On 4 May 2023, China National Institute for Food and Drug Control released a preliminary opinion on the Guideline to Fill Cosmetic Formula for notification/registration in China (Hereinafter referred to as the Guideline), which is open for comments until 20 May 2023. Industrial stakeholders can submit opinions to hzppjzx@nifdc.org.cn .
Even though requirements are specified in the Rules for the Management of Cosmetics Registration and Notification Dossier as of 1 May 2021, many problems are still found in the filling of cosmetic formula during the government review of dossiers, such as non-compliance with names and purposes of ingredients. Based on this situation, it is necessary to sort out the common issues and provide corresponding guidance. Therefore, the government releases The Guideline that provides guidance for filling in the cosmetic formula, such as ingredient names, percentages, purpose of use, safety information, notes, etc.
ZMUni sorts out some highlights in the Guideline that are of great concern to stakeholders in the cosmetic industry.
What types of cosmetic ingredients are required to be filled in for registration/notification?
With regard to the Guidance, cosmetic ingredients are those purposely added to the product formula during the production process and play a certain role in the finished products, including preservatives, UV filters, hair dyes, colorants, moisturizers, pH regulators, etc.
It does not include ingredients used to ensure the quality of raw materials, ingredients in extremely small amounts (such as antioxidants), unavoidable traces of impurities, and processing aids added in the production process, but without chemical reaction with other ingredients and not present in the finished products.
Is safety assessment required for ingredients that are not used as formula ingredients?
Regarding the Guideline, ingredients that are not used as formula ingredients should be described one by one in the product safety assessment documents. Though they are not filled in the formula table, cosmetics registration and notification persons are still responsible for the quality of these ingredients and shall conduct safety analysis and assessment. Special attention should be given to ingredients produced by new technologies (such as trace cholesterol in liposomes, phospholipids, etc.) and ingredients used in kids’ products, in order to ensure quality and control risk. When the composition or proportion of such ingredients changes and has a substantial impact on product quality and safety, the cosmetics registration and notification persons shall change the product safety assessment data accordingly.
What is the template of the formula table?
Number | Standard Chinese Name | INCI/English Name | Raw Material Percentage (%） | Compounds Percentage (%) | Actual Percentage (%) | Purpose of Use | Note |
In principle, the percentage of raw material and actual percentage in the formula table shall not be less than one valid figure, and shall not exceed five valid figures.
The release of the Guideline could be a good signal to the cosmetic industry in China. It provides specific guidance on filling in cosmetics formula and provides a standard for dossier review, which is likely to improve the pass rate and shortens review time for cosmetics registration and notification. At the same time, it also means that the supervision and administration of the cosmetic industry are becoming increasingly standardized and strict, which requires cosmetic stakeholders to strengthen their quality management and leaves less space for non-compliant practices.
If you have any questions or have opinions to submit, please feel free to contact us: info@zmuni.com
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