Commission Implementing Regulation (EU) 2023/2847 of 20 December 2023 authorising the placing on the market of apple fruit cell culture biomass as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2023/2847
• Articles: 3

Article 1

1.   Apple fruit cell culture biomass is authorised to be placed on the market within the Union.

Apple fruit cell culture biomass shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

2.   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 following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

“ Apple fruit cell culture biomass

Specified food category

Maximum levels

Food supplements as defined in Directive 2002/46/EC for the adult population

0,15 mg/day

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘apple fruit cell culture biomass’.

2.

The labelling of food supplements containing the novel food shall bear a statement that they should only be consumed by persons above 18 years of age.”

(2)

in Table 2 (Specifications), the following entry is inserted:

Authorised Novel Food

Specification

“ Apple fruit cell culture biomass

Description/Definition:

The novel food is a biomass of cultivated and homogenised cells of the Swiss apple variety Uttwiler Spätlauber (Malus domestica Borkh.).

The production process consists of collecting under sterile conditions specific sections of the apple, which are then placed on solid medium with the aim to induce the formation of a primary callus tissue comprised of dedifferentiated cells under sterile conditions. The callus cells are then cultivated in liquid medium and subsequently homogenised, heat treated and dried.

Characteristics/composition:

Moisture: 10,9–15,5 g/100 g

Ash: 11,8–20,8 g/100 g

Proteins: 14,3–20,0 g/100 g

Fats: 0,6–2,5 g/100 g

Non-digestible carbohydrates: 17,1–25,2 g/100 g

Other carbohydrates (calculated  ( *1 ) ): 21,9–38,9 g/100 g

Total sugars: 17,1–32,6 g/100g

Fructose: 10,8–20,2 g/100 g

Glucose: 3,8–7,0 g/100 g

Total phenols: 0,15–0,29 g/100 g

Malic acid: 0,41–1,19 g/100 g

Succinic acid: 0,14–0,26 g/100 g

( *1 )   Other carbohydrates (g/100g) = 100 (Dry residue) – Ash – Protein (Nitrogen × 6,25) – Total fat – Succinic acid – L-malic acid – Dietary fibre”