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Notification of hazardous mixtures (PCN notifications), is a legal requirement under Article 45 of the CLP Regulation (1272/2008/EC), the principles and requirements of which are described in detail in Annex VIII to the Regulation.
Directly related to the PCN notification is also the assignment of a UFI number to the product, which should then appear on the label of the chemical product. The purpose of filing a notification is to make the data on the chemical product available to selected appointed bodies, which, in the event of an accident or poisoning, related to the product, will be able to properly assist injured persons on the basis of the data.
The obligation to notify the PCN is present in all European Union member states where the product is marketed. Similarly, the presence of the UFI number on the product label will be required in every EU country.
Once prepared, the Safety Data Sheet does not have an "expiration date", it can remain in circulation for as long as all the data contained therein remain valid and comply with applicable regulations. The Safety Data Sheet may require updating for various reasons, the most important and most common of which are:- change in the composition of the chemical product, which will affect the information contained in the Safety Data Sheet- change of the classification of one or more substances contained in a chemical product, which will change the content of the Safety Data Sheet, but may also affect the CLP classification of the entire product- change of the applicable regulations regarding the requirements for Safety Data Sheets, or update of the legislation related to substances contained in the product- administrative changes, such as change of the name of the company or the trade name of the product
The Safety Data Sheet compilation cost covers all of the process phases: collecting data for the development of an SDS, analysis of the received data, product classification in accordance with the CLP Regulation (or other applicable), preparation of a preliminary version of the Safety Data Sheet based on the received data and product classification, submission of the document for customer assessment and finalization of the Safety Data Sheet. The price does not include laboratory tests if they are needed to prepare the Safety Data Sheet (for example, flash point tests or kinematic viscosity measurement of a chemical product).
The price of a Safety Data Sheet compilation will always depend on several factors, including the type and number of Safety Data Sheets, the languages โโin which they are to be prepared, the complexity of the products and the deadline by which the Safety Data Sheets are needed. Our services are characterized by an individual approach to the client and this is also reflected in our price structure.
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.
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 even further in advance to allow timely printing of labels including the UFI number. Failing to submit a PCN notification on time might create roadblocks in sales of your products and be subject to administrative fines in case of inspections. Please note that on top of a fine, failure to include the UFI number on the product label may result in an order to halt the sale of the product until the non-compliance is removed and the labels are corrected.
According to Article 45 of the CLP Regulation, every importer and downstream user of a chemical product is required to notify the PCN of their chemical product. This obligation exists for mixtures that are classified as hazardous to human health or due to their physicochemical properties. Products that are classified only for harmful or toxic effects on the environment are not subject to PCN notification. Products that are substances within the meaning of REACH and CLP and mixtures that are not classified as hazardous at all are also not subject to the provisions of Article 45. Products for which a PCN notification is not required by law can still be notified through voluntary notification, which can sometimes be one of the expectations of the recipients of the chemical product in the supply chain.
Making a PCN notification is therefore one of the basic steps to be taken when planning to market a chemical mixture that is classified as hazardous. As with the Safety Data Sheet, providing a UFI number or submitting proof of notification will often be one of the documentation requirements in supply chains. It is also vital as the UFI number is required to be displayed on the product label and thus it is one of those elements of chemical regulations that is easily audited during inspections.
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