BIS Certification for Bromadiolone RB IS 12912

The BIS registration is accredited to only those Bromadiolone RB products that meet the requirements of BIS including active ingredient content, formulation stability, moisture content, packaging, and labelling. After certification, manufacturers are legally allowed to produce, distribute, and market Bromadiolone RB in the Indian market. 

An overview of BIS Certification

The quality and safety requirements of Bromadiolone RB are specified in Indian Standard IS 12912. It addresses important parameters such as the concentration of active ingredients, physical and chemical stability, moisture content, packaging integrity, labelling standards, and storage conditions.

Products of Bromadiolone RB certified under IS 12912 are expected to be highly safe and effective. Manufacturers that meet these requirements are allowed to display the ISI Mark, which guarantees end users the reliability, safety, and regulatory compliance of the products used. 

How does BIS Certification benefits your product?

There are several benefits associated with obtaining a BIS licence for Bromadiolone RB:

1. Better Quality :  Meets IS 12912 requirements and reduces faulty or unsafe products.
2. Compliance with Regulations: Legalizes manufacturing and selling in India; uncertified products can be penalized or prohibited.
3. Market Credibility: ISI-marked Bromadiolone RB generates confidence among customers, distributors, and government officials.
4. Competitive Advantage: BIS-certified products are preferred in tenders, institutional purchases, and exports.
5. Consistent Performance: Predictable formulation and packaging ensure effective rodent control with minimized risks. . 

Important requirements of Indian Standard IS 12912

IS 12912 is the quality and safety standard for Bromadiolone RB as a rodenticide. The standard specifies acceptable concentrations of active ingredients, formulation stability, and moisture content to guarantee efficacy and shelf life.

It also includes packaging requirements to avoid leakage and contamination, as well as mandatory labelling and marking requirements for safe handling and regulatory compliance. Compliance with IS 12912 is necessary to receive BIS Certification and the ISI Mark. 

How to prepare document 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

Step-by-step BIS License process

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. EVTL India Engineer- Factory Inspection : The BIS auditor and an engineer at EVTL India undertake a proper inspection at the factory.
9. Independent Collection of Samples : The BIS auditor draws samples to be tested by the post-audit.
10. Sample Testing at BIS Lab : BIS sealed samples are sent to BIS laboratories, and the BIS department pays the price of testing.
11. 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 BIS Approval takes

According to IS 12912, the approximate schedule of BIS License for Bromadiolone RB is:

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 support does EVTL India provide for BIS Licensing?

EVTL India supports manufacturers with the BIS Certification process through professional advice on the compliance of IS 12912. The team, as a BIS Consultant for Bromadiolone RB assists in documentation, organization of sample testing, and filing on the BIS portal. They also train manufacturers to do BIS factory inspections.

In the case of foreign companies, EVTL India is a BIS Agent of Bromadiolone RB and Authorized Indian Representative (AIR). Collaboration with EVTL India is a sure way of quick and transparent BIS certification hassle-free.

Conclusion

The manufacturers of bromadiolone RB are required to comply with IS 12912 and to be BIS certified to ensure the safety, efficacy, and legality of the products in India. Through the guidance of EVTL India, manufacturers will be able to obtain approvals in an efficient manner, enhance product credibility and have easy access to regulated markets.

Today, partner with EVTL India and ensure that your BIS certification process is quick, painless and hassle-free.

Frequently Asked Questions (FAQs)

1. Should BIS Certifications be required for bromadiolone RB?

Yes, BIS certification (IS 12912) is mandatory in India. 

2. Who is eligible for BIS Certification?

Indian and foreign manufacturers but foreign manufacturers must appoint an AIR. 

3. Is BIS Certification inclusive of packaging and labelling?

Yes, IS 12912 covers packaging, labelling, and storage requirements.

4. What tests are conducted under IS 12912?

Tests included are active ingredient concentration, stability, moisture content, packaging, and marking compliance. 

5. Can foreign manufacturer get BIS Certification?

Yes, by an Authorized Indian Representative (AIR).