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.)

• CELEX: Implementing Regulation (EU) 2018/1122
• Articles: 5

Article 1

1.   Pyrroloquinoline quinone disodium salt as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

2.   For a period of five years from the date of entry into force of this Regulation only the initial Applicant:

Company: Mitsubishi Gas Chemical Company, Inc.

Address: Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan

is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Mitsubishi Gas Chemical Company, Inc.

3.   The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

4.   The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.

Article 2

The studies contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the applicant as proprietary and without which the data protection could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Mitsubishi Gas Chemical Company, Inc.

Article 3

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

the following last column is added in Table 1 (Authorised novel foods):

‘Data Protection’

(2)

The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data Protection

‘ 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

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

(3)

The following entry is inserted in Table 2 (Specifications) in alphabetical order:

Authorised Novel Food

Specification

‘ Pyrroloquinoline quinone disodium salt

Definition:

Chemical name: disodium 9-carboxy-4,5-dioxo-1 H -pyrrolo[5,4-f]quinoline-2,7-dicarboxylate

Chemical formula: C 14 H 4 N 2 Na 2 O 8

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’