What is a Chinese Responsible Person?
EU Cosmetic Regulation defines the idea of a responsible person:
“Only cosmetic products for which a legal or natural person is designated within the EU as a ‘responsible person’ can be placed on the market. The new cosmetics regulation allows the precise identification of the responsible person is and clearly outlines their obligations.”
A Chinese Responsible Person is a qualified Chinese company who can handle the registration of your cosmetic products in compliance with the regulations of the Chinese NMPA and must be a corporate body, juridical person, or corporation. Designating a Chinese Responsible Person before you enter the Chinese market is required by Chinese law.
Why do you need a Chinese Responsible Person?
In EU Cosmetic Regulation, a responsible person must report any serious undesirable effects (SUE):
“A responsible person will have an obligation to notify serious undesirable effects to national authorities. The authorities will also collect information coming from users, health professionals, and others. They will be obliged to share the information with other EU countries.”
Under Chinese Cosmetic Regulations, if you would like to import your cosmetics into the Chinese market, then you MUST have appointed a Chinese Responsible Person.
The Chinese Responsible Person is responsible for ensuring the cosmetic products are compliant with all Chinese Cosmetic Regulations.
What does the Chinese Responsible Person do?
The Chinese Responsible Person performs the following functions:
- Handles the registration and filing/notification of cosmetics and new cosmetic ingredient (NCI) in the name of the registrant and filing person (such as the brand owner or licensee).
- Assists registrants and filing person to carry out cosmetic adverse reaction monitoring, safety monitoring and reporting of new cosmetic ingredient (NCI).
- Assists registrants and filing person to implement the recall of cosmetics and new cosmetic raw materials.
- Assumes the corresponding quality and safety responsibilities for the cosmetics and new cosmetic raw materials put on the domestic market as agreed by the registrant and filing person.
- Cooperates with the supervision and inspection work of the drug supervision and administration department.
The Chinese Regulation states under Article 52:
If the Chinese NMPA authority responsible for registration and filing management is unable to contact the registrant, filing person, or Chinese responsible person through the registration and filing/notification information, it may assign the registrant, filing person, and domestic responsibility on the information service platform People. They will be listed as key targets for supervision and announced through the information service platform.
Changing your Chinese Responsible Person
Choosing the correct responsible person is extremely important. If you wish to switch later, you will need the informed consent of your current responsible person. Due diligence on your part and building a good working relationship are essential. The best company will be able to open the Chinese market to you in as little as three months.