How to manage hazardous substances with changing policy and regulatory demands: Where to spend your resources
Matthew Lambert, managing director, and David Lever, technical director, at RPA look at why early engagement, robust evidence and strategic prioritisation are essential for chemical companies to retain market access * al stages in the development of chemical regulatory initiatives
Chemical regulation in Europe continues to evolve at pace. Over the past decades, regulatory frameworks such as REACH have significantly reshaped how substances are assessed and managed.
At the same time, new initiatives and policy priorities continue to emerge, ranging from large-scale restriction proposals to increasing scrutiny of substances used across multiple sectors and new initiatives such as Safe and Sustainable by Design( SSbD).
The outcome of the REACH review is overdue, and the policy landscape discussions continue on Generic Risk Assessment, the use of New Approach Methodologies and Next Generation Risk Assessments, as well as whether the focus should be on hazards or risk. In the EU, ECHA will be expanding into other existing regulations and directives, while in the UK greater harmonisation and recognition of EU decisions are being proposed.
For companies operating in the chemicals sector, regulation is no longer simply a matter of compliance. Increasingly it is a question of market access. Decisions taken through regulatory processes can determine whether substances remain available for specific uses, products can continue to be sold in particular markets and supply chains remain viable.
Policy concerns identified l
Hazard & risk assessment l
Regulatory proposal developed l
Consultation & evidence gathering l
Impact assessment & technical review l
Final regulatory decision
Against this backdrop, many companies are facing a fundamental challenge. Regulatory demands are expanding, while the resources available to manage them remain limited. The key question is therefore not whether to engage with regulation, but where to focus effort in order to maintain the most important parts of the business( Figure 1).
Regulation beyond compliance
The regulatory landscape for chemicals is becoming more complex. Existing frameworks continue
Early engagement help ensure regulators understand real world uses and impacts
Figure 1 – Typical stages in the development of chemical regulatory initiatives
to evolve, while new initiatives are emerging to address wider environmental and health concerns.
Recent proposals targeting groups of substances illustrate the scale of potential change. In parallel, broader policy initiatives aimed at strengthening chemical safety and sustainability are increasing regulatory scrutiny across many sectors.
For companies, these developments mean that regulatory outcomes increasingly shape commercial reality. Decisions taken by regulators directly influence whether certain substances
42 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981