The First Approved Whitening Ingredient Under CSAR: A Milestone for China’s NCI Registration

On November 4, 2024, the National Medical Products Administration (NMPA) of China officially approved the registration of Isobutylamido Thiazolyl Resorcinol (Thiamidol 630), an innovative whitening ingredient developed by Beiersdorf Group.

This approval marks a significant milestone for the beauty industry, quickly sparking widespread discussions. Thiamidol 630 is the first high-risk cosmetic ingredient approved under the Cosmetic Supervision and Administration Regulation (CSAR) since its implementation in 2021 and the second whitening ingredient approved in China in the past 12 years.

This article delves into the significance of this approval and analyzes its implications for the industry and the development of new whitening ingredients in China.

Thiamidol 630: “The Most Powerful” Whitening Ingredient

The formation of skin melanin begins with the oxidation of tyrosine by tyrosinase, followed by a series of conversion steps that ultimately result in the production of melanin. Thiamidol 630 has undergone efficacy and safety verification by the registrant. It is extraordinarily effective in inhibiting tyrosinase, with its potency 119 times greater than that of Phenylethyl Resorcinol (commonly known as 377, the first registered whitening ingredient in China), 455 times than kojic acid, and over 3,000 times than arbutin. Due to its impressive efficacy, Thiamidol 630 has been called “the most powerful whitening ingredient”, approved in leave-on cosmetics (excluding products that may pose inhalation risks).

Currently, Beiersdorf has incorporated this breakthrough ingredient into several products, including Nivea’s 630 whitening essence and Eucerin’s spotless brightening serum. In April 2024, Nivea’s 630 Dual-Energy Bottle was launched in the Chinese market through cross-border e-commerce and showcased in live streaming by the top influencer Li Jiaqi during the Double 11 shopping festival this year.

Source: Tmall Global 

A Milestone in NCI Registration

Under the CSAR, new cosmetic ingredients (NCI) are categorized by their risk level. High-risk NCIs such as preservatives, UV filters, colorants, hair dyes, as well as freckle removal and whitening ingredients are subject to comprehensive registration and approval from the NMPA, including format review and technical review, while other ingredients are subject to a less rigorous notification process. (For more detailed information, please refer to the China New Cosmetic Ingredient (NCI) Regulation)

Following the implementation of the new NCI pre-market approval system in January 2021, there are almost 200 NCIs have been notified, signaling explosive growth. Despite this surge in ingredient notification, no ingredient had been registered. The approval of Thiamidol 630, therefore, marks a key milestone as the first high-risk ingredient registered under the CSAR. This breakthrough signifies a new starting point for the registration of new cosmetic ingredients. and underscores the NMPA’s commitment to promoting innovation and embracing new, high-quality ingredients.

Additionally, Chinese officials have not yet released a list of approved anti-freckle and whitening ingredients for cosmetics. Based on a series of articles issued by NMPA (such as A Brief Discussion on Whitening Cosmetics and Whitening Ingredients), there are 15 commonly used whitening ingredients in cosmetics in China, Japan, and South Korea, including

• Arbutin, Niacinamide, Glabridin, Phenylethyl Resorcinol (377), Ascorbic Acid (Vitamin C), Ascorbyl Glucoside, 3-o-Ethyl Ascorbic Acid, Magnesium Ascorbyl Phosphate, Tranexamic Acid, Potassium Methoxysalicylate, Bisabolol, Kojic acid, 4-Hydroxy-3-methoxycinnamic acid, 4-Butylresorcinol, and Ellagic acid.

In other words, with the approval of Thiamidol 630, the total number of officially recognized whitening ingredients has now increased to 16. This approval introduces a new, innovative option that is expected to offer consumers a safe and effective alternative to existing whitening ingredients.

New Vitality into the Whitening Market

Whitening has long been a prominent beauty trend in China. According to predictions from JGAG, a Chinese think tank, China’s whitening market is expected to reach 674 billion yuan by 2026, highlighting its immense market potential. The vast potential of the whitening market has attracted numerous brands to capture a share of the growing demand. Data from Beauty in Sight reveals that in 2024, the whitening market remains dynamic, with Q1 data showing 529 new product registrations, a 177% year-on-year growth. Brands such as OLAY, Nivea, Guerlain, Clarins, and Hanshu have launched a range of products, including creams, masks, sunscreens, and body lotions, spanning from affordable to premium, which further fuels the market’s expansion.

As the competition between established and emerging brands intensifies, the whitening cosmetic market is struggling with ingredient homogenization and market saturation. Many brands are facing the shortage of unique whitening ingredients, making it difficult to differentiate their products. As a result, more brands are realizing that exclusive whitening ingredients are essential for securing a competitive edge in this fiercely crowded market.

The approval of Thiamidol 630 would inject new vitality into the whitening market, encouraging companies to invest in R&D to develop unique, scientifically backed ingredients that can deliver differentiated products to meet the growing consumer demand for high-performance options.

Future NCI Registration Trends

The approval of Thiamidol 630, which took Beiersdorf Group 15 years—including 10 years for the application process—highlights the complexity of registering new ingredients. This approval has sparked significant discussion about the future of ingredient registration in China. Many in the industry are optimistic, believing it signals a potential easing of the registration approval and may lead to a surge in new ingredient approvals.

The Cosmetics Regulatory and Technical Director at REACH24H, the compliance service provider of Beiersdorf Group, noted that “The registration process involves numerous technical and regulatory challenges. However, our team overcame these challenges and finally achieved a breakthrough. This opens a new chapter for us. We believe there will be more NCIs to be registered in the future.” Mei Hexiang, former general manager of Symrise China, noted, “This approval sets a reference for successful registration under the new regulations and lightens the pessimistic view that the registration process is nearly impossible.”

However, some others take a more cautious view. Jiang Ligang, Chief Technology Officer of Pechoin, pointed out, “The approval of 377, the first whitening ingredient approved in China, was a long and difficult process. Similarly, the approval of 630 did not come easily, and this should not be interpreted as the registration barriers for whitening and other new high-risk ingredients being significantly lowered. Instead, it reflects a message from the NMPA that, while ensuring safety and efficacy, the authorities remain open to innovation.”

Additionally, Thiamidol 630 has currently only been approved for registration so far. According to the Administrative Measures on Cosmetics Registration and Notification, the next step for the ingredient is to be used in special cosmetics. After the product is registered, it will undergo a 3-year monitoring period before Thiamidol 630 can be included in the Inventory of Existing Cosmetic Ingredients in China (IECIC). Furthermore, since it is currently brand exclusive, it will likely not be available to other brands in the short term.

Chemlinked Comment

In summary, the approval of Thiamidol 630 represents a significant step forward in the development of new whitening ingredients in China, fostering innovation in the cosmetic industry. However, the approval process for new high-risk ingredients still requires substantial technological innovation, rigorous safety assessments, and significant financial investment. The success of companies in this area will depend on their ability to meet these high standards and their continued commitment to research and development.

REACH24H Consulting Group, the founder of ChemLinked, as a third-party compliance service provider, assisted Beiersdorf Group in successfully obtaining the registration approval. If you have any compliance needs regarding new cosmetic ingredient notification or registration, please contact us at cosmetic@chemlinked.com.