
Article 1 

1. Vitamin D2 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:
— Company: Oakshire Naturals, LP.
— Address: PO Box 388, Kennett Square, Pennsylvania 19348, United Statesis 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.
Article 2 
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.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 6 August 2020.
For the Commission
The President
Ursula VON DER LEYEN
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 D2 mushroom powder Specified food category Maximum levels of vitamin D2 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  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
Yeast-leavened bread and pastries 2,25 μg of vitamin D2/100 g
Grain products and pastas 2,25 μg of vitamin D2/100 g
Fruit juice and fruit/vegetable blend beverages 1,125 μg of vitamin D2/100 mL
Milk and dairy products (excluding fluid milks) 2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages)
Cheese (excluding cottage cheese, ricotta cheese, and hard-grating cheeses) 2,25 μg of vitamin D2/100 g
Meal replacement bars and beverages 2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages)
Dairy analogues 2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages)
Meat analogues 2,25 μg of vitamin D2/100 g
Soups and broths 2,25 μg of vitamin D2/100 g
Extruded vegetable snacks 2,25 μg of vitamin D2/100 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 D2 mushroom powder Description/DefinitionVitamin 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/CompositionVitamin D2 content: 1 000–1 300 μg/g of mushroom powderMoisture: ≤ 10,0 %Ash: ≤ 13,5 %Heavy MetalsLead (as Pb): ≤ 0,5 mg/kgCadmium: ≤ 0,5 mg/kgMercury: ≤ 0,1 mg/kgArsenic: ≤ 0,3 mg/kgMycotoxinsAflatoxins (sum of B1+B2+G1+G2): < 4 μg/kgMicrobiological criteria:Total plate count: ≤ 5 000 CFU/gYeast and mould: ≤ 100 CFU/gSalmonella sp.: Absent in 25 gStaphylococcus aureus: ≤ 10 CFU/gEscherichia coli: ≤ 10 CFU/gColiforms: ≤ 10 CFU/gEnterobacteriaceae: ≤ 10 CFU/gListeria monocytogenes: Absent in 25 g


