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Commission authorizes cellobiose as a novel food

European Union

May 18, 2023

The NF consists of two glucose monomers linked by a β‐(1–4) glucosidic bond. The applicant intends to add the NF to a variety of foods, and to food supplements aimed at the general population 3 years and older. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. The applicant provided a subchronic toxicological study which did not raise safety concerns. The applicant provided a human dose‐escalation study from which the Panel concludes that the consumption of 20 g per day of cellobiose (equivalent to 290 mg/kg body weight (bw) per day in a 70‐kg adult) does not raise concern regarding gastrointestinal tolerability. The maximum anticipated daily intake of cellobiose from the proposed uses is below 290 mg/kg bw per day in the target population. Considering the nature, source, compositional characterisation, and production process of the NF, as well as the toxicological data provided, the Panel considers that the NF does not raise safety concerns under the proposed conditions of use.

Cf. 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.

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

 

 

For further information (in English), click on the Link

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