LACTIC ACID

B

one or two randomised trials

C

uncontrolled or multi-ingredient studies

May make skin more sensitive to sunlight.

2-hydroxypropanoic acid is a 2-hydroxy monocarboxylic acid that is propanoic acid in which one of the alpha-hydrogens is replaced by a hydroxy group. It has a role as a Daphnia magna metabolite and an algal metabolite. It is functionally related to a propionic acid. It is a conjugate acid of a lactate.

Source: PubChem

US FDA substance register · UNII 3B8D35Y7S4 · registered name LACTIC ACID, DL- · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

ASEAN

• Field of application and/or use : (a) Skin products (i) For general use (ii) For professional use (iii) For use by a qualified medical practitioner (b) Other products
• Maximum authorised concentration in the finished cosmetic product : (a) Skin products (i) ≤ 10% total when calculated as the acids (ii) > 10% - 20% total when calculated as the acids (iii) > 20%, total when calculated as the acids (b) Other products None
• Other limitations and requirements : (a) Skin products (i) Final formulation ≥ pH 3.5 (ii) Final formulation ≥ pH 3.0 For professional use only (iii) Final formulation ≥ pH 3.0 for products up to 30% total when calculated as the acids. For use by a qualified medical practitioner only. (b) Other products None
• Conditions of use and warning which must be printed on the labels : (a) Skin products All Sunburn alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear sun protective clothing, and limit sun exposure while using this product and for a week afterwards(13) (ii) For professional use only (iii) For use by a qualified medical practitioner only. (b) Other products None

Canada

• <Alpha-hydroxy acids, including polyhydroxy acids and bionic acids with alpha hydroxyl groups, and their salts lactic acid>
• Conditions of Use by product type : (a) Products for use on the skin for consumer use. Manufacturer or importer to provide pH levels. (b) Products for use on the skin for professional use: Manufacturer must provide Health Canada with evidence of safety including: 1. pH levels 2. AHA concentrations 3. Directions for use 4. Clinical studies demonstrating minimal skin irritation (c) Products intended to be diluted in bath water may contain levels of AHAs exceeding 10% (d) Other cosmetics (e) Any cosmetics
• Maximum Concentration Permitted : (a) Between 3% and 18% total mono-AHA equivalents with a pH equal to or greater than 3.5 (b) Between 18% and 30% total mono-AHA equivalents and/or a pH between 3.0 to 3.5 (d) Between 3% and 30% total mono-AHA equivalents with a pH equal to or greater than 3.0 (e) 3%
• Warnings and Cautionary Statements: (to the effect of) : (a) and (b) : "Use only as directed", "Avoid contact with the eyes", "If irritation persists, discontinue use and consult a physician", "It is recommended that prior to exposure to the sun, users cover areas where AHAs have been applied with sunscreen" Product labels should contain appropriate directions regarding frequency and/or duration of use. (b only) "For professional use only" (d) "Use only as directed", "Avoid contact with eyes", "Discontinue use if rash or irritation occurs"
• Conditions of Use by product type : See "Alpha-hydroxy acids".

Taiwan

• Maximum concentration : pH≧3.5;
• pH≥3.5;

Not classified under Korea’s toxic-substance GHS list · existing chemical substance

Source: Korea toxic substances GHS register (NIER)

Other restriction: ban substances that deplete the ozone layer · SCCS opinion: Position paper on the Safety of alpha-Hydroxy Acids; Updated position paper concerning consumer Safety of alpha-hydroxy acids

Source: EU CosIng ingredient list

Reviewed by CIR: 40th Anniversary Overview and Rereview Summaries From 2011 to 2015

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Final Report on the Safety Assessment of Glycolic Acid, Ammonium, Calcium, Potassium, and Sodium Glycolates, Methyl, Ethyl, Propyl, and Butyl Glycolates, and Lactic Acid, Ammonium, Calcium, Potassium, Sodium, and TEA-Lactates, Methyl, Ethyl, Isopropyl, and Butyl Lactates, and Lauryl, Myristyl, and Cetyl Lactates

Source: US Cosmetic Ingredient Review (CIR)