BIOCIDES
if there is a market for that product outside the EU . Since gaining approval for a new biocide requires five batches of the substance , produced via industrialscale manufacturing , the presence of commercial products for use in markets outside the EU can also be a way to use material that has most likely cost a substantial amount of money to produce . Without an available market outside the EU , there is a huge risk that a company that has developed a new biocide could face at least a ten-year timeline from allocation for approval until market access is unlocked . While innovation within the biocides field is rare , approximately ten new active substances have been approved for all biocide types since the common EU legislation was implemented in 1998 . Since fewer active substances are available , there is an increasing need for new biocides to help protect humans , animals and materials against harmful bacteria or pests . Most recently the emergency approvals of hand disinfectants during the COVID pandemic made the importance of biocides very apparent .
After reading this far , maybe the reason why there is so little innovation in the biocides field has already become quite clear . To summarise , innovation challenges lay initially in finding a substance with all of the desired traits regarding efficacy , safety , formulation properties and scalability from R & D to industrial production . If a substance fulfils all these requirements , funding must be attained to carry out a regulatory approval process and then for the biocide to comply with all the requirements under the biocidal legislation . To meet the societal need for protection against harmful organisms , innovation in the biocides field must be stimulated . From I-Tech ’ s experiences as an SME developing a new active substance under the EU biocidal legislation , we believe that three crucial actions could facilitate innovation and ensure that more ideas reach the market . 1 . Grants for regulatory development : Public funding which can be used to develop regulatory files for promising innovations is difficult to find . Usually , the type of data needed must generated by an independent research organisation , due to certification requirements . Most funding organisations have limits on how much of a grant can be used on consultant services , which this type of cost represents . Since financing regulatory development is the major hurdle for a promising biocide , such support would make a large difference
2 . A tiered approach to data requirements : Adapting the amount of regulatory data required for a new biocide to its intended use and the amounts used . For a biocide with limited use and exposure , a reduced data package could be accepted . While with increasing human and environmental exposure the data requirements should also increase 3 . Early market access and facilitating market access for products containing new actives : Following approval , a new product containing a new biocide should be able to be placed on the market until the biocidal products have been fully evaluated . Not many companies can survive the ten-year regulatory approval period without sales , and this is currently is a relatively optimistic time-line for a new active substance going through substance and product approval in the EU Hopefully the Chemical Strategy for Sustainability , which puts much hope into innovation circles , will stimulate the development of new innovative substances in the biocidal field . Until then , there remains to be a great risk of innovation being stifled in the field of biocide development . •
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Cecilia Ohlauson
I-TECH AB cecilia . ohlauson @ i-tech-se www . i-tech . se
28 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981