e551 food additive

Does nanostructured synthetic amorphous silica in industrially manufactured powered food products disintegrate after oral uptake? However, it was stressed that to estimate the fraction below 100 nm for particle size distribution, multiple conversions need to be performed: i.e. 260. 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 November 2017. Robust study summary. Table 1 quantum satis. Fumed silica nanoparticles (NM 203) interacted with macrophages more strongly than the precipitated NM‐200 and triggered a more evident inflammatory response, as assessed by nitric oxide synthase 2 induction, NO production and the secretion of tumour necrosis factor (TNF)‐α, IL‐6 and IL‐1β’. Recently modified products. EU references in FSA guidance documents. A prenatal developmental toxicity study with precipitated nano‐precipitated silica (NM‐200, (JRC, 2013), Appendix B) (BASF, 2013 (Documentation provided to EFSA n. 3); Hofmann et al., 2015) was performed in Wistar rats in compliance with OECD TG 414 and GLP. the EU specifications for silicon dioxide (E 551) are insufficient to adequately characterise silicon dioxide used as a food additive. The study was conducted with an inductively coupled plasma high‐resolution mass spectrometer (ICP‐HRMS) operated in a standard and a single particle inductively coupled plasma high‐resolution mass spectrometry (spICP‐HRMS) mode. nanomaterials Article Toxicity to RAW264.7 Macrophages of Silica Nanoparticles and the E551 Food Additive, in Combination with Genotoxic Agents Fanny Dussert 1, Pierre-Adrien Arthaud 1, Marie-Edith Arnal 1, Bastien Dalzon 2, Anaëlle Torres 2, Thierry Douki 1, Nathalie Herlin 3, Thierry Rabilloud 2 and Marie Carriere 1,* 1 Université Grenoble-Alpes, CEA, CNRS, IRIG-DIESE, SyMMES, Dietary surveys with only one day per subject were excluded as they are considered as not adequate to assess repeated exposure. Inbifo Institut für Biologische Forschung, Köln. The toxicity of precipitated silica (Sipernat 22, Appendix A) was studied in a feeding study, performed with a protocol close to the current OECD Guideline No 408, with groups of 10 male and 10 female Wistar rats, which received the test substance in the diet at concentration levels of 0%, 0.5%, 2% or 8 % (equal to 0, 300–330, 1,200–1,400 and 4,000–4,500 mg/kg bw per day) for a period of 13 weeks (Degussa, 1981 (Documentation provided to EFSA n. 20); Til et al., 1981 (Documentation provided to EFSA n. 62)). Up to a dose of 5% in the diet, no clinical signs were noted and there were no effects of toxicological relevance on body weight (difference compared with control < 10%) and food consumption. Five male and five female Sprague–Dawley rats received via gavage 31,600 mg/kg bw (no further details). Unpublished report. The shelf life is between 12 and 36 months from the date of production. Civo Institutes TNO, Zeist NL. According to these authors, studies using nanoparticles for oral exposure may lead to misinterpretation and underestimation or overestimation of toxicity of nanoparticles, and it is necessary to assess the synergistic effects of nanoparticles in a complex system when considering the safety of nanoparticles used in food. Submitted to EFSA by CEFIC, July 2016. I have already donated or I'm not interested. Submitted to EFSA by CEFIC, September 2011. SP513 (referred as Degussa AG, 1983d by ECETOC. Doses of 10, 12.6, 15.8 or 20 g/kg bw were tested. What are food additive E numbers? For FC 11.1 ‘sugars and syrups as defined by Directive 2001/111/EC’, no comparable food subcategory could be identified. Microbiological Associates, Rockville, Maryland, USA. ). The same parameters than in the study on mice were investigated. Is a food additive dangerous or not? The Panel considered that while this was expressed as silica by the authors, it was not possible to determine whether it was silica or silicon that was measured. Emulsifiers are additives used in food industry as a means to achieve the emulsion, i.e. Nevertheless, despite the limitations of the toxicological database available with SAS samples closely related to the food additive E 551, there was no indication of adverse effects. 02G10031. The particles were prepared from rice husks; in a first step, microsized particles (0.5–30 μm) were prepared from rice husk, then nanoparticles (30–90 nm) were produced by ultrasonication and stabilisation. Napierska et al. Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food. Overall, the Panel noted that there was evidence that SAS and engineered nano‐silica had a low acute toxicity after oral administration. Submitted to EFSA by CEFIC, September 2011. FSE (Food Supplements Europe), 2016. Studies with precipitated silica (FK 700; Appendix A) and fumed silica (AEROSIL, crystalline‐free (particle size from 10 to 40 nm) were performed in volunteers (each group comprised five men and one woman; aged 22–28 years, not on a controlled diet). The Panel considered that in this study the documentation of data and the number of litters for fetopathological examination were not sufficient to reach a final conclusion. In the non‐brand‐loyal scenario, the mean and high exposure to silicon dioxide (E 551) from its use as a food additive ranged from 0.7 to 18.4 mg/kg bw per day and from 1.7 to 49.7 mg/kg bw per day, respectively. Overall, no adverse effects were induced in rats and mice after chronic oral exposure up to 2,500 mg/kg bw per day in rats and up to 7,500 mg/kg bw per day in mice, the highest doses tested. The LD50 was > 4,000 mg/kg bw for both species (Saruta et al., 1969; study in Japanese, data from an abstract). (2016) examined the presence of nanoparticles in silicon dioxide (E 551) and in food products, and their impacts on human gastrointestinal tract in vitro. The Panel noted furthermore that the estimates for the distribution constants were characterised by a high uncertainty, and that important details of the model were not given. Therefore, eating occasions belonging to these FCs were also reclassified under food categories in accordance with their main component. Van Kesteren et al. The E indicates that it is a "European Union approved" food additive. Submitted to EFSA by CEFIC, October 2017. The Children’s Hospital “St. The data reported in this study have been discussed (Krueger et al., 2017), and in particular, it was considered that the definition of fibrosis as well as the statistical analysis needed reappraisal. The authors concluded that, when compared to precipitated silica nanoparticles, fumed silica nanoparticles exhibit enhanced interaction with serum proteins and cell membranes, and cause greater oxidative stress and stronger pro‐inflammatory effects in macrophages. Zane et al. Robust study summary. Additional food categories for which use levels were submitted were also taken into account in the exposure estimates considering the presence of silicon dioxide (E 551) due to carry‐over (Annex III of Regulation No 1333/2008) as reported by industry. The Panel considered that the uncertainties identified would result in an overestimation of the exposure to silicon dioxide (E 551) in the refined exposure scenario at the reported uses and used levels. According to JECFA specifications for silicon dioxide (JECFA, 2015), silicon dioxide is insoluble in water when solubility is determined after no more than 5 min (JECFA, 2016). Teratology evaluation of FDA 71‐48 in rabbits. particle size distribution). Inconsistent results of limited relevance were observed in in vitro studies for chromosomal aberrations and DNA fragmentation while negative results were observed in vivo for these genetic endpoints. Yun et al. The effect of the presence of food components, such as sugar and protein, on the absorption of nanoparticles was also evaluated by measuring silicon urinary excretion. Silica nanoparticles (12 nm) were identified as the most potent, with particle surface acidity associated with their cytotoxic and inflammatory potency across the cell lines. However, because nanoparticles of silicon dioxide are present in the food additive E 551 (see Table 2), studies performed with specifically designed engineered nanoparticles of SAS have also been included in this assessment in order to assess any toxicity associated with nanoparticles present in the food additive, provided they were prepared using amorphous silicon dioxide. Overall, the Panel agreed with the conclusion of the review by Bellmann et al. These aggregates can further agglomerate to form larger structures. The food additive, silicon dioxide (E 551), is a material comprised of aggregated nanosized primary particles. In primary human umbilical vein endothelial cells, Corbalan et al. Til HP, Hollanders VMH and Beems RB, 1981. This was transient and silicon content in all organs was almost back to the background level on day 14 after administration. Submitted to EFSA by CEFIC, September 2011. The extraction method from food was, however, not described. (2011) study, all the ICR mice, treated as previously described in Section 3.6.1, survived well 1 month after being injected intravenously with MSN and PEG–MSN samples (5 mg/kg), and no pathological abnormality was observed in both gross and microscopic histological examinations. The pyrogenic (fumed) silica forms agglomerates inside the cooling system. , ‘nanomaterial’ means ‘a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1–100 nm’. The biodistribution percentages of MSNs and PEG–MSNs of the particle sizes of 80 and 120 nm in liver and spleen firstly decreased, then increased, and finally decreased again; however, those of 200 and 360 nm decreased continuously in the time period from 30 min to 1 month after injection. Silicon Dioxide (E551), a common food additive made up of particles in the nano-range, is found in spices, salt, sweets and some frozen foods and functions as an anti-caking agent to allow these food products to flow and mix evenly. Publicatie Reeks (2008) studied the toxic effects of nano‐ and microsilica particles in Balb/c and C57BL/6J (black) mice (5 animals of each sex per group) fed for 10 weeks a diet containing 1% of micron (0.5–30 μm) or nanosized (30–90 nm) silica particles. Pellet was re‐suspended in water, Suspension were mixed on a vortex (30 s) and then: stirred using magnetic bar (15 min); or sonicated 120 s; or sonicated in water bath for 15 min, Ultrasonic probe used as dispersing technique, Primary particles (20–50 nm) were aggregated, All samples contained agglomerates (0.5–2 m); the mean diameters of all primary particles below 100 nm with mean primary particle sizes of 9–26 nm (no quantification), Nanoparticles of SAS observed in 10 out of the 13 samples (no quantification). No adverse clinical effects were induced at doses up to 20,000 mg/kg bw. The regulatory maximum level exposure assessment scenario is based on the MPLs as set in Annex II to Regulation (EC) No 1333/2008 and listed in Table 4 and/or on the maximum reported use levels provided by industry for food categories in which the food additive is allowed at QS, as described in the EFSA Conceptual framework (EFSA ANS Panel, 2014). There were some indications from in vitro studies for structural and/or numerical chromosomal aberrations with intentionally engineered nano‐SAS. (2016) used, in addition to the analytical techniques as in the study described above Contado et al. Despite the limitations in the subchronic, reproductive and developmental toxicological studies, including studies with nano silicon dioxide, there was no indication of adverse effects. Submitted to EFSA by CEFIC, September 2011. The only reported effect was an increased (doubling) serum ALT of BALB/c and C57BL/6 mice fed the diet with nanosized and microsized silica. The committee established an ADI ‘not limited’ for silicon dioxide and certain silicates. SAS has been traditionally used as food additive under the code E551; however, there is still a lack of detailed methodologies for the determination of SAS’ particle size and concentration. January 1963. Overall, as regards SAS, no reproductive toxicity was noted in a study, which was limited since only one low dose of AEROSIL was tested in a small group of pregnant rats. Products from the Canned foods category - 7 products: However, the relevance of this finding was questionable since the initial weight of dams in this group at GD 0 was 8 % lower than in controls. Blood and urine samples of four rats per sex per dose were collected for haematology and urinalysis (parameters: pH, albumin, glucose, ketones, sediment, bilirubin, occult blood) at 6, 13 and 26 weeks after initiation of the exposure period. Overall, the subchronic toxicity of SAS, including food‐grade material, appeared low. In Vitro Colloidal SAS did not show evidence for mutagenicity in the bacterial gene mutation assays (Ames test) in a study of high relevance (Kwon et al., 2014). Study No. These results were not considered relevant by the Panel for the re‐evaluation of silicon dioxide (E 551), since this material is not used as a food additive. 878894. (2015) observed that after incubation at a concentration of 100 mg/cm2, stable fluorophore/silica nanoparticles (30 nm) were visible in the cytoplasm but not in the nucleus of cells from the mouse macrophage cell line MH‐S, and of C2BBe1 (derived from Caco‐2) cells. Gavage studies on prenatal developmental toxicity of silica gel (Syloid 244; Appendix A) were performed in mice (FDRL, 1973a (Documentation provided to EFSA n. 30)), rats (FDRL, 1973c (Documentation provided to EFSA n. 32)), hamsters (FDRL, 1973d (Documentation provided to EFSA n. 33)) and rabbits (FDRL, 1973e (Documentation provided to EFSA n. 34)) using a similar experimental design. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Members States relating to food supplements. All food additives are listed below by code number and by name There are about 350 permitted food additives in Australia/New Zealand. The mean diameter of synthetic amorphous silica is typically in the micrometre range’. Silica particles, identified by the fluorescent dye, were trapped by macrophages in the spleen and liver until 4 weeks after the single injection. Silicon dioxide (E 551) is authorised as a food additive in the EU in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008 on food additives and specific purity criteria have been defined in the Commission Regulation (EU) No 231/201233 Necropsy of rats after 45 or 90 days of treatment revealed no test item related effects. No effects of toxicological relevance on body weight were reported (difference to control < 10%). Fu et al. Nevertheless, the EFSA Comprehensive Database represents the currently best available source of food consumption data across Europe. The Panel stated that silicon occurs naturally in foods as silicon dioxide (silica) and silicates, and may also be added as an anticaking and antifoaming agent in the form of silica, silicates and dimethylpolysiloxane. None of these substances induced any signs of intoxication during the 14‐day post‐exposure observation period except increased size of faecal pellets due to the indigestibility of the test substances. AEROSIL (130, 150, 200, 300, 380, OX 50), Ultrasil VN 2 and VN 3, Sident 3, Sipernat 22, 30 or 42, Silteg AS 7 and AS 9, Appendix A). The biochemical compositions of liver tissues and serum were analysed by integrated metabonomics analysis based on gas chromatography–mass spectrometry (GC‐MS) and in combination with pattern recognition approaches. AF4‐ICPMS: in 7 out of the 11 samples particles < 100 nm (number of particles/L 10−11 range 0.1–11.4). According to Commission Regulation (EU) No 231/2012, the food additive silicon dioxide (E 551) is defined as ‘an amorphous substance, which is produced synthetically by either a vapour‐phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel or hydrous silica. Serum biochemistry and haematological examination was performed. Primary particle size was 9–26 nm within agglomerates of 0.5 to 2 μm. Ultrasonication 3 min, Concentration 0.8% w/v. About 50 are likely to cause adverse reactions. In addition, when reported by the authors, the percentage of absorbed SiO2 is usually very low (3%). Therefore, in the present assessment, the 95th percentiles of exposure for infants from Italy and for toddlers from Belgium, Italy and Spain were not estimated. Maier M, Albers P, Babick F, Retamal Marín RR and Stintz M, 2014. Bericht vom 2. Putman DL and Morris MJ. (2016). Eleven different food‐grade samples were analysed using DLS, MALS, asymmetric flow‐field flow fractionation (AF4), inductively coupled plasma mass spectrometry (ICP‐MS) and TEM. They reported ‘when incubated in protein‐rich fluids, NM‐203 adsorbed on their surface more proteins than NM‐200 and, once incubated with macrophages, elicited a greater oxidative stress, assessed from Hmox1 induction and ROS production. Silicon dioxide was reviewed by TemaNord (2002) along with calcium silicate, magnesium silicate, magnesium trisilicate and talc. Only one use level was reported by industry on a niche product of FSMP described as special infant formulae (Appendix D). Silicon is an inorganic compound, which is broadly present in the natural environment. Untersuchungsbericht über den Einfluß polymerer Kieselsäuren auf die renale SiO. Submitted to EFSA on 31 May 2016. Tenzer et al. Laboratory No. In this article we'll discuss e551 food additive. No dose‐related alterations of organ weights were recorded except reduced absolute liver weights (no data about relative weight) in females of the mid‐ and high‐dose group after 12 and 24 months; body weight was reduced by less than 10%. range, median, quartiles) as well as the percentage (in number and by mass) of particles in the nanoscale (with at least one dimension < 100 nm) present in silicon dioxide (E 551) used as a food additive. Снеки «Бульбарикы» сметана зелень. silica gel, precipitated silica, pyrogenic (fumed) silica and colloidal silica (silica sol)), colloidal silica is not authorised as a food additive (E 551). Unpublished report V 81.268/201741. List of representative Nanomaterials (December 2014), JRC Nanomaterials repository. Grace GmbH, 1975a. Finally, the Panel noted that, as already noted by others (Fruijtier‐Poelloth, 2012), the test material was amorphous silica of biogenic origin and may include impurities of crystalline silica. Mintel started covering EU's food markets in 1996, currently having 20 out of its 28 member countries and Norway presented in the Mintel's GNPD.1616 Silicon dioxide is also used in cosmetic products, as excipient in drugs and as a source of silicon in food supplements (Directive 2002/46/EC). Histopathology of ‘representative’ rats of control and treatment groups after 90 days of exposure did not reveal any significant findings. Rabolli et al. Di Cristo et al. According to information provided by interested parties (CEFIC, 2016a (Documentation provided to EFSA n. 15)), amorphous silicon dioxide is an inert substance that has a tendency to adsorb moisture and volatile substances. Because nanoparticles of silicon dioxide are present in the food additive E 551, studies performed with specifically designed engineered nano silicon dioxide have also been included in this assessment in order to assess any toxicity associated with nanoparticles present in the food additive, provided they were prepared using amorphous silicon dioxide. Uncertainties in the exposure assessment of silicon dioxide (E 551) have been discussed above. Interphase phenomena in a composite system based on methylsilica and crushed mushrooms Amanita muscaria. Silica gel (Syloid 244; Appendix A) was tested in a feeding study in rats (Grace GmbH, 1975a, 1975b (Documentation provided to EFSA n. 43 and 44)). In a subchronic feeding study, male and female albino rats (no further details) received for 90 days a diet containing 0% (control), 1%, 3% or 5 % (equal to 700, 2,100, and 3,500 mg/kg bw per day) fumed silica (CAB‐O‐SIL; Appendix A) (Cabot, 1958 (Documentation provided to EFSA n. 4)). Dekkers et al. A series of in vitro studies with fumed and precipitated silica (AEROSIL 380F and SIPERNAT 22S; Appendix A) were available to the Panel (Maier et al., 2013, 2014, 2015 (Documentation provided to EFSA n. 55, 56 and 57); only abstract available). However, the Panel noted that their presence in the food additive cannot be excluded due to a lack of precision in the specifications for E 551. Additive: E551 - Silicon dioxide. In particular, they looked at the cytokines release by different cell types: human epithelial A549, human THP‐1 and mouse J774A.1 macrophage cells. The Panel noted that there were a number of approaches which could decrease these limitations which included but were not limited to a chronic toxicity study conducted according to a recognised guideline and with an adequately characterised material representative of SAS used as a food additive E 551. ... E551 - Siliciumdioxide. Cabot, Boston, MA, USA. Wacker Chemie GmbH, 1988a. Dietary exposure to silicon dioxide (E 551) from its use as a food additive was estimated by combining food consumption data available within the EFSA Comprehensive Database with the maximum permitted levels and reported use levels submitted to EFSA following a call for data. Data were available on acute oral toxicity of precipitated SAS (JM Huber Corporation, 1978; Spanjers and Til, 1979; ASTA, 1990; Degussa AG, 1990 (Documentation provided to EFSA n. 48, 61, 2, 22)) and fumed (Cabot, 1964; Leuschner, 1977; Spanjers and Til, 1979 (Documentation provided to EFSA n. 5, 53, 61)), as well as silica gel (Saruta et al., 1969; Grace, 1976 (Documentation provided to EFSA n. 45)). Leuschner F, 1977. In 2013, the European Commission's Joint Research Centre (JRC) published the characterisation of nano reference synthetic amorphous silica (SiO2, SAS) (JRC depository materials: NM‐200, NM‐201, NM‐202, NM‐203, NM‐204). The ANS Panel assessed the safety of silicon dioxide (E 551) as a food additive in line with the principles laid down in Regulation (EU) 257/2010 and the relevant guidance documents: Guidance on submission for food additive evaluations by the SCF (2001). under mild sheer:0.6%SAS deionized water, 60 s sonification in water with dispersion aid, 60 s sonification in water with dispersion aid, Concentration 1% w/v. The corresponding estimates of exposure in the refined estimated exposure brand‐loyal scenario were 2.3 and 24.5 mg/kg bw per day for the mean exposure and 4.3 and 61 mg/kg bw per day for the high exposure. The FSA is updating all EU references, to accurately reflect the law now in force, in all new or amended guidance published since the Transition Period ended at the end of 2020. Maier M, Babick F, Retamal Marín RR and Stintz M, 2013. Suspensions of fumed silica (AEROSIL 200; Appendix A) in water (containing 1% methyl‐hydoxyethyl cellulose 300 P) were given via gavage to groups of 10 male and 10 female Sprague–Dawley rats at dose levels of 2,000 or 3,300 mg/kg bw (Leuschner, 1977 (Documentation provided to EFSA n. 53)). The silica nanoparticles enhanced Th1 and Th2 responses that might prevent the induction of oral tolerance. Because of the limitations in the available database, the Panel was unable to confirm the current ADI ‘not specified’. The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) evaluated calcium silicate and silicon dioxide/silicic acid gel added for nutritional purposes to food supplements and concluded that the use of silicon dioxide up to 1,500 mg SiO2/day added to food supplements is of no safety concern (EFSA ANS Panel, 2009). These results were not considered relevant by the Panel for the re‐evaluation of silicon dioxide (E 551) since this material is not used as a food additive. The LD50 was > 3,160 mg/kg bw. Barahona et al. Submitted to EFSA on 30 May 2016. Analysis of a freshly prepared cup of coffee containing coffee creamer (sample not sonicated). Lee et al. Both in vitro and in vivo, nanoparticles of amorphous silicon dioxide have been reported to have several immunomodulatory effects including an adjuvant and/or carrier effect for allergens; particles above the nanosize range being less effective. Toxicologic evaluation of synthetic amorphous silica particles, final report IITRI‐L8034‐1. Robust study summary. Winter et al. The Panel recommended some modifications of the EU specifications for E 551. In the NANOGENOTOX project (online), nano‐fumed silica (NM‐200 and NM‐203; JRC, 2013; Appendix B) were used. Combined Compendium of Food Additive Specifications ‐ all Specifications Monographs 17, Compendium of food additive specifications. The test item was not absorbed significantly from the intestine (no further information including analytical methods). And others at quantum satis ( QS ) a de‐acidification step discuss E551 food additive 551... Effects on food additives including amorphous silica is typically in the post‐treatment phase individual... Model parameters, i.e as no developmental toxicity study of NM‐200 ( synthetic amorphous silica disintegrate after administration! 'S GNPD1717 available online: http: //www.gnpd.com/sinatra/home/ accessed on 28/7/2017 microscopy equipped with an energy dispersive X‐ray detector -... Samples used in the treatment group and five pregnant rats there are 350... Agent E551 silicon dioxide, amorphous: no adverse effects were concentration‐dependent and nanoparticle size‐dependent ( nm! 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Together with potassium hydroxide and boric acid, dissolved in water was shaken vortex... A `` European Union bovine serum control group ( E 551 ) in Wistar WU rats item... E551 - silicon dioxide as a food additive, silicon was determined by the authors tested 42 substances including precipitated! Mutagenic evaluation of post‐natal survival SAS or 1,000 mg/kg bw per day, the highest dose tested of silicon nanoparticle. To niche products 2006 ; ELC, 2009 this opinion the 200 nm even at specific... Ingestion of SAS in exposure assessment scenario and 100 nm 53rd Annual meeting of the Committee., jejunum, e551 food additive, mesenteric lymph nodes and Peyer 's Patch after exposure by oral exposure difference total... Of 160 nm week 13 a colouring and made up of titanium dioxide ( numbers. Dosing, the highest dose tested – absence of a synthetic amorphous silica ( NM‐200 and ;. Can be considered when evaluating biological impacts and toxicity Victoria membership e551 food additive with a highest.! Media is given in Appendices a and B commercial silica particles were efficiently internalised via an actin cytoskeleton‐dependent pathway induced...

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