Reaching out

BY NEIL EISBERG, EDITOR

Chemical regulation has been near or at the top of every chemical company’s agenda for the last couple of decades. The EU’s Regulation – Registration, Evaluation, Authorisation and Restriction of Chemicals, better known as Reach – was designed to provide protection for human health and the environment across the EU, which then included the UK. The regulation dates back to June 2007, when it came into force, and despite many concerns expressed at the time by the chemical sector in Europe and elsewhere, it has generally been judged a success although cost of registration etc has remained a major issue.

As the problem Reach addresses is common across the world, the EU’s approach was also studied and adopted elsewhere, in countries such as Korea for example. While the overall aims have remained the same, the details vary between the different implementations.

With the UK’s eventual departure from the EU, so-called Brexit, on 31 January 2020, following almost four years of negotiations after the referendum in June 2016, the UK chemical industry was told by the then UK Government that EU Reach would be superseded by UK Reach.

This UK version of Reach finally came into force on 1 January 2021, but has since been the focus for continued debate, ranging from the amount of information required for registration to the actual cost of that registration. Fortunately, there has been the opportunity to have existing EU Reach registrations recognised under UK Reach – so-called grandfathering – and the deadlines for this have been extended by three years to October in 2026, 2028 and 2030, depending on the tonnage and toxicity of the substances concerned.

One of the major criticisms from the chemicals sector concerning EU Reach was the expected cost involved in generating the data required for substance registration. For the grandfathering of EU registrations into UK Reach no further registration fee was required to be collected by the UK Health & Safety Executive, the authority responsible for administering UK Reach, which also took over the functions of the European Chemicals Agency (ECHA).

A key requirement for the operation of UK Reach has been the establishment of a database of registered substances, similar to that established by ECHA. The internal Digital Data and Technology Services department of the UK Department for Environment, Food & Rural Affairs (Defra) has been developing the UK Reach IT system, which it is claimed by the UK Government, will operate ‘very much like’ like the system developed by ECHA, ‘with the same software requirements’ and processes. In October 2019, the UK Government revealed that the cost of establishing the UK Reach IT system had been £14.32m. The Government also estimated the cost of running the UK Reach system at around £13m/year.

UK Reach has been the subject of much debate, which still continues. There has, for example, been a long-standing call for a public consultation on an alternative UK Reach registration model. This call has now been answered with a government proposal for reducing the level of hazard information being required, with the introduction of a revised data set of use and exposure information.

A key discussion on chemical safety dating back to the introduction of EU Reach has involved the focus of chemical management and whether it should be based on the hazard, or the risk posed by a chemical substance. In the UK, the Chemical Industries Association (CIA), for example, has always supported a risk-based approach rather than hazard. The CIA sees that the task for the UK chemical sector is to examine the details of the UK proposals and ensure that the proposed legislation is workable. ‘The devil is in the detail’, says the CIA, echoing what was said when EU Reach was first proposed.

‘In a tough economic environment, we hope this announcement [of a public consultation] will signal future regulatory certainty which has been and remains a significant barrier for UK investment,’ says the CIA. ‘We also hope that the process – now started – can be continued and fully rolled out by any new government with pace.’

The impact on investment should not be underestimated and the parties in the UK’s recent general election have not provided the industry with the confidence required for a stable future. And many observers say it is not just regulation where the industry is looking for help. Paul Hudson – the CEO of Sanofi, the French based multinational pharma group – has highlighted patient access to new medicines as well as the failure to drive inward investment as key areas where the new UK government needs to focus its attention. He believes that prior to the general election, while the major political parties talked about making the UK attractive for investment, they failed to give clear indications about how they would bring this about.

It is to be hoped the new UK Government will now give this important issue the attention it deserves.