EHS Product Notification for EU PCN Format

Solution

opesus EPN for EU PCN Format

opesus EPN is a comprehensive solution that supports the end-to-end process of poison centre notifications for SAP customers to fulfill their legal obligation for CLP Article 45.

According to Article 45 of the CLP regulation, companies placing mixtures classified for human health or physical hazards on the market must provide information to the relevant national bodies. Annex VIII of the CLP regulation defines the harmonized requirements for poison centre notifications (PCN).

With opesus EPN for PCN format, you can:

  • Easily identify notification-relevant mixtures via a built-in search
  • Protect your confidential business information with the randomize algorithm
  • Generate unique formula identifiers (UFI) directly in your SAP EHS system
  • Efficiently assign EU product categories to your mixtures
  • Run validation rules to ensure that data is compliant with the PCN requirements
  • Do system-to-system notification submissions

Key Capabilities

Manage UFI generation and PCN data efficiently
  • Automatic UFI generation within your SAP system
  • Built-in validation rules and checks help to easily identify data gaps
  • Manage update scenarios easily by automatically generating UFIs, where required
Generate dossiers for submission to the ECHA poison centre portal
  • Generate dossiers in the required  IUCLID format for the poison centre portal (PCN format)
  • Manual upload of generated dossiers into the ECHA poison centres portal
  • Automatically submit dossiers from your SAP system to the ECHA poison centres portal using the system-to-system (S2S) interface
Monitor PCN submissions
  • Identify relevant products for submission
  • Monitor the status of a submission
  • Get informed when a submission needs to be renewed

Key Benefits

Over 60 companies are using opesus EHS Product Notification to create dossiers. With our software you can:

  • Search for mixtures that are categorized for physical and health hazards
  • Create UFIs for your products and update UFIs and notifications if your formulation changes
  • Protect the formulations of your mixtures with the randomize algorithm
  • Assign product categories according to the European Product Categorization System (EuPCS)
  • Validate data required for a PCN dossier
  • Create dossiers for notification in the right format
  • Submit notifications to the ECHA Submission Portal directly from your SAP system (system-to-system communication)
  • Track the status of your notifications
  • Manage user access in managing notifications

If you’re using SAP EH&S and are still searching for software to support you with the complex requirements of Art. 45 and Annex VIII to the CLP, contact us!

Example Customers

BASF

Biesterfeld

Symrise

Linde Group

Dalli Group

Technical Information

opesus EHS Product Notification for the PCN format is tightly integrated into your SAP ERP and SAP EH&S. This means that you can manage your notifications to the ECHA poison centres completely within your in-house system, especially by utilizing the system-to-system (S2S) interface.

About CLP Art. 45, Annex VIII

What is the CLP Art. 45 Annex VIII?

Article 45 of the CLP regulation implements the requirement of harmonized information requirements for notifications to poison centers that is used for emergency health response. Annex VIII was added to the CLP regulation in 2017, which defines the unique formula identifier (UFI) that must be printed on the label of mixtures. The first amendment of Annex VIII was published on 10th January 2020. The compliance date for consumer and professional use is 1st January 2021 and for industrial use on 1st January 2024.

Is my company affected?

Under Annex VIII of the CLP regulation, importers and downstream users placing hazardous mixtures within the European Economic Area (EEA) must provide specific information on their mixtures as outlined in the harmonized format.

The obligation applies to mixtures placed on the market that are classified for human health or physical hazards. The following exceptions apply:

  • mixtures classified only for environmental hazards
  • radioactive mixtures
  • mixtures used in scientific research and development
  • medicinal and veterinary products, cosmetic products, medical devices, food and feeding stuffs
  • mixtures classified only as gases under pressure and explosives

What is UFI?

UFI is the abbreviation for “Unique Formula Identifier”. It is a 16-character alphanumeric code that must appear on the labels of products that are classified as hazardous under the CLP Art. 45 Annex VIII regulation. The purpose of the UFI is to ensure an unambiguous link between the mixture placed on the market and the information made available to poison centres.

Products need to have a valid UFI before they are placed on the market within the European Economic Area (EEA). A UFI is considered valid only after a notification has been submitted and accepted by the ECHA Submission Portal.

How can I create UFIs for my products?

There are also two ways you can generate a UFI – entering the previously mentioned information into the UFI Generator tool provided by ECHA or develop your own UFI generator in your company’s IT system. For the latter, the UFI developer’s manual is available.

At opesus, we developed a UFI generator that you can implement into your SAP system to automatically generate and store UFIs. While this option allows you to be more efficient, especially if you have a large portfolio, UFI handling is much more complex. In other words, simply generating UFIs and sticking them on the labels of products is not advisable in the long run. Why?

In the real world, products are reformulated, and enter new markets. You need to consider how to manage these changes and the update cases as outlined by ECHA in managing your portfolio. opesus EHS Product Notification helps you manage all of that within your SAP system.