Poison Centre Notifications (PCN) for hazardous mixtures

Rebecca Karjalainen

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Phone +358 44 974 0601
rebecca.karjalainen@chementors.fi
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    What a Poison Centre Notification is...

    Article 45 and Annex VIII to the CLP Regulation harmonise poison centres throughout the EU. This legislation came into force on 1 January 2021, introducing several significant changes and imposing obligations on companies that supply hazardous chemicals.

    As a result, importers and downstream users must provide poison centres with information on mixtures classified as hazardous on the basis of their health and physical effects.

    The CLP Regulation obligates companies to provide all the countries in which they place such mixtures on the market with information on the mixture’s product category, complete chemical composition, toxicological information and UFI code, among other things.

    ...and why it is necessary

    The harmonisation of Poison Centre Notifications (PCN) will contribute to product safety throughout the EU. As a result, every poison centre in the countries in which the product is marketed within the EU will have the necessary information and instructions on the mixtures’ composition and hazardous characteristics in the event of a poisoning, for example.

    Chementors

    Consistent information in poison centres throughout the EU

    Before this notification obligation was imposed, poison centres faced challenges in identifying the mixtures involved in accidents, as the information requirements were still inconsistent.
    There were also differences between national notification systems in the information reported, which resulted in the medical professionals of different Member States having inconsistent instructions for cases of exposure.
    The harmonisation of notifications and the adoption of unique formula identifiers (UFI) provided a solution to these challenges. Submitting notifications through the ECHA Poison Centre Notification Portal (PCN portal) makes consistent information available in all of the Member States in which the mixture is marketed.

    What information is required in a notification (PCN)?

    The Safety Data Sheets (SDS) concerning your mixtures may contain much of the information required for a Poison Centre Notification, but the information on an SDS does not meet all of the notification requirements. You must gather the additional information required separately, and you may have to request more specific information from your suppliers, for example.

    In addition to information often found on the SDS, such as the product name, CLP classifications, precautionary statements and hazard statements, a PCN also requires the following information, which is less frequently found on the SDS:

    UFI code

    pH

    EuPCS code

    Type and size of packaging

    Colour

    Complete chemical information, including non-hazardous substances in a concentration above 1%

    Toxicological information, translated into the necessary languages

    Do I have to submit a Poison Centre Notification?

    The obligation applies to importers, manufacturers and repackagers that place mixtures on the market. They are responsible for submitting a PCN in every EU Member State in which the mixture is marketed.

    If you are not sure about your company’s obligations, please contact Chementors and we will help you to identify them!

    Preparing and sending Poison Centre Notifications

    Although the process of preparing Poison Centre Notifications (PCN) has been harmonised, sending the information to poison centres is still a complex process, requiring companies that supply chemicals to have the necessary skills and invest their time and resources. The companies’ obligations include opening up an ECHA account, creating UFI codes, understanding what information they need to prepare the PCN and where they can find this information, and compiling and sending the information through the ECHA PCN portal to every country in which the mixture is on the market. Chementors can do all of this on your behalf. Tell us what products you need to report and we will take care of your remaining notification obligations on your behalf.
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    What products must be reported to poison centres?

    Companies must report mixtures classified as hazardous on the basis of their health and physical effects through the ECHA PCN portal. This does not apply to mixtures only placed in the hazard categories ‘gases under pressure’ or ‘explosive’. The obligation also does not apply to substances or objects.

    Chementors helps companies survive in the jungle of laws concerning chemical safety in Europe and throughout the world.

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      FAQ

      Frequently asked questions

      The notification obligation applies to importers and downstream users operating in the EU/EEA. Companies must submit a PCN to the EU/EEA countries in which they market mixtures classified as hazardous on the basis of their health or physical effects. This obligation does not apply to downstream users who only use the mixtures (end users).
      Companies must report mixtures classified as hazardous on the basis of their health and physical effects through the ECHA PCN portal. This does not apply to mixtures only placed in the hazard categories ‘gases under pressure’ or ‘explosive’. The obligation also does not apply to substances or objects.
      • Contact information
      • Trade name of the mixture
      • Type and size of packaging
      • Product category (EuPCS)
      • Unique formula identifier (UFI)
      • Hazard information
      • Toxicological information
      • Information on physicochemical characteristics

      The information required on the mixture must be compiled and sent through the ECHA PCN portal to all the EU/EEA countries in which the mixture is on the market.

      You can create a unique formula identifier (UFI code) with the application available on the ECHA website. A UFI code is a 16-character alphanumeric code included in a product’s warning label.

      UFI code

      A unique formula identifier (UFI) is used to identify a mixture classified as hazardous on the basis of its health or physical effects.

      The UFI code and other information you provide are primarily used by poison centres when answering emergency calls.

      In addition to the trade name, the poison centre employee may check the product label directly for information such as the UFI code, allowing the employee to identify the product related to the incident precisely. A UFI code is unique and based on the company’s VAT number.

      By 2025, the UFI code will become a mandatory element in the labels of all products classified as hazardous on the basis of their health and physical effects.

      UFI codes were adopted for use in consumer products and products intended for professional use on 1 January 2021. For products intended for industrial use, UFI codes will become mandatory by 1 January 2024.

       

      Importers and downstream users that place such products on the market must provide poison centres with specific product information and the products’ UFI code.

      The UFI Generator tool and instructions are available in 23 EU languages on the ECHA Poison Centres website.

      A UFI is a 16-character alphanumeric code. The code must not be preceded by anything other than the acronym ‘UFI’, and it must be printed on or attached to the labels of products containing hazardous mixtures, or clearly visible and legible near the label.

      If the products are unlabelled (as is the case for certain products used in industrial facilities), the UFI code can be provided on the Safety Data Sheet.

      The UFI code may also alternatively be provided on the Safety Data Sheet in the case of mixtures intended for industrial use.

      How do I create and use a UFI code?

      You can create a UFI code with the application found on the ECHA website when submitting a Poison Centre Notification (PCN).
      There were also differences between national notification systems in the information reported, which resulted in the medical professionals of different Member States having inconsistent instructions for cases of exposure.
      Chementors can provide you with the help and instructions you need when dealing with UFI codes and submitting PCNs.
      READ MORE ABOUT SAFETY DATA SHEETS AND LABELS HERE.

      Chemeter software as a tool for preparing notifications

      Chemeter is a piece of software that can create your Safety Data Sheets (SDS) in a fully automated manner, in many different languages. Chemeter also compiles and sends Poison Centre Notifications (PCN).Chemeter creates Safety Data Sheets and Poison Centre Notifications with the help of an automated calculation system adapted to the legislation of the country in which the product is marketed.You can also fully integrate the software into your production system. Combine the creation of documents (e.g. Safety Data Sheets, labels and waybills) with your production processes in a fully automated and seamless manner.In addition to Safety Data Sheets and Poison Centre Notifications, the software also prepares such things as labels, Toxicological Sheets and dockets.
      READ MORE ABOUT CHEMETER HERE

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