ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

  1. (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

    ‘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”

    Yeast-leavened breads and rolls

    5 μg of vitamin D2/100 g

    Yeast-leavened fine bakery wares

    5 μg of vitamin D2/100 g

    Food supplements as defined in 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 D2 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 D2 in final home-baked products is not exceeded.’

  2. (2)

    the entry for ‘UV-treated baker's yeast (Saccharomyces cerevisiae)’ in Table 2 (Specifications) is replaced by the following:

    Authorised Novel Food

    Specification

    ‘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 may 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’