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

In the first quarter of 2024, according to the European Food Safety Authority (EFSA) and the Official Journal of the European Union, EFSA published assessment results for 6 Novel Foods, including applications for 4 new Novel Foods, notification on 1 new traditional food from a third country and the modification of 1 novel food already authorized.

Additionally, EFSA requested scientific and technical assistance as regards the evaluation of 1 Novel Food, and there were no new authorizations (approvals) for Novel Food in the EU in the first quarter of 2024.

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

New Novel Food applications

1. Mg L-threonate

• Applicant: Company AIDP Inc. (Application submitted on March 24, 2024)
• Production process: Chemical synthesis
• Quality specifications:

Parameter	Specification
Loss on drying	≤ 5.0%
Mg l-threonate monohydrate	98%–102%
Magnesium	7.2%–8.3%
l-Threonate	82%–91%
Oxalic acid	≤ 1%
Ethanol	≤ 5000 ppm
Microbiological parameters
TAMC	≤ 100 CFU/g
Yeast and mould	≤ 10 CFU/g
E. coli	ND/10 g
Salmonella	ND/25 g

• Proposed uses and use levels:
  • Target population: the general adult population, excluding pregnant and lactating women;
  • Proposed uses: The applicant intends to market the NF for use in food supplements;
  • Proposed use levels: a maximum dose of 3000 mg of the NF per day, which corresponds to - 250 mg magnesium and 2730 mg l-threonate per day.
• EFSA conclusions: The Panel concludes that the NF, Mg l-threonate, is safe under the proposed conditions of use. The Panel concludes that the NF is a source from which magnesium is bioavailable.

2. Isomaltulose syrup (dried)

• Applicant: Evonik Creavis GmbH (Application submitted on April 30, 2018)
• Production process: Enzymatic isomerisation
• Quality specifications:

Description: Isomaltulose syrup (dried) is a white to yellowish powder produced from sucrose by a microbiological process using Serratia plymuthica
Parameter	Specification
Isomaltulose (% DM)	≥ 75
Trehalulose (% DM)	≤ 13
Glucose (% DM)	≤ 3
Fructose (% DM)	≤ 4
Sucrose (% DM)	≤ 5
Moisture (%)	≤ 7
Ash (%)	<0.05
Protein (%)	<0.1
Lead (mg/kg)	<0.1
Microbial parameters
TAMC (CFU/g)	<100
TYMC (CFU/g)	<100
E. coli (CFU/g)	< 10
Enterobacteriaceae (CFU/g)	<100
Salmonella	n.d. in 25 g

• Proposed uses and use levels:
  • Target population: The general population;
  • Proposed uses: The applicant intends to market the NF as a replacement for sucrose already on the market. No food categories were specified. The applicant does not intend to make use of the NF in infant and follow-on formulae (as per Commission Delegated Regulation (EU) 2016/127), and/or in processed cereal-based foods, and/or baby foods for infants and young children (as per Commission Directive 2006/125/EC).
• EFSA conclusions: The Panel concludes that the NF, isomaltulose syrup (dried), is as safe as sucrose.

3. Ashitaba sap

• Applicant: Japan Bio Science Laboratory (JBSL)-USA, Inc. (Application submitted on August 8, 2019)
• Production process: Plants concentration
• Quality specifications:

Description: The NF is the sap, which is a viscous yellow liquid, from the stems of Angelica keiskei (ashitaba) plants.
Parameter	Specification
Chalcones (xanthoangelol +4-hydroxyderricin)	1%–2.25%, w/v
Water	90%–95%
Carbohydrates	5%–7.5%
Fat	0.1%–0.3%
Protein	0.15%–0.45%
Sum of angular-type dihydropyranocoumarins	< 10 mg/kg
Sum of furanocoumarins	< 100 mg/kg
Heavy metals
Lead	≤ 0.1 mg/kg
Arsenic	≤ 0.3 mg/kg
Mercury	≤ 0.1 mg/kg
Cadmium	≤ 1 mg/kg
Microbiological parameters
Total viable aerobic count (CFU/g)	≤1000 CFU/g
Yeast/mould (CFU/g)	≤100 CFU/g
Salmonella	Not detected in 25 g
Escherichia coli	Not detected in 10 g
Coliforms	≤ 30 CFU/g

• Proposed uses and use levels:
  • Target population: The NF is intended for use by adults, excluding pregnant and lactating women;
  • Proposed uses: The applicant intends to market the NF in the EU for use in food supplements as a freeze-dried product consisting of 30% ashitaba sap powder and 70% cyclodextrins (the product as it is intended to be placed on the market), in the form of capsules, tablets and powder;
  • Proposed use levels: 200 mg per day (freeze-dried product), corresponding to a maximum use level of 780 mg of the NF per day (containing 90–95% of water).
• EFSA conclusions: The Panel concludes that the NF is safe for the target population at intake levels up to 137 mg per day, corresponding to 35 mg per day of the product as intended to be placed on the market (30% ashitaba sap powder and 70% cyclodextrins).

4. Helix Complex snail mucus (HSM)

• Applicant: Helix Pharma Srl. (Application submitted on May 2, 2019)
• Production process: Animal source
• Quality specifications: Not available
• Proposed uses and use levels:
  • Target population: Adult population excluding pregnant women;
  • Proposed uses: The applicant intends to market the NF for use as food supplements in the form of syrup;
  • Proposed use levels: At a maximum dose of three tablespoons a day corresponding to ca. 45 mL/day, which corresponds to c.a. 0.64 mL/kg bw per day for adults.
• EFSA conclusions: The Panel concludes that the safety of the NF has not been established.

New traditional food from a third country

1. Bambara Groundnut

• Applicant: WhatIF F&I Pte Ltd (Singapore) (Application submitted on May 2, 2019)
• Production process: Plant source
  • Quality specifications:

Specifications of the TF (bambara groundnutsdried seeds)

Parameter	Unit of measure	Limits
Energy	(kal/100g)	365-380
Moisture	(g/100g)	07-11
Protein	(g/100g)	>15
Carbohydrates	(g/100g)	32.0-65.0
Sugar	(g/100g)	<6.0
Fat	(g/100g)	4.0-7.0
Fibre	(g/100g)	7-31
Arsenic	(mg/kg)	<0.05
Cadmium	(mg/kg)	<0.02
Lead	(mg/kg)	<0.05
Mercury	(mg/kg)	<0.01
Sum of Aflatoxins (B1+B2+G1+G2)	(μg/kg)	<4
Sum of Fumonisin (B1+B2+B3)	(μg/kg)	<60
Deoxynivalenol	(mg/kg)	<0.1
Ochratoxin A	(μg/kg)	<0.5
Aerobic mesophilic spore	(spore/g)	<1
Alicyclobacillus	(/10g)	Absent
Presumptive Bacillus cereus	(cfu/g)	<10
Corliforms	(cfu/g)	<10
E.coli	(cfu/g)	<10
Salmonella	(/25g)	Absent
Staphylococcus aureus	(cfu/g)	<10
Total plate count	(cfu/g)	<5,000
Yeast and moulds	(cfu/g)	<100

Specifications of the TF (bambara groundnut flour)

Parameter	Unit of measure	Limits
Energy	(kal/100g)	300-380
Moisture	(g/100g)	4-7
Protein	(g/100g)	>15
Carbohydrates	(g/100g)	55.0-75.0
Sugar	(g/100g)	5-20
Fat	(g/100g)	4.0-9.0
Fibre	(g/100g)	10.0-30.0
Arsenic	(mg/kg)	<0.05
Cadmium	(mg/kg)	<0.02
Lead	(mg/kg)	<0.05
Mercury	(mg/kg)	<0.01
Sum of Aflatoxins (B1+B2+G1+G2)	(μg/kg)	<4
Sum of Fumonisin (B1+B2+B3)	(μg/kg)	<60
Deoxynivalenol	(mg/kg)	<0.1
Ochratoxin A	(μg/kg)	<0.5
Zeralenone	(mg/kg)	<0.1
Aerobic mesophilic spore	(spore/g)	<1
Alicyclobacillus	(/10g)	Absent
Presumptive Bacillus cereus	(cfu/g)	<10
Coliforms	(cfu/g)	<10
E.coli	(cfu/g)	<10
Salmonella	(/25g)	Absent
Staphylococcus aureus	(cfu/g)	<10
Total plate count	(cfu/g)	<1,000
Yeast and moulds	(cfu/g)	<100

• Proposed uses and use levels:
  • Target population: The general population (without any age or gender restrictions);
  • Proposed uses and use levels: The TF (bambara groundnut dried seeds and flour) is intended to be consumed as a whole food (cooked seeds) or as flour. The applicant intends to market the TF to both end consumersand to the food industry. According to the applicant the TF is not intended to replace another food;
• EFSA conclusions: EFSA considers that the available data on composition and history of use of the TF do not raise safety concerns.Considering the available data, EFSA does not raise safety objections to the placing on the market of the TF (dried seeds and flour thereof of Vigna subterranea (L.) Verdc.) within the EU.

Modification of an already authorised novel food

1. Isomalto-oligosaccharide

• Applicant: BioNeutra North America Inc. (Application submitted on March 6, 2022)
• Production process: Enzyme-catalysed hydrolysis
• Quality specifications:

Specifications of the NF in syrup form

Description: Isomalto-oligosaccharide is a light-yellow transparent syrup produced via enzyme-catalysed hydrolysis of food-grade starch from different plant-based crops
Parameter	Specification
Dried solids (g/100g)	>75
Glucose (%, dry basis)	≤ 5
Isomaltose + DP3 to DP9 (%, dry basis)	≥ 90
pH	4-6
Sulfated ash (g/100g)	≤ 0.3
Heavy metals
Lead	≤ 0.5 mg/kg
Arsenic	≤ 0.5 mg/kg
Microbiological
TAMC	<1000 CFU/g
TYMC	<100 CFU/g
E.coli	Not detected in 10 g
Salmonella	Not detected in 25 g

Specifications of the NF in powder form

Description: Isomalto-oligosaccharide is a white powder produced via enzyme-catalysed hydrolysis of food grade starch from different plant-based crops
Parameter	Specification
Solubility (water), %	>99
Glucose (%, dry basis)	≤ 5
Isomaltose + DP3 to DP9 (%, dry basis)	≥ 90
Moisture (%)	≤ 4
Sulfated ash (g/100g)	≤ 0.3
Heavy metals
Lead	≤ 0.5 mg/kg
Arsenic	≤ 0.5 mg/kg
Microbiological
TAMC	<1000 CFU/g
TYMC	<100 CFU/g
E.coli	Not detected in 10 g
Salmonella	Not detected in 25 g

• Proposed uses and use levels:
  • Proposed uses and target population: For use as a food ingredient, the target population proposed by the applicant is the general population. For use in food supplements, the target population proposed by the applicant is the general population older than 10 years of age;
  • Proposed use levels:

As food ingredient:

Food category	Max use level (mg NF/100g)
Dairy desserts and similar	8000
Spoonable desserts and ice creams (generic)	8000
Instant coffee (beverage)	10,000
Table-top sweeteners formulations	100,000
Cakes	20,000
Shortcrust (pies-tarts)	20,000
Choux pastry	15,000
Various pastry	15,000
Breakfast cereals	10,000
Muesli and similar mixed breakfast cereals	10,000
Breakfast cereals, plain	10,000
Processed and mixed breakfast cereals	10,000
Savoury sauces	10,000
Vinegar	10,000
Water-based desserts spoonable	15,000
Rice pudding	15,000
Jam of fruit/vegetables	50,000
Fermented milk products	2500
Flavoured milks	5000
Fried or extruded cereal, seed or root-based products	5000
Dessert sauces/toppings	50,000

The applicant also intends to market the NF for use in food supplements, at a maximum dose of 30 g/day.

• EFSA conclusions: The Panel concludes that the NF, IMO, is safe under the proposed conditions of use.

EFSA requested for scientific and technical assistance as regards the evaluation of Novel Food

1. Calcidiol monohydrate

EFSA conclusion:

• Based on the information and data considered in this report (Section 5), EFSA concludes that the NF calcidiol monohydrate (25-hydroxycholecalciferol monohydrate) proposed for use in food supplements is:
• bioavailable source of the biologically active metabolite of vitamin D, i.e. 1,25-dihydroxyvitamin D. A conversion factor of 2.5 reflects the relative bioavailability of calcidiol vs vitamin D3 under the proposed conditions of use and use levels;
• safe under the proposed conditions of use and use levels (up to 10 μg/day) for children ≥ 11 years old and adults, including pregnant and lactating women; and
• safe under the proposed conditions of use and use levels (up to 5 μg/day) for children 3–10 years of age.

Note: The information is from the official website of EFSA and the Official Journal of the European Union, for reference only.

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Further Information

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