January 1, 2025, is approaching quickly! To help you prepare, we’ve put together answers to the most common questions about Poison Centre notifications (PCNs)
1. What is a Poison Centre notification?
- PCN or PCN notification is a notification process by which a company reports information about a hazardous mixture to a single European poison center database.
2. Who is required to submit a Poison Centre notification?
- PCN notifications need to be submitted by importers and downstream users placing mixtures classified for human health or physical hazards on the market.
- The obligation covers mixtures for consumer, professional and industrial use.
3. What information needs to be included in a Poison Centre notification?
- The PCN notification usually include data like contact details, trade name or names of the mixture, Packaging type and size, Product category (main intented use), UFI code, The human health and physical hazard classifications of the mixture, label elements, Toxicological information, Information on physico-chemical properties and full mixture composition information.
4. What is a UFI (Unique Formula Identifier), and why is it important?
- The UFI is a 16-digit code. It is indicated on the labels of products that are classified as dangerous mixtures. It is also usually listed in safety data sheets.
- The UFI is part of the chemical legislation that came into force on January 1, 2021, and is intended to protect users of chemicals and to take appropriate action in case of poisoning.
5. When is a Poison Centre notification required to be submitted?
- Starting January 1, 2021, the Poison Centre Notification is mandatory for hazardous mixtures intended for consumer and professional use.
- Only mixtures exclusively used for industrial purposes are exempt from this requirement until January 1, 2024.
- For mixtures already notified under existing national procedures, a transitional period extends until January 1, 2025.
- If a mixture has more than one of the above uses – whether through direct use or through its presence in a product manufactured further down the supply chain – the earliest date applies. Before the relevant applicability date, the mixture continues to be subject to existing national information requirements.
6. What is the difference between a mixture and a substance in the context of Poison Centre notifications?
- A mixture refers to a combination of two or more substances, while a substance is a single chemical element or compound.
- UFI and PCN notification is required for hazardous mixtures and not for substances.
7. How often do Poison Centre notifications need to be updated?
- PCN notifications must be updated whenever there is a significant or a minor change in the products information.
- This information can be supplemented, modified, or adjusted in line with changes regarding the product. This process is termed an update to the PCN notification.
8. What are the consequences of failing to submit a Poison Centre notification?
- Non-compliance with CLP Regulation nb. 1272/2008, Article 45, can result in fines, product recalls, or restrictions on placing the product on the market.
9. How does the Poison Centre use the information provided in the notification?
- Poison Centres uses the information in order to provide medical advice in health emergencies such as poisoning incidents.
10. What is the deadline for submitting Poison Centre notifications under the European Union's CLP Regulation?
- Deadlines vary by product type, but for consumer products, the deadline was January 1, 2021. For professional use products, it was January 1, 2024, and for industrial use, it is January 1, 2025.
11. Are there any exemptions to the Poison Centre notification requirements?
- Yes, The obligation to submit information does not apply to mixtures classified as hazardous only due to environmental hazards (H4xx).
- Mixtures exempted from the submission requirements include also:
- mixtures classified as radioactive mixtures,
- mixtures subject to customs supervision,
- mixtures used in scientific research and development,
- medicinal and veterinary products, cosmetic products, medical devices and food and feeding stuffs, and
- mixtures only classified as gases under pressure and explosives.
12. Can I submit a Poison Centre notification for multiple countries at once?
- Yes, you can use IUCLID application inside the ECHA Submission Portal, which allows for notifications to multiple member states through a single submission.
While some of these points may seem straightforward, it is surprising how often they still come up. That’s why we’re committed to ensuring you have all the information you need well ahead of the deadline. Let's make sure everything is in order before January 1, 2025!
If you’re short of time you can still contact me al spela.hudobivnik@bens-consulting.eu or hop on to our PCN webpage.
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