1. The entry in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 referring to the substance UV-treated baker's yeast ( Saccharomyces cerevisiae ) shall be amended as specified in the Annex to this Regulation.
2. The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
3. The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC and Regulation (EC) No 1925/2006.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEXSupplementary provisions
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
‘ 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 of vitamin D 2 /100 g
Yeast-leavened fine bakery wares
5 μg of vitamin D 2 /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 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.’
(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 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 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 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’
