CSAR Subsidiary Regulations: China Publishes the Finalized Administrative Measures on Cosmetics Registration and Notification

Recent Update

On December 31, 2020, the draft Administrative Measures on Cosmetic Registration officially passed the State Administration for Market Regulation (SAMR) and was renamed Administrative Measures on Cosmetics Registration and Notification^[2]. On January 12, 2021, the finalized regulation's full text was officially published and will take effect on May 1, 2021 ^[3].

The new regulation includes a total of 6 chapters and 63 articles. Compared to the previous draft released in July 2020, the new regulation is further modified and simplified to add clarity and increase the logicality.

The main revisions are as follows:

1. Amends the requirements for cosmetic/new cosmetic ingredient registrant and notifier, and adds a new obligation for domestic responsible person.

Administrative Measures on Cosmetic Registration (Draft)

Administrative Measures on Cosmetics Registration and Notification

Cosmetic /new cosmetic ingredient registrant and notifier

Having a quality management system compatible with the cosmetics to be registered or notified, and equipped with a quality and safety responsible person with professional knowledge of cosmetics quality and safety and more than 5 years of experience in cosmetics production or quality management;
Having management systems for supplier selection, ingredients acceptance, production process, and quality control, equipment management, product testing, and sample retention, etc. that are compatible with the cosmetics to be registered or notified;
Having cosmetics safety risk assessment, adverse reaction monitoring and evaluation, and cosmetics recall systems that are compatible with the cosmetics to be registered or notified. Cosmetic registrants and notifiers shall be equipped with the institutions and personnel that are compatible with the implementation of the aforementioned systems and have the ability to ensure the implementation of various systems.

It is an enterprise or other organization established according to the law;
Having a quality management system compatible with the cosmetics to be registered or notified;
Having the ability of adverse reaction monitoring and evaluation.

If the registrant applies for the registration of special cosmetics for the first time or the notifier conducts the notification of general cosmetics for the first time, he/she shall submit relevant certification documents that meet the requirements herein.

Cosmetic /new cosmetic ingredient domestic responsible person

Registering or notifying cosmetics or new ingredients in the name of the registrant or notifier, and putting the products on the domestic market;
Assisting the registrant or notifier to carry out adverse cosmetic reaction monitoring, product recalls, and new ingredient safety monitoring and reporting;
Cooperating with the supervision and inspection of supervision departments.

Registering or notifying cosmetics or new ingredients in the name of the registrant or notifier;
Assisting the registrant or notifier to carry out adverse cosmetic reaction monitoring, and new ingredient safety monitoring and reporting;
Assisting the registrant or notifier to implement the recall of cosmetics and new cosmetic ingredients;
Bearing corresponding quality and safety responsibilities of cosmetics and new cosmetic placed on the domestic market, per the agreement with the registrant and notifier;
Cooperating with the supervision and inspection of medical product administration departments.

2. Refines the requirements for the confirmation of cosmetic entrusted production.

Administrative Measures on Cosmetic Registration (Draft)	Administrative Measures on Cosmetics Registration and Notification
In the case of cosmetic entrusted production, the cosmetics registrants or notifiers shall submit the entrustment relationship documents at the time of applying for registration or notification.	Domestic cosmetics: the cosmetics manufacturer shall confirm the entrusted production relationship through the information service platform when applying for registration or notification; Imported cosmetics: the cosmetics registrant or notifier shall submit the entrustment relationship documents.

3. Adds a new situation for the change of cosmetic notification. The new regulation stipulates that the notified general cosmetics are not allowed to change the product formula, except for minor changes in the product formula caused by changes in the source of ingredients and other reasons.

4. Deletes the registrants’ self-inspection requirements for the renewal of special cosmetic registration certificate and specifies that the renewal application shall be submitted within 90 to 30 working days before the expiration of the product registration certificate.

5. Deletes the provisions related to soap management.

Note: Text in red indicates changes in comparison to the draft Measures. The English transaltion and the interpretation article will come soon.

[July 21, 2020] China Consults on the Draft Administrative Measures on Cosmetic Registration

On July 21, China Ministry of Justice opened a public consultation on the Administrative Measures on Cosmetic Registration, one of the subsidiary regulations of the Cosmetic Supervision and Administration Regulation (CSAR). The deadline for the consultation is August 20, 2020.

Stakeholders can feedback suggestions in one of the following ways within the period:

Log in to the official website of China Ministry of Justice, and enter the "Legislative Opinion Collection" section of the main menu on the home page to submit opinions.
Submit comments by mail or by courier, with the envelope indicating “化妆品注册管理办法征求意见 (Consultation on Administrative Measures on Cosmetic Registration)”.
* Address: No. 1, Beiluyuan, Zhanlan Road, Xicheng District, Beijing
* Zip Code: 100037
Email to [email protected].

Main Content

The Administrative Measures on Cosmetic Registration (hereinafter referred to as “The Measures”) encompasses 7 chapters and 88 articles and are primarily designed to specify the basic requirements for the administration of cosmetic pre-market approval coupled with new cosmetic ingredients registration and filing.

Specifics are as follows:

1. Clarification of Some Basic Concepts

There are some new concepts in the CSAR and the Measures make further explanations on them.

Registration refers to the activity in which the registrant submits a registration application in accordance with legal conditions, procedures and requirements, and the medical products administration department reviews the safety and quality controllability of the cosmetics or new cosmetic ingredients applied for registration, and decides whether to approve the registration application.
Filing refers to the activity that the filer submits documents indicating product safety and quality controllability to the medical products administration department for archiving for future reference in accordance with legal conditions, procedures and requirements.
Registrant or filer refers to the enterprise or other organization that brings products to the market in its own name, and can bear civil liabilities independently.
The registration/filer shall have quality management capability, establish systems relating to quality control, cosmetic safety risk assessment, adverse reaction monitoring and evaluation, and cosmetic recall, and shall be equipped with institutions and personnel capable of implementing the above systems.
If the registrant or filer is an overseas enterprise, a corporate legal person in the territory of China shall be designated as the domestic responsible person to handle cosmetics/new ingredient registration and filing, market the products and assist in monitoring of cosmetics adverse reactions and implementation of product recalls.

It is worth noting that both special and general cosmetics adopt the concept of "domestic responsible person", who not only be liable for product registration/filing, but will undertake the responsibility of product operation and post-market monitoring, and cancel the original concept of "responsible agent" of special cosmetics.

2. Management on New Cosmetic Ingredients

Concerning cosmetic ingredients, the Measure stipulate the filing and registration procedures of new cosmetic ingredients as well as the safety monitoring obligation, safety situation report, and annual report of registered/filed new raw materials.

Significantly, the "patent protection system" has been specifically explained. Within the three-year monitoring period after successful registration or filing of the new ingredients, only the registrant or filer of the new ingredient can use it or authorize cosmetic companies (cosmetics registrant/filer) to use the new ingredient to produce cosmetics. Other cosmetics registrant or filer who intends to use this new ingredient for manufacture shall apply for new ingredient registration or filing in line with the requirements of the Measures.

In terms of safety monitoring, the new ingredient registrant or filer shall establish a safety risk monitoring and evaluation system after the new ingredient is listed on the market, and conduct continuous tracking, research, monitoring and evaluation of the safety of the new ingredient.

Meanwhile, cosmetic companies who use this new ingredient to produce cosmetics also need to cooperate with the ingredient registrant/filer to report the product safety situation during the monitoring period. If the new ingredient is deemed to have a safety risk during the monitoring period, the production or import of related cosmetic products should be suspended at the same time, or the registration/filing should be cancelled.

Besides, the new ingredient registrant or filer shall prepare an annual report on the use and safety situation of the new ingredient and submit it to the adverse reaction monitoring department and the technical review department.

3. Management on Cosmetic Products

Implements traceability management on cosmetic ingredients. Cosmetic registrant/filer shall be responsible for the safety of the cosmetic ingredients used. When applying for cosmetic registration or filing, the source of the ingredients and their quality specifications shall be clarified by them. If the source or the quality specification of the ingredient is changed, the safety assessment shall be carried out and the relevant registration/filing information shall be updated.

Formulates and submits the executive standards of cosmetic products to be registered or filed. Currently, it is required to mark the number of the standard that the domestic cosmetic product complies with on the label, which are national standards or enterprise standards (enterprise standard requirements shall be stricter than national standard).
Submits sufficient scientific basis for product efficacy claims when apply for cosmetic registration or filing. The scientific basis can include research data and evaluation conclusions derived from human efficacy evaluation tests, laboratory tests, consumer use tests, and relevant scientific literature materials.
Carries out classified management for changes of registered information:
※ If the changes do not involve safety and efficacy claims, the registrant just need to notify the changed items;
※ If the items involving safety and efficacy claims such as actual production site, product executive standards, etc., are to be changed, the registrant shall submit an application for modification of the items;
※ If the product name and formula are to be changed, the registrant shall cancel the original registration certificate and reapply for registration.
Conducts Annual report. After filing of general cosmetics, the filer shall report the production, import and adverse reaction monitoring of the product to the medical products administration departments responsible for the filing management every year.
Discloses the label of special cosmetics to the public. At present, only the filing of general cosmetics requires disclosure of product technical requirements, packaging, and label information. In the future, special products will also need to update the packaging information in real time.

4. Supervision and Management

Can conduct overseas on-site inspection;
If necessary, the safety of marketed products can be reassessed;
The quantitative and graded administration system will subject to full implementation.