Data Requirements, Test Guidelines and Data Submission for Registration of an Agricultural Chemical

An applicant who wants to obtain registration of an agricultural chemical shall submit to Minister of Agriculture, Forestry and Fisheries the application form, sample and dossier including data regarding efficacy, phytotoxicity, toxicity and residues, and other data and information, pertaining to that agricultural chemical in accordance with the Agricultural Chemicals Regulation Law.

Necessary matters for application are provided for in the notifications published by Ministry of Agriculture, Forestry and Fisheries.

This page provides such current notifications in effect.

NOTICE TO USERS:
All of the translations of notifications in this page are unofficial. Only the original Japanese texts of the notifications are official, and the translations are to be used solely as reference materials to aid in the understanding of Japanese notifications. FAMIC is not responsible for the accuracy, reliability or currency of the translations provided in this page, or for any consequence resulting from use of the information in this page. Any translation has not yet been proofread or corrected by a native English speaker or legal translation expert. These translations may be modified in the future.


[Data Requirements and Test Guidelines]

The data requirements and test guidelines regarding efficacy, phytotoxicity, toxicity and residues of an agricultural chemical for registration are specified by the notification No.12-Nousan-8147 and notification No.13-Seisan-3986.

Title of notification Japanese
(revision date*)
English
(revision date*)
Data requirements for registration of agricultural chemicals (The notification No.12-Nousan-8147, issued on November 24, 2000 by Director-General, Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries) PDF(PDF:1,422KB)
(Mar.31, 2017)
PDF(PDF:3,517KB)
(May.15, 2014)
Implementing rules of “Data requirements for registration of agricultural chemicals” (The notification No.13-Seisan-3986, issued on October 10, 2001 by the Director, Agricultural Production Materials Division,Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries) PDF(PDF:1,244KB)
(Mar.31, 2017)
PDF(PDF:5,055KB)
(May.15, 2014)
* The difference between revision dates of Japanese and English means the translation does not reflect the latest original notification.

The other data and information requirements (e.g. the data and information regarding physical and chemical properties, storage stability, composition, manufacturing methods, etc. of an agricultural chemical) for supporting registration are specified by the notification No.13-Seisan-3987 and notification No.13-Seisan-3988.

Title of notification Japanese
(revision date*)
English
(revision date*)
Other data and information to be attached to the application for registration of an agricultural chemical (The notification No. 13-Nousan-3987, issued on January 10, 2002 by Director-General, Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries) PDF(PDF:998KB)
(Oct.31, 2016)
PDF(PDF:1,303KB)
(May.15, 2014)
Implementing rules of “Other data and information to be attached to the application for registration of an agricultural chemical” (The notification No. 13-Seisan-3988, issued on January 10, 2002 by the Director, Agricultural Production Materials Division, Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries) PDF(PDF:792KB)
(Oct.31, 2016)
PDF(PDF:437KB)
(May 31, 2013)
* The difference between revision dates of Japanese and English means the translation does not reflect the latest original notification.

[Data Submission formats]

OECD dossier forms, which are common formats of data submission adopted among many OECD member countries, have been introduced into Japan in 2014. An application using the dossier forms is accepted on and after May 15, 2014.


The details on necessary matters for submission of dossier, which are referred to both in the section III of Appendix to the notification No.12-Nousan-8147 and the section III of Appendix to the notification No.13-Seisan-3987, are specified by the notification No.26-Shoan-537.

Title of notification Japanese
(revision date*)
English
(revision date*)
Guidance on dossier to be submitted for application for registration of an agricultural chemical (The notification No. 26-Shouan-537,issued on May 15,2014 by Director of Plant Products Safety Division of Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries) PDF(PDF:2,070KB)
(Mar.31, 2017)
Under translation
* The difference between revision dates of Japanese and English means the translation does not reflect the latest original notification.

[Microbial Pesticides]

With regard to microbial pesticides, the data requirements are specified by the notification No.9-Seisan-5090 which consists of two documents.

Title of notification Japanese
(revision date*)
English
(revision date*)
Guidelines for safety evaluation of microbial pesticides (The notification No. 9-Seisan-5090,issued on August 29, 1997 by Director-General, Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries) PDF(PDF:411KB)
(Aug.29, 1997)
PDF(PDF:172KB)
(Aug.29, 1997)
Guidelines for preparation of data necessary for safety evaluation of microbial pesticides (The notification No. 9-Seisan-5090,issued on August 29, 1997 by the Director, Plant Protection Division, Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries) PDF(PDF:757KB)
(Aug.29, 1997)
PDF(PDF:263KB)
(Aug.29, 1997)
* The difference between revision dates of Japanese and English means the translation does not reflect the latest original notification.

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