by Lily Hou, PhD, CHMM
On April 29, 2020, the Ministry of Ecology and Environment of the People’s Republic of China (MEE) issued the final Measures on Registrations of New Chemical Substances for Environmental Management under Ministry Order No. 12. The new Measures will replace the current 2010 version and enter into force on January 1, 2021.
Same as the current version, the new measures require manufacturers and importers to register new chemical substances with MEE before placing the new chemical substances on the Chinese market.
The new measures are intended to reduce registration burdens for chemical manufacturers and importers and strengthen the management of highly hazardous chemicals, such as Persistent, Bioaccumulative and Toxic (PBTs) substances and very Persistent and very Bio-accumulative (vPvB) substances.
As such, the following key changes are introduced:
- Fertilizers and radioactive substances are explicitly exempted from registration requirements as they are subject to other laws and regulations.
- The thresholds of annual introduction quantities for registration categories are changed. Under the new Measures, a registration certificate will be issued under the following two registration categories:
- Simplified registration: applies to new chemical substances with an annual introduction quantity between 1 to 10 tonnes which is comparable to the required annual introduction volume of less than 1 tonne under the current Measures. Highly hazardous chemicals will be excluded from the simplified registration category.
- Regular registration: applies to new chemical substances with an annual introduction quantity of 10 tonnes and above which is higher than the annual threshold quantity of 1 tonne under the current Measures.
- New chemical substances manufactured/imported at under 1 tonne a year and polymers with no more than 2% of new chemical monomers or polymers of low concern (PLC) will only need to submit documentation to the MEE for record-keeping purposes. The entity doesn’t need to wait for an approval from the MEE. Once the documents are accepted, the entity may proceed with their introduction activities.
- Data requirements for regular registration will no longer be solely dependent on the annual introduction quantity. Factors including hazards and exposure will now be taken into account.
- For highly hazardous chemical substances, the registrant should also submit a report identifying socio-economic benefits of the chemical substances, including whether the new chemical substances have obvious advantages over the substitutes in terms of performance and environmental friendliness.
- The requirements on each activity report and five years activity report will be canceled. Registrants must still submit an annual report and the first activity report. However, the first activity report is now required for both regular registrations and simplified registrations, while the annual report is only required for highly hazardous chemicals.
- New chemical substances will be included in the Inventory of Existing Chemical Substance in China (IECSC) five years after the date of approval of regular registrations. The retrospective assessment on actual activities of hazardous new chemicals will no longer be required under the new measures.
Recommended Action Items:
- Learn how the new Measures will affect your products and plan ahead for the January 1, 2021 implementation date.
- The Measures should be used in conjunction with the “Guidance for New Chemical Substance Registrations” which is currently under revision by the MEE. Continue to watch this space, as we will post updates once the final Guidance is available.
MEE Order No. 12, “Measures on Registrations of New Chemical Substances for Environmental Management” (生态环境部部令第12号, 新化学物质环境管理登记办法, only available in Chinese):
MEE Order No. 12, China New Chemical Registrations
Never Miss an Update:
UL’s global Regulatory Assurance Team contains more than 50 regulatory analysts worldwide, serving customers in six continents, with multi-lingual support in more than 30 languages. Our team can help you navigate the complex, ever changing regulatory landscape to understand and execute your compliance obligations.
For all of the latest regulatory news and the most important industry updates, sign up for our monthly Regulatory Round-Up Newsletter.