KKDIK compliance is required to access the Turkish market and entails fulfilling the obligations of the KKDIK Regulation. This ensures that companies can maintain uninterrupted market access in Türkiye and operate with full regulatory confidence.
There are several obligations that must be met to ensure KKDIK compliance. With Chemleg Product Stewardship, you benefit from an integrated service that ensures full KKDIK compliance.
Obligations of KKDIK Compliance
1 – Substance Registration
Manufacturers and importers producing or importing ≥1 tonne/year of a substance must complete pre-registration and registration.
- Pre-SIEF (Substance Information Exchange Forum) and SIEF participation
Each potential registrant of a substance manufactured or imported at 1 tonne/year or more must submit a Pre-SIEF to continue manufacture or import. SIEF aims to avoid duplication of studies by sharing registration information on the substance and to reach an agreement on classification and labelling. - One substance, one registration principle
Potential registrants must check the registration status of the same substance through the Chemicals Registration System (KKS) via SIEF inquiry. Unless a valid justification exists, registrants must be part of the same registration.
- Selection of the Lead Registrant
A candidate lead registrant must notify all SIEF members of their intention via KKS with justifications and collect members’ opinions within 30 days. The candidate accepted by the majority is designated as the lead registrant.
- Temporary Registration
If a full dossier is not ready, a temporary registration must be submitted by 31 March 2026 (lead registrant). Joint registrants must submit by 30 September 2026.
2 – Data Sharing
SIEF members must share data fairly and transparently to avoid duplication of studies. For your company: This reduces costs, avoids unnecessary animal testing, and ensures regulatory acceptance.
3 – Chemical Safety Report (CSR)
For substances ≥10 tonnes/year, a Chemical Safety Assessment must be conducted and a CSR prepared. For your company: Demonstrates that your substance can be safely manufactured and used.
4 – Safety Data Sheets (SDS)
Hazardous substances/mixtures require SDSs prepared by a certified Chemical Assessment Expert. For your company: Ensures downstream users handle substances safely and in compliance with KKDIK.
5 – Authorisation (Annex 14, implementation pending)
Substances of Very High Concern (SVHCs) cannot be used or marketed without prior authorisation from MoEUCC. For your company: Without authorisation, market access is blocked.
6 – Restrictions (Annex 17)
Certain substances may only be manufactured, marketed, or used under strict conditions. For your company: Compliance is mandatory to avoid enforcement actions and penalties.
Product Stewardship and KKDIK Compliance
Meeting all KKDIK obligations is not an easy task. Each requirement demands time and resources. Therefore, as an integrated service, product stewardship plays a crucial role in managing regulatory responsibilities and ensuring the safe and sustainable use of chemicals.
How Chemleg Supports Your Company
- Regulatory Compliance Management – Ensuring all substances meet KKDIK requirements.
- Chemical Registration & Dossier Submission – Assistance with IUCLID dossier preparation and KKS submissions.
- Supply Chain Coordination – Managing communication across suppliers, manufacturers, and downstream users.
- Safety Data Sheets (SDS) & Labelling Compliance – Ensuring alignment with KKDIK, CLP, and SEA requirements.
- Risk Assessment & Chemical Safety Reports (CSR) – Protecting workplace and environmental safety.
- Ongoing Compliance Monitoring – Keeping your company up to date with regulatory changes.
By filling out the form, you can schedule a consultation with our experts and begin your journey towards accessing the Turkish market.
