Probiotics are among the fastest-growing health supplement categories in the UAE, driven by rising consumer focus on gut health, immunity, metabolic wellness, and overall well-being. As demand surges across Dubai and the wider GCC region, the regulatory environment has become more structured, ensuring product safety, quality, and transparency.

If your company aims to import, manufacture, distribute, or sell probiotic supplements in Dubai, obtaining regulatory approval through Dubai Municipality’s Montaji System is mandatory. This comprehensive guide provides an in-depth, technically detailed pathway for successful probiotics registration in Dubai, prepared by Maven Regulatory Solutions.

Understanding Probiotics Registration in Dubai

Probiotics fall under the category of health supplements, regulated by the Health & Safety Department of Dubai Municipality (DM). Without proper registration, probiotics cannot be imported, marketed, or sold within the UAE.

Dubai Municipality uses the Montaji platform to manage all regulatory submissions for dietary supplements.

The system ensures:

• Safety and quality verification
• Accurate labeling
• Compliance with UAE supplement standards
• Screening for prohibited or unsafe ingredients
• Unified approval that allows sales in all emirates

Regulatory Workflow: Probiotics Registration in Dubai

Below is the updated, technical, step-by-step process prepared for 2025:

Step 1 — Obtain a Valid Trading License

Your business must hold a Dubai-issued trade license with activities such as:

• Health Supplements Trading
• General Trading
• Dietary Supplement Import / Export

This license is mandatory before accessing Montaji.

Step 2 — Register the Company on the Dubai Municipality Portal

You must create a corporate account on the DM Smart Portal to activate access to Montaji services.
This stage includes:

• Verifying trade license details
• Linking UAE Pass for authentication
• Activating product registration services

Step 3 — Submit Probiotics Product Registration Application (Montaji)

This includes uploading:

• Product dossier
• Supplemental facts
• Ingredient breakdown with concentrations
• Certificates & lab results
• High-resolution artwork and label layout

Each document must be aligned with UAE.S GSO & Dubai Municipality Supplement Regulations.

Step 4 — Montaji Review, Document Verification & Fee Payment

After application submission:

• The system assigns a unique application reference
• DM experts perform technical evaluation
• Required fees must be paid online
• Additional clarifications may be requested

Step 5 — Product Sampling & Laboratory Testing

Dubai Municipality may request market samples for:

• Microbiological analysis
• Heavy metal screening
• Active ingredient verification (CFUs, strain identification)
• Contaminant analysis
• Stability assessment

Only compliant products proceed to approval.

Post-Market Surveillance Requirements (Mandatory)

After approval, probiotics must meet ongoing regulatory obligations.

1. Regulatory Updates

Monitor Dubai Municipality circulars, new supplement regulations & labeling updates.

2. Adverse Event Reporting

Any side effects or complaints must be reported through the designated reporting system.

3. Batch Testing

Random batch sampling ensures consistent safety & efficacy.

4. Label Updates

Any changes in formulation, packaging, dosage, or claims require mandatory re-submission.

Validity of Probiotics Registration Certificate

• The registration certificate is valid for 5 years.
• After expiry, products must be re-registered to remain in the market.

Common Reasons for Application Rejection

Dubai Municipality may reject applications due to:

• Unclear or incomplete labeling
• Misleading claims (“treats disease”, “cures conditions”)
• Prohibited substances
• Undisclosed ingredients
• Non-English/Arabic content
• Absence of scientific evidence

Documents Required for Probiotics Registration (Updated 2025)

Below is the most complete and updated document list:

• Trade license copy
• Product image
• Artwork / packaging label
• Supplement facts panel
• Ingredient list with concentrations
• Certificate of Free Sale (CFS)
• GMP certificate
• ISO certification (if applicable)
• Laboratory analysis report
• Clinical evidence / scientific claim report
• Stability study
• Certificate of Analysis (CoA)
• Product safety report
• Company profile
• Manufacturing process overview
• Halal certificate (optional)
• Organic certificate (optional)
• Microbiological test report
• Heavy metal analysis report

Labeling Requirements for Probiotics (Dubai Standards)

Labels must include the following mandatory elements:

Primary Requirements

• Product name
• Supplement category
• Brand name
• Manufacturer’s name & address
• Country of origin
• Net weight / volume
• Batch number
• Production & expiration date or PAO (Period After Opening)
• Ingredients list (including allergens)
• Storage instructions
• Usage instructions
• Warning statements
• Barcode

Prohibitions

• No medical claims
• No misleading statements
• No unsubstantiated health benefits

What Are Probiotics?

Probiotics are live microorganisms, administered in adequate quantities, that provide verified health benefits to the host.

These may include:

• Improved gut microbiota
• Enhanced immunity
• Metabolic improvements
• Mental health benefits
• Digestive support

Popular Probiotic Strains Found in Supplements

Types of Probiotics Available in the UAE

• Probiotics for women
• Probiotics for digestion
• Probiotics for constipation
• Probiotics for weight management
• Probiotics for kids
• Vegan probiotics
• Plant-based probiotics

Why Register Probiotics in Dubai?

• Ensure product safety & quality
• Protect consumer health
• Prevents counterfeit & unsafe supplements
• Builds trust and brand credibility
• Required for import, sale & advertising
• Ensures compliance with UAE supplement standards

FAQs – Probiotics Registration UAE

Are probiotics legal in Dubai?
Yes, probiotics are legal but must be approved by Dubai Municipality before sale.

Which authority regulates supplements in Dubai?
Dubai Municipality – Health & Safety Department.

How long does the registration process take?
Typically 2–6 weeks, depending on documentation and testing.

Is laboratory testing mandatory?
Yes, depending on product type and DM evaluation requirements.

Can I import probiotics after approval?
Yes. Approval allows import, distribution, and sale across all UAE emirates.