China Blueprints Cosmetic Regulatory Reforms

5 Nov 2013, China Food & Drug Administration (CFDA) unveiled a draft measure aimed at partially revising the current regulatory system for pre-market assessment of cosmetics. The draft measure is currently undergoing public consultation until 12-Nov-2013.

This is the first time that the CFDA has publically explained the rationale behind its plans for regulatory reform. In this release the CFDA outlined its management strategy for centralization of the on-line notification system, re-classification of whitening products, and deregulation of imported ordinary cosmetics. Since 11-Sep-2013 the CFDA has been officially collecting opinions on recasting the current overarching cosmetic law, Regulations concerning the Hygiene Supervision over Cosmetics.

Centralization of On-line Notification System

Under the current regulatory scheme for domestically manufactured ordinary cosmetics, the industry should submit the notification to the provisional FDA (the local branch of CFDA). Similar to the European regulatory environment under 76/768/EEC, regional disparities in operational procedures relating to notification and post market monitoring has plagued efficient regulation.

The reformed notification system will be effective in 1-Jun-2014, and managed by local FDA and CFDA. The major difference is that now the buck will stop with the CFDA, which will have complete oversight on all final decisions relating to notification application. Local FDAs will be responsible for checking the completeness of the notification information regarding formulation and packaging whilst the CFDA will function as the central portal for collection and publication of notified information.

Re-Classification of Whitening Products

CFDA will regulate the whitening products as “special use cosmetics”, and require all imported or domestically manufactured brightening products are subject to the pre-market assessment after 1-Jan-2015. The Kanebo safety crisis is likely a major contributory factor in this administrative decision which has been in the works since its predecessor the SFDA expressed intentions to reclassify this category of ordinary cosmetics in Feb-2012.

Deregulation of Imported Ordinary Cosmetics

Pre-market assessment of imported ordinary cosmetics will be shifted from CFDA to local FDA in 30-Jun-2014, through a devolutionary process. Local FDAs that meet technical standards and with competent staff qualified to conduct reviews can apply for an assessment from the CFDA in 1-Jan-2014. Training and inspection will be carried out by CFDA prior to delegating increased responsibility. Forerunners in this process will likely be in Beijing, Shanghai and Guangdong province which are the major hubs of cosmetics production in China

Alleviating the burden on animal testing

The world cosmetic community would be happy to see administrative changes on animal testing by the CFDA. Regarding the domestically manufactured ordinary products (such as shampoo, skincare or perfume), the industry will have two options to substantiate the product safety from 1-Jun-2014. The first avenue will continue to utilize animal testing, however a second option of assessing safety based on the toxicological profile of ingredients will be available (similar to Cosmetic Product Safety Report under EU Cosmetic Regulation). All relevant material gathered during safety assessments should be archived and ready for official inspection.

China intends to adopt modern safety assessment methodologies using ordinary products as the starting point, from here as experience and understanding of these new technologies is gained we can expect their applications to be expanded to encompass both imported and special use cosmetics.

For more information, please contact: 

Tommy Kong  

Head of Cosmetic & Personal Care Products Services
Email: [email protected] 
Tel: +86 0571 8700 7517