The harmonization of info needs replaced EU’s varied national demands with unified 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.
The Role of Unique Formula Identifier (UFI) in Mixture Regulation
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 an 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.
Comprehensive Chemical Composition Reporting
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.
Inclusive Classification and Labelling
The final product needs classification and labeling. Furthermore, it’s necessary to provide classification details for MiM components, including substances within.
Providing Essential Toxicological Information
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.
Categorizing Products According to Intended Use
The product’s primary use determines its assigned category, such as dishwashing detergent or decorative paint, using EuPCS guidelines.
Submission Details and Identifying Information
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.
Exposure Scenarios and Safety Data Sheet Requirements
- Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14 or 37 shall place the relevant exposure scenarios (including use and exposure categories where appropriate) in an annex to the safety data sheet covering identified uses and including specific conditions resulting from the application of Section 3 of Annex XI.
Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses.
Any distributor shall pass on relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for uses for which he has passed on information according to Article 37(2).
Provision of Safety Data Sheets
- A safety data sheet shall be provided free of charge on paper or electronically.
Updates and Revisions to Safety Data Sheets
- Suppliers shall update the safety data sheet without delay on the following occasions:
(a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available;
(b) once an authorisation has been granted or refused;
(c) once a restriction has been imposed.
The new, dated version of the information, identified as ‘Revision: (date)’, shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or preparation within the preceding 12 months. Any updates following registration shall include the registration number.
Article 32