South Korea
Change in authority for K-BPR processes and evaluations
As of April 30th, the authority for the Consumer Chemical Products and Biocides Safety Control Act (the K-BPR) is now the National Institute of Chemical Safety (NICS). The previous authority, the National Institute of Environmental Research (NIER), was the competent authority for all K-BPR biocide-related processes from the coming into force of the Act back in 2019 and this is thus the first time such a transfer of responsibilities has taken place. It remains to be seen how smooth the transfer will be, but as the personnel previously taking care of biocides applications will also now be part of NICS we are hopeful that the transfer will not significantly impact ongoing evaluations.
New rules for timelines when replying to K-BPR authority and rejection example list published
The authority has published an important notice detailing a difference in how they intend on handling authority request deadlines for future K-BPR applications. During the completeness check phase, the authority will issue a request for additional information with a deadline of 14 days, extendable by a total of 14 days. If a further request is sent after replying to the first request, then this will only be granted for another non-extendable period of 14 days.
Meanwhile, for requests issued after the start of the evaluation, whilst it is possible to ask for deadline extensions, the time granted to reply to authority requests will now be set at a maximum of 40 days. This 40-day period includes the original timeline set by the authority plus any extension asked for. This means for example that if the authority asks for additional information with a deadline of 30 days, then it will only be possible to extend by a further 10 days.
This notice shows a marked change from how deadlines were set for authority requests in the past and shows also that NICS aims to be stricter with K-BPR applications going forward. Apart from the deadlines now being tighter, the authority also published a list of criteria which would result in applications being rejected outright – for example, missing certificate of manufacture, inconsistencies in the dossier with regards to the submitted active substance or representative biocidal product information, or submitting a dossier for multiple user categories at once (professional and non-professional – one application per user category is required).
It is possible that with these strict rejection criteria and tight deadlines, we may see more rejected applications in the near future. Prior to submission, knoell recommends making absolutely sure that the dossier is totally complete, in order to minimise the chances that the authority comes back to the applicant with comments. If you need assistance with the submission of biocidal active substance or product applications in Korea, please get in touch with our team of experts at k-bpr@knoell.com.
