Cosmetic Efficacy Evaluation: Requirements and Test Method Selection in China

 

With the continuous development of society, people's demand for beauty is also constantly upgrading. Cosmetic efficacy claims help consumers choose products suitable for themselves. But do the claimed efficacies of cosmetics really exist? How should we prove the claimed efficacies of cosmetics?

The Regulations on Supervision and Administration of Cosmetics clearly require that cosmetic efficacy claims should have a sufficient scientific basis. The Technical Specifications for Efficacy Evaluation of Cosmetic Efficacy Claims further stipulates that the basis for efficacy claims includes literature, research data, or results of cosmetic efficacy evaluation experiments. Among them, cosmetic efficacy evaluation experiments are an important evaluation tool, including human efficacy evaluation experiments, consumer use tests, and laboratory tests. The following introduces the related contents of cosmetic efficacy evaluation experiments.

I. Requirements for Efficacy Evaluation Experiments

1. Human Efficacy Evaluation Experiments

Cosmetics with whitening, sun protection, hair loss prevention, acne removal, nourishing, and repairing efficacies should be evaluated for efficacy claims through human efficacy evaluation experiments.

2. Choose One of Two (Human Efficacy Evaluation Experiments or Consumer Use Tests)

Cosmetics with specific claims (such as suitable for sensitive skin, and tear-free formula) should be evaluated for efficacy claims through human efficacy evaluation experiments or consumer use tests.

3. Choose One of Three (Human Efficacy Evaluation Experiments, Consumer Use Tests, or Laboratory Tests)

Cosmetics claiming to have tightening, soothing, anti-wrinkle, oil control, exfoliating, split end prevention and dandruff removal efficacies, as well as those claiming to be mild (such as non-irritating) or having quantitative indicators (such as duration of efficacy, statistics related to efficacy), should choose at least one of human efficacy evaluation experiments, consumer use tests or laboratory tests for evaluation. The analysis results of literature or research data can also be combined for efficacy claim evaluation.

4. Cosmetics Claiming New Efficacy

Cosmetics claiming new efficacy should be scientifically and rationally analyzed based on specific efficacy claims. For those requiring submission of efficacy claim evaluation data, test methods other than mandatory national standards and technical specifications should be verified by two or more cosmetic registration and filing testing institutions. Only after verification of meeting the requirements can the evaluation of new efficacy be carried out. The validity and reliability parameters of the methods should also be explained in the efficacy claim evaluation report.

II. Selection of Efficacy Evaluation Test Methods

There are many cosmetic efficacy evaluation methods/standards, which can usually be divided into the following 4 categories based on their sources. Except for special provisions, cosmetic efficacy claim evaluation experiments should give priority to the test methods in categories 1 and 2 below. For categories 1 and 2 without provisions, any method in categories 3 and 4 can be chosen.

1. Methods Specified in China's Mandatory National Standards and Technical Specifications for Cosmetics

Such as the determination methods for sun protection factor (SPF) value, water resistance performance, and long wave UV protection factor (PFA) of sunscreen cosmetics in the Technical Specifications for Safety of Cosmetics (2015 Edition).

In addition, in 2021, the State Administration for Market Regulation issued Announcement No. 17, incorporating the Test Methods for Whitening and Anti-hair Loss Efficacy of Cosmetics into the Technical Specifications for Safety of Cosmetics (2015 Edition), further providing scientific and valid reference standards for product registration and filing.

Therefore, cosmetics with whitening, sun protection, and hair loss prevention efficacies should be evaluated for human efficacy by cosmetic registration and filing testing institutions in accordance with the requirements of mandatory national standards and technical specifications, and issue reports.

2. Methods Specified in China's Other Relevant Laws, National Standards and Industry Standards

Such as the industry standard QB/T 4256-2011 Technical Guidelines for Efficacy Evaluation of Moisturizing Cosmetics.

3. Methods Specified in Foreign Relevant Laws or Technical Standards

Such as the Korean Ministry of Food and Drug Safety has also issued a series of efficacy evaluation guidelines including whitening, anti-wrinkle, and hair loss prevention efficacy evaluation guidelines.

4. Methods issued by domestic and foreign authoritative organizations, technical institutions, and industry associations, methods published in academic journals, or self-formulated methods

For example, most Western countries do not have relevant regulatory documents on specific cosmetic efficacy evaluation methods. Efficacy evaluations can be based on relevant ISO standards, efficacy evaluation guidelines for cosmetics and other topical products issued by the European Experts Group on Efficacy Evaluation of Cosmetics and Other Topical Products (EEMCO) or other industry associations, or methods published in academic journals or self-formulated. But before conducting efficacy evaluations, the evaluation institutions should complete the necessary test method transfer, confirmation or verification to ensure the scientific and reliability of the evaluation work.

III. Report Contents

Human efficacy evaluation experiments and consumer use tests should follow ethical principles. Necessary product safety assessments should be completed before the experiments to ensure no harm to the subjects' health under normal and foreseeable conditions. All subjects should sign informed consent forms before participating in the experiments.

After the cosmetic efficacy evaluation experiments are completed, the institutions undertaking the efficacy evaluation should issue cosmetic efficacy evaluation reports. The reports should contain complete information, standardized formats, and clear conclusions, and be confirmed with the seal of the evaluation institutions. The reports generally should include the following contents:

(1) Name, address, and other relevant information of the cosmetic registrant, recorder, or domestic agent;

(2) Name, address, and other relevant information of the efficacy claim evaluation institution;

(3) Product name, quantity, specifications, production date or batch number, color, texture, and other relevant information;

(4) Test items and basis, start and completion dates of the test, materials and methods, test results, test conclusions, and other relevant information.

For test methods other than those specified in China's mandatory national standards and technical specifications for cosmetics, and other relevant laws, national standards, and industry standards, the complete text of the test methods should be attached after the report. The method texts and test reports in foreign languages should also be translated into standard Chinese.

IV. Data Management

The cosmetic applicants should promptly file and properly retain the basis and abstracts of the cosmetic efficacy claims for future reference. The basic materials in foreign languages should also be translated into standard Chinese for archiving. The product formulas used in the efficacy claim evaluation experiments should remain consistent with those for registration and filing, and the consistency certification materials should be filed together with the efficacy claim basis materials.

The institutions undertaking the efficacy claim evaluation tests should organize, file and retain the relevant materials such as the product efficacy evaluation reports for future reference.