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

According to the European Food Safety Authority (EFSA) and the Official Journal of the European Union, in the third quarter of 2024, EFSA published assessment results for two Novel Foods (NFs), including two new NF applications.

EU,Food,Novel,Application,EFSA,Summary

In addition, the EU approved ten NFs in the third quarter of 2024, including amendments to the specifications and conditions of use of five already authorized NFs.

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

New NF Applications

Acheta domesticus powder

Applicant: Società Agricola Italian Cricket Farm S.r.l. (Application submitted on June 11, 2020)
Specifications:

Description: Thermally processed, dried, Acheta domesticus powder Source: Acheta domesticus
Parameter	Unit	Specification
Crude protein (N × 6.25)	% w/w	61-72
Fat	% w/w	11-22
Saturated fatty acids	% w/w	1.5-12
Dietary fibre	% w/w	4.0-14
Chitin*	% w/w	2.5-9.0
Moisture	% w/w	1.0-5.5
Digestible carbohydrates	% w/w	≤ 5.0
Digestible carbohydrates	mg/kg	≤ 7.0
Peroxide value	meq O2/kg fat	≤ 2.5
Peroxide value	—	≤ 1.0
Heavy metals
Heavy metals	mg/kg	≤ 0.10
Heavy metals	mg/kg	≤ 0.06
Mycotoxins
Aflatoxins (sum of B1, B2, G1, G2)	μg/kg	≤ 1.6
Deoxynivalenol	μg/kg	≤ 10
Deoxynivalenol	μg/kg	≤ 0.3
Fumonisins B1 & B2	μg/kg	≤ 40
Ochratoxin A	μg/kg	≤ 0.3
Zearalenone	μg/kg	≤ 10
Sum of dioxins and dioxins-like PCBs (UB WHO2005 PCDD/F-PCB-TEQ)	pg/g fat	< 3.5
Microbiological
TAMC	CFU/g	< 105
Enterobacteriaceae (presumptive)	CFU/g	≤ 100
Escherichia coli	CFU/g	≤ 50
Listeria monocytogenes	in 25g	Not detected
Salmonella spp.	in 25g	Not detected
Bacillus cereus (presumptive)	CFU/g	≤ 100
Coagulase positive – staphylococci	CFU/g	≤ 100
Clostridium perfringens	CFU/g	≤ 10
TYMC	CFU/g	≤ 100 (< 10)

* Chitin is calculated as the difference between the acid detergent fibre fraction and the acid detergent lignin fraction (ADF-ADL), as described by Hahn et al. (2018).

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

Food category	Max use level (g NF/100 g)
Cakes	10
Biscuits	15
Pasta and similar products	15
Whey powder	50
Meat imitates (meat alternatives)	15
Sandwiches, pizza and other stuffed bread-like cereal products	10
Chocolate and similar products	15

Conclusions: 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.

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	Parameter
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
Salmonella spp.	< 100 CFU/g

Proposed uses
- Target population: the general population, except for food supplements for which the proposed target population is adults and children older than 1.
- Proposed uses and Proposed use levels

Food category	Max use level
200 mg/day for the general population older than 10 years	200 mg/day for the general population older than 10 years
	115 mg/day for children between ages 3 and 10
	60 mg/day for young children between ages 1 and 3
Functional drinks^a	525 mg/L

^aThis 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)’. This code does not indicate a health claim under Regulation (EC) No 1924/2006.

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

Approved NF

Lacto-N-fucopentaose I and 2’-Fucosyllactose mixture produced using a derivative strain of Escherichia coli K-12 DH1

Applicant: Glycom A/S (Denmark)
Application submitted on: March 1, 2021
Authorized to be placed on the market on: July 30, 2024
Authorized uses and use levels:

Authorized novel food	Conditions under which the novel food may be used
‘Lacto-N-fucopentaose I and 2'-Fucosyllactose (‘LNFP-I and 2'-FL’) mixture (produced using a derivative strain of E. coli K-12 DH1)	Specified food category	Maximum levels (expressed as Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture)
	Infant formula	2.0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Follow-on formula	2.0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Unflavored pasteurized and unflavored sterilized (including UHT) milk products	1.5 g/L
	Unflavored fermented milk-based products	1.5 g/L (beverages)
	Unflavored fermented milk-based products	3.0 g/kg (products other than beverages)
	Flavored fermented milk-based products including heat-treated products	1.5 g/L (beverages)
		15.0 g/kg (products other than beverages)
	Milk-based drinks and similar products	1.5 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Food for special medical purposes for infants and young children	In accordance with the particular nutritional requirements of the persons for whom the products are intended but in any case not higher than the maximum levels specified for the proposed food categories or higher than 2.0 g/L or 2.0 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Food for special medical purposes excluding foods for infants and young children	In accordance with the particular nutritional requirements of the persons for whom the products are intended but in any case not higher than the maximum levels specified for the proposed food categories or higher than 4,5 g/day in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Total diet replacement foods for weight control	3.0 g/L (beverages)
	Total diet replacement foods for weight control	4.5 g/kg (products other than beverages)
	Beverages (flavored drinks, excluding drinks with a pH less than 5)	1.5 g/kg
	Cereal bars	15.0 g/kg
	Processed cereal-based food and baby food for infants and young children	1.5 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
		9.1 g/kg (products other than beverages)
	Food supplements for the general population, excluding infants and young children	4.5 g/day
	labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be ‘Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture’. The labeling of food supplements containing Lacto-N-fucopentaose I and 2'-Fucosyllactose (‘LNFP-I and 2'-FL’) mixture produced by a derivative strain of E. coli K-12 DH1 shall bear a statement that: they should not be consumed by children under the age of 3; (b) they should not be used, if other foods containing added Lacto-N-fucopentaose I and 2'-Fucosyllactose mixture and/or foods containing added 2'-Fucosyllactose are consumed on the same day.

2’-Fucosyllactose produced by a derivative strain of Escherichia coli BL-21

Applicant: Kyowa Hakko Bio Co., Ltd (Japan)
Application submitted on: March 23, 2021
Authorized to be placed on the market on: July 30, 2024
Authorized uses and use levels:

Authorised novel food	Conditions under which the novel food may be used
2′-Fucosyllactose (microbial source)	Food category	Max use level
	Unflavored pasteurized and sterilized (including UHT) milk-based products	1.2 g/L
	Unflavored fermented milk-based products	1.2 g/L (beverages)
	Unflavored fermented milk-based products	19.2 g/kg (products other than beverages)
	Flavored fermented milk-based products including heat-treated products	1.2 g/L (beverages)
		19.2 g/kg (products other than beverages)
	Dairy analogs, including beverage whiteners	1.2 g/L (beverages)
		12 g/kg (products other than beverages)
		400 g/kg for whitener
	Cereal bars	12 g/kg
	Table-top sweeteners	200 g/kg
	Infant formula	3.0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Follow-on formula	3.64 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Milk-based drinks and similar products	1.2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Processed cereal-based foods and baby foods for infants and young children	12 g/kg (products other than beverages)
		1.2 g/kg (beverages)
	Foods for special medical purposes	Following the particular nutritional requirements of the persons for whom the products are intended
	Total diet replacement for weight control	4.8 g/L (beverages)
	Total diet replacement for weight control	40g/kg (products other than beverages)
	Bread and pasta products bearing statements on the absence or reduced presence of gluten	60 g/kg
	Flavored drinks	1.2 g/L
	Processed cereal products and infant food products	1.5 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products	9.6 g/L
	Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants	3.0 g/day for general population
		1.2 g/day for young children
	Labeling requirements
	The designation of the novel food on the labelling of the foodstuffs containing it shall be “2′-Fucosyllactose”. The labelling of food supplements containing 2′-Fucosyllactose shall bear a statement that the supplements should not be used if other foods with added 2′-fucosyllactose are consumed the same day. The labelling of food supplements containing 2′-Fucosyllactose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added 2′-fucosyllactose are consumed the same day.’

Schizochytrium limacinum (TKD-1) oil

Applicant: ATK Biotech Co., Ltd. (China)
Application submitted on: December 17, 2020
Authorized to be placed on the market on: July 31, 2024
Authorized uses and use levels:

Authorized novel food	Conditions under which the novel food may be used
Schizochytrium limacinum (TKD-1) oil	Food category	Max use level of DHA
	Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013	In accordance with Regulation (EU) No 609/2013
	Labeling requirements
	The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium limacinum’.”

Juice of the stems of the Angelica keiskei plant (Ashitaba stem juice)

Applicant: Japan Bio Science Laboratory (JBSL)-USA, Inc. (U.S.)
Application submitted on: August 8, 2019
Authorized to be placed on the market on: July 31, 2024
Authorized uses and use levels:

Authorized novel food	Conditions under which the novel food may be used
Juice of the stems of the Angelica keiskei plant (Ashitaba stem juice)	Food category	Max use level (expressed on the juice)
	Food Supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and lactating women	137 mg/day
	Labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be “Ashitaba (Angelica keiskei) stem juice”. The labeling of food supplements containing the juice of the stems of the Angelica keiskei plant (Ashitaba stem juice) shall bear a statement that they should be consumed by adults only, excluding pregnant and lactating women.

Schizochytrium sp. (CABIO-A-2) oil

Applicant: CABIO Biotech (Wuhan) Co., Ltd. (China)
Application submitted on: March 19, 2021
Authorized to be placed on the market on: July 31, 2024
Authorized uses and use levels:

Authorized novel food	Conditions under which the novel food may be used
Schizochytrium sp. (CABIO-A-2) oil	Food category	Max use level of DHA
	Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013	In accordance with Regulation (EU) No 609/2013
	Labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be “Oil from the microalgae Schizochytrium sp.”

Amendments to already authorized NF

Yarrowia lipolytica yeast biomass

Applicant: Skotan S.A.（Poland）
Application submitted on: July 5, 2020
Authorized to be placed on the market on: July 30, 2024
Authorized uses and use levels:

Authorized novel food	Conditions under which the novel food may be used
Yarrowia lipolytica yeast biomass	Food category	Max use level
	Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children	6 g/day for children from 10 years of age, adolescents and general adult population 3 g/day for children from 3 to 9 years of age
	Meal replacements for weight control for the adult population	3 g/meal (maximum 2 meals/day up to a maximum of 6 g/day)
	Foods for special medical purposes as defined in Regulation (EU) No 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended but not in any case higher than 6 g/day
	Total diet replacement for weight control as defined in Regulation (EU) No 609/2013	6 g/day
	Unflavored milk products	5 g/kg
	Flavored fermented milk products	10 g/kg
	Cheese and cheese products; (excluding desserts)	10 g/kg
	Nut spreads	30 g/kg
	Processed potato products	10 g/kg
	Cocoa and chocolate confectionery	10 g/kg
	Grains and breakfast cereals	20 g/kg
	Pasta-based products and noodles	10 g/kg
	Pre-cooked or processed cereals	10 g/kg
	Bread and rolls	6 g/kg
	Fine bakery wares	15 g/kg
	Heat-treated meat products	15 g/kg
	Herbs and spices; seasonings and condiments	50 g/kg
	Soups and broths	5 g/kg
	Sauces	10 g/kg
	Salads and savory-based sandwich spreads	30 g/kg
	Yeast and yeast products	30 g/kg
	Protein products, excluding dairy analogs and beverage whiteners	30 g/kg
	Flavored drinks	10 g/L
	Coffee, coffee extracts	20 g/kg
	Other non-alcoholic beverages	10 g/L
	Potato-, cereal-, flour- or starch-based snacks	300 g/kg
	Processed nuts	20 g/kg
	Labeling requirements
	1. The designation of the novel food on the labeling of the foodstuffs containing it shall be ‘Yarrowia lipolytica yeast biomass’. 2. Food supplements containing the novel food should bear a statement that they should not be consumed if other foods with added Yarrowia lipolytica yeast biomass are consumed on the same day.’

Partially hydrolyzed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa)

Applicant: Evergrain LLC (U.S.)
Application submitted on: February 6, 2024
Authorized to be placed on the market on: July 30, 2024
Authorized uses and use levels:

Authorized novel food	Conditions under which the novel food may be used
Partially hydrolyzed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa)	Food category	Max use level
	Fried or extruded cereal, seed or root-based products	5 g/100 g
	Confectionery including chocolate	5 g/100 g
	Breakfast cereals	5 g/100 g
	Pastas and rice (or other cereal)-based dishes	8 g/100 g
	Soups (dry mixture)	50 g/100 g
	Soups (ready-to-eat)	5 g/100 g
	Sauces	10 g/100 g
	Dried sauce preparation	50 g/100 g
	Meat analogues	15 g/100 g
	Cereal bars	30 g/100 g
	Butter and margarine/oil blends	10 g/100 g
	Milk analogs based ice creams	10 g/100 g
	Milk analogues	5 g/100 ml
	Nut/seeds paste/emulsion	15 g/100 g
	Energy drinks	8 g/100 ml
	Soft drinks marketed in relation to physical exercise	5 g/100 ml
	Cola type drinks	5 g/100 g
	Powdered drink bases	90 g/100 g
	Beverages based on fruit and/or vegetable juices	5 g/100 ml
	Cream, cheese and yogurt (non-soy) analogs	10 g/100 g
	Hummus	10 g/100 g
	Alcohol-free beer	5 g/100 ml
	Meal replacement for weight control	30 g/100 g
	Labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be “Partially hydrolyzed protein from barley and rice”. In accordance with Article 21 of Regulation (EU) No 1169/2011.

Protein extract from pig kidneys

Applicant: Dr Healthcare España, S.L.U.（Spain）
Application submitted on: June 28, 2023
Authorized to be placed on the market on: July 30, 2024
Authorized uses and use levels:

Authorized novel food	Conditions under which the novel food may be used
Protein extract from pig kidneys	Food category	Max use level
	Food supplements as defined in Directive 2002/46/EC	12.6 mg protein extract from pig kidney/day containing 0.9 mg/day diamine oxidase (DAO) taken in 3 doses per day, each dose containing a maximum of 0.3 mg DAO
	Food for special medical purposes as defined in Regulation (EU) No 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended, but not higher than 1.6 mg protein extract from pig kidney/day containing 0.9 mg/day DAO’
	Labeling requirements
	—

2’-Fucosyllactose produced with a derivative strain of Escherichia coli BL-21

Applicant: Chr. Hansen A/S（Denmark）
Application submitted on: June 30, 2021
Authorized to be placed on the market on: July 31, 2024
Authorized uses and use levels:

Authorized novel food	Conditions under which the novel food may be used
‘2′-Fucosyllactose (microbial source)	Food category	Max use level
	Unflavoured pasteurized and sterilized (including UHT) milk-based products	1.2 g/L
	Unflavoured fermented milk-based products	1.2 g/L (beverages)
	Unflavoured fermented milk-based products	19.2 g/kg (products other than beverages)
	Flavored fermented milk-based products including heat-treated products	1.2 g/L (beverages)
		19.2 g/kg (products other than beverages)
	Dairy analogs, including beverage whiteners	1.2 g/L (beverages)
		12 g/kg (products other than beverages)
		400 g/kg for whitener
	Cereal bars	12 g/kg
	Table-top sweeteners	200 g/kg
	Infant formula	3.0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Follow-on formula	3.64 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Milk-based drinks and similar products	1.2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Processed cereal-based foods and baby foods for infants and young children	12 g/kg (products other than beverages)
		1.2 g/kg (beverages)
	Foods for special medical purposes	In accordance with the particular nutritional requirements of the persons for whom the products are intended
	Total diet replacement for weight control	4.8 g/L (beverages)
	Total diet replacement for weight control	40g/kg (products other than beverages)
	Bread and pasta products bearing statements on the absence or reduced presence of gluten	60 g/kg
	Flavored drinks	1.2 g/L
	Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products	9.6 g/L
	Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants	3.0 g/day for general population
		1.2 g/day for young children
	Labeling requirements
	The designation of the novel food on the labelling of the foodstuffs containing it shall be “2′-Fucosyllactose”. The labelling of food supplements containing 2′-Fucosyllactose shall bear a statement that the supplements should not be used if other foods with added 2′-fucosyllactose are consumed the same day. The labeling of food supplements containing 2′-Fucosyllactose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added 2′-fucosyllactose are consumed the same day.’

Schizochytrium sp. oil rich in DHA and EPA

Applicant: DSM Nutritional Products Ltd. (Switzerland)
Application submitted on: January 30, 2024
Authorized to be placed on the market on: July 31, 2024
Authorized uses and use levels:

Authorised novel food

Conditions under which the novel food may be used

Schizochytrium sp. oil rich in DHA and EPA

Acid value: ≤ 0,5 mg KOH/g

Peroxide value (PV): ≤ 5,0 meq/kg oil

Oxidative stability: All food products containing Schizochytrium sp. oil rich in DHA and EPA should demonstrate oxidative stability by appropriate and recognized national/international test methodology (e.g. AOAC)

Moisture and volatiles: ≤ 0,05 %

Unsaponifiables: ≤ 4,5 %

Trans-fatty acids: ≤ 1 %

DHA content: ≥ 15 %

EPA content: ≥ 10 %

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

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