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In order to further optimize the management of cosmetics safety assessment and promote the implementation of the cosmetics safety assessment system in an orderly manner, in accordance with the Regulations on the Supervision and Administration of Cosmetics, the Administrative Measures for the Registration and Filing of Cosmetics, the Technical Guidelines for the Safety Assessment of Cosmetics (2021 Edition) (hereinafter referred to as the "Guidelines") and other relevant laws and regulations, the State Food and Drug Administration has formulated the Several Measures for Optimizing the Safety Assessment and Management of Cosmetics, which is hereby promulgated and will come into force on May 1, 2024. The relevant matters are announced as follows:
1. Implement classified management of cosmetics safety assessment materials, and allow some qualified ordinary cosmetics to submit basic conclusions of safety assessment, and the safety assessment report shall be archived by the cosmetics enterprise for future reference.
2. In view of the fact that cosmetics R&D requires a certain period, in order to avoid duplicate investment in R&D resources of enterprises, cosmetics registrants and record-filing persons can still submit simplified safety assessment reports that meet the requirements of the Guidelines before May 1, 2025.
The announcement is hereby made.
Appendix: Several measures to optimize the safety assessment and management of cosmetics
State Food and Drug Administration
April 22, 2024
Appendix: Several measures to optimize the safety assessment and management of cosmetics
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Policy interpretation of the announcement of the State Food and Drug Administration on issuing several measures to optimize the management of cosmetics safety assessment
01What is the purpose of the drafting of the Announcement?
The Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the "Regulations") specifically introduce a safety assessment system, which stipulates that "before the registration and filing of new cosmetic raw materials and cosmetics, the registration applicant and filing person shall carry out the safety assessment on their own or by entrusting a professional institution." In order to implement the relevant provisions of the Regulations, the State Food and Drug Administration formulated and issued the Technical Guidelines for Safety Assessment of Cosmetics (2021 Edition) to guide the industry to carry out safety assessment.
Generally speaking, through the implementation of the cosmetics safety assessment system, the safety assessment awareness and ability level of cosmetics enterprises have been significantly improved, and the safety guarantee level of cosmetics in mainland China has been generally improved, which is conducive to the high-quality development of the cosmetics industry. At the same time, the State Food and Drug Administration focuses on the implementation effect of the safety assessment system, and timely grasps the difficulties and challenges reported by enterprises, such as the lack of assessment data, the lack of detailed rules for the application of assessment technology, and the need to strengthen the construction of domestic safety assessment personnel.
In order to help guide enterprises to carry out cosmetics safety assessment and solve the problems and difficulties of enterprises in carrying out safety assessment, the State Food and Drug Administration organized the drafting of this announcement, striving to improve the operability of industry safety assessment and the availability of raw material data without lowering safety standards, and effectively solve the problems and difficulties existing in the safety assessment of cosmetics enterprises.
02What is the main content of the Announcement?
The Announcement is divided into two parts: the main text and the annexes. There are two main aspects of the main text:
Implement classified management of safety assessment data, and make it clear that for eligible ordinary cosmetics, enterprises can submit basic conclusions of safety assessment, and the safety assessment report will be archived by the enterprise for future reference.
Considering the long R&D cycle of cosmetics, a one-year transition period has been set for products that have been evaluated in accordance with the original requirements in order to avoid duplication of R&D investment.
The annex to the announcement is the "Several Measures to Optimize the Management of Cosmetics Safety Assessment", which mainly involves strengthening technical guidance, integrating raw material data resources, innovating the management mechanism of assessment reports, and promoting the construction of safety assessment system. The highlights are as follows:
✍ Develop technical guidelines to enhance your organization's assessment capabilities.
The first is to formulate technical guidelines such as cross-referencing and toxicological concern thresholds to help solve the safety assessment problem of raw materials with large safety data gaps such as plant extracts and fermentation raw materials.
The second is to formulate three test-related technical guidelines for stability, preservative challenges, and packaging material compatibility, and make it clear that enterprises can carry out research through self-built methods, and only submit test or evaluation conclusions, giving the industry enough room for operation.
✍ Integrate raw material data resources to solve the problem of raw material data gap.
By collecting, collating and publishing the international authoritative cosmetics safety assessment data, the raw material use information of the products listed in the registration and filing system, and accepting the historical data of the company's raw material use, the problem of missing raw material data is alleviated, and the foundation for the establishment of the mainland raw material database in the future is also laid. At the same time, the "Guidelines for the Use of Cosmetic Raw Material Data" was formulated to guide enterprises to standardize the rational use of relevant data, especially the three-year use history and safe consumption history data of enterprise raw materials.
✍ Implement classified management of safety assessment data submission to improve regulatory efficiency.
In order to improve the efficiency of registration and filing and help improve the quality and speed of product launch, it is necessary to implement classified management of the submission of safety assessment materials according to the level of product risk.
On the one hand, for products with higher risks, such as children's cosmetics, freckle removal and whitening cosmetics, enterprises are required to continue to submit complete safety assessment reports;
In addition, it is clarified that when an enterprise lacks a small amount of raw material safety assessment data, it can supplement the final product safety test, and use its conclusions and safety assessment report as the basis for product safety evaluation.
✍ Plan for the long term and promote the construction of a safety assessment system.
It mainly focuses on the basic construction related to safety assessment, implements the management of the whole life cycle of products, the construction of safety assessment disciplines and personnel training, and the exchange of safety assessment work and technical cooperation, and plans the layout for the gradual improvement of the safety assessment system of mainland cosmetics.
03Why is there a classification and submission system for safety assessment reports?
Cosmetics safety assessment is an important way for cosmetics registrants and record-filing persons to implement the main responsibility for product quality and safety, and enterprises should carry out safety assessment according to the product and quality management system. The safety assessment work is highly scientific and professional.
There are three main considerations to adopt the classification management model:
The first is to give more prominence to the main responsibilities of enterprises and guide enterprises to improve the safety assessment system, neither exempting enterprises from the responsibility of security assessment, nor reducing product safety requirements;
The second is to improve the efficiency of supervision, concentrate limited regulatory resources on the supervision of higher-risk products, and the regulatory authorities will deal with problems found in the inspection of enterprises in accordance with the law;
Third, the classification and submission of safety assessment reports refer to the international experience of the European Union in the management of safety assessment data, and are also in line with the current development reality of the domestic industry.
This article is translated and organized by Yireh, please indicate the source for reprinting!
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