China Cosmetics Licensing

SFDA notice No. 427 which clarifies application requirements lists the below points:

1) Chinese Pinyin is added to the section of “Reason of the Product (Chinese) Name” of the application form.

2) Four items, namely (i) sensory indicators, (ii) chemical indicators of health and microbial indicators, (iii) storage conditions and (iv) shelf life, are added to the section of “Product Quality and Safety Control Requirements” of the application form.

(i) Sensory indicators shall cover the color (like white or light yellow), odor (odor type like fragrant, mild, pungent or odorless) and characters (like cream or lotion) of the product contained.

(ii) Health indicators refer to the test items and their respective restrictions related to the product. For instance, mercury and its threshold value, or asbestos not detected. The set indicators shall be followed by their corresponding testing method. For testing method not available in China’s existing regulations or national standards, a full testing method description shall be provided either. For the sake of product safety, the applicant could also include other information like certain commonly used quality control standards within the applying company.

(iii) Storage conditions shall cover information like temperature, kept in dark or not, based on the product packaging and the stability of product. And storage conditions on the application form should be consistent with the product label or the content marked on its instruction sheet.

(iv) Product shelf life (recommended in the form of xxx months or xx years) shall consider factors like packaging, product stability and other relevant test results, plus climate impact of the targeted market. Shelf life shall be printed together with the production date, batch number and use deadline date.

3) The section of “Product Design &Package (including label and instruction sheet)” shall add items on how to use the product and the usage precautions, both consistent with the product label or the content marked on its instruction sheet. The usage precautions shall apply the warning phrases specified in China’s Hygienic Standard for Cosmetics (2007 version).

The SFDA notice No. 428, which clarifies issues on the record & modification of the applicant information contains the below main areas:

1) For cosmetics or new cosmetic ingredients exported to China, if their manufacturers plan to change for a new responsible reporting unit based in China, the new reporting unit should report SFDA and have their letter of attorney recorded before the agency submits the first cosmetics administrative license application. This Chinese reporter shall submit the below materials:

a. The original letter of attorney and relevant certification originals of the new Chinese responsible reporter;

b. Business license copies of the new Chinese responsible reporter;

c. The original documents notarized by a public agency that cancels the reporting of a former Chinese responsible unit.

2) If the Chinese responsible unit has changed its own identification or address, it should supply SFDA the relevant notarization (in copies) or certifying documents (in originals) issued by the local administration of industry and commerce.

3) The letter of attorney offered to the Chinese responsible reporting unit should meet the below requirements:

a. Signed by both the cosmetic manufacturer and its Chinese reporting unit;

b. With public notarization;

c. Supplying Chinese translation and notarization on the translated version if the attorney letter is issued in a foreign language other than Chinese;

d. Containing at least the information such as identification, addresses and company seals of the authorizing entity and its Chinese responsible reporting unit, contact information of both parties, etc.;

e. The letter of attorney has no expiry date.

4) When the new Chinese responsible reporting unit has completed the recording in SFDA, the Chinese unit should not submit application to change any information regarding the former reporting unit on the cosmetic administrative permit document (record certificate).

5) If the new Chinese responsible reporting unit applies to extend or modify the record certificate acquired by the former reporting unit, it should submit its own (new) letter of attorney (in copies) and the notarization documents that revoke the reporting of its previous counterpart.

6) In the case that a new Chinese responsible reporting unit has completed the recording in SFDA but the cosmetics licensing procedure started with the former reporting unit is still under way, then the former reporting unit should nevertheless be responsible for the following-up of the license acquisition.

For more regulatory policies about China’s imported cosmetics/new cosmetic ingredients, please review our knowledge base or send your question to info@reach24h.com.