IHS Chemical Week


Risk Versus Hazard; EU Requires a Fundamental Rethink of Risk Policy

4:03 AM MDT | September 26, 2011 | By RAGNAR LOFSTEDT

Opinion Article by Ragnar Lofstedt PhD, Professor and Director, Kings Centre for Risk Management Department of Geography, King’s College, London.
Since the early 1970s with the formation of environmental regulatory agencies in many European states, there has been growing debate about how best to regulate chemicals including metals, food additives and preservatives.
The debate has centred on whether regulations should be based on a hazard classification (that is the potential for a substance, activity or process to cause harm or adverse effect) or a risk assessment (a combination of the likelihood and the severity of a substance, activity or process to cause harm).
It is commonly accepted that flying on a plane is a potential ‘hazard’ to passengers especially under difficult weather conditions. However, planes are generally considered to present an acceptably low ‘risk’ to passengers as it is the means of transportation with the lowest number of accidents.
The key component of this debate is whether regulatory decision-making can/should be based on hazard classification alone, eschewing risk assessment. From an economics perspective, decision making on the basis of just hazard classification usually ignores impact assessment, which is a distinct factor and in so doing often contributes to poor regulatory policy-making.
In Europe there has been a rather long and at times acrimonious discussion, as to the merits of risk assessments for regulatory purposes especially with regard to chemical substances. There is no European consensus of when to use risk assessments and when to use hazard classifications. Often, positions are partially due to the culture and history of the country in question, leading to wide discrepancies between Member States and between regulatory agencies within Member States.
Austrians, for example, are much more comfortable using hazard assessments than risk assessments when it comes to regulating genetically modified foods than in Spain. Similarly, the Swedes are more comfortable calling for bans for chemicals based on hazard assessments than, for example, the UK. 
Basing regulations on hazard assessments can exclude ‘real world’ information about the real likelihood of harm. If hazard-based regulation were widely implemented, it could lead to the banning of a wide array of substances, ranging from petrol, to cars, even to computers!
One of the main problems with hazard classifications is that they are only one initial part of the risk analysis – policy makers can take the decision to ban certain chemicals and metals on the assumption or idea that they may be hazardous without testing whether this is actually the case.
Many officials in the European Commission are concerned about this too, recognising that a hazard-based approach takes away the scientific rigour of risk assessments. They also allow regulations to be de-facto based on the cultural norms, emotions and histories of certain Member states. 
Risk assessments carry more regulatory certainty than hazard assessments – they examine the weight of evidence as to whether a risk actually exists – and they often provide a quantitative indication of the probability of various outcomes, including a characterisation of the severity of these possible events. 
Currently, multiple actors at different member state and European levels are pushing their own views and opinions of how regulations should be formed, resulting in the passing of bans/directives and regulations that are at times hazard based and at other times risk based.
What is needed is a fundamental re-think of European risk policy to ensure that, as we go forward, it is based on the best available science. It is also important: to educate stakeholders and the public on what a risk assessment actually is; to ensure that risk assessments and other underlying scientific arguments are based on appropriate peer review; to promote European-wide media guidelines; to improve the risk communication capacity and competencies of regulators in Europe; to increase the scientific competency of the European Parliament.
The regulation of chemicals and food is never easy and it is too fundamental to let it be politicised. I hope that these suggestions will contribute to the development of legislation that is more scientific and risk based.

Comments (1) for Risk Versus Hazard; EU Requires a Fundamental Rethink of Risk Policy
As a gardener I'm frustrated by the continuing EU bans on certain chemicals approved in the US (i.e. which pass their stringent risk-assessed criteria) and I find myself gravitating toward political views impatient of further European integration.
God help us all - if this goes on I'm going to vote UKIP!
No, obviously not, but there is definitely a problem.
Posted by Rupert Rankin on Saturday, April 19, 2014 @ 05:38 AM

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