Borderline Products - Regulatory Challenges and Impact on Design and Innovation

The notion of borderline products refers to products that are, or appear to be, located at the intersection of several regulatory frameworks, making their classification often complex and open to interpretation. These products, referred to as "borderline" by the European Commission, share characteristics common to several regulatory categories, such as cosmetics, medicinal products, medical devices, food supplements and biocides. This ambiguity poses a major challenge to their development, marketing and regulatory compliance.

The regulatory classification of a product is a key determinant of its successful development, directly influencing strategic decisions at all levels:

• marketing: this determines product communication, time-to-market, and the choice of distribution channels;

• research and development (R&D): this affects composition, formulation, packaging and the galenic or technical forms envisaged;

• quality: it guides manufacturing processes, applicable standards and the selection of raw materials;

• regulatory: it sets the rules for marketing, defines authorized claims and influences evaluation procedures.

Conversely, the marketing claims desired in a development strategy may themselves condition the regulatory status of the future product. For example, a toothpaste with a claim such as "helps prevent cavities" may have cosmetic status, while a claim such as "fights cavities" is reserved for medical status. This dynamic interplay between marketing strategy and regulatory requirements can be problematic, particularly in cases where the boundaries between product statuses are blurred. In some sectors, such as essential oils, the absence of specific regulations compounds this complexity.

In a context where the health, beauty and nutrition industries are looking for innovative solutions adapted to consumer expectations, managing these issues is crucial. Inadequate classification can lead to delays, unforeseen costs or restrictions, limiting market access and sometimes holding back innovation. Unless we reverse the trend and take advantage of this complexity to innovate rather than suffer.

This article looks at the design implications of borderline products, highlighting issues related to their regulatory classification and strategic impacts. It explores the sectors where these products are most common, such as cosmetics, medical devices, herbal medicines, fortified foods and biocides. Using concrete examples, the aim is to provide an overview of the technical and regulatory challenges facing designers and manufacturers, while developing a simple model...