Why is Bulgaria holding on to its national Poison Centre Notification system?

Bulgaria remains the only EU member state that continues to accept Poison Centre Notifications (PCN) exclusively through its national system, rather than transitioning to the ECHA (European Chemicals Agency) portal.  

This decision is influenced by several factors related to regulatory independence, existing infrastructure, and the complexities of transition.  

Since we have quite a few clients asking about this, I decided to do a bit of research on the subject and provide my view of the matter. Let's dive in together shall we.  

Here's a quick summary of the current status of Bulgaria's PCN system:

1. Regulatory Framework: Bulgaria has not yet fully transitioned from its national notification system to the ECHA submission portal, which is mandated by Annex VIII of the CLP Regulation. This requires all hazardous mixtures to be notified to poison centers in a harmonized format.
   
   
2. Lack of Confirmation: As of recent updates, Bulgaria has not confirmed its readiness to accept notifications via the ECHA portal. This means that if you're selling in Bulgarian market, you must continue using the national system until further notice. There is no information available as to when they will transition to ECHA notifications at the moment.
   
   
3. Transitional Period: If you've been keeping up with PCNs then you know the transitional period for member states to adapt to the new notification requirements was set to end on January 1, 2025. Bulgaria’s decision to maintain its current system may stem from the need for additional time to prepare its infrastructure and processes for these new requirements.
   
   
4. Comparison with other EU countries: As mentioned at the beginning, Bulgaria remains the only country relying only on national systems.
   
   
5. Implementation challenges: Transitioning involves significant logistical and administrative changes, which may pose challenges for Bulgaria. Factors such as technical readiness, personnel training, and compliance with new data submission formats can contribute to delays.

Now that we've dealt with the overview, we need to look at the possible reasons for such a decision. Here are six reasons I believe could be factored in when making such a decision:

1. Regulatory independence: By maintaining its own notification system, Bulgaria retains regulatory independence and control over how notifications are processed. This can be crucial for ensuring adherence to local regulations and practices.
   
   
2. Existing infrastructure: The country likely has an established infrastructure that predates the ECHA portal's introduction. Transitioning to a new system can be resource-intensive and time-consuming due to necessary changes in processes and technology.
   
   
3. Complexity of transition: Adapting to the ECHA portal requires confirmation of readiness and alignment with a new harmonized format. Bulgaria may still be navigating these complexities, including ensuring that all stakeholders are prepared for the change.
   
   
4. Language and communication: The national system operates in Bulgaria's official language, facilitating better communication for local companies submitting notifications. The ECHA portal may therefore present language barriers or require additional resources for translation.
   
   
5. Timeframe for compliance: Despite missing the final compliance deadline (January 1st, 2025), Bulgaria decided to continue with its existing system until it is fully ready for integration with the ECHA portal. This approach allows companies to operate without disruption while preparations are made.
   
   
6. Assessment of local needs: Bulgaria might determine that its national system better meets the specific needs of local industry and stakeholders at this time, allowing for tailored responses aligned with national priorities.

Here's my TLDR: Bulgaria's continued use of its national PCN system reflects a combination of regulatory independence, existing infrastructure, and the complexities involved in transitioning to a new centralized system.  
 
From the current development it appears that Bulgaria is committed to ensuring that it is adequately prepared before making this significant change.

Hope you find this insightful and helpful. Now, if you need help with submitting PCNs quickly and effortlessly then it might be time to contact me. You can write to me at Luka.Rifelj@bens-consulting.eu.

Image by Виктор Сапожников from Pixabay