Are you aware of upcoming deadlines?
Are you aware that the BPR dossier deadline for ADBAC C12-C16 disinfectants is approaching? Please submit your dossier by July 2025 to avoid market withdrawal.
In December 2021, the EU Chemicals Agency (ECHA) Biocidal Products Committee (BPC) adopted an opinion for approval of ADBAC (C12-C16) in PT02 (disinfectants and algaecides not intended for direct application to humans or animals). Based on this BPC opinion, the approval date of ADBAC (C12-C16) for PT02 biocidal applications is July 2025.
To maintain your ADBAC (C12-C16) based products on the market, it is imperative to submit a biocidal product dossier by the PT02 active approval deadline (July 2025). The product dossier will then undergo evaluation for authorization.
Failure to comply with this deadline may result in:
• Market Withdrawal
• Reputational Damage
• Business loss
The required costs to successfully achieve product authorizations can be in excess of €500K, not to mention the time and resource required to support your products through this process. Additionally, as the BPR evolves, there is increasing complexity and unpredictability relating to guidance, data requirements and interpretation of the legislation.
Have you considered how Regulatory, Supply Chain and Product Development complexities may slow your speed to market ?
To help mitigate these risks and costs Arxada is offering a safety net, which with little effort from you, can provide the reassurance you need to keep disinfectants in your portfolio.
Our fully formulated NUGEN® hard surface disinfectants, algaecides and hand hygiene products, suitable for use in healthcare, industrial and institutional and food manufacturing/processing segments and Bardac® active substance may just help to alleviate some of this pressure by offering:
• Formulated disinfectants with broad spectrums of efficacy including viruses as well as very good compatibility with a wide range of materials, – Products registered in selected European Countries,
• Support with Marketing and Regulatory expertise to aid obtaining National Registrations
• Cost and resource savings,
• A choice of product paths, either branding of our formulated disinfectants or formulate own product based on our active substance.
The DDAC (C8-C10) active approval date and BPR product dossier submission deadline has not yet been set. Therefore, any biocidal products containing DDAC (C8-C10) which are placed on the EU market are subject to the specific national transitional requirements of Member States.
By switching to DDAC C8-C10 based products, you can contribute to a more sustainable future for the hygiene industry.
• ADBAC (C12-C16) is facing a tight deadline: BPR require prompt preparation and submission of the necessary documentation. Our formulated DDAC C8-C10 based solutions are available for a quick adoption.
• Streamline your processes with Arxada's formulations, supported by wide data set for immediate implementation/adoption.
• Boost performance: DDAC (C8-C10) offers superior efficacy at lower concentrations compared to ADBAC (C12-C16).
Customers adopting NUGEN® and Bardac® Disinfectants, Disinfectant Cleaners and Disinfectant Soaps will be supported through their notification process. Arxada’s support will vary depending on the country of notification/registration and may include e.g. ‘How To’ guidance documents (on how to comply with national requirements in relevant European countries under the Transitional Arrangements of the BPR), Letters of Access (LoA) and Letters of Supply (LoS).
Once the DDAC C8-C10 active substance is approved, customers using our formulations will be able to join the Arxada BPR dossier.
Register for our upcoming webinar where our experts will discuss the latest advancements in DDAC technology and answer your questions live.
For the most up to date national notification status or for further information on how Arxada may be able to support you with a notification/registration in your country of interest, please contact your Arxada sales representative or send an email: hygiene@arxada.com
By choosing Arxada, you can focus on your core business while we take care of the regulatory complexities. Together, we can ensure a sustainable and successful future for your disinfectant products.
Connect with an Arxada representative to discuss your disinfection requirements.