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From Toxicology to Credibility: Why Dichloromethane BIS Compliance Is Now Non-Negotiable


 

Why BIS Certification Matters for Methylene Chloride in 2025

Methylene Chloride (also known as Dichloromethane or DCM) is now under mandatory regulation in India. As per Indian BIS standards, any manufacturing entity, DCM in India must comply with IS 17446:2020.
With its use across pharmaceuticals, paint removers, and industrial cleaning, BIS certification is not just mandatory it’s critical for business continuity and legal compliance.

Key Reasons for Compliance:

  • Toxicity Concerns: Banned in consumer products in several countries
  • High Volatility: Requires controlled packaging and handling
  • Pharma Dependency: DCM is essential in many pharma formulations
     

Breaking Down the Certification Requirements

Who Must Comply?

Entity Type Certification Route Notes
Indian Manufacturers ISI Mark Scheme Must comply with domestic ISI certification norms
Foreign Manufacturers FMCS Scheme Must appoint an Authorized Indian Representative (AIR)
Importers & Distributors N/A Can only import BIS certified DCM from licensed sources


Important: Non-compliant shipments will be rejected at Indian ports under the updated QCO (effective Q1 2025).
 

Why DCM Certification Is More Complex Than Other Chemicals

A. Strict Testing Standards:

  • Minimum Purity: ≥99.8%
  • Methanol residue limits
  • Heavy metal contamination tests
  • Packaging under safety-grade containers

B. Extended Documentation Requirements:

  • Toxic substance handling SOPs
  • Factory ventilation layout
  • Worker protection & training records
  • Emergency containment plan

 

Step-by-Step: How to Obtain Indian BIS Certification for Methylene Chloride

Phase 1: Pre-Certification Preparation (30–45 Days)

  1. Product Gap Analysis – Ensure conformity with IS 17446
  2. Authorized Indian Representative (AIR) – Appoint if you're a foreign entity
  3. Lab Coordination – Only BIS-recognized labs can test DCM samples

 

Phase 2: Certification Procedure (90–120 Days)

  1. Submit Application via Manakonline
  2. Send Samples to BIS Lab for testing under IS 17446:2020
  3. Factory Audit – Includes checks on manufacturing process, quality controls, safety compliance
  4. Grant of BIS Licence – Get approval to use the ISI mark on product packaging
     

Want to get full Information about BIS Product Certification:-
FMCS - For foreign manufacturers who are looking to get BIS certified in India
ISI Domestic manufacturers- For Indian manufacturers who are want to get certified for their products
 

post-certification:

  • Quarterly test reporting
  • Annual licence renewal
  • Surprise audits by BIS
     

Why 32% of Applications Get Rejected (And How to Avoid It)

  • Incomplete MSDS or formulation documents
  • Lack of ventilation system plans
  • Untrained staff in safety protocols
  • Incorrect labelling or missing batch IDs
  • Improper sampling techniques

Our Solution: Use our expert-backed DCM Compliance Checklist to ensure every document and test point aligns with Indian BIS standards.
 

Final Takeaway: Indian BIS Certification for DCM Is a Must
Whether you're a domestic producer or foreign manufacturer, compliance with Indian BIS and IS 17446:2020 is mandatory. Certification ensures legal supply, market access, and customer trust.

Let KMA GLOBAL Guide Your Certification Journey

We offer:

  • End-to-end BIS certification support
  • AIR appointment & document handling
  • Lab coordination & audit readiness
  • Renewal management & surprise audit prep

Schedule your strategy call today to secure your Indian BIS certification for Methylene Chloride!