China Promulgates 2019 Revised Cosmetics Hygiene Supervision Regulations

On March 18, China State Council published a Decision on Amending Some Administrative Regulations ^[1], Article 45 specifically stipulates the amendment requirements of the existing effective Cosmetics Hygiene Supervision Regulations. This decision took effect upon its issuance.

The amendments to the Cosmetics Hygiene Supervision Regulations mainly focused on two aspects (the full revised regulation is accessible here):

1. Clarify competent authorities. After China’s largescale institutional reform, the supervision responsibilities of cosmetics originally designated to hygiene departments has now been taken over by the National Medical Products Administration. The new regulations accordingly made some refinements of the expressions relating to competent authority's name:

• The expressions pertain to “Health Administration Departments” in Article 3, Article 9 Section 1, Article 10 Section 1, Article 19, Article 23, Article 29, Article 30, Article 32 of the 1989 CASR were modified to “Cosmetic Supervision and Administration Departments”;

• The expressions “Industry and Commerce Administrative Department” in Article 29 was modified to “Market Supervision and Administration Departments”;

• Article 17 was changed to “The cosmetic supervision and administration departments at all levels shall exercise hygiene supervision over cosmetics”;

• Article 18 was changed to “The cosmetic supervision and administration departments under the State Council shall invite research specialists and experts from medical units, production enterprises and health administration departments to form a cosmetic safety assessment group, responsible for evaluating the safety of special use cosmetics and the new cosmetic ingredients and conducting technical appraisal of major accidents caused by cosmetics.”;

• Article 22 was changed to “The cosmetic supervision and administration departments and the cosmetic hygiene supervisors at all levels are not allowed to have a hand in the production, sale or supervision of the making of cosmetics in the guise of a technical consultancy and service provider”.

• Article 34 was changed to “The enforcement rules of these regulations shall be formulated by the cosmetics supervision and administration departments under the State Council”.

2. Optimize cosmetic administration approval procedures. In the course of carrying out State Council’s reform on streamlining administration, the management on imported non-special use cosmetics has been entirely changed to filing management from registration. Additionally, the administrative license for cosmetic production and the administrative license for hygiene of cosmetic manufacturing enterprise have been integrated into a single Cosmetic Manufacture License. Based on the current practices, the new Cosmetics Hygiene Supervision Regulations thereby made several corresponding updates, as listed below:

• The expression of “Hygiene License” in Article 12 and the expressions regarding “Hygiene License for the Production Enterprise of Cosmetics” in Article 13, Article 24, Article 25, Article 28, Article 29 Section 2 of the 1989 CASR were modified to “Cosmetic Manufacture License”;

• Article 5 was changed to “The State shall implement the cosmetic manufacture license system to the enterprises engaged in the production of cosmetics. The Cosmetic Manufacture License shall be approved and issued by the cosmetic supervision and administration departments at the provincial, autonomous regional or municipal (directly under the Central Government) level. The term of validity of a Cosmetic Manufacture License is 5 years. No enterprise shall be allowed to engage in the production of cosmetics without a Cosmetic Manufacture License”;

• Article 15 was changed to “For first imported special use cosmetics, the importer has to submit relevant materials such as the product specification, the quality standards and the testing methods as well as a sample, together with the certification documents approved by the exporting country (region) for production to the cosmetic supervision and administration departments under the State Council. Only after the approval is obtained can the import contract be signed. For other first imported cosmetics, they shall be filed in accordance with regulations”.

Other Modifications

Article 26 Section 1 was amended to “Those who violate the regulation—import or sell imported cosmetics that have not been approved or inspected—shall be punished by having their goods and illegal earnings confiscated and will be issued a fine of 3 to 5x their illegal profits”.