Know the standard information requirements
What has changed?
What has changed?
The harmonisation of information requirements means that the existing national requirements across the EU have been replaced by one set of information requirements and one format of data submission, the Poison Centres Notification (PCN) format.
Some information requirements may be new compared to previous obligations that applied at national level. You may need to generate new information or adjust the existing information to the PCN format.
Industry steps 2 illustration
Information requirements -2
The unique formula identifier (UFI) is a new submission requirement and a new label element that is described in detail in step 4. An example of a UFI in the correct format is YV9K-3J9A-G209-C2T7. The UFI establishes a unequivocal link between the information you provide on a mixture through the notification and the corresponding product placed on the market, which helps ensure that the appropriate emergency health response is quickly identified in the event of an incident.
The full chemical composition of the mixture will be required. That means that you must indicate the exact concentrations or concentration ranges for hazardous and non-hazardous components. This is more than the information usually present in a safety data sheet.
The classification and labelling for the final mixture/product is required – in addition to this, the classification information of both the substance and mixture in mixture (MiM) components (including the substances contained in the MiM as well) will also need to be provided.
Toxicological information for the mixture will need to be provided. This information will need to be provided as free text, and is normally available in section 11 of a safety data sheet.
A product category must be assigned to the product based on its main intended use – for example, dishwashing detergent, adhesive, decorative paint – in accordance with the European product categorisation system (EuPCS).All submissions must also include information identifying the submitter, the product (e.g. trade name, packaging, colour) and whether the mixture has consumer, professional or industrial uses.
Information requirements - links
Support and essential reading
- ECHA animation: What is the UFI and what does it mean for your product labels?
- Presentation: What is a UFI [PDF] [EN]
- In brief: Information requirements for poison centres notifications
- Guidance on harmonised information relating to emergency health response – Annex VIII to CLP
- Annex VIII to the CLP Regulation
- The European product categorisation system (EuPCS)
- The European product categorisation system – A practical guide