REGULATION & COMPLIANCE
assess risks and benefits more accurately. It can also demonstrate the socio-economic importance of certain uses and the challenges associated with substitution.
In large regulatory initiatives affecting groups of substances, such as those currently under discussion for PFAS as well for the ongoing ECHA Cr( VI) restriction, the availability of robust technical and socio-economic evidence becomes particularly important.
For companies, ensuring that relevant data are available and presented effectively is therefore a critical part of maintaining market access. It is well known that the exercise within companies to allocate scarce resources to provide input to consultations organised by regulators that may be perceived to be far away in the future is challenging.
However, companies need to look a few years ahead to be prepared, and provide input to influence upcoming policy and regulatory changes. Thus, a process for constant monitoring the chemical landscape based on the internal substance inventory is crucial.
A framework for prioritising
Given the number of regulatory initiatives affecting the chemicals sector, companies need a structured approach to prioritisation. Not every substance will present the same level of regulatory risk or commercial importance.
Several factors can help guide decisions about where to focus regulatory effort. First, the regulatory trajectory of a substance should be assessed. Substances already under scrutiny through restriction proposals, classification reviews, or other regulatory initiatives may require closer attention.
Second, the substance’ s commercial importance should be considered. In some cases, some substances may have suitable alternatives that can replace the substance. Substances that play a critical role in key products or supply chains that cannot easily be substituted may warrant greater engagement.
Third, the availability of technically and economically viable alternatives should be evaluated. Where substitution is complex or uncertain, stronger evidence may be required to support continued uses.
Finally, companies should identify areas where additional data could strengthen the understanding of how substances are used and what impacts regulatory decisions might have. Applying a structured framework helps organisations allocate regulatory effort where it can have the greatest impact.
An organisational risk
While regulatory teams play a central role in managing compliance, the implications of regulatory decisions extend far beyond regulatory functions( Figure 3). Changes affecting key substances may influence product design, supply chains, customer relationships and long-term investment decisions.
As a result, regulatory strategy should not be considered in isolation. Effective responses often require collaboration between regulatory specialists, technical teams, commercial management and senior leadership.
In some situations, it may be appropriate to form consortia for stronger collective approaches. Organisations that recognise
Regulatory strategy & market access protection
Figure 3 – Functions involved in managing regulatory risk
regulation as a strategic business issue are generally better placed to anticipate change and respond effectively.
Conclusion
Chemical regulation is becoming increasingly complex and dynamic across Europe. For companies operating in this environment, protecting market access requires more than simply meeting compliance obligations. Businesses must identify which substances and uses are most important to their operations and allocate regulatory effort accordingly.
Early engagement with regulatory processes and the provision of robust evidence can play a crucial role in ensuring that regulatory decisions reflect practical realities. If competence does not lie within the business, our advice is to seek external support, e. g. via dedicated chemical consultancies, to follow regulatory developments and prepare relevant information to support strategic decisions. ●
*- Also contributing to this article was Max La Vedrine, technical director at RPA
Matthew Lambert
MANAGING DIRECTOR
RPA k + 44 1603 558 442 J matthew. lambert @ rpaltd. co. uk j www. rpaltd. co. uk
44 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981