UFI (Unique Formula Identifier)

Assistance in the marketing of chemical products

A vast number of chemical products (such as detergents, air fresheners, pet care products, raw materials, and semi-finished products) are placed on the EU market. These products are used both by end consumers in their daily lives and by professional users in their work.

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In general, the safety of all consumer products placed on the Union market is ensured by the manufacturer. Under EU Regulation 2023/988 on General Product Safety (GPSR), the manufacturer is required to compile a technical dossier, including a risk analysis when the products are used as intended and in accordance with the provided instructions. However, accidental exposures may occur, for example, due to improper use or an accident. When this happens, it is crucial that medical and emergency personnel have immediate access to relevant product information to ensure prompt and appropriate treatment.

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The UFI and Its Regulatory Framework

Introduced under Annex VIII of Regulation (EC) No. 1272/2008 (CLP), the UFI (Unique Formula Identifier) is a mandatory requirement for all mixtures classified as hazardous to health or with physical risks. The UFI is designed to meet the requirements of emergency health response communication outlined in Article 45 of the CLP Regulation.

Annex VIII, Part B, details all the information that the notifier must provide to Poison Centres (PCN) across the EU, as well as the submission procedures via the centralized notification system, the Poison Centres Notification (PCN) portal, established within the ECHA (European Chemicals Agency) submission portal.

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Importance of the UFI

The UFI (Unique Formula Identifier) is a key tool in facilitating emergency responses and enhancing consumer safety. This 16-character alphanumeric code must be included on the product label, allowing Poison Centres to quickly access precise information about the mixture’s composition. This ensures timely and effective interventions in cases of accidental exposure.

Economic operators placing hazardous mixtures on the market are responsible for transmitting information to the designated bodies. These operators must submit their products through the PCN notification system and ensure that the UFI code is printed on product labels before they are placed on the market.

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Challenges and Complexities in Managing the UFI

Managing UFI compliance and meeting notification requirements is often a challenge, particularly for companies exporting to multiple countries. Some common difficulties include:

• Correctly generating the UFI code using the dedicated tool provided by ECHA.

• Compiling or sourcing the technical dossier and conducting risk analysis in accordance with Regulation 2023/988 (GPSR).

• Preparing the PCN notification dossier, which must include detailed technical information, intended uses, and chemical and toxicological data of ingredients, which can sometimes be difficult to obtain.

• Translating the PCN dossier into the languages of all target countries, as most national Poison Centres accept submissions only in their official language.

• Uploading data to the IUCLID portal, the interface for the PCN portal, which must be done manually, followed by submission through the PCN notification system.

• Adapting to non-EU regulations, which may have different labeling formats, stricter national laws, or require additional information.
  
   

Our UFI Compliance and Export Assistance Service

To help companies navigate this complex process, we offer a comprehensive UFI compliance and notification assistance service tailored to each client’s specific needs. Our main activities include:

• Technical documentation and risk analysis in compliance with the GPSR Regulation.

• UFI Code Generation: We assist in creating the UFI code using the ECHA UFI Generator, ensuring all necessary data is accurate and up-to-date.

• Chemical classification and supplier data validation.

• IFRA compliance verification for various product categories.

• Safety Data Sheet (SDS) preparation: We create REACH-compliant SDSs in accordance with EU Regulation 2020/878, customized with company logos and branding.

• Formula notification: We prepare and submit the PCN dossier, ensuring compliance with regulatory requirements and market-specific needs.

• Label compliance: We verify that the UFI is correctly displayed on product labels, alongside all required regulatory information. On request, we also provide artwork review services, collaborating with your design team to ensure full compliance with labeling regulations.

• International compliance support: We offer regulatory assistance for placing chemical products on the EU and global markets, including registration fee management for ISS (Italy), Belgium, Hungary, the UK, and Switzerland. Additionally, we help adapt hazardous mixture formulations to local regulations outside the EU.
  
   

Business Benefits

By using our services, companies can delegate all regulatory tasks, stay updated on constantly evolving regulations, and focus on their core activities while minimizing the risk of non-compliance and penalties. We ensure that products are ready for export quickly and safely, streamlining international market access.

Our expertise in regulatory compliance enables us to provide customized solutions with high standards of quality and safety for every project.

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Conclusion

Our UFI Compliance and Export Assistance Service is a reliable partner for companies in the fragrance, detergent, and pet care industries. We help them navigate regulatory challenges while ensuring consumer safety and international compliance.