Guidelines for Registration of Insecticidal Formulations for Use in Aircraft Disinsection

Guidelines for registration of insecticidal formulations for use in aircraft disinsection (As approved in 280th meeting of RC held on 6th September, 2007)

General requirement 1. All insecticides for aircraft disinsection must be manufactured only from the technical grade insecticides which are registered under the Insecticides Act, 1968

2. Data on insecticides formulation shall be considered along with the data on technical grade insecticides and not in isolation.

Data requirement from Chemistry parameters

The common name of the aircraft disinsection insecticides which is to be printed on the labels and leaflets should be written as aircraft disinsection insecticide containing ‘X’……. %w/w and ’Z’…………%w/w etc.

1. Chemical composition and allied data requirement

1.1 Source of supply of the technical grade material with minimum purity to be used in the formulation should be given.

2. Chemical composition

2.1 Complete chemical composition of the formulation should be submitted.

2. Complete data on the identity and physico-chemical characters of various ingredients of the formulation should be submitted.

2.3 The chemical composition for the formulation should include the kind, name and percentage of all the ingredients that is to be used in the formulation.

2.4 “The number of active ingredients in the aircraft disinsection combination product should not be more than two. However, if any applicant is able to submit satisfactory method of analysis for more than two active ingredients in the combination product, the Committee may consider such request on its merit”.

Specification Wherever no specifications are available, the Registration Secretariat may harmonize specification evolving its own procedure. Analytical Test Report

The analytical test report giving the analysis of a particular batch of all the

D:\Docs\2018-04-27\0227af5889190f56f32f2a864a52cb23.doc parameters included in the specifications shall be submitted from an independent reputed National/International laboratory. Shelf life data The expected shelf life claim for the product along with the supporting data be submitted. This data should confirm to the guidelines prescribed by the Central Insecticides Board.

Method of analysis Wherever available, an BIS method for analysis is followed.

The methods for the analysis of various active ingredients used in a formulation be provided. As far as possible, single, multiple insecticides analysis method be suggested.

For identification of active ingredient in the formulation, suitable qualitative methods may be developed and provided followed by detailed analysis as for quantification as stated above.

Bioefficacy claims to be given on the labels i A brief direction concerning the major usage of the insecticide should be given on the labels. ii Wherever the Registration Committee has approved the product for restricted use, this should be indicated very clearly on the labels in capital letters. ‘For ______use only” iii Instructions regarding insecticide ‘Note to be used on any food as well as crops to be given’.

Bioefficacy claims to be given on the leaflets i Detailed information on the usage of insecticide indicating the names of insects, method of application, dosage, places of treatments, appliances to be used etc. should be given in paragraph forms. Common name of the insects should be given. ii Wherever the Registration Committee has approved the product for restricted use, this fact should be indicated very clearly on the leaflets in bold letters. iii Instructions regarding insecticide ‘Not to be used on any food crop to be given’

Bioefficacy and residue data i Bioefficacy test on the proposed formulation should be conducted in Indian conditions minimum 2 trials in each of 3 National Laboratories / NABL accredited laboratories, recognized by Government of India. ii Data on persistence of pesticides on commonly used surfaces in the aircrafts and concentration in air, as applicable, should be generated in three National

D:\Docs\2018-04-27\0227af5889190f56f32f2a864a52cb23.doc Laboratories/ NABL accredited laboratories.

Toxicology 1 Acute oral rat and mice

2. Acute dermal

3. Acute inhalation

4. Primary skin irritation

5. Irritation to mucous membrane

6. Health monitoring studies on spray men and/or volunteers on board as per the protocol to be approved by the Registration Committee-(NR per decision of 318th RC held on 27-04-2011).

Packaging and labeling A Type of packaging

1. Specification of primary packaging system.

2. Specification of secondary packaging system.

3. Specification of transport packaging system.

B Manner of packing Detailed information with reference to method by which inner most pack shall be further packed in secondary and transport packing.

C Container content compatibility study As per relevant B.I.S. method

D Manner of labeling Method of labeling as per requirements of Insecticides Rule, 1971 along with direction of use. E Labels and leaflets 7 copies of labels and leaflets as per requirements of Insecticides Rule, 1971 for 1. Small size packing up to 250ml capacity and below

2. Large size packing up to 500ml capacity and above.

Note: The above guidelines are for registration of those insecticidal formulations whose technical grade material is registered u/s 9(3) of the Insecticides Act, 1968.

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