China Releases Enforcement Rules for Filing of First Import Non-special Use Cosmetics through Shanghai Pudong

Takehome:

• From Mar 1 2017 to Dec 21 2018 if a non-special use cosmetic product is imported through the port of Shanghai Pudong New Area for the first time and the responsible agent is located in the New Area, the product will be subject to filing management instead of registration.
• Only after obtaining a filing certificate on an online filing system will the product be permitted to be imported and distributed.

In May 2016, the State Council of China announced that it was to adjust registration management to filing management for non-special use cosmetics imported for the first time in Shanghai Pudong New Area (see CL news). To implement the notice, China Food and Drug Administration which is responsible for the formulation of cosmetic regulations and registration/filing of cosmetics released further enforcement rules on Jan 17 2017.

As stipulated in the announcement, from Mar 1 2017 to Dec 21 2018 if a non-special use cosmetic product is imported through the port of Shanghai Pudong New Area for the first time and the responsible agent is located in the New Area, the product will be subject to filing management instead of registration. The manufacturer or domestic responsible agent shall apply for filing prior to import. An online filing system will be established for the applications. Only after obtaining a filing certificate on the online system will the product be permitted to be imported and distributed.

For products filed in accordance with the announcement, if they are imported though other ports, the manufacturer or domestic responsible agent shall cancel the filing, then register their products according to the normal requirements for first import non-special use cosmetics.

FDA and CIQ in China will together implement the rules. FDA will be in charge of the filing while CIQ will be responsible for checking the filing certification.

Reach24h's Interpretation:

• It is good news for importers and international cosmetic enterprise exporting to China. During the trial period, importers of non-special use cosmetics can choose to enter into China through Pudong New Area and have products subject to reduced approval time and cost.
• The requirements for filing dossiers and the details about the online filing system are still unclear. According to our inside information, a further announcement is likely to be released within the two days.
• As we know, domestic non-special use cosmetics are also subject to filing management. They can be exempted from animal testing if safety assessment can prove their safety. Industry are still waiting for clarifications on whether or not first import non-special use cosmetics in Shanghai Pudong New Area will be subject to the same exemption rule.