BIOCIDES
Citrepel is already widely used in commercial products
with the data owners already , would also cover access to that data for the purpose of the evaluation of CWO ”. However , Chemian ’ s LoA was only for the purpose of Article 95 listing of the renamed EC Oil H / C . Using it to support a new purpose , the listing of a ( supposedly ) different substance was a separate cost , which came as a shock .
Data issues
In order to share data , companies must make an official Article 62 request , even if they know the data owner and have already shared data with them . The idea of this is to avoid duplicating vertebrate tests and ensure that companies pay their way – which Chemian was already doing . “ The contradictory element here is that on one hand , CWO is deemed a separate substance , but on the other , the vertebrate data from existing PMDRBO tests and the EC Oil H / C evaluation were relevant for CWO and could not be regenerated – so it is not a separate substance ,” Walker observed . Although data owners cannot profit from sharing data , they are allowed to charge certain ‘ reasonable ’ but often hard to quantify costs , such as for risks taken , inflation , administration , study monitoring and IUCLID summary writing . Substance identity is a frequent battleground between companies .
Chemian , Walker said , found itself without the right to use the EC Oil H / C data for CWO and it could not afford repeat access to the data . Data negotiation proved “ lengthy , stressful and expensive in terms of legal and consultant support . In the end , after a year , agreement was reached a few hours before the dossier submission deadline . As an SME , Chemian should have had a 60 % discount on its evaluation fees , bringing the cost down from € 120,000 to € 50,000 . However , this is based on the size of the manufacturer . Chemian uses a toll manufacturer and so got only a 20 % reduction . And it has still achieved neither dossier validation nor Article 95 listing . “ After listening to the experience of Chemian , which I am sure mirror others ’, we might ask ‘ Is the BPR achieving its objectives ?’” asked Walker . “ Are the effort , cost and time proportionate to the risks ? Is it simple and timely ? Are there equal opportunities for small business ? Is the process stifling innovation ?... Chemian have done well to get as far as they have and I ’ m sure others might have given up .” •
Dr Samantha Walker
SENIOR CONSULTANT , BIOCIDES
TSG CONSULTING k + 44 1372 822 301 J samantha . walker @ tsgconsulting . com j www . tsgconsulting . com
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