Pesticide Registration
It is important to establish first the intended use of the pesticide: food crop or non-food crop (such as flowers and trees). This is necessary in order to determine the data requirements for the pesticide. Pesticide for food crops have to establish an ADI and have to meet ALL the data requirements. For non-food crops such as flowers, exemption is possible on SOME data requirements. Furthermore, it should be noted that there is no generic registration system in Japan. All products labeled as “AI Technical”, even if old, have to conduct most of the toxicological studies. In addition, there are additional requirements in Japan that are not required in other countries such as pharmacology studies, absorption study with volcanic ash soil, acute and sub-acute neurotoxicity study, acute toxicity of silkworm, and photolysis in water. It is recommended to confirm the data requirement and apply for exemption to the Famic (authority). Joy Consulting Ltd can submit and negotiate the data requirements on behalf of their clients.

In the table below,
Y: necessary, N: not required, CR: conditional requirement


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Documents Test
substance
Food Crop
use
Non Food
Crop use
Well known
safe products
1 Application form with signature Y Y Y
2 Applicant's identification Y Y Y
3 Agent's identification Y Y Y
Application fee Y Y Y
4 1. Physical chemical properties of formulation F Y Y Y
 5 2. Storage stability of a formulation F Y Y Y
 6 3-1 Specification of the techical T Y Y Y
3-2 Specification of the formulation F Y Y Y
3-3 Manufacturing method of the technical T Y Y Y
3-4 Manufacturing method of the formulation F Y Y Y
3-5 Five batch analysis with report in Japanese T Y Y Y
原体分析法 Y Y Y
7 4. Characterization of product
(5samples analysis of AI concentration)
F Y Y Y
8 5. Information of dioxins in the technical and the formulation T Y Y Y
9 6. Information of other toxic impurities in the technical and the formulation T Y Y Y
10 7-1 PEC calculation for aquatic organisms risk assessment T Y Y Y
11 7-2 PEC calculation for drinking water risk assessment T Y Y Y
12 8. Summary of dossier Y Y Y
8-1 History of development Y Y Y
8-2 Physical chemical properties Y Y Y
8-3 Biological activeties Y Y Y
8-4 Use method Y Y Y
8-5 Residual properties and water pollution properties Y Y Y
8-6 Toxicity to environmental organism Y Y Y
8-7 Attention on use Y Y Y
8-8 Summary reports of toxicology, environmental fate Y Y Y
8-9 Historial table of daminozide development Y Y Y
Applicant's comment on ADI and MRL and Workers and Environmental sataty Y Y Y
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Documents Test
substance
Food Crop
use
Non Food
Crop use
Well known
safe products
(1)
13 (1) Efficacy study / phytotoxicity tests F Y Y Y
duble rate phytotoxicity F Y Y Y
tests of residual odor in tea and tabacco F CR CR CR
14 peripheral crop (drift, paddy field, volatilization) F Y Y Y
15 succeeding crop F CR CR N
(2)
(2)-1 Acute toxicity studies
16 Acute oral toxicity study T Y Y N
F Y Y Y
17 Acute dermal toxicity study T Y Y N
F Y Y Y
18 Skin irriatation study F Y Y Y
19 Eye irriatation study F Y Y Y
20 Acte inhalation toxicity study T Y Y N
21 Skin sensitization properties study T Y Y N
F Y Y Y
22 Acte neurotoxicity study T CR CR N
23 Acte delayed neurotoxicity study T CR CR N
(2)-2 Subacute toxicity studies
24 90-days repeated dose oral toxicity study (Rat) T Y Y N
25 90-days repeated dose oral toxicity study (Dog) T Y N N
26 21-days repeated dermal toxicity study T CR CR N
27 90-days repeated inhalation toxicity study T CR CR N
28 Repeated dose oral neurotoxicity study T CR CR N
29 28-days repeated delayed neurotoxicity study T CR CR N
(2)-3 Chronif toxicity studies
30 1-year dog feeding study T Y N N
31 2-year combined feeding study T Y N N
32 Carcinogenisity study T Y N N
(2)-4 Reproductive toxicity studies
33 2-Generations reproductive toxicity study T Y N N
34 Teratogenicity study (Rat) T Y Y N
35 Teratogenicity study (Rabbit) T Y Y N
(2)-5 Mutagenicity studies
36 Reverse mutation tests T Y Y Y
37 Chromosomal mutation tests T Y Y N
38 Micronucleous tests T Y Y N
(2)-6 Other studies
39 Pharmacology study T Y Y N
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Documents Test
substance
Food Crop
use
Non Food
Crop use
Well known
safe products
(3) Metabolism studies
40 Study in regard to Animal metabolism L Y Y N
41 Study in regard to Plant metabolism L Y N N
(4) Environmental Fate
42 Aquatic aerobic fate in soil L CR CR
(paddy field ude)
N
43 Aerobic fate in soil L Y CR
(uppland field ude)
N
44 Anaerobic fate in soil L CR CR N
45 Hydrolysis in water L Y Y N
46 Photolysisi in water (Pure water) L Y Y N
46 Photolysisi in water (Natural water) Y Y N
47 Adsorption and desoroption L Y Y N
48 Adsorption and desoroption(Voleanic ash soil) Y Y N
49 Fish accumulation study Y Y N
(5) Toxicity to aquatic organisms
50 Acute fish toxicity (Carp ot killifish for technical) T Y Y CR
F Y Y Y
51 Acute daphnia toxicity T Y Y CR
F Y Y Y
52 Daphnia reproduction T CR CR CR
53 Algal Growth Inhibition
(Pseodokirchneriella aubcapitara for technical)
T Y Y CR
F Y Y Y
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Documents Test
substance
Food Crop
use
Non Food
Crop use
Well known
safe products
(6) Beneficial organisms other than aquatic organisms     
54 Bee Toxicity T / F Y Y N
55 Silkworm impact T / F Y Y N
56 Impact to natural enemy insects
(domestic species)
T / F Y Y N
57 Avian acute oral toxicity Y Y N
58 Avian dietary toxicity T CR CR N
59 (7) Pheysical, Chemical properties of AI colour, phsical state, odor, spectram (OECD 101)....... P Y Y N
(7) Study in regard to water polluting properries
 60 Study in regard to water polluting properties F CR CR N
(8) Study reports / date in regard to residues in crops
61 Crop residue study F Y N N
62 Translocation to milk of cow T / P CR N N
(9) Study reports / data in regard to soil persisitence
63 Field tests F Y Y N
64 Residue in succeeding crops F CR CR N
  F: Formulation, T:Technical, P:purified compound, L:Labelled compound
GLP Report: Japan accepts only GLP reports conducted in OECD countries and some MDA(Mutual Acceptance of Data)countries. The reports have to verified and checked if they are accepted in Japan. Reports generated before MAD are not accepted in Japan.
Well known safe products: This is to be confirmed by authority. It is impotant that the active ingredient is known as a safe substance suc as a part off food or food additive that has been used without any problem.
Joy Consulting