What is Turkey REACH Registration?
Aligning with the EU REACH Regulation, Turkey’s KKDIK Regulation requires companies manufacturing or importing chemical substances to comply with registration obligations. A pivotal step in this process is the preparation of a complete registration dossier, submitted via the KKS (Chemical Registration System).
Chemleg provides comprehensive support to guide companies through this entire process.
IUCLID & KKS in KKDIK Registration
The International Uniform Chemical Information Database (IUCLID) is the standard tool for preparing and managing chemical data under KKDIK.
IUCLID’s critical roles in KKDIK include:
- Data Hub: Collecting and organizing information on substance identity, physicochemical properties, toxicology, and ecotoxicology.
- Dossier Generation: Creating submission-ready technical dossiers for the Ministry.
- Global Standardization: Ensuring alignment with EU REACH, providing efficiency for companies registering in both the EU and Türkiye.
- Integrated Assessment Reports: Incorporating Chemical Safety Reports (CSR) and Chemical Safety Assessments (CSA) for substances ≥10 tonnes/year.
How is a Turkey REACH Registration Dossier Prepared?
Preparing a dossier is a multi-stage process that requires both technical expertise and regulatory precision:
- Data Compilation in IUCLID: Entering all mandatory information (identity, manufacture, uses, classification, properties).
- Expert Translation & Localization: Translating all data and reports into Turkish with sector-specific accuracy.
- Chemical Safety Assessment: Preparing CSR/CSA for substances ≥10 tonnes/year.
- Final Submission via KKS: Submitting dossiers through the MoEUCC online system and monitoring application status.
Chemleg’s Comprehensive KKDIK Dossier Support Services
- Dossier Preparation & Data Entry: Structuring technical data in IUCLID for KKDIK compliance.
- KKS Submission & Validation: Ensuring smooth submission via the MoEUCC portal.
- Technical Dossier Review & Quality Check: Identifying and correcting data gaps or inconsistencies before submission.
- Lead & Joint Registration Support: Managing SIEF participation and data-sharing.
- Post-Submission Compliance Management: Handling updates, inquiries, and Ministry responses.
KKDIK Translation Services
The KKDIK Regulation mandates that all registration dossiers, safety data sheets (SDS), and technical documents must be submitted in Turkish to the MoEUCC.
Our professional KKDIK translation services eliminate language barriers and guarantee your submissions meet all requirements with technical precision.
- SDS & Technical Document Translation: Full compliance with KKDIK & CLP.
- IUCLID Dossier Translation: Accurate, submission-ready translations.
- Chemical Safety Report (CSR) Translation: Scientific and regulatory accuracy ensured.
- Regulatory Correspondence Translation: Smooth communication with authorities.
- Expert Review & Proofreading: Final quality checks for flawless submissions.
Our regulatory experts ensure your KKDIK dossiers are complete, accurate, and fully compliant, minimizing the risk of delays or rejections.
Fill out the form now to schedule a consultation.
Frequently Asked Questions
What are the Turkey REACH (KKDIK) deadlines?
The Ministry (MoEUCC) has recently updated the registration timelines, including new deadlines for pre-registration and temporary registration. This means companies must act quickly to secure compliance.
Read our article here to learn more about the current timeline.
What information is required in a registration dossier?
A complete dossier includes:
- Substance identity
- Manufacture and use(s)
- Classification and labelling
- Physicochemical, toxicological, and ecotoxicological data
- Guidance on safe use (GoSU)
Note: Requirements vary depending on the tonnage band.
What are the registration fees?
Fees are announced annually by MoEUCC. See current fees here.
Planning ahead helps you budget effectively for compliance.
Does every tonnage band require the same data?
No. Lower tonnage bands (1–10 tonnes/year) require basic studies, while higher tonnage bands need more extensive data and a Chemical Safety Report (CSR).
Smaller registrants face lighter requirements; higher tonnage registrants must prepare comprehensive studies.
What is a Joint Submission?
It is a collective process where companies registering the same substance share data and costs by preparing one technical dossier together, whichreduces workload and avoids duplicate testing.
