Biocidal product: Higher Regional Court (OVG) Bremen clarifies classification

A recent decision of the Higher Regional Court (OVG) Bremen (Beschl. vom 15.04.2025 – 1 LA 273/23) distinguishes between medicinal products, medical devices, food supplements and biocidal products.

A recent decision of the Higher Regional Court (OVG) Bremen (Beschl. vom 15.04.2025 – 1 LA 273/23) concerning an allegedly "technical" processing aid demonstrates exemplarily how important the correct legal classification of health products is. Manufacturers and distributors are repeatedly confronted with complex classification issues in practice: Is it a medicinal product, a medical device, a food supplement or a biocidal product? This decision assists with the legal classification and at the same time highlights the legal pitfalls.

The case: processing aid or biocide?

At the centre of the case was a product which was placed on the market as a "ready-to-use solution for microbiological hygienisation of the media air and process water for the food industry". It was declared by the manufacturer as a processing aid. In reality, however, it exerted an effect against microorganisms and thus constituted a disinfectant. The Higher Regional Court (OVG) Bremen made clear: what is decisive is not the declaration by the manufacturer, but the objectively intended or at least existing microbiological effect. The product thus fell within the scope of the Biocidal Products Regulation (EU) No. 528/2012 and required appropriate authorisation.

Legal classification: classification problems in health product law (simplified overview)

Medicinal products vs. food supplements

The distinction is made primarily on the basis of intended purpose and effect:

• Medicinal products pursuant to § 2 AMG: for the cure, mitigation or prevention of diseases; pharmacological effect.
• Food supplements: foodstuffs with a nutritional physiological function, no pharmacological effect.

It becomes problematic with health-related claims or ingredients with potentially therapeutic effect.

Medicinal products vs. medical devices

• Medicinal products: pharmacological, immunological or metabolic effect.
• Medical devices: physical mechanisms of action (e.g. barrier effect, mechanical protection).

In the case of products with a "dual function", the primary effect is decisive. Case law and authorities require clear scientific documentation here. We reported previously on a recent judgment of the Court of Justice of the European Union (EuGH) on this subject.

Biocides vs. other product categories

• Biocidal products serve to combat harmful organisms via chemical or biological mechanisms of action.
• They must not have a primary therapeutic effect on humans (these would then be medicinal products).

Classic borderline cases:

• Hand disinfectants: medicinal products in the medical field, biocides in private use.
• Surface disinfection in clinics: biocides, provided there is no medical device classification purpose.

Assessment of the Higher Regional Court (OVG) decision

The Higher Regional Court (OVG) Bremen confirms a decisive principle:

The objective mode of action and the intended use of the product determine the legal classification – not (solely) the self-representation by the manufacturer.

This clarification is of considerable relevance, in particular for manufacturers of technical auxiliary substances, cosmetic additives and other products in borderline areas.

Recommendations for handling the classification of biocidal products for manufacturers and distributors

1. Carry out legal classification at an early stage: It is advisable to have a specialised legal classification carried out by a lawyer at AVANTCORE Rechtsanwälte already during the development stage.
2. Documentation of mode of action and intended use: Clear, scientifically comprehensible documentation is essential.
3. Review advertising and labelling: Health-related statements should not be made that suggest a medicinal property.

Conclusion: The decision of the Higher Regional Court (OVG) Bremen illustrates how quickly an incorrect product classification can lead to significant legal and economic consequences. The lawyers at AVANTCORE Rechtsanwälte in Stuttgart are happy to advise you on the legally compliant classification, authorisation and marketing of your products.