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. Does of the high‐dose group lost weight from GD 6 to 8. It is made for all, by all, and it is funded by all. 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. Nowadays, it is very hard to identify halal e codes so people are eating with pig fat code in food items without their knowledge. EUROTALC, 2018b. Call for scientific data on miscellaneous food additives permitted in the EU and belonging to several functional classes. At 24 h following addition of the test substance, 100 cells in anaphase from each culture were analysed for chromosomal aberrations and no cytogenetic effects were observed. Normal tap water was given to the control group throughout, and on 2 days/week for the test group. Thirtieth Report of the Joint FAO/WHO Expert Committee on Food Additives. Furthermore, the Panel noted that no foods belonging to an important contributing food category in all population groups, i.e. By 24 h after administration, only 0.08% of the dose remained in the gastrointestinal tract. Silicates (E 552–553) are authorised in 28 food categories, including FC 0, according to Annex II to Regulation (EC) No 1333/2008. A second experiment was additionally performed under the same experimental conditions with only one dose‐level of calcium silicate at 5,000 mg/kg. Available online: https://echa.europa.eu/information-on-chemicals/ec-inventory 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). 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. Information on a method for the detection of talc (E 553b) in food or beverage samples was submitted by industry (EUROTALC, 2012 (Documentation provided to EFSA n. 10)). 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. Most of the data provided to EFSA referred to talc (E 553b) (n = 287). 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 EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of calcium silicate (E 552), magnesium silicate (E 553a) and talc (E 553b) when used as food additives. According to industry (CEFIC, 2017b (Documentation provided to EFSA n. 5)), magnesium silicate (E 553(i)) – CAS 1343‐88‐0 and an EINECS number 215‐681‐1 – has the name ‘Synthetic amorphous magnesium silicate, with molar ratio (SiO2:MgO) range of 1.4‐4’. Taking into account the analysis by TEM provided by industry, calcium silicate falls under the definition of nanomaterial according to the Commission Recommendation 2011/696/EU. The sex distribution of fetuses was not affected by the treatment. ’ submitted by the Nordic Council of Ministers to the Commission, provides additional information for the prioritisation of additives for re‐evaluation. Response to EFSA's letter dated 9 June 2016‐ Request for additional information. The numbers of live or dead fetuses, resorptions and implantations, as well as the fetal weights did not differ among the groups. The FCs 17.1/17.2/17.3 Food supplements, in solid, liquid, syrup‐type or chewable form, the form cannot be differentiated and the same use level was applied to the whole FC 17. E552 can be used by all religious groups, vegetarians and vegans. Urine and faeces samples were collected at 24 h intervals for 4 days and then on day 10 following administration. Aluminiumsilicat (E559) ist ein natürlich vorkommender Stoff. ripened cheese, were labelled to contain silicates (E 552–553) according to the Mintel GNPD. In accordance with the guidance provided in the EFSA opinion related to uncertainties in dietary exposure assessment (EFSA, 2007), the following sources of uncertainties have been considered and summarised in Table 8. The LD50 was determined by the authors to be 3,400 mg/kg bw (Litton Bionetics Inc, 1974a). FDA contract 71‐260. The report ‘Food additives in Europe 200055 At necropsy on GD 20, animals that had received doses up to 1,600 mg talc/kg bw per day appeared to be completely normal and had no noticeable effects on implantation nor on maternal and fetal survival. The committee requested short‐term studies to differentiate between medicinal magnesium trisilicate and the insoluble magnesium silicate in food processing. Synthetic hydrated magnesium trisilicate was then given to each subject in the form of 0.5 g compressed products suspended in water. SEM data for talc indicated a range of particle size distribution of 20–40 μm (EUROTALC, 2018; Documentation provided to EFSA n. X). Published 24 May 2016. No particles had sizes below 100 nm. As such, silicates (E 552–553) can be found in many foods via carry‐over. No data measured by TEM were provided following a request from EFSA. It contains information of over 2.5 million food and beverage products of which more than 900,000 are or have been available on the European food market. For the food categories authorised at QS, the maximum reported use levels when available was used (Appendix C). In the REACH registration dossier, water solubility of calcium silicate has been reported to be in the region of 260 mg/L, using EU Method A.6 (which extends the measurement time for several days) (CEFIC, 2017a (Documentation provided to EFSA n. 4)). Drying is performed according to different processes depending on the characteristics required for the final product. 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). An ADI ‘not specified’ was allocated for talc, provided that the talc used in food processing complied with the new specifications (JECFA, 1987). 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. The highest dose group was fed a diet containing 10% calcium silicate from 11 weeks. Regulation (EC) No 1831/2003 of the European Parliament and the Council of 22 September 2003 on additives for use in animal nutrition. The authors estimated that no more than a further 1% would be absorbed from the gut. The Panel noted that crystalline silica is a class 1 carcinogen by inhalation (IARC, 1997) and no maximum limit for quartz has been established in the EU specifications for talc (E 553b). The Panel noted that the test substance used by the authors was given as CAS Number 15702‐53‐1. Two days after magnesium trisilicate had been stopped, the excretion had fallen to 24.5 mg and reported by the authors to be within the normal excretion range of these subjects. Calcium silicate, magnesium silicate, magnesium trisilicate and talc are permitted as ingredients in cosmetic products and as an excipient for drugs. For the present assessment, food consumption data were available from 33 different dietary surveys carried out in 19 European countries (Table 6). After 10 days, the animals were sacrificed, and the liver, kidney and gastrointestinal tract removed for determination of radioactivity. (2018) was not characterised and, according to Singh et al. Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) no 1333/2008 of the European Parliament and of the Council. You are destroying your own health, and the health of your kids and you are paying for it out of ignorance! Considering only the food categories for which use levels were provided, nine food categories were included in the refined exposure assessment to silicates (E 552–553), including the two FCs 15.1 and 15.2 and excluding exposure via food supplements (Appendix C). The authors reported animals showing slightly rough fur, decreased activity and light‐coloured faeces; no adverse pathological findings were reported. The highest dose level of talc (3,000 mg/kg) corresponded to the calculated LD5. 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. The Panel noted that the main food category labelled with silicates (E 552–553) in the Mintel GNPD was also food supplements (Appendix B). Therefore, the use of these substances as food additives was ‘not limited except for good manufacturing practice’ (JECFA, 1969). This decreased to 5.1% in the 200 mg/kg bw group, and 1.5% in the 1,000 mg/kg bw group. 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. 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). However, most of the data in these monographs relate to the inhalation toxicity and do not include any good quality oral chronic toxicity or carcinogenicity studies. FASEB, 1979. more data on the actual usage and use levels of silicates (E 552, E 553a(i)), E 553a(ii)) should be provided because most of the data submitted were for talc (E 553b). In addition, biological relevance of SCEs is unclear and the test for induction of sister chromatid exchanges does not belong to the assays recommended for regulatory purposes (EFSA Scientific Committee, 2011). http://www.minerals.net/mineral/phlogopite.aspx. 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. Response to EFSA's letter dated 9 June 2016‐ Request for additional information. 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 this study, essentially complies with the OECD Guideline 475 requirements, although it was performed before this Guideline was established. Optionally, after the drying step, the product can be milled and/or granulated. The mean baseline fasting serum silicon concentration for all participants reported in this study was 113.9 μg/mL. The solubility of three non‐food‐grade commercial magnesium silicates by following this approach varied between 127 and 268 mg/L. ASASP (2012). 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. On the second day, urine was collected and contained 172, 178 and 162 mg SiO2 on the second, third and fourth days, respectively. 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. The SCF also concluded that: ‘any silicate absorbed is excreted by the kidney without evidence of toxic accumulation in the body, except for the reported damage to dog kidney by magnesium trisilicate and sodium silicate’. No chemical formula, molecular weight and EINECS number indicated. According to industry, the manufacturing process for calcium silicate (E 552) comprises the following stages: dilution of raw materials, mixing and precipitation, solid–liquid filtration/washing, drying and packaging. Reported use levels were only available for seven food categories in the refined scenario. For the remaining food categories, the mean of the typical reported use levels of silicates was used. According to the Mintel's GNPD, silicates (E 552–553) were labelled on more than 1,000 products between January 2013 and January 2018. no confirmed cases of kidney effects have been found in the EudraVigilance database despite the wide and long‐term use of high doses of magnesium trisilicate up to 4 g/person/day over decades. Volume 93. At necropsy on GD 20, animals that had received doses up to 1,600 mg calcium silicate/kg bw per day appeared to be completely normal and had no noticeable effects on implantation nor on maternal and fetal survival. Average silicon dioxide contents in organs showed a dose‐dependent increase in the liver and kidney, with the highest levels found in the kidney. For talc (E 553b), arsenic and lead are accepted up to concentrations of 10 and 2 mg/kg. However, the authors also reported that stone analysis in hospitals was limited, so the composition of the stones might not be accurate. 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. On the basis of these distributions, the mean and 95th percentile of exposure were calculated per survey and per population group. The author of this study did not consider the intake of magnesium trisilicate to be excessive, and that if the stones were due to magnesium trisilicate then more silica stones should have be reported. Geneva, Switzerland, Monograph 1. Belling E552 Freestanding Electric Cooker, Silver installation guide Made in the UK, Belling produce classic looking cookers that add a touch of classic sophistication to your home. There were no abnormal findings involving the glomeruli. The numbers of live or dead fetuses, resorptions, implantations or fetal weights did not differ amongst the groups. 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. Food Additive Codes You are digging your grave with your teeth! Peak urinary and serum concentrations of silicon were reached after 1–2 h (10.68 mmol/L and 2‐ to 3‐fold above the baseline of approximately 30 μmol/L, respectively). 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. Following an European Food Safety Authority (EFSA) request, no TEM data were provided for magnesium silicate (E 553a(i)) and magnesium trisilicate (E 553a(ii)). Sprague–Dawley CD rats (5 males/group, average weight 250 g) were administered a single oral dose of talc (0, 50, 100, 500, 1,000, 2,000 or 3,000 mg/kg bw) suspended in saline by gavage. The sex distribution of fetuses was not affected by the treatment. This represents at the maximum 2.5% of all food products within the food category (Appendix B). Groups of five male albino rats were administered with test substance by gavage 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. 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. The study was terminated at 104 weeks, and liver, kidney and spleen wet weights determined. FAO Nutrition Meetings Report Series, 46A, Toxicological evaluation of some food additives including anticaking agents, antimicrobials, antioxidants, emulsifiers, and thickening agents. At 24 h following addition of the test substance, 100 cells in anaphase from each culture were analysed for chromosomal aberrations and no cytogenetic effects were observed. 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. Calcium silicate is used as an anticaking agent in food preparation, including table salt and as an antacid. For children, the main contributing food categories in the brand‐loyal were FC 01.7.2 Ripened cheese, FC 05.2 Other confectionery including breath freshening microsweets and FC 05.3 Chewing gum. 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). To be completed / E552. 01.7.2 Ripened cheese, only sliced or grated cheese hard and semi‐hard cheese. Submitted to EFSA on 15 November 2016. Following the single dose of 3H‐labelled talc, approximately 75% and 95.8% of radioactivity was found in the faeces within the first 24 h, and 96 h, respectively. In 2003, the Commission already requested EFSA to start a systematic re‐evaluation of authorised food additives. After 4 months, all animals were killed and a necropsy examination of the kidneys conducted (no other organs were examined). There were no deaths, no signs of toxicity or abnormal necropsy findings. Dietary restrictions: None. 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). This exposure source is covered in an additional scenario detailed below (food supplements consumers only scenario). The effects on the kidney reported in guinea pigs treated with magnesium trisilicate could be due to higher concentrations in the primary urine as a consequence of lower glomerular filtration‐rates in guinea pigs (2.29 mL plasma/min per kg; Neiberger, 1992) as compared to rats (4.63 mL plasma/min per kg; Pestel et al., 2007). Therefore, information on actual use levels is required for performing a more realistic exposure assessment, especially for those food additives, which are authorised according at QS in all or part of the authorised food categories. Finally, the talc is filtered, washed and dried, and may be heat sterilised (CIR, 2013; Fiume et al., 2015). No gross pathology or histopathological findings that could be attributed to calcium silicate were observed in rats of the 1% and 5% calcium silicate groups. 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 Negative and positive control animal groups were also included. Pooled faeces were collected prior to termination for the determination of silicon dioxide content. Information on particle size of calcium silicate analysed by laser diffraction (LD) and transmission electron microscopy (TEM) were provided. The sex distribution of fetuses was not affected by the treatment. A possible additional exposure from the use of silicates as food additives in food additives and nutrients in accordance with Annex III to Regulation (EC) No 1333/2008 (Parts 1, 2 and 5A) was not considered in any of the exposure assessment scenarios. 98% of the reported use levels referred to the use of talc (E 553b). Other substances, Glutamates of natural origin observation period France, L'Arbrele basis the... 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