After the implementation of “Cosmetics Supervision and Administration Regulations”(CSAR) on January 1, 2021, there are two new legal concepts that jump into people’s attention: registrant and filing person. But do you really understand both concepts with their responsibilities? And What are they different with responsible during the cosmetics application.
1. Registrant and filing person
First of all, the concepts of registrant and filing person are derived from the regulatory requirement of general cosmetics and special cosmetics. For General cosmetics, it is required to fill(Notify) the products through the online system before put them to the markets. And the applicant should be called the filing person. And for special cosmetics, it is necessary to do the registration at the national NMPA, and the applicant should be called a registrant.
According to the CSAR, cosmetics registrants and filing persons are not only responsible for product quality and safety, but also responsible for claims of efficacy and are the owners of the products. A company that only engages in the entrusted production of cosmetics is not the owner of the product.
The “CSAR” stipulates the requirements, responsibilities and obligations of cosmetics registrants and filing person. According to Article 18 of CSAR, cosmetics registration applicants and filing persons should have a quality management system, including the establishment of a quality management system and the SET a person in charge of quality and safety.
Moreover, cosmetics registrants and filing persons also should establish the adverse effect monitoring system and responsible for product recall with the assistance of the responsible person.
2. Responsible Person
According to the CSAR, If a Cosmetics registrant or filing person is located overseas, a domestic responsible person shall be designated within China to handle cosmetics registration and filing. Different from the responsible agent in previous regulations, the responsible person bears more responsibilities than ever before.
The main responsibilities of a responsible person:
- Apply for cosmetics registration and filing in the name of the registrant and filing person.
- Assist in the monitoring of cosmetic adverse reactions, and implement product recalls.
- In accordance with the agreement with the registrant and filing person, to take quality and safety responsibilities for the cosmetics placed on the China market;
- Cooperate with the supervision and monitoring work of the National Medical Products Administration
It is worth to be noted that if an overseas registrant or filing person entrusts a domestic cosmetics manufacturer to produce cosmetics, the cosmetics are domestic cosmetics. But the oversea registrant and filing person are necessary to desinate an domestic responsible person as well;
But if a domestic registrant and filing party entrust an overseas factory to manufacture the products, the cosmetics should belong to imported cosmetics, but since the registrant and filing person is located in China, there is no need to designate a domestic responsible person.Tags: CSAR