1.6.

1
Guidelines/Data Requirement for Registration of New
Formulation for Seed Treatment U/s.9(!
(As approved in 296
th
meeting 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$ti%eness
(io-efficacy evaluation of the product for seed treatment is to be evaluated a!ainst
insects pest (s). diseases (s) as per label claim (s) under different a!ro-climatic /ones%
multi-location field trial for two season% year$
&. '()toto*i$it)
0ata re1uired as for bio-effectiveness above$
. +ffe$t on ,arasites - ,redators
0ata on effect on parasites and predators is not re1uired in case of fun!icides. but data
on beneficial flora and fauna in soil is re1uired$
2
.. 'ersisten$e in soil/ water and ,lant# Data as ,er e*isting guidelines required
0. 1om,ati2ilit) wit( ot(er $(emi$als/ if $laimed
If the product is proposed to be mi#ed with other chemicals. the data on compatibility with
other pesticides%bio-pesticides and bio-fertili/ers used for seed dressin! are re1uired to
be submitted$
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 $ountries# required
4. 1o,) of Form#5# required
9. 1(emi$al $om,osition# required
16. 1o,) of RTT ,ermit/ if rele%ant#required
11. 7a2els/7eaflets# required
C. TOXICITY
&$ Acute oral in rat and mice
)$ Acute dermal
*$ Acute Inhalation
,$ Primary s2in irritation
3$ 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 318
th
RC 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
3
*$ +eaflets to contain
(a) 0etailed Chemical composition leaflets accompanyin! small labels (up to )3: ml si/e
container)
(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!
<$ Specification for primary pac2a!e
9$ Specification for secondary pac2a!in!
=$ Specification for transport pac2a!in!
8$ 'anner of labelin!
&:$ Performance of container durin! stora!e stability test
&&$ Copy of "orm-I
4