The EU's Climate Ambitions at Risk Due to Regulatory Failures in Maritime Transportation

In a pressing announcement, I-Tech, a Swedish biotechnology firm renowned for its innovative antifouling agent, Selektope®, has raised alarms about the current regulatory framework affecting the European Union's (EU) climate objectives. The core issue lies in the faulty processes surrounding the renewal and risk evaluation of medetomidine, the active ingredient in Selektope®. According to I-Tech, the Commission needs to urgently reconsider these processes to mitigate the potential negative impacts on innovation within the shipping industry, thereby safeguarding the EU's global competitiveness in maritime coatings and ensuring adherence to sustainability goals.

Calling for Immediate Regulatory Reevaluation

I-Tech has emphasized that the existing evaluation methods are fundamentally flawed and rely on misleading scientific data. These deficiencies could stifle innovation, undermine the yacht and shipbuilding industries, and jeopardize the EU's ambitious climate targets. A recent exclusive report from the Financial Times accentuated the urgency of this issue, pushing the need for immediate and corrective regulatory actions.

Markus Jönsson, CEO of I-Tech, stated, "It is urgent to revise and amend the regulatory evaluation of medetomidine. A robust scientific assessment for alternative substances or technologies is necessary, along with a greater consideration of socio-economic factors to ensure alignment with the overarching objectives and ambitions of the EU. Failure to act now will further erode the EU's global competitiveness and make achieving its climate and innovation goals even more challenging."

Scientific Misjudgments and Regulatory Errors

The shortcomings in the renewal and approval processes under the Biocidal Products Regulation (BPR) stem from numerous regulatory blunders, which misinterpret the unique, non-lethal mode of action of Selektope®. This agent temporarily encourages swimming behavior in barnacle larvae, preventing them from settling on vessel hulls.

One significant error was the classification of medetomidine as an endocrine disruptor (ED), which is based on usage data from pharmaceuticals—an entirely different context from its application in marine coatings. This misunderstanding, compounded by exaggerated claims regarding the availability of alternatives and the neglect of Selektope®'s sustainable benefits, has led to severe consequences for the industry.

Inadequate Alternative Analysis (AoA)

The alternative analysis being employed is heavily flawed, attempting to justify the denial of new approvals for Selektope®. It incorrectly suggests that several biocidal substances, which cannot effectively control barnacle fouling (the specific function of Selektope®), are viable alternatives. This mischaracterization distorts the limited efficacy of available alternatives. Moreover, among the non-biocidal antifouling technologies, many are not commercially viable or widely adopted, thus questioning their suitability as alternatives. Stakeholder interviews for an independent socio-economic analysis validating the renewal of medetomidine underscore that the market is unprepared to transition to non-biocidal alternatives due to significant modernization needs, high initial costs, or their specific operational efficacy.

Selektope® as a Key Tool for Climate Goals

Selektope® represents a cutting-edge solution that enables ultra-low biocidal concentrations (ranging from 2 to 4 grams per liter of antifouling paint), which is a fraction of the biocidal concentrations found in traditional copper-based systems (up to 900 grams per liter). This non-lethal approach to addressing barnacle fouling minimizes biocidal burdens and prevents resistance development.

Coatings utilizing Selektope® align directly with the EU and the United Nations' International Maritime Organization goals for reducing greenhouse gas emissions. Effective antifouling systems are estimated to save the shipping industry over 100 million tons of carbon dioxide emissions annually by significantly diminishing ships' hydrodynamic drag and fuel consumption.

Threats to EU Competitiveness

Despite being fully approved under the EU’s BPR since 2016, regulatory failures by the European Commission and bottlenecks in member state approvals have hindered Selektope®-based products from entering the EU market. In contrast, Asian markets, including South Korea, Japan, and China, have capitalized on their opportunity, granting their shipyards a competitive edge in implementing state-of-the-art fuel-saving systems.

A poor regulatory outcome would disproportionately affect the EU maritime industry and may eventually prevent European shipyards from maintaining and repainting vessels equipped with Selektope® antifouling systems. Instead of individualized assessments for active substance renewals, several EU member states have proposed a more fitting approach of collectively reevaluating remaining biocidal tools while ensuring enhanced stakeholder engagement.

About I-Tech AB

I-Tech is a biotechnology company that has pioneered the antifouling technology Selektope®, an active substance that prevents barnacle adhesion to submerged surfaces such as boats and ship hulls. By enhancing antifouling performance in marine coatings, it reduces fuel and maintenance costs while improving the energy efficiency of vessels. I-Tech has secured the necessary regulatory approvals for Selektope® and collaborates with several of the world's leading manufacturers of marine antifouling coatings.