Detailing Administrative Measures on Cosmetics Labelling

On November 15 2014, CFDA published the draft Administrative Measures on Cosmetics Labelling for public comment. This draft will be implemented from July 1 2015. Cosmetics marketed already can use their existing labels until June 30 2016. From the day of implementation, these measures will replace the "Administrative Provisions on Cosmetics Labelling" and "Guide to the Naming of Cosmetics" as the main basis of law enforcement in the administration of cosmetics labelling. The provisions in GB 5296.3 – 2008 that do not conflict with the new measures will continue to be applicable.

According to the draft, the following information shall be indicated on labels of cosmetics:

• Product name

• Name and address of manufacturer

• Actual Production and Processing Place

• Cosmetics Manufacturing Enterprise License number and product standard number

• Approval number or record number

• List of all ingredients

• Shelf-life

• Net content

• Other info

The CFDA made further clarifications about the requirements for the name and address of manufacturers as well as the record number for domestic non-special use cosmetics. The manufacturer refers to the enterprise that produces the finished sales product or is the last party to conduct any formulation based production processes. Imported cosmetics should be marked with the name and address of the companies in China responsible for safety. OEM cosmetics shall bear the names and addresses of the two entrusting parties. For domestic manufacturers of non-special use cosmetics, the record number can be automatically obtained after filing a record with provincial FDAs online 6 month before marketing the cosmetics. Furthermore, cosmetics with contents less than 15g(ml) such as samples for trial/ nail polish are required to be labeled with product name, name and address of manufacturer, approval number or filing number and net content (see CL news on 18 November 2014).

Streamlining of Cosmetic Production Licensing

The former supervisory system placed cosmetics production under the dual regulation of both CFDA and AQSIQ. Cosmetics manufactured in China were required to not only obtain a "Cosmetics Manufacturing Enterprise Hygiene License" from provincial FDAs but also a "Cosmetics Production License" from provincial quality and technology supervision administrations under AQSIQ. The redundancy inherent in the old model whereby two departments issued two similar licenses decreased the efficiency of cosmetics supervision and also overburdened the cosmetic industry. To reduce regulatory overlap and enhance working efficiency, the former SFDA was reorganized as the CFDA in March 2013, becoming the sole competent authority of cosmetics regulation. Meanwhile, CFDA announced the integration of the two licenses to streamline cosmetic production licensing system in China. At present, AQSIQ has stopped issuing the "Cosmetics Production License" and newly established cosmetics manufacturers now just need to obtain a "Cosmetics Manufacturing Enterprise Hygiene License" from provincial FDAs. There are still inevitably many existing manufacturers holding two licenses and the full withdrawal of the Cosmetics Production License is still incomplete. As specified in the draft regulation only the " Cosmetics Manufacturing Enterprise Hygiene License Number" is required to be marked on labels.

Mandatory Indication of Efficacy Information

The efficacy of cosmetics is a major consumer concern followed closely by quality, safety and price. 70% of consumers say that cosmetic enterprises should be required to publish efficacy information and that cosmetics without validated efficacy should be required to label such information. However such requirements were not stipulated in the former labelling regulations. The CFDA is increasing public input into cosmetic regulation and has taken specific consideration of public feedback regarding efficacy claims during the formulation of Administrative Measures on Cosmetics Labelling. CFDA will mandate full disclosure of efficacy information rather than the traditional license-based approach with the aim of stimulating cosmetic companies to innovate.

From July 1 2015, all products except moisturizing products and hair dying products with efficacy validated by accredited testing institutions can be labeled with relevant validation data. Products without validated efficacy data should be labeled with "efficacy has not been validated". Although not a mandatory regulatory requirement, efficacy claims are likely to be necessary in terms of consumer acceptance. Cosmetic products using specific efficacy claims should have adequate test and evaluation data to support the claim, making efficacy testing in these instances a mandatory requirement. The draft does not stipulate which testing facilities are accredited to perform efficacy testing. The draft does however require that efficacy evaluation and validation institutions should meet certain conditions specified by the CFDA. Qi Liubin has revealed that any cosmetic companies or testing institutions that meet the requirements of the CFDA can conduct efficacy testing, however the details of the requirements have yet to be elucidated.

Standardization of Over-labels used for Imported Cosmetics

Differences in international regulations result in inconsistent requirements for cosmetic over-labels. In the past over labels were permitted for imported cosmetics which we essentially Chinese translations of the original label affixed over the original ingredients list. In the new draft any form of relabelling, stickers, or other modification of original labeling will not be allowed, which means foreign suppliers must redesign original labels in Chinese specifically for the Chinese market.

Softening of Stance on Labelling Claims and Wordings

Regulators are increasingly making provision for the association between the fashion industry, the cosmetics industry and some other inherently creative industries. As a consequence the CFDA is softening its stance on labelling claims and the wording used in labels. Creative terms will be acceptable as long as the specific meaning is explained on the same label. Furthermore, the CFDA issued the "List of Prohibited Wordings for Cosmetic Labelling" in the draft. Compared to the prohibited wordings in the " Guide to the Naming of Cosmetics", the list primarily adjusts the following three aspects:

• The loosening of restrictions on wordings that is inconsistent with the products' properties but can be easily recognized by consumers.

• Permissions for use of partly prohibited claims that meet the demands of consumers and are already generally accepted by consumers, such as anti-aging, anti-wrinkle, etc.

• Increased regulation on claims relating to medical efficacy and other misleading advertising.