Safety of pyrroloquinoline quinone disodium salt as a novel food pursuant to Regulation (EC) No 258/97

Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on pyrroloquinoline quinone disodium salt (PQQ), trade name BioPQQ TM , as a novel food pursuant to Regulation (EC) No 258/97. PQQ is produced by fermentation using Hyphomicrobium denitrificans CK-275 and purification process. PQQ has a minimum purity of 99.0%. The information provided on the composition, specifications, batch-to-batch variability, stability and production process of PQQ is sufficient and does not raise safety concerns. The applicant intends to market PQQ for use in food supplements for healthy adults, except pregnant and lactating women, at a maximum proposed level of consumption of 20 mg/day (corresponding to 0.29 mg/kg bw per day for a 70-kg person). The proposed level of consumption is at least 250 times higher than the estimated background intake of PQQ occurring naturally in foods. Information on the absorption, distribution, metabolism and excretion of PQQ in animals and humans is limited. Considering the no-observed-adverse-effect-level (NOAEL) of 100 mg/kg bw per day from a 90-day repeated dose oral toxicity study with BioPQQ TM , and the maximum proposed level of consumption, the Panel concludes that the margin of exposure (of 344) is sufficient. The Panel concludes that the novel food, pyrroloquinoline quinone disodium salt (BioPQQ TM ), is safe under the intended conditions of use as specified by the applicant. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. SummaryFollowing a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the safety of pyrroloquinoline quinone disodium salt (PQQ), trade name BioPQQ TM , as a novel food (NF) pursuant to Regulation (EC) No 258/97. The assessment, which follows the methodology set out in Commission Recommendation 97/618/EC, is based on the data supplied in the original application, the initial assessment by the competent authority of Ireland, the concerns and objections of a scientific nature raised by the other Member States and the responses of the applicant.PQQ is produced by fermentation using Hyphomicrobium denitrificans CK-275 and purification process. The final form of the PQQ is a reddish-brown powder with a minimum purity of 99.0%. The source organism does not have a history of use in food. Notwithstanding the limited knowledge on the bacterial strain, neither the live bacteria nor the DNA are present in the NF above the detection limits of the analytical techniques applied. H. denitrificans is included in the microbiological specifications of the NF. The Panel therefore considers that the use of H. deni...

Pyrroloquinoline quinone ameliorates diabetic cardiomyopathy by inhibiting the pyroptosis signaling pathway in C57BL/6 mice and AC16 cells

“…Supplementing PQQ has a protective effect on many diseases, such as diabetes, osteoporosis and so on [ 8 ]. In Japan, Takaoki Kasahara et al proposed to define PQQ as a new type of vitamin in 2003 [ 11 ]; in the United States, FDA included PQQ as a new food ingredient and obtained GRAS certification [ 40 ]; in the European Union, the European Food Safety Authority approved PQQ as a new food ingredient [ 41 ]. We clarify the role and mechanism of PQQ as a bioactive substance in alleviating the inflammatory death of cardiomyocytes and delaying the development of DCM, providing new ideas for the treatment of DCM.…”

PQQ Supplementation and SARS-CoV-2 Spike Protein-Induced Heart Inflammation

“…It has been recently discovered that PQQ can prevent chronic heart failure by regulating mitochondrial function. 37 As COVID-19 infection (and to some extent vaccination against COVID-19) has associated cardiovascular complications such as arrhythmias, thrombosis, heart failure, cardiomyopathy, myocardial damage, and acute coronary syndromes, 38 , 39 through inflammatory processes linked to the SARS-CoV-2 spike protein, PQQ could likely help against these specific complications of COVID-19 infection, as well as against the side effects of COVID-19 vaccinations.…”

Safety Assessment Systems for Microbial Starters Derived from Fermented Foods

“…Four involved E. coli, which is excluded from the QPS because of the complexity of its various disease and pathotoxicity mechanisms [ 8 ]. In the remaining case, Hyphomicrobium denitrificans strain CK-275 was evaluated as not having QPS status because of a lack of information about it, but the final food product was approved as a Novel Food [ 18 ].…”