In a PCN notification, the formulator or the first importer is required to submit the complete composition of the mixture that is being placed on the market. If other mixtures with unknown composition are used in the formulation, the supplier can, in the notification, refer to their UFI code when indicating the unknown part of composition.
But what should an entity that is required to make a PCN notification do if the supplier of the mixture is not required to provide a UFI code because the mixture is only intended for industrial or professional use and the UFI code has not been provided yet (and no PCN notification has been made)?
There are two options.
First, the suppliers should ask the manufacturer of the mixture to disclose the complete composition of the mixture for the purposes of a PCN notification. This is an option preferred by ECHA and completely fulfils the legal obligation of the company making the PCN notification.
But, as you can imagine, suppliers will rarely disclose the complete composition of their products, because complete compositions of mixtures are usually considered trade secrets.
If the entity required to make a PCN notification cannot acquire this piece of information, they have another option.
In their application, they can list the specific mixture without the UFI code (known substances in the mixture should be listed separately), but they must attach the safety data sheet for that mixtureand the contact details of the SDS supplier.
Such applications, however, are only valid until 2025. In case of inspection, the competent authorities have the right to demand the review of correspondence in which the entity required to make a PCN notification asked the manufacturer to provide the complete composition of the mixture for the purposes of the notification.
This second option is further explained in recently published guidelines, i.e. in section 5.3.3., and is applicable for the transitional period. This transitional period refers to the time when not all mixtures on the market have UFI codes and PCN notifications.
If you have any questions regarding the UFI, PCN and other topics connected to providing data to poison centres, follow our blog or contact us.
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