‣ citriadora , it is no longer covered by the new title , causing confusion for authorities and customers alike . In addition , the starting material for Citrepel 75 had been proprietary knowledge . Chemian had to go on a steep learning curve , trying to estimate what data it needed , what had to be done in terms of regulatory arrangement , and the time and costs involved .
Snakes and ladders
“ If you liken the road to approval to that of a child ’ s game of snakes and ladders , redefinition was a roll of the dice which unfortunately took Chemian down the massive snake on the final part of the board ,” Walker said . Chemian was once again at the start of the regulatory process for gaining approval for Citrepel 75 . ECHA now issued an open invitation to take over the role of participant for the now-orphaned ‘ Mixture of cis and trans PMD ’. Chemian ’ s application was accepted in December 2017 , after a complex , 14-month process . The HSE assured Chemian that the data it would need was already in existence with them and with the required letters of access could be read across . Communication with ECHA intimated that the work needed for study summaries , IUCLID and evaluation work ( by HSE ) could be minimal . Citrepel 75 now has its own name : ‘ Cymbopogon Winterianus Oil , fractionated , hydrated , cyclised ’ ( CWO ). A data gap analysis was performed , and essential studies on product efficacy and storage stability were provided . The company ’ s priority now was to be listed again as an approved active substance supplier on Article 95 with the newly named substance . As CWO was already on the market , Chemian was considered to be an ‘ existing ’ substance supplier and could join the list before approval . The deadline to submit a complete dossier was 1 December 2019 and the authorities were to provide comments on completeness within 90 days of receiving the fee . If it was complete ,
Chemian could be listed – even though the company had already been through this all before . The obligation for Article 95 listing only applies after the product has a validated dossier but products containing the active can still be placed on the market , in accordance with Article 89 . This , said Walker , highlights the difference between being ‘ in the review programme ’ and ‘ being listed on Article 95 ’. “ CWO is ‘ in the review programme ’, in PT 19 , and therefore allowable in biocidal products under transitional rules . Many potential customers do not know this . Disappointingly , many authorities seem not to know either . Chemian needs to sell active to finance the evaluation . This situation is a problem and one that , at the moment , is out of their hands .”
Another roadblock …
And then there was Brexit ...! Not being listed on Article 95 prior to the end of the transition period meant that the substance was not ‘ grandfathered ’ across into the new GB Article 95 . Without any input from Chemian , it was decided that the HSE would transfer the two actives to the same new EU competent authority , the Czech Republic . However , several months on , this had still not taken place . Chemian thus lost the benefits of the long relationship it had with the HSE . This was compounded by the complex nature of how , as a UVCB , the active should be evaluated in terms of the read-across data in the original dossier , obtaining the numbers to do risk assessment , the new requirement for ED assessment and how that should be handled in the absence of data . “ Brexit was definitely another snake ,” Walker said . A key need to support CWO was obtaining data and endpoints to do risk assessment . “ There had been a naïve assumption that the money Chemian paid towards the evaluation of EC oil – which is still ongoing - and the data sharing agreement they had
Java citronella is the source of Citrepel 75
48 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981