Commission Implementing Regulation (EU) 2025/691 of 9 April 2025 authorising the placing on the market of vitamin D2 mushroom powder as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2025/691
• Articles: 5

Article 1

1.   Vitamin D 2 mushroom powder is authorised to be placed on the market within the Union.

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 Luxidum GmbH  ( 8 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 30 April 2025, 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 Luxidum GmbH.

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 5 years from the date of entry into force of this Regulation without the agreement of Luxidum GmbH.

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.

Schedules & Appendices

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 young children.

Authorised on 30 April 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Luxidum GmbH, Tempelhof 3, 74594 Kressberg, Germany.

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 Luxidum GmbH, 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 Luxidum GmbH.

End date of the date protection: 30 April 2030.’

Breakfast cereals

2,4

Yeast-leavened breads and pastries

2,4

Pasta based products and similar products

2,4

Fruit beverages (except products defined in Part I of Annex I to Directive 2001/112/EC) and vegetable beverages

1,2

Concentrated or dehydrated fruit beverages (except products defined in Part I of Annex I to Directive 2001/112/EC) and concentrated or dehydrated vegetable beverages

8,4

Yoghurt drinks and other fermented milk-based drinks, flavoured milks

1,2

Milk concentrate

2,4

Milk powder, whey powder

24

Cream powder

98,4

Whey

2,4

Dairy dessert and similar products

2,4

Cheese

2,4

Meal replacements for weight control

2,4

Meat and dairy analogues

2,4

Soups

2,4

Dried soups

21,6

Extruded snacks, potato crisps, sticks

2,4

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

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 Agaricus bisporus mushrooms 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: 245-460 μg/g

Moisture: ≤ 10 %

Ash: ≤ 12 %

Water activity: < 0,5

Fat: ≤ 4,5 %

Total carbohydrates: ≤ 45 %

Protein: ≤ 36 %

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

Salmonella spp.: Not detected in 25 g

Staphylococcus aureus : Not detected in 10 g

Coliforms: ≤ 10 CFU/g

Escherichia coli : Not detected in 10 g

Listeria monocytogenes : Not detected in 25 g

CFU: colony forming units’