COMPLIANCES APPLICABLE TO PESTICIDES
A. Registration and Licensing
1.1 Registration of Pesticide: The importer or manufacturer of any pesticide is required to obtain the registration for such pesticide by making application in Form I before the Registration Committee, along with the applicable fee. The certificate of registration is issued within a period of twelve (12) months from the date of receipt of application (extendable to a further period of six (6) months). It is important to note that a provisional registration is provided for a period of two (2) years in case of introduction of a new pesticide in the country.
1.2 License: In order to manufacture or to sell, stock or exhibit for sale or distribute any pesticide, an application for grant of license in Form II, is required to be made before the licensing officer, along with applicable fee. The license is granted by the licensing officer on his satisfaction that the necessary plant and machinery, safety devices, etc. are made available in the manufacturing premise.
1.3 It is pertinent for the person filing the application for manufacturing license to possess or to employ a person who possesses, the requisite educational qualification, i.e.,
(a) Doctorate in chemistry or agriculture chemistry or agriculture chemicals or Master of Technology or Master of Science in chemical engineering or equivalent for manufacture of technical grade pesticides; or
(b) Master’s degree in science with chemistry or agricultural chemistry or agriculture chemicals or equivalent as one of the subjects for manufacture of pesticide formulation.
1.4 The person applying for grant of license to sell, stock or exhibit to sell or distribute pesticides shall possess or employ a person who possesses the following educational qualification:
(a) graduate degree in Agricultura Sciences or Biochemistry or Biotechnology or Life Sciences or in Science with Chemistry or Botany or Zoology from a recognised university or institute or,
(b) one year diploma course in Agriculture or Horticulture or related subjects from any government recognised university or institute with course content on plant protection and pesticides management.
1.5 The license to sell, stock or exhibit for sale or distribute pesticides issued in Form III, needs to be displayed at a prominent place in the premises which is open to the public.
B. Packaging and Labelling Requirements
2.1 Prior approval shall be obtained from the Registration Committee with respect to the packages containing the pesticides.
2.2 Every package shall contain leaflet providing for the following details:
(a) The plant disease, insects and noxious animals or weeds for which the pesticide is to be applied, the adequate direction concerning the manner in which the pesticide is to be used at the time of application;
(b) Particulars regarding chemicals harmful to human beings, animals and wild life, warning and cautionary statements including the symptoms of poisoning, suitable and adequate safety measures and emergency first-aid treatment where necessary;
(c) Cautions regarding storage and application of pesticides with suitable warnings relating to inflammable, explosive or other substances harmful to the skin;
(d) Instructions concerning the decontamination or safe disposal of used containers;
(e) A statement showing the antidote for the poison shall be included in the leaflet and the label.
(f) If the pesticide is irritating to the skin, nose, throat or eyes, a statement shall be included to that effect;
(g) Common name of the pesticide as adopted by the International Standards Organisation and where such a name has not yet been adopted such other name as may be approved by the Registration Committee;
(h) The information furnished on the label in English and Hindi shall be translated and published on the leaflet in Hindi, English and in the regional language of the region where the product is proposed for sale;
(i) The leaflet shall be printed legibly and font size of the text shall be not less than eight points (8) or 2mm;
(j) Safety pictograms provided on the label and others, if any, shall also be printed on the leaflet;
(k) Leaflet shall contain advice to physicians for treatment in cases of poisoning
(l) Details of label claims and directions for use with reference to target organism and crop shall be printed on the leaflet;
(m) Good practices relating to pesticide application techniques covering the following shall be provided for each crop or recommended other use, whichever is applicable, namely (i) weather conditions in general, (ii) soil and water, wherever applicable, (iii) crops stage for application, (iv) application techniques, (v) equipment type, (vi) nozzle type, (vii) dosage (include gram active ingredient formulation and dilution in litres), (viii) instructions for mixing, (ix) re-entry period, (x) pre-harvest interval, (xi) application timings, (xii) fertilisers including maximum number of sprays;
(n) Stages during which pesticides should not be applied on any crop shall be furnished;
(o) Precautions to be taken to avoid harm to the beneficial insects like honey bees and natural enemies of pests shall be furnished;
(p) The leaflet shall also contain the practices to be followed for usage of pesticides in confined areas, such as glasshouses, polyhouses, nursery beds, storage structures, fumigation chambers and public dwellings;
(q) The warning directing the users not to re-use the containers- “Dangerous to re-use empty containers” shall be printed in bold letters;
(r) Directions for safe disposal of used containers shall be provided;
(s) Instructions on leaflets shall be appropriately coloured or printed in bold to draw attention of all users;
(t) Company shall furnish all information about the label and leaflet on their website and the address of the website shall be printed on the leaflet; and
(u) The leaflet for the pesticide formulations shall be secured to primary pack or inserted or kept in between primary and secondary packing or pouch.
2.3 The packages containing pesticides shall be labelled inter alia the following manner:
(a) The label shall have either one, two or three panels and shall be printed only in English and Hindi languages
(b) The minimum size of all label panels shall be according to the size affixed on the face of the package. There shall be three types of labels depending on the content as prescribed under Rule 19 of the Insecticides Rules which inter alia includes
(i) The name of pesticide (brand name or trade name under which the pesticide is sold), along with the common name as approved by Registration Committee
(ii) The instructions to “Read Leaflet Before Use” shall be placed on the top of the label in bold, in a prominent place at least in English and Hindi languages in all package sizes. In addition, for big pack size in all such regional languages where it is proposed for sale.
(iii) The directions for use, manner and time of application and broad category of pests on which it is registered to apply.
(iv) The dosage (include gram active ingredient, formulation and dilution in litres and area) (Please refer leaflet for details).
(v) The purpose of the chemical shall be mentioned on the label, for example— for agricultural use
(vi) The optimal re-entry period after each application of pesticide as approved by the Registration Committee.
(vii) The safety precautions as approved by Registration Committee.
(viii) The composition of the formulation or pesticides.
(ix) The symptoms of poisoning and first aid.
(x) The antidote statement.
(xi) The name of the manufacturer and marketer.
(xii) The imported and re-packed by (wherever applicable), marketed by.
(xiii) Registration number of the pesticide and the manufacturing license number.
(xiv) Batch number, manufacturing date along with the expiry date.
(xv) Maximum Retail Price (MRP) Inclusive of all taxes.
(xvi) Net content weight or volume (in metric system).
(xvii) Cautionary statement,—
Not to be used for any purpose other than those subscribed on label and leaflets;
Destroy the container after use as directed on leaflet; and
Any other warning or cautionary statement as approved by Registration Committee.
(xviii) Customer care details.
(xix) QR Code shall be placed on retail pack for opening the URL of the manufacturing company and to take the user to the entire unique information of label and leaflet and the QR code shall contain at least the following information:
Unique Identifier or GTIN;
Batch Number;
Date of Manufacturing;
Date of Expiry; and
Web link or URL.
(c) The label shall be printed legibly with indelible ink in English and Hindi languages in the font sizes not less than the size prescribed under Rule 19 of the Insecticides Rules.
(d) The ultra small or small packages shall also be packed in a secondary pack and manufacturer shall ensure leaflet and QR code be securely attached with each primary pack before packing them in one secondary pack.
(e) For ultra-small packs, multiple primary packs may be packed in one secondary pack and the manufacturer shall ensure leaflet and QR code be securely attached with each primary pack before packing them in one secondary pack.
(f) The label shall contain in a prominent place and occupying not less than one-sixteenth of the area of the panel or four-square centimetres whichever is greater, a square, set at an angle of 45 degrees (diamond shape). The dimension of the said square shall depend on the size of the package on which the label is to be affixed. The upper portion of square shall contain the following symbols and warning statements:
(i) Pesticides belonging to Category I (Extremely toxic) shall contain the symbol of a skull and cross-bones and the word “POISON” printed in red. The following warning statements shall also appear on the label at appropriate place, outside the triangle – “KEEP OUT OF THE REACH OF CHILDREN”; “IF SWALLOWED, OR IF SYMPTOMS OF POISONING OCCUR CALL PHYSICIAN IMMEDIATELY.”
(ii) Pesticides in Category II (Highly toxic) will contain the word “POISON” printed in red and the statement “KEEP OUT OF THE REACH OF CHILDREN”; shall also appear on the label at appropriate place, outside the triangle.
(iii) Pesticides in Category III (Moderately toxic) shall bear the word “DANGER” and the statement “KEEP OUT OF THE REACH OF CHILDREN”; shall also appear on the label at suitable place outside the triangle.
(iv) Pesticides in Category IV (Slightly toxic) shall bear the word “CAUTION”.
The lower portion of the square shall contain the following colours:
Classification of the Pesticides | Medium lethal dose by the oral route (acute toxicity) LD 50 mg/kg body weight of test animal | Medium lethal dose by the dermal route (dermal toxicity) LD 50 mg/kg body weight of test animal | Colour of identification brand on the label |
---|---|---|---|
| 10 – 50 | 1 – 200 | Bright red |
| 51 – 500 | 201 – 2000 | Bright yellow |
| 501 – 5000 | 2001 – 20000 | Bright blue |
| More than 5000 | More than 20000 | Bright green |
(g) The label shall be affixed in the package containing pesticides which are highly inflammable shall indicate that it is inflammable or that the pesticides should be kept away from heat or open flame and the like.
(h) The label of the big package shall be printed with indelible ink displaying all contents of Rule 19(1)(i). The big package may also be packed in a secondary pack.
(i) The label shall be printed at least in English and Hindi languages unless stated otherwise. The leaflets attached to the package containing pesticides shall be printed in Hindi, English and such regional languages in use in the areas where the said packages are likely to be stocked, sold or distributed.
(j) Labelling of pesticides must not bear any unwarranted claims for the safety of the product or its ingredients. This includes statements such as ‘SAFE’, ‘NON-POISONOUS’, ‘NON-INJURIOUS’ or ‘HARMLESS’ with or without such qualified phrase as “when used as directed”.
2.4 The manufacturer is required to pack every container of the pesticide in the following manner:
(a) The package shall bear the particulars as specified by the Controller
(b) The container shall be packed and sealed such that the contents cannot be tampered with without breaking the seal.
(c) The bags containing pesticide shall be stitched in such a manner that the contents cannot be tampered with or without visible break in the stitching.
2.5 Any inscription or mark made by the manufacturer on the container, label or wrapper of any pesticide shall not be altered.
C. Import of pesticides
3.1 Pesticides shall only be imported through one of the following places:
(a) Inland Container Depot, Gurugram, Haryana.
(b) Chennai Port, Jawaharlal Nehru Port and Mumbai Port (Mumbai), in respect of pesticides imported by sea.
(c) Chennai International Airport (Chennai), Chhatrapati Shivaji International Airport (Mumbai), Indira Gandhi International Airport (New Delhi), in respect of pesticides imported by air into India.
D. Sale through e-commerce
4.1 A licensee may undertake sale of any pesticide through e-commerce entity for supply of pesticides to farmers. Such licensee shall comply with the provisions of the Insecticides Act and rules made thereunder as well as provisions of the Consumer Protection (E-Commerce) Rules, 2020 (as discussed under Annexure E above). The e-commerce operator before engaging with the licensee for sale, shall verify the validity of the license issued by the concerned Licensing Officer of the respective state.
E. Other Compliances
In addition to the above requirements, the Pesticides Laws prescribe inter alia the following key compliances:
5.1 No person shall manufacture or import the pesticides for supply, wherein:
(a) the label provides for any false or misleading information (in the form of statement, design, graphic representation);
(b) the package is deceptive with respect to its contents;
(c) the pesticide is an imitation of another pesticide or is sold under the name of another pesticide;
(d) the label does not provide for warning or caution necessary to prevent risk to human beings or animals;
(e) the relevant information as required under the Insecticides Act is not displayed on the label in conspicuous manner or displayed as a customary condition of purchase and use;
(f) the registration number is different from the registration number of respective pesticide;
(g) the toxicity is higher than the prescribed level; or
(h) the pesticide has been mixed or packed with any substance to alter its nature or quality or it contains any substance which is not covered under the registration.
5.2 No person shall manufacture, import, formulate, transport, sell, use any pesticide enlisted in Schedule to the Pesticides (Prohibition) Order, 2018 (“Pesticides Prohibition Order”). The said Schedule to the Pesticides Prohibition Order is extracted in Annexure R (Pesticide Prohibition Schedule) attached herewith.
5.3 The manufacturers and distributors shall keep sufficient stocks of first aid tools, equipment, antidotes, medicine and injections to treat poisoning resulting from the inhalation, skin or eye contamination and swallowing. The workers shall be provided with protective clothing and respiratory devices in accordance with Rules 39 and 40 of the Insecticides Rules.
5.4 Disposal of pesticides: The manner of disposal as prescribed under Insecticides Rules has been discussed hereinbelow:
S. No. | Description | Manner of Disposal |
---|---|---|
(a) | Surplus Material and washings | The manufacturers, formulators and operators shall dispose the surplus and washings in safe manner which prevents environment or water pollution. |
(b) | Used packages | The manufacturers, formulators and operators shall dispose the used packaged in safe manner which prevents environment or water pollution. Further, the used packages shall not be left outside to prevent their re-use and shall be broken and buried away from habitation. |
(c) | Date expired pesticides | The date expired pesticides shall be kept by the licensee in a separate place demarked for the purpose with a declaration “date expired insecticides” to be exhibited conspicuously. The record of such stock shall be maintained in Appendix A to Form III. Such stock shall then be disposed of in a manner that is environment friendly, as prescribed by the Central Government. |
5.5 Conditions for storage: The following conditions with respect to the storage of fertilisers shall be followed:
(a) Conditions of packaging while transporting: The pesticides shall be transported and stored in such a manner that they do not come in direct contact with food stuff or animal feed. The pesticides shall be packed in accordance with the conditions prescribed in the red tariff, when transported by rail. In case of any leakage, the transport agency shall take such measures to prevent poisoning and pollution of soil or water, if any.
(b) Conditions for storage of pesticide: The packages shall be stored in separate rooms or premises, away from other articles. Such rooms or premises shall be well-built, dry, well-lit and ventilated and of sufficient dimensions.
It is pertinent to note that no person shall manufacture, store or expose for sale or permit the sale or storage of any pesticide in the same building where any consumable article for humans or animals are manufactured, stored or exposed for sale.
5.6 In case ‘Sulphur’ or its formulations are used as pesticide, all licenses shall observe precautions to prevent its theft; report the theft to the nearest police station, if any; and maintain separate register of the persons and their address, to whom it has been sold or distributed.
5.7 All sales of pesticides shall be made by a bill or cash memo or credit memo in the manner prescribed under Rule 15 of the Insecticides Rules. Further, the importers and manufacturers shall maintain the stock register, books of accounts and register for sale, manufacture or import of pesticides as per Rule Further, the Controller may direct the manufacturer or dealer to maintain the books, accounts and records relating to the manufacture and sale of the pesticides, to submit returns or statement or to produce the stocks, accounts or records, when so required for inspection in the manner specified by the Controller.