China to Expand Recognized Ingredient Safety Data for Safety Assessment Report

China released the draft Guidelines for Cosmetic Ingredient Data Usage, which expands the range of recognized ingredient data in the full version of the safety assessment report. The Guidelines also details the adoption requirements for ingredient data and the corresponding documents needed.

Background

As per the Technical Guidelines for Cosmetic Safety Assessment, until May 1, 2024, registrants and notifiers of cosmetics have the option to submit a simplified version of the product safety assessment report during product registration or notification process. However, starting from May 1, 2024, registrants and notifiers should submit the full version of the safety assessment report. Due to difficulties such as the lack of toxicological data for various ingredients and the shortage of safety assessment personnel, the shift to the full version of the safety assessment report presents a challenge for the industry.

According to the official industry newspaper of the National Medical Products Administration (NMPA) on March 15, 2024, NMPA plans to introduce a six-month transition period for the submission of the full version of the assessment report. Additionally, NMPA will introduce multiple measures aimed at optimizing the management of safety assessment.

On April 3, 2024, China's National Institutes for Food and Drug Control (NIFDC) released the draft Guidelines for Cosmetic Ingredient Data Usage, broadening the range of recognized ingredient data for the full version of the safety assessment report. ¹ It is currently open for public feedback until April 10, 2024. Interested parties are encouraged to submit their comments to hzpbwh@nifdc.org.cn before the deadline.

Main Contents

The Guidelines is divided into three parts:

Part 1 Main Ingredient Data Types: It clarifies the data types that can be used to prove ingredient safety in the cosmetic safety assessment report.

Part 2 Data Usage and Supporting Documents: It outlines the fundamental principles and requirements for using ingredient data, as well as the supporting documents that registrants and notifiers need to provide during the safety assessment.

Part 3 Others: It specifies the data types that are not applicable when assessing the safety of freckle-removing and whitening agents, anti-hair loss agents, anti-acne agents, anti-wrinkle agents (with the exception of physical anti-wrinkle agents), anti-dandruff agents, deodorants, and ingredients with high biological activity.

Key Highlights

Key highlights of the Guidelines are as follows.

1. Expanding the range of recognized ingredient data in the safety assessment report

The scope of recognized ingredient data for cosmetic safety assessment is broadened to include seven categories. The newly recognized ingredient data is highlighted in red.