Useful information for PCN (Poison Centre Notification) submission

Safety data sheet knowledge base – PCN submission useful

The unified, harmonized notification of mixtures with a unique formula identifier (UFI) specified in Commission Regulation (EU) no. 2017/542 (PCN submission) provides an opportunity in all EEC Member States to rapidly report information regarding the mixture during an emergency health response situation.

Latest news

The transition period announced for mixtures has ended. Current notifications under national regulations are valid until the 1st of January 2025!

From the 1st of January 2025, “old” notifications (in accordance with national regulations) will be changed to “archive” status so they will be considered as not relevant information based on Annex VIII of Regulation (EU) 2017/542.

Economic operators must make a new (PCN) submission in time (until the end of this year) in accordance with Annex VIII to be able to continue distributing the mixture after the end of the transitional period.

Putting this into practice:

After the compliance date, only the hazardous mixtures with a PCN submission can be placed on market.

This also means that downstream users or importers, and in certain cases, distributors (if they change the trade name or if they want to distribute the product in countries where the supplier has not submitted the mixture) also have to make a PCN submission for new hazardous mixtures placed on the market.

The obligations to update the national notification must continue to be fulfilled during the transitional period!

Information required for PCN submission – in most cases – are not contained in the safety data sheets!

It is important to use the transition period to gather the necessary information from both your suppliers and your customers.

Safety data sheet check, classification and updating of toxicological data.

First of all, ask your suppliers for a safety data sheet that complies with current regulations.

The constant changes of CLP regulation may affect the classification of the mixture on the market or its ingredients as well.

Update your safety data sheets to provide up-to-date classification/labelling and toxicological data for PCN submission. If necessary, update your own SDSs in Hungarian/English as well!

Data on the total composition.

Obtaining data on the composition of at least 90 % of the mixture. Different rules apply to the ingredients that must be indicated in the safety data sheet, so that in many cases the combined concentration of the ingredients contained is much less than the desired 90 %.

Note: technically, the PCN submission can be made by knowing 70 % of the ingredients, however in this case authorities may verify the submission and request further data.

Clarification of concentration ranges.

The concentration ranges indicated for the PCN submission are way more “smaller” than those generally used in the SDSs (not to mention that the upper values of the concentration ranges used in SDSs can be based on a combined percentage of ingredients that exceeds 100 %).

pH value.

Another mandatory element of the PCN submission that are often missing from safety data sheets. It is important that the “not relevant” option is not enough because we have to indicate the reason too (e.g. not soluble in water, etc.).

Mixture in mixture (MiM).

If your mixture (also) contains a mixture as a raw material, you should obtain information about the ingredients (at least the SDS) or, if that mixture has been submitted under PCN, the UFI provided for the submission. The date of the supplier of the MiM is also necessary.

Note: the above-mentioned information is meant for hazardous fragrance or colorant mixtures as well, even if they are typically presented in a low concentration in the mixture to be submitted.

Trade names, target markets, UFI codes.

If you are a “re-brander” distributor then you may be exempted from PCN submission obligation if you provide the trade name under you want to place the product on the market to the notifier in the supplier chain.

The same applies if you want to use your own unique UFI code or if you want to place the hazardous mixture on a different target market than the one for which you are required to notify.

Note: it is up to the notifier to decide whether to comply with your request

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Obliged to PCN submission

If your company manufactures, import or downstream uses mixtures classified as hazardous in accordance with CLP regulation then it you have to make a PCN submission.

Persons required to submit a PCN notification:

Manufacturers: Companies that manufacture hazardous mixtures in the EU.
Importers: Legal entities importing dangerous mixtures from non-EU countries into the EU.
Downstream users: Legal entities that use hazardous mixtures for manufacturing other products. This includes other activities too: formulation of mixture, re-import and re-filling, re-packaging of hazardous mixtures.

Shared responsibility between the members of the supply chain is also fundamental in PCN submission. The distributor may also be obliged to notification!

* Placing on the market: import activity. Off-site storage of a mixture formulated only for export.

Note:

Changing the name or the labelling of a product does not count as downstream use.

Does not have (direct) obligation to notification:

distributors (there may be an indirect obligation to notification)
end users

Distributor as obliged to notification:

In certain cases, the distributor can also be obliged to notification:

If the distributor places the mixture on the market in such an EU Member State for which the supplier has not submitted the notification, or if the supplier has not been informed about this by the distributor. The distributor is obliged to submit the notification for the target country.

If the distributor who creates a new trade name or a new label does not inform the formulator of the mixture, the distributor is obliged to submit the necessary notification.

PCN consultancy for distributors

May submit notification:

Instead of the obliged party, a third person can submit the notification.

the parent company instead of the subsidiary company
the distributor instead of the supplier
supplier outside of the EU instead of the importer
consulting company

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.

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

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.

The following uses are concerned, based on the type of use:

consumer
professional
industrial

The deadline for notification is also defined by the type of the end use (in the case of more than one uses, certainly the earlier date should be respected).

Consultancy for strategic planning, preparatory education

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Limited submission

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).

Data to be supplied is limited to the information contained in the safety data sheet, provided that the accessibility of the components’ data is ensured 24 hours per day, 7 days per week (it is mandatory to provide a name, a telephone number and an e-mail address at which rapid access to detailed additional product information is available for appointed bodies during emergencies).

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Group submission

Submitting information regarding more than one mixture is also possible within the framework of a single submission if all the mixtures in a group belong to the same hazard class and product category and their composition is also the same (the total concentration of fragrances differ up to 5%).

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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

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Information to provide during PCN submission

Information required for the PCN submission

Identification of the mixture:

Product name, brand name, variants
Unique formula identifier (UFI)
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
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 intended use, product category (EuPCS)**

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.

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.

Our complex package of services regarding PCN submission

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

Our complex package of services regarding PCN submission

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Making a submission up-to-date

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.

Updating PCN submissions is necessary in the following cases:

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

When is it necessary to update the PCN submission or maybe carry out a new submission?

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.

If you are in doubt about carrying out the above activities in practice, engage our service for PCN update notification.

Read more about the conditions of the preparation of a new UFI

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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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Do you have more question?

Please contact our customer service or ask a question from our expert online.

Related helpful information

Information relating to the application of the UFI (unique formula identifier)
Label and labelling in practice according to CLP
Label elements of the safety data sheet

Service recommendation

Creation of CLP label draft for substances and mixtures
Safety data sheet translation in accordance with the regulations of chemical safety
Our services related to UFI creation and notification

Tags: CLP labelling, safety data sheet knowledge base, UFI