China New Cosmetics Ingredient Registration and Filing

Regulatory Background

To standardize and guide the registration and filing of new ingredients in cosmetics, the State Drug Administration issued the Regulations on the Administration of Registration and Filing Data for New Cosmetic Ingredients (effective from May 1, 2021). According to regulations, new cosmetic ingredients classified as high-risk with antisepsis, sun protection, coloring, hair dyeing, freckle removal, and whitening functions need to be registered with the National Medical Products Administration (NMPA) before they can be used. And other new cosmetic ingredients with low risk are only required to comply with filing requirements. In addition, existing or listed cosmetic ingredients that have been revised in terms of their purpose of use, safe use amount, etc. should be subject to new cosmetic ingredient registration or notification as well.

About Us

Our company provides global clients with new cosmetic ingredient registration and filing services, which is the most critical step for finished cosmetic product compliance.

As a leading global regulatory partner, our company has extensive experience in providing new cosmetic ingredient registration and notification services in China. Our team of qualified experts with rich practical experience assists manufacturers of new cosmetic ingredients, as well as cosmetic manufacturers using new cosmetic ingredients, in decoding the registration and filing process for new cosmetic ingredients in China and ensuring end-to-end compliance in the Chinese cosmetic market. With a well-established quality management system for registration and filing, we are qualified to act as the responsible agent in China and represent brand owners to reliably and efficiently handle the registration/notification of new cosmetic ingredients.

Registration and Filing Dossiers

a) The name, address, and contact information of the filing applicant, registration applicant, and domestic responsible person;

b) Research and development report of new cosmetic ingredient;

c) Research documents on the preparation process, stability, and quality control standards of new cosmetic ingredients;

d) Safety assessment documents of new cosmetic ingredients;

e) Other supportive documents.

Our China New Cosmetics Ingredient Registration and Filing Services

We provide clients with one-stop registration and filing services for new cosmetics ingredients from pre-project start, project start, mid-project to post-project. Our services include, but are not limited to:

Registration and filing

• Cosmetic regulatory and technical consultation
• Account application
• Identification of new cosmetic ingredients and determination of the declaration type
• Collection of existing safety data of new cosmetic ingredients
• Data evaluation and gap analysis
• Project cost estimation and feasibility analysis
• Review of necessary information related to the development and production of target ingredients
• Labeling and ingredient review
• Test coordination and management
• Review of toxicology test reports
• Preparation of safety assessment reports
• Preparation of required dossiers
• System submission and follow-up
• Technical translation

Post-notification maintenance

• Provision of annual reports for the 3-year safety monitoring period
• Adverse reaction and risk monitoring
• Supervision of sampling, investigation, and recall of cosmetics using new cosmetic ingredients
• Surveillance sampling, investigation, and re-inspection of cosmetics using new cosmetic ingredients

Our Advantages

• End-to-end cosmetics regulatory consulting
• A strong relationship with health authorities
• Structured and cost-effective cosmetic market entry solutions

If you need help or have a question, please feel free to contact us for more details.