Whether a business operates in the agricultural, chemical, cosmetic, bio-scientific or pharmaceutical sector (or any other), a precise, proactive, and timely regulatory and public affairs strategy can make the difference between having a substance and product on the EU market, or having to withdraw them.
The evaluation and approval of active substances has become so complex and unpredictable that companies increasingly find themselves “lost in translation” when they realize the risk of losing market access is likely to happen.
Substances evaluation and approval is not a purely scientific exercise. It entails long, complex, and consensus-building procedures designed to ensure compliance with the highest degrees of health and environment standards, in exchange for a licence to operate. However, these procedures increasingly fail to take into account state-of the-art scientific input, innovative risk-mitigation technologies, or sometimes even pure scientific clarifications throughout the process. As a result, the evaluation and approval of active substances has become so complex and unpredictable that companies increasingly find themselves “lost in translation” when they realize the risk of losing market access is likely to happen.
The recent “glyphosatization” of scientific and technical discussions related to chemicals has introduced a further layer of complexity and unpredictability in these processes: its politicization in Brussels and in several Member States.
In this ever-complex framework, EPPA works together with its clients to approach regulatory requirements from a broader perspective rather than mere compliance. This includes identifying the intangible societal, economic and political “currents” that drive discussions and decisions, and facilitating on that basis acceptable compromises which align scientific evidence, business and societal interests, especially in borderline cases. More than ever, constructive dialogue with Member States authorities, but also with the Commission and Parliament, is crucial for sustainable and trustworthy business operations.
The “glyfosatization” of scientific discussions related to chemicals has brought a further layer of complexity and unpredictability to the process: its politicization.
EPPA advises its clients in all authorisation and approval processes in the above mentioned highly regulated sectors, but its experience and expertise is applicable of course in other sectors too.