RAPEX guidelines for B2B as well

The "Rapid Exchange of Information" (RAPEX) system is a European early warning system for hazardous and potentially hazardous consumer products. The European Commission significantly extended the scope of the system at the end of 2018.

What's new?

In addition to consumer products, the system now applies to all B2B products which at least have the chance of migrating to the consumer products sector.

This naturally includes all products which

  • are purchased by consumers; 
  • can be used without specialized knowledge or experience; and
  • which were originally intended for commercial use.

As examples, the European Commission primarily cites conventional tools such as drills and angle grinders, but the changes should be even more significant for electronic components such as power outlets.

The rapid warning system is designed to ensure that information about potential threats and the measures taken to address those threats are communicated in a timely manner to authorities in the individual EU member states and the European Commission. The RAPEX system is based on the Product Safety Directive, Directive 2001/95/EC. The Directorate-General for Health and Consumers of the European Commission publishes a weekly report about recent RAPEX warnings.

Although the system was generally designed for public authorities, manufacturers should use the system for risk assessments in case of unsafe products. The discussion about methodology at least, is now moot. Accordingly, every company would be well-advised to implement the RAPEX risk assessment system in-house and use it as part of a standard process in the event of complaints or other indications of hazards from their products.

Important for manufacturers and importers

This means that manufacturers and importers of B2B products will have to adhere to a system which they only had to contend with in marginal cases in the past, if at all.

The results of the risk assessment form the basis for a report to the competent authorities which may be required in accordance with the Product Safety Act.

Companies are urgently advised to establish appropriate in-house expertise before the next product incident and to set up management teams which can perform the risk assessment. It is also advisable to examine the guidelines themselves in each case. For example, it is necessary to address one misunderstanding which is frequently encountered in this regard: the number of defective products relative to the total number of all products plays no role in the risk assessment. Affected companies should be aware of this, as well as the rules for when the international traffic of goods is presumed in the EU. In the era of online sales, it is highly probable that this will result in application of the RAPEX guidelines.

[April 2019]