Compliance date for industrial use only mixtures approaching - January 2024
Importers and downstream users of industrial use only mixtures need to be aware of the upcoming second poison centre compliance date. From 1 January 2024, all newly submitted poison centre notifications must comply with the harmonised information requirements outlined in Annex VIII to the CLP Regulation.
The difference between mixtures for industrial use only and industrial use
Industrial use only mixtures are exclusively used at industrial sites and are not available to consumer or professional users either as a final product or in diluted form through reformulation (a mixture in mixture (MiM)).
An example of an industrial use only mixture (as a final product) could be an automotive paint used only at industrial site and accessible only by industrial end users. While an example of an industrial use only mixture (as a MiM) would be the pigment used to make the automotive paint.
On the other hand, industrial use mixtures do serve industrial end users but may also find their way into the market for professional and/or consumer user types due to two factors. Either they are available as a final product for multiple user types, or, they are reformulated into other mixtures, which become available to consumer or professional users (in diluted form). The compliance date for harmonised notification of these industrial use mixtures was already in 2021 and must include all relevant user types.
If an industrial use only mixture is on the market and already notified via national submission systems before the 2024 compliance date, it may benefit from the transitional period until 1 January 2025. This means that after this date, all notifications, regardless of the use type, will need to notified in the harmonised format.
Companies need to know that during the transitional period, should any modifications be made to the mixture's composition, product identifiers, classification (for health or physical hazards), or toxicological information, this will require a notification in the harmonised format before introducing the modified mixture to the market.
The harmonised information requirements include the full chemical composition, the toxicological information, information about the product, and the unique formula identifier (UFI), according to Annex VIII to the CLP Regulation.
However, industrial use mixtures have the option of making a "limited submission", where compositional information from the Safety Data Sheet can be used. If this option is used, the notification must include a contact person who can provide around the clock rapid access to the complete compositional details in case of an incident.
UFI in the notification and the label
All hazardous mixtures requiring a notification must have a UFI in both the PCN notification and on the product label so poison centres can establish the correct link between the product and the submitted data. However, if a hazardous mixture is used exclusively at an industrial site, the UFI may be indicated in Section 1.1 of the Safety Data Sheet only and not on the label. If the same mixture is available also for consumer or professional users, the UFI is required on the label to ensure the commitment to safety for those users.
Main use from the European Product Categorisation System (EuPCS)
To identify the main intended use of a mixture, the most relevant category is selected from the EuPCS. For example, if the mixture is primarily used for reformulation into other mixtures, choose "F – for further formulation." If the mixture has an end use, select the relevant category (e.g. automotive and aerospace coatings). If mixtures have multiple intended uses, it is possible to include secondary uses. In some cases, it may be difficult to assign a product category – if in doubt, please contact your industry association for any recommendations. It is also possible to request a change to the EuPCS through our Helpdesk.
Tools and support to help you notify
To facilitate successful notification in the new harmonised format, tools and step-by-step support are available on our website. Most materials are already accessible in all EU official languages. For specific regulatory advice, contact your national helpdesk for support in your preferred language or the ECHA Helpdesk for any support with the IT tools. We also have an active LinkedIn community where you can interact with the poison centre team at ECHA and other duty holders.
- Guidance on Annex VIII
- PCN Practical Guide Prepare & submit poison centre notifications (PCN)
- Video tutorial on how to prepare and submit an initial PCN e-Learning
- Overview of Member States' document
- National appointed bodies
- ECHA’s LinkedIn poison centre notification group
- National Helpdesks
- ECHA Helpdesk contact form