On June 29, 2020, the State Council of the People’s Republic of China released the long-awaited Cosmetics Supervision and Administration Regulation (CSAR). Due to be implemented from January 1, 2021, the CSAR will replace the existing cosmetics regulation, Cosmetics Hygiene Supervision Regulation (CHSR), which was first established over 30 years ago.
The regulation stipulates the production, operation and supervision of cosmetics in China, covering cosmetics raw materials and products, production and operation, labelling and advertising, supervision and management, legal responsibilities and more. Taking several years to come to fruition, the new regulation is comprehensive, with six chapters and 80 articles and will radically change the way the Chinese cosmetics ingredient is managed.
Talking about the significance of the CSAR, Chen Shaojun, Chairman of the Council of China Association of Fragrance Flavour and Cosmetic Industries (CAFFCI) said: “Thanks to seven years of government and cosmetic enterprises’ joint efforts, the CSAR has aligned the regulatory regime with the current industry practices and global trends. 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.”
The new regulation will bring about substantial changes to China’s cosmetics regulatory framework, aiming to closer align with current global industry practices. Some of the most notable updates include a new process for cosmetics ingredient registration and management and new rules on efficacy testing and claim substantiation. “2020 will be a big year for cosmetics regulation in China. The whole industry will be very busy complying with the new game rules” commented April Guo, General Manager, Personal Care Division at CIRS Group. So what could these changes mean for the industry?
The pace of innovation: registering ingredients made easy
For many, there will be fewer obstacles to register ingredients. High-risk ingredients – such as preservatives, sunscreens, hair dyes and whitening agents – require registration with the National Medical Products Administration (NMPA) and are subject to strict supervision. However, with the new regulation, low-risk ingredients do not need to be registered to launch into the market as long as they have been filed with the NMPA. If, after three years of being registered and filed, new ingredients continue to be used without safety concerns, they will be automatically added to the Inventory of Existing Cosmetic Ingredients (IECIC)4. By simplifying the procedures for cosmetic companies to introduce new ingredients, this new regulation will encourage innovation in the market at a much faster pace. As a result, “more and more advanced ingredients can be placed in the Chinese market to promote industrial developments” commented April Guo.
“At present, the registration process is tedious and the requirements are quite strict. It generally takes several years for enterprises to register a new ingredient as the documents may need to be supplemented many times, even if it is only a high molecular polymer without transdermal absorption or edible ordinary vegetable oil. Under the new regulation, low-risk ingredients are available for use after quick notifications” according to Hedy He, Cosmetics Regulatory Analyst at ChemLinked.
She added: “Also, China has released two draft Instructions for Cosmetics and New Ingredient Registration and Notification Dossiers to further clarify the requirements and review key points. It is believed that the enterprises’ enthusiasm for new ingredients application will be significantly improved.”
Zhang Taijun, R&D Director at Quan Zhimei reflected this, stating that “using a triage approach involving the stratification of ingredients by risk can effectively manage ingredients and will promote R&D, usage, and circulation of the ingredients, and inject new life into the industry.”
Increased trust in products and brands with scientific claims
With the new regulation, any scientific claim would require sufficient evidence before being published on the official NMPA website and approved by the administration. These claims must be substantiated by published literature, research data or product efficacy evaluation data. As this part of the regulation becomes tighter, there will be increased consumer confidence that any product with a claim has been proven by scientific testing before reaching the market.
“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. Companies will 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” commented Zhang Taijun.
Better regulation will also mean consumers can trust that ingredients are meeting the expected standards across the board. “The CSAR requires cosmetic ingredients and packaging materials in direct contact with cosmetics to comply with the mandatory national and technical standards. But the reality is that many cosmetic ingredients, such as plant extracts, lack corresponding mandatory national and technical standards. In the future, there will be more mandatory standards relating to cosmetic ingredients. The compliance responsibilities of enterprises are relatively heavier, but also clearer,” added Hedy He.
Further to this, the new regulation is likely to prompt ingredient suppliers and finished product manufacturers to conduct joint supervision of both ingredients and products, creating a unified system. At present, if a new ingredient registration is rejected by the government within the three-year monitoring period, then the registration of the finished product containing this ingredient would also be rejected accordingly. “This innovative twin-track supervision will further ensure the consumers’ safety,” according to Hedy He.
Ultimately, the increased focus on safety through regulations will further consumer confidence in the Chinese cosmetics market. “We can find see 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” comments Zhang Taijun.
The most debated question: animal testing
Finally, one of the most hotly debated aspects of the new regulation is whether the new regulation will see the end of controversial mandatory animal testing for imported cosmetics. Indeed, organisations like People for the Ethical Treatment of Animals (PETA) are “cautiously optimistic” that it would.
The question remains somewhat unanswered. However encouragingly, a draft subsidiary regulation of CSAR released on August 28 (Instructions for Cosmetic Registration and Notification Dossiers) introduced a policy shift towards animal testing management in China.
More specifically, according to this new document, companies can apply for exemption of animal testing for imported general cosmetics. Here, manufacturers are required to obtain the relevant certification of Good Manufacturing Practice (GMP) issued by the cosmetic regulatory authority of the country where they are located. In addition, safety assessment results must fully prove the safety of the ingredients intended for use.
However, the document also stipulates certain conditions where animal testing will still be required. This list includes products to be used by children, products using new cosmetic ingredients during their three years of required monitoring, if the notifier/RP/manufacturer is listed as a key supervision target according to the results of the quantitative rating system established by the NMPA, and if the notifier/RP/manufacturer has been previously investigated and penalised due to quality or safety issues. Should this draft come into play, if any of the above conditions apply, companies are required to still conduct animal testing.
With a clear focus on safety, the long-awaited Cosmetics Supervision and Administration Regulation is set to completely change the cosmetics ingredient landscape in China. With these changes, we can expect to see greater innovation in new product development as well as greater collaboration between manufacturers and formulators. Not least, with tighter regulation also comes increased consumer confidence which should be a big boost for the market.
Hear more from Hedy He, Cosmetics Regulatory Analyst at ChemLinked, in the in-cosmetics Asia ‘Meet the Speaker’ series, now available on the in-cosmetics Connect website here: Asia Pacific Cosmetics Regulations with Hedy He