Poison Centre Notification (PCN)
By adapting Annex VIII of the CLP Regulation and amending the ChemG, the exceedingly changes resulting from the new harmonised procedure for product notification of hazardous chemicals will be specified and implemented nationally. Hereinafter you will find a short summary of the obligations resulting from the Poison Centre Notification (PCN).
When placing hazardous chemical mixtures on the market within the EU, national product notification has been a difficult task so far. Numerous national legislations and a wide range of different systems with various requirements eventuate in a time-consuming and costly procedure for product notifications. As an implementation of article 45 of the CLP Regulation, the introduction of Annex VIII will harmonise and fundamentally change the notification system. Additionally, the UFI code will be introduced as a marking element. However, special national provisions, such as the charging of fees for emergency advice or the notification of non-hazardous detergents and cleaning agents, remain unaffected by these adjustments.
Which products are mandatory to be notified?
The new Poison Centre Notification (PCN) must be carried out for all mixtures classified as hazardous based on their health or physical effects. Mixtures only classified as dangerous for the environment do not (no longer) have to be notified.
When has the new notification to be carried out?
Starting 01.01.2021 the Poison Centre Notification (PCN) and the new marking with the UFI Code are required. Only mixtures exclusively used for industrial purposes (i.e. no application in a mixture for consumers or for professional users) do not have to meet the new requirements before 01.01.2024. If a mixture is already notified according to the existing national procedures, a transitional period until 01.01.2025 applies. Attention: In Germany, this transitional period does not apply to products which only have been notified to the ISi database.
Who is required to submit?
While up to now, the importer in the respective EU country was usually responsible for the national product notification, now the downstream user producing the mixture himself or the importer who imports the mixture into the EU is liable for the Poison Centre Notification according to Annex VIII of the CLP Regulation. But also other actors in the supply chain are obliged by article 4(10) of the CLP Regulation to ensure that the notification has been carried out.
With the assignment of responsibility to the downstream user and importer, the contract manufacturer who produces the mixture on behalf of another company is now also responsible for the notification - even if he is not shown himself as the manufacturer on the packaging. Anyone who transfers mixtures into other containers is also considered as downstream user and is subject to notification. The EU states are currently in disagreement as to whether the re-brander or re-labeller can also be made responsible for the notification. It is therefore necessary to check very carefully who is responsible for the notification in each individual case.
The notification itself can also be carried out by third parties such as asseso AG.
Implementation of the notification?
The notification has to be sent to the Appointed Body of the member state where the product will be placed on the market. The company to be in charge for the notification must also consider the countries in which the product will be resold by other market participants.
The notification can be submitted either directly, via IUCLID or via the ECHA submission portal.
Further to information on the notifying company and the product identifier, the following information are required for the notification:
- classification and labelling
- formulation (the complete formulation is required for the notification, the mandatory information in section 3 of the safety data sheet is mostly not sufficient)
- toxicological information
- pH value, aggregate state, appearance
- Unique Formula Identifier (UFI-Code)
- product category according to European product categorisation system (EuPCS)
- Angaben zur Verpackung
If the recipe of individual mixtures used in your product is not available to yourself, a so-called MiM (mixture in mixture) message can be issued. This means that trade secrets do not have to be passed on and yet all actors in the supply chain are able to carry out a complete notification.