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BIS Certification for Bromadiolone CB IS 12913

The use of inconsistent rodenticides may cause serious issues in warehouses, grain silos, food manufacturing plants and agriculture. The inability of the active formula to conform to quality standards may result in ineffectiveness, which in turn would cause the loss of goods and production interruptions. In order to address this issue, a standardized testing of quality and conformance of Bromadiolone Bait Concentrate products has been established through the process known as BIS Certification of Bromadiolone CB.

It is now becoming mandatory for Indian manufacturers and importers to prove their conformity through proper testing and regulation. The requirements mentioned under IS 12913:1990 are useful in determining the Bromadiolone CB formulations quality. Therefore, knowledge of the certification process is vital to those intending to comply with relevant regulations.

What is IS 12913:1990

IS 12913:1990 defines the Indian Standard applicable to Bromadiolone CB, a concentrated bait formulation used in pest control operations across industrial and agricultural sectors. It focuses on maintaining formulation accuracy and dependable performance under real usage conditions. Under BIS evaluation, Bromadiolone CB products are:

  • Verified for chemical composition accuracy
  • Checked for mixing and uniformity consistency
  • Assessed for performance effectiveness
  • Evaluated for stability under storage conditions

Who should obtain BIS Approval for Bromadiolone CB

BIS authorisation under IS 12913:1990 is required for businesses involved in manufacturing, importing, or supplying Bromadiolone CB in India.

Applicable to:

  • Manufacturers (India) - Must get BIS approval if the products are covered under QCO.
  • Foreign Manufacturers - Need certification to export the Bromadiolone CB Pest Control Bait to India.
  • Importers/Brand Owners - Must ensure that the products are BIS-certified before sale.
  • Sellers/Distributors - Should only sell certified Rodenticide Bait Concentrate.

Testing Requirements for IS 12913:1990 Compliance

To maintain consistency in concentrated rodent bait formulations used across agricultural and industrial applications, IS 12913:1990 establishes defined quality standards for Bromadiolone CB. This certification ensures controlled composition accuracy and dependable pest control performance under practical usage conditions.

The BIS testing parameters and quality checks for the Bromadiolone CB are listed below:

Test Group What is Tested What is Tested
Sieving / Particle Size Test Material passing through a 75-micron IS sieveEnsures proper fineness and uniform distribution for effective bait performance
Active Ingredient Content Test Bromadiolone concentration using the HPLC method Ensures correct chemical potency (0.25% CB) for effectiveness and safety compliance
Formulation Uniformity Test Distribution of active ingredient within batch/mixture Ensures homogeneous mixing and consistent toxicity level throughout the product
Packaging & Labeling InspectionContainer labeling, BIS Standard Mark, licence number, mandatory declarations Ensures regulatory compliance and correct product identification in the market
Control Unit Verification Entire batch mixed in single operation Ensures traceability and batch-wise conformity control as per the BIS scheme
Sampling & Batch Testing Control Sample from each control unit or consignment Ensures statistical and batch-level quality verification
Storage Stability (Indirect Check) Expiry date declaration, physical stability during storage Ensures product remains stable and effective over shelf life

Procedure for BIS Approval of Bromadiolone CB in India


The BIS Certification process for Bromadiolone CB (IS 12913:1990) ensures that the rodenticide bait concentrate meets the required quality, safety, and performance standards prescribed by the Bureau of Indian Standards (BIS). This process includes the following steps:

  1. 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).
  2. Testing at BIS-Approved Laboratory: Product samples are tested in BIS-approved laboratories for bromadiolone content, formulation uniformity, sieving requirements and overall product consistency.
  3. Application Submission: The application is submitted along with test reports, technical documents, and factory details. Foreign manufacturers must also submit AIR-related documents.
  4. Factory Inspection: The BIS team conducts an inspection at the manufacturer’s plant to assess the manufacturing process, safety precautions, and the quality assurance system.
  5. Grant of BIS License: After all compliance requirements are satisfactorily met, BIS grants the certification license under Scheme-I.
  6. Use of ISI Mark: Upon getting the license, the manufacturer becomes eligible to stamp the ISI mark on the product together with the CM/L number.

Checklist for IS 12913:1990 Approval

Document CategoryDocuments Required
Basic DetailsGST Certificate, Email ID & Contact Number, Factory & Office Address, Rent Agreement / Lease Deed (if applicable),Partnership Deed (if applicable for partnership firms)
Manufacturing DetailsList of Machinery, Process Flow Chart, Factory Layout Plan
Raw Material DetailsList of Raw Materials, Supplier Details, Raw Material Invoices, Raw Material Test Certificates
Testing & Quality ControlList of Testing Equipment, Calibration Certificates, QC/Lab In-charge Appointment Letter & Qualification
Production DetailsAnnual Installed Capacity, Last Year Production Value
Product & Packaging DetailsQuantity per Package, Nature of Packing, Product Printing / Marking Details
Management DetailsTop Management Details, BIS Communication Contact Person
Brand & Certification DocumentsTrademark / Brand Certificate, Consent Letter from BIS Recognized Laboratory
Additional DocumentsWeekly Off Details, Hygiene Document (if applicable), Relaxation Letter (if applicable), Any Other Relevant Document
Foreign Manufacturer RequirementAppointment of Authorized Indian Representative (AIR) for BIS coordination and compliance in India

The Foreign manufacturers must designate an Authorized Indian Representative (AIR) in India. The representative is the local point of contact for the Bureau of Indian Standards (BIS) and manages all compliance and regulatory requirements in India.

BIS Marking Requirements for Bromadiolone CB

Once the license is acquired by the manufacturer, the ISI Mark for Bromadiolone CB must be written clearly and permanently on its packaging. Additional details are provided below:

RequirementDetails
ISI MarkIndicates that the product is BIS certified and conforms to standards
Standard NumberIS 12913:1990
CML NumberCertification Marks License (CML) number issued by BIS
Manufacturer DetailsName 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 and Renewal Process for IS 12913:1990 License

particularsDetails
Initial ValidityTypically 1 to 2 years, depending on BIS approval conditions
RenewalMust be renewed before expiry by submitting the application along with the prescribed fee and updated documents
SurveillaneBIS may inspect factories and test samples periodically
Annual FeesAnnual license fee must be paid regularly
ComplianceContinuous compliance with BIS requirements is necessary
License FormatBIS is shifting towards a 10-digit license number format
Non-Compliance RiskMay lead to suspension or cancellation of license

Total Cost of BIS Approval for Bromadiolone CB

Fees charged for obtaining the certification for Bromadiolone CB (IS 12913:1990) include fees for application, product testing, plant inspection, license and marking. All these charges have to be paid to BIS under the Scheme-I guidelines.

Charge TypeIndian ManufacturersForeign Manufacturers
Application FeeINR 1,000USD 15
Audit ChargesINR 7,000USD 3,200 – 5,900
License FeeINR 1,000USD 15
Marking FeeAs applicableAs applicable
Testing ChargesAs applicableAs applicable
EVTL India Consultancy FeeAs per actualAs 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

The compliance issue is highly interrelated with product efficacy, quality management and marketing. The compliance with IS 12913:1990 requirements allows showing that Bromadiolone CB formulations have been tested according to established standards that can promote reliability and trustworthiness of the product in the market.

With the increase in demand for such products and services, the need for their BIS Certification according to IS 12913:1990 arises. Becoming a part of this certification process will enable the enterprise to successfully enter the market in the long term. EVTL India can help your business to plan and undergo all the necessary stages of this certification process.

BIS Certification for Bromadiolone CB IS 12913