On March 27, 2023, China's NMPA (National Medical Products Administration) issued an announcement on matters related to further optimizing the measures of cosmetic ingredient safety information, which is undoubtedly good news for cosmetic registrants and filers in China.
Cosmetic ingredient safety information mainly includes ingredient quality specifications, safety risk substances control, ingredient safety risk assessment conclusions, and other safety-related information about cosmetic ingredients.
EnterCo has sorted out and analyzed the points of this announcement:
I. Three Methods of Submitting Cosmetic Ingredient Safety Information
According to the actual situation of ingredients used in product formulas, cosmetic registrants and filers shall choose the following three ways to submit cosmetic ingredient safety information:
1. Fill in the ingredient submission code
Cosmetic registrants and filers shall directly fill in the ingredient submission code obtained from cosmetic ingredient manufacturers. They shall also request the ingredient manufacturer of the corresponding ingredient safety information and archive for future inspection;
2. Fill out and submit the ingredient safety information by yourself
For cosmetic product ingredients without ingredient submission codes, cosmetic registrants, and filers can fill in the ingredient safety information through the Information Service Platform for Registration and Filing of Cosmetics on their own, and upload scanned paper documents with their seal. The supporting materials related to ingredient safety information documents, such as ingredient quality specification certification documents provided by the ingredient manufacturer, the literature reviewed, relevant research, and test data should be archived by cosmetic registrants and filers for future inspection;
3. Combination of filling in the ingredient submission code and filling out and submitting the ingredient safety information by yourself
Only part of the ingredients in the cosmetic formula has an ingredient submission code, cosmetic registrants, and filers can be in accordance with the above requirements, adopt the combination of filling ingredient submission code, and fill in the ingredient safety information on their own.
It should be stressed that, regardless of the choice of which way to submit the cosmetic ingredient safety information, cosmetic registrants and filers shall be archived for future inspection.
Previous cosmetic ingredients regulations:
For cosmetic product ingredients without ingredient submission codes, there are two methods of submitting cosmetics ingredients safety information (see NIFDC Notice on September 9, 2022, for details)
1. Provide ingredient quality specifications with the official seal of the ingredient manufacturer or ingredient safety-related information (Annex 14 of the Provisions for the Registration or Filing Dossier of Cosmetics with the official seal of the ingredient manufacturer)
2. Ingredient manufacturers authorize registrants, filers, or responsible persons within the territory of China to fill in the ingredient safety-related information (Annex 14)
EnterCo's analysis:
The announcement stipulated that cosmetic registrant and filer could fill in ingredient safety-related information on their own, and no longer need to obtain the ingredient manufacturer's authorization, which not only greatly improves the initiative of cosmetic registrants and filers, but also save time to supplement ingredient safety-related information and communication costs.
II. Transition Period Adjustment of Policy Implementation
1. Since January 1, 2024, under special cosmetic registration or general cosmetic notification, cosmetic registrants or filers shall fill out and submit safety-related information about all the ingredients in the product formula in accordance with relevant regulations, technical specifications, and the requirements of this announcement.
EnterCo's analysis:
The starting time for submitting ingredient safety information for all ingredients is postponed from January 1, 2023, to January 1, 2024.
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. Ingredient safety-related information documents for other ingredients used in cosmetic formulas shall be archived by cosmetic registrants and filers for future inspection.
EnterCo's analysis:
Relaxed from submitting all ingredient safety information to ingredient safety information of other ingredients need not be submitted, which only need be archived by cosmetic registrants and filers for future inspection.
3. For the cosmetic with registration or notification that 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. Ingredient safety information documents of other ingredients shall be archived by cosmetic registrants and filers for future inspection.
EnterCo's analysis:
Relaxed from submitting all ingredient safety information to submitting safety-related information of ingredients with functions of preservative, sunscreen, colorant, hair dye, anti-spot and whitening. Ingredient safety information documents of other ingredients no longer need to be submitted, which shall only be archived by cosmetic registrants and filers for future inspection.
Comparison of policy implementation transition period
New China NMPA Regulations | Previous China NMPA Regulations |
|---|---|
Since January 1, 2024, in case of special cosmetic registration or general cosmetic notification, cosmetic registrants or filers shall submit safety-related information about all the ingredients in the product formula in accordance with relevant regulations, technical specifications, and the requirements of this announcement. 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, and filers shall supplement to fill in the relevant ingredient quality specifications documents or ingredient safety-related information documents before January 1, 2024. Ingredient safety-related information documents for other ingredients used in the cosmetic formula shall be archived by cosmetic registrants and filers for future inspection. For the cosmetic 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. Ingredient safety information documents of other ingredients shall be archived by cosmetic registrants and filers for future inspection. | Since May 1, 2021, registrants and filing applicants when applying for registration or filing, shall fill in the source of the product formula ingredients and trade name information. For ingredients involve quality specifications requirements stipulated in the Technical Specification for the Safety of Cosmetics, their quality specifications certification or safety-related information shall also be submitted. Since January 1, 2022, registrants and filing applicants when applying for registration or filing, shall provide safety information related to cosmetic ingredients with functions of preservative, sunscreen, colorant, hair dye, spot corrector and whitening in accordance with the Rules for Registration and Notification Dossiers of Cosmetics. Since January 1, 2023, registrants and filing applicants when applying for registration or filing, shall provide safety information related to all the cosmetic product ingredients in accordance with the Rules for Registration and Notification Dossiers of Cosmetics. For the cosmetic with registration or notification has already been completed, registrants and notification persons shall supplement the safety information related to all ingredients in the product formula before May 1, 2023. |
If you have any questions related to cosmetic ingredient safety information or ingredient submission code, please contact us via info@enter-co.com.
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