BIS Certification for 2,4-D Ethyl Ester EC IS 10243

BIS Certification for 2, 4- D Ethyl Ester EC in IS 10243 will help guarantee that the product is in compliance with Indian Standards of composition, efficacy, safety, and stability. The certification will offer confidence to farmers, regulators, and authorities that the herbicide formulation is trustworthy, viable and safe to use under the Indian agricultural environment conditions.

What does BIS License mean?

An IS 10243 BIS License known as 2,4-D Ethyl Ester EC authorizes manufacturers to manufacture, store, sell and distribute 2,4-D Ethyl Ester EC bearing the ISI Mark. The certification provides that the product satisfies the quality, safety, and performance standards which are established by the Bureau of Indian Standards.

BIS licensing procedure includes testing of products in BIS-approved test labs and inspection of factories, review of manufacturing and quality control systems and continuous surveillance. The mandated BIS certification is required in those places where notified and is necessary in the legal manufacture and sale of agrochemical products in India.

Why is ISI Certification necessary for manufacturers?

The ISI Certification of 2,4-D Ethyl Ester EC is valuable to manufacturers because of the following reasons:    

1. Quality Assurance : The compliance with required composition, purity, and formulation.
2. Safety & Performance : Proves efficacy, stability, and safe use under recommended conditions.
3. Regulatory Compliance : Helps manufacturers comply with the statutory and agrochemical regulations in India.
4. Market Acceptance : Increases acceptance by the farmers, distributors, governmental agencies and institutional buyers.
5. Brand  Trust & Credibility : Develops trust through showing compliance with the Indian standards of quality and safety.

Technical specifications of IS 10243

IS 10243 is a specification of the technical and quality standards of 2,4-D Ethyl Ester EC, which is:

• Content and tolerance limits of active ingredients.
• Emulsion stability
• Acidity/alkalinity
• Moisture content
• Flash point requirements
• Storage conditions stability.
• Packaging and labeling specifications.
• Sampling and testing procedures. 

The adherence to the IS 10243 leads to the effectiveness, stability, and safety of the herbicide formulation to use in agriculture. 

Document list required for BIS registration 

The following documents are necessary for Domestic Manufacturers:

1. List of raw material
2. Layout plan of the factory premises
3. List of testing equipment as per the Indian standard
4. Quality Control (QC) Personnel Details (Education degree and Aadhaar card)
5. GST
6. Authorized Person Aadhar & Pan Card
7. MSME
8. Electricity Bill
9. Email Address & Permanent Contact Number
10. Office Address
11. Factory Address
12. Copy of Partnership Deed / MOA (for Private Limited Co.)
13. Premises document / Rent Agreement
14. List of Manufacturing Machinery  

The following documents are necessary for Foreign Manufacturers:

1. Checklist for Application
2. Copy of Swift Remittance
3. Duly Filled Application Form
4. Copy of Business License
5. List of Machinery
6. List of Raw Material
7. Test certificate of Raw Material
8. List of Testing Equipment
9. Calibration certificate of Test Equipment
10. Process Flowchart
11. Layout Plan
12. Location Plan (Route Map)
13. Details of Technical Personnel
14. Qualification of QC
15. Copy of Certification of Product and/ System
16. Factory Test Report  
17. Agreement with AIR
18. Aadhar Card of AIR
19. AIR Nomination Form
20. Educational Degree of AIR
21. Undertakings
22. Scope of License

Stepwise procedure for BIS Certification

There are two key procedures to get your BIS license: Simplified and Normal.

Simplified Procedure

The steps involved in the simplified procedure are:

1. Document Collection : All the necessary KYC and technical documents are collected in order to start the BIS application without problems.
2. BIS Portal Registration : The license application is processed by the manufacturer being registered on the official portal of BIS.
3. Pre-Testing of Samples : Before submission, product samples are tested in a BIS authorized laboratory.
4. In-House Lab Requirement : Depending on the product, an internal laboratory facility might be necessary according to the BIS requirements.
5. BIS Review & Clarifications : BIS examines the submissions of documents and test reports and may request clarification.
6. BIS Audit at Factory : The audit of the product samples carried out by the BIS inspectors is done at the factory. 
7. Timely Audit Completion : The audit, inspection and sample collection are conducted within 17 days of the application submission along with the EVTL India engineer.
8. Independent Collection of Samples : The BIS auditor draws samples to be tested by the post-audit.
9. Sample Testing at BIS Lab : BIS sealed samples are sent to BIS laboratories, and the BIS department pays the price of testing.
10. Grant of BIS License : Upon satisfactory document inspection, testing and audit, ISI license is issued. 

Normal Procedure

The steps involved in the normal procedure are:

1. Submit Documents : Firstly, it is required to submit all the KYC and technical documentation to start the BIS application.
2.  Plan In-House Laboratory and Technical Proposal : Prepare an internal lab in case necessary and prepare all technical documentation.
3. Ready Factory Test Report (FTR) : Carry out in-house tests and document the FTR to demonstrate that the product is to the standards.
4. Submit Application & Fees : Includes your BIS application and the amount of fees necessary by the government.
5. BIS Audit : An audit of documents and processes at a BIS takes place within 3 weeks.
6. EVTL India Engineer Factory Inspection : BIS auditor inspects the factory with an EVTL India engineer to make sure that everything is in order. 
7. Sample Collection & Sealing : The BIS auditor picks samples randomly, puts them into a sealed sample and forward the sample to a BIS authorized lab to be tested.
8. License Approval : After the lab tests of the sample are passed-on, BIS issues the ISI license, and your product is certified and market-ready. 

How long does the BIS Licensing process take?

According to IS 10243, a BIS license 2,4-D Ethyl Ester EC is expected to take: 

For Simplified Procedure (Indian manufacturers)

Average 40-45 days

For Normal procedure  

• For Indian Manufacturers : 50-60 days
• For International Manufacturers : Approximately 180 days  

What makes clients choose EVTL India ?

EVTL India has been a reliable BIS consultant for 2,4-D Ethyl Ester EC at IS 10243. The company also offers end-to-end support, such as documentation, BIS portal management, interaction with BIS certified laboratories, technical advice, and support when inspecting the factories. EVTL India assists foreign and Indian manufacturers to have compliant, cost-effective and time-bound solutions of BIS certification. 

Conclusion

The 2,4-D Ethyl Ester EC according to the IS 10243 requirements needs certification as a BIS to secure the quality, safety, regulatory compliance, and acceptance of the products. The certification protects the agricultural activities and creates confidence between the users and authorities.

Through the expert advice of EVTL India, the manufacturers will be able to ease the BIS licensing process and easily launch ISI-marked agrochemicals products in the Indian market.

Frequently Asked Questions (FAQs)

1. Is 2, 4-D Ethyl Ester EC 2 , 4-D EC 2, 4-D EC BIS Certified in India?

Yes, BIS certification (under IS 10243) is obligatory wherever indicated.

2. Who is allowed to apply for BIS Certification under IS 10243?

Both foreign manufacturers and Indians can apply. The foreign manufacturers should have an Authorized Indian Representative (AIR). 

3. Which are the tests that are carried out in relation to IS 10243?

Such tests involve active ingredient content, emulsion stability, moisture content, acidity, flash point and storage stability.

4. Is it possible to have foreign manufacturers acquire ISI certification?

Yes, should appoint an AIR in India. 

5. Is ISI marking required following the certification?

Yes, the ISI marking on the product and the packaging is compulsory after BIS certification.