(Source: https://pltfrm.com.cn)
In China, specific types of beauty products, such as those containing SPF (Sun Protection Factor) and other special purpose cosmetics, are subject to more stringent regulations than general cosmetics. These regulations are in place to ensure product safety and efficacy due to the specific functions these products serve. Here’s an overview of the special regulations for such products in China:
1. Registration and Filing Requirements
Special Purpose Cosmetics Registration: Products like sunscreens are classified as special purpose cosmetics in China. They require registration with the National Medical Products Administration (NMPA), formerly known as the CFDA, before they can be marketed.
Dossier Submission: This registration process involves submitting a detailed dossier, including product formulation, safety assessment data, efficacy claims, and testing reports.
2. Ingredient Regulations
Approved Ingredients: Only approved UV filters and active ingredients can be used in sunscreens. The list of approved ingredients is periodically updated by the NMPA.
Concentration Limits: There are specific concentration limits for certain active ingredients, which must be adhered to.
3. Efficacy Claims and Labeling
SPF and PA Ratings: Sunscreens must have their SPF ratings tested and verified. Additionally, PA ratings (which indicate the level of UVA protection) are often included.
Claims Substantiation: Any claims made about the product’s effectiveness, such as “broad-spectrum” protection, must be substantiated with evidence.
Mandatory Labeling: Labels must include complete ingredient lists, SPF and PA ratings, usage instructions, and warnings. All labels must be in Mandarin Chinese.
4. Safety and Quality Testing
Safety Assessments: Safety testing is required to ensure that the product does not cause adverse skin reactions or other health issues.
Quality Control: Ongoing quality control and batch testing are necessary to ensure consistent product efficacy and safety.
5. Post-Market Surveillance
Adverse Reaction Monitoring: Companies are required to monitor and report any adverse reactions to their products.
Random Inspections: The Chinese authorities may conduct random inspections and product testing to ensure ongoing compliance.
6. Advertising Regulations
Compliant Marketing: Marketing and advertising should be truthful and not misleading. Claims made in advertising must be supported by evidence.
7. Import Regulations
For Imported Products: Imported sunscreens and special purpose cosmetics must comply with all the above regulations and may require additional documentation and testing to be accepted into the Chinese market.
Conclusion
The regulatory landscape for special types of beauty products in China, such as sunscreens, is complex and demands careful attention to compliance. Manufacturers and importers need to navigate these regulations effectively, ensuring that all product claims are substantiated, ingredients are approved, and labeling meets the required standards. Given the evolving nature of these regulations, staying updated and possibly consulting with regulatory experts is advisable.
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