by Lily Hou, PhD, CHMM
On July 9, 2019, the Ministry of Ecology and Environment (MEE) published the draft “Measures on the Environmental Management of New Chemical Substances” for public comments. The new measures will replace the current Measures published under MEP Order No. 7 of 2010 that require manufacturers and importers to register new chemical substances with the MEE before they may place the chemical substances on the Chinese market.
China has been actively working on revising the rules on new chemical substance registrations and the following is the timeline of the activities conducted by the MEE since 2015:
- June 25, 2015: China’s former Ministry of Environmental Protection (MEP, replaced by the MEE in 2018) drafted the first revision to the “Guidance for New Chemical Substance Notification” for public comment;
- March 8, 2016: the former MEP submitted a Technical Barrier to Trade (TBT) notification on the second draft revision to the Guidance to the World Trade Organization (WTO);
- August 31, 2017: the former MEP published Announcement No. 42 of 2017: Regarding Amendment to the Data Requirements Under the “Guidance for New Chemical Substance Notification.” The new requirements reduced the test data requirements for regular notifications, especially for lower tonnage levels;
- January 2019: the MEE published the draft “Regulations on Chemical Substances Environmental Risk Assessment” which covers both new chemical and existing chemical substances;
- July 9, 2019, the MEE published draft “Measures on the Environmental Management of New Chemical Substances” for public comments.
MEP Order No. 7 uses both words “notification” and “registration” interchangeably in the Measures, such as regular notification, simplified notification, registration certificate, which have caused confusion of the application process among manufacturers and importers. The new measures removed the word “notification” from the articles and replaced the notification types with “regular registration” and “simplified registration”.
The new measures intend to reduce registration burdens for chemical manufacturers and importers and introduce the following key changes:
- New chemical substances used for research with an annual production or import quantity less than 100 kg are exempt from the registrations. Under the current Measures, new chemical substance with quantity below 10 kg/year for scientific research purpose require a Scientific Research Record submission.
- New chemical substances manufactured/imported at under 1 tonne per year shall be submitted to the MEE for their records. The entity doesn’t need to wait for an approval from the MEE. Once the documents are submitted, the entity may proceed with their import or manufacturing activities.
- For new chemical substances with an annual production or import quantity between 1 to 10 tonnes, the simplified registration process applies.
- Data requirements for regular registration, which applies to an annual production or import quantity greater than 10 tonnes, are no longer solely dependent on the annual quantity of import/manufacture. Factors including hazards and exposure will be taken into account.
- The requirements on each activity report and five years activity report are canceled. Registrants must still submit an annual report and the first activity report.
- New chemical substances are included into 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 are no longer required under the draft measures.
Submit Your Revisions Suggestions
Revision suggestions can be submitted via email to: email@example.com. The public comment period for the new Measures ends on August 16, 2019.
Notice of Public Consultation on the Draft Measures on Environmental Management of New Chemical Substances (Chinese only):
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