KKDIK Leader Registration Case in 1,000+ Ton Band: Completed in 14 Months

Company, item and commercial data are anonymized to protect customer privacy.

Case summary

A company that produces industrial chemicals in Turkey decided to become a Leading Registrar within the scope of KKDIK for a substance that it produces 1,000 tons annually. Due to the comprehensive data set required by the high tonnage band, missing study titles, and the data sharing process that had to be carried out with MBDF members, the project was not just about technical file preparation.

The process managed end to end by ONAY Mühendislik was completed within 14 months. The lead registration dossier was submitted through KKS and a full registration number was obtained.

Initial status

When the data presented by the company at the beginning of the project was examined, the following were determined:

• Need for standardization of substance identity and composition information
• Deficiencies in some physicochemical, toxicological and ecotoxicological data headings required for the 1,000+ tonne band
• The need to re-evaluate existing studies in terms of reliability and usability
• Inconsistencies between classification and study results that need to be eliminated
• Uncertainties regarding data access and common registration conditions for MBDF members What path did

ONAY Mühendislik take?

In the first stage, the substance profile within the scope of registration was clarified by examining the substance identity, production process, purity profile, impurities and component ranges. A detailed data gap analysis was then performed based on the data requirements of the 1,000+ tone band.

Existing studies were evaluated for scientific reliability, relevance and usability in the registry file. For titles where data was not available, literature searches, weighted evidence approach, read-across and appropriate alternative methods were used; An additional work strategy was created in areas deemed necessary.

Simultaneously with technical studies:

• Safe usage conditions and exposure scenarios have been established
• Chemical Safety Report (CSR) was prepared
• Classification and labeling information harmonized with technical data
• Communication and data sharing process with MBDF members was managed
• Joint registration terms and cost sharing principles have been configured
• The leader file was transferred to KKS and underwent a comprehensive quality control process

14-month project schedule

Result

At the end of the project, the company:

• CompletedLeader Registration File in 1,000+ tone band
• KKDIK received the full registration number
• MBDF created the technical and administrative infrastructure where members can participate in joint registration
• Reduced recording and audit risks that may arise from data deficiencies
• Secured supply continuity of the substance in the Turkish market

This case demonstrates that a high tonnage Leader Registration process cannot be completed by simply entering data into the KKS; It shows that the topics substance identity, scientific data, chemical safety, MBDF management and data sharing should be carried out together.

ONAY Mühendislik manages the registration process from the beginning to obtaining the full registration number by handling KKDIK Lider Registration and MBDF management projects together with their technical, legal and operational components.

Related pages

KKDIK Consultancy Services · MBDF management · KKDIK statistics and counting method · KKDIK Registration Guide

Other project examples: ONAY Mühendislik case studies — lead registration, temporary registration, Only Representative and UFI–PCN projects.