UFI Requirements Explained: Everything You Need To Know For Compliant Crafting
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Tijd om te lezen 12 min
Navigating home fragrance regulations can feel overwhelming. For makers selling into Northern Ireland, the Republic of Ireland, and the European Union, the Unique Formula Identifier (UFI) plays a crucial role in keeping your products legal and safe. This 16-character code connects your mixture to poison centres, helping emergency responders act quickly when seconds count.
Table Of Contents
Understanding The Unique Formula Identifier (UFI) When Is A UFI Required For Crafting Products In The UK And Ireland Generating Your UFI: The Process And Tools You'll Need Essential Information For Your UFI Dossier And Poison Centre Notification (PCN) Correctly Applying The UFI To Your Product Labels Ensuring Your Crafting Business Stays UFI Compliant FAQs
Understanding The Unique Formula Identifier (UFI)
Think of the UFI as a bridge connecting your product's trade name to its chemical composition during emergencies.
What is a unique formula identifier (UFI)?
The unique formula identifier, known by its acronym UFI, is a 16-character alphanumeric code that must be included on the Product CLP label when human health or physical hazards are triggered in a product. In addition to the UFI, you are also required to provide other information on your mixture and associated products to poison centres, such as composition, trade name, colour, packaging, product category, pH and toxicological information. The UFI aims to establish an unambiguous link between the information you provide and the product you place on the market. The condition for assigning a UFI is that all products labelled and notified with the same UFI must share the same mixture composition and product category. For example, a candle and a wax melt could share the same mixture composition, but will need separate UFI numbers and dossiers as they fall into different EuPC categories.
a generic example of the format of a UFI number
Why the UFI is essential for emergency health response
Many chemical products (e.g., detergents, paints, adhesives) are placed on the EU market and used both by the general public in their everyday lives and by professionals in their working environments. Chemical products are generally considered safe when their use instructions are followed. Nevertheless, unintentional exposure to chemicals can occur, for example, due to inappropriate use or accidents. When this happens, immediate access to relevant information about that product's chemical makeup is vitally important. therefore, under Article 45 & Annex VIII to Regulation (EC) No. 1272/2008 on the classification, labelling and packaging of substances and mixtures, the requirement has been established to provide a dossier of information regarding hazardous products to be submitted to Poison Centres, so that emergency responders can obtain accurate information about the composition of a product.
Some Oils That Don't Require A UFI (Up To 10% In A Non-Hazardous Base)
When Is A UFI Required For Crafting Products In The UK And Ireland?
The requirement hinges on the types of hazards your ingredients trigger and whether you are selling into a region covered by the EU CLP Regulations.
Identifying products that need a UFI
Among the mixtures which fall under the scope of the CLP Regulation, those classified for environmental hazards only are outside the scope of Article 45 and information according to Annex VIII does not need to be submitted. Also, mixtures that are subject to supplemental labelling requirements under Parts 1 and 2 of Annex II to CLP but are not themselves classified for health or physical hazards are not subject to submission requirements. In other words, if the product only triggers environmental hazards (H400, H410, H411, H412) and /or only has supplemental information on the CLP label (e.g. Contains: XXX, YYY, ZZZ. May cause an allergic reaction.), it will not require a UFI number. However, we recommend you still register these products, and indeed, ECHA encourages voluntary registration.
Specific requirements for candles, melts, sprays, and diffusers
Candles, melts, reed diffusers, and other home fragrance products fall under the remit of CLP and therefore these products will require (where mandated due to the nature of the hazards triggered) a UFI number to be present on the CLP label in addition to the other CLP safety information being and affixed to the finished product.
Navigating regulations in the UK, Northern Ireland, and the Republic of Ireland
The landscape differs across these three regions. In the Republic of Ireland and Northern Ireland, EU CLP regulations apply directly, requiring UFI and PCN. Great Britain has its own system through the National Poisons Information Service (NPIS), where UFIs are not mandatory but are widely accepted for consistency.
Confusion often occurs when a maker is based in Great Britain, but sells into Northern Ireland, the Republic of Ireland, or the European Union.
Our table below aims to demystify the process:
When Is A UFI Required?
Understanding the Legal Entity Requirements for GB Makers lodging UFI Dossiers under EU CLP Regulations
For Great Britain-based manufacturers seeking to comply with EU CLP notification requirements, the regulatory framework mandates the appointment of a formal Legal Entity established within the European Union or Northern Ireland. Under the EU CLP Regulation, manufacturers and importers placing hazardous substances on the EU market must submit notifications to the European Chemicals Agency (ECHA), including UFI dossiers for mixtures. Since Brexit, GB-based businesses are treated as third-country entities and cannot submit these notifications directly.
Establishing Legal Representation in the EU
The Legal Entity serves as the legal representative throughout the EU. This arrangement must be formalised through written agreements, as the appointed entity assumes legal responsibility for compliance with EU chemical regulations. The EU General Product Safety Regulation reinforces this requirement by mandating that non-EU manufacturers nominate an authorised representative within the EU for compliance purposes.
For small manufacturers, the cost of establishing either a subsidiary or engaging a professional Legal Entity can be prohibitive, leading many to restrict their operations to the GB market only. It is important to note that placing a product on the NI, ROI, or EU market without a Legal Entity in place and without adhering to the UFI requirements means the product is being sold illegally, opening makers up to potential fines and voiding insurance cover should something go wrong.
Some No UFI Diffuser Suitable Oils (In A Non-Hazardous Base)
Generating Your UFI: The Process And Tools You'll Need
Creating your UFI involves specific calculations based on your business information.
Accessing the official UFI generator
Start with the official ECHA UFI Generator tool. You'll need your VAT number (or company key) and a specific formulation number that you assign. This combination produces a unique alphanumeric code, preventing duplicates across the system. If you don’t have a VAT or company key, there is a tick box you need to tick to generate the UFI.
The ECHA Unique Formula Identifier Generator
Key steps to create a valid UFI
Begin by assigning a unique internal formulation number (ranging from 0 to 268,435,455) to your mixture. When combined with your VAT number, this generates the 16-character UFI. If your composition changes down the line, you'll need to assign a fresh formulation number to create a new UFI. You can either obtain a single UFI number or a UFI number range.
Essential Information For Your UFI Dossier And Poison Centre Notification (PCN)
Your UFI connects to a technical dossier that gets submitted to ECHA's system.
To submit Poison Centres Notification (PCN) dossiers for your products, you will need to register with ECHA (see the ECHA Accounts Manual). Once you have registered, you will need to register with the Poison Centres Notification Portal (click here to access the ECHA cloud services and here for FAQs relating to these services).
The IUCLID 6 (International Uniform Chemical Information Database) dashboard
Once you have access to the ECHA cloud services, you can access the IUCLID 6 (International Uniform Chemical Information Database) dashboard. We recommend familiarising yourself with the IUCLID layout before attempting to lodge any dossiers.
The application is divided into three sections: Substances, Mixtures, and Articles. When you first access the dashboard, the Datasets and Dossiers for each section will show zero, as no information has been submitted.
If you're not familiar with creating a dossier, we recommend starting by reviewing the tutorials, additional information, and the question-and-answer section provided by ECHA. These are all accessible via the ‘?’ chat bubble in the top right corner of the dashboard.
the ‘?’ chat bubble in the top right corner of the dashboard.
If you are unable to find the answer to your question, you can also raise a support request via this same section, and someone from ECHA will respond to you accordingly.
Information you will be asked includes:
Name of product
Product Category (EuPC)
Composition (from the SDS) – note you will also need to include information on non-hazardous substances that you add to the fragrance oil – such as wax, dye and additive. The application will not accept a dossier with only 10% or 25% of the substances listed; at least 70% of the ingredients must be listed for the dossier to be accepted.
Hazards triggered (From SDS)
Toxicological information (From SDS)
Packaging (you can add more than one size of packaging per product)
Hazard and Precautionary Statements grouped by hazard classification (From SDS).
Once the dossier has been completed, you will be able to validate the dossier before submitting it. To validate the dossier, click on the ‘Validate’ button in the top right corner within the Dataset. This will open a new tab with the validation page. Before validating, ensure the following fields have been populated:
- Dossier Name
- Submitting legal entity
- PCN Number
- Country (market Placement)
- Language
- Notification Type
If any of these fields are missing, you need to go back into your dossier and enter the information before returning to the validation screen once more.
After validating your dossier, the following message will appear, assuming there are no errors that need to be corrected:
The message that should appear once the dossier has been successfully validated
If you received error messages, you would need to correct each error before you can move on to the submission process. You should validate your dossier again once you believe all errors have been corrected to be sure before proceeding to submission.
When you are ready to submit your dossier, click on the ‘Create Dossier’ button in the top right corner of your Dataset. This will take you to a screen like the validation page, but with a ‘Create Dossier’ button in the bottom-right corner. When you click on this button, a ‘Proceed to Submission’ pop-up will appear. Click on this, and you will be redirected to the ECHA Submission Portal, where the file will upload for you to submit.
the ECHA Submission Portal, where the file will upload for you to submit.
After submitting your dossier, you should click on the icon next in the top left corner, next to ‘Upload and Submit’, to search for your dossier and ensure it has been submitted without any errors. Do this by clicking on ‘Search for a PCN Submission’.
Your dossier should show with a tick next to the submission number; this means it is successful. If you have any other symbol next to the submission number, it is vital to review this and to take action to correct any errors. Otherwise, your submission will not be valid.
Your dossier should show with a tick next to the submission number; this means it is successful.
Assuming that you have successfully completed your dossier submission, the UFI and PCN Dossier are now active, and the UFI number is ready for use on your products. 🎉
Correctly Applying The UFI To Your Product Labels
Getting the placement right prevents compliance headaches later!
Placement and format guidelines for labels
The UFI must be included on your CLP label; it cannot be included on the product label or elsewhere on your goods. Within the CLP label, the UFI may be positioned either with the Product Identifier or within the Supplemental Information Section. For further information on the correct placement of the UFI number, please refer to the CLP Guidelines.
the CLP label for our fragrance oil 'Lychee Peony' with the UFI number highlighted on the label.
Ensuring compliance and readability
The code needs to be legible, permanent, and clearly visible to emergency responders. It's typically printed in capital letters, divided into four blocks separated by hyphens (like "UFI: VDU1-414F-1003-X862") to help emergency operators read it quickly and accurately.
the UFI number for our fragrance oil 'Lychee Peony'
Ensuring Your Crafting Business Stays UFI Compliant
Compliance isn't a one-time task!
Regulations evolve, and your product range might expand. NI Candle Supplies supports customers with educational resources for ongoing compliance. We also carry a range of fragrance oils that don't require a UFI in the finished product, which can simplify your compliance workload while still creating beautiful, scented products.
When used at 10% in a non-hazardous base, these fragrances do not require a UFI number as they do not trigger any health or physical hazards. (Although you can, if you wish, still include a UFI number on your CLP label and voluntarily submit the UFI dossier to the PCN/NPIS).
We stock a range of fragrance oils that do not require a UFI under certain conditions:
- No UFI - up to 10% in a non-hazardous base
- No UFI - Diffuser Suitable Oils in a Non-Hazardous Base
- Phthalate Free & No UFI up to 10% Fragrance Oils
Please note that if these oils are used in a hazardous base (such as Augeo or perfumer’s alcohol), then a UFI number will be required. If you are using these fragrances at a concentration of more than 10% then a UFI number may be required.
Key takeaways about UFI requirements
- The UFI (Unique Formula Identifier) is a 16-character code that connects your product to its chemical composition during emergencies, helping poison centres provide proper treatment when needed
- Your products require a UFI if they're classified for health or physical hazards, but not if they only have environmental hazards or supplemental labelling
- Creating a UFI requires a unique formulation number through the ECHA UFI Generator tool, with at least 70% of ingredients documented in your submission
- The UFI must be placed on your CLP label (not the product label) in a clearly visible format, typically in capital letters separated by hyphens
FAQs
What does UFI mean?
UFI stands for Unique Formula Identifier. It's a 16-character alphanumeric code that links hazardous mixtures to their chemical dossier, helping poison centres provide accurate emergency response information.
What is the UFI code in the UK?
The requirements vary by region and where you sell your goods. In Northern Ireland, UFIs are mandatory under EU CLP regulations, and makers must submit their UFI Dossier to the National Poisons Information Service (NPIS) as part of the .i6z file. In Great Britain, submissions also go through the NPIS; however, submission is voluntary, and there is no requirement to include a UFI number.
However, suppose you sell your product into Northern Ireland, the Republic of Ireland, or the European Union. In that case, you must comply with EU CLP regulations, include a UFI number, and submit a dossier, regardless of where you are located. You will need to appoint a Legal Entity to act on your behalf when submitting your dossier. See the full article above for guidance on this point.
Does the Windsor Agreement change the need to have UFIs in Northern Ireland?
Unfortunately, not. Under the NI Protocol, EU CLP regulations were adopted to maintain the free movement of goods on the island of Ireland and, in turn, within the EU. The Windsor Agreement does not include changes to the movement of chemicals (hazardous substances) and therefore the requirement to comply with the EU CLP regulations, including the UFI requirements, still stands.
Want assistance with preparing dossiers?
We always recommend seeking professional advice if this is something you’re uncertain about to ensure you meet regulatory requirements.
CLP Services for Candle Makers offers services to prepare required dossiers in English, French, German, and Spanish, and offers a reduced rate when using NI Candle Supplies fragrances; they also have a wealth of knowledge when it comes to CLP regulations.
Learn more at https://clpservicesforcandlemakers.co.uk
You can also follow CLP Services for Candle Makers on Facebook for future updates and resources on understanding UFI’s and the CLP regulations.
NI Candle Supplies specialises in high-quality candle-making materials, offering a diverse range of waxes, wicks, and fragrances. Committed to inspiring creativity, we provide resources for beginners and seasoned artisans. Our mission is to empower candle makers with quality products and expert guidance, fostering a vibrant community of enthusiasts who share a passion for craftsmanship and creativity.
