Short introduction to the Japanese system to register agrochemicals, revised version
Date: 5 June 2020
Like in the EU, a system to register agrochemical products is also in place in Japan. For people familiar with the process and history of registrations in EU, the current registration process in Japan is reminiscent of the national – i.e. Member State specific - registration legislation before Council Directive 91/414/EEC became effective.
In Japan, registering an agricultural chemical is regulated by the Agricultural Chemical Regulation Act (Act No 82 of 1948, last version amendment No 53 of 2018). The procedure described in the regulation act does not differentiate between active substance and product as is the case in the EU. Active substance data is required for registration of a product, but no separate procedure for approval of an active substance exists.
Manufacturers and importers of agricultural chemicals must submit an application for registration via the Incorporated Administrative Agency Food and Agricultural Materials Inspection Centre (FAMIC) to the Minister of Agriculture, Forestry, and Fisheries (MAFF), accompanied by documentation to confirm the quality and safety of the relevant agricultural chemical. This includes various test results concerning the efficacy against diseases and pests, negative effect on crops, toxicity to humans and non-target organisms as well as residue in crops. Historically, strong emphasis is given to maximum residue levels and consumer exposure.
The data requirements and test guidelines for these tests are specified by the notification No.30-Shoan-6278 (summarizing the previous 4 notifications No.12-Nousan-8147, No.13-Seisan-3986, No.13-Seisan-3987 and No.13-Seisan-3988). For applicants usually dealing with applications in EU or US, they should be considered carefully, as they vary from requirements in the EU or US. For field studies it is important to note that they are usually only accepted if performed in Japan. Good laboratory praxis (GLP) is established in Japan and has to be respected for studies to be considered reliable like in EU.
The data necessary for registration is presented to the authorities in the standard OECD dossier format, as detailed in notification No.26-Shoan-537.
The evaluation is coordinated by the Ministry of Agriculture, Forestry, and Fisheries, who directs FAMIC to evaluate, whether the relevant agricultural chemical is suitable for registration. FAMIC then reports back to Ministry of Agriculture, Forestry, and Fisheries. Further, the Ministry of Health, the Japan Food Safety Commission as well as the Ministry of Environment are involved by establishing standards for withholding the agricultural chemical registration. These standards are threshold values (such as e.g. maximum residue levels) that the agricultural chemical must not exceed. Otherwise, registration will be withheld (thus the name as “Standards for withholding registration”). If the agricultural chemical meets the requirements, the Ministry of Agriculture, Forestry, and Fisheries grants registration.
According to the Agricultural Chemical Regulation Act, re-evaluation of the registered products is conducted upon request from the Ministry of Agriculture, Forestry, and Fisheries and all products containing the same active substance are re-evaluated simultaneously. Compared to the system in EU where active substances are re-evaluated, the Japanese regulation chooses a way in between, where products grouped according to their active substance are re-assessed. Therefore, even though products are formally re-registered, the re-evaluation is active substance based. Again, as indicated in the first paragraph, for those familiar to the history of and the changes in regulatory affairs in the EU, this intention to review all existing products / active substances is highly reminiscent of the review of existing active substances under Council Directive 91/414/EEC in EU.
For microbial pesticides, special guidance exists in form of the notification No.9-Seisan-5090.
Sarah-Madeleine Hönig