Europe - Chemical regulations

Poison Centers, UFI and harmonised format for notifications

What are Poison Centers?

Poison Centers play a crucial role in chemical safety by providing immediate medical advice in case of exposure to hazardous substances. They are vital in responding to chemical incidents and poisoning emergencies, ensuring that appropriate treatment can be administered quickly. To support this function, companies that place hazardous mixtures on the market are required to submit detailed information about these mixtures to Poison Centers. This enables the centers to accurately identify the substances involved in an incident and offer precise guidance for medical treatment.

What is the Annex VIII to the CLP Regulation and how does it relate to Poison Centers?

Annex VIII to the Classification, Labelling and Packaging (CLP) Regulation outlines the requirements for companies to notify Poison Centers about hazardous mixtures they place on the market. This annex mandates the submission of specific information, including the mixture’s composition, hazard classification, and the unique formula identifier (UFI). The purpose of Annex VIII is to harmonize the information provided to Poison Centers across all EU Member States, ensuring that emergency responses are consistent and reliable throughout Europe​.

What is the Unique Formula Identifier (UFI) and how does it impact chemical labeling?

The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that must be included on the labels of products containing hazardous mixtures. The UFI is essential for linking a product to the specific information submitted to Poison Centers. In an emergency, this code enables Poison Centers to quickly and accurately identify the chemical mixture involved and provide appropriate medical advice. The UFI requirement is part of the broader effort to standardize chemical safety information across Europe, and it must be included on product labels by specific deadlines depending on the type of use.

What are the key requirements for submitting information to Poison Centers under Annex VIII?

Companies must submit detailed information on hazardous mixtures, including:

 

  • Contact details: Information about the submitting company.
  • Trade name(s): Including any brand or variant names.
  • Packaging and product category: Type, size, and intended use of the product.
  • Hazard information: Human health and physical hazard classifications.
  • Toxicological information: Possible exposure routes and effects.
  • Full mixture composition: All components and their concentrations.
  • Unique Formula Identifier (UFI): Must be generated and included on the label.


The submission must be made using the harmonized Poison Centers Notification (PCN) format, which ensures uniformity across all EU Member States. Notifications must be submitted before the product is placed on the market, with deadlines depending on the product's end use (consumer, professional, or industrial)​.

How do companies submit information to Poison Centers?

Companies can submit the required information through the ECHA Submission portal, which offers several methods depending on the company's internal processes:

 

  • Online Submission: Directly through the portal using IUCLID Cloud services.
  • System-to-System Service: For automated submissions from company systems.
  • Offline Preparation: Using IUCLID for manual entry and local storage.


The ECHA Submission portal allows companies to submit notifications to multiple Member States simultaneously, track submission status, and ensure the quality of data before submission. This harmonized approach helps to maintain the consistency and security of information across the EU​.

What are the deadlines for compliance with Annex VIII?

The compliance deadlines for submitting information to Poison Centers under Annex VIII are:

 

  • 1 January 2021: For mixtures intended for consumer and professional use.

  • 1 January 2024: For mixtures intended for industrial use.


Existing mixtures notified under national legislation are valid until 1 January 2025, after which they must comply with the new requirements. Companies should ensure that any changes to their mixtures or products are promptly updated in their submissions to avoid non-compliance​,

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