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Two Sets of Implementation Rules under China’s New Pesticide Regulations Released
By J. Brian Xu, M.D., Ph.D., DABT®
On June 1, 2017, in the People’s Republic of China (China), the newly revised Regulation on Pesticide Administration (RPA) became effective. The newly revised RPA was approved during the 164th executive meeting of the State Council of China on February 8, 2017, and published as Decree Number 677 of the State Council of China (China Decree 677) on April 1, 2017. It requires the Ministry of Agriculture (MOA) to formulate relevant rules and measures for its implementation.
The first set of five implementation rules was initially released for public comment on March 17, 2017, and made final on June 21, 2017. The five implementation rules include: Pesticide Registration Management Measures (MOA Order No. 3, 2017), Measures for the Management of Pesticide Production License (MOA Order No. 4, 2017), Measures for the Administration of Pesticide Business License (MOA Order No. 5, 2017), Measures for the Management of Tests Used for Pesticide Registration (MOA Order No. 6, 2017), and Measures for the Administration of Pesticide Labels and Manuals (MOA Order No. 7, 2017). They will become effective on August 1, 2017.
On June 30, 2017, the MOA released the second set of six implementation rules for public comment under the new RPA, which include Data Requirements on Pesticide Registration (Draft); List of Pesticides with Restricted Uses (Draft); Measures for the Management of QR Code Pesticide Label (Draft); Review Rules of Pesticide Production License (Draft); Review Rules of the Test Institutes that Conduct Tests Used for Pesticide Registration (Draft); and Quality Management Practices of Tests Used for Pesticide Registration (Draft). The comment period will end on July 30, 2017, but an implementation date was not provided.
The MOA Order No. 3, 2017 requires that chemistry and toxicology tests should be completed in Chinese laboratories approved by the MOA or overseas laboratories that have a mutual recognition agreement with the relevant Chinese Authority, and that the tests for efficacy, residue, environment, and others that are closely related to environmental conditions and Chinese specific species shall be conducted in China. Since China is not a member country of the Organization for Economic Cooperation and Development’s (OECD) Mutual Acceptance of Data (MAD) system, this requirement could reject all test reports from overseas for pesticide registration in China.
The requirements that literature or data in a foreign language shall be translated to Chinese are moved from the Pesticide Registration Management Measures (Draft) to the new Data Requirements on Pesticide Registration (Draft), but it is still not clear if whole articles/reports or only summaries should be translated into Chinese. In addition, the new Data Requirements on Pesticide Registration (Draft) would add a new category of registration, “Pesticides for Overseas Uses Only.” The registration of “Pesticides for Overseas Uses Only” requires only chemistry and toxicology data for the products at issue; the data that must be submitted include information on the production process, component analysis, quality specifications and analytical methods, acute “six-pack,” Acceptable Daily Intake (ADI), Acute Reference Dose (ARfD), and other safety and toxicology information. The new draft rules would not require any efficacy, residue, or environment tests for registration of “Pesticides for Overseas Uses Only.” The timeline for the second set of six implementation rules under the new RPA is not provided. Considering it took only three months for the first set of five implementation measures to proceed from drafts for public comments to final versions that will become effective about one and half a months later (August 1, 2017), it is expected that the second set of six implementation rules will become effective by the end of the year.
The new RPA and its implementation rules significantly change registrations for pesticides in China. Temporary pesticide registration is no longer an option, and pesticide registration now requires a full set of data, including two-year stability data in the initial submission, and requires that many of the tests must be conducted in China. With these new requirements, the new pesticide registration process may extend the time for manufacturers to bring products to the Chinese market. Because of many ambiguities in the new RPA and its implementation rules, many questions and uncertainties regarding the process for pesticide registration under the new RPA remain.