Poison Centre Notifications
Under the CLP Art. 45 Annex VIII, products classified for health and physical hazards need to be notified before they are placed on the market in the European Economic Area (EEA). They need to have validated UFIs printed on or in the proximity of labels. The UFI is only one aspect of this new requirement. Besides the UFI, you will also be required to provide information on the mixture such as the composition, product category according to the European Product Category System (EuPCS), product packaging according to the ECHA defined list of packaging, color in accordance to the ECHA list of accepted colors, and many more.
What is a UFI?
UFI is the acronym for “Unique Formula Identifier”. It is a 16-character alphanumeric code that has to appear on the labels of products that are considered hazardous under the CLP Art. 45 Annex VIII regulation.
Products, or more precisely, the chemical mixture of the product, is considered hazardous if it is classified for health or physical hazards. Products that are a chemical mixture need to have a valid UFI before they are placed on the market within the European Economic Area (EEA). A UFI is considered valid only after a notification in the PCN format has been submitted and accepted by the ECHA Submission Portal. Or respectively once they are downloaded by the member state.
What is the UFI used for?
The purpose of the UFI is ensure an unambiguous link between the information you provide to poison centers about the mixture that you placed on the market. In an event of a poisoning emergency call, the UFI allows the poison centre operator to find the right information to administer appropriate advice.
Therefore, the UFI will enable a better medical response, added level of certainty to treat poisoning cases, and reduce unnecessary over-treatment of poisoning cases.
How can I create a UFI?
There are two parts to creating a UFI – the VAT number of your company (or an ECHA company key) and the formulation number of the mixture. The VAT number or company key is required to ensure that that the UFI is unique and does not overlap with that from other companies.
There are also two ways you can generate a UFI – entering the previously mentioned information into the UFI Generator tool provided by ECHA or develop your own UFI generator in your company’s IT system. For the latter, the UFI developer’s manual is available.
At opesus, we developed a UFI generator that you can implement into your SAP system to automatically generate and store UFIs. This option allows you to be more efficient, especially if you have a large portfolio. But, UFI handling is more complex. In other words, simply generating UFIs and sticking them on the labels of products is not advisable. Why?
UFIs need to be linked to exactly one chemical composition. In the real world, one chemical mixture may be linked to several products. Furthermore, products go through a lifecycle, are reformulated, and enter new markets. You need to consider how to manage these changes and the update cases as outlined by ECHA in managing your portfolio.
Can I create several UFIs for one product?
The short answer: yes. One UFI is always assigned to exactly one mixture. This means that products with the same mixture can be bundled into one notification with one UFI. Alternatively, if you have different products created from the same mixture, it is possible to generate several UFis for the same mixture and submit them with your products in one notification.
Note: The UFI is publicly available and printed on the label of products. If you create products with different names and/or brands from the same chemical mixture, you most likely want to keep this information confidential. In these cases, we highly recommend to general several UFIs for the same mixture and submit each product with a different UFI.
To support the different scenarios, during consulting, we determine which product determination profile is relevant for your business scenario. Product determination profile allows to have the same understanding on how UFIs should be generated for your scenario. Specifically, it refers to how specifications and products relate in your system.
What are the label requirements for the UFI?
The UFI must be printed on or affixed in close proximity to other labeling information of the hazardous mixture. For hazardous mixtures for industrial use only or mixtures that are not labelled, the UFI must be included in section 1.1 of the safety data sheet (SDS).
The acronym UFI must be in capital letters followed by the 16-character code, for example, UFI: A123-B123-C123-D123.
The code is divided into four blocks, each separated by hyphen. The UFI must be clearly visible and legible on the label of the product. Essentially, the onus is on you to determine the location of the UFI such that it is displayed on the product in the most effective manner to assist with communication to poison centres.