Cosmetics legislation and product notification in Turkey

Turkey

Applicable legislation

Cosmetic products in Turkey are governed by a comprehensive legal framework designed to ensure consumer safety and product quality. The primary legislation includes:

Cosmetic Law No. 5324

Cosmetic Products Regulation (No. 32184, 2023), which is largely aligned with EU legislation, particularly Regulation (EC) No 1223/2009

The regulatory system is enforced by the Turkish Medicines and Medical Devices Agency (TİTCK) under the Ministry of Health, which oversees product safety, market surveillance, and compliance.

What type of products are cosmetics?

Cosmetic products are defined as:

"Any substance or mixture intended to be placed in contact with the 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, protecting them, keeping them in good condition or correcting body odours."

Products with therapeutic or medical claims are not considered cosmetics and may be classified as medicines or medical devices.

Claims play a key role in determining classification.

Examples of Non-Cosmetic Products:

Products intended to treat or prevent diseases

Products affecting physiological functions through pharmacological action

Injectable or invasive products

Products requiring medical supervision

Requirements

In Turkey, cosmetic products must be notified before being placed on the market via the national Product Tracking System (ÜTS).

The notification ensures that products comply with safety and regulatory requirements set by authorities.

Responsible Person Requirement

All cosmetic products must have a Responsible Person (RP) established in Turkey. The Responsible Person is responsible for:

Product compliance with legislation

Keeping and maintaining the Product Information File (PIF)

Communication with authorities

Post-market surveillance and safety reporting

Required Documents

The following documentation is required for compliance and notification:

Product Information File (PIF)

Cosmetic Product Safety Report (CPSR) prepared and signed by a qualified safety assessor

Ingredient list (INCI format)

Product label and artwork

Manufacturing information (GMP compliance)

Safety and test data (if applicable)

Labelling Requirements

Cosmetic products must comply with strict labelling rules. Labels must be in Turkish. All claims must comply with EU Regulation (EU) No 655/2013 and must not imply medicinal effects.

Notification Process

Appoint a Responsible Person in Turkey

Prepare Product Information File (PIF)

Submit product notification via ÜTS

Ensure safety assessment is completed

Product can be placed on the market after notification

There is no pre-market approval or authorization system for cosmetic products in Turkey. Products are placed on the market following notification (registration) via the Product Tracking System (ÜTS).

Post-Market Surveillance

Products placed on the Turkish market must comply with post-market obligations, including:

Reporting serious undesirable effects

Keeping product documentation available for authorities

Notifying any changes in formulation or labelling

Cooperating with inspections and corrective actions

Timelines

Once the Product Information File is prepared, the information and documentation needed for the notification is submitted to ÜTS.

The officer at the Ministry reviews the submitted information, which usually takes around 3 to 4 weeks. If there are no further objections from the reviewing officer, the product is recorded in the ÜTS system in approximately 1.5 months.

Services offered

Product classification

Formula review

Labelling review and translation

Product registration to UTS

Testing services

Responsible person service

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