For each substance all relevant data available in your organisation needs to be collected and evaluated for use in the registration dossier. You also need to find out whether you are entitled to use the data. The availability of data is to be checked against the data requirements to identify the data gaps and the costs to fill them is to be estimated.

After Pre-registration, a Substance Information Exchange Forum (SIEF) will be formed with other potential registrants to ensure that one substance is registered with one dossier and that animal test data will be shared.

The cooperation may lead to the formation of a Consortium, including formal agreements and budgets. For the information in the technical dossier as well as for the chemical safety assessment for substances classified as dangerous, the Regulation calls for an assessor with appropriate experience and qualifications.

Royal Haskoning experts can support you in these tasks, either in company or in a Consortium:

• Quality check of the available data
• Development of an approach to fill data gaps withcreative solutions
• Development of strategic testing proposals where needed
• Development of emission scenarios (including risk management measures)
• Chemical Safety Assessment and drafting of Chemical Safety Report
• Preparation of the dossier and entering the information in the IUCLID database

For more information please contact:

Froukje Balk

Telephone: +31 (0)24 328 45 59