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Executive summary: Synthetic chemicals have become very much part of our lives. They may be seen to serve useful purposes and to bring substantial benefits to our lives and our health. At the same time, however, many are already known to possess dangerous properties while many more have never had their safety properly assessed. We should certainly not be indiscriminately exposed to chemical pollutants on an ongoing basis. Nevertheless, we are. Research into levels of industrial chemicals in the human body shows that we are continuously exposed to a large number of chemical pollutants.The fact that we are all continuously exposed to many different chemicals is because the law allows this to happen. European law is currently based on an assumption that there are ‘acceptable´ levels of risk, even from the most hazardous chemicals, and regulators determine acceptable levels of exposure from these risk calculations.It is further assumed that the quantity of substances that we are exposed to can be controlled through dilution and dispersion of chemicals throughout the environment. However, this assumption falls apart for chemicals which do not degrade, or degrade only slowly in the environment and which can bioaccumulate. Additionally, a surprising number of hazardous chemicals are used in consumer products and there is another, implicit, assumption that exposure to hazardous chemicals from consumer products and other dispersed sources, is negligible. Recent research suggests it is not.As a result of these assumptions we are all continuously, and quite legally, exposed to multiple and ongoing small doses of many different substances. As long as chemical regulation is based on this risk-based philosophy, human and environmental exposure to dangerous chemicals – ‘substances of very high concern´ – will continue. The ‘disperse and dilute´ model does not work for persistent bioaccumulative chemicals because Nature quite simply collects and concentrates these materials over time. What is needed is a shift from ‘permissive´ regulations based on attempted control of exposure and risk, to one based on prevention. The goal of chemicals policy should be the elimination of exposure to intentionally manufactured substances whose intrinsic properties give cause for high concern.European chemicals regulations are currently being completely overhauled and new legislation will be passing through Parliament in 2005. But the EU´s proposed new chemical policy does not as yet include measures that will move us away from a permissive regime. Although the framework (REACH) and mechanism (Authorisation) are there, as it stands, the draft legislation continues with ‘adequate control´ as the regulatory paradigm. Human exposure to what are considered ‘acceptable levels´ of exposure to chemicals that may cause cancer, or genetic damage, endocrine disrupting chemicals and substances that build up in our bodies, seems set to continue.We know there is a problem, what is the solution?The most important step towards a preventive regime, one that truly has protection of human health and the environment at its core, is to give a central place in chemicals legislation to the Substitution Principle. This can be defined quite simply as ‘the substitution of hazardous substances by less hazardous, or preferably non-hazardous, alternatives where such alternatives are available´. It means that if a product that uses a hazardous chemical can be manufactured using a safer alternative, at a reasonable cost, the hazardous substance will no longer be permitted for that use. Common sense? Yes, but currently things do not work that way, and many hazardous substances are used without need, simply because there is no legislative or economic reason for substitution to take place systematically.Is the Substitution Principle workable?Some companies are already using substitution as a means of eliminating hazardous chemicals from their businesses. (see Annex I) A variety of reasons exist for why some companies are searching for safer substitutes and these include regulatory drivers (such as the recent Directive on the Restriction of Hazardous Substances), increased public awareness, demands from downstream users or clients, worker protection, liability issues, competitive advantage and company ethics. However, there are also barriers and the development and adoption of safer substitutes is happening only slowly, in a piecemeal fashion and in some sectors not at all.For this reason, the Substitution Principle cannot be implemented to its full and necessary effect simply as a general policy statement within the regulatory framework, since this will be an insufficient driver for change. Instead it needs a clear mandatory imperative to drive it. Within REACH, this means that the Substitution Principle needs to be written into the authorisation procedure so that the availability of a safer alternative is sufficient grounds for an authorisation to be refused.A safer alternative is one that does not meet the requirements for a substance of very high concern as defined in the authorisation procedure of the REACH proposed regulation. Obviously, every effort must be made to select the least hazardous alternative within this universe of “safer” chemicals.‘Availability´ means the substitute must be available on the market and is defined to include an economic element (i.e. at a reasonable cost). It must also be technically effective and fit for the use to which the application applies. An alternative may be safer in that it does not meet the criteria for very high concern, but it may have other hazards such as corrosivity or flammability. These hazards are easier to control, but if there is a serious health and safety issue with a proposed substitute, that alternative would not be deemed an available alternative. When an application for an authorisation is made, the applicant should provide details of alternative substances, materials, processes or products currently in use(substitution plan). A comparative assessment of alternatives should be provided in order to justify the need seen by the applicant for authorisation to be granted. Other parties (e.g. manufacturers of potential substitutes) should be invited to respond to this Substitution Assessment.If the manufacturer, importer or user of a chemical of very high concern can demonstrate that no viable alternative is available, that there is need for the chemical (with a transparent socio/economic assessment) and that all steps are taken to minimise exposure, and therefore risks, from continued use of the substance, then a time-limited authorisation may be granted. A time-limited authorisation will both ease costs of a phaseout and encourage development of alternatives.This basis of this system is the presumption that a chemical of very high concern will be phased out unless the applicant can demonstrate that there is no safer alternative, there is a compelling reason for production to continue and that the risks can be controlled. Only in those circumstances would a time-limited authorisation be granted. Otherwise authorisations should be refused.
Num. pages: 40