Adapt your data
You need to perform a number of other tasks to have all the required information at hand and to be able to submit it for effective use by poison centres.
Check the formulation and components of all your mixtures affected by your obligations. Start assigning exact concentrations or appropriate concentration ranges distinguishing between components of major concern and other components. See ‘Declaring concentrations under Annex VIII to the CLP Regulation’ for more information on how to provide component concentrations.
There are some exceptions for perfumes for which you may not need to provide information on the concentration. The exception can be applied if the components are not classified or classified only for skin sensitisation or aspiration toxicity and their total concentration does not exceed 5 %.
Additionally, generic component identifiers (GCI), can be used to identify components of a mixture, if they are used exclusively as a perfume or colouring agent in the mixture. This is possible only if they are not classified as hazardous to human health and their total concentration does not exceed 5 % for perfumes or 25 % for colouring agents.
A list of Standard Formulas (specifying specific components’ identity and concentrations) has been introduced to Annex VIII and limited to cement, gypsum and concrete products. Mixtures conforming to one of these Standard Formulas do not need to comply with the standard requirements with regards to the information on composition.
In some cases it is not possible to determine the exact mixture composition because of an unforeseeable change in components, but with no changes with regard to classification, hazard or emergency health response e.g. when a component which is toxicologically similar but not exactly the same, is purchased from different suppliers. If the components meet the specific criteria defined in Annex VIII (Section 3.5 of Part B), they can be grouped in an Interchangeable Component Group.
Other exceptions exist regarding the reporting of the composition for certain fuels, i.e. those listed in Annex VIII Table 3. These fuels may be reported according to safety data sheet listing also any other known components.
Mixtures in mixtures
Specific rules have been established for mixtures incorporated into other mixtures, i.e. mixtures in mixtures (MiMs). Information on substances contained in the MiMs used in the final mixture should be provided just as for other component substances of the final mixture. Obtaining this information may require enhanced communication in the supply chain, as safety data sheet information will in most cases not be sufficient.
If the full compositional information of the MiM is not available, you may use the UFI of the MiM provided by your supplier along with the information on the known components in your submission. You should make sure that your supplier has included this UFI in a submission to the relvant appointed body.
If the UFI is absent, or has not been notified to the relevant Appointed Body, compositional information available from the safety data sheet of the MiM can be used together with the name and contact information of the EU supplier, but this should only be done as a last resort.
Toxicological information on the mixture will need to be entered as free text and therefore cannot be automatically translated into other EU languages in the same way as all the structured information. For this purpose, review the quality of information in Section 11 of the safety data sheet as you may need to extract and re-work the relevant information to ensure that poison centres can easily access it during emergencies. For example, the information should not contain cross-references to other sections of the safety data sheet.
Because the safety data sheet is not an information requirement, all data should be provided directly in the PCN format, not in attachments.
Unique formula identifier (UFI)
Be prepared to provide UFIs to your customers and to ask for UFIs from your suppliers. In the case of a MiM, you may provide the UFI to your downstream formulator, just as you can receive a UFI from your upstream supplier. This helps to protect confidential business information, as no information on the full composition of the MiM is disclosed. It will be possible to use UFIs in this way also for non-hazardous
mixtures and mixtures classified as hazardous to the environment only.
Note that before a UFI is communicated in the supply chain instead of composition information, the UFI must already be known to poison centres as part of a submission.
Additional product information
Set up or adapt your data management system by collecting or mapping additional product information that is required for the submission which may be new for you. For instance:
- The product category is one of the new information requirements. The product category is based on the main intended use of the product. This needs to be indicated according to the harmonised European product categorisation system (EuPCS), a system comprising around 250 categories. Both the EuPCS itself and a practical guide are available to assist you in selecting the appropriate product categories for your mixtures.
- Colour information, while relatively straightforward, may require mapping between the colour descriptions used by your company and the 14 colours available in the PCN format. This information must be useful for emergency response and realistically reflect the colours a person contacting a poison centre would be able to describe.
- For consumer and professional use products, packaging information may also require some work at company level. A set list of different packaging types and sizes is available for selection in the PCN format. Ranges are not permitted in the notification.