2025/691

10.4.2025

COMMISSION IMPLEMENTING REGULATION (EU) 2025/691

of 9 April 2025

authorising the placing on the market of vitamin D

2 mushroom powder as a novel food and amending Implementing Regulation (EU) 2017/2470

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12(1) thereof,

Whereas:

(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

(3) On 14 December 2020, the company Luxidum GmbH (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place vitamin D

mushroom powder on the Union market as a novel food. The applicant requested for the novel food to be used in a number of foods intended for the general population. The applicant also requested the novel food to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3) excluding food supplements for infants, and in foods for special medical purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (4), excluding foods for special medical purposes intended for infants. Subsequently, on 5 July 2024, the applicant modified the initial request in the application on the use of vitamin D

mushroom powder in food supplements to exclude young children.

(4) On 14 December 2020, the applicant also made a request to the Commission for the protection of the following proprietary data: the production process (5) and the stability tests, including the respective certificate of analysis (6).

(5) On 28 May 2021, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of vitamin D

mushroom powder as a novel food.

(6) On 30 April 2024, the Authority adopted its scientific opinion on the ‘Safety of vitamin D

mushroom powder as a Novel food pursuant to Regulation (EU) 2015/2283 (NF 2020/2226)’ (7) in accordance with Article 11 of Regulation (EU) 2015/2283.

(7) In its scientific opinion, the Authority concluded that the novel food, vitamin D

mushroom powder, is safe under the proposed conditions of use.

(8) In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the data concerning the production process and the stability tests, including the respective certificate analysis, without which it could not have assessed the novel food and reached its conclusion.

(9) The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those data and studies and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2)(b) of Regulation (EU) 2015/2283.

(10) The applicant declared that it held proprietary and exclusive rights of reference to the data on the production process and the stability tests, including the respective certificate analysis, at the time it submitted the application, and that third parties cannot lawfully access, use or refer to those data.

(11) The Commission assessed all the information provided by the applicant and considered that it has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, data on the production process and the stability tests, including the respective certificate analysis, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place vitamin D

mushroom powder on the market within the Union during a period of five years from the entry into force of this Regulation.

(12) However, restricting the authorisation of vitamin D

mushroom powder and the reference to the data contained in the applicant’s file for their sole use does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.

(13) A labelling requirement should be provided in order to properly inform the consumers that infants and young children should not consume food supplements containing vitamin D

mushroom powder.

(14) It is appropriate that the inclusion of vitamin D

mushroom powder as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283.

(15) Vitamin D

mushroom powder should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

1. Vitamin D

mushroom powder is authorised to be placed on the market within the Union.

Vitamin D

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 9 April 2025.

For the Commission

The President

Ursula VON DER LEYEN

(1)

OJ L 327, 11.12.2015, p. 1

, ELI:

http://data.europa.eu/eli/reg/2015/2283/oj

(2) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (

OJ L 351, 30.12.2017, p. 72

, ELI:

http://data.europa.eu/eli/reg_impl/2017/2470/oj

(3) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (

OJ L 183, 12.7.2002, p. 51

, ELI:

http://data.europa.eu/eli/dir/2002/46/oj

(4) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (

OJ L 181, 29.6.2013, p. 35

, ELI:

http://data.europa.eu/eli/reg/2013/609/oj

(5) Section of “3.2 Description of the production process”.

(6) Sections “4.3 Stability of vitamin D

” and “4.4 Stability of NF as an ingredient in a representative processed food”.

(7)

EFSA Journal

2024;22:e8817.

(8) Tempelhof 3, 74594 Kressberg, Germany.

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 D2 mushroom powder

Specified food category

Maximum levels of vitamin D2 (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 D2’.

2.	The labelling of food supplements containing vitamin D2 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 D2 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

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 D2 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 D2 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’

ELI: http://data.europa.eu/eli/reg_impl/2025/691/oj

ISSN 1977-0677 (electronic edition)