Missed the BPR deadline for ADBAC/BKC (C12-C16) based products in PT 2?

 

Relax – we have a solution.

Yes, we know. The July 2025 deadline for submitting the biocidal dossier for ADBAC (C12-C16) based formulations in Product Type 2 (PT 2) may have been a significant challenge for many. If your ADBAC-based disinfectants haven't been submitted yet, we understand this situation can be highly concerning.

Product withdrawal, reputational damage, or business loss are real consequences of non-compliance with the Biocidal Products Regulation (BPR).  

But all is not lost! In this article, you'll find practical advice on how to navigate the current situation and plan your next move.

 

What happens when your dossier isn't submitted on time?

According to the Biocidal Products Regulation (BPR), the consequences are clear:

• Loss of market availability: If a product authorization application is not submitted by the designated deadline, the biocidal product can no longer be made available on the market. This takes effect 180 days after the deadline..

• Disposal and use of existing stocks of the biocidal product may continue until 365 days after the approval of the active substance. Understanding these consequences is the first step towards finding a solution.

What can you do if you missed the deadline?

There are several paths worth considering:

1. Late submission of the application:

Yes, a product authorization application can still be submitted after the designated deadline. However, it's crucial to remember that the product will not be available on the market until authorization is granted. For products submitted after the deadline, the BPR authorization process can take 3-5 years. This means you would need to halt sales and distribution until full authorization is obtained.

2. Employing “delay techniques”:

While these techniques might seem tempting, it's important to weigh their pros and cons, which we've discussed before. The main risks include:

• Significant costs: Reformulation (e.g., adding a new active substance) means new efficacy and stability studies, national registrations, and certifications — generating enormous expenses without any guarantee of success.

• Risk of non-approval: The added active substance may not be approved, or it may be approved with restrictions, rendering the entire product non-compliant.

• Uncertain future: There's no telling how long the evaluation of the added substance will take, or if supporting companies will withdraw due to rising costs.

• Re-certification requirements: dual-use products (e.g., medical devices and desinfectants) will require new national biocidal registrations and medical device re-certification incurring additional costs and time.

To delve deeper into delay techniques, we invite you to read our previous post, where we discussed this issue in detail.

3. Collaborating with a supplier of a yet-to-be-approved active substance:

This option entails collaborating with a supplier of an active substance currently approved for national (country-specific) registration for Product Type 2 (PT2). This partner commits to supporting future BPR (Biocidal Products Regulation) registration of the active substance-based product by preparing the necessary dossier when the EU registration date is confirmed.

Here's where Arxada steps in — and why it's a game-changer for you:

At Arxada, we understand the complexities of BPR regulations and the challenges you face. That's why we offer solutions that can completely change your situation:

We provide Bardac® 2080 active substances and ready-to-use NUGEN® disinfectant formulations based upon DDAC C8-C10. 

These are ready for immediate market introduction in EU Member States – under your own brand!

We ensure that all our products meet national notification requirements and adhere to rigorous safety and efficacy standards.

We simplify the regulatory process, supporting your applications to the Member State Competent Authorities (MSCA) by providing expert advice, Letters of Access (LoA), and Letters of Supply (LoS). Obtaining a Letter of Access to a product with existing country registrations enables data sharing, helping you avoid the need to generate costly data independently. This saves time and money, allowing your products to be nationally notified before the active substance's full approval, permitting continuous market availability under transitional arrangements until full BPR authorization is achieved.

We are fully committed to supporting NUGEN® formulations' BPR authorization. This comprehensive support ensures regulatory compliance and accelerates your market entry.

We're here to help you navigate the complexities of BPR regulations. Please reach out if you need personalized support. Don't let an unsubmitted dossier jeopardize your business!

 

Don't gamble with your company's future. Choose certainty and security with Arxada.