EU legislation for the registration of new bio-based products : Current challenges and barriers. A case study of products derived from municipal bio-waste for use in the agriculture and chemical industry sectors

Abstract

The present paper analyses current EU legislation governing the production and commercialisation of bio-based products, with a focus on the challenges and regulatory barriers faced by novel bio-based products seeking compliance. The analysis aims to provide a useful tool for manufacturers and/or importers navigating the complex legal landscape associated with the registration of bio-based products derived from various sources and intended for diverse applications. To this end, the analysis is applied to a case study of new bio-based products (NBPs) produced from municipal bio-waste, developed for use in both agricultural and chemical sectors. Although these products are not yet commercially available, they are at an advanced stage of development and nearing market entry. Owing to their multifunctional properties and multipurpose applications, such NBPs may be subject to registration under both the REACH regulation and the Fertilising Products Regulation (FPR). The results show that registration at the EU level provides a significant advantage – namely, market access across all Member States via the CE mark, in line with the Treaty on the Functioning of the European Union and EU regulation on the mutual recognition of goods lawfully marketed in another Member State. In contrast, national-level registration within individual Member States remains significantly more complex and time-consuming. The NBPs case study suggests that EU legislation should be updated to include a dedicated category for multifunctional bio-based products. The collection of more data from more case studies would allow assessing the real impact of national regulatory discrepancies on the industrial scalability and cross-border trade of new multifunctional bio-based products as they become available. © 2026 The Author(s)