EU regulatory status

The regulatory status of Selektope® in the European Union has changed. But what does this mean for operators, shipyards and paint manufacturers – and what does the scientific evidence say?

STATUS

What is the regulatory status of Selektope® in the EU?

Selektope® is not approved for continued use as an active substance in antifouling products within the European Union.

The decision applies specifically to the EU market. Selektope® remains approved for use in key marine markets outside the EU and can continue to be used in accordance with applicable national and regional regulations.

The EU decision does not change Selektope®'s regulatory status in markets outside the EU.

Global regulatory status

Do you manufacture antifouling coatings containing Selektope®?

The EU decision affects the use of Selektope® as an active substance in antifouling products within the EU market.

Selektope® remains approved in key marine markets outside the EU. Paint manufacturers can therefore continue to use Selektope® in products for markets where its use is approved, subject to applicable local requirements.

I-Tech continues to support paint manufacturers with regulatory information and guidance for individual markets.

Selektope® continues to be available for use in approved markets outside the EU

Does your vessel already have Selektope® applied?

If your vessel already has an antifouling coating containing Selektope®, the EU decision does not mean that the coating must be removed or that the vessel can no longer operate in or call at EU ports.

Existing coated vessels can continue normal operation. Internationally trading vessels can also continue to call at EU ports, and an EU flag or EU port call alone does not determine whether a vessel is affected by the restriction.

Existing Selektope®-coated vessels can continue normal operation, including EU port calls for internationally trading vessels

Are you planning a newbuild or dry docking?

The EU decision does not prevent Selektope® from being specified for all vessels connected to the EU.

Selektope® can continue to be specified for internationally trading vessels and authorised non-EU markets. Existing vessels can also continue to be drydocked or recoated in many situations.

Additional review is required where a vessel will be transferred to an EU-registered owner and is intended to operate solely within the EU. These cases should be assessed individually before Selektope® is specified.

International trade, EU flag or EU port calls do not in themselves prevent the use or specification of Selektope®

What decision has actually been taken?

The European Union has decided not to renew the approval of medetomidine under the Biocidal Products Regulation.

As a result, following the applicable transition arrangements, products containing Selektope can no longer be placed on the EU market under the approval that previously existed.

However, it is very important to understand what the decision does and does not mean. This is a regulatory decision within a specific legislative framework and jurisdiction.

It is not a global ban on Selektope, nor does it prohibit the operation of vessels that are coated with Selektope-containing products.

Key things to understand about the decision

The most important thing is that this decision should not be interpreted as a sudden change in Selektope's performance, operational track record or real-world use experience.

The technology itself has not changed. The operational results achieved by customers have not changed. And the significant body of scientific evidence and experience supporting Selektope's use in antifouling coatings has not changed.

What has changed is the outcome of a regulatory process in one jurisdiction. It is also important to emphasize that we remain fully committed to supporting our customers.

Selektope continues to be available for use in antifouling products in markets where regulatory approvals are in place, and we will continue working closely with customers and partners as they navigate the implications of this decision.

What does the EU decision mean in practice?

Most vessels remain unaffected. The key factors are how the vessel trades, whether a transfer is involved and who the registered owner is.

Disclaimer: The information provided is I-Tech’s interpretation of the Biocidal Products Regulation((EU) No 528/2012) and Commission notice The ‘BlueGuide’ on the implementation of EU product rules. Customers remain responsible for complying with all applicablelegal and regulatory requirements in their intendedmarkets.

Why was Selektope® not renewed in the EU?

The EU decision is based on the regulatory assessment of medetomidine, the active substance in Selektope®, under the EU Biocidal Products Regulation (BPR).

As part of the renewal process, medetomidine was identified as having endocrine-disrupting properties. Under the BPR, substances that meet certain exclusion criteria are generally not approved unless specific conditions for derogation are met.

The assessment focuses on the hazardous properties of medetomidine. I-Tech's position is that this does not reflect risk associated with Selektope® under use in antifouling coatings.

Why does I-Tech disagree with the EU assessment?

I-Tech respects the EU regulatory process but disagrees with the conclusion that the available scientific evidence justifies excluding medetomidine from continued use in antifouling coatings.

I-Tech believes that the assessment focuses on the intrinsic hazard of medetomidine without sufficiently reflecting the very low levels of exposure associated with its actual use in antifouling coatings.

In I-Tech's view, understanding the real-world risk requires considering both the properties of the substance and how, where and at what concentration it is actually used. I-Tech believes real-world exposure and conditions of use are essential to understanding the actual risk of Selektope®

Hazard does not automatically equal real-world risk

Selektope® is effective at very low concentrations

Selektope® provides effective protection against barnacle fouling with only 2–3 grams of the active substance per litre of antifouling paint.

This low concentration results in very low exposure. According to I-Tech's risk assessment, maximum assessed daily worker exposure is at least 36 times lower than the levels associated with the effects discussed in the endocrine-disruption assessment.

Environmental exposure is also very low

I-Tech's environmental risk assessment indicates that the predicted concentration of Selektope® in harbour waters is approximately 70,000 times lower than the levels associated with the effects discussed in the endocrine-disruption assessment.

I-Tech believes this difference between identified hazard and expected real-world exposure is essential when evaluating the environmental risk of Selektope®.

View from a different angle on a ships hull in drydock

THE SCIENCE

What does the scientific evidence show?

Selektope® is backed by more than two decades of research into its mode of action, efficacy, environmental behaviour and use in marine antifouling coatings.

The evidence shows that Selektope® works differently from many conventional antifouling substances. It provides effective protection against barnacle fouling at a very low active-substance load and works by temporarily stimulating the swimming behaviour of barnacle larvae, preventing them from settling on the hull without killing them.

Japanese subtitles
Korean subtitles

Effective at very low concentrations

A non-lethal, reversible mode of action

A low active-substance load with wider environmental benefits

High efficacy means only a small amount of active substance is required
Because Selektope® is effective at very low concentrations, only a small amount of active substance is required in the coating formulation. According to I-Tech's environmental data, medetomidine does not bioaccumulate and undergoes microbial degradation over time in the marine environment. By helping prevent barnacle fouling, Selektope® also supports cleaner hulls, helping reduce fuel consumption, CO₂ emissions and the risk of spreading invasive aquatic species.

Backed by extensive research and real-world use

More than two decades of research – and thousands of vessels
Selektope® originated from marine paint research involving the University of Gothenburg and Chalmers University of Technology and is backed by more than two decades of scientific research and development. Since its first commercial introduction in 2015, Selektope® has progressed from laboratory research to widespread commercial use in marine antifouling coatings. Today, Selektope®-containing coatings are used on thousands of vessels worldwide.

Antifouling – the bigger picture

Assessing the environmental impact of antifouling requires looking beyond the properties of an individual active substance.

Effective antifouling keeps hulls clean, reducing hydrodynamic resistance, fuel consumption and emissions. It also helps prevent the transfer of invasive aquatic species between marine ecosystems.

The environmental impact must therefore be considered as a whole – including the effectiveness of the coating and the benefits of preventing fouling.

High efficacy with a low active-substance load

Selektope® provides effective barnacle protection using only a small amount of active substance, helping maintain cleaner hulls with a low active-substance load.

Cleaner hulls mean less fuel and lower emissions

Preventing barnacle fouling reduces resistance and the additional fuel consumption and emissions associated with fouled hulls. Research cited by I-Tech found that just 10% barnacle coverage could require 36% more propulsion power to maintain the same speed on the vessel model studied.

Reducing the spread of invasive aquatic species

Biofouling can transport invasive aquatic species between marine ecosystems, threatening native biodiversity. Keeping hulls clean helps reduce this risk by preventing organisms from attaching to vessels and being transported to new environments.

What happens if Selektope® is removed from the toolbox?

The environmental impact of a regulatory decision also depends on the technologies available to replace the substance.

Removing an effective antifouling technology from the toolbox can have consequences beyond the active substance itself. The overall environmental impact should therefore be considered as a whole – including hazard, exposure, antifouling efficacy, vessel efficiency, biofouling and the alternatives available.

Watch the video: What does this decision mean for the future of sustainable fouling management?

What does the maritime industry say?

Stakeholders have raised concerns about the consequences of non-renewal. The potential loss of Selektope® from the EU market has raised concerns among stakeholders across the maritime industry.

During the European Commission's public consultation on the renewal of medetomidine, stakeholders from across the maritime value chain submitted information on the potential consequences of non-renewal. Respondents included shipowners, shipyards, marine paint manufacturers, industry associations, marine equipment manufacturers and alternative technology providers.

Across the non-confidential submissions reviewed by I-Tech, several recurring concerns emerged.

Limited suitable alternatives

Stakeholders highlighted the limited availability of alternatives offering comparable protection against hard fouling on commercial vessels. The submissions also noted that non-biocidal hull coatings are not technically suitable for all vessel types and operating conditions.

Access to a range of effective antifouling technologies remains important for different vessels and operating profiles

Impact on climate and efficiency goals

Impact on the European maritime industry

"The efficacy of marine biocides in Pt21 (Product Type 21, Antifouling Products) is rigorously tested and is an essential technology for the decarbonisation of global shipping.”

Source: Paint Manufacturer

“As a result of evaluation in real sea with various conditions, it was confirmed that the antifouling performance of products containing a small amount of 'Medetomidine' was far superior to those that did not."

Source: Ship Builder

"The increase in emissions to air that a non-approval could cause would go against all efforts for a more sustainable shipping industry in Europe."

Source: Distributor

What happens next?

I-Tech remains committed to supporting customers through the changing regulatory landscape and providing clear, up-to-date guidance on where and how Selektope® can be used.

Following the EU decision, I-Tech will continue to support customers in understanding its practical implications, while supplying Selektope® in markets where its use remains approved.

1. Helping customers understand what the EU decision means in practice

The implications of the EU decision can vary depending on the vessel, intended trade, ownership and where the coating is applied.

I-Tech will support paint manufacturers, shipowners, operators and shipyards with guidance on individual cases, including newbuilds, dry dockings, internationally trading vessels and EU-only operations.

I-Tech can help assess what the EU decision means for your specific vessel, project or market.

2. Continuing Selektope® globally

3. Continuing regulatory and scientific engagement

I-Tech continues to stand behind the scientific evidence supporting Selektope® and will evaluate the regulatory pathways available following the EU decision.

The company will continue to engage with relevant authorities, industry stakeholders and customers, while monitoring regulatory developments and communicating any changes that affect the use of Selektope®.

I-Tech will continue to support customers with science-based regulatory information as the situation develops.

Stay updated

Regulatory requirements can evolve. I-Tech will continue to update this page with relevant information about Selektope® in the EU and other marine markets.

Have a question about a specific vessel, coating, or market? Contact I-Tech for guidance based on your situation.

Contact information
I-Tech AB
Förändringens gata 10
SE-431 53 Mölndal, Sweden
Phone: +46 10 30 33 999
Email: in**@****ch.se

View global regulatory status

FAQ

Frequently asked questions

Here are the most frequently asked questions.

Is Selektope® banned in the EU?

Can vessels with Selektope® already applied still enter EU waters?

Can I still specify a Selektope®-containing coating for my vessel?

Does an EU flag mean I cannot use Selektope®?

Can shipyards outside the EU still apply Selektope®-containing coatings?

Can paint manufacturers continue to use Selektope®?

When is a vessel considered to be placed on the EU market?

The legislation focuses on treated articles; for antifouling, this means vessels that are made available to EU customers in some form.

For a vessel to be considered placed on the EU market, transfer of ownership to an EU-based owner is required.

Another key requirement is that the vessel is intended to operate within EU waters.

Internationally trading vessels can continue using Selektope-containing coatings as before. EU port calls are not affected.

Is Selektope® still approved outside the EU?

Why did the EU not renew Selektope®?

The EU assessment concerns medetomidine, the active substance in Selektope®. As part of the renewal process, medetomidine was identified as having endocrine-disrupting properties and meeting relevant exclusion criteria under the EU Biocidal Products Regulation. I-Tech disagrees with key aspects of the assessment and believes that actual exposure and conditions of use are essential when evaluating the real-world risk associated with Selektope®.

Is Selektope® dangerous to humans or the environment?

The identification of a hazardous property does not by itself describe the risk associated with a specific use. Risk also depends on the level and likelihood of exposure.

According to I-Tech's risk assessments, exposure associated with the approved use of Selektope® in antifouling coatings is very low. Assessed worker exposure is at least 36 times lower than levels associated with the effects discussed in the endocrine-disruption assessment, while predicted concentrations in harbour waters are approximately 70,000 times lower.

I-Tech therefore believes that actual exposure and conditions of use are essential when assessing the human-health and environmental risk of Selektope®.

Explore the scientific evidence

What should I do if I have a specific vessel, coating or project?

Before specifying Selektope®, consider three key questions:

How will the vessel trade? Internationally or solely within the EU?
Is a transfer involved? For example, a transfer of ownership or possession?
Who is the registered owner? EU-established or non-EU?

If your project involves EU-only operation together with a transfer to an EU-registered owner, contact I-Tech for guidance before specifying Selektope®.

Contact our regulatory team

Not sure what the EU decision means for you?