The Evolution of Chinese Cosmetic Regulations

On November 08 2014, China Food and Drug Administration (CFDA) officially published the draft Regulations concerning the Supervision and Administration of Cosmetics for public opinions. Closely following it, on November 15 2014, CFDA started to solicit public opinions on the draft new Measures on Cosmetic Labeling. The draft Regulations concerning the Supervision and Administration of Cosmetics will replace the Hygiene Supervision over Cosmetics issued in 1989 and the new Measures on Cosmetic Labeling will be replaced by the Administrative Provisions on Cosmetics Labeling (Decree 100) and Guide to the Naming of Cosmetics as the main basis of law-enforcement in the administration of cosmetics labeling. The GB 5296.3-2008 provisions that do not conflict with the new regulations will continue to be applicable. Based on the new regulations a number of important questions arise,

• How many new rules are introduced?

• Who will be affected by these changes?

Definition of Cosmetics in China

First of all, the draft Regulations concerning the Supervision and Administration of Cosmetics redefined cosmetic products as those 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.  Similar to the European regulatory framework, tooth and oral mucosa are now considered cosmetics, and based on solid information gathered from multiple external sources it is very likely that some oral products will be supervised as cosmetic and some oral products may be supervised under other regulations (e.g. OTC). As to controversy surrounding regulation of soap, the new draft has yet to clarify its regulatory status.

The emphasis individual responsibility

CFDA emphasized enterprise's individual responsibility to ensure cosmetic quality and safety. Cosmetics manufacturers and sellers should bear responsibility to supervise and ensure the quality and safety of cosmetics they produce or sell.

Pre-market regulatory burdens will be replaced by post-market compliance, such as the product traceability, labeling re-design for China market and adverse effect monitoring. For adverse effect monitoring, the plan is to set up a monitoring system to cover specific areas of the supply chain such as the supplier and any related clinical and social resource. A recall system is also officially introduced. The recall system stipulates that in the case of any adverse events or quality issues the manufacturer should stop marketing, recall the products, report to CFDA and publically notify all distributors and consumers.

Meanwhile for imported cosmetics, responsible agents (importers, e-commerce platforms etc.) are responsible for the safety and quality of the products they distribute. That means local responsible agent should be quite familiar with the formula, claims, manufacturing process, safety risk substance, etc. CFDA also retains the right to conduct onsite inspection of foreign suppliers or manufacturers.

The Reiteration of NCI management

In the draft Regulations concerning the Supervision and Administration of Cosmetics CFDA also stipulates a 4-year observation period for newly approved new cosmetic ingredient (NCI). This 4-year observation period requires enterprise to self-regulate and report any adverse effects to CFDA.

As yet the detail of how to perform a product safety assessment, which is applicable for domestic products, is not mentioned. However the use of a designated safety assessor is specified for the first time and requires that safety assessment of cosmetics should be examined and signed by a safety assessor, who can be a qualified and competent employee or a third party.

Over-label and claims

Any form of relabeling, sticking, changing, modification will not be allowed according to this new draft, which means the routine use of Chinese stickers (over-label) on imported products would be prohibited. Foreign suppliers must re-designed original labels in Chinese for the Chinese market.

The requirements for use and range of permitted efficacy claims are also specified. Cosmetic products using specific efficacy claims should have adequate test and evaluation data to support the claim. Otherwise any claims must bear be balanced with a disclaimer "efficacy has not been validated". This is not an entirely new requirement and the CFDA expert panel has already been partially following these rules in the current review system. We can see a huge demand for testing facilities here.

There is certainly the potential for another round or rounds of public and internal discussion before the final version of the Regulations concerning the Supervision and Administration of Cosmetics and management on labels is nailed down. During this stage more changes are still possible, after which, we can expect the release of more supporting documents or guidance which should see the refinement of the cosmetic regulations in China.