In 2015, the SFDA enforced the cosmetics regulations in Saudi Arabia for the first time. Binding the industry to seek SFDA registration before marketing their products. The registration takes place in the SFDA cosmetics registration system (eCosma). The route of registration is called “Notification Procedure” since products receive the approval and appear in the SFDA-approved cosmetics list without SFDA’s review of the application content.
It is called “Notification” since the SFDA will not necessarily review the content of Ghad eCosma applications. SFDA holds the applicants responsible for compliance with cosmetic standards. In other words, a non-compliant cosmetic product may pass through the notification system and appear in the SFDA cosmetics list. That is why SFDA heavily reject cosmetic shipments and withdraws quantities from the market due to im-compliance.
Therefore, companies must hire professionals with a deep understanding of the applicable standards since the application is just an announcement from the applicant that their products are compliant and ready for marketing.
In this article, we will outline the cosmetics types in SFDA and their registration requirements.
Table of contents
SFDA Cosmetics Regulations
Cosmetics regulations enforcement takes place in the post-marketing stage by the SFDA officials at the port or in the market. They continuously perform inspections as follows:
- During clearance:
Saudi Customs at the port of entry will refer the cosmetics shipment to the SFDA officials, who will do the following:- Inspect the cosmetic artwork (carton and label) for compliance with approved claims.
- Review the certificates of conformity (COC), which must reflect the lab analysis result of the same batches mentioned in the shipment invoice and issued by an accredited lab.
- Check that there are no prohibited or controlled substances in the ingredients (active ingredients, colourants, preservatives, etc.).
- Withdraw samples for analysis, if necessary.
- During marketing
SFDA monitors products on the retail shelves to ensure the following:- Compliance with the same points mentioned above in the clearance stage.
- Quality of the materials by anonymously purchasing products for lab analysis.
- Review the marketing activities to ensure that the materials, advertisements, influencers, campaigns, and products are pre-approved by SFDA.
Who can apply for cosmetics registration?
Only local Saudi companies can apply for SFDA cosmetics registration. They must be licensed by SFDA for cosmetics trading by providing
- Commercial record from the Saudi Ministry of Commerce.
- Trading activity is wholesale cosmetics.
- SFDA-licensed warehouse or a contract with a third-party warehouse. (waived in some cases).
Note: having an account inGhad eCosma might enable the user to list the products; however, this is not sufficient 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
Online business (e-commerce)
The SFDA cosmetics regulations require e-commerce businesses to register their products in Saudi Arabia if they are going to ship commercial quantities or conduct marketing or advertising activities. Even online advertising for cosmetics on social media is not allowed before registering the products in SFDA.
Looking for support? In PharmaKnowl, we help international and local companies with the following:
– Cosmetics registration services
– Distributor search n Saudi Arabia and GCC countries
– Cosmetics online business (no commercial shipments)
– Local company without a warehouse
– Receive budget estimates required for cosmetics trading projects.
– Sourcing warehouse spaces
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).
Ghad eCosma system
eCosma has been cancelled by SFDA in April 2023 and replaced it with Ghad system for cosmetics registration.
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.
Ghad for Cosmetics Registration
The SFDA has launched cosmetics module in Ghad system and stopped receiving cosmetics registration applications in eCosma. This new system should provide more advanced features such as integration with warehouses, clearance agents, accredited labs for COC certificate, and more. However, the regstration process should remain the same in Ghad and enables companies to have their products available in the approved sfda cosmetics list. Untill writing this update, Ghad system is not fully operational and SFDA still migrating products from eCosma to Ghad.
Accepted SFDA cosmetics types
Simple
- It is a simple one-component pack such as shampoo.
- One single pack
- Covered by one notification application in
eCosmaGhad. - 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 application in
eCosmaGhad - 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 notification application for the whole set in
eCosmaGhad. - 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 in its own notification application 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 Ghad, companies can register cosmetic products, 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 earlier, compliance with the content and label claims are the responsibility of the applicant. E.g. 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 mistake in these points will result in an unlawful listing in the SFDA cosmetics list.
Cosmetics Manufacturer Registration
Local cosmetic manufacturer
Local cosmetics manufacturers need to be inspected by SFDA before approval. The registration process should start in Ghad eCosma system by providing 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 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, a thorough review by SFDA, waves of inquiries, and requests for technical files are all expected. The local representative needs to provide the correct interpretations to the manufacturer and mediate with SFDA on 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 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. Therefore, you should expect no invoices or fees in Ghad eCosma system, even for manufacturers (except Saudi manufacturers). 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.
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