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Reflections on a pragmatic approach to regulatory measures addressing risk from combined exposure – REACH as an exampleRIVM-KEMI workshop

5-03-2020Steven Van de Broeck | sva@cefic.be

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A workable methodological framework for all chemicals (COM, 2019)

• Need to have a holistic view• Retrospective and prospective action

need to go hand in hand– Retrospective actions supporting and

strengthening prospective actions – eg.advanced monitoring under the WFD

• Methodological consistency needed across EU agencies– At least on core assessment principles

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An intermediate measure?

• What is meant with an intermediate measure?– Scope and application are broad– How would one roll it out?

◦ New registrations?◦ Updates?

• Creating non-compliance situations?◦ What is assessed safe today would suddenly become unsafe?

• Once rolled out, it cannot be turned back• Consider guidance before legislation?

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Need to balance robustness and pragmatismro

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complexity regulatory response

low

high

challenging straight foward

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low

highTypical research area mixture projects

MAF approach?

Are multiple layers of worst-case assumptionsstill reprentative for the real life?

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Finding a better balance … few ideas

For example:• Use & exposure patterns• Systemic vs local effects• Likelihood of co-exposure at given

time and space• Human health <> environment

Getting more focus

A tiered assessment strategy

Refinement where possible / needed

Utilise outcomes of research projects

Increased knowledge baseFor example:• Use of monitoring data• Single substances driving mixture risks• Cases where single substance

assessment need to be complemented

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We’re not yet there, but …

Let’s work together to find a balanced, structured approach beyond REACH

Knowledge has significantly increased, let’s build on it and improve it further

Perfection is not attainable, but if we chase perfection we can catch exellence