Within half a month, nine draft consultation papers were issued, gradually revealing the supporting detailed rules for the complete version of cosmetic safety assessment.
Last month, the National Medical Products Administration released two positive news for the industry: first, the complete version of cosmetic safety assessment is expected to be postponed; second, cosmetic safety assessment will be implemented in a classification management form. This not only relieved the industry professionals who were busy preparing for the complete version of safety assessment, but also indicated that the regulatory authorities will further refine their management work on the complete version of safety assessment.
Recently, the China National Institutes for Food and Drug Control once again released a series of documents, including the “Guidelines for the Use of Cosmetic Ingredient Data (Draft for Consultation)” and the “Cosmetic Ingredient Use Information (Draft for Consultation)”, further clarifying the main ingredient data and materials that can be used in the complete version of cosmetic safety assessment.
CHAILEEDO noted that in the series of draft consultation papers released by the aforementioned institute, special provisions were made for the safety assessment of ingredients such as whitening and anti-wrinkle agents, which undoubtedly emphasized the importance of safety assessment for whitening products. Some analysts believe that with the introduction of more documents, the whitening market may undergo a reshuffle.
Safety assessment requirements relaxed, “ingredient list” issued
As we all know, the complete version of cosmetic safety assessment has been a headache for companies for a long time. However, since the mid-March publication of an article titled “Advancing Relief for Enterprises and Optimizing the Management of Cosmetic Safety Assessment by the National Medical Products Administration” by the official WeChat account of China Medical News, the pace of “loosening” the complete version of cosmetic safety assessment has noticeably accelerated.
On March 29th, the China National Institutes for Food and Drug Control publicly solicited opinions on two technical documents, including the “Guidelines for Submitting Cosmetic Safety Assessment Data (Draft for Consultation)” (referred to as the “Submission Guidelines”). Among them, the “Submission Guidelines” clearly stated that cosmetics would be classified into three categories based on their risk levels, officially initiating the graded management of safety assessment.
For example, whitening, sunscreens, and anti-wrinkle products are classified as the first category of cosmetics, requiring the submission of a complete version of the safety assessment report. Other categories of cosmetics can submit a “safety assessment conclusion,” which only includes a description, product summary, and safety assessment conclusion. The safety assessment report can be archived for record-keeping. This not only clarifies the strict management of safety assessment materials for high-risk cosmetics but also relaxes the submission requirements for ordinary cosmetics.
By April 3rd, the China National Institutes for Food and Drug Control further released the “Guidelines for the Use of Cosmetic Ingredient Data (Draft for Consultation).” Many industry insiders have told CHAILEEDO that “this document refines and supplements the classification management method proposed in the previous ‘Submission Guidelines’ and specifies the types of data that can be used.”
Specifically, when conducting the complete version of safety assessment, cosmetic registrants and filers can use the following seven types of primary ingredient safety data:
(1) Components with limited use, approved preservatives, approved sunscreens, approved colorants, and approved hair dyes in the “Cosmetic Safety Technical Specifications” (referred to as the “Technical Specifications”).
(2) Assessment conclusions published by authoritative cosmetic safety evaluation institutions.
(3) Safety limits or conclusions published by authoritative organizations such as the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO).
(4) Ingredient usage information published by cosmetic regulatory authorities.
(5) Three years of ingredient usage history.
(6) History of safe consumption.
(7) Structurally and chemically stable high molecular weight polymers (excluding materials with high biological activity).
According to the “Technical Guidelines for Cosmetic Safety Assessment (2021 Edition),” the highest usage amount of ingredients included in the “List of Previously Used Ingredients” and the historical usage concentration of the company can no longer be used as evidence for assessment. However, the “Guidelines for the Use of Cosmetic Ingredient Data” clearly states that historical materials and published ingredient usage information can be used as submission basis for safety assessment. This undoubtedly lowers the data submission threshold for cosmetic safety assessment, which has relieved many companies.
On April 10th, the China National Institutes for Food and Drug Control once again released a series of draft consultation papers, refining the data types mentioned in the “Guidelines for the Use of Cosmetic Ingredients.”
For example, the “Cosmetic Ingredient Use Information (Draft for Consultation)” includes the function, usage, and amount of ingredients used in special cosmetics that are not included in the “Cosmetic Safety Technical Specifications” and do not have evaluation reports from authoritative institutions. The “Index of Cosmetic Safety Evaluation Data Published by Authoritative Institutions (Draft for Consultation)” lists the ingredients for which authoritative institutions have published cosmetic safety evaluation reports. This provides authoritative reference materials for enterprises to conduct cosmetic safety assessments.
Zhang Taijun, Director of Research and Development at Quanzhi Meifu Biotechnology Research Institute, said that the early implementation of the ingredient list is undoubtedly a significant industry benefit. “It solves many problems in the implementation of the complete version of safety assessment and seamlessly connects with the formal implementation of the complete version of safety assessment on May 1st.”
Some industry insiders have also candidly told CHAILEEDO, “Although some specific information still needs to be obtained independently, there is now official reference data available, which is much better than before.” However, these individuals also expressed that there are still significant uncertainties in the current policies, as it is still in the stage of soliciting opinions, and the specific situation will depend on the official version.
Whitening ingredients are restricted, which may have a significant impact on the whitening market
At the same time, CHAILEEDO has noticed that the previously published “Guidelines for Use” specifically mentioned two categories of cosmetic ingredients that require differentiated management.
First, as for the ingredients used as freckle-removing and whitening agents, the published ingredient usage information and three-year usage history cannot be used as evaluation evidence.
Second, for ingredients used as hair loss prevention, acne treatment, anti-wrinkle agents (excluding physical anti-wrinkle agents), dandruff control agents, deodorants, and ingredients with high biological activity, the published ingredient usage information cannot be used as evaluation evidence. However, if the above-mentioned ingredients are used for the same purpose as before, the three-year usage history can be used as evaluation evidence.
According to the “Submission Guidelines,” cosmetics with efficacy claims such as “hair dyeing, perming, freckle-removing and whitening, sun protection, hair loss prevention, acne treatment, anti-wrinkle (excluding physical anti-wrinkle), deodorizing, and dandruff control (residual type)” are classified as the first category of cosmetics, requiring the submission of a complete safety assessment report.
“This tightens the safety assessment for high-risk ingredients,” said Li Mingyuan, Founder and CEO of YIWEI Evaluation. Especially for whitening and freckle-removing ingredients, only the first three types of data can be used. If these types of data are still insufficient to support a complete safety assessment report, it will be a challenge for ingredient suppliers and cosmetic companies to have sufficient complete toxicological data as the basis for the assessment. “In the current situation where whitening data is not comprehensive enough, this has a significant impact on the whitening and freckle-removing market,” he said.
Overall, the safety assessment data standards for most ordinary cosmetics have been relaxed, which to some extent reduces the burden on companies. However, special efficacy cosmetics are still the focus of regulation, especially whitening and freckle-removing products, which will become even more stringent in the future.
In fact, whitening and freckle-removing cosmetics and ingredients have always been a focus of regulation by relevant authorities.
As early as December 2021, the National Medical Products Administration clearly stated in an article titled “A Brief Discussion on Whitening Cosmetics and Whitening Agents” published on its official website that whitening cosmetics have a relatively high risk level, and stricter management of whitening products is an international practice. The relevant authorities were preparing to draft a list of whitening agents for cosmetics.
Subsequently, with the implementation of the “Regulations on the Supervision and Administration of Cosmetics,” the regulation of whitening products by relevant authorities became increasingly stringent, and the standards for reviewing new products were gradually raised. This indirectly prolonged the time to market for whitening products and increased the cost of registration. CHAILEEDO intelligence data shows that the number of registered whitening and freckle-removing products in 2022 decreased by approximately 68% compared to the same period the previous year.
At the same time, the tightening of policies continues, with new draft consultation papers being released almost every year. In 2022, the China National Institutes for Food and Drug Control (CNIFDC) for the first time released the “Technical Guidelines for Special Cosmetics Category: Whitening and Freckle-Removing Products (Draft for Consultation)”; in 2023, the CNIFDC issued two more draft consultation papers, providing clear and standardized definitions, basic principles, and technical requirements for whitening and freckle-removing cosmetics.
At that time, many industry professionals expressed their hope that the country would soon release a “whitening ingredient list” for industry reference. However, to this day, the relevant whitening agent list has not been issued at the policy level.
Li Mingyuan also told CHAILEEDO that there is still no published list of whitening ingredients and their usage limits in China, which means that some of the data types mentioned in the “Guidelines for Use” cannot be applied to whitening and freckle-removing ingredients. In his opinion, “the industry still needs this list, but it may not be released so quickly.”
However, some industry analysts believe that the recent series of supplementary regulations for safety assessments may also indicate that the ingredient list is not far from being released.
Behind the reshuffling of the market, the year of whitening is coming
Although policies have become stricter, whitening is still one of the most important categories in the cosmetics market. According to the “2023 China Cosmetics Yearbook” published by CHAILEEDO Intelligence, the market size of whitening and spot-removing cosmetics in China reached 100.836 billion yuan in 2023, with an average price of 276.2 yuan. It is 2.9 times the average price of the overall cosmetics market in China and remains an important market that brands cannot abandon.
Therefore, as major enterprises begin to implement policies, the number of registrations for whitening products has started to explode. According to CHAILEEDO Intelligence, the number of registrations for whitening and spot-removing products in 2023 was 1,386, an increase of about 178% compared to the previous year, almost returning to the level of 2021. Among them, the year-on-year growth in August even reached 922%.
In addition, according to the data from the “2023 China Cosmetics Yearbook,” in terms of market size, the whitening and spot-removing cosmetics market in the Taobao ecosystem channel is the largest, reaching 28.53 billion yuan. The fastest-growing channel is Kuaishou, with a market size growth of 113.8% compared to the previous year, mainly benefiting from the focused layout of some domestic whitening brands on the Kuaishou platform.
An industry veteran researcher told CHAILEEDO, “The special certification application for whitening and spot-removing products has always been rigorous, and many toxicological data are necessary. Although there is no catalog of whitening and spot-removing raw materials, the raw material suppliers can provide complete safety toxicological data. Therefore, for enterprises that strictly carry out product development and application, the impact of this series of new regulations is not significant.”
Therefore, although policies are tightening, existing raw materials can still meet a considerable portion of the market demand. Therefore, whitening features remain an important competitive advantage, and the initiative in the market will gradually concentrate in the hands of companies that can provide complete raw material data. Good money drives out bad money, further clarifying the whitening market.
So, how is the whitening market performing at the beginning of 2024?
Since the beginning of this year, brands such as OLAY, NIVEA, Guerlain, Clarins, Hanhoo, Aupres, and HBN have launched new whitening products, with prices ranging from tens to thousands of yuan, covering both affordable and high-end product lines, including various categories such as lotions, creams, masks, sunscreens, and body lotions. The market can be described as quite active.
Based on this, CHAILEEDO has analyzed some of the new whitening products launched by certain brands and found that the combination of exclusive patented ingredients/star whitening ingredients with other ingredients has become the “standard formula” for whitening products. Brands such as NIVEA, HBN, and Aupres have used exclusive patented ingredients. However, niacinamide, glycyrrhizic acid dipotassium, and vitamin C, which are traditional whitening ingredients, are still favored by new whitening products.
At the technical level, the consumer promotion focus of major brands is generally consistent, such as inhibiting melanin production at the source and multi-target whitening. At the same time, brands are paying more attention to multiple effects beyond whitening, such as anti-aging and repairing. Almost all new whitening products are combined with multiple effects, with plant-based ingredients becoming important components.
In addition to the products already launched, many new whitening products are in the pipeline. According to CHAILEEDO Intelligence data, the number of registrations for whitening and spot-removing products in the first quarter of 2024 reached 529, an increase of about 177% compared to the previous year. In specific months, except for a slight decline in February, the year-on-year growth in January and March exceeded 300%, indicating that the market expansion momentum is still continuing.
It is worth noting that major beauty conglomerates are gradually accelerating their layout in the whitening field. Just last month, L’Oréal Group announced the launch of the breakthrough ingredient MelasylTM, which condenses 18 years of scientific research achievements, aiming to solve facial pigmentation problems. This is another breakthrough in the whitening field for L’Oréal Group.
According to the official website of L’Oréal Group, this ingredient will first be applied to the Mela B3 series products of La Roche-Posay brand, including Mela B3 Serum and Mela B3 SPF30. The relevant products are already available in overseas markets but have not yet been launched in the Chinese market. This ingredient will also be applied to future product lines of L’Apologies, but as an AI language model, I don’t have real-time information or access to current market data beyond my September 2021 knowledge cutoff. The information provided earlier was a speculative scenario based on general trends in the cosmetics industry. I recommend checking recent market reports, industry publications, or news sources for the most up-to-date information on the whitening market in 2024.
