UKCA and UK REACH – Post-Brexit Regulatory Capacity Under Pressure

UKCA and UK REACH were designed to replace functions previously supported through European systems. The record shows repeated timetable changes alongside unresolved questions about testing capacity, chemical data and specialist staff.

The Post Brexit Regulatory Transition

At the end of the Brexit transition period on 31 December 2020, the UK began operating two regulatory systems intended to take over functions previously performed through European institutions.

UKCA, the UK Conformity Assessed mark, was intended to become the British equivalent of the European CE mark used to show that regulated products met applicable safety requirements. UK REACH became the domestic system for registering and controlling chemicals previously covered through the EU’s REACH regime.

Neither European system disappeared from British commerce immediately. Transitional arrangements allowed manufacturers to continue using CE marking and gave chemical companies time to provide information required under UK REACH. Those arrangements were supposed to provide a route towards separate British systems.

What followed was a series of extensions and policy changes on both sides. The documentary record raises a common question: whether the laboratories, specialist staff and legal rights to chemical safety data needed to operate the two regimes had been available on the scale their original timetables required.

Challenges in UKCA Testing Capacity

UKCA conformity assessment was designed to resemble the process already used for CE marking. Where regulations required independent assessment, however, manufacturers would use UK Approved Bodies rather than the European organisations used for CE certification. Approved Bodies were listed on the government’s UK Market Conformity Assessment Bodies database.

That made the number and capabilities of those organisations important. A legal requirement for third-party certification is useful only if manufacturers can obtain the required service.

The UKMCAB register shows particularly thin provision in some specialist, high-risk product areas. Pyrotechnics provides one example. The number of bodies listed to perform relevant conformity-assessment work is small, and one of the Approved Bodies appearing in the records, CERTRUST Inspection and Certification Ltd, has its registered test location in Budapest, Hungary.

CERTRUST can appear as an Approved Body for the UK regime while the registered testing location recorded by the government’s own database is outside the United Kingdom.

Available register data does not establish how many product categories depended entirely on overseas facilities, nor whether UK-based testing could be obtained for every product within a listed category. It does show why physical capacity mattered. The government could establish the rules governing UKCA assessment, but the laboratories themselves were supplied largely by private organisations that had to invest in equipment, expertise and accreditation.

No pre-launch audit establishing how much domestic testing capacity existed against the requirements that would eventually become mandatory has been identified in the material reviewed for this investigation.

Economic Impact of UKCA Conformity Assessments

When the Department for Business and Trade later announced indefinite recognition of CE marking for many products, it presented the change as a substantial saving to business. The figure attached to the policy was £640.5 million over ten years.

The Regulatory Policy Committee’s March 2024 opinion on the department’s Impact Assessment shows how that figure was constructed. The comparison was not between the new policy and the system businesses were already operating under. It was measured against a ‘do nothing’ counterfactual in which mandatory UKCA requirements would take effect.

In other words, the £640.5 million represented expenditure businesses were expected to avoid once the planned transition to mandatory UKCA marking was changed.

Some of the individual costs were substantial. Material assembled for the assessment process put third-party conformity assessment at roughly £500 to £5,000 per product. Estimates for product marking and relabelling were between £11,500 and £20,000 per product, covering such changes as packaging, technical documentation and manufacturing arrangements.

The Regulatory Policy Committee also identified a significant assumption in the department’s modelling. The assessment treated the cost of conformity assessment as the same under CE and UKCA and, according to the committee, would have benefited from further justification for doing so.

That leaves a gap in the published record. Earlier drafts of the assessment, produced before the August 2023 decision to recognise CE marking indefinitely, have not been made available. It is therefore unclear whether the department modelled alternative outcomes before changing the previous UKCA timetable.

Chemical Data Access Issues for UK REACH

UK REACH encountered a different capacity problem.

Chemical regulation depends not only on legislation and regulators but on data. Registrations can require extensive information about toxicity, environmental effects and other hazards. Much of the information used by companies under EU REACH formed part of registrations held through the European Chemicals Agency.

After Brexit, the UK retained requirements for chemical safety information but did not retain general legal access to the European database containing the underlying registration material. Companies could therefore need rights to use data again when supplying it for the British system.

By 2024, DEFRA’s consultation on an Alternative Transitional Registration model put the estimated cost of acquiring the data required under the original approach at approximately £2 billion by 2030. Its uncertainty range was £1.3 billion to £3.5 billion.

Industry also warned that companies might withdraw products from the British market rather than pay to obtain data rights for a second regulatory system. The issue was especially awkward because companies could have participated in generating or purchasing the same data for their European registrations while still lacking the right to reuse it freely for UK REACH.

DEFRA began reconsidering the original approach. In December 2021 it announced that it would explore an Alternative Transitional Registration model. The later proposal reduced the amount of hazard information that companies would have to submit directly to the British regulator.

What remains unavailable is the model behind the headline £2 billion estimate. The published material gives the midpoint and the £1.3 billion to £3.5 billion range, but not the underlying dataset or calculations that produced them.

Scientific Expertise Challenges Post Brexit

National Audit Office figures recorded apparently rapid growth inside the Health and Safety Executive’s Chemicals Regulation Division, which was responsible for substantial parts of the post-Brexit chemicals workload.

Between September 2020 and March 2022, staffing in the division increased by 46 per cent.

Headcount alone did not describe the expertise available. Parliamentary records cited in the supplied material show that the division had fifteen toxicologists, scientists who assess how chemicals can harm humans or other living organisms. Six were established toxicologists and nine were early-career staff.

Rapid recruitment also carried a substantial training burden. Across 2021 and 2022, 25 per cent of staff time in the Chemicals Regulation Division was spent training new recruits.

Increasing total staffing was not the same as increasing experienced scientific capacity, particularly when UK REACH gave the British regulator work previously supported by a much larger European system.

The confirmed figures already establish the pressure created by recruitment and training. A division whose overall workforce had risen by 46 per cent was simultaneously devoting a quarter of its staff time to bringing recruits up to speed, while its specialist toxicology workforce numbered fifteen.

The supplied material does not establish why experienced toxicologists left or why more could not be retained. HSE exit-interview records covering the relevant period have not been made available here.

Policy Shifts in UK Regulation Timelines

Changes to UK REACH and UKCA accumulated over roughly the same period.

In December 2021, DEFRA announced that it would explore an alternative registration model for UK REACH. The decision came after the emerging dispute over the cost and practicality of reproducing chemical safety data within the British system.

On 14 November 2022, the government changed the UKCA timetable. CE-marked products would continue to be accepted on the Great Britain market until 31 December 2024, adding another two years to the transition.

A larger change followed on 1 August 2023. The Department for Business and Trade announced indefinite recognition of CE marking across eighteen product regulations.

On 24 January 2024 the policy was widened again, extending indefinite recognition across twenty-one regulations and bringing in areas overseen by DEFRA and the Department for Energy Security and Net Zero.

UK REACH continued moving in the same direction. On 16 May 2024, DEFRA opened its consultation on the Alternative Transitional Registration model. Registration deadlines were also pushed further back, with deadlines falling between 2029 and 2031 depending on the relevant tonnage and hazard category.

The sequence is documented. The published record does not show that ministers made each policy change because of any single one of those constraints.

Source Box

Sources include: the Department for Business and Trade’s UK Market Conformity Assessment Bodies database and CERTRUST Inspection and Certification Ltd CAB profile; the Regulatory Policy Committee’s 2024 opinion on ‘The Product Safety and Metrology etc. (Amendment) Regulations 2024’; DEFRA’s 2024 ‘Consultation on UK REACH’ and Alternative Transitional Registration model material; the National Audit Office’s 2022 ‘Regulating after EU Exit’ report; parliamentary records on UK REACH and Chemicals Regulation Division staffing; and Department for Business and Trade announcements and guidance covering extensions and continued recognition of CE marking.