eCosma: SFDA Cosmetics Registration Requirements (Guide)

cosmetics registration in eCosma sfda

SFDA is the regulating body for cosmetics in the Kingdom of Saudi Arabia. Cosmetics imported to or manufactured in Saudi need to be approved by SFDA through the submission of cosmetic registration applications in eCosma system. In this system, companies can register their cosmetics products and manufacturers.

In this article, we are going to outline the cosmetics types in SFDA and their registration requirements. For other types of registration, you may refer to SFDA products registration article.

What is a Cosmetic Product

Defines cosmetics as “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition”.

(The rules governing cosmetic products in the European Union, 1999, p. 7)

Examples of Cosmetics

  • Creams, emulsions, lotions, gels, and oils for the skin (hands, face feet, etc)
  • Face Masks (with the exception of peeling products).
  • Tinted bases (liquids, pastes, powders)
  • Make-up powders, after-bath powders, hygienic powders, etc.
  • Toilet soaps, deodorant soaps, etc.
  • Perfumes, toilet waters, and eau de cologne
  • Batch and shower preparations (salts, foams, oils, gels, etc)
  • Depilatories
  • Deodorants and antiperspirant
  • Haircare products
  • Shaving products (creams, foams, lotions, etc).
  • Products for making up and removing make-up from the face and eyes.
  • Products intended for application to lips.
  • Products for care of teeth and the mouth.
  • Nail care and make-up
  • External intimate hygiene
  • Sunbathing
  • Tanning without sun
  • Skin-whitening
  • Anti-wrinkle
  • Eye decorative cosmetics (Eye shadow, Mascara, brows, lids, pencil, lashes, cream, and athmad (al-kohol).

eCosma: SFDA system for cosmetics registration

Local Saudi companies with licensed cosmetics warehouses can login to eCosma system, create a user, then license their business for cosmetics trading and importing activities. Cosmetics manufacturers are also to be registered in eCosma.

SFDA eCosma system for csmetics registration in Saudi Arabia
SFDA eCosma system

Cosmetics Types in SFDA eCosma System

Simple

  • It is a simple one-component pack such as a shampoo.
  • One single pack
  • Covered by one notification in eCosma
  • One product information file.
  • One category.
  • One frame formulation.

Simple with Variation

  • It is a shade/fragrance variant cosmetic such as lipstick
  • Range of cosmetics that are the same, except for a change in color, fragrance, strength etc.
  • The whole range is covered by one product information file
  • One notification in eCosma
  • One category.

Composite

  • It is a composite cosmetics product (shade variant or not) e.g. Palette lips, eyes, cheeks.
  • A set containing several individual components.
  • Each component is a “simple product”
  • Not sold individually.
  • Only one product information file
  • One notification for the whole set in eCosma.
  • One or several cosmetics categories.
  • Each component can have a different formula.
  • One or several frame formulations.

Kit

  • It is a composite cosmetics product (shade variant or not) e.g. Palette lips, eyes, cheeks.
  • A set containing several individual “simple” products.
  • Each with its own notification in eCosma
  • Each with its own product information file.
  • Product 1 :
    • One cosmetics Category
    • One frame formulation
  • Product 2 :
    • One cosmetics Category
    • One frame formulation

Cosmetics Registration Requirments in eCosma

In eCosma, companies can register cosmetics, renew the license, and apply for variations and updates. The SFDA does not issue an official registration certificate for cosmetics. They only issue an approval notification number in the system after they review and accept the profile. The requirements for cosmetics registration in eCsoma are:

  • Owner information:
    • Manufacturer name
    • License number
    • Production line
  • Product Information:
    • Name in English and Arabic,
    • barcode
    • Country of the company
    • Country of manufacturing
    • Category
  • Ingredients:
    • Volume
    • Unit size
    • Ingredient name (Ingredient name should be as per INCI name International Nomenclature Cosmetic Ingredient)
    • Ingredient concentration in percentage
    • The function of each substance.
  • The label of finished product packaging: The finished label should include the following in English and Arabic:
    • Brand name
    • Manufacturing site name, address, and the country of origin
    • Instructions of Use
    • In addition, the artwork must include the volume of the package (the container size, the unit of measure (UOM), and barcode). Artwork must be printed both at the front and back of the packaging.
  • Other Information:
    • Storage Conditions
    • Protection instruction
    • Usage instruction.

For support in Cosmetics registration in Saudi Arabia

Cosmetics Manufacturer Registration

Local Cosmetic Manufacturer Registration Requirements

Local cosmetics manufacturers need to be inspected by SFDA before approval for the activity. The registration process should start in eCosma system by registering the company with all local trade and municipality licenses available. The application will only require basic information such as:

  • Owner information
    • Company name
    • Main Commercial record number
    • Issue/expiry date
    • Company type
  • Individual Establishment address
  • Authorized Person Information
    • Name
    • ID number
    • Email ID
    • Authorization Letter
  • Cosmetic Manufacturer owner information
  • Address
  • Location
  • Activities
  • Production Lines
  • Contact Person Information

International Cosmetic Manufacturer Registration

Foreign manufacturers need to sign with a local distribution company to register their manufacturer or through PharmaKnowl, an SFDA consulting company. The inspection of foreign cosmetics manufacturers is not required by SFDA and the registration process is not complicated. However, a thorough SFDA review of the application, multiple waves of inquiries, and requests of technical files are expected. The local company or representative needs to provide the correct interpretations to the manufacturer and mediate with SFDA the right way to lower the risk of rejection.

The cosmetics manufacturer registration requirements are:

  • Manufacturer name and Nationality
  • Manufacture Address
  • GMP certificate in Country of Origin
  • Authorization letter for marketing in KSA
  • License certificate in Country of Origin
  • License number in Country of Origin
  • Contact Person Information and Authorization Letter (in KSA)
  • Relationship letter between the brand owner and manufacturer, if the manufacturer is different from the brand owner.
  • Production lines information: (eg Skin cream or Lotion, Skin soap liquid, Skin soap solid, Hair shampoo or conditioner, Toothpaste, Mouth wash).

Cosmetics Registration Fee in eCosma

There are no fees for cosmetics registration or their manufacturers in the SFDA eCosma system. Fees are applicable for licensing the local warehouses and manufacturers.

Cosmetics Registration Timelines

The SFDA evaluation timelines for cosmetic product is 15 working days.

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