On July 24, Beijing MPA issued some faqs related to general cosmetic filing, covering the topics of the submission of cosmetic ingredient safety information, cosmetic name and label requirements, etc.
1. The transition period of policy adjustments on filling out and submission of cosmetic ingredient safety information
According to the NMPA Announcement on Matters Related to Further Optimize the Measures of Cosmetic Ingredient Safety Information (No.34, 2023) (hereinafter referred to as Announcement), the following adjustments will be made during the transitional period of the implementation of policies related to the submission of cosmetic ingredient safety information:
(1) Since January 1, 2024, under application for special cosmetic registration or general cosmetic notification, cosmetic registrants or filers shall fill out and submit safety-related information of all the ingredients in the product formula in accordance with relevant regulations, technical specifications and the requirements of the Announcement.
(2) For the cosmetic with registration or notification that has already been completed before May 1, 2021, if ingredients with quality specifications stipulated in the Technical Specification for the Safety of Cosmetics are used in the cosmetic formula, cosmetic registrants, filers shall supplement to fill in the relevant ingredient quality specifications documents or ingredient safety-related information documents before January 1, 2024. Safety-related information documents for other ingredients used in cosmetic formulas shall be archived by cosmetic registrants and filers for future inspection.
For cosmetics with registration or notification has already been completed between the period from May 1, 2021, to December 31, 2023, if the product formula covers the ingredients with functions of preservative, sunscreen, colorant, hair dye, anti-spot and whitening, cosmetic registrants and filers shall supplement to fill in the relevant ingredient quality specification documents or ingredient safety information documents before January 1, 2024. Safety information documents for other ingredients shall be archived by cosmetic registrants and filers for future inspection.
2. For products filed before May 1, 2021, can the product name be changed if the efficacy evaluation results do not support the product name?
According to the NMPA FAQs on Cosmetics Supervision and Management (3), for cosmetics that have been registered or filed before May 1, 2021, the registrant or filer can apply for changes before the expiration of the transition period if the evaluation results cannot support the efficacy claims involved in their product names or labels after the efficacy claims of the products have been evaluated in accordance with the Standard for the Evaluation of Efficacy Claims of Cosmetics. The classification code can be adjusted according to the actual attributes of the product, and the content of the product name or label can be modified to comply with the relevant regulations. In addition, according to the NMPA Announcement on Issuing the Standard for the Evaluation of Efficacy Claims of Cosmetics (No. 50, 2021), for cosmetics that have been registered or filed before May 1, 2023, according to the Standard for the Evaluation of Efficacy Claims of Cosmetics, efficacy claims should be evaluated with uploading a summary of efficacy claims basis.
Therefore, products filed before May 1, 2021, whose efficacy evaluation results do not support the product name, can undergo a product name change subject to the above conditions.
3. What are the requirements for using trademark names in Chinese names of cosmetic products?
According to Article 8 (1) of the Measures for the Administration of Cosmetics Labels, the use of trademark names should not only comply with the relevant laws and regulations on trademarks, but also comply with the relevant laws and regulations on the management of cosmetics. It is not allowed to claim medical effects or functions that the product does not possess in the form of the trademark name. The words that imply certain kinds of ingredients are used as the trademark name: If such ingredients are contained in the product formula, the purpose of use shall be explained on the visible surface of the sales package. If such ingredients are not contained in the product formula, it shall be labeled definitely on the visible surface of the sales package that such ingredients are not contained and relevant words are only used as a trademark name. In addition, according to Article 9 of the Measures for the Administration of Cosmetics Labels, the Chinese name of cosmetics shall not be named with letters, Chinese pinyin, numbers, symbols, etc., except for registered trademarks, sun protection factor, color number, serial number, or other letters, Chinese pinyin, numbers, symbols, etc. that must be used. The registered trademark in the Chinese name of cosmetics uses letters, Chinese pinyin, numbers, symbols, etc., its meaning shall be explained on the visible face of the sales package.
4. Can cosmetics be labeled with words such as "XXX医院研制 (developed by XXX hospital)"?
According to Article 19 of the Measures for the Administration of Cosmetics Labels, cosmetic labels prohibit the use of state organs, institutions, medical institutions, public welfare institutions, and other units and their staff, the name and image of the appointed experts for proof or recommendation.
The words "XXX医院研制 (developed by XXX hospital)" in the label are suspected of using medical institutions as proof or recommendation, which is not in line with the relevant requirements.
5. If the product with the new formula still uses the name of the product with an old formula that has been cancelled after the adjustment of the product formula, can words such as "升级版 (upgraded version)" be added to distinguish the product with two formulas?
According to NMPA FAQs on Cosmetics Supervision and Management (2), considering that the new product still uses the name of the product with an old formula which has been cancelled after the change of the product formula, and the new product and the old one may exist in the market at the same time, the new product label can be marked with "新配方 (new formula)", "配方调整 (formula adjustment)" and other objective words so as to protect the consumer's right to know and distinguish the product with two formulas. Words such as "升级版 (upgraded version)" have no clear basis for judgement, and are suspected of misleading consumers.
If you have any questions related to the submission of cosmetic ingredient safety information, cosmetic name change, as well as the cosmetic name and label requirements, please contact us via info@enter-co.com.
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