Identifiers
Functions
7 regulations
Silica, vitreous is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Silica, vitreous are required to report information about their production and use of this chemical to the EPA under the Toxic Substances Control Act (TSCA). (40 eCFR Part 711)
Tolerance exemptions for minimal risk active and inert ingredients. Unless specifically excluded, residues resulting from the use of the following substances as either an inert or an active ingredient in a pesticide chemical formulation, including antimicrobial pesticide chemicals, are exempted from the requirement of a tolerance under FFDCA section 408, if such use is in accordance with good agricultural or manufacturing practices. Silica, amorphous, fumed (crystalline-free); silica, amorphous, precipitated and gel; silica gel; silica gel, precipitated, crystalline-free, silica, hydrate; and silica, vitreous are included on this list.
Sources
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 73.1 | 21 CFR 73.1 | Color Additive | authorized | View |
| 73.575 | 21 CFR 73.575 | Color Additive | authorized | View |
| 173.340 | 21 CFR 173.340 | Food Additive | authorized | View |
| 176.170 | 21 CFR 176.170 | Food Additive | authorized | View |
| 176.180 | 21 CFR 176.180 | Food Additive | authorized | View |
| 176.200 | 21 CFR 176.200 | Food Additive | authorized | View |
| 176.210 | 21 CFR 176.210 | Food Additive | authorized | View |
| 177.1200 | 21 CFR 177.1200 | Food Additive | authorized | View |
| 177.2250 | 21 CFR 177.2250 | Food Additive | authorized | View |
| 177.2420 | 21 CFR 177.2420 | Food Additive | authorized | View |
| 177.2600 | 21 CFR 177.2600 | Food Additive | authorized | View |
| 182.90 | 21 CFR 182.90 | Food Additive | authorized | View |
| 160.105 | 21 CFR 160.105 | Labeling Standards | authorized | View |
| 160.185 | 21 CFR 160.185 | Labeling Standards | authorized | View |
GRAS notices
| Notice | Notifier | Intended use | Basis | Filed | Closed | FDA response | Status |
|---|---|---|---|---|---|---|---|
| 298 | CCabot Corporation | Use in a variety of foods and food-packing materials | Scientific procedures | 14 Jul 2009 | 09 Oct 2009 | At the notifier's request, FDA ceased to evaluate this notice | authorized |
| 321 | CCabot Corporation | Anticaking agent, defoaming agent, stabilizer, adsorbent, carrier, conditioning agent, chill proofing agent, filter aid, emulsifying agent, viscosity control agent, and anti-settling agent in a variety of food categories defined by the Codex Alimentarius General Standard for Food Additives | Scientific procedures | 18 Feb 2010 | 18 Aug 2010 | FDA has no questions | authorized |
| 554 | EEvonik Corporation | For use as a multi-functional direct ingredient in a broad range of food categories at levels not to exceed 2% of the finished food. Also intended for use as an indirect ingredient in the manufacture of adhesives; coatings; defoaming agents; greases and lubricants; paper and paperboard; and polymers that are used as components of food-packaging material. | Scientific procedures | 23 Dec 2014 | 14 May 2015 | FDA has no questions | authorized |
| 996 | DDouxMatok Ltd. | Intended for use as a carrier in white sugar at levels from 0.05 to 0.30 g/100 g. | Scientific procedures | 04 Feb 2022 | FDA has no questions (in PDF) | authorized |
Food contact notifications
| Notification | Manufacturer / supplier | Intended use | Limitations | Effective | Status |
|---|---|---|---|---|---|
| 155 | TTetra Pak, Inc. | The FCS will be used as an amorphous plasma-deposited silicon coating on the food-contact surface of polyethylene terephthalate (PET) food packaging articles. | The finished FCS will be used as a thin coating for PET articles complying with the provisions of applicable food additive regulations or FCNs, in contact with all types of food under Conditions of Use C through G, as described in Tables 1 and 2. The average thickness of the coating shall not exceed 440 angstroms and the maximum thickness of the coating shall not exceed 500 angstroms. | 31 Aug 2001 | active |
| 329 | SSchott HiCotec, Division of Schott Spezialglas GmbH
KHS Plasmax GmbH | To be used as an amorphous plasma-deposited silicon barrier coating on the food-contact surface of PET food packaging articles. | The maximum thickness of the double layered coating shall not exceed 100 nm. The coating may contact all food types, as described in Table 1, under Conditions of Use A through H, as described in Table 2 . | 17 Jul 2003 | active |
| 401 | TToyo Seikan Kaisha, Ltd. | To be used as an amorphous plasma-deposited silicon barrier coating on the food-contact surface of PET food packaging articles. | The maximum thickness of the double layered coating shall not exceed 60 nm. The coating may contact all types of food under Conditions of Use C through G, as described in Tables 1 and 2. | 29 Apr 2004 | active |
| 549 | TToyo Seikan Kaisha, Ltd. | To be used as an amorphous plasma-deposited silicon barrier coating on the food-contact surface of PET food packaging articles. | The maximum thickness of the three layered coating shall not exceed 60 nm. The coating may contact all types of food under Conditions of Use C through G, as described in Tables 1 and 2. | 21 Dec 2005 | active |
| 904 | KKHS Plasmax GmbH | To be used as a barrier coating on the food-contact surface of polyethylene terephthalate (PET) articles. | The maximum thickness of the triple layered coating shall not exceed 200 nm. The FCS may be used in contact with all food types under Conditions of Use C through G. | 16 Sept 2009 | active |
| 1073 | KKHS Plasmax GmbH | To be used as an amorphous plasma-deposited silicon barrier coating on the food-contact surface of PLA and HDPE food packaging articles. | The maximum thickness of the double layered coating shall not exceed 100 nm. The coating may contact all food types under Conditions of Use C through G as described in Tables 1 and 2. | 03 Jun 2011 | active |
| 1159 | KKHS Plasmax GmbH | As a barrier coating on the surfaces of polyethylene terephthalate (PET) articles that may contact food. | The maximum thickness of the triple layered coating shall not exceed 200 nm. The FCS will be used in contact with all food types under Conditions of Use A through H as described in Table 2. | 23 May 2012 | active |
| 2356 | PPPG Industries, Inc. | As a coating for use on food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications). | The FCS may be used on repeated-use food contact articles that may contact all food types up to a maximum use temperature of 400°C. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN. | 28 May 2024 | active |
Regulatory records
| Regulation | Status |
|---|---|
| FDA Technical Effect: ANTICAKING AGENT OR FREE-FLOW AGENT | authorized |
| FDA Technical Effect: ANTIOXIDANT | authorized |
| FDA Technical Effect: COLOR OR COLORING ADJUNCT | authorized |
| FDA Technical Effect: DRYING AGENT | authorized |
| FDA Technical Effect: EMULSIFIER OR EMULSIFIER SALT | authorized |
| FDA Technical Effect: FLAVORING AGENT OR ADJUVANT | authorized |
| FDA Technical Effect: FORMULATION AID | authorized |
| FDA Technical Effect: HUMECTANT | authorized |
| FDA Technical Effect: LUBRICANT OR RELEASE AGENT | authorized |
3 regulations
Status: Active Update: 13-09-2021 https://echa.europa.eu/registration-dossier/-/registered-dossier/15556
Regulation (EC) No 257/2010
2008/127, Reg. (EU) 2017/195, Reg. (EU) 2020/1160, Reg. (EU) 2021/745, Reg. (EU) 2022/708, Reg. (EU) 2023/1488, Reg. (EU) No 369/2012, Reg. (EU) No 540/2011
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 7631-86-9 | SOR/94-311 | DSL | authorized |
| 63231-67-4 | SOR/94-311 | DSL | authorized |
Conditions
This substance is on the Domestic Substances List (DSL). This substance was added to the DSL as an “Existing Substance” given that it meets the criteria set out in CEPA for substances that were in commerce in Canada between 1984 and 1986.
Record details
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 2648 | Inventory of Existing Cosmetic Ingredients in China (IECIC) I | List I | authorized |
Record details
1 regulation
Chemical: Silica
1 regulation
Silica, amorphous, fumed, cryst.-free: Does not have an individual approval but may be used under an appropriate group standard