On 18 December 2006, REACH (the Registration, Evaluation and Authorisation of Chemicals) became law in the European Parliament. After a year of debate, the EU framed its legislation so that the control of potentially harmful chemicals would be based on risk rather than hazard alone. This was especially gratifying for the RSC as we have been campaigning hard for such a distinction to be made in any legislation passed. In fact, further evidence of RSC influence can be seen in the form of words used in a key section of the legislation pertaining to authorisation - it reflects the exact wording used in RSC policy documents on the issue. The REACH regulation requires that chemicals be 'authorised' for specified uses in those cases where the perceived benefit is large in comparison to the risk. 

The RSC has closely followed the development of REACH over the past five years and has worked with other stakeholders including NGOs and industry. The RSC has also sought to influence the UK government's attitude to risk and precaution and gave written and oral evidence to the House of Commons Science and Technology Committee inquiry on scientific advice, risk
and evidence in February 2006. 

Hazard or risk?

When formulating the REACH legislation, several pressure groups were lobbying the EU to introduce hazard based approaches and use the precautionary principle rather than a risk based approach. Hazard is defined as the potential to cause harm; risk on the other hand is qualified by the likelihood of such harm to occur in any defined circumstances. 

The appeal of hazard based approaches is that they are easier to apply and administer. But such approaches may not result in safer outcomes because they do not deal with the likelihood of a particular hazard occurring. For example, one solvent may be less toxic than an alternative but may be of higher flammability, so how can we assess the overall hazard from each? 

Hazard based approaches that try to eliminate a particular substance may also run counter to sustainability. Substitutes with a lower hazard profile may also have to be used in greater quantities or may consume more energy in their production or use.

Precautionary approach

The precautionary principle was often evoked by groups lobbying for heavy regulation of the use of chemicals. The principle, as set out in the 1992 Rio de Janeiro UN conference on environment and
development, states that if a practice seems likely to harm the environment, even if proof of harm is not definitive, actions should be taken to eliminate or control the practice. 

Embedded within the precautionary principle is the idea that protection of human health and the environment is taken in advance, not after the potential for damage has occurred. Whilst this seems sensible, its application needs to be proportional to the risks involved. 

The issue that needs to be recognised is that the principle does not mean 'better safe than sorry' since its application can often have adverse effects. This can be seen in the banning of DDT which has lead to significant increases in deaths from malaria in some regions. Equally, banning brominated flame retardants could lead to more deaths from fire.

There is a danger that, by introducing the principle disproportionately, innovation will be stifled through the high costs that would be associated with introducing new materials, even if they turn out to be less risky than those already on the market.

Ideally society would like industry to develop chemicals that can deliver a desired property without negative side-effects. We want flame retardant clothes but not flame retardant chemicals with bio-accumulative properties.

In reality, when developing health and environmental policies, risk has to be the main consideration. To some extent all processes and chemicals are hazardous.

Risk and policy

During consultations on REACH it often seemed that European Government Agencies did not have a good understanding of the conceptual basis of health and environmental risk analysis, making serious discussion of individual points difficult.

Looking at issues surrounding chemical risk, campaigning organisations often make unsubstantiated claims that can distort the scientific discussion and make informed, evidence-based policy-making difficult. Their views are sometimes regarded as more credible and independent than industry or learned and professional bodies. It is claimed they do not have vested interests in a particular industry. But they often have a vested interest in a particular outcome.

Evidence from scientific experts on advisory groups is sometimes marginalised because they may not be considered 'independent' by virtue of industrial affiliations. But experts working in the
field are more likely to be up-to-date with developments than those who are not. In particular, it is industry that has the most in depth knowledge of how risk analysis takes place.

Unless good scientific and technical advice is taken into the policy making process, it will yield policies that are not technically feasible. Governments end up with inappropriate positions and unsatisfactory and unenforceable legislation.

Authorisation in REACH

The aim of the Authorisation process in REACH is to ensure that the risks from chemical substances of high concern are adequately controlled. Substances enter the process on grounds of their intrinsic harmful properties such as flammability, toxicity or corrosivity. The process is essentially a risk management process.  

All manufacturers, importers and downstream users applying for authorisation's to use substances of very high concern must analyse the availability of alternatives and consider their risks, and
the technical and economic feasibility of substituting the substance with another. If society has a need for the chemical and the risks from exposure are not unacceptably high, they can be deemed 'tolerable' on socio-economic considerations.

Where exposure to a substance cannot be controlled to 'broadly acceptable' levels of risk, further risk/benefit evaluation is required. But what constitutes an acceptable risk and when should one chemical be substituted for another?

An example of this dilemma was the introduction of non-toxic and non-flammable CFCs in the 1930's. These replaced refrigerants that were either very toxic to humans, such as ammonia, or were extremely flammable, such as propane. When the substitution took place, the impact of CFCs on the ozone layer was unknown. Once their effect was discovered some of the older high risk refrigerants were re-introduced.

Such an example highlights the complexity of assessing risk and the need for clear guidelines in the implementation of REACH. Without clear authorisation requirements, legal certainty can't be established. Furthermore the willingness of industry to develop business opportunities and investment in innovation could be eroded.

Substitution and balancing risk

Substitution is central to the Authorisation process. It should be a practical outcome of comparative risk assessment and evaluation. The aim is to optimise the choice of substances for a particular use, taking into account risks to health, wildlife and the environment and the benefits to society including sustainability issues.

Under REACH, the final substitution decision will be a value judgement on the balance of risk and benefit made by the new European Chemicals Agency which will be set up in Helsinki by June 2007.

Putting RSC policy into practice

In view of its acknowledged expertise in the practical aspects of chemical substitution, the RSC has been invited to become a member of the Stakeholder Expert Group helping to develop the Technical Guidance Documents for preparing a REACH application for authorisation.

Established over 20 years ago, the Environment, Health and Safety Committee (EHSC) is tasked with developing the RSC's position on the control and safe use of chemicals. This expert group's role is
primarily focused on promoting a balanced understanding of hazards and risks associated with chemicals.