Classification and Labelling - Background
Classification identifies potential 'hazard', not 'risk'
The purpose of classification is to identify the hazardous intrinsic properties of substances. It is important to remember that hazard is different to risk.
Chemicals are fundamental to our everyday lives. Not only are they the basis for the fertilisers, pesticides and food additives that improve our nutrition and for the pharmaceuticals that benefit our health, they are also essential for the production of many of the man-made materials on which our standard of living now depends.
Through constant research, industry endeavours to ensure that the use of such chemicals in end-products does not adversely effect our health and safety or the environment. In the case of phthalate plasticisers, more than €110 million has been spent on research during more than 40 years of safe production and use making phthalates one of the best evaluated groups of substances.
A significant part of this research addresses the intrinsic properties of chemicals, e.g. their possible adverse physical, health or environmental effects.
The manufacture, transportation and use of chemicals in Europe is closely regulated at national and EU level and the volume of such regulation has increased rapidly in recent years. In 1967 the EU established a classification and labelling scheme for substances (DSD), which in 1988 was extended to preparations (DPD). Classification and Labelling is one component of the EU chemicals management and applies to existing and all new chemical substances and preparations.
The classification of substances is based on establishing the possible adverse effects of their intrinsic properties, their hazards - by the use of tests and evaluating the results of those tests against standards or criteria. It is only when the intrinsic properties meet the criteria that chemicals are deemed to be hazardous. The specific objective of this is to enable the establishment of any necessary protective measures required (e.g. safety gloves) during normal handling and use.
There are two basic concepts that need to be considered here, hazard and risk. Some relevant definitions from ISO 11014 are:
Harm: Physical injury and/or damage to health or property
Hazard: A potential source of harm
Risk: The probable rate of occurrence of a hazard causing harm; and the degree of severity of the harm
Safety: Freedom from unacceptable risk of harm
It is commonly accepted that Hazard x Exposure = Risk
In Europe, much but not all the relevant legislation we face is based on the classification, which is hazard based.
One of the consequences of classification is labelling, which requires a pictorial representation of the main hazards of a chemical and a series of statements, inappropriately named "Risk Phrases", stating its hazards. Both are designed to provide immediate information to users, in the same way that road signs are used to inform drivers of traffic hazards and regulations.
Risks are identified separately at different stages in the manufacturing and use life cycle according to numerous Directives and ultimately as part of the European Risk Assessment process. Here the focus is on the likelihood of coming into contact with the substance (exposure).
Classification has no effect on articles containing such substances and these do not have to be labelled.