PCN notification update – what is it and when should you do it?

We’ve already discussed various aspects of PCN notifications and UFI codes extensively on the blog. However, one important topic we’ve overlooked so far is the updating of PCN notifications.

Let’s start with the basics: What exactly is a PCN notification? And what constitutes an update to a PCN notification?

A PCN notification, or simply a submission, is the process of reporting data on a hazardous mixture into the unified European database of poison centers.

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.

Updating a PCN notification occurs in the case of the following changes:

• expansion of market area,
• correction/deletion of trade name,
• cease product from the market,
• change in the mixture composition without requiring a new UFI,
• re-place product on the market,
• change in the mixture classification,
• change in the product identifier,
• new toxicological information available,
• correction of error.

Let’s delve deeper into each reason:

Expansion of market area involves expanding marketing to new markets beyond existing ones.

Correction/deletion of trade name is necessary in cases of grammatical errors or incorrect trade names.

Cease product from the market is a significant update indicating the cessation of product marketing in a specific market. It’s important to note that in one update, only withdrawal from one or more countries can be selected, but countries cannot be added or removed at the same time.

Change in the mixture composition without requiring a new UFI refers to minimal deviations in ingredient concentrations, where the product composition remains the same, only the concentration ratio changes.

Re-place product on the market refers to the situation where a product resumes marketing in a market from which it was previously withdrawn.

Change in the mixture classification refers to any change in mixture classification, including a change from a hazardous mixture to a nonhazardous mixture.

Change in the product identifier involves the submission of a new trade name, additional UFI codes, or other identification data.

New toxicological information available includes updated ecological and toxicological information on the safety data sheet.

Correction of error entails rectifying incorrect or invalid data in the existing submission, such as correcting an invalid phone number.

Understanding the changes and procedures for updating PCN notifications enables effective risk management and ensures safety for both consumers and the environment. Therefore, it’s crucial for companies to regularly monitor their PCN notifications and, when necessary, perform appropriate updates in compliance with regulations.

If you have any further questions or need assistance with cases that may not fit into any of the listed reasons, please contact me via email at spela.hudobivnik@bens-consulting.eu.