Useful information for PCN (Poison Centre Notification) submission

Safety Data Sheet Knowledge Base – PCN submission guide

As defined in Commission Regulation (EU) 2017/542, the unified, harmonised notification (Poison Centre Notification, PCN) submitted with the mixture’s Unique Formula Identifier (UFI) enables all EEA (European Economic Area) countries to quickly access information about the mixture in emergency situations. This system is not only about regulatory compliance: it can save lives when it matters most.

The aim of this article is to present the most important facts about PCN notification in a comprehensive yet clear manner: who is affected, what data must be provided, how the notification process works, and what actions follow afterwards.

Latest news

The transitional period for mixtures notified under the previous system has ended.

The PCN notification obligation entered into force gradually in the EU. Annex VIII to the CLP Regulation was introduced in 2017, providing transitional arrangements for companies. The start date of the notification obligation depended on the intended use of the mixture. For mixtures intended for consumer or professional use, the harmonised format notification became mandatory from 1 January 2021; for mixtures intended for industrial use, from 1 January 2024.

In practice, this meant that from 2021 every hazardous mixture for consumer or professional use had to be notified in the EU’s PCN system, while mixtures used exclusively in industrial settings had a reprieve until 2024. If a mixture was marketed for more than one type of use (e.g. both industrial and professional), then the earlier date applied – in other words, the notification could not be postponed until the industrial deadline.

In practice:

From 1 January 2025, only hazardous mixtures with a PCN notification may be placed on the market. This also means that for any new hazardous mixture placed on the market, a PCN notification must be submitted by downstream users or importers, and in certain cases by distributors (if they change the trade name, or intend to place the product on the market in a Member State where the supplier has not notified the mixture).

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Who must submit a PCN notification?

The legislation clearly defines which economic operators are obliged: every importer or downstream user (e.g. a mixture manufacturer or re-labelling company) who places on the market* in the EU a mixture that is classified as hazardous on the basis of health hazards or physical hazards.

*Placing on the market includes import; it can also include the storage of a mixture produced exclusively for export if stored outside the manufacturer’s own premises.

Entities required to submit PCN notifications:

Manufacturers/formulators: companies producing hazardous mixtures within the EU.
Importers: legal entities importing hazardous mixtures into the EU from non-EU countries.
Downstream users: legal entities that use hazardous mixtures to produce other products. This category includes related activities such as formulating mixtures, re-importing, and transferring or repackaging hazardous mixtures.

Note: changing the product’s name or labelling, or simply storing the mixture, is not considered downstream use.

These actors are referred to as notifiers in the regulation, and they are responsible for submitting the information. In contrast, companies that only act as distributors – who simply pass on, store, and sell the mixture without changes – are generally not subject to the PCN notification obligation.

For manufacturers and brand owners based outside the EU/EEA, our dedicated service on PCN submissions for non-EU companies and EU legal representation explains how these obligations can be fulfilled in practice.

Distributor as an obliged notifier

In certain cases, a distributor can also be obliged to notify:

If a distributor places the mixture on the market in an EU Member State for which the supplier did not perform the notification (and the distributor does not inform the supplier). For that target country, the distributor must submit the notification.
If a distributor assigns a new brand name (re-labelling) and does not inform the mixture manufacturer, then the distributor must carry out the required notification.

PCN consultancy for distributors

Additionally, the following can also submit the notification:

A third party can submit the notification on behalf of the obliged party, for example:

a parent company on behalf of a subsidiary,
a distributor on behalf of the supplier,
a consultant.

How can you determine your obligations?

Check the classification: make sure that your mixtures are classified as hazardous in accordance with the CLP Regulation. Only mixtures that present a health or physical hazard are subject to the PCN submission requirements.
Define your role: determine your role in the supply chain. Submitting a notification is usually the responsibility of manufacturers and importers. However, if you are a downstream user, you must ensure that your suppliers comply with their notification obligations, and submit your own notification where required.
Submission process: use the ECHA (European Chemicals Agency) Submission Portal to prepare and submit notifications. If you would like experts to handle the submission, please contact our customer service.

If you need help understanding the PCN submission process or ensuring compliance, we are ready to help.

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Mixtures and products concerned

The PCN notification obligation is prescribed by Article 45 of the CLP Regulation (Regulation (EC) No 1272/2008) and Annex VIII. Based on these provisions, the mixtures that must be notified can be determined according to the following criteria. In terms of intended use, mixtures for consumer, professional, and industrial use may all be affected.

Mixtures classified in the following hazard classes are subject to notification:

health hazards (H-statements starting with 3)
physical hazards (H-statements starting with 2, except H200, H201, H202, H203, H204, H205, H280, H281)

Products that are NOT subject to notification:

gases under pressure (if they are not classified in any other hazard class)
unstable explosives
R&D (substances and mixtures for research and development)
PPORD (substances and mixtures for process- and product-oriented research and development)
mixtures exempt from CLP (e.g. waste, medicinal products, mixtures under customs supervision)

Warning!

Biocidal products and plant protection products are not exempt.

Notification is not mandatory but may be beneficial:

Where it is likely that a mixture will be used as a component of another mixture, assigning a UFI may also be useful for non-hazardous mixtures or mixtures classified only for environmental hazards (H400, H410, H411, H412, H413, H420).

With a valid UFI, the complete composition does not need to be disclosed to the customer, who can still submit their own notification by referencing the MiM UFI where applicable.

Consultancy for strategic planning and preparatory training

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Limited submission

This is a special PCN notification option. Annex VIII to CLP provides certain flexibility in two specific cases.

One option is limited submission. This applies exclusively to mixtures intended for industrial use. The essence is that if a mixture is used only in industrial facilities (i.e. the general public or typical professional users cannot access it — typically a mixture used within a single site), then the notifier may choose limited submission.

In such cases, the scope of information submitted to the appointed body can be narrower: you do not have to provide the exact concentration of every component in advance, provided that the notifier commits to make the detailed composition immediately available to medical personnel (or toxicologists) upon request. In practice, limited submission works like an emergency access model: the notification contains the key data of the mixture, while certain details treated as trade secrets (e.g. the exact formulation) are not routinely submitted. Instead, the company maintains an internal 24/7 arrangement to provide the full composition without delay if requested by a poison centre.

Naturally, the company must ensure 24/7 availability of competent personnel who can assist. Limited submission is therefore an optional simplification for industrial formulations. It is important to know that if a mixture initially intended for industrial use and notified via limited submission is later placed on the market for consumer or professional use, it can no longer remain limited – a regular (full) notification must be submitted.

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Group submission

Another special option is group submission. This means that if a company has several mixtures with very similar composition, it may not be necessary to notify each mixture separately; instead, they can be grouped under a single notification.

The conditions are strict: the mixtures must belong to the same hazard classes for all health and physical hazards (meaning the same label elements apply), and their composition may only differ to a limited extent. In particular, the grouped mixtures must contain the same components in the same concentrations or concentration ranges, except for certain fragrance components, which may differ.

Typical example:

A cleaning product with lemon-scented, lavender-scented, and unscented variants – the active ingredients are the same in each; only the perfume oil differs. In this case, the company may submit one group notification listing all variants (trade names, UFIs, etc.), providing the common composition, and indicating that a “fragrance component” varies among the products.

The main advantage of group submission is reduced administrative burden, but it must only be used when all criteria are met.

If, over time, one product’s composition becomes more divergent (e.g. a new hazardous component is added that is not present in the others), then that product must be removed from the group and notified separately.

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Generic component identifier (GCI)

A generic component identifier (GCI) (e.g. “fragrances” or “colourants”) can be used to identify one or more components of the mixture if they are used exclusively to add fragrance or colour to the mixture.

This can apply to both individual substances and mixtures-in-mixture (MiMs), provided that the criteria below are met.

The generic component identifier is used in place of the actual chemical identity or product identifier of the component(s), and it can only be applied if the following conditions are fulfilled:

the component(s) in question are not classified for any health hazards; and
the total concentration of components covered by the generic component identifier does not exceed:
- 5% for all fragrances combined;
- 25% for all colourants combined.

It should be noted that if the ingredient used to add fragrance or colour is supplied as a MiM (which may contain, in addition to the main substance, e.g. stabilisers or binders), the criterion regarding the absence of health hazard classification applies to the MiM as a whole.

Mixtures whose composition differs only in those components that can be identified with the same GCI can be included in the same notification. These mixtures can be placed on the market under different trade names, which can all be included in the same notification.

Within the same notification, a given GCI can be used once (to cover one or more components meeting the same criteria) or more than once (if, for example, the notifier wishes to list separately the fragrance components identified by the same GCI but with different physical hazard classifications). In both cases, the maximum total concentration remains the same (5% for fragrances and 25% for colourants).

Note: the use of a generic component identifier is optional and at the notifier’s discretion.

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General provisions on PCN submission

Under Commission Regulation (EU) No 2017/542, the notifier submits the notification to the appointed bodies of the Member States (generally poison centres) in accordance with the following general principles:

the notification must be submitted before placing on the market
the notification must be submitted in all Member States where the mixture is placed on the market
the notification must be submitted in the official language of the Member State; in certain cases (where allowed nationally), English may also be accepted
the notification is submitted in PCN (XML) format (structured electronic format)
group submission is possible for mixtures meeting the grouping criteria
limited submission may only be chosen for mixtures intended for industrial use (see Part B, Section 3.1.1 and Section 5.3 of Annex VIII)
notification fees may vary by country (Member States may decide whether to charge an administrative fee)
all information required for the notification should be collected prior to submission; incomplete notifications cannot be finalised
the Unique Formula Identifier (UFI) (generated in advance or during the submission) and the EuPCS product category are required elements for the notification
the official format is an IUCLID XML file, which can be created offline; the completed notification can then be uploaded via the PCN portal (IUCLID Cloud) using the guided workflow

Notification via the ECHA portal:

The European Union has established a centralised electronic system for receiving PCN notifications. This system is operated by ECHA (European Chemicals Agency) and is generally referred to as the ECHA Submission Portal (PCN portal). Notifiers must first register in the ECHA system (if they do not already have an ECHA account).

The portal allows a company to prepare and submit a mixture notification via a single interface, including submission to multiple Member States. In practice, the company logs in, creates the notification, fills in the required fields, and then selects the Member State(s) where it wishes to submit the notification.

The notification must be submitted in the official language of the relevant country, or at least the product name and any free-text toxicological information must be provided in the appropriate language.

(The portal interface is in English, but content fields must comply with national language requirements. For example, in Hungary, product names and other descriptions should be provided in Hungarian to ensure the local poison centre can use them effectively.)

Methods of data submission:

There are two main options. One is completing the online form in the portal, which is practical for a smaller or moderate number of notifications – the system guides the user and flags missing or incorrectly formatted information in real time.

The other option is uploading a PCN format file. This is an XML-based format: essentially an IUCLID dataset exported for submission. Larger companies and service providers often use IUCLID 6 to manage mixture data and generate a file directly for upload.

For smaller companies, however, the online interface is typically sufficient. ECHA also provides a public UFI generator tool and documentation on the Poison Centre Notification format.

Once all required data have been entered, the portal allows a final validation check (e.g. mandatory fields, UFI format, concentration totals close to 100%).

If errors are detected, the portal displays error messages that must be corrected before submission.

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Information to provide in a PCN notification

Now let’s turn to the data that must be provided in a PCN notification. The harmonised notification requires the information to be detailed and accurate, since poison centres may base emergency advice on it.

The information required for a PCN notification is, in most cases, not included in Safety Data Sheets, so additional consultation and information exchange within the supply chain may be necessary.

Identification of the mixture:

Product name, brand name, variants
Unique Formula Identifier (UFI)

The UFI is one of the best-known elements of PCN notification. It is a 16-character alphanumeric code presented in blocks. The UFI provides an unambiguous link between the information submitted in the notification and the specific product.

All trade names appearing on the label

Identification of the notifier:

Name, address, telephone number and email address of the notifier
Contact person details for emergencies

Hazard classification and label elements:

Classification of the mixture for health and physical hazards

Request from your suppliers an up-to-date Safety Data Sheet that complies with the latest requirements. Continuous amendments to the CLP Regulation can affect the classification of the mixture or its components. Keep your SDS inventory up to date so you can provide current classification/labelling and toxicological data for the PCN notification. If necessary, update your own SDSs as well.

Hazard pictograms, hazard statement codes, and precautionary statement codes

Toxicological information:

Information on the toxicological effects of the mixture or its components
Data on acute toxicity, skin corrosion, serious eye damage, etc.

Additional information:

Type and size of the packaging
Colour and physical characteristics of the mixture
pH value

This is a mandatory element of the PCN notification and is often not included in Safety Data Sheets. It is important not to settle for “not relevant” without justification, because the notification requires a reason (e.g. not soluble in water).

Intended use, product category (EuPCS)

A product category under the European Product Categorisation System (EuPCS) must be assigned to all mixtures subject to notification. EuPCS describes the product category based on intended use.

Information on the components:*

Chemical identity and concentration of all components
Classification of components for health and physical hazards

*Provisions regarding composition:

Data contained in the Safety Data Sheet are not necessarily sufficient to fulfil the notification requirements. In the notification, information must also be provided on non-hazardous ingredients (present at a concentration of at least 1%).

Substances present at a concentration of at least 0.1% must be indicated based on their health or physical hazards, and identified substances present below 0.1% may also need to be indicated where required by Annex VIII rules.

Accurate identification of ingredients is necessary (chemical name, CAS number and EC number).

For SVHCs, indicating the exact concentration is mandatory; in other cases, concentration ranges may be used where permitted.

If not all components are known because one component is a mixture (MiM), the MiM should have a UFI that can be referenced in the notification together with the MiM concentration. If it does not have a UFI and neither the composition nor the concentrations are known, the supplier data and the Safety Data Sheet of the MiM must be attached to the notification.

Generic descriptions such as “perfume” or “colouring agent” may be used if the components are not classified for any health hazards and their total concentration does not exceed 5% for perfumes and 25% for colouring agents.

Our comprehensive package of services related to PCN submissions

Security and confidentiality of the submitted information

Information submitted to appointed bodies must be handled in accordance with strict security standards and may only be used by authorised personnel.

ECHA ensures the security of submitted information within its protected IT infrastructure, which is strictly controlled and regularly backed up.

Appointed bodies and poison centres must ensure the confidential treatment of the information received.

In emergencies, they must respond without disclosing confidential business information, unless disclosure is necessary to inform medical professionals.

If you use our PCN notification or PCN update services, we guarantee confidentiality of the information you provide and will not disclose it to third parties (other than the authorities involved in the notification).

If you need further information or help regarding PCN submissions, please contact us

Our comprehensive package of services related to PCN submissions

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Keeping a notification up to date

Finally, let’s address what happens after submission, and what manufacturers, importers and distributors should pay attention to once the notification is in place.

A PCN notification is not merely an administrative act: it also creates an ongoing responsibility for as long as the mixture is placed on the market.

Use of the submitted information

Once the mixture data are entered into the system, the designated national body of the country (and the country’s poison centres) can access them.

Under normal circumstances, the data remain available for immediate retrieval. Authorities do not necessarily review each notification upon receipt, but they ensure it can be retrieved without delay if needed.

When a poison centre is contacted in connection with a poisoning incident, they search for the relevant notification based on information obtained (e.g. product name or UFI from the label) and access the information package submitted by the notifier.

Every data point can help to provide correct medical advice. The information is primarily used for emergency medical guidance, but Article 45 of CLP also allows it to be used for toxicovigilance purposes.

In practice, this means authorities may analyse incidents statistically, monitor which product categories are involved more frequently, and potentially take preventive measures.

Contact with the authorities

After submission, the authority will typically contact the notifier only if they identify a problem (e.g. incomplete or contradictory data).

Automatic validation checks in the PCN portal filter out many errors, but authorities may later request clarification.

Typically, the notifier does not need formal approval to place the product on the market – once the notification is submitted and confirmation is received, the mixture may be placed on the market (provided all other requirements are met, e.g. compliant labelling and the UFI on the label where required).

During inspections, authorities may request proof of PCN submission. The company should be able to provide the notification ID or confirmation.

If a product has not been notified as required, this constitutes non-compliance and may result in penalties.

When do PCN notifications need to be updated?

Keeping PCN (Poison Centre Notification) submissions up to date is essential for legal compliance and the protection of public health.

Below is a summary of typical cases where action is required:

the product category (EuPCS) and/or the UFI of the mixture has changed
the hazard classification of the mixture has changed (Section 2.1 of the Safety Data Sheet) or additional toxicological information has been added (Section 11)
the composition of the mixture has changed (addition, replacement, or removal of one or more components)
the concentration of one or more components has changed beyond the concentration ranges notified, or an exact concentration component has changed within the limits set out in Part B, Table 3 of Annex VIII
in a group submission, fragrance components have changed and the list under Section 3.1 (mixtures and fragrances) needs to be updated
packaging and/or labelling has changed
the intended use has changed

The following guidance helps determine what type of update is required:

New submission following a significant composition change:

Addition of a new component.
Replacement of a component.
Removal of a component.
Concentration changes beyond the limits established in Annex VIII.

Update of an existing submission:

Additional toxicological information becomes available.
The labelling, trade name, or packaging changes.
The intended use is expanded to a new area.
The telephone number providing rapid access to further product information changes.

Warning! If the composition of the mixture changes, a new UFI may be required. For details, see our article on the application of the UFI.

If you are unsure how to apply the above in practice, engage our service for PCN update notifications.

Read more about the conditions for generating a new UFI

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Deadlines

Notifiers must submit a notification before placing a hazardous mixture on the market. The key application dates depended on the intended use, as laid down in Annex VIII:

1 January 2021

PCN notification (including UFI and product information) for mixtures intended for consumer use and professional use.

1 January 2024

PCN notification for mixtures intended for industrial use.

1 January 2025

End of the transitional period for mixtures already placed on the market under the previous national systems.

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