China China’s National Medical Products Administration answers FAQs about cosmetics management

China’s National Medical Products Administration answers FAQs about cosmetics management

On March 10, China’s National Medical Products Administration published on its website answers to FAQs about cosmetics management, such as where to keep samples of imported cosmetics. Three of the FAQs and the administration’s answers to them are shown below.

What is the correct way to provide the safety information of cosmetics ingredients in the registration or notification of cosmetics?

Answer — In the registration or notification of cosmetics, registrants and notifiers must assess the safety risks of the cosmetics ingredients and provide the safety information of the raw materials used in the product’s formula in accordance with regulations, such as the Regulations on Cosmetics, the Measures on Cosmetics Registration and Notification and the Safety and Technical Standards for Cosmetics. Registrants and notifiers have only to provide the “reporting codes for raw materials” of the ingredients on the cosmetics ingredient safety information reporting platform. These codes are the codes automatically created for cosmetics ingredients when raw material companies register the safety information of the ingredients on this platform.

How should cosmetics registrants and notifiers keep product samples? How should they determine the number of samples to keep?

Answer — Cosmetics registrants and notifiers must keep samples from each shipment of their products for the traceability of the quality and safety information of products in accordance with the Measures on the Manufacturing and Business Management of Cosmetics, the Provisions on the Registration and Notification Documents of Cosmetics and the Standards for the Manufacturing Quality of Cosmetics.

To reduce the financial burden on companies, the National Medical Products Administration have comprehensively considered the categories and packaging specifications of products and the status of finished products; sorted out the numbers of samples to keep for common products in the market for reference; and set out the numbers of samples to keep for 10 types of products, including toothpastes and hair dyes. For products for which this number is not published, cosmetics registrants and notifiers must determine the number of samples to keep in accordance with regulatory requirements.

Where should registrants and notifiers of imported cosmetics keep samples of imported products?

Answer — From Jan. 1 onward, registrants and notifiers of foreign cosmetics must keep samples from each lot of imported products and have the samples and their records kept by a person in charge who is in China according to a public notice on the implementation of the Measures on the Manufacturing and Business Management of Cosmetics (Public Notice No. 140 of 2021) issued in November 2021.

When importing products belonging to the same lot in installments, registrants and notifiers must keep samples at least from the first installment of the import. In the case of contract manufacturing, they are allowed to keep samples at their address or in their main office, or in another office located at their address or in the same location of the main office. The place where samples are kept must meet regulatory requirements and the product storage conditions stated on the cosmetics labels.

 

The full text of the FAQs and the administration’s answers (in Chinese) is available at
https://www.nmpa.gov.cn/hzhp/hzhpjgdt/20220310144159124.html?type=pc&m=

Author / Responsibility

AOKI Kenji

Senior Consultant, EnviX Ltd.
General Director, E&H Consulting Co., Ltd.

Business Performance

Expertise in EHS (environment, health and safety) consulting in ASEAN region.
- Environmental regulations updating
- Chemical regulations consulting

Background

MSc in Earth Science, The University of Tokyo

AOKI Kenji