Classification and Labelling

Classification and Labelling of some phthalates for reproductive effects

Three phthalates, di(2-ethylhexyl) phthalate (DEHP), di-n-butyl phthalate (DBP) and butylbenzyl phthalate (BBP) are classified in the European Union as reproductive toxicants.

Chemicals that are classified in this way means that they are potentially hazardous if not used carefully. But it does not necessarily mean they pose a risk. Indeed, scientific risk assessments on all three of these phthalates have shown there is no risk to the general population from any of these substances under normal use.

In March 2001, the European Commission adopted a proposal by the Classification and Labelling Committee to classify DEHP as a category 2 reproductive toxicant for both fertility and developmental effects. Similarly it decided that DBP should be classified as a reproductive toxicant in category 2 for developmental effects and category 3 for fertility effects.  

The necessary amendments to the Dangerous Substances Directive were agreed on August 7, 2001 and published in the Official Journal of the European Community on August 21. The directive required that the new labelling be introduced by no later than July 30, 2002.

BBP was clasified as category 2 for developmental effects, category 3 for fertility effects and as dangerous to the environment in June 2004.

As a result of the classifications, containers and preparations containing 0.5% or more DBP, DEHP and BBP now have to carry a label with the skull and crossbones symbol and the appropriate risk phrases. There is no requirement to label finished articles such as PVC flooring, leathercloth etc.

It is important to note that these labelling changes are not the result of new information regarding the toxicology of phthalates but because, under the EU Council Regulation 793/93, data on the potential hazards of a substance have to be passed on to the Classification and Labelling Committee at the time that a substance is being risk assessed.

The Dangerous Substances Directive 67/548/EEC specifies the hazard classification, packaging and labelling requirements for dangerous substances based on their intrinsic properties. The aim being to ensure that users and handlers take appropriate measures.

Due to evidence from scientific studies, ECPI members had been labelling DEHP and DBP as toxic to reproduction, category 3, since 1994. Both substances therefore already carried the St Andrew's Cross and so the changes in working practices required by the change to category 2  will not be great.

It is also important to remember that :

  • The classification and labelling system is based on existing data found only in high concentration studies on animals and describes the inherent properties of the chemical substance. The properties of a substance should not be mistaken for actual risk, which depends on what you do with a substance and how you handle it. Labelling sets the frame for good working practices and suitable protection measures. It may still be used safely in the work place and any risks associated with its use will be assessed on the basis of hazard and exposure in the usual manner.
  • Articles made of flexible PVC or some other polymer, containing these phthalates, should not be labelled and their sale is not restricted.
  • ECPI believes that granules of PVC compound are virtually fully processed and do not need to be labelled but they should be accompanied by a safety data sheet because they may be heated, extruded, reshaped etc. However these activities are all carried out by professionals - the general public is not involved.
  • Plastisols are not processed, hence in our view they are preparations. They are normally only sold to professional users who convert them into finished PVC articles. We do not know of any situations where plastisols are sold to the public.
  • Adhesives, paints, and printing inks, etc containing these phthalates are preparations and thus may not be sold to the general public. However, they may be sold to professionals.

For more details on classification and labelling please refer to the following sources: