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
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
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
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
3. On what basis was
the decision made?
The decision was based on toxicological evidence found by tests
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
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
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
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
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