Neem based products are generally considered to be naturally safe; however, variations in the
quantity of azadirachtin, selection of solvents and quality of emulsifiers may affect their
performance and compatibility with crops. The BIS Certification for Neem Based EC Containing
Azadirachtin under IS 14300:1995 ensures that the product shows high bio-efficacy and also
chemical stability and safety at the same time. The regulation works as an insurance
mechanism against inferior bio-pesticides entering agricultural markets.
The compliance system aims at establishing the verification of active ingredient homogeneity
and emulsion stability using certain techniques. Certification is issued only if there is evidence of
controlled manufacture and laboratory testing.
What is IS 14300:1995?
This is the Indian Standard for Neem-Based Emulsifiable Concentrate (EC) containing
Azadirachtin, used as a botanical pesticide for crop protection. It specifies the quality
requirements and testing procedures to ensure the effectiveness, stability, and safety of the
formulation. As per the Bureau of Indian Standards (BIS), Neem-based EC with Azadirachtin is:
- Checked for azadirachtin content conformity
- Assessed for emulsion stability
- Tested for physicochemical properties
- Evaluated for storage stability
Who must obtain a BIS License?
BIS authorisation under IS 14300:1995 is required for businesses involved in manufacturing,
importing, or supplying Neem-based EC with Azadirachtin in India.
Applicable to:
- Manufacturers (India) - Must get BIS approval if the products are covered under QCO.
- Foreign Manufacturers - Need certification to export the pesticides to India.
- Importers/Brand Owners - Must ensure that the products are BIS-certified before sale.
- Sellers/Distributors - Should only sell certified products.
Testing and Inspection Requirements
In order to guarantee the quality standard of pesticide formulations based on neem in
agriculture, the Bureau of Indian Standards specifies the minimum standards that must be met
according to IS 14300:1995. This certification guarantees that pesticide formulations containing
the prescribed levels of azadirachtin are produced effectively.
The BIS testing parameters and quality checks for the Neem based EC (Azadirachtin) are listed
below:
BIS Licensing Procedure for Neem-based EC with
Azadirachtin
The BIS Approval process ensures that the neem-based pesticides meet the required safety
and performance standards. This process is set by the Bureau of Indian Standards (BIS) and
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 moisture content, fibre level, purity, nutritional composition and absence of contaminants.
- 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: Officials from the BIS come to the manufacturing unit to evaluate production processes, safety measures, and the quality control system.
- Grant of BIS License: Once all compliance procedures have been satisfactorily met, the certification license is granted by BIS under Scheme I.
- Use of ISI Mark: Following approval, the manufacturer is authorized to use the ISI Mark on the product along with a valid CM/L number, confirming that the product meets BIS standards.
required Documents for IS 14300:1995 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 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 PRODUCT MARKING GUIDELINES FOR IS 14300:1995
Once the manufacturer gets a BIS License, the ISI Mark for Azadirachtin Pesticides has to be
clearly marked on its packaging. More information about this is stated below:
| Requirement | Details |
|---|
| ISI Mark | Indicates that the product is BIS certified and conforms to standards |
| Standard Number | IS 14300:1995 |
| 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.
License continuity rules for neem ec with azadirachtin
| 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 |
application and inspection fees under is 14300:1995
The BIS certification cost for neem insecticide emulsifiable concentrate 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
IS 14300:1995 ensures that all neem based EC products with azadirachtin as active ingredients
comply with important standards in terms of quality, stability and effectiveness for efficient crop
protection from pests. The Indian BIS certification process checks vital attributes like active
ingredient content, emulsification property and stability during storage ensuring that the product
works efficiently under actual use conditions.
The process of BIS certification of Neem-based EC with azadirachtin improves product
reliability, along with conforming to the manufacturing procedures of bio-agrochemicals in
accordance with the requirements of India. It adds value to the bio-pesticide products through
standardized formulation quality assurance process. Usually, EVTL India assists in document
preparation, test execution and the BIS certification process on behalf of the applicants.
