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On August 28, 2023, China National Medical Products Administration (NMPA) announced significant amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC), involving changes to prohibited ingredients and testing methods for cosmetics. Notably, except that the revised methods are scheduled to come into force on March 1, 2024, all other new contents will take immediate effect upon release.
The specific amendments are as follows:
1. Adding a prohibited cosmetic ingredient Benvimod, and specifying the prohibited ingredient benzene’s limitation requirements
The updated List of Prohibited Ingredients Used in Cosmetics in STSC now includes "Benvimod" as the newly banned ingredient (No. 1285). Furthermore, a new note states that if benzene is technically unavoidable to be present in cosmetics as an impurity, its limit should not exceed 2mg/kg.
2. Releasing five testing methods to supersede the original methods outlined in "Chapter 4 Physical and Chemical Testing Methods for Cosmetics" in STSC
No. | Revised Testing Methods | Original Testing Methods |
1 | Determination of Acrylamide in Cosmetics | 2. Testing Methods of Prohibited Ingredients: 2.16 Acrylamide |
2 | Determination of Desloratadine and Other 50 Kinds of Components in Cosmetics | 2. Testing Methods of Prohibited Ingredients: 2.18 Desloratadine and other 14 kinds of components; Determination of Cimetidine in Cosmetics (high performance liquid chromatography, HPLC) (NMPA No. 48 in 2019) |
3 | Thioglycollic Acid and Other 7 Kinds of Components in Cosmetics | 3. Testing Methods of Restricted Ingredients: The first Method: HPLC in 3.9 Thioglycollic Acid |
4 | Determination of Free Formaldehyde in Cosmetics | 4. Testing Methods of Preservatives: 4.9 Free Formaldehyde |
5 | α-Arbutin and Other 3 Kinds of Components in Cosmetics | 2. Testing Methods of Prohibited Ingredients: 2.26 Hydroquinone and phenol |
These revised testing methods will be applicable to the testing work related to cosmetics registration, notification, and sampling inspection from March 1, 2024.
3. Introducing 14 additional new test methods
No. | New Testing Methods | Types |
1 | Determination of pH in Cosmetics (W/O) | New physical and chemical testing methods of pH value |
2 | Determination of Ethyl Acrylate and Other 39 Kinds of Components in Cosmetics | New physical and chemical testing methods of prohibited ingredients |
3 | CI 10020 and Other 10 Kinds of Components | New physical and chemical testing methods of colorants |
4 | CI 11920 and Other 12 Kinds of Components | |
5 | Determination of 5-(2-Hydroxyethylamino)-2-Methoxylaniline Sulfate and Other 14 Kinds of Components | New physical and chemical testing methods of hair dyes |
6 | Determination of L-Ascorbic Acid 2-Phosphate Magnesium Ester and Other Ten Components in Cosmetics | New physical and chemical testing methods of other ingredients, except the above-mentioned ingredients |
7 | Disodium Distyrylbiphenyl Disulfonate and Other 4 Kinds of Components in Cosmetics | |
8 | In Vitro Skin Sensitisation: Human Cell Line Activation Test (h-CLAT) | Animal testing alternatives for cosmetic ingredients |
9 | In Chemico Skin Sensitisation: Amino acid Derivative Reactivity Assay (ADRA) | |
10 | Fluorescein Leakage In Vitro Test Method | New toxicological test methods |
11 | Acute Oral Toxicity Test Up-and Down Procedure | |
12 | Acute Oral Toxicity Test The Fixed-Dose Procedure | |
13 | Acute Oral Toxicity Acute Toxic Class Method | |
14 | In Vivo Mammalian Alkaline Comet Assay |
It is worth noting that some industry experts show that the "Determination of L-Ascorbic Acid 2-Phosphate Magnesium Ester and Other Ten Components in Cosmetics" closely mirrors the GB/T35954-2018 Determination of 10 Whitening and Freckle-Removing Components in Cosmetics - High Performance Liquid Chromatography, with minor modifications. Thus, although the new method does not explicitly mention “whitening” and “freckle removing”, the 11 ingredients listed can be considered as the public-accepted/recognized list off the record of whitening and freckle-removing agents at this stage. In addition, plus the whitening ingredients α-Arbutin and Arbutin from the "α-Arbutin and Other 3 Kinds of Components in Cosmetic", currently there are 13 kinds of whitening and freckle-removing agents available.
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ChemLinked Comments
Chemlinked recommends that businesses to familiarize themselves with these new methods to ensure that test reports for their new products comply with the requirements. Additionally, businesses should check existing products added with the relevant ingredients, to ensure their actual concentration and the residual amount of risk substances meet the limitations outlined in the new methods, and determine if further testing is necessary.
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