What is a PCN submission and when is it required?
A PCN submission (Poison Centre Notification) is a mandatory part of the documentation for hazardous chemical mixtures. Although the obligation to notify poison centres has existed in many EU countries for years, the format was only harmonised with the introduction of Annex VIII to the CLP Regulation. Today, PCN submissions are standardised across the European Union and must be prepared in a unified format.
Previously, notifications had to be submitted separately in each Member State where the product was placed on the market, in accordance with different national requirements. This made the process difficult and time-consuming, and many companies struggled to meet the obligations. With harmonisation, the process has been simplified, but expectations from the market and inspections regarding compliance have increased. Today, PCN submission is an integral part of placing hazardous chemical mixtures on the market, and throughout the supply chain, your customers will ask for the UFI code and confirmation of notification submission.
Let’s take a closer look at PCN submissions and answer a few basic questions.
What is a PCN submission?
A PCN submission involves providing the relevant information about a chemical mixture to the Poison Centre via the ECHA Submission Portal. The purpose of this notification is to ensure that medical professionals have rapid access to data on the composition of hazardous mixtures. This information is used to provide assistance in cases of exposure to the product. It turns out that poison centres across the European Union respond to as many as 600,000 such calls annually, making PCN submission a crucial element in ensuring the safety of chemical product users.
A PCN submission must include, among others:
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the detailed composition of the mixture – it is allowed to use precisely defined concentration ranges and omit substances that do not affect the toxicological profile of the product,
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classification in line with the CLP Regulation, along with labelling elements consistent with the product label,
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the UFI (Unique Formula Identifier),
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toxicological information,
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use types and user categories of the product.
When is a PCN submission required?
The obligation applies to mixtures classified as hazardous:
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to human health (e.g. irritating, toxic, sensitising effects),
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due to physicochemical properties (e.g. flammability, oxidising properties).
The PCN submission must be made before placing the mixture on the market in a specific EU Member State. This includes both manufacturers and importers of hazardous mixtures. Distributors may also have obligations under Article 45 of the CLP Regulation – for example, if they place a chemical product on a market where the manufacturer has not yet submitted the notification.
In some countries, PCN submission is mandatory even for products that do not meet the criteria of Article 45. This is because, to use national emergency numbers in certain countries, operators may require prior submission of data in the format specified in Annex VIII to the CLP Regulation (this is the case, for example, in Ireland).
Since when is the PCN submission required?
The harmonised obligation entered into force with Annex VIII to the CLP Regulation, which applies:
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from 1 January 2021 – for mixtures intended for consumer and professional use,
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from 1 January 2024 – for industrial use mixtures.
For products previously notified under national systems, there was a transitional period until 1 January 2025. Currently, all products on the market that fall under Article 45 of the CLP Regulation must be properly submitted and must have a UFI code assigned (which must also appear on the label). More about the UFI code: LINK
What does PCN notification duty mean in practice?
For companies placing mixtures on the EU market, this means the need to:
✅ check whether the mixture is subject to notification,
✅ generate a UFI code,
✅ prepare the notification in the PCN format,
✅ submit it to ECHA via the ECHA Submission Portal.
Failure to submit a PCN can result in border detentions, administrative penalties, or even civil liability if the lack of data impedes medical assistance.
Summary
PCN submission is a key element of compliance with the CLP Regulation for all companies placing hazardous mixtures on the EU market. Harmonisation under Annex VIII simplified the process, but also increased the scope of obligations and expectations from supply chains. If your company manufactures or imports hazardous mixtures – PCN submission is mandatory.
Need help with a PCN submission?
Contact us – we will prepare the PCN notification in accordance with CLP requirements and submit it to ECHA.
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