If you manufacture or import hazardous chemical mixtures into the EU, you’re probably familiar with the requirement to submit a Poison Centre Notification (PCN).
But what if your company isn’t based in the EU? Or what if you want to protect your product’s formula while ensuring compliance? This is where Voluntary PCN comes into play.
What exactly is Voluntary PCN?
A Voluntary PCN is a notification submitted by a company that is not legally obligated to notify Poison Centres but chooses to do so to facilitate compliance for their customers. This is commonly used by non-EU manufacturers who want to support their EU-based importers or distributors.
Unlike a mandatory PCN, a voluntary notification does not fulfill all regulatory obligations on its own. Importers still need to ensure compliance, but a voluntary PCN can make their job easier and help protect confidential business information (CBI).
When should you consider a voluntary PCN?
If you’re a non-EU manufacturer – You cannot submit a mandatory PCN because you are not an EU entity, but a voluntary PCN allows you to support your customers.
If your importers are struggling with compliance – Many importers lack the resources or expertise to handle PCN submissions. Providing them with a voluntary UFI can simplify their process.
If you want to protect your formulation – Instead of disclosing full composition details to each importer, you can submit a voluntary PCN and give them the UFI code they need to fulfil the composition requirements when submitting their own PCNs.
What are the limitations of a voluntary PCN?
While voluntary PCN can be helpful, it’s important to be aware of its drawbacks:
- The UFI from a voluntary PCN cannot appear on product labels – Only a legally required UFI, submitted by a duty holder (an EU/EEA entity or entity based in Northern Ireland), can be printed on the packaging.
- The responsibility still falls on the importer – importers must still create their own mandatory PCN submission in most cases.
- It adds an extra cost – Since a voluntary PCN does not replace a mandatory submission, it may lead to higher compliance costs.
Should you use a voluntary PCN?
The decision to use a voluntary PCN depends on your business structure and goals. If protecting your formulation is a priority and your customers need compliance support, it’s a strong option.
However, if your importers are well-versed in PCN requirements, it may not be necessary.
In the next blog post, we’ll dive into the specific benefits and challenges of Voluntary PCN for importers vs. manufacturers—so stay tuned.
Back to posts
