1. The vitamin D 2 mushroom powder as specified in the Annex shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of 5 years from 19 December 2021 only the initial applicant:
Company: MBio, Monaghan Mushrooms,
Address: Tullygony, Tyholland, Co. Monaghan, Ireland,
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 the novel food without reference to the data protected pursuant to Article 2 or with the agreement of MBio, Monaghan Mushrooms.
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.
The data contained in the application file on the basis of which the novel food referred to in Article 1 have been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of 5 years from 19 December 2021 without the agreement of MBio, Monaghan Mushrooms.
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:
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 2 ’
2.
The labelling of food supplements containing vitamin D 2 mushroom powder shall bear a statement that they should not be consumed by infants and children under 3 years of age.
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 D 2 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.’
Breakfast cereals
2,1 μg/100 g
Yeast leavened bread and similar pastries
2,1 μg/100 g
Grain products and pasta and similar products
2,1 μg/100 g
Fruit/vegetable juices and nectars
1,1 μg/100 ml (marketed as such or reconstituted as instructed by the manufacturer)
Dairy products and analogues other than beverages
2,1 μg/100 g (marketed as such or reconstituted as instructed by the manufacturer)
Dairy products and analogues as beverages
1,1 μg/100 ml (marketed as such or reconstituted as instructed by the manufacturer)
Milk and dairy powders
21,3 μg/100 g (marketed as such or reconstituted as instructed by the manufacturer)
Meat analogues
2,1 μg/100 g
Soups
2,1 μg/100 ml (marketed as such or reconstituted as instructed by the manufacturer)
Extruded vegetable snack
2,1 μg/100 g
Meal replacement for weight control
2,1 μg/100 g
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
Food supplements as defined in Directive 2002/46/EC excluding food supplements intended for infants and young children
15 μg of vitamin D 2 /day
(2)
in Table 2 (Specifications), the following entry is inserted:
Authorised Novel Food
Specifications
‘ Vitamin D 2 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 D 2 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’
( 1 ) CFU: colony forming units.
