Toothpaste functions as a frequently used consumer item that directly influences both oral hygiene standards and public health outcomes. The Bureau of Indian Standards now requires mandatory BIS Certification for toothpaste under IS 6356:1993 to guarantee both safety and quality. This certification guarantees that all toothpaste products available in India adhere to rigorous governmental quality standards along with safety protocols and labeling requirements. BIS certification stands as a mandatory legal prerequisite for both domestic manufacturers and importers seeking entry into the Indian market.

This blog explores the significance of obtaining a BIS certificate for toothpaste alongside applicable standards and necessary documentation through a detailed step-by-step process.

What Is BIS Certification  

The Bureau of Indian Standards (BIS) is the national standards body of India, operating under the Ministry of Consumer Affairs, Food & Public Distribution. BIS certification is a quality assurance mechanism that confirms that a product complies with Indian Standards for safety, performance, and reliability. For products listed under Quality Control Orders (QCOs), BIS certification is mandatory. This includes infant milk substitutes, where consumer health and safety are of utmost concern.

Read More: Introduction To Bureau Of Indian Standards

Applicable Standards for Toothpaste: IS 6356:2021

IS 6356:2021 lays down the specifications for dentifrices (Toothpaste) intended for dental hygiene. This standard cover:

• pH level 
• Abrasiveness
• Fluoride content 
• Microbial contamination 
• Packing and lebelling norms

Note: Products not conforming to IS 6356 cannot be marketed legally in India.

Who Needs a BIS Certification for Toothpaste?

Below we mentioned who needs BIS certificate for toothpaste:

• Domestic Manufacturers: Every manufacturer of toothpaste in India must obtain BIS certification before selling their products.
• Importers: Foreign manufacturers or Indian importers must get their toothpaste certified under the Foreign Manufacturers Certification Scheme(FMCS)

Why is BIS Certification for Toothpaste Important?

Below we mentioned some reasons why is BIS Certificate for toothpaste important:

• Ensures Legal Complaint: Toothpaste is covered under a mandatory BIS certification scheme. Without this certification, manufacturing, importing, or selling the products in India is illegal. BIS Compliance protects your business from penalties, product recalls, and regulatory action under the BIS Act, 2016.
• Guarantees Products Safety & Quality: Toothpaste directly impacts oral and overall health. BIS-certified toothpaste undergoes rigorous lab testing as per IS 6356 to ensure it is free from harmful microbes, contains permissible fluoride levels, and maintains the correct pH and abrasiveness, This helps prevent dental damage and ensures consumer safety.
• Boost Market Access and sales: With BIS certification, your products become eligible for sale across Indian weather online or offline retailers, e-commerce platforms, and distributors are more willing to stock certified products, leading to wider market reach and faster scalability.
• Enhances Brand Credibility: The BIS Standards Mark on your toothpaste builds consumer trust. It acts as a mark of authenticity quality assurance, and regulatory approval-making your products stand out in a competitive market.
• Enables International Recognition: For exporters and foreign brands targeting the Indian market, BIS certification reflects a commitment to Indian quality standards. It improves your global reputation and allows you to enter government tenders or major retail chains that demand certified goods.

Step-by-Step Process BIS Certification for Toothpaste

Below, we mentioned some processes to obtain BIS Certificate for Toothpaste:

A. For Indian Manufacturers – ISI Mark Scheme (Simplified Procedure)

1. Application Submission (Form V)
2. Product Testing at BIS-Recognized Lab
3. Factory Audit by BIS Officer
4. Compliance Verification
5. Grant of BIS Certificate (CM/L Number)
6. Timeline: 45 -60 working days

B. For Foreign Manufacturers – FMCS (Foreign Manufacturers Certification Scheme)

1. Application Filing
2. Nomination of Indian Representative (AIR)
3. Product Testing in India
4. Factory Audit (Outside India)
5. Grant of License to Use BIS Standard Mark
6.  Timeline: 90–120 working days

Read More: Process for getting BIS for Certification

Documents Required for BIS Certification for Toothpaste

Below we mentioned some documents required for BIS Certificate for toothpaste:

Read More: Documents Required For BIS Registration

Penalty For Non-Compliance 

Marketing or selling toothpaste without a BIS license is a punishable offence under the BIS Act, 2016. It may lead to:

• Seizure of products 
• Heavy penalties 
• Prosecution and legal action

How ELT Corporate Can Help You

At ELT Corporate, we specialize in providing end-to-end assistance for BIS certification of toothpaste, including:

• Document preparation
• Lab coordination
• BIS portal submission
• Factory inspection support
• Liaison with BIS officials

 Whether you are a domestic brand or a global exporter, we ensure fast-track BIS certification with complete legal compliance.

 Get in touch with our experts today and simplify your certification journey!

Conclusion 

BIS certification for toothpaste is essential to ensure to ensures safety, quality, and legal compliance in the Indian market. It builds consumer trust. Enhance brand credibility and open up broader sales opportunities. Whether you’re local manufacturer or an importer, complying with IS 6356:2021 is mandatory. If you need expert help. ELT Corporate offers complete assistance from documentation to final BIS approval.