BIOCIDES
and this is certainly the case for those intended for use in marine antifouling coatings . Despite all of the data generated in the research project , it would be impossible to sell Selektope-containing products on the EU market without the achievement of regulatory approval . All substances that control organisms in a non-physical manner are considered to be biocides . Selektope ’ s mode of action is receptor activation , which triggers swimming behaviour in the barnacle larvae . Therefore , even though its effect on the affected organism is not fatal , from a regulatory perspective it is a biocide . As such , I-Tech made a strategic decision to seek regulatory approval of Selektope under the then newly implemented biocides legislation in EU , the Biocidal Products Directive 98 / 8 / EC ( BPD ). The requirements for an application dossier under the BPD were extensive and these have not lessened with time . Credible information generated by independent research organisations is required to determine an active substance ’ s identity and impurity profile , the physical and chemical properties , suitable analytical methods in different matrices , its toxicological and ecotoxicological profile , and its environmental fate . To cover all these factors , I-Tech submitted a dossier containing approximately 70 original studies on Selektope in 2009 . By the end of the evaluation , the number of studies had increased to 90 .
Figure 1 - Medetomidine
The amount of information needed during the application for regulatory approval of a new active substance is understandable . The BPR was put in place to regulate the use of biocides and avoid the situation of any substances that could pose a risk for humans or the environment being placed on the market . At the same time , these stringent requirements could block new biocides from reaching the market . The cost of developing a dossier for EU approval application containing all of the required information is in the range of € 5-10 million in investment . However , without EU approval , a new biocide is unlikely to reach the market at all . I-Tech was lucky to have patient and strong owners supporting the company through the European regulatory process . That , in combination with an existing toxicology data package from its approval as a pharmaceutical substance , made a large difference to the financial burden we took on . The fact that the process was approached from a very optimistic standpoint regarding costs , time and outcome certainly helped as well . Had it been apparent at the start of the process what the cost would be and that it would take seven years to gain approval for Selektope , the support might have been more difficult to find , especially as a small start-up company . I-Tech ’ s journey to getting Selektope on the market in antifouling coatings reflects some of the key factors that limit innovation in the biocides sector , with cost and time being the major inhibitors . However , the financial requirements and long timeframes for getting a new active substance approved in the EU is only part of the problem . Under the BPR , biocidal products also have to be approved before sales . Without an approved product incorporating it , the new biocide is basically locked out from the market . The only way for a new biocide to be commercialised during this time is
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