New KKDIK Regulation Rules and Principles Now Published
- Admin
- Aug 13
- 6 min read
The landscape of chemical regulation in Turkey is undergoing a significant transformation with the newly proposed “Rules and Principles” for the implementation of the KKDIK Regulation. These changes, introduced by the Ministry of Environment, Urbanization, and Climate Change, aim to enhance the efficiency, transparency, and reliability of the chemical registration process. Whether you are a manufacturer, importer, distributor, or Only Representative, understanding these updates is crucial to ensuring compliance, avoiding penalties, and maintaining uninterrupted market access. This article provides a comprehensive breakdown of the new requirements, timelines, and procedures to help companies prepare for a smooth transition.
What’s Changing (At a Glance)
Mandatory pre-MBDF filing: All potential registrants must submit a pre-MBDF via KKS by 31 October 2025. New substances placed on the market after 31 October 2025 must file pre-MBDF within 30 days of first placing on the market.
One-substance, one-registration: Joint registration is the default. Separate dossiers require a valid justification and written notification to the Ministry. The lead registrant is responsible for proactive communications and updates.
Lead registrant selection (with TOBB involvement — The Union of Chambers and Commodity Exchanges of Turkey): This process ensures that each substance under the KKDIK framework has a designated leader responsible for coordinating joint registration activities. For substances already on the market, leaders must be appointed by 31 December 2025. For new substances, the selection must occur within six months of market entry. The Ministry and TOBB facilitate this process, starting with volunteer candidates. All MBDF members are notified via KKS and have 30 days to respond; lack of response is considered consent. Leadership is confirmed by an absolute majority. If no consensus is reached, a new election cycle is initiated. This system aims to promote transparency, streamline communication, and ensure that all registrants are effectively represented.
Provisional registration fallback: This mechanism serves as a contingency plan for cases where a complete joint registration dossier cannot be finalized within the primary deadlines. It allows the process to proceed in two phases: the lead registrant must be appointed by 31 March 2026, and member company entries must be submitted by 30 September 2026. These entries must be prepared by a Chemical Assessment Specialist (KDU), ensuring technical accuracy, and must include the KDU’s official credentials. This approach prevents market disruption by enabling partial compliance while the full joint registration is being completed.
Dossier updates & extensions: Registrants are required to update their submitted dossiers within 3 months of any change that triggers an update obligation, ensuring that information remains accurate and compliant. If there are unavoidable data gaps preventing completion of the dossier, companies may apply to the Ministry for a time extension of up to two years beyond the last tonnage-tier registration date, provided they submit a clear, evidence-based justification. This flexibility is designed to balance regulatory integrity with the practical challenges of obtaining certain technical data.
SDS obligations: Under the newly published “Rules and Principles” for KKDIK implementation, Safety Data Sheets must be uploaded to the Ministry’s dedicated SDS notification system in the correct format and within the specified deadlines. This requirement ensures that critical chemical safety information is centrally stored and available for regulatory oversight. In line with these rules, Section 16 of each SDS must clearly state the full contact details of the KDU (Chemical Assessment Specialist) responsible, along with the official certificate date and number. This not only provides traceability but also confirms that the SDS has been prepared or reviewed by a certified professional, aligning the process with the Ministry’s latest procedural framework.
Supplier notification obligation: In accordance with Article 24 of the KKDIK Regulation, registrants who act as Only Representatives for non-Turkish manufacturers must notify the domestic suppliers (importers within Turkey) designated by the foreign manufacturer. This notification must include the substances and dossiers registered under KKDIK, relevant registration numbers, compliance status, and any applicable restrictions or conditions. The purpose is to ensure that designated Turkish importers are aware of the registration coverage and can align their own activities fully with regulatory requirements.
Background and Purpose
The Ministry of Environment, Urbanization and Climate Change has circulated a draft “Rules and Principles” text intended to make KKDIK implementation more effective. It clarifies how potential registrants must join MBDFs, how leaders are chosen and changed, how joint registrations should function, and what to do if full dossiers cannot be finalized on time.
1) Pre-MBDF Registration — Who Must File, By When
Scope: Each potential registrant (manufacturer/importer ≥1 t/y, including relevant article manufacturers/importers) must submit a pre-MBDF via KKS.
Deadline for existing substances: 31 October 2025.
New substances: For first manufacture/import after 31 October 2025, submit pre-MBDF within 30 days of placing on the market.
Effect: Pre-MBDF filing makes all potential registrants’ participants of the MBDF and opens the path to joint registration.
2) “One Substance, One Registration” — Joint by Default
Registrants of the same substance are expected to submit the same (joint) dossier. Separate submissions are allowed only with valid reasons (e.g., confidentiality, disproportionate cost) and must be formally notified to the Ministry with evidence. The lead registrant has a continuing duty to communicate with prior and potential registrants, particularly for updates and dossier maintenance.
3) Lead Registrant Selection — Timeline and Process
By 31 December 2025: Leaders must be determined for substances already on the market.
Within 6 months of market entry: Leaders must be determined for new substances.
How selection works:
Volunteerism first. If nobody volunteers, the Ministry—in consultation with TOBB—initiates a process to identify a leader from among manufacturers/importers.
A leader candidate notifies all MBDF members via KKS, who have 30 days to respond with a reasoned positive/negative opinion. Silence = positive.
Absolute majority acceptance confirms leadership. If not achieved, the cycle restarts.
If a leader cannot continue, a transfer occurs; the current leader must deliver all necessary information to the new leader within 30 days after the Ministry’s approval, respecting confidentiality and data rights.
Where a leader was previously chosen but no dossier has been submitted, a re-election may be required under the new rules.
4) Joint Registration Groups — Governance and Support
A Joint Registration Group comprises registrants of the same substance and coordinates within the MBDF to build the dossier. Each group sets its own operating rules. TOBB coordinates with sector bodies and the Ministry to help joint registration groups function effectively and reports annually in December to the Ministry; topics are also discussed in Chemicals Advisory Group meetings.
5) Provisional Registration — A Safety Valve if Full Dossiers Slip
If a leading company cannot meet full-dossier obligations in time, it can file a Provisional Registration by 31 March 2026 using the Annex-1 data set in KKS; member companies must then submit their entries by 30 September 2026.
Provisional entries must be completed by a KDU, with the KDU’s certificate attached.
Ministry revolving-fund registration fees apply.
If a full dossier is submitted by 31 March 2026, the provisional route does not apply.
6) Completing Registration and Possible Extensions
Completion aligns with the tonnage-tiered deadlines in the KKDIK Regulation’s Provisional Article 2 (unchanged by the Rules & Principles). If data cannot be obtained for the full dossier (joint or justified separate), the registrant may request additional time via KKS with a detailed justification.
The maximum extension the Ministry may grant is two years after the last registration date for the relevant tonnage range.
If data still cannot be provided at the end of the extension, following Chemicals Advisory Group evaluation, the Ministry may approve or reject the registration for that substance.
7) Ongoing Duties — Updates, SDS Upload, Oversight
Dossier Updates: When an update is required (per Article 22 scenarios in KKDIK), registrants must update within 3 months of the trigger. If that is impossible, notify the Ministry with justification and request additional time; Ministry-mandated updates must be completed within the specified period.
SDS Upload: Suppliers must upload SDSs to the Ministry’s dedicated software. In Section 16 of each SDS, list the KDU’s contact and the certificate date/number. KDU training and certification are coordinated by the Ministry.
Governance Bodies: A Chemicals Science Group (academia-led) and a Chemicals Advisory Group (multi-ministry + TOBB) support policy and case escalations; both meet at least twice a year and may form sub-groups.
Sanctions & Entry into Force: Non-compliance triggers sanctions under Law No. 2872. These Rules & Principles take effect on their publication date and are enforced by the Minister.
Why Partner with DORUKSISTEM for KKDIK Compliance?
Experienced Team: KKDIK specialists, including KDU-qualified experts, tailor guidance to your supply chain and product portfolio.
Proactive Compliance: We design a timeline that aligns pre-MBDF, leader selection, data-gap closure, and—if necessary—provisional registration milestones.
Seamless Transitions: If your current Only Representative is struggling to keep pace, switching to Doruksistem A.Ş. can be completed with minimal disruption.
End-to-End Support: From MBDF participation and leader coordination to dossier updates, SDS uploads, and extension strategies, we manage the entire lifecycle.
Switching is straightforward. If your current Only Representative cannot keep up with these updates—or doesn’t provide the level of support, you require—transitioning to Doruksistem A.Ş. keeps your KKDIK compliance on track.
Contact us to discuss your KKDIK strategy and to receive our annotated walkthrough of the published Rules & Principles aligned to your product list and tonnage bands. You can also request the English text of the new Rules and Principles Document by contacting us.