Great News!
The European Commission (EC) has authorized PQQ Disodium Salt to be categorized as novel foods for use in food supplements. Commission Implementing Regulation (EU) 2018/1122 of 10 August 2018 authorising the placing on the market of pyrroloquinoline quinone disodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)
The official document in PDF format from the EU website is downloadable here: The European Commission officially authorizes PQQ Disodisum Salt as Novel Foods
If you are still not know what PQQ Disodium Salt is, you may need to read this. PQQ is a fermentation product of Hyphomicrobium denitrifican. The bacteria does not have a history of consumption in the EU prior to 1997, therefore the fermentation product is considered novel. The applicant is proposing the PQQ, in the form of 99% pure red brown powder, is added to food supplements at the level of up to 50mg/day.
This is a brief introduction of PQQ in August 2016 from The Irish Competent Authority (CA) ADVISORY COMMITTEE FOR NOVEL FOODS AND PROCESSES PYRROLOQUINOLINE QUINONE DISODIUM SALT (PQQ) – DOSSIER 180. With the new approval, the maximum dosage is only 20mg/day, not 50mg/day.
Date of entry into force unknown (pending notification) or not yet in force. Date of effect: 02/09/2018
Pyrroloquinoline quinone disodium salt is authorized as novel food, and can be used directly in food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women, at maximum levels of 20 mg/day.
PQQ disodium Salt Definition:
Chemical name: disodium 9-carboxy-4,5-dioxo-1H-pyrrolo[5,4-f]quinoline-2,7-dicarboxylate
structure of PQQ and PQQH2
Chemical formula: C14H4N2Na2O8
CAS No: 122628-50-6
Molecular weight: 374,17 Da
PQQ disodium Salt Description
Pyrroloquinoline quinone disodium salt is a reddish–brown powder produced by the non-genetically modified bacterium Hyphomicrobium denitrificans strain CK-275.
PQQ disodium Salt Characteristics/Composition
Appearance: Reddish-brown powder
Purity: ≥ 99,0 % (dry weight)
UV absorbance (A322/A259): 0,56 ± 0,03
UV absorbance (A233/A259): 0,90 ± 0,09
Moisture: ≤ 12,0 %
Residual Solvent
Ethanol: ≤ 0,05 %
Heavy metals
Lead: < 3 mg/kg
Arsenic: < 2 mg/kg
Microbiological criteria:
Total viable cell count: ≤ 300 CFU/g
Mould/yeast: ≤ 12 CFU/g
Coliforms: absent in 1 g
Hyphomicrobium denitrificans: ≤ 25 CFU/g
CFU: Colony Forming Units’
PQQ disodium salt from Herb Nutritionals is manufactured in compliance with cGMP as part of a preventative controls approach. In addition, Herb Nutritionals utilizes quality management systems based on the principles of HACCP standards.
Updated Discussion of PQQ Disodium Salt Safety
An updated search of the published scientific literature was conducted through August 2016 using the search program Proquest to identify published studies relevant to the safety of PQQ disodium salt and the source organism, Hyphomicrobium. The search was conducted on databases including Adis Clinical Trials Insight, AGRICOLA, AGRIS, Allied & Complementary Medicine™, BIOSIS® Toxicology, CAB ABSTRACTS, Embase®, Foodline®: SCIENCE, FSTA®, MEDLINE®, and Toxfile®. No additional studies addressing the preclinical safety of PQQ were identified through these searches.
Therefore, both FDA from the United States, and the EC from Europe admit PQQ’s safe status, more supplement brands in the USA and the European Union will try this anti-aging, vitamin-based antioxidant.