European Harmonization of Product Notification

Speaking at the 6. BfR user conference, Dr. Roberto Scazzola from the European Commission (DG GROW) revealed the current status of the European Harmonization of Product Notification. You can find the presentation here and some of the key messages below.

The legal foundations for the notification of formulations are mostly enactments of different European legislation and oblige importers and producers of chemicals, biocides, cosmetics and detergents in European countries to notify their products to authorities in that country.

Key Elements

• Timeline
  The European XML format with a basic web application will be available December 2015.  However, the UFI generator and the new product categorization system, which are part of the notification, will only be delivered end of 2016.
• No central database
  Notifications have to be submitted to each country individually. There will be no central European database. The submission language has to be the official language of the country, or – if accepted – English.
• Unique Formula Identifier (UFI)
  A notification will include a UFI code which links the mixture with its composition and has to be printed on the label of the product. The UFI changes with the formula. Companies create their UFI codes with the UFI generator.
• Different component types
  The new XML format includes three different component types: substances, mixtures and generic components. The UFI code provides a solution for a (unknown) mixture in the composition. It is not necessary to know the exact formulation from your supplier for Notification, the UFI for the mixture in the mixture is sufficient. Also the use of generic components for fragrances and coloring agents is possible.
• New product categorization
  The new product categorization system enables an EU wide statistical analysis of incidents to identify where risk reduction measures may be needed.
• Limited Submissions
  A limited submission for mixtures will be possible for industrial use only. In that case the information of the SDS is sufficient, but a contact information with 24/7 access has to be provided.
• Notifications already made remain valid
  Notifications already made remain valid until 2025, unless there is a major change in the formula.
• opesus EHS Product Notification (EPN) will support the upcoming European XML and will be a convenient and reliable way for customers of SAP EHSM to fulfill their notification duties. EPN is the preferred software tool for customers of SAP EHSM to notify formulations in Germany and Switzerland.