COMMISSION IMPLEMENTING REGULATION (EU) 2020/1163
of 6 August 2020
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 (1) |
The designation of the novel food on the labelling of the foodstuffs containing it shall be “UV-treated mushroom powder containing vitamin D” or “UV-treated mushroom powder containing vitamin D2” The labelling of food supplements containing vitamin D2 mushroom powder shall bear a statement that they should not be consumed by infants |
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Authorised on 27 August 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Oakshire Naturals, LP., PO Box 388 Kennett Square, Pennsylvania 19348, United States. 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 Oakshire Naturals, LP., 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 Oakshire Naturals, LP. End date of the data protection: 27 August 2025. |
Breakfast cereals |
2,25 μg of vitamin D2/100 g |
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Yeast-leavened bread and pastries |
2,25 μg of vitamin D2/100 g |
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Grain products and pastas |
2,25 μg of vitamin D2/100 g |
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Fruit juice and fruit/vegetable blend beverages |
1,125 μg of vitamin D2/100 mL |
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Milk and dairy products (excluding fluid milks) |
2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages) |
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Cheese (excluding cottage cheese, ricotta cheese, and hard-grating cheeses) |
2,25 μg of vitamin D2/100 g |
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Meal replacement bars and beverages |
2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages) |
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Dairy analogues |
2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages) |
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Meat analogues |
2,25 μg of vitamin D2/100 g |
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Soups and broths |
2,25 μg of vitamin D2/100 g |
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Extruded vegetable snacks |
2,25 μg of vitamin D2/100 g |
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Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infants |
15 μg/day |
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Food supplements as defined in Directive 2002/46/EC intended for the general population excluding infants |
15 μg/day |
Authorised Novel Food |
Specification |
‘Vitamin D2 mushroom powder |
Description/Definition Vitamin D2 mushroom powder is a granular powder made from homogenised Agaricus bisporus mushrooms that have been exposed to UV light. The mushrooms are washed, homogenised and suspended in water to produce a mushroom slurry. The mushroom slurry is passed under a UV lamp. The slurry is then filtered, dried and ground, producing vitamin D2 mushroom powder. UV radiation: A process of radiation in ultraviolet light within a range of wavelength similar to those UV-treated novel foods authorised under the novel food regulation. Characteristics/Composition Vitamin D2 content: 1 000–1 300 μg/g of mushroom powder (*1) Moisture: ≤ 10,0 % Ash: ≤ 13,5 % Heavy Metals Lead (as Pb): ≤ 0,5 mg/kg Cadmium: ≤ 0,5 mg/kg Mercury: ≤ 0,1 mg/kg Arsenic: ≤ 0,3 mg/kg Mycotoxins Aflatoxins (sum of B1+B2+G1+G2): < 4 μg/kg Microbiological criteria: Total plate count: ≤ 5 000 CFU (*2)/g Yeast and mould: ≤ 100 CFU/g Salmonella sp.: Absent in 25 g Staphylococcus aureus: ≤ 10 CFU/g Escherichia coli: ≤ 10 CFU/g Coliforms: ≤ 10 CFU/g Enterobacteriaceae: ≤ 10 CFU/g Listeria monocytogenes: Absent in 25 g |