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Navigating the Market: A Guide to Skin Care Product Certification in Saudi Arabia
The Kingdom of Saudi Arabia represents a dynamic and rapidly growing market for beauty and personal care products. However, gaining entry into this lucrative market requires navigating a stringent regulatory landscape designed to ensure consumer safety and product quality.
For any brand looking to succeed, understanding and securing the mandatory skin care product certification is the critical first step, and this process, governed by the Saudi Food and Drug Authority (SFDA), involves a detailed procedure of notification, documentation, and compliance. Failure to comply can result in seized shipments, financial losses, and market exclusion.
This comprehensive guide will walk you through the key pillars of the SFDA for cosmetic products, outlining the regulatory bodies, the step-by-step certification process, import requirements, and how expert consultancies can facilitate a smooth market entry.
Who Regulates Cosmetic & Skin Care Product Certification in Saudi Arabia?
The primary regulatory body responsible for the oversight, regulation, and certification of all cosmetic and skin care products in Saudi Arabia is the Saudi Food and Drug Authority (SFDA). It is established to ensure the safety and quality of food, drugs, and cosmetic products; the SFDA’s mandate is comprehensive.
For cosmetics, which include skin care items, the authority operates under the “Cosmetics Products Regulation” and its associated technical regulations. The SFDA does not issue a “certificate” in the traditional sense for each product batch. Instead, it operates a Cosmetic Products Notification (CPN)
A program which requires importers and manufacturers to notify the SFDA about their products before they can be placed on the market.
The notification is not a pre-market approval but a mandatory registration of the product’s information in the SFDA’s electronic system. The responsibility lies with the “Responsible Person” (often the local importer or distributor) to ensure that all products comply with the SFDA’s safety, labeling, and compositional requirements before and after notification.
This system places the onus on the company to guarantee compliance, with the SFDA conducting post-market surveillance and audits to enforce regulations.
Read More : Why Certification Matters for Cosmetics Imports in Saudi Arabia?
Steps to Certify Skin Care Products with the SFDA
The journey to achieve SFDA product registration for a skin care item is a multi-stage process that demands meticulous attention to detail. It is almost always conducted through the SFDA’s online portal, known as the “Cosmetics Notification System.”
1- Registering your Product with the SFDA
The process begins with the “Responsible Person” creating an account in the SFDA’s Cosmetics Notification System. This entity, which must be a legally established company within Saudi Arabia, is the official point of contact with the SFDA and is legally liable for the product’s compliance. The notification process involves submitting detailed information about the product, its composition, and its manufacturing.
2-Required Documentation
A successful notification hinges on preparing a complete and accurate dossier. The key documents required for SFDA registration typically include:
- Product Information Form (PIF): This is the core of the notification, containing comprehensive data such as the product’s trade name, category, and physical characteristics.
- Ingredients List: A full and detailed list of all ingredients, using International Nomenclature of Cosmetic Ingredients (INCI) names, along with their exact concentrations or concentration ranges.
- Product Labeling: Images of the final product label in Arabic, or both Arabic and English, which must meet all SFDA labeling requirements.
- Certificate of Analysis (CoA): A document from the manufacturer certifying that the product has been tested and meets its specified quality and safety standards.
- Good Manufacturing Practices (GMP) Certificate: Proof that the manufacturing facility complies with internationally recognized GMP standards, such as ISO 22716.
- Product Claim Sheet: A list of all marketing and functional claims made about the product (e.g., “moisturizes,” “anti-aging”).
- Authorization Letter: A letter from the foreign manufacturer appointing the Saudi-based company as the “Responsible Person.”
3- Labelling and Claims Review
The SFDA has strict guidelines for product labeling and claims. All labels must be in Arabic or bilingual (Arabic/English), and must include:
- Product name and function.
- Ingredients list in descending order of weight.
- Name and address of the Responsible Person and the manufacturer.
- Country of origin.
- Net quantity.
- Batch number.
- Expiry date.
- Precautions for use, if any.
Crucially, product claims must be substantiated and cannot be of a therapeutic or medicinal nature. Claims like “treats eczema” or “heals psoriasis” are prohibited for cosmetic products and would lead to a rejected notification. The SFDA provides guidance on acceptable versus prohibited claims.
Read More : Food Contact Products Labeling & Packaging Requirements
Inspection and Conformity Assessment
While the notification is primarily a documentary review, the SFDA maintains the right to conduct post-market surveillance. This can include random sampling and laboratory testing of products from the market to verify compliance with the submitted notification and the absence of prohibited substances. Furthermore, the SFDA may request additional information or clarification during the notification review process, and failure to provide it can halt the entire process.
Read More : Inspection Company For Saudi Arabia Market
Steps for Launching a Cosmetics Conformity Certificate
Launching a Cosmetics Conformity Certificate begins with a clear, structured process that ensures cosmetic and skincare products meet Saudi Arabia’s strict regulatory standards. These steps ensure full compliance and safe market entry.
The same process applies specifically to Skin Care Product Certification in Saudi Arabia.
Key Steps for Obtaining the Cosmetics Conformity Certificate:
Step 1: Begin by completing the certificate application along with the declaration of conformity, submitted through Tabseer Company by either the importer or exporter.
Step 2: The Tabseer team thoroughly reviews the submitted request to ensure it meets initial requirements.
Step 3: Verification of all required documents is conducted, confirming that they comply with the import regulations set by the Saudi Food and Drug Authority (SFDA).
Step 4: Required product samples undergo testing and examination to validate safety and compliance.
Step 5: Product listing numbers are generated and provided through the official SFDA platforms (Ghad and Ecosma.)
Step 6: A conformity request is then filed through the FASEH platform for official processing.
Step 7: A detailed pre-shipment inspection is carried out to ensure that the shipped products match approved specifications.
Step 8: Finally, upon successful completion of all steps, the Conformity Certificate is officially issued.
SFDA Import Requirements for Skin Care Products
SFDA Import Requirements for Skin Care Products
SFDA product registration is intrinsically linked to the import process. Without a successful notification in the SFDA’s system, a skin care product cannot clear Saudi Customs. The “Responsible Person” is the entity that must handle the customs clearance, and they are required to provide the SFDA notification number as proof of compliance.
The Saudi Customs Authority, in coordination with the SFDA, will verify the status of the product in the notification system before releasing the shipment. Any discrepancy between the shipped goods and the details in the notification (e.g., a different ingredient, a missing label requirement) can lead to the shipment being held, rejected, or even destroyed at the port of entry, incurring significant costs for the importer. Therefore, a complete and accurate SFDA notification is not just a regulatory formality but a direct prerequisite for the physical entry of goods into the Saudi market.
How Tabseer Supports Skin Care Product Certification
Given the complexity, language barriers, and stringent nature of the SFDA for cosmetic products regulations, many international brands and even local importers turn to specialized regulatory consultants. Firms like Tabseer provide an invaluable service by acting as a bridge between companies and the regulatory authority.
Tabseer and similar consultancies offer end-to-end support for the entire skin care product certification journey.
Their services typically include:
- They begin by reviewing a company’s product portfolio, documentation, and labels against SFDA requirements, identifying any compliance gaps before the formal submission.
- Experts ensure that the Product Information Form, ingredient lists, and all supporting documents are complete, accurately translated, and formatted to meet SFDA standards, significantly reducing the risk of rejection.
- They assist in adapting existing product labels to include all mandatory Arabic elements and ensure all claims are permissible and correctly stated.
- Consultants manage the entire electronic notification process on behalf of their clients, from account creation to final submission and communication with the SFDA.
- They can also provide ongoing support for managing product renewals, reporting adverse events, and handling any post-market queries from the SFDA.
Tabseer helps companies avoid common pitfalls, streamline the SFDA registration process, and accelerate their time-to-market in Saudi Arabia. By leveraging local expertise and deep regulatory knowledge.
This allows brands to focus on their marketing and sales strategies, confident that their regulatory compliance is in expert hands. In a market as promising yet demanding as Saudi Arabia, such a partnership is often the key to a successful and sustainable market entry. – contact us today