Carcinogenic substances: risk-based concepts for limiting exposure in Europe

Status:

completed 10/2016

Aims:

Since 2005, a concept has been under development in Germany for limiting occupational exposure to carcinogenic substances. The concept aims for exposure to be reduced, irrespective of the particular substance concerned, to the risk of disease that is deemed "acceptable" or "tolerable" by social policy. A somewhat older Dutch model served as a basis during development of the concept. At the same time, a risk-based concept was produced in Poland for the regulation of carcinogenic substances at the workplace.

The German "risk concept" is still at the trial phase. For a range of relevant carcinogenic substances however, the AGS Committee for Hazardous Substances has already defined exposure-risk relationships. The possible consequences of these relationships for risk management are currently the subject of heated discussion.

Before the risk concept is adopted in whole or part in the German body of regulations, it appears constructive for the criteria and results to be compared to arrangements of a similar kind already in place in a number of other European countries.

Activities/Methods:

In conjunction with the Dutch Health Council in the Hague and the Central Institute for Labour Protection in Warsaw, the Dutch, Polish and German risk models were to be compared. Plans are for a table to be produced showing the substances for which at least two of the three countries have identified a risk of cancer at exposure concentrations relevant to workplaces, and for the reasons for any discrepancies to be investigated. A further objective was the production of an outline of current developments in other European countries (Switzerland, France) and at the European Chemicals Agency with regard to the regulation of carcinogenic substances.

Results:

Risk-based concepts, differing in their statutory relevance, are found in Poland, the Netherlands, France and Germany. At the present time (end of 2016), over 50 risk-based atmospheric limits have been formulated in Poland for carcinogenic agents and over 30 in the Netherlands. In Germany, exposure-risk relationships have been published. In 2012, France began publishing the "Valeurs toxicologiques de référence sans seuil". In Germany, clear target risk levels are specified the violation of which triggers certain measures; in Poland and the Netherlands, target corridors have been agreed. In France, the atmospheric concentrations of specific substances corresponding to certain risks have been calculated and published for guidance purposes. The methods employed for risk assessment are comparable: the results of epidemiological or animal trials are extrapolated for the most part linearly to the workplace dosage range. In Germany in particular, the trend is for a health-based limit to be set where possible, provided the specific mechanism of action permits an adequately reliable prognosis that observance of this limit value does actually prevent cancer being caused by the substance. The "reference dose-response relationships", which are not legally binding, published by the Committee for Risk Assessment (RAC) of the European Chemicals Agency constitute a completely new development. The IFA has reported on these relationships in several articles in journals. A number of modifications to the IFA project were necessary in the course of its term. The "Overview of methodologies for the derivation of Occupational Exposure Limits for non-threshold carcinogens in the EU" was published online in 2014 by the RIVM in the Netherlands on behalf of the responsible ministry. The consortium was consulted in advance of its publication. Essential content had already been published by other parties. The results compiled by the consortium were presented in a keynote address at the annual conference of the Austrian Society of Occupational Medicine (ÖGA) in 2016 at the invitation of the ÖGA.

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