Certification of BIS Bromadiolone RB ensures that bromadiolone rodent bait preparations sold in India comply with established standards of quality. Since Bromadiolone RB is a rodenticide based on an anticoagulant mechanism of action, it is extensively used for controlling rat and mouse populations in commercial, industrial and residential areas.
Compliance in case of rodenticides is not limited only to their manufacture but also includes testing and certification procedures. Conformity with IS 12912:1990 ensures that there are no issues concerning the quality, consistency of the formula used, and market acceptability. This article covers details related to the certification of Bromadiolone RB in accordance with the BIS standards.
What is IS 12912:1990 Standard for Bromadiolone RB
IS 12912:1990 is the Indian Standard that specifies requirements for Bromadiolone RB, a ready-to-use rodenticide formulation used for controlling rats and mice in agricultural and storage environments. The standard ensures that the product maintains consistent performance, controlled toxicity, and reliable field effectiveness. As per BIS requirements, Bromadiolone RB formulations are:
- Checked for active ingredient concentration
- Assessed for formulation uniformity
- Evaluated for product stability
- Tested for overall rodent control effectiveness
Eligibility for BIS License under IS 12912:1990
BIS authorisation under IS 12912:1990 is required for businesses involved in manufacturing, importing, or supplying Bromadiolone RB Rodenticide in India.
Applicable to:
- Manufacturers (India) - Need to seek BIS certification for Bromadiolone RB, especially in cases involving a compulsory certificate of quality (QCO).
- Foreign Manufacturers - Need certification to export rodenticide to India.
- Importers/Brand Owners - Must ensure that the products are BIS-certified before sale.
- Sellers/Distributors - They should trade with BIS-compliant Bromadiolone RB products only.
BIS Testing Requirements for Bromadiolone RB
To guarantee stability in terms of formulation, the Bureau of Indian Standards has set requirements for Bromadiolone RB under IS 12912:1990. By obtaining the certificate, the manufacturers of bromadiolone RB will be assured of producing rodenticide baits with an appropriate amount of active ingredients.
The following are the requirements specified by the BIS for Bromadiolone RB:
How to Apply for BIS License under IS 12912:1990
The BIS Certification process for Bromadiolone RB (IS 12912:1990) ensures that the rodenticide formulation meets the required quality, safety and performance standards as prescribed by the Bureau of Indian Standards (BIS). This process includes the following steps:
- Online Registration: Manufacturers register on the BIS Manak portal by submitting company, factory, and product details. Foreign manufacturers must appoint an Authorized Indian Representative (AIR).
- Testing at BIS-Approved Laboratory: Product samples are tested in BIS-approved laboratories for bromadiolone content (HPLC method), formulation uniformity, sieving requirements, and overall product quality and stability.
- Application Submission: The application is submitted along with test reports, technical documents, and factory details. Foreign manufacturers must also submit AIR-related documents.
- Factory Inspection: Inspection by the BIS officers takes place at the factory, where production processes, safety measures, and the quality control system are inspected.
- Grant of BIS License: In case all compliance requirements have been fulfilled successfully, BIS issues the certification under Scheme-I.
- Use of ISI Mark: The ISI mark can be used by the manufacturer once the application for the same is approved.
Required Documents for IS 12912:1990 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 manufacturers have to appoint an Authorized Indian Representative (AIR) within India. This person will act as the local contact person of the Bureau of Indian Standards (BIS).
Marking Requirements under IS 12912:1990
Upon receiving the BIS license for Bromadiolone RB, the BIS Standard Mark should be affixed distinctly and permanently on every single container/packaging. This should contain relevant information, including the identity of the manufacturer and also the legitimate CM/L (Certification Mark Licence) No. assigned by BIS. Further details are provided below:
| Requirement | Details |
|---|
| ISI Mark | Indicates that the product is BIS certified and conforms to standards |
| Standard Number | IS 12912:1990 |
| 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 typically applied using durable stamping, tagging, or permanent printing to ensure clear identification during handling, storage, and transportation, as per BIS marking requirements.
Validity of BIS Certification for Bromadiolone RB
| 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 |
Fees for IS 12912:1990 BIS Approval
The costs associated with BIS Certification for Bromadiolone RB (IS 12912:1990) include the cost of application, factory inspection, product testing, license fee and marking fee. 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 fees are charged by location for foreign manufacturers.
- The marking fee is determined based on the product category and production volume (MSME benefits may apply).
- Test fees should be paid directly to BIS-approved labs.
- The consultancy fee can depend on various factors.
Conclusion
IS 12912:1990 is an essential standard which can be used by manufacturers planning to manufacture Bromadiolone RB in India. The compliance with quality standards laid down will help the manufacturers enhance the quality of their products as well as ensure they meet their regulatory objectives. In addition, manufacturers will also be able to build trust among their distributors and end-users of their products through BIS Certification.
The process of obtaining BIS Certification for Bromadiolone RB can greatly help manufacturers gain access to the market. EVTL India provides services relating to BIS Certification to aid companies in fulfilling their BIS Certification needs.
