From 1st Jan 2021, a new label element will have to appear on the labels of all products in the EU classified for Health and/or Physical Hazards. A 16-character code called the Unique Formula Identifier (UFI) will be mandatory on the labels of such products and importers and downstream users placing these products on the market will have to provide specific product information, including the UFI, to poison centres.
The UFI, alongside the product name, allows poison centres to provide a faster emergency response by being able to identify the product composition and its hazards.
The clocks are ticking – Inform yourself now.
REQUIREMENTS IN BRIEF:
- To obtain a Unique Formula Identifier (UFI) from ECHA for the hazardous mixture.
- To notify the poison centre of the EU member state and/or use the ECHA central portal to make a PoisonCentre Notification (PCN).
- To ensure the UFI is available on the product label for non-industrial use products.
- To ensure the UFI is available on the SDS for industrial use products.
- To update the poison centre notification if various criteria are met.
WHO IS OBLIGED TO SUBMIT A POISON CENTRE NOTIFICATION
The obligation to submit a Poison Centre Notification (PCN) is dependent on your role in the EU supply chain and the products in your portfolio.
The first step is to determine whether you are a duty holder. This will need to be determined on a case-by-case basis as your role may vary from product to product.
In the context of Article 45 and Annex VIII, duty holders, or “submitters”, are importers and downstream users that place hazardous mixtures on the market. Hazardous mixtures are those mixtures that (a) fall into the scope of CLP and (b) have a physical or health hazard classification.
WHICH PRODUCTS MUST BE LABELLED WITH THE UFI – AND WHERE TO PUT IT
If your product/mixture is labelled with one of the following hazard pictograms for human exposure, the UFI code must be included on the label.
LABELS – The UFI should be printed or affixed to the Supplementary Information portion of the product label for all mixtures classified for physical or health hazards for consumer and professional use. It can also be printed or affixed on the inner packaging provided it is in close proximity to the other labelling elements. It is not necessary to include the UFI on each layer of packaging. If it is not possible to include the UFI on the inner packaging due its shape or size, the UFI can be printed or affixed on the outer packaging, located with the other label information.
For an Industrial Use notified mixture the UFI does not need to be included on the label (but can be included optionally).
SDSs – If the UFI appears on your label, then it must also be added to Section 2.2 (label elements) of the associated SDS.
SDS are not required for consumer products, but if you do prepare an SDS on request, you do have to include the UFI in section 2.2 as the UFI is a label element.
For Industrial Use mixtures, the UFI may be included only in the SDS (section 15), if it does not appear on the label.
If the mixture is not packaged, the UFI must be included in section 1.1 of the safety data sheet. For all other mixtures, the UFI can be included voluntarily in the SDS in subsection 1.1.
The acronym ‘UFI’ must be the same in all EU languages and alphabets, and not translated. It must be in capital letters and be followed by colon and a 16-character alphanumeric code. The code is divided into four blocks, each separated by a hyphen. For example: UFI: W1QX-B24C-L55M-WDV9
While no specific requirements have been set, for instance, for font type or size, the UFI has to be clearly visible and legible on the label of the product. Given the variation in label sizes, and other labelling requirements competing for label space, the UFI should be positioned so that it is easy to locate (e.g. near the barcode or hazard pictograms). In essence, you must determine how the UFI is displayed on the product in the most effective manner to assist with its communication to poison centres.
The following mixtures are exempted from notification since they are not covered by Annex VIII regulations (they have their own specific legislation):
- Mixtures ONLY classified with environmental hazards
- Radioactive mixtures
- Mixtures that are classified only as gases under pressure and/or explosives.
- Mixtures under customs supervision
- Mixtures used for Research & Development purposes
- Medicinal and Veterinary products
- Cosmetic products
- Food and feeding stuffs.
Mixtures that are only subject to supplemental labelling requirements – EUH208, for example – are not themselves classified as hazardous under CLP and are therefore not required to be notified.
REACH UK & UFIS
For products/mixtures that are for the UK market only, under REACH UK, the requirement of UFIs on labels/SDSs, and notification to poison centres, will be on a voluntary basis only.
HOW TO GENERATE A UFI CODE
Companies will need to generate their UFIs using the UFI generator. This can be done via the ECHA Online Generator Tool, a third party software provider or an internal system.
Two numbers are required to generate a UFI:
1) VAT number (or a “company key” in certain cases). If you can’t provide a VAT number number you can create a UFI through the UFI Generator – you will only need to assign a formulation number to the mixture to create a UFI.
2) Internal formulation number (number between 0 and 268 435 255); this will ensure there is no duplication across companies.
UFI CODES – POST BREXIT
REACH registrations submitted by UK-based manufacturers, importers and representatives that were not completed by 31 December 2020 have been terminated.
Any transfer of registrations by a UK company not initiated before 31 December 2020, and accepted by the successor by 31 March 2021, will be revoked.
After 31st December, 2020:
- All pending UK submissions in REACH-IT will be terminated.
- No registration numbers will be issued to UK companies.
- Companies in the UK cannot perform any actions as duty holders in REACH-IT.
- All registrations held by or returned to UK companies will be revoked gradually in REACH-IT.
REACH stipulates that registrants must be established in the European Union.
HOW TO SUBMIT THE DOSSIER
REACH requires the manufacturers or importers of substances to submit a dossier documenting the identity and properties of a substance, and how it is used safely.
The notification dossiers can be submitted through the ECHA submission portal. Additionally, some State members can provide with other alternative delivery form through their own system; however, all dossiers must follow the harmonised PCN format in order to be valid.
For mixtures not already on the market, your obligations to submit harmonised information and place the UFI on the label will apply from:
- 1 January 2021 for products/mixtures intended for CONSUMER use
- 1 January 2021 for products/mixtures intended for PROFESSIONAL use
- 1 January 2024 for products/mixtures intended for INDUSTRIAL use only
- 1 January 2025 for existing product/mixtures already on the market
In all situations, the timing for including the UFI on the label of the product should coincide with the submission of harmonised information. It is not recommended to place the UFI on the label of the product if that UFI has not been included in a valid notification to the relevant Member State. In such cases, an ‘empty UFI’ will not provide any assistance to poison centres in the event of an emergency.
If you have existing products/mixtures already notified to a national poison centre, you may benefit from a transitional period which ends 1st Jan 2025. If you make a change to such mixtures though, you will need to comply with the harmonised information obligations, before you place the changed mixture on the market.
CHECKLIST – WHAT TO DO NEXT
A proactive approach to label & SDS compliance can reduce the risks of unexpected costs and disruption from urgent regulatory demands.
- Collect your data – have you gathered all the required information for the Poison Centre Notification? Do you need to talk to your suppliers and customers to get all the information?
- Prepare your submission – how are you going to prepare your XML file?
- Keep your information up to date – how will you continuously monitor your portfolio and supply chain in order to submit revised PCNs if necessary?
- know your obligations – are you a duty holder (remember this answer may be different for different products)? Are you an importer or downstream user of mixtures classified for physical and health hazards? Will you need/want to perform any voluntary submissions?
- Review your portfolio – which products need to be notified? In which countries are you placing your products on the market?
- Understand your supply chain – does your product end up in a ‘final mixture’ intended for consumer, professional and/or industrial use? What markets are your customers selling into? Are your customers re-branding the product?
HOW CAN HIBISCUS HELP?
UFIs – We’ve got you Covered! Despite complex and continuously evolving regulatory requirements, it’s never been easier for companies to produce their own chemical labels – provided they have the right software.
Label Enterprise has been updated to include the mandatory field for UFI numbers and it is the perfect solution for creating and printing GHS (Global Harmonized System) compliant labels for all major commercial markets. It offers chemical manufacturers and distributors a convenient, automated, and accurate tool for meeting global chemical labelling requirements.
IF YOU NEED ASSISTANCE WITH UPDATING YOUR CURRENT LABELS TO INCLUDE THE UFI, JUST CONTACT OUR SALES OFFICE ON 0113 242 4272