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China finalized the long-awaited overarching regulation - Cosmetic Supervision and Administration Regulation (CSAR) on June 29, 2020, formally replacing the very outdated 30-year-old regulation Cosmetics Hygiene Supervision Regulations (CHSR).
Talking on the significance of CSAR, Chen Shaojun, Chairman of the Council of China Association of Fragrance Flavour and Cosmetic Industries (CAFFCI) stated, "Thanks to 7 years of government and cosmetic enterprises’ joint efforts, the CSAR has aligned the regulatory regime with the current industry practices and global trends. The CSAR strengthens the post-market surveillance with the increases of enterprises' obligations, simplifies the pre-market approval, and focuses on risk management. The implementation of CSAR will be nonetheless a major milestone for China to the modernization of China's cosmetic supervision. It will contribute to the healthy, orderly, and sustainable development of the cosmetic industry.”
Zhang Taijun, R&D Director at Quan Zhimei, said this is the most thorough, meaningful, and profound reform in the cosmetics industry for 30 years. The CSAR indicates precise management of every link in the supply chain, including the source of ingredients, production, distribution, sales, and operation.
New Cosmetic Ingredients
In the past, regulation of new cosmetic ingredients lacked clear approval procedures and review requirements. Under the new system, cosmetic ingredients are classified and supervised based on their risk and comply with clear and standardized application and approval requirements.
High-risk ingredients require registration with NMPA and are subject to strict supervision. The ingredients with low risk is subject to filing, requiring enterprises to declare ingredients, prepare materials, and conduct risk monitoring themselves. "Using a triage approach involving the stratification of ingredient by risk can effectively manage ingredients and will promote R&D, usage, and circulation of the ingredients, and inject new life into the industry." Zhang Taijun commented.
In the past, many globally popular cosmetic ingredients were not listed in the Inventory of Existing Cosmetics Ingredients in China (IECIC). Ingredients outside of the IECIC were automatically classed as "new ingredients" and, therefore, subject to costly and time-consuming registration requirements, irrespective of the inherent risk pose by the ingredient. This requirement will change in the CSAR, and the industry highly anticipates the specific details of these changes.
Efficacy Verification
In the new regulation, the manufacturer shall take full responsibility for any efficacy claims. Relevant literature, adequate research data, or testing reports are required and available to the public on NMPA's website.
“In the past, only sunscreen products required detailed efficacy reports. Now efficacy verification reports are also mandatory for whitening products, freckle-removing products, or other functional cosmetics bearing efficacy claims on the label or other advertising material.” Noted Zhang Taijun, “Companies shall be more cautious about using cosmetic efficacy claims. If no solid evidence supports the claim, they will be sanctioned for false advertising and face severe administrative penalties."
Regarding how the efficacy data will be exposed to the public, Zhang Taijun said it remains to be seen. Companies are advised to establish a system of efficacy verification and toxicological testing rather than worrying about the disclosure of efficacy data.
Safety
“We can find that the core of CSAR is the management of safety. The new regulation requires companies to establish a complete management system, covering product safety assessment, quality management, efficacy verification, cosmetic circulation, and adverse reaction monitoring.” Zhang Taijun summarized.
In the past, cosmetic businesses can be carried out as long as a pre-market licensing was obtained. Now the supervision has shifted to the management of pre-market, in-market, and post-market and a focus on traceability throughout the supply chain.
To ensure product safety, penalties for violations are also subject to a significant change. The CSAR diversifies and clarifies the penalties for different violations instead of the previous very vague penalty provisions. The fines are greatly increased, and for serious violations, responsible persons face serious legal liabilities.
Related Resources:
News : China Finalized the Long-Awaited Cosmetic Supervision and Administration Regulation
Webinar (Live Streaming): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)
English Translation: Cosmetic Supervision and Administration Regulation 2020 (Coming Soon)
Featured Page: Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking
