China Strengthens Management of Cosmetic Production Licensing

Two years ago the CFDA announced the integration of “Cosmetics Manufacturing Enterprise Hygiene License” and “Cosmetics Production License” to streamline cosmetic production licensing system in China. In an effort to standardize cosmetics production licensing procedures and set clear inspection standards, on March 17 2015 China Food and Drug Administration (CFDA) released “Guidelines for Cosmetics Production Licensing (Interim)” and “Key Points for Inspection of Cosmetics Production Licensing (Interim)”. These two regulations are now undergoing public consultation until April 10 2015.

Guidelines for Cosmetics Production Licensing (Interim)

According to the Guidelines, CFDA is responsible for the administration of national cosmetic production licensing while provincial FDAs are responsible for the licensing work of their own provinces. Under the new regulatory amendments cosmetics are broadly categorized into:

• General liquids
• Creams/lotions
• Powders
• Aerosols and organic solvents
• Toothpaste
• Ceryl
• Other unit

It should be noted that toothpaste including functional toothpaste are regulated under these categories, aligning with the definition of cosmetics in the Regulation concerning Administration and Supervision of Cosmetics (draft) released on November 8 2014.

The Guidelines also strengthens the management of OEM production. As stipulated in the guidelines the entrusting party and commissioned party are required to sign an OEM contract to specify the obligation of each party and ensure the quality of products. The entrusting party should comply with the requirements regarding product name and over-label and the commissioned party should produce cosmetics in strict accordance with relevant measures, guidelines and standards.

Key Points for Inspection of Cosmetics Production Licensing (Interim)

This regulation stipulates 106 inspection items including organization and personnel, quality control, plant and facilities, equipment, etc. to improve the manufacturing quality and final product standards. Manufacturers are required to establish a monitoring and reporting system to record all adverse reactions in addition to a product recall system. Adverse reaction cases shall be recorded, investigated, analyzed, evaluated, dealt with and reported to local monitoring organizations regularly and the recall processes shall also be recorded.

To facilitate traceability through the supply chain, manufacturers are required to establish a management system to track the movement of materials at acceptance and during product production and sale.

“The greatest significance of this regulation is to pave the way for implementation of China’s future Good Manufacturing Practice.” Technical Manager of Cosmetic Division at Reach24h Consulting Group, Martin Hu comments. However when China’s first GMP regulation will be released is still a mystery although the draft has already been completed according to Liu Yuan, Vice President of Guangdong FDA Technology Association for Evaluation and Certification which is designated to draft it by the CFDA (see CL news on December 15 2014)