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Hazardous mixtures: European online submission portal for product notifications

43/2020, 14.12.2020

From 2021 onwards, companies must submit the composition of their products classified as hazardous in PCN format

The variety of chemical products such as detergents and cleaning agents is large. In addition, product formulas are usually based on many different ingredients. It is therefore important for poison centres to have reliable data on their composition at hand in the event of poisoning with hazardous products. To ensure this, companies are obliged to submit information about their products to the German Federal Institute for Risk Assessment (BfR). Up to now, a BfR-own format has been used for this purpose, which is now being replaced by the new European Poison Centres Notification Format (PCN). After a transitional period, during which both notification formats could be used in parallel, from 2021 onwards only notification in PCN format will be possible for products for private or commercial end use. A comparable regulation for products with industrial consumption will apply from 2024. "The PCN notification supports Poisons Centres and BfR in providing reliable information on chemical products," says BfR President Professor Dr. Dr. Andreas Hensel. "This serves both emergency medical care and consumer health protection."

Link to the message portals:

The European Chemicals Agency (ECHA) has been making available an online portal for sending notifications. This enables companies to inform various European countries in which they plan to market their products with a single submission. ECHA forwards the notifications intended for Germany to BfR. For products marketed exclusively in Germany it is possible to send product notifications in PCN format directly to the BfR.

The legal basis for product notification is Article 45 and Annex VIII of the European CLP Regulation (EC) No. 1272/2008, which are implemented by § 16e of the Chemicals Act (ChemG) in Germany.

With the entry into force of the CLP Regulation in 2009, the harmonisation and standardisation of product notification in the European Economic Area began. The aim was, on the one hand, to elevate the care of poisoned or suspectedly poisoned patients - especially children - to a uniformly high level and, on the other hand, to simplify notification for companies operating throughout Europe.

ECHA's Submission Portal is a reliable way to centrally manage product notifications within the company, from creation and submission to confirmation of successful submission to the Member State Competent Authorities. It reduces administrative burden and costs for companies marketing their products in several countries of the European Economic Area. The use of the portal and the notification to the BfR are free of charge. However, other Member States may charge fees. The long-established national product notification portal of the BfR will be retained and can be used alternatively for product notifications for Germany.

For detergents and cleaning agents that are not subject to the CLP Regulation, Article 9 of the European Detergents Regulation and § 10 of the German Detergents and Cleaning Agents Act (WRMG) stipulate another obligation to notify the BfR.

For other products that are not classified as hazardous to health and not due to a physical hazard, there is no obligation to notify. Voluntary information on products not subject to notification can, however, make a significant contribution to the clarification of suspected cases of poisoning and is therefore welcomed by BfR. BfR also receives this information via the European or national product notification portal and forwards it to the poison information centres for emergency medical advice.

The BfR as well as the Poisons Information Centres use the transmitted data exclusively for the legally defined tasks and treat all product information confidentially.

About the BfR

The German Federal Institute for Risk Assessment (BfR) is a scientifically independent institution within the portfolio of the Federal Ministry of Food and Agriculture (BMEL) in Germany. It advises the German federal government and German federal states ("Laender") on questions of food, chemical and product safety. BfR conducts its own research on topics that are closely linked to its assessment tasks.

This text version is a translation of the original German text which is the only legally binding version.

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