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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).