Additives food contact articles coe resolution ap 2005 2, packaging inks, 21 december 2006 ref. Chemically, silica is an oxide of silicon silicon dioxide, sio 2. Both silicon dioxide and silica gel are generally recognized as safe, or gras, as food additives 21 cfr 182. Amorphous sio 2 particles have been approved for use as food additives since they were first tested more than 40. Silicon dioxide, amorphous safety data sheet 09142015 en english us sds id. Aerosil in the food industryfood additive certification. Jun 18, 2018 silicon dioxide is also added to many foods and supplements.
The food additive, silicon dioxide e551 or sassynthetic amorphous silica, is used in the food industry as an anticaking agent, thickener or carrier of flavours, therefore is often added to. Combined compendium of food additive specifications online help about the data general specifications for enzymes analytical methods volume 4 additive. The reevaluation of the substance was requested based on the fact that the substance has always been produced on the basis of synthetic amorphous silicon dioxide in nanoform. The efsa panel on food additives and nutrient sources added to food ans provides a scientific opinion re. Amorphous silicon dioxide sio2 obtained by aerosol or solgel methods, registered and approved in the eu and the usa as a food additive e551. Silicon dioxide or silica is a combination of silicon and oxygen. Abstract the efsa panel on food additives and nutrient sources added to food.
According to the commission regulation eu 2312012 the following testsmethods have to. The substance silicon dioxide, silanated, with fcm substance no 87, is authorised for use as an additive in all types of plastics, without restriction. The forms of synthetic amorphous silica sas used as e 551 include fumed. Nm200 was selected as principal material for the oecd test programme testing a representative set of manufactured nanomaterials. Epa, fda, and state regulatory authority registrationsof the substance being petitioned for removal.
Silicon dioxide, also known as synthetic amorphous silica sas, is used by food manufacturers as an anticaking agent in spices or creamers, to ensure fine flowing powders or to absorb water. Combined compendium of food additive specifications. European food safety authority scientific opinion of the panel on food additives and nutrient sources added to food on calcium silicate, silicon dioxide and silicic acid gel added for nutritional purposes to food supplements following a request from the european commission. The efsa panel on food additives and nutrient sources added to food ans provides a scientific opinion reevaluating the safety of silicon dioxide e 551 when used as a food additive. The forms of synthetic amorphous silica sas used as e 551 include. Gsfa online food additive details for silicon dioxide. Food additive code numbers numerical order 2 flavoxanthin 161a lutein 161b kryptoxanthin 161c rubixanthin 161d violoxanthin 161e rhodoxanthin 161f beet red 162 anthocyanins or grape skin extract or blackcurrent extract 163 saffron or crocetin or crocin 164 calcium carbonate 170 titanium dioxide 171 iron oxide 172 aluminium 173. Codex silicon dioxide amorphous e 551 is a food additive that is included in. Material safety data sheet synthetic amorphous silica.
Committee on food additives jecfa, 84th meeting 2017. Precipitated silica trade names pirosil ps120, pirosil ps200, pirosil ps250, pirosil ps300, pirosil ps2000 chemical family precipitated amorphous silica. It may be used at the maximum levels of 10,000 and 15,000 mgkg in the dried whey and. Silicon dioxide agricultural marketing service usda. Code of federal regulations title 21 food and drug.
Since silicon dioxide can neither be absorbed nor salvaged by the human organism, it is excreted in its unchanged form. Silicon dioxide also occurs naturally in the human body, though it is. Sio 2 content of the water free compound to 12 volunteers caused a slight but statistically insignificant increase in the silicon dioxide level of the urine langendorf et al. Both the joint faowho expert committee on food additives jecfa and the eu sci. Silicon dioxides most common insecticidal use today is for control of. Silicon dioxide sio 2 nanoparticles are added to certain powdered foods as anticaking agents to enhance flow properties, e. The forms of synthetic amorphous silica sas used as e 551 include fumed silica and hydrated silica precipitated silica, silica gel and hydrous silica. The safety of nanostructured synthetic amorphous silica sas as a.
Regarding the appropriate methodology for risk assessment of nanomaterials there is an ongoing debate on how this topic can be best approached holsapple et al. For the most uptodate version of cfr title 21, go to the electronic code of federal regulations ecfr. Jan 17, 2018 the efsa panel on food additives and nutrient sources added to food ans provides a scientific opinion re. Silicon dioxide sio2, also known as silica, is a natural compound made of two of the earths most abundant materials. The information on this page is current as of april 1 2019. Synthetic amorphous silica sas, also known as synthetic amorphous silicon dioxide, has been used as a direct food additive for decades. Risk assessment of amorphous silicon dioxide nanoparticles in. However, there are no food additive provisions for the use of silicon dioxide to stabilize colouring agents, either in the lists of permitted food additives or in the standards in division 6 of the food and drug regulations that set out specifications for colouring agents. Evaluation report on the analytical methods submitted in. Exposure controls appropriate engineering controls. Silicon dioxide is already a permitted food additive in canada. According to commission regulation eu no 2312012, the food additive silicon dioxide e 551 is defined as an amorphous substance, which is produced synthetically by either a vapour. Presence and risks of nanosilica in food products request pdf. Food applications and the toxicological and nutritional implications.
Silicon dioxide, silanated european food safety authority. Silicon dioxide quartz in food mainly used as bulking agent of type, plastic shoes sole, also used in pesticide, dope and other silicon compound. Silica in the form of orthosilicic acid is the form predominantly absorbed by humans and is found in numerous tissues including bone, tendons, aorta, liver, and kidney. Applicator exposure people may inhale particles of silicon dioxide and silica gel when applying these dust, aerosol, or crackandcrevice injection formulations. Synthetic amorphous silicon dioxide nm200, nm201, nm202. Pdf the efsa panel on food additives and nutrient sources added.
Characteristics of food nanoparticles npj science of food. Hydrophilic aerosil, fumed, synthetic amorphous silicon dioxide. The food categories in which silicon dioxide is permitted are listed in attachment 10 in the codex general standard for food additives gsfa table 3 provisions. The association of synthetic amorphous silica amorphous silica producers asasp are pleased that the european food safety authority efsa panel on food additives and nutrient sources ans have given a positive opinion on the safety of silicon dioxide e 551 as a food additive. Latest report covid 19 impact on silicon dioxide market. China silicon dioxide quartz in food suppliers, manufacturers. Identification of the substance and the manufacturer company product label name. As a food additive, it serves as an anticaking agent to avoid clumping. Silicon element is found naturally in foods in the form of silicon dioxide sio 2. According to the eu rules on organic farming 11, sio 2 additives are also approved for use in biological food. Amorphous silicon dioxide with submicron particle size has a variety of highly unique physical and chemical properties and enormous potential as an additive in. Reevaluation of silicon dioxide e 551 as a food additive. Flogard silica is specifically approved for use in the following sections of the food and drug administration fda, title 21 food and drugs, code of federal regulations cfr. The food additive, silicon dioxide e 551, is a material comprised of.
Jun 14, 2012 this study presents the human and environmental risk assessment of colloidal sas amorphous silicon dioxide nanoparticles in a glass cleaner. The primary regulatory citation for the food additive silicon dioxide is 21 cfr 172. It is generally safe and occurs in many leafy greens and other vegetables. Jun 12, 2014 the substance silicon dioxide, silanated, with fcm substance no 87, is authorised for use as an additive in all types of plastics, without restriction. Silica represents a wellsuited material for biomedical applications and in particular to dentistry. Notice of modification to the list of permitted food. It is mainly used as an anticaking agent to improve. Aug 20, 2019 silicon dioxide helps keep the powders freeflowing and moisturefree and is a common additive in foods like flour, baking powder, sugar and salt, according to the food and drug administration fda.
Efsa raises red flag for silicon dioxide safety over. Synthetic amorphous silicon dioxide european commission. Silicon dioxide is found in higher amounts in plantbased foods. The forms of synthetic amorphous silica sas used as e 551 include fumed silica and. Silicon dioxide quartz in food cas no14808607 einecs no2156848. See specific citations for possible limitations on use. Silicon dioxide e 551 is used as a food additive and has an amorphous structure that consists of numerous aggregates and agglomerates. In supplements, its used to prevent the various powdered. Joint faowho expert committee on food additives jecfa, 84th meeting 2017.
For direct food contact uses, silicon dioxide is cleared under. The journal of nutrition, health and aging, volume 1 1, november 2, 2007. The maximum use rate when added directly to food is 2%. The food additive silicon dioxide may be safely used in food in accordance with the following conditions. Statement regarding the efsa opinion on the reevaluation of.
Regulation eu 2312012 and submitted the fao jecfa silicon dioxide, amorphous monograph of compendium for food additives 5, and the dedicated food chemicals codex fcc monograph silicon dioxide 6. Us epa pesticides fact sheet for silica and silicates. An adi not specified for silicon dioxide and certain silicates was established at the 29th jecfa 1985. Keywords synthetic amorphous silica sas silicon dioxide e 551 food safety nanostructured introduction synthetic amorphous silica sas, also known as synthetic amorphous silicon dioxide, has been used as a direct food additive for decades. Silicon is never present in its original or free form, and always occurs as silicon dioxide silica in food. There are provisions in t he gsfa step process for the use of these additives in the gsfa in fc 12. Nm200, nm201 and nm204 precipitated sas are produced via the precipitation. Silicon dioxide, amorphous safety data sheet sis6960. While silicon dioxide is safe for consumption, it can be unnerving to hear that you may be eating the same additive used in your makeup.
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