Interview Vol. 2 | Sharing Key Points of NMPA Internal Training on China Cosmetic Registration and Notification Regulations

The finalized Administrative Measures on Cosmetics Labeling and Inventory of Existing Cosmetic Ingredients in China 2021 will be released before May 1. Both the labeling regulation and the IECIC 2021 are of great significance to cosmetic enterprises. In particular, IECIC 2021 will include the ingredient's highest historical use concentration. Generally speaking, NMPA will recognize that an ingredient is safe to use in cosmetics as long as the usage is lower than the highest historical use concentration.

Following that, from May to June, the post-market surveillance regulation—Supervision and Administration Measures on Cosmetics Manufacture and Operation and toothpaste-related regulations will be unveiled.

Regulations still under formulation include the Key Points of Registration and Notification Dossiers Review, Provisions on the Administration of Cosmetics Overseas Inspection, List of Permitted Whitening Ingredients in STSC, etc.

In the regulation, requirements for GMP certificate is quite general. NMPA understands that enterprises are eager to know more specific requirements, so during the training, the officials detailed three principles for GMP certificates:

• First of all, the certificates shall be issued by the government competent authority to prove that the government has conducted actual supervision and GMP compliance inspections on the manufacturers. There is no mandatory or unified template for GMP certificates. Any format works for the NMPA.

• Second, GMP certificates shall reflect an endorsement of the entire manufacturing process and the overall quality management system rather than a partial process and system.

• Third is about foreign cosmetic production licenses. Whether international cosmetic production licenses can be accepted for animal testing exemption shall depend on the local manufacturing standards complied. If the standards are below the requirements prescribed in the international GMP/ISO, the corresponding license won’t be accepted. For Japan, their production license may be accepted as their manufacturing standards almost equal to China’s.

Here I also want to make a clarification. Some foreign enterprises misunderstand that NMPA only accepts GMP certificates issued by the government during registration and notification. The actual situation is that GMP certificate required to be submitted, whether the certificate is issued by the government or a third-party association, is acceptable for registration and notification. But if you want to exempt animal testing, then the GMP certificate submitted must be issued by the government. Another precondition is that you must submit a safety assessment report.

The relevant requirements are not very clear at present. But the industry estimates that both answers might be positive if the safety assessment report issued by an international institution can fully prove the safety of products, and the international safety assessor sign the report truthfully and take relative responsibilities.