Possible China New Chemical Substance Notification Exemption for APIs and TCs

As specified in the China NCSN FAQ, all new chemicals require China New Chemical Substance Notification (China NCSN) irrespective of final applications including chemicals which also require new cosmetic ingredients registration, pesticide registration and API registration (see ChemLinked news). However, the Solid Waste and Chemicals Management Center under the Ministry of Environment (SCC-MEP, formerly the CRC-MEP) is now reconsidering these rules.

The SCC-MEP is inclined to no longer require China NCSN on APIs having completed API registration and TCs (technical materials) having completed pesticide registration. The regulatory departments (CFDA and ICAMA) responsible for management of APIs and TCs are believed to have the capacity to fully supervise all aspects of these chemicals registration which will free up SCC-MEP to focus on other NCSN registration work. However, Intermediates or raw materials for production of drugs or pesticides are still subject to China NCSN if they are a new chemical substance and have never undergone any registration process.

For new cosmetic ingredients, the SCC-MEP is unlikely to let go of administrative responsibility. A contributing factor in this is that the revised inventory of existing cosmetic ingredients (IECIC 2014) is still under public consultation which is due on June 15, 2014 (see ChemLinked news). The outlook is still pretty uncertain, and the SCC-MEP will probably still require China NCSN on new cosmetic ingredients if they are also a new chemical substances.

This information is merely my own interpretation of SCC-MEP’s internal discussion, which has not been publicly announced. It is likely these issues will be clarified in the upcoming revised guidance document. The revision of the guidance is SCC-MEP’s main task this year. It is hoped that draft guidance will be published by the end of this year.

*Kindly note that APIs and TCs, even approved by the CFDA and the ICAMA, will be subject to China NCSN if their practical application scope has pharmaceutical uses.