Poison Centres

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Poisons Centres represented in each Member State aim to inform medical personnel and the public with information and advice in the event of excessive, inappropriate or harmful exposure to a hazardous mixture. This ensures that adequate first aid measures and the right medical treatment options are given to a patient regardless of exposure route.

Back in 2016, Member States voted in favour on the Commission’s proposal to harmonise information submitted to poison centres on hazardous mixtures. Following this vote Annex VIII to CLP was published in 2017 highlighting the harmonised information relating to emergency health response. But what does this mean for industry? Article 45 of CLP requires Member States to appoint a body for receiving information on the composition of hazardous mixtures that are placed on the market. The introduction of Annex VIII implements a harmonised format to the notification submitted to the Member States.

Who has to notify?

Importers and downstream users are duty holders that are required to submit information stated in Annex VIII if they place hazardous mixtures on the EU market. Formulators, toll formulators, repacking and refilling activities qualify as downstream user activities, therefore these actors will have obligations to submit notifications.

When do I have to notify?

Submissions must be made before placing hazardous mixtures on the EU market. Notifications already submitted under national legislation will remain valid until 1 January 2025 unless changes are made which requires an update according to Part B of Annex VIII. A notification has to be submitted in each Member State where you intend to place the mixture on the market. Specific compliance dates are determined according to the end use of the mixture:

• Consumer use 1 January 2021
• Professional use 1 January 2021
• Industrial use 1 January 2024.

What information do I need to submit?

Part B of Annex VIII details the information that is required for the submission. The notification should include the following data; product identifier with trade names and Unique Formula Identifier (UFI), details of submitter consistent with the label details, classification of the mixture and label elements, mixture composition within set concentration bands, toxicological information & type and size of packaging along with the product categorisation code. 

To find the most updated version of the CLP legislation in force (including the text of Annex VIII), see our Legislation page for more details. ECHA’s “Guidance on harmonised information relating to emergency health response” also has a lot of helpful information.

How do I submit a notification?

ECHA developed several tools in 2018 to aid companies when making a notification. These include: the Poison Centres Notification (PCN) format, UFI generator and EU Product Categorisation System (EU PCS). The PCN format is the structure in which information on hazardous mixtures has to be submitted to the Member State appointed bodies. The format is based on the data requirements stated in Part B of Annex VIII and is now available in the new version of IUCLID.

 The UFI is a new notification requirement under Annex VIII and will need to be included on the product label. The UFI links the notified mixture information to a specific product on the market. The UFI generator uses the company’s VAT number and mixture formulation number to create a 16-digit alphanumeric code. The final version of the UFI generator is already available.

The EU PCS was designed to help companies describe the intended use of their mixture. Each mixture will need to be assigned a single product category. Where mixtures have dual or multiple uses only the main intended use would be selected. The product category needs to be included in the notification. A guidance document on the EU PCS has been developed to help industry determine which category the intended use of their mixture fits into.

Launched in 2019, the ECHA submission portal for poison centre notifications allows companies to create and submit dossiers as well as track notifications to poison centres in Member States. Further improvements to the user interface and more advanced functionalities will be implemented in future releases of the portal. Please note that some member states may be accepting notifications via their existing national systems too - full details can be seen in the Overview of Member State decisions in implementing Annex VIII document.