DEHP Information Center

Hazard vs Risk

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 will probably 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.

For more information please refer to the Cefic publication "Risk and Hazard - How they Differ" published in September 2003.

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 European Chemicals Bureau has decided that DEHP should be classified as Category 1B reproductive toxicant. This means that 'based on clear evidence in animal studies', DEHP should be regarded 'as if it impaired fertility and/or caused developmental toxicity in humans'.

As part of its 'Responsible Care' programme, industry had already been classifying DEHP as a Category 3 reproductive toxicant since 1994.The EU authorities have now chosen to interpret the available data more conservatively and classify it as category 1B.

A Category 1B product requires the display of a 'skull and crossbones' symbol, rather than the previous 'St. Andrew's Cross', 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 substances are no more dangerous than previously, either in a preparation or as part of a finished article.

Under the Marketing and Use Directive, a Category 1B 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 DEHP 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 February 2000 the World Health Organisation's International Agency for Research on Cancer (IARC) downgraded 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.