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)). Attempts were made at retrieving relevant original study reports on which previous evaluations or reviews were based; however, not always these were available to the Panel. However, due to the heterogeneity of the physico‐chemical properties of nanoparticles and their interactions in biological matrices, it remains necessary to test all particles on a case‐by‐case basis and to conduct targeted validations via in vivo animal exposure studies’. Open Food Facts is a collaborative project built by tens of thousands of volunteers and managed by a non-profit organization with 3 employees. Teratologic Evaluation of FDA 71‐48 (Syloid; silica aerogel). The Committee argued that the available data confirmed the inertness of these compounds (SCF, 1991). Prior to dosing, the test substance was suspended in highly deionised water containing 10% fetal bovine serum. The Panel noted that three different analytical methods were used (i.e. EHPM (European federation of Associations of Health Products Manufacturers), 2016. BET: Brunauer–Emmett–Teller; TEM: transmission electron microscopy. Negative findings were also observed in studies evaluated to be of limited relevance for DNA fragmentation in the comet assay (Gonzales et al., 2010; Fraunhofer 2012c (Documentation provided to EFSA n. 39); Watson et al., 2014; Guichard et al., 2015a,b), for the induction of chromosomal aberrations (Fraunhofer 2012b (Documentation provided to EFSA n. 38)) and micronuclei (Vecchio et al., 2014). FDA 71‐48 (syloid; silica aerogel). Groups of 10–15 pregnant Dutch‐belted rabbits were gavaged at GD 6–18 with 0 (vehicle, presumably water) 16, 74, 345 or 1,600 mg/kg bw per day (FDRL, 1973d (Documentation provided to EFSA n. 34)). Based on the results of the 14‐day study, the animals were orally administered doses of 0, 245, 490 or 980 mg/kg bw per day. and you may need to create a new Wiley Online Library account. In addition, a number of studies were available with chemically modified amorphous silicon dioxide particles such as some of those used by the pharmaceutical industry. This opinion was formulated following the principles described in the EFSA Guidance on transparency with regard to scientific aspects of risk assessment (EFSA Scientific Committee, 2009) and following the relevant existing guidance documents from the EFSA Scientific Committee. 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. 17N11540. Food consumption data used to estimate the dietary exposure to silicon dioxide (E 551) were derived from the EFSA Comprehensive European Food Consumption Database (Comprehensive Database1010 The toxic effects were dose‐dependent. According to the authors, these results indicated that silica nanoparticles can be absorbed through the intestine and that particle diameter and surface properties are major determinants of the degree of absorption. Yun et al. All samples contained agglomerates of SiO2. In the van der Zande et al. No analytical data on the concentration of silicon dioxide (E 551) in foods were made available by the Member States. The animals (5 weeks old at initiation) received for 93 weeks a diet containing 0%, 1.25%, 2.5% or 5 % of the test item (equivalent to 0, 1,875, 3,750 and 7,500 mg/kg bw per day). The food categories which were not taken into account are (in ascending order of the FCS codes): For the following food categories, the restrictions/exceptions which apply to the use of silicon dioxide (E 551) were also not referenced. Given the absence of information about the particle size distribution for silicon dioxide (E 551) in the current EU specifications, the Panel considered that no SAS preparation used in any single study might be fully representative of the food additive E 551. Available online: http://www.efsa.europa.eu/en/datexfoodcdb/datexfooddb.htm Study summary. Synthetic amorphous silica (SAS) has been used as food additive for decades under the name of "Silicon dioxide" or "E551" and in the European Union is authorized under Regulation (EC) No 1333/2008. OJ L 80, 26.3.2010, p. 19–27. (2013, 2014 (Documentation provided to EFSA n. 55 and 56) reported that in vitro, pyrogenic and precipitated silica in a tomato soup did not present significant changes in both their structure and size distribution after heating in water or an acidic medium simulating the gastric environment (pH 1.3) as well as in a fed‐state simulated intestinal fluid (pH 5). However, in most of the toxicological studies, the consequence of the potential interaction between nanoparticles and food components in real life was ignored. 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). MSG flavor information also under microscope. The food industry has adapted nanotechnology using engineered nanoparticles to improve the quality of their products. The composition of this corona may have consequence on the biological reactivity of the particles as, for instance, it has been reported that some proteins of the complement system, which have significant roles in the development of inflammation, are present in the corona after incubation of silicon dioxide nanoparticles in serum (Strojan et al., 2017). (2014) studied the absorption on human Caco‐2 cells of amorphous silica particles (diameters of 50, 100 or 200 nm) in fasted‐ and fed‐state simulated gastric or intestinal fluids. Uncertainties in the exposure assessment of silicon dioxide (E 551) have been discussed above. No other developmental abnormalities were observed. Food additives codes, numbers and guide - E500 to E579, mineral salts and anti-caking agents What you always wanted to know about Food Additives but had no one to ask. Most of the primary particles seem to form larger aggregated and/IR agglomerates. The authors calculated a mean dose of 500 mg/kg bw per day. Silica particles, identified by the fluorescent dye, were trapped by macrophages in the spleen and liver until 4 weeks after the single injection. (2013) analysed an instant barley coffee (stated to be silica free) and an instant cappuccino (containing E 551) both in powder form. 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 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. An overview of amorphous silica commercially available as a food additive E 551 and measured by different analytical techniques is given in Table 2 (CEFIC, 2016b, 2017, (Documentation provided to EFSA n. 16, 17)). Learn more information about e551 food additive. These samples were considered as ‘pristine’ silicon dioxide because they had not yet been mixed or reacted with food matrices. Crystalline solids often cake by formation of liquid bridge and subsequent fusion of microcrystals. FDRL (Food and Drug Research Laboratories), 1973c. Untersuchungsbericht über den Einfluß polymerer Kieselsäuren auf die renale SiO. A300 (TEM): primary particles (7–10 nm) with tendency for form aggregates of different sizes. Submitted to EFSA by CEFIC, September 2011. Necropsy after the 14‐day observation period revealed no pathological effects. Manufacturers must provide information about any additives used in the foods they produce. Dekkers et al. Machine Learning as a Proposal for a Better Application of Food Nanotechnology Regulation in the European Union. What exactly are nanoparticles and are they safe for humans and the environment? However, considering that FC 18 is very unspecific, the foods belonging to this food category (e.g. (2015) identified several significant knowledge gaps such as: physical forces, osmotic concentration, pH, digestive enzymes, and commensal microbes, inherent properties of NMs of different chemical makeup in the determination of their percent absorption through mucus and epithelial cells. The most common methods for sensitive silicon analysis are inductively coupled plasma atomic absorption spectrometry (ICP‐AES) and flameless atomic absorption spectrometry (AAS) (Carlisle, 1997). The Panel noted that the relevance of these studies to the risk assessment of silicon dioxide as a food additive was low. Data on usage levels of silicon dioxide (E 551) 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 (2016). Degussa AG, 1990. According to the authors, 10 mg silica nanoparticles/mouse per day significantly blocked oral tolerance induced by consumption of OVA; this dose corresponded to 30 g silica nanoparticles/day for a 70‐kg reference adult. In the European Union all food additives are identified by an E number. Then, the suspension was centrifuged. The sizes of the aggregates and agglomerates are normally greater than 100 nm. 44Ti diffusion labelling of commercially available, engineered TiO2 and SiO2 nanoparticles. In supplements, it’s used to prevent the various powdered ingredients from sticking together. Date Published 11/06/2015. The Panel noted that several analytical methods are available to measure the particle size of nanomaterials (dynamic light scattering (DLS), laser diffraction (LD), transmission electron microscopy (TEM), scanning electron microscopy (SEM)). Mating resulted in five pregnant animals in the treatment group and five pregnant rats in the control group. Agglomerates can be separated into the original aggregates only by strong dilution and dispersion (e.g. Reports of the National Academy of Sciences of Ukraine. The Panel noted that this dose was much higher than the exposure estimated in this opinion for the adult population (from 20 to 200 times higher than the mean and 95th percentile exposure, respectively). Report FDABF‐GRAS‐311. 1.91 ± 0.05 to 2.76 ± 0.02 mmol/L). Based on the available in vitro studies, there was no concern with respect to the induction of gene mutations. Food consumption data from the following population groups were used in the exposure assessment: infants, toddlers, children, adolescents, adults and the elderly. According to CEFIC (2017 (Documentation provided to EFSA n. 17)), precipitated amorphous silica is manufactured by the precipitation of diluted aqueous alkali metal silicate (e.g. Submitted to EFSA by CEFIC, July 2016. 01.8 Dairy analogues, including beverages whiteners, only sliced or grated cheese analogues and processed cheese analogue; beverages whiteners. Unpublished report 2446 by Litton Bionetics, Kensington, Maryland, USA. Emulsifiers are additives used in food industry as a means to achieve the emulsion, i.e. Laboratory No. However, some uncertainty remains because only limited relevance could be assigned to these in vivo results. Huntingdon Research Center. Technical dossier, Volume I of VIII Date of submission: 18 July 2016, Submitted by: The Association of Synthetic Amorphous Silica Producers (ASASP), Belgium. waterglass1313 Histopathological examinations and serum biochemical analysis were also performed. Haematological, histopathological and biochemical analyses showed no significant differences between control mice and mice treated with the silica particles. No macroscopic changes were found at necropsy. TNO, Zeist. Submitted to EFSA by CEFIC, September 2011. For an elaborate discussion of the uncertainties, see Section 3.4.5. 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). 81‐0016‐DKT. In the study by Yoshida et al. Data on usage levels of silicon dioxide (E 551) 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 (2016). The provisions of this new piece of legislation would be very similar to those adopted for the feed additives, and industrial minerals producers will be required to reapply for an authori-sation for the same minerals for use as a food additive. 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