Recently, the Guangzhou Market Supervision Administration of China released the “FAQs on General Cosmetics Notification (Issue 62),” providing authoritative interpretations regarding the widely discussed claim of “itch relief” in cosmetics. However, according to a previous investigation by CHAILEEDO, different regions have different criteria for evaluating the “itch relief” claim. For example, Guangzhou does not prohibit this claim, while some areas in East China do.
In fact, the above phenomenon is not an isolated case. For a long time, the inconsistent requirements, standards, and interpretations caused by regional differences have become an insurmountable “invisible barrier” for many cosmetic companies during the notification process. However, the evaluation differences brought about by regional barriers are quietly being broken.
CHAILEEDO has noticed that recently, the integration research of cosmetic notification standards in the Yangtze River Delta area has been initiated for the first time. Shanghai, Zhejiang, Jiangsu, Anhui, and Jiangxi have joined hands to explore a collaborative governance model for cosmetic regulation in the Yangtze River Delta. This move signifies the first step towards unifying regional cosmetic notification standards in the Yangtze River Delta, as it is a crucial hub for China’s cosmetic industry.
“It has a significant symbolic meaning!” “It reflects that regulators in East China are actively breaking the evaluation differences caused by regions.” “We hope this can promote the national standardization of cosmetic notification,” expressed several senior industry insiders enthusiastically to CHAILEEDO.
So, what policy signals does the “integration of cosmetic notification standards in the Yangtze River Delta” represent? Is it practically feasible to achieve “national standardization of cosmetic notification”?
“The pursuit of unity and consistent standards” – The new “Regulations on the Management of Cosmetic Registration Notifications” serve as a significant demonstration
In May 2021, the “Regulations on the Management of Cosmetic Registration Notifications” were officially implemented, clearly stating that after submitting notification materials through the information service platform in accordance with the requirements of the National Medical Products Administration, the notification process for general cosmetics is considered complete. There are no further review processes before market entry.
However, completing the notification for general cosmetics does not mean they can be safely marketed. Following the notification, there is still the scrutiny of technical data. Currently, due to the lack of specific review criteria or authoritative guideline documents for the new notification platform, different regional pharmaceutical regulatory departments have varying interpretations of how to review domestic notification materials for general cosmetics and determine the criteria for evaluation.
In response to this situation, since the promulgation of the new regulations, various regions have been actively taking measures such as issuing documents and providing guidance to unify the evaluation criteria within provinces and cities, thus improving the efficiency and quality of the review of notification materials. For example, the Guangdong Provincial Medical Products Administration issued the “Key Points for Verification of Domestic General Cosmetics Notification Materials in Guangdong Province (2022 Edition)” in 2022. Recently, the Shanghai Market Supervision Administration also released the first local standard called “Requirements for General Cosmetics Notification Materials.”
However, the problem of inconsistent notification standards, criteria, and interpretations among provincial pharmaceutical regulatory departments has not been effectively resolved. CHAILEEDO has reported on this issue several times, highlighting the differences in evaluation criteria for claims such as “hypoallergenic” and “silicone-free” in different regions.
CHAILEEDO’s ongoing investigation has found that the aforementioned issue may be addressed through cross-regional cooperation. In October of last year, the Chongqing Medical Products Administration and the Sichuan Provincial Medical Products Administration jointly issued the “Key Points for Technical Verification of General Cosmetics Notification in Chongqing and Sichuan (2023 Edition),” announcing the unified technical verification standards for general cosmetics notification in the two regions.
Recently, during the second joint meeting on regulatory cooperation for cosmetics in the Yangtze River Delta region, Zhejiang Province announced the initiation of research on the “Integration of General Cosmetics Notification Standards in the Yangtze River Delta Region” this year. The aim is to explore the establishment of a unified understanding and consistent standards for cosmetic regulation in the Yangtze River Delta, marking the official entry of the Yangtze River Delta into the exploration of unified notification standards.
“We have already conducted various forms of communication, such as face-to-face meetings with companies, questionnaires, and thematic discussions, to identify the differences and difficulties in the evaluation criteria for domestic general cosmetics notification within the Yangtze River Delta region. This work lays a solid foundation for establishing the requirements for notification documents of general cosmetics and guidelines for notification in the Yangtze River Delta,” said Wang Jiawei, Deputy Director of the Zhejiang Provincial Medical Products Administration, during the meeting.
It is worth mentioning that during the meeting, the pharmaceutical regulatory departments of Zhejiang, Shanghai, Jiangsu, Anhui, and Jiangxi provinces exchanged views and conducted discussions on common challenging issues in cosmetic notification, such as “children’s nail polish,” labeling with “hospital judgment,” and “product packaging label images.”
As an important hub in the Chinese cosmetics market, the cosmetic industry in the Yangtze River Delta region has been developing rapidly. Shanghai has long ranked first in terms of the number of imported general cosmetics notifications, accounting for nearly 60% of the total number of imported cosmetic products and their value nationwide. Last year, Zhejiang Province ranked second in the country in terms of the number of cosmetic notifications. Therefore, the exploration of unified requirements for notification documents of general cosmetics in the Yangtze River Delta region undoubtedly plays a significant exemplary and leading role in achieving cross-regional standardization of cosmetic notifications in China.
Is it possible to achieve unified national notification standards?
Regarding the exploration of integrated cosmetic notification standards in the Yangtze River Delta, CHAILEEDO interviewed nearly ten senior industry professionals, most of whom expressed that this initiative is highly significant, indicating that provincial-level regulatory departments have realized and actively started to break the phenomenon of inconsistent cosmetic evaluation standards in different regions.
Shi Changsong, the R&D Director of Guangdong Baiya Cosmetics Co., Ltd., told CHAILEEDO, “The exploration in the Yangtze River Delta is highly influential. On the one hand, it can reduce the inequality caused by different evaluation standards in various regions. On the other hand, the current situation where cosmetic evaluators in different regions have different levels of understanding and professionalism has finally been addressed by local regulatory departments. This may ultimately promote the formation of unified national standards.”
Wang, an engineer from a well-known cosmetic company in the Yangtze River Delta, also stated that the unification of cosmetic notification standards has multiple implications. “The standardization of notification standards helps cosmetic companies compete on a level playing field. Previously, different regions had different interpretations of advertising claims, leading to differences in brand promotion.”
“Furthermore, unified standards make the notification process more efficient for companies, allowing them to follow a standardized workflow and focus more on product quality. Unified standards also benefit industry regulation, further ensuring the development of standardized practices within the industry,” added Wang.
As for whether the exploration of cosmetic standards in the Yangtze River Delta can promote unified national notification standards, many industry professionals hold a cautiously optimistic attitude.
“It is a positive development,” said Jiang Ligang, the founder of Hangzhou Ruiyan Forward-looking Biotechnology. “The initiation of research on the integration of cosmetic notification standards in the Yangtze River Delta region is essentially a discussion on practical notification details, providing suggestions to the industry or regulatory authorities. However, based on the documents currently issued by the regulatory authorities, the specific requirements for notification are still in the exploratory stage, and many requirements are being refined through continuous document updates.”
Several industry professionals also expressed to CHAILEEDO that achieving unified national notification standards may pose significant challenges. On the one hand, the Chinese language is vast and profound, and different contexts can convey rich meanings, making it difficult to achieve uniformity. On the other hand, although there are existing national standards for cosmetic evaluation, the viewpoints and interpretations of evaluators may still vary over time and in different regions, making it difficult to completely eliminate human factors. Therefore, ensuring complete uniformity is challenging.
Li Jincong, the founder of the Cosmetics Forbidden Words website, stated in an interview with CHAILEEDO, “It has been ten years since the implementation of non-special network notifications, and the regulatory framework has become quite mature in recent years. It is understandable that there are inconsistencies in evaluation standards in certain regions, as seen in the recent ‘anti-itch’ claims. Achieving complete uniformity is challenging.”
However, Li Jincong also acknowledged the exploration in the Yangtze River Delta region, saying, “It is possible to achieve uniformity by driving the inland regions through the coastal areas.”
Guo Qingquan, a member of the Academic Committee of the National Medical Products Administration’s Cosmetic Risk Assessment Key Laboratory, stated to CHAILEEDO, “The national regulatory authorities have noticed the issue of inconsistent evaluation standards in different regions and have strengthened guidance through the National Medical Products Administration and the Chinese Academy of Inspection and Quarantine. They have monthly internal work and exchange relevant documents to learn from each other. I believe that in the future, the problem of inconsistent notification standards will become less common.”
In Guo Qingquan’s view, since evaluations are conducted by people, and people’s opinions and perspectives are subject to change, completely eliminating inconsistent notification standards may be difficult. Implementing a truly informative notification system where the national regulatory authorities do not conduct notification reviews and the responsibility lies entirely with the notifier may be a worthwhile direction to pursue.
The improvement of enterprise notification capabilities is particularly urgent
Regarding the discussion on unified national cosmetic notification standards, senior industry professionals have expressed that this reflects the current situation in which the construction of cosmetic standardization in China is unable to keep up with the rapid development needs of the industry. Some viewpoints also suggest that the most pressing issue currently is the improvement of enterprise notification capabilities.
In the view of Li Jincong, “The most important indicator is the proportion of notifications that companies can complete independently. Most small and medium-sized enterprises entrust notification-related matters to third-party intermediaries because business leaders believe that third-party intermediaries offer better cost-effectiveness.”
“Currently, in some areas of Guangdong, notifications are entrusted to third-party organizations for review. However, if companies do not understand and learn about regulations regarding quality, regulations, and technical personnel, and overly rely on third-party intermediaries, they will be unable to control the compliance and legality of their products, undoubtedly leading to many risks for the company,” further stated Li Jincong.
The lack of enterprise notification capabilities reflects that under the current regulatory system, the role of enterprises has not been fully utilized. In an article published in the Journal of China Food and Drug Administration, a journal supervised by the National Medical Products Administration, titled “Research on Foreign Cosmetic Supervision and Inspection Systems and Their Enlightenment to China,” the author found through research on cosmetic regulatory legal systems in countries and regions such as the United States, the European Union, and Japan that the current regulation of cosmetics in China is primarily government-led, with a focus on cosmetic licensing, sampling inspections, and routine supervision. Enterprises’ role as the main body is far from sufficient, particularly in terms of their subjective initiative in managing cosmetic quality and safety. There is a lack of motivation to improve awareness, means, and techniques for quality management.
Another viewpoint suggests that the lack of unified scales for cosmetic notifications across the country reflects problems such as the lack of top-level design and systematic planning in China’s standard system, standards not keeping up with the rapid development needs of the industry, and inadequate incorporation of social forces in standard development.
In an article titled “Exploration of Building China’s Cosmetic Standard System,” with pharmacist Xiao Shuxiong, the director of the Guangdong Provincial Institute of Drug Inspection, as the first author, it is mentioned that the current cosmetic standard system in China lacks a higher-level top-level design and systematic planning that aligns with the development trends of consumption and the industry. It has failed to form a scientific, reasonable, standardized, and effective standard system.
The article also points out that although the “Fourteenth Five-Year Plan for National Drug Safety and Promotion of High-Quality Development” proposes to integrate existing national cosmetic standards and technical specifications, forming a unified national cosmetic standard system, progress has been slow. Although the “Cosmetic Supervision and Administration Regulations” have been promulgated and implemented, many detailed implementation rules and specific operational guidelines have not yet been formulated. It is suggested to establish several category standardization sub-organizations (such as the Raw Material Standard Subcommittee) under the Cosmetic Standardization Technical Committee of the National Medical Products Administration, thereby establishing an organizational assurance system that is compatible with the standard system.
CHAILEEDO has noted that just last month, the National Medical Products Administration announced the establishment of the Cosmetic Standardization Technical Committee, which includes eight technical subcommittees, such as General Technical Requirements, Raw Materials and Packaging Materials, Safety Evaluation, Human Safety and Efficacy Evaluation, Products, Inspection and Testing, General Requirements for Toothpaste, and Inspection and Testing of Toothpaste. The committee aims to further improve the revision of cosmetic standards (including toothpaste), marking an important step in the construction of cosmetic standards in China.
“Usually, it is difficult to achieve bottom-up standardization, but it does not hinder the contribution of such exploration to the industry. The more we debate, the clearer the truth becomes. I hope it can promote the standardization of national notification standards.” As Jiang Ligang said, the exploration of unified cosmetic standards in the Yangtze River Delta is undoubtedly a positive signal, and the unified evaluation standards across the country may have already begun.
