On 5 Nov, Dept. of Drug and Cosmetics Registration under CFDA issued a notice to consult on the registration adjustment of domestic and imported non-special use cosmetics as well as re-classification of skin-whitening products. The opinion soliciting period is soon to be closed till 12 Nov.
China has the unique management mechanism towards cosmetics by dividing them into non-special use cosmetic products (Non-SUCPs) and special use cosmetic products (SUCPs) which meet different licensing requirements. With the former referring to general cosmetics for skin, hair and nail (toe) care, make-ups and fragrance, the latter includes 9 subcategories, namely products for hair growth and hair perming, hair dyes, depilatories, breast beauty products, body-shaping products, deodorants, spot-removing products and sunscreens.
Under the notice, skin-whitening or brightening products will be newly incorporated into the scope of spot-removing products and are managed as SUCPs. From 1 Jan 2015, all whitening products intended to be placed on the Chinese market should get approval from CFDA. Those produced before the date are allowed to be sold until the expiration date.
The rationale behind the enhanced strict control over whitening products is that the function mechanism of new generation of those products has converged to that of freckle-removing products due to technological invocation. They are different from those used in 1990’s which achieved the skin-brightening effect through physical methods with relatively low risk presented. The reclassification of skin-whitening products could pose a challenge for concerned companies because higher testing requirements and longer duration are needed for their registration as SUCPs which naturally leads to be more time and money invested on each product.
As is planned CFDA specifies in the notice how and when to transfer the power of approval of imported Non-SUCPs down to the provincial FDAs. A risk-based and step-wise approach will be taken to deal with the discrepant abilities and inconsistent approval criteria of different provincial FDAs. The power to approve those posing relatively low risks will be decentralized at first and then the scope is to be extended gradually to all imported Non-SUCPs until local departments are equipped with necessary technical review experts and are capable enough to assess their safety.
Food and drug administration departments in costal or developed provinces, such as Beijing, Shanghaia and Guangdong, which are already competent enough can apply to CFDA for the power of approving imported Non-SUCPs from 1 Jan 2014 and then receive professional trainings from CFDA. Overseas cosmetic companies can turn to those FDAs to get their products registered from 30 June of 2014.
Different from imported Non-SUCPs that still need pre-market registration, the domestic counterparts are managed in a much looser way. Cosmetic companies just need to keep required information on record for future reference and notify the formula and package to provincial FDAs through an online notification platform. It is worth highlighting that toxicological tests are no longer mandatory requirements for domestic Non-SUCPs (see ChemLinked news: Chinese Authority Softens Stance on Cosmetics Animal Testing Policy).
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