Identifiers
Hazards
Regulatory treatment differs by market and product category. In the US, propionic acid is FDA-affirmed as GRAS for direct addition to human food and as a preservative in animal feed, and EPA has exempted it from tolerance requirements for certain pesticide uses. In the EU, it is a REACH-registered substance with active and ceased-manufacture dossiers, and EFSA has evaluated it as a food additive. In Australia, it appears on the industrial chemicals inventory, while New Zealand allows use only under group standards. However, these references pertain to propionic acid, not the ester, so direct extrapolation to inulin propionate ester is not supported.
8 regulations
Propanoic acid is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Propanoic 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)
Postharvest application of propanoic acid or a mixture of methylene bispropionate and oxy(bismethylene) bisproprionate when used as a fungicide is exempted from the requirement of a tolerance for residues in or on the following raw agricultural commodities: alfalfa, barley grain, Bermuda grass, bluegrass, brome grass, clover, corn grain, cowpea hay, fescue, lespedeza, lupines, oat grain, orchard grass, peanut hay, peavine hay, rye grass, sorghum grain, soybean hay, sudan grass, timothy, vetch, and wheat grain.
Sources
Postharvest application of propanoic acid or a mixture of methylene bispropionate and oxy(bismethylene) bisproprionate when used as a fungicide is exempted from the requirement of a tolerance for residues in or on the following raw agricultural commodities: alfalfa, barley grain, Bermuda grass, bluegrass, brome grass, clover, corn grain, cowpea hay, fescue, lespedeza, lupines, oat grain, orchard grass, peanut hay, peavine hay, rye grass, sorghum grain, soybean hay, sudan grass, timothy, vetch, and wheat grain.
Sources
Regulatory records
| Regulation | Status |
|---|---|
| FDA Technical Effect: ANTIMICROBIAL AGENT | authorized |
| FDA Technical Effect: FLAVORING AGENT OR ADJUVANT | authorized |
| FDA Technical Effect: PH CONTROL AGENT | authorized |
Propionic acid is designated as a hazardous substance under section 311(b)(2)(A) of the Federal Water Pollution Control Act and further regulated by the Clean Water Act Amendments of 1977 and 1978. These regulations apply to discharges of this substance. This designation includes any isomers and hydrates, as well as any solutions and mixtures containing this substance.
Sources
Persons in charge of vessels or facilities are required to notify the National Response Center (NRC) immediately, when there is a release of this designated hazardous substance, in an amount equal to or greater than its reportable quantity of 5000 lb or 2270 kg. The toll free number of the NRC is (800) 424-8802. The rule for determining when notification is required is stated in 40 CFR 302.4 (section IV. D.3.b).
Sources
This action promulgates standards of performance for equipment leaks of Volatile Organic Compounds (VOC) in the Synthetic Organic Chemical Manufacturing Industry (SOCMI). The intended effect of these standards is to require all newly constructed, modified, and reconstructed SOCMI process units to use the best demonstrated system of continuous emission reduction for equipment leaks of VOC, considering costs, non air quality health and environmental impact and energy requirements. Propionic acid is produced, as an intermediate or a final product, by process units covered under this subpart.
3 regulations
Status: Active Update: 06-12-2021 https://echa.europa.eu/registration-dossier/-/registered-dossier/14128
Regulation (EC) No 257/2010
2004/129/EC
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 79-09-4 | 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
Chemical: Propanoic acid
1 regulation
Propionic acid: Does not have an individual approval but may be used under an appropriate group standard
1 regulation
The New Jersey Worker and Community Right to Know Act requires public and private employers to provide information about hazardous substances at their workplaces. (N.J.S.A. 34:5A-1 et. seq.)
Key conditions include FDA GRAS status for propionic acid as a direct food additive and preservative, with no specified limit, and JECFA's 'not limited' ADI for propionic acid and its salts. In the US, EPA has exempted propionic acid from tolerance requirements for certain pesticide applications, and it is subject to TSCA reporting. Occupational exposure limits (e.g., 10 ppm TWA) and GHS hazard classifications (skin corrosion, flammability) affect handling and labeling. For the ester, these conditions do not directly apply; its own safety and use limits are not established in the evidence.
Before launch assessment, confirm the exact identity of inulin propionate ester, as the evidence only covers propionic acid. For propionic acid, US FDA GRAS affirmation and EPA tolerance exemptions are documented, but these do not extend to the ester. In the EU, REACH registration status is active for propionic acid, but the ester would require its own registration. Documentation should include the ester's physicochemical properties, safety data, and intended use category. Without specific regulatory status for the ester, a pre-launch assessment cannot rely on propionic acid's approvals.
The available regulatory position stops short of supporting a decision on inulin propionate ester because all cited regulations, GRAS affirmations, and exposure limits apply to propionic acid, not the ester. There is no evidence of the ester's approval, registration, or safety evaluation in any market. The ester's distinct chemical structure means its hydrolysis, toxicity, and regulatory classification cannot be inferred from propionic acid data. Therefore, any compliance decision would require new data and regulatory submissions specific to the ester.
No recent regulatory changes or effective dates are identified for inulin propionate ester. For propionic acid, the evidence includes a 2021 REACH registration update and a 2018 cease-manufacture notice, but these do not affect the ester. The 1991 EPA Reregistration Eligibility Decision for propionic acid is historical, not recent. Without specific regulatory actions for the ester, no material changes can be cited.