KKDİK Procedures and Principles 2025 – Compliance Guide for Manufacturers and Importers
KKDIK Procedures & Principles (2025): Compliance Guide for Manufacturers and Importers
Introduction & Purpose
The KKDIK Procedures & Principles (2025) — officially published on August 5, 2025 — define the detailed procedures for implementing Türkiye’s KKDIK Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals), also known as TURKREACH.
These Procedures & Principles establish the administrative and technical framework for chemical registration, data sharing, and compliance management within the Chemical Registration System (CRS), operated by the Ministry of Environment, Urbanization and Climate Change (MoEUCC).
They apply to all companies that manufacture or import substances or mixtures in quantities of one tonne or more per year in Türkiye, including foreign manufacturers represented by an Only Representative (OR).
The purpose of the KKDIK Procedures & Principles is to:
Ensure a harmonized, transparent, and efficient registration system,
Promote data sharing and coordination among manufacturers and importers,
Strengthen chemical safety and regulatory compliance,
Implement procedures and principles applicable to KKDİK and Turkish Integrated Chemical Management.
For companies active in the Turkish market, these procedures outline a step-by-step compliance roadmap, including:
Pre-MBDF (Substance Information Exchange Forum – SIEF) submission,
Lead Registrant selection and coordination,
Joint and individual registration processes,
Provisional registration options,
Safety Data Sheet (SDS) preparation and validation,
Continuous data updates and ministry audits.
By following these procedures, manufacturers and importers can maintain uninterrupted market access in Türkiye and achieve full conformity with both national and international chemical safety regulations.
Why "KKDIK Procedures & Principles" Compliance Matters
Non-compliance with the KKDIK Procedures & Principles may result in:
Market bans or suspension of product sales,
Administrative penalties under Environmental Law No. 2872,
Reputational damage and disruption of supply chains.
Doruksistem, a leading Turkish regulatory compliance and chemical safety consultancy, provides end-to-end support for:
KKDIK registration management,
SDS (Safety Data Sheet) preparation and verification,
Only Representative (OR) services,
MBDF coordination and lead registrant communication,
Digital document control and liaison with the Ministry.
KKDIK Procedures and Principles Article Titles and Explanations
Initial Provisions - Regulations and Principles of the Personal Data Protection Law
Article 1 – Purpose: These Procedures and Principles have been prepared in order to determine the issues related to the effective implementation of the Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals.
These Procedures and Principles have been prepared to define the provisions ensuring the effective implementation of the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (KKDIK), enacted under the authority of the Ministry of Environment, Urbanization and Climate Change (MoEUCC).
Explanation
Article 1 establishes the objective and scope of the KKDIK Procedures & Principles.
It confirms that these Procedures are not a separate regulation, but an operational framework designed to:
Clarify how KKDIK should be implemented by manufacturers, importers, and Only Representatives;
Ensure consistency, transparency, and efficiency in the national chemical registration process;
Provide the legal foundation for subsequent articles governing MBDF formation, joint registration, SDS management, and compliance oversight.
📘 Effect: This article makes clear that every subsequent provision (Articles 2 – 19) serves the single purpose of making KKDIK implementation functional, verifiable, and enforceable across Türkiye.
🔹 The KKDIK application has been activated through procedures and principles. The roadmap for manufacturers and importers has become clear.
Article 2 – Scope : (1) These Procedures and Principles cover the issues related to the Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals and integrated chemicals management.
These Procedures and Principles cover all matters related to the Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals (KKDIK) and the framework for integrated chemicals management in Türkiye.
Explanation
Article 2 defines the regulatory reach and coverage of the KKDIK Procedures & Principles.
It clarifies that these Procedures apply to:
All provisions and processes set forth in the KKDIK Regulation, including registration, evaluation, authorisation, and restriction of substances;
The broader integrated chemicals management system established by the Ministry of Environment, Urbanization and Climate Change (MoEUCC), which connects KKDIK with other national environmental and product-safety regulations.
📘 Effect: This article ensures that the Procedures & Principles function as the operational backbone for Türkiye’s chemical safety framework — not only implementing KKDIK requirements but also supporting their integration with related environmental and industrial legislation.
🔹 It encompasses all manufacturers, importers, and article manufacturers.
🔹 Each company should reevaluate its obligations..
🔹 Attention: These Procedures and Principles cover not only KKDİK (By- Law on Registration, Evaluation, Authorization and Restriction of Chemicals) but also matters related to “Integrated Chemicals Management” (SEA (TR-CLP) – By-Law on Classification, Labelling and Packaging of Substances and Mixtures, KOK (TR-POP) – Regulation on Persistent Organic Pollutants, e-PIC – Regulation on the Export and Import of Certain Hazardous Chemicals, MERCURY (upcoming), etc.).
Article 3 – Legal Basis :(1) These Procedures and Principles have been prepared on the basis of the Environmental Law dated 09/08/1983 and numbered 2872 and the Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals published in the Official Gazette dated 23/06/2017 and numbered 30105.
Explanation
Article 3 establishes the statutory foundation of the KKDIK Procedures & Principles.
It confirms that the Procedures are derived directly from Türkiye’s two key legal instruments governing environmental and chemical safety management:
Environmental Law No. 2872 (1983) – the overarching national framework empowering the Ministry to regulate activities affecting the environment, including chemicals;
KKDIK Regulation (2017) – Türkiye’s national legislation equivalent to the EU REACH Regulation, setting requirements for chemical registration, evaluation, authorisation and restriction.
📘 Effect: This article ensures that all provisions of the KKDIK Procedures & Principles are legally binding, having been issued under the authority granted by the Environmental Law and aligned with the 2017 KKDIK Regulation.
- Article 4 – Definitions : (1) In these Procedures and Principles;
(a) Ministry: Ministry of Environment, Urbanization and Climate Change,
(b) Potential registrant: The manufacturer or importer of the substance or the manufacturer or importer of the article that has not yet registered but intends to register,
(c) Contract: A comprehensive Agreement between the lead company and potential registrants, including all matters related to the fulfillment of joint registration obligations,
ç) Regulation: Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals
expresses.
Explanation
Article 4 defines the key terms used throughout the KKDIK Procedures & Principles, ensuring legal precision and interpretive consistency across all subsequent articles.
Each definition reflects the framework of Turkish REACH (KKDIK) and aligns conceptually with corresponding EU REACH terminology.
📘 Effect: These definitions provide the foundational clarity necessary for interpreting responsibilities, rights, and procedural steps described in later sections—particularly in relation to MBDF formation, joint registration, and lead company coordination.
General Rules - KKDİK Procedures and Principles
Article 5 – Registration : Article 5 of the KKDIK Procedures & Principles (2025) establishes the core registration obligation for all companies manufacturing or importing chemical substances into Türkiye.
It defines who must register, which substances are subject to registration, and how the registration process must be carried out through the Chemical Registration System (CRS) of the Ministry of Environment, Urbanization and Climate Change (MoEUCC).
Article 5(1) The manufacturer or importer who manufactures or imports the substance in its own form or in a mixture in an annual amount of one ton or more submits the information in Article 11 of the Regulation to the Ministry through the Chemical Registration System, which is one of the Integrated Environmental Information System applications of the Ministry, and applies for registration.
🔹 Mandatory Registration Requirement
Any manufacturer or importer who produces or imports a substance on its own or in a mixture in quantities of one tonne or more per year must:
Prepare the information required under Article 11 of the KKDIK Regulation, and
Submit a registration dossier through the Chemical Registration System (KKS), which is part of the Integrated Environmental Information System managed by the Ministry.
📘 Effect: This means that no substance can be legally manufactured or placed on the Turkish market in quantities of one tonne or more per year without a valid KKDIK registration.
Article 5(2) Each potential registrant of a substance manufactured or imported in quantities of 1 ton or more per year must submit a “Pre-Substance Information Exchange Forum” (pre-MBDF) in order to continue manufacturing or importing. This process allows potential registrants to get in touch for data sharing through the MBDF and to apply for registration as specified in the first paragraph of this article. All potential registrants of the same substance will be participants of the MBDF.
🔹 As a manufacturer and/or importer, do you primarily have an account in the EÇBS system with your Environmental Identity Number? If not, you should immediately create an account to become an EÇBS user and activate the Chemical Registration System (KKS) Module. Then, you should complete your pre-MBDF registration.
Pre-MBDF (SIEF) Requirement
For each substance manufactured or imported at one tonne or more per year:
Every potential registrant must submit a Pre-Substance Information Exchange Forum (Pre-MBDF / Pre-SIEF) notification through the KKS.
This enables data sharing, communication, and coordination between companies handling the same substance.
All potential registrants of the same substance automatically become members of the same MBDF (SIEF).
📘 Effect:
Registration is not an individual process — it requires collaboration through the MBDF structure.
Companies failing to submit a Pre-MBDF notification will not be allowed to continue manufacturing or importing, nor can they join the joint registration process later.
Pre-Registration: All companies producing/importing ≥1 ton/year must register through the KKS module in the EÇBS system. The first step is to submit your SEA Notification and then send your pre-MBDF registration. Remember, the SEA notification must be made for each substance, even if it is harmless, and it should be indicated during the pre-MBDF registration whether the substance is harmful or not.
💡 Practical Implications for Manufacturers and Importers
One-tonne threshold: Any company manufacturing or importing ≥1 tonne/year must register.
Pre-MBDF submission: Mandatory to initiate participation in the joint registration process.
Joint responsibility: All companies handling the same substance become part of the same data-sharing forum.
Market access: Substances not registered cannot legally be placed on the Turkish market.
Verification: The Ministry may cross-check production, import, and customs data to verify compliance.
Article 6 – Substance Information Exchange Forum (MBDF) : Article 6 of the KKDIK Procedures & Principles (2025) sets forth the requirements for forming and participating in the Substance Information Exchange Forum (MBDF) — Türkiye’s equivalent of the EU SIEF (Substance Information Exchange Forum) under REACH.
It defines when and how potential registrants must submit their Pre-MBDF notifications through the Chemical Registration System (KKS) and officially become MBDF participants.
Article 6(1) All potential registrants submit the pre-MBDF of their substances to the Ministry through the Chemical Registration System (KKS) until 31/10/2025 and become MBDF participants.
Pre-MBDF Obligation for Existing Substances
All potential registrants that manufacture or import a substance in quantities of one tonne or more per year must, no later than 31 October 2025, submit their Pre-MBDF notification via the Chemical Registration System (KKS).
Once submitted, the company automatically becomes a member of the MBDF for that substance.
📘 Effect: Failure to submit a Pre-MBDF notification before the 31 October 2025 deadline means the company cannot participate in the joint registration and will lose the right to manufacture or import the substance in Türkiye.
Article 6(2) For substances that will be manufactured and/or imported for the first time after 31/10/2025; Pre-MBDFs created by potential registrants are submitted to the Ministry via KKS within 30 days following the placing on the market, and potential registrants become MBDF participants.
Obligation for New Substances after 31 October 2025
For substances that are manufactured or imported for the first time after 31 October 2025,
The potential registrant must submit the Pre-MBDF notification within 30 days following the first placing of the substance on the Turkish market.
After submission, the company becomes a full MBDF participant and gains the right to proceed with registration.
📘 Effect: This provision ensures that new market entrants are incorporated into the MBDF process in a timely and consistent manner.
🧩 Role of the MBDF (SIEF)
The MBDF serves as a collaborative platform for companies handling the same substance to:
Exchange existing data and identify data gaps,
Share costs of testing and dossier preparation,
Harmonize classification and labeling,
Prevent duplication of studies, especially on vertebrate animals.
🎯 Practical Implications for Companies
Deadline:
Existing substances → Pre-MBDF submission by 31 October 2025.
New substances → 30 days after market introduction.
Automatic Membership:
Submission of Pre-MBDF = automatic MBDF participation.
Data Sharing Requirement:
Members must cooperate and contribute fairly to data and cost sharing.
Compliance Impact:
MBDF participation is a prerequisite for KKDIK registration; non-members cannot submit dossiers.
📊 Simplified MBDF Timeline
| Process Step | Responsible Party | Deadline |
|---|---|---|
| Pre-MBDF submission (existing substances) | All potential registrants | 31 October 2025 |
| Pre-MBDF submission (new substances) | Potential registrants entering the market | Within 30 days after first placing on the market |
| Data sharing & coordination | MBDF members (manufacturers/importers) | Continuous |
| Joint registration dossier submission | Lead Registrant & members | According to tonnage band deadlines (2026–2030) |
Tasks to be completed by October 31, 2025.
Who is included? All producers and importers in Turkey with an annual manufacturing/importing of ≥1 ton.
What should be done? A “pre-SIEF” (pre-MBDF) file for the relevant substance must be submitted to the Ministry via the Chemical Registration System (KKS).
Path to Registration through SEA Notification: The SEA Notification must be done before the pre-MBDF registration. Even if the substance is harmless, it must be reported as “harmless or harmful” in the pre-MBDF registration. Supplier lists should be entered during SEA registration, and suppliers must be selected in section 1.7, with the relevant facilities added in section 3. Domestic manufacturers and importers in Turkey should add themselves as suppliers and then add their facilities. Companies that are manufacturers abroad and have appointed a “Single Representative” should add the suppliers (importers) of the companies they represent in the “Represented Companies” section through their Single Representatives. This should be considered the first step towards these importers being relieved of the registration responsibility as End Users.
Conclusion: When the pre-MBDF registration is completed, the company automatically becomes a participant in the MBDF. This guarantees participation in the joint registration process. The SEA notification is vital for MBDF communication.
🔹 Effect on the manufacturer/Importer: If a pre-MBDF registration is not made by the manufacturer or producer of a substance that is currently being placed on the market by October 31, 2025, the company cannot be included in the registration process, and the marketing of the substance will be prohibited.
New manufacturing/import situations after October 31, 2025.
If a substance is manufactured/imported for the first time after this date:
The potential registrant must submit the preliminary MBDF file to the Ministry via KKS within 30 days following the market release. Potential registrants will become MBDF participants.
This means that companies starting manufacturing or importing after this date can also join the system, but if they do not inform the Ministry of the preliminary MBDF on time (within 30 days of market release), the substance’s market release will be halted.
🔹 Impact on the Manufacturer/Importer: When a new substance is introduced, companies are required to submit the pre-MBDF dossier to the Ministry via KKS within a maximum of 30 days. Subsequently, the inclusion of the relevant substance in the MBDF will be ensured. Otherwise, the product cannot be legally released to the market.
- Article 7 – One Substance, One Registration Principle: Article 7 introduces the “One Substance, One Registration” (OSOR) principle under Türkiye’s KKDIK Procedures & Principles (2025).
This rule ensures that all registrants placing the same substance on the Turkish market submit one harmonized registration dossier through the Chemical Registration System (CRS), avoiding duplication of data, cost, and animal testing.
Article 7(1) Registrants must be a part of the same registration, unless they have valid reasons specified within the scope of the Regulation. For this purpose, potential registrants can obtain information about the registration status of the same substance by querying MBDF via KKS.
Joint Registration Requirement
All potential registrants manufacturing or importing the same substance must participate in a single joint registration unless a valid justification exists.
To determine whether the substance is already registered, companies can use the CRS query tool within the Ministry’s portal to check existing MBDF (SIEF) data.
📘 Effect: Separate dossiers for the same substance are not permitted unless the company can justify technical or confidentiality reasons.
Article 7(2) Within the scope of the third paragraph of Article 12 of the Regulation, companies that will submit their registration dossier separately from the joint registration group with a valid justification shall notify the Ministry in writing of their reasons and all information and documents proving this reason.
Exceptional Cases for Individual Submissions
In rare situations where joint submission is not technically or legally feasible, a registrant may submit an individual dossier.
Such companies must:
Provide a written justification describing the reason for separation (e.g., trade-secret protection, data-sharing disputes, or differing substance identity).
Upload all supporting documents to the Ministry through the CRS.
📘 Effect: Independent registration is the exception, not the rule, and must be substantiated with verifiable evidence.
Article 7(3) The lead registrant communicates in writing with previous registrants and potential registrants, when necessary, such as the obligation to update.
Lead Registrant Communication
The Lead Registrant (LR) is responsible for maintaining communication with:
Previous registrants,
Potential registrants,
And the Ministry, particularly in cases of dossier updates or new data requirements.
📘 Effect: Transparent communication within the MBDF (SIEF) ensures dossier consistency and shared responsibility for data maintenance.
🎯 Practical Implications for Companies
Single Dossier Policy: All manufacturers/importers of the same substance file a unified dossier.
Joint Responsibility: Each participant contributes to data and cost sharing.
Transparency: All communication goes through the Lead Registrant within the MBDF structure.
Exceptions: Separate submissions accepted only with written, Ministry-approved justification.
Regulatory Risk: Failure to join the joint registration may lead to rejection of the dossier and prohibition of market access.
📊 Simplified Workflow
Identify identical substances in the Turkish market.
Join the relevant MBDF (SIEF) through KKS.
Agree on data sharing and cost contribution.
Collaborate with the Lead Registrant on dossier preparation.
Submit a single joint registration to the Ministry.
- Article 8 – Determination of the Lead Registrant: Article 8 of the KKDIK Procedures & Principles (2025) defines how the Lead Registrant (LR) for each substance is determined within the MBDF (Substance Information Exchange Forum).
The Lead Registrant plays a pivotal role under Turkish REACH (KKDIK) — coordinating dossier preparation, data sharing, and communication with the Ministry of Environment, Urbanization and Climate Change (MoEUCC).
Article 8(1) The leading companies of the substances placed on the market before the date of publication of these Procedures and Principles are determined by 31/12/2025 at the latest. After the date of publication of these Procedures and Principles, the leaders of the substances to be placed on the market for the first time are determined within the first six months following the placing on the market.
Deadlines for Lead Registrant Selection
For substances that were already on the Turkish market before the publication of these Procedures, the Lead Registrant must be determined by 31 December 2025.
For substances introduced after publication, the Lead Registrant must be selected within six months following the first market placement.
📘 Effect: Every substance registered under KKDIK must have a designated Lead Registrant responsible for coordinating the joint dossier.
Article 8(2) Volunteerism is primarily essential in determining the leading companies. In the absence of a volunteer lead registrant, taking into account criteria such as tonnage range, available data, and company size, the Ministry initiates studies to determine a company among the manufacturers/importers of the substance to be registered, in consultation with the Union of Chambers and Commodity Exchanges of Turkey (TOBB).
Priority for Voluntary Nomination
The selection of the Lead Registrant is based on voluntary nomination among MBDF members.
If no company volunteers, the Ministry — in coordination with the Union of Chambers and Commodity Exchanges of Türkiye (TOBB) — may appoint a company as the Lead Registrant.
Factors considered include tonnage band, availability of existing data, and company capacity or experience.
📘 Effect: Companies with higher tonnage or extensive technical documentation are more likely to be selected as the Lead Registrant if no volunteer emerges.
Article 8(3) The leader candidate company notifies all MBDF members of its request to be a leader, together with the justifications, through the KKS and makes the necessary correspondence. Within 30 days at the latest following the submission of the request of the leader candidate, all MBDF members must convey their positive or negative opinions to the leader candidate company together with their justifications. It is accepted that the companies that do not return to the leader candidate company within the specified time give a positive opinion and all correspondence related to this is kept. The determined candidate;
(a) If the MBDF is accepted by the absolute majority of its members, the leader candidate is determined as the leading company.
(b) In the event that it is not accepted by the absolute majority specified in subparagraph (a) of this paragraph, all MBDF members shall be informed of the situation by the candidate and the candidate shall withdraw from the leadership. In this case, the process of electing a new leader from among the MBDF members begins again.
Nomination and Voting Process
A company wishing to act as Lead Registrant must submit a formal declaration with justification to all MBDF members via the Chemical Registration System (CRS).
MBDF members have 30 days to respond with an approval or objection and justification.
Failure to respond within the 30-day window will be considered as implicit approval.
The candidate becomes Lead Registrant if approved by the simple majority (more than 50%) of MBDF members.
If not approved, the nomination process restarts with new candidates.
📘 Effect: This transparent and documented voting process ensures fairness and avoids disputes in MBDF coordination.
Article 8(4) The leader of a substance for which a registration dossier has not yet been submitted performs the MBDF communication, including tonnage ranges, data gap analysis, etc. It notifies MBDF members in writing of the matters stipulated to be included in the contract with all the details. If these issues are accepted by the absolute majority of MBDF members, action is taken within the framework of the Agreement to be drawn up between the lead company and the member companies. After this stage, the leading company can start the registration process.
Responsibilities of the Lead Registrant
Before submitting the joint registration dossier, the Lead Registrant must:
Manage all MBDF communications and ensure active participation by co-registrants.
Coordinate tonnage band alignment and data gap analyses.
Draft and share the Joint Registration Agreement (contract) with MBDF members for approval.
Once approved by the majority, begin dossier preparation and submission.
📘 Effect: The Lead Registrant functions as the technical and administrative coordinator of the entire joint registration process.
🔹 Attention: It is of great importance for member registrants to carefully examine the Joint Registration Agreements and to maintain regular communication with the lead company.
Article 8(5) If the majority specified in the fourth paragraph is not achieved, the process for the election of a new leader starts again.
If No Majority Is Reached
If the proposed Lead Registrant fails to obtain majority approval,
→ The selection process restarts among MBDF members until a Lead Registrant is successfully chosen.
Article 8(6) In the event that the lead company of the substance for which the registration dossier has been submitted is unable to continue as the leader, the lead company notifies this request to all members of the existing MBDF and then submits its request in writing to the Ministry together with the necessary information and documents. As a result of the evaluation of the Ministry, the election of a new leader is allowed through the system. The current leader is obliged to transfer all necessary information and documents to the new leader within the framework of leader sharing rights and within the scope of the Regulation’s Privacy and data right principles within 30 days after the written approval of the Ministry.
Replacement of the Lead Registrant
If an existing Lead Registrant is unable to continue, it must notify all MBDF members and the Ministry in writing.
Upon Ministry approval, a new Lead Registrant is selected through the same process.
The outgoing Lead Registrant must transfer all data and rights to the new Lead Registrant within 30 days in accordance with confidentiality and data ownership rules.
📘 Effect: Ensures continuity and transparency in the registration process even if leadership changes.
Article 8(7) The election of leadership in the joint registration groups of the substances whose leader company has been determined before the date of publication of these Procedures and Principles, but whose registration dossier has not been submitted, shall be re-elected within the framework of these Procedures and Principles, if necessary.
Reassessment for Previously Selected LRs
If a Lead Registrant had already been selected before these Procedures were published but had not yet submitted the dossier,
The MBDF may re-evaluate and, if necessary, re-select a new Lead Registrant under the 2025 Procedures.
🔹 Attention: It is important to evaluate companies that appoint their leaders without fulfilling the procedures outlined in the Principles and Procedures. Additionally, companies that have not shared information with member firms through opaque contracts should also be examined.
🎯 Practical Implications for Companies
Deadline: Lead Registrants must be selected by 31 December 2025 (existing substances).
Governance: MBDF members vote; non-responses = automatic approval.
Coordination Role: LR manages data-sharing, agreement drafts, and dossier preparation.
Continuity: Replacement process ensures no interruption in registration.
Authority Oversight: The Ministry and TOBB supervise fair appointment and transparency.
- Article 9 – Joint Registration Group : Article 9 of the KKDIK Procedures & Principles (2025) defines the structure and operation of the Joint Registration Group (JRG) — the collaborative entity through which all companies handling the same substance coordinate their joint registration activities under Turkish REACH (KKDIK). The JRG ensures that registration dossiers are prepared collectively, costs are shared fairly, and communication with the Ministry remains structured and transparent.
Article 9(1) The Joint Registration Group consists of the registrants of the same substance. It works by ensuring coordination within the MBDF for the preparation of the registration dossier to be submitted to the Ministry. Each co-registration group is responsible for establishing its own registration and operating Procedures.
Definition and Responsibilities
The Joint Registration Group (JRG) consists of all registrants submitting a dossier for the same substance.
Within the MBDF (Substance Information Exchange Forum), the JRG coordinates the preparation of the joint registration dossier to be submitted to the Ministry.
Each JRG determines its own internal operating procedures, including decision-making, cost-sharing, and data access policies.
📘 Effect: The JRG creates a cooperative framework that ensures efficient communication, eliminates redundant testing, and supports the principle of “One Substance, One Registration.”
Article 9(2) TOBB works in coordination with the organizations representing the sector operating in chemicals and the Ministry in processes such as the effective functioning of joint registration groups and the preparation of joint registration group type contracts.
Role of TOBB (Union of Chambers and Commodity Exchanges of Türkiye)
TOBB plays a crucial role in supporting the functioning of Joint Registration Groups.
Its responsibilities include:
Facilitating coordination between JRGs, sector associations, and the Ministry,
Developing template contracts and model procedures for fair and transparent operation,
Ensuring consistent communication between industry stakeholders and authorities.
📘 Effect: TOBB acts as a national coordination hub ensuring harmonized practices across sectors.
Article 9(3) The studies carried out within the scope of the second paragraph of this article are reported to the Ministry by TOBB in December of each year.
Annual Reporting to the Ministry
TOBB must submit an annual report every December to the Ministry, summarizing:
The operational status of JRGs,
The effectiveness of data-sharing mechanisms,
Observed challenges and proposed improvements.
📘 Effect: This annual reporting system provides the Ministry with visibility into how joint registration groups are functioning and allows early intervention if coordination issues arise.
Article 9(4) The studies are discussed at the meetings of the Chemicals Advisory Group.
Review by the Chemicals Advisory Group
The activities and reports of Joint Registration Groups are periodically reviewed during Chemicals Advisory Group meetings organized by the Ministry.
These reviews aim to improve sectoral alignment and encourage good practices among JRGs.
📘 Effect: Creates a feedback loop between industry, TOBB, and the Ministry — enhancing regulatory efficiency and compliance quality.
🎯 Practical Implications for Companies
Mandatory Participation: All registrants of the same substance must join the same Joint Registration Group.
Governance: Each JRG must define internal rules for communication, cost-sharing, and decision-making.
TOBB Oversight: Ensures standardized agreements and fair cooperation between participants.
Transparency: Annual reporting and advisory group reviews increase accountability.
Efficiency: Reduces duplicate work, harmonizes registration quality, and strengthens market credibility.
📊 Simplified Joint Registration Process
Companies identify identical substances and join the relevant MBDF.
The MBDF forms a Joint Registration Group (JRG).
Members sign a Joint Registration Agreement (JRA) developed under TOBB templates.
The Lead Registrant coordinates dossier preparation and submission.
Annual progress reports go to TOBB and the Ministry.
- Article 10 – Provisional Registration: Article 10 of the KKDIK Procedures & Principles (2025) introduces the Provisional Registration mechanism — a transitional compliance process that allows manufacturers and importers additional time to complete full registration dossiers when certain data or testing requirements are not yet available. This approach ensures business continuity and controlled compliance with the Ministry of Environment, Urbanization and Climate Change (MoEUCC), maintaining alignment with the overarching principles of TURKREACH (KKDIK).
Article 10(1) In the event that the leading company fails to meet its obligations regarding full registration, it submits the data in Annex-1 of these Procedures and Principles to the Ministry until 31/03/2026 and makes a provisional registration. Following the provisional registration of the leading company, the member companies submit their member registration entries to the Ministry via KKS until 30/09/2026.
Provisional Registration by the Lead Registrant
If the Lead Registrant (LR) cannot provide all data required for a full registration dossier, they must submit a Provisional Registration to the Ministry by 31 March 2026.
This submission must include the data specified in Annex-1 of the Procedures.
After the Lead Registrant’s submission, member companies must complete their entries via the Chemical Registration System (CRS) by 30 September 2026.
📘 Effect: This ensures that registration activities proceed even if certain datasets are incomplete, thereby avoiding trade disruptions for compliant companies.
📘 Important Warning: Provisional registrations should be done for all tonnage bands until the specified dates.
Article 10(2) Companies that are not included in the joint registration group and will submit their registration dossier separately within the scope of the second paragraph of Article 6, in case they cannot meet their obligations regarding full registration, make a temporary registration by transmitting the data in Annex-1 of these Procedures and Principles to the Ministry through KKS until 31/03/2026.
Provisional Registration for Individual Registrants
Companies that have opted to submit individual dossiers (outside a Joint Registration Group) and cannot complete full registration data are also required to submit a Provisional Registration by 31 March 2026.
The same data structure and Annex-1 format apply.
📘 Effect: Both joint and individual registrants can rely on the provisional registration route to maintain legal compliance during the data-completion phase.
Article 10(3) The data in Annex-1 of these Procedures and Principles are entered into the KKS by a Chemical Assessment Specialist (KDU) and the qualification certificate of the relevant KDU is attached.
Submission by a Certified Chemical Assessment Specialist (KDU)
All Annex-1 data must be prepared and entered into the KKS by a Certified Chemical Assessment Specialist (KDU).
The KDU’s qualification certificate number and issue date must accompany the submission.
📘 Effect: Guarantees that each provisional registration is prepared by a Ministry-approved professional, ensuring data reliability and technical integrity.
Article 10(4) The provisions of the Regulation on registration fees in the Revolving Fund Unit Price List of the Ministry are applied during the temporary registration process.
Fees and Administrative Rules
Provisional registrations are subject to the Ministry’s Revolving Fund Price List, following the same fee policy as full registrations.
There are no fee exemptions for provisional submissions.
📘 Effect: Provisional registration is a regulated compliance stage, not a free or informal exception.
Article 10(5) The provisions in the first, second, third and fourth paragraphs of this article do not apply to companies that will submit a full registration dossier until 31/03/2026.
Exemption for Full Registrations
Companies submitting a complete registration dossier by 31 March 2026 are not required to file a provisional registration.
📘 Effect: Firms completing full registration within the timeline can bypass provisional submission entirely.
🎯 Practical Implications for Companies
Lead Registrant deadline: 31 March 2026.
Member company deadline: 30 September 2026.
Certified Expert required: All data must be submitted by a qualified CAE.
Fees apply: Provisional registration follows standard Ministry fee schedules.
Strategic purpose: Provides additional time to close data gaps while maintaining legal market access.
📊 Simplified Timeline for KKDİK Provisional Registrations
| Stage | Responsible Party | Deadline |
|---|---|---|
| Provisional registration submission | Lead Registrant / Individual registrant | 31 March 2026 |
| Co-registrant data entry | Member companies | 30 September 2026 |
| Completion of full dossier | All registrants | By 2030 (based on tonnage band) |
Article 11 – Completion of the Registration Process: Article 11 of the KKDIK Procedures & Principles (2025) describes the steps required to finalize a registration dossier and the conditions under which companies may request additional time from the Ministry of Environment, Urbanization and Climate Change (MoEUCC).It links the provisional registration phase to the final registration stage and clarifies the Ministry’s evaluation and decision-making process.
Article 11(1) By the deadlines in the provisional article 2 of the Regulation, it is necessary for the full registration dossier and completes the tonnage-related information requirements in the Regulation;
(a) Companies that submit the same registration dossier within the scope of the second paragraph of Article 7,
(b)Leading companies applying for joint registration
(c) Member companies of joint registration groups whose leader submits a full registration dossier
completes the registration.
Completion of the Full Registration
Registration is considered complete once all data required under the KKDIK Regulation—as determined by tonnage-band obligations—have been submitted to the Ministry by the relevant deadlines in the Regulation’s Provisional Article 2.
The following categories are deemed to have completed their registrations:
(a) Companies submitting an individual registration dossier under Article 7(2),
(b) Lead Registrants that have filed a complete joint dossier,
(c) Member companies whose Lead Registrant has successfully submitted the final dossier.
📘 Effect: Each registrant becomes fully compliant once the dossier for its tonnage band is accepted by the Ministry.
Article 11(2) In the event that potential registrants are unable to obtain the necessary data for the full registration dossier or cannot access the data from publicly available non-copyrighted global data sources, by the lead registrant of the substance in question in the joint registration, or by the company itself if the registration dossier is submitted separately within the scope of the second paragraph of Article 7, by filling in the relevant sections in the KKS, the request for additional time together with the detailed justification informing the said situation to the Ministry is presented
Requesting Additional Time
If a registrant or Lead Registrant cannot obtain certain test data or access copyrighted information, they may submit a reasoned request for an extension via the Chemical Registration System (CRS).
The request must include:
A detailed justification describing why the data cannot be provided,
Documentation proving attempts to access or generate the data.
📘 Effect: Provides an official mechanism for companies to seek deadline flexibility without breaching compliance.
Article 11(3) The Ministry evaluates the justification specified in the second paragraph and notifies the relevant party of its decision regarding the request for additional time.
Ministry Evaluation
The Ministry reviews each justification and decides whether to approve or reject the request for additional time.
Article 11(4) In the event that the Ministry requests additional information within the given additional period, these requests are met within the period determined by the Ministry. If the request for additional information cannot be provided within the specified time, additional time is requested from the Ministry by stating the reason.
Supplementary Information During the Extension Period
The Ministry may request extra information during the granted extension.
Companies must provide this information within the specified timeframe.
If this is not feasible, an additional, well-documented extension request may be filed.
📘 Effect: Maintains continuous oversight while giving companies room to complete complex data requirements.
Article 11(5) The additional period to be granted by the Ministry within the scope of the third paragraph is a maximum of two years after the last registration date determined for the relevant tonnage range of the substance. In the event that the data cannot be provided at the end of the additional periods, after the evaluation of the submitted reasons by the Chemical Advisory Group, the Ministry approves/rejects the registration specific to the relevant substance.
Maximum Extension Period and Final Decision
The maximum extension permitted is two years beyond the applicable final registration deadline for that tonnage band.
If data are still missing after this period, the Chemicals Advisory Group reviews the case, and the Ministry issues either:
Registration Approval, or
Rejection of the registration for that specific substance.
📘 Effect: Sets a firm upper limit—preventing indefinite extensions and ensuring regulatory certainty.
🎯 Practical Implications for Manufacturers and Importers
Deadlines are tonnage-based: (1000 t+, 100 t+, 1 t+) per KKDIK Annexes.
Extension requests must be formalized through the CRS, with supporting evidence.
Maximum two-year limit: After that, the Ministry will issue an approval or rejection.
Continuous monitoring: Even during extensions, companies remain under compliance scrutiny.
Provisional Registration link: Firms moving from provisional to full registration must align with these timeframes.
📊 Simplified Timeline for Registration Completion
| Stage | Responsible Party | Deadline |
|---|---|---|
| Full registration submission | Lead Registrant / Individual Registrant | By tonnage band deadlines (2026 – 2030) |
| Request for extension (if needed) | Lead Registrant or Registrant | Before final deadline expires |
| Ministry review and decision | MoEUCC / Chemicals Advisory Group | Within approved extension period (max 2 years) |
- Article 12 – Chemicals Science Group: Article 12 of the KKDIK Procedures & Principles (2025) establishes the Chemicals Science Group (CSG)—a scientific advisory body created by the Ministry of Environment, Urbanization and Climate Change (MoEUCC) to strengthen the technical and academic foundation of chemical management under Turkish REACH (KKDIK).
The Group functions as an independent panel of scientific experts that supports decision-making, training, and evaluation activities in coordination with the Ministry and the Chemicals Advisory Group (CAG).
Article 12(1) The Chemicals Science Group established under the coordination of the Ministry,
(a) To inform and evaluate the current questions and problems related to the work and activities within the scope of chemicals management,
(b) To carry out studies on the training processes of chemicals,
(c) Chemicals Consultation In the group Specified and Unresolvable Assessing the issues
fulfills its duties.
Main Functions of the Chemicals Science Group (CSG)
Under the Ministry’s coordination, the Chemicals Science Group is responsible for:
(a) Providing information and evaluations on current questions and technical issues within chemical management,
(b) Participating in the development and execution of educational programs related to chemical safety and regulation,
(c) Assessing unresolved matters referred from the Chemicals Advisory Group (CAG).
📘 Effect: The CSG ensures that regulatory implementation is guided by scientific evidence and expert judgment, bridging the gap between policy and research.
Article 12(2) In the Chemicals Science Group; There are lecturers working on chemicals and their effects on human health and the environment in universities.
Composition of the Group
The Group is composed of academics and researchers from universities who specialize in chemicals and their impacts on human health and the environment.
Members bring multidisciplinary expertise in toxicology, ecotoxicology, industrial chemistry, environmental engineering, and public health.
📘 Effect: Scientific diversity within the Group enables holistic evaluation of chemical risks and regulatory needs.
Article 12(3) The group consists of at least 7 members, convenes with the absolute majority of the total number of members and attends the meeting.
It takes recommendations with an absolute majority of the number of participating members.
Structure and Decision-Making
The Group consists of at least seven members.
Meetings require a simple majority for quorum, and recommendations are adopted by majority vote of attending members.
Decisions serve as advisory opinions to the Ministry and other regulatory bodies.
Article 12(4) The group is chaired by the Director General of Environmental Management, and in cases where the Director General of Environmental Management is unable to participate, by the Deputy Director General.
Leadership
The Group is chaired by the Director General of Environmental Management (or, if absent, the Deputy Director General).
This ensures alignment between scientific recommendations and national policy objectives.
Article 12(5) The group meets twice a year at the call of the Ministry. When deemed necessary, additional meetings are held upon the call of the Ministry.
Meetings
The Group meets twice a year upon the Ministry’s invitation.
Extraordinary meetings may be held when urgent scientific issues arise.
📘 Effect: Regular interaction guarantees that scientific input remains current and responsive to emerging regulatory challenges.
Article 12(6) The secretariat services of the Group are carried out by the General Directorate of Environmental Management of the Ministry.
Secretariat and Support
Secretariat services are provided by the General Directorate of Environmental Management, ensuring administrative continuity and record keeping for all CSG activities.
Article 12(7) When deemed necessary, sub-working groups are formed.
Sub-Working Groups
When necessary, the CSG may form sub-groups to focus on specific topics such as toxicological testing methods, data sharing practices, polymer classification, or endocrine disruptors.
📘 Effect: This modular structure enhances efficiency and allows for deep technical analysis of complex subjects.
🎯 Practical Implications for Industry
Scientific Oversight: The CSG’s recommendations inform policy updates that impact manufacturers and importers.
Training and Capacity Building: The Group supports education programs for Chemical Assessment Experts (CAEs) and industry stakeholders.
Evidence-Based Regulation: Ensures that future restrictions and data requirements are rooted in scientific evaluation.
Transparency: Academic involvement reinforces trust between industry and the regulatory authority.
- Article 13 – Chemicals Advisory Group: Article 13 of the KKDIK Procedures & Principles (2025) establishes the Chemicals Advisory Group (CAG) — a multi-stakeholder coordination body under the Ministry of Environment, Urbanization and Climate Change (MoEUCC).
The CAG plays a central role in strategic consultation, policy alignment, and inter-institutional coordination regarding the management of chemicals in Türkiye. It complements the scientific and technical work of the Chemicals Science Group (CSG) by integrating policy, industry, and regulatory perspectives under the framework of Turkish REACH (KKDIK).
Article 13(1) The Chemicals Advisory Group established under the coordination of the Ministry,
(a) To consult on the current situation, planned studies and international developments within the scope of Chemicals Management,
(b) To make recommendations in identifying, monitoring and evaluating plans, policies, strategies and actions related to chemicals management,
(c) It fulfills the duties of evaluating the issues that have been identified and cannot be resolved in the Chemicals Science Group.
Functions of the Chemicals Advisory Group (CAG)
Under the coordination of the Ministry, the Chemicals Advisory Group performs the following duties:
(a) Conducts consultations on the current situation, planned activities, and international developments in chemical management.
(b) Provides recommendations on national plans, policies, strategies, and action programs related to chemical management.
(c) Evaluates issues referred by the Chemicals Science Group (CSG) that could not be resolved through scientific assessment alone.
📘 Effect: The CAG acts as a strategic advisory board, transforming scientific insights into policy guidance and national implementation plans.
Article 13(2) In the Chemicals Consultancy Group, there are members from the Ministry of Health, Ministry of Agriculture and Forestry, Ministry of Commerce, Ministry of Industry and Technology, Ministry of Interior, Ministry of Labor and Social Security, Union of Chambers and Commodity Exchanges of Turkey (TOBB), and other relevant institutions and organizations as needed, along with members of the Chemicals Scientific Group.
Composition of the Group
The CAG includes representatives from key ministries and institutions involved in chemical management, specifically:
Ministry of Health,
Ministry of Agriculture and Forestry,
Ministry of Trade,
Ministry of Industry and Technology,
Ministry of Interior,
Ministry of Labor and Social Security,
Union of Chambers and Commodity Exchanges of Türkiye (TOBB),
Other relevant institutions and organizations as needed,
Members of the Chemicals Science Group (CSG).
📘 Effect: Brings together policy makers, regulators, industry representatives, and academia into a single coordination platform, ensuring balanced decision-making.
Article 13(3) The group consists of at least 7 members, convenes with the absolute majority of the total number of members and takes recommendations with the absolute majority of the number of members attending the meeting.
Structure and Decision-Making
The Group comprises at least seven members.
Meetings are held with a simple majority and decisions are adopted by majority vote of attending members.
All outputs are recommendatory, designed to guide the Ministry’s policy and enforcement strategies.
Article 13(4) The group is chaired by the Director General of Environmental Management, and in cases where the Director General of Environmental Management is unable to participate, by the Deputy Director General.
Leadership
The CAG is chaired by the Director General of Environmental Management or, when unavailable, by the Deputy Director General.
This leadership ensures that high-level policy direction remains integrated with regulatory decision-making.
Article 13(5) Group meets twice a year at the call of the Ministry. When deemed necessary, additional meetings are held upon the call of the Ministry.
Meeting Frequency
The CAG convenes twice per year under the Ministry’s invitation.
Extraordinary meetings may be called by the Ministry in case of urgent regulatory or international developments.
📘 Effect: Guarantees timely response to evolving chemical safety challenges and alignment with international REACH developments.
Article 13(6) The secretariat services of the Group are carried out by the General Directorate of Environmental Management of the Ministry.
Secretariat Support
The General Directorate of Environmental Management provides secretariat services for the CAG, ensuring documentation, coordination, and follow-up of group decisions.
Article 13(7) When deemed necessary, sub-working groups are formed.
Formation of Sub-Working Groups
When necessary, the CAG can establish sub-working groups to focus on specific thematic areas such as industrial chemicals, consumer safety, environmental exposure, or international harmonization.
📘 Effect: Allows flexibility and targeted expertise for complex policy topics, ensuring efficient decision support for the Ministry.
🎯 Practical Implications for Industry and Stakeholders
Institutional Alignment: Ensures consistent national policy between ministries and industry sectors.
TOBB Representation: Provides industry a formal voice in policy dialogue, allowing feedback from manufacturers and importers.
Strategic Influence: CAG recommendations may shape future restrictions, data requirements, and regulatory priorities.
Transparency: Public–private collaboration underpins trust and compliance within the KKDIK framework.
- Article 14 – Application Considerations : Article 14 of the KKDIK Procedures & Principles (2025) clarifies how the KKDIK Regulation and these Procedures must be implemented in practice. It states that all stakeholders must follow the official implementation guidelines (also referred to as MoEUCC Guidance Documents) published by the Ministry of Environment, Urbanization and Climate Change (MoEUCC).
These guidelines serve as the authoritative interpretation and operational framework for the KKDİK (TURKREACH) system—providing step-by-step instructions on dossier preparation, MBDF communication, Safety Data Sheet (SDS) submission, and registration updates.
Article 14(1) The guidelines published by the Ministry are taken into account in the implementation of the Regulation and these Procedures and Principles.
Binding Reference to Ministry Guidance
All activities carried out under the KKDIK Regulation and the Procedures & Principles must be performed in accordance with the Ministry’s official guidance documents.
The MoEUCC regularly issues and updates these guidelines to reflect technical progress, EU REACH developments, and lessons learned from national implementation.
- These guidelines explain how companies should operate in practice, which documents need to be prepared, and which technical details should be considered during the registration processes.
📘 Effect: The Ministry’s guidance documents serve as the primary reference for how companies should interpret and apply each KKDIK requirement. Failure to follow them may result in non-compliance during audits or inspections.
🎯 Practical Implications for Manufacturers and Importers
Relevance: All registrations and SDS submissions must strictly align with the latest MoEUCC guidance versions.
Documentation: Companies should maintain copies of the guidance documents used during registration for audit traceability.
Continuous Monitoring: Guidelines are regularly revised — firms must stay informed through official Ministry announcements.
Risk Reduction: Following official guidance reduces interpretation errors and ensures uniform compliance across the supply chain.
- Article 15 – Update of Registration Dossiers: Article 15 of the KKDIK Procedures & Principles (2025) defines the conditions under which registration dossiers must be updated, corrected, or supplemented.
This provision ensures that information submitted under KKDIK remains accurate, complete, and up to date throughout the life cycle of a substance.
The article emphasizes that both registrants and the Ministry of Environment, Urbanization and Climate Change (MoEUCC) have roles in triggering dossier updates.
Article 15(1) In cases where the registrations made within the scope of the Regulation are required to be updated within the scope of the first paragraph of Article 22 of the Regulation, the existing registrations are updated within 3 months from the date on which the need for updating arises. If there is a situation that prevents the update from being made within this period, this situation is notified to the Ministry in writing with a detailed justification and additional time is requested from the Ministry.
Registrant-Initiated Updates (Three-Month Rule)
When a registrant becomes aware of any change requiring dossier revision—such as a change in tonnage, composition, uses, or classification—they must update their registration within three (3) months of identifying the change.
If technical or administrative barriers prevent timely updating, the registrant must submit a written justification to the Ministry and formally request an extension.
📘 Effect: Registrants are responsible for continuous dossier maintenance; failure to update within three months may result in non-compliance or suspension of the registration.
Article 15(2) If there is an update decision taken by the Ministry within the scope of the second paragraph of Article 22 of the Regulation, the registrant shall update the registration containing the information required by the decision within the period specified in the decision.
Ministry-Initiated Updates
When the MoEUCC issues a formal decision under Article 22(2) of the KKDIK Regulation requiring dossier updates, the registrant must provide the requested information within the deadline specified in the Ministry’s decision.
📘 Effect: The Ministry retains authority to require additional information, ensuring that dossiers meet evolving regulatory and scientific standards.
Article 15(3) Updates of registrations made before the publication of these Procedures and Principles can be made until the deadlines specified in the Regulation.
Updates for Pre-Existing Registrations
Dossiers submitted before the entry into force of these KKDİK Procedures and Principles may also require updating.
Such updates can be completed up to the final registration deadlines defined in the KKDIK Regulation (based on tonnage band).
📘 Effect: Legacy registrations are not exempt from compliance improvements; all must align with the updated procedural and technical requirements. There is also an obligation to update submitted registrations; companies cannot say, “I registered earlier, so I no longer need to make updates.”
🎯 Practical Implications for Companies
Three-Month Obligation: Any change to registered data must be reflected in the dossier within three months.
Extension Possibility: Written justification required for delays.
Ministry Oversight: MoEUCC decisions can impose additional data or documentation.
Continuous Compliance: Dossiers are “living documents” that evolve as operations, tonnage, or scientific knowledge changes.
Legacy Adjustments: Even earlier submissions must be updated to align with the 2025 KKDİK Procedures and Principles.
🧭 Typical Dossier Update Triggers
| Trigger Event | Example | Action Required |
|---|---|---|
| Change in tonnage band | Increase from 10–100 t/y to 100–1000 t/y | Submit updated technical dossier |
| Change in substance composition | New impurity identified | Update substance identity section |
| New use identified | New downstream application | Add exposure scenario and CSR revision |
| Reclassification | Revised hazard category | Update SDS and classification data |
| Ministry request | Decision under Article 22(2) | Submit supplementary data within deadline |
Article 16 – Safety Data Sheets (SDS/GBF): Article 16 of the KKDIK Procedures & Principles (2025) specifies how Safety Data Sheets (GBF)—the cornerstone of chemical communication and safety management—must be prepared, verified, and uploaded under KKDIK.
It establishes new digital submission requirements, strengthens the role of the Certified Chemical Assessment Specialist (CAS), and aligns Turkish SDS practices with KKDİK Annex II.
Article 16(1) The safety data sheets prepared within the scope of the first paragraph of Article 27 of the Regulation are uploaded by the supplier to the special package program related to the safety data sheets of the Ministry.
Digital Submission through the Ministry’s GBF Platform (The obligation to upload GBFs to the Ministry’s Digital Environment.)
All Safety Data Sheets prepared in accordance with Article 27(1) of the KKDIK Regulation must be electronically uploaded by the supplier to the Ministry’s dedicated SDS software platform.
Paper-based or email submissions are no longer accepted.
The platform ensures verification, traceability, and centralized management of all SDS records in Türkiye.
- GBF files are no longer distributed solely as PDFs or physical documents; they are now also submitted to the Ministry’s awareness by uploading them through an official digital platform.
📘 Effect: Companies must integrate SDS preparation into a digital compliance workflow to maintain valid market access.
Article 16(2) Under the 16th heading of the safety data sheets to be prepared within the scope of the Regulation and within the framework of the headings in Annex-2, the contact information of the KDU that prepared the safety data sheet and the date and number of the qualification certificate are written.
Mandatory Information under Section 16 of the Safety Data Sheet
Every SDS must include the following information in Section 16 – Other Information:
The name and contact details of the Chemical Assessment Specialist (KDU) who prepared or reviewed the Safety Data Sheet (GBF), and
The certificate number and issue date of the KDU’s qualification, as approved by the Ministry.
📘 Effect: Anonymous or unsigned SDS documents are not valid under KKDIK; each must identify the certified chemical assessment specialist responsible for its preparation.
Article 16(3) KDU training and certification processes are carried out under the coordination of the Ministry.
KDU Training and Certification Requirements
The training, examination, and certification of Chemical Assessment Specialists (KDUs) are conducted under the supervision and coordination of the MoEUCC.
Only KDUs with valid and current Ministry certificates are authorized to prepare or approve SDSs for KKDIK purposes.
📘 Effect: Ensures technical competence and harmonized quality across all SDS documentation submitted in Türkiye. Companies should only work with qualified specialists who have official documents when preparing SDS/GBF.
🎯 Practical Implications for Manufacturers, Importers, and Distributors
Digital Obligation: All SDSs must be uploaded through the official Ministry platform.
Certified Expertise: Each SDS must be prepared or validated by a Ministry-approved KDU.
Identification Transparency: The KDU’s credentials must appear clearly in Section 16.
Legal Liability: Incorrect or uncertified SDSs may lead to enforcement action or removal of products from the market.
Alignment with EU Practices: Compliance with Annex II guarantees interoperability with EU REACH systems and enhances export readiness.
🧭 Doruksistem’s SDS Compliance Support
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SDS preparation and multilingual alignment (TR / EN / EU formats),
Verification and uploading via the Ministry’s SDS portal,
KDU-led document review and certification,
Integration of SDS data with KKDIK registration dossiers.
📩 Contact Doruksistem to ensure your SDS documentation fully complies with the 2025 KKDIK digital and certification requirements.
- Article 17 – Inspection and Administrative Sanctions : Article 17 of the KKDIK Procedures & Principles (2025) establishes the legal foundation for enforcement and administrative penalties when companies fail to comply with the obligations set out in the KKDIK Regulation and these Procedures.
All inspections and sanctions are implemented under Environmental Law No. 2872, which authorizes the Ministry of Environment, Urbanization and Climate Change (MoEUCC) to conduct investigations, issue fines, and impose market restrictions.
Article 17(1) In case of non-compliance with the conditions specified in these Procedures and Principles, sanctions are applied in accordance with Law No. 2872.
Legal Basis for Sanctions
Non-compliance with any requirement of the KKDIK Procedures & Principles—including registration, MBDF participation, dossier updates, SDS submission, or KDU certification—may lead to enforcement measures under Environmental Law No. 2872.
The Ministry may apply:
Administrative fines,
Suspension of manufacture or import activities,
Market withdrawal or sales bans for unregistered or non-compliant substances.
📘 Effect: Failure to register, update, or provide valid documentation can directly result in prohibition from placing products on the Turkish market.
Inspection Authority
The MoEUCC and its authorized inspectors oversee the implementation of KKDIK through:
Document audits (KKS/CRS data verification),
On-site inspections at manufacturing and storage facilities,
Sampling and testing for substance verification.
Inspectors may request any documentation or declaration necessary to verify compliance.
📘 Effect: Companies must maintain complete, traceable records of all KKDIK activities—including registration numbers, SDS archives, and KDU certificates—for immediate presentation during inspection.
Administrative Process and Penalties
When non-compliance is detected, the Ministry issues an official notice requiring corrective action within a defined period.
Failure to remedy violations within the deadline results in:
Financial penalties, and/or
Suspension of KKDIK registration and market access.
Repeated or deliberate non-compliance may lead to permanent revocation of registration and criminal referral under national law.
Preventive Compliance Approach
The MoEUCC encourages proactive compliance by promoting:
Training for Chemical Assessment Specialists (KDUs),
Industry outreach through TOBB and sectoral associations,
Continuous updates of KKDIK guidance and Application Considerations.
📘 Effect: Companies adopting early compliance programs and periodic audits can minimize enforcement risk.
🎯 Practical Implications for Companies
Maintain valid registration numbers and SDS documentation for all marketed substances.
Respond promptly to any Ministry inspection request or corrective action notice.
Engage certified KDUs to ensure documentation accuracy.
Implement internal audit systems to detect and resolve compliance gaps.
- Ensure that the certification of KDU, which prepared the SDS, remains valid.
Partner with professional consultants such as Doruksistem for continuous monitoring and regulatory updates.
The KKDİK Principles and Procedures (P&P) require very careful monitoring of the KKDİK implementation in Turkey. To avoid issues in tracking your existing pre-registrations, SEA notifications, MBDF management, provisional or full registrations, as well as in communications with downstream-users (DU), we recommend working with real experts.
DORUKSISTEM will be by your side for your questions and concerns.