Annex VIII of the CLP: Harmonised Notification to Poison Centres

1. What is the harmonised notification under Annex VIII of the CLP?

2. Does it affect me?

3. For which mixtures must I submit information?

4. What must the notification include?

5. Where should I submit the notification?

6. How are notifications submitted?

7. What might happen during the notification process?

8. National Appointed Bodies

9. What about notifications submitted before the harmonised format?

As of 1 January 2025, it is mandatory to use the harmonised format for notifications to Poison Centres (PCNs) in the European Union. This requirement applies to all hazardous mixtures placed on the market that pose a physical and/or health hazard within the EU, and is based on Annex VIII of the CLP Regulation, Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging.

If you market hazardous mixtures and need to understand which products require notification or updating, what steps to follow to comply with the regulation, how to protect users, and how to avoid legal risks for your company—this article is for you. Keep reading!

What is the harmonised notification under Annex VIII of the CLP?

The harmonised notification is the procedure for communicating the composition and characteristics of hazardous mixtures to Poison Centres, following a common format across the European Union.

This obligation is framed under Article 45 of the CLP Regulation, which requires Member States to designate bodies responsible for receiving relevant information to enable an appropriate emergency health response.

The article also specifies that the information must be submitted in accordance with the provisions set out in Annex VIII of the Regulation. This annex outlines the technical requirements, the harmonised format, and the necessary data to ensure an effective response by emergency services.

In essence, while Article 45 establishes the "who" and the "why", Annex VIII provides the "how". The ultimate aim of this harmonisation is to improve the quality, consistency and availability of information on hazardous mixtures, enabling a quicker and more appropriate response in the event of chemical exposure or accidents.

If a mixture is placed on the market in multiple countries within the European Economic Area, it must be notified for each of them through the harmonised system established by ECHA.

However, some Member States may have additional national requirements (such as language, deadlines, or fees), so it is important to be aware of specific regulatory details in each country.

Now that we’ve established the context, let’s see if this affects you—and what the process involves!

Does it affect me?

With Regulation (EU) 2024/2865 (November 2024), amendments have been introduced to the CLP Regulation. In particular, the scope of Article 45 has been expanded, stating that the obligation to notify lies with downstream users, importers, and distributors who place hazardous mixtures on the EU market.

Distributors who market, relabel, or rebrand these mixtures must also submit the same information to the designated bodies when distributing products in other Member States—unless they can prove that this information has already been submitted by the importer or downstream user.

It is also crucial to note that notification is a prerequisite for placing the mixture on the market. This becomes particularly relevant when the product is marketed by a third party different from the importer or downstream user.

For which mixtures must I submit information?

The harmonised notification requirement applies to all hazardous mixtures placed on the market that are classified for health and/or physical hazards.

It’s important to note that this requirement also extends to biocides and plant protection products, both of which fall within the scope of the CLP Regulation.

In such cases, the notification requirements are in addition to those already established under the Biocidal Products Regulation and the Plant Protection Products Regulation, so it’s essential to consider all applicable legal frameworks when preparing documentation.

Are any products excluded?

The following are excluded from the scope of the CLP Regulation (Article 1), and therefore from the harmonised notification:

• Radioactive mixtures

• Mixtures under customs supervision

• Non-isolated intermediates

• Mixtures for scientific research and development not intended for commercialisation

• Waste

• Mixtures intended for end users, meaning final products (e.g. medicinal products, veterinary medicines, cosmetics, medical devices, food or feed: food additives, flavourings, feed additives, animal feed)

What must the notification include?

The notification under Annex VIII of the CLP involves the creation of a dossier that must meet several requirements laid out in the PCN format. Below are the most important elements:

Exact Composition

The dossier must include the precise formulation of the mixture, specifying:

• The substances present and their concentrations

• CLP classification

• Relevant toxicological information
  

UFI – Unique Formula Identifier

The UFI is a mandatory alphanumeric code that must appear on both the product label and in the dossier. This identifier links the product information to the submitted notification, improving traceability in the event of an incident.

For more on the UFI, check out our comprehensive article on the subject.

EuPCS

The European Product Categorisation System (EuPCS) is a classification system used to identify the intended use of a mixture (e.g., bathroom cleaner, paint, adhesive, etc.).
Selecting the correct EuPCS is critical, as it helps Poison Centres quickly understand the nature of the product.

Countries of Sale

Another essential element is specifying the countries where the mixture will be marketed. This determines which national Poison Centres will receive the information.

Where should I submit the notification?

As of 1 January 2025, any mixture that poses a physical and/or health hazard and is placed on the market must have been notified using the PCN format and submitted through the ECHA Submission Portal. From this date onward, the harmonised procedure is the only valid method for submitting notifications.

How are notifications submitted?

Notifications of hazardous mixtures to Poison Centres in accordance with Annex VIII of the CLP Regulation can be submitted through different channels. Companies may choose to prepare and submit their PCN notifications using IUCLID software or other compatible tools that allow the creation of dossiers in the required format, submitted via the System-to-System (S2S) channel. Once prepared, the dossier can be sent directly to the European Chemicals Agency (ECHA).

The S2S channel acts as a “connector” that enables specialised software to send dossiers to the ECHA portal, ensuring efficiency, traceability, and ongoing regulatory compliance.

In this context, eQgest offers an advanced solution tailored to these requirements. Since 2018, the company has provided a specific module for Poison Centre notifications, fully aligned with current regulations and designed to facilitate the creation and submission of dossiers in PCN format.

If your company has not yet implemented our notification module for Poison Centres, there is still time to integrate a streamlined, efficient, and hassle-free solution. Our system is fully compatible with the System-to-System (S2S) channel, allowing you to manage dossier submissions directly through eQgest with complete efficiency, traceability, and compliance.

Contact us to discover how to simplify your notification management with a professional, intuitive, and constantly evolving tool.

What might happen during the notification process?

Once your hazardous mixture dossier has been prepared and submitted via the ECHA portal, several outcomes are possible during the process. Here are the most common scenarios and their implications:

• Submission Report – Accepted

In the best-case scenario, ECHA issues a Submission Report indicating that the dossier has passed the automatic validation and has been successfully forwarded to the Poison Centres.

• Submission Report with Warnings (QLT)

Even if the dossier is accepted, the report may include Quality rule warnings (QLT). These indicate inconsistencies or possible gaps in the information provided. While these do not prevent submission, it is recommended to review and correct the dossier to avoid future update requests from Poison Centres.

• Submission Report with Business Rule Error (BR)

In some cases, the automatic check detects errors that prevent the dossier from being submitted to Poison Centres. This happens when ECHA’s Business Rules (BR) are violated. In such cases, the dossier is rejected and must be corrected before resubmission.

• Subsequent Review by National Appointed Bodies

Even if the dossier has been accepted by ECHA, Poison Centres in the Member States may request modifications if they identify incomplete, unclear, or inconsistent information. In this case, you must update and resubmit the dossier with the required changes.

To avoid delays or resubmissions, be sure to carefully review the dossier content before submission. Using pre-validation tools and addressing any warnings early on can save time and complications later.

To support this process and help you comply from the outset, the dedicated PCN Format module in eQgest guides users according to format requirements, ensuring that your dossier is aligned with Annex VIII of the CLP Regulation before submission. This reduces the risk of errors and prevents unnecessary setbacks.

You can consult detailed information about Quality Rule Warnings (QLT) and Business Rules (BR) that may affect your notification.

National Appointed Bodies

Each EU Member State has a national appointed body responsible for managing toxicological information related to hazardous mixtures.

Via the link provided by ECHA, you can access a complete list of these bodies, including their contact details, to resolve any questions regarding the harmonised notification.

ECHA has also published a comprehensive document explaining how each country implements key aspects of Annex VIII of the CLP Regulation, including fees and specific national requirements.

Countries Connected to the ECHA Portal

Currently, the following countries are fully connected to the European harmonised notification portal, meaning they accept notifications via the ECHA Submission Portal without requiring additional or national systems:

• Austria

• Belgium

• Bulgaria (notified nationally)

• Croatia

• Cyprus

• Czech Republic

• Denmark

• Estonia

• Finland

• France

• Germany

• Greece

• Hungary

• Iceland

• Ireland

• Italy

• Latvia

• Lithuania

• Liechtenstein

• Luxembourg

• Malta

• Netherlands

• Norway

• Poland

• Portugal

• Romania

• Slovakia

• Slovenia

• Spain

• Sweden
  

You can also find a full list of national appointed bodies, including contact information, through the same link.

This is especially useful for obtaining the emergency phone number of the Poison Centre that must be included in Section 1.4 of the Safety Data Sheet (SDS).

What about notifications submitted before the harmonised format?

All products must eventually be updated to the harmonised format. There is no data migration from non-harmonised notifications (i.e., those submitted directly to a Poison Centre). However, if your product is discontinued before the end of the transition period (1 January 2025), you do not need to submit a new notification.

What about harmonised notifications already submitted before using eQgest?

No problem—these previously submitted notifications can be imported into eQgest, allowing you to maintain complete and centralised traceability of everything communicated to ECHA.

This enables you to manage both past and future notifications in a unified way, maintaining control and making any necessary updates or modifications more efficiently.