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China has finalised a major revision of its chemical registration regime, replacing MEE Order 12 with new rules that reshape registration obligations while retaining several key features the government had proposed removing.
The Ministry of Ecology and Environment (MEE) published the revised Measures for the Registration of New Chemical Substances for Environmental Management as MEE Order 40, effective immediately. The measures implement the Ecological and Environmental Code, in force since 15 August, which puts the registration obligation and penalties for non-compliance into statute.
For companies, the final text is less sweeping than the June consultation draft. It retains existing exemptions for sectors including cosmetics and food, as well as the current simplified and regular registration thresholds. However, it replaces record filing with a new pro forma registration, restricts applicants to mainland Chinese manufacturers and importers, and brings the regime under much tougher statutory penalties.
Scope and exemptions
Order 40 retains Order 12's exemptions for pharmaceuticals, veterinary drugs, cosmetics, food, food additives, feed, feed additives and fertilisers, which the June draft had proposed removing. As before, a new substance still needs registration if it is switched from one of these products to another industrial use, or if it is used as a raw material or intermediate to make them.
Pesticides have been removed from the exemption list. New substances in pesticide products instead fall under pesticide law, although the same two triggers for registration continue to apply.
Registration is now required only for the production or import of a new substance. Order 12 also covered research and processing use, such as repackaging or formulating a new substance, or using it to make other products. Companies that only conduct R&D or processing, without producing or importing the substances, therefore no longer need to register.
The draft's outright exemption for research and testing substances, however, has not survived.
Registration tiers
Record filing, which under Order 12 covered substances below one tonne per year (t/y), polymers containing no more than 2% new substance monomers or reactants, and polymers of low concern (PLCs), has been scrapped.
Companies must instead apply for a pro forma registration for the same substances. Under this route, the MEE checks only substance identity, polymer eligibility and confidential business information (CBI) claims, also referred to as trade secrets.
Unlike record filing, which did not require ministry approval, pro forma registration will involve a 30-day technical review followed by a decision within 20 working days.
Regular registration, for substances at 10t/y or more, and simplified registration, covering 1–10t/y, remain unchanged. This reverses another proposal in the June draft, which would have merged them into a single regular registration tier for substances at 1t/y or more.
Joint registration
Data requirements within each tonnage band remain broadly the same as under Order 12.
The final text also retains the option to register structurally similar substances in a single application, which the draft would have removed, and allows joint registration.
Since 15 August, the MEE has handled former record filing substances through registration applications reviewed under simplified registration procedures, while the treatment of polymers had remained unresolved. Order 40 now settles both issues.
Applicants
Only manufacturers and importers registered in mainland China can apply.
Overseas companies can no longer register through a local representative, and downstream users lose the two registration routes available to them under Order 12, including for the industrial use of otherwise exempt substances.
Post-registration duties
Producers and importers must pass the certificate number, registered uses, hazard and risk control information and environmental management requirements to downstream users.
However, the final text drops the draft requirements to include this information in supply contracts and for downstream users to submit annual reports.
Certificate holders must report first production or import within 60 days and keep activity records for ten years, or three for pro forma registrations. They must also submit annual reports by 30 April where the registration certificate requires it.
Producers of regularly registered substances must publicly disclose, through their websites or other means, how they implement environmental risk controls.
Applicants seeking registration of highly hazardous substances must demonstrate a socio-economic case, including whether the substance offers clear advantages over chemicals already in use for the same purpose.
CBI on substance identity is protected for up to five years. Regular registered substances are added to the Inventory of Existing Chemical Substances in China (IECSC) five years after registration, while simplified and pro forma substances do not qualify for listing.
The requirement for domestic test laboratories to hold CMA accreditation has also been removed. Laboratories must instead follow applicable test standards and good laboratory practice (GLP).
Penalties and transition
The draft's legal liability chapter has been deleted, while violations are now subject to penalties under the Ecological and Environmental Code.
Fines for producing or importing a new substance without registration range from ¥200,000 to ¥1m ($1,266 to $6,345), rising to ¥1–2m ($6,345-$12,662), with production restrictions or suspension, where a company fails to rectify the violation. Serious cases can result in certificate revocation or closure. By comparison, Order 12 set a maximum fine of ¥30,000 ($189).
The final text contains no transitional provisions.
The order is dated 24 October and was published on the MEE website on 26 October, following approval at a ministerial meeting on 15 October.