Notifications according to Annex VIII to the CLP Regulation

Poison Centre Notifications (PCN) are primarily a challenge for companies in the EU or the EEA. However, Swiss companies may also be affected by this requirement if they export preparations (mixtures) to the EU or EEA. In such cases, it is often in the Swiss exporter’s interest to support the PCN obligation. Subsidiaries based in the EU that act as manufacturers, importers or distributors are also responsible for PCN.

In some ERP systems or special software applications, it is possible to transmit PCN data sets at a mouse click to ECHA, from where they are distributed to the poison centers of the selected EU countries. Depending on the system, this may work quickly and easily. However, the question arises as to whether it is actually the best solution to transfer sensitive product data from your own database without checking it first. After all, a PCN requires the transmission of almost complete information about the composition of a chemical product, i.e., data that is protected as intellectual property or confidential business information.

Not every ingredient has to be specified exactly

Annex VIII of the CLP Regulation, which specifies the technical requirements for PCNs, contains several clauses that allow a certain amount of flexibility with regard to the data to be submitted. It may be advantageous for companies which are subject to the notification requirements to make use of this flexibility.
For example, depending on the ingredient, a “fuzziness” in the reported concentration is permitted. For certain components, it is permissible that they are not identified exactly but can be represented by a generic identifier. In addition, several mixtures that are sufficiently similar can be combined into a group notification. It may therefore be useful to develop a PCN concept that significantly reduces the overall effort required for PCN notifications, while at the same time not disclosing the composition of the mixtures in more detail than is required by Annex VIII.

Higher efficiency and protection of intellectual property

In summary, it can be said that an intelligent PCN notification concept supports compliance for your customers and users in the EU. If the regulatory leeway is fully utilized, this can help to increase the efficiency of the PCN process while protecting formulation information.

We would be happy to advise you on the optimal concept and can also support you in preparing and implementing PCN notifications.

Your Benefits

PCN notifications in accordance with Annex VIII make a significant contribution to compliance with the EU CLP Regulation. This means security and service for your customers, partners, and subsidiaries in the EU.

Use the flexibility offered by Annex VIII to your advantage. By carefully selecting and designing the notification data, you have more control and you can protect your intellectual property.

Every single PCN notification involves effort. We identify options for you how to improve the efficiency. For example, several similar products can be communicated via group notifications if the technical requirements are met.

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