Some questions you might be asking

The EU Classification and Labelling Working Group (CMR) agreed on September 23, 2002 to recommend that BBP be classified as category 2 for developmental effects and category 3 for fertility effects.

The EU Classification and Labelling Working Group (Environmental Effects) proposed on June 11, 2002 that BBP should be classified as dangerous for the environment and should therefore carry the dead fish and tree symbol

   1.   What does a category 2 classification mean and what is the impact?

A category 2 classification means that the substance, when packaged or stored, has to be labelled with a skull and crossbones symbol. However, it should be remembered that this is a symbol of potential hazard and not of risk. The classification is intended to provide guidelines for safe handling during "occupational use". There is no requirement to label finished articles containing the phthalates and neither is there any suggestion that the continued use of such phthalates in finished articles is unsafe.

A category 2 classification also restricts substances to professional use. i.e. they cannot be sold in their original form, or mixtures (>0.5%) to the general public. Since this practice does not occur in a significant way it should not affect existing business practices.  

   2.   Does this mean that manufacturers of products containing BBP now have to
         label them with the skull and crossbones?

Finished PVC products - such as flooring, cable compounds and cable, sheeting etc, are "articles" and are therefore not labelled.

Preparations such as plastisols or sealant intermediates on the other hand are to be labelled accordingly and are restricted to "professional use" meaning that they cannot be sold to the general public.

    3.    On what basis was the decision made?

The decision was based on toxicological evidence found by tests on rodents.

However, adverse effects were seen only over prolonged periods and at extremely high exposure levels - many times higher than is experienced on a daily basis in the workplace or any other environment. It is therefore expected that the final Risk Assessment will not call for significant new risk reduction measures.

It is still unclear whether these data have any relevance to humans but the Classification and Labelling Working Group made its recommendation without waiting for this relevance to be demonstrated.

The new classification is not based on data or effects that were hitherto unknown but is the result of a more precautionary interpretation of the existing data by regulators.

BBP has been used for nearly 50 years around the globe without any documented effect on human health.

   4.   When does this classification take effect?

The decision was announced in the EU Official Journal on June 16, 2004. Member States have until October 31 2005 to introduce the new labelling requirements into their national laws. However, to ensure consistency within the European market, manufacturers began labelling from November 2004.

   5.   Classification as Category 2 impacts on worker safety. Do manufacturers have
         to put in place new standards so as to protect workers?

It appears that in practically all cases the requirements are already being met. 

Most plasticiser users have used category 2 and 3 chemicals, including some phthalates, for many years and are in compliance with existing EU and national regulations.

   7.   Do employers have to substitute BBP?

For substances in categories 2 and 3 the Chemical Agents Directive 98/24 and Directive 92/85 EEC requires employers to carry out a risk assessment and identify such measures as personal protection and ventilation that may be required. Only if these measures do not help to comply with the occupational limits, other measures such as a change of production procedures must be considered.