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

Regulation 6

SCHEDULE 4 Amendments to the list of novel foods in the Annex to Commission Implementing Regulation (EU) 2017/2470 for the authorisation of UV-treated baker’s yeast (Saccharomyces cerevisiae) as a novel food

1.  In Commission Implementing Regulation (EU) 2017/2470, the Annex (list of novel foods) is amended as follows.

2.  In Table 1 (authorised novel foods), for the entry for “UV-treated baker’s yeast (Saccharomyces cerevisiae)” substitute—

“UV-treated baker’s yeast (Saccharomyces cerevisiae)	Specified food category	Maximum levels of vitamin D2		The novel food must be inactivated for use in infant formula, follow-on formula, processed cereal-based food and food for special medical purposes.
	Yeast-leavened breads and rolls	5 µg/100 g	The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D2 yeast”.
	Yeast-leavened fine bakery wares	5 µg/100 g
	Food supplements as defined in the Food Supplements (Wales) Regulations 2003(1)	In accordance with any relevant requirements contained in regulations applying in relation to Wales and made under regulation 4 of the Nutrition (Amendment etc.) (EU Exit) Regulations 2019(2)
	Pre-packed fresh or dry yeast for home baking	45 µg/100 g for fresh yeast 200 µg/100 g for dry yeast	The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D2 yeast”. The labelling of the novel food must bear a statement that the food is only intended for baking and should not be eaten raw. The labelling of the novel food must bear instructions for use for the final consumer to ensure a maximum concentration of 5µg/100g of vitamin D2 in the final home-baked product is not exceeded.
	Dishes, including ready-to-eat meals (excluding soups and salads)	3 µg/100 g	The designation of the novel food on the labelling of food containing it is “vitamin D yeast” or “vitamin D2 yeast”.
	Soups and salads	5 µg/100 g
	Fried or extruded cereal, seed or root-based products	5 µg/100 g
	Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013(3)	In accordance with Regulation (EU) No 609/2013
	Processed cereal-based food as defined in Regulation (EU) No 609/2013	In accordance with Regulation (EU) No 609/2013
	Processed fruit products	1.5 µg/100 g
	Processed vegetables	2 µg/100 g
	Bread and similar products	5 µg/100 g
	Breakfast cereals	4 µg/100 g
	Pasta, doughs and similar products	5 µg/100 g
	Other cereal-based products	3 µg/100 g
	Spices, seasonings, condiments, sauce ingredients, dessert sauces/ toppings	10 µg/100 g
	Protein products	10 µg/100 g
	Cheese	2 µg/100 g
	Dairy desserts and similar products	2 µg/100 g
	Fermented milk or fermented cream	1.5 µg/100 g
	Dairy powders and concentrates	25 µg/100 g
	Milk-based products, whey and cream	0.5 µg/100 g
	Meat and dairy analogues	2.5 µg/100 g
	Total diet replacement for weight control as defined in Regulation (EU) No 609/2013	5 µg/100 g
	Meal replacement for weight control	5 µg/100 g
	Food for special medical purposes as defined in Regulation (EU) No 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended”

3.  In Table 2 (specifications) for the entry for “UV-treated baker’s yeast (Saccharomyces cerevisiae)” substitute—

“UV-treated baker’s yeast (Saccharomyces cerevisiae)

Description/Definition Baker’s yeast (Saccharomyces cerevisiae) is treated with ultraviolet light to induce the conversion of ergosterol to vitamin D2 (ergocalciferol). Vitamin D2 content in the yeast concentrate varies between 800,000 - 3,500,000 IU vitamin D/100 g (200-875 μg/g). The yeast is inactivated for use in infant formula, follow-on formula, processed cereal-based food, and food for special medical purposes as defined in Regulation (EU) No 609/2013. The yeast can be active or inactive for use in other foods. The yeast concentrate is blended with regular baker’s yeast in order not to exceed the maximum level in the pre-packed fresh or dry yeast for home baking. Tan-coloured, free-flowing granules. Vitamin D2 Chemical name: (5Z,7E,22E)-(3S)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol Synonym: Ergocalciferol CAS No.: 50-14-6 Molecular weight: 396.65 g/mol Microbiological criteria for the yeast concentrate Coliforms: ≤ 103 CFU/g Escherichia coli: ≤ 10 CFU/g Salmonella spp.: Absence in 25 g CFU: Colony Forming Units”.

(1)

S.I. 2003/1719 (W. 186), to which there are amendments not relevant to these Regulations.

(2)

S.I. 2019/651, amended by S.I. 2020/1476 and 2023/28.

(3)

EUR 2013/609, amended by S.I. 2019/651 and 2023/28. S.I. 2019/651 was amended by S.I. 2020/1476 and 2023/28.