Identifiers
Hazards
The available evidence shows only a US regulatory flag for bacillus coagulans: an EPA TSCA exemption from Chemical Data Reporting Rule (CDR) reporting under 40 CFR 711. No market-specific or product-category distinctions are documented, so differences between dietary supplements, foods, or pharmaceuticals cannot be established from this evidence. This means a compliance assessment cannot rely on category-specific regulatory treatment beyond the TSCA exemption. Business decisions should treat the regulatory landscape as undifferentiated until further jurisdiction- or category-specific data is obtained.
8 regulations
Propanoic acid, 2-hydroxy- is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Propanoic acid, 2-hydroxy- 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)
Lactic acid (2-hydroxypropanoic acid) is exempted from the requirement of a tolerance when used as a plant growth regulator in or on all raw agricultural commodities.
Sources
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 178.1010 | 21 CFR 178.1010 | Food Additive | authorized | View |
| 184.1061 | 21 CFR 184.1061 | Food Additive | authorized | View |
| 133.123 | 21 CFR 133.123 | Labeling Standards | authorized | View |
| 133.124 | 21 CFR 133.124 | Labeling Standards | authorized | View |
| 133.129 | 21 CFR 133.129 | Labeling Standards | authorized | View |
| 133.169 | 21 CFR 133.169 | Labeling Standards | authorized | View |
| 133.173 | 21 CFR 133.173 | Labeling Standards | authorized | View |
| 133.178 | 21 CFR 133.178 | Labeling Standards | authorized | View |
| 133.179 | 21 CFR 133.179 | Labeling Standards | authorized | View |
Regulatory records
| Entry | Regulation | Type | Status | Source |
|---|---|---|---|---|
| 172.814 | 21 CFR 172.814 | Food Additive | authorized | View |
Corrosive to skin; [Quick CPC] A skin and respiratory tract irritant; Corrosive to eyes; [ICSC] Causes burns to skin and eyes; Vapors cause eye and mucous membrane irritation and can cause coughing and difficulty breathing; [CHRIS] Safe when used as a flavoring agent in food; [JECFA] Corrosive to rabbit skin, mildly irritating to guinea pig skin, and not irritating to pig skin; Not sensitizing in a study of guinea pigs; A 13-week oral study of rats produced a NOAEL of 500 mg/kg/day (highest tested dose); Studies on reproductive and developmental toxicity not considered necessary because lactic acid is a product of human intermediary metabolism; [EPA ChAMP] A skin and strong eye irritant; [Aldrich MSDS]
Sources
Food contact notifications
| Notification | Manufacturer / supplier | Intended use | Limitations | Effective | Status |
|---|---|---|---|---|---|
| 1995 | VValley Chemical Solutions | As an antimicrobial agent in process water, brine, or ice in the processing of meat and poultry. | Components of the FCS mixture will not exceed: 1000 parts per million (ppm) PLA, 2480 ppm HP, 5.7 ppm HEDP, and 1.64 ppm DPA in process water or ice that contacts meat or poultry carcasses, parts, trim, and organs. 268 ppm PLA, 665 ppm HP, 1.53 ppm HEDP, and 0.44 ppm DPA in process water, ice, or brine that contacts processed and pre-formed meat and poultry. | 30 Oct 2019 | active |
| 2242 | EEvonik Active Oxygens, LLC | As an antimicrobial agent used in process water, ice, or brine used in the production, processing, and preparation of poultry, meat, processed and pre-formed meat and poultry, fruits, vegetables, fish, and seafood. | The components of the FCS will not exceed: 2000 ppm PCA, 2480 ppm HP, and 136 ppm HEDP in process water, ice, or brine applied as a wash, spray, dip, rinse, chiller water, low-temperature (less than 40°F) immersion bath, or scald water for whole or cut poultry, including carcasses, parts, trim, and organs. 495 ppm PCA, 1180 ppm HP, and 29 ppm HEDP in process water, ice, or brine for washing, rinsing, or cooling processed and pre-formed poultry. 2000 ppm PCA, 2480 ppm HP, and 121.5 ppm HEDP in process water, ice, or brine applied as a wash, spray, dip, rinse, chiller water, low-temperature (less than 40°F) immersion bath, or scald water for whole or cut meat, including carcasses, parts, trim, and organs. 495 ppm PCA, 1180 ppm HP, and 33.5 ppm HEDP in process water, ice, or brine for washing, rinsing, or cooling processed and pre-formed meat. 600 ppm PCA, 1112 ppm HP, and 34 ppm HEDP in process water or ice used for washing, rinsing, chilling, or processing fruits and vegetables in food processing facilities. 230 ppm PCA, 280 ppm HP, and 15 ppm HEDP in process water, ice, or brine used during commercial preparation of fish and seafood in food processing facilities. | 28 Sept 2022 | active |
Regulatory records
| Regulation | Status |
|---|---|
| FDA Technical Effect: ANTIMICROBIAL AGENT | authorized |
| FDA Technical Effect: CURING OR PICKLING AGENT | authorized |
| FDA Technical Effect: FLAVOR ENHANCER | authorized |
| FDA Technical Effect: FLAVORING AGENT OR ADJUVANT | authorized |
| FDA Technical Effect: PH CONTROL AGENT | authorized |
| FDA Technical Effect: SOLVENT OR VEHICLE | 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: 04-01-2023 https://echa.europa.eu/registration-dossier/-/registered-dossier/5165
Regulation (EC) No 178/2002 (amended)
2004/129/EC
1 regulation
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 50-21-5 | 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, 2-hydroxy-
1 regulation
Lactic acid: Does not have an individual approval but may be used under an appropriate group standard
The only documented condition is the US EPA TSCA exemption from CDR reporting, which applies to the substance itself and does not specify use conditions, concentration limits, or product-category constraints. No other limits or use contexts are provided in the evidence. For a compliance assessment, this means the substance is not subject to CDR reporting under the stated rule, but other federal or state requirements may still apply. Formulators should not infer broader safety or usage limits from this exemption, as it is a reporting flag, not a use authorization.
Before launch assessment, the only confirmed regulatory documentation is the EPA TSCA exemption from CDR reporting, which should be verified for applicability to the specific product form and use. No other pre-launch documentation—such as food additive petitions, GRAS determinations, or drug approvals—is evidenced. This means the compliance file is incomplete for most product categories, and additional regulatory research is necessary to identify applicable requirements. The TSCA exemption alone does not satisfy potential FDA or other agency obligations.
The regulatory position stops at a single US TSCA reporting exemption, which does not address safety, efficacy, or market authorization. There is no evidence of FDA drug or food additive status, no international regulatory data, and no product-category-specific guidance. Consequently, the available information cannot support a launch decision for any product category. Decision-makers should treat the regulatory status as largely unknown beyond the TSCA flag and commission further research to fill the gap before proceeding.