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REGULATION


UFI for hazardous mixtures – Overview and practical case studies relevant for the German lubricants industry and beyond Dr. Ralf Michael, UNITI e. V., Berlin


Introduction


On the subject of “UFI for hazardous mixtures”, there are often questions from companies, regarding the obligation to generate a Unique Formula Identifier (UFI) and to indicate or update it on the label or to include it in the safety data sheet. In this article, corresponding questions are dealt with on the basis of practical case studies. To introduce the topic, some basic information is summarised in advance.


An overview of the basics According to Annex VIII of the Classification, Labelling and Packaging (CLP) Regulation, hazardous mixtures classified as hazardous on the basis of their health or physical effects according to this Regulation must be notified to the appointed body of the respective EU/ EEA Member State before placing on the market. The notification shall provide comprehensive information on the notifiable mixture. This information is made available to the respective national poison centres for advice in cases of emergency health response (e.g. poisoning cases). The information required in a Poison Centre Notification (PCN) includes: Information on the product (trade name, product category, use, packaging, etc.), information on the mixture (classification and labelling, toxicological information, physical state, pH value, etc.), information on the composition of the mixture (components with concentrations or concentration ranges) and the UFI.


The UFI (Unique Formula Identifier) is a 16-digit alphanumeric code (e. g. UFI: E600-30P1-S10Y-5079) which refers to the composition of the respective mixture. It is to be generated by the notifying company using the company’s VAT number and a numerical formulation number for the mixture in question, e. g. with the UFI generator of the European Chemicals Agency (ECHA). Alternatively, an anonymous company code can be used instead of the VAT number.


The UFI is printed or affixed on the CLP label 38 LUBE MAGAZINE NO.165 OCTOBER 2021


or packaging for packaged mixtures subject to notification. For non-packaged mixtures, the UFI shall be indicated in the safety data sheet. As an alternative to the information on the label or packaging, it may be provided in the safety data sheet for mixtures supplied for industrial use only.


The UFI is intended to ensure that poison centres have rapid access to the exact composition of the mixture in question in emergencies.


The following dates are defined according to Annex VIII of CLP for the notification and thus also the indication of the UFI on the label or packaging or in the safety data sheet: - 1.1.2021 for mixtures for use by private consumers - 1.1.2021 for mixtures for professional use - 1.1.2024 for mixtures for industrial use (use at industrial sites)


- 1.1.2025 for mixtures notified to the respective appointed bodies before the above dates according to national requirements (transitional arrangement).


Note as an example: In Germany, the transitional arrangement can only be used for mixtures for which national notifications to the Federal Institute for Risk Assessment (BfR) have been made.


Practical case studies with solutions / explanations


Practical case studies on the topic of “UFI” are listed below, with the question of whether the companies are acting correctly or not. For each case study, the respective solution is given with corresponding explanations.


Case 1: A hydrocarbon mixture classified as an aspiration hazard with the hazard statement H304 (“May be fatal if swallowed and enters airways.”) is delivered to customers in tank trucks. As it is an unpackaged


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