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

Regulation 6(2)(b)

SCHEDULE 5 Insertion of entry in Table 1 in the Annex to Commission Implementing Regulation (EU) 2017/2470

“Vitamin D2 mushroom powder	Specified food category	Maximum levels of vitamin D2	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, containing vitamin D2 mushroom powder must bear a statement that they should not be consumed by infants and children under 3 years of age.		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 2015/2283. Applicant: MBio, Monaghan Mushrooms of 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 England, 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 2015/2283 or with the agreement of MBio, Monaghan Mushrooms. The data protection will expire at the end of 14 May 2028.
	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”