Ensuring compliance: A review of EU regulations and standards for incorporating legume and legume by-product proteins in food formulations.

Consumers are increasingly seeking nutritionally enhanced products, unique flavours and packaging, and ethically sourced ingredients. Significant technological advancements and investments in product innovation by manufacturers are driving the overall market growth for plant-based protein alternatives. In Europe, this growth is largely due to the rising adoption of veganism and the flexitarian trend. During vegetable processing, certain activities generate large amounts of by-products, many of which are discarded by manufacturers. These legumes and their by-products contain substantial amounts of protein. Manufacturers using legumes and their by-products-based proteins in food formulations must comply with European Union (EU) regulations and standards to obtain market approval. For this study, the regulatory framework and novel food dossier application process were sourced from the official EU website (Europa), while relevant standards were obtained from the International Organisation for Standardisation (ISO) and European Committee for Standardisation (CEN)-European Committee for Electrotechnical Standardisation (CENELEC) website. This review provides an overview of protein extraction from legumes and their by-products, followed by an analysis of the legal requirements for processing, production, and commercialisation of these extracted proteins in food formulations. It addresses standardisation and relevant standards in areas such as characterisation and safety. Furthermore, the novel food dossier application process and the EU requirements for legume proteins, if considered novel in the EU, are discussed. This review aims to serve as a guide for manufacturers already using, or considering the use of, legume proteins in food formulations within the EU, providing essential insights for gaining market acceptance and regulatory approval for these ingredients, whether existing or novel. Further research is needed to explore the incorporation of proteins extracted from legume by-products into food formulations.