Why Industry is still struggling with Poison Centre Notifications and Unique Formula Identifiers
Since the rollout of Poison Centre Notifications (PCNs) under Annex VIII of the Classification, Labelling and Packaging (CLP) Regulation, many companies, especially those dealing with hazardous mixtures, have had to adapt to new technical rules, evolving guidance and practical complexities. From minor label tweaks to managing complex supply chains, PCNs and Unique Formula Identifiers (UFIs) remain a significant compliance focus.
Here’s a look at some of the common challenges businesses are facing and what companies can do to navigate them.
Is a New UFI needed for a small change in composition?
A common issue. Making a seemingly minor change to your formulation can require a new UFI. This means businesses might need to scrap or reprint entire batches of product labels, which can be costly.
While a UFI is meant to be “recipe-specific,” many are left wondering whether there’s room for flexibility when the change doesn’t affect classification. The guidance remains firm that any shift in composition beyond the bounds of the notified ranges will trigger a new UFI.
What can be done: Companies should review the ranges they have notified for each of their substances and/or Mixture in Mixtures (MiMs) in their product. There is some flexibility to amend compositions whilst remaining within the notified ranges.
Ricardo offers a range of services to support with UFI management including:
- Assessing the impact on a UFI when sourcing a new supplier of a Mixture in Mixture (MiM)
- Assessing the impact of formulation changes
- Assessing the impact of new suppliers of MiMs on Interchangeable component groups (ICGs) and/or Group submissions
Learn more about maintaining Poison Centre compliance
Where does the UFI belong: label or SDS?
For mixtures used in consumer and/or professional settings, the UFI must be present on the label, however for mixtures used only in industrial settings, the UFI doesn’t need to go on the label, it can be included in the Safety Data Sheet (SDS) (Section 1.1).
Confusion arises when users aren’t sure if their product qualifies as “industrial-only” or when it’s sold to other businesses that might rebrand it. Different EU countries may also have varying enforcement practices, leading to uncertainty around whether the UFI should appear on the label.
What can be done: Companies should engage in clear communication with their supply chain to ascertain the use of their product.
Learn more about Ricardo’s SDS services
What if full composition information isn’t available?
If you’re working with a fragrance oil or a colorant as a MiM and don’t have the full composition, just the SDS, can you still submit a valid PCN?
In many cases, businesses try to submit MiMs by uploading the supplier’s SDS. However, without a UFI or full breakdown from the supplier, the notification is not compliant, even if the company is doing its best with the available information.
What can be done: Companies should proactively engage with their suppliers to obtain complete and accurate composition data. This is essential for ensuring that PCNs are compliant and that emergency responders have the information they need.
How to support non-EU suppliers with PCNs
Non-EU suppliers selling into the EU often face additional challenges. Without an EU VAT number or legal presence, they may be unable to generate a UFI themselves. This raises questions like:
- Do we need to create the UFI?
- Should the UFI go on the label?
- Or should we send the UFI to the importer?
While the EU-based importer is legally responsible for submitting the PCN, suppliers with detailed formulation data may choose to take on the notification voluntarily to support the notification obligations of the EU-based importer. In such cases, close coordination between both parties is essential.
What can be done: Ricardo offers a practical solution for non-EU suppliers. By leveraging Ricardo’s EU legal entity, suppliers can generate UFIs and pass them along the supply chain, without disclosing sensitive formulation details to their customers. This approach helps maintain confidentiality while ensuring regulatory compliance.
Open communication between suppliers and EU-based importers is also key. Defining roles early and aligning on data-sharing protocols can streamline the PCN process and avoid delays.
Understanding member state fees and requirements
Some countries, like Belgium, Italy, and Hungary, charge fees for PCN submissions, adding complexity and cost for companies. These fees, combined with varying procedural requirements, can make it difficult to manage PCNs at scale, particularly for SMEs.
What can be done: Companies should stay informed about each country’s specific requirements, including fees and submission processes. Working with local consultants or legal advisors can help to ensure smooth compliance with national regulations.
Learn more about national regulations with Ricardo’s compliance reports
What’s Next for PCN Compliance?
Although Annex VIII has been in force for several years, the PCN system continues to evolve. Businesses are still navigating grey areas, especially when dealing with complex mixtures, cross-border supply chains, and non-EU partners. While ECHA has made strides in refining tools like IUCLID and the Submission Portal, many practical scenarios remain challenging.
Ricardo has submitted thousands of notifications since the introduction of Annex VIII and continues to support companies across sectors in managing PCN compliance. Whether you're struggling with MiMs, coordinating with non-EU suppliers, or navigating national submission requirements, Ricardo’s regulatory experts can help you streamline processes, reduce risk and maintain compliance with confidence.
