Navigating China’s Regulatory Landscape: Requirements and Updates on Ingredient Safety Information Submission
On January 1, 2021, the Cosmetic Supervision and Administration Regulation (CSAR) officially came into force, ushering in a new era of cosmetics supervision that prioritizes product safety. Under CSAR, cosmetic enterprises are responsible for ensuring the quality, safety, and efficacy claims of their products, with a particular emphasis on the safety of cosmetic ingredients. In line with CSAR, one of its significant subsidiary regulations – the Provisions for Management of Cosmetic Registration and Notification Dossiers (the Provisions) – puts forward relevant provisions for the submission of cosmetic ingredient safety information.
Cosmetic Ingredient Safety Information and Its Components
In conformity with the Provisions, when applying for cosmetic registration and notification, the registrant, notifier or domestic responsible person shall provide the safety information documents of cosmetic ingredients. If ingredient manufacturers or their authorized enterprises have submitted ingredient safety information on the Cosmetic Ingredients Safety Information Submission Platform, the registrant, notifier or domestic responsible person can fill in the ingredient submission code generated by the platform to associate it with the ingredient’s safety information documents. Please note that only cosmetic ingredients already in use, those listed in the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021), are eligible for the ingredient submission code application. Annex 14 to the Provisions introduces the components of ingredient safety information. These components and their general requirements are summarized in the table below:
ComponentsofIngredient Safety Information
Ingredient basic information
The basic information about ingredients includes ingredient composition, rec- ommended maximum addition amount, ingredient use restrictions, ingredient traits, as well as the description of physical and chemical properties.
Brief description of the production technique
The description should be based on the actual production situation, and focus on the steps in the process that are related to safety risks.
Quality control requirements
Unless otherwise specified, the quality control information submitted for in- gredients should be based on the relevant information provided by ingredient manufacturers.
Assessment conclusion of the authoritative international organization
If cosmetic registrants and notifiers have referred to any technical organiza- tions for authoritative data and information on cosmetic safety assessments, they shall specify the organizations.
Brief description of use require- ments for other industries
The description can be based on the information provided by ingredient man- ufacturers, or on research conducted by cosmetic registrants and notifiers.
Risk substance limit requirements
When analyzing potential risk substances in cosmetic ingredients, the prop- erties, source, production, and processing of ingredients, as well as other rel- evant information, shall be taken into account. Besides, limit requirements for these risk substances shall be specified.
Other issues that need explanation
If there is any additional information related to the quality and safety informa- tion of ingredients, or if further explanation of the ingredient’s safety informa- tion is necessary, it may be specified. Relevant documents may also be at- tached if necessary.
Cosmetic Registrants and Notifiers: Entities Primarily Responsible for Information Submission
The responsibility of submitting the safety information of cos- metic ingredients falls on cosmetic registrants and notifiers. They are required to collect detailed ingredient safety information and compile the documents, which involves requesting information from the ingredient manufacturers, reviewing literature, conduct- ing research, performing testing, etc.
Additionally, cosmetic registrants and notifiers should review and evaluate the authenticity and completeness of the submission code and the corresponding ingredient safety information pro- vided by ingredient manufacturers. If there is any problem with the authenticity, the ingredient concerned should not be used; if there are completeness issues, the registrants or notifiers can sup- plement corresponding ingredient safety information documents, then fill in and submit the documents by themselves. The problems in the ingredient submission code shall also be explained.
Ways of Submitting Ingredient Safety Information
The purpose of submitting ingredient safety information is to trace and monitor potentially problematic ingredients as well as the products containing them. In the event of a safety incident, National Medical Products Administration (NMPA) can quickly trace and analyze ingredients used in the product, identify the source of the incident, track and monitor other products that use the same problematic ingredient, and eventually control the risk. On March 27, 2023, NMPA announced adjustments to its man- agement policies on the submission of cosmetic ingredient safety information, which further clarified the practical ways for the submission. 1
Subject to this announcement,
For ingredients with a submission code, cosmetic registrants or notifiers can directly fill in the submission code, and request the corresponding safety information documents from the ingredient manufacturer for archiving for future reference;
For ingredients without a submission code, cosmetic registrants or notifiers can fill in the ingredients’ safety information through the Cosmetics Registration and Notification Information Service Platform, and upload a scanned copy of the paper documents stamped with the seal of the registrant or notifier. Relevant sup- porting materials of ingredient safety information documents, such as ingredient quality specification certification documents provided by ingredient manufacturers, literature, relevant re- search and test data, etc., shall be archived for future reference;
If a product contains the above two types of ingredients, the enterprise should adopt both submission methods simultaneously.
Updates and Changes on Ingredient Safety Information
As scientific research and understanding of cosmetic ingredi- ents advances, the quality and safety information of ingredients may change. Depending on how the ingredient safety information is provided, the changes can be handled as follows:
(I) Ingredient Submission Code
Once the ingredient is registered on the Cosmetic Ingredients Safety Information Submission Platform and the code is obtained, the registered information cannot be updated, changed or delet- ed. If ingredient suppliers have to modify the ingredient safety information, they need to re-submit the information and apply for a new submission code.
(II) Ingredient Safety Information Documents
In terms of the update on ingredient safety information docu- ments, China National Institutes for Food and Drug Control (NIFDC) proposed detailed instructions in the draft Technical Guidelines for Filling in and Submitting Safety Information of Cosmetic Ingredients (the draft Guidelines), which was released on May 4, 2023. 2
Subject to the draft Guidelines, if the changes are not related to the ingredient’s attributes and do not affect the safety assessment conclusion of cosmetics, it is not required to update the ingredi- ent safety information submitted. However, if the changes are re- lated to the ingredient’s attributes, cosmetic registrants and noti- fiers shall update the submitted ingredient safety information as follows:
If there is a change in the quality specification information of ingredients, which does not result in a change in the formula, cosmetic registrants and notifiers shall update and maintain the ingredient safety information on their own, following the first paragraph of Article 42 of the Provisions. If there is a change in the product’s safety assessment documents, a corresponding up- date shall also be completed.
If there is a slight change in the ingredient components, which leads to a change in the formula, cosmetic registrants and notifi- ers shall make a change to the registration or notification docu- ments following the second paragraph of Article 42 of the Provi- sions. As in (1), a corresponding update on the product’s safety assessment documents shall be completed if applicable.
If there is a substantial change in ingredients, the use of such ingredients shall not be continued. Cosmetic registrants and noti- fiers shall replace these ingredients, as well as maintain or update relevant information and documents based on the specific situa- tion of the ingredients to be replaced, in accordance with the conditions described in (1) or (2) above.
As early as March 5, 2021, NMPA introduced transitional meas- ures regarding the submission of ingredient safety information. 3 Under the guidance of these measures, effective January 1, 2023, the registrants and notifiers of the newly registered and notified cosmetics shall provide safety information on all ingredients used in their product formulas. Additionally, before May 1, 2023, regis- trants and notifiers shall complete the supplementation of safety information for all ingredients in the product formula of cosmet ics previously registered or notified.
As previously mentioned, on March 27, 2023, NMPA announced changes to its policies on the submission of safety information for cosmetic ingredients. This announcement also grants an additional one-year buffer period for the policy of submitting cosmetic ingredient safety information. Based on the registration or notifi- cation date of cosmetics, specific transitional measures have been introduced.
Initial registra- tion/notification date of cosmetics
Prior to May 1, 2021
For registered or notifier cosmetics that contain ingredients subject to quality specification requirements as specified in the Safety and Techni- cal Standards for Cosmetics (STSC), the registrant or notifier shall supplement and submit the quality specification certification documents or ingredient safety information documents of these ingredients before January 1, 2024.The registrant or notifier shall archive the ingre- dient safety information documents of other ingredients in the product formula for future reference.
Between May 1, 2021, and December 31, 2023
For registered or notified cosmetics that contain preservatives, sunscreens, colorants, hair dyes, as well as freckle-removing and whitening ingre- dients, the registrant or notifier shall supplement and submit the quality specification certification documents or ingredient safety information documents of these ingredients before January 1, 2024.The registrant or notifier shall archive the ingredient safety information documents of other ingredients in the product formula for future reference.
Since January 1, 2024
When applying for cosmetic registration or notification, the registrant or notifier shall fill in and submit the ingredient safety information documents of all ingredients used in the product formula.
China National Institutes for Food and Drug Control (NIFDC). (2023, May 4). Notice on Public Solicitation of Opinions on “Technical Guidelines for Filling in and Submitting Safety Information of Cosmetic Ingredients (Draft for Comments)”. Retrieved from: https://www.nifdc.org.cn/nifdc/xxgk/ggtzh/ tongzhi/20230504160415576847.html.
China National Medical Products Administration (NMPA). (2021, Mar 5). Announcement of NMPA on Implementing the “Provisions for Management of Cosmetic Registration and Notification Dossiers” (No. 35 of 2021). Retrieved from: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210305172050192.html.
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