Take home: CFDA has drafted a guidance to instruct industry on how to evaluate cosmetic efficacy claims effectively and guarantee the claim is based on scientific evidence.
The guidance applies to any specific efficacy claim that requires evaluation before it is permitted to be used on labels (except for direct recognizable efficacies such as beautification, modification, cleansing, perfume). For example: UV-protection, whitening, growing hair, body building, deodorizing, anti-wrinkle, anti-freckle, controlling oil, anti-dandruff, repairing, moisturizing (more than 2h), etc. Efficacy claims used in adverts or on packages should be equivalent with evaluated results. Enterprises are authorized to conduct evaluation work themselves or entrust qualified institutions.
4 methodologies can be used to substantiate efficacy: In-vivo/in-vitro testing, clinical trials, animal testing and quantitative/qualitative consumer feedback studies. The results of evaluation should be sorted out by groups in report forms
Ⅰ Clinical trials
Ⅱ Animal testing report
Ⅲ Consumer investigation report
Ⅳ In-vitro/In-vivo alternative testing report
Ⅴ Other in-vitro testing report
Ⅵ relevant documents and materials with industrial agreement
Qualified institution for efficacy claim evaluation should:
Independently shoulder the legal liability;
Have an efficacy claim evaluation lab and operate independently
Setup an effective and proper management system;
Ensure the equipment and environment are adequate for evaluation work;
Equipped with sufficient technology, quality and operating staff
Entrusted institution should setup a complaint system
Setup a file management system to ensure traceability
Setup an accident/adverse reaction management system and disposition workflow
Sign the entrusted contract
The draft is for public consultation until Feb 5th 2018, any advices or suggestions can be submitted through hzpbwh@nifdc.org.cn. For more information, you may refer to original document on ChemLinked Database.