What is a UFI?
The unique formula identifier, known by its acronym UFI, is a 16-character alphanumeric code that will need to be included on the Product CLP label. 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 and toxicological information. The UFI aims to establish an unambiguous link between the information you provide with the product you place on the market. The condition for assigning a UFI is that all products labelled and notified with the same UFI need to share the same mixture composition and/or product category (a candle and room spray could have the same composition, but will need separate dossiers as they fall into different categories).
Why do my products need a UFI number/registration with the Poison Centre?
A large number of chemical products (e.g. detergents, paints, adhesives) are placed on the EU market and used both by the general public in their everyday lives as well as by professionals in their working environments. Chemical products are in general considered to be 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 on the chemical make-up of that product 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 has made the requirement 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.
As with CLP, candles, melts, reed diffusers and other home fragrance products fall under the remit of CLP and therefore these products will require (where required due to the nature of the hazards triggered) a UFI number to be present on the CLP label and the formulation information submitted to the Poison Centre Portal Notification (PCN) via a dossier.
Where must the UFI be shown?
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.
What information is needed to create a dossier?
In order to submit Poison Centres Notification (PCN) dossiers for your products, you will need to register with ECHA (the ECHA Accounts Manual can be read here.)
Once you have registered you will need to register with the Poison Centres Notification Portal (see page 26 of the guide or click here to access the ECHA cloud services).
Once you have access to the ECHA cloud services you can access the IUCLID 6 (International Uniform Chemical Information Database) dashboard. On your first (and subsequent visits) you will be given the option to ‘take a tour’. I recommend you do this to familiarise yourself with the layout of the IUCLID.
The application is divided into three sections – Guided dossier, substances and mixtures. If you’re not familiar with how to create a dossier, I recommend you start with the guided dossier. This will take you through all the steps you need to create your dossier.
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 let you submit a dossier with only 10% or 25% of substances listed, at least 70% of the ingredients need to be listed for the dossier to be accepted.
- Hazards triggered (From SDS)
- Toxicological information (From SDS)
- Packaging (you can add more than one size 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 and submit it. You can only submit a validated dossier and the validation process enables you to amend /add information to enable you to submit the dossier. Please note the legal entity is required to be included as part of the submission however presently this is not selected as default, so an error will appear when validating. To resolve this, click on the ‘…’ shown on the screen to access the advanced settings and then tick the box that states, ‘include legal entity’, this will then resolve the issue. It’s necessary to undertake this step for each dossier submission.
Will all products need to have a UFI / submit a dossier to the Poison Centre?
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 which are subject to supplemental labelling requirements according to Part 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.) will not require a UFI number. However, we recommend you still register these products and indeed ECHA encourages voluntary registration.
Timelines:
The deadline for the submission of the information following the new requirements set by the amended CLP Regulation will apply in a stepwise manner, according to the use type of the mixture i.e. consumer, professional or industrial use.
Importers and downstream users placing mixtures on the market not notified already under national legislation* must comply with Annex VIII of the Regulation from the following dates:
- Mixtures for consumer use: from 1 January 2021
- Mixtures for professional use: from 1 January 2021
- Mixtures for industrial use: from 1 January 2024
Where a mixture has several types of use, the earlier corresponding deadline applies and related requirements must be met. For instance, in the case of a fragrance oil classified as hazardous for health effects, and placed on the market for both consumer and professional use, the earlier deadline of 1 January 2021 will apply.
*Further “not notified already under the national legislation” in layman terms means products that have not already completed and submitted a dossier (notification) to the Poison Centres. So, in other words, if you haven’t already submitted a dossier to the Poison Centre Portal about your product (products) then this mean you only have until 1st January 2021 to comply with the new UFI requirement. Any references to ‘mixtures already placed on the market’ assumes that the mixture is already registered with the Poison Centre under the old rules.
Further reading:
Below you can find a list of websites that explain the following topics.
CLP guidelines:
Guidance on harmonised information relating to emergency health response – Annex VII to CLP
ECHA UFI Webinar:
https://www.youtube.com/watch?v=zJegybGwiMY&feature=youtu.be
https://echa.europa.eu/support/training-material/webinars
Q&As and Support:
https://poisoncentres.echa.europa.eu/
3 Response(s)
Really interesting and useful! Thank you so much for your advice.
Great Advice!
Fantastic advice. Thank you for posting this.