Development Trends in Chinese Cosmetic Regulations

In the second half of 2013, CFDA announced its decision to reform China's cosmetic regulatory framework in order to align it with the actual industry situation (see CL news on 7 Nov 2013). The government began with a series of public consultations on China's overarching regulation Regulations concerning the Hygiene Supervision over Cosmetics. Until now, three major regulatory adjustments were officially promulgated and implemented:

• The post-market filing requirements for domestic non-special use cosmetics changed into pre-market online notification (see CL news on Jun 10 2014)

• Whitening products got reclassified as special use cosmetics (see CL news on Apr 21 2014)

• A consolidated list of IECIC 2014 released (see CL news on July 2 2014)

The CFDA has also softened its stance on animal testing with toxicological tests becoming an optional requirement for domestic non-special use cosmetics. Cosmetic enterprises are allowed to prepare safety assessment materials to demonstrate product safety without carrying out animal testing (see CL news on Dec 23 2013).

In November 2014 the reform process took a major step forward when the CFDA released two major drafts, namely Regulations concerning the Supervision and Administration of Cosmetics and Administrative Measures on Cosmetics Labeling. These two drafts feature several future regulatory changes including:

• a batch-wise inventory release approach of approved ingredients

• a 4-year trial use of new cosmetic ingredients

• efficacy claims management

• online filing of imported non-special use cosmetics

• the decentralization of approval power

By studying the regulations implemented already and the two newly released drafts and speculating from the disclosure from officials of the FDAs, five major development trends in Chinese cosmetic regulations can be seen and are summarized as follows:

1 Quantitative assessment replaces qualitative

The CFDA is prioritizing scientific data to substantiate safety and efficacy of cosmetics. We can see from the reclassification of whitening products and changes to management of efficacy claims that safeguarding consumers' health and safety through scientific assessment of cosmetics is a significant development. Xie Zhijie, Director of the Cosmetics Supervision Department of Guangdong FDA noted that testing results will be more and more important. It can be expected that cosmetic companies will be posed with significant regulatory burdens.

2 Pre-market surveillance changes into post-market surveillance

The cosmetic regulatory control in many counties/areas such as EU and ASEAN has moved from pre-marketing approval to post-marketing surveillance. The CFDA has been making regulations based on the EU cosmetic regulations so post-marketing surveillance will be a major focus of the CFDA. Qi Liubin, Director of Cosmetics Division, CFDA confirmed this trend. He remarked, "Although pre-market administrative licensing will exist for a long time due to its effectiveness and convenience in China, post-marketing surveillance is undoubtedly the future trend of Chinese cosmetic regulatory control. We are also endeavoring to make some changes on post-marketing surveillance." During the past one year there were no major changes on post-marketing surveillance except the filing changes of domestic non-special use cosmetics. Under the new system only online notification with product formula and sales packaging is needed prior to marketing while post-market examination of the remaining documents and product quality will be the focus.

3 Quality control changes into risk control

The most direct embodiment of this trend is the strengthening of new ingredient management and the reduction of importance of production management (see CL news on Nov 18 2014). In an effort to reduce the importance the CFDA unified the Cosmetic Hygiene License and Cosmetic Production License into a single Manufacturing Enterprise Administrative License. According to the draft of Regulations concerning the Supervision and Administration of Cosmetics, cosmetic new ingredients will be subject to stricter evaluation and supervision on the history of the new ingredient, physical and chemical properties, QSAR, efficacy characteristics, etc. Xie Zhijie stated, "The chief culprit of recent cosmetic safety cases is the illegal use of ingredients. Provided the usage of ingredients gets better regulated, 70%-80% of the cosmetic supervisory task can be accomplished." It should be expected that ingredient management will be more rigorous in the future.

4 Incentives for innovation

"It is a decision based on the industry development", says Xie Zhijie, "our goal of cosmetics supervision is to pursue the development of industry rather than to stifle companies with controls". The batch-wise release approach and 4-year trial use of new cosmetic ingredients are major approaches designed to increase and reward innovation (see CL news on Nov 11 2014).

5 Social Surveillance Encouraged

Actually the CFDA has long stressed the importance of society co-governance and aspires to achieve this goal. As stipulated in the draft of Regulations concerning the Supervision and Administration of Cosmetics, "any organizations and individuals are entitled to report any activities done by cosmetics manufacturers and operators which violate this Regulation, and also make comments and suggestions on the supervision and administration of cosmetics. Where reports concerning the quality and safety of cosmetics are proved to be true, food and drug supervision and administration departments will reward relevant organizations or individuals according to the relevant regulations."

It was revealed that the draft of "Technical Safety Standard for Cosmetics" and "Administration Measures on Registration of Cosmetics" will be published soon (see CL news on Nov 5 2014) and several regulations concerning the filing of imported non-special use cosmetics (see CL news on Oct 17 2014), labeling management (see CL news on Oct 10 2014) and ingredient management will be implemented next year. For cosmetic companies, they could never anticipate what specific regulatory changes will occur but catching the regulatory development trends is a perfect way for them to cope with the desultory nature of China's regulatory environment.