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Breaking News: China Publishes Amended New Chemical Regulation
May 13, 2020
On April 29, 2020, China's Ministry of Ecology and Environment (MEE) published the
Measures on Environmental Management Registration of New Chemical Substances
(hereinafter "MEE Order 12"), to amend its new chemical regulation. This is the second revision of China's regulation on the management of new chemical substances since it was adopted in 2003. The amendment will become effective on January 1, 2021 and replace the current MEP Order 7. MEE is also revising the technical guidelines for new chemical registrations, which will include more details about data requirements and practical procedures.
Overall, MEE Order 12 sets forth reduced requirements for new chemical substances that are not listed in the Inventory of Existing Chemical Substance in China (IECSC). New exemptions will be applicable to fertilizers that are already subject to the regulations of Ministry of Agriculture and Rural Affairs (MARA). More notably, MEE Order 12 establishes new, easy-to-follow chemical management systems. New chemical substances will be subject to three types of registrations: Regular Registration, Simplified Registration, and Filing. The type of registration is determined primarily by annual tonnage.
Specifically, all substances for which the annual volume is less than one ton, and qualified polymers, including polymers for which new monomers are no more than 2%, and polymers of low concern (PLC), are subject to Filings.
According to MEE Order 12, the registrants of Filings will only receive a notice of reception from MEE and can start the activities immediately after the Filings are submitted. Under MEP Order 7, Simplified Notifications normally take several months to receive approval, but the amended regulation provides a more convenient process for the industry to manufacture and import qualified polymers and new substances with low annual volumes.
New substances with annual volumes at or above one ton, but less than 10 tons, will be subject to the newly defined Simplified Registrations under MEE Order 12. The following materials should be submitted: (1) the application form; (2) physicochemical properties, and ecotoxicological study reports or materials regarding persistency, bioaccumulation, and aquatic environmental toxicity; and (3) a commitment letter on implementation or transmission of environmental risk control measures. We note that toxicological data do not appear to be mandatory for Simplified Registrations. This should reduce some of the burden on the registrant.
The new Regular Registrations under MEE Order 12 will apply to new substances of which the annual volume reaches or exceeds 10 tons. The notifiers should submit the following materials to support the Regular Registrations: (1) the application form; (2) physicochemical, toxicological and ecotoxicological test reports or materials; (3) an environmental risk assessment report; and (4) a commitment letter on implementation or transmission of environmental risk control measures. It is currently unknown whether different tiers will be established for Regular Registrations and what types of studies will be required for each tier. This information is likely to be included in the coming technical guidelines.
The post-registration management under MEE Order 12 also has some significant changes. The first-activity report is required for both Simplified Registrations and Regular Registrations and should be submitted within 60 days since the first manufacture or the first transfer to customers after import. By contrast, the annual activity report will only be mandatory for Regular Registrations, unless the authority otherwise exempts this requirement in the registration certificates. The deadline for annual report submissions will be postponed from the current calendar date of February 1 to April 30, which will provide industry more time to consolidate the manufacture and import data from the previous year.
Moreover, the requirement to file a five-year report before a new substance is added to the IECSC no longer exists. A new substance that is the subject of a Regular Registration will be automatically added to the inventory in five years since its first approval. Simplified Registrations or Filings will not lead to listings in the IECSC. In addition, MEE Order 12 stipulates that in case a new substance is notified with a generic name, its chemical identity will be made public in five years since the substance is added in the IECSC. This provision also will apply to the substances currently listed in the confidential portion of IECSC, as well as those notified under MEP Order 7 and the prior SEPA Order 17 (predecessor of MEP Order 7).
We will continue to monitor the developments of China's new chemical regulation. In the meantime, should you have any questions concerning the MEE Order 12 or the new chemical management policy in China, please do not hesitate to contact (
), Chen Hu (
), or your existing contact at Keller and Heckman LLP.
David J. Ettinger
Suyan (Sharon) Tian
Food & Drug
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