Borderline products in the EU: Obstacles for manufacturers and importers

In order to be compliant with the regulatory requirements for a specific product in the EU market, one crucial preliminary step is to identify and categorise a given product and determine to which regulatory framework it belongs. This can be a quite challenging task since there are products that lie between two categories consequently being affected by different regulatory frameworks. The term borderline product is used when a product lies on the edge of one product category and verges on another.

In the recent article "Borderline products in the EU: Obstacles for manufacturers and importers" (published in ICRL 2/2021), Dr Minetta Wunderskirchner, Regulatory Affairs Manager - Cosmetics and Chemcials at knoell Germany, describes typical examples of borderline products and their properties.

Do you need regulatory support for borderline products in the EU? Contact us, we will be happy to advise you.