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

We were looking for a stand-alone service, not too sure what to expect... The professionalism, the assistance and the responsiveness were very much appreciated, amongst the best we have ever experienced.

Carol, Switzerland

Alpure

We are a small manufacturing company located in the US. We recently used CE.way Regulatory Consultants to help guide us through the Cosmetic regulatory changes that have taken place in the EU. They were instrumental in helping us understand the new laws and streamline the entire process. I would highly recommend their services.

Lena and Clay, USA

IBP

We didn't have any knowledge about the registration process for cosmetics in EU and were very concerned about this, but we met CE.way and they gave us whole packages of consultation and support. It was really helpful and we could do the registration without any problem. We will definitely ask CE.way again when we have new product to register in EU.

Masa, Japan

Nash Corporation

We used Tadej and CE.way for EU compliance with our products. He was very helpful and worked directly with our lab which made the process much easier for us. Tadej worked with me directly on all of our products to make sure I had the right documents. I really liked the attention to detail and how I could work with the owner of the company directly. I would highly recommend their services.

Steve, Canada

Curly Hair Solutions

Tadej from CE.way is the best consultant I've ever worked with. It's a great luck that we've found him. He is knowledgeable, fast, helpful & always ready to answer a million questions that we have. We had no exposure to cosmetics market before, so we didn't even know where to start. So he helped us to do EVERYTHING. The quality of service for the amount of money that we pay is absolutely the best! BIG THANK YOU to you Tadej & we'll definitely keep working with you!

Natalia, USA

Hi Tadej, Thank you for your highly professional approach, extremely helpful information and advice on getting our product registration under way and completed in record time! What we thought to be a very tiresome and laborious task was made quick and simple. Thank you again! The Thermitek Team.

Rene, Greece

Funkitup

It's been our first time lodging an application for EU Compliance. Although a big task, Tadej from CE.way made it as painless as possible. His patience and help were invaluable. He was so responsive and was available at all times to work with myself and my manufacturers. We now have our first round of product successfully assessed and notified. I will be placing our next round asap for notification, I can't recommend CE.way highly enough, thanks Tadej - Heather Spierings Eye of Horus Cosmetics.

Heather, Australia

RA Cosmetics

CE.way offers professional and reliable service. The team is diligent and extremely helpful throughout the whole process. We are very satisfied the way the work was executed. We definitely recommend CE.way to others.

Tamar, USA

Nuvision

CE.way made the whole EU process easy to understand. They were very responsive to all our needs.

James, USA

Eufora

This is a major investment for a small business like ours and it took me a few years to find a company (CE.way) that I felt comfortable working with! That speaks volume to my appreciation of the quality of your communications with me.

Vivian, USA

VB cosmetics

Our company had a great experience with CE.way. They were very organized and provided us with a detailed roadmap of exactly what we needed to gather on our end for them to put together our Product Information File and complete the notification process for the EU. They continued to help us along the way, providing quick feedback on any changes we needed to make to a document for it to work and reminders on what we still needed to provide. They are organized, knowledgeable, fast, and attentive; I would absolutely recommend them to any companies looking to get their products approved in the EU.

Cyrus, USA

SBBM

CE.way's assistance was tremendous, helping our company navigate the EU cosmetic regulation and efficiently get products to market.

Mike, USA

Inverness

Our cooperation with Tadej and his team at CE.way Consultants aimed to assist us to launch our products in UK for the first time. Tadej is a very hands on and always quick with his responses. The process was smooth and beyond our expectations in terms of cost savings and the speed with which we accomplished our goal. We look forward to working with them again.

Ruta, UK

Art de Parfum

We are really appreciate your speedy replies and clear and understandable guide. As there are a lot of differences in cosmetic regulations between Japan and EU first we thought that it would be hard to make all necessary procedures for our products compliance with EU laws, but thanks for your prompt support, all procedures were made smoothly. And now we are successfully selling MT Metatron in EU. We also thinking to expand our other brands in EU and when we start - definitely will ask your company for assist again.

Olga, Japan

MT Cosmetics, Inc.

After a less than pleasurable experience with another company, we found CE.way and we can honestly say that it could not be more beneficial for our brand. The whole notification process is made as easy as possible. The people at CE.way are all very accessible, knowledgeable and always ready to answer questions. CE.way is a great asset to our company and we are grateful for all the help and support we receive. Navigating through all rules and regulations alone is impossible, with the team at CE.way, we have the best support that we could ask for. Highly recommended in all aspects from their support to their reliable service!

Daniel, USA

NCLA

Testimonials

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