The “Regulations on the Supervision and Administration of Cosmetics” issued by NMPA has been in effect for three years since January 1, 2021. During this period, China’s secondary regulations on cosmetics have been continuously introduced and implemented, strengthening the supervision and management of cosmetics and implementing the company’s main responsibilities. Besides, it also protects the rights and interests of consumers and promotes the compliance development of the cosmetics industry. In addition, NMPA’s announcement (2021 No. 51) on the release of “Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)” states that cosmetics registrants and filers can submit a simplified version of the product safety assessment report before May 1, 2024. That is, filing/registration after May 1, 2024 requires the submission of a complete security assessment report.
The full version of the safety assessment report adds 3 items that must be tested:
- Physical and chemical properties and stability report (the estimated period is 3 months);
- Packaging material compatibility test report;
- Preservative challenge test report (estimated period is 40 days).
And the evaluation data of the safety assessment report can no longer refer to the Catalog of Used Cosmetic Raw Materials (2021 edition) and the three-year history of the company. You can refer to authority data, such as the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO), the European Union Scientific Committee on Consumer Safety (SCCS), the United States Cosmetic Raw Materials Evaluation Committee (CIR) and other published safety limits or conclusions such as cosmetics safe use conclusions, daily allowable intake, daily tolerated dose, reference dose, generally considered safe substances (GRAS) and so on. You can also refer to the requirements of the “Safety Technical Specifications for Cosmetics”. If the authoritative agency and the “Safety Technical Specifications for Cosmetics” cannot provide data to evaluate safety, then the toxicology test report including local toxicity (such as polyderma, acute skin disease), systemic toxicity (such as oral administration), etc. provided by the ingredients supplier should be provided.
In addition, the general cosmetics annual report will be implemented from January 1, 2022. As a task that cosmetics companies must complete every year, cosmetics companies that meet the requirements need to submit product annual reports between January 1st and March 31, 2024. For filed products that require annual reports, the regulatory authorities will order rectification within a time limit in accordance with Article 58 of the “Cosmetics Registration and Filing Management Measures”. If the filer fails to make corrections within the prescribed time limit as required, the regulatory authorities will follow the Article 59 of “Measures” to cancel the filing of related-products.
Cosmetics and ingredient companies should screen the ingredients used internally in advance to analyze whether they meet the full version of the assessment, and at the same time make reserves of new formulas that meet the full version of the safety assessment. Cosmetic factories should negotiate and communicate with raw material manufacturers in a timely manner to jointly solve the problem of raw material evaluation without authoritative safety evaluation data and minimize the impact of the implementation of new regulations.
At present, the implementation time of the complete version of the safety assessment is getting closer. According to the new regulations, the registration period for a new cosmetics will take at least more than three months. In order to ensure the smooth filing of new products, it is recommended to start preparations as early as possible.
If you have a new product registration plan, please contact us to learn more about the latest regulatory policies of China’s cosmetics industry, and we will prepare a filing and registration plan for you in advance.
