Interpretation of New Regulations for the Filing of Non-Special Use Cosmetics

Feb. 29th, 2020

Measures for the filing of Non-special Use Cosmetics (Draft for Comments) published on May 27, 2019. A total of five chapters and 30 articles were added to the draft. Below is an overview of the draft and interpretation by the REACH24H Cosmetics Team.

Before Filing

Original text: Chapter I Article 2 These provisions are applicable to the filing management of non-special use cosmetics produced and imported to the territory of the People’s Republic of China.

Interpretation: Domestic non-special use cosmetics and imported non-special use cosmetics will all be subject to unified filing management system.

Original text: Chapter II Article 8 Point 2 Before first-time filing, the domestic enterprise must submit the following information to achieve registration through the online filing platform… The letter of commitment should be signed by CEO and stamped with the official seal to confirm the authenticity of the submitted materials.

Interpretation: An additional letter of commitment is required when applying for a username and password.

Filing Dossier Preparation

Original text: Chapter II Article 10 For imported products, it is necessary for enterprises to submit relevant materials for the quality management system or good manufacturing practices of overseas manufacturing companies issued by the cosmetics regulatory department or industry association in the host country (…) For market production, in the event it is impossible to submit certificate of free sales documents from the marketed country (region) or the country where it was manufactured (region), relevant research and test data materials for Chinese consumers will have to be submitted. “

In addition, Article 11 of the Annex states that “A manufacturer that obtains the qualification for good manufacturing practices of cosmetics must also submit the certificate and the relevant information of the certifying body.

Interpretation: Regardless of whether the imported products are produced independently or entrusted, a GMP certificate must be provided. It is also necessary to provide relevant information of organization to ensure the authenticity of the document.

Original text: Chapter II Article 11 the toxicological test can be exempted only if the manufacturer has obtained the relevant certificate of the quality management system and the product is deemed safe after risk assessment, except in one of the following circumstances:

1) The product which is claimed to be used for children and infants

2) The product which contains new ingredients that have been approved or filed, but the ingredients have not yet been included in the IECIC

3) The applicant, responsible person and manufacturer which are emphatically supervised according to the results of quantitative scores

4) The applicant, responsible person and manufacturer which were investigated and prosecuted due to the quality and safety of cosmetics

Interpretation: It is very likely that animal testing will be cancelled on imported non-special use cosmetics. But still mandatory when it comes to baby products, products containing new ingredient which have been approved but not included in IECIC as well as for companies with bad records.

After Filing

Original text: Chapter IV Article 26 The National Medical Products Administration determines the frequency of inspections in accordance with the results of the quantitative scores of the applicant or the domestic responsible person. It also focuses on strengthening supervision and inspection duties on enterprises and products with lower quantified scoring points.”

Interpretation: Products can be divided into bad and good, the same as enterprises. The implementation of quantitative management will help regulators monitor the safety of cosmetics companies and their products more effectively.

Original text: Chapter III Article 17 Previous responsible person and the one planned to designate will have to reach an agreement regarding liability for the product that was imported or sold before if overseas brand company intends to change responsible person. The previously mentioned point will be required, as well as a written notification proposing the change, which will be filed by the post-owner through the online filing platform, including a written consent signed by the previous person. The change will become effective once the previous responsible person confirms such change through the online filing platform.

Interpretation: The following three points should be noted during changing responsible person:

1) Negotiation of terms of liability

2) Application for the change and submission of informed agreement

3) Online confirmation

The above three points are crucial to obtaining the change of responsible person, in addition to other updates in the draft stage regarding non-special use filing management. The overarching cosmetic regulation Cosmetics Supervision and Administration Regulation is expected to be updated in the beginning of this year and serial rules, like Cosmetics Registration Management, Cosmetics Label Management, and Cosmetics Production Management Supervision and Management will be launched soon.