Identifiers
Functions
Hazards
Regulatory treatment of polylactic acid varies by market and product category. In the US, it is referenced for therapeutic uses such as delayed-action preparations, artificial membranes, dental implants, and drug delivery systems, specifically for facial lipoatrophy in HIV patients. The EU listing also covers these therapeutic uses. In cosmetics, polylactic acid is an active ingredient in the EU with the function of an abrasive, with no restrictions or concentration limits specified. This indicates that while therapeutic applications are recognized across US and EU, cosmetic use is separately acknowledged in the EU without specific constraints.
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
For polylactic acid, the most relevant conditions and limits depend on the product category. In therapeutic contexts, the evidence highlights its use in delayed-action preparations, membranes, dental implants, and drug delivery systems, with a specific indication for facial lipoatrophy in HIV patients. Notably, an example notes that injectable poly-L-lactic acid is not FDA-approved for hand use, indicating off-label use is a consideration. In cosmetics, the EU lists polylactic acid as an abrasive with no restrictions, conditions, or maximum concentration limits. Thus, compliance hinges on intended use and whether the application falls within approved therapeutic indications or cosmetic functions.
Before launching a product containing polylactic acid, the following should be in place: confirmation of the intended product category and its corresponding regulatory framework. For therapeutic uses, evidence of approval or clearance for the specific indication is necessary, as the FDA has not approved all uses (e.g., hand injections). For cosmetic products in the EU, the ingredient is listed as active with an abrasive function, but no restrictions or conditions are specified, so a basic compliance check should verify that the product's use aligns with this function. Documentation should include the ingredient's CAS number (9051-89-2) and its regulatory status in the target market.
The available regulatory position is insufficient to support a full decision on polylactic acid because it lacks specific details on food additive approvals, drug listings, GHS classification, and exposure limits. The evidence only covers therapeutic uses and cosmetic listing, with no information on permissible concentrations, safety assessments, or labeling requirements. Additionally, the therapeutic use information is largely descriptive and does not clarify approval status across all jurisdictions. Therefore, a compliance assessment cannot be completed without additional regulatory data specific to the intended product category and market.
No recent regulatory changes or effective dates for polylactic acid were identified in the evidence. The available information does not indicate any updates to its regulatory status, restrictions, or conditions. This absence of change information suggests that the regulatory landscape for polylactic acid may be stable, but it also means that any assessment must rely on current listings and approvals without knowledge of upcoming modifications. For decision-making, it is prudent to verify the latest regulatory status directly with relevant authorities, as the evidence does not capture recent developments.