China’s Ministry of Ecology and Environment (MEE)—formerly the Ministry of Environmental Protection (MEP)—issued a notice of public consultation on a draft revision to the “Environmental Management of New Chemical Substances” (MEP Order No. 7) on July 9, 2019.
The draft revision addresses the registration requirements for certain new chemicals and polymers; establishes a process to add new chemical substances to the Inventory of Existing Chemical Substances in China (IECSC); includes more stringent requirements for registering and using high-risk—mainly persistent, bioaccumulative, and toxic (PBT) and very persistent and very bioaccumulative (vPvB)—chemicals; and requires substantiation of confidential business information (CBI) claims.
The draft revisions would largely simplify the registration process for new chemicals, particularly those of low concern and low volume. At the same time, high-risk chemicals would be subject to more stringent requirements. The proposed changes to the CBI provisions are significant for companies accustomed to being able to claim information as CBI with no substantiation.
MEP Order No. 7 has been in force since 2010 and revised the 2003 regulations of new chemical substances.
Since 2016, the Chinese government has endeavored to update its regulations on new chemical substances to improve environmental quality, promote green chemistry, and streamline the current regulations.
This long-awaited draft revision, which has been under internal review since the fall of 2017, would replace MEP Order No. 7 and address several of its major shortcomings. These include the lack of a registration exclusion for low-volume substances; similar treatment of high- and low-risk substances; an ambiguous procedure to add registered new chemical substances to the IECSC; and generalized reporting requirements for almost all chemical substances after registration.
Reduced Registration Burdens
Among the most welcomed changes are those intended to reduce some of the registration burdens for new chemical substances, particularly for low-risk new chemicals that are produced or imported annually in volumes of less than 10 metric tons.
Included in the draft is a registration exemption for low volumes (less than 100 kilograms per year) of new chemicals used for research. The draft also clarifies the registration exemption for fertilizers. Downstream industrial users, in addition to manufacturers, importers, and exporters, would be eligible to register new chemical substances.
The current simplified registration available for new chemical substances with annual production or import volumes of less than one metric ton, polymers containing less than 2% of a new chemical monomer/reactant, or polymers of low concern (PLC) will be replaced, under the draft, with a record-filing process, which will not require pre-market approval by MEE.
New chemical substances with annual production or import volumes of one to 10 metric tons currently must complete a level-1 regular registration. The draft revision would require that they complete only a simplified registration, a process that does not require toxicology tests to address potential hazards to human health. High-risk substances would not be eligible for simplified registration.
A substantiation requirement would be added for all CBI claims, including those regarding chemical identity and labeling, according to the draft. CBI claims for the protection of chemical identity and labeling information will expire after five years, while no expiration period is provided for all other CBI claims, such as trade secrets.
This is a significant change as currently all registrants, including manufacturers, importers, and exporters, can claim almost all information as CBI without providing any substantiation and with no expiration period.
The draft revision would limit annual reporting to new chemical substances with regular registration containing specific reporting requirements and the report date is changed from Feb. 1 to April 30 each year.
The draft revision provides a clear path for adding new chemicals to the IECSC.
New chemical substances would be listed five years after the registration date instead of the date of the first production or importation. High-risk substances that are approved with use-specific restrictions would be listed, along with the use restrictions, five years after the registration date.
The draft revision also would introduce a requirement for the registration of new uses of high-risk substances already listed on the IECSC.
Manufacturers and importers should take advantage of the comment opportunity to express their support for changes intended to simplify and streamline the registration process and ensure that new chemical substances are added to the IECSC.
Manufacturers, importers, and exporters that have relied on the low threshold to claim information as CBI should review the draft revision carefully.
Government approval of a new chemical substance is currently based on the risk control measures associated with the manufacture and use of the new chemical substances. The draft revision requires justification of the manufacture and uses of the new chemical substance for registration approval, especially for high-risk substances, and requires sufficient elaboration of their social and economic benefits and availability of alternatives.
Registrants should be aware that the registration of a high-risk substance may not be approved if the current revision is issued in final in substantially the same form as the draft.
MEE will accept comments by email to email@example.com until Aug. 16, 2019.
The full revision of “Guidance for New Chemical Substance Notification and Registration” is expected after the draft revision to MEP Order No. 7 is released in final. The schedule for release of this revision in final was not provided, however.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
J. Brian Xu, M.D., PH.D., DABT, a senior toxicologist with The Acta Group, has significant experience with the orders and decrees of the Chinese regulatory system that helps him anticipate potential hurdles for clients registering or marketing products in China.
Jane S. Vergnes, PH.D., DABT, vice president, scientific affairs, and director of toxicology for Acta, provides clients with toxicology expertise for the broad range of chemical regulatory and support services offered, including chemical registration and notification.
Carla N. Hutton is a regulatory analyst for Bergeson & Campbell P.C. where she monitors and assesses global regulatory developments and trends, with particular focus on chemical regulatory schemes.