Navigating the Turkish Cosmetics Market: The Responsible Person, ÜTS, and ÜGD

Turkey's vibrant and growing cosmetics market presents lucrative opportunities for both domestic and international businesses. However, navigating the regulatory landscape requires a thorough understanding of key concepts and obligations, including the role of the Responsible Person, the Ürün Takip Sistemi (ÜTS), and the Uygunluk Değerlendirme ve Güvenlik Dosyası (ÜGD).1

The Responsible Person in Turkey

Similar to the EU and UK, Turkey mandates the designation of a Responsible Person for all cosmetic products placed on the market.2 This individual or legal entity, based in Turkey, acts as the primary point of contact for regulatory authorities and bears the legal responsibility for ensuring product compliance.3

Key Responsibilities of the Responsible Person:

• Product Safety: Ensuring the safety of cosmetic products through adequate testing and safety assessments.4

• ÜTS Registration: Registering the company and its products on the Ürün Takip Sistemi (Product Tracking System).5

• ÜGD Compilation: Preparing and maintaining the Uygunluk Değerlendirme ve Güvenlik Dosyası (Conformity Assessment and Safety File), similar to the EU's Product Information File (PIF).

• Labeling Compliance: Ensuring product labels comply with Turkish regulations, including language requirements and mandatory information.

• Notification and Reporting: Notifying the authorities about product placements and reporting any serious undesirable effects (SUE).

• Market Surveillance Cooperation: Cooperating with market surveillance authorities and providing necessary documentation upon request.

Understanding the Ürün Takip Sistemi (ÜTS)

The ÜTS is an online platform managed by the Turkish Medicines and Medical Devices Agency (TİTCK) for tracking and monitoring cosmetic products in Turkey.6 It serves as a centralized database for product information, facilitating market surveillance and ensuring consumer safety.

Key Aspects of ÜTS:

• Company Registration: All cosmetic companies operating in Turkey must register on the ÜTS.7

• Product Notification: Before placing a product on the market, the Responsible Person must notify the authorities through the ÜTS, providing detailed product information.8

• Tracking and Traceability: The ÜTS enables the tracking of cosmetic products throughout the supply chain, enhancing transparency and accountability.

The Uygunluk Değerlendirme ve Güvenlik Dosyası (ÜGD)

The ÜGD is a comprehensive document, similar to the EU's PIF, containing all relevant information about a cosmetic product. It demonstrates the product's compliance with Turkish regulations and serves as a technical dossier for safety assessment.

Key Components of the ÜGD:

• Product Description: Detailed information about the product, its intended use, and target users.

• Formulation and Ingredients: A complete list of ingredients with their functions and concentrations.

• Manufacturing Method: Description of the manufacturing process.

• Safety Assessment: Safety data and risk assessment of the product, including any toxicological data.

• Labeling Information: A copy of the product label and any supporting documentation for claims made.

• Proof of Compliance: Documents demonstrating compliance with Turkish regulations, such as test reports and certificates.9

Navigating Turkish Cosmetics Regulations with Kompass Europe

While Kompass Europe specializes in EU and UK regulations, we understand the interconnectedness of global markets. We can connect you with trusted partners and resources in Turkey to help you navigate the complexities of Turkish cosmetic regulations, including:

• Responsible Person services: Appointing a qualified Responsible Person in Turkey.

• ÜTS registration and product notification: Ensuring compliance with ÜTS requirements.10

• ÜGD compilation and review: Preparing and maintaining comprehensive ÜGDs.

• Labeling compliance: Adapting your labels to meet Turkish regulations.

By understanding the roles of the Responsible Person, the ÜTS, and the ÜGD, and by seeking expert guidance, businesses can confidently enter the Turkish cosmetics market and ensure the compliance and success of their products.