[Updated] China Finalizes Technical Guidance on Ingredient Safety Information Filling and Submission

Editor's Note: This article was originally published on May 9, 2023, and was updated on September 4, 2023, as per the latest developments.

In May 2023, China National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on the Technical Guidelines for Filling in and Submitting Safety Information of Cosmetic Ingredients (the Guidelines).¹ On September 4, 2023, NIFDC released the finalized Guidelines with immediate effect.²

The Guidelines consists of 11 parts and systematically outlines vital points and technical principles for filling in and submitting ingredient safety information, covering aspects of ingredient basic information, brief descriptions of ingredient production technique, necessary quality control requirements, limit requirements for risk substances, etc. It should be noted that, the Guidelines is applicable to situations where cosmetic registrants, notifiers and Chinese domestic responsible persons fill in and submit ingredient safety information in cosmetic registration or notification documents on their own, and not applicable to cases where ingredient manufacturers fill in and submit ingredient safety information through the Cosmetic Ingredients Safety Information Submission Platform. 

Highlights of the Guidelines 

1. Specifying registrants' and notifiers' responsibility for ingredient quality and safety

Cosmetic Supervision and Administration Regulation (CSAR) stipulates that, cosmetic registrants and notifiers shall be responsible for cosmetics' quality, safety and efficacy claims. As cosmetics quality and safety are based on ingredient quality and safety, the Guidelines rolls out detailed requirements for registrants and notifiers to follow.

Specifically, registrants and notifiers shall inquire, verify, and manage 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 used, and fill in ingredient safety information on this basis.

Moreover, the ingredient safety information filled out in cosmetic registration and notification documents and submitted by registrants and notifiers shall be stamped by the registrants and notifiers concerned, who shall be responsible for the content of the information. Besides, cosmetic registrants and notifiers shall retain relevant documents and keep them for reference at all times, and be responsible for the authenticity, accuracy, completeness, and traceability of the documents.

2. Refining requirements for the filling and submission of ingredient safety information

Annex 14 to the Provisions presents the components of ingredient safety information, and briefly introduces the general principles to fill in the information for each component. To provide clearer guidance for cosmetic registrants and notifiers, the Guidelines supplements detailed requirements under these general principles, and clarifies issues that require special attention, as summarized in the table below. 

3. Giving instructions on handling changes to ingredient safety information

As scientific research and understanding of cosmetic ingredients advances, the quality and safety information of ingredients may change. According to the 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 ingredient safety information that have already been submitted in the registration and notification dossiers. 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 the ingredient undergoes substantial changes that render its use impractical, cosmetic registrants and notifiers shall 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.

Further Reading

• Pedia | Regulations on Cosmetic Ingredient Safety Information Submission

• News | China Implements Guidelines for Submitting Information through the Cosmetic Ingredient Safety Information Submission Platform

• Webinar | China Cosmetic Ingredient Submission Code Application – Latest Updates and Practical Guidance