Many of our clients are still struggling to connect all of the necessary data which is needed for a successful PCN notification. In this post, I'll answer the most common questions we are getting, regarding PCN notifications.
1. Do we have to disclose the whole composition of our products to comply with European requirements for PCN notifications?
While it is desirable, it is not necessary condition. The minimal concentration of the composition you need to show is 70%.
If you do not want to disclose the minimal amount – 70%, there is a option of doing MiM (mixture in mixture) notification.
The point of PCN notification is that the EU receives the necessary information about the dangerousness of the product in the event of emergency, threatening the human life or the envirnoment. With EU Submission Portal the data becomes very accessable to emergency and first responders.
2. Do we need to do a PCN notification for all countries we sell into?
Yes, the PCN (Poison Centre Notification) notification is country specific. If you sell your products in Slovenia, you do the PCN for Slovenia, so the notification is valid only in Slovenia, not the whole EU (European Union).
This is important, because 4 of the EU countries are charging an additional cost of notifying the product in their market. These countries are Ireland, Hungary, Belgium, and Italy. They all have different conditions and different prices.
3. Do we need to create different UFI codes, if we sell the product to different countries?
No. You create a single UFI (Unique Formula Identifier) number for the product, which can be used across multiple markets.
You can have one UFI code per product, but you also have the choice to assign multiple UFI codes to one product – the choice is yours. But UFI codes are not country specific.
The most common example is a cleaner which has multiple scents, yet the composition stays the same. You can:
- Generate a single UFI for all scents.
- Generate multiple UFIs, assigning each scent its own UFI code.
If a single UFI code is used for all products, it implies that their composition is identical. However, listing different UFI codes on the label can obscure the fact that the composition is the same as in other products.
4. Is an English SDS (Safety Data Sheets) enough for the whole EU?
No. It can cover most of the countries but not all. And if you are wondering in which languages you need to have SDSs then this post is for you.
If you have another question or two, you can write to me at spela.hudobivnik@bens-consulting.eu, and I will help you to get started.