Guidelines on Efficacy Verification of Cosmetic Products Issued in China for Public Comments

Nov 10 2015, National Institute for Food and Drug Control invite public comments on the Guidelines on Efficacy Verification of Cosmetic Products. Any opinions shall be sent to wujing@nifdc.org.cn by email before Mar 31 2016.

Background

Currently, the efficacy claiming is used by most cosmetics on the market and it has great attraction to customers. However, there is lacking of scientific basis and conformity standards to supervise the efficacy claiming in China. Considering that foreign corporations are guided by academy/organization recommended evaluation methods and procedures, it is necessary to legislate Guidelines to regulate the efficacy verification of cosmetic products. The Guidelines on Efficacy Verification of Cosmetic Products is drafted based on the requirements of Regulations Concerning the Supervision and Administration of Cosmetics (RSAC), Measures on the Management of Cosmetics Labelling and Measures on the Ethical Review of Human Related Biomedical Research etc.

What’s New

Guidelines on Efficacy Verification of Cosmetic Productsconsist of 15 chapters:

1. General rules

2. Responsibility requirement

3. Application condition

4. Subject management

5. Staff requirement

6. The hardware equipment requirement

7. Sample management

8. Lab environment condition

9. Efficacy verification scheme

10. Organization and implementation

11. Ethical review

12. Data management and statistics analysis

13. Report

14. Contract management

15. Supplementary provisions and Appendix

The overall concepts of theGUIDELINEScan be summarized into following main points:

• The efficacy verification can be conducted by one or multiple methods. The common methods include human trial, in vitro test, etc.
• The GUIDELINES are available to efficacy verification by human trial. In vitro test must be carried out by GLP labs.
• Efficacy claim can be classified into five grades: I –Clinical research based ondouble-blinded and randomized control data in large samples; II –Clinical research based on double-blinded randomized controldatain small samples or on non-blinded and randomized control data; III – Non-random clinical research data; IV –Vitro test data by GLP lab and authoritative opinions from committee of experts; V – Related literatures.
• Related technical staff shall take no less than 10 courses in dermatosis, cosmetics science, skin bioinstrumentation, etc.
• Cosmetics manufacturers or distributors are responsible for the efficacy claiming
• Having specific requirements in degree and working experience for the staff of lab

• Emergency plan for SAE must be prepared during the process of efficacy verification.

The report consists of general and specific information.

General Information:

1. Applicant, lab address, main and other researchers, product info (type, formula, batch number, etc.), issue date.

2. Purpose of verification

3. Verification progress: start time and end time.

4. Verification method: summary of the proposal, proposal deviation

5. Statistic: method adopted, analysis result

6. Result: analysis method, result interpretation. The individual data shall be included in appendix.

7. Discussion if needed

8. Conclusion

9. Signature of responsible persons of project: including the director in charge of testing, quality, research, statistics and technique.

Specific information:

1. Human Subjects: basic and special information

2. Personnel withdrawal: amount of analytical sample, explanation of personnel withdrawal

3. Interpretation of results: quantitative and qualitative data.

CIRS Comments

• According to Entry 9, the efficacy verification for specific items have to be performed in designated lab. The other verification items not subject to administrative approval can be tested in third-party lab or internal lab of enterprise
• Separate handbook of cosmetics efficacy evaluation will be issued in terms of the item of efficacy verification. The proposal of efficacy verification shall be designed based on the HANDBOOK.