Domestic Special-use Cosmetics Licensing

As required by regulations,all special-use cosmetics produced in China must be approved by the National Medical Products Administration and obtain the registration certificate before they can be mass-produced and marketed.Otherwise,severe penalties will be imposed.

 

Legal Accordance

Regulations on the Supervision and Administration of Cosmetics,Administration for cosmetics registration and Record-filing ,Standards for cosmetics registration and Record-filing materials,Classification Rules and Catalogues of Cosmetics,Evaluation Standards for Cosmetic Efficacy Claims ,Technical Guidelines for Cosmetic Safety Assessment(2021 edition).

 

Regulatory Target

Cosmetics used for hair dyeing, perming, spot-removal,whitening, sun protection, anti-hair loss and cosmetics claiming new effects are special-use cosmetics.Cosmetics other than special cosmetics are ordinary cosmetics.

 

Application Process of Registration Certificate for Domestic Special-use Cosmetics

initial registration→account application→confirm formula,labels→ sample testing→collate other information→submit documents to the NMPA→formal examination(to determine admissibility)→technical review(experts assessment)→administrative approval(whether approved)→issue a registration certificate

 

Dossiers Required for Registration

1. Cosmetics Registration and Filing Information Form and relevant materials .
2. Product name information.
3. Product formula((including name and CAS number of raw material ,percentage, purpose of use, safety information).
4. Carried standard for the product.
5. Product label draft.
6. Product test reports(including microbiological,physical and chemical tests, toxicology tests, human safety tests and human efficacy test reports, etc.).
7. Product safety assessment.

 

Others:

when registering,the summary of the basis for the product efficacy claim shall be uploaded to the website designated by the NMPA (starting from 1 January 2022).

If the conditions for alteration are met, alteration  for the registration certificate may be applied for.

The registration certificate for domestic special-use cosmetics is valid for 5 years, and the holder shall apply for extension 90 working days to 30 working days before the expiry of the registration certificate.Expiration is automatically invalidated and shall be reapplied.

 

Our Professional Services & Advantages

As one of the senior service organizations of filing and registration for cosmetics in the industry, with profound accumulation in the field of product compliance consulting and experienced technical team, the following services are available:

(I) Coaching the establishment of quality management system and checking the qualification of the head of quality and safety ;

(2) Counseling to establish an adverse reaction monitoring and evaluation system;

(3) Pre-examination of production capacity ;

(4) Review of formula compliance;

(5) Compilation of product implementation standards;

(6)Review of label compliance;

(7)Product tests on safety and efficacy;

(8)Compilation of product safety assessment report;

(9)Fully acting for cosmetics

(10)Full agency for cosmetics registration .

 

Why choose ZOOP:

Since its establishment in 2010, zoop has focused on product compliance-related services.The company's technical team is composed of professionals with biomedical, cosmetics, chemistry and other related academic backgrounds,who are familiar with the dynamics of cosmetics regulatory. At the same time,the sophisticated process management for compliance registration makes the service and cycle more guaranteed.