China Imported Cosmetics Will Likely Be Exempt from Mandatory Animal Testing

On May 27^th, China National Medical Products Administration (NMPA) released a draft version of Administration Measures for Filing of Non-Special Use Cosmetics for public consultation. Any modification suggestions can be sent back by email at [email protected] prior to June 15^th, 2019. Please contact us at [email protected] if translations are required.

Existing regulations

Currently, China's imported and domestic non-special use cosmetics (Non-SUC) are subject to different operations in practical implementation which can be seen in the table below:

Significant changes of the new Measures

The new Measures consists of 5 chapters with 30 provisions, which are general provisions, product filing, filing management, supervision and inspection, and supplementary regulations.

According to the consultation draft, a new filing system will be developed that aligns the requirements for imported and domestic non-special use cosmetics. The post-reform filing guidance for imported non-special use cosmetics will also be specified.

The key changes include:

1. Imported Non-Special Use Cosmetics Will Probably Be Eligible for Exemptions from Mandatory Animal Testing

As per the draft, cosmetic products manufactured under certified GMP conditions and with substantiated safety as defined by risk assessment will be exempted from relevant toxicology tests, except in one of the following circumstances:

1. The product is for specific use by children or infants;

2. The product uses new raw materials that have been approved or filed, but have not been included in the IECIC;

3. The filer, the domestic responsible person and the actual manufacturing enterprise are listed as the key supervision targets according to the results of credit rating;

4. The filer, the domestic responsible person and the actual manufacturing enterprise were investigated and punished for the quality and safety of cosmetics in the past three years.

Simply speaking, the assessment report that uses existing animal testing data or data drawn from EU validated non-animal tests will be applicable to nearly all imported non-special use cosmetics except for imported children cosmetic products.

But ChemLinked technical expert believes that even though the animal testing exemption is planned to be extended to imported non-special use cosmetics, it still takes time to finalize and pass the Measures.

2. New documentation requirements for imported cosmetics filing.

Apart from the conventional dossiers, the relevant certification materials for quality management system or GMP of overseas production enterprises that is issued by the cosmetics regulatory authorities or industry associations in the country/region of origin shall also be submitted when applying for import cosmetics filing.
 

3. New documentation requirements for the domestic responsible person.

A domestic responsible person intending to import a filed product from more ports outside the administrative region where the domestic responsible person located is required to supplement relevant information such as the new import port and the consignee through the online filing platform.

Specifically, the materials required include:

• The name, address and contact information of the consignee;

• The acceptance agreement for imported products signed by the domestic responsible person and the consignee of other provinces.

Note: ChemLinked technical experts’ in-depth explanation of the draft Measures will be issued soon, please stay tuned for us.