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)
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 |
|
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’ |
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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 |
‘Authorised Novel Food |
Specification |
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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)
Total phenolics (GAE(4), % w/w dry weight)(3)
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 |