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 Act.

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.

DISCLAIMER:
The translations of notifications on this page are not official. Only the original Japanese texts of notifications have legal effect, and the translations are to be used solely as reference materials to aid in the understanding of the original texts. Neither FAMIC nor the government of Japan shall be held responsible for the accuracy, reliability or currency of the translations provided on this website, or for any consequences resulting from the use of information on this website. For all purposes of interpreting and applying notices to any legal issue or dispute, users should consult the original Japanese texts. The translations may be revised in the future. The data contained on this page may be reprinted or reproduced, provided that the disclaimer is accompanied and the source is shown.


[Data Requirements and Test Guidelines]
Title of notification Japanese
(revision date*)
English
(revision date*)
Data requirements for registration of agricultural chemicals (The notification No.30-Shouan-6278, issued on March 29, 2019 by Director-General, Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries) PDF
(Jun.28, 2019)
PDF
(Jun.28, 2019)
*limited to main text and Appendix Tables
Names of crops to be used in the scope of the applicable pests and application methods (The notification No.30-Shouan-6281, issued on March 29, 2019 by Director, Plant Products Safety Division, Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries) PDF
(Mar.29, 2019)
Under translation
Names of Documents to be attached to the application for registration of an agricultural chemical and notificatinos by registrants (The notification No.30-Shouan-6282, issued on March 29, 2019 by Director, Plant Products Safety Division, Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries) PDF
(Mar.29, 2019)
PDF
(Mar.29, 2019)
* The difference between revision dates of Japanese and English means the translation does not reflect the latest revision.

[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.

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
(Jul.5, 2019)
Under translation
* The difference between revision dates of Japanese and English means the translation does not reflect the latest revision.

[Microbial Pesticides]
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
(Feb.26, 2019)
PDF
(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
(Mar.29, 2019)
PDF
(Aug.29, 1997)
* The difference between revision dates of Japanese and English means the translation does not reflect the latest revision.



    The following are old notifications that are not currently applied.

    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
    (Mar.29, 2018)
    PDF
    (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
    (Mar.29, 2018)
    PDF
    (May.15, 2014)
    * The difference between revision dates of Japanese and English means the translation does not reflect the latest revision.

    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
    (Oct.31, 2016)
    PDF
    (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
    (Oct.31, 2016)
    PDF
    (May 31, 2013)
    * The difference between revision dates of Japanese and English means the translation does not reflect the latest revision.

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