Regulation of chemicals (Part 2)

Risk management within the new UK REACH framework

Part two of our mini-series on the regulation of chemicals, regulators and policy makers focused on UK REACH – a new framework of chemical regulation in the UK post-Brexit. We discovered how it will go about tackling the UK’s first ‘substances of concern’ – lead ammunition and tattoo inks – and the highly complex challenge of per- and poly-fluoroalkyl substances (PFAs) or ‘forever chemicals’.

UK REACH (Registration, evaluation, authorisation and restriction of chemicals) came into being on 1 January 2021. Though all existing EU REACH regulations were brought into UK law, a gradual divergence between the two has begun. While able to use EU REACH templates, UK REACH has the power – and responsibility – to go it alone when regulating chemicals as concerns their effect on human health and the environment.

It’s a case of much remaining the same – the shared processes and reciprocal, cooperative relationship between Department for Environment Food and Rural Affairs (DEFRA), the Health and Safety Executive (HSE) and Environment Agency (EA) are a bedrock of the new REACH, for example. The panellists weren’t concerned that chemical regulation would be weakened. 

About the panellists

Ruth Wilkinson, chair of the Hazards Forum technical advisory committee, introduced Jack Blandy, policy lead for the UK REACH Work Programme at the DEFRA, and Claire Massey and Richard Dean, both senior specialists in the Chemicals Assessment Unit of the EA, who work closely with the HSE.

Jack coordinates the process for identifying and prioritising activities in UK REACH, working closely with the EA and the HSE, devolved administrations, and external stakeholders.

Claire leads on restrictions under UK REACH, is responsible for the environmental aspects of restriction proposals and contributes to regulatory management options analyses (RMOA) and substance prioritisation.

Richard leads on environmental risk management considerations in applications for authorisation under UK REACH, and on certain RMOAs, including the latest one that will cover PFAs.

Jack Blandy summary 

Jack spelt out the process now in place for regulating the use, manufacture, selling and importation of chemicals in the UK.  He’s the lead on the UK REACH Work Programme which will articulate the roles of the HSE and EA, and is expected to be published later this year.

UK REACH regulations are intended:

  • To provide a high level of protection of human health and the environment from the use of chemicals.
  • To make the people who place chemicals on the market (manufacturers and importers) responsible for understanding and managing the risks associated with their use.
  • To promote the use of alternative methods for the assessment of the hazardous properties of substances.

UK REACH’s work includes; new registrations, processing applications, evaluating testing proposals, compliance checks, and, importantly, providing advice to companies through its helpdesk.

But this is all in addition to its vital proactive risk management work; identifying and analysing substances of very high concern.

How to restrict a ‘substance of concern’

Jack explained how the lengthy restriction process begins with DEFRA, or ministers of state in England and the devolved nations, identifying and prioritising a ‘substance of concern’ – lead ammunition, for example, because of the harm it causes wildfowl and to humans who eat game contaminated with shot.

  • The HSE / EA investigate and prepare a restriction dossier within a year, which is followed by a 6-month public consultation, a risk assessment and an assessment of the socio-economic impact of restriction.
  • There may be further public consultation before the HSE/EA gives a final opinion and the government makes a final decision.
  • The restriction is drawn up, and then the World Trade Organisation has to be informed that the UK is introducing a barrier to trade.
  • Then follows legislation and usually a transition period to allow those affected to adapt to the change.

It’s also resource intensive, Jack explained, because the burden of proof is on the government, rather than industries. The case for regulation needs to be thoroughly demonstrated, which needs more trained staff at the HSE and EA.

Jack recommended the HSE website as a good first source of information about risk management under UK REACH. See HSE information on UK REACH (https://www.hse.gov.uk/reach/brexit.htm)

Claire Massey summary

Claire discussed the first two restriction dossiers being prepared by UK REACH: lead ammunition and tattoo inks/permanent make-up. 

Lead poisoning is of particular concern to wildfowl; it’s thought that between 50,000 – 100,000 birds are killed a year due to exposure to lead shot. And there are human health concerns (particularly to children), from eating game contaminated by lead shot.

While there are partial restrictions on the use of lead shot on foreshores, and a ban its use when shooting ducks, geese and swans, evidence suggests compliance is low.

This is one area where there has already been divergence between EU and UK REACH; restrictions on the use of lead in all EU wetlands was introduced earlier this year and consultation has started on a complete EU-wide ban on the use of lead in all shot and fishing tackle.

Work on the UK REACH dossier began on 29 April 2021, aiming to ensure consistency across England and the devolved nations. Claire said: ‘The EU’s proposals will be used in preparing our case’.

The dossier will assess the hazards, consider particular exposure risks in the UK, and consider if and what restrictions are needed.

UK REACH dossier two was launched on the same day and deals with tattoo inks and permanent make-up – which are not subject to any regulations controlling their composition. It’s a risk to human health that needs to be addressed urgently. Again, the EU REACH is a step ahead, having introduced regulations just after the UK’s exit. This includes the exclusion of inks including carcinogenic and mutagenic substances, and labelling and information requirements.

Claire explained how the dossier needed to cover the scope of any restrictions, and possible derogations from them.

Richard Dean summary 

The ‘forever chemicals’ used in everything from non-stick pans to fire fighting and cosmetics were the topic of Richard’s discussion.

He’s using a regulatory management option analysis (RMOA) to consider PFAs. RMOAs help authorities clarify whether regulatory action is necessary for a given substance and to identify the most appropriate measures to address a concern.

He said: ‘We need to give the appropriate authorities enough information to let the government make informed decisions about what action to take.  We can decide what works best for the UK, starting from the EU process. There will be some to-ing and fro-ing until we get the right process.’

There was a need to identify and limit the scope of restrictions, he said, so they were manageable and enforceable; many thousands of individual chemicals could be classed as PFAs, and some were already restricted or covered by a ‘whole host of existing directives’:

‘It also includes voluntary schemes – there are lots of options outside REACH and REACH aims to avoid double-regulating chemicals.’

Some of the questions to be asked include:

  • Can the chemicals be grouped together?
  • What are the hazards of the group as a whole?
  • Do they bio accumulate?
  • What is their toxicity?
  • What are the uses?
  • What are the emissions?
  • What leads to concerns – production, use, disposal?

Richard said: ‘The key part of the process is to see what less risky alternatives there are to these chemicals – we’re looking at them through their entire life cycle.’

He said the UK REACH would recommend the most appropriate measures to take forward and it would probably be for the government to take a decision next year.

Q and A 

Asked how regulators engaged with stakeholders who may hold strong views on issues, the panelists agreed that stakeholder involvement was important to UK REACH because, as Jack explained, ‘As well as getting views, it’s about getting evidence.’

While groups have strong views that a substance – such as lead ammunition – should be further regulated, there are often vocal opponents to change. Claire said: ‘We are evidence based so we welcome views from both sides, based on fact and evidence rather than anecdote.’

UK REACH holds informal discussions with industry groups and non-governmental organisations. Umbrella groups can apply to become accredited stakeholders, which will allow them to observe meetings. Jack said: ‘We want to make the process transparent’.

Asked about the working relationship between DEFRA, the HSE and the EA, Jack said:

‘What’s important is the separation of the policy and evidence teams. We meet up and discuss scope but there does come a point where we ask HSE and EA to look at an issue. We need to take a step back and let the scientists do the work.’

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