To gauge risks in using carcinogenic compounds without threshold level, REACH allows for applying qualitative methods to assess the likelihood of effects. In the "Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health" the Derived Minimal Effect Level (DMEL) is described as an assessment tool for this purpose. It transpired that there is a need for a European consensus on how DMELs can be more effectively used.

To further develop the discussion on this issue, the German Federal Institute for Occupational Safety and Health (BAuA) organized a workshop to initiate a more in depth discussion and the development of a common view on this matter. Objectives of this workshop were:

1. Evaluate the use of DMEL/risk relationships in recent registration dossiers.
2. Discuss DMEL/risk relationships that will be acceptable to all Member States.
3. Exchange views on possible integration of risk considerations into national regulations for occupational health, using the German "traffic light model" as an example.
4. Agree on the framework for a recommendation on behalf of Member State Competent Authorities (MSCA) to General Directorates for Employment on which risk levels should be considered acceptable

This workshop took place on 17 May 2011 at BAuA in Dortmund with About 50 participants from eleven EU member states. They represented the respective MSCAs, but also industry, industry associations, trade unions and the EU General Directorates for Employment, Enterprises and Environment.

The presentations are workshop are available here.

Programme (PDF, 99 KB)

History of German traffic light model (PDF, 774 KB)
Prof. Dr. Herbert. F. Bender, BASF AG Ludwigshafen, Germany

Minimizing exposure to carcinogens: Risk limits and their interplay with risk reduction measures (PDF, 64 KB)
Dr. Henning Wriedt, Beratungs- und Informationsstelle Arbeit & Gesundheit Hamburg, Germany

Carcinogenic risk assessment and evaluation in the upcoming REACH authorisation process (PDF, 105 KB)
Dr. Norbert Rupprich, Federal Institute for Occupational Safety and Health (BAuA), Germany

Risk considerations from Austria (PDF, 40 KB)
Derived Minimal Effect Levels (DMEL) in ECHA Guidance Documents (PDF, 159 KB)
Joe Püringer, AUVA Austria

Risk values in the Netherlands (PDF, 119 KB)
Nathan Kuper, MSc, MSHE; Ministry of Social Affairs and Employment, The Netherlands

"Real DMELs" - What do they look like (PDF, 200 KB)
Dr. Aart Rouw, Federal Institute for Occupational Safety and Health (BAuA), Germany

A closer look to DMELs and the German "traffic light model" (PDF, 80 KB)
Dr. Aart Rouw, Federal Institute for Occupational Safety and Health (BAuA), Germany