On September 20, 2021, the National Medical Products Administration of China notified the WTO with the “Good manufacture practice for cosmetics (Draft)”. The final date for comments is 60 days from the notification, and the proposed date of adoption and proposed date of entry into force are still to be determined. The outline of the notification, which stipulates the regulations on the safety and quality management of cosmetics, are as follows.
Domestic registrants, record person, contract manufactures in China.
Establishment of the quality and safety responsibility system
In the Article 5, cosmetics manufactures are requested to set up the quality and safety responsibility system, and set the position of quality and safety responsibility or appoint the responsible person of the quality management department.
Provisions on quality and safety responsible person
Article 7 stipulated the qualifications that the quality and safety responsible person should have and his responsibilities. The following are some examples of the responsibilities.
- Establishing and implementing the production quality management system in the enterprises.
- Carrying out audit and management of products formula, production process, material suppliers, product labels and etc.
Zoning of the production workplace
In the Article 21, manufactures are requested to zone the production workplace into “clean area”, “quasi clean area”, “normal production area”.
Environmental requirements for production workplace
In the Annex 2, environmental requirements for production workplace are specified as follows.
|Area||Classification||Production process||Environmental indicators|
|Clean area||Eye skin care cosmetics, children skin care cosmetics, toothpaste||Storage, filling, bottling of semi-finished products, storage of clean containers and utensil||Suspended particles：the number of particle bigger than 0.5μm should less than 1050000/m3, the number of particle bigger than 5μm should less than 6000/m3.
Less than 500cfu/m3
Falling bacteria: less than 15cfu/utensil
|Static pressure difference: 10Pa higher than normal production area, 5Pa higher than quasi clean area.|
|Quasi clean area||Eye skin care cosmetics, children skin care cosmetics, toothpaste||Weighing, formulating, buffering, dressing||Total bacterial colonies in the air：≤1000cfu/m3||–|
|Other cosmetics||Storage, filling, bottling of semi-finished products, storage of clean containers and utensil, Weighing, formulating, buffering, dressing|
|Normal production area||–||Packaging, storage, etc.||Keep clean and tidy|
For the original text of the “Good manufacture practice for cosmetics (Draft)”, please refer to the following URL (in simplified Chinese)
For the details of the WTO notification, please refer to the following URL (in English).