Borderline products: between innovation and regulatory uncertainty

Within the European regulatory framework, each product category—cosmetics, medicines, medical devices, biocides, foodstuffs, and food supplements—is subject to specific requirements. However, some products do not clearly fall into any one of these categories. They exist at the intersection of several regulations, which complicates their legal classification. These borderline products pose significant challenges in terms of formulation, claims, market access procedures, and regulatory compliance.

These issues are addressed at EBI in the fourth year of the engineering program, within the course dedicated to pharmaceutical, nutraceutical, and cosmetic regulations. This module benefits from the expertise of Mr. Mathieu Bouarfa, a biologist and biochemist, and an EBI Specialized Master’s® alumnus, who guides students in understanding and analyzing these hybrid products.

This article reviews the qualification criteria, the impacts on product development, and some emblematic examples.

A vague definition, but with very real effects.

A borderline product is a product whose nature is not immediately identifiable because its characteristics could theoretically fall under several regulatory statuses. This uncertainty may be related to the product’s composition, its mode of action, its marketing claims, or even its presentation or foreseeable use.

European legislation—particularly regulations concerning cosmetics (1223/2009), medical devices (2017/745), biocidal products (528/2012), and food supplements (2002/46)—provides precise definitions. However, in practice, grey areas remain. For example, the same product may be considered a cosmetic in one Member State and a medical device in another. This heterogeneity of interpretation, although addressed by European guidelines, underscores the importance of a case-by-case analysis.

The consequences of incorrect classification can be severe: regulatory blockages, market withdrawal, changes to labeling or formulation, or even financial penalties. Conversely, a strategic and justified classification can accelerate market entry and create a competitive advantage.

An impact at every stage of product development

The regulatory qualification of a product is not just an administrative issue: it has direct implications for the entire development chain, from formulation to marketing.

From a scientific and technical point of view, the classification dictates the applicable constraints in terms of formulation (choice of active substances, permitted concentration thresholds, interactions), packaging (materials, specific functions), and manufacturing processes (required quality level, good manufacturing practices, validation requirements).

From a marketing perspective, the nature of permitted claims varies radically from one regulatory framework to another. For example, a cosmetic product may claim an effect on skin appearance or comfort (“reduces the appearance of imperfections”), while a drug may claim to treat a medical condition (“topical treatment of moderate acne”). This marketing discourse has a direct impact on the product’s legal status: it can transform a cosmetic product into a drug, or a food supplement into a medical device.

From a regulatory point of view, the status chosen determines the market entry process (notification or authorization), the necessary studies (toxicological, clinical), the post-marketing surveillance obligations, and the role of the competent authorities (DGCCRF, ANSM, ANSES, DGAL…).

Thus, classification is the point of convergence between marketing, R&D, regulations, and commercial strategy. A coordinated approach is essential to anticipate constraints, avoid costly reclassifications, and ensure a successful market launch.

Some revealing examples

Several examples illustrate the complexity of these situations.

Hand sanitizer is a good example: if it is presented as a hand cleaner without any claim of disinfection, it falls under the category of cosmetics. However, if it mentions bactericidal or virucidal activity, it becomes a biocidal product as defined by Regulation 528/2012, requiring specific authorization. The amount of alcohol is also limited for this type of product classified as a cosmetic.

Another case: anti-acne products. A cream containing moisturizing agents and salicylic acid, without a therapeutic claim, is a cosmetic. A formulation based on isotretinoin or benzoyl peroxide, with a treatment claim, is a medicinal product. A cream containing substances that modulate skin pH (such as lauric acid or sodium stearoyl lactylate), without a direct pharmacological effect, may be considered a medical device.

A third example is that of sunscreens with a repellent effect. If the cream claims to offer both UV protection and mosquito repellent properties, it falls into two categories: cosmetic (sun protection) and biocide (repellent action). It must therefore comply with both regulatory frameworks.

Finally, energy drinks can be either fortified foodstuffs (for example, a can of caffeinated beverage), or food supplements, if they are offered in measured doses of small volume, with a specific functional objective and an individualized method of consumption.

Conclusion

Borderline products reflect the increasing complexity of innovation within a structured but sometimes rigid regulatory framework. In the absence of a harmonized European definition, only a multi-factor analysis—based on composition, mode of action, claims, and presentation—can determine their classification. Regulatory anticipation from the earliest stages of development is becoming a strategic imperative to secure innovation, reduce risks, and optimize market access.

By Mathieu Bouarfa – Biologist Biochemist – Founder of Nutrastream – Speaker in the training of health professionals, engineers and scientists – Scientific author.