Commission Implementing Regulation (EU) 2019/760 of 13 May 2019 authorising the placing on the market of Yarrowia lipolytica yeast biomass 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.)

• CELEX: Implementing Regulation (EU) 2019/760
• Articles: 4

Article 1

1.    Yarrowia lipolytica yeast biomass as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

2.   The entry in the Union list referred to in paragraph 1 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.

Article 2

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

Article 3

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)

The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:

‘Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Yarrowia lipolytica yeast biomass

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be “ Yarrowia lipolytica yeast heat-killed biomass”’

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

(2)

The following entry is inserted in Table 2 (Specifications) in alphabetical order:

‘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: < 1,0 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 lipolytica cells  ( 1 ) : < 10 CFU/g (i.e. limit of detection)

Coliforms: ≤ 10 CFU/g

Salmonella spp.: Absence in 25 g

( 1 )   To be tested immediately after the heat-treatment step. Measures have to be in place to prevent cross-contamination with viable Yarrowia lipolytica cells during packaging and/or storage of the NF’