The Saudi Food and Drug Authority (SFDA) has introduced updated regulations for 2025, bringing significant changes for distributors and manufacturers in the Middle East. These rules impact product labeling, barcode compliance, and import requirements—yet many businesses remain unaware of critical updates, risking fines, shipment delays, and market access issues.
This article breaks down the key SFDA 2025 changes, common oversights by distributors, and actionable steps to ensure compliance.
Key SFDA 2025 Regulatory Updates
1. Stricter Barcode & Labeling Requirements
- New Mandate: All products must now carry GS1-compliant barcodes (GTINs) with Arabic/English labeling.
- Common Mistake: Using outdated or non-GS1 barcodes, leading to rejected shipments.
- Solution: Verify barcodes with GS1 Saudi Arabia and ensure dual-language labels.
2. Enhanced Traceability for Pharmaceuticals & Food
- New Mandate: Serialization and track-and-trace systems for high-risk products (medicines, infant formula).
- Common Mistake: Relying on manual tracking instead of digital systems.
- Solution: Implement SFDA-approved serialization software for real-time monitoring.
3. Tougher Import Documentation
- New Mandate: Additional halal certifications, storage conditions, and expiry dates must be clearly stated.
- Common Mistake: Incomplete or missing documentation causing customs delays.
- Solution: Work with accredited halal certifiers and pre-submit documents via SFDA’s FSAH platform.
4. Expanded Product Categories Under SFDA Oversight
- New Mandate: Cosmetics, medical devices, and health supplements now face stricter SFDA scrutiny.
- Common Mistake: Assuming old approvals still apply—many now require re-registration.
- Solution: Check the SFDA Product List for updated category-specific rules.
What Most Middle East Distributors Are Overlooking
1. Ignoring GS1 Saudi Arabia’s New Prefix Rules
- Some distributors still use global GS1 prefixes instead of Saudi-specific ones, leading to non-compliance.
- Fix: Register with GS1 Saudi Arabia for a local company prefix.
2. Underestimating Label Design Changes
- Arabic text must now be equal in size or larger than English.
- Fix: Redesign packaging with SFDA-approved templates.
3. Missing Deadlines for Serialization
- Many pharmaceutical distributors haven’t adopted SFDA’s serialization mandate, risking bans.
- Fix: Partner with SFDA-accredited solution providers before enforcement begins.
4. Not Using SFDA’s Digital Platforms
- The SFDA FSAH portal is now mandatory for pre-approvals—manual submissions face delays.
- Fix: Train staff on e-submissions and automate compliance checks.
How to Ensure Compliance Before 2025 Enforcement
1. Conduct a Compliance Audit
- Review product labels, barcodes, and certifications against SFDA’s 2025 checklist.
2. Upgrade to GS1 Saudi Barcodes
- Ensure all products have a valid GTIN from GS1 Saudi Arabia (not third-party sellers).
3. Implement Track-and-Trace Systems
- For pharmaceuticals & perishables, invest in SFDA-recognized serialization tools.
4. Train Your Supply Chain Team
- Educate staff on new labeling rules, e-submissions, and halal certification processes.
5. Partner with SFDA-Accredited Consultants
- If unsure, work with local compliance experts to avoid costly mistakes.
Conclusion
The SFDA’s 2025 regulations bring stricter controls on labeling, barcoding, and traceability—but many Middle East distributors are still unprepared. Ignoring these changes can lead to customs rejections, fines, and lost market access.
Act Now:
✅ Audit your current compliance status
✅ Update barcodes and labels
✅ Adopt digital traceability systems
✅ Submit documents via SFDA’s FSAH portal
By staying ahead of these updates, you’ll ensure smooth imports, avoid penalties, and maintain retail access in Saudi Arabia’s growing market.
