IUCLID 6 – Dossier preparation for „Lead registrants”

upon request

Introduction to the current version of the IUCLID software tool and requirements for the preparation of a valid LEAD dossier in accordance with REACH. Information on data sharing and preparion of Letter of Access (LoA).

REACH basics for LEAD registrants

Brief introduction to REACH for LEAD registrants
Data request for a registration
Implementing Regulation (EU) 2016/9 on data sharing (Letter of Access (LoA))
Substance Identity Profile (SIP)

Working with IUCLID

• Preparation of a substance data set for LEAD Registrants
  • IUCLID Inventories (Reference Inventory, Test Materials, Literature References)
  • Data import/export
  •  Registrant-specific information:
    • chapter 1: Identity of the Registrant, substance identity, Analytics
    • chapter 3: Inforamtion on manufacturing and handeling of the substance
  • Substance-specific Information:
    • chapter 2: Classification and Labelling (in accordance with CLP), PBT/PMT assessment
    • chapters 4-7: Simple and qualified study summaries for physico-chemical, toxicological and ecotoxicological endpoints and environmental fate
    • chapter 11: Guidance on Safe Use
  • Preparation of Chemical Safety Report (CSR)
  • Data protection/Confidentiality
  • IUCLID plugins
• Preparation of Dossier
  • Upload of the Dossiers via REACH-IT to ECHA
• Tips and pitfalls

Contact information

Bianca Leubner
Telefon: +49 341 223 292 36
E-Mail: aca_campus@aca-pharma.eu