Useful information for PCN (Poison Centre Notification) submission
Safety data sheet knowledge base – PCN submission useful
As defined in Commission (EU) Regulation 2017/542 the unified, harmonised notification (PCN notification) made with the mixture’s unique formula identifier provides the possibility in all EEA (European Economic Area) member countries to quickly supply information about the mixture during emergency situations. This system is not only about regulatory compliance, but also saves lives when it is needed most.
The aim of our 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 takes place, and what actions follow afterward.
Mixtures and products concerned
Generic component identifier (GCI)
General provisions concerning PCN submission
Information to provide during PCN submission
Making a submission up-to-date
Information concerning the application on the UFI (Unique formula identifier)
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The transitional period for mixtures that had already been notified under the old system has ended.
The PCN notification obligation came into effect gradually in the EU. Annex VIII to the CLP Regulation was introduced in 2017, providing a transitional period for companies. The start date of the notification obligation depended on the intended use of the mixture. For mixtures intended for consumer use or professional (occupational) use, the new harmonised format notification became mandatory from January 1, 2021; for mixtures intended for industrial use, from January 1, 2024.
In practice, this meant that from 2021 every hazardous mixture for consumer or professional use had to be registered in the EU’s PCN system, while mixtures used exclusively in industrial settings had a reprieve until 2024. If a mixture was marketed for multiple types 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 January 1, 2025, only hazardous mixtures with a PCN notification may be on the market.
This also means that for any new hazardous mixture placed on the market, a PCN notification must be made 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 target country where the supplier has not notified the mixture).
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Obliged to PCN submission
The legislation clearly defines which economic operators are obliged: every importer or downstream user (e.g. a mixture manufacturer or re-labeling company) who places on the market* in the EU a mixture that is classified as hazardous on the basis of health or physical effects.
*Placing on the market: includes import activities; also the storage of a mixture produced exclusively for export, when 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, as well as transferring or repackaging hazardous mixtures.
Note: Changing the product’s name or labeling, 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 play the role of distributors – who simply pass on, store, and sell the mixture without changes – are generally not subject to the PCN notification obligation.
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 about this). For that target country, the distributor must make the notification.
- If a distributor that assigns a new brand name (re-labeler) does not inform the mixture manufacturer, then the distributor must carry out the required notification.
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Additionally, the following can also submit the notification:
A third party can perform 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 you can define your obligations?
- Check the classification: Make sure that your mixtures are classified as hazardous in accordance with CLP regulation. Only mixtures that present a health or physical hazard are subject to the PCN submission requirements.
- Defining the obligations: Define your role in the supply chain. For making a submission is usually the responsibility of the manufacturer and the importers. However, if you are a downstream user, you must ensure that your suppliers comply with their submitting obligations.
- Submitting process: Use the ECHA (European Chemical Agency) submission portal for making and submitting notifications. If you want to leave the submission for experts, please contact our customer service.
Mixtures and products concerned
The PCN notification obligation is prescribed by Article 45 of the EU CLP Regulation (Regulation (EC) No 1272/2008) and its Annex VIII. Based on these, the group of mixtures that must be notified can be determined according to the following criteria. In terms of usage, mixtures for consumer, professional (occupational), and industrial use are all affected.
Mixtures classified in the following hazard categories are subject to notification:
- health hazard (H phrases beginning with number 3)
- physical hazard (H phrases beginning with number 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 categories)
- explosives (unstable explosives)
- R&D (products subject to research and development)
- PPORD (products subject to process orientated research and development)
- all mixtures that are not subject to CLP regulation (wastes, drugs, mixtures under customs supervision etc.)
Warning!
Biocides and plant protection products are not exempt!
Notification is not mandatory but recommended:
In cases where it can be supposed that the given mixture can be an ingredient of another mixture, assigning a unique formula identifier may also be reasonable to non-hazardous products or products that are classified for environmental hazards only (H400, H410, H411, H412, H413, H420). In possession of an UFI, the complete composition does not need to be given to the customer who, in spite of this, will be able to submit their own notification.
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Limited submission
This is a special PCN notification option. Annex VIII of the CLP provides certain flexibility for companies in two special cases.
One special option is the limited notification (commonly referred to in practice as “limited submission”). This is a relief that 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 a typical professional user cannot access it — typically a mixture used within a single plant), then the company may choose the limited notification.
In such cases, the scope of information submitted to the authority can be narrower: you do not have to provide the exact proportion of every component in advance, provided that the company commits to make the detailed composition immediately available to toxicologists if needed. Essentially, you can think of the limited notification as an emergency plan: the notification contains the basic data of the mixture, but certain details considered to be trade secrets (e.g. the exact recipe) are not provided routinely. Instead, the company’s own on-call service keeps these details ready. In case of a poisoning, the poison centre will see that the mixture has a limited notification, and they will have contact details from which they can immediately request the full formula.
Naturally, the company must ensure 24/7 availability of expert personnel who can assist. The limited notification is thus a kind of trust-based simplification for industrial formulations, but it is optional: if a company does not want to use it, they can simply submit the full data as well. It is important to know, however, that if a mixture was initially intended for industrial use and notified with a limited submission, but later it is extended to consumer or professional use, then it can no longer remain limited – a regular (full) notification must be made for it afterward. This ensures that for products accessible to a wider audience, full information is always available.
Group submission
Another special option is the group submission. This means that if a company has several mixtures with very similar composition, it is not necessary to notify each of them separately; instead, they can be grouped under a single notification.
The conditions for this are strict: the mixtures must belong to the same hazard classes for all health and physical hazards (meaning the same warning labels apply to them), and their composition may only differ to a small extent. Specifically, the rule states that the grouped mixtures must contain the same components in the same concentration or concentration range, except for certain fragrance components, which may differ.
Typical example:
A cleaning product that has a lemon-scented, a lavender-scented, and an unscented version – the active ingredients are the same in each; only the perfume oil is different. In this case, the company may decide to submit one group submission in which it lists all variants (their trade names, UFI codes, etc.), provides the common composition, and indicates, for example, that “fragrance 1” or “fragrance 2” varies among the products. The big advantage of a group submission is that it reduces administrative burden, but care must be taken to only apply it when the criteria are fulfilled. 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.
Generic component identifier (GCI)
A generic component identifier (GCI) – “fragrances” or “colorants” – can be used to identify one or more components of the mixture, if they are used exclusively for the purpose of adding fragrance or color to the mixture.
This can apply to both individual substances and to mixtures-in-mixture (MiMs), provided that the criteria described 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 have not been classified for any health hazard; and
- the total concentration of components covered by the generic component identifier does not exceed:
- 5% for all fragrances combined;
- 25% for all colorants combined.
It should be noted that if the ingredient used to add a scent or color is itself supplied as a MiM (which may contain, in addition to the main substance, e.g. stabilizers or binders), the criterion regarding lack 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 generic component identifier can be included in the same notification. These mixtures can be placed on the market under different trade names, which can all be provided in the same notification.
Within the same notification, a given generic component identifier 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 classifications for physical hazards). In both cases, the allowed maximum total concentration remains the same (5% for fragrances and 25% for colorants).
Note: The use of a generic component identifier is optional and at the notifier’s discretion.
General provisions concerning PCN submission
The submitter specified by Commission Regulation (EU) no. 2017/542 carries out the submission towards the appointed bodies of the Member State (generally poison centres) in accordance with the following general criteria:
- submission shall be carried out before the placing on the market
- submission shall be carried out in all Member States where the mixture is placed on the market
- submission shall be carried out in the official language of the Member State or, in certain cases (where the given country allows it) it can also be carried out in English language
- submission is carried out in PCN (XML) format (structured electronic format)
- group submission is possible in the case of products with the same composition
- limited submission can only be chosen in the case of industrial use (according to point 3.1.1, part B and point 5.3 of Commission Regulation (EU) no. 2017/542)
- the fees for notification can vary from country to country (it is the right of the country’s relevant authorities to decide whether an administrative fee will be imposed or not)
- all information necessary for submitting the notification should be collected prior to the submission. Incomplete submissions cannot be closed
- the unique formula identifier (UFI) generated previously or during the submission and the EuPCS classification of the product will be necessary for the notification
- the official format of the submission is IUCLID XML format which can be created antecedently in offline mode, then the finished notification can be uploaded or sent in via the online PCN portal to the IUCLID Cloud with the help of the navigation wizard
Notification via the ECHA portal:
The European Union has established a centralized 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 or 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 the mixture notification through a single interface, even to multiple member state authorities at once. In practice, this means that the company logs into the portal, creates the mixture notification, fills in the required data fields, then selects in which country or countries it wishes to validate the notification. It is important that the notification be submitted in the official language of the given country, or at least the product name and toxicological information text must be provided in the appropriate language. (The user interface of the ECHA portal is in English, but for content fields one must pay attention to language requirements – e.g. in Hungary, product names and other descriptions should be in Hungarian so that the local poison centre can easily use them.)
Methods of data submission:
There are two main options. One is filling out the online form on the portal, which is practical for a smaller or moderate number of notifications – the system guides you through the process and warns you in real time if something is missing or not in the correct format. The other option is uploading a PCN format file. This latter is an XML-based format, essentially a data set generated with IUCLID 6 software. Larger companies or service providers often use the IUCLID application to manage mixture data and generate a file directly for submission. However, for smaller companies, the online interface is more than sufficient. ECHA also provides a UFI generator tool (which is public and available to anyone), and documentation on the Poison Centre Notification format, but the average user will find the web form to be enough. Once all required data have been entered, the portal allows you to perform a final check – at this point a validation runs to ensure all mandatory fields are filled, the UFI format is correct, the sum of concentrations is around 100%, etc. If something is wrong, an error message is shown, which must be corrected before submission.
Information to provide during PCN submission
Now let’s turn to what data must be supplied in a PCN notification. The harmonised notification requires that the information provided about the mixture be detailed and accurate, since poison centres will base their emergency advice on it. The information required for a PCN notification – in the vast majority of cases – is 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)
Perhaps the most well-known element of PCN notification. The UFI (Unique Formula Identifier) is a 16-character alphanumeric code divided into blocks. The UFI code creates an unambiguous link between the information provided in the notification and the specific product.
- All the trade names that are included in the label
Identification of the submitter:
- Name, address, phone number and e-mail address of the submitter
- Data concerning the contact person in case of emergency
Identification and label elements of danger:
- Classification of the mixture in health and physical hazard categories
First, request from your suppliers a current safety data sheet that complies with the latest requirements. Continuous changes in the CLP Regulation can affect the classification of the mixture or its components. Update your SDS inventory to ensure you can provide up-to-date classification/labeling and toxicological data during the PCN notification. If necessary, update your own SDSs as well!
- Hazard pictograms, codes of hazard statements and precautionary statements
Toxicological information:
- Information regarding the toxicological effects of the mixture or its components
- Data regarding acute toxicity, skin corrosion, eye damage etc.
Additional information:
- Type and size of the packaging of the mixture
- Colour and physical characteristics of the mixture
- pH value and
This is also a mandatory element of the PCN notification that in many cases is not included in safety data sheets. It is important not to settle for “not relevant” as an answer, because during the notification you will need to provide a justification (for example: not soluble in water, etc.).
- intended use, product category (EuPCS)
A product category according to the European product categorisation system (EuPCS) has to be assigned to all products that are subject to submission. The EuPCS is used to describe the classification of a product according to its intended use.
Information regarding the components:*
- Chemical identification and concentration of all the components
- Classification of the components in health and physical hazard categories
*Provisions regarding composition:
Data contained in the safety data sheet is not necessarily sufficient for fulfilling the obligation for submission. During the submission, information should be given about the non-hazardous ingredients (which are present at a concentration of at least 1%). Substances present at a concentration of at least 0,1% should be indicated based on their health or physical effects, and identified substances present at a concentration below 0,1% should also be indicated.
Exact identification of the ingredients is also necessary (chemical name, CAS and EU numbers).
In the case of SVHC substances, the indication of the exact concentration is mandatory, in other cases, concentration ranges may be used.
If not all of the components are known (one of the components is a mixture – MiM), the involved mixture has to have a UFI code which has to be given during the submission together with the concentration). If it does not have a UFI and neither the actual components nor their concentrations are known, the data of the supplier and the safety data sheet of the mixture have to be attached to the submission.
General denominations like “perfume” or “colouring agent” can be used if they do not have health effects and their total concentration does not exceed 5% in the case of perfumes, and 25% in the case of colouring agents.
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Safety and confidentiality of the submitted information
The information submitted to the appointed bodies must be handled in accordance with the relevant strict safety standards and can only be used by the authorised personnel.
The ECHA guarantees the safety of the submitted information in its secure IT infrastructure. This infrastructure is strictly controlled and regularly saved.
The appointed bodies and poison centres must ensure the confidential treatment of the received information.
In case of emergency, they must respond without the publication of confidential business data, unless it is necessary to inform the medical professionals.
If you request our service for PCN notification or PCN update notification, we guarantee that we ensure the confidentiality of the provided information and that we will not pass on such information to third parties (other than the authorities concerned by the notification).
If you need further information or help regarding PCN submissions, please contact us
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Making a submission up-to-date
Finally, let’s address what happens after the notification, and what manufacturers, importers, and distributors need to pay attention to following the notification. A PCN notification is not merely an administrative act, but also represents an ongoing responsibility during the time the mixture is on the market.
Use of the submitted information
Once the mixture’s data are entered into the system, the designated national body for the country of distribution and the country’s poison centres gain access to them. Under normal circumstances, these data sit in readiness – authorities do not necessarily review each notification upon arrival, but they ensure that it can be immediately retrieved if needed. When a poison centre is contacted in connection with a poisoning incident, they search for the relevant notification based on the information obtained (e.g. the product name or UFI code from the label) and thus obtain the information package that the company provided. Every piece of data can help in giving the correct medical advice. This information is used primarily for emergency medical guidance, but Article 45 of CLP also allows the data to be used for toxicovigilance purposes.
In practice, the latter means that authorities can analyze the received data on a statistical basis, monitor which product types are involved in many incidents, etc., and based on this, even take preventive measures.
Contact with the authorities
After the notification, the authority will typically only contact the notifier if they notice a problem. Such a case could be, for example, if the submitted data are incomplete or contradictory. The automatic checks performed on the PCN portal filter out many potential errors in advance, but it is conceivable that the authority might later request further clarification. Typically, however, the notifier does not need to wait for any approval from the authority in order to market the product – once the notification is submitted and confirmation is received, the product can be placed on the market (provided it meets all other requirements, e.g. label elements, UFI on label, etc.). During random or targeted inspections, however, authorities may ask for proof of the PCN notification. In such cases, the company must be able to show, for example, the notification ID or confirmation. If it turns out that a product did not undergo the required notification, that is a non-compliance and can result in a fine.
When is it necessary to update PCN submissions?
Making PCN (Poison Centre Notification) submissions up-to-date is of fundamental importance for the compliance with the legislation and the protection of public health.
Below we summarize when and in what cases actions must be taken regarding PCN notifications:
- the product category and/or 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 data has been added to section 11 of the safety data sheet
- the composition of the mixture has changed (addition, replacement or removal of one or more components)
- the concentration of the mixture’s components has changed in an extent which exceeds the concentration range provided in the notification, or change has occurred by a component for which an exact concentration was given in the notification, but the extent of the change does not exceed the data given in table 3, part B, annex VIII of CLP regulation
- if perfumes in a group submission have changed, the list described in point 3.1 containing the mixtures and the perfumes present in them should be made up-to-date
- packaging and labelling have changed
- use has changed
The following guidelines help determine what type of update is required:
New submission after the significant change of the composition:
- Addition of a new component to the mixture.
- Replacement of a component.
- Removal of a component.
- Change of the concentration of the components in an extent which exceeds the range established in the legislation.
Update of a technically existent submission:
- Additional toxicological data are available.
- The labelling, the trade name or the packaging of the mixture has changed.
- There use of the mixture is expanded for a new area.
- The telephone number providing quick access to further product information has changed.
Warning! If the composition of the mixture has changed, a new UFI code has to be given to the mixture. Regarding this topic our article on the application of the UFI is recommended.
Read more about the conditions of the preparation of a new UFI
Deadlines
Involved persons have an obligation for notification before placing on the market and until the deadline depending on the final use, in accordance with the relevant regulation.
1 January 2021
Submission of the UFI and the product information (PCN submission) in the case of products intended for consumer and in the case of products intended for professional use.
1 January 2024
In the case of products intended for industrial use.
1 January 2025
End of “transition” period for mixtures already placed on market.
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