China Notifies WTO: New Chemical Substance Notification Guidance (Draft)

On 8 March 2016, China’s Ministry of Environmental Protection notified the Committee on Technical Barriers to Trade under World Trade Organization (WTO) a draft guidance on China new chemical notification (G/TBT/N/CHN/1170). According to the WTO notification, the Guidance is proposed to enter into force on 1 Nov 2016. The Guidance specifies the applicable scope, notification type and procedure, dossier requirements, and post-notification supervision and management of new chemical substances. Compared to the previous draft revision introduced on 25 June 2015, the major updates are summarised as below.

(1)  APIs and TCs will no longer require China new chemical notification, since they will be officially included into the exemption criteria, except for those used for other industrial purposes.

(2)  The situations previously applicable to Scientific Research Record Notification will need to simultaneously meet the new volume threshold: > 10kg per year.

(3)  All new chemical substances contained in articles with exposure to environment/human body during normal use are exempt from registration requirements and will only require registration if they pose hazards.

(4)  Reaction products of additives/surface treating agents with specific functions will also be exempt from notification, except for those with characterised hazards.

(5)  If the notifier considers testing reports generated using outdated testing methods (have been updated for more than five years) as still being valid, a self-evaluation report can be submitted and the expert review committee will decide whether it is acceptable. Under the previous MEP draft only updated testing methods were acceptable during compilation of notification dossiers.

It is noteworthy that the new draft has just been notified to the WTO for comments and before its actual implementation the current Guidance still needs to be followed. A copy of the guidance document is available at: Guidance on China New Chemical Notification (Draft) notified to WTO

Chemlinked, 11 March 2016 ;http://chemlinked.com/en/news ;