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Voluntary PCN: Key takeaways and how to simplify your compliance strategy

We’ve covered everything from what a Voluntary Poison Centre Notification (PCN) is, its benefits and challenges, how to submit one, and how it compares to mandatory PCNs.

Now, let’s wrap up with some key takeaways and practical steps to make compliance easier for your business.

Key takeaways from this series

✅ A voluntary PCN is a strategic tool, not a replacement for mandatory PCNs. It can support importers and protect formulations, but it doesn’t eliminate compliance obligations for EEA-based businesses.

✅ A single UFI can be used across multiple countries, but only if properly registered. Without a PCN submission in each relevant country, the UFI alone is meaningless for compliance.

✅ Non-EU manufacturers benefit from voluntary PCNs by protecting proprietary formulas. Instead of disclosing full ingredient details, they can submit a voluntary PCN and provide importers with the voluntary UFI they need link to composition.

✅ Importers remain responsible for mandatory PCN submissions. Even if a voluntary PCN is in place, importers still need to notify Poison Centres themselves.

✅ Choosing between an EEA-wide PCN and country-specific PCNs depends on your business model. EEA-wide PCNs save time and effort but require an EU legal entity, while country-specific PCNs offer flexibility for businesses working with multiple importers.

How to simplify your PCN compliance?

1️⃣ Decide whether a voluntary PCN makes sense for your business. If you’re a non-EU manufacturer or need to protect your formula, it may be the best option.

2️⃣ Work with a compliance partner if needed. If you don’t have an EEA entity, experts like BENS Consulting can act as your notifier.

3️⃣ Coordinate with your importers and distributors. Ensure they understand their obligations and how your voluntary PCN fits into their compliance process.

4️⃣ Keep your PCNs up to date. If your product formulation changes, you need to update your PCN submission to remain compliant.

5️⃣ Plan ahead. Don’t wait until the last minute to address PCN requirements, as delays can lead to regulatory issues.

Final thoughts

PCN compliance can be complex, but by understanding your options—whether it’s voluntary PCN, EEA-wide PCN, or country-specific PCNs—you can make informed decisions that protect your business and streamline regulatory processes.

Need help navigating PCN requirements? Contact us today at info@bens-consulting.eu to discuss the best strategy for your products.

Disclaimer:
Information on this blog is prepared with utmost care, but it is not about (chemical) consulting, and the provider does not assume any responsibility or liability for the correctness, accuracy and up-to-dateness of published content. If you need advice for a specific case, you can write to us at bojan.dimic@bens-consulting.eu
UFI / PCN | March 14, 2025

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