The 2,4-D Ethyl Ester EC formulation is widely used for weed control purposes in agricultural practices involving broad-leaf weed control in cereal and plantation crops. Proper concentration of chemicals and stability of the formulation are essential factors that determine its efficiency in terms of its use in the field. Given the fact that such agrochemicals affect the well-being of plants and environmental balance, failure in the formulation parameters can result in significant agricultural and ecological dangers.
Certification of the 2,4-D Ethyl Ester EC by BIS, as per standard IS 10243:1993, ensures that the formulation is tested for its chemical parameters and safe use. The testing process ensures safe usage of pesticides in agriculture. The standard helps in maintaining uniformity of the product quality from different manufacturers.
What is IS 10243:1993
This is the Indian Standard for 2,4-D Ethyl Ester Emulsifiable Concentrate (EC) used as a selective herbicide in agricultural applications. It specifies the requirements, sampling methods, and tests to ensure the quality, stability, and effectiveness of the formulation. As per the Bureau of Indian Standards (BIS), Ethyl Ester is:
- Assessed for emulsion stability
- Evaluated for storage stability
- Tested for physicochemical properties
- Checked for active ingredient conformity
Who Needs BIS Approval
BIS certification under IS 10243:1993 is required for businesses involved in manufacturing, importing, or supplying 2,4-D Ethyl Ester EC in India.
Applicable to:
- Manufacturers (India) - Must get BIS approval if the products are covered under QCO.
- Foreign Manufacturers - Need certification to export the herbicide to India.
- Importers/Brand Owners - Must ensure that the products are BIS-certified before sale.
- Sellers/Distributors - Should only sell certified 2,4-D Ethyl Ester EC.
Testing and Inspection Requirements
In order to maintain consistency in the quality of 2,4-D Ethyl Ester EC used for weed control in agriculture, the Indian Bureau of Standards specifies the minimum criteria that should be followed by IS 10243:1993. This certification guarantees the manufacture of formulations containing the necessary specifications of performance.
The BIS testing parameters and quality checks for the 2,4-D Ethyl Ester Emulsifiable Concentrate are listed below:
Step-by-Step BIS Licensing Process
BIS Authorisation makes sure that the formulation 2,4-D Ethyl Ester EC (IS 10243:1993) fulfills all necessary qualities of safety and efficacy in agriculture use. The process of BIS certification involves the following steps:
- Online Registration: Manufacturers register themselves in the BIS Manak portal using company, factory, and product information. Foreign manufacturers will have to have an Authorized Indian Representative (AIR).
- Testing at BIS-Approved Laboratory: Product samples are tested in BIS-approved laboratories for compliance as per the IS 10243 standard.
- Application Submission: The BIS personnel will visit the manufacturing plant to check various aspects including production, safety, and quality control process.
- Factory Inspection: BIS officials visit the manufacturing facility to evaluate production processes, safety measures, and the quality control system.
- Grant of BIS License: Once all the criteria for compliance are fulfilled, BIS issues the license under Scheme-I.
- Use of ISI Mark: Upon obtaining approval, the manufacturer gets permission to apply the ISI mark to their product along with a proper CM/L Number.
Documentation Checklist for IS 10243:1993 Approval
| Document Category | Documents Required |
|---|
| Basic Details | GST Certificate, Email ID & Contact Number, Factory & Office Address, Rent Agreement / Lease Deed (if applicable),Partnership Deed (if applicable for partnership firms) |
| Manufacturing Details | List of Machinery, Process Flow Chart, Factory Layout Plan |
| Raw Material Details | List of Raw Materials, Supplier Details, Raw Material Invoices, Raw Material Test Certificates |
| Testing & Quality Control | List of Testing Equipment, Calibration Certificates, QC/Lab In-charge Appointment Letter & Qualification |
| Production Details | Annual Installed Capacity, Last Year Production Value |
| Product & Packaging Details | Quantity per Package, Nature of Packing, Product Printing / Marking Details |
| Management Details | Top Management Details, BIS Communication Contact Person |
| Brand & Certification Documents | Trademark / Brand Certificate, Consent Letter from BIS Recognized Laboratory |
| Additional Documents | Weekly Off Details, Hygiene Document (if applicable), Relaxation Letter (if applicable), Any Other Relevant Document |
| Foreign Manufacturer Requirement | Appointment of Authorized Indian Representative (AIR) for BIS coordination and compliance in India |
The Foreign manufacturer should appoint an Authorized Indian Representative (AIR). The AIR serves as the point of contact between BIS and the manufacturer and deals with all regulatory issues within India.
BIS Marking Guidelines for 2,4-D Ethyl Ester EC
Once the company receives the BIS license, the ISI Mark for Ethyl Ester emulsifiable concentrate agrochemical should be clearly written on the package. This will ensure that the product meets all the required standards. More information is provided below:
| Requirement | Details |
|---|
| ISI Mark | Indicates that the product is BIS certified and conforms to standards |
| Standard Number | IS 10243:1993 |
| CML Number | Certification Marks License (CML) number issued by BIS |
| Manufacturer Details | Name of manufacturer or registered trademark |
| Batch / Date | Batch number, heat number, or manufacturing date for traceability |
Note: Marking is normally done through stamping, tagging or permanent printing of letters so that identification is made clear during handling, storage and transport, according to BIS marking guidelines.
Renewal Process and Compliance Monitoring Under IS 10243:1993
| particulars | Details |
|---|
| Initial Validity | Typically 1 to 2 years, depending on BIS approval conditions |
| Renewal | Must be renewed before expiry by submitting the application along with the prescribed fee and updated documents |
| Surveillane | BIS may inspect factories and test samples periodically |
| Annual Fees | Annual license fee must be paid regularly |
| Compliance | Continuous compliance with BIS requirements is necessary |
| License Format | BIS is shifting towards a 10-digit license number format |
| Non-Compliance Risk | May lead to suspension or cancellation of license |
BIS Certification Cost Breakdown for IS 10243:1993
The BIS Approval fee for herbicide includes charges for application, inspection, license, testing, and marking. These fees are paid to BIS as per Scheme I guidelines.
| Charge Type | Indian Manufacturers | Foreign Manufacturers |
|---|
| Application Fee | INR 1,000 | USD 15 |
| Audit Charges | INR 7,000 | USD 3,200 – 5,900 |
| License Fee | INR 1,000 | USD 15 |
| Marking Fee | As applicable | As applicable |
| Testing Charges | As applicable | As applicable |
| EVTL India Consultancy Fee | As per actual | As per actual |
Note:
- Application fee for foreign manufacturers is payable via SWIFT (SAARC countries may pay in INR with applicable GST).
- Audit charges for foreign manufacturers vary based on country/location.
- The marking fee is determined based on the product category and production volume (MSME benefits may apply).
- Testing charges are to be paid directly to BIS-recognised laboratories.
- Consultancy fees can vary depending on product type and factory location.
Conclusion
BIS Certification for 2,4-D Ethyl Ester EC as per IS 10243:1993 creates a strong regulatory system that guarantees uniformity in herbicide composition and safety of agricultural application. This system reduces all potential risks associated with any chemical imbalance, lack of proper weed destruction, and environmental pollution by ensuring quality standards. Certification benefits manufacturers in ensuring compliance in regulations and building product credibility, both domestically and internationally. EVTL India has a systematic compliance process that helps in following the documentation, laboratory testing procedures and approval from BIS for certification requirements as per IS 10243 standards.
