KKDIK Procedures and Principles

2025 KKDIK Regulatory Framework (Türkiye REACH)

(Aligned to the Procedures & Principles dated 5 August 2025)

1) What KKDIK Controls

KKDIK governs Registration, Evaluation, Authorization, and Restriction of chemicals placed on the Turkish market. It applies to manufacturers, importers, Only Representatives (OR), downstream users, and data holders. Compliance is executed through a digitized system model, where datasets across KKDIK and SEA (TR-CLP) are increasingly cross-checked for consistency.

2) Compliance Domains Under the 2025 Procedures & Principles

The Procedures & Principles operationalize how obligations are executed across:

  • Registration: dossier route, joint data use, substance identity matching

  • Evaluation: technical review, completeness checks, data adequacy

  • Authorization: controlled use of SVHC-type substances

  • Restriction: market limitations, prohibitions, enforcement logic

  • Data Governance: access, ownership, cost allocation, auditability

  • Digital Compliance: KKS operations, traceability, e-signature, audit trail

A) Substance Registration Operating Model (KKS-Based)

3) Registration Trigger

All substances ≥ 1 t/y manufactured or imported into Türkiye require registration via KKS. Registration is not just “a dossier”; it is a controlled workflow with identity matching, cooperation governance, and traceability expectations.

4) Core Registration Workflow

  1. SEA (TR-CLP) notification must exist first (prerequisite dataset).

  2. Pre-MBDF Notification (mandatory gate): substance identity declaration + discovery of potential registrants.

  3. MBDF Participation: membership in the substance forum for structured cooperation.

  4. Lead Registrant (LR) appointment: governance + lead dossier responsibility.

  5. Joint or Individual Submission: route selection under KKS rules and MBDF governance.

  6. Provisional Registration: market continuity mechanism while full data obligations continue.

5) Pre-MBDF Notification (Non-Optional Gate)

Pre-MBDF is the entry control step for:

  • Substance identity matching

  • Registrant communication

  • Data-sharing preparation
    Failure typically results in losing structured participation rights within MBDF and increased compliance exposure.

6) MBDF Governance (Regulated, Auditable)

MBDFs are no longer informal “SIEF-style” forums. They require:

  • documented governance structure

  • records (minutes, decisions, voting)

  • data access logs and traceable permissions

  • transparent cost files and auditable allocation

  • non-discriminatory access rules
    MoEUCC can audit MBDF documentation.

7) Lead Registrant (LR) — Control Point

LR responsibilities typically include:

  • lead technical dossier

  • CSR (Chemical Safety Report) where applicable

  • SEA-aligned classification consistency logic

  • coordination of joint submission
    If no LR is chosen, MoEUCC may designate an LR based on capability, tonnage band, and REACH experience—removing industry control over leadership.

8) Joint Registration Group (JRG) — Cost & Data Sharing Engine

JRG is the cooperation and cost-sharing mechanism within MBDF and must be:

  • fair (equal access conditions)

  • transparent (documented cost model)

  • non-discriminatory (same rules for all)

  • data-efficient (avoid duplicate testing)
    Conceptually similar to EU REACH Art. 27 logic, but enforceable under Turkish oversight.

9) Provisional Registration Deadlines (Operational Timetable)

  • LR provisional dossier: 31 March 2026

  • Member dossiers: 30 September 2026
    Provisional status supports market continuity but does not remove full data and update obligations.

10) Dossier Update Triggers (3-Month Rule)

Updates are mandatory within the defined period when:

  • substance composition changes

  • identified uses change

  • tonnage band changes
    Failure to update is a direct non-compliance risk.

11) Scientific & Advisory Bodies

  • CSG: scientific assessment influence (data needs / methodology)

  • CAG: regulatory/policy advisory influence (restriction proposals / approach)

12) Digital Compliance Reality (No “Paper Logic”)

KKS operates as a fully digital system with:

  • electronic submissions

  • e-signature validation

  • full audit trail

  • interoperability expectations
    Compliance is increasingly enforced via dataset consistency and traceability.

B) SDS Requirements Under KKDIK + SEA (Operational Controls)

13) Legal Status of SDS

SDS is a mandatory hazard communication instrument under KKDIK and SEA (TR-CLP). The 2025 Procedures strengthen obligations around preparation, verification/certification, submission, and lifecycle control.

14) Language & Format

SDS placed on the Turkish market must:

  • be in Turkish

  • comply with KKDIK Annex II and the 16-section structure

  • be consistent with SEA classification and labeling (same hazard logic across datasets)

15) Certified Author (KDU) Requirement

SDS must be prepared or formally verified by a Ministry-certified Chemical Assessment Specialist (KDU). SDS issued without KDU authorization is treated as non-compliant.

16) Mandatory SDS Portal Submission

Finalized SDSs must be uploaded to the MoEUCC SDS Portal enabling:

  • centralized SDS registration

  • version traceability

  • inspection access

  • cross-checks vs KKDIK registration + SEA data
    Failure to upload can trigger enforcement measures.

17) When SDS Is Required + Update Duty

SDS must be supplied for hazardous substances/mixtures and certain threshold cases, at first supply and after updates affecting: classification, composition, or risk management measures. Updated SDS must be redistributed free of charge within three months to downstream users.

18) Enforcement & Core Legality Principle

Non-compliance can lead to fines, market surveillance actions, supply suspension, and withdrawals. Operationally: a substance cannot legally remain on the market if registration status, SDS compliance, and SEA data are not aligned, because authorities now perform systematic digital cross-checks.