1. Vitamin D 2 mushroom powder as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established by 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: Oakshire Naturals, LP.
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Address: PO Box 388, Kennett Square, Pennsylvania 19348, United States
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 that novel food without reference to the data protected pursuant to Article 2 or with the agreement of Oakshire Naturals, LP.
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.
The studies and reports contained in the applicant’s 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 (EU) 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 Oakshire Naturals, LP.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEXSupplementary provisions
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data protection
‘ Vitamin D 2 mushroom powder
Specified food category
Maximum levels of vitamin D 2
( 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 D 2 ”
The labelling of food supplements containing vitamin D 2 mushroom powder shall bear a statement that they should not be consumed by infants
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 D 2 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 D 2 /100 g
Yeast-leavened bread and pastries
2,25 μg of vitamin D 2 /100 g
Grain products and pastas
2,25 μg of vitamin D 2 /100 g
Fruit juice and fruit/vegetable blend beverages
1,125 μg of vitamin D 2 /100 mL
Milk and dairy products (excluding fluid milks)
2,25 μg of vitamin D 2 /100 g/1,125 μg of vitamin D 2 /100 mL (beverages)
Cheese (excluding cottage cheese, ricotta cheese, and hard-grating cheeses)
2,25 μg of vitamin D 2 /100 g
Meal replacement bars and beverages
2,25 μg of vitamin D 2 /100 g/1,125 μg of vitamin D 2 /100 mL (beverages)
Dairy analogues
2,25 μg of vitamin D 2 /100 g/1,125 μg of vitamin D 2 /100 mL (beverages)
Meat analogues
2,25 μg of vitamin D 2 /100 g
Soups and broths
2,25 μg of vitamin D 2 /100 g
Extruded vegetable snacks
2,25 μg of vitamin D 2 /100 g
Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infants
15 μg/day
Food supplements as defined in Directive 2002/46/EC intended for the general population excluding infants
15 μg/day
(2)
in Table 2 (Specifications), the following entry is inserted in alphabetical order:
Authorised Novel Food
Specification
‘ Vitamin D 2 mushroom powder
Description/Definition
Vitamin D 2 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 D 2 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 D 2 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
( 1 ) The minimum specification for vitamin D content in vitamin D 2 mushroom powder of 1 000 μg vitamin D 2 /gram of mushroom powder is used.’
( *1 ) Converted from International Units (IU) using the conversion factor of 0,025 μg = 1 IU.
( *2 ) CFU: Colony Forming Units.’.
