SFDA Cosmetics Registration

sfda cosmetics registration

The Saudi Food and Drug Authority (SFDA) enforces cosmetics regulations in Saudi Arabia since 2015. They bind the industry to acquire SFDA registration before product marketing. The cosmetics registration process is called “Notification” or “Listing” since SFDA does not necessarily review the content of the submitted files. It is a fast process yet tricky since listing of cosmetics by non-professionals might make the company suffer consequences when clearing shipments into Saudi Arabia.

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

SFDA Cosmetics Regulations

Unlike all other types of products, cosmetics registration files are not fully reviewed by SFDA. Therefore, companies must apply all applicable standards before registering the cosmetic product in SFDA. We have outlines the most important regulation in below:

Notification Procedure

The registration process is called “Notification” or “Listing”. Meaning, the company should apply the standards then submit the files to officially declare that their products are compliant and ready for marketing. The SFDA does not necessarily review the submitted files, confirms compliance, or grant approval. They hold the company responsible for compliance with the cosmetic standards.

What is different in Saudi Standards?

Having the product marketed in Europe, USA, or the GCC does not mean it is accepted in Saudi. SFDA is very stringent in the cosmetics standards. Here are below few examples:

  • Prohibited substances: scope of this list is wider in Saudi vs most countries.
  • Limited substances: conditions must be met when they are used.
  • Strict labelling: implicit vs explicit wording & absolute claims are usual issues. In fact, this is the most common reason for shipment rejection & products withdrawals.
  • Substance Strength limits: For example, what is globally marketed with 40% potency is only 10% allowed in Saudi.
  • Advertisement: SFDA heavily monitors cosmetics advertisements and marketing campaigns. The ad script for social influencer must be scrutinised by an expert to avoid SFDA penalties.
  • Preservatives: Special standards applies.
  • Colouring agents: Special standards applies.
  • Use location: it is per substance. For example, one substance in the ingredients list might make the term (Use around the eye) is not allowed for an a product intended for eyes beauty.

When SFDA checks compliance?

Since the submitted cosmetic registration file is not fully reviewed by SFDA, they enforce the regulations at the post-marketing stage. Meaning that SFDA officials monitor compliance during shipments clearance and in the market, we clarify both in below:

Shipment Clearance Check

SFDA officials at the port of entry will check the following points before approving the shipment into the Saudi market:

  • Ingredients Check: Active ingredients, colourants, preservatives, etc.
  • Design Check
  • Translation Check
  • Analysis: Withdraw samples for analysis, if necessary.
  • Importer/Distributor Check: Reviewing licenses against shipment documents.
  • Artwork Check: received goods caries same submitted carton & label in SFDA system.
  • Labelling check: wording, use claims, etc
  • COC Check: Review few elements in the certificates of conformity (COC)

Store Shelves & online Stores Check

SFDA inspectors roam the market to do the following:

  • Re-check all the clearance points
  • Perform lab analysis to ensure quality after transportation and storage.

Samples are withdrawn from different cities by either:

  • Secretly & randomly from physical retail stores and pharmacies.
  • Explicitly during stores & warehouse inspections.

Cosmetics Classification

Classification of cosmetics can be different in SFDA. A well-known cosmetic product might be classified as a medicine or a medical device. Examples of products that are candidate for SFDA complications include: Mesotherapy, exosomes, placenta based, micro-needled, derma-roller used, and those in vials or ampules. Contact us for support.

Who can register cosmetics?

Only a local Saudi company can apply for SFDA cosmetics registration. It must have an SFDA license for importation & distribution of cosmetics (not only an account on the system). This license requires having a warehouse in all importing cases without exceptions. Contact us for support.

Online Business (e-commerce)

The SFDA cosmetics regulations require e-commerce businesses to register their products in the following cases:

  • They ship commercial quantities to Saudi.
  • They need to conduct marketing or advertising activities in Saudi.

Looking for support? In PharmaKnowl, we provide international and local companies with the following services:
– Cosmetics Registration (with or without distributor)
– Warehouse
– Distributor Search
– Shipments Clearance
Contact us

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 water, 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 the 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).

Cosmetics types

Simple

  • It is a simple one-component pack such as shampoo.
  • One single pack
  • 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 category.

Composite

  • It is a composite cosmetics product (shade variant or not), e.g., Palette lips, eyes, and cheeks.
  • A set containing several individual components.
  • Each component is a “simple product.”
  • They are not sold individually.
  • Only one product information file
  • 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, and cheeks.
  • A set containing several individual “simple” products.
  • Each with its own product information file.
  • Product 1 :
    • One cosmetics Category
    • One frame formulation
  • Product 2 :
    • One cosmetics Category
    • One frame formulation

Registration Requirements

According to the SFDA cosmetics regulations, the requirements for cosmetics registration 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.

Cosmetics Manufacturer Registration

Local cosmetic manufacturer

Local cosmetics manufacturers need to be inspected by SFDA before approval. The registration process start by providing a commercial record (trade License), civil defence license, municipality license, etc. The application will require basic information such as:

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

International cosmetics 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, SFDA will perform a thorough review on files, send inquiries, and request for technical files. The local representative needs to provide the correct interpretations to the manufacturer and mediate with SFDA on the right way.

The cosmetics manufacturer registration requirements are:

  • Manufacturer name and Nationality
  • Manufacture Address
  • GMP certificate in Country of Origin
  • Authorisation letter for marketing in Saudi
  • License certificate in Country of Origin
  • License number in Country of Origin
  • Contact Person Information and Authorisation Letter (in KSA)
  • Relationship letter between the brand owner and manufacturer if the manufacturer differs 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).

Fees

There are no SFDA fees for cosmetics registration in Saudi Arabia. On the other hand, SFDA fees are applicable when licensing local cosmetic companies, warehouses, and manufacturers. For more details, refer to our SFDA Fees article.

Timelines

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

Read More

Our website uses cookies and asks for your insensitive personal data to enhance your browsing experience.