SFDA Cosmetics

The SFDA is the central government body in Saudi Arabia responsible for ensuring the safety, quality, and efficacy of food, drugs, medical devices, and cosmetics. Its primary goal is to protect public health by implementing stringent standards that align with international best practices.

For cosmetics, the SFDA governs every stage of the product lifecycle, from initial manufacturing to sale and post-market surveillance. Compliance is non-negotiable; without a successful SFDA registration (Product Notification), a cosmetic product cannot be legally imported or sold.

The SFDA Scope: Cosmetics vs. Drugs

It is important for manufacturers to correctly classify their products, as the regulatory path for cosmetics is distinct from pharmaceuticals. While the SFDA oversees both, the requirements are different.

• Cosmetic Product: Any substance or mixture intended to be placed in contact with the external parts of the human body (skin, hair, nails, lips, etc.) with a view to cleaning, perfuming, changing appearance, protecting, or correcting body odors. Examples: Shampoo, lipstick, perfume, moisturizer.
• Drug/Pharmaceutical Product: Any substance used to treat, prevent, or diagnose disease, or to restore, correct, or modify physiological functions.

Confusion often arises, especially with “cosmeceuticals.” The SFDA assesses product claims and intended use. Products making therapeutic or medical claims (e.g., treating severe acne, curing hair loss) may be classified as drugs and will require a full drug registration, which is significantly more complex and lengthier. If you are reviewing the SFDA drug list of approved medicines, be sure your cosmetic is not making a claim that would inadvertently place it on that register. Our expert team ensures your product is correctly classified to avoid delays.

The foundation of SFDA compliance for cosmetics rests on two core pillars:

1. The Cosmetic Products Law (Royal Decree M/49)

This decree established the legal mandate for regulating cosmetics. It requires all cosmetic products to be safe, properly labeled, and notified to the SFDA before being placed on the market.

2. GSO Technical Regulation SFDA.CO/GSO 1943:2016

This is the main standard that specifies the safety requirements for cosmetic and personal care products in the Gulf Cooperation Council (GCC) member states, including KSA. Key elements include:

• Safety Assessment: Mandatory requirement for a product safety report proving the product is safe under normal use.
• Restricted and Prohibited Substances: Detailed annexes listing substances that are entirely banned or can only be used under specific concentration limits (e.g., certain preservatives, colorants, and UV filters).
• Labeling and Packaging: Detailed rules on information placement, language (mandatory Arabic), and font size.
• Good Manufacturing Practice (GMP): Requirement for products to be manufactured in accordance with internationally recognized GMP standards.

The SFDA’s jurisdiction is broad, covering any substance intended for external contact with the human body for cleaning, perfuming, or protecting. Our expertise covers:

• Skin Care: Creams, emulsions, lotions, and anti-aging serums.
• Hair Care: Shampoos, conditioners, and specialized dyes.
• Color Cosmetics: Foundations, lipsticks, and eye-area products.
• Hygiene & Fragrance: Deodorants, soaps, and high-end perfumes.
• Oral Care: Toothpastes and mouthwashes.

A successful application rests on the quality of your documentation. We meticulously compile the following:

• GMP Certificate: Proof of Good Manufacturing Practice (ISO 22716).
• Full Quantitative Formula: 100% breakdown of ingredients with CAS numbers.
• Certificate of Free Sale (CFS): Evidence of legal sale in the country of origin.
• Labeling Artwork: Bilingual (Arabic/English) labels meeting SFDA font and claim specs.
• Safety Data: Certificate of Analysis (CoA) for specific batches.

The process to obtain an SFDA certificate and market access is multifaceted. Instacertify breaks down this complexity into a clear, manageable workflow, ensuring efficient SFDA registration and compliance.

Phase 1: Establishment and Account Setup

Step 1: Appointment of a Responsible Person (Notifier)

The Responsible Person, who can be the local manufacturer or the importer, is legally accountable for the product’s compliance. We assist in formalizing this role.

Step 2: Company Registration on GHAD

The SFDA uses the unified electronic system, GHAD (Gulf Health Administration), which hosts the cosmetic notification module (often referred to as eCosma).

• We handle the creation of the company account on GHAD.
• We ensure all necessary commercial registrations (CR) and industrial licenses are uploaded and verified by the SFDA.

Phase 2: Technical File Compilation and Review

Step 3: Product Classification and Ingredient Review

Before proceeding with the SFDA registration, we verify that your product is correctly classified as a cosmetic. We meticulously cross-reference your full ingredient list against the SFDA’s prohibited and restricted lists, including the special limitations for specific substances. This step is crucial to prevent rejection and is where many applicants falter.

Step 4: The Product Information File (PIF) Compilation

The PIF is the core technical document required for SFDA registration. It must contain comprehensive data to prove the product’s safety and quality. Instacertify ensures every element of your PIF is complete and compliant:

Phase 3: Product Notification and SFDA Certificate Issuance

Step 5: Submission of Product Notification (SFDA Registration)

We upload the complete PIF and all supporting documents into the GHAD system (eCosma). The system will generate a notification number after successful submission. This is the official SFDA registration step.

Step 6: SFDA Evaluation and Approval

The SFDA reviews the submitted application. If any documentation is missing or technical issues are found (e.g., non-compliant ingredient concentrations), they issue an inquiry. Our team manages all communications and promptly addresses any deficiency notices.

Step 7: Issuance of the SFDA Certificate

Upon successful evaluation, the product is listed in the SFDA’s official register, and an SFDA certificate (Product Notification Certificate) is issued. This certificate confirms that the product is approved for trade in KSA. The certificate is typically valid for five years, but this may vary based on SFDA circulars.

Phase 4: Importation and Customs Clearance (SFDA Certification – CoC)

Step 8: Obtaining the Certificate of Conformity (CoC)

For every shipment of imported cosmetics, a Certificate of Conformity (CoC) is mandatory for customs clearance via the FASEH system (Saudi Customs Gate).

• The CoC is a shipping document that confirms the consignment complies with the prior SFDA registration.
• We coordinate with the Importer, the shipment details, and an SFDA-approved Certification Body (Notified Body) to issue the CoC, preventing costly delays and penalties at Saudi ports. This is often what importers refer to as “receiving their SFDA certification.”

A key part of strategic market entry is budgeting for the regulatory process. While costs and timelines are subject to variables like product complexity and applicant responsiveness, Instacertify provides clear estimates.

SFDA Registration Timeline (Estimated)

The overall cost includes mandatory government fees and professional consultancy fees.

Securing your certificate is only the beginning. Professional lifecycle management ensures uninterrupted trade:

• Validity: Notification Certificates are valid for 5 years.
• The 90-Day Rule: Renewal applications must be initiated 90 days prior to expiration to avoid de-listing.
• Variation Management: Any change in formulation, manufacturing site, or label artwork requires an immediate "Update Request" to maintain the validity of your listing.