Background: An EU-based Client provides raw materials (less than 1 tonne per year) to importers in China. They have three substances not listed on the Inventory of Existing Chemical Substances in China (IECSC) 2010 and requested notification services from us.

Since the manufacturing process of these substances involves only a physical process, the client believes the substances extracted from these naturally occurring substances should qualify for exemption rules.

Solution: According to the “Guidance on China New Chemical Substance Notification”, notification is not required for the following:

• Finished products (cosmetics, pharmaceuticals, etc.)
• Naturally occurring substances
• Impurities (<10% w/w)
• Alloys
• Non-isolated intermediates
• Materials (glass materials, ceramics, etc)

We analyzed situation for each of the three substances of the European-based company.

Substance A is a plant stem cell extract (solid powder) according to its Safety Data Sheet and its purification process is purely physical, i.e. grinding and vacuum freeze-drying. Therefore we confirmed that Substance A could be exempted from notification under China New Chemical Substance Notification.

Substance B is composed of water and Pelvetia Canaliculata Extract only, and the extraction process is also physical. Therefore exemption from notification could also apply.

Substance C is composed of a seaweed extract and approximately 50% water and 50% 1,2-propanediol (propylene glycol). If certain solvent is used for purification process, then this substance cannot be exempted from notification; Please note that it could only be exempted if water is used for purification. Thus, in this case exemption could not apply for Substance.