China’s Ministry of Ecology and Environment is encouraging companies to nominate substances for inclusion in the country’s Inventory of Existing Chemical Substances (IECSC) until 30th September 2019. Chemical companies that produced, imported or used chemicals in China prior to 15 October 2003 can nominate them for inclusion into the inventory. China is also consulting on the revisions to MEP Order 7 (regulation that governs new chemical substances).
This consultation process is on-going until 16th August 2019. The main changes include the following:-
Simplified registration for low-volume new substances
R&D substances <100kg that were subject to “record-keeping” obligation would be fully exempt. Substances <1t, which are currently subject to simplified registration would be subject to “record keeping” only. Substances between 1 and 10 tonnes, which currently require regular registration would be subject to simplified registration.
Downstream users are currently excluded from registering new substances, however this revision would allow them to register the substances if they are considered for “industrial use”. Also, any company in China can currently manufacture or import substances on the existing chemicals list without having to register how they are used. The revisions would allow the MEE to permit certain uses of substances when issuing registration certificates. Fertilisers are out of the Regulations scope.
Substances of concern
Under the proposal, if new substances are considered persistent, bioaccumulative or toxic (PBTs) or very persistent and very bioaccumulative (vPvBs) – or substances of ‘equivalent concern’ – the government would only grant approval for use if registrants provide socio-economic analysis demonstrating its necessity. After these substances have been added to the existing chemicals list, companies would then only be able to use them for specific, ‘approved’ uses. If companies wanted to use them for a different purpose, they must be re-registered.
Inclusion on the existing list & significant new use
The revisions propose that new substances will be added to the IECSC – and be regulated as existing substances – five years after their approval date. Currently, newly approved substances are added five years after the date they are first produced or imported. In addition, if an approved new substance is considered very hazardous, for example PBT or vBvP, the MEE will place restrictions on its use when it is added to the existing chemicals inventory. In a process similar to the significant new use rules (Snurs) under US TSCA, any new uses of these chemicals will require additional approval.
The proposed revisions would mean a reduced number of chemicals are subject to annual reporting obligations. Currently, companies must report annually for the majority of new substances, regardless of their hazard or risk. But this would only be required if the government specifically asks for it after registration, on a substance by substance basis. And the deadline for annual reports would be changed from 1 February to 30 April each year.
To find out more regarding MEP Order 7 and other chemical regulations from around the world, please get in touch.