[Updated] China Implements Guidelines for Submitting Information through the Cosmetic Ingredient Safety Information Submission Platform

Editor's Note: This article was originally published on May 17, 2023, and was updated on September 4, 2023, as per the latest developments.

Latest Updates

On September 4, 2023, China National Institutes for Food and Drug Control (NIFDC) approved the Guidelines for Submitting Information through the Cosmetic Ingredient Safety Information Submission Platform. ¹

Background

According to the Provisions for Management of Cosmetic Registration and Notification Dossiers (the Provisions), when applying for cosmetic registration and notification, it is required to submit ingredient safety information;
On March 27, 2023, National Medical Products Administration (NMPA) announced to extend the transition period of the cosmetic ingredient safety information submission policies to January 1, 2024. Since January 1, 2024, the cosmetic registrant and notifier shall fill in and submit the ingredient safety information documents for all ingredients used in the product formula per relevant regulations and technical specifications.

On May 12, 2023, China National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on the Guidelines for Submitting Information through the Cosmetic Ingredient Safety Information Submission Platform (the Guidelines). Any suggestions can be sent to [email protected] by May 31, 2023. ²

The objective of developing the Guidelines is to provide guidance to ingredient manufacturers on the correct use of the Ingredient Safety Information Submission Platform (the Platform) and standardize the submission of ingredient safety information. The Guidelines consists of 13 Articles, including the basis, purpose, application scope, submitting entity, submission content, the generation and use of ingredient submission codes, etc.

Clarifying the application scope of the platform

The Platform is exclusively applicable to the submission of safety information for ingredients that are listed in the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC) with independent serial numbers.

There are varying interpretations of this requirement within the industry. One perspective is that this requirement excludes group ingredients listed in IECIC, implying that safety information can only be submitted for specific ingredients under the group ingredient.

Another viewpoint is that the Guidelines applies solely to the submission of safety information for a single ingredient, and it remains unclear whether and how to submit the safety information for compound ingredients.

Clarifying the submission principles

Ingredient manufacturers must submit safety information in accordance with relevant regulations and technical specifications, and be responsible for the authenticity and completeness of the information. They can either submit the safety information themselves or authorize Chinese domestic or foreign legal entities to submit and maintain it. However, for ingredients with the same quality specification, only one enterprise can be authorized to submit the safety information.

Clarifying necessary documents for submitting ingredient safety information

The Guidelines clarifies the necessary documents for registering an account and submitting the ingredient safety information on the Platform.

1. Register a platform account

Ways to Submit Application	Required Documents
Chinese Domestic ingredient manufacturers - direct submission	Enterprise information form stamped - digital copy Business license - digital copy
Foreign ingredient manufacturers - direct submission	Enterprise information form stamped - digital copy Business registration certificate (needs to be notarized by a Chinese notary or certificated by the Chinese embassy/consulate) - digital copy
Foreign ingredient manufacturers authorize Chinese domestic enterprises to submit	Enterprise information form stamped by the authorized party - digital copy Business registration certificate - digital copy Names of the foreign ingredient manufacturers in Chinese A power of attorney issued by the foreign ingredient manufacturers
Foreign ingredient manufacturers authorize foreign enterprises to submit	Foreign enterprise (authorized party) Enterprise information form stamped - digital copy Business registration certificate (needs to be notarized by a Chinese notary or certificated by the Chinese embassy/consulate) - digital copy Foreign ingredient manufacturer (authorizing party) Business registration certificate (needs to be notarized by a Chinese notary or certificated by the Chinese embassy/consulate) - digital copy Company name in Chinese A power of attorney issued by the foreign ingredient manufacturers

2. Required ingredient safety information

Cosmetic ingredient safety information mainly includes ingredient quality specification, safety risk substance control information, ingredient safety risk assessment conclusion and other related information.

Ingredient Safety Information	Details
Ingredient Quality Specification	Ingredient’s basic information, a brief description of the ingredient’s production process, ingredient quality and characteristic indicators, etc.
Safety Risk Substance Control Information	Risk information, control indicators, etc.
Ingredient Safety Risk Assessment Conclusion	If any authoritative institutions at home and abroad have organized safety risk assessments for the ingredient and have assessment conclusions, the name of the assessment institution, assessment conclusions, and other related information should be filled in.

The Guidelines also provides a document template of ingredient safety information. Compared to the Guidelines’ previous version implemented on December 31, 2021, the new template has removed content related to the production method of physical mixing, the reason for compounding/mixing of ingredients, and the content of ingredient components. Additionally, changes have been made to the filling positions of necessary solvents, stabilizers, preservatives, antioxidants added in the production process. These changes suggest that the Guidelines may only apply to the submission of safety information for a single ingredient.

Clarifying the composition of ingredient submission code

After completing the submission of ingredient safety information, the Platform will automatically generate the corresponding ingredient submission code. The submission code consists of the serial number corresponding to the ingredient in IECIC, the ingredient manufacturer code, and the submission serial number of the ingredient on the Platform.

The submission code is exclusively utilized by cosmetics registrants and notifiers to link the ingredient safety information during product registration and notification. It is provided by the ingredient manufacturer to the registrant and notifier, and will not be publicly disclosed by the Platform.

Clarifying the obligations of cosmetics registrants and notifiers

As the responsible party for product quality and safety, cosmetics registrants and notifiers must review and evaluate the authenticity and completeness of the ingredient safety information provided by the manufacturers. If authenticity problems are found, the ingredient cannot be used. If completeness problems are found, the registrant or notifier can supplement the corresponding safety information and submit it by themselves. Any problems with the submission code should also be explained.

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 [email protected].