Prepare SFDA Dossier in 2025 | Saudi Food Registration

How to Prepare a Complete Dossier for SFDA Food Registration in Saudi Arabia

Preparing a complete and compliant dossier is one of the most critical steps in securing SFDA approval for food product registration in Saudi Arabia.

A dossier is more than just a collection of documents — it’s your product’s official regulatory profile.

Missing, outdated, or incorrect data can lead to delays, rejection, or even a product ban.

This 2025 guide explains exactly what goes into a successful SFDA food dossier and how to prepare it correctly the first time.

What Is a Product Dossier?

An SFDA dossier is a comprehensive file that contains all required information about your product, including technical data, safety evaluations, labeling details, and certificates.

It allows the SFDA to assess whether your product is safe, compliant, and accurately represented.

Key Components of an SFDA Food Dossier

To avoid rejection or resubmission, your dossier must include the following:

1. Product Description and Classification

• Commercial name and product type

• Intended use (e.g., supplement, functional food, etc.)

• SFDA category and subcategory

2. Ingredient and Formula Details

• Full list of ingredients with concentrations

• Functional purpose of each ingredient

• Certificate of analysis (COA) for each component, if available

3. Label Design and Translations

• English and Arabic versions of the label

• Nutritional table (with Arabic translation)

• Claims with substantiation (if applicable)

• Barcode and expiry formatting

4. Product Specifications and Shelf Life

• Physical and chemical properties

• Microbiological test results

• Shelf life studies and packaging compatibility

5. Certification and Compliance Documents

• Halal certification (GSO 2055-1 or equivalent)

• GMP or ISO certification of manufacturing facility

• SASO or conformity assessment reports (if required)

• Free Sale Certificate from country of origin

6. Testing Reports and Safety Data

• Laboratory test reports (where applicable)

• Heavy metals, pesticide residues, allergen testing

• All tests must be from SFDA-approved or recognized labs

7. Legal and Administrative Documents

• Authorized representative in Saudi Arabia

• Manufacturer’s license or facility registration

• Power of attorney (if a third-party is applying on your behalf)

Common Mistakes to Avoid When Compiling Your Dossier

• Submitting outdated or expired certificates

• Incomplete translation of labels or claims

• Missing ingredient COAs or test results

• Using templates not aligned with SFDA’s latest formats

Small errors in formatting or data can lead to rejection — even if the product is otherwise compliant.

The Importance of Pre-Submission Review

Before submitting, your dossier should go through a regulatory pre-check. This ensures:

• All documents meet SFDA formatting and language requirements

• No gaps exist in ingredient or safety data

• All supporting materials are validated and current

A professional review significantly reduces processing time and minimizes risk of rejection.

Related Topics You Might Find Helpful

• How shelf life testing impacts product approval in KSA

• Explore what documents are required for SFDA compliance

• Learn how to manage crises after a rejected application

• See what SFDA requires to register your food facility in 2025.

Build Your SFDA Dossier Right from the Start

Creating a strong dossier isn’t just about paperwork — it’s about building trust with the SFDA.

Whether you're registering a product for the first time or revising an older file, a complete, well-organized dossier can fast-track your approval and protect your brand.

Need help preparing your product dossier?
Speak with our regulatory consultants or use our chatbot now in the bottom right corner to start.

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