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

Regulation 7

SCHEDULE 5 Amendments to the list of novel foods in the Annex to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of vitamin D₂ mushroom powder as a novel food

1.  In Table 1 (authorised novel foods), after the existing entry for Vitamin D₂ mushroom powder insert the following entry—

“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 by the Food Supplements (Scotland) 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 (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 Scotland, 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.
	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 snack	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) 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 (Scotland) Regulations 2003 excluding food supplements for infants and children under 3 years of age	15 µg of vitamin D₂/day”

2.  In Table 2 (specifications), after the entry for Vitamin D₂ mushroom powder insert the following entry—

“Vitamin D₂ mushroom powder

Description/Definition 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. Characteristics/Composition Vitamin D₂ content: 580-595 µg/g of mushroom powder Ash: ≤ 13.5% Water activity: < 0.5 Moisture content: ≤ 7.5% Carbohydrates: ≤ 35% Total dietary fibre: ≥ 15% Crude protein (N x 6.25): ≥ 22% Fat: ≤ 4.5% 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: ≤ 0.1 µg/kg Aflatoxins (sum of B1 + B2 + G1 + G2): < 4 µg/kg Microbiological criteria Total plate count: ≤ 5000 CFU 14 Total yeast and mould count: ≤ 100 CFU/g Escherichia coli: < 10 CFU/g Salmonella spp.: Absence in 25 g Staphylococcus aureus: ≤ 10 CFU/g Coliforms: ≤ 10 CFU/g Listeria spp.: Absence in 25 g Enterobacteriaceae: < 10 CFU/g CFU: Colony Forming Units.”.