China Consults on Administration Measures for Cosmetic Registration and Filing Testing

Testing of cosmetic ingredients/products to generate the safety/efficacy data necessary for cosmetic registration and filing in China will be subject to more stringent compliance requirements going forward. Stakeholders are encouraged to provide suggestions or comments to improve business interoperability. More testing institutions will be available for cosmetic toxicological testing.

On Jan. 4, China NMPA issued a new cosmetic inspection regulation Administration Measures for Cosmetic Registration and Filing Testing (Draft) for public consultation proposing to replace and repeal the previous Measures for Cosmetic Administrative Licensing Testing and Measures for Qualification of Cosmetic Administrative Licensing Testing Institutions. Any suggestions or comments can be sent back by email at [email protected] prior to Jan. 31, 2019. Please contact us at [email protected] if translations are required.

Substantiating Ingredient Safety/Efficacy during Cosmetic registration or filing

One of the most crucial market entry prerequisites facing imported cosmetics products in China is filing/registration and involves entrusting a testing agency to conduct the technical inspection and to generate the safety/efficacy data used to substantiate safety and ultimately comply with the regulatory compliance obligations of filing/registration.

Administration Measures for Cosmetic Registration and Filing Testing

The Measures which encompass 34 clauses and 2 lengthy appendices on requirements for testing and testing reports are primarily designed to specify the qualification criteria and procedures for testing institutions, but also contain provisions of relevant responsibilities and obligations for administrative departments and cosmetic manufacturers to exercise supervision and inspection on cosmetics.

Key provisions for those related cosmetic entities are summarized below:

NMPA

A new testing information system for cosmetic registration and filing will be established by NMPA to undertake filing management for testing institutions and inspection management for cosmetic registration and filing.

Testing Institution

♦ A testing institution that is responsible for carrying out necessary tests and issuing testing reports for cosmetic registration and filing should meet the specified qualification requirements and file with NMPA.

Qualification criteria:

The testing institution should be an independent legal entity which has already obtained CMA (short for “China Metrology Accreditation”)
Human safety testing institution and human trial testing institution for cosmetic efficacy assessment shall establish an ethics committee, volunteer management system and adverse reaction management system
Technical personnel engaged in clinical assessment shall have medical qualification and more than 5 years working experience
When applying for filing, the testing institution should have at least 3 years working experience in cosmetic testing and no violation record and serious accidence during the latest three years

♦ Any changes to the filed information shall be updated timely via the testing information system.

Cosmetic Manufacturers

► Cosmetic manufacturers should choose an approved (previously filed) testing institution to conduct product entrusted inspection in accordance with the specified testing items requirements.

Microbiological testing items,
Physicochemical testing items,
Toxicological testing items for non-special use cosmetics (non-SUC),
Toxicological testing items for SUC,
Human safety testing items,
Human trial testing item for cosmetic efficacy assessment.

► The application of entrusted inspection to the accredited testing institutions together with relevant documents such as product information and product instructions shall be submitted simultaneously via the testing information system. Notably, the product formula can’t be altered once submitted.
► All samples for inspection should be provided to the first testing institution that accepts the application, with more than half of the shelf life. Those submitted samples shall be unopened products in final sales packaging with complete package and the same batch number.

While for finished products that may affect the inspection result due to packaging reasons, such as spray products* and cushion cosmetics, the manufacturers are required to provide semi-finished products (finished to state just before the final packaging process), which shall be clearly stated by the testing institution in the report.