PCN Notification: Why notification to poison control centers is not always enough
The PCN (Poison Centre Notification) notification is a major regulatory obligation for companies that place certain hazardous mixtures on the European market .
Under the CLP regulation, information relating to the mixtures concerned must be transmitted to poison control centers in order to allow appropriate management in the event of exposure.
The procedure is harmonized at European level and notifications are generally transmitted via the ECHA (European Chemical Agency) system.
But one question is often forgotten: is the PCN declaration free in all European countries?
The answer is no.
Submitting a PCN notification to ECHA is free of charge. However, some Member States have introduced national fees or charges related to notifications to poison control centers.
In other words, having made a PCN notification does not necessarily mean having fulfilled all national obligations.
What is a PCN declaration?
PCN, for Poison Centre Notification , corresponds to the notification of information relating to certain dangerous mixtures to bodies designated by the Member States.
This obligation stems from Article 45 and Annex VIII of the CLP Regulation.
The notification must, in particular, allow poison control centers to quickly identify:
- the mixture in question;
- its composition;
- the dangerous substances it contains;
- its dangerous properties;
- its intended use;
- the company responsible for placing it on the market;
- its unique formula identifier (UFI).
Since the implementation of Annex VIII of the CLP Regulation, the format of the information to be transmitted has been harmonized at the European level.
The goal is to enable poison control centers to have reliable and up-to-date information when a healthcare professional contacts them following exposure to a product.
The role of the UFI in PCN notification
The UFI (Unique Formula Identifier) is a unique alphanumeric identifier that allows a mixture to be associated with its declared composition.
It therefore plays an essential role in the PCN system.
When a mixture must be notified, the company must, in particular, ensure that:
- The UFI corresponds well to the declared formulation;
- the PCN information is consistent with the actual composition of the product;
- UFI is correctly used on the label when required;
- The wording changes are correctly taken into account.
A mismatch between UFI, formulation and PCN notification can lead to difficulties in managing an accidental exposure.
The management of UFIs must therefore be integrated into the regulatory product management process.
Is there a fee for submitting a PCN notification to ECHA?
No, but beware of national fees
Submitting a PCN notification via the ECHA system does not, in itself, entail the payment of a fee to ECHA.
However, this does not mean that the procedure is free in all Member States.
Some countries have introduced national fees or charges to finance the receipt, management or processing of information transmitted to poison control centers.
Therefore, we must distinguish between two elements:
1. Submitting the PCN notification
It is carried out according to the system provided for in the CLP regulation and can in particular be done via the ECHA portal.
2. Any potential national costs
They depend on the country in which the mixture is placed on the market and the applicable national rules.
This distinction is particularly important for companies that market the same product in several European countries.
In which countries can a PCN fee apply?
The regulatory situation is not identical in all Member States.
Royalty systems exist in Belgium, Hungary and Italy, among others.
The calculation methods, amounts and payment procedures are specific to each country and may change.
Belgium: a fee calculated according to the number of mixtures
Since January 1, 2026, an annual fee is applied based on the number of mixtures declared by the operator.
The system notably provides for no fee for operators declaring 1 to 5 mixtures, then progressive amounts depending on the number of mixtures declared.
Italy: an annual fee
In Italy, there are also fees associated with managing information related to dangerous mixtures.
The Italian Institute of Health (ISS) indicates, in particular, an annual fee of €50 per declarant for the Archivio Preparati Pericolosi.
Hungary: specific fees
The companies concerned must check the applicable procedures with the relevant authorities before marketing the product.
Why then might a PCN declaration be insufficient?
A company wishing to market a hazardous mixture must verify, for each of the countries concerned:
- the competent body;
- national requirements;
- accepted languages;
- any fees;
- the payment terms;
- deadlines;
- any additional steps that may be required;
- the obligations in case of a change in formula.
PCN compliance must therefore be considered using a country-by-country approach.
PCN: The main mistakes to avoid
Thinking that ECHA notification is sufficient in all countries
The harmonization of the PCN format does not mean that all national administrative formalities are identical.
Forgetting about national fees
A company may have a correctly submitted PCN declaration while having forgotten an applicable fee in the country concerned.
Using a UFI that does not match the formula
The UFI must be consistent with the composition and information transmitted in the notification.
Not updating the PCN notification after a change
A change in formulation, packaging, classification, or certain regulatory information may require an update to the notification.
Using old pricing information
National systems can evolve. A procedure or tariff found in old documentation should therefore not be considered valid indefinitely.
PCN and market access: a verification to be integrated into the regulatory process
Notification to poison control centers is part of a broader set of obligations applicable to hazardous mixtures.
Before placing the product on the market, it is therefore important to check simultaneously:
- classification of the mixture;
- CLP labelling;
- safety data sheet;
- UFI;
- PCN notification;
- national requirements;
- any fees;
- procedures for updating notifications.
This approach helps to reduce the risk of discovering, after the commercial launch of a product, that an additional national formality or payment was required.
PCN Notification key points to remember
The PCN declaration is a key European requirement for mixtures covered by Annex VIII of the CLP Regulation. However, compliance does not necessarily end with the submission of the dossier to ECHA.
Depending on the country of sale, the company may also have to comply with specific national requirements and, in some cases, pay a fee.
It is therefore recommended to systematically check, for each country:
- if the product is subject to PCN notification;
- how to send the notification;
- what information needs to be transmitted;
- which UFI should be used;
- which national body is competent;
- if a fee is applicable;
- and how to manage future updates.
Need help with your PCN declarations?
Managing PCNs, UFIs and national bonds can quickly become complex when multiple products and European markets are involved.
ECOMUNDO provides you with structured monitoring which helps to limit the risks of error and to anticipate regulatory changes and the costs associated with bringing the product to market.
Contact us for a personalized quote
The PCN (Poison Centre Notification) notification is a major regulatory obligation for companies that place certain hazardous mixtures on the European market .
Under the CLP regulation, information relating to the mixtures concerned must be transmitted to poison control centers in order to allow appropriate management in the event of exposure.
The procedure is harmonized at European level and notifications are generally transmitted via the ECHA (European Chemical Agency) system.
But one question is often forgotten: is the PCN declaration free in all European countries?
The answer is no.
Submitting a PCN notification to ECHA is free of charge. However, some Member States have introduced national fees or charges related to notifications to poison control centers.
In other words, having made a PCN notification does not necessarily mean having fulfilled all national obligations.
What is a PCN declaration?
PCN, for Poison Centre Notification , corresponds to the notification of information relating to certain dangerous mixtures to bodies designated by the Member States.
This obligation stems from Article 45 and Annex VIII of the CLP Regulation.
The notification must, in particular, allow poison control centers to quickly identify:
- the mixture in question;
- its composition;
- the dangerous substances it contains;
- its dangerous properties;
- its intended use;
- the company responsible for placing it on the market;
- its unique formula identifier (UFI).
Since the implementation of Annex VIII of the CLP Regulation, the format of the information to be transmitted has been harmonized at the European level.
The goal is to enable poison control centers to have reliable and up-to-date information when a healthcare professional contacts them following exposure to a product.
The role of the UFI in PCN notification
The UFI (Unique Formula Identifier) is a unique alphanumeric identifier that allows a mixture to be associated with its declared composition.
It therefore plays an essential role in the PCN system.
When a mixture must be notified, the company must, in particular, ensure that:
- The UFI corresponds well to the declared formulation;
- the PCN information is consistent with the actual composition of the product;
- UFI is correctly used on the label when required;
- The wording changes are correctly taken into account.
A mismatch between UFI, formulation and PCN notification can lead to difficulties in managing an accidental exposure.
The management of UFIs must therefore be integrated into the regulatory product management process.
Is there a fee for submitting a PCN notification to ECHA?
No, but beware of national fees
Submitting a PCN notification via the ECHA system does not, in itself, entail the payment of a fee to ECHA.
However, this does not mean that the procedure is free in all Member States.
Some countries have introduced national fees or charges to finance the receipt, management or processing of information transmitted to poison control centers.
Therefore, we must distinguish between two elements:
1. Submitting the PCN notification
It is carried out according to the system provided for in the CLP regulation and can in particular be done via the ECHA portal.
2. Any potential national costs
They depend on the country in which the mixture is placed on the market and the applicable national rules.
This distinction is particularly important for companies that market the same product in several European countries.
In which countries can a PCN fee apply?
The regulatory situation is not identical in all Member States.
Royalty systems exist in Belgium, Hungary and Italy, among others.
The calculation methods, amounts and payment procedures are specific to each country and may change.
Belgium: a fee calculated according to the number of mixtures
Since January 1, 2026, an annual fee is applied based on the number of mixtures declared by the operator.
The system notably provides for no fee for operators declaring 1 to 5 mixtures, then progressive amounts depending on the number of mixtures declared.
Italy: an annual fee
In Italy, there are also fees associated with managing information related to dangerous mixtures.
The Italian Institute of Health (ISS) indicates, in particular, an annual fee of €50 per declarant for the Archivio Preparati Pericolosi.
Hungary: specific fees
The companies concerned must check the applicable procedures with the relevant authorities before marketing the product.
Why then might a PCN declaration be insufficient?
A company wishing to market a hazardous mixture must verify, for each of the countries concerned:
- the competent body;
- national requirements;
- accepted languages;
- any fees;
- the payment terms;
- deadlines;
- any additional steps that may be required;
- the obligations in case of a change in formula.
PCN compliance must therefore be considered using a country-by-country approach.
PCN: The main mistakes to avoid
Thinking that ECHA notification is sufficient in all countries
The harmonization of the PCN format does not mean that all national administrative formalities are identical.
Forgetting about national fees
A company may have a correctly submitted PCN declaration while having forgotten an applicable fee in the country concerned.
Using a UFI that does not match the formula
The UFI must be consistent with the composition and information transmitted in the notification.
Not updating the PCN notification after a change
A change in formulation, packaging, classification, or certain regulatory information may require an update to the notification.
Using old pricing information
National systems can evolve. A procedure or tariff found in old documentation should therefore not be considered valid indefinitely.
PCN and market access: a verification to be integrated into the regulatory process
Notification to poison control centers is part of a broader set of obligations applicable to hazardous mixtures.
Before placing the product on the market, it is therefore important to check simultaneously:
- classification of the mixture;
- CLP labelling;
- safety data sheet;
- UFI;
- PCN notification;
- national requirements;
- any fees;
- procedures for updating notifications.
This approach helps to reduce the risk of discovering, after the commercial launch of a product, that an additional national formality or payment was required.
PCN Notification key points to remember
The PCN declaration is a key European requirement for mixtures covered by Annex VIII of the CLP Regulation. However, compliance does not necessarily end with the submission of the dossier to ECHA.
Depending on the country of sale, the company may also have to comply with specific national requirements and, in some cases, pay a fee.
It is therefore recommended to systematically check, for each country:
- if the product is subject to PCN notification;
- how to send the notification;
- what information needs to be transmitted;
- which UFI should be used;
- which national body is competent;
- if a fee is applicable;
- and how to manage future updates.
Need help with your PCN declarations?
Managing PCNs, UFIs and national bonds can quickly become complex when multiple products and European markets are involved.
ECOMUNDO provides you with structured monitoring which helps to limit the risks of error and to anticipate regulatory changes and the costs associated with bringing the product to market.
Contact us for a personalized quote
