2019 Compliance Review: China New Chemical Substance Notification

Mar. 01st, 2020
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The Measures on the Environmental Management of New Chemical Substances (MEP Order No.7) has entered its 10th year since its promulgation. This year brought along key changes on the MEP Order No.7, in January, Ministry of Ecology and Environment (MEE) published the Environmental Risk Assessment and Control Regulation for Chemical Substances (Consultative Draft), which means that China will not only manage new chemical substances in the future but will move in a new direction to manage all chemical substances. In July, MEE published the draft revision of the Measures on the Environmental Management of New Chemical Substances. At the end of November, three Chinese companies were fined for manufactured new chemical substances without notification, which is a signal that regulatory enforcement will be enhanced and we will see more supervisory activities.

•  On January 8th, 2019, MEE published the Environmental Risk Assessment and Control Regulation for Chemical Substances (Consultative Draft) for public comment. This is another milestone in China’s environmental management of chemicals, means that China will try to bring more than 40,000 existing chemical substances into environmental management.

• On January 14th, 2019, MEE announced to officially list 28 substances into the Inventory of Existing Chemical Substances in China (IECSC). These substances were then managed as existing chemical substances. Among the 28 substances, 10 of them were listed into the confidential part of IECSC with generic names only while another 18 substances were listed into the public part of IECSC with public identification information. In addition, 9 of 28 substances with specific environmental management category as general new chemical substances, were new chemical substances that notified under MEP Order No. 7 and then listed in IECSC automatically by MEE after 5 years from the first activity date. The other 19 substances with no environmental management category were new chemical substances that notified under Order No.17 and applied for listing in IECSC by the enterprises.

•  On June 21st, 2019, MEE reopened the supplementation of the Inventory of Existing Chemical Substances in China (IECSC). This is the first time
to restart the supplementation since the authority called a halt to IECSC supplementation in Nov 2011. The submission of application materials ended in November, and the materials are now under review by the authority.

•  On July 9th, 2019, MEE published the draft revision of the Measures on the Environmental Management of New Chemical Substances (MEP Order No.7) for public comment. It took around two and a half years from the start of the revision to the release of the draft. The draft mainly focused on streamlining administration, highlighting management priorities, continuing to adhere to source management, and strengthening the tracking and management of notified substances, with the objective of eventually realizing a closed-loop management model from risk assessment to risk monitoring.

• On September 2nd, 2019, the notification draft of the Environmental Risk Assessment and Control Regulation for Chemical Substances and the Measures on the Environmental Management of New Chemical Substances were submitted to WTO. Compared with the draft revision, the notification draft of the Regulation made some adjustments, yet the core content remained unchanged.

• On September 3rd, 2019, MEE issued the Framework Guide for Technology Methods for Environmental Risk Assessment of Chemical Substances (Trial). This trial Guide was jointly prepared by MEE and the National Health Commission, with the purpose to strengthen the environmental management of chemicals, to establish a sound technical method system and to standardize the environmental risk assessment of chemicals in China. It is worth noticing that the Guide is applicable to the environmental risk assessments of different exposure pathways for the normal production and use of a single chemical substance. And it also specifies the basic framework of environmental risk assessment of chemical substances, as well as the basic points, technical and reporting requirements of environmental risk assessment of chemical substances. As an important supporting technical document, the release of the Guide also indicates that the competent authorities have offered sufficient technical and institutional guarantees to promote the fast implementation of the risk assessment and risk control system of chemical substances in China.

•  In September and October 2019, the national-level training course on the environmental management  of new chemical substances were held in Jinan, Shandong by the Solid Waste and Chemical Management Centre (MEE-SCC) to help enterprises, associations, and organizations understand the regulation of the environmental management of the new chemical substance and to ensure a smooth work of the new chemical notification and the IECSC supplementation. It shows that the authorities attach great importance to the environmental management of new chemical substances and their determination to promote the regulations and policies.

• On September 24th, 2019, MEE-SCC published a notice on the comparison of technical capabilities of chemical testing institutions, the targets are mainly the institutions who made self-declarations on the website of MEE-SCC. The aim of this notice is to standardize the eco-toxicology test and further improve the quality of test data, which means the authority attach great importance to the quality of test data submitted during the notification of new chemical substances.

• In September 2019, MEE released the information of scientific research record notification (SRRN) of new chemical substances for the first half of 2019, in a total of 691 SRRN notifications from January 1, 2019 to June 30, 2019.

•  On November 19th, 2019, two eye-catching public announcements were published on MEE’s website, stating that three Chinese companies were fined for manufactured new chemical substances without notification. This was the very first time that MEE issued a notice of violation about enterprises that who should have notified for new chemical substances but they hadn’t. This means that following the continuous follow-up and control inspection of new chemical substances in Shanghai in early 2017 and September 2018, local ecological and environmental authorities in Shandong and Jiangsu have also stepped up local supervision of new chemical substance compliance.

•  On December 13th, 2019, MEE-SCC issued a notice reminding notification certificate holders to submit their annual reports for the information of production and import activities of new chemical substances in year 2019. The online submission system will open on Jan 1st, 2020 and submissions will be due by Feb 1st, 2020. Annual reporting of notified new chemical substances is a basic post-notification requirement in China, holders of regular notification certificates (hazardous new chemical substance and hazardous new chemical substances of priority environmental concern) and all simplified notifications are obliged to submit an annual report to MEE-SCC by February 1st every year.

•  In year 2019, 6 batches of regular notifications of new chemical substances were approved by MEE, in a total of 107 substances which including 51 hazardous substances of priority environmental concern, 39 hazardous substances and 16 general substances.

•  In year 2019, 15 batches of simplified notifications of new chemical substances were approved by MEE, including 645 basic case of simplified notifications and 2, 298 special case of simplified notifications.