China NIFDC Consults on Eight Technical Guidelines for the Testing of Cosmetic Products and New Cosmetic Ingredients

On April 27 and May 4, 2023, China National Institutes for Food and Drug Control (NIFDC) released eight technical testing guidelines for public consultation. Stakeholders with any comments can mail to [email protected] by May 20, 2023.^1-2

The details of the eight draft technical guidelines are as follows:

1. Technical Guidelines for Dermal Irritation/Corrosion Test

Dermal irritation/corrosion test assesses the irritation or corrosion effect and the irritation/corrosion degree of a test substance on mammalian skin. The Safety and Technical Standards for Cosmetics (STSC) sets it a compulsory testing item for cosmetic products and new cosmetic ingredients (NCIs). The Working Rules for Cosmetic Registration and Notification Testing (the Working Rules) and Provisions for Management of Cosmetic Registration and Notification Dossiers further specify that hair care and aromatic cosmetics shall undergo acute dermal irritation test, while skin care and makeup cosmetics shall go through multiple dermal irritation tests.

This guideline is developed to standardize the application of dermal irritation/corrosion tests in assessing the dermal irritation of cosmetic products and NCIs. Its main contents include the formulation background, legal basis, application scope, basic principles, operation requirements, result analysis and evaluation, etc.

2. Technical Guidelines for Acute Eye Irritation/Corrosion Test

The acute eye irritation/corrosion test is used to determine the test substance's irritation or corrosion effects on mammalian eyes, and assess their degrees. It is required to submit data from this test for the registration application of hair dyeing, hair perming and anti-hair loss products, as well as for the registration and notification application of NCIs. Additionally, in the safety assessment of cosmetic ingredients, data from this test is commonly adopted as evidence for assessing ingredients' irritation or corrosion.

This guideline is to provide standards for conducting acute eye irritation/corrosion tests for cosmetic products and NCIs. Specifically, it introduces applicable test methods, requirements for evaluating test data, and issues that require special attention. 

3. Technical Guidelines for Dermal Phototoxicity Test

The Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers stipulates that, NCIs with UV absorption properties shall be tested for dermal phototoxicity. Besides, according to the Working Rules, the following cosmetics shall undergo a dermal phototoxicity test:

• General cosmetics with chemical sunscreen concentration ≥0.5% (w/w), except for perfumes, as well as rinse-off and nail polish products;

• All anti-hair loss, freckle-removing and whitening, and sunscreen products, as well as other special cosmetics with chemical sunscreen concentration ≥0.5% (w/w), except for perfumes and nail polish products.

This guideline is formulated to instruct the phototoxicity research and safety assessment of cosmetic products and NCIs. Its main contents include the formulation background, legal basis, application scope, basic principles, operation requirements, result analysis and evaluation, etc. 

4. Technical Guidelines for Bacterial Reverse Mutation Test

When applying for anti-hair loss or hair dyeing products registration, it is required to submit bacterial reverse mutation test data. In addition, this test is used to assess the mutagenicity of NCIs, and is commonly adopted as evidence for assessing the mutagenicity of cosmetic ingredients in safety assessments.

During the review of test reports or data, it was frequently found that there were errors in the setting of the highest concentration of the test substance, or the result judgement was unreasonable. This guideline is therefore established to standardize the practical application of the bacterial reverse mutation test. Consisting of 5 parts, it introduces basic test principles and operation requirements, and gives guidance on result analysis and evaluation. 

5. Technical Guidelines for Human Skin Patch Test

The human skin patch test aims at detecting the potential possibility of adverse reactions caused by the test substance on the skin. As an essential part of cosmetic safety assessment, it is a mandatory testing item for the registration application of sunscreens as well as freckle-removing and whitening cosmetics.

NIFDC compiled this guideline to provide technical guidance for the operation of the human skin patch test. It explains the key contents of the test design, gives instructions for the major links in the test, and establishes safety assessment principles for products. 

6. Technical Guidelines for Cosmetic Safety In-use Test

Cosmetic safety in-use test plays an important role in the safety evaluation system of finished cosmetic products. It applies to the testing of anti-hair loss and depilating products, leave-on cosmetics whose pH is tested ≤3.5 in physical and chemical test or set as ≤3.5 by the enterprise, and other cosmetics requiring similar testing. 

For this test, STSC includes the in-use test methods and the skin reaction classification standard. On this basis, this guideline gives instructions for analyzing and evaluating the test product's potential to cause adverse reactions on human skin, further guiding the cosmetic safety assessment. 

7. Technical Guidelines for the Determination of Sunscreen Product's Protection Factor of UVA (PFA)

The Working Rules specifies that, for products labelled with PFA value or PA+ to PA++++, the PFA value shall be tested; for products claiming UVA protection or broad-spectrum sun protection, the testing of cosmetic anti-UVA ability parameter (critical wavelength or PFA value) is required.

This guideline is to offer scientific suggestions for PFA testing of sunscreen products, test result analysis and evaluation, and the claiming requirements for PFA value. Its main contents include the formulation background, legal basis, application scope basic principles, essential test contents, result analysis, etc. 

8. Technical Guidelines for Skin Sensitization Test

Skin sensitization test is a key component in the toxicological test on cosmetic ingredients and products. Additionally, this test is used to assess the sensitization of NCIs, and is frequently employed as evidence in the safety assessment of cosmetic ingredients for assessing sensitization. 

To guide the safety assessment of cosmetic products and NCIs, NIFDC drafted this guideline. Consisting of five parts, it introduces the basic test principles and contents, and gives instructions on result analysis and evaluation.