Classification and Labelling

Although DEHP is classified in the European Union as a Category 2 reproductive toxicant for both fertility and developmental effects consumers can remain assured that its use in everyday products does not pose a health risk.

The classification, which requires Category 2 substances and mixtures containing the substance (preparations) to carry a skull and crossbones label, is designed purely to indicate the hazard properties and not the risks it may pose through normal use. There is a wide range of substances used in the manufacture of finished products that are similarly labelled.

The labelling indicates how substances should be properly handled as a raw material in the manufacturing process. Finished products containing such a substance do not have to be labelled.

The classification was agreed by the European Union on January 25 2001 and is based on effects seen in rodents when fed with very large amounts of DEHP - quantities many hundreds of times higher than would normally ever be ingested by human beings. Once an effect has been seen - regardless of the level - then on a precautionary basis they have to be considered as having the potential to cause such effects.

For DEHP the classification meant very little change as the plasticiser has already been classified by industry as a category 3 substance (requiring the St Andrews Cross label) since 1994. Therefore the requirements for manufacturing and processing workers to be properly protected when handling it, and for premises to be properly ventilated, were already being applied.

"It is important to emphasise that DEHP has been used as a safe and effective plasticiser for more than 40 years without a single known case of it ever having caused any adverse health effects," said Dr David Cadogan, Director of the European Council for Plasticisers and Intermediates (ECPI).  "Its continued safe use is supported by the many industries in which it is used including the medical industry where it is a vital component of life-saving devices.

"We must also remember that is still very uncertain whether reproductive and fertility effects that have been seen in rodents are even relevant to humans," said Dr Cadogan, "There are some very distinct species differences that have to be taken into account."

It was on the basis of species differences that exist between humans and rodents that the World Health Organisation's International Agency for Research into Cancer (IARC) confirmed DEHP as non-carcinogenic (ECPI Press Release, February 2000).