A hazard does not necessarily put you at risk
Hazards and the risks associated with them are everywhere, but
when known measures can be taken to minimise or eliminate risk.
When we go up or down stairs it is possible that we might fall, but
the likelihood is that we will not. Stairs are a hazard, the
likelihood of injury is known as the risk. The latter is often
expressed as a fraction like 1 in 100 or 1 in a million.
Everything we do exposes us to hazards. However, it is HOW we do
things that determines the risk.
It is also the case that some hazards are only significant if we
do something in large amounts or for long periods of time. Drinking
too much water can cause the brain to expand and kill you, but it
is unlikely that many of us would ever drink the amount necessary
over a short period of time. Smoking one cigarette in your life
will not have much of an effect. Smoking 60 a day for 40
years may lead to developing some kind of respiratory problem,
if not worse.
We often assume, quite wrongly, that natural products or
processes are better for us than man-made ones. But standing in the
sun for too long is much more harmful than listening to a mobile
phone. And whilst you'd have to drink a vast amount for it to be a
problem, a single cup of coffee contains more carcinogens than most
of the synthetic substances we ever encounter.
In the United States Ethyl Alcohol is classified as a
reproductive toxicant. Drinking wine or other alcoholic beverages
may be beneficial in moderation, but if consumed to excess they can
have adverse effects on health.
The first rule of toxicology is that all substances produce an
effect, but it is the dose that decides whether the effects are
adverse or beneficial.
The European Union's classification process
The European Union's classification and labelling process is
designed to indicate the hazard of chemical substances, not the
statistical risk they may pose through normal, or even extreme,
use. The hazard's 'critical end-point' is determined from the
effects obtained in high dose animal studies which are designed to
give conservative results so as to afford protection to all sectors
of the population, rather than an assessment of realistic exposure
levels from everyday handling or use of the product.
Using this conservative methodology the Classification and
Labelling Working Group has decided that BBP should be classified
as Category 2 reproductive toxicant. This means that 'based on
clear evidence in animal studies', BBP should be regarded 'as if it
caused developmental toxicity in humans'.
A Category 2 product requires the display of a 'skull and
crossbones' symbol upon the labels of vessels containing the
substance. This merely reflects the more conservative
interpretation of the data, not that the risk has changed.
Indeed, the substance is no more dangerous than previously,
either in a preparation or as part of a finished article.
Under the Marketing and Use Directive, a Category 2 product is
likely to be considered for restriction from sale to the general
public unless a case is made that a specific use in a preparation
is both necessary and safe. This will not affect BBP because it
only ever reaches consumers as a constituent of finished articles
which do not require labelling. The industry's own regulatory
practice has meant that most requirements with respect to workers
handling the substances have already been met.
It is worth remembering that this hazard labelling is based upon
tests that involve administering high doses of the substances to
animals over prolonged periods. Under conditions of normal handling
and use human exposure never reaches these levels. Furthermore,
ECPI doubts whether effects observed in rodents during these tests
with phthalates would occur in primates and is currently trying to
establish if this is the case.
It would not be the first time that such variation in
mechanistic effects between species had been observed. In 2000 the
World Health Organisation's International Agency for Research on
Cancer downgraded another phthalate, DEHP, from 'possibly
carcinogenic to humans' to 'unclassifiable as to its
carcinogenicity to humans', recognising that the mechanism causing
cancer in rodents was not relevant to primates.