Welcome To RegXComply
Saudi Arabia Novel Food Registration & Regulatory Compliance — SFDA Approved
Introducing novel foods in Saudi Arabia requires SFDA approval to guarantee safety, labeling compliance, and product integrity. RegXComply provides end-to-end solutions for seamless registration and compliance management.
Novel foods—including functional foods, fortified products, new ingredient formulations, or innovative dietary products—require SFDA approval prior to marketing in Saudi Arabia. RegXComply supports your business with comprehensive dossier preparation, authority submission, labeling compliance, and post-registration assistance. Our team ensures your novel food products meet all SFDA requirements, minimizing delays and maximizing market access.
Understanding the Regulatory Requirements:
In Saudi Arabia, novel foods are regulated by the SFDA to ensure public safety and accurate consumer information. Compliance requires thorough evaluation of product composition, labeling, safety documentation, and manufacturing standards.
Key regulatory requirements include:
- Product Composition & Safety: Only approved ingredients are permitted. Novel ingredients require safety and toxicology data, along with scientific justification for their use.
- Labeling Compliance: Labels must be bilingual (Arabic & English) with ingredients, nutritional information, usage instructions, warnings, and claims. Mislabeling may result in fines or rejection.
- Documentation & Dossier: Complete dossier including GMP certificates, safety studies, scientific evidence, and product specifications is mandatory.
- Manufacturing & Import Compliance: Products must be manufactured in GMP-certified facilities, and importers must maintain full traceability of batches.
- Post-Market Surveillance: SFDA may inspect products, verify claims, or request additional data to ensure ongoing compliance.
The registration process can involve multiple rounds of clarifications. Common issues include incomplete dossiers, unsupported claims, or incorrect labeling. RegXComply provides expert guidance at each stage, ensuring smooth approval and ongoing compliance.
Proper registration allows your novel foods to enter the Saudi market quickly, avoid regulatory fines, and establish consumer trust.
Products Covered:
- Functional and fortified foods
- Innovative ingredients and formulations
- Nutraceutical combinations not previously marketed in KSA
- Specialty beverages, bars, and dietary products
- Foods with medical or health claims
Our Services / How It Works :
1. Product Assessment & Classification
- Evaluate ingredient novelty and intended use
- Determine SFDA regulatory classification
2. Dossier Preparation
- Compile safety, efficacy, and formulation documentation
- Review labeling and claim compliance
3. Authority Submission & Follow-Up
- Submit registration to SFDA|
- Address queries and provide additional information
4. Labeling & Compliance Review
- Ensure Arabic and English label compliance
- Adjust labels per SFDA requireme
5. Approval & Certification
- Obtain final SFDA approval
- Provide certification for import, distribution, and retail
FAQ
Frequently Asked Questions
Who must register novel foods in Saudi Arabia?
Any company introducing functional, fortified, or innovative foods in KSA.
What documents are required for registration?
Product dossier, safety studies, labeling samples, GMP certificates, and trade license.
How long does registration take?
Typically 6–12 weeks depending on product complexity and SFDA review.
Can novel ingredients be used in Saudi foods?
Only approved ingredients or those with sufficient safety data are allowed.
Can I modify a registered novel food product?
Yes, any changes in formulation, labeling, or claims must be submitted for approval.
Bring Your Innovative Foods to Market in Saudi Arabia with Confidence
Avoid regulatory delays or rejection. Book a consultation with RegXComply’s experts for a step-by-step roadmap to fast, compliant SFDA approval.
200+
Companies Advised
500+
Product Registered
$25M+
Cost Savings