Saudi Arabia Cosmetic Registration (SFDA – Saudi Food & Drug Authority)

1. Regulatory Authority & Framework

Cosmetics in Saudi Arabia are regulated under:

• SFDA Cosmetic Regulation (2005, updated series)
• GSO (GCC Standardization Organization) Cosmetic Standards
  • GSO 1943 (Safety Requirements)
  • GSO 2528 (Cosmetic Claims)
  • GSO 2525/2526 (Labeling)
  • GSO 1546 (Safety of Cosmetic Products)
• SFDA eCosma portal – mandatory electronic registration

Authority:
SFDA – Saudi Food and Drug Authority
Sector: Cosmetics & Household Products Department

Saudi Arabia operates a pre-market notification/registration system.
All cosmetic products must be registered in eCosma before importation.

2. Scope – What Is Considered a Cosmetic in Saudi Arabia?

A cosmetic is defined as a substance/preparation intended for external body areas for:

• Cleansing
• Perfuming
• Appearance alteration
• Correcting body odours
• Protecting or maintaining condition

Borderline classifications (hair growth, acne treatment, whitening with medical claims, melasma treatment) may be treated as health products or drugs, not cosmetics.

3. Registration Type – eCosma Cosmetic Product Notification

All cosmetics must be registered in eCosma prior to import.

Output:

• SFDA eCosma Notification Certificate
• Required for customs clearance
• No expiry, but must update if formula/label changes

4. Local Authorized Representative (KSA Responsible Person)

Foreign manufacturers cannot register products directly.

A Saudi-based entity must serve as the Responsible Person (RP):

• Saudi importer/distributor
• Must hold a valid Commercial Registration (CR) and SASO/SFDA approvals

Responsibilities:

• Maintain PIF & safety data
• Submit eCosma notifications
• Handle PMS, recalls, AE reporting
• Ensure Arabic labeling compliance
• Serve as communication bridge with SFDA
• Maintain traceability records

5. eCosma Registration Requirements (Dossier)

A. Administrative Documents

• Authorization Letter (Power of Attorney) from manufacturer
• Manufacturer’s Free Sale Certificate (FSC) from country of origin
  • Notarized + legalized (depending on country)
• GMP certificate (ISO 22716 preferred)
• Saudi company CR + facility license

B. Technical Documents (Product Information File – PIF)

Aligned with EU PIF structure:

1. Product description
2. Full formula (%)
3. Specifications & test results
   • Microbiological limits
   • Heavy metal tests
   • Stability data
4. Safety assessment report (toxicology + margin of safety)
5. Manufacturing process + GMP evidence
6. Claims substantiation
7. Labeling content in Arabic

C. Labeling (Must be Arabic or bilingual)

Mandatory:

• Product name & function
• Batch/lot number
• Manufacturing / expiry date
• Country of origin
• Full ingredient list (INCI)
• Net content
• Warnings (if required)
• Name & address of RP/importer in KSA
• Storage conditions (if necessary)

Arabic language is mandatory; English is optional.

6. Ingredient Control (GCC GSO Standards)

SFDA enforces GSO Annex lists aligned with EU Cosing:

• Prohibited substances (Annex II)
• Restricted substances (Annex III)
• Colorants (Annex IV)
• Preservatives (Annex VI)
• UV filters (Annex VII)

Saudi Arabia has zero-tolerance for:

• Mercury, steroids, hydroquinone, tretinoin
• High-risk skin-lightening actives
• Any ingredient banned under GSO/EU lists

SFDA aggressively monitors whitening products due to frequent non-compliance.

7. Fees & Timelines

Government Fees

• eCosma notification fee: ~SAR 200 per product (≈ USD 53)
• Additional fees for legalization of certificates (vary by origin country)

Timeline

• Dossier preparation: 1–3 weeks
• eCosma submission & review: 5–15 working days
• Valid indefinitely unless changes occur
• Updates/variations: 5–10 days

Saudi is one of the fastest GCC cosmetic markets once documentation is complete.

8. Importation Requirements

To import cosmetic products into Saudi Arabia:

• eCosma Registration Certificate
• Shipment documentation (invoice, packing list, C/O, etc.)
• Label in Arabic
• Barcode (GS1 Saudi preferred)
• Products may be inspected by SFDA at ports
• Random sampling and testing possible
• Compliance with Saber/SASO for packaging & labeling

Without valid eCosma registration, customs will block importation.

9. Post-Market Surveillance (PMS)

SFDA performs:

• Market inspections
• Laboratory testing (heavy metals, microbial limits)
• Online and retail monitoring
• Advertising claim checks
• Traceability audits
• Enforcement actions (recalls, bans, suspensions)

RP must:

• Maintain PIF for minimum 10 years
• Report adverse events
• Conduct recalls when required
• Update eCosma for formula/label changes

10. Borderline Product Classification Rules

Cannot be registered as cosmetics in Saudi Arabia:

• Acne treatment (benzoyl peroxide, high-level salicylic acid)
• Melasma treatment (“treat” or “cure” pigmentation)
• Hair growth/anti-hair loss products
• Anti-inflammatory creams
• Antiseptic/antibacterial products
• Skin bleaching with pharmaceutical actives
• Medicated shampoos
• Products containing corticosteroids or tretinoin

These fall under SFDA Drug or Health Product regulations.

11. Consulting Notes for Your Portfolio

12. Advantages of Saudi Cosmetic Market

• Large, fast-growing beauty market (>USD 5 billion)
• GCC-wide harmonization (products accepted in UAE/Qatar/Bahrain with minor changes)
• Fast eCosma approval (5–15 days)
• High acceptance of Korean/Japanese/Chinese skincare
• Strong regulation improves consumer trust