Commission Implementing Regulation (EU) 2023/943 of 11 May 2023 authorising the placing on the market of cellobiose as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/943
• Articles: 5

Article 1

1.   Cellobiose is authorised to be placed on the market within the Union.

Cellobiose 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

Only the company SAVANNA Ingredients GmbH  ( 11 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of five years from 1 June 2023, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of SAVANNA Ingredients GmbH.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of SAVANNA Ingredients GmbH.

Article 4

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

‘ Cellobiose

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘cellobiose’.

2.

The labelling of food supplements containing cellobiose shall bear a statement that those food supplements should not be consumed by infants and young children.

Authorised on 1 June 2023. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: SAVANNA Ingredients GmbH, Dürener Straße 67, 50189 Elsdorf, Germany. During the period of data protection, the novel food cellobiose is authorised for placing on the market within the Union only by SAVANNA Ingredients GmbH, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of SAVANNA Ingredients GmbH.

End date of the data protection: 1 June 2028.’

Food supplements as defined in Directive 2002/46/EC for the general population, excluding infants and young children

3 g/day

Dried, canned-tinned, raw cured (or seasoned), cooked cured (or seasoned) meat

2 g/100 g

Fresh raw, preserved or partly preserved sausages

2 g/100 g

Meat based spreadable-textured specialties

2 g/100 g

Liver based spreadable-textured specialties

2 g/100 g

Savoury sauce dry preparation

40 g/100 g

Table-top sweeteners in powder form

60 g/100 g

Table-top sweeteners in tablets

60 g/100 g

(2)

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

Authorised Novel Food

Specification

‘ Cellobiose

Description/Definition:

Cellobiose is a disaccharide with two glucose monomers linked by a β-(1–4) glucosidic bond, that is produced from sucrose and glucose in a two-step enzymatic reaction, followed by a series of purification steps.

Characteristics/composition:

Cellobiose DM (%): ≥ 99

Moisture (%): < 1

Other identified sugars (%): ≤ 1

Optical rotation [α] D (c 10, water): +33–36

Ash (g/100 g): < 0,1

Protein content (g/100 g): < 0,01

Heavy metals:

Arsenic: < 0,1 mg/kg

Microbiological criteria:

Total aerobic count (cfu/g): ≤ 1 000

Yeast and moulds (cfu/g): ≤ 100

Salmonella (in 25 g): n.d.

Coliforms (cfu/g): ≤ 10

E. coli (in 10 g): n.d.

cfu: colony forming units

n.d.: not detected’