(Re)classification criteria: example of a mouthwash
Borderline Products - Regulatory Challenges and Impact on Design and Innovation

Product classification, right from the earliest stages of design, is a critical factor in guaranteeing optimal, compliant marketing.

Three cases are possible:

• use regulations to innovate or simply to comply with product development and marketing guidelines;

• not knowing how to choose the product's regulatory status for various reasons (lack of knowledge, legal uncertainty or lack of regulations specific to the future product);

• undergo reclassification, notably by national authorities.

The criteria for determining or reclassifying a product between different regulatory categories are complex, and vary according to a number of factors. This section details these criteria and explores their implications for product design...