SoftOx Solutions AS
SoftOx Solutions AS
09/17/2021 | Press release | Distributed by Public on 09/17/2021 04:11
SoftOx Solutions AS has received a response from the Norwegian Environment Agency (NEA) regarding the new application for national approval for its disinfection products
Update regarding the ongoing application process for national approval of biocidal products (disinfection products) in Norway (with reference to the stock exchange announcement from SoftOx Solutions AS (SoftOx) on March 29th and July 2. 2021). The Norwegian Environment Agency has rejected that SoftOx 'hand disinfection can be covered by a transitional scheme during the period in which the application for product approval is processed. The Norwegian Environment Agency's interpretation of the regulations is disputed by SoftOx. - The company does not understand the directorate's interpretation of the text in the hearing proposal. The situation has been assessed together with leading lawyers. Our opinion is that the NEA here has made a mistake. That SoftOx as a small company should now bear the risk of mistakes made by the Norwegian Environment Agency is perceived as grossly unfair, says CEO Geir Almås of SoftOx Solutions. SoftOx has two processes towards regulatory authorities associated with its disinfection products: application for approval based on active chlorine released from hypochloric acid and an application for approval based on active chlorine released from sodium hypochlorite. The products are identical, except for a regulatory term for active substance. The fact that the company has two ongoing application processes is because the regulations are complex and that they are interpreted differently from country to country. SoftOx's application for approval of the product family in disinfection based on active chlorine released from hypochlorous acid has been submitted in accordance with requirements specified in the Norwegian Environment Agency's hearing memorandum from March 2021 to new regulations (2021/2157). SoftOx bases its opinion on the fact that there is a transitional arrangement for all disinfection products when the application for approval was submitted within the deadline specified in the hearing memorandum. However, the Norwegian Environment Agency has by letter, and as part of an ongoing dialogue, announced that the that there should be no transitional scheme for products based on active chlorine from hypochlorous acid Product type 1 (hand disinfection). Without a valid transitional arrangement or temporary permit, SoftOx cannot place its disinfectant products based on this active substance on the market until the Norwegian Environment Agency has approved SoftOx's new application. SoftOx is now undertaking a thorough review of the letter from the Norwegian Environment Agency and is considering submitting the case to the Ministry of Climate and Environment. In addition to the application for disinfection based on active chlorine released from hypochlorous acid, there is an ongoing appeal process in the Ministry of Climate and Environment regarding the approval of SoftOx disinfection based on active chlorine released from sodium hypochlorite. This application was rejected by KemI in Sweden, and an appeal is pending in the Ministry of Climate and Environment as to whether there should be a deadline in Norway for SoftOx to suspend sales by October 3, 2021 with the possibility of continued use for a period of six months thereafter - We strongly disagree with the Norwegian Environment Agency's perception of the regulations. We recently won the contract announced by HINAS (Helseforetakenes Innkjøpsservice AS) for hand disinfection products, which shows that our product is best in class. However, we believe in a good and fair treatment from the Ministry of Climate and Environment, to continue to deliver products to our customers. The conclusion is that the regulatory situation is still unclear, says CEO Geir Almås of SoftOx Solutions. For further information, please contact: CEO Geir Almås of SoftOx Solutions AS, or Mail: [email protected] Mobile: (+47) 948 59 599 About SoftOx Solutions AS SoftOx Solutions AS (Softx, listed on Euronext Growth Oslo) is a Norwegian BioTech company based in Oslo with the aim of helping to combat major threats to human health, namely the emergence of antimicrobial resistance (AMR), biofilm infections in chronic wounds and the spread of viruses. For more information on SoftOx, visit www.soft-ox.com