China Filing of Non-special Use Cosmetics Draft Administration Measures

On 27th May 2019, China National Medical Products Administration (NMPA) released a draft version of Administrative Measures for Filing of Non-special Use Cosmetics. The public consultation period on the draft policy will end on June 15th 2019.

China's government has required all imported non-special use cosmetics undergo filing since 10th Nov. 2018 ^[1]. Pudong later issued Specification for Initial Imported Non-Special Use Cosmetics Filing Documents Review ^[2] and some provinces also released their local enforcement rules of the new filing policy. Currently China lacks a unified management standard. The release of these Administrative Measures aims to put an end to this situation and standardize the regulation of Non-special Use Cosmetics filing nationwide.

The draft version has 5 Chapters and 30 Articles with an attachment. Here are ChemLinked’s interpretations of some of the major clauses in the Measures:

Before filing

Chapter 1 Article 2: These measures apply to the administration of filing of domestic and imported non-special use cosmetics within the People’s Republic of China.

ChemLinked Interpretation:
Domestic and imported non-special use beauty products will be subject to a unified filing system with identical requirements. This is a marked deviation from how filing has been administrated in the past, whereby domestic and imported non-special use products were subject to differential treatment using two different sets of standards.

Chapter 2 Article 8 Point 2: Before starting the filing of first imported non-special use cosmetics, domestic enterprises should submit the following documents on the online filing platform for filing account registration…A letter of commitment needs to be submitted by the filing applicant or domestic responsible person. The validity of the information submitted shall be confirmed by official seals affixed by the filing entity or the domestic responsible person as well as signatures provided by the person in charge of the enterprise.

ChemLinked Interpretation:
When applying for a filing account on the system, a document (A letter of commitment) is required.

Materials Prepared for filing

Chapter 2 Article 10: Relevant certification materials demonstrating the quality management system of overseas production enterprises or good manufacturing practice (GMP) certification issued by the cosmetics regulatory authorities or industry associations in the countries (regions) of origin should be submitted for imported products…

Article 11 of the Attachment: If a production enterprise obtains the GMP certification, it shall submit the qualification certificate and the relevant information of the certifying body.

ChemLinked Interpretation:
Imported products, whether they are self-produced or commissioned, are all required to submit GMP certificates of manufacturers, as well as the qualification certificate and the relevant information of the certifying body to ensure the reliability and accuracy of the documents.

Chapter 2 Article 11: If the production enterprise has obtained the Good Manufacturer Practices certificate and product safety risk assessment results can fully confirm this product’s safety, the toxicological testing for this product is not required, except in the following situations...

ChemLinked Interpretation:
There is a big possibility that imported non-special cosmetics will be exempt from mandatory animal testing.Animal testing is still mandatory for the following products: children’s products, products which contain the new ingredient that has filed and been approved but not included in the IECIC, products manufactured by enterprises which have bad records.

After filing

Chapter 4 Article 26: The MPA shall determine the frequency of random sampling based on the credit rating results of the filing applicant and the domestic responsible person, and focuses on strengthening supervision and inspection of enterprises and their products when they have a low score.

ChemLinked Interpretation:
The government is going to set up a credit rating system to supervise cosmetic enterprises and the safety of their products.

Chapter 3 Article 17: If a domestic responsible person for imported products that have been filed is changed, the domestic responsible persons before and after the change shall reach a consensus on the attribution of the products that have been imported and sold in the previous period, and the domestic responsible person after the proposed change shall make an application of change via online filing platform, and submit the informed consent form signed by the original responsible person at the same time. The change is completed after the original responsible person submits a confirmation on the online filing platform.

ChemLinked Interpretation:
There are three steps to change the domestic responsible person of a filed imported product:

• Both sides consult on attribution of the products that have been imported and sold in the previous period.

• The new domestic responsible person makes an application for change online and submits the informed consent form signed by the original responsible person at the same time.

• The original responsible person confirms online.

In conclusion, it is worth noting that there are a fair number of important changes in this draft version which may have a significant influence on China’s cosmetics sector. International stakeholders shall read the regulation thoroughly and submit any feedback thoughts/opinions to the authority.