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EU Poison Centre Notifications (PCN) for non-EU companies


Table of Contents

Voluntary submission is a regulated option for non-EU companies and non-duty holders or mixtures outside the scope of Article 45 of CLP Regulation (EC) No. 1272/2008.

Chementors can assist non-EU companies with preparing and submitting the PCN voluntary dossier in compliance with the Regulation.

After the voluntary submission, every European importer must also make the mandatory submission. Chementors can handle this mandatory submission as well.

Therefore, we have a full-service package for non-EU companies to handle the complex EU Poison Centre Notification process.

Please rest assured and let us handle the task.

Voluntary submission: what and why

CLP Regulation (EC) No. 1272/2008 places obligations to importers and downstream users (i.e. EU countries, Norway, Iceland, and Liechtenstein) to submit Poison Centre Notifications to relevant authorities for mixtures that are classified as hazardous for any health or physical effects. This is a mandatory obligation.

Voluntary submission, on the other hand, is a regulated option to benefit other scenarios.

While mandatory submission is an obligation, voluntary submission is optional to help non-EU companies and non-duty holders or mixtures outside the PCN scope to protect confidential business information from their clients. This is because, to make the compulsory submission, EU importers and downstream users must input the mixture’s full composition including the chemical name and concentration. It means the non-EU suppliers must reveal the composition information including confidential data to their EU clients.

Likewise, EU companies, that provide non-hazardous mixtures or mixtures classified for the environment only, do not have a PCN obligation under the CLP Regulation. However, if their mixtures are purchased to be used as an ingredient in a mixture that requires mandatory PCN submission by their clients, they also need to provide full composition information of the mixture.

To tackle this unfavorable situation, the Regulation provides the option of a Voluntary submission, whose basic process includes:

  1. An EU-based entity makes a voluntary submission on behalf of the non-EU supplier. The voluntary dossier will also include all required composition information as a normal dossier.
  2. The voluntary submission will have its own unique formula identifier or UFI code
  3. The EEA importers and downstream users refer to the UFI code of the voluntary submission in their mandatory submission.

With this process, by referring to the UFI code of the voluntary submission, the mixture formulation will not be known by the EEA importers and downstream users.

“With the voluntary submission, non-EU companies and non-duty holders or mixtures outside the PCN scope will not be required to disclose the substance formulation to their clients”

Read more about what ECHA says about Voluntary submission here.

Voluntary submission: who can make

According to the CLP Regulation, a natural or legal person established in the EU, i.e., EU entities, can legally make a voluntary submission on behalf of non-EU suppliers.

Chementors is an EU company based in Finland. We, therefore, are entirely allowed under the Regulation to conduct voluntary submission.

Voluntary submission: how to make

Chementors strictly follows the voluntary submission process, guided by the European Chemicals Agency (ECHA).

  • Receive the required product information from the client
  • Create a UFI code
  • Prepare the PCN dossier
  • Submit the dossier to the PCN portal via the ECHA account of Chementors
  • Keep the PCN notification up to date

The submission will be made within a few working days after all required product information has been submitted to Chementors .

Voluntary submission: when to make

For all ‘new’ products not previously notified under national legislation, the required information must be submitted prior to placing the mixture on the market. The applicability dates depend on the type of use:

  • For consumer use and professional use mixtures, the date is 1 January 2021.
  • For industrial use mixtures, the date is 1 January 2024.

There is a transitional period for products that have been previously notified nationally and are already on the market. These notifications will remain valid until 1 January 2025 or until changes are made to the product.

Mandatory Submission

As duty holders under the CLP Regulation, It should be noted that all importers and downstream users must also still make the mandatory submission. An entity placing mixtures on the market is always responsible for submitting a PCN in every EU Member State where the mixture is marketed.

After the voluntary submission for the non-EU company, Chementors can handle all duty holders’ mandatory Poison Centre Notifications in every European country.

Our PCN Team

Satu Salomäki

Antti Aalto

Our experts are experienced in PCN notifications. As a one-stop service provider, we have handled the complete processes of a few hundred PCN submissions including:

  • mandatory submission for EEA entities
  • voluntary submission for non-EU suppliers and non-duty holders.

Maintain the confidentiality of your product formulation with our services. Please contact us for more information.

Chementors’ team of specialists helps companies to survive in the ever changing jungle of laws concerning chemical, environmental and product safety in Europe and all around the World.

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