The Ministry of Environment, Urbanization, and Climate Change has prepared a new draft under the Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals (KKDIK) to introduce significant changes in the sector. This draft aims to clarify chemical registration processes, strengthen the mechanism for selecting lead registrants, and make the joint registration system more functional.
This article highlights the key changes in the KKDIK Regulation, including mandatory pre-MBDF registration, stricter lead registrant selection criteria, enhanced inspection mechanisms, and a digital transition for compliance documentation. It also evaluates the potential impact of these changes on chemical manufacturers, importers, and article producers.
Key Changes Introduced by the New KKDIK Procedures and Principles
Comprehensive Chemical Registration Requirements and Deadlines
The Chemical Registration System (KKS), managed by the Ministry, is a crucial platform for chemical compliance under the KKDIK framework. The revised regulation introduces a two-step registration process, ensuring comprehensive chemical data collection and regulatory alignment.
Step 1: Mandatory Pre-MBDF Registration
According to Article 5(1) of the draft regulation, all potential registrants must submit their pre-MBDF (Substance Information Exchange Forum) registration via the Chemical Registration System (KKS) on the Ministry’s website by June 30, 2025. This step ensures that all entities participating in the chemical registration process are included in the MBDF, facilitating data exchange and preventing redundant registrations.
Step 2: Full Registration and Compliance Deadlines
Under Article 5(2) of the draft regulation, companies registering chemicals for the first time after June 30, 2025, or those introducing new chemicals into the market, must follow specific compliance deadlines based on their production or import volume. Existing registrants must ensure their compliance aligns with the updated regulatory framework. The revised requirements are categorized as follows:
100-1000 tons/year manufacturers or importers (first-time production or import after June 30, 2025):
Pre-MBDF registration must be submitted via the Chemical Registration System (KKS), and the registration must be completed by December 31, 2027.
Required submissions include comprehensive safety data, risk assessments, and exposure scenarios.
Companies must ensure all provided data aligns with updated regulatory compliance measures.
1-100 tons/year manufacturers or importers (first-time production or import after June 30, 2025):
Pre-MBDF registration must be completed via the Chemical Registration System (KKS), with the registration required by December 31, 2029.
This extension provides additional preparation time for small-scale manufacturers and importers.
Compliance documentation must include relevant safety assessments, exposure analysis, and proper data sharing within MBDF.
New chemical registrations (post-2025): Any new chemical introduced after June 30, 2025, must complete MBDF participation and full registration within 12 months of market entry.
This structured approach ensures proactive regulatory compliance, promotes efficient data management, and mitigates last-minute industry disruptions. Companies are urged to engage early in the registration process to meet these legally binding deadlines. Failure to comply may result in significant regulatory penalties, restrictions on market access, and potential disruptions to business operations.
Single Substance, Single Registration Principle
According to Article 6(1) of the draft regulation, all registrants must be part of the same registration for a given substance unless they have a valid justification for individual registration. Companies requesting separate registrations must submit supporting documentation to the Ministry, including:
Correspondence justifying individual registration,
Evidence of disproportionate cost-sharing issues,
Documentation on potential commercial damage resulting from joint registration.
Article 6(2) mandates that the lead registrant must communicate with existing or potential registrants regarding necessary updates, ensuring that all parties comply with the regulatory requirements. The lead registrant is responsible for managing information sharing and updating records as needed.
Enhanced Requirements for MBDF (Substance Information Exchange Forum) Participation
Participation in the MBDF is a crucial element in the chemical registration process under KKDIK. The new regulation aims to strengthen MBDF compliance by ensuring that companies actively contribute to data sharing and joint registration efforts.
New KKDIK Procedures and Principles
Key updates in MBDF participation include:
Mandatory Pre-MBDF Registration: All companies must submit their pre-MBDF registration via the Chemical Registration System (KKS) by June 30, 2025. Failure to comply with this deadline may result in regulatory penalties.
Joint Data Sharing and Cost Allocation Framework: Companies must engage in structured data-sharing agreements within the MBDF, ensuring cost distribution is fair and in accordance with industry standards.
Transparency and Dispute Resolution: MBDF members will be required to adhere to a formal dispute resolution mechanism to resolve disagreements over data access, costs, and compliance responsibilities.
Regulatory Oversight: The Ministry will implement monitoring mechanisms to ensure MBDF compliance, preventing redundant registrations and promoting efficient industry collaboration.
These enhancements are designed to eliminate inefficiencies, streamline the registration process, and create a more transparent and structured approach to data exchange in the chemical industry.
Conclusion
With this draft regulation, the Ministry aims to bring significant structural changes to the implementation of the KKDIK Regulation. Companies must complete their pre-MBDF registrations, integrate into the KKS system, and comply with lead registrant procedures.
To adapt to this new process, companies in the sector must transition to digital registration systems, actively participate in lead registrant selection processes, and be prepared for inspections. In the upcoming period, significant changes are expected as the draft regulation is finalized.
These changes, which aim to establish a more effective structure for chemical registration, will provide a transparent process for companies and increase the reliability of the market. It is essential for companies to closely monitor developments under KKDIK and adjust their strategies accordingly.
Frequently Asked Questions (FAQ)
1. I have not joined the MBDF. What should I do?
You must complete your registration via the Chemical Registration System (KKS) by June 30, 2025.
2. What happens if a lead registrant is not appointed?
If a lead registrant is not selected, the Ministry and TOBB will appoint one.
3. What are the consequences for companies that fail to register their chemicals?
Companies that do not register may face trade bans and severe penalties.
4. Is it mandatory to upload Safety Data Sheets (GBF)?
Yes, all Safety Data Sheets must be uploaded to the Ministry’s designated system.
5. How can a company appeal a decision made regarding their registration?
Companies can submit an appeal to the Ministry with supporting documentation and justifications for reconsideration.
6. What happens if incorrect information is provided in the registration process?
Providing inaccurate or misleading data can result in fines, rejection of the registration, or further legal consequences.
7. How can companies ensure compliance with updates to KKDIK regulations?
Companies should regularly check the Ministry’s official updates, attend industry seminars, and consult compliance experts to stay informed.
8. Will there be an extension of deadlines if a company faces unforeseen challenges?
While extensions are not guaranteed, companies facing significant challenges may submit a request for reconsideration with valid justifications.
9. How does the new regulation impact chemical distributors?
Distributors are responsible for ensuring that the chemicals they sell are fully registered and compliant with KKDIK requirements.
10. What resources are available to help companies with KKDIK compliance?
Companies can access guidelines from the Ministry’s website, seek legal and compliance consulting, and participate in industry association discussions.
Why Partner with DORUKSISTEM for KKDIK Compliance?
Ensuring compliance with the evolving KKDIK regulations can be challenging, especially with the newly introduced requirements. Doruksistem AS specializes in helping companies navigate these regulatory complexities with tailored compliance solutions and Only Representative services. Whether you are new to KKDIK or need assistance adapting to recent changes, we provide end-to-end support to safeguard your business operations.
Experienced Team: Our specialists provide guidance tailored to your company’s specific regulatory needs.
Proactive Compliance Solutions: We help you meet KKDIK deadlines efficiently, avoiding penalties and trade restrictions.
Seamless Transition Assistance: If you already have an Only Representative but they are struggling to keep up with these updates, switching to Doruksistem AS is straightforward and hassle-free.
End-to-End Support: From MBDF registration to documentation management and lead registrant coordination, we handle all aspects of the compliance process.
Switching to Doruksistem is simple and seamless. If your current Only Representative is unable to keep up with these regulatory updates or does not provide the level of expertise you require, transitioning to Doruksistem AS ensures that your compliance efforts remain on track without disruptions.
By choosing Doruksistem AS, you gain a partner who is dedicated to keeping your business compliant, competitive, and prepared for future regulatory shifts.
Contact us today to discuss how we can support your KKDIK compliance strategy and the full version of the draft regulation.
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