Identifiers
Functions
Regulatory treatment of ascorbic acid varies by market and product category. In the US, it is generally recognized as safe (GRAS) as a chemical preservative and nutrient in human food, and as a preservative and nutrient in animal drugs, feeds, and related products, when used per good manufacturing practices. It is also exempt from pesticide tolerance requirements under FIFRA. In the EU, it is a REACH-registered substance and has an active ECHA C&L notification. In Australia, it is listed on the industrial chemicals inventory. In New Zealand, it lacks individual approval but may be used under a group standard. In cosmetics, it is listed as active in the EU with functions including antioxidant and buffering, with no specific restrictions.
7 regulations
L-Ascorbic acid is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of L-Ascorbic acid 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)
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. Ascorbic acid is included on this list.
Sources
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 182.3013 | 21 CFR 182.3013 | Food Additive | authorized | View |
| 182.8013 | 21 CFR 182.8013 | Food Additive | authorized | View |
| 101.14 | 21 CFR 101.14 | Labeling Standards | authorized | View |
| 101.9 | 21 CFR 101.9 | Labeling Standards | authorized | View |
| 107.100 | 21 CFR 107.100 | Labeling Standards | authorized | View |
| 137.105 | 21 CFR 137.105 | Labeling Standards | authorized | View |
| 137.200 | 21 CFR 137.200 | Labeling Standards | authorized | View |
| 145.110 | 21 CFR 145.110 | Labeling Standards | authorized | View |
| 145.115 | 21 CFR 145.115 | Labeling Standards | authorized | View |
| 145.135 | 21 CFR 145.135 | Labeling Standards | authorized | View |
| 145.170 | 21 CFR 145.170 | Labeling Standards | authorized | View |
| 146.185 | 21 CFR 146.185 | Labeling Standards | authorized | View |
| 146.187 | 21 CFR 146.187 | Labeling Standards | authorized | View |
| 155.200 | 21 CFR 155.200 | Labeling Standards | authorized | View |
| 155.201 | 21 CFR 155.201 | Labeling Standards | authorized | View |
| 161.175 | 21 CFR 161.175 | Labeling Standards | authorized | View |
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 172.280 | 21 CFR 172.280 | Food Additive | authorized | View |
An antioxidant essential in the human diet; Used as an antioxidant for foods and therapeutic vitamin; [Merck Index] Used as an antioxidant and pH adjustor in cosmetics (over 75% in hair dyes and colors), for abscission of citrus fruit in harvesting, as a reducing agent in analytical chemistry, skin protectant, and UV sunscreen; [HSDB] Used in chemical synthesis; [IUCLID] Used as flavoring agent, antimicrobial agent, antioxidant, dough strengthener, nutritional supplement, pH control agent, sequestrant, and stabilizer or thickener for foods; [FDA] Permitted for use as an inert ingredient in non-food pesticide products; [EPA]
Regulatory records
| Regulation | Status |
|---|---|
| FDA Technical Effect: ANTIMICROBIAL AGENT | authorized |
| FDA Technical Effect: ANTIOXIDANT | authorized |
| FDA Technical Effect: COLOR OR COLORING ADJUNCT | authorized |
| FDA Technical Effect: DOUGH STRENGTHENER | authorized |
| FDA Technical Effect: FLAVOR ENHANCER | authorized |
| FDA Technical Effect: FLAVORING AGENT OR ADJUVANT | authorized |
| FDA Technical Effect: NUTRIENT SUPPLEMENT | authorized |
| FDA Technical Effect: PH CONTROL AGENT | authorized |
| FDA Technical Effect: SEQUESTRANT | authorized |
| FDA Technical Effect: STABILIZER OR THICKENER | authorized |
SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.
3 regulations
Status: Active Update: 25-10-2012 https://echa.europa.eu/registration-dossier/-/registered-dossier/2848
Regulation (EC) No 178/2002 (amended)
Dossier complete 05/751/EC, Reg (EU) 2018/155, Reg. (EU) 2020/2007, Reg. (EU) 2022/489, Reg. (EU) No 149/2014
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 62624-30-0 | 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 |
|---|---|---|---|
| 4092 | Inventory of Existing Cosmetic Ingredients in China (IECIC) I | List I | authorized |
Record details
1 regulation
Chemical: L-Ascorbic acid
1 regulation
Ascorbic acid: Does not have an individual approval but may be used under an appropriate group standard
The most impactful conditions are the US FDA GRAS determinations for food and animal feed uses, which require adherence to good manufacturing or feeding practices. For pesticide uses, FIFRA exempts residues from tolerance requirements if used per good agricultural or manufacturing practices. In the EU, REACH registration is active, and the substance is subject to ECHA C&L notifications. No specific concentration limits or use restrictions are provided for cosmetics. The EPA Safer Chemical listing and TSCA CDR reporting obligations apply to manufacturers and importers. Storage separation from strong oxidants and bases is noted, and disposal of waste pharmaceuticals must follow applicable DEA, EPA, and FDA regulations.
Before launch, confirm the product category and jurisdiction to determine applicable requirements. For US food or feed uses, ensure use aligns with GRAS conditions and good manufacturing practices. For pesticide products, verify FIFRA tolerance exemption applicability. For industrial uses, confirm TSCA CDR reporting obligations if manufacturing or importing. In the EU, ensure REACH registration is active and C&L notification is current. For cosmetics, verify the ingredient is listed as active in the EU inventory and that no specific restrictions apply. Also, review storage and disposal guidance, including separation from strong oxidants and bases, and proper waste handling for pharmaceuticals.
The available regulatory position does not provide quantitative limits, exposure thresholds, or GHS classifications for ascorbic acid, which limits a full compliance assessment. For cosmetics, no maximum concentration or restriction conditions are specified, so safety assessment must rely on other sources. The New Zealand status indicates no individual approval, but group standard use is possible, leaving uncertainty about specific product eligibility. Additionally, the FDA notes inadequate data to establish safety and effectiveness for ascorbic acid in OTC weight control drug products, which is a specific limitation for that category. These gaps mean a decision cannot be fully supported without additional data.
The evidence indicates that ascorbic acid's EU regulatory status is active under REACH, with a dossier complete as of 2012, and it is referenced in several EU regulations including Reg (EU) 2018/155, 2020/2007, 2022/489, and No 149/2014. These regulations may represent recent amendments or updates relevant to its use. However, the specific content or effective dates of these regulations are not detailed in the evidence. For US, the TSCA CDR reporting requirement is ongoing, and the EPA Safer Chemical listing is current. No other recent changes or effective dates were provided.