CHINESE COSMETICS REGULATION
The implementation of a new Cosmetics Supervision and Administration Regulation (CSAR) has come into force on 1st of January (2021). On the 4th of March (2021) the National Medical Products Administration (NMPA) released the final versions of the two regulations: Provisions for Management of Cosmetic Registration and Notifications Dossiers (previously called as Instructions for Cosmetic Registration and Notification Dossiers) and Provisions for Management of New Cosmetic Ingredient Registration and Notifications Dossiers. The key goal of both regulations is to standardize and guide the registration and filing of new cosmetic materials and products. The documentation requirements for application, modification, renewal and cancellation of a cosmetic registration and notification are specified on these regulations.
According to these new Chinese regulations, animal testing of ‘general’ cosmetic products is no longer mandatory.
SAFETY ASSESSMENT AND EFFICACY CLAIMS
Standards for the testing of product’s safety and testing of efficacy of claims have been issued by the NMPA: “Cosmetics Efficacy Claim Evaluation Standards” and “The Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)”.
Starting 1st of January 2022, cosmetic registrants and filling persons (Brands) that apply for special cosmetics registration or general cosmetics notification must evaluate the efficacy claims of cosmetics in accordance with the requirements of the standard. This means that all cosmetic products (‘general’ or ‘special’) are subject to the requirements set in such standards and must provide a summary of the basis for product efficacy claims (through a website designated by the NMPA).
Safety assessment of cosmetic products shall be performed before notification/registration (both for general and special cosmetics) and it needs to be done according to the Technical Guidelines.
According to the efficacy testing Standards,“claim evaluation of cosmetic efficacy” refers to the process of scientific testing and reasonable evaluation of the efficacy claim content of cosmetics under normal conditions of use by means of literature research, research data analysis or cosmetic efficacy claim evaluation test, and corresponding evaluation conclusions.
The method chosen for the evaluation of the efficacy claim made for a cosmetic product needs to be scientific, reasonable and feasible. Furthermore, it must “meet the purpose of the evaluation of cosmetic efficacy claim”. It should be directly identified by visual, olfactory and other sensory senses (e.g., cleaning, deodorant, refreshing, dyed, etc.) or through simple physical cover effects (e.g., whitening, physical exfoliation, etc.). On the label it must be clearly identified if efficacy claims have only a physical effect.
For example, literature research, research data analysis or cosmetic efficacy claim evaluation tests shall be performed in order to evaluate cosmetic products with moisturising and hair care effects. But when we are talking about products with anti-wrinkle, firmness, soothing, oil control, exfoliation, hair loss and dandruff effectiveness, they should be evaluated (and their claims proved) through cosmetic efficacy evaluation test method, which can be combined with literature or research data analysis results. Human efficacy evaluation tests need to be performed in regard to whitening, sun protection, hair loss and acne cosmetic products’ claims.
The safety testing “Technical Guidelines” aim to standardize and provide guidance for the safety assessment of cosmetic products. Relevant available literature information (chemical, toxicological, etc.) analysis and its appropriate evaluation and interpretation should be performed by safety assessors. The safety evaluator should have up-to-date knowledge and be subject to continuous professional training, by learning new theories, techniques and methods, putting them into practice. The safety assessment of cosmetic products should be conducted in a fair and objective way, based on a comprehensive analysis of all available data and exposure conditions. The reports need to be scientific, accurate, authentic and reliable.
Raw materials and substances assessment should include the identification of health hazard effects, obtained by toxicological tests. Acute toxicity, dermal irritation/corrosivity, allergenicity, phototoxicity, light pervert reaction, genetic toxicity, repeated dose toxicity, reproductive development toxicity and chronic toxicity/carcinogenicity should all be taken into account.
Dose-reaction relationship should be studied and evaluated, and the No Observed Adverse Effect Level (NOAEL) or Benchmark Dose (BMD) needs to be calculated. If a risk of allergenicity of the raw material or ingredient is concluded, the No Expected Sensitization Induction Level (NESIL) should be calculated.
In sum, sufficient evidence (including relevant literature, research data or efficacy evaluation documents) should be included in cosmetic efficacy claims. This information shall become public via the NPMA’s website.
If you need any further enquiry about this process and the standards to be followed, feel free to contact us using our email firstname.lastname@example.org.
- Technical Guidelines for Cosmetic Safety Assessment. 2021. (Chinese).
- China Finalizes Dossier Requirements for Registration and Notification of Cosmetics and New Cosmetic Ingredients. Chemlinked. Mar 04, 2021. Available at: https://cosmetic.chemlinked.com/news/cosmetic-news/china-finalizes-dossier-requirements-for-registration-and-notification-of-cosmetics-and-new-cosmetic-ingredients