Subject: Kohtumise soov seoses toimeaine medetomidine kasutusloa pikendamisega
From: "Christman Roos" <[email-masked]>
To: Enda Veskimäe <[email-masked]>
Cc: "TA Info" <[email-masked]>
Date: Tue, 20 May 2025 14:31:01 +0300

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu
saatja korral palume linke ja faile mitte avada.

Lugupeetud Enda Veskimäe

Pöördun Teie poole palvega, mille osas on varasemalt kontakteerunud minu
kolleeg Paula Pecorelli.

Nimelt soovib Rootsi biotehnoloogia ettevõte I-Tech AB kohtumist seoses
nende tootes Selektope kasutatava toimeaine medetomidine kasutusloa
pikendamisega. Tänaseks on läbi viidud põhjalikke analüüse ja
mõjuhinnanguid, millest tulenevaid kasutusloa pikendamise vajadust ja
põhjendusi soovivad ettevõtte esindajad tutvustada. Kokkuvõte
olulisematest punktidest ning biotsiidimääruse artikkel 5 lg 2
kohaldumisest on meenutuseks allpool toodud kirjavahetuses.

Kohtumise soov sai esmakordselt edastatud juba eelmise aasta septembris,
kuid paraku ei leidunud Riina Lahne sõnul toona selleks ressurssi. Kuna
täiendav SCBP komitee arutelu on toimumas täpselt kuu aja pärast, oleksime
väga tänulikud kui leiaksite lähinädalatel siiski aega ettevõtte
regulaatorsuhete ja kestlikkuse juhi ära kuulamiseks – see on loomulik osa
sidusrühmade kaasamisprotsessist ning seisukoha kujundamise õigus jääb
täielikult Terviseametile.

Kohtumise formaadiks sobib nii online kui piisava ette teatamisega ka
füüsiline kohtumine teie juures.

Soovi korral olen kättesaadav ka telefonitsi.

Peatset vastust oodates,

lugupidamisega

Christman Roos

Vanemkonsultant

 <mailto:[email-masked]> [email-masked]

Tel: 5740 2000

META / Rud Pedersen Group

 <http://www.metaadvisory.ee/> www.metaadvisory.ee

 <http://www.rudpedersengroup.com/> www.rudpedersengroup.com

From: Paula Pecorelli <[email-masked]>
Sent: Thursday, March 13, 2025 2:31 PM
To: Enda Veskimäe <[email-masked]>;
[email-masked]; [email-masked]
Cc: Tommaso Grasso <[email-masked]>; Selma Abed
<[email-masked]>; Adam Sebesta <[email-masked]>
Subject: Renewal of medetomidine's approval under BPR | I-Tech - SCBP
Meeting

Dear Ms Veskimae, dear Colleagues,

We hope this email finds you well. We would like to thank you for your
attention to the important dossier of medetomidine’s re-approval.

In this spirit, since medetomidine’s renewal of approval will be discussed
in the next week’s Standing Committee on Biocidal Products (SCBP) on 19
March as point A.05 of the agenda, we would like to take the opportunity
to reiterate why we strongly believe that a derogation renewal under
Article 5.2 of the BPR is justified:

1.	As confirmed in the Socio-Economic Analysis (SEA) previously
shared with you and submitted in the public consultation, medetomidine
qualifies for derogation under the BPR, as its non-renewal would result in
a “disproportionate negative impact on European society.” Non-renewal of
medetomidine would have no benefit at all for public health, while having
negative impacts on both the economy and the environment. In particular,
medetomidine plays a critical role in abating fuel consumption and GHG
emissions from ships.

2.	There are no sufficient alternatives to medetomidine in PT21. Only
two substances (dicopper oxide and tralopyril) beyond medetomidine are
effective for the intended use - i.e., against hard fouling (barnacles).
However, both substances face regulatory uncertainties and do not offer a
significantly improved hazard and risk profile compared to medetomidine.

3.	Differently from these two alternatives, medetomidine is used in
ultra-low concentrations in marine paint (0.1% w/w), in line with the EU
objective of reducing overall use of biocides. These extremely low
concentrations do not result in the claimed ED effects, which are
associated with properties of medetomidine at high concentrations in
pharmaceutical uses.

4.	Thanks to its unique, non-lethal mode of action, medetomidine is
essential to maintain sufficient chemical diversity in PT21, critical to
prevent the development of resistance in target organisms and prevent the
spread of invasive alien species.

5.	Under request to access to information, we know that over 50
stakeholders who participated in the European Commission’s public
consultation on whether medetomidine’s meets Article 5.2 criteria,
highlighted that its reapproval is warranted. They emphasised the lack of
viable alternatives; the substance’s contribution to the EU and IMO’s
greenhouse gas reduction goals for the shipping sector; and the potential
negative impact on EU competitiveness, as vessels coated with
medetomidine-based antifouling coatings would be restricted from the EU
market.

6.	Although products containing medetomidine are not yet widely used
in Europe, there is a clear commitment by industry players to invest in
this innovative solution, provided that the regulatory environment favours
this investment. Request for authorisations of antifouling coatings
containing medetomidine have already been filed by a large paint
manufacturer via the national regulatory regimes of several EEA countries,
and commercial plans for further investments would be put in place in the
case of re-approval.

7.	At this stage, medetomidine is already the preferred antifouling
solution in the key markets of Korea and Japan. Not reapproving the
substance in the EU would cause disruptions in the global shipping value
chain and in trade with these commercial partners.

8.	Finally, a positive decision on medetomidine’s derogation approval
in the EU is fully in line with the recently presented goals of the
European Commission to strengthen Europe’s competitiveness, ease
administrative burden, support simplification and boost European
industrial capacity (Competitiveness Compass, Clean Industrial Deal,
etc.).

DG SANTE has indicated that they will highly value input from the Member
States on this case before they proceed with drafting the Implementing
Act. Your perspectives and insights will be instrumental in shaping the
discussions and ensuring a well-informed decision-making process.

Therefore, we thank you in advance for kindly considering these key points
and for bringing them to the discussion at the upcoming Standing Committee
meeting.

We remain available should you have any questions or comments and hope to
stay in touch after the March meeting.

Best regards,

Paula Pérez Pecorelli

Senior Associate

 <mailto:[email-masked]> [email-masked]

M: +32 492583922

Rud Pedersen Public Affairs

Avenue Marnix 28

1000 Bruxelles

Belgium

 <http://www.rudpedersen.com/> www.rudpedersen.com

 <http://www.rudpedersengroup.com/> www.rudpedersengroup.com

EU Transparency Register nr.: 165838227131-07

Member of EPACA,  the European Public Affairs Consultancies' Association

Signatory to the EPACA Code of Practice

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