The safety of cosmetic products is assured based on the safety of their ingredients. Therefore, strengthening the safety management of ingredients has always been a core aspect of the cosmetic regulatory framework in China. Under the framework of previous Regulations Concerning the Hygiene Supervision over Cosmetics, strict management requirements were put forward for ensuring the ingredient's safety. Ingredients used in production were required to comply with national hygiene standards. Additionally, any new cosmetic ingredient to be used in cosmetics shall obtain the approval from the former China Food and Drug Administration (CFDA), before it can be used.
On this basis, China officially implemented the Cosmetic Supervision and Administration Regulation (CSAR) on January 1, 2021. It adopts a risk-based classification management approach for new cosmetic ingredients, wherein high-risk ingredients require registration with NMPA, while low-risk ingredients are available for use only after quick notifications. Moreover, CSAR innovatively develops a system for the submission of safety information for existing cosmetic ingredients, aiming to more effectively control product quality and safety from the source. Along with its supporting regulations, CSAR has established a regulatory framework which further enhances the supervision of cosmetic ingredient safety.
Part 1 General Introduction
1.1 Regulatory Requirements
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 requirements for the submission of cosmetic ingredient safety information. According to the Provisions, when applying for cosmetics registration and notification, the registrant, notifier, or the Chinese domestic responsible person shall provide the manufacturer information of the ingredients used in the product, and upload the ingredient safety information documents issued by the ingredient manufacturer. If the ingredient manufacturer has already submitted the ingredient safety information following the Guidance on Submitting Cosmetic Ingredient Safety Information (Annex 12 to the Provisions), the manufacturer will get an ingredient submission code. In this case, the registrant, notifier, or the Chinese domestic responsible person can enter the code to link to the submitted ingredient safety information documents.
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 any 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 are added with the same problematic ingredient, and eventually control the risk.
1.2 Subjects of Responsibility
Under CSAR, cosmetic registrants and notifiers are responsible for ensuring the quality, safety, and efficacy claims of their products. As the entity responsible for product quality and safety, they are required to collect the detailed safety information of ingredients included in the Inventory of Existing Cosmetic Ingredients in China (IECIC), and compile the corresponding documents by requesting information from ingredient manufacturers, reviewing literature, conducting research, performing testing, etc.
Moreover, cosmetic registrants and notifiers should review and evaluate the authenticity and completeness of the submission code and the corresponding ingredient safety information provided by ingredient manufacturers. If there is any problem with the authenticity, the ingredient concerned should not be used; if the ingredient safety information has any completeness issue, the registrants or notifiers can supplement corresponding ingredient safety information documents, then fill in and submit the documents by themselves. The problems of the ingredient submission code shall also be explained.
Part 2 Ingredient Safety Information
The safety information of cosmetic ingredients is crucial for evaluating the safety of products. Annex 14 to the Provisions outlines the essential items of ingredient safety information, including:
Part 3 Submission of Ingredient Safety Information
In terms of submission methods, currently, cosmetic registrants, notifiers, and domestic responsible persons can submit the cosmetic ingredient's safety information in either of the following ways:
For ingredients with a submission code, they can directly fill in the submission code to link the ingredient safety information;
For ingredients without a submission code, they can fill in the ingredient's 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;
If a product contains the above two types of ingredients, both submission methods should be adopted simultaneously.
3.1 Submission via Ingredient Submission Code
3.1.1 Ingredient Submission Code
The ingredient submission code is a unique code that consists of three parts, the serial number corresponding to the ingredient in IECIC, the ingredient manufacturer code, and the registration serial number of the ingredient on the Cosmetic Ingredients Safety Information Registration Platform (the ingredient platform). It is automatically generated after the cosmetic ingredient manufacturer submits the ingredient's safety information through the ingredient platform.
It needs to be emphasized that only cosmetic ingredients that are already in use, i.e., those listed in the IECIC, qualify for the ingredient submission code application. New cosmetic ingredients can only apply for the code once they have been added to the IECIC, provided no safety issues arise during the three-year monitoring period. If required by downstream parties during the monitoring period, manufacturers of new cosmetic ingredients can provide the ingredient safety information specified in Annex 14 instead.
3.1.2 Qualified Applicant
The cosmetic ingredient manufacturer, which is responsible for ingredient safety, is eligible to submit the ingredient's safety information to obtain the submission code. This manufacturer can be the actual production enterprise of ingredients, the affiliated enterprise belonging to the same group company with the actual manufacturer, or the entrusting enterprise that entrusts the ingredient production to another party.
The manufacturers shall ensure the authenticity and completeness of the information submitted through the ingredient platform. They can either submit the safety information themselves, or authorize Chinse domestic or foreign legal entities to submit and maintain it. However, it is important to note that for ingredients with the same quality specification, only one enterprise can be authorized to submit the safety information.
3.1.3 Required Ingredient Safety Information
When applying for the submission code, it is mandatory to provide the ingredient's basic information, a brief description of the production technique, as well as the information about the ingredient's quality and characteristic indicator. The submission of the remaining safety information is optional and depends on the specific ingredient. However, NMPA encourages applicants to provide such information as well.
3.1.4 Application Procedures
To set up an application account, cosmetic ingredient manufacturers shall submit the enterprise information form (Annex 13 to the Provisions) and the certification documents of the enterprise entity through the ingredient platform. A power of attorney issued by the ingredient manufacturer is required for authorized submission. For overseas ingredient manufacturers, there are three options to open an account: setting up the account by themselves, authorizing a Chinese domestic company, or authorizing another foreign company.
Depending on the application method, the documents required for opening an account on the ingredient platform are summarized as follows:
Upon opening the application account, the applicant needs to register the ingredient manufacturer's information on the ingredient platform to obtain a manufacturer code. Once this step is completed, the applicant can proceed to submit the required safety information. After that, a submission code will be automatically generated.
Workflow of Ingredient Submission Code Application
After submission, the information of the registered code will be made public on a platform designated by NMPA, as shown in the picture below. This platform neither displays the ingredient's composition ratio or trade name, nor the manufacturer's information. It only publicizes partial components of the ingredient, and partial digits of the submission code.
3.1.5 Other Points for Attention
The ingredient platform is established solely to streamline the cosmetic registration and notification process. Regulatory authorities do not review or approve the ingredient safety information that is registered on the ingredient platform. Therefore, obtaining the ingredient submission code does not mean that the ingredient has been approved or recognized by the authorities. Any advertising claims that suggest the ingredients have been approved or recognized, including using the term "ingredient submission code obtained" to imply the approval of the ingredient, may be considered false or exaggerated, and may result in investigation and punishment.
3.2 Submission of Annex 14
3.2.1 Subjects of the Submission
As introduced above, for ingredients without a submission code, it is the cosmetic registrants or notifiers who are responsible for filling in the required information and uploading the ingredient safety information documents (Annex 14 to the Provisions) when applying for cosmetic registration and notification.
Specifically, they shall inquire, verify, and manage the ingredient's quality and safety-related information in various links such as supplier selection, as well as the purchase, acceptance, and use of ingredients. If necessary, they can carry out relevant research to ensure a thorough understanding of the quality and safety situation of the ingredients, and fill in the ingredient safety information on this basis.
Moreover, the ingredient safety information filled out in the cosmetic registration and notification documents and submitted by registrants and notifiers themselves shall be signed and stamped by the registrants and notifiers concerned, who shall be responsible for the information. Besides, cosmetic registrants and notifiers shall retain relevant documents for reference at all times, and be responsible for the authenticity, accuracy, completeness, and traceability of the documents.
3.2.2 Main Sources of Ingredient Safety Information
Generally, cosmetic registrants and notifiers can collect the ingredient's safety information from the following aspects:
quality specification documents or related dossiers, data, information, etc., provided by ingredient manufacturers;
literature review; and
self-conducted quality control measures or testing and research data.
In principle, the information that is closely related to the attributes, production, and processing of ingredients, such as the basic information, the brief description of ingredient production technique, quality control requirements, limits on risk substances, etc., shall be based on the quality specification documents or other related information provided by ingredient manufacturers.
Cosmetic registrants and notifiers shall screen the documents and information provided by ingredient manufacturers. They may also independently review additional literature, take quality control measures, or conduct relevant research to supplement or refine ingredient safety information as needed. On this basis, cosmetic registrants and notifiers shall accurately fill out and submit ingredient safety information, with a focus on ingredient quality specification, the control of substances with safety risks, ingredient safety assessment conclusions, and other information closely related to cosmetic quality and safety.
3.2.3 Submission Requirement
Cosmetic registrants and notifiers who submit ingredient's safety information on their own can complete the submission through the Cosmetics Registration and Notification Information Service Platform. They shall upload a scanned copy of the Annex 14 stamped with the seal of the registrant or notifier. Apart from that, they need to fill in the safety information again on the submission portal, as shown below.
3.3 Transitional Period
To allow cosmetic stakeholders to have enough time to comply with the requirement for safety information submission, NMPA sets phased transitional provisions. According to NMPA,
a. Starting from January 1, 2024, when applying for the registration of special cosmetics or for the notification of general cosmetics, the cosmetic registrant or notifier should fill in and submit the ingredient safety information of all ingredients used in the product formula per relevant regulations and technical specifications;
b. For cosmetics that had been registered or notified before May 1, 2021, if the ingredients that are subject to the quality specification requirements as specified in the Safety and Technical Standards for Cosmetics (STSC) were used in the product formula, the registrant or notifier should supplement and submit the quality specification certification documents or ingredient safety information documents of the relevant ingredients before January 1, 2024. The ingredient safety information documents of other ingredients in the product formula should be archived by the registrant or notifier for future reference;
c. For cosmetics registered or notified between May 1, 2021 and December 31, 2023, if preservative, sunscreen, colorant, hair dye, as well as freckle-removing and whitening ingredients are used in the product formula, the registrant or notifier should supplement and submit the quality specification certification documents or ingredient safety information of the relevant ingredients before January 1, 2024. The ingredient safety information documents of other ingredients in the product formula should be archived by the registrant or notifier for future reference.
Part 4 Maintenance and Update on Safety Information
4.1 Safety Information Submitted by Ingredient Submission Code
Currently, only unsubmitted ingredient safety information can be modified. Once the ingredient is registered and the submission code is obtained, the ingredient platform doesn't allow the registered information to be changed, updated or deleted. Therefore, for any change to the ingredient's safety information, ingredient manufacturers will need to apply for a new code. The same trade name and ingredient composition can be registered for more than one code.
4.2 Safety Information Submitted Through Annex 14
For cosmetic registrant or notifier who submit ingredients' safety information through Annex 14, they can file a change application or directly update ingredient safety information when there are changes to the ingredient information.
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 ingredient safety information that have already been submitted. However, if the changes are related to the ingredient's attributes, cosmetic registrants and notifiers shall update the submitted ingredient safety information as follows:
(1) 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 update shall also be completed.
(2) If there is a slight change in the ingredient components, which leads to a change in the formula, cosmetic registrants and notifiers shall update the registration or notification documents following the second paragraph of Article 42 of the Provisions. Same as the situation in (1), a corresponding update on the product's safety assessment documents shall also be completed if applicable.
(3) If there is a substantial change in ingredients, such ingredients shall not be used. Cosmetic registrants and notifiers shall replace these ingredients, as well as maintain or update relevant information and documents based on the specific situation of the replacement, in accordance with the situations described in (1) or (2) above.
* ChemLinked expects to assist companies in applying for ingredient submission codes and registering/notifying cosmetics in China. If you have any further cosmetic compliance consultation needs, please contact us at cosmetic@chemlinked.com.
