China Consults on Guidelines for Submitting Information through the Cosmetic Ingredient Safety Information Submission Platform

Guidelines for Submitting Information through the Cosmetic Ingredient Safety Information Submission Platform clarifies the application scope of the platform, the submission principles, necessary documents, and the obligations of cosmetics registrants and notifiers.

Background

According to the Provisions for Management of Cosmetic Registration and Notification Dossiers (the Provisions), when applying for cosmetic registration and notification, it is required to submit ingredient safety information;
On March 27, 2023, National Medical Products Administration (NMPA) announced to extend the transition period of the cosmetic ingredient safety information submission policies to January 1, 2024. Since January 1, 2024, the cosmetic registrant and notifier shall fill in and submit the ingredient safety information documents for all ingredients used in the product formula per relevant regulations and technical specifications.

On May 12, 2023, China National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on the Guidelines for Submitting Information through the Cosmetic Ingredient Safety Information Submission Platform (the Guidelines). Any suggestions can be sent to hzppjzx@nifdc.org.cn by May 31, 2023. ¹

The objective of developing the Guidelines is to provide guidance to ingredient manufacturers on the correct use of the Ingredient Safety Information Submission Platform (the Platform) and standardize the submission of ingredient safety information. The Guidelines consists of 12 Articles, including the basis, purpose, application scope, submitting entity, submission content, the generation and use of ingredient submission codes, etc.

Clarifying the application scope of the platform

The Platform is exclusively applicable to the submission of safety information for ingredients that are listed in the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC) with independent serial numbers.

There are varying interpretations of this requirement within the industry. One perspective is that this requirement excludes group ingredients listed in IECIC, implying that safety information can only be submitted for specific ingredients under the group ingredient.

Another viewpoint is that the Guidelines applies solely to the submission of safety information for a single ingredient, and it remains unclear whether and how to submit the safety information for compound ingredients.

Clarifying the submission principles

Ingredient manufacturers must submit safety information in accordance with relevant regulations and technical specifications, and be responsible for the authenticity and completeness of the information. They can either submit the safety information themselves or authorize Chinese domestic or foreign legal entities to submit and maintain it. However, for ingredients with the same quality specification, only one enterprise can be authorized to submit the safety information.

Clarifying necessary documents for submitting ingredient safety information

The Guidelines clarifies the necessary documents for registering an account and submitting the ingredient safety information on the Platform.

1. Register a platform account