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On May 4, 2023, China National Institutes for Food and Drug Control (NIFDC) released the draft Technical Guidelines for Filling in and Submitting Cosmetic Formula (Guidelines) for public consultation. After a period of four months, the finalized Guidelines was released and implemented by NIFDC on September 4, 2023.
Applicable Scope
The Guidelines provides instructions for enterprises seeking to register or notify special/general cosmetics, outlining the requirements for completing the cosmetic formula table, which includes ingredient names, concentration, main use purpose, remarks and safety information, etc.
During the review of registration and notification information, NIFDC has found problems in the filling-in of product formulas, such as non-standard and unreasonable ingredient names, use purposes, etc., which contributes to the introduction of the Guidelines. To address these problems, NIFDC has sorted out the specific issues involved in the filling-in and provided corresponding guidance to enterprises.
Main Contents
The Guidelines consists of ten parts and three annexes.
I. Introduction
II. Scope
III. General Principles
IV. Formula Filling and Submitting Methods
V. Ingredient Name in Formula
VI. Percentage Content of Ingredients in Formula
VII. Use Purpose of Ingredients in Formula
VIII. Remarks Column in Formula
IX. Ingredient Safety Information
X. Safety Assessment of Ingredients/Ingredient Components Not Listed as Formula Components
Annex 1 Formula Table Template
Annex 2 Sample of Formula Table (without ingredient components that are not considered part of the formula)
Annex 3 Sample of Formula Table (with ingredient components that are not considered part of the formula)
