Javier Morán

Postbiotics—preparations of inanimate microorganisms and/or their components—are expanding rapidly in the food supplement sector, yet their status under Regulation (EU) 2015/2283 remains unsettled, and operators are routinely told that inactivating a lactic acid bacterium (LAB) they already market creates a novel food. We test that proposition against the analytical and regulatory record. Published stability data show that a marketed probiotic supplement is never purely viable: about one third of cells are already dead at release, culturable counts then decline one to two orders of magnitude faster than total-cell counts, and residual fermentation medium carries secreted metabolites into the product from manufacture onwards. The inanimate fraction has therefore been consumed in the Union continuously and in quantity. Lactiplantibacillus plantarum and Lactiplantibacillus pentosus have a documented pre-1997 history in European foods, are listed as not novel in the Commission’s Catalogue, and hold Qualified Presumption of Safety status that the European Food Safety Authority extends to non-viable biomass. Article 3(2)(a)(ii) contains no viability qualifier, and (vii) fails at its first limb because thermal treatment of fermented matrices predates 1997. Two determinations—heat-killed Propionibacterium freudenreichii (2021) and a heat-treated LAB fermentate (2026)—confirm this reading. Conventional thermal inactivation of LAB with pre-1997 history does not, by itself, create a novel food.

Regulation (EU) 2017/745, addresses medical devices and clarifies the scope regarding products containing viable biological materials or organisms. This regulation excludes products containing viable cells or tissues of human or animal origin, as well as those containing viable biological materials or organisms of other origins intended to achieve or support the intended purpose of the products. The term "inviable" is defined as incapable of metabolism or multiplication. The regulation mandates that products manufactured using non-viable biological substances must ensure the highest safety standards, including validated methods of elimination or inactivation of transmissible agents during manufacturing. Several Directives and Regulations provide context for the term "viable" in medical devices, emphasizing the device's ability to perform effectively and safely. Notified Bodies in the EU have interpreted that thermally inactivated microorganisms in a product do not classify it as a medical device under Regulation 2017/745. To address this, it is crucial to differentiate between the inactivation of microorganisms and the viability of their metabolites. Demonstrating the inviability of microorganisms through rigorous testing and evidence is essential for regulatory compliance and safe use in medical products. Clarifying these points and providing necessary evidence can establish that inactivated microorganisms are inviable and meet the requirements for use in medical products.

The study examines the integration of postbiotics in food products through the use of attenuated probiotics, specifically lactic acid bacteria (LAB) in bread. Postbiotics, non-viable microorganisms or their metabolites, offer health benefits similar to probiotics without the risks associated with live bacteria. This research evaluates the regulatory aspects and safety of LAB in sourdough bread production, highlighting their historical and significant use in Europe before 1997. The study includes microbial quantification and Next-Generation Sequencing (NGS) to identify LAB in traditional sourdough, comparing them with historical and current EFSA Qualified Presumption of Safety (QPS) lists. Findings show that the LAB present in sourdough have been extensively and safely used in bread making, supporting their classification as non-novel foods under EU regulations. The stability and consistency of LAB metabolites in sourdough bread are also confirmed, ensuring quality and safety in each batch. The study concludes that LAB in sourdough, when inactivated through bread-making processes, are not considered novel foods, aligning with historical, scientific, and regulatory evidence.

The study examines the integration of postbiotics in food products through the use of attenuated probiotics, specifically lactic acid bacteria (LAB) in bread. Postbiotics, non-viable microorganisms or their metabolites, offer health benefits similar to probiotics without the risks associated with live bacteria. This research evaluates the regulatory aspects and safety of LAB in sourdough bread production, highlighting their historical and significant use in Europe before 1997. The study includes microbial quantification and Next-Generation Sequencing (NGS) to identify LAB in traditional sourdough, comparing them with historical and current EFSA Qualified Presumption of Safety (QPS) lists. Findings show that the LAB present in sourdough have been extensively and safely used in bread making, supporting their classification as non-novel foods under EU regulations. The stability and consistency of LAB metabolites in sourdough bread are also confirmed, ensuring quality and safety in each batch. The study concludes that LAB in sourdough, when inactivated through bread-making processes, are not considered novel foods, aligning with historical, scientific, and regulatory evidence.

The European Union classifies “novel foods” as those not widely consumed before 15 May 1997. This category includes recently created, innovative foods, as well as those made using new technologies and processes, and foods with a traditional consumption history outside the EU. Distinguishing between “novel” and “conventional” foods is legally significant, as the former require official authorization under the Novel Foods Regulation. The regulation prioritizes safety, accurate labeling, and nutritional parity with replaced foods. Regulation (EU) 2015/2283, effective from 1 January 2018, replaced prior regulations, facilitating access to the EU market for novel and innovative foods while maintaining high safety standards. Classifying botanical products as novel can be intricate. Safety assessments for plant products must consider diversity in species, varieties, ecotypes, and chemotypes, as cultivation practices influence chemical composition. The article reviews the legislation applicable to botanicals and proposes different ways to evaluate in advance whether a product is “novel” or not, emphasizing the evaluation of the origin and consumption history of foods of plant origin.