Whitening products to be classified as special use cosmetics in China

On December 16, 2013, China Food and Drug Administration (CFDA) released an announcement about the adjustments of registration, record and management of cosmetics to request that informative record should be conducted on the domestic cosmetics for non-special use and the whitening products be re-classified in the management of spot-removing products.

According to the announcement, in order to control the safety risk of the whitening products, it is decided that the whitening products be classified as special use cosmetics and fall into the category of spot-removing products to conduct strict management on them, as currently, most of the whitening products have the same mechanism of action as that of skin-lightening products on the market. From the day of the release of this announcement, food and drug regulators do not take care of the applications for record of domestic or imported whitening products for general use. Manufacturing enterprises should apply for registration in accordance with the Management Requirements of Whitening Products. In respect of the accepted whitening products, food and drug regulators should continue to review and issue the record certificate and urge enterprises to provide relevant supplementary materials and complete relevant inspection items on time. After that, enterprises should report the whitening products to be classified as the cosmetics for special purposes once again. It is forbidden to manufacture or import the whitening products that have already obtained the record certificate but are not reported and have the approval certificate of cosmetics for special purposes in line with requirements stated in the announcement since June 30, 2015.

Enterprises should not claim that products, which only have the functions of cleaning and exfoliating, are able to whiten the skin. And they should submit applications for changing the name and label of the products that already have the record certificates to former record and management departments. The original product packaging can be used as of June 30, 2015, and relevant products can be sold until the day when the shelf life expires.

The Letter of Soliciting Opinions on the Classified Management of Cosmetics for General Use issued on February 17, 2012, stated that products, which are able to or declared to whiten (with exception to the products that only have the function of physical coverage), lighten dark eye circle and remove skin keratoderma, should be classified as the skin-lightening cosmetics.
Another Letter of Soliciting Opinion on the Classified Management of Cosmetics for General Use issued by CFDA on May 29, 2012, mentioned once again that products, which are able to or are declared to whiten skin (with exception to the products that have the function of physical coverage), remove acne or restrain the acne with accepted high-level safety risk, should be included in the management of skin-lightening cosmetics and the administrative license management of cosmetics for special purposes should be implemented.

This proves that this rule is really not an accidental phenomenon, for it takes two years for CFDA to finally carry out this rule since it put forward this rule for the first time. During the period of two years, CFDA solicited opinion from the public for three times. The presence of this rule is no doubt a fatal attack for the SMEs (small and medium-sized enterprises). But multinational corporations with the foresight maybe have already make preparations for the upcoming new cosmetics control and management policy.