The extensive changes resulting from the new harmonized procedure for product notification of hazardous chemicals have been specified and implemented nationally through the adaptation of Annex VIII of the Classification, Labeling and Packaging (CLP) Regulation and amendments to the Chemical Act (ChemG). Below is a brief summary outlining the obligations arising from the Poison Centre Notification (PCN).
Which products are mandatory to be notified?
The PCN is mandatory for all mixtures classified as hazardous due to their health or physical effects. However, mixtures classified only as hazardous to the environment no longer require notification.
When has the new notification to be carried out?
Since January 1, 2021, the Poison Centre Notification (PCN) and the marking with the UFI Code have become mandatory. Mixtures used exclusively for industrial purposes (i.e., not intended for consumer or professional use in a mixture) are exempt from meeting these new requirements until January 1, 2024. For mixtures already notified following existing national procedures, a transitional period until January 1, 2025, is granted. Please be aware that in Germany, this transitional period does not extend to products solely notified in ISi information system for sa-fety data sheets (SDSs).
Who is required to submit?
Responsibility for PCN under Annex VIII of the CLP Regulation has shifted to the downstream user or the EU importer, whereas previously it was typically the responsibility of the importer in the respective EU country. Article 4(10) of the CLP Regulation mandates all actors in the supply chain to ensure the notification is completed. This includes contract manufacturers and anyone transferring mixtures into different containers, even if they are not the displayed manufacturer on the packaging. The EU states are currently debating whether re-branders or re-labellers can also be held accountable for the notification. It is crucial to meticulously determine the responsible party for notification in each case. Third parties like Dr. Gans-Eichler Chemieberatung GmbH can handle the notification process.
Implementation of the notification
The notification has to be sent to the Appointed Body of the member state where the product will be placed on the market. The company to be in charge for the notification must also consider the countries in which the product will be resold by other market participants.
The notification can be submitted either directly, via IUCLID or via the ECHA submission portal. Further to information on the notifying company and the product identifier, the following information are required for the notification:
- classification and labelling
- formulation (the complete formulation is required for the notification, the mandatory information in section 3 of the safety data sheet is mostly not sufficient)
- toxicological information
- pH value
- aggregate state
- Unique Formula Identifier (UFI-Code)
- product category according to European product categorisation system (EuPCS)
- information on packaging
For mixtures with undisclosed recipes, a 'Mixture in Mixture' (MiM) message can be issued, protecting trade secrets while enabling comprehensive notification across the supply chain.