A new labelling requirement introduced in the Classification, Labelling and Packaging (CLP) regulation (EU Chemicals Regulation [EC] No. 1272/2008) will make it easier for healthcare providers to obtain information on the chemical make-up of hazardous substances in case of improper use or digestion of hazardous chemicals.
Concerned about what the new regulations mean for you? Volker Watzke, EU Medical Devices and Chemical Sector Manager at Domino Printing Sciences, explores how users are required to expand their product labels to include a unique 16-digit alphanumeric code to identify the mixture of chemicals present within a hazardous substance.
What is a Unique Formula Identifier?
The UFI serves as a unique recipe identifier and helps with the exact identification of a dangerous mixture to enable faster first aid from a poison control centre.
This identifier – a 16-digit alphanumeric code that is specific to each product formulation – establishes a direct and unique connection between any mixture that is brought onto the market and the associated safety information.
UFI codes are always encrypted, so the composition of the mixture cannot be accessed externally. Suppliers can pass the code on in the supply chain without fear that the unique makeup of their product will be made publicly available.
This code is linked to a central database that contains safety instructions for each dangerous mixture. EU poison control centres are provided with access to the centralised product database to obtain safety information, and provide first aid, in case of emergencies.
Where is the CLP regulation valid?
The CLP regulation is valid in the European Economic Area (EEA). This includes all 28 member states as well as Norway, Iceland, Lichtenstein and Switzerland.
What products require a UFI?
UFI codes are required for any products that contain dangerous or hazardous mixtures. It is important to know that the UFI code always refers to the mixture it contains. If, for example, the trade name or the product label changes, no adjustment of the UFI code is required.
However, the situation is different when the composition of the mixture changes. In this case, a new UFI code is required.
A dangerous mixture can also have several UFI codes, if, for example, two commercial products contain the same mixture, each product should still have its own UFI – the same UFI code cannot be valid for several mixtures.
Content and structure of a UFI code
The 16-digit alphanumeric code consists of a formulation number that defines the content and composition of the mixture and the VAT identification number of the company. If no sales tax identification number is available, a unique, fictitious sales ID is created.
There is no specification regarding the font size and type, but the UFI code must be legible.
Where is a UFI code applied?
For products requiring labels, the UFI code must be printed in a visible position on, or, in the event of lack of space, near to the product label. For mixtures which do not require product labels, the UFI code must be indicated in the safety data sheet.
The central database for generating and managing UFI codes
The European Chemicals Agency (ECHA) is responsible for the central administration of UFI codes. As an EU authority, the ECHA is responsible for the technical, scientific, and administrative aspects of the registration, evaluation, and approval of chemicals within the scope of the CLP Regulation.
The ECHA provides an online UFI code generator, which can be accessed by manufacturers. UFI codes must be communicated to the ECHA together with the assigned mixture to enable them to be officially registered.
Any subsequent changes to the composition or concentration of a hazardous mixture must be communicated to the ECHA and the entire supply chain.
What does the regulation mean for you?
The deadlines for compliance are as follows
- January 2021: New dangerous mixtures that are sold to consumers
- January 2021: New hazardous mixtures for commercial use
- January 2024: New hazardous mixtures that are used industrially
- January 2025: Existing hazardous mixtures that are already registered on the market
Application of a UFI code
Depending on your production environment and the product to be labelled, various technologies are available with which the UFI code can be applied to your product. The UFI code can then be printed on an existing label/packaging design or integrated into the label production in advance.
Who can offer further advice and support?
In principle, the first step on this journey is to clarify whether or not your products are affected by the CLP regulation and then follow the steps to ensure that your production environment and product labelling solution is set up for UFI compliance, ready for 2021.
As a manufacturer, you have various options for assigning a UFI code to your product depending on your production environment and the product to be labelled. A UFI code can be retrospectively printed onto an existing label/packaging design or integrated into the label production at an earlier stage.
To adapt product labels, and ensure compliance with the CLP regulation, manufacturers may be required to adjust existing production processes.
Partnering with a reliable coding and marking supplier can ensure that manufacturers of hazardous products have access to the industry knowledge necessary to choose the most appropriate solution for their production environment and ensure that their products are UFI compliant.