Continued from page 11
In response to the issue of the cost of registration ECHA have suggested that companies use their automated registration system to reduce cost and also consider consortium working which essentially spreads the registration cost and risk amongst more than one company. In a single supply chain relationship of manufacturer and importer then consortium working makes sense. By coming together both producer and supplier can work jointly to reduce the burden of registration and share the costs. Where relationships work across supply chains then there is little realistic hope in competitors working together, sharing their intellectual property freely with one another and jointly registering chemical substances or mixtures. Common sense tells us that companies do not freely share their intellectual property with their competitors.
In assessing risk here are basically two approaches that regulators can take, one is to look at absolute risk such is the approach that the REACH regulation takes, and the other is to consider exposure limits. In the UK we look at Occupational Exposure Limits (OELs) in relation to the workplace. So if a chemical substance or mixture is injurious to public health then a pragmatic approach could be to look at the proportion of a chemical substance that is contained within a mixture and then consider the frequency and type of exposure a user would have to this substance or mixture.
If we take tobacco then the more a person smokes then the higher the likely risk of affecting their health although no level of smoking should be considered safe. Similarly within a chemical substance or mixture if a perceived injurious component makes up 0.0001% of the finished mixture and the public could be exposed to the mixture for 0.0001% of the time, then should this be perceived as carrying the same risk as a mixture containing 100% of an injurious chemical substance where the user would be exposed to this for 100% of the time? The answer is that it depends on what the substance or mixture is and so we need to take a proportionate and risk-based approach to restricting chemical substances looking at exposure levels and not absolute limits.
Finally there is the issue of appeals against the restriction or outright banning of chemicals by ECHA. Although there is an appeals process that is set out on ECHA’s website this appeals process is very much contained within the agency’s processes and systems. The Board of Appeal is comprised of three people as laid out in the Commission Regulation (EC) No 1238/2007 and they are all employees of ECHA. Although these appeal board members are said not to perform any other function in the agency there could still be the perception that employees of a body that decided in the first place to restrict or ban a substance have a conflict of interest if other of the agency’s employees are then asked to consider an appeal against the agency’s original decision. Surely it would be better for the panel to be completely separate from that of ECHA by, for example, being composed of people with no vested interest in the decision such as academics, professors or scientific experts from universities who might consider an appeal. Using employees of ECHA for appeals risks the process being less than open and transparent and to date as far as I understand it, no appeal against the restriction of a chemical substance or mixture has ever been successful.
As I mentioned in the beginning of my article, the principles of REACH are right and the aims of protecting public health and the environment are ones that no one can argue with, including me. What is more of an issue is the way in which the regulation has been set out using the precautionary principle and the way the regulation could affect or distort certain behaviours in the marketplace which may be an intended or unintended consequence. For REACH to be seen to be a fair and reasonable regulation, it needs to be proportionate, managed in an impartial manner and achieve its intended aim.
LINK
www.ukla.org.uk
LUBE MAGAZINE NO.144 APRIL 2018
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