From 1st January 2021, any product placed on European market, classified for either physical or health hazards, has to have UFI code placed on CLP label. The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that aims to provide a clear link between the information your provide to poison centres with the product you place on the market.
The information provided by you to poison centres will be used in case of emergency call. The UFI code should be clearly visible, so it can be easily read directly from the product. This will enable more accurate advice and avoid unnecessary over precautious treatment, which is often given just to be on the safe side.
UFI placement on the label should coincide with a submission to avoid 'empty' UFI's. If it's not linked to a submission, the UFI has no value and the mixture to which it refers will not be considered compliant.
How to obtain UFI code
The first step is to generate a UFI code. This can be done via ECHA UFI generator website. It's a simple process where you need to provide your company VAT number and internal formulation number for your product.
Next step will be submitting a dossier in harmonised PCN (Poison Centres Notification) format, which is common to all EU Member States. The list of Members States accepting notification via ECHA submission portal can be found here.
To complete the notification in the harmonised format, you will need to fill in various information about your mixture, this will include:
Company details;
The UFI;
Classification of mixture
Translated labelling elements and toxicological information
Product details: trade name, type of use (consumer, professional, industrial), type of packaging and size, product category (EuPCS), colour, ph.
Updating your notification
After submitting your initial notification, there might be a case where update to you notification becomes necessary. There are two possible scenarios. First one, where an update needs to be done but UFI code will stay the same as with the initial notification. Second one, where update needs to be done as well as a new UFI code generated.
A simple update to your initial notification without creation of a new UFI will need to be done if:
name of the mixture (product) has changed
you would like to expand an market area (notifying new members of states)
in case of new packaging
there is a change in the mixture classification
new toxicological information available
An update to your notification and creation of a new UFI will become necessary in the following cases:
Addition, replacement or removal of an ingredient. In other words, any change of mixture composition.
In case of “Mixture in Mixture” (MiM) type of product, if the UFI code of the mixture in the composition has changed by the supplier.
Change in composition exceeds the concentration limits specified in legislation
To summarise
UFI is an obligation.
UFI needs to be visible on the label (or SDS) and in the submission.
PCN submitted with complete information (Annex VIII)
UFI becomes meaningful once submitted
The UFI is a link - the code itself does not reveal any compositional information
UFI is unique per mixture composition.