FAQ for General Cosmetics Filing is a publication first issued by the Beijing Municipal Medical Products Administration (MPA) in November 2021. It informs filers and users about the most common filing application issues for public reference periodically:
- On April 7, 2022, the Beijing MPA published the 7th issue of the FAQ for General Cosmetics Filing.
- On April 24, 2022, the Beijing MPA published the 8th issue of the FAQ for General Cosmetics Filing.
The frequent questions and Beijing MPA’s answers are set out below.
Question 1: Requirements for reporting information on the safety of cosmetic raw materials
From May 1, 2021, the source and trade name information of the raw materials of the product formula should be reported, which involves the raw materials that have quality specifications in the “Cosmetic Safety Technical Specifications”, and the quality specification certificate or safety-related information of the raw materials should also be submitted.
From January 1, 2022, safety-related information on raw materials with antiseptic, sunscreen, colouring, hair dyeing, freckle-removing and whitening functions shall be provided in accordance with the requirements of the Regulations.
From January 1, 2023, safety-related information for all raw materials will be provided. For cosmetic products that have been registered or filed before, the registrant and filer shall provide additional safety-related information on all raw materials in the product formula before May 1, 2023.
Question 2: Requirements for cosmetic classification rules and categories
Cosmetics that have been registered or completed before May 1, 2021 should supplement the product classification code through the Cosmetics Registration and Filing Information Service Platform before May 1, 2022.
Question 3: Requirements for a summary of the basis for cosmetic efficacy claims
From January 1, 2022, cosmetics registrants and filers who apply for special cosmetics registration or general cosmetics registration shall evaluate the efficacy claims of cosmetics in accordance with the requirements of the “Specifications”, and submit them in the special designated by the NMPA. The website uploads a summary of the basis for product efficacy claims.
For cosmetics that have been registered or completed before May 1, 2021, the cosmetics registrant and filer shall evaluate the efficacy claims of cosmetics before May 1, 2023, in accordance with the requirements of the “Specification”, and upload the basis for the product efficacy claims. summary.
For cosmetics registered or filed between May 1, 2021 and December 31, 2021, cosmetic registrants and filers shall evaluate the efficacy claims of cosmetics before May 1, 2022 in accordance with the requirements of the specification , and upload a summary of the basis for product efficacy claims.
For cosmetics that have been registered and filed before May 1, 2021, cosmetic registrants and filers should upload a summary of the basis for the efficacy claims of the relevant products in accordance with the transition period policy. After the registrant or filer evaluates the efficacy claims of related products in accordance with the requirements of the “Specifications”, if the evaluation results cannot support the content of the efficacy claims involved in the product name or label, they may file a change application before the expiry of the transition period. The classification code of the product is adjusted, and the relevant content of the product name or label is modified to make it meet the regulatory requirements.
Question 4: Requirements for the submission of cosmetic safety assessment materials
From January 1, 2022, cosmetic registrants and filers must conduct cosmetic safety assessments and submit product safety assessment materials in accordance with the requirements of the Technical Guidelines before applying for special cosmetic registrations or ordinary cosmetic filings.
Before May 1, 2024, cosmetic registrants and filers can submit a simplified version of the product safety assessment report in accordance with the relevant requirements of the “Technical Guidelines”.
Question 5: Requirements for the annual report of ordinary cosmetics
From January 1, 2022, general cosmetics filed through the original registration and filing platform and the new registration and filing platform will implement the annual report system uniformly.
The filer shall, from January 1 to March 31 each year, submit the annual report of ordinary cosmetics through the new registration and filing platform for one year.
For the filing products that did not complete the annual report as required by Article 5 of the Announcement before March 31, 2022, the filing certificate of the filing certificate has shown on the official website of the NMPA that “abnormal! The filing person did not file the annual report as required by regulations”. Relevant filers should complete the rectification of the annual report before June 30, 2022. If the overdue date is exceeded, the procedures for canceling the filing of related products will be initiated in accordance with Article 59 of the “Administrative Measures for Registration and Filing of Cosmetics”.
The products whose registration has been cancelled by the regulatory authorities shall not be marketed for sale or imported from the date of cancellation of the registration. If the product is still marketed and imported, the regulatory authorities will punish it according to the “Regulations”.
According to Paragraph 2 of Article 37 of the “Administrative Measures for Registration and Filing of Cosmetics”, if the products that have been filed are no longer produced or imported, the filing person shall promptly report to the drug regulatory department responsible for filing management to cancel the filing.
If the products that have not completed the annual report are no longer produced or imported, the relevant filing party shall apply for cancellation of the filing in time before June 30, 2022. For products that have voluntarily applied for cancellation of the record, if there is no violation of laws and regulations, the related products that have been listed before the cancellation of the record information can be sold until the end of the shelf life.
Question 6: Requirements for cosmetic labels
Cosmetics registrants and filers are encouraged to label cosmetics in accordance with the “Measures” from the date of this announcement.
From May 1, 2022, cosmetics applying for registration or filing must comply with the regulations and requirements of the “Administrative Measures for Cosmetics Labeling”.
Cosmetics that have previously applied for registration or filing have not been labelled in accordance with the “Administrative Measures for Cosmetics Labeling”, the cosmetic registrant and filing person must complete the update of the product label before May 1, 2023 to make it compliant with the “Cosmetics Labeling Management Measures”. Regulations and requirements.
According to the announcement of the NMPA on the issuance of the “Regulations on the Supervision and Administration of Children’s Cosmetics” (No. 123 of 2021):
1. In addition to the labeling requirements, other regulations on children’s cosmetics will come into force on January 1, 2022.
2. From May 1, 2022, children’s cosmetics that apply for registration or filing must be labeled and marked in accordance with the “Regulations”; children’s cosmetics that have previously applied for registration or filing have not been labeled and marked in accordance with the “Regulations”. The registrant and filer should complete the update of the product label before May 1, 2023 to make it comply with the “Regulations”.
Question 7: Relevant requirements for supplementary reporting
Before May 1, 2022, submit the product implementation standards and product label samples, fill in the product formula of domestic ordinary cosmetics, and upload the label pictures of special cosmetics sales packaging. The supplementary information is used as a necessary condition to prove that the relevant products comply with the “Regulations” and its supporting regulations. For products that have not been supplemented as required, production and import shall not be continued until the supplementary information is completed.
Question 1: How to deal with situations when information (product name, sender, product registration/filing information) in the inspection report is inconsistent?
Answer: The registered/filed product information should be the same as indicated in the inspection report. If there is a change with the name of the product, company, etc., further explanation can be accepted along with a supplementary inspection report.
Question 2: If there are different packaging and formulas but only one product name, how should the sample be tested for general cosmetics filing?
Answer: There are different testing methods for the following case scenarios:
- Microbiological items: Test separately if a sample package is divided into separate packages or if the product is a combination of different categories such as a makeup kit; Mixed sampling test if a sample package is divided into non-independent packaging.
- Physicochemical items should be tested separately for each part; if they cannot be sampled separately, and does not involve the formulation of raw material content of the relevant test items, follow the instruction manual for testing; if involved with the formulation of raw material content, the manufacturer can submit a product sample that is semi-finished and before packaging for testing, the sampling method should be described in the inspection report.
- Toxicological tests, human safety and efficacy evaluation test: According with the instruction manual for testing. If any parts of the product would be used by the consumer separately, the product should also be tested separately.
Question 3: What tests should be carried out for general cosmetics containing chemical sunscreen ingredients?
Answer: Skin phototoxicity tests and skin metamorphosis test should be carried out for chemical sunscreen content ≥ 0.5% (w/w) in the product except for shower, perfume, nail polish products. SPF needs to be tested on non-sunscreen cosmetics containing ≥0.5% (w/w) of chemical sunscreens ingredients except for lotion, perfume and nail polish products.
Question 4: How should sensory indicators be described for products using stickers and face mask materials?
Answer: The color, properties, odor and other sensory indicators should be described accordingly.
Question 5: How to indicate the inconsistency between test method used in quality control measures of microbiological and physicochemical indicators and the “Technical Specification for Cosmetic Safety”?
Answer: Provide the name of the test method and indicate whether verification had been carried out between both testing methods. The complete test method and method validation information should be kept on file for inspection.
By Jeff Jiang. If you would like to learn more about our regulatory services for cosmetics in China, or our registration and CRO services for cosmetics, pharmaceuticals, medical devices, IVDs or other products, please contact Cisema.