Completed Task Force

Guidance for classification of reproductive toxicants under GHS

Health Sciences Manager Christa Hennes

Administrative Assistant Christine Yannakas


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.

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, it is recommendable to develop guidance for the application of the GHS criteria to reproductive toxicity, whilst recognising the differences between reproductive toxicity and carcinogenicity. Many chemicals which have not yet been assessed for their potential in this area 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.

Related publication

Article: Guidance for the classification of carcinogens under the globally harmonised system of classification and labelling of chemicals (GHS). March 2010. McGregor D, Boobis A, Binaglia M, Botham P, Hoffstadt L, Hubbard S, Petry T, Riley A, Schwartz D, Hennes EC. Critical Reviews in Toxicology 40, 3, 245-285. - doi:10.3109/10408440903384717

corrigendum note to above article: doi:10.3109/10408444.2010.511521