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Notifications of hazardous mixtures (PCN notifications) are a legal requirement resulting from Article 45 of the CLP Regulation (1272/2008/EC). Provisions and requirements of Poison Centre Notifications are described in detail in the Annex VIII to this regulation. Directly related to the PCN notification is also alocation of a UFI number, which should then appear on the chemical product label. The purpose of reporting is to make data about the chemical product available to the relevant bodies and offices, which in the event of an accident or poisoning related to the product will be able, on the basis of this data, to provide appropriate assistance to the people involved in the incident. The obligation to notify PCN applies in all European Union member states where the product is placed on the market. Similarly, the presence of a UFI number on the product label will be required in every EU country.
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Pursuant to Article 45 of the CLP Regulation, every importer and downstream user of a chemical product is obliged to submit a PCN notification for his chemical product. This obligation applies to mixtures that are classified as hazardous to human health and due to their physicochemical properties. Products that are classified only because of their harmful or toxic effects on the environment are not subject to the obligation to submit a PCN notification. Products that are substances under REACH and mixtures that are not classified as hazardous at all are also not covered by Article 45. Products for which PCN notification is not required by regulation can still be notified via a voluntary notification, which may sometimes be one of the expectations of the recipients of goods in the supply chain. Submitting a PCN notification is therefore one of the basic activities that must be performed if you want to introduce a chemical mixture that is classified as hazardous to the market. As in the case of the Safety Data Sheet, providing a UFI number or submitting confirmation of notification will often constitute one of the documentation requirements in supply chains. It is also important that due to the obligation to provide the UFI number on the product label, it is one of the elements of chemical regulations that is easy to check during inspection by the relevant services.
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The Poison Centre Notification should be submitted before the product is first placed on the market. Due to the need to include the UFI number on the product label, the PCN notification is usually made eben further in advance to allow timely printing of labels including the UFI number.
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The standard time for completing a PCN notification by our experts is 3-5 business days, but it may change if additional questions arise during the analysis of the documentation. For larger orders, the time for submitting PCN notifications is determined individually based on the customer's needs and the number of notifications in scope. In the case of a PCN application, its validation takes place almost immediately, so after submitting the notification, it is immediately active and you can use the UFI number contained in it.
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The price for a PCN submission will always depend on several factors, including the number of PCN notifications, the languages in which they are to be prepared, the complexity of the products and the deadline by which the applications are to be submitted. Our services are characterized by an individual approach to the client and this is also reflected in our price structure. In some European Union countries, for example Belgium, an administrative fee must also be paid for submitted notifications.
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The PCN notification cost covers all of the process phases: collection of data for the PCN notification, analysis of the received data, generation of a UFI number, compilation of the PCN notification and submission via the ECHA Submission Portal, validation of the notification and provision of the confirmation of the notification. The price does not include administrative fees charged by some European Union countries, as these should be paid by the entity responsible for notification.
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As in the case of, for example, Safety Data Sheets, the PCN notification is valid indefinitely, but it may be necessary to update the notification if significant elements contained therein have changed, including:
- change in the composition of the chemical product
- alteration or addition of a trade name
- change of product classification