Commission Implementing Regulation (EU) 2023/4 of 3 January 2023 authorising the placing on the market of vitamin D2 mushroom powder as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

Article 1

1.   The vitamin D 2 mushroom powder is authorised to be placed on the market within the Union.
The vitamin D 2 mushroom powder shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.
2.   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company Monterey Mushrooms Inc ( 13 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 24 January 2023, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of Monterey Mushrooms Inc.

Article 3

The scientific data contained in the application file and fulfilling the conditions 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 Monterey Mushrooms Inc.

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.

ANNEX

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 (μg/100 g or 100 ml)
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 24 January 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: Monterey Mushrooms Inc, 260 Westgate Drive Watsonville, CA 95076, the 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 Monterey Mushrooms Inc, 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 Monterey Mushrooms Inc.
End date of the date protection: 24 January 2028.’
Milk analogues
1,1
Dairy analogues other than milks
2,2
Breakfast cereals and cereal bars
2,2
Soups
2,2
Dried soups
22,5
Whey powder
14,1
Fruit/vegetable juices and nectars
1,1
Fruit/vegetable juice powder
12,4
Fruit/vegetable juice concentrate (liquid)
3,4
Soft drinks marketed in relation to physical exercise and fermented non-alcoholic drinks (with exclusion of dairy fermented drinks)
1,1
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 but not higher than 15 μg/day
Total diet replacement for weight control as defined in
Regulation (EU) No 609/2013
15 μg/day
Meal replacements for weight control
5 μg/meal
Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children
15 μg/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 produced by controlled exposure of sliced/diced Agaricus bisporus mushrooms to UV irradiation followed by dehydration and grinding into a powder.
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: 125–375 μg/g
Moisture: ≤ 7 %
Ash: ≤ 13,5 %
Water activity: < 0,5
Fat: ≤ 4,5 %
Total carbohydrates: ≤ 60 %
Protein: ≤ 40 %
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: ≤ 2 μg/kg
Aflatoxins (sum of B1 + B2 + G1 + G2): < 4 μg/kg
Microbiological criteria:
Total aerobic microbial count: ≤ 5 000 CFU/g
Total yeast and mould count: < 100 CFU/g
Coliforms: < 100 MPN/g
Salmonella spp.: Absence in 25 g
Staphylococcus aureus : Absence in 10 g
Escherichia coli : Absence in 10 g
Listeria monocytogenes : Absence in 25 g
CFU: colony forming units. MPN: most probable number.’

Commission Implementing Regulation (EU) 2023/4 of 3 January 2023 authorising the placing on the market of vitamin D2 mushroom powder as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

Schedules & Appendices

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