SFDA Cosmetics Registration

The Saudi Food and Drug Authority (SFDA) enforced cosmetics regulations in 2015, requiring the industry to secure SFDA registration before marketing their products. Note that cosmetics registration is a “notification” or “listing” procedure, which means the SFDA does not necessarily review the submitted registration file. This fact makes the process fast but also very tricky because if you submit non-compliant files, the SFDA will not reject your request. Therefore, the authority ensures compliance more in the post-marketing phase, such as at the port of entry and inside the market.

This article will outline the cosmetics registration requirements in SFDA and their application types.

Cosmetics Regulations and Standards

Unlike all other types of products, SFDA does not review the cosmetics application files since it is a notification process. Any files will be accepted even if they do not comply with the standards. The authority publishes the regulations and related technical standards for the industry, which need to apply to their products. Here is more about the procedure and other essential points below:

Notification Procedure

The registration process is called “Notification” or “Listing.” That means the company shall apply the standards on the product file and then submit it to declare compliance. In other words, the SFDA does not necessarily review the submitted files to confirm compliance; they leave companies responsible.

What is different in Saudi Standards?

Having the product registered and marketed in Europe or GCC countries does not guarantee its compliance in Saudi Arabia. It is well known that SFDA is stringent in cosmetics standards. Here are a few examples below:

• Prohibited substances: The scope of this list is broader in Saudi vs most countries.
• Limited substances: They require additional conditions before marketing.
• Strict labelling: implicit vs. explicit wording and absolute claims are usual compliance issues. They are the most common reason for shipment rejection and product withdrawals.
• Substance Strength Limits: For example, 40% potency is allowed in most countries, but only 10% is allowed in Saudi Arabia.
• Advertisement: The SFDA heavily monitors cosmetics advertisements and marketing campaigns. For example, an expert must scrutinise the ad script for a social influencer to avoid SFDA penalties.
• Preservatives: Special standards apply.
• Colouring agents: Special standards apply.
• 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 a product intended for eye beauty.

When does SFDA check compliance?

Since SFDA does not review the submitted cosmetic registration files, they enforce the regulations at the post-marketing stage. The SFDA officials will monitor compliance during shipment clearance and in the market. We will clarify both points below:

Custom 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: SFDA ensures only the license holder is allowed to import the product.
• Artwork Check: received goods caries same submitted carton & label in SFDA system.
• Labelling check: wording, use claims, etc
• COC Check: Review a few elements in the certificates of conformity (COC)

Market Check

SFDA inspectors roam the market, both the store shelves and online stores, 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 store & warehouse inspections.

Cosmetics Classification

Cosmetics classification can differ in SFDA; a cosmetic product in one country might be a health product or a medical device in Saudi Arabia. Examples of candidate products for SFDA complications include:

• Mesotherapy
• Exosomes
• Placenta-based
• Micro-needling
• derma-roller
• Peeling and depigmenting
• Whitening
• in vials or ampules

Who can register cosmetics?

Only local companies can apply for SFDA cosmetics registration. They must be SFDA-licensed for importing and distributing cosmetics with an SFDA-inspected warehouse.

Online Stores

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.

Use the Contact Us form to email or request a meeting about cosmetics registration, warehouse spaces, distribution search, and other regulatory services.

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)

Cosmetics Examples

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.).
• Make-up products
• Make-up cleaning products
• Lips Products
• Teeth and mouth care products
• 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.
• One product information file for the whole range.
• One category.

Composite

• It is a composite cosmetics product (shade variant or not), such as 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), such as palette lips, eyes, and cheeks.
• A set containing several individual “simple” products.
• Each has its 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 package’s volume (the container size, the unit of measure (UOM), and the barcode). It must be printed on both the front and back of the packaging.
• Other Information:
  • Storage Conditions
  • Protection instruction
  • Usage instruction.

Manufacturer Registration

Local manufacturer

Local cosmetics manufacturers need to be inspected by SFDA before approval. The registration process starts 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 manufacturer

SFDA does not physically inspect international cosmetics manufacturers; their authorised local importer or service provider should register their sites in SFDA. The authority will review the files, send inquiries, and request additional technical files.

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. However, SFDA fees apply 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.

Registration Support

If you need registration support services, you may request a meeting or send your inquiry using our Contact Us form.