What is Cosmetic Notification (ÜTS) in Turkey and Why is it Mandatory?
Cosmetic notification is the official process of registering all cosmetic products intended for sale on the Turkish market or export from Turkey into the Product Tracking System (ÜTS – Ürün Takip Sistemi), governed by the Ministry of Health’s Turkish Medicines and Medical Devices Agency (TİTCK). This notification is a mandatory legal requirement implemented to ensure full product traceability, safeguard public health, and eliminate illicit manufacturing. No cosmetic product without a completed ÜTS notification can be legally sold, distributed, or promoted commercially.
Pursuant to Cosmetic Law No. 5324 and the Turkish Cosmetic Regulation, all brand owners introducing products to the market hold direct responsibility for the notification process. If unregistered products are detected during regulatory audits, severe legal sanctions are enforced, including substantial administrative fines, mandatory market recalls, and product destruction.
For entrepreneurs, global importers, and corporate procurement buyers engaging in contract manufacturing (private label) within the detergent and cosmetics sector, ÜTS notification represents the most critical regulatory milestone. At Ezel Premium, alongside our advanced manufacturing capabilities, we ensure our business partners operate in full compliance with local and international regulatory frameworks.
ÜTS Cosmetic Registration Process: A Step-by-Step Implementation Guide
The ÜTS cosmetic notification process involves opening a corporate account, appointing a qualified Responsible Technical Person (STE), preparing a comprehensive Product Information File (PIF), and declaring detailed product parameters to TİTCK via the digital portal. The process concludes when the submitted data is validated by the system and the product status shifts to ‘notified’.
With precise planning, ÜTS registration can be executed swiftly. However, even minor discrepancies in technical documentation can delay market entry. Below is the step-by-step workflow:
Step 1: Company Registration and E-Signature Setup
To perform transactions on ÜTS, a company must first register in the ÜTS database through Turkish E-Devlet (e-Government) and MERSİS integration. The authorized corporate representative must possess a valid Turkish electronic signature (e-signature).
Once company registration is approved, authorized system users and legal representatives acting on behalf of the company are formally designated within the portal.
Step 2: Appointment of a Responsible Technical Person (STE)
Under Turkish cosmetic regulations, every registered cosmetics company must appoint a qualified Responsible Technical Person (Sorumlu Teknik Eleman – STE). Professionals holding university degrees in pharmacy, chemistry, chemical engineering, biology, or microbiology qualify for the STE role.
The STE is legally accountable to regulatory authorities for ensuring that products conform strictly to health standards, Good Manufacturing Practices (GMP), and technical regulations. STE appointments are executed officially through the ÜTS portal.
Step 3: Product Information File (PIF) and Safety Assessment
Prior to submitting a notification, a comprehensive Product Information File (PIF / ÜBD) must be compiled for every individual formulation. The cornerstone of this dossier is the “Cosmetic Product Safety Assessment Report,” authored by a qualified safety assessor/toxicologist.
The PIF contains the complete product formulation, Safety Data Sheets (MSDS/SDS) for all raw materials, finished product analysis reports, microbiological test results, and packaging specifications. While the PIF is not directly uploaded to the online portal, it must be archived at the company’s premises for regulatory inspections.
Step 4: Product Registration and Label Submission on ÜTS
Once technical dossiers are complete, the registration process begins on the ÜTS portal under the “Cosmetic Product Notification” tab. Key metrics including trade name, product category, intended application, and the full ingredient list (using standardized INCI terminology) are entered into the database.
Furthermore, artwork renderings of primary and secondary packaging, label text, and marketing claims are uploaded in PDF format. Upon notification acceptance, a unique product-specific ÜTS registration barcode is generated.
Required Documents and Technical Details for Cosmetic Notification
Ensuring complete and precise data entry during the Ministry of Health notification process is crucial for long-term commercial compliance. Inaccurate ingredient ratios or missing laboratory reports can result in administrative freezes or market bans.
The table below summarizes the core technical documentation required during ÜTS notification and PIF compilation:
| Document / Test Name | Description | Responsible Party / Source |
|---|---|---|
| Formulation & INCI List | 100% qualitative and quantitative breakdown of the formulation. | Manufacturing Facility (Ezel Premium) |
| Safety Assessment Report | Technical evaluation certifying safety for human health. | Toxicologist / STE |
| MSDS / SDS (Safety Data Sheets) | Safety data sheets for all individual raw materials used. | Raw Material Suppliers |
| Stability & Preservative Efficacy Testing | Analytical tests establishing shelf life and microbial defense (Challenge Test). | Accredited Laboratory |
| Label & Packaging Artwork | Graphic layouts detailing legal warnings, ingredients, and instructions. | Brand Owner / Graphic Designer |
Who is Responsible for ÜTS Notification in Private Label Manufacturing?
In contract and private label cosmetic manufacturing, legal responsibility for registering the product and placing it on the market rests with the legal entity identified as the “Responsible Person” (Brand Owner) on the product packaging. The contract manufacturer is accountable for producing the goods in full alignment with GMP guidelines and the validated formulation.
However, for international investors or companies unfamiliar with local regulations, compiling technical dossiers can prove challenging. Partnering with an experienced contract manufacturer mitigates operational and legal risks.
At Ezel Premium, we offer comprehensive support for private label cosmetic and cleaning product projects. Beyond manufacturing, we deliver turnkey solutions encompassing formula R&D, laboratory testing, label compliance checks, and regulatory ÜTS consultancy for our global partners.
ÜTS Notification and Free Sale Certificate (FSC) for Exports
Cosmetics manufactured in Turkey for export to international markets must also maintain active ÜTS registration. Regulatory bodies and customs authorities in many destination countries require a “Free Sale Certificate” (FSC) issued by the Turkish Ministry of Health.
An FSC can only be issued by TİTCK for products that hold an active, fully verified ÜTS notification status. Export-focused brands must structure their regulatory steps to ensure alignment with international legal standards from inception.
Common Mistakes and Key Considerations in ÜTS Notifications
Errors committed during cosmetic notifications can cause severe launch delays and significant legal penalties. The most common industry oversights include:
- Making Unlawful Medical Claims: Using medical language such as “cures eczema,” “treats dermatitis,” or “regenerates skin cells” on cosmetic packaging is strictly forbidden. Cosmetics must solely serve to clean, perfume, protect, or alter appearance.
- Inaccurate INCI Terminology: Listing ingredients outside standard International Nomenclature of Cosmetic Ingredients (INCI) formatting leads to immediate registration rejection.
- Deficient Laboratory Testing: Omitting real-time stability testing or microbial Challenge Tests (preservative efficacy) constitutes a major regulatory violation.
- Prohibited or Excess Substances: Utilizing ingredients listed in restricted or prohibited Annexes of the Cosmetic Regulation beyond authorized threshold levels.
Seamless and Turnkey Contract Manufacturing with Ezel Premium
Navigating regulatory hurdles should not delay your brand’s international expansion. Ezel Premium simplifies market entry through state-of-the-art production infrastructure, experienced R&D scientists, and dedicated regulatory experts.
From personal care items like liquid soaps and shampoos to heavy-duty household detergents, our facilities maintain strict adherence to ISO and GMP quality standards. We offer our technical knowledge and regulatory capabilities to elevate your brand from concept to commercial success.
Contact the Ezel Premium sales and regulatory team today to discuss wholesale purchasing, private label cosmetic manufacturing, and complete ÜTS compliance support.
Sıkça Sorulan Sorular
How long does Ministry of Health cosmetic notification approval take in Turkey?
When data and packaging artwork are submitted completely into the ÜTS system, notifications are processed instantly by the platform. However, TİTCK retains authority to perform post-market risk-based audits and request additional technical revisions.
Who performs the ÜTS registration during private label cosmetic manufacturing?
Legally, ÜTS registration must be filed under the account of the ‘Responsible Person’ (the brand owner listed on the label). However, contract manufacturer Ezel Premium assists brand owners by preparing all formulation data, laboratory tests, and technical dossiers required for registration.
What are the consequences of selling cosmetics in Turkey without ÜTS notification?
Products distributed without active ÜTS registration are classified as ‘unsafe’ and ‘illegal’ goods. Regulatory enforcement by the Ministry of Health results in heavy financial penalties, immediate product recalls, and mandatory product destruction.
Is it mandatory to employ a Responsible Technical Person (STE) for cosmetic notifications?
Yes, Cosmetic Law mandates that every business distributing cosmetic products in Turkey must employ or contract a qualified Responsible Technical Person (STE), such as a Pharmacist, Chemist, or Chemical Engineer.