Taotlus

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

[email protected]

Tel: 5740 2000

META / Rud Pedersen Group

www.metaadvisory.ee

www.rudpedersengroup.com

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

[email protected]

M: +32 492583922

Rud Pedersen Public Affairs

Avenue Marnix 28

1000 Bruxelles

Belgium

www.rudpedersen.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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