Position paper

Warnings on chemical hazards CLP – the EU implementation of GHS

In this document EDMA makes recommendations to in vitro diagnostic medical device (IVD) manufacturers to address a number of issues with regard to device label adaptation which arise over the implementation of the Global Harmonised System for Labelling and Classification of Hazardous Chemicals (GHS). It has been prepared on the assumption that most IVD manufacturers place on the market preparations (mixtures) rather than substances.

IVDs are specifically exempted from the scope of the Regulation 1272/2008 on Classification, Labelling and Packaging of substances and mixtures (CLP Regulation) in order to allow the use of GHS through the specific provisions applicable to IVD labels which are outlined in the IVD Directive 98/79/EC. The current labelling regime of hazardous substances and preparations in IVDs is defined by Directive 67/548/EEC and Directive 88/379/EEC (repealed by directive 1999/45/EC).

Despite this explicit exemption, the CLP Regulation does have an impact on IVD manufacturers.