SFDA Cosmetics Regulations & Registration (eCosma)

sfda cosmetics registration

In 2015, SFDA cosmetics regulations were enforced in Saudi Arabia, binding companies to receive an SFDA registration before marketing their products. Cosmetics distributors and consulting companies should register the products through the SFDA cosmetics registration system (eCosma). It is a notification procedure that lands the approved products on the SFDA cosmetics list.

In the Saudi cosmetics regulations, the registration process is named “notification” since the SFDA might not necessarily review the content of the eCosma applications. They hold the applicants responsible for compliance with cosmetic standards.

In other words, a non-compliant cosmetic product may pass through the notification system to reach the SFDA cosmetics list. However, SFDA will eventually either reject its clearance or withdraw it from the market.

In this article, we will outline the cosmetics types in SFDA and their registration requirements.

Checkpoints of SFDA cosmetics regulations

Most of the enforcement of the regulations occurs during post-marketing surveillance. The SFDA inspects the cosmetics as follows:

  • During clearance, the customs at the port of entry will refer the process to the SFDA officials, who will do the following:
    • Inspect the cosmetic artworks (carton and label) for compliance.
    • Inspect the certificates of analysis for test conformity & lab accreditation.
    • Withdraw samples for analysis, if necessary.
  • During marketing, SFDA monitors the cosmetics by:
    • Checking the artwork of products on the shelf for compliance
    • Anonymously buying products for lab analysis purposes.
    • Review live marketing activities to ensure that the materials, advertisements, influencers, campaigns, and products are pre-approved.

Who can apply for cosmetics registration?

Only local Saudi companies can apply for SFDA cosmetics registration. Before submitting product applications, they must apply for the establishment license for cosmetics trading. SFDA grants it to local companies who meet the following terms and conditions:

  • Having a commercial record from the Saudi Ministry of Commerce.
  • Their trading activity is wholesale cosmetics.
  • Have a third-party warehouse contract with an SFDA licensed warehouse or storage company. (waived in some cases).

Note: opening an account in eCosma might enable the user to list the products; however, this is not enough to receive SFDA approval on clearance of commercial shipments.

Contact us in PharmaKnowl to know more about:
– When it is a must to have a warehouse
– Price range or quotation for an SFDA licensed warehouse space
– How to ensure SFDA approval for your third-party warehouse contract
– The best way to trade in compliance without bearing more costs

Cosmetics online business (e-commerce)

The SFDA cosmetics regulations require e-commerce businesses to register their products in Saudi Arabia. It is necessary even when shipments are for individuals (i.e. not wholesale quantities). The law implies the registration of all cosmetics marketed to the Saudi population.

In PharmaKnowl Consulting, we help international companies to secure SFDA approvals for their cosmetics products. Our services ensure compliance when they want to conduct business activities such as online marketing campaigns and offline event participation.
We represent some of the top cosmetics companies worldwide; contact us for more details.

What is a cosmetic product?

Cosmetics are “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

Here are a few examples of cosmetics as per the SFDA classification:

  • Creams, emulsions, lotions, gels, and oils for the skin (hands, face, feet, etc.)
  • Face Masks (except 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 kohl (athmad).

eCosma: the SFDA cosmetics registration system

Local Saudi companies and warehouses can log in to the eCosma system, create a user, and authorize their business for cosmetics trading and importing activities. Cosmetics manufacturers are also to be registered in eCosma.

SFDA eCosma system

Accepted SFDA cosmetics types

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
  • It is a range of the same cosmetic products, except for a change in colour, 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.”
  • They are 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

SFDA Cosmetics Registration Requirements

In eCosma, companies can register cosmetics, renew their licenses, and apply for updates. The SFDA does not issue an official registration certificate for cosmetics. Instead, they issue an approval notification number in the system after they review and accept the profile. A while afterwards, the product will be available in the approved sfda cosmetics list. According to the sfda cosmetics regulations, 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 country of origin
    • Instructions of Use
    • The artwork must also include the volume of the package (the container size, the unit of measure (UOM), and the barcode). Artwork must be printed both at the front and back of the packaging.
  • Other Information:
    • Storage Conditions
    • Protection instruction
    • Usage instruction.

As mentioned in the introduction of this article, the compliance of the content and label claims are the responsibility of the applicant. The SFDA will not reject a product that has illegal ingredients.

Therefore, the applicants must ensure that their products do not contain banned ingredients (substances, preservatives, colouring agents), above-limit concentrations, or non-approved claims. Any miss in these points will result in unlawful listing in the SFDA cosmetics list.

Cosmetics Manufacturer Registration

Local cosmetic manufacturer

Local cosmetics manufacturers need to be inspected by SFDA before approval for the activity. The registration process should start in the eCosma system by registering the company with all local trade and municipality licenses. 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

International cosmetic companies must have an agreement with a Saudi importer or a consulting company to register their manufacturers and products. SFDA does not require the inspection of foreign cosmetics manufacturers, and the registration process is not complicated. However, a thorough review, waves of inquiries, and requests for technical files are all 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.

Contact us to inquire about the facilitation service by Pharmaknowl, an SFDA consulting company.

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: (e.g., Skin cream or Lotion, Skin soap liquid, Skin soap solid, Hair shampoo or conditioner, Toothpaste, Mouth wash).

Registration fee in eCosma

There are no fees for cosmetics registration in Saudi Arabia. It is at no governmental cost to have the products approved in the sfda cosmetics list. Therefore, you should expect no invoices or fees in the eCosma system even for manufacturers (except Saudi manufacturers). On the other hand, licensing the local companies, warehouses, and cosmetics manufacturers are all with SFDA charges. For more details, refer to our SFDA Fees article.

Timelines

The SFDA timeline for cosmetic product and manufacturer registration is 15 working days.

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