China Proposes Category Control over Non/Special-use Cosmetics

SFDA consulting on a draft proposal of category control over non/special-sue cosmetics which will re-define cosmetics of five special uses and streamline the record system of domestic and imported non special-use cosmetics

February 17, 2012, China State Food and Drug Administration (SFDA) published a notice to call for public commentary on performing category control over the current non special-use cosmetics on the Chinese market. The deadline of public feedback is 20 March 2012.

About Category Control and Class II Special-Use Cosmetics

In brief, the proposed modification will expand China’s current determination of special-use cosmetics into two broad classes. China’s existing special-use cosmetics defined according to the original 9 special functions become Class I Special-Use Cosmetics and a group of current non special-use cosmetics that may pose potential significant safety risks shall be included into Class II Special-Use Cosmetics. This means some of the current non special-use cosmetics would turn to be special-use.

According to SFDA’s opinion-soliciting draft, the Class II Special-Use Cosmetics are supposed to cover the following types:

A. Some cosmetics that have or claim to have functions of hair restoring, body shaping, freckle elimination, deodorizing and sun screen;

• Hair products having or claiming to have functions that control head skin grease secretion or that remove dandruff will be introduced as hair restorers;

• Products having or claiming to have functions of anti-wrinkles, acne treatment, easing or slowing eye pouch, and natural plant oils (having functions of essence excluded) or other similar products as body shaping cosmetics;

• Products having or claiming to have functions that suppress or stop sweating in order to eliminate or mitigate unpleasant human odors (aromatic products that cover up odors excluded) as deodorant cosmetics;

• Products having or claiming to have functions of brightening or whitening (products only functions through physical cover excluded), easing black eye, stripping of keratin as wrinkle elimination cosmetics;

• Products having or claiming to have functions of sun tanning, browning or other similar effects as sun screen cosmetics.

B. Certain cosmetics used on mouth and lips (those containing no artificial colors excluded) or eyes (eyebrow pencils excluded)

C. Cosmetics for special populations, such as women during pregnancy or breastfeeding, children and infants, etc.;

D. Cosmetics treated with new technologies or materials like Gene technology or nano materials.

List of Effective Compositions Used in Current Non Special-Use Cosmetics

In order to determine and quantify Class II special-use cosmetics, SFDA now provides a list of 20 substances commonly used as effective compositions for the current non special-use cosmetics, but some of which have not been listed with their effective volume range due to data gap. The agency notes that any cosmetic product of which the formulation concerns a listed substance can be defined as having relevant special functions/uses, thus under the category of Class II Special-Use Cosmetics. Also, it adds that effective composition substances of Class II special-use cosmetics include but are not limited to the listed 20 substances. This list will be under irregular update by SFDA.

Simplified Record/Approval Systems for Imported Non Special-Use Cosmetics

Based on the revised category control system, SFDA is trying to adopt more differentiated management for the license and record systems of non special-use and Class II special use cosmetics. Non special-use cosmetics after the modification will be subject to a simplified system of informing-record management; instead, the current system of approval-record for imported non special-use cosmetics shall be annulled.

According to SFDA’s drafting explanation, the agency managed to take account of the recent complaints from cosmetic importers to facilitate the approval and review procedures of first imported non special-use cosmetics. The compromise includes the adoption to practice an industry preferred informing and filing model on first imported non special-use cosmetics and a sharp cut in red tape time. So importers with all required documents prepared will receive the license within 5 working days instead of 20. In contrast, both Class I and Class II special-use cosmetics are obliged to a stricter approval & registration management system. Class I follows the existing approval method with the total review duration (from accepting to review and approval) lasting about 115 working days, while Class II is shortened to 55 working days. Other new supporting documents are supplied to guide producers and importers of Class II special-use cosmetics on how to apply for administrative license and prepare for the SFDA technical reviews.

The notice contains the following documents:

• SFDA’s opinion-soliciting draft on category control over non special-use cosmetics, attached with the list of effective compositions used in current non special-use cosmetics;
• Quick understanding of the category control over non-special-use cosmetics;
• SFDA Order on performing category control over non special-use cosmetics;
• Documents required to apply for the administrative license of domestic/imported Class II special-use cosmetics
• Documents on SFDA technical review of Class II special-use cosmetics
• Feedback sheet

Reference Links

• SFDA's news alert (in Chinese)
• The opinion-soliciting draft and associated documents (download rar, in Chinese)