Classification & Labelling
Butylbenzyl phthalate (BBP) is classified in the European
Union as a Category 2 reproductive toxicant for developmental
effects, as a Category 3 toxicant for fertility effects and as
dangerous for the environment.
However, consumers can remain assured that its use in everyday
products does not pose a health risk and that the
classification does not prevent the continued safe use of this
plasticiser.
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.
Furthermore, this calssification is based on effects seen
only at high exposure levels in rodents, the relevance of which to
humans is questionable. Indeed, 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 another phthalate, DEHP, as non-carcinogenic in
2000.
Considerable research into phthalates, including BBP, is ongoing
and will hopefully lead to an understanding of the mechanisms
underlying the reproductive effects seen in rodents, their
relevance to humans and, if appropriate, a change in the
classification.
A detailed risk assessment of BBP in all its applications is
being carried out by EU Member State experts in line with the
requirements of Council Regulation 793/93/EEC. It is anticipated
that this will be completed by the end of 2005. At present no risks
to consumers or workers have been identified.
The proposals to classify BBP were made by the Commission
Working Group on Classification and Labelling in September 2002
(Health) and June 2002 (Environment) and were published in the
Official Journal of the European Union on June 16, 2004 (L
216, vol 47, pages 3-310)
Now that these proposals have been ratified and published there
will be a requirement for drums and small containers of BBP, and
preparations containing 0.5% or more, to carry appropriate
labelling which will include the skull and crossbones symbol.
The new labelling requirements are expected to be introduced by
respective EU Member States prior to the deadline of 31 October,
2005. To ensure consistency of labelling within the European single
market, the producers of BBP therefore began labelling from
November 1, 2004. Copies of the new safety data sheets have been
provided by suppliers.
"It is important to remember that BBP has been used as a
safe and effective plasticiser for nearly 50 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 findings of the EU risk assessment."
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