What is KKDIK and who is obligated?

Obligations under KKDIK typically arise based on CAS/EC substances and affect these actors: • Manufacturers of substances in Turkey • Importers of substances into Turkey • Parties in the supply chain whose roles must be clarified (importer/manufacturer, formulator, distributor, etc.) • Lead and member parties in joint registrations The most critical first step is correctly answering the question "what is our role?" A wrong role definition increases the risk of wrong timelines, wrong costs, and interruptions to market access.

The backbone of the process: substance inventory, tonnage and prioritization

KKDIK projects require inventory discipline first: • Substance list (CAS/EC), substance name matches and synonyms • Tonnage bands and portfolio priorities (strategic products / critical supply) • Import/manufacturing flow, supplier and customer map • Substance identity: purity, additives/stabilizers, impurity profile Pier Compliance breaks the portfolio into manageable work packages: • Rapid scope scan (risky/priority substances) • Critical substance plan (registration scenario + data strategy + timeline) • Cost/workload forecasting (joint registration/analytics/data needs)

KKS (Chemical Registration System) operations and traceable dossier logic

Beyond KKS steps, it is critical to build an auditable “evidence package” throughout the process: • Substance-based decisions (role, tonnage, registration scenario) • MBDF communications and agreements • Analytical/technical evidence (substance identity, similarity justification) • Contracts (data sharing, cost sharing, confidentiality) • Version control (document revision discipline) Pier Compliance manages KKS operations within a single plan that integrates documentation and decision chain.

Pre-MBDF and MBDF communication: the layer that accelerates the process

Pre-MBDF is the starting step that helps parties find each other around the same substance and structure the process. MBDF communication acts like an “operations center” in the registration journey. Topics clarified in MBDF: • Substance identity match (same substance?) • Classification/label approach and SDS/GBF consistency • Data scope (which endpoints exist/are missing?) • Data sharing and cost model • Lead selection and member management • Temporary registration and full registration timeline Pier Compliance structures MBDF communication as project management: • Classifying parties by role/tonnage/data ownership • Progress through meeting minutes and decision records (evidence chain) • Technical topic templates: substance identity, similarity, data-gap, test needs, cost model • Option sets for dispute management (similarity rejection, impurity differences, UVCB uncertainty, etc.)

Lead / joint registration management: data and contract architecture

Three elements determine quality in joint registration: leadership, data strategy, and contract/cost model. Lead selection criteria: • Data access and sharing capacity • Technical coordination (substance identity/similarity/test strategy) • Timeline management and member communication discipline Joint registration agreements typically cover: • Data sharing (scope, usage rights, confidentiality) • Cost sharing (fair and traceable model) • Dispute resolution and exit/entry clauses • Version and revision management Pier Compliance turns this into a project structure that reduces registration risk and makes costs predictable.

Temporary registration: a strategic bridge for market access continuity

When technical dossier/data/contract processes extend, market access can be at risk. Temporary registration should be considered a controlled bridge to full registration. Pier Compliance approach: • Minimum eligible technical package for temporary registration (role/tonnage/substance identity/MBDF status/plan) • Parallel data strategy and timeline for full registration • Post-temporary registration transition plan to full registration (milestones, closure criteria)

Analytical tests and substance identity: proving “the same substance”

The most critical technical debate in joint registration: “Is it the same substance?” This often requires analytical evidence. Managed package: • Purity, main constituent, impurity profile, additives/stabilizers • Suitable analytical set selection (by substance type): GC-MS/GC-FID/HPLC, FT-IR, and when needed NMR and supporting parameters • Fingerprint approach and comparison logic for UVCB/complex substances The goal is to make similarity/identity discussions in MBDF measurable.

Similarity, read-across and category approach: using data smartly

For some substances, scientific justification via read-across or category approach may be possible instead of direct testing. If built correctly, it reduces cost; if built incorrectly, it increases dossier rejection risk. Pier Compliance in this process: • Defines the similarity hypothesis clearly (structural similarity, mechanism similarity, etc.) • Builds a data matrix (which endpoint can be transferred from which substance?) • Prepares the justification package (uncertainty analysis, boundaries) • Strengthens the approach with minimum confirmation tests when needed

Data-gap analysis and test management

Preparing the registration dossier is about “what data is missing and how will it be filled?” • Endpoint-based data-gap analysis • Data acquisition options: data-sharing, read-across/category/QSAR alternatives, analytical verification, planning of required tests • Time-cost-risk optimization and laboratory coordination

CSR (Chemical Safety Report) and exposure scenarios

Depending on tonnage/use/risk profile, CSR and exposure scenarios may be required. The goal is to define use conditions correctly, build consistent risk characterization, and produce a defensible report set in audits.

SEA / SDS-GBF integration: compliance without contradictions in the dossier

In KKDIK, inconsistencies between classification–label–SDS/GBF–registration strategy create operational risk. Pier Compliance integration approach: • SEA/CLP classification accuracy • Label and SDS/GBF consistency • SDS language aligned with registration dossier use scenarios • A single defensible compliance story in audits

Pier Compliance KKDIK Service Scope

Substance inventory & tonnage mapping (CAS/EC-based portfolio and prioritization)
Pre-MBDF preparations (data set, substance identity, plan)
MBDF communication (role/tonnage/data ownership separation, decision and evidence chain)
Lead/member joint registration coordination (lead selection, contract/cost model)
Temporary registration strategy + full registration roadmap (milestones and transition plan)
Analytical test strategy (substance identity, impurity profile, UVCB fingerprint)
Similarity / read-across justification and data matrix
Data-gap & test management (laboratory coordination, time-cost-risk optimization)
CSR / exposure scenarios (when required)
SEA–SDS/GBF integration and supply chain documentation
Audit readiness: traceable dossier library and archive system

Why Pier Compliance?

End-to-end project management (from MBDF communication to dossier architecture)
Technical accuracy (substance identity/similarity/data strategy)
Continuity (temporary registration + full registration transition plan)
Cost-effective approach (data-sharing, read-across, minimum confirmation tests)
Auditability (evidence chain and version control)

KKDIK (TURKREACH) Process Management