Commission Implementing Regulation (EU) 2022/196 of 11 February 2022 authorising an extension of use and the change of the specifications of UV-treated baker’s yeast (Saccharomyces cerevisiae) 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)

Article 1

1. The entry in the Union list of authorised novel foods in the Annex to Implementing Regulation (EU) 2017/2470, referring to the novel food UV-treated baker’s yeast (Saccharomyces cerevisiae), is amended as specified in the Annex to this Regulation.

2. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEX

ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
the entry for ‘UV-treated baker’s yeast ( Saccharomyces cerevisiae )’ in Table 1 (Authorised novel foods) is replaced by the following:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data protection
“ UV-treated baker’s yeast ( Saccharomyces cerevisiae )
Specified food category
Maximum levels of vitamin D 2
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘vitamin D yeast’ or ‘vitamin D 2 yeast’
Yeast-leavened breads and rolls
5 μg/100 g
Yeast-leavened fine bakery wares
5 μg/100 g
Food supplements as defined in Directive 2002/46/EC
In accordance with Directive 2002/46/EC
Pre-packed fresh or dry yeast for home baking
45 μg/100 g for fresh yeast
200 μg/100 g for dried yeast
1.
The designation of the novel food on the labelling of the foodstuffs shall be ‘vitamin D yeast’ or ‘vitamin D 2 yeast’.
2.
The labelling of the novel food shall bear a statement that the foodstuff is only intended for baking and that it should not be eaten raw.
3.
The labelling of the novel food shall bear instructions for use for the final consumers so that a maximum concentration of 5 μg/100 g of vitamin D 2 in final home-baked products is not exceeded.
Dishes, incl. ready-to-eat meals (excluding soups and salads)
3 μg/100 g
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘vitamin D yeast’ or ‘vitamin D 2 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 by Regulation (EU) No 609/2013
In accordance with Regulation (EU) No 609/2013
Processed cereal-based food as defined by 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 dessert 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 by Regulation (EU) No 609/2013
5 μg/100 g
Meal replacements for weight control
5 μg/100 g
Foods 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
(2)
the entry for ‘UV-treated baker’s yeast ( Saccharomyces cerevisiae )’ in Table 2 (Specifications) is replaced by the following:
Authorised Novel Food
Specifications
“ 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 D 2 (ergocalciferol). Vitamin D 2 content in the yeast concentrate varies between 800 000 – 3 500 000 IU vitamin D/100 g (200-875 μg/g).
The yeast shall be inactivated for use in infant formula and follow-on formula, processed cereal-based food and foods for special medical purposes as defined by Regulation (EU) No 609/2013, while for use in other foods the yeast may or may not be inactivated.
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 D 2
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: ≤ 10 3 /g
Escherichia coli : ≤ 10/g
Salmonella : Absence in 25 g”

Schedules & Appendices

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