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June 2020 saw the official introduction of “Cosmetics Supervision and Administration Regulations.” A series of new concepts, systems, mechanisms, and regulatory features established with regards to registration filing on cosmetics and new ingredients. One special mechanism is holding the filing person responsible for quality and safety. The new regulations has been implemented as of January 1, 2021.
During the 26th China Beauty Expo, CBE in cooperation with Shanghai Institute of Technology, Diarybiotec and Shanghai Daily Chemistry Trade Association, hosted a series of regulation related forums to provide knowledge to the beauty industry. Authoritative experts, industry professionals, scholars, and dermatologists, came together to analyze new cosmetics-related regulations, impact of the new policies on the industry, and interpret future development and transformation of beauty enterprises.
01 Study the 24 attachments
The "Regulations on the Administration of Cosmetics Registration and Filing Documents" includes a total of 24 appendices. Among them, 19 appendices clarify the format of the application form, information form, summary form, etc. required in the registration process; 3 appendices are prepared for the authorization letter of the domestic responsible person, the standards for product implementation, and the self-examination report on the continuation of registration, etc. The two remaining appendices provide detailed technical details on the standard weaving of the product and the detailed submission of raw material safety.
Attention must be given to "domestic/overseas", "domestic/imported", etc. when selecting the corresponding attachment forms. Registrants and filing persons should determine the product category and corresponding regulations in accordance with the "Regulations on Supervision and Administration of Cosmetics" and the rules and catalogs Product classification codes and designing special cosmetics’ efficacy promotion shall be declared as special cosmetics.
02 Registrants/filers’ responsibilities & obligations
The registrant/filer, overseas cosmetics registrant/filer, and domestic responsible person shall be responsible for the legality, authenticity, accuracy, completeness, and traceability of the information. When there is a change, it shall be updated in time to ensure all recorded information on the service platform are true and accurate.
03 Four main purposes of the Regulations
The "Regulations" mainly focus on implementing the requirements of the "Regulations", insisting on fairness and consistency, reducing the burden on enterprises, and promoting "Internet + government services", etc.
--1 Adverse reaction testing is lacking in most SME’s, which should be implemented as soon as possible.
--2 Three key points of product quality management system Three key points to product quality management system: product name, product formula, & product implementation standards.
It is very important when filling in the formula table to include raw material serial number, raw material name, and percentage content (mass percentage). ODM companies must be aware that because it involves the specific component ratio of a product, it might pose a challenge for ODM companies, because there might be confidential contracts executed to the brand side.
--3 Changes require transition period Changes include changes in raw materials and product implementation standards. If the registration items changes, the corresponding materials should be submitted before the production or import, and the production or import can only be made after the corresponding changes are completed; if the filing items are being changed, the corresponding materials should be submitted before the product to be changed is marketed or imported. Only after completing the corresponding changes can the product be listed or imported; it should be noted that products that have been produced, listed, or imported before the change can be sold until the end of the warranty period.
--4 New vs. old, convenience & challenge Although new regulations can cause inconveniences for enterprises in the short run, the government is fully aware of the hurdles and have implemented a transition period as well as other conveniences for cosmetics companies. For example, domestic ordinary cosmetics have no need to review multiple packaging multiple times, avoiding repetitive work caused by different audit standards of the drug regulatory bureaus in various regions.
Of course, it is undeniable that the new filing also brings a certain degree of challenge to enterprises. For example, the filling of product classification codes; the management of raw material safety information, product performance standards etc.
#Efficacy claim, regulations are just the baseline#
From the initial selection of raw materials to the final formulation application, the research on the effective ingredients of cosmetics is inseparable. Under the new regulations, we must pay attention to efficacy verification, including the evaluation of the relationship between clinical efficacy and dose-effect, before the final application of the formula. The standards currently issued by the country are just baselines.
#New Regulations Promote the industry wide developments#
Thenew regulations clarify that the government encourages and supports thedevelopment of cosmetics research and innovation, as well as promoting thecreation of cosmetic brands.
At the moment, many domestic brands developed rapidly relies on e-commerce, but most of the products are OEM listings, (high ingredient content, does not represent absolutely efficiency, and may even be accompanied by safety hazards), lack of technical precipitation.
The new regulations clarify that the government encourages and supports the development of cosmetics research and innovation, as well as promoting the creation of cosmetic brands.
Raw material manufacturer and cosmetics enterprises should strengthen its R&D and increase technological prospective research. Innovation must emphasize the importance of strengthening basic research and develop core technologies for raw materials.
The new regulations require that product efficacy claims must be tested for efficacy, which will promote the development of the raw material industry and the development of efficacy testing technology. The requirements for the safety risks of raw materials and products will promote the development of technologies such as animal substitution tests, artificial skins, and organ models.
#Inspections Empower qualified products#
The new regulations clarify that cosmetics that claim new efficacy must submit product efficacy claims evaluation data, the cosmetics registration and filing testing agency shall conduct product efficacy evaluation and issue a report in accordance with the test methods specified in mandatory national standards and technical specifications. To use national standard testing methods and technical specifications, two or more cosmetic registration and filing inspection agencies should be entrusted to conduct method verification.
The evaluation of the new efficacy can only be carried out if it is verified to meet the requirements. At the same time, the effectiveness and reliability of the testing methods need to be clarified in the product efficacy claim evaluation report.
After years of development, China’s cosmetics industry is embarking on a new journey, whether it’s new regulations, newer technology, IP integration, category sub-division, China Beauty Expo has you covered.
For more trend and insights, category analysis, please follow the official WeChat account “ChinaBeautyExpoGlobal”.
At present, laboratory experiments fall mainly under three categories: physical and chemical detection methods, biochemical detection methods and biological detection methods. It is reported that Bawei has laid out more than 6,000 sqm of R&D and inspection laboratories and is committed to providing accurate and efficient services to the industry.
#Zebrafish Technology- New testing method of safety#
One example of toxicology testing is utilizing the properties of zebrafish. The physiology, development and metabolism of zebrafish are highly similar to mammals, and their genes are 87% homologous to humans, they can reliably simulate and predict human physiological and pathological processes.
In addition, based on its sensitivity to toxicity in vivo, zebrafish has five major advantages as a brand-new evaluation method: high throughput, transparency and intuitiveness, high reliability, shorter cycle, and compliance with the 3R principle.
#Increase repurchase rate-KOL & Brands Win-Win#
Relevant research data shows that: at present, most of the brands that Chinese consumers have used in the past year and have a strong willingness to continue to use are international brands. And a number of overseas cosmetic enterprises will increase investment in the Chinese market in 2021, and increase productivity and social influence through a series of reforms such as the introduction of new brands and accelerating channel transformation.
The repurchase rate is the core of the brand. As a constituent party, KOLs pay more attention to product information transparency and channel credibility. With the help of KOLs and their fans in the target user group, it is possible to develop products that users can feel, answers for specific usage scenarios, and promote social communication.
#Made in China cosmeticscan be expected#
Outstanding product is the cornerstone of the enterprise/brands. A good product is bound to have excellent performance in repurchase rate, user attractiveness and credibility. Driven by the new regulations, it is a good time for enterprises to integrate resources, organize product lines, and increase R&D investment. It is believed that made in China cosmetics will have a place in the world in five or ten years.