The regulation of whitening products is currently in a transitional period after the CFDA released Circular No.10-2013 on 16 Dec last year. In this circular whitening products were re-categorized from non-special to special use cosmetics (see CL news on 23 Dec). Uncertainty still exists as to what kinds of products are considered whitening products in China. Ideally the government should publish a positive list of substances regulated as existing whitening ingredients in China. However, a CFDA official revealed that it is unable to publish such a list at present but that the government has the intention to do so in the future.
To address the concern of defining whitening products in China, on the 11th of April the CFDA released a “guidance-like” letter stipulating the criteria for determining whitening products are based on “function and claim”.
The scope of whitening products
If either of the following criteria is satisfied, the product will be defined as a whitening product and subject to management in accordance with special use cosmetic regulations:
- Claiming to have a whitening effect on the skin due to reduction of melanin production;
- Whitening the skin through a superficial physical covering and the label bears the expression of whitening.
Companies should register type 1 according to requirements for registration of freckle-removing cosmetics. Type 2 products are not regulated as strictly and have requirements identical to registration of imported non-special use cosmetics. Under the new regulatory scheme, all whitening products already commercially available and approved before re-categorization will require generation of safety and efficacy data in accordance with new standards.
CFDA also states that the following products are not whitening products and that cosmetic companies should not use any confusing statements or words to imply a whitening effect.
- Explicitly indicate or imply that the product achieves a whitening effect through physical coverage but without an accompanying efficacy claim
- Only having the function of cleaning or exfoliating
With the introduction of these new defining principles a large number of products will not be allowed to market themselves as “whitening products”. A CFDA official stated that in the future a guidance document on verification of efficacy claims of functional cosmetics, including whitening products will be issued. Testing will be required to generate testing reports to corroborate cosmetic functional claims. It is clear that the regulatory environment for whitening products is moving towards much stricter regulation. The increase in regulatory requirements also indicates the CFDA’s determination to overhaul whitening product regulations, encourage domestic enterprises to enhance R&D ability and innovation, and largely inhibit false advertisement and marketing claims.
In this circular the CFDA also reminded cosmetic companies that the new on-line filing system for domestic non-special use cosmetics will be launched from 30 Jun 2014 as scheduled. In addition, in light of the huge demand and backlog of work facing cosmetics testing institutions the CFDA has decided to increase the number of testing institutes used for generating test data for domestic non-special use cosmetics.
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