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1.6.1

Guidelines/Data Requirement for Registration of NewFormulation for Seed Treatment U/s.9(!

(As approved in 296thmeeting of RC held on 24.12.2008)

A. CHEMISTRY

i) Source of supply of technical

ii) Chemical composition

iii) Chemical identity of technical

iv) Physico-chemical properties of technical and adjuvants

v) specification method of analysis

vi) Analytical test report

vii) Shelf life claim & data

viii) (a) Process of manufacture(b) Information about raw material used(c) heir source of supply(d) Step-wise manufacturin! process(e) "low-sheet dia!ram of process of manufacture

(i#) he applicant should provide sample alon! with ref$%analytical standard for pre-re!istration verification$

(#) () 'ethodolo!y for residue estimation as per IS format() Copy of "orm-I(*) +abels%+eaflets(,) Copy of permit. if relevant

B. BIOEFFICACY AND RESIDUES

1. "io#effe$ti%enessio-efficacy evaluation of the product for seed treatment is to be evaluated a!ainst

insects pest (s). diseases (s) as per label claim (s) under different a!ro-climatic /ones%multi-location field trial for two season% year$

&. ')toto*i$it)0ata re1uired as for bio-effectiveness above$

. +ffe$t on ,arasites - ,redators

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0ata on effect on parasites and predators is not re1uired in case of fun!icides. but dataon beneficial flora and fauna in soil is re1uired$

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. 'ersisten$e in soil water and ,lant# Data as ,er e*isting guidelines required

0. om,ati2ilit) wit oter $emi$als if $laimed

If the product is proposed to be mi#ed with other chemicals. the data on compatibility withother pesticides%bio-pesticides and bio-fertili/ers used for seed dressin! are re1uired tobe submitted$

6. Residue in ,lant and soil

esidue data as per label claim for four locations. one season is re1uired to be

submitted$

3. Registration status in foreign $ountries# required

4. o,) of Form#5# required

9. emi$al $om,osition# required

1. o,) of RTT ,ermit if rele%ant#required

11. 7a2els/7eaflets# required

C. TOXICITY

$ Acute oral in rat and mice$ Acute dermal

*$ Acute Inhalation,$ Primary s2in irritation3$ Irritation to mucous membrane

6. 4bservation in man- If the concentration is lower and type of formulation is such i$e$ 56

in place of 7C etc$. data may not be re1uired$ (NR per decision of 318thRC held on

27-04-2011)

D. Packaging and Labeling

$ +abels and leaflets as per-89 e#istin! norms (i) for si/e 3: ml & below (ii) for 3:: &above$

$ +abel to contents

(a) 0etailed Chemical composition(b)Purpose for import%manufacture(c) Antidote(d) o#icity trian!le(e)Cautionary statement(f) rief direction concernin! usa!es(!) estriction if any

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*$ +eaflets to contain(a) 0etailed Chemical composition leaflets accompanyin! small labels (up to 3: ml si/econtainer)(b) Introductory para about the pesticide(c) 0etailed directions concernin! usa!es(d) ime of application(e) Application e1uipment(f) 5aitin! period(!) Symptoms of poisonin!(h) "irst-aid measures(i) Antidote and treatment(j) estriction. if any(2) Instruction for stora!e(i) Information re!ardin! disposal of used pac2a!es

,$ ype of pac2a!in! (pac2in! material ; compatibility with content)3$ 'anner of pac2in!