COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/2079 
of 26 November 2021
author ising the placing on the market of vitamin D2 mushroom powder as a novel food under 
Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending 
Commission Implementing Regulation (EU) 2017/2470 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d 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 thereof,
Whereas:
(1) Regulation (EU) 2015/2283 provides that only novel foods author ised and included in the Union list may be placed 
on the mark et within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Imple menting Regulation (EU) 2017/2470 (2)
establishing a Union list of author ised novel foods was adopt ed.
(3) On 29 July 2019 , the compan y MBio, Monaghan Mushrooms (‘the applicant’) submitt ed an application to the 
Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 to place vitamin D2 mushroom powder on 
the Union mark et as a novel food. The applicant request ed vitamin D2 mushroom powder to be used in number of 
foods intended for the general population. The applicant also request ed 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), excl uding in 
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), excl uding foods for special medical purposes intended for infants. 
Dur ing the application process, the applicant agreed to exclude children under 3 years of age from the request for 
author isation of the novel food in food supplements.
(1)OJ L 327, 11.12.2015, p. 1.
(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).
(3)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the 
Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).
(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).EN Offi cial Jour nal of the European Union L 426/16 29.11.2021  (4) The applicant also submitted a request to the Commission for the protection of propr ietar y data for a number of 
original data submitt ed in suppor t of the application, namely , data concer ning the production process (5); 
compo sitional data: particle size (6), physico-c hemical proper ties (7), vitamin D analysis (8), nutr itional analysis (9), 
vitamin D2 analysis (10), vitamin D analysis validation (11), stability studies (12), toxicological analysis (13), data 
concer ning tach ysterol and lumist erol (14), ergostero l ratio analysis (15), vitamin D ratio analysis (16), data concer ning 
ergostero l(17); specif ications of fresh mushrooms (18); data concer ning allergenicit y(19).
(5) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food 
Safety Author ity (‘the Author ity’) on 24 Januar y 2020 , requesting it to provide a scientifi c opinion by carrying out 
an assessment of the safety of vitamin D2 mushroom powder as a novel food.
(6) On 24 Febr uary 2021 , the Author ity adopt ed its scientific opinion on the ‘Safe ty of Vitamin D2 mushroom powder 
(Agaricus bispor us) as a novel food pursuant to Regulation (EU) 2015/2283’ (20). That opinion is in line with the 
requirements of Article 11 of Regulation (EU) 2015/2283.
(7) In that opinion, the Authority concluded that vitamin D2 mushroom powder is safe at the proposed uses and use 
levels. Theref ore, the opinion of the Author ity gives sufficient grounds to establish that vitamin D2 mushroom 
powder under the specific conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.
(8) A labelling requirement should be provided in order to properly inform the consumers that infants and children 
under 3 years of age should not consume food supplements containing vitamin D2 mushroom powder .
(9) In its opinion, the Author ity considered that the data concer ning the production process and compo sitional data 
served as a basis to establish the safety of the novel food. On this basis, the Commission considers that the 
conclusions on the safety of vitamin D2 mushroom powder could not have been reac hed without that data.
(10) The Commission request ed the applicant to further clarify the justification provi ded with regard to their propr ietar y 
claim over those data and to clarify their claim to an excl usive right of reference to those data, as required under 
Article 26(2)(b) of Regulation (EU) 2015/2283.
(11) The applicant declared that, at the time of the submission of the application, they held propr ietar y and excl usive 
rights of reference to those data under national law, and that theref ore third parties cannot lawfully access or use 
those data or refer to those data.
(12) The Commission assessed all the information provid ed by the applicant and considered that the applicant has 
suffi ciently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 
2015/2283. Theref ore, data concer ning the production process; compo sitional data: particle size, physico-chem ical 
proper ties, vitamin D analysis, nutr itional analysis, vitamin D2 analysis, vitamin D analysis validation, stability 
(5)2.3.1 Production Process Confidential_F inal.
(6)Annex 1 Particle Size Repor t.
(7)Annex 3 NIZO Repor t physico-c hemical proper ties.
(8)Annex 4 COA vitamin D analysis.
(9)Annex 5 COA nutr itional analysis.
(10)Annex 7 MBio SOP Vitamin D2 analysis.
(11)Annex 8 MBio Vit. D analysis validation repor t.
(12)Annex 9 Stability Study Repor t UCC; Annex 14 COA Vit. D stability study ; Annex 24 Stability study Repor t Cam pdenBRI; Annex 25 
Stability study repor t meat free product ; Annex 29 COAs Stability Meat free.
(13)Annex 16 COA Toxicological analysis.
(14)Annex 17 Repor t Tachysterol and lumisterol.
(15)Annex 20 COA Ergosterol ratio analysis.
(16)Annex 21 COA Vitamin D ratio analysis.
(17)Annex 22 MBio Ergosterol.
(18)Annex 13 COA fresh mushrooms analysis.
(19)Annex 12 MBio Allergen Policy .
(20)EFSA Jour nal 2021;19(4):6516.EN Offi cial Jour nal of the European Union 29.11.2021 L 426/17  studies, toxicological analysis, data concer ning tach ysterol and lumist erol, ergoste rol ratio analysis, vitamin D ratio 
analysis, data concer ning ergosterol contained in the applicant’s file, on which the Author ity based its conclusion 
on the safety of the novel food and without which it could not have assessed the novel food, should not be used by 
the Author ity for the benefit of any subsequent applicant for a period of 5 years from the date of entr y into force of 
this Regulation. According ly, only the applicant should be author ised to place vitamin D2 mushroom powder on the 
mark et within the Union during that period.
(13) However , restr icting the author isation of vitamin D2 mushroom powder and the referen ce to the data contained in 
the applicant ’s file for the sole use of the applicant, does not prevent other applicants from applying for an 
author isation to place on the market the same novel food, provid ed that their application is based on legally 
obtained information suppor ting such an author isation under Regulation (EU) 2015/2283.
(14) Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly.
(15) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
1. The vitamin D2 mushroom powder as specifi ed in the Annex shall be included in the Union list of author ised novel 
foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of 5 years from 19 December 2021 only the initial applicant :
Com pany: MBio, Monaghan Mushrooms,
Address: Tullygony , Tyholland, Co. Monaghan, Ireland ,
is author ised to place on the mark et within the Union the novel food refer red to in paragraph 1, unless a subsequent 
applicant obtains author isation for the novel food without reference to the data protect ed pursuant to Article 2 or with the 
agreement of MBio, Monaghan Mushrooms.
3. The entr y in the Union list refer red to in paragraph 1 shall include the conditions of use and labelling requirements 
laid down in the Annex.
Article 2
The data contained in the application file on the basis of which the novel food refer red to in Article 1 have been assessed by 
the Author ity, claimed by the applicant as propr ietar y and without whic h the novel food could not have been author ised, 
shall not be used for the benefi t of a subsequent applicant for a period of 5 years from 19 December 2021 without the 
agreement of MBio, Monaghan Mushrooms.
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 followi ng that of its publication in the Official Journal of the 
European Union.EN Offi cial Jour nal of the European Union L 426/18 29.11.2021  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 26 November 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 29.11.2021 L 426/19  ANNEX 
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1) in Table 1 (Author ised novel foods), the follo wing entr y is inser ted:
Authorised 
novel foodConditions under whic h the novel food may be usedAdditio nal specific labelling 
requirementsOther 
requirementsData protection
‘Vitamin D2 
mushroom 
powderSpecified food categor y Maximum levels of vitamin D2 1.The designation of the novel 
food on the labelling of the 
foodstuffs containing it shall 
be ‘UV-treat ed mushroom 
powder containing vitamin 
D2’
2.The labelling of food supple ­
ments containing vitamin D2 
mushroom powder shall bear 
a statement that they should 
not be consumed by infants 
and children under 3 years 
of age.Author ised on 19 December 
2021 . This inclusion is based on 
propr ietar y scientifi c evidence and 
scientific data prot ected in 
accordance with Article 26 of 
Regulation (EU) 2015/2283.
Applicant: MBio, Monaghan 
Mushrooms, Tullygony , 
Tyholland, Co. Monaghan, 
Ireland. Dur ing the period of data 
prot ection, the novel food vitamin 
D2 mushroom powder is 
author ised for placing on the 
mark et within the Union only by 
MBio, Monaghan Mushrooms, 
unless a subsequent applicant 
obtains author isation for the 
novel food without reference to 
the propr ietar y scientific evidence 
or scientific data prote cted in 
accordance with Article 26 of 
Regulation (EU) 2015/2283 or 
with the agreement of MBio, 
Monaghan Mushrooms.
End date of the date prote ction: 
19 December 2026 .’Breakf ast cereals 2,1 μg/100 g
Yeast leav ened bread and similar 
pastr ies2,1 μg/100 g
Grain products and pasta and similar 
products2,1 μg/100 g
Fruit/vege table juices and nectars 1,1 μg/100 ml (mark eted as such or 
reconstituted as instr ucted by the 
manufacturer)
Dair y products and analogues other 
than beverages2,1 μg/100 g (marke ted as such or 
reconstituted as instr ucted by the 
manufacturer)
Dair y products and analogues as 
beverage s1,1 μg/100 ml (mark eted as such or 
reconstituted as instr ucted by the 
manufacturer)
Milk and dair y powders 21,3 μg/100 g (market ed as such or 
reconstituted as instr ucted by the 
manufacturer)
Meat analogues 2,1 μg/100 g
Soups 2,1 μg/100 ml (mark eted as such or 
reconstituted as instr ucted by the 
manufacturer)
Extr uded vegetable snack 2,1 μg/100 g
Meal replacement for weight control 2,1 μg/100 gEN Offi cial Jour nal of the European Union L 426/20 29.11.2021  Foods for Special Medical Purposes as 
defined under Regulation (EU)  
No 609/2013 excl uding those 
intended for infantsIn accordance with the particular nutr itional 
requirements of the persons for whom the 
products are intended
Food supplements as defined in 
Directive 2002/46/EC excl uding food 
supplements intended for infants and 
young children15 μg of vitamin D2/day
(2) in Table 2 (Specif ications), the followi ng entr y is inser ted:
Authorised Novel Food Specificatio ns
‘Vitamin D2 mushroom powder Descr iption/Def inition:
The novel food is mushroom powder produced from the dried whole Agaricus bispor us 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 wav elength similar to those UV-treated novel foods author ised 
under Regulation (EU) 2015/2283.
Character istics/composition:
Vitamin D2 content: 580-595 μg/g of mushroom powder
Ash: ≤ 13,5 %
Water activity : < 0,5
Moisture conte nt: ≤ 7,5 %
Carbohydr ates: ≤ 35,0 %
Total Dietar y Fibre: ≥ 15 %
Crude protein (N × 6,25): ≥ 22 %
Fat: ≤ 4,5 %
Hea vy metals:
Lead: ≤ 0,5 mg/kg
Cadmium: ≤ 0,5 mg/kg
Mercur y: ≤ 0,1 mg/kg
Arsenic: ≤ 0,3 mg/kg
Mycoto xins:
Aflatoxin B1: ≤ 0,10 μg/kg
Aflatoxins (sum of B1 + B2 + G1 + G2): < 4 μg/kg
Microbiological criter ia:
Total plate count: ≤ 5 000 CFU (a)
Total yeast and mould count: < 100 CFU/g
E. coli: < 10 CFU/gEN Offi cial Jour nal of the European Union 29.11.2021 L 426/21  Salmonella spp.: Absence in 25 g
Staphy lococcus aureu s: ≤ 10 CFU/g
Colif orms: ≤ 10 CFU/g
Lister ia spp.: Absence in 25 g
Enterobacteri aceae: < 10 CFU/g’
(a)CFU: colony forming units.EN Offi cial Jour nal of the European Union L 426/22 29.11.2021