Minutes of the 253 rd meeting of the Registration Committee held on 30 th May,2005 in Committee Room No.139, Krishi Bhavan, New Delhi The 253rd meeting of the Registration Committee (RC) was held under the Chairmanship of Dr. N.B. Singh, Agriculture Commissioner on 30 th May,,2005 at 1030 hrs. in Krishi Bhavan, New Delhi. Dr. P.S. Chandurkar, Plant Protection Adviser to the Govt. of India, Dr. O.P. Dubey, Assistant Director General (PP), ICAR,Shri P.N.Maji, Addl. Industrial Adviser, and Dr. (Mrs.) S. Kulshrestha, Secretary, CIB&RC attended the meeting. Following officers from the Secretariat of CIB&RC were also present: (i) Dr.(Mrs.) G.Mukherjee, Jt.Dir.(Chem.) (i) Sh.Vipin Bhatnagar, Jt.Dir.(Chem.) (ii) Dr. Ravi Prakash, JD (Bio) (iii) Dr. R.M. Shukla, DD (Ent.) (iv) Dr. (Mrs.) Mukul Singh, DD (Med.) (v) Dr. Subhash Kumar, Agro (H) (vi) Smt. Kanta Arora, AO (CIB&RC) (vii) Sh. Rajmant Singh, Section officer (viii) Sh. Niraj Kulshrestha, Assistant Legal At the outset, the Chairman welcomed the participants and requested Secretary,CIB&RC to take up the Agenda for discussion. The following decisions were taken:- Agenda Item No.1.0 Confirmation of minutes of the 252 nd meeting of the Registration Committee.
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Minutes of the 253 rd meeting of the Registration Committee held on 30 th May,2005 in Committee Room No.139, Krishi Bhavan, New Delhi
The 253rd meeting of the Registration Committee (RC) was held under the Chairmanship
of Dr. N.B. Singh, Agriculture Commissioner on 30 th May,,2005 at 1030 hrs. in Krishi Bhavan,
New Delhi. Dr. P.S. Chandurkar, Plant Protection Adviser to the Govt. of India, Dr. O.P. Dubey,
Assistant Director General (PP), ICAR,Shri P.N.Maji, Addl. Industrial Adviser, and Dr. (Mrs.) S.
Kulshrestha, Secretary, CIB&RC attended the meeting.
Following officers from the Secretariat of CIB&RC were also present:
(i) Dr.(Mrs.) G.Mukherjee, Jt.Dir.(Chem.)
(i) Sh.Vipin Bhatnagar, Jt.Dir.(Chem.)
(ii) Dr. Ravi Prakash, JD (Bio)
(iii) Dr. R.M. Shukla, DD (Ent.)
(iv) Dr. (Mrs.) Mukul Singh, DD (Med.)
(v) Dr. Subhash Kumar, Agro (H)
(vi) Smt. Kanta Arora, AO (CIB&RC)
(vii) Sh. Rajmant Singh, Section officer
(viii) Sh. Niraj Kulshrestha, Assistant Legal
At the outset, the Chairman welcomed the participants and requested
Secretary,CIB&RC to take up the Agenda for discussion. The following decisions were
taken:-
Agenda ItemNo.1.0
Confirmation of minutes of the 252nd meeting of the Registration Committee.
While confirming the minutes, the Members observed that the decision relating to
Agenda Item No.3.5 of 252nd RC meeting may be re-worded as follows:-
“The Committee deliberated the Agenda in detail and decided to phase out all
uses of Lindane except for termite control in agriculture (presently approved for
sugarcane), in buildings and for export.”
The minutes were confirmed with the suggested amendment.
Agenda ItemNo.2.0
Follow up action on the decisions taken by the Registration Committee in its 252nd meeting.
The Committee noted with satisfaction the follow up action on the decisions of
the 252nd meeting of the RC.
Agenda ItemNo.2.1
Applications pending under various sub-sections of the Insecticides Act,1968
The Committee perused the pending applications under various sub-sections of
the Insecticides Act,1968.
Agenda ItemNo.3.1
Harmonisation of the coding of the pesticide technical and formulation in line with international coding.
The Committee approved the harmonization of the coding of the pesticide
(technical and formulation) in line with the international system as proposed in the
Need for submission of consent letter, duly attested by India Embassy/High Commission/Consulate in the country of origin with application for grant of registration for import of insecticides (Technical & Formulations) under Section 9(4)
The Committee deliberated the Agenda in detail and approved the submission of
Consent letter, duly certified by the Indian Embassy/High Commission/Consulate in the
country of origin(manufacture) by the applicant(s) for grant of registration for import of
insecticides (technical and formulation) under Sec.9(4). Such letter of consent should
also indicate the minimum purity of the technical grade material in case of import of
technical grade pesticides.
Agenda ItemNo.3.3
Adoption of alternative test (OECD test guidelines 420, 423 and 425) in place of the classical LD50 test (401) for acute oral toxicity and review of the toxicity classification, etc.
The Committee deliberated the Agenda in detail and accepted the recommendations of the Expert Group which are as follows:
(i) To phase out classical, acute oral LD50 (based on GCR) and replace it with alternative OECD test guidelines 423 and 425. Considering the fact that some studies will be under generation adopting the test methods as given in GCR, it was decided to also accept the said data generated up to Dec., 2005 for the purpose of registration. However, after this period (31st
Dec., 2005) studies conducted as per OECD test guidelines 423 and 425 will only be accepted.
(ii) To adopt Globally Harmonized System of Classification and labeling of Chemicals to overcome trade and tariff barriers in international trade of pesticides. However, considering the socio-economic and educational status of the users of the country and the fact that the users in India are acquainted and familiar with colour coding and warning statements on labels as provided under the Insecticides Rule, 1971, it is recommended that colour coding and also warning statement as earlier prescribed in the Insecticides Rules are to be incorporated appropriately in the GHS classification.
(iii) Accordingly, the Committee suggested the revision of relevant Rule 19 regarding classification of the pesticides by toxicity as follows:
Exposure Route
Category1 Category2 Category3
Category4 Category5
Oral (Rat) mg/kg body weight
5 50 300 2000 5000
Se detailed criteria in note (b)
Dermal (Rat or Rabbit) mg/kg body weight
50 200 1000 2000
Gases ppm V (4 hr. expression value)See: Note (a)
100 500 2500 5000
Vapours (mg/l) (4 hr. expression value)
0.5 2.0 10 20
Dusts and Mists (mg/l) (4 hr. expression value)
0.05 0.5 1.0 5
Symbol Skull and crossbones Skull and crossbones
Skull and crossbones
Exclamation mark
No symbol is used
Signal word Danger Danger Danger Warning WarningHazard statement:--Oral
Fatal if swallowed Fatal if swallowed Toxic if swallowed
Harmful if swallowed
May be harmful if swallowed
--Dermal Fatal in contact with skin
Fatal in contact with skin
Toxic in contact with skin
Harmful in contact with skin
May be harmful in contact with skin
--Inhalation Fatal if inhaled Fatal if inhaled Toxic if inhaled
Harmful if inhaled
May be harmful if inhaled
Colour coding Red Red Yellow Blue GreenWarning Statement
“KEEP OUT OF THE REACH OF CHILDREN”“IF SWALLOWED OR IF, SYMPTOMS OF POISONING OCCUR CALL PHYSICIAN IMMEDIAT-ELY”
“KEEP OUT OF THE REACH OF CHILDREN”“IF SWALLOWED OR IF, SYMPTOMS OF POISONING OCCUR CALL PHYSICIAN IMMEDIAT-ELY”
KEEP OUT OF THE REACH OF CHILDREN
KEEP OUT OF THE REACH OF CHILDREN
Note (a) Gases concentration are expressed in parts per million per volume (ppmV)
(b)The substance is classified in this Category, through extrapolation, estimation or measurement of data, if assignment to a more hazardous category is not warranted, and:reliable information is available indicating significant toxic effects in humans; orany mortality is observed when tested up to category 4 values by the oral, inhalation, or dermal routes; orwhere expert judgement confirms significant clinical signs of toxicity, when tested up to Category 4 values, except for diarrhoea, piloerection or an ungroomed appearance; orwhere expert judgement confirms reliable information indicating the potential for significant acute effects from other animal studies.
Agenda ItemNo.4.0
Export Cases
Agenda ItemNo.4.1
Export under Sec.9(3) as per details at Annexure-4.1.
Approved.
Agenda ItemNo.5.0
9(3B) cases.
Agenda ItemNo.5.1
Consideration of application of M/s Universal Agro Bio-Tech., Nohar (Rajasthan) for grant of registration for indigenous manufacture of Trichoderma Viride 1% WP under Sec.9(3B)
Approved for a period of 2 years with commercialization.
Addl. Agenda Item No. 5.2
Consideration of application of M/s Ruchi Oyste Mushroom, Gondia (M.S.) for grant of registration for indigenous manufacture of Pseudomonas fluorescens 0.5% WP (CFU 2 x 108 gm/min.) under Section 9(3B)
Approved for a period of 2 years with commercialization.
Addl. Agenda Item No. 5.3
Consideration of application of M/s Durva Biotech, Nagpur for grant of registration for indigenous manufacture of Trichoderma Viride 1% WP under Sec.9(3B).
Approved for a period of 2 years with commercialization.
Agenda ItemNo.6.0
9(3) cases.
Agenda Item Consideration of application of M/s Bayer Crop Science India
No.6.1 Limited, Mumbai for grant of registration for indigenous manufacture of Tebuconazole 25.9% EW, formulation (Fungicide) under Sec.9(3)
The Committee deliberated the Agenda in detail. The Committee noted that the
product is highly irritant to eyes causing corneal opacity, irritation of iris, conjunctival
redness etc. The Committee also noted that this formulation is much more irritant than its
technical and other formulations used in the country. The Committee also deliberated the
explanation given by the applicant regarding irritation potential of the formulation and the
proposed innovative user friendly packaging system. After detailed deliberation, the
Committee did not approve this formulation with the proposed composition.
Agenda ItemNo.6.2
Reconsideration of application of M/s Gharda Chemicals Ltd., Mumbai for registration of Indoxacarb Tech. For indigenous manufacture under Sec.9(3) TIM.
The Committee deliberated the Agenda in detail and noted that as decided in
252nd RC meeting, the bioefficacy data submitted by the applicant on Cabbage has been
got verified from the MPUAT, Udaipur and BHU, Varanasi. Both the Institutes have
confirmed the generation of data on cabbage. The Committee noted that the bioefficacy
data submitted by the applicant fulfills the requirement of registration under Sec.9(3) TIM
category. The Committee was apprised about the receipt of representation dated 23 rd
May,2005 from M/s EI Du Pont India Pvt. Ltd., Gurgaon, regarding detailed enquiry into
the data submitted by M/s Gharda Chemicals Ltd., Mumbai. The Committee deliberated
the issue and was of the opinion that all points as indicated in their representation have
already been considered by the RC/Expert Committee earlier and, therefore, decided to
grant registration to the applicant.
Agenda ItemNo.7.0
9(4) cases.
Agenda Item Applications for registration under Sec.9(4)
No.7.1
The Committee approved the grant of registration for the pesticides for which
MRL has been totally fixed, not required or partially fixed.
Agenda ItemNo.7.2
Consideration of an application of M/s Heranba Industries Ltd., Mumbai under Sec.9(4) for grant of registration of Sulfosulfuron Technical for indigenous manufacture.
Approved.
Agenda ItemNo.8.0
Miscellaneous items
Agenda ItemNo.8.1
Endorsement cases as per Annexure-8.1.
Approved.
Agenda ItemNo.8.2
Endorsement for change in the existing specification for household insecticides w.r.t. weight of Cypermethrin 1% chalk.
The applicant may be called for making presentation in the next RC meeting to
justify change in the weight of the chalk.
Agenda ItemNo.8.3
Change of name of the source of import of Copper Hydroxide 77% WP.
Approved.
Agenda ItemNo.8.4
Application for approval of 300ml HDPE container in lieu of 250ml capacity for packing Chlorfenapyr 10% SC – Proposed by M/s BASF India Ltd., Mumbai.
The Committee deliberated the agenda in detail and decided to seek clarification
from the applicant with reference to the justification provided for approval of 300ml
capacity packing in place of 250ml, as the other packings already approved i.e. 100ml,
500ml and 1 Lt. are not in multiple of 30.
Agenda ItemNo.8.5
Ex-post facto approval for import permits issued.
Approved.
Agenda ItemNo.8.6
Consideration of extension of bio-efficacy claim for Fenpropathrin 30% EC in favour of M/s Sumitomo Chemicals India Pvt. Ltd., Mumbai
The Committee deliberated the Agenda and observed that tea is exported from
India and therefore to ensure that the consignments are not rejected due to residues,
views of Tea Board may also be obtained.
Agenda ItemNo.8.7
Approval of Protocols.
Approved.
Agenda ItemNo.8.8
Application of M/s Agrico Organic Ltd for permission to import of samples quantity of Abamectin technical 5Kg. For trials and data generation etc.
The Committee approved the import of 3Kg. Of Abamectin Technical for trial and
data generation.
Agenda ItemNo.8.9
Application of Cheminova India Ltd. for permission to import of samples quantity of Abamectin 1.8% EC of 20 liters to conduct
toxicology, Bioefficacy and residue shelf-life and persistence studies, etc.
The Committee approved the import of 20 Lts. of Abamectin 1.8% EC for test
and trials.
Agenda ItemNo.9
Any other item with the permission of the Chair.
(i) Guidelines for Export: The Committee was apprised that the meeting of the Expert
Group to frame the guidelines for export has already been held and as per the decision of
the RC, the guidelines are being forwarded to the Industry Associations for comments.
However, Secretary, CIB&RC apprised that there is one application pending in the
Registration Secretariat for which no guidelines were existing before and have nowbeen
framed by the Expert Group. The Committee decided to process the said application on
the basis of the guidelines as proposed by the Expert Group and to be put up for
consideration of the RC in its forthcoming meeting.
(ii) Infrastructure for issue of manufacturing licence by the States: The
Committee was apprised about the meeting of the Expert Group constituted by the
Registration Committee and the guidelines framed as per the decision of RC, which are
being sent to the Industry Associations for their comments.
(iii) Issue of Free Sale Certificate: The Committee was apprised that the Free Sale
Certificate will be issued by the Registration Secretariat in the following format::
CERTIFICATETO WHOMSOEVER MAY IT CONERN
This is to certify that M/s …………………………………is registered with the
Registration Committee, constituted under Section 5 of the Insecticides Act, 1968, for
manufacturing following products, for use in India as well as export:
S.No. Name of the Insecticide Registration Number
(Complete with coding)
(Dr. (Mrs.) Sandhya Kulshretha)Secretary
CERTIFICATE
TO WHOMSOEVER MAY IT CONERN
This is to certify that M/s …………………………………is registered with the Registration Committee, constituted under Section 5 of the Insecticides Act, 1968, for the Manufacturing of following products for the sole purpose of export:
S.No. Name of the Insecticide (Complete with coding)
Registration Number
(Dr. (Mrs.) Sandhya Kulshretha)Secretary
Outcome of the 7 th meeting of the Core Group of Experts on deemed registered pesticides:
The Committee deliberated in detail and accepted the recommendations given by
the Core Group of Experts in its 7th meeting which are at Annexure.
Expert Group to review pesticides as per Agenda Items No.9.1: ADG(PP)
pointed out that there is no representation from ICAR in the Expert Group constituted
under Agenda Item No.9.1 of 252nd RC meeting. Further, the Committee noted that
there is no Member-Secretary in the said Group. The Committee revised the composition
of the Expert Group as under:
(1) Dr. C.D. Mayee ChairmanChairman, ASRB, New Delhi
(2) Dr. B.S. Parmer MemberJt. Director & former Head, Agril.Chem
(3) Dr. R.A. Triphati MemberProf.& Head, Div. Member ofEntomology, CS Azad Uni. of Agri.& Tech, Kanpur
(4) Dr. Y.S. Ahlawat MemberSr. Scientist (PP)Deptt. of Plant Pathology, IARI, New Delhi
(5) Dr. L.S. Barar MemberProf.& Head, Deptt. of Agronomy,PAU, Ludhiana
(6) Dr. S.N. Saiyed MemberDirector, NIOH, Ahmedabad
(7) Dr. Y.K. Gupta MemberDirector, ITRC, Lucknow
(8) Dr. O.P. Dubey MemberADG, ICAR, New Delhi
(9) Plant Protection Adviser Memberto the Govt. of India, Dte. of PPQ&S, Faridabad
(10) Representative from PFA Div. MemberMin. Of Health & Family Welfare,New Delhi
(11) Representative from Deptt. of Chemicals Member& Petro Chemicals, New Delhi
(12) Representative from Min. of Environment Member& Forests, New Delhi
(13) Dr. S. Kulshrestha Member SecretarySecretary (CIB&RC)
The meeting ended with a vote of thanks to the Chair.
Annexure
APPROVED USAGES, MRL FIXED AND RESIDUES DATA SUBMITTED IN RESPECT OF DEEMED REGISTERED PESTICIDES
Food grains Food grains Food grains Food grains Food grains Food grains ----Oilseeds Oilseeds--OilseedsSugarcane fruit and vegetables fruit and vegetables fruit and vegetables fruit and vegetables fruit and vegetables fruit and vegetables --fruit and vegetables fruit and vegetables fruit and vegetables fruit and vegetables --
Safflower Brinjal Bhindi Cabbage Cauliflower Chilly Onion Potato Snakegourd SpongegourdTomato Apple Apricot Arecanut Banana Ber Betelvine Citrus Fig Litchi Mango Peach Plum Pomegranate Coffee Lucerne Pepper Rose Tapioca Tea
--------------
-----
-
Fruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetablesChilliesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetables--Fruits and vegetablesFruits and vegetables--Fruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetables--------Fruit and vegetables--
------Fruits and vegetables Fruits and vegetablesFruits and vegetablesChillies TeaFruits and vegetables--Fruits and vegetablesFruits and vegetables--Fruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetables----Fruits and vegetables------Fruits and vegetablesFruits and vegetablesFruits and vegetables
------Pigeonpea Bengalgram --Cottonseed Cottonseed oil ----ChilliesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetablesFruits and vegetables--Cardamom----
--Fruits and vegetables ----Fruits and vegetablesFruits and vegetables--
Rice grains ----------fruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetables----fruit and vegetables----fruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetables--
fruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesfruit and vegetablesFruit and vegetablesFruit and vegetables------
Complete (Data submitted for Mancozeb 64% + Metalaxyl 8%)DeleteComplete(Based on Mancozeb)
DeletionDeletionComplete (based on mancozeb)Deletion
NRNRNRNR
28. 2, 4-Dichloro phenoxy acetic acid
Sorghum Maize Wheat
Food grains Food grains Food grains
-- ----
Sugarcane Cherry Potato Tea
CitrusAquatic weeds
--Fruitspotatoes --
Fruits--
--------
----
Complete
Data under generation
NR
NR – Not Required CG – Crop Grouping* These are important commodities for exports. The monitoring data available with Spices Board may be considered for MRL fixation as considered by Codex.** In the national interest label claim is to be retained, as no economical viable alternates are available