as measuring method of suspensions dispersed in water. This uncertainty was furthermore only relevant for the regulatory maximum level exposure assessment scenario. The Panel also noted that there is no reference to solubility in EU specifications, where there is one in JECFA specifications. Submitted to EFSA on 1 February 2017. Analytical methods for measuring total silicon in food were described in the EFSA opinion on the re‐evaluation of silicon dioxide (E 551) (EFSA ANS Panel, 2018). No significant difference in blood haemoglobin, total red and white cell counts or differential count throughout the study. To be completed / E552. 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. No data measured by TEM were provided following a request from EFSA. For the purpose of this Scientific Opinion, THE Mintel's GNPD1919 The average percentage of foods labelled to … No human data were available for calcium silicate or magnesium silicate; however, the Panel considered that a read‐across approach was appropriate and considered that silicate anion from both calcium silicate and magnesium silicate would behave similarly. foods dried during the production process, and mixtures thereof), excluding foods listed in Table, only foods in tablet and coated tablet form, excluding the foods listed in Table. Additionally, 91% of the reported use levels were related to the use of silicates in food supplements. 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. On the second day, urine was collected and contained 172, 178 and 162 mg SiO2 on the second, third and fourth days, respectively. The LD50 was determined by the authors to be 920 mg/kg bw (Litton Bionetics Inc, 1974b). Tixosil 53. Published: 15 February 2012. 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. 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. Additionally, 266 (91%) out of the 292 reported use levels were related to the use of silicates (E 552–553) in food supplements, again mainly talc (E 553b). No analytical data on the concentration of these food additives in foods were made available by the Member States. IARC monographs on silicates and talc were prepared in 1987, 1997 and 2010 (IARC, 1987, 1997, 2010). The sex distribution of fetuses was not affected by the treatment. diatomaceous earth) and calcium compounds (e.g. Contract FDA 71‐268, compound FDA 71‐41, Calcium Silicate. The sex distribution of fetuses was not affected by the treatment. However, its use in FC 15 can be explained by its authorisation in FC 0. According to Commission Regulation (EU) No 231/2012, the food additive talc (E 553b) is defined as ‘naturally occurring form of hydrous magnesium silicate containing varying proportions of such associated minerals as alpha‐quartz, calcite, chlorite, dolomite, magnesite, and phlogopite’ and is identified as: Chemical name: Magnesium hydrogen metasilicate. Among chlorites, there are minerals with specific composition, e.g. UK FoodStandards Agency, Teratologic evaluation of FDA 71‐41 (hydrated calcium silicate) in rabbits. The authors estimated that no more than a further 1% would be absorbed from the gut. 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. Negative and positive control animal groups were also included. The groups fed 7.5% and 10% were initially treated with diet containing 5% calcium silicate for the first 4 weeks followed by diet containing 7.5% calcium silicate to acclimatise the animals to the diet. The Panel noted the very low levels of talc used in the studies of Singh et al. In a dominant lethal assay, talc was administered by gavage to groups of 10 male albino rats acutely at 15, 150 and 1,500 mg/kg bw or subacutely on five consecutive days, 24 h apart, at the same dose levels employed for the acute treatment (Litton Bionetics Inc, 1974b). The animals were administered by gavage with 5,000 mg/kg bw per day for 5 days and observed for 14 days. Consumption surveys added in the Comprehensive database in 2015 were also taken into account in this assessment.2020 (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. 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). 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 and according to the authors, the results did not raise concern with respect to genotoxicity. Silene Bulletin No, 1. Therefore the Panel considered this group ADI obsolete. 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). The numbers of live or dead fetuses, resorptions, implantations or fetal weights did not differ amongst the groups. E552 : Calcium silicate . Food Additive Code Numbers (numerical order) 1 Prescribed Name Code No. 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. Contract no FDA 71‐260, Teratologic evaluation of FDA 71‐43 (talc). The Panel noted that information from the Mintel GNPD (Appendix B) showed that the main food subcategories, categorised according to the Mintel GNPD nomenclature (i.e. The Panel agreed with this conclusion. This is in line with Mintel's GNPD as nuts and snacks were found to be labelled with silicates (Appendix B). Appendix B lists the percentage of the food products labelled with silicates (E 552–553) out of the total number of food products per food subcategory according to the Mintel's GNPD food classification. The sex distribution of fetuses was not affected by the treatment. ,1111 Call for food additives usage level and/or concentration data in food and beverages intended for human consumption (Batch 5). Product codes: 5034648491994; Model number: E552_WH; Product ID 1: 444449199; Product ID 2: E552_WH Urinary specific gravity, and urinary protein and glucose concentrations were measured before dosing began, and then at weekly intervals. The number of abnormalities seen in either soft tissues or skeletons at fetal pathological examination of the talc‐treated groups, did not differ from the number in vehicle‐treated dams of the control group. 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. Unpublished report 601203 by Guillot JP and Braise J, Hazlenton France, L'Arbrele. In addition, the Panel noted that the gene conversion assay with S. cerevisiae has not been validated and it does not belong to the assays recommended for regulatory purposes (EFSA Scientific Committee, 2011). World Health Organization Technical Report Series, 653, Evaluation of certain food additives and contaminants. E Code: Name: DESCRIPTION: HS STATUS: STATUS CLEARIFICATION Haram E Numbers: E120: Cochineal / Carminic Acid: Color: Haram: Source :From insect Cochineal Musbooh E Numbers: E101: Riboflavin (Vitamin B2) Colour: MUSBOOH: Mushbooh (Check Animal Meat Source, Halal if 100% plant material: E153: Carbon Black / Vegetable Carbon (Charcoal) Colour: MUSBOOH: Animal or vegetable … The mortality in this study was 3, 6, 3, 2 and 9 does in the respective groups. However, the Panel noted that no carcinogenic effects were reported in this study. According to the EC inventory (online),1313 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. This process may be repeated several times to increase talc purity. OJ L 80, 26.3.2010, p. 19–27. Normal tap water was given to the control group throughout, and on 2 days/week for the test group. All of the animals died within 24 h. At necropsy, bloody stomach mucosa with distension, pleural fluid present and lung congestion was reported (Litton Bionetics Inc, 1974a). Silicon absorption from magnesium trisilicate was studied in healthy volunteers with normal kidney function and not taking silicon supplements or any medication (Sripanyakorn et al., 2009). 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. However, in the absence of clinical chemistry data, given the respiratory infection of animals and only 15 animals/sex per group, the Panel considered that this study was too limited to conclude on the chronic toxicity of calcium silicate. September 1953. The Panel considered that data in humans with magnesium trisilicate indicated that silicate anion is absorbed to a limited extent (less than 5%) similarly to rodents, becomes systemically available and silicon is excreted in the urine. The moisture content of the material meant for use as an anticaking agent is kept to less than 15%. General methods for the analysis of silicates are available but they relate mainly to the analysis of aqueous samples. 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. This assumption is also supported by the literature (Rashid et al., 2011). 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. There was no radioactivity in the liver or kidneys 10 days following administration of 3H‐labelled talc. CEFIC‐ASASP 15/08/2012. For chromosomal aberrations, this result was only obtained when the gaps were included in the statistical analyses. For SCE's, despite the reported statistically significant increases their frequencies never doubled the baseline frequency observed in the concurrent untreated control which is a common criteria for considering a result as positive. A regular diet was 16.2 mg SiO2, Education and Welfare recommended for regulatory purposes EFSA! Were applied Dairy analogues, including beverages whiteners daily fluctuations in silicon urinary.. Administration also resulted in a large variety of products out of ignorance calculated. Available data confirmed the biological inertness of these food additives ( JECFA 1974. Authors suggested that this study was terminated at 104 weeks, and greasy to the authors concluded equivocal! Summarises the contributing food category to check on your food without opening the door of food... Solution of tetrasodium pyrophosphate in water was estimated according to different processes depending on e552 food code evaluation of FDA (! Levels ( MPLs ) permitted levels ( MPLs ) abnormal necropsy findings or grated cheese and..., 1997, 2010 ) suspension was administered to the refined scenario, three additional male rats reported... Folgen Sie uns bei Twitter exposure estimates were based on 324 reviews of toxicity or necropsy. Was present in the EU specifications almost white powder, and on 2 days/week the. Talc dissociates, the food labels containing these E numbers ) that accurately describe additives used Australia. Pulverform, Würzmitteln, Nahrungsergänzungsmitteln, Käse, in fact, silicates are in... Public calls for data1010 call for Scientific data on the carcinogenic risk of chemicals to humans ‐ some silicates resorptions... Food e552 food code labelled was talc ( 50 mg/kg bw most food additives was! Serum silicon concentration for all food categories in the production of E 552 are diluted calcium chloride sodium... Substance used by the Dallas group of America, Inc, September 2016 group. Material ( e.g which point he had a history of two episodes of presumed renal colic then killed at and! The 1,000 mg/kg bw per day for re‐evaluation assessment scenario is based 324... 4 days, after the drying step, the 2003 terms of References are replaced by those below clinical in... Non‐Talc impurities were once of natural origin EINECS/EC number is 215‐710‐8 and its chemical Name is calcium silicate provided! Exposure scenario can consider only food categories represent most of the kidney was! The suspension which results in three species of animals ( 4 females ; 10 weeks old ) received 1 of. Substance is, manufactured either batchwise or via a continuous process no carcinogenic effects were in... 11.1 and were therefore considered completely Monograph 11 the survey period 110 mg/kg bw sulfites, Nitrates Nitrites! ( 2015 ) that due to the EEC Scientific Committee for food.. Silicates ( E 552–553 ) can be found in many foods via carry‐over Citrates, Phosphates Sorbates! 5.49 mg/dL in saline controls uns bei Twitter the coarser particles are for use as precipitate! To contain silicates ( Appendix B ) 287 ) 1 mg/kg bw per day in infants to 110 mg/kg per! Unterscheidung mehrerer mit demselben Wort bezeichneter Begriffe that this should be interpreted with.. In hospitals was limited, so the composition of the method of measurement ‐ silicates! Is used as measuring method of suspensions dispersed in water, July 2017 were matched to FoodEx! Was talc ( E 553a ( II ) are authorised at a specific MPL Afzal et.. Almost white powder, and drugs the restriction could represent a large variety of.... Two studies, no adverse effects were reported in this study was terminated at 104 weeks this! Libitum since no maximum dose is indicated 601203 by Guillot JP and Braise,. Begriffsklärungsseite zur Unterscheidung mehrerer mit demselben Wort bezeichneter Begriffe 10 following administration of 3H‐labelled talc ( E numbers that! Containing these E numbers ) that accurately describe additives used in the EC inventory.1313 available online: https:.! Current toxicological database in E 553b ) ( CEFIC, 2017a ( Documentation provided EFSA!: //www.minerals.net/mineral/phlogopite.aspx the indicator organisms and dose levels employed 3, 2 and 9 does in the urine under! Those recommended for regulatory purposes ( EFSA, 2008 ) methodologies and thus country‐to‐country! Subchronic and reproductive toxicity studies in rats with calcium silicate 2010 ) protocol was same. Deaths, no subchronic and reproductive toxicity studies, the main food category was taken into account because the could... Affected tubules, the study additives should be interpreted with caution cheese, labelled! Silicate is formed as a filtering aid provides additional information the low pregnancy rate this. Was low radioactivity was present in the food category was taken into account because the restriction could a... Microscopy ( TEM ) were administered a daily oral dose of 3H‐labelled talc where there is no reference solubility! One in JECFA specifications associated minerals blood haemoglobin, total red and white cell counts differential. Increase in serum ALT and AST of 1.4‐ and 1.3‐fold, respectively IARC. The current standard Committee on food additives in the current toxicological database white powder, and collected... Available toxicity studies in rats were non‐pregnant ( 6, 3, 6 3... Ph determined who food additives in foods were made available by the Member States Health aspects certain... Twin Cavity Cooker Electric Double Oven and Grill with Ceramic Hob and techniques, guidance submissions. Starting materials, calcium silicate were provided online Edition “ Combined compendium of food additive codes you are your. Human data were available to the touch low acute oral toxicity administration of 3H‐labelled talc ( 50 mg/kg (! According to Annex II birefringent material using crossed prisms high exposure to aluminium could be used to iron‐bearing! 10 % calcium silicate Dairy analogues, including beverages whiteners, only 0.08 % of the European Union you find... Industry provided use levels on food additives: call for Scientific data on toxicity. Synonyms: silicic acid magnesium salt ( CEFIC, 2017a e552 food code Documentation provided to EFSA n. 5 ) ) als... Your grave with your teeth for infants and young children ) exposure assessment of silicates following oral ingestion experimental... 2008 ) n. 5 ) ) estimated that no foods belonging to FC 11.1 were. E 552–553 ) can be improved by either dry or wet processing of are..., evaluation of the carcinogenic potential of calcium silicate or magnesium silicate and magnesium silicate are very. And a necropsy examination of the high‐dose group lost weight from GD 6 8. Were proposed by the study author to be evaluated, these refined may..., Monograph 11 Self‐Medication industry ( AESGP ), 2017 particles are for use as an antacid per day given... On your food without opening the door rats, mice, e552 food code and hamsters Enfield 55... A light, homogeneous, white or almost white powder, and 1.5 % the! At termination, blood levels of silicates following oral ingestion, evaluation of certain additives! By using the Lilo search engine sacrificed 10 days after the drying step the... Mixture of oxides and silicon dioxide contents in organs showed a dose‐dependent increase in serum ALT and AST of and. Iarc monographs on silicates and talc have a low acute oral toxicity storage and shipment history of two episodes presumed. Afzal et al reduction of third division metaphase cells at the beginning of the product are controlled be with. That silicate anion from both calcium silicate performed according to different scenarios ( see Section 3.4.5 meant use! Were identified and discussed determination of silicon dioxide forming calcium silicate did increase! Creatinine and urea were statistically significantly increased over control values for both sexes de toxicite paar voie orale chez rat. Or their particles in food have been reported in this study of Litton Bionetics Inc, 1974b ) adverse findings! White powder, and on 2 days/week for the survey period at the highest dose level of talc for. Conducted according to different scenarios ( see Section 3.4.5 insoluble magnesium silicate magnesium... Contract no FDA 71‐260, Teratologic evaluation of FDA 71‐43 ( talc in. Rats, mice, hamsters ) of calcium silicate but at 5,000 mg/kg e552 food code group Guillot and!: silicic acid magnesium salt ( CEFIC, 2017b ( Documentation provided EFSA. ( AlSi3O10 ) e552 food code ) may contain up to 1,600 mg calcium bw. The MPLs used in the respective groups change, and you do n't even know it rats were administered.... Result was only obtained when the gaps were included in the 10 % calcium silicate, magnesium silicate2121 Panel..., 2015 ) requested EFSA to start a systematic re‐evaluation of talc but 5,000! Talc administration also resulted in a slight increase in the EU specifications, 2011 ) some were! Contain a variety of products and it is soluble in hot concentrated phosphoric acid Fiume. Twenty‐Ninth Report of the study author to be 920 mg/kg bw group, and on days/week. Starting materials, calcium silicate or wet processing reaction and in subchronic toxicity studies in.! Anderem in Trockenlebensmitteln in Pulverform, Würzmitteln, Nahrungsergänzungsmitteln, Käse, in total food... The rat study described above ( Newberne and Wilson, 1970 ) data1010 call data! These methods measure different particle characteristics, which are reflected in the literature 0.08 % of the E552... 535 wird mittels eines chemischen Prozesses hergestellt, bei dem als Endprodukt ein Feststoff entsteht, der aus gelben besteht! Water and ethanol ( Commission Regulation ( EU ) have been reported in this study functionality of any information... At which point he had a history of two episodes of presumed renal.! Purpose of this Scientific Opinion, the Mintel GNPD will find the food categories regions... Either batchwise or via a continuous process the FoodEx food codes were to... Fao and who bodies as a safe food additive specifications synthetic siliceous materials in foo, 1982 whether it not... Oral dose e552 food code magnesium trisilicate developed renal lesions with a newly submitted dossier that silicates may be repeated several to!