Development of a Technical Guidance Document for preparing the Chemical Safety Report
(REACH Implementation Project 3.2-2)
Commissioned by:
European Commission
Carried out by:

Co-operation partners:
Federal Institute for Occupational Safety and Health (BAuA), Federal Institute for Risk Assessment (BfR), DHI Water & Environment, European Plastics Converters (EuPC), Ökopol GmbH, RIVM, TNO Chemistry, German Environmental Protection Agency (UBA)

June 2006 - August 2007
The future new regulation on "Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)" puts responsibility for the safe manufacture, import and use of chemicals throughout the chemical supply chain on industry. For substances manufactured or imported in quantities above 10 t/a and actor, substance manufacturers and importers are required to conduct and document a chemical safety assessment (CSA). This shall comprise an assessment of intrinsic hazards and, if the substance fulfils the criteria of being dangerous, an assessment of exposure and risks is also required with the purpose of documenting the safe manufacture and use. The increased emphasis on CSA and communication regarding safe use of chemicals in the supply chain requires a major build-up of competence throughout industry.
Objectives and tasks
This project has two main objectives:
  • To further develop the exposure scenario concept, its use for quantitative exposure assessment and its incorporation in safety data sheets; and
  • To develop the guidance document for preparing the CSA and documenting it in the CSR.
The project is divided into three work packages. The first work package consists of case studies in four industry sectors, aiming at creating exposure scenario examples and testing a framework guidance developed in the scoping phase (RIP 3.2-1). The second work package aims at refining the exposure scenario concept and further developing methods and tools for specific issues within that. In the frame of the third work package, issues related to substances in articles will be clarified, the TGD will be tested by industry and the final version of it will be drafted.
Expected results
It is expected that the end product will be a two-level Technical Guidance Document (TGD); a 'concise TGD' for less complicated cases and applicable by persons/companies with limited risk assessment experience and a 'reference TGD' providing scientific background for cases where such is needed and where expert knowledge is required.
Dirk Jepsen