Integration of Postbiotics in Food Products through Attenuated Probiotics: A Case Study with Lactic Acid Bacteria in Bread
Abstract
:1. Introduction
2. Attenuated Microorganisms
3. Regulatory Aspects of Attenuated Microorganisms
- EFSA did not consider presence in the human microbiota to demonstrate the safety of the microorganisms (for example, B. xylanisolvens represents approximately a quarter of all anaerobic microorganisms inhabiting the human colon and are mostly non-pathogenic commensals, and A. muciniphila has been detected in human milk by quantitative PCR as reported by the applicant).
- EFSA and European Regulators considered the QPS list as the gold standard for ensuring the safe use of microorganisms (B. xylanisolvens is not on the QPS list and had not been evaluated under the QPS qualified presumption of safety system at the time this novel food was evaluated by Member States), and although the QPS evaluation does not take into account specific dossier data such as the production process or unpublished data, the published studies on B. xylanisolvens are insufficient for inclusion in the QPS list. In the case of IBalance, it was highlighted that within the combination of 13 heat-treated dead microorganisms, Bacillus sp. on the QPS list only applies to the production process and not as a food ingredient. The same applied to Whole cell heat-killed non-GMM M. aurum Aogashima DSM33539 and A. soehngenii CH106).
- EFSA and European Regulators also considered the production process to ensure the safety of the microorganisms (B. xylanisolvens uses standard dairy industry techniques. The production process of A. muciniphila involves anaerobic fermentation followed by pasteurization and concentration of bacterial cells. M. setense manresensis is a capsule composed of heat-killed, lyophilized bacteria with mannitol as a carrier agent, and the inactivation of growth and bacterial death is achieved by heating the bacterial culture to 80 °C for 32 min. The biomass of heat-killed P. freudenreichii with increased cobalamin content is produced by fermentation in bioreactors with cobalt salts, followed by centrifugation, washing, heat-fixing, and drying. In IBalance, the combination of 13 heat-treated dead microorganisms consists of a mixture of lysates of probiotic bacteria and yeasts, purchased from specific suppliers or individually cultured in fermenters, with each strain processed individually and then the lysates mixed).
- EFSA and European Regulators also considered the history of safe use of the microorganism (in the case of B. xylanisolvens, neither the DSM 23964 strain nor any other strain of Bacteroides has a history of use in food production and consumption, and the use of Bacteroides in food production had not been reported in the EU before May 1997. M. setense manresensis has no history of consumption in the EU. The biomass of heat-killed P. freudenreichii with increased cobalamin content is not a novel food because significant consumption in the EU was established before 15 May 1997. In IBalance, a combination of 13 heat-treated dead microorganisms, some microorganisms have been used in baked and dairy products but their use as an ingredient before 15 May 1997, in the EU had not been established. Whole cell heat-killed non-GMM M. aurum Aogashima DSM33539 and A. soehngenii CH106 have no history of use in the EU).
4. Proposal of a “Regulatory Case”
5. Conclusions
- Traditional Production Process of Sourdough Bread: The process is traditional and well-documented. It includes fermenting a mixture of flour and water with LAB and yeasts, followed by kneading, resting, dividing, shaping, proofing, and baking. During baking, LAB are inactivated due to high temperatures and dehydration. Factors affecting LAB viability include temperature, moisture content, and bread matrix structure. However, metabolites produced by LAB during fermentation remain in the bread, contributing to its sensory and nutritional properties.
- History of Significant Use: LAB have been traditionally used in sourdough fermentation in bread production in Europe and have a historical and documented use in the EU before May 15, 1997. This includes the presence of LAB in the EFSA’s Qualified Presumption of Safety (QPS) list. Therefore, the use of LAB in sourdough does not introduce new or unknown risks to human health.
- Safety: LAB used in sourdough have a history of safe use in food production. Many of these bacteria are on the EFSA’s QPS list, ensuring their safety. The presence of LAB in the human microbiota and their historical use in fermented foods like sourdough bread support their safety and significant consumption.
- Consistency of Ingredients and Processes: The use of consistent ingredients and processes ensures stability in LAB metabolite production across different batches of bread. Sourdough is fermented using well-documented traditional techniques widely employed in artisanal and home baking. During the bread baking process, LAB are inactivated due to high temperatures. Metabolites produced by LAB during fermentation remain in the bread, but the non-viable bacteria do not pose health risks.
- Scientific Research: Historical studies and current microbiological analyses confirm the presence and safe use of LAB in sourdough. These studies have shown that LAB fermentation improves the digestibility and nutritional value of bread.
- EFSA and other European regulators have evaluated various inanimate microorganisms as novel foods, considering aspects such as safety (QPS list), production and inactivation processes, and history of use. LAB used in sourdough have a history of safe and significant use in the EU before 1997 and are on the QPS list.
- There is no information indicating that sourdough is used as a medicinal product according to Directive 2001/83/EC [66] in the European Union. Sourdough is exclusively used in baking to produce bread and other fermented products, and it is not promoted or administered for therapeutic or medical purposes.
Author Contributions
Funding
Conflicts of Interest
References
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Author(s) | Year | Type of Study | Key Findings |
---|---|---|---|
Kataria, J., et al. [8] | 2009 | Review | Postbiotics can maintain a healthy microbiome without the risks of live bacteria. |
Adams, C.A. [1] | 2010 | Review | Postbiotics offer health benefits without the risks associated with live bacteria. |
Taverniti, V.; Guglielmetti, S. [4] | 2011 | In vitro Study | Paraprobiotics may be safer for individuals with compromised immune systems. |
Hill, C., et al. [2] | 2014 | Experimental Study | Viability is not essential for some beneficial effects of probiotics. |
Cicenia, A., et al. [7] | 2014 | Clinical Study | Compounds derived from lactobacilli have beneficial postbiotic activities. |
Gänzle, M.G. [10] | 2014 | Experimental Study | Fermentation with LAB improves the sensory and nutritional properties of bread. |
De Almada, C.N., et al. [5] | 2016 | Review | Evidence on the ability of paraprobiotics to modify biological responses. |
Salminen, S., et al. [11] | 2021 | Review | Definition and scope of postbiotics; health benefits and safety. |
EFSA NDA Panel, 2015 [27]. | Neither B. xylanisolvens DSM 23964 nor any other strain of Bacteroides has a history of use in food production and consumption. The applicant and the FSAI noted that the use of Bacteroides in food production had not been reported in the EU before May 1997 and that B. xylanisolvens had not been evaluated under the qualified presumption of safety (QPS) system in the moment when this novel food was evaluated by the Member States. |
EFSA NDA Panel, 2021 [29]. | The production process of A. muciniphila consists of anaerobic fermentation followed by pasteurization and concentration of bacterial cells. |
EFSA NDA Panel, 2019 [28]. | Inactivation of growth and death of the bacteria occurs by heating the final bacterial culture to 80 °C for 32 min. The novel food has no history of consumption in the European Union (EU). |
European Commission, 2021 [32]. | Human consumption of P. freudenreichii biomass is established to a significant extent within the Union before 15 May 1997. In the opinion of the recipient Member State, no significant change has occurred affecting its nutritional value, its metabolism or its level of adverse effects leading to the conclusion that category vii (Article 3(2)(a)(vii) of Regulation (EU) 2015/2283) is not applicable. |
European Commission, 2022 [33]. | The EFSA Qualified Presumption of Safety (QPS) list for Bacillus sp. It only applies to the production process, not as a food ingredient. No consumption history has been established before 15 May 1997 for the ingredient IBalance in the European Union that falls within the scope of Regulation (EU) 2015/2283 on novel foods. |
European Commission, 2021 [35]. | The application refers to a non-QPS bacteria with no history of consumption in the EU. |
EFSA NDA Panel, 2022 [36]. | The application refers to a non-QPS bacteria with no history of consumption in the EU. |
Country | Lactic Acid Bacteria | Reference(s) |
---|---|---|
Finland | L. acidophilus, L. plantarum, L. casei | [42] |
France | L. plantarum, L. casei, L. delbrueckii subsp. delbrueckii, L. acidophilus, L. brevis, Leuc. mesenteroides subsp. mesenteroides, Leuc. mesenteroides subsp. dextranicum, P. pentosaceus, L. curvatus | [43] |
Germany | L. delbrueckii, L. plantarum, L. casei, L. fermentum, L. buchneri, L. brevis | [44] |
L. acidophilus, L. farciminis, L. alimentarius, L. casei, L. plantarum, L. brevis, L. sanfranciscensis, L. fructivorans, L. fermentum, L. buchneri | [45] | |
L. acidophilus, L. casei, L. plantarum, L. farciminis, L. alimentarius, L. brevis, L. buchneri, L. fermentum, L. fructivorans, L. sanfranciscensis, Pediococcus spp. | [46] | |
L. plantarum, L. casei, L. farciminis, L. homo- hiochii, L. brevis, L. hilgardii (spontaneous); L. sanfranciscensis, L. brevis, L. hilgardii, W. viridescens | [47,48] | |
Italy | L. brevis, L. plantarum | [49] |
L. sanfranciscensis, L. fermentum, L. plantarum, Leuc. mesenteroides, Pediococcus spp. | [50] | |
L. sanfranciscensis, L. plantarum, L. farciminis | [51] | |
L. sakei, L. plantarum, Leuc. gelidum, Leuc. Mesenteroides | [52] | |
Spain | L. brevis, L. plantarum | [53] |
L. brevis, L. plantarum, L. cellobiosus, Leuc. Mesenteroides | [54,55] | |
Sweden | L. fermentum, L. delbrueckii, L. acidophilus, L. plantarum, L. rhamnosus, L. farciminis, L. fermentum, L. sanfranciscensis, L. brevis, W. viridescens | [56] |
Lactobacillus sp., P. pentosaceus | [57] |
<1997 | QPS 2022 | Sourdough | |
---|---|---|---|
Bacillus paralicheniformis | YES | YES | |
Bacillus subtilis | YES | YES | |
Lactobacillus acidophilus | YES | ||
Lactobacillus alimentarius | YES | ||
Lactobacillus brevis | YES | YES | YES |
Lactobacillus buchneri | YES | ||
Lactobacillus casei | YES | YES | YES |
Lactobacillus cellobiosus | YES | YES | |
Lactobacillus curvatus | YES | YES | YES |
Lactobacillus delbrueckii subsp. delbrueckii | YES | YES | YES |
Lactobacillus farciminis | YES | ||
Lactobacillus fermentum | YES | YES | YES |
Lactobacillus fructivorans | YES | ||
Lactobacillus hilgardii | YES | ||
Lactobacillus homo-hiochii | YES | ||
Lactobacillus paracasei | YES | YES | |
Lactobacillus plantarum | YES | YES | YES |
Lactobacillus rhamnosus | YES | YES | YES |
Lactobacillus sakei | YES | YES | YES |
Lactobacillus sanfranciscensis | YES | ||
Leuconostoc gelidum | YES | ||
Leuconostoc mesenteroides subsp. dextranicum | YES | ||
Leuconostoc mesenteroides subsp. mesenteroides | YES | ||
Pediococcus pentosaceus | YES | ||
Pediococcus spp. | YES | YES | YES |
Weissella viridescens | YES |
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© 2024 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
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Morán, J.; Kilasoniya, A. Integration of Postbiotics in Food Products through Attenuated Probiotics: A Case Study with Lactic Acid Bacteria in Bread. Foods 2024, 13, 2042. https://doi.org/10.3390/foods13132042
Morán J, Kilasoniya A. Integration of Postbiotics in Food Products through Attenuated Probiotics: A Case Study with Lactic Acid Bacteria in Bread. Foods. 2024; 13(13):2042. https://doi.org/10.3390/foods13132042
Chicago/Turabian StyleMorán, Javier, and Alina Kilasoniya. 2024. "Integration of Postbiotics in Food Products through Attenuated Probiotics: A Case Study with Lactic Acid Bacteria in Bread" Foods 13, no. 13: 2042. https://doi.org/10.3390/foods13132042
APA StyleMorán, J., & Kilasoniya, A. (2024). Integration of Postbiotics in Food Products through Attenuated Probiotics: A Case Study with Lactic Acid Bacteria in Bread. Foods, 13(13), 2042. https://doi.org/10.3390/foods13132042