China NIFDC Details Principles for Determining and Researching New Cosmetic Ingredients (NCIs)

On December 1, 2023, NIFDC released the second draft of the Technical Guidelines for Determination and Research of New Cosmetic Ingredients (NCIs). The purpose of the Guidelines is to establish standardized guiding principles for the identification and research of New Cosmetic Ingredients. It offers comprehensive information on NCI categorization, as well as the research content of and naming requirements for NCIs.

Background

Since the implementation of the Cosmetic Supervision and Administration Regulation (CSAR) in 2021, the China National Medical Product Administration (NMPA) has introduced a risk-based classification system for cosmetic products and NCIs. High-risk NCIs must undergo registration with the NMPA, while low-risk NCIs only need to be notified and can subsequently be manufactured and imported once enterprises complete the online dossier submission. This streamlined process reduces the market entry threshold for NCIs in China.

However, challenges have arisen during the registration and notification process for NCIs. Some registrants and notifiers have encountered difficulties due to their incomplete understanding of the identification and categorization of NCIs as well as inadequate data preparation. Common mistakes include the unclear definitions of NCIs, NCIs’ functions exceeding the scope of cosmetic definitions, and the inaccurate determination of applicable situations for NCIs.

To standardize and provide guidance for the determination and research of NCIs, the China National Institutes for Food and Drug Control (NIFDC) released the first draft of the Technical Guidelines for Determination of New Cosmetic Ingredients on January 19, 2023, to seek feedback from the public. ¹

Taking industry input into account, NIFDC released the second draft, which was renamed to Technical Guidelines for Determination and Research of New Cosmetic Ingredients(Guidelines) on December 1, 2023. ² Any suggestions can be submitted to hzppjzx@nifdc.org.cn until December 18.

The Guidelines is divided into four parts: overview, categorization, general requirements, and explanation of terms. Notifiers and registrants should utilize the Guidelines to assess whether an ingredient belongs to NCI, determine the appropriate NCI category, and conduct research in alignment with the provided requirements.

NCI Categorization

The first draft primarily categorized NCIs based on four aspects: ingredient composition, source attribute, preparation process, and actual function. However, the second draft restructures the categorization, focusing on "management attributes," and "management categories." Additionally, the second draft provides clarity on "ingredients that are not considered NCIs."

1. Categorization based on Management Attributes

In terms of management attributes, the Guidelines categorizes NCIs into three groups: "NCIs that affect cosmetic products," "NCIs that affect the surface of the human body," and "NCIs that affect both products and the surface of the human body."