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

According to the European Food Safety Authority (EFSA) and the Official Journal of the European Union, in the second quarter of 2024, the EFSA published assessment results for three Novel Foods (NF), including one new NF application, modification of one already authorized NF, and notification on one new traditional food from a third country.

In addition, the EU approved nine NF in the second quarter of 2024, including amendments to the specifications and conditions of use of three already authorized NF.

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

New NF application

Vitamin D2 mushroom powder

Applicant: Luxidum GmbH (Application submitted on December 14, 2020)
Specifications:

Description: Slightly brown, granular powder made from UV-irradiated Agaricus bisporus mushroom powder
Parameter	Specification
Vitamin D2	245–460 μg/g
Moisture	≤ 10%
Ash	≤ 12%
Water activity	≤ 0.5
Proximate parameters
Total carbohydrates	40%–45%
Protein	30%–36%
Fat	3.0%–4.5%
Heavy metals
Arsenic	≤ 0.3 mg/kg
Lead	≤ 0.3 mg/kg
Cadmium	≤ 0.05 mg/kg
Mercury	≤ 0.1 mg/kg
Mycotoxins
Aflatoxin B1	≤ 2 μg/kg
Aflatoxins (sum of B1 + B2 + G1 + G2)	< 4 μg/kg
Microbiological
TAMC	≤ 5000 CFU/g
TYMC	≤ 100 CFU/g
Salmonella spp.	Not detected in 25 g
Escherichia coli	Not detected in 10 g
Staphylococcus aureus	Not detected in 10 g
Listeria monocytogenes	Not detected in 25 g

Proposed uses
- Target population: The target population for the consumption of the NF added to foods and beverages is the general public. For the NF added to food supplements, the proposed target population is individuals over 1 year of age. Similarly, for the NF added to food for special medical purposes (FSMPs) as defined in Regulation (EU) No 609/2013, the target population is individuals over 1 year of age;
- Proposed uses: The NF is proposed to be used as an ingredient in common foods, food supplements, and FSMPs;
- Proposed use levels:

a) Common foods:

Food category	Max use level (mg NF/100 g)
Breakfast cereals	5.22
Leavened bread and similar	5.22
Yeast leavened pastry	5.22
Pasta and similar products	5.22
Fruit/vegetable juices and nectars	2.61
Concentrated or dehydrated fruit/vegetables juices	18.3
Yoghurt drinks	2.61
Probiotic milk-like drinks	2.61
Milk and dairy concentrate	5.22
Milk powder	52.2
Cream powder	214.0
Whey powder	52.2
Flavoured milks	2.61
Whey	5.22
Dairy dessert and similar	5.22
Cheese	5.22
Food for weight reduction	5.22
Meat and dairy imitates	5.22
Soups, dry mixture, uncooked	47.0
Soups, ready-to-eat	5.22
Puffs/curls-type extruded snack	5.22
Potato crisps or sticks	5.22

b) For food supplements and FSMPs: a maximum dose of 15 μg of vitamin D2/day, for individuals above 1 year of age.

Conclusions: The Panel concludes that the NF, vitamin D2 mushroom powder containing vitamin D2 in the range of 245–460 μg/g, is safe under the proposed conditions of use.

Modification of already authorized NF

2’-fucosyllactose, 2’-FL

Applicant: Chr. Hansen A/S (Application submitted on June 30, 2021)
Proposed uses
- Target population: infants and young children;
- Proposed uses: infant formula and follow-on formula;
- Proposed use levels: 3.0 g/L in infant formula; 3.64 g/L in follow-on formula.
Conclusions: The Panel concludes that the NF, 2’-FL, is safe under the proposed conditions of use.

Notification on new traditional food from a third country

Roasted and popped kernels from the seeds of Euryale ferox Salisb.

Applicant: Zenko Superfoods Pte. Ltd. (Application submitted on October 8, 2021)
Specifications:

Nutrient content (in 100 g)
Energy	1643 kJ/392 kcal
Total fat	13 g
Total carbohydrates	75 g
of which sugars	< 0.4 g
Fiber	2.5 g
Protein	7 g
Moisture (w/w)	< 5%
Microbiological limits
Total plate count	≤ 103 cfu/g
Yeast and mould	≤ 102 cfu/g
Enterobacteriaceae	≤ 10 cfu/g
Salmonella spp.	Absent/25 g
Listeria monocytogenes	Absent/25 g
Pesticides limit	≤ 0.01 mg/kg
Selenium	80 µg/100 g
Heavy metals limits
Cadmium	≤ 0.1 mg/kg
Lead	≤ 0.1 mg/kg
Arsenic	≤ 0.1 mg/kg
Mercury	≤ 25 µg/kg
Tin	≤ 3.5 mg/kg
Toxins
Aflatoxins
Ochratoxin A	≤ 1 µg/kg
Citrinin	≤ 20 µg/kg
Microcystins	0.0015 µg/g
Process contaminants
Acrylamide	≤ 40 µg/kg
The sum of PAH	≤ 10 µg/kg
The sum of dioxin-like PCBs	≤ 0.35 pg/g
3-MCPD	≤ 20 µg/kg
Glycidyl fatty acid esters (expressed as glycidol)	≤ 500 µg/kg
Sum of 3-MCPD and 3-MCPD fatty acid esters,(expressed as 3-MCPD) 750 µg/kg	≤ 750 µg/kg

Proposed uses
- Target population: the general population;
- Proposed uses: The NF is intended to be consumed as a snack;
- Proposed use levels: The applicant proposes a serving size of 28 g and a maximum daily intake of four servings (112 g/day).
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, the EFSA does not raise safety objections to the placing on the market of the TF (roasted and popped kernels from the seeds of Euryale ferox Salisb.) within the EU.

Approved NF

Monosodium salt of L-5-methyltetrahydrofolic acid

Applicant: Merck & Cie KmG (Switzerland)
Application submitted on: November 12, 2020
Authorized to be placed on the market on: April 9, 2024
Authorized uses and use levels:

Monosodium salt of L-5-methyltetrahydrofolic acid	Conditions under which the novel food may be used
	Specified food category	Maximum levels (expressed as folic acid)
	Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children	In accordance with Directive 2002/46/EC
	Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013	In accordance with Regulation (EU) No 609/2013
	Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013	In accordance with Regulation (EU) No 609/2013
	Foods for special medical purposes as defined in Regulation (EU) No 609/2013	In accordance with Regulation (EU) No 609/2013
	Total diet replacement for weight control as defined in Regulation (EU) No 609/2013	In accordance with Regulation (EU) No 609/2013
	Food fortified in accordance with Regulation (EC) No 1925/2006	In accordance with Regulation (EC) No 1925/2006
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be “Monosodium salt of L-5-methyltetrahydrofolic acid (folic acid)”. The labeling of food supplements containing monosodium salt of L-5-methyltetrahydrofolic acid shall bear a statement that the food supplements should not be consumed by infants and young children (children under 3 years of age)

Protein concentrate from Lemna gibba and Lemna minor

Applicant: ABC Kroos BV (Netherlands)
Application submitted on: December 28, 2018
Authorized to be placed on the market on: April 9, 2024
Authorized uses and use levels:

Protein concentrate from Lemna gibba and Lemna minor	Conditions under which the novel food may be used
	Specified food category	Maximum levels
	Cereal bars	10 g/100 g
	Prepacked bread and rolls	1.7 g/100 g
	Powdered drink mixes	20 g/100 g
	Noodles	6 g/100 g
	Food supplements as defined in Directive 2002/46/EC for the adult population	1 g/day
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be “protein concentrate from the Lemna gibba and Lemna minor plants” or “protein concentrate from the Lemna gibba plant” depending on the presence of Lemna minor. Where foods containing the novel food include an amount of vitamin K that is considered significant in accordance with point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011, the nutrition declaration shall indicate the amount of vitamin K. The labeling of food supplements containing the novel food shall bear a statement that they should only be consumed by adults. Where food supplements containing the novel food include an amount of vitamin K that is considered significant in accordance with point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011 and Article 8 of Directive 2002/46/EC, the labeling of food supplements containing novel food shall indicate the amount of vitamin K.

3’-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637)

Applicant: Kyowa Hakko Bio Co., Ltd (Japan)
Application submitted on: March 25, 2021
Authorized to be placed on the market on: April 9, 2024
Authorized uses and use levels:

3’-Sialyllactose (3’-SL) sodium salt (produced using a derivative strain of E. coli W (ATCC 9637))	Conditions under which the novel food may be used
	Specified food category	Maximum levels (expressed as 3’-Sialyllactose)
	Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products	0.25 g/L
	Unflavoured fermented milk-based products	0.25 g/L (beverages)
	Unflavoured fermented milk-based products	0.5 g/kg (products other than beverages)
	Flavoured fermented milk-based products including heat-treated products	0.25 g/L (beverages)
		2.5 g/kg (products other than beverages)
	Beverages (flavoured drinks, excluding drinks with a pH less than 5)	0.25 g/L
	Cereal bars	2.5 g/kg
	Infant formula as defined under Regulation (EU) No 609/2013	0.2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Follow-on formula as defined under Regulation (EU) No 609/2013	0.15g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013	0.15g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
		1.25 g/kg for products other than beverages
	Milk based drinks and similar products	0.15g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013	0.5 g/L (beverages)
		5.0 g/kg (products other than beverages)
	Food for special medical purposes as defined under Regulation (EU) No 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
	Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children	1.0 g/day
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be “3’-Sialyllactose sodium salt”. 2. The labeling of food supplements containing 3’-Sialyllactose (3’-SL) sodium salt shall bear a statement that they should not be consumed: if foods containing added 3’-Sialyllactose sodium salt are consumed on the same day; (b) by children under 3 years of age.

Beta-glucan from Euglena gracilis microalgae

Applicant: Kemin Foods L.C. (USA)
Application submitted on: August 15, 2019
Authorized to be placed on the market on: April 9, 2024
Authorized uses and use levels:

Beta-glucan from Euglena gracilis microalgae	Conditions under which the novel food may be used
	Specified food category	Maximum levels
	Cereal bars	670 mg/100 g
	Total diet replacement for weight control as defined in Regulation (EU) No 609/2013	670 mg/day
	Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children	100 mg/day for children from 3 to 9 years of age
		150 mg/day for children from 10 to 17 years of age
		200 mg/day for adults
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be “beta-glucan from Euglena gracilis microalgae”. 2. The labeling of food supplements containing the novel food shall bear a statement that they should only be consumed by persons above 3 years of age/above 9 years of age/adults, depending on the age group the product is intended for.

Calcidiol monohydrate

Applicant: DSM Nutritional Products Ltd. (Switzerland)
Application submitted on: May 16, 2018
Authorized to be placed on the market on: April 10, 2024
Authorized uses and use levels:

Calcidiol monohydrate	Conditions under which the novel food may be used
	Specified food category	Maximum levels
	Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children	10 μg/day for children from 11 years of age and adults 5 μg/day for children from 3 to 10 years of age
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be “calcidiol (calcifediol) monohydrate (vitamin D)”. The labeling of food supplements containing the novel food shall bear a statement that they should not be consumed by infants and children under 3 years of age/children under 11 years of age, depending on the age group the product is intended for.

Isomaltulose powder

Applicant: Evonik Operations GmbH (Germany)
Application submitted on: April 30, 2018
Authorized to be placed on the market on: June 7, 2024
Authorized uses and use levels:

Isomaltulose powder	Conditions under which the novel food may be used
	Specified food category	Maximum levels
	All foods, excluding foods and drinks intended specifically for infants and young children	—
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be “isomaltulose powder”. The designation of the novel food on the labeling shall be accompanied by indication that the “Isomaltulose is a source of glucose and fructose”.

Amendmens to already authorized NF

Astaxanthin-rich oleoresin from Haematococcus pluvialis algae

Applicant: Astareal AB (Sweden)
Application submitted on: June 20, 2022
Authorized to be placed on the market on: April 9, 2024
In Table 2 (‘Specifications’) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Astaxanthin-rich oleoresin from Haematococcus pluvialis algae’ is replaced by the following:

Authorized Novel Food	Specification
Astaxanthin-rich oleoresin from Haematococcus pluvialis algae	Description: Astaxanthin is a carotenoid produced by Haematococcus pluvialis algae. Production methods for the growth of the algae are variable; using “closed” systems exposed to sunlight or strictly controlled illuminated light alternatively open ponds may be used. The algal cells are harvested and dried; the oleoresin is extracted using either super critical CO2 or a solvent (ethyl acetate). The Astaxanthin is diluted and standardized to 2,5 %, 5,0 %, 7,0 %, 10 %, 15 % or 20 % using olive oil, safflower oil, Sunflower oil or MCT (Medium Chain Triglycerides).
	Characteristics/Composition Fat: 42.2-99 % Protein: ≤ 4.4 % Carbohydrate: ≤ 52.8% Fiber: <1.0% Ash: ≤ 4.2% Specification of Carotenoids (% w/w) Total Astaxanthins: 2.9-11.1% 9-cis-astaxanthin: 0.3-30.0 % 13-cis-astaxanthin: 0.2-7.0 % Astaxanthin monoesters: 66.7-91.5 % Astaxanthin diesters: 0.16-32.5 % Beta-Carotene: 0.01-0.3 % Lutein: ≤ 1.8 % Canthaxanthin: ≤ 1.30 %
	Microbiological criteria: Total aerobic bacteria: < 3000 CFU/g Yeast and moulds: < 100 CFU/g Coliforms: < 10 CFU/g E.coli: Negative Salmonella: Negative Staphylococcus: Negative

Lactitol

Applicant: H.C. Clover Productos y Servicios, S.L. (Spain)
Application submitted on: October 31, 2023
Authorized to be placed on the market on: April 9, 2024
In Table 1 (Authorized novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Lactitol’ is replaced by the following:

Authorized novel food	Conditions under which the novel food may be used
	Specified food category	Maximum levels
Lactitol	Food supplements as defined in Directive 2002/46/EC intended for the adult population	20g/day
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the food supplements containing it shall be “Lactitol”.

Galacto-oligosaccharide

Applicant: FrieslandCampina Ingredients (Netherlands)
Application submitted on: July 28, 2023
Authorized to be placed on the market on: April 9, 2024
In Table 2 (‘Specifications’) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Galacto-oligosaccharide’ is replaced by the following:

Authorized novel food

Specification

galacto-oligosaccharide

Description/Definition:

Galacto-oligosaccharide is produced from milk lactose by an enzymatic process using β-galactosidases from Aspergillus oryzae, Bifidobacterium bifidum, Pichia pastoris, Sporobolomyces singularis, Kluyveromyces lactis and Papiliotrema terrestris.

GOS: min 46 % Dry Matter (DM)

Lactose: max. 40 %, DM

Glucose: max. 22 %, DM

Ash: max. 4.0 %, DM

Protein: max. 4.5%, DM

Nitrite: max. 2mg/kg

Source: The official website of EFSA and the Official Journal of the European Union.

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Further information

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

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