FAMIC Pesticide Registration: How Japan’s Reviewing Body Works

The Agricultural Chemicals Regulation Act requires anyone who manufactures, processes, or imports a pesticide for sale in Japan to register it with the Minister of Agriculture, Forestry and Fisheries first. The Minister does not examine the file. That is done by the Food and Agricultural Materials Inspection Center, FAMIC, through its Agricultural Chemicals Inspection Station, which receives the application, the study reports, and the sample, examines them, and reports to the Minister. If there is no concern on efficacy, quality, or safety, the pesticide is registered with its approved uses (crops, rate, pre-harvest interval, and the label's use instructions) and the Minister issues the registration certificate (FAMIC, outline of activities).

The system in numbers

As of 30 September 2025, 24,985 pesticides had been registered since the Act came into force, of which 3,908 products across 577 active ingredients remained registered. By target, 38 percent of registered products are herbicides, 25 percent insecticides, 22 percent fungicides, 8 percent insecticide-fungicide mixtures, and 3 percent plant-growth regulators; herbicides overtook insecticides as the largest category around 2005. By formulation, wettable powders lead at about 35 percent, followed by granules, solutions, emulsifiable concentrates, and dusts. Roughly 120 new registrations are granted a year against a published standard processing period of 18 months.

What FAMIC does

• Registration examination. Physical and chemical properties, efficacy, phytotoxicity, toxicity, and residue chemistry, assessed against the data requirements in MAFF Notice 6278. Review questions come from FAMIC, in Japanese, and the applicant's answers go back the same way.
• Sample inspection. Where the active is not already registered, and in other cases on request, FAMIC tests a sample against the dossier's specification.
• Re-evaluation. FAMIC examines re-evaluation applications in the same way as first registrations, as part of the fifteen-year cycle that began in 2021.
• GLP compliance monitoring. Japan has applied GLP to pesticide toxicology since 1984. FAMIC inspects test facilities on organisation, personnel, equipment, study performance, records, and archiving, across toxicity, mutagenicity, water and soil behaviour and bioaccumulation, physical and chemical testing, analytical testing, environmental toxicity, and residue studies.
• Market surveillance. On-site inspection of manufacturers, distributors, and users for unregistered product, ledger audits, and checks on quality and labels.
• International work. Participation in OECD and Codex work on harmonised registration and maximum residue limits, and collection of overseas evaluation reports.

What FAMIC expects before you file

FAMIC's own reception guidance is short and worth taking literally. Applicants are expected to make contact before any application is filed, and the filing itself follows that contact rather than replacing it. A sample is required when the product contains an active ingredient not present in any registered pesticide. Filing is possible on paper or electronically through eMAFF, the ministry's common application service, and the statutory fee is paid on filing.

The application types FAMIC receives are the new registration, the change registration extending crops or pests, changes to registered particulars, and the pre-consultation itself, each with its own form. The pre-consultation is where a foreign applicant's questions about data gaps, waivers, and the Japanese-language summaries are best raised, and it is conducted in Japanese.

Where FAMIC's role ends

FAMIC examines and reports. It does not set the acceptable daily intake or acute reference dose; the Food Safety Commission does that from the metabolism and toxicology summaries, which is why those summaries must be in Japanese. It does not set residue standards; the Consumer Affairs Agency does. It does not assess effects on organisms in the living environment or on water; the Ministry of the Environment does. And it does not grant the registration; the Minister does. A foreign applicant that treats FAMIC as the whole of the process will be surprised by questions arriving from bodies it has not heard of, on timelines it did not plan for. The published 18-month standard period is FAMIC's step; the chain is what governs the calendar.

Using FAMIC's English materials

FAMIC publishes reference translations of the registration notices on its English data requirements page: the data requirements (6278), crop and pest names (6281), documents to attach (6282), the OECD dossier guidance (26-Shouan-537), and the microbial and natural-enemy guidelines, alongside an English list of registered active ingredients. Two cautions. The translations are explicitly non-binding and the page notes where the English lags the Japanese revision. And the notices are the requirement, not the interpretation; how a conditional item is read, and whether a waiver argument lands, is settled in the Japanese-language exchange with the reviewer.

That exchange is the part of the process we run for foreign manufacturers: the pre-submission contact, the filing, and every round of questions, in Japanese, reported back in English. See Japan pesticide registration support.