Artixio

SFDA Cosmetics Regulations in Saudi Arabia for Notification and Import

SFDA Cosmetics Regulations in Saudi Arabia

Cosmetics are huge in Saudi Arabia right now. The government is paying close attention to it. SFDA, which oversees beauty products, food, and drugs, makes sure every cosmetic product is listed for notification before hitting the shelves. No shortcuts here—even a single lipstick needs to be listed with them. 

The whole thing might look complicated at first. There’s more than one portal, lots of paperwork, and a few steps that can trip you up if you miss them. But once you know the flow, it starts to make sense. That’s what this guide is here for—you’ll get a clear overview of SFDA cosmetics regulations in Saudi Arabia and what they mean for your products.

Who Regulates Cosmetics in Saudi Arabia?

SFDA (Saudi Food and Drug Authority) is the agency. They regulate cosmetics in Saudi Arabia. They’re the same body that keeps an eye on food, medicine, and medical devices too—not just beauty products. Within SFDA, there’s a dedicated Cosmetic Products Department. They deal specifically with the reviewing, checking, and setting of the following, respectively:

  • Cosmetic ingredients and formulations
  • Product safety before and after market launch
  • Rules for labeling, packaging, and advertising

Types Of Cosmetics According To SFDA

Here are the categories:

Types Of Cosmetics According To SFDA

1. Simple:

  • They are single-component products.
  • They have one product package, with one information leaflet. They belong to one category.

2. Single Cosmetic Product with Variation:

  • It is a simple cosmetic product with variations.
  • This cosmetic product may have a varied fragrance, shade, strength, or other specified characteristics, etc.
  • The variations may occur but the product identity/category remains the same.

3. Composite:

  • This category involves a composite product such as an eye shade palette, lip palette, etc.
  • It is basically a set comprised of individual components.
  • It has a single information file.
  • And each product of the composite product may belong to one or more categories.

4. Kit:

  • It is a composite product containing several individual single products.
  • Each product will have its individual information file.
  • Saudi FDA (SFDA) Regulation of Cosmetics in Saudi Arabia

Current Regulatory Standards for Cosmetics in Saudi Arabia

Cosmetic products in Saudi Arabia must adhere to the Saudi Food and Drug Authority’s cosmetic regulatory framework, including SFDA.CO/GSO 1943:2024. It covers safety requirements for cosmetics and personal care products. SFDA.CO/GSO 2528:2024 covers cosmetic and personal-care product claims.

In June 2025, SFDA announced the adoption of updated versions of these technical regulations. They also moved the lists of prohibited and restricted substances, preservatives, colorants, and UV filters from the technical regulation itself to its website. Thus, manufacturers and importers should check the current SFDA lists.

Key requirements of SFDA for Cosmetics

The following are the requirements for cosmetics in Saudi Arabia:

  • Before you even upload a single document on SFDA’s eCosma / GHAD portal, make sure your product checks the main compliance boxes:
  • No prohibited ingredients – Certain substances are completely banned. (SFDA publishes a prohibited list.)
  • Ingredient safety – Even approved preservatives or colorants can only be used within set limits.
  • Labeling rules – Clear images of the internal and external labels and any leaflet are required. The label must adhere to the Cosmetic Products Law, its implementing regulations, and SFDA.CO/GSO 1943.
  • Product Information File (PIF) – The notifier must maintain the cosmetic Product Information File and provide it to SFDA when requested. The PIF is maintained as part of the product’s compliance documentation.
  • Advertisement control – Marketing must stick to facts—“medicinal claims” can lead to penalties.

👉 In short: if your product isn’t safe, properly labeled, or backed by a PIF, SFDA can block it before it reaches shelves.

Steps to Notify Cosmetics in Saudi Arabia

Here are the quick steps for the cosmetic product notification process in Saudi Arabia by SFDA:

1. Confirm the category
Make sure your product is considered a cosmetic under SFDA rules (not a drug or medical device).

2. Create a GHAD account
Your Saudi legal entity or importer must register in SFDA’s GHAD system.

3. Prepare your documents

  • Full ingredient list (INCI + %)
  • Draft labels in applicable English
  • Product safety file (PIF) with testing + GMP proof
  • Certificates for any restricted ingredients

4. Notify the cosmetic product through GHAD

Submit the required product information through the unified electronic system (GHAD), including the required product images/artwork, manufacturer information, and ingredient information.

5. Apply for activity licenses
Depending on your role (importer, distributor, or manufacturer), get the required SFDA license via GHAD.

6. Complete import clearance, where applicable

For imported cosmetic products, submit the electronic clearance application through the FASH service at GHAD and through the Fasah (Tabadul) platform. A Certificate of Conformity issued through the required electronic process is part of the applicable import-clearance requirements.

7. Clear goods at port
Use the FASAH ↔ GHAD platform to complete customs + SFDA checks.

8. Monitor after launch
Report serious side effects, keep records updated, and provide the PIF if SFDA requests it.

Lifecycle of Cosmetic Products in Saudi ArabiaLifecycle Of Cosmetic Products In Saudi Arabia:

The first step is checking if your product is actually classified as a cosmetic under SFDA rules. Once that’s confirmed, you can move through the registration process. Here are the steps of the lifecycle most cosmetic products follow in Saudi Arabia:

Cosmetic Raw Material Verification

This is the first step in the cosmetic manufacturing process.

  • All the raw materials used should comply with the SFDA.CO/GSO 1943- Clause 6-2 and its latest updates, if any.
  • While selecting the raw materials for cosmetics, the manufacturer should take care that he avoids the ingredients from the prohibited list. To check whether your ingredients fall on the prohibited list, click here.
  • The formulation must comply with the current restrictions and conditions applicable to cosmetic ingredients, including the SFDA lists of prohibited and restricted ingredients, preservatives, colourants, and UV filters.
  • If using restricted preservatives in cosmetics, they should be used only under regulated limits.

Formulation and Testing

  • The formulation and testing of the cosmetics are regulated under SFDA.CO/GSO 1943 – Annex 3 & Clause 5-2
  • Cosmetic manufacturing should meet the Good Manufacturing Practice requirements that apply. SFDA’s conformity-assessment guidance provides the reference of ISO 22716 for cosmetic GMP.
  • During the manufacturing process, a technical product file (PIF) should be maintained for SFDA review.
  • During manufacturing and post-manufacturing, all the necessary tests should be conducted on cosmetic products, such as stability studies, shelf life, etc.

Product Notification Through GHAD

SFDA requires cosmetic products intended for commercial use to be notified through its electronic system. The current process is conducted through the unified GHAD system. The notification requires product information, manufacturer information, product images/artwork, and ingredient information, including ingredient concentrations and roles.

Some Requirements For Product Notification:

  • Labeling:
    • A proper image should be provided of the front and back label including the barcode.
    • The label should be prepared in compliance with the SFDA standards.
  • Ingredients:
    • A dossier should be submitted that includes all the ingredients along with their concentration.
    • The notifier should confirm that there are no ingredients on the prohibited ingredients list.
    • The notifier is solely responsible for the information on the dossier.
  • Documents:

The following is the list of documents required for creating a GHAD account:

    • Commercial registration record.
    • Copy of Ministry of Investment License.
    • Notarized Authorization from the Chamber of Commerce.

The following is the list of documents for notifying a cosmetic product:

  • Manufacturer/distributor authorization letter, where required
  • Clear product images/artwork
  • Ingredient list showing concentrations and roles
  • Product image suitable for publication on the SFDA website

Renewal Of Cosmetic Product Listing

Any applicable renewal or update requirements should be completed through the current SFDA electronic system according to the requirements that apply.

Deactivation of Cosmetic Product Notification

The notifier can deactivate a cosmetic product notification through the applicable services in the SFDA electronic system, subject to the current system requirements.

To know more about the Cosmetic Notification process in Saudi Arabia, click here.

Licensing Through GHAD System

The applicant needs to apply for a license for his intended cosmetic product use in Saudi Arabia, such as import, manufacture, sale, etc.

The Implementing Regulation—Article 13 states all the necessary requirements for licensing cosmetics.

The following is the process for licensing by SFDA:

  1. Register for a GHAD account.
  2. Select the appropriate licensing type. It can be based on the intended use, such as manufacturing, distributing, importing, etc.
  3. Upload the required documents. Pay the fees. Submit the application.
  4. The SFDA carries out an inspection of the applied-for license facility.
  5. If all parameters are found to be authentic, the applicant is granted the license.
  6. The GHAD portal is used to update any documents, renew licenses, or perform any cosmetic-related procedure later after the grant of the license.

Port Clearance via FASH at GHAD and Fasah (Tabadul) System

  • According to the SFDA.CO/GSO 1943 – Clause 6-3, on the arrival of cosmetics at the port, for import or export, the person in charge is required to submit a clearance request using FASH at GHAD and the Fasah Tabadul system.
  • This clearance request should be submitted before the cosmetics stock reaches the port using the Fasah Tabadul, which is integrated with GHAD.
  • The documents, such as product details, GHAD license, Fasah Tabadul clearance request, import/export purpose, and lab testing certifications, should be produced at the port.
  • Original clearance documents should be preserved for a period of at least 5 years so that they can be reproduced as and when required.

SFDA Cosmetics Import Clearance And Distribution

  • The SFDA.CO/GSO 1943 – Clause 7; the GSDP Guide states all the requirements for the import clearance and distribution of cosmetics.
  • Now, all the process of shipment is automated through the GHAD portal, hence speeding up the import clearance and distribution.

The following are some of the essential requirements for import clearance and distribution:

  • GHAD Notification: It is essential to notify the product through GHAD before the import.
  • Certificate of Conformity (CoC): The Certificate of Conformity must relate to the notified product. It should be issued through the required conformity-assessment process. SFDA’s clearance guidance states that a CoC must be issued through the electronic Fasah platform for acceptance during cosmetic product clearance.
  • Importer Account & Licensed Warehouse: The importer must have an SFDA GHAD account, and the warehouse should be licensed.
  • Compliance with SFDA.CO/GSO 1943:2024: Cosmetic shipments must comply with the applicable requirements of the current cosmetic safety regulation and related SFDA requirements.
  • Good Storage & Distribution Practices: The shipments should be stored in the warehouse in compliance with all the Good Storage & Distribution Practices.
  • Documentation: Documents such as test reports, ingredient lists, safety data, label copies, etc. should be produced at the time of shipment.

Cosmetic Products Market Launch in Saudi Arabia

  • SFDA.CO/GSO 1943 – Clause 5 regulates the Market Launch.
  • Once the product is successfully notified and an authentic facility license is granted, the product can enter the Saudi market.
  • Manufacturing should ensure proper labelling before its market entry.
  • The label should comply with the applicable Saudi/Gulf cosmetic labelling requirements, including required product information, ingredient information, and barcode requirements.
  • The product should have a CoC if it is imported. It also applies to its distribution warehouse, which should adhere to the Good Storage and Distribution Practices.

Post-Marketing Surveillance

Post-market responsibilities continue after a cosmetic product has been notified. The notifier is responsible for the product’s safety. They must inform SFDA when any of the following happens:

  • Harm is caused by the product
  • A manufacturing error occurs
  • The product is recalled in another country

The notifier must also maintain the PIF, report misuse, and provide analytical results. It should show conformity when requested and support product recall or withdrawal where necessary.

Fees Associated With Cosmetic Products

The current SFDA cosmetic product notification service is listed as having no service fee. However, other regulatory activities, such as establishment-related services, conformity assessment, or import-clearance activities, may involve separate costs.

Conclusion

Saudi Arabia’s cosmetic framework is based on product notification and not a pharmaceutical-style product marketing authorization. Notification does not remove the manufacturer’s or importer’s responsibility to meet all the requirements. SFDA can take regulatory action when products or establishments do not comply.

Navigate cosmetic regulatory requirements with support from Artixio. Explore our cosmetics regulatory services for assistance with compliance, market entry, and product requirements.

FAQs

How long does the Saudi FDA take for cosmetic product notification?

The Saudi FDA’s current cosmetic product notification service is listed as having an immediate implementation period through its digital platform, provided the submission meets the required conditions.

What is a Product Information File (PIF)?

A PIF is a cosmetic dossier file required at the time of SFDA inspection. The PIF includes all the information regarding the formulation, manufacturing, labeling, etc. The notifier maintains and provides it when requested.

What are the consequences of non-compliance with the SFDA regulations?

Consequences such as product recalls, suspension, penalties, etc. are faced by the manufacturers upon non-compliance with the Saudi FDA.

Can the same cosmetic product with different shades or fragrances be submitted under one cosmetic notification?

Yes. SFDA’s cosmetic product notification system recognizes a ‘single cosmetic product with variation’ category, which can cover specified variations such as shades or fragrances. Current product notification is handled through GHAD rather than the former eCosma system.

Get in touch

×