I got these two questions recently from a fellow regulatory expert:
»I have found one article from you about the UFI and I wanted to re-assure two points and ask you:
Here’s what I answered an I hope it helps you as well:
First, UFI codes and PCN notifications are meant to serve as information in case of poisoning by people. Therefore, as far as we know, it is not expected that the obligation would be expanded to mixtures, classified with environmental hazards only.
My answer to your second question about placements of UFI codes on SDSs originates from REACH regulation. Here’s what is says:
»Where a mixture has a Unique Formula Identifier (UFI) in accordance with section 5 of Part A of Annex VIII to Regulation (EC) No 1272/2008 and that UFI is indicated in the safety data sheet, then the UFI shall be provided in this subsection.«
So let’s look in Part A, Section 5 of CLP regulaton, ANNEX VIII, that is relevant:
In the case of mixtures which are not packaged, the UFI shall be indicated in the Safety Data Sheet or be included in the copy of the label elements referred to in Article 29(3), as applicable.
In the case of packaged mixtures supplied for use at an industrial site, instead of including the UFI on the label or packaging, the submitter may opt to indicate it in the Safety Data Sheet.
Further on, Guidance on Annex VIII says:
»In general, the inclusion of the UFI in the safety data sheet is not a standard requirement. In cases where a hazardous mixture is used at an industrial site, the UFI may be indicated in Section 1.1 of the SDS (in this case the inclusion on the label or packaging is not mandatory.«
»In the case of hazardous mixtures which are sold not packaged, the UFI must be indicated in Section 1.1 of the SDS. In the specific case of hazardous mixtures listed in Part 5 of Annex II to CLP that are supplied to the general public the UFI has to be included in the copy of the label elements provided for in Article 29(3), e.g. attached to the delivery note.«
So the bottom line is this – a valid UFI code can always be placed in the SDS. If you decide to do so, it should be provided in subsection 1.1. – Product identifier. This does not mean it is mandatory to always place it in the SDS, as we have seen above.
I hope you find this article useful. If you have any specific questions regarding UFI and PCN, we can help you. Just write us at firstname.lastname@example.org.