Saudi Arabia

Cosmetics testingCosmetics testingCosmetics testing

Applicable legislation

Cosmetic products sold in Saudi Arabia (KSA) are regulated by the following legislations:

GSO 1943:2016 : Safety Requirements of Cosmetics and Personal Care Products

SFDA Cosmetic Guidelines

Saudi Food and Drug Authority (SFDA) Law

SFDA Registration Regulations for Cosmetics

Federal Law on Consumer Protection

Certain cosmetics must comply with Halal certification requirements, ensuring that products do not contain ingredients prohibited under Islamic law (e.g., alcohol, pork derivatives).

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What type of products are cosmetics?

Cosmetic product are defined by the SFDA (Saudi Arabian FDA) as “The Cosmetic product is any product contains one or more substance intended to use on the outer parts of the human body (Skin, hair, nails, lips and the outer parts of the genital) Or teeth and the mucous lining of the oral cavity for cleaning purposes or Perfuming, protection or kept in good condition and to change or improve appearance or to change and improve the smell of the body.”

It is important to note that products intended for therapeutic use (e.g., treating or preventing diseases or affecting the body's structure or function) are classified as drugs or medical devices, even if they also affect appearance. Some personal care products may also be regulated as food supplements, consumer products, or over-the-counter (OTC) drugs.

Claims made regarding a certain product can often determine how the product is going to be classified.

Examples of Non-Cosmetic Products:

Product indicated to prevent, cure diagnose, or alleviate a disease or its symptoms

Product containing substances which restore, correct or modify physiological functions by exerting a pharmacological or metabolic action

Products intended to be used with invasive techniques

Product intended to be used with special device to induce a deeper penetration

Examples of Non-Cosmetic Products in Saudi Arabia:

Acne Products

Excezma, Psoriasis, Dermatitis Treatment

Rosacea, Weaken and damaged capillaries treatment

Relieve tired swollen, heavy legs Varicose Veins

Hair loss & Alopecia etc.

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Requirements

In Saudi Arabia, cosmetic products must be listed with the SFDA's GHAD system before being sold or distributed in the local market. The listing process ensures that all cosmetic products are safe for human use and meet the standards set by the government. If the product meets the guidelines set by SFDA, it will receive a product listing certificate, once it is approved or listed. In order to get the products cleared from the port, a Certificate of Conformance (CoC)also needs to be obtained.

Local Distributor Requirement

Registration and listing must be conducted through a local distributor based in Saudi Arabia.

Classification and Regulatory Categories

Cosmetic products are classified into low-risk, medium-risk, and high-risk categories, determined by ingredients, usage, and target audience.

Required Documents

Product image

Product artwork

Free Sale Certificate

Certificate of Analysis

Ingredient list

Product sample

GMP Certificate

PIF File

Laboratory Test Reports

Safety Assessment Report: Confirms product safety, including information on toxicity, allergenic substances, and clinical testing (if required)

Registration Process

Submit the application: Submit the listing application to the SFDA through the GHAD system

Evaluation: The SFDA evaluates the application, may request additional information or clarification, and conducts a safety assessment to ensure compliance with safety standards

Approval: Once approved, the product receives a listing certificate valid for five years (renewable upon expiry)

Post-Market Surveillance

After listing, products must comply with post-market requirements, including:

Reporting adverse effects

Notifying changes in product formulation or labeling

Complying with recalls or corrective actions, if necessary

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Timelines

Standard Process

Complete listing (with all required documents): 30 working days

Laboratory testing (if required): Additional 20 working days

Notes

The approval of product listing is subject to SFDA regulations

Delays may occur due to changes or updates in SFDA processing systems

In summary, registering cosmetic products in Saudi Arabia requires compliance with SFDA's safety and regulatory requirements, proper documentation, and adherence to timelines set by the authority.

Services offered

Product classification

Formula review

Labelling review

Product registration to GHAD

Testing services

Responsible person service

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And what do they say about us?

Pharmaplast began to work with CE.way almost one year ago. CE.way is our cosmetics consultant who look after compilation of PIF, safety assessments and CPNP notifications. In addition to this, CE.way is our European representative as our company is not located in Europe. Working with CE.way has been a joy so far. Their replies are very swift and Mr Tadej is very cooperative, helpful and with a deep knowledge about the cosmetics regulations. In addition to this, CE.way is very cost effective company in comparison with their European counterparts. For all the above reasons, I really recommend CE.way to other cosmetic product manufacturers.

Mena, Egypt

Pharmaplast

Testimonials

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