LACTIC ACID

B

一至两项随机试验

C

无对照或复方产品研究

可能使皮肤对阳光更敏感。

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.

来源: PubChem

美国FDA 物质登记 · UNII 3B8D35Y7S4 · 登记名称 LACTIC ACID, DL- · 单一化学物质

来源: 美国FDA 物质识别码（UNII）

东盟

• 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

加拿大

• <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".

台湾

• ※ 染髮產品之限量標準：係指該成分依產品使用說明書混合後之最高允許使用量。
• ※ 化粧品之外包裝或容器，應明顯標示本表所列成分之注意事項。因外包裝或容器表面積過小或其他特殊情形致不能標示者，應於標籤、仿單或以其他方式刊載之。
• ※ 本表所稱之口腔製劑，包含非藥用牙膏、漱口水類及美白牙齒類等化粧品。
• ※ 化粧品宣稱效能者，須符合化粧品標示宣傳廣告涉及虛偽誇大或醫療效能認定準則規定。
• 用途 : 使用限制
• 最大配合量 : pH≧3.5;
• 惟使用後立即沖洗之洗髮或潤髮等產品， 其 AHA 含量為 3%以下時，其 pH 值得為 3.2 以上至3.5 以下。
• 有關pH 值檢測方式，依產品實際情形，參照「『中華民國標準』（CNS）化粧品pH 值酸鹼性試驗法（ 總號9036 類號S2073）」檢驗之。
• pH≥3.5;
• (1) 皮膚敏感者，使用前請先作皮膚敏感性測試。
• (2) 皮膚有損傷、傷口或紅腫時不得使用。
• (3) 嬰兒及孩童不宜使用本產品。
• (4) 使用時皮膚如有異常現象，請暫停使用。
• (5) 使用後皮膚如有持續紅腫或出現不適應症狀時，請立即就醫診治。
• (6) 本產品含 α-Hydroxy acids 成分，可能增加皮膚對陽光敏感及曬傷可能性。
• (7) 使用本產品後必須使用防曬劑、穿著有保護衣物及一個星期內應避免陽光曝曬。
• 2. 化粧品中含 α-Hydroxy acids 成分，其含量為 10%以下，且產品 pH值為 3.5 以上，作為 pH值調整液時，其標籤、仿單或包裝，得免刊載前開注意事項。

未列入韩国有毒物质 GHS 分类 · 现有化学物质

来源: 韩国有毒物质 GHS 信息（环境公团）

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

来源: 欧盟 CosIng 成分清单

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

来源: 美国CIR 安全性评估

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

来源: 美国CIR 安全性评估