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. 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