In recent years, China’s cosmetic regulatory environment is developing in the direction of greater stringency, standardization and transparency.

Since the release of the “Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)”, the regulatory agencies have also intensively issued a series of cosmetics and new raw materials related regulations or guidance documents to help enterprises better understand the new regulatory requirements, and at the same time for some of the filing work to open a “fast-track” to improve efficiency.

National Mediacal Products Administration(NMPA) issued “on the full implementation of cosmetics and cosmetics and new raw materials for the electronic filing of registration information on matters related to the announcement” (referred to as: “Announcement”), announced that the full implementation of cosmetics and new raw materials for the electronic filing of registration information, and further improve the level of cosmetics regulatory services.

At the same time, China National Institutes for Food and Drug Control (NIFDC)released the “Cosmetics Stability Testing and Assessment Technical Guidelines” “Cosmetics Preservative Challenge Testing and Assessment Technical Guidelines” “Cosmetics and Packaging Materials Compatibility Testing and Assessment Technical Guidelines” “Skin Sensitization Integration of Testing and Evaluation Strategies for the Application of Technical Guidelines” 4 technical documents and Q&A, and released “Cosmetics New Ingredients Frequently Asked Questions and Answers (Q&A)” “New Cosmetic Ingredients Frequently Asked Questions and Answers ( I) “Cosmetics New Ingredients Common Technical Questions and Answers (II)”, to provide guidance for the declaration of new raw materials and the full version of the safety assessment landing.

Key points of the announcement

Two keywords: September 1, only electronic version of the information required

Announcement shows that since September 1, 2024, the territory of the cosmetics and cosmetics new raw materials registrant, filer, the responsible person in the territory and cosmetics manufacturers in the submission of user information, cosmetics and cosmetics new raw materials registration and filing information, only through the cosmetics registration and filing information service platform to submit the electronic version of the information, the relevant paper version of the information does not need to be submitted by the territory of the cosmetics and cosmetics New raw materials registrants, filers, responsible persons in the territory or cosmetics manufacturers to file their own.

This means that, through the Internet to upload information can be submitted to the registration and filing of cosmetics or new cosmetic raw materials information, without the need to submit paper information to the regulatory authorities, to further simplify the registration and filing process. This initiative is bound to improve the efficiency of cosmetic registration and filing work and the level of government services, but what is needed is that the business side needs to more strictly comply with the relevant provisions to ensure the authenticity and accuracy of the information submitted.

The Announcement clearly pointed out that, in accordance with the ’Cosmetics Registration and Filing Information Management Regulations” “Cosmetics New Raw Material Registration and Filing Information Management Regulations” “Cosmetics Registration and Filing Information Submission Technical Guidelines (Trial)” and other provisions of the need to submit the original information, third-party proof of information and other paper version of the information, by the territory of the cosmetic and cosmetics and cosmetic raw materials registrant, the filing of the person or the territory of the person responsible for the authenticity of the signed confirmation of the information and through the information service platform to submit the relevant electronic version of the information.

In addition, the initiative from September 1, there are about two months from the full implementation of the time for enterprises to complete the relevant procedures to leave enough time to carry out the new raw materials declaration process will not be affected.

Process simplification, or will accelerate the cosmetic raw materials on the market

“Complex process,” ‘cumbersome details,’ ‘long review time,’ etc., has been plagued by cosmetic manufacturers of raw materials and product registration filing problems. Over the years, the regulatory authorities are also committed to simplifying the filing process.

According to the 2021 release of the “new cosmetic raw materials registration filing information management regulations” “cosmetics registration filing information submitted to the Technical Guidelines (Trial)” and many other circulars, the regulatory level has long been advocating the use of information technology, accept electronic registration and filing information to achieve the whole process of paperless filing for the purpose of changing the old redundant means of review and information submission process.

Cosmetic registration and filing information submission technical guidelines (for trial implementation)” shows that the territory of the registrant, the filing, the territory of the responsible person or cosmetic manufacturer through the information service platform to submit the electronic version of the registration and filing information, should be in accordance with the requirements of this guide to the registration department or filing management department to submit the registration and filing information with the electronic version of the original registration and filing information consistent with the paper version of the original registration and filing information. And third-party proof of information, the issuer has used CA (Digital Certification Certificate Certificate Authority) for the signature and can be effectively accessed and verified through the information service platform, can be exempted from submitting paper information; other information, the registrant, the filing of the person responsible for the territory has been the use of CA for the signing of the seal and the seal is complete, can be exempted from submitting paper information.

That is to say, the previous cosmetics and new raw materials registration declaration, apply for a CA chapter of the enterprise has long been exempted from the submission of part of the paper information. Obviously, CA chapter is an important tool for submitting electronic version of the registration filing information. Enterprises can apply through the national government service platform.

The full implementation of the electronic is undoubtedly a major positive policy to simplify the flow of cumbersome paper documents and new raw material declaration process, improve the efficiency of the approval process, but also to reduce the operating costs of the enterprise and the cost of manpower and material resources, to a certain extent, to accelerate the filing of new raw materials.

Public data show that the number of new raw materials filed in 2021-2024 is 165, of which 6 in 2021; 42 in 2022; 69 in 2023, 2 new raw material write-off; as of July 9, 2024, the new raw materials filed for 48 paragraphs. Just over half of the year, the number of record compared to the same period last year, 24 new ingredients through the record, an increase of 87.5%. With the implementation of the simple government, or will promote new ingredients to accelerate the filing of new.

It is worth noting that the previously released cosmetics and cosmetic new raw materials related to the provisions of the “Notice” is inconsistent with the “Notice” shall prevail.

Next, NMPA cosmetics technical review organizations and provincial drug supervision and management departments, but also in accordance with the requirements of this announcement, to optimize the adjustment of cosmetics and new cosmetic raw materials registration acceptance, technical review and filing of management-related work procedures and requirements. To the day of formal implementation, perhaps the declaration process will be more clear and detailed.

A number of technical Q&A, new raw material declaration requirements are gradually improved

Almost at the same time, the National Institute for Food and Drug Control (hereinafter referred to as: NIFDC) released four technical documents and Q&A, namely, “Technical Guidelines for Testing and Evaluation of Cosmetic Stability”, “Technical Guidelines for Testing and Evaluation of Cosmetic Preservative Challenges”, “Technical Guidelines for Testing and Evaluation of Cosmetics and Packaging Materials Compatibility”, “Technical Guidelines for the Integration of Testing and Evaluation of Skin Allergenicity Strategies and Their Application”, and also released the “Technical Questions and Answers (I)” and “Technical Questions and Answers (II)” on the declaration of new ingredients in the cosmetics industry. Technical Questions and Answers (I) and Common Technical Questions and Answers for New Cosmetic Ingredients (II)”, explaining and answering common questions on the declaration of new ingredients in the cosmetic industry, and providing technical guidance and support for researchers and technicians.

Cosmetics safety assessment work has been hotly debated, the discussion of the relevant provisions of the increasing degree, some of the requirements are even more difficult to defeat a number of enterprises. With the implementation of the full version of the safety assessment and simplified version of the same time, enterprises can breathe a sigh of relief, but is always hanging over the head of a sword, will fall at any time. The high cost of testing, how to test, testing standards and other issues, so that many enterprises in a difficult situation.

NMPA also encourages enterprises to carry out their own exploration and practice, “cosmetic registrants, filers can be based on national standards, technical specifications, industry standards, international standards, this technical guide or self-constructed methodology to carry out relevant research, and submit the relevant tests or assessment conclusions in the safety assessment report.”

In fact, from a series of actions can be seen, the regulatory policy of new cosmetic ingredients tends to be strict and standardized. This series of relevant regulations and policy documents of the FDA, the registration of new cosmetic raw materials for the record, safety assessment, quality control and other aspects of the higher requirements, not only to strengthen the supervision of cosmetics, improve the safety of cosmetics, but also to provide a healthy soil for the more orderly and sound development of enterprises.

Beijing HMK specializes in global ingredient innovation compliance business and is committed to providing global compliance solutions for new cosmetic and food ingredients. Please feel free to contact us for more information!