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)
Article 1
Article 2
Article 3
Article 4
ANNEX
Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
Data Protection |
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‘Pyrroloquinoline quinone disodium salt |
Specified food category |
Maximum levels |
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Pyrroloquinoline quinone disodium salt”. Food supplements containing Pyrroloquinoline quinone disodium salt shall bear the following statement: This food supplement should be consumed by adults only excluding pregnant and lactating women |
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Authorised on 2 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Mitsubishi Gas Chemical Company, Inc., Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan. During the period of data protection the novel food Pyrroloquinoline quinone disodium salt is authorised for placing on the market within the Union only by Mitsubishi Gas Chemical Company, Inc., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Mitsubishi Gas Chemical Company, Inc. End date of the data protection: 2 september 2023’ |
Food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women |
20 mg/day |
Authorised Novel Food |
Specification |
‘Pyrroloquinoline quinone disodium salt |
Definition: Chemical name: disodium 9-carboxy-4,5-dioxo-1H-pyrrolo[5,4-f]quinoline-2,7-dicarboxylate Chemical formula: C14H4N2Na2O8 CAS No: 122628-50-6 Molecular weight: 374,17 Da Description Pyrroloquinoline quinone disodium salt is a reddish–brown powder produced by the non-genetically modified bacterium Hyphomicrobium denitrificans strain CK-275. 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’ |