Speciality Chemicals Magazine NOV / DEC 2026 | Page 23

BIOCIDES deadlines currently run to 31 December 2027, while the recent statutory instrument has postponed the expiry of certain active substance approvals until July 2031.5

Although these measures address different stages of the regulatory process, the disparity highlights the need for clarity over how outstanding product applications and associated transitional market access will be managed beyond 2027.

Without further clarification, businesses face continued uncertainty over the regulatory pathway and timescales for products awaiting full GB BPR authorisation. These overlapping timelines provide some short-term continuity but little certainty over the longer-term regulatory pathway.

Other practical challenges also remain unresolved. The Article 55 amendments provide targeted flexibility, but the broader essential-use reforms have not been fully implemented.

Another challenge is the increased scrutiny we have encountered from the HSE regarding COPR applications, which continues to create difficulties for applicants. Based on our experience and the updated guidance, there is no clear indication of a return to the more straightforward precedentbased approach previously applied to comparable products.

What this means in practice

For industry, the developments of the past four months present a mixed picture. While SI 2026 / 484 has addressed the immediate expiry risks for qualifying active substance approvals, uncertainty remains over the future regulatory framework, transitional arrangements and treatment of applications already affected by divergence between GB and EU assessments. Until the SPS agreement and its implications for GB

BPR are confirmed, applicants must continue planning around existing requirements, assessment backlogs and transitional arrangements.

In our experience, this uncertainty is increasingly influencing investment decisions. While regulators encourage innovation, the development of new active substances already involves substantial costs, and businesses are understandably reluctant to invest further while facing prolonged assessments, uncertain regulatory requirements and increasingly difficult routes to market.

Greater scrutiny of COPR applications compounds these pressures, making it harder for companies to commit resources to new product dossiers, testing and authorisations. Innovation cannot flourish when businesses lack the regulatory certainty and financial confidence needed to invest, risking stagnation in product development and leaving companies increasingly reliant on existing portfolios.

Consequences for business

The consequences are particularly significant for businesses that depend on revenue generated under transitional arrangements to finance their transition to full GB BPR compliance.

Difficulties securing continued market access can undermine the income needed to fund the very testing and dossier preparation required to achieve authorisation, creating a cycle in which regulatory barriers make compliance increasingly difficult to finance. These pressures are compounded by the ongoing geopolitical situation, which is contributing to supply chain disruption, rising raw material and transportation costs and further commercial uncertainty.

Moreover, these challenges are not confined to GB. Many businesses operate across multiple international markets, facing additional regulatory obligations and costs, while encountering similar assessment delays and uncertainties under EU BPR, albeit within a framework progressing at a different pace from GB BPR. The cumulative burden makes investment and innovation increasingly difficult to justify, particularly for smaller businesses.

Dynamic alignment may ultimately reduce duplication between GB and EU regulatory requirements and establish a more coherent framework, but it offers little immediate certainty and cannot, in itself, resolve the wider commercial and regulatory pressures facing industry. Businesses need clarity on transitional market access, outstanding applications, the intended handling of historic regulatory divergence and implementation timelines to make informed investment decisions.

Ultimately, providing businesses with a clear, predictable and commercially viable pathway through the transition will be just as important as the reforms themselves. ●

NOV / DEC 2026 SPECCHEMONLINE. COM

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