Exposure-based waiving: Concrete specifications of the waiving-conditions in the context of the registration procedure according to REACH

Project Report

In October 2003 a proposal for a Regulation concerning the registration, evaluation, authorisation and restriction of chemicals (REACH) was presented, that sets forth which information is to be provided in the framework of the registration procedure for substances. Within the framework of REACH, several provisions are made to avoid conducting specific tests if this is sufficiently justified. The exemption from conducting individual tests is termed „waiving“ in REACH.

As „exposure-based waiving“ one means here the exemption from the conducting of studies according to Annex VI, when the justification for the waiving is based on the fact that there is no relevant exposure of humans and environment to the substance to be registered. Up until now there is no legally certain definition or criteria, as to what is meant concretely for the condition „no relevant exposure“. In the Proposal for a Regulation in Annexes VI, VII and VIII, depending on the specific place in the text, different terms are used for a waiving on the basis of the exposure („no relevant exposure“, „limited exposure“, „no exposure“, „no significant exposure“, „unlikely exposure“). Hereby exposure means the contact of humans or the environment with a substance (see here also Section 3). For completeness, also in Annex IX exposure-based waiving is considered. Risk management measures, which influence the exposure, are mentioned in several places in the REACH-Regulation proposal.

In a joint research project the Bundesumweltministerium (BMU) and the Verband der Chemischen Industrie (VCI) has now concretely specified in a working group with further experts, what is meant by non-relevant exposure – with support of the Öko-Institut e.V. in cooperation with the Forschungs- und Beratungsinstitut Gefahrstoffe (FoBiG) and the Institute Ökologische Netze.

By analysing 17 example substances the experts worked out the respective exposure situations and discussed concrete criteria for “non-relevant” exposures supporting the waiving of test requirements. Further it has been examined whether such waiving conditions could be implemented in practice.

In the human toxicological area high priority was given to dealing with the question, under which conditions the 28-day-toxicity test can be waived, as an example of a test with repeated application.

Beside the Öko-Insitut further experts of the VCI and its member enterprises have worked in the project, the Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA), the Umweltbundesamtes (UBA) and the Bundesinstitutes für Risikobewertung (BfR), the Bundesministeriums für Wirtschaft und Arbeit (BMWA), the Beratergremiums für Altstoffe (BUA) and the Sachverständigenrates für Umweltfragen (SRU) took part in the project.