COMMISSION IMPLEMENTING REGULATION (EU) 2021/2079
of 26 November 2021
authorising the placing on the market of vitamin D
2
mushroom 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 |
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‘Vitamin D2 mushroom powder |
Specified food category |
Maximum levels of vitamin D2 |
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Authorised on 19 December 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: MBio, Monaghan Mushrooms, Tullygony, Tyholland, Co. Monaghan, Ireland. During the period of data protection, the novel food vitamin D2 mushroom powder is authorised for placing on the market within the Union only by MBio, Monaghan Mushrooms, 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 MBio, Monaghan Mushrooms. End date of the date protection: 19 December 2026.’ |
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Breakfast cereals |
2,1 μg/100 g |
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Yeast leavened bread and similar pastries |
2,1 μg/100 g |
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Grain products and pasta and similar products |
2,1 μg/100 g |
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Fruit/vegetable juices and nectars |
1,1 μg/100 ml (marketed as such or reconstituted as instructed by the manufacturer) |
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Dairy products and analogues other than beverages |
2,1 μg/100 g (marketed as such or reconstituted as instructed by the manufacturer) |
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Dairy products and analogues as beverages |
1,1 μg/100 ml (marketed as such or reconstituted as instructed by the manufacturer) |
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Milk and dairy powders |
21,3 μg/100 g (marketed as such or reconstituted as instructed by the manufacturer) |
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Meat analogues |
2,1 μg/100 g |
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Soups |
2,1 μg/100 ml (marketed as such or reconstituted as instructed by the manufacturer) |
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Extruded vegetable snack |
2,1 μg/100 g |
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Meal replacement for weight control |
2,1 μg/100 g |
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Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infants |
In accordance with the particular nutritional requirements of the persons for whom the products are intended |
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Food supplements as defined in Directive 2002/46/EC excluding food supplements intended for infants and young children |
15 μg of vitamin D2/day |
Authorised Novel Food |
Specifications |
‘Vitamin D2 mushroom powder |
Description/Definition: The novel food is mushroom powder produced from the dried whole Agaricus bisporus mushrooms. The process includes drying, milling and the controlled exposure of the mushroom powder to UV irradiation. UV radiation: A process of radiation in ultraviolet light within a range of wavelength similar to those UV-treated novel foods authorised under Regulation (EU) 2015/2283. Characteristics/composition: Vitamin D2 content: 580-595 μg/g of mushroom powder Ash: ≤ 13,5 % Water activity: < 0,5 Moisture content: ≤ 7,5 % Carbohydrates: ≤ 35,0 % Total Dietary Fibre: ≥ 15 % Crude protein (N × 6,25): ≥ 22 % Fat: ≤ 4,5 % Heavy metals: Lead: ≤ 0,5 mg/kg Cadmium: ≤ 0,5 mg/kg Mercury: ≤ 0,1 mg/kg Arsenic: ≤ 0,3 mg/kg Mycotoxins: Aflatoxin B1: ≤ 0,10 μg/kg Aflatoxins (sum of B1 + B2 + G1 + G2): < 4 μg/kg Microbiological criteria: Total plate count: ≤ 5 000 CFU(1) Total yeast and mould count: < 100 CFU/g E. coli: < 10 CFU/g Salmonella spp.: Absence in 25 g Staphylococcus aureus: ≤ 10 CFU/g Coliforms: ≤ 10 CFU/g Listeria spp.: Absence in 25 g Enterobacteriaceae: < 10 CFU/g’ |