Annex VIII Regulation (EC) No 1272/2008 requires companies, before placing hazardous mixtures on the EU market, to submit notifications to Poison Centres in a prescribed format.  Countries may also decide to submit notifications via a portal designed by European Chemical Agency (ECHA). The first deadline for submission is January 1, 2021 and it applies to products with consumer and/or professional uses.

To help support customers with the upcoming EU PCN requirements, Sphera has added new product features to its chemical compliance solutions: Intelligent Authoring™ and Compliance Engine for EH&S.

With Sphera’s solution for PCN, companies can:

• Define and manage the specific market placement of their products to identify all notifications required
• Meet new notification and product label data requirements
• Automatically create submissions for one or multiple mixtures and target one or multiple markets and legal entities

Additionally, for SAP customers, Sphera has partnered with opesus to provide the best possible end-to-end PCN solution. This solution integrates Sphera’s Compliance Engine for EH&S with opesus’ EHS Product Notification (EPN). The integrated solution enables the creation of PCN dossiers that are compliant with the ECHA harmonized requirements for submission to EU Poison Centres. The software offers extended capabilities including data validity checks, system-to-system connectivity to ECHA, and automated submissions through integration into existing processes.

“Sphera’s EU PCN solution helps organizations protect their bottom-line,” said Sphera President & CEO Paul Marushka. “Our technology reduces the resource burden of the very labor-intensive dossier creation and submission process. It also ensures perfect harmonization of information between the different required documents, SDSs, Labels and PCN dossiers. This results in fewer questions and fewer business risks caused by inconsistent information.”

To learn more about how Sphera is helping organizations with PCN requirements, view our EU PCN Resource page.

About opesus

opesus specializes in the area of SAP Environment, Health, and Safety Management and provides SAP-based consulting and software solutions that allow companies to run a sustainable business. Our flagship product, opesus EHS Product Notification (EPN), is the market-leading solution among SAP customers, helping them to fulfill their legal obligations. The solution supports various formats including PCN and SCIP. It is currently used by over 60 customers, including 8 of the top 10 largest chemical companies in Germany.