China Consults on Five Testing Methods for Cosmetics Products and Ingredients, New Animal Testing Alternatives Included

China NIFDC is seeking public comments on five testing methods, which pertain to the pH determination of cosmetics as well as the in-vitro skin sensitization, in-vitro eye irritation/corrosion, genotoxicity test of cosmetic ingredients.

On November 12, 2021, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation on five draft testing standards for cosmetic products and ingredients. Stakeholders with any comments can send them to the NIFDC via email at [email protected] before November 28, 2021.

The details of the five draft testing methods are as follows:

No.	Draft Name	Content
1	pH	This method stipulates the acidimeter method for pH determination in cosmetics. It is applicable to determine the pH of water-in-oil cosmetics.
2	In Chemico Skin Sensitisation: Amino Acid Derivative Reactivity Assay (ADRA)	This method aims to determine whether the chemical ingredients used in cosmetics can cause skin sensitization. This method applies to the evaluation of potential sensitization of known single-component cosmetic ingredients.
3	Fluorescein Leakage In Vitro Test Method	This method specifies the scope, test purpose, terms and definitions, test principles, test materials and reagents, test procedures, and results judgment criteria of the fluorescein leakage in vitro test method for chemical ingredients used in cosmetics. This method applies to the detection of eye irritation/corrosion of water-soluble chemical ingredients used in cosmetics.
4	Human Cell Line Activation Test	This method specifies the basic principles, requirements, and methods of in vitro skin sensitization: human cell line activation test. It applies to the evaluation of potential sensitization of chemical ingredients used in cosmetics.
5	In Vivo Mammalian Alkaline Comet Assay	This method specifies the basic principles, requirements, and methods of in vivo mammalian alkaline comet assay. It applies to the genotoxicity test of cosmetic ingredients.

Notably, the drafts In Chemico Skin Sensitisation: Amino acid Derivative Reactivity Assay (ADRA) and Human Cell Line Activation Test are new in vitro alternative methods for cosmetic ingredients’ skin sensitization test. The draft Fluorescein Leakage In Vitro Test Method is a new in vitro alternative method for cosmetic ingredients’ eye irritation/corrosion test. The release of these methods will promote the establishment of an alternative method system for animal testing in China and reduce the authority and the industry’s reliance on the use of animal testing.

Alternatives to Animal Testing in China

Since 2011, China NIFDC has initiated the research and validation of alternatives for animal testing with reference to OECD guidelines. Up to now, six alternative methods have been approved and incorporated into Safety and Technical Standards for Cosmetics for relevant cosmetic registration/notification and post-market surveillance testing, as shown below.

Approved Alternative Methods in China

In-vitro 3T3 Neutral Red Uptake Phototoxicity Test Method for Chemicals used in Cosmetics (non-animal test)
In Vitro Skin Corrosion Transcutaneous Electrical Resistance Test (TER) for Chemicals Used in Cosmetics (animal test is still needed)
Short Time Exposure In Vitro Test Method (STE) (non-animal test)
In Chemico Skin Sensitization: Direct Peptide Reactivity Assay (DPRA) (non-animal test)
Skin Sensitization: Local Lymph Node Assay: DA（LLNA: DA）(animal test is still needed)
Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA（LLNA: BrdU-ELISA）(animal test is still needed)

In addition, according to ChemLinked’s inside sources, the methods Skin Sensitisation: ARE-Nrf2 Luciferase LuSens Test Method and Skin Sensitisation: U937 Cell Line Activation Test (U-SENS™) are under validation.