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COSMETIC PRODUCT NOTIFICATION PROCEDURES

PRODUCT TRACKING SYSTEM (URUN TAKIP SISTEMI – UTS)

 

In this article you will find answers to the following topics:

How to sell cosmetic products in Turkey? How can I produce cosmetic products in Turkey? How can I register cosmetic products to Ministry of Health in Turkey ? How to register my cosmetic products to Urun Takip Sistemi?

It is a legal obligation that imported and domestic cosmetic products are notified to the Ministry of Health in Turkiye’s Cosmetic Product Registration System before they are launched to the market. Before seeking an answer to the question “How is a cosmetic product register in Turkiye?”, one must be sure about whether such imported or produced cosmetic product, its content, notifications on the package, and the place of production are in compliance with legislations of the Ministry of Health. Severe penal sanctions may be applied by the Ministry of Health, as a result of faulty or inaccurate notifications.

Cosmetic Product Registration (UTS) procedure is a very complicated process consisting of different stages. An unintentional error may cause undesirable consequences (fine, product withdrawal and destruction, suspension of advertising and promotion of the product, company disclosure, etc.).
Lore Consulting Company Ltd. will always be with you in order for you to complete cosmetic notification process in a prompt, accurate and reliable manner through its experienced and specialised chemical engineers and biologist experts.

Should you have any questions or problems during or after cosmetic notification process, you can contact our experts.

Lore Consulting Company Ltd. will always be with you in order for you to complete cosmetic notification process in a prompt, accurate and reliable manner through its experienced and specialised chemical engineers and biologist experts.

Should you have any questions or problems during or after cosmetic notification process, you can contact our experts.

 

Please feel free contact with our experts!!
lore@lore.com.tr
Tel: 90 312 215 42 22
Whatsapp

DO NOT FORGET!

You can not sell your cosmetic products in Turkish Market without registering to the Ministry of Health!

 

COSMETIC PRODUCT REGISTRATION PROCEDURES in TURKIYE

 

Cosmetic product notification process is elaborately evaluated by Lore Consulting Company Ltd. and the following procedures are followed.

Notification procedures are safely completed thanks to controls carried out and feedbacks provided by our experts at every stage of Notification process.

Compliance of products to be launched to the market, risks and processes are analysed free of charge. If there is a risk for your company, detailed information is provided to you at this stage.

Notification procedures are performed through Product Tracking System / Urun Takip Sistemi (UTS) and Electronic Document System (EBS). In order to perform such procedures, your company must be introduced to these systems. Company registration is carried out by Lore Consulting Company Ltd. experts.

As per Article 13 of Regulation on Cosmetic Products, companies importing or producing cosmetic products are obliged to employ chemist, biochemist, chemical engineer, biologist or microbiologist, and responsible technical Manager, who hold a bachelor’s degree and document that they have actually worked at least for 2 years in the field of pharmaceuticals and cosmetic.

Since employment means hiring personnel, Responsible Technical Manager contract should continue as long as the products remain in the market.

Responsible Technical Manager is responsible for controlling the compliance of the product to be launched with legislation on cosmetic products, best production practices and other relevant legislation. If you do not have any staff member who meets these requirements, Lore Consulting Company Ltd can also provide you support on this matter.

IMPORTANT: If you do not have a Responsible Technical Manager designated for your company in Product Tracking System (UTS), you can not register your cosmetic products in Turkiye.

Legislation on Cosmetic Products and the Ministry of Health’s practices regulating this sector are very detailed and comprehensive. Above all, it is extremely important to assess whether a product is a cosmetic product or not. For example, while “Nappy Cream” is assessed under cosmetic class, “rash cream” is assessed as cosmetic product because while “rash” is addressed as a health problem, a product that prevents such rash is classified as a therapeutic product and excluded from legislation of cosmetic products. On the other hand, a product which helps “hair growth” is not evaluated as a cosmetic product even though its ingredients are appropriate.

As understood, although a product initially seems to be a cosmetic product, small details may cause such product to be outside the scope of the legislation on cosmetic products. In order to avoid this, our experts carry out a preliminary assessment to determine whether your products comply with the legislation on cosmetic products, then analyse the compliance of ingredients with the legislation. If there is an obstacle regarding cosmetic notification, they will let you know about such situation, including its reasons, if any.

It is very important that the product in compliance with technical legislation is launched with proper label and package. Promotional expressions and “does not contain” claims (paraben-free, no colourants, sls free, etc.) on the product should be carefully examined, and a label should be drafted in compliance with Article 10 of the Legislation on Cosmetic Products, and subsequently, the product is launched to the market.

If such kind of “does not contain” claims are placed on the product, it must be analyses at the laboratories authorised by the Ministry. Lore Consulting Company Ltd also provides services on getting these analyses conducted.

Cosmetic product notification stage follows all these preliminary preparations and examinations.

Product data and information prepared by LLore Consulting Company Ltd’s experts is properly uploaded to Product Tracking System.

Upon the approval of the applications, they are submitted to the examination of the Ministry of Health. This period takes 15 to 30 days, depending on the workload of the Ministry. If notification is deemed suitable as a result of such controls, it is recorded by the Ministry of Health.


Following cosmetic notification application, products may be introduced to the market. There is no need to wait for the Ministry’s analysis result.


In some cases, the Ministry of Health may provide feedback for the application. In such case, necessary amendments are carried out and products are resubmitted for approval. Until this product is recorded by the Ministry of Health, procedures are sustained without requiring extra fees.

Following cosmetic notification, our experts send you an information e-mail about the process.

Cosmetic Product Safety Assessment is also known as Cosmetic Safety Assessment or Product Information File (PIF).

In accordance with Article 12 of the Legislation on Cosmetic Products, Cosmetic Product Safety Assessment must be drafted for each product released. A product, safety assessment of which has not been conducted technically, is evaluated as an “unsafe product”.

Safety assessment documents a product’s reliability in terms of human health through tests (microbiological effectiveness, stability test, challenge test, etc.) and subsequent expert assessment.

Such files are generally available for imported products at manufacturing companies. And yet, since this document contains data that may be regarded as “business secret”, these companies do not wish to provide this document. This is a grave risk especially for cosmetic product importing companies.

Lore Consulting Company Ltd also provides service on getting product samples tested and later on drawing up safety assessment report.

Notification and registration technically means that the process is completed. However, Lore Consulting Company Ltd does not complete the process here. You can contact with our experts for all kinds of questions, problems, and exchange of ideas.

SANCTIONS AND PENALTIES


The Ministry of Health has adopted an efficient market surveillance and inspection in recent years. In this regard, experts of the Ministry of Health carefully examine notified cosmetic products, and may conduct on-site inspection at company’s address for products that they regard as faulty or defective. Therefore, it is of crucial importance to manage cosmetic notification process by a professional company.

During such inspection, Responsible Technical Manager and Safety Assessments must be made available.

Penalties defined in Law No. 5324 on Cosmetic Products are as follows:

 

Releasing cosmetic product to the market without making Cosmetic Product Notification

20.000 TL

Producing, packaging, opening or running importing company without notifying the Ministry of Health or expanding a company’s field of business without reporting amendments made after the first notification,

20.000 TL

Failure to have a Responsible Technical Manager

20.000 TL

Producing/importing cosmetic products that may be harmful to human health

50.000 TL

Substances within cosmetic product are on the list of forbidden substances (Annex-II), specified in the legislation

20.000 TL

Place of production does not comply with the legislation

10.000 TL

Recalling and destroying products which do not comply with the legislation.

Disclosing companies, about whom an irregularity has been reported and who make product notification against the legislation, on the website of the Ministry

20.000 TL

 

And in addition to all these;

Recall of products from the Turkish market and disposelling the nonconforming products!

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