KKDİK Technical Dossier Services

One Step Ahead in KKDİK (Turkish REACH) Registration

The KKDİK (Turkish REACH) Registration process is both complex and time-consuming, requiring the creation and submission of a technical dossier to the Ministry of Environment, Urbanization, and Climate Change (MoEU).

Key Aspects of KKDİK Registration:

  • Two registration types: Individual and Joint submissions.
  • Comprehensive dossier content:
    • Physicochemical, toxicological, and ecotoxicological properties.
    • Human and environmental exposure details.
    • Intended uses, classification, and labeling.
    • Proposed risk management measures.

Lisam’s KKDİK Registration Technical Dossier Services

  • Data Gap Analysis: Identify missing information required for KKDİK compliance.
  • Expert Consulting: Support from LISAM’s certified KKDİK chemical safety assessors.
  • SIEF and Consortia Management: Coordination when required.
  • Literature Search: Locate existing data for substances of interest.
  • Study Evaluation: Review and rate study reports using Klimisch criteria.
  • Data Analysis: Compare data against KKDİK requirements to pinpoint key studies and gaps.
  • Robust Summaries: Prepare summaries for KKS, including Derived-No-Effect-Levels (DNELs).
  • Data Filling Strategies: Address gaps using:
    • KKDİK-compliant testing.
    • Exposure scenarios and waiver arguments.
    • (Q)SARs, extrapolation, and read-across data.
  • IUCLID 5 Dossier Creation: Complete dossier preparation and submission to MoEU.

✔ Does your checklist have three or more unmet needs?

Lisam Systems is the solution you've been searching for!

📩 Request a Quote today and let our experts guide you through the process with precision and expertise.