China, the world’s largest producer and consumer of pesticides, is strengthening its regulation of agrochemicals. The Ministry of Agriculture (MOA) recently issued revisions to the country’s pesticide registration requirements, which officially came into effect on November 1, 2017. Pesticide use in China accounts for over one-third of total world pesticide usage, so the new rules will affect a significant number of national and multinational entities and a large percentage of the country’s population.
The MOA issued the revisions pursuant to the new Regulation on Pesticide Administration (RPA) and Pesticide Registration Management Measures (MOA Order No. 3, 2017). The new rules, entitled “Data Requirements on Pesticide Registration” (MOA Proclamation No. 2569), require all pesticide chemistry and toxicology tests required under the RPA to be conducted by laboratories located in China, or overseas laboratories possessing a mutual recognition agreement with China. The new rules do not offer much granular detail with respect to how laboratories would obtain such recognition or the applicable requirements — for example, the rules do not indicate whether application data prepared in a foreign language must be translated into Chinese prior to submission. The revisions also follow the MOA’s recent elimination of temporary pesticide registrations, which effectively prolongs the timeline for the review and use of all pesticides in China.
The revisions are the latest rules that China has implemented pursuant to amendments made to the RPA, which became effective on June 1, 2017. The new rules exacerbate existing ambiguities regarding the requirements of new application submissions and amendments to existing pesticide registrations. However, the new rules clearly aim to ensure that pesticide manufacturers and distributors provide fulsome and verified information to the MOA, signaling that the bureau will be scrutinizing pesticide applications carefully. Notably, the MOA took steps to render the process of pesticide review and approval more efficient in October 2017 with the establishment of the Pesticide Management Office, which will regulate the review, approval, production, sale, advertisement, and use of pesticides throughout China. Previously, several independent bureaus shared responsibility for the regulation and oversight of pesticides; the new pesticide bureau replace all of them to serve as a central authority.
As the new Pesticide Management Office develops policies and priorities, stakeholders in Chinese agrochemical businesses will likely see further guidance in key areas: pesticide registration and approvals; marketing; production; and licensing. Latham will continue to observe and assess new pesticide regulations and issued guidance in this developing area of regulation in China.
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This post was prepared with the assistance of Tegan Creedy in the London office of Latham & Watkins.