BIS Certification for Chemicals

The chemical industry in India is vast and diverse, supplying essential materials to sectors like agriculture, pharmaceuticals, textiles, and manufacturing. Due to the sensitive and often hazardous nature of chemicals, ensuring their quality and safety is critical. To regulate this, the Bureau of Indian Standards mandates certification for certain chemicals under the Quality Control Order. BIS Certification ensures that these chemicals meet defined safety and performance standards before entering the market-protecting both consumer and the environment.

In this blog, we are going to read about the importance of BIS Certificate for chemicals, the list of regulated products, application process, and the documents required to get certified.

What is BIS, and Why is It Important?

The Bureau of Indian Standards (BIS) is India’s national standards body, operating under the Ministry of Consumer Affairs, Food & Public Distribution. BIS develops and enforces quality standards through certifications, inspections, and audits.
BIS certification for chemicals ensures that products meet Indian Standards (IS) for purity, performance, environmental safety, and public health. This is especially vital for chemicals used in industries like:

• Pharmaceuticals
• Fertilizers
• Food processing
• Paints & coatings
• Textile processing
• Petrochemicals
• Automotive and construction

Why is BIS Certification for Chemicals Mandatory?

Several chemicals have been brought under mandatory BIS certification through Quality Control Orders (QCOs) issued by the Department for Promotion of Industry and Internal Trade (DPIIT). These orders are issued under the BIS Act, 2016 and empower BIS to enforce compliance across manufacturers, importers, and distributors.

Objectives:

• Minimize health hazards and environmental pollution
• Prevent the circulation of sub-standard or counterfeit chemicals
• Ensure uniformity in product quality
• Promote Make in India and reduce dependence on poor-quality imports

List of Chemicals under Mandatory BIS Certification (Sample)

The BIS, along with concerned ministries, notifies Indian Standards for various chemicals. Some examples include:

Note: New QCOs are issued frequently. Always refer to the BIS website or Gazette notifications for the latest list.

Types of BIS Certification Schemes

1. ISI Mark Scheme (Scheme I): Applicable to domestic manufacturers for chemicals covered under mandatory certification. Products must meet the IS specifications and bear the ISI logo after approval.

2. Foreign Manufacturers Certification Scheme (FMCS): Mandatory for foreign manufacturers exporting regulated chemicals to India. Requires appointment of an Indian representative and factory inspection.

3. Self-Declaration of Conformity (Registration Scheme/Scheme II): Used mainly for low-risk consumer goods, not typically applicable to hazardous chemicals.

Documents Required for BIS Certification of Chemicals

Here’s a list of mandatory documents required for BIS Certificate of Chemicals

• Application Form (Form I or VI, depending on manufacturer’s origin)
• Manufacturing License or Company Incorporation Certificate
• List of Manufacturing Machinery and Equipment
• Product Test Report from BIS-recognised lab (not older than 90 days)
• Internal Quality Control Plan
• Manufacturing Process Flowchart
• Organizational Structure and staff details
• Authorisation Letter (in case of third-party consultant or AIR)
• Product Labels and Packaging Samples
• Previous Compliance or Certifications (if any)

Read More: Documents Required For BIS Registration

Step-by-Step BIS Certification of Chemical Process

Obtaining BIS Certificate of Chemical involves several steps to ensure product safety and compliance:

Step 1: Identify Applicable IS Standard: Find the Indian Standard that applies to your chemical product. This forms the basis for testing and documentation.

Step 2: Product Testing: Send product samples to a BIS-approved laboratory for testing as per relevant IS specifications. Testing is mandatory and must be current.

Step 3: Online Application on Manakonline: Create an account and apply via the BIS Manakonline Portal, uploading test reports, supporting documents, and paying requisite fees.

Step 4: Factory Audit (If Applicable): BIS may conduct an on-site inspection to verify compliance with quality processes and infrastructure.

Step 5: Grant of BIS License: After review and verification, BIS grants the license, which allows you to affix the ISI mark on product packaging.

Step 6: Post-Licensing Surveillance: BIS may conduct periodic surveillance, retesting, or audits to ensure continued compliance.

Read More: Process for getting BIS for Certification

BIS Certification for Foreign Chemical Manufacturers

Under the FMCS scheme, foreign manufacturers must:

• Appoint an Authorized Indian Representative (AIR)
• Submit samples to BIS-recognized Indian labs
• Host BIS auditors at their overseas manufacturing unit
• Comply with labelling and packaging norms as per Indian standards

FMCS certification generally takes 6–8 months, subject to documentation and audit schedules.

License Validity and Renewal BIS Certification for Chemicals

• The initial BIS license is valid for 1–2 years
• Renewable for up to 5 years, provided surveillance and compliance conditions are met
• Failure to renew can lead to revocation or legal action

Legal Consequences of Non-Compliance

Under the BIS Act, 2016, failure to comply with QCOs and BIS norms can lead to:

• Product seizure
• Monetary fines up to ₹5 lakh
• Imprisonment (up to 2 years)
• Import bans
• De-registration and blacklisting of the brand

Benefits of BIS Certification for Chemical Manufacturers

BIS Certificate for Chemical offers several key benefits to manufacturers, consumers, and regulators in India. Here’s a breakdown:

• Market Access: Mandatory for selling regulated chemicals in India.
• Improved Brand Trust: BIS mark signifies quality, safety, and reliability.
• Legal Safety: Avoid penalties, litigation, and product recalls.
• Competitive Advantage: Stand out in both domestic and international markets.
• Support for Exports: BIS certification may be recognized under mutual recognition treaties

How ELT Corporate Can Assist

As a leading consultancy in BIS and regulatory compliance, ELT Corporate offers end-to-end assistance for:

• Identifying applicable Indian Standards
• Preparing documentation and quality manuals
• Coordinating BIS lab testing
• Managing communication with BIS
• Preparing for inspections and audits
• Post-certification renewals and compliance tracking

 Conclusion

In an era of tighter regulations and increasing demand for safety and quality, BIS certification for chemicals is a necessity—not a choice. Whether you’re a domestic manufacturer or an international exporter, obtaining BIS approval can unlock new markets, build customer trust, and ensure full legal compliance. Stay ahead of regulatory changes. Partner with ELT Corporate to navigate the BIS registration process efficiently and confidently.