China Approves Efficacy Evaluation Methods for Freckle Removing (Whitening) and Anti-Hair Loss Products

Earlier in November 2020, China NIFDC consulted on seven draft cosmetic testing methods. ¹ Four months later, on March 2, 2021, China approved seven cosmetic testing methods and included them in the Safety and Technical Standards for Cosmetics 2015 (STSC). ²

Details of the 7 Testing Methods

No.	Name		Applicable Scope	Types of Change
1	Determination of Preservatives in Cosmetics	Determination of Methylisothiazolinone and Other 22 Kinds of Components in Cosmetics	The method is applicable to determine the content of 23 preservatives in cosmetics, namely: Methylisothiazolinone 2-Br-2-nitropropane-1,3-diol 4-Hydroxybenzoic acid Methylchloroisothiazolinone Benzyl alcohol Phenoxyethanol Benzoic acid 4-Hydroxybenzoic acid methyl ester Chlorphenesin Dehydroacetic 5-Bromo-5-nitro-1,3-dioxane 4-hydroxy ethyl benzoate Isopropyl 4-hydroxybenzoate 4-Hydroxybenzoic acid propylester Phenylparaben Isobutyl 4-hydroxybenzoate Butyl-4-hydroxybenzoate Benzyl 4-hydroxybenzoate Ethyl benzoate Amyl 4-Hydroxybenzoate Isopropyl benzoate Propyl benzoate Phenyl benzoate	Content Amendments
		Determination of Zinc Pyrithione and Other 18 Kinds of Components in Cosmetics	The method is applicable to determine the content of 19 preservatives in cosmetics, namely: Zinc Pyrithione Salicylic acid Sorbic acid Phenoxyisopropanol 2,6-Dichlorobenzyl alcohol Methyl benzoate Iodopropynyl butylcarbamate p-Chloro-m-cresol 2,4-Dichlorobenzyl alcohol Biphenyl-2-ol o-Cymen-5-ol Chloroxylenol Climbazole Chlorophene Piroctone Olamine Triclocarban Triclosan Bromochlorophene Thimerosal
		Determination of Hexamidine diisethionate and Other 6 Kinds of Components in Cosmetics	The method is applicable to determine the content of 7 preservatives in cosmetics, namely: Hexamidine diisethionate Chlorhexidine Dodecyltrimethylammonium bromide Dodecyl dimethyl benzyl ammonium chloride Benzethonium chloride Tetradecyl dimethyl benzyl ammonium chloride Hexadecyl dimethyl benzyl ammonium chloride
		Determination of Polyaminopropyl Biguanide in Cosmetics	The method is applicable to determine the content of Polyaminopropyl biguanide in cosmetics.
		Determination of Hexetidine in Cosmetics	The method is applicable to determine the content of Hexetidine in cosmetics.
		Determination of Phenylmercuric Borate in Cosmetics	The method is applicable to determine the content of Phenylmercuric Borate in cosmetics.
		Determination of Formic Acid and Other 8 Kinds of Components in Cosmetics	The method is applicable to determine the content of 9 preservatives in cosmetics, namely: Formic acid Propionic acid Chlorobutanol Isobutyl benzoate Butyl benzoate Undec-10-enoic acid 7-Ethyldicyclooxazoline Dimethyl oxazolidine Glutaral
		Chapter IV Physical and Chemical Testing Methods for Cosmetics 4. Determination of Preservatives in Cosmetics 4.6 Formaldehyde	The method is applicable to determine the content of formaldehyde in cosmetics.	Serial Number Adjustments
		Chapter IV Physical and Chemical Testing Methods for Cosmetics 4. Determination of Preservatives in Cosmetics 4.12 Free Formaldehyde	The method is applicable to determine the content of free formaldehyde in cosmetics.	Serial Number Adjustments
		Notes: The updated chapter numbers of the Determination of Preservatives in Cosmetics in STSC are as follows: Chapter IV Physical and Chemical Testing Methods 4 Determination of Preservatives in Cosmetics 4.1 Methylisothiazolinone and other 22 Kinds of Components 4.2 Zinc Pyrithione and other 18 Kinds of Components 4.3 Hexamidine diisethionate and other 6 Kinds of Components 4.4 Polyaminopropyl Biguanide 4.5 Hexetidine 4.6 Phenylmercuric Borate 4.7 Formic Acid and other 8 Kinds of Components 4.8 Formaldehyde 4.9 Free Formaldehyde
2	Determination of Boric Acid and Borate in Cosmetics		The method is applicable to determine the content of boric acid and borate in the liquid, cream, lotion, powder, and gel cosmetics by ion chromatography.	Content Amendments
3	Determination of P-phenylenediamine and Other 31 Kinds of Components in Cosmetics		The method is applicable to determine the content of 32 hair dyeing agents in hair dyes by High-Performance Liquid Chromatography, namely: p-Phenylenediamine p-Aminophenol toluene-2,5-diamine sulfate m-Aminophenol o-Phenylenediamine 2-Chloro-p-phenylenediamine sulfate o-Aminophenol resorcinol 2-Nitro-p-phenylenediamine toluene-3,4-Diamine 4-Amino-2-hydroxytoluene 2-Methylresorcinol 6-Amino-m-cresol phenyl methyl pyrazolone N,N-diethyl toluene-2,5-diamine hydrochloride 4-Amino-3-nitrophenol m-Phenylenediamine 2,4-Diaminophenoxyethanol HCl Hydroquinone 4-Amino-m-cresol 2-Amino-3-hydroxypyridine N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate p-Methylaminophenol sulfate 4- Nitro-o-phenylenediamine 2,6-Diaminopyridine N,N-diethyl-1,4-phenylenediamine sulfate 6-Hydroxyindole 4-Chlororesorcinol 2,7-Naphthalenediol N-phenyl-p-phenylenediamine 1,5-Naphthalenediol Naphthol
4	Determination of Tretinoin and Other 7 Kinds of Components in Cosmetics		The method is applicable to determine the content of tretinoin and other seven kinds of components in cosmetics by High-Performance Liquid Chromatography, namely: Tacalcitol Tazarotene Acitretin Isotretinoin Tretinoin Etretinate Viaminate Adapalene
5	In Vitro Mammalian Cells Micronucleus Test		The method is applicable for the testing of mutagenicity of cosmetic ingredients and their products.	Newly Added
6	Test Method for Efficacy Measurement of Skin Whitening Cosmetic Products		The method is applicable for the evaluation of cosmetics claiming freckle removing and whitening by human trials.
7	Test Method for Efficacy Measurement of Anti-hair Loss Cosmetic Products		The method is applicable for the evaluation of cosmetics claiming anti-hair loss by human trials.

Among the seven testing methods, In Vitro Mammalian Cells Micronucleus Test, Test Method for Efficacy Measurement of Skin Whitening Cosmetic Products, and Test Method for Efficacy Measurement of Anti-hair Loss Cosmetic Products are newly introduced testing methods, which took effect on March 2, 2021. The other four testing methods are revised testing methods and will be effective on May 1, 2021.

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Influence

The release of the first five testing methods will help standardize the cosmetic ingredients management and improve the cosmetic risk assessment system. The other two fill the gap where China lacks the efficacy evaluation methods and conform to the upcoming efficacy evaluation requirements under China's new cosmetic regulatory framework.

The newly implemented evaluation methods clarify freckle-removing (whitening) and anti-hair loss products to conduct efficacy evaluation through human trials. Excluding the time required to recruit volunteers, the efficacy evaluation cycle of freckle-removing (whitening) products is at least 37 days, and for anti-hair loss products, at least 12 weeks.

A domestic R&D engineer said, "Previously it took at least 12 months to launch freckle-removing (whitening) products. In the future, it will take at least 18 months." ³This will extend the time for product to enter the market and increase R&D costs. Enterprises may reduce the R&D of freckle-removing and whitening products in the future.