China general cosmetics filing and inspection measures have been released by the National Medical Products Administration (NMPA). They came into effect upon release on January 18, 2023.
They aim to optimize the filing of general cosmetics by allowing general cosmetics manufacturers within China to conduct self-testing and inspection of products. The reports generated from this self-testing and inspection can be used as part of the general cosmetics filing application.
The filer may submit an inspection report carried out by the cosmetics filer or the entrusted manufacturer in accordance with the relevant requirements of the cosmetics technical specifications when filing the product if:
- inspection methods have been adopted as quality control measures
- the production license has been included in the daily supervision scope of the provincial MPA
- the product safety risk assessment results can fully confirm the safety of the product
- except in any of the following cases:
- The product claims to be used by infants and children
- The product uses new cosmetic raw materials that are still under safety monitoring
- The product claims to have acne removal, nourishment, repair, anti-wrinkle, dandruff, deodorization and other effects
- Other situations where the product may present high risks.
If a cosmetics manufacturer chooses to use self-testing and inspection and submits a self-inspection report, then a self-inspection report must be submitted at the time of filing. The filer must also submit a statement of the corresponding inspection capabilities of the cosmetics filing and inspection as stipulated in the “Specifications for Cosmetics Registration and Filing and Inspection Work”.
The filer must provide a description of the corresponding inspection personnel, equipment, facilities and site environment where the self-inspection is carried out. The filer must also promise to be responsible for the authenticity and accuracy of the inspection report.
Where filing and inspection is carried out by means of self-inspection, the filer or entrusted manufacturer shall:
- obtain a cosmetics production license in accordance with the law
- have corresponding inspection capabilities
- establish and implement an inspection management system and laboratory management system
- carry out inspections and issue an inspection report in accordance with the inspection items and relevant inspection requirements as stipulated in the “Specifications for Cosmetics Registration and Filing Inspection Work”.
- incorporate the self-inspection work into the cosmetics quality management system
- be equipped with inspection equipment and facilities suitable for product inspection requirements
- have corresponding quality inspection departments or full-time inspectors, and strictly control the inspection process.
- strengthen the management of inspection samples
- be responsible for the authenticity of the samples, the scientificity and rationality of the inspection items
- ensure that the inspection results are true, accurate, complete and traceable.
Verification by provincial-level Medical Products Administrations
As general cosmetics filing applications are submitted to provincial-level Medical Product Administrations (MPA), they are responsible for verifying that China General Cosmetics Filing and Inspection Measures are being adhered to. Provincial MPAs are required to:
- strengthen their supervision measures
- organize and carry out technical verification of data after product filing
- strengthen supervision and inspection of filer or entrusted manufacturers who carry out filing and inspection by means of self-inspection
- inspect the establishment and implementation of enterprise inspection management systems and laboratory management systems
- focus on inspecting manufacturers’ inspection capabilities and inspection records.
Non-compliance of China General Cosmetics Filing & Inspection Measures
- Where it is discovered that the filer has provided false self-inspection reports or other violations of laws and regulations, it will be seriously investigated and dealt with in accordance with the law.
Further information
Refer to NMPA’s original announcement (No.13-2022) on China general cosmetics filing and inspection measures.
Read the latest regulatory updates for cosmetics in China:
- Quality and Safety Responsibilities Regulation (No.125-2022) comes into effect on March 1 2023
- NMPA Cosmetic Sampling Inspection Measures (No.90-2022) come into force on March 1, 2023
China cosmetics GMP inspections points and judgment principles (No. 90-2022) came into force on December 1, 2022.
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