REGULATION & COMPLIANCE
remain available, how they may be used, and under what conditions products can be placed on the market.
In this context, regulatory management is not simply a technical exercise carried out by compliance teams. It is a strategic issue that affects product portfolios, investment decisions and long-term competitiveness.
Scale of the challenge
Most chemical companies manage portfolios that include numerous substances, applications and markets. Each substance may face a different regulatory trajectory, while policy developments increasingly target groups of substances rather than individual chemicals, significantly increasing the scale of analysis required by companies.
Recent developments concerning per- and polyfluoroalkyl substances( PFAS) illustrate the scale of potential regulatory change. The proposed restriction covering a wide range of PFAS has prompted many companies to review the role these substances play within their portfolios and consider how potential regulatory outcomes could affect key products and markets.
For many organisations, the challenge is determining which uses are most critical, which uses can be substituted, and for those that are unable to be substituted, where requirement for this activity. decisions often depend on the Illustrative framework for prioritising regulatory effort acros s a substance portfolio
Regulatory risk / Regulatory trajectory
Monitor
Low priority evidence generation and engagement efforts should be focused. At the same time, internal regulatory teams must deal with multiple processes running in parallel. These may include restriction proposals, classification changes, authorisation requirements and evolving national regulatory frameworks.
Understanding portfolios
Given this environment, it is rarely realistic for companies to address every issue with equal intensity. Management, regulatory and commercial teams must decide where to focus attention, where additional evidence is required and where early engagement may influence outcomes.
In practice, this means companies must make deliberate choices about how regulatory effort is allocated across their substance portfolios( Figure 2). It is critical for companies to have a good understanding of what substances are present in their portfolios, the markets in which these substances are used and the regulatory status of the substances in the existing and prospective markets.
By understanding these factors companies are better able to fulfil their existing regulatory obligations and it reduces the risks of unexpected regulatory outcomes. A current and updated substance inventory and directory is a fundamental
Figure 2 – Illustrative framework for prioritising regulatory effort across a substance portfolio
Active engagement required
Evaluate substitution
Commercial Importance
Ongoing monitoring is also important as in recent years thousands of substances have been evaluated by regulatory authorities and considered for additional regulatory action.
Early engagement matters
Many regulatory processes include opportunities for stakeholder input. Consultation periods, evidence calls and technical discussions allow regulators to gather information on how substances are used and what impacts potential regulatory measures may have.
However, companies sometimes engage only once proposals are already well developed. At that stage, the scope for influencing the regulatory outcome may be limited.
Early engagement allows regulators to better understand the practical role of substances in industrial applications, the feasibility of substitution and the wider economic implications of potential restrictions.
By contributing early and constructively to regulatory processes, companies can help ensure that regulatory decisions are based on a realistic understanding of how substances are used in practice.
Data & evidence
Evidence plays a central role in chemical regulation. Regulatory
quality of the information available regarding substance uses, exposure patterns, technical performance and potential alternatives.
Where evidence is incomplete or uncertain, regulators may need to adopt precautionary assumptions. This can lead to outcomes that do not fully reflect the practical realities of industrial or societal use.
Providing robust and well-documented evidence helps regulators
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