Summary of EU EFSA Novel Food Application and Approval Status in the Last Quarter of 2024

According to the European Food Safety Authority (EFSA) and the Official Journal of the European Union, in the last quarter of 2024, EFSA published assessment results for five Novel Foods (NF), including the application for two new NF and the modification for three novel food already authorized. Additionally, EFSA requested scientific and technical assistance regarding the evaluation of one Novel Food.

In addition, the EU approved two NF in the last quarter of 2024, including amendments to the specifications and conditions of use of one already authorized NF.

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This article provides a summary of the EU EFSA Novel Food application and approval status for the last quarter of 2024, for the reference of businesses.

New NF application

1. Glucosyl hesperidin

Applicant: Hayashibara Co., Ltd. (Application submitted on March 26, 2021)
Specifications:

Description: A pale yellow to yellow-brown powder produced enzymatically from hesperidin and dextrin.
Parameter	Specification
General
Monoglucosyl hesperidin (MGH) (dry basis)	75.0%–85.0%
Hesperidin (dry basis)	10%–20%
Loss on drying	≤ 6%
Residue on ignition	≤ 2%
Heavy metals
Lead	≤ 2 mg/kg
Arsenic	≤ 1.5 mg/kg
Microbiological
TAMC	≤ 100 CFU/g
Total coliforms	Not detected in 10 g
Salmonella spp.	Not detected in 25 g
Yeast and moulds	< 100 CFU/g

*Abbreviations: CFU, colony forming units; TAMC, total aerobic microbial count.

Proposed uses
- Target population: the general population, except for food supplements for which the proposed target population is children from one year onwards and adults.
- Proposed uses and Proposed use levels

Food category

Max use level

Food supplements

200 mg/day for the general population older than 10 years

115 mg/day for children between 3 and 10 years of age

60 mg/day for young children between 1 and 3 years of age

Functional drinks^a

525 mg/L

^a This food category includes: energy drinks, isotonic and sport drinks and fermented functional drinks (i.e. ‘fermented non-alcoholic drinks with exclusion of dairy fermented drinks)’. The use of this code does not indicate a health claim under Regulation (EC) No 1924/2006.

Conclusions: The Panel concludes that the NF, glucosyl hesperidin, is safe for the target population at the proposed uses and use levels.

2. Tiger nuts (Cyperus esculentus) oil

Applicant: Tigernuts traders, S.L. (Application submitted on October 29, 2020)
Specifications:

Description: The NF is obtained from a cold-pressing process of tiger nuts Source: Cyperus esculentus
Parameter		Specification
Fatty acid composition
Palmitic acid		12.0%–15%
Stearic acid		5%–8%
Oleic acid		65%- 69%
Linoleic acid		9%-12%
Heavy metals
Lead		≤ 0.1 mg/kg
Cadmium		≤ 0.1 mg/kg
Mycotoxins
Aflatoxins total (Σ B1,B2, G1,G2)	< 4 μg/kg
Aflatoxin B1	< 1 μg/kg
Ochratoxin A	< 3 μg/kg
Microbiological
TAMC		≤ 10³ CFU/g
TYMC		≤ 102 CFU/g
Coliforms		≤ 10 CFU/g
Salmonella		Not detected in 25 g

Proposed uses
- Target population: the general population.
- Proposed uses and Proposed use levels

Food category	Max use level (mL NF/100 g)
As a replacement for other oils (used for cooking or added as a condiment)	100
Pasta and similar products	30
Bread and similar products	30
Snacks other than chips and similar (crackers)	30
Salad dressing	50
Margarines and similar	80
Various pastry	30
Cream and cream products	60

Conclusions: The Panel concludes that the NF, tiger nuts oil, is safe under the proposed conditions of use.

Modification of an already authorised novel food

1. 2′-Fucosyllactose, 2’-FL

Applicant: Kyowa Hakko Bio Co., Ltd. (Application submitted on March 23, 2021)
Proposed uses
- Target population: infants and young children;
- Proposed uses: food supplement;
- Proposed use levels: the applicant proposes to extend the use of 2’-FL in FS for infants at the use level of 1.2 g/day.
Conclusion: The Panel concludes that the NF, which is composed of 2’-FL and other structurally related mono- and oligosaccharides, is safe under the proposed conditions of use.

2. DHA 550 oil from Schizochytrium sp.

Applicant: Fermentalg (Application submitted on June 22, 2023)
Authorized uses and use levels:

Authorised novel food	Conditions under which the novel food may be used
DHA 550 oil from Schizochytrium sp.	Food category	Max use level
DHA 550 oil from Schizochytrium sp.	Protein products, excluding dairy analogues	1 g DHA/100 g of protein products

Conclusion: The Panel concludes that the NF (oil from S. limacinum (FCC-3204)) is safe under the new intended use.

3. Oleoresin from Haematococcus pluvialis containing astaxanthin

Applicant: Astareal AB (Application submitted on June 20, 2022)
Proposed uses
- Target population: infants and young children;
- Proposed uses: food supplement;
Proposed use levels: the applicant seeks to lower the minimum specification limits as set in the EU Union list for the protein content in the NF from currently 0.3% to 0.0% and for ATX monoesters (as % of total ATX, esterified and free) from currently 79.8% to 66.7%. Furthermore, they propose to increase the maximum specification limits for 9-cis-ATX from currently 17.3% to 30.0% and for ATX diesters (as % of total ATX, esterified and free) from currently 19.0% to 32.5%.
Conclusions: The Panel concludes that the NF, oleoresin from H. pluvialis containing ATX, is safe with the proposed specification limits.

EFSA requested scientific and technical assistance with regard to the evaluation of Novel Food

1. Acheta domesticus

EFSA conclusion: The Panel concludes that the NF is safe under the proposed uses and use levels. In addition, the Panel notes that allergic reactions may occur upon consumption. The Panel recommends that research should be undertaken on the allergenicity of A. domesticus, including cross-reactivity to other allergens.

Approved NF

1. Magnesium L-threonate

Applicant: AIDP Inc. (the United States)
Application submitted on: March 1, 2021
Authorized to be placed on the market on: November 7, 2024
Authorized uses and use levels:

Authorised novel food	Conditions under which the novel food may be used
Magnesium L-threonate	Specified food category		Maximum levels of Mg
	Food supplements as defined in Directive 2002/46/EC for adults, excluding pregnant and lactating women		250 mg/day
	Labeling requirements
	1. The designation of the novel food on the labelling of the foodstuffs containing it shall be “Magnesium L-threonate”. 2. The labeling of food supplements containing magnesium L-threonate shall bear a statement that the food supplements should be consumed by adults only, excluding pregnant and breastfeeding women.
	Specification
	Description/Definition: The novel food is produced by chemical synthesis and consists of magnesium L-threonate.
	Chemical identity
	Chemical (IUPAC) name	Magnesium (2R,3S)-2,3,4-trihydroxybutanoate monohydrate
	Common name	magnesium L-threonate
	Molecular formula	C8H16MgO11
	CAS number	500304-76-7
	Molecular weight	312,5 Da
	Characteristics/composition:
	Appearance	White powder
	Mg L-threonate monohydrate	98 %–102 %
	Magnesium	7,2 %–8,3 %
	L-Threonate	82 %-91 %
	Oxalic acid	≤ 1 %
	Ethanol	≤ 5 000 ppm
	Loss on drying	≤ 5,0 %
	Microbiological criteria
	Total aerobic microbial count	≤ 100 CFU/g
	Total yeast and mold count	≤ 10 CFU/g
	E. coli	Not detected in 10 g
	Salmonella	Not detected in 25 g

Abbreviations:

CAS: chemical abstracts service
IUPAC: International Union of Pure and Applied Chemistry
CFU: colony forming unit

Amendments to already authorized NF

1. Vitamin D₂ mushroom powder

Applicant: MBio, Monaghan Mushrooms (Canada)
Application submitted on: March 29, 2024
Authorized to be placed on the market on: October 16, 2024
Authorized uses and use levels:

Authorised novel food	Specification
Vitamin D₂ mushroom powder	Description/Definition
	The novel food is mushroom powder produced from dried whole Agaricus bisporus mushrooms. The process includes drying, milling, and the controlled exposure of the mushroom powder to UV irradiation. UV radiation: A process of radiation in ultraviolet light within a range of wavelength similar to those UV-treated novel foods authorised under Regulation (EU) 2015/2283.
	Characteristics/composition
	Vitamin D₂ content	137-595 μg/g of mushroom powder
	Ash	≤ 13,5 %
	Water activity	< 0,5
	Moisture content	≤ 7,5 %
	Total carbohydrates	≤ 60 %
	Crude protein (N × 6,25)	≥ 22 %
	Fat	≤ 4,5 %
	Heavy metals
	Lead	≤ 0,5 mg/kg
	Cadmium	≤ 0,5 mg/kg
	Mercury	≤ 0,1 mg/kg
	Arsenic	≤ 0,3 mg/kg
	Mycotoxins
	Aflatoxin B1	≤ 0,10 μg/kg
	Aflatoxins (sum of B1 + B2 + G1 + G2)	< 4 μg/kg
	Microbiological criteria
	Total plate count	≤ 5 000 CFU
	Total yeast and mould count	< 100 CFU/g
	E. coli	< 10 CFU/g
	Salmonella spp.	Absence in 25 g
	Staphylococcus aureus	≤ 10 CFU/g
	Coliforms	≤ 10 CFU/g
	Listeria spp.	Absence in 25 g
	Enterobacteriaceae	< 10 CFU/g
	CFU	colony forming units

Source: The inventory of GRAS notices.

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Further information

Summary of EU EFSA Novel Food Application and Approval Status in the First Quarter of 2024

Summary of EU EFSA Novel Food Application and Approval Status in the Second Quarter of 2024

Summary of EU EFSA Novel Food Application and Approval Status in the Third Quarter of 2024

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