The Globally Harmonised System of Classification and Labelling of Chemicals (GHS) has been introduced into the EU legislative framework under CLP Regulation No. 1272/2008. It is replacing the current guidelines under the Directives 67/548/EEC and 1999/45/EC. Regulatory authorities worldwide are beginning to use the GHS criteria and it is already being noticed that their interpretation varies in different parts of the world. Further to this, many chemicals which have not yet been assessed for reproductive toxicity will be tested under REACH, and cut-off criteria currently applied to agrochemicals may be applied to other categories of chemicals. It is important that industry has a clear position to contribute to the way chemicals are classified for reproductive toxicity.
ECETOC recently published guidance for the classification of chemicals with regard to the endpoint of carcinogenicity, which incorporated the concept of potency. This guidance has been well received. Building on the approach for carcinogenicity, a task force has been formed with the remit to develop guidance for the application of the GHS criteria to reproductive (developmental, fertility) toxicity that will include consideration of mode of action, potency and exposure.