The European Poison Centres Notification (PCN) is already firmly established for many manufacturers, formulators and distributors. Nevertheless, there is still a proportion of products that do not yet have a UFI on the label, even though the obligation to indicate it would be there. The reason for this is a transitional regulation that will no longer apply from 2025. I am taking this change as an opportunity to summarize the PCN obligation here for all those affected and newcomers.

Where does the PCN obligation come from?

The obligation to prepare PCNs can be found in Article 45 of the CLP Regulation. Details of the content and further information can be found in Annex VIII. Tip: ECHA guidance is available in the sources.

Which products are affected?

All products that are a mixture of substances and have a physico-chemical classification or a health classification according to the CLP Regulation. Pictograms therefore appear on the label, with the exception of environmental hazards (tree and fish). If you want to be absolutely sure, pay attention to the H-phrases: If H-phrases occur with H2XX or H3XX, then the label should include a UFI (unique formulation identifier) and a PCN should exist for the product. Exception: There is only a classification for gases under pressure and / or explosive classifications (these have other requirements outside the PCN).

From 2025, it will therefore be easy for both authorities and customers to understand whether a UFI should be on the hazardous substance label or not.

Who has to report?

Any manufacturer / formulator who places the affected mixtures on the market, i.e. transfers them to another company, a dealer, private individuals, etc.. It is not decisive whether money was charged for the product.

The UFI must already be included on the label for the mixtures concerned and the notification must be submitted to the relevant member states.

Traders should ensure that their goods have the UFI if necessary and that the PCN has been provided for all member countries concerned. Alternatively, they can also self-report. In detail, the obligations for traders with PCNs differ from member state to member state, so those affected should read more carefully here.

How does the message work?

PCN is a purely electronic format. It is possible to record the product data using the IUCLID 6 software provided by ECHA and send it to the ECHA portal as a PCN.

However, for users of SDS creation software, such as GeSi³ from our company, it is usually easier to create the PCN directly with this software. Much of the information is necessary for the creation of safety data sheets anyway and there is even the option of sending the PCN directly from the software to the ECHA portal using the System 2 system. Creating them in this way not only saves time, but also the tedious insertion of translations and guarantees the uniqueness of the software-generated UFI for the products.

Sources:

[1] CLP Regulation on EUR-Lex (Regulation (EC) No 1272/2008)

[2] Poison Centers page of the ECHA

[3] Guidance on compliance with Annex VIII of the CLP Regulation (ECHA)