Navigating regulatory compliance in the chemical industry can be complex, especially when it comes to KKDIK (Turkish REACH) and the Turkish Biocidal Products Regulation. If you are a non-Turkish manufacturer looking to market your chemical or biocidal products in Türkiye, appointing a Turkey Only Representative (OR) is a crucial requirement.
Only Representative for Biocidal Products
Legal Requirement
Under the Turkish Biocidal Products Regulation, manufacturers or importers located outside Türkiye must appoint a legal entity established in Türkiye as their “Only Representative” to enable the placement of their products on the Turkish market.
Purpose and Function
The appointment of an Only Representative allows foreign manufacturers to comply with the legislation without having to establish a separate company in Türkiye. The Only Representative communicates with the competent authorities on behalf of the manufacturer, manages the required registration and notification processes, and assumes responsibility for regulatory compliance.
Advantages for Foreign Manufacturers
- Provides faster and efficient access to the Turkish market.
- Ensures compliance with local legislation through a specialized representative.
- Eliminates the need for foreign manufacturers to establish a branch or subsidiary in Türkiye.
Chemleg’s Distinctive Approach in Turkey Only Representative Services
For companies placing biocidal products on the Turkish market, Chemleg offers Only Representative services. With our services, you gain access to:
- Expertise in Turkish Chemical Regulations: Our team specializes in KKDIK, CLP, SEA, PIC, Cosmetics, Detergents, and Biocidal regulations.
- Confidentiality & Compliance: We ensure secure handling of your product data and compliance with legal requirements.
- Seamless Market Access: With our representation, you can confidently introduce your chemical and biocidal products in Türkiye.
Ensure your regulatory compliance in Türkiye with our trusted Only Representation services, including:
- Submission & management of Biocidal Product applications
- Product registration & authorization support
- Communication with the Turkish Ministry of Health
- Technical Dossier & Risk Assessment compliance
- Post-market regulatory updates & renewals
Fill in the form now to schedule a meeting with our experts.
Frequently Asked Questions
Is it mandatory for a foreign manufacturer to appoint an Only Representative in Türkiye?
Under the Biocidal Products Regulation, authorization applications can only be submitted by companies established in Türkiye. This means that the manufacturer, its headquarters, or a branch must be located within the borders of Türkiye. Companies not meeting this requirement may appoint a locally established “Only Representative” to submit their Biocidal Product applications.
Who can be an Only Representative?
An Only Representative can be a legal entity or a natural person who is legally authorized to perform this role. Typically, regulatory consultancy firms or importer companies are appointed as the Only Representative.
What is the role of the Only Representative in the authorization application?
The Only Representative is the primary responsible party for the authorization application process. They submit the application on behalf of the manufacturer, prepare or coordinate the preparation of technical documents (active substance, product composition, label, Safety Data Sheet, etc.), and submit them to the Authority. After the authorization is granted, the Only Representative continues to be responsible for communication with the Authority.