China Clarifies Registration Requirements for New Cosmetic Ingredients
As China continues tightening its cosmetic regulations under the Cosmetic Supervision and Administration Regulation (CSAR), stakeholders are seeking greater clarity on how new cosmetic ingredients are regulated. To address growing industry concerns, the National Institutes for Food and Drug Control (NIFDC) released Guidelines for the Approval of Registration of Cosmetics and New Cosmetic Ingredients in June 2023, shedding light on key issues related to registration and filing.
Here’s what international cosmetic brands, ingredient suppliers, and regulatory professionals need to know.
Q&A
What Must Be Included in the Authorization Letter of the Domestic Responsible Person when opening a new account??
According to Article 11 of the Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers ,the authorization letter should clearly specify:
The name of the registrant or filer of the new cosmetic ingredient;
The name of the domestic responsible person;
The relationship between the authorizer and the authorized;
The scope of authorization;
The authorization period.
What Happens When the Authorization Letter Expires?
Before the expiration date, an updated authorization letter must be submitted at least 30 days in advance, or the domestic responsible person must be updated via an official change procedure.
Can a New Cosmetic Ingredient Have Multiple Domestic Responsible Persons?
No. Each new cosmetic ingredient may be assigned to only one domestic responsible person. Multiple authorizations are not permitted under the current regulation.
What Are the Requirements for Foreign-Language Documents in Registration and Notification/Filing?
All registration and filing documents must be submitted in standard Chinese characters, except in cases where foreign language use is necessary (e.g., trademarks, URLs, patent names, overseas entity names and addresses). Foreign documents must be translated in full and accompanied by the original text.
What Ingredients Are Regulated as New Cosmetic Ingredients?
A “new cosmetic ingredient” refers to any natural or synthetic ingredient used for the first time in China’s cosmetic market. This applies only if the intended use, application method, and purpose align with cosmetic definitions—i.e., via topical application, not oral or injectable use.
What Ingredients Are Not Considered New Cosmetic Ingredients?
The following do not qualify as new cosmetic ingredients:
Ingredients listed in the 2021 Inventory of Existing Cosmetic Ingredients in China (IECIC);
Subtypes included under a general category (e.g., collagen types I & III are both covered under “collagen”);
Ingredients explicitly banned under the “Safety and Technical Standards for Cosmetics 2015” (e.g., hormones, antihistamines, human cell derivatives);
Substances with pharmacological or therapeutic effects beyond cosmetic scope.
What Does Filing Actually Mean?
Filing is a record-based system where the new ingredient filer submits documentation via the National Medical Products Administration (NMPA) online portal. Successful submission means the formality requirements are met, but does not imply approval of safety or efficacy. The authority may later conduct technical reviews and audits of submitted materials.
What Are the Obligations After Registration or Filing?
New cosmetic ingredients are subject to a monitoring period. During this time, the registrant or filer must:
Submit an annual safety monitoring report within 30 business days before each anniversary;
Report any emerging safety concerns via a risk control report;
Ensure full traceability, accuracy, and integrity of the ingredient data.
Filing vs. Registration: How to Determine the Right Path?
China applies a risk-based classification system:
New ingredients with preservative, sunscreen, whitening, hair dyeing, or coloring functions require pre-market registration;
All others may proceed with filing, provided they do not present higher risks.
In cases where an ingredient has multiple functions, the most stringent requirement applies—if any function falls under registration, the entire ingredient must be registered.
Final Thoughts
This official Q&A offers much-needed transparency on China’s cosmetic ingredient regulatory framework. With safety and risk management at its core, the system places a significant responsibility on registrants and domestic responsible persons to provide truthful, scientific, and comprehensive data.
As China’s regulatory landscape evolves, staying compliant means not only understanding what to file, but also when, how, and under what conditions—a must for every cosmetics business targeting the Chinese market.
Need Help with Cosmetic Ingredient Filing in China?
Our regulatory experts assist with new ingredient registration, translation services, dossier compilation, and safety reporting. Contact us for a consultation. If you have any questions, please feel free to contact us at customer@reach24h.com.
