The qualified presumption of safety assessment and its role in EFSA risk evaluations: 15 years past

Herman, Lieve; Chemaly, Marianne; Cocconcelli, Pier Sandro; Fernández, Pablo S.; Klein, Günter; Peixe, Luı́sa; Prieto, Miguel; Querol, Amparo; Súarez, Juan E.; Sundh, Ingvar; Vlak, Just M.; Correia, Sandra

doi:10.1093/femsle/fny260

Cited by 56 publications

(26 citation statements)

References 13 publications

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“…In this study, we have shown the potential sleep-improving effects of PS150 TM , which has also been demonstrated as a psychobiotic capable of alleviating abnormal behaviors induced by mild chronic stress in rats [16]. The use of PS150 TM as a dietary supplement is generally considered as safe, since PS150 TM is classified as the species L. fermentum, with the qualified presumption of safety (QPS) status suggested by the European Food Safety Authority [61]. One major limitation of this study is the non-use of polysomnography; moreover, possible interactions between pentobarbital and probiotics cannot be excluded.…”

Section: Discussionmentioning

confidence: 99%

Hypnotic Effects of Lactobacillus fermentum PS150TM on Pentobarbital-Induced Sleep in Mice

et al. 2019

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The bidirectional communication between the gastrointestinal tract and the central nervous system appears to be functionally linked to the intestinal microbiome, namely the microbiome–gut–brain axis (MGBA). Probiotics with health benefits on psychiatric or neurological illnesses are generally called psychobiotics, and some of them may also be able to improve sleep by targeting the MGBA. This study aimed to investigate the effects of a psychobiotic strain, Lactobacillus fermentum PS150TM (PS150TM), on sleep improvement by using a pentobarbital-induced sleep mouse model. Compared with the vehicle control group, the oral administration of PS150TM, but not the other L. fermentum strains, significantly decreased the sleep latency and increased the sleep duration of mice, suggesting strain-specific sleep-improving effects of PS150TM. Moreover, the ingestion of diphenhydramine, an antihistamine used to treat insomnia, as a drug control group, only increased the sleep duration of mice. We also found that the sleep-improving effects of PS150TM are time- and dose-dependent. Furthermore, the oral administration of PS150TM could attenuate a caffeine-induced sleep disturbance in mice, and PS150TM appeared to increase the expression of the gene encoding the adenosine 1 receptor in the hypothalamus of mice, as assessed by quantitative real-time polymerase chain reaction. Taken together, our results present a potential application of PS150TM as a dietary supplement for sleep improvement.

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Section: Discussionmentioning

confidence: 99%

Hypnotic Effects of Lactobacillus fermentum PS150TM on Pentobarbital-Induced Sleep in Mice

et al. 2019

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“…In addition to synthetic, there are simple biosynthetic procedures of GABA with high efficiency and environmental compatibility 10 . The promising source of GABA for the potential treatment of exacerbated inflammation are probiotic bacteria, considering the fact that main producers of GABA belong to lactic acid bacteria (LAB) 11 which have the "Qualified Presumption of Safety" (QPS) status 12,13 .…”

mentioning

confidence: 99%

GABA potentiate the immunoregulatory effects of Lactobacillus brevis BGZLS10-17 via ATG5-dependent autophagy in vitro

Bajić

Đokić

Dinić

et al. 2020

Sci Rep

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The characterization of mechanisms involved in the positive effects of probiotic bacteria in various pathophysiological conditions is a prerogative for their safe and efficient application in biomedicine. We have investigated the immunological effects of live bacteria-free supernatant collected from GABAproducing Lactobacillus brevis BGZLS10-17 on Concanavalin A-stimulated mesenteric lymph node cells (MLNC), an in vitro model of activated immune cells. We have shown that GABA containing and GABA-free supernatant of Lactobacillus brevis BGZLS10-17 have strong immunoregulatory effects on MLNC. Further, GABA produced by this strain exhibit additional inhibitory effects on proliferation, IFN-γ and IL-17 production by MLNC, and the expression of MHCII and CD80 on antigen presenting cells. At the other hand, GABA-containing supernatants displayed the strongest stimulatory effects on the expression of immunoregulatory molecules, such as Foxp3 + , IL-10, TGF-β, CTLA4 and SIRP-α. By looking for the mechanisms of actions, we found that supernatants produced by BGZLS10-17 induce autophagy in different MLNC, such as CD4 + and CD8 + T lymphocytes, NK and NKT cells, as well as antigen presenting cells. Further, we showed that the stimulation of Foxp3 + , IL-10 and TGF-β expression by BGZLS10-17 produced GABA is completely mediated by the induction of ATG5 dependent autophagy, and that other molecules in the supernatants display GABA-, ATG5-, Foxp3 +-, IL-10-and TGF-β-independent, immunoregulatory effects.

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“…Protection of public health against the adverse effects of mTG should be of the utmost importance. The FDA and the European Food Safety Authority recently published the regulatory demands and follow-ups on the GRAS status of food additives and microbial enzyme usage by the food industries [107][108][109][110]. Because of the enzyme mTG and its gliadin cross-linked complexes' potential pathogenic activities, summarized in Figure 1, the authors urge the worldwide food safety regulatory authorities to analyze the current knowledge and consider the alleviation of the GRAS status from this heavily used food additive.…”

Section: Should Microbial Transglutaminase Be Declared As a Public Hementioning

confidence: 99%

Processed Food Additive Microbial Transglutaminase and Its Cross-Linked Gliadin Complexes Are Potential Public Health Concerns in Celiac Disease

Lerner¹,

Tenbusch²

2020

IJMS

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Microbial transglutaminase (mTG) is a survival factor for microbes, but yeasts, fungi, and plants also produce transglutaminase. mTG is a cross-linker that is heavily consumed as a protein glue in multiple processed food industries. According to the manufacturers' claims, microbial transglutaminase and its cross-linked products are safe, i.e., nonallergenic, nonimmunogenic, and nonpathogenic. The regulatory authorities declare it as "generally recognized as safe" for public users. However, scientific observations are accumulating concerning its undesirable effects on human health. Functionally, mTG imitates its family member, tissue transglutaminase, which is the autoantigen of celiac disease. Both these transglutaminases mediate cross-linked complexes, which are immunogenic in celiac patients. The enzyme enhances intestinal permeability, suppresses mechanical (mucus) and immunological (anti phagocytic) enteric protective barriers, stimulates luminal bacterial growth, and augments the uptake of gliadin peptide. mTG and gliadin molecules are cotranscytosed through the enterocytes and deposited subepithelially. Moreover, mucosal dendritic cell surface transglutaminase induces gliadin endocytosis, and the enzyme-treated wheat products are immunoreactive in CD patients. The present review summarizes and updates the potentially detrimental effects of mTG, aiming to stimulate scientific and regulatory debates on its safety, to protect the public from the enzyme's unwanted effects.

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The qualified presumption of safety assessment and its role in EFSA risk evaluations: 15 years past

Cited by 56 publications

References 13 publications

Hypnotic Effects of Lactobacillus fermentum PS150TM on Pentobarbital-Induced Sleep in Mice

Hypnotic Effects of Lactobacillus fermentum PS150TM on Pentobarbital-Induced Sleep in Mice

GABA potentiate the immunoregulatory effects of Lactobacillus brevis BGZLS10-17 via ATG5-dependent autophagy in vitro

Processed Food Additive Microbial Transglutaminase and Its Cross-Linked Gliadin Complexes Are Potential Public Health Concerns in Celiac Disease

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