Commission Implementing Regulation (EU) 2018/1631 of 30 October 2018 authorising the placing on the market of cranberry extract powder 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) 2018/1631
• Articles: 5

Article 1

1.   Cranberry extract powder 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 Applicant:

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Company: Ocean Spray Cranberries Inc.

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Address: One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA;

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 same novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Ocean Spray Cranberries Inc.

3.   The entry in the Union list referred to in paragraph 1 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 data 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 fulfilling the requirements laid down in Article 26(2) of Regulation (EC) No 2015/2283, 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 Ocean Spray Cranberries 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

Cranberry extract powder

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘cranberry extract powder’

Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Ocean Spray Cranberries Inc. One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA.

During the period of data protection the novel food, cranberry extract powder, is authorised for placing on the market within the Union only by Ocean Spray Cranberries 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 Ocean Spray Cranberries Inc.

End date of the data protection: 20 November 2023.’

Food Supplements as defined in Directive 2002/46/EC for the adult population

350 mg/day

(3)

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

‘Authorised Novel Food

Specification

Cranberry extract powder

Description/Definition:

Cranberry extract powder is a water-soluble phenolic-rich powder extract prepared through an ethanolic extraction from the juice concentrate of sound, mature berries of the cranberry cultivar Vaccinium macrocarpon .

Characteristics/Composition

Moisture (% w/w): ≤ 4

Proanthocyanidins — PACs (% w/w dry weight)

—

OSC-DMAC method  ( 1 )

( 3 ) : 55.0-60.0 or

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BL-DMAC method  ( 2 )

( 3 ) : 15.0-18.0

Total phenolics (GAE  ( 4 ) , % w/w dry weight)  ( 3 )

—

Folin-Ciocalteau method: > 46.2

Solubility (water): 100 %, with no visible insoluble particles

Ethanol Content (mg/kg): ≤ 100

Screen Analysis: 100 % through 30 mesh screen

Appearance and aroma, as powder: Free-flowing, deep red colour. Earthy aroma with no burnt character.

Heavy metals:

Arsenic (ppm): < 3

Microbiological criteria:

Yeast: < 100 CFU  ( 5 ) /g

Mould: < 100 CFU/g

Aerobic plate count: < 1 000 CFU/g

Coliforms: < 10 CFU/g

Escherichia coli : < 10 CFU/g

Salmonella : Absent in 375 g

( 1 )   OSC-DMAC (4-dimethylaminocinnamaldehyde) method (Ocean Spray Cranberries, Inc) Martin MA, Ramos S, Mateos R, Marais JPJ, Bravo-Clemente, L, Khoo C and Goya L. Food Res Intl 2015 71: 68-82. Modified from Cunningham DG, Vannozzi S, O'Shea E, Turk R (2002) In: Ho C-T, Zheng QY (eds) Quality Management of Nutraceuticals ACS Symposium series 803, Washington DC. Quantitation of PACs by DMAC Color Reaction pp 151-166.

( 2 )   BL-DMAC 4-dimethylaminocinnamaldehyde) method (Brunswick Lab) Multi-laboratory validation of a standard method for quantifying proanthocyanidins in cranberry powders. Prior RL, Fan E, Ji H, Howell A, Nio C, Payne MJ, Reed J. J Sci Food Agric. 2010 Jul;90(9):1473-8.

( 3 )   The different values for these three parameters are due to the different methods used.

( 4 )   GAE: Gallic Acid Equivalents

( 5 )   CFU: Colony Forming Units’