In an Expert focus article for WaterBriefing, Philip Gaffey, Managing Director of Gaffey, UK-based specialists in the design and manufacture of advanced in-situ chemical generation and blending systems for the global water treatment market, takes an in-depth look at the impact of Brexit on biocides regulation and the risk for the water sector supply chain.

Philip Gaffey: Since Brexit, the regulatory landscape governing biocides in Great Britain has become progressively more complex. For those responsible for water treatment and disinfection, that complexity is starting to translate into a genuine supply-chain risk.

Much of the conversation has centred on the introduction of the GB Biocidal Products Regulation (GB BPR). Less attention has been paid to the equally pressing issue of Article 95 compliance, and what happens if the paper trail of an active substance is far from watertight.

For manufacturers, distributors and end users across the water treatment sector, documented evidence has transitioned from administrative routine to the very core of accountability.

A different framework

GB BPR exists because the UK’s departure from the EU meant Great Britain could no longer rely automatically on EU-wide biocides decisions. The Health and Safety Executive now administers a self-contained system; its own active substance evaluations, its own authorisation processes and its own Article 95 list of approved suppliers. In principle, GB BPR mirrors its EU predecessor closely. In practice, the two frameworks have diverged, and continue to separate, as HSE works through its own review programme at its own pace.

That split is the root of most of the confusion. Products, suppliers and active substances that were compliant under EU BPR are not automatically compliant under GB BPR. Two parallel systems now exist, and an organisation operating across both jurisdictions must satisfy each on its own terms.

The pace of change has added a further layer of difficulty. HSE is still working through its own review programme, meaning active substance approvals, Article 95 listings and product authorisation decisions are being issued on a rolling basis rather than all at once. A supply chain that is fully compliant this quarter can find its position altered by a listing update the next, simply because the regulator has reached that particular active substance in its review sequence. For an industry that’s lived with the relatively stable EU framework, the rolling uncertainty is itself a new operational reality to plan around.

What’s causing the confusion?

A great deal of the uncertainty in the sector stems from assumption rather than fact. Many organisations that built their compliance processes around EU approvals have assumed those approvals would simply carry across. That’s not the case; GB BPR and EU BPR maintain separate Article 95 lists, separate reviews of active substances, and separate regulatory rulings, so a supplier’s presence on one list says nothing about their status on the other.

This has been compounded by speculation about the standing of certain technologies under the new regime, on-site generation methods such as electrochlorination among them, with some in the sector questioning whether the underlying chemistry remains recognised at all.

HSE’s own confirmations tell a different story: active chlorine generated from sodium chloride by electrolysis remains notified within the GB Review Programme. But the speculation itself has been enough to unsettle confidence, and it illustrates just how quickly the smallest gaps in published guidance are soon filled with assumptions.

What it means for end users

Photo: Gaffey Technology Hyprolyser® installation at Canada’s largest YMCA in Seton, Calgary

For operators, facilities teams and specifiers, the practical implication of Article 95 is straightforward and easily overlooked; a biocidal product, or the active substance generated by an in-situ device, cannot legally be supplied or used in Great Britain unless every active substance involved can be traced back to a supplier on the GB Article 95 list.

Depending on the technology, that obligation can sit with the salt manufacturer, the equipment manufacturer, or the end user themselves.

That means the questions to ask any water treatment partner have changed; does the organisation appear on the published GB Article 95 list, or hold a valid Letter of Access (LoA) that supports its inclusion? Is that status current, given the list itself is subject to ongoing review? And where claims are made about compliance, is there evidence behind them, or simply reassurance? None of this is unreasonable due diligence, it’s the minimum required to establish that a product can legally remain in use.

It’s also worth being clear about what Article 95 does not require. It isn’t a product performance standard, and it says nothing about how effective a disinfection technology is at controlling pathogens or biofilm.

A technology can be entirely fit for purpose technically and still be unsupportable commercially if the active substance behind it cannot be traced to a listed, LoA-holding supplier. Conflating the two, treating regulatory listing and technical performance as the same, is one of the more common errors end users make, and one that a straightforward supplier conversation can usually resolve.

Verification as risk management

This is where the supply-chain risk becomes tangible. An organisation that has not verified the Article 95 status of its active substance suppliers has no way of knowing whether its water treatment products are compliant, until something forces the question; a regulatory review, an audit, or a supplier losing its listed status without warning.

For those specifying water treatment technologies, including on-site electrochlorination systems such as Gaffey’s Hyprolyser® iSEC®, verification needs to move earlier in the process, into procurement and specification, rather than being treated as something to confirm after installation.

That means requesting documented evidence of Article 95 status or LoA coverage, understanding where the responsibility for compliance sits within the supply chain, and building in periodic re-checks rather than treating compliance as a one-off tick-box exercise. Supply chains that were compliant eighteen months ago are not guaranteed to be compliant today.

Who’s responsible?

Responsibility for demonstrating compliance rests primarily with manufacturers and distributors, the organisations putting products and systems on the market. For technologies generating active substances in-situ, that means securing and maintaining a Letter of Access independently, rather than relying on a third-party’s status, and being able to evidence that position clearly and readily when asked.

It is also worth restating plainly what HSE’s confirmations already establish: electrochlorination remains a recognised, compliant technology under GB BPR. The uncertainty in the sector has largely concerned process and paperwork, not the underlying legitimacy of the approach. Responsible manufacturers, including ourselves, have responded by investing directly in their own LoAs rather than depending on suppliers further up the chain, a step that both protects customers from exposure further downstream and gives the manufacturer more direct control over sourcing.

We have followed through on that commitment directly. The GB Article 95 list sets out approved suppliers for each active substance/product type combination permitted in biocidal products under GB BPR, and Gaffey (as a device manufacturer) is listed as a Product Supplier. Because our systems generate the active substance on-site, each one is backed by an accepted dossier or Letter of Access, meeting Article 95’s data submission obligations without relying on assurances further up the chain. For end users, that means no disruption should a regulatory review come knocking.

A simpler approach

Two years into GB BPR’s operation, the case for a more accessible, better signposted compliance framework is growing harder to dismiss. Much of the current confusion lies in a lack of visibility. Article 95 lists are published, but not always easily interpreted by those outside a regulatory affairs function. LoA requirements are well understood by manufacturers with the resources to track them, less so by smaller distributors and end users managing compliance alongside everything else.

Whether that responsibility for simplification falls to HSE, to industry bodies, or to manufacturers taking a more proactive role in educating their customers, is an open question.

What’s less in doubt is that supply-chain verification, once a background administrative task, now sits squarely within the risk management responsibilities of anyone specifying, supplying or operating water treatment technology in Great Britain. Confusion is manageable. Compliance that remains unverified is not.

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