CFDA Consults on Draft Regulations concerning the Supervision and Administration of Cosmetics

In the second half of 2013, CFDA began reforms of Regulations concerning the Hygiene Supervision over Cosmetics in order to further standardize the production and operation of cosmetics, reinforce the supervision and administration of cosmetics, ensure the quality of cosmetics and safety and safeguard consumers’ health. On November 8 2014, CFDA started to solicit public opinion on the revised version, renamed Regulations concerning the Supervision and Administration over Cosmetics. The regulation gives clear provisions for filing or registration of cosmetic ingredients and products, production of cosmetics, labeling and advertisement as well as supervision over cosmetics throughout the supply chain. Once this regulation comes into effect, the Regulations concerning the Hygiene Supervision over Cosmetics shall be repealed simultaneously.

According to Regulations concerning the Supervision and Administration over Cosmetics, cosmetic products are redefined as products intended to be applied on the surface of human body (such as skin, hair, nails, lips etc.), teeth and oral mucosa by spreading, spraying or other similar ways for the purpose of cleansing, protecting, beautifying or grooming skin or maintaining the good condition of skin. Meanwhile, the CFDA adds three basic principles to supervise and administrate cosmetics, namely the enterprise entity responsibility principle, industry self-regulation principle and social supervision principle and stresses that all FDAs should open relevant government information to the public in a timely fashion.

Cosmetic Ingredients and Products Management

The CFDA has decided to adopt an inventory approach to manage cosmetic ingredients, namely the “Inventory of Existing Cosmetic Ingredients in China” (IECIC). Ingredients excluded from the inventory are regarded as new ingredients and subject to evaluation and review by the CFDA. Applicants can freely use approved new ingredients, but should provide a regular safety report to the CFDA during the initial 4 year observation period. If no adverse events occur during the 4 years, the ingredient will be listed into the IECIC.

Special use cosmetics require registration with the CFDA prior to marketing while non-special use cosmetics require record filing with the CFDA. A registration certificate which is valid for 5 years will be issued by the CFDA if the special use cosmetics get approval. The applicant can apply for extension of the validity term 6 months before the expiry date. As for imported non-special use cosmetics, applicants are permitted to import and sell their products provided they don’t receive a notification that their filing application is rejected within 10 days after the date of filing. Domestic manufacturers don’t need to submit safety evaluation documents, product standard reports and testing reports when filing their non-special use cosmetics with provincial FDAs but are subject to examination conducted by FDAs within 3 months of the date of filing. The purpose of this examination is to validate the information provided and the legality of filing dossiers. It is worth noting importation of cosmetics requires submission of sales information in the country of origin. The pre-condition for foreign companies looking to export cosmetics to china is designation of a responsible agent in China in order to file a record or register with FDAs or CFDA. The agent must be a Chinese legal entity, for example REACH24H Consulting Group.

Production and Operation of Cosmetics

Manufacturers shall meet the requirements of the CFDA and obtain the production license issued by the FDAs prior to manufacturing cosmetics. The production license is valid for 5 years and can be extended. Furthermore, manufacturers should submit a self-examination report to provincial FDAs every year and are required to establish a stock check record system, product inspection and sales records system.

Cosmetic producers shall establish a stock check record system and ask suppliers for relevant certificates and invoices. Cosmetics must be stored, transported and delivered in accordance with the provisions of labeling. It is prohibited for cosmetic operators to prepare and sub package cosmetics.

If cosmetic manufacturers or operators intend to use a third-party online platform for selling cosmetics, the online platform will require them to register with real names because the provider of this platform is responsible ensuring authenticity of all products sold on the platform.

Labeling

As prescribed in the Regulations concerning the Supervision and Administration over Cosmetics, the following information shall be indicated on labels of cosmetics:

Regulations concerning the Supervision and Administration over Cosmetics (draft)

• Product name
• Name and address of manufacturer
• Actual Production and Processing Place
• Country of origin
• Manufacturing Enterprise Administrative License number and product standard number
• Cosmetics Registration Certificate number or record number
• List of all ingredients
• Shelf-life
• Net content
• Other info

Cosmetic labeling should be true, accurate, complete, normalized and clear and use standard Chinese characters to indicate the contents except registered trademark, address of foreign manufacturer and conventional technical terms. Those contents that express or imply medical effects, exaggerate the function, make misleading claims, criticize products of the same kind, mislead consumers or violate the public order and good custom are prohibited.

Efficacy claims are permitted to be marked on the labels provided adequate testing or evaluation data supports the claim. Products whose efficacy has been validated by testing institutions can be labeled with relevant validation information while those whose efficacy has not been validated should be labeled with “efficacy has not been validated”. The efficacy validation institution should meet the requirements specified by CFDA.

The consultation runs until 24 November 2014. If you have any comment, please send it to [email protected].