Commission Implementing Regulation (EU) 2024/2044 of 29 July 2024 amending Implementing Regulation (EU) 2017/2470 as regards the specifications and the conditions of use of the novel food Yarrowia lipolytica yeast biomass — Full Text

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

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.

Supplementary provisions

ANNEXSupplementary provisions

ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (1) in Table 1 (Authorised novel foods), the entry for ‘ Yarrowia lipolytica yeast biomass’ 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 ‘ Yarrowia lipolytica yeast biomass Specified food category Maximum levels 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘ Yarrowia lipolytica yeast biomass’. 2. Food supplements containing the novel food should bear a statement that they should not be consumed if other foods with added Yarrowia lipolytica yeast biomass are consumed on the same day.’ Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children 6 g/day for children from 10 years of age, adolescents and general adult population 3 g/day for children from 3 to 9 years of age Meal replacements for weight control for the adult population 3 g/meal (maximum 2 meals/day up to a maximum of 6 g/day) 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 but not in any case higher than 6 g/day Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 6 g/day Unflavoured milk products 5 g/kg Flavoured fermented milk products 10 g/kg Cheese and cheese products; (excluding desserts) 10 g/kg Nut spreads 30 g/kg Processed potato products 10 g/kg Cocoa and chocolate confectionary 10 g/kg Grains and breakfast cereals 20 g/kg Pasta based products and noodles 10 g/kg Pre-cooked or processed cereals 10 g/kg Bread and rolls 6 g/kg Fine bakery wares 15 g/kg Heat-treated meat products 15 g/kg Herbs and spices; seasonings and condiments 50 g/kg Soups and broths 5 g/kg Sauces 10 g/kg Salads and savoury based sandwich spreads 30 g/kg Yeast and yeast products 30 g/kg Protein products, excluding dairy analogues and beverage whiteners 30 g/kg Flavoured drinks 10 g/l Coffee, coffee extracts 20 g/kg Other non-alcoholic beverages 10 g/l Potato-, cereal-, flour- or starch-based snacks 300 g/kg Processed nuts 20 g/kg (2) in Table 2 (Specifications), the entry for ‘ Yarrowia lipolytica yeast biomass’ is replaced by the following: Authorised novel food Specification ‘ Yarrowia lipolytica yeast biomass Description/Definition: The novel food is the dried and heat-killed biomass of the yeast Yarrowia lipolytica . Characteristics/Composition: Protein: 45-55 g/100 g Dietary fibre: 24-30 g/100 g Sugars: < 1 g/100 g Fat: 7-10 g/100 g Total ash: ≤ 12 % Water content: ≤ 5 % Dry matter content: ≥ 95 % Microbiological criteria: Total Aerobic Microbial Count: ≤ 5 × 10 3 CFU/g Total Yeast and Mould Count: ≤ 10 2 CFU/g Viable Yarrowia lipolytic a cells (a) : < 10 CFU/g (i.e. limit of detection) Coliforms: ≤ 10 CFU/g Salmonella spp.: Not detected in 25 g Contaminants : Lead: ≤ 0,1 mg/kg Mercury: ≤ 0,1 mg/kg Cadmium: ≤ 0,1 mg/kg Arsenic: ≤ 0,15 mg/kg Abbreviations: CFU, colony forming units (a) To be tested immediately after the heat-treatment step. Measures have to be in place to prevent cross-contamination with viable Y. lipolytica cells during packaging and/or storage of the novel food’

Article 1

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Supplementary provisions

ANNEXSupplementary provisions

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