Japan Takes Step Forward to Improve its Pesticide Review Process

On May 14, 2013, Ministry of Health, Labor and Welfare (MHLW) of the Government of Japan (GOJ) announced that it would accept applications for Import Tolerances (IT) even if the maximum residue level (MRL) of the chemical is not finalized in the export country. MHLW’s new system will allow import tolerance applications to start the review process 12 to 15 months earlier than in the previous system and will therefore minimize delays in the establishment of new MRLs. The real-time establishment of MRLs in Japan for new agrochemicals will allow U.S. agricultural exporters to minimize uncertainties in trade to Japan.

In the past, the Ministry of Health, Labor and Welfare (MHLW) accepted the application for import tolerances (IT) only after the MRL was officially finalized in the country where the substance would be used (Figure 1). Depending on the substance, Japan’s review of new agrochemicals took 24 to 36 months to complete. As a result, there was a significant delay between the time an agrochemical was approved for use in the United States and when it was approved in Japan. Hence, U.S. growers exporting commodities to Japan were often unable to use the latest pest management technology in order to avoid being found in violation of Japanese import regulations. New substances are often safer, more effective and necessary for farmers to manage increasing pest pressure, chemical resistant weeds, pests and fungi. This time-lag between the registration in the original country (e.g., the United States) and the MRL establishment in an export market (e.g., Japan) has been extremely problematic for U.S. agricultural trade to Japan.

Figure 1. Japan’s Previous MRL establishment and IT application scheme (before May 14, 2013)


However, on May 14, 2013, MHLW announced that it would accept IT applications even when the MRL of the chemical is not finalized in the applicant country (Figure 2). Under this new scheme, MHLW will no longer require that the MRL in the export country be officially announced in order to submit an IT application in Japan. MHLW does require that the MRL in the export country be officially finalized by the time Japan’s Food Safety Commission (FSC) returns the application dossier back to MHLW for MRL review. Although the timeframe varies significantly depending on the substance, it usually took a total of 12 months for MHLW to conduct its preliminary assessment and the FSC to complete its toxicity review. Now, under the new IT application scheme, the provider can start the application process with MHLW while the review of the agrochemical in the export country is still ongoing. Therefore, the new scheme promises to significantly reduce the duration of Japan’s review process by as much as 12 to 15 months.

Figure 2. Japan’s New MRL establishment and IT application scheme (after May 14, 2013)