Safety data sheet knowledge base – Unique Formula Identifier. Application of the UFI and labelling of mixtures
The unique formula identifier (UFI) is a 16-character code to be indicated on the label of mixtures. The UFI is an element of the submission of hazardous mixtures which has to be carried out in a harmonized form (PCN).
As a result of the submission, unified data will be available in the EU member states for medical personnel. The application of the code makes it possible for Poison Centres to provide information about the hazardous mixture during emergency situations.
Provisions regarding the application of the UFI as well as the labelling of mixtures have been announced in Commission Regulation (EU) 2017/542 which amends Regulation (EC) 1272/2008 (CLP) by adding a new Annex (VIII) to it. These provisions will be mandatory for all member states of the EEA.
In the possession of the UFI code (which is given for the authorities during the procedure of the submission) the composition of a certain mixture is clearly identifiable, thus helping a quick response during an emergency. At the same time, is also makes the safe handling of the composition possible. Only the relevant authority (of the member state) is informed about the data given during submission.
A given mixture composition is identified by a given formula identifier.
Products with identical composition but different fantasy names (so the same mixture is placed on the market with different commercial names) get the same UFI code.
All products get individual formula identifiers.
In this case, a product will have more UFI codes. This is applicable in cases where one mixture is placed on the market with more different fantasy names (product names).
For a better understanding of the mixture-based and product-based approaches it is essential to specify the definition of mixture and product:
Contains at least two ingredients (which can be a substance and a mixture (MiM – Mixture in mixture), as well).
Characteristics of a mixture are mainly determined by its composition and physical-chemical properties.
Mixture intended for sale, which is typically identified by a commercial (fantasy) name and whose characteristics are determined mainly by the packaging, the labelling and the product category.
The same mixtures get different formula identifiers if they are placed on the market in different countries.
For instance, “Product 1” placed on the market in Germany gets a unique formula identifier (“UFI 1”) but “Product 1” placed on the market in Spain gets another (“UFI 2”) code.
Language / label-centred approach
Similar to the “market-based approach” but this one also takes into account the fact that the official language of some countries can be the same (e.g. German language in Germany, Austria).
Any of the above-mentioned strategies can be correct until the following fundamental principle is not violated:
The UFI has to identify a given composition and can never indicate mixtures with different composition!
The UFI generator is a web-based application that can be used online (in browser). Its use is free of charge and available in all official languages of the European Union.
The Unique UFI code can be created by providing the batch number of the mixture.
The update of the UFI is necessary:
In case of change in composition (if the degree of change falls inside the limits specified by legislation, see: below) it is necessary to assign a new composition identifier (batch number) to the UFI.
The UFI code remains the same, only the identification number changes.
Creation of a new UFI* is necessary in the following cases:
Change in the concentration of the mixture’s components that makes the creation of a new UFI necessary:
Concentration of the component in the mixture (degree of change):
< 2.5% (30%)
Steps to be taken after the creation of a new UFI:
The creation of a new UFI is not necessary if:
Further information in relation with the obligation regarding the update of the PCN submission
If the downstream user uses a mixture (MIM – Mixture in mixture) for the formulation of the mixture, it is sufficient to know the UFI code instead of the composition of the mixture.
The practical background of this is that virtually every component has to be given during submission that could cause serious difficulties in the case of a “Mixture in Mixture” type of product. The composition of the used mixture has probably been submitted formerly in the supply chain, so, in the knowledge of the UFI, the possible dangers will also be known by the authority. As a matter of course, the unique formula identifier of the mixture used in formulating the mixture does not have to be indicated on the label (the code of the finished product has to be indicated on it), therefore the outgiving of confidential information can be avoided.
Taking into account the above information, it is clearly important to communicate the changes of the mixtures’ UFI number inside the supply chain because in such cases parties using the mixture in formulating an own mixture have to update their own submission.
Further information regarding other obligations for communication can be found here.
Further information about the placement of the unique formula identifier and about CLP labelling can be found in our article entitled “CLP label, labelling in practice”.