FOR many, chemical policy is abstract. Since the European Union's flagship policy on chemicals, the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, made it onto the statue book in 2006, chemical campaigners have largely decamped to Brussels, and Helsinki, home of the European Chemicals Agency (ECHA). As a result, there have perhaps been fewer stories in the press about the risks of particular chemicals, fewer public campaigns directed at UK consumers, and perhaps a corresponding falling away of public awareness and concern.
But quietly, companies have been working hard to comply with REACH, the world's most ambitious and far-ranging chemicals regime. Its ambition cannot be denied: the creation of a database, which sits within ECHA, which identifies the health and environmental risks associated with every use of every substance that is used within Europe, and manages the risks of the most dangerous.
At the moment, we aren't even sure how many substances are used in Europe. Under REACH, manufacturers of substances are required to submit registration dossiers outlining the scientific data that establishes their characteristics and properties in the various different ways they are used. This is then used to generate classifications and instructions for safe use, and regulators draw from the information to identify which substances should be targeted for more rigorous action.
To manage the workload, registration has been staggered. Larger volume substances were registered in 2010, mid-volume substances in 2013, and niche chemicals must be registered in 2018. So far, around 10,000 substances have been registered, but there could be as many as 35,000 by 2018, although estimates vary. Failure to register means substances can no longer be placed on the market.
The amount of new data that is being generated is staggering. And unfortunately, carrying out work of this nature means, in some cases, animal testing. To minimise the need for animal testing, companies were compelled to work with their competitors to submit joint registration dossiers and to fill data gaps. Indeed, they have to continue to update and work on their dossiers to reflect any new developments and scientific research that may have any bearing to the classification and use. Understandably, this has not been easy and these groups are underpinned by complex legal contracts outlining how the group works together; who owns which data; how costs will be shared; and who has responsibility for coordinating the work.
And here lies the unenviable problem faced by UK legislators - UK chemical manufacturers have invested millions into registration (a recent survey by the Chemicals Industries Association indicated two-thirds of its members have already each spent in excess of £1m [US$1.25m] on registration), many own core data sets used in registration dossiers, and some are acting as lead registrant. Will this work have been in vain? Will it have to be replicated in order to create a UK REACH database at a very high cost? Is the UK market sufficiently big to justify the cost? We have seen some suppliers withdraw substances from the market in the EU because the cost of registration was more than the substance's economic value. This could spell trouble for the functioning of some UK supply chains.
There are further questions around some of the other really important elements of REACH: restrictions of high-risk chemicals and the authorisation process, a de-facto ban of certain chemicals unless companies can make a compelling case that they can use the substances for uses which have significant economic and social advantage to society, but within acceptable limits. Questions here range from whether these controlled conditions will still apply post-Brexit, to whether companies will still need to apply for authorisation to continue to use substances after a specific date.
The message from industry, NGOs and academics has been clear: despite ongoing concerns about REACH's complexity and indeed, how it operates in practice, the majority want to retain or mirror REACH and the systems that support it.
For industry, access to the single market remains the priority. For NGOs and academics, REACH is seen as a robust and ambitious framework for managing chemical risk. But politically this is problematic – especially when it comes to accepting decisions on controversial substances without access to the data that underpins them. Would the UK government accept that? Would the devolved assemblies in Scotland and Wales agree?
There are many unanswered questions. So many, in fact, that the Environmental Audit Committee is currently running an inquiry looking specifically at the future of UK environmental legislation. On 7 March, Therese Coffrey, the minister with responsibility for chemicals policy, gave the clearest indication yet of the government's current thinking. She confirmed that the UK cannot continue to be in REACH because it is overseen by the European Court of Justice, future UK jurisdiction of which has already been firmly rejected by the prime minister. The UK will have its own working chemicals regime from day one of Brexit and it will follow the REACH registration, authorisation and restriction process. Primary legislation may be used. The Health and Safety Executive will probably design the new registration system and it could cost 'at the extreme end' tens of millions of pounds, primarily funded by industry. She also confirmed the UK might then diverge from the EU.
So in short, the government won't just convert the Regulation and then leave it – it intends to use powers under the Great Repeal Bill to set up a UK version of REACH. Furthermore, businesses could see themselves hit with a second round of additional, significant compliance costs to replicate the work they have already done.
With the Brexit clock now officially ticking it is clear it will be difficult to be sure of the framework for REACH without the context provided by some of the higher political issues, such as the nature of our future relationship with the EU and the Customs Union. We may even see the EU demand we comply with REACH as part of our planned Comprehensive Free Trade Agreement (CFTA).
But there remains a risk we could face a regulatory cliff edge on chemicals if it does not feature in the CFTA. Legislators will have to be nimble to respond to developments. We won't have the luxury of the 12 years that REACH negotiators enjoyed to develop a UK version of the 505-page regulation. We will also need guidance, advice, decision-making bodies, and a secure database from day one. And this must be done with sufficient engagement from industry, NGOs and the scientific community to get it right.
More than anything we need clarity and soon. As it stands, to paraphrase Douglas Adams, all we have at the moment is rigidly-defined areas of doubt and uncertainty.
Susanne Baker is head of the environment and compliance programme at techUK.
techUK, Chemical Watch and the NGO Chem Trust are organising a conference on 25 May in London that will explore the UK's options for REACH, considering views from both sides of the negotiating table, analysis from trade experts and concerns from industry and civil society.
This article was first published at www.businessgreen.com
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