Saudi Arabia is one of the GCC’s most tightly regulated beauty markets. Before import or sale, every cosmetic must be listed (“notified”) in SFDA’s eCosma system. Notification creates an official record; it is not a safety “approval,” and you still need shipment compliance (CoC) for customs.
Below is the clean, practical process—optimized for private-label importers, distributors, and brand owners.
1) Understand how the rules fit together
- eCosma (SFDA): Online portal where you list each cosmetic. Listing produces a notification number used in market and clearance paperwork.
- GSO 1943:2024 (GCC safety/labeling): Baseline safety + labeling/packaging requirements used in KSA. Your formula and labels must meet this.
- GSO 2528:2024 (claims): Defines acceptable cosmetic claims; medical/therapeutic claims can push a product out of the cosmetic scope.
- Shipment CoC via FASEH: For each shipment, SFDA-approved bodies issue a Certificate of Conformity (CoC) through FASEH. CoC is in addition to eCosma listing.
Key concept: eCosma = product listing. CoC/FASEH = shipment compliance. You generally need both.
2) Pre-requisites (before you touch eCosma)
- Right classification: Confirm your item is a “cosmetic” under GSO 1943:2024 (scope + definitions). If claims drift into medical benefit, adjust claims or classification.
- Arabic labeling ready: Outer pack must include Arabic (EN can be added). Include INCI list, function, batch/expiry or PAO, responsible party, volume, storage/precautions, country of origin.
- Local responsible party: Importer/distributor with Saudi CR and an active SFDA account (establishment). If the notifier isn’t the brand owner, secure an authorization letter.
- PIF on file (not uploaded by default): Keep a Product Information File in KSA—formula, safety assessment/tests, manufacturing & GMP evidence, labels, etc.—ready for inspection.
3) Create/activate your access
- Register or log in to eCosma (SFDA cosmetic notification portal) with establishment credentials and assign the Notifier role.
4) eCosma notification — exact data you’ll enter
Expect to provide (data fields may vary slightly by category):
- Product name (AR/EN), brand, category/subcategory, form & intended use
- Country of origin, manufacturer and responsible party details (KSA)
- Label artwork (primary & secondary) and clear product images (Arabic content visible)
- INCI ingredient list; if restricted substances are included, SFDA may ask for concentrations just to verify limits (you’ll hold exact formula in the PIF)
- Barcode (if any), pack sizes/variants, packaging type
5) Step-by-step flow (what actually happens)
- Start a “Cosmetic Product Notification” in eCosma and select the correct category.
- Enter product details + responsible party.
- Upload labels/images; verify Arabic fields match GSO 1943.
- List ingredients (INCI). If any are restricted, respond to system prompts or attach justification on request.
- Submit and pay any fees if prompted; SFDA reviews and may raise queries.
- Receive the notification number. Use it consistently across clearance documentation.
- For each shipment, obtain a CoC on FASEH from an SFDA-approved body (SGS, TÜV, BV, etc.).
6) After listing: ongoing duties
- Keep the PIF current and accessible in KSA.
- Adverse event & recall readiness: maintain procedures to report undesirable effects or quality issues.
- Update the notification if you change formula, claims, packaging/size, or labels.
7) Common mistakes (and how to avoid them)
- Medical claims (e.g., “treats eczema”) → violates GSO 2528. Keep to cosmetic claims.
- Missing Arabic content on labels → automatic rework.
- Wrong category/subcategory selected in eCosma → delays.
- Ingredient list too vague when a restricted substance is present → SFDA can request concentrations for verification.
- Assuming eCosma replaces CoC → it doesn’t; you still need CoC on FASEH for each shipment.
8) FAQ
Is eCosma an approval?
No—notification is a listing. You still need to meet the technical regulations and obtain a CoC for shipments.
Do I upload the full formula to eCosma?
You’ll list INCI ingredients; exact concentrations may be requested only to verify limits for restricted substances. Keep the full formula inside the PIF.
What standards do labels follow?
GSO 1943:2024 governs labeling/packaging; Arabic is mandatory on outer packaging in KSA.
What else is needed at import?
An SFDA-approved body issues a Certificate of Conformity (CoC) via FASEH for each shipment.
Sources & references
- SFDA – Guidance & Requirements for Cosmetic Product Notification (latest & prior editions). Saudi Food and Drug AuthoritySaudi Food and Drug Authority
- SFDA – Cosmetic Products Notification System (eCosma) User Guide. Saudi Food and Drug Authority
- GSO – GSO 1943:2024 – Safety Requirements of Cosmetics and Personal Care Products. GCC Standardization Authority
- GSO – GSO 2528:2024 – Cosmetic and Personal Care Products Claims. Istitlaa
- SFDA – Conditions of cosmetic products clearance & raw materials used in their manufacturing. Saudi Food and Drug Authority
- SFDA-approved bodies / FASEH – CoC program overviews. TÜV RheinlandSGSCorp
