# LACTIC ACID, DL-

URL: https://app.greenveil.ai/ingredients/ingredient_dtxsid_dtxsid7023192
Categories: beauty, cleaning, food, industrial, pharma
Functions: Humectant, Skin conditioning, Buffering, Flavouring agent, acid, acidity regulator, Antioxidant, Preservative
Identifier: DTXSID7023192

> LACTIC ACID, DL-: Used in cosmetics as a humectant, a skin-conditioning agent and a pH buffer. Greenveil chemical-concern score: 60/100 — High concern based on regulatory listings.. Compiled from 10 published data sources.

## Safety assessment

- Chemical concern score: 60/100 — High concern based on regulatory listings.
- Confidence in this assessment: High
- Is it a concern? High concern: no hazard classifications on record. It is listed for cosmetic use in the EU.
- Rationale: EPA CPDat observed this chemical in 2472 composition records across product categories including Laboratory supplies, Personal care, Food and drug.

## Regulatory status

- EU: Active — Listed in CosIng inventory for cosmetic use.
- EU: EFSA statement — Statement of the Scientific Panel of Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the European Commission concerning the use of lactic acid and sodium lactate and sodium lactate for poultry carcass decontamination (EFSA AFC)
- EU: EFSA opinion — Flavouring Group Evaluation 64 (FGE.64): Consideration of aliphatic acyclic diols, triols, and related substances evaluated by JECFA (57th meeting) structurally related to aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical groups 9, 13 and 30 evaluated by EFSA in FGE.10Rev1 (EFSA, 2008ab). Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) (EFSA AFC)
- EU: EFSA opinion — Scientific Opinion on Flavouring Group Evaluation 96 (FGE.96): Consideration of 88 flavouring substances considered by EFSA for which EU production volumes / anticipated production volumes have been submitted on request by DG SANCO. Addendum to FGE. 51, 52, 53, 54, 56, 58, 61, 62, 63, 64, 68, 69, 70, 71, 73, 76, 77, 79, 80, 83, 84, 85 and 87 (EFSA CEF)
- EU: EFSA opinion — Scientific Opinion on the safety and efficacy of primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones (chemical group 9) when used as flavourings for all animal species (EFSA FEEDAP)
- EU: EFSA opinion — Scientific Opinion on the re-evaluation of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) as food additives (EFSA ANS)
- EU: EFSA opinion — Safety and efficacy of lactic acid and calcium lactate when used as technological additives for all animal species (EFSA FEEDAP)
- EU: EFSA opinion — Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts (EFSA CEP)
- EU: EFSA opinion — Evaluation of the safety and efficacy of lactic acid to reduce microbiological surface contamination on carcases from kangaroos, wild pigs, goats and sheep (EFSA CEP)
- EU: EFSA opinion — Safety of lactic acid and calcium lactate when used as technological additives for all animal species (EFSA FEEDAP)
- GLOBAL: NOT LIMITED (1973) — JECFA evaluation lists ADI NOT LIMITED (1973). Functional class: flavouring agent, acid, acidity regulator.
- US: commercial use observed — EPA CPDat observed this chemical in 2472 composition records across product categories including Laboratory supplies, Personal care, Food and drug. EPA CPDat classifies this chemical for functional uses including pH regulating agent, Humectant, Softener and conditioner.
- US: inactive ingredient database — Route: TOPICAL; Dosage form: GEL; Potency: 3.65 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: LOTION; Potency: ADJ PH
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SOLUTION; Potency: 7.4 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SUSPENSION; Potency: 0.5 %w/w
- US: inactive ingredient database — Route: VAGINAL; Dosage form: JELLY; Potency: 3.1 %w/w
- US: inactive ingredient database — Route: VAGINAL; Dosage form: SUPPOSITORY; Potency: NA
- US: marketed drug occurrence — FDA NDC lists this ingredient in 52 active drug products and 60 total products.
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as chemical.
- US: inactive ingredient database — Route: TOPICAL; Dosage form: CREAM; Potency: 0.45 %w/w
- US: inactive ingredient database — Route: SUBCUTANEOUS; Dosage form: PELLET, IMPLANTABLE; Potency: NA
- US: inactive ingredient database — Route: ORAL; Dosage form: SOLUTION; Maximum daily exposure: 106 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: LIQUID; Potency: 10 mg/5ml
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE; Maximum daily exposure: 127 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, SOLUTION; Maximum daily exposure: 3 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION; Potency: 5.64 %w/v
- US: inactive ingredient database — Route: INTRAMUSCULAR; Dosage form: INJECTION, SOLUTION; Maximum daily exposure: 3 mg
- US: inactive ingredient database — Route: INTRAMUSCULAR; Dosage form: INJECTION; Potency: ADJ PH
- US: inactive ingredient database — Route: TOPICAL; Dosage form: AEROSOL, FOAM; Maximum daily exposure: 27 mg

## Expert safety opinions

- SCCS (EU Scientific Committee on Consumer Safety): no opinion on file.
- CIR (Cosmetic Ingredient Review (US expert panel)): no opinion on file.
- EFSA (European Food Safety Authority): Statement of the Scientific Panel of Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the European Commission concerning the use of lactic acid and sodium lactate and sodium lactate for poultry carcass decontamination (EFSA AFC) — 2006 — https://doi.org/10.2903/j.efsa.2008.234r; Flavouring Group Evaluation 64 (FGE.64): Consideration of aliphatic acyclic diols, triols, and related substances evaluated by JECFA (57th meeting) structurally related to aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical groups 9, 13 and 30 evaluated by EFSA in FGE.10Rev1 (EFSA, 2008ab). Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) (EFSA AFC) — 2009 — https://doi.org/10.2903/j.efsa.2009.975; Scientific Opinion on Flavouring Group Evaluation 96 (FGE.96): Consideration of 88 flavouring substances considered by EFSA for which EU production volumes / anticipated production volumes have been submitted on request by DG SANCO. Addendum to FGE. 51, 52, 53, 54, 56, 58, 61, 62, 63, 64, 68, 69, 70, 71, 73, 76, 77, 79, 80, 83, 84, 85 and 87 (EFSA CEF) — 2011 — https://doi.org/10.2903/j.efsa.2011.1924; Scientific Opinion on the safety and efficacy of primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones (chemical group 9) when used as flavourings for all animal species (EFSA FEEDAP) — 2012 — https://doi.org/10.2903/j.efsa.2012.2928; Scientific Opinion on the re-evaluation of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) as food additives (EFSA ANS) — 2013 — https://doi.org/10.2903/j.efsa.2013.3144; Safety and efficacy of lactic acid and calcium lactate when used as technological additives for all animal species (EFSA FEEDAP) — 2015 — https://doi.org/10.2903/j.efsa.2015.4198; Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts (EFSA CEP) — 2018 — https://doi.org/10.2903/j.efsa.2018.5482; Evaluation of the safety and efficacy of lactic acid to reduce microbiological surface contamination on carcases from kangaroos, wild pigs, goats and sheep (EFSA CEP) — 2022 — https://doi.org/10.2903/j.efsa.2022.7265; Safety of lactic acid and calcium lactate when used as technological additives for all animal species (EFSA FEEDAP) — 2019 — https://doi.org/10.2903/j.efsa.2019.5914.
- JECFA (Joint FAO/WHO Expert Committee on Food Additives): JECFA evaluation lists ADI NOT LIMITED (1973). Functional class: flavouring agent, acid, acidity regulator. — https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/3367.

## Data sources

- CosIng (updated 2026-09-23): https://ec.europa.eu/growth/tools-databases/cosing/details/34809
- EFSA OpenFoodTox (updated 2026-10-04): https://doi.org/10.5281/zenodo.8120114
- EPA Chemical and Products Database (updated october 7, 2011): http://siri.org/msds/f1/bsm/bsmyb.html
- EPA DSSTox Identifiers (updated 2025-12-29): https://epa.figshare.com/articles/dataset/Chemistry_Dashboard_Data_DSSTox_Identifiers_Mapped_to_CAS_Numbers_and_Names/5588566
- FDA Inactive Ingredient Database (updated 2026-01-09): https://www.fda.gov/drugs/drug-approvals-and-databases/inactive-ingredients-database-download
- FDA National Drug Code Directory (updated 2029-08-02): https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory-support-files
- FDA GSRS UNII (updated 2026-02-26): https://precision.fda.gov/uniisearch/
- WHO JECFA Database (updated 2026-10-04): https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/3367
- openFDA Substance (updated 2026-05-24): https://api.fda.gov/other/substance.json?search=unii:3B8D35Y7S4
- PubChem Live Enrichment (updated 2026-05-17): https://pubchem.ncbi.nlm.nih.gov/compound/612

_Assessed by Greenveil._