PCS.08 Risk assessment versus risk management – is there a role for legislation? Yes

Abstract

Classification and labeling of substances and preparations within the EU is made in accordance with the criteria as written out in Directive 67/548/EEC (‘the substances directive’) and Directive 1999/45/EC (‘the preparation directive’ setting general concentration limits for preparations containing substances classified under 67/548). The basis for the criteria concerning hazard for skin sensitisation is based on practical experience showing that the substance or preparation is capable to induce a sensitization by skin contact in a substantial number of persons (appropriate patch testing or epidemiological data); or where positive tests from appropriate animal testing are available. Recently at the EU level and currently continued at the OECD, there is an expert discussion on the appropriateness to make potency considerations of skin sensitisers. The experts evaluate the possibility to set specific concentration limits for induction skin sensitisers contained in preparations. These limits would then give the possibility to classify such preparations better mirroring the reality than the current general limits given in the preparations directive. The first measure to prevent the hazard when a chemical or preparation fulfills the criteria to be classified as a skin sensitiser, is through the labeling indicating the standardized risk phrase: ‘May cause sensitization by skin contact’, which also must be followed with an adequate safety advice. The classification of a substance has further consequences in other legal instruments on EU level leading to additional risk management measures.