#Sweden #Gothenburg #I-Tech #Selektope #EU Climate Goals

Introduction

The ambitious climate objectives set by the European Union (EU) are facing significant risks due to apparent regulatory flaws that threaten innovation within the maritime industry. At the forefront of this issue is I-Tech, a Swedish biotechnology firm that has developed Selektope®, a groundbreaking antifouling agent. Its active ingredient, Medetomidine, presents unique advantages for reducing marine fouling, yet its future hangs in the balance as the EU's regulatory landscape comes under scrutiny.

Call for Action by I-Tech

I-Tech has formally appealed to the European Commission to prompt an immediate review of the renewal and risk assessment procedures involving Medetomidine. They assert that the existing frameworks are fundamentally flawed, leading to potentially misleading scientific conclusions. If not addressed swiftly, these shortcomings could have dire consequences for the EU's innovative climate solutions, ultimately undermining its global competitiveness in shipbuilding and marine coatings and jeopardizing its climate and sustainability ambitions.

The urgency of this matter was highlighted in a recent Financial Times report, emphasizing the need for regulatory adjustments to utilize Selektope® effectively and facilitate a more sustainable maritime industry.

Regulation Concerns

The current inadequacies in revisiting the Biocidal Products Regulation (BPR) and the product approval processes encompass various regulatory oversights which misrepresent the non-lethal mode of action exhibited by Selektope®. By temporarily altering the swimming behavior of barnacle larvae, Selektope® effectively prevents adhesion to ship hulls, thus reducing drag and fuel consumption.

Initially, Medetomidine was mistakenly classified as an endocrine disruptor (ED) based on hazard-driven assessments from its usage in pharmaceuticals, without consideration of its unique application within marine coatings. Furthermore, an overestimation of alternatives has overshadowed the environmental advantages offered by Selektope® in decreasing fuel consumption.

Markus Jönsson, CEO of I-Tech, has emphasized the urgent need for a thorough reevaluation of Medetomidine’s regulatory status. He argues that a scientifically informed assessment of alternatives, alongside socioeconomic factors, is critical to align with the EU's overarching goals. Without swift action, the EU risks losing its competitive edge in a global marketplace increasingly keen on sustainability.

Flawed Alternative Analyses

A severely compromised analysis of alternatives (AoA) has been the basis for impeding the re-approval of Selektope®. The AoA concluded that non-equivalent biocidal substances that cannot effectively combat barnacle fouling should be considered suitable alternatives—an evaluation that clearly mishandles the limited range of effective antifouling agents.

Additionally, the analysis suggests impractical non-biocidal antifouling technologies as viable substitutes, which are neither commercially feasible nor widely adopted. Independent survey results from socioeconomic analysis conducted to support the Medetomidine renewal highlight a market threshold that isn’t ready to transition to non-biocidal solutions due to exorbitant retrofitting costs and operational limitations.

Selektope® and Climate Goals

Selektope® stands as a next-generation agent, permitting a remarkably low concentration of biocides (2-4 grams per liter of antifouling paint), far below that of traditional copper-based systems, which can reach up to 900 grams per liter. This non-lethal approach not only minimizes the deployment of biocides but also prevents resistance development among marine organisms.

Moreover, surfaces coated with Selektope® directly align with the EU and the International Maritime Organization's goals of reducing greenhouse gas emissions. Effective antifouling systems could save the shipping industry over 100 million tons of CO2 emission annually by significantly lowering both vessel resistance and fuel consumption.

EU Global Competitiveness Under Threat

Regulatory failures within the European Commission, alongside bottlenecks in product approvals among EU member states, have stalled the market introduction of Selektope®-based products, even though they have been fully compliant with the EU-BPR since 2016. Meanwhile, competitors from Asia, including Korea, Japan, and China, have capitalized on this delay, gaining a technological edge with advanced fuel-saving systems.

A detrimental regulatory outcome for the EU would severely impact its shipping industry, jeopardizing the capability of EU shipyards to maintain and coat vessels utilizing Selektope® antifouling systems. Instead of pursuing a substance-based evaluation for renewing biocidal agents, several EU states are suggesting that a comprehensive scientific reassessment of remaining biocidal options as a more effective approach, emphasizing deeper stakeholder engagement.

Conclusion

I-Tech's call for a rigorous reevaluation of Medetomidine is a pivotal moment for the European Union's climate aspirations. Ensuring that decisions are rooted in scientific integrity and reflective of actual market capabilities is essential for fostering an innovative and sustainable maritime industry that adheres to the EU's ambitious environmental goals.

As the dialogue unfolds regarding regulatory best practices, the future of Europe's competitive standing in the global maritime landscape could very well rely on these critical changes in policy and perception.