Unlocking New Opportunities in China's Booming Peptide Market

In recent years, peptides have gained significant momentum in the anti-aging sector?in China, emerging as a key ingredient alongside renowned components like retinol, pro-xylene, and collagen.

As of the end of September 2024, there were 21,665 skincare products featuring peptides as their primary?selling point that are active?in China, with the majority of them registered/notified?in the past two years. According to data from Frost & Sullivan, the market size for peptide-based cosmetic ingredients in China reached RMB 1.45 billion in 2021 and is projected to grow to RMB 2.32 billion by 2025, reflecting an impressive compound annual growth rate (CAGR) of 12.5%, far outpacing the overall beauty industry's growth.

Compared to international brands such as Estée Lauder, Olay, La Mer, and Lanc?me, which have a longer history of research and application of peptide ingredients, Chinese cosmetic companies have been able to capture the market more rapidly by focusing on 1-2 innovative peptide ingredients and concentrating their resources. This targeted approach has allowed them to move swiftly toward systematization. In recent years, several leading Chinese cosmetic companies have launched their peptide-based products. For example, Proya introduced the popular?Advanced?Firming Series?(“红宝石系列”?in Chinese)?by incorporating Cyclic Peptide-161?into its formula, while Shanghai Jahwa developed its own Cyclic Hexapeptide-9, which was featured in the KANS Polypeptide Collagen Series(”韩束红蛮腰系列”?in?Chinese).

Opportunities for Overseas Companies in China’s Peptide Market

The regulatory landscape in China presents significant growth opportunities for peptide ingredients. According to the 2021 edition of the Inventory of Existing Cosmetic Ingredients?(IECIC?2021)?published by China’s National Medical Products Administration (NMPA), only 79 peptide ingredients have been approved for use in the country. In contrast, the European Union has approved around 2,500 peptide ingredients, and the United States approximately 1,200. This gap signals substantial potential for expansion in China’s cosmetics market.

Under China's Cosmetics Supervision and Administration Regulations (CSAR)?released in 2020, companies must apply for registration?and notification?for cosmetic ingredients that are not listed in the IECIC 2021. Thus,?any peptide ingredients not listed in the?IECIC 2021?must undergo the New Cosmetic Ingredient (NCI) application process before they can be used in cosmetic products.

According to the NMPA?of China,?as of the publication date, a total of 16?peptide-based NCIs?have successfully completed the notification?process, accounting for approximately 9% of the total number of notified?NCIs (187 in total from 2021 to the present). Of these, 4 were notified in 2022, 8 in 2023, and 4 in 2024. Notably, 15?peptide-based NCIs were notified?by Chinese companies.?

Navigating the Complexities of China's Cosmetic Compliance

1. Key Situations for NCI?Applications Involving Peptides

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Peptide-based NCI typically falls under three main application situations in China:

Situation 2:?New ingredients used for the first time in China or internationally, which do not have preservatives, sunscreen, coloring, hair dyeing, freckle removal, whitening, hair loss prevention, acne treatment, anti-wrinkle (except physical anti-wrinkle), dandruff removal, or deodorant functions.

Situation 5: NCI?with a history of safe consumption, where the parts of the ingredient used match the parts consumed as food.?

Situation 6: Polymers synthesized from one or more structural units connected by covalent bonds, with an average molecular weight greater than 1,000 Daltons and an oligomer content (molecular weight below 1,000 Daltons) of less than 10%, exhibiting stable structure and properties (excluding materials with high biological activity).

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2. Documentation and Toxicological Tests Required for NCI Applications

When applying for NCI registration/notification, the following documentation is required:

• The name, address, and contact information of the registrant, filing applicant, and domestic responsible person.
• R&D report of NCI.
• Research materials on the manufacturing process, stability, and quality control standards of?NCI.
• Safety assessment documents of NCI.

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Additionally, specific toxicological tests may be required depending on the application situation.?For example, in Situation 2, tests as follows are required:

• Acute oral or acute dermal toxicity test.
• Skin and eye irritation/corrosion test.
• Skin sensitization test.
• Skin phototoxicity test (if the ingredient has ultraviolet absorption properties, this test is required).
• Skin photoallergy test (if the ingredient has ultraviolet absorption properties, this test is required).
• Mutagenicity test (should include at least one gene mutation test and one chromosomal aberration test).
• Subchronic oral or dermal toxicity test (if the ingredient is likely to be ingested orally in cosmetics, a subchronic oral toxicity test should be provided).
• Inhalation toxicity test (if there is inhalation toxicity).

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For new oligopeptide, polypeptide, and protein ingredients with high biological activity, in addition to the toxicological tests required for Situation?2, the following are also needed:

• Teratogenicity test.
• Chronic toxicity/carcinogenicity combined test.
• Long-term human safety trial.
• Toxicokinetics and metabolism test materials.
• Skin absorption/percutaneous test.
• Immunotoxicity test materials.
• Other toxicological test materials.

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Since the new regulations were implemented in 2021, 中贸合规中心 has assisted in the notification of dozens of NCIs.

Based on our experience, the most significant challenges in NCI notification?are the applicant's ability to accurately define whether the ingredient qualifies as an NCI and determining the correct notification?situation. A misjudgment in either area can result in complications later in the process, causing delays or even leading to the outright rejection of the application.

Now, three years into the enforcement of these regulations, it remains crucial for companies to conduct thorough research into the ingredient's safety, intended use, and composition to ensure full compliance with regulatory requirements and review standards.

For further inquiries or assistance with peptide-based or other NCI applications, feel free to reach out to us at [email protected]. You can also explore more resources and articles on our website: www.zmuni.com/en.