Guidance of pesticide registration in Japan

Reasons to Buy

• Readers who wish to register pesticide in Japan will learn:
• Japanese pesticide registration system and guideline.
• Important changes of Japanese pesticide registration under new law.
• Data requirement of pesticide registration in Japan.
• Data requirement for Bio-pesticide registration.
• All kinds of standards, skills and experiences for Japanese pesticide registration.
• The reports concludes all necessary data in figure or in table. You can study the necessary information from the report.

<Japan pesticide market, size and feature>...................................................................3

<Feature of Japanese pesticide registration system>....................................................4

<Pesticide registration by foreign companies>...............................................................5

<Sub-registration>............................................................................................................6

<Language of dossier>......................................................................................................6

<Authority>.......................................................................................................................6

<Procedure of evaluation and model schedule of pesticide development up to registration in Japan>......................................................................................................7

<Inquiry letter to Famic>.................................................................................................8

<Registration fee>.............................................................................................................9

<How to conduct local studies>........................................................................................9

II. Pesticide registration system in Japan.....................................................................10

<Guideline for chemicals>..............................................................................................10

<Guideline for microbial>...............................................................................................10

<Classification of pesticide products for data requirement>.......................................10

1. Data requirement of chemical pesticides...................................................................12

Table II-1.1 Data requirement of Japanese pesticide registration (of April 2017) for chemicals including well-known-safe-products and edible plant extracts. .................13

1.1 Points of information and studies for Japanese registration.................................20

1.1.1 Application form and attached documents.......................................................20

1.1.2 Efficacy and phytotoxicity studies....................................................................23

1.1.3.Toxicity studies, metabolism, environmental fate and environmental toxicity studies..........................................................................................................................28

1.1.3.1 Acute toxicity studies..................................................................................29

1.1.3.2 Subacute toxicity studies............................................................................30

1.1.3.3 Chronic toxicity studies..............................................................................31

1.1.3.4 Reproductive toxicity studies.....................................................................31

1.1.3.5 Mutagenicity study......................................................................................31

1.1.3.6 Studies of detoxification method or life saving method............................32

1.1.3.7 Metabolism studies.....................................................................................32

1.1.3.8 Environmental Fate studies.......................................................................33

1.1.3.9 Studies of toxicity to aquatic organisms....................................................34

1.1.3.10 Studies of impact to beneficial organisms other than aquatic organisms..................................................................................................................35

1.1.3.11 Studies of physical chemical properties of active ingredient.................36

1.1.3.12 Test results regarding derivation of predicted environmental concentration............................................................................................................37

1.1.3.13 Information regarding TGAI....................................................................37

1.1.3.14. Study reports in regard to residues in crops..........................................38

1.1.3.15. Study reports in regard to soil persistence.............................................40

1.2 Consideration on pesticide registration of edible plant extract......................40

2. Data requirement for bio-chemical pesticides....................................................41

We have special data requirement only for pesticide registration of microbials and natural enemies........................................................................................................41

2.1. Microbial pesticides..........................................................................................41

Table II-2.1 Data requirement of Japanese pesticide registration for microbials.43

2.2. Natural enemies.................................................................................................44

Table II-2.2 Data requirement of Japanese pesticide registration for Natural enemies......................................................................................................................45

3. Registration withholding standards for pesticide registration..........................46

3.1 Pesticide Registration Withholding Standard for crop residue.......................46

3.2 Pesticide registration withholding standard related to soil residue.................46

3.3 Pesticide registration withholding standard related to toxicity to aquatic organisms..................................................................................................................46

3.4 Pesticide registration withholding standard related to water pollution..........46

III. Generic registration............................................................................................47

Appendix guidelines..................................................................................................48