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

• CELEX: Implementing Regulation (EU) 2024/2044
• Articles: 3

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.

Schedules & Appendices

ANNEX

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’