CIRS Group Successfully Facilitates Scenario 3 Filing of New Cosmetic Ingredient -Defensamide

In June 2025, CIRS Group once again assisted in the successful filing of a new cosmetic ingredient--Defensamide (Filing No.: GZYBZ*20250070), and the filing was submitted under Scenario 3. The filer is NeoPharm Co., Ltd.

To date, the Personal and Home Care Division of CIRS Group has supported dozens of companies in securing new cosmetic ingredient filing numbers in China, and continues to provide technical support throughout the monitoring period.

Filing Entity and Basic Information of the Ingredient

NeoPharm Co., Ltd., the filer, is a South Korean company specializing in skin barrier research and product development. It owns several well-known skincare brands, including ATOPALM, ZEROID, and DERMA-B.

Defensamide is a proprietary ingredient independently developed by NeoPharm, known for its skin-protective properties. It serves as a core active ingredient in NeoPharm’s flagship skincare lines, ATOPALM and ZEROID. Defensamide’s efficacy has also been internationally recognized — it was awarded the Silver Prize in the “Innovation Zone Best Ingredient Award” at “2012 in-cosmetics Global” , one of the world’s largest trade shows for cosmetic ingredients.

The research and development of Defensamide was supported by the Korean Ministry of Health and Welfare under the “Innovative Growth-oriented Skin Health Technology Development Program.” This ingredient marks the fifth new cosmetic ingredient filing number obtained by a South Korean company in China since the implementation of China’s new cosmetic ingredient regulations. (According to available information, one of the five filings was later voluntarily withdrawn by the company.)

The Korean Ministry of Health and Welfare believes that the successful filing of Defensamide not only has a positive impact on K-Beauty enterprises, but also holds promise for further boosting South Korea’s cosmetic exports and supporting the sustainable growth of the industry.

Difficulties and Key Considerations

The ingredient is filed under Scenario 3, which applies to new cosmetic ingredients that do not possess functions such as preservation, sun protection, coloring, hair dyeing, freckle-removing/whitening, anti-hair loss, anti-acne, anti-wrinkle (excluding physical anti-wrinkle), anti-dandruff, or deodorization, and for which sufficient supporting documentation is provided to demonstrate a history of safe use in overseas marketed cosmetics for more than three years.

According to the Provisions on the Administration of New Cosmetic Ingredients Registration and Filing Data in China, new ingredients that fall under Scenario 3 must submit the following documentation:

• The quality specifications, intended use, and applicable or usage scope of the new ingredient shall be the same as those of the ingredient used in overseas marketed cosmetics, and the safe use level of the new ingredient shall not exceed that in the overseas products.
• Cosmetics containing the ingredient must have been marketed overseas for no less than three years.
• Relevant evidence shall be provided to demonstrate that cosmetics containing the ingredient have been used by a sufficiently large population overseas.
• There shall be no reports of serious adverse reactions or group adverse events caused by the ingredient in the overseas marketed cosmetics.
• There shall be no literature reports indicating that the ingredient may pose risks to human health.

Follows are the evidence requirements for Ingredient Consistency, Market History, and Safety Assessment.

• Ingredient Consistency

The filing entity of the new cosmetic ingredient shall have a thorough understanding of the production and usage of the ingredient to ensure that the ingredient used in the marketed cosmetics cited in the supporting documents is the same as the new ingredient intended for filing. Specifically, consistency shall be maintained in terms of ingredient composition, quality specifications, and manufacturing process.

• Types and Marketing Duration of Marketed Cosmetics

The intended use and applicable or usage scope of the new ingredient in the marketed cosmetics shall be consistent with the relevant information provided in the filing documents. The usage level of the new ingredient in the marketed cosmetics shall not be lower than the safe use level declared in the filing documents. In terms of time requirements, cosmetics containing the new ingredient must have been marketed for no less than three years, and at least one product must have been continuously sold for three years or more.

• Usage Volume of Marketed Cosmetics

Focus should be placed on cosmetics containing the new ingredient that have been continuously sold for three years or more to ensure sufficient usage volume. This may be supported by terminal retail sales data (i.e., actual consumer purchases) or factory shipment volumes from the cosmetic manufacturer.

• Safety and Adverse Reaction Monitoring

The filing entity shall conduct comprehensive research to determine whether the new ingredient poses any risk to human health and to assess adverse reactions related to cosmetics containing the ingredient. Adverse reaction monitoring includes information on how cosmetic manufacturers collect reports of adverse events involving products containing the ingredient, and whether there have been any records of consumer adverse reactions since the product's launch.

Based on the findings, the filing entity shall prepare a summary of adverse reactions related to marketed cosmetics containing the ingredient. If adverse reactions have occurred, the incidence rate shall be calculated, the types of adverse reactions identified, and an analysis conducted of the adverse reactions and their possible causes.

Recently, CIRS Group is proud to officially launch the Global CosIng-A One-Stop Search Tool for Global Cosmetic Compliance Information. You can visit Global CosIng and find out more via the following link: https://globalcosing.chemradar.com/

About CIRS

The CIRS cosmetic team is dedicated to ensuring that cosmetic products meet stringent global regulatory standards. It can provide one-stop services covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in vitro), efficacy studies (in vivo & in vitro), ingredient registration, and product registration.

Cosmetic services in China:

• China Cosmetic Registration and Filing;
• China New Cosmetic Ingredient Registration and Filing;
• China Cosmetic Ingredient Quality and Safety Information Code Application (NMPA Code);
• China Cosmetics Safety and Efficacy Test;
• China Cosmetic Safety Assessment Report;
• China Toothpaste Filing;
• China Disinfectant Notification; and
• China Cosmetic Formula/Label/Claim Review

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.