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By J. Brian Xu, M.D., Ph.D., DABT®

On September 29, 2017, the Ministry of Agriculture of China (MOA) issued the final revisions to Data Requirements on Pesticide Registration (MOA Proclamation No. 2569).  The revisions will become effective on November 1, 2017, under the new Regulation on Pesticide Administration (RPA) and Pesticide Registration Management Measures (MOA Order No. 3, 2017).  The draft revisions to Data Requirements on Pesticide Registration were initially released for public comment on June 30, 2017.  The new Data Requirements include 10 chapters and 14 annexes and a category of pesticides for specialty minor crops has been added.  More information on China’s new pesticide regulations is available in our blog under key word China.

Commentary

MOA Order No. 3, 2017 requires chemistry and toxicology tests to be completed in laboratories located in China approved by the MOA or overseas laboratories that have a mutual recognition agreement with the relevant Chinese Authority.  The new Data Requirements on Pesticide Registration do not provide any additional information about the acceptance of data generated in overseas laboratories.

It remains unclear whether, for example, for literature or data prepared in a foreign language, entire study reports/articles, or only summaries, must be translated into Chinese.  In addition, the final revision of Data Requirements on Pesticide Registration deletes the category of “Pesticides for Overseas Uses Only” that was set forth in the draft revision of Data Requirements on Pesticide Registration.

The new RPA, MOA Order No. 3, 2017, and the Data Requirements on Pesticide Registration significantly change the registration requirements and the registration process for pesticides in China.  These new requirements, and the many ambiguities they contain, will likely extend the time for obtaining registrations and impose additional challenges on manufacturers to overcome, particularly foreign manufacturers who wish to bring pesticide products to the Chinese market.


 

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.

Commentary

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.


 

By J. Brian Xu, M.D., Ph.D., DABT®

On June 1, 2017, in the People’s Republic of China (China), a 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 (in Chinese only) (China Decree 677) on April 1, 2017.

The first version of the RPA became effective on May 8, 1997, and was revised on November 29, 2001, by China Decree 326.  China Decree 677 makes significant changes to the current version of RPA (China Decree 326), and requires the Ministry of Agriculture (MOA) to formulate relevant rules and measures for its implementation.  The revised RPA includes eight chapters:  General Provisions; Pesticide Registration; Production of Pesticides; Distribution of Pesticides; Uses of Pesticides; Supervision and Management; Legal Liability; and Supplementary Provisions.

On March 17, 2017, the MOA released five implementation measures for public comments (in Chinese only) but did not provide an implementation date.  The measures include:  Pesticide Registration Management Measures (Draft); Measures for the Management of Pesticide Production License (Draft); Measures for the Administration of Pesticide Business License (Draft); Measures for the Administration of Pesticide Labels and Manuals (Draft); and Measures for the Management of Tests Used for Pesticide Registration (Draft).

The new RPA is intended to:  streamline the administration process; implement licensing systems for pesticide production and distribution; promote the reduction of pesticide uses and enhance the management of highly toxic pesticides; clarify the responsibilities of manufacturers, sponsors of the contracted manufacturers, and distributors for the safety, efficacy, and quality of pesticides; establish pesticide recall and pesticide waste recycling systems; and prevent and punish the adulteration of pesticides.  The new RPA also revises the registration process and labeling requirements of pesticides, removes temporary pesticide registration, includes increased fines and blacklisting, and requires that manufacturers and distributors/retailers of pesticides establish a tracking system and maintain the required records for at least two years.

Commentary

The new RPA significantly changed registrations for pesticides in China.  Temporary pesticide registration is no longer an option.  There were two registration review committees:  the Temporary Pesticide Registration Review Committee that held a review meeting every two months; and the Full Pesticide Registration Review Committee that held a review meeting every six months, before the new RPA became effective.  The two committees are being replaced by the National Pesticide Registration Review Committee, but no frequency of review meetings was provided.  It is expected that the National Pesticide Registration Review Committee will meet less frequently than once every two months, which may result in a longer timeline for review and approval.  Without temporary pesticide registrations, a full set of data will be required with every pesticide registration, including two-year stability data in the initial submission.  Therefore, the new pesticide registration process may extend the time for manufacturers to bring products to the Chinese market.

The new RPA requires the foreign registration of active ingredients; possibly new formulations will obtain the registration in another country before registering it in China.

In addition, the Pesticide Registration Management Measures (Draft) requires that chemistry and toxicology tests should be completed in laboratories approved by the MOA or overseas laboratories maintaining mutual recognition agreements with the Chinese Government and complying with Good Laboratory Practices (GLP), and that efficacy, residue, and environment tests 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 proposed requirement could reject all test reports from overseas for pesticide registration in China.  It also requires that literature or data in a foreign language shall be translated to Chinese, but is not clear if the whole article/reports or only the summary should be translated into Chinese.  The timeline for new data requirements on pesticide registration under the new RPA is not provided.  Many questions for pesticide registration under the new RPA remain.


 

By J. Brian Xu, M.D., Ph.D., DABT®  and Margaret R. Graham

Like so many other regulatory programs in China, pesticide regulations are changing.  At the 8th China High-Level Forum on Pesticides, Ying Ji, Chief Agronomist of the Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA), stated that the future of pesticide regulation in China will see more emphasis placed on industrial development, registration security, the application of more risk assessment techniques, and will focus more on reducing the burden of procuring registrations for minor use crops.  In China, the vast majority of registrations are for major crops and only a few registrations have been issued for minor crops.  The Ministry of Agriculture also intends to prepare a "List of Pests and Pesticide Shortage for Minor Crops.”

Jun Yang, Director of the Efficacy Division, ICAMA, summarized recent trials and registrations of pesticides.  By the end of August 2015, China had a total of 33,029 registered pesticide products, an increase of 4,300 products when compared with 2013.  The total includes insecticides (12,812), fungicides (8,378), herbicides (7,807), and others including acaricides and plant growth regulators (4,032).  Insecticides were down 3 percent and fungicides and herbicides up 2 percent as a proportion of the total when compared with the total at the end of 2013.  The majority of registered products were issued for off-patent products.  The top ten active ingredients for which products were registered as of 2014 were reported to include:  the antifeedant, pymetrozine; the fungicides, azoxystrobin, tebuconazole and difenoconazole; the insecticides, thiamethoxam, emamectin-benzoate, avermectin and imidacloprid; and the herbicide, cyhalofop and glufosinate.  For more information on the report (which is available only in Mandarin), please e-mail Dr. Brian Xu at .(JavaScript must be enabled to view this email address).