Authorised Regulated Food and Feed Products for Great Britain

Definition/Description: The novel food is mushroom powder produced from dried whole Agaricus bisporus mushrooms. The process includes drying, milling and the controlled exposure of the mushroom powder to ultraviolet light.

Specification: https://www.legislation.gov.uk/uksi/2023/334/made#Legislation-1-1-7-13-5-1-0

Conditions under which the novel food may be used: Food category Maximum levels of vitamin D2

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 snacks 2.1 µg/100 g

Meal replacement for weight control 2.1 µg/100 g

Food for special medical purposes as defined in 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 the Food Supplements (England) Regulations 2003 excluding food supplements for infants and children under 3 years of age. 15 µg of vitamin D2/day

Food category	Maximum levels of vitamin D2
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 snacks	2.1 µg/100 g
Meal replacement for weight control	2.1 µg/100 g
Food for special medical purposes as defined in 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 the Food Supplements (England) Regulations 2003 excluding food supplements for infants and children under 3 years of age.	15 µg of vitamin D2/day

Additional specific labelling requirements: The designation of the novel food on the labelling of food containing it is “UV-treated mushroom powder containing vitamin D2”. The labelling of food supplements, as defined in the Food Supplements (England) Regulations 2003/Food Supplements (Scotland) Regulations 2003/Food Supplements (Wales) Regulations 2003, containing vitamin D2 mushroom powder must bear a statement that they should not be consumed by infants and children under 3 years of age.

Data Protection: Included in the list on 15 May 2023.

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, H18 FW95. During the period of data protection, vitamin D₂ mushroom powder is authorised for placing on the market, within Great Britain, 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. The data protection will expire at the end of 14 May 2028.

Link to legislation: Retained EU Regulations 2017/2470

The Food Additives, Food Flavourings and Novel Foods (Authorisations) (England) Regulations 2023

The Food Additives, Food Flavourings and Novel Foods (Authorisations) (Scotland) Regulations 2023

The Food Additives, Food Flavourings, and Novel Foods (Authorisations) and Food and Feed (Miscellaneous Amendments) (Wales) Regulations 2023

Rheoliadau Ychwanegion Bwyd, Cyflasynnau Bwyd, a Bwydydd Newydd (Awdurdodiadau) a Bwyd a Bwyd Anifeiliaid (Diwygiadau Amrywiol) (Cymru) 2023

Vitamin D2 mushroom powder