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
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