Following the release of the new Cosmetic Supervision and Administration Regulation (CSAR), China Ministry of Justice has shared two drafted implementation measures “The Administrative Measures of Cosmetics Registration” and “Measures for Supervision and Management of Cosmetics Production and Operation”. These new implementation measures provide more clarity for the cosmetic industry players wanting to register new raw materials for use in China. As these are draft measures there is a window of time for companies to provide their feedback and comments on the measures.
The new drafts first provide clarity on the roles and responsibilities for the responsible agent, the manufacturer and the brand owner at each step in the process. There is also a huge step forward to improve and standardize the systems supporting product safety and raw material supply. It is clear that China is putting consumer safety at the center of their policies, while enabling more diversity in raw materials.
At this time, there was no updated news on removing mandatory animal testing for imported cosmetics.
“THE ADMINISTRATIVE MEASURES OF COSMETICS REGISTRATION”
The purpose of issuing the “The Administrative Measures of Cosmetics Registration” is to implement the requirements of the CSAR, further strengthen the management of cosmetics registration and filing, protect the rights and interests of consumers, as well as, standardize and promote the healthy development of the cosmetics industry.
The scope of the new draft measures not only includes product filing and registration, but also a focus on the new raw material application process, raw material quality and raw material safety. It clarifies basic requirements and each party’s responsibilities for registration and filing management. The scope of the draft addresses both cosmetic products and new cosmetic raw materials. New concepts are also introduced. Patent protection for new ingredients and ingredient traceability were two great additions.
1. Clarification of requirements for the registrant and the applicant of cosmetics and new raw materials
- Quality management system shall be set.
- A product quality responsible person needs to be appointed. A product quality responsible person should have a relevant background, including more than five years of experience in cosmetics manufacturing or quality management.
- Applicable management systems shall be established. This includes supply chain selection, raw material evaluation and reception, production and quality control, equipment management, product testing and sample storage.
- Handling systems shall be built. This should address cosmetic safety, risk assessment, adverse reaction supervision and product recall protocol.
- The cosmetics registrant and applicant shall appoint a responsible person to be in charge of these systems. The responsible person ensures that each system is implemented consistently and to the guidelines.
2. Further details on the requirements for the responsible agent for imported cosmetics
- The responsible agent shall be in charge of the filing and registration process on behalf of the cosmetic’s registrant and applicant.
- The responsible agent shall assist with the cosmetics or new raw material registration and application. They will develop the system of adverse reaction supervision, product recall and safety supervision of new raw materials.
- The responsible agent shall cooperate with the authority to develop supervision in alignment with local guidelines.
3. General new raw materials
- The applicant for general new raw materials can get approval immediately after all of the qualified documents are submitted. This is similar to the cosmetics filing process.
4. Special-use new raw materials
- Special use new raw materials are required to go through the registration process. This includes materials with the function of preservative, UV filter, colorant, hair dye and whitening products.
- It may take up to 90 days for document review. If the authorities require additional information, it will take more time (around 60-150 days) for final approval.
5. The post-market supervision of new raw materials
- The post-market supervision of new raw materials will be stricter. After approval, there is a three year period of post-filing evaluation of new raw materials.
- If any safety issues occur within three years, then the filing of new raw materials will be canceled. In these cases, the finished cosmetics containing these new raw materials will also be cancelled and may no longer be sold.
6. Applicant Authorization Letter
- After obtaining approval for a new raw material, the applicant can use it in finished cosmetic products. If another company wishes to use this new raw material in a product, they need to get an authorization from the applicant with this new raw material approval.
7. Strengthening of raw material safety supervision
- The authorities will pay more attention to safety control of raw materials. The cosmetics brands shall also take responsibility for the safety of ingredients they use in their products.
- Both the new raw material supplier and the cosmetics brands who use the new raw materials shall set up a safety assessment system and an adverse reaction system. In the case of any safety issues, all the parties shall cooperate with the authorities to re-evaluate the raw material filing and registration.
8. Applicant and responsible agent revision
- When a new applicant or new responsible agent is appointed, the company will need to confirm the location. If they are located in a different district in China, then the company would need to re-file the product with the new local filing authority. This applies to products that are already filed in the system.
9. New coding filing format
- When the new draft passes, the new coding filing format will be introduced.
10. Punishment measures
- Stricter punishment measures will be applied in cases of safety and quality issues.
“MEASURES FOR SUPERVISION AND MANAGEMENT OF COSMETICS PRODUCTION AND OPERATION”
The purpose of issuing the “measures” is to implement the newly introduced CSAR guidelines, to further stipulate the requirements, and to clarify the legal responsibilities for the production and operation supervision of cosmetics. This includes refining manufacturing, license and production quality management, improving operation management and supply chain supervision. The important legal basis of post market supervision is to guide the behaviors of cosmetics manufacturers and operators, standardize the law enforcement of regulatory departments at all levels within the cosmetic production industry and ultimately support consumer safety.
1. Entrusting Party Responsibilities
- Entrusting Party (product owner for domestic cosmetics) should have a quality management system and be involved in the whole manufacturing process.
2. Production Safety and Supervision
- The authorities will pay more attention to the production safety and supervision. They will monitor to ensure that all the parties act according to the relevant operation and management procedures.
3. Punishment Measures
- Stricter punishment measures will be applied in cases of production safety and quality issues.
Please note that the above measures are drafts and have been issued for public opinion. The authorities may amend, add, delete, or abolish the measures based on the industry feedback. The public opinion can be submitted till August 20, 2020 via:
1. Website: visit the Chinese government legal information website of the Ministry of Justice of the People’s Republic of China (website: www.moj.gov.cn , www.chinalaw.gov.cn ), find the tab “legislative opinion collection” and write your suggestions.
2. Mailing address: No.1, Beiluyuan, Zhanzhan Road, Xicheng District, Beijing, postcode: 100037, with the remark “soliciting opinions on “name of the regulation draft”” on the envelope.
3. E-mail: firstname.lastname@example.org
Knudsen&CRC is happy to assist with compiling, translating and submitting suggestions to the authorities on your behalf. Please feel free to contact us via e-mail: email@example.com
Knudsen&CRC will follow the development of further implementation guidelines and share the updates as well as prepare a webinar on the implications of the new laws once it finalized.
Knudsen&CRC supports foreign companies in overcoming regulatory barriers by providing regulatory compliance advisory services within a number of highly regulated industries: cosmetics & skincare, food&beverage, dietary supplements, medical devices, pharmaceutical. For more information on the new cosmetics regulations, please contact us firstname.lastname@example.org