Responding to Europe's New Chemical Control Regulation

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EU REACH Project Management Tool

Step 1: Develop a Scope of Work

Overview: The work to be performed must be clearly defined so that: (1) minimum vendor qualifications can be developed, (2) all bidders have a common understanding of the project, and (3) the selected vendor can be held accountable for their performance.

Process: Presented below is a list of tasks that may be needed under REACH. A particular project may require one or more combinations of these tasks. Each task has been described in general terms. More detailed descriptions are included in the downloadable Scope of Work (SOW) documents.

Choose one or more of the following tasks for your project and/or develop your own list. Task descriptions should be modified as needed. Click on each link to view a sample portion. Become a registered user to download editable versions.

Choose the task you need or create your own

The vendor will provide all labor and materials necessary to:

Task 1: Third Party Representative - Serve as "Third Party Representative" for each substance listed by the buyer, as further detailed in SOW-1.

Task 2: Consortia Participation - Represent the buyer in one or more consortia, as further defined in SOW-2.

Task 3: Consortia Management - Provide administrative, accounting, and legal support to form and manage a consortium of companies that share a common interest in ensuring compliance with the REACH regulation for each of the substances listed by the buyer, as further detailed in SOW-3.

Task 4: Sameness Determination - Review SIEF member's confidential information to determine the sameness of substance(s), as further detailed in SOW-4.

Task 5: Data Availability / Needs Assessment - Assist buyer in determining what data and information is presently available and what data and information will be needed for each substance listed by the buyer, as further detailed in SOW-5.

Task 6: Substance (Q)SAR and Read-Across Evaluation - Assess and propose (Q)SAR and read-across opportunities for each substance listed by the buyer, as further detailed in SOW-6.

Task 7: Data and Cost Sharing Negotiation - Assist buyer in defining and negotiating data and cost sharing terms and prices for each substance listed by the buyer, as further detailed in SOW-7.

Task 8: Prepare IUCLID Endpoint (Robust) Study Summaries - Compile available chemical, physical, hazard information and prepare (robust) study summaries for each substance listed by the buyer, as further detailed in SOW-8.

Task 9: Data Evaluation and Testing Proposals - Perform a thorough evaluation of existing data available for each substance listed by the buyer and develop a testing proposal, as further detailed in SOW-9.

Task 10: Use & Exposure Information - Compile use and release / exposure information for each substance and each user listed by the buyer, as further detailed in SOW10.

Task 11: Risk Management Measures and Operational Conditions - Compile feasible risk management measures (RMM) and operational conditions (OC) for each substance listed by the buyer, as further detailed in SOW-11.

Task 12: Initial Exposure Scenarios - Develop initial exposure scenarios for each substance and each use listed by the buyer, as further detailed in SOW-12.

Task 13: Exposure Assessment and Risk Characterisation - Complete an exposure assessment and risk characterisation for each substance listed by the buyer, as further detailed in SOW-13.

Task 14: Prepare Technical Documents - Prepare the following technical documents using the information compiled by the vendor and/or supplied by the buyer for each substance listed by the buyer, as further detailed in SOW-14 (select only those that apply).

  • Chemical Safety Report
  • Technical Dossier (All Sections for Lead Registrant)
  • Technical Dossier (Only Sections for Assenting Registrant)
  • Mapping / Scaling Recommendations for Extended Safety Data Sheet

Task 15: Test Plan Management - Manage all laboratory testing required for each substance listed by the buyer, as further detailed in SOW-15.

Step 2: Prequalify Your Bidders

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