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
Article 2
ANNEX
Authorised novel food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
Data protection |
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“UV-treated baker’s yeast (Saccharomyces cerevisiae) |
Specified food category |
Maximum levels of vitamin D2 |
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘vitamin D yeast’ or ‘vitamin D2 yeast’ |
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Yeast-leavened breads and rolls |
5 μg/100 g |
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Yeast-leavened fine bakery wares |
5 μg/100 g |
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Food supplements as defined in Directive 2002/46/EC |
In accordance with Directive 2002/46/EC |
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Pre-packed fresh or dry yeast for home baking |
45 μg/100 g for fresh yeast 200 μg/100 g for dried yeast |
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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 D2 yeast’” |
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Soups and salads |
5 μg/100 g |
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Fried or extruded cereal, seed or root-based products |
5 μg/100 g |
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Infant formula and follow-on formula as defined by Regulation (EU) No 609/2013 |
In accordance with Regulation (EU) No 609/2013 |
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Processed cereal-based food as defined by Regulation (EU) No 609/2013 |
In accordance with Regulation (EU) No 609/2013 |
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Processed fruit products |
1,5 μg/100 g |
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Processed vegetables |
2 μg/100 g |
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Bread and similar products |
5 μg/100 g |
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Breakfast cereals |
4 μg/100 g |
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Pasta, doughs and similar products |
5 μg/100 g |
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Other cereal based products |
3 μg/100 g |
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Spices, seasonings, condiments, sauce ingredients, dessert sauces/toppings |
10 μg/100 g |
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Protein products |
10 μg/100 g |
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Cheese |
2 μg/100 g |
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Dairy dessert and similar products |
2 μg/100 g |
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Fermented milk or fermented cream |
1,5 μg/100 g |
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Dairy powders and concentrates |
25 μg/100 g |
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Milk based products, whey and cream |
0,5 μg/100 g |
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Meat and dairy analogues |
2,5 μg/100 g |
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Total diet replacement for weight control as defined by Regulation (EU) No 609/2013 |
5 μg/100 g |
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Meal replacements for weight control |
5 μg/100 g |
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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 |
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 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 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 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/g Escherichia coli: ≤ 10/g Salmonella: Absence in 25 g” |