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 (NF), including two new NF application.
In addition, the EU approved ten NF in the third quarter of 2024, including amendments to the specifications and conditions of use of five already authorized NF.
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 application
Acheta domesticus powder
- Applicant: Società Agricola Italian Cricket Farm S.r.l. (Application submitted on June 11, 2020)
- Specifications:
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Description: Thermally processed, dried, Acheta domesticus powder Source: Acheta domesticus |
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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 |
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Dietary fibre |
% w/w |
4.0-14 |
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Chitin* |
% w/w |
2.5-9.0 |
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Moisture |
% w/w |
1.0-5.5 |
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Digestible carbohydrates |
% w/w |
≤ 5.0 |
|
Digestible carbohydrates |
mg/kg |
≤ 7.0 |
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Peroxide value |
meq O2/kg fat |
≤ 2.5 |
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Peroxide value |
— |
≤ 1.0 |
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Heavy metals |
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Heavy metals |
mg/kg |
≤ 0.10 |
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Heavy metals |
mg/kg |
≤ 0.06 |
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Mycotoxins |
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Aflatoxins (sum of B1, B2, G1, G2) |
μg/kg |
≤ 1.6 |
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Deoxynivalenol |
μg/kg |
≤ 10 |
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Deoxynivalenol |
μg/kg |
≤ 0.3 |
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Fumonisins B1 & B2 |
μg/kg |
≤ 40 |
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Ochratoxin A |
μg/kg |
≤ 0.3 |
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Zearalenone |
μg/kg |
≤ 10 |
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Sum of dioxins and dioxins-like PCBs (UB WHO2005 PCDD/F-PCB-TEQ) |
pg/g fat |
< 3.5 |
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Microbiological |
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TAMC |
CFU/g |
< 105 |
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Enterobacteriaceae (presumptive) |
CFU/g |
≤ 100 |
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Escherichia coli |
CFU/g |
≤ 50 |
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Listeria monocytogenes |
in 25g |
Not detected |
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Salmonella spp. |
in 25g |
Not detected |
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Bacillus cereus (presumptive) |
CFU/g |
≤ 100 |
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Coagulase positive – staphylococci |
CFU/g |
≤ 100 |
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Clostridium perfringens |
CFU/g |
≤ 10 |
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TYMC |
CFU/g |
≤ 100 (< 10) |
*Chitin 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 |
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Biscuite |
15 |
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Pasta and similar products |
15 |
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Whey powder |
50 |
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Meat imitates |
15 |
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Sandwiches, pizza and other stuffed bread-like cereal products |
10 |
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Chocolate and similar |
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:
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Description: A pale yellow to yellow-brown powder produced enzymatically from hesperidin and dextrin |
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|
Parameter |
Parameter |
|
General |
|
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Monoglucosyl hesperidin (MGH) (dry basis) |
75.0%–85.0% |
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Hesperidin (dry basis) |
10%–20% |
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Loss on drying |
≤ 6% |
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Residue on ignition |
≤ 2% |
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Heavy metals |
|
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Lead |
≤ 2 mg/kg |
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Arsenic |
≤ 1.5 mg/kg |
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Microbiological |
|
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TAMC |
≤ 100 CFU/g |
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Total coliforms |
Not detected in 10 g |
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Salmonella spp. |
Not detected in 25 g |
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Salmonella spp. |
< 100 CFU/g |
- Proposed uses
- Target population: the general population, except for food supplements for which the proposed target population is children from 1 year onwards and adults.
- Proposed uses and Proposed use levels
|
Food category |
Max use level |
|
200 mg/day for general population older than 10 years |
200 mg/day for 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 |
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Functional drinksa |
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.
- 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:
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Conditions under which the novel food may be used |
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‘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) |
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Infant formula |
2,0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
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Follow-on formula |
2,0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
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Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products |
1.5 g/L |
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Unflavoured fermented milk-based products |
1.5 g/L (beverages) |
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|
3.0 g/kg (products other than beverages) |
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Flavoured fermented milk-based products including heat-treated products |
1.5 g/L(beverages) |
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15.0 g/kg (products other than beverages) |
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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 |
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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 |
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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 |
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Total diet replacement foods for weight control |
3.0 g/L (beverages) |
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4.5 g/kg (products other than beverages) |
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Beverages (flavoured drinks, excluding drinks with a pH less than 5) |
1.5 g/kg |
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Cereal bars |
15.0 g/kg |
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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 |
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9.1 g/kg (products other than beverages) |
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Food supplements for the general population, excluding infants and young children |
4.5 g/day |
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labelling requirements |
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(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. |
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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 |
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|
2′-Fucosyllactose (microbial source) |
Food category |
Max use level |
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Unflavoured pasteurised and sterilised (including UHT) milk-based products |
1.2 g/L |
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Unflavoured fermented milk-based products |
1.2 g/L (beverages) |
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19.2 g/kg (products other than beverages) |
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Flavoured fermented milk-based products including heat-treated products |
1.2 g/L (beverages) |
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Dairy analogues, including beverage whiteners |
1.2 g/L (beverages) |
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12 g/kg (products other than beverages) |
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400 g/kg for whitener |
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Cereal bars |
12 g/kg |
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Table-top sweeteners |
200 g/kg |
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Infant formula |
3,0 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
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Follow-on formula |
3,64 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
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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 |
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Processed cereal-based foods and baby foods for infants and young children |
12 g/kg (products other than beverages) |
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1.2 g/kg (beverages) |
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Foods for special medical purposes |
In accordance with the particular nutritional requirements of the persons for whom the products are intended |
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Total diet replacement for weight control |
4.8 g/L (beverages) |
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40g/kg (products other than beverages) |
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Bread and pasta products bearing statements on the absence or reduced presence of gluten |
60 g/kg |
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Flavoured drinks |
1.2 g/L |
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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 |
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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 |
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Food supplements as defined in Directive 2002/46/EC, for the general population, excluding infants |
3,0 g/day for general population |
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1,2 g/day for young children |
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Labelling requirements |
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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.’ |
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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:
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Authorised novel food |
Conditions under which the novel food may be used |
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Schizochytrium limacinum (TKD-1) oil |
Food category |
Max use level of DHA |
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Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 |
In accordance with Regulation (EU) No 609/2013 |
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Labelling requirements |
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The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium limacinum’.” |
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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:
|
Authorised novel food |
Conditions under which the novel food may be used |
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Juice of the stems of the Angelica keiskei plant (Ashitaba stem juice) |
Food category |
Max use level (expressed on the juice) |
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Food Supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and lactating women |
137 mg/day |
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Labelling requirements |
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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:
|
Authorised novel food |
Conditions under which the novel food may be used |
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Schizochytrium sp. (CABIO-A-2) oil |
Food category |
Max use level of DHA |
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Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 |
In accordance with Regulation (EU) No 609/2013 |
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Labelling requirements |
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The designation of the novel food on the labelling of the foodstuffs containing it shall be “Oil from the microalgae Schizochytrium sp.” |
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Amendmens 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:
|
Authorised novel food |
Conditions under which the novel food may be used |
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Yarrowia lipolytica yeast biomass |
Food category |
Max use level |
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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 |
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Meal replacements for weight control for the adult population |
3 g/meal (maximum 2 meals/day up to a maximum of 6 g/day) |
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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 |
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Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 |
6 g/day |
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Unflavoured milk products |
5 g/kg |
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Flavoured fermented milk products |
10 g/kg |
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Cheese and cheese products; (excluding desserts) |
10 g/kg |
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Nut spreads |
30 g/kg |
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Processed potato products |
10 g/kg |
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Cocoa and chocolate confectionary |
10 g/kg |
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Grains and breakfast cereals |
20 g/kg |
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Pasta based products and noodles |
10 g/kg |
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Pre-cooked or processed cereals |
10 g/kg |
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Bread and rolls |
6 g/kg |
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Fine bakery wares |
15 g/kg |
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Heat-treated meat products |
15 g/kg |
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Herbs and spices; seasonings and condiments |
50 g/kg |
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Soups and broths |
5 g/kg |
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Sauces |
10 g/kg |
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Salads and savoury based sandwich spreads |
30 g/kg |
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Yeast and yeast products |
30 g/kg |
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Protein products, excluding dairy analogues and beverage whiteners |
30 g/kg |
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Flavoured drinks |
10 g/L |
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Coffee, coffee extracts |
20 g/kg |
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Other non-alcoholic beverages |
10 g/L |
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Potato-, cereal-, flour- or starch-based snacks |
300 g/kg |
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Processed nuts |
20 g/kg |
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Labelling requirements |
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1.The designation of the novel food on the labelling 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.’ |
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Partially hydrolysed 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:
|
Authorised novel food |
Conditions under which the novel food may be used |
|
|
Partially hydrolysed 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 |
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Confectionery including chocolate |
5 g/100 g |
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Breakfast cereals |
5 g/100 g |
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Pastas and rice (or other cereal)-based dishes |
8 g/100 g |
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Soups (dry mixture) |
50 g/100 g |
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Soups (ready-to-eat) |
5 g/100 g |
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Sauces |
10 g/100 g |
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Dried sauce preparation |
50 g/100 g |
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Meat analogues |
15 g/100 g |
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Cereal bars |
30 g/100 g |
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Butter and margarine/oil blends |
10 g/100 g |
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Milk analogues based ice creams |
10 g/100 g |
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Milk analogues |
5 g/100 ml |
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Nut/seeds paste/emulsion |
15 g/100 g |
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Energy drinks |
8 g/100 ml |
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Soft drinks marketed in relation to physical exercise |
5 g/100 ml |
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Cola type drinks |
5 g/100 g |
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Powdered drink bases |
90 g/100 g |
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Beverages based on fruit and/or vegetable juices |
5 g/100 ml |
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Cream, cheese and yoghurt (non-soy) analogues |
10 g/100 g |
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Hummus |
10 g/100 g |
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Alcohol-free beer |
5 g/100 ml |
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Meal replacement for weight control |
30 g/100 g |
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Labelling requirements |
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The designation of the novel food on the labelling of the foodstuffs containing it shall be “Partially hydrolysed protein from barley and rice”. In accordance with Article 21 of Regulation (EU) No 1169/2011. |
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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:
|
Authorised 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 |
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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 12,6 mg protein extract from pig kidney/day containing 0,9 mg/day DAO’ |
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Labelling requirements |
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— |
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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:
|
Authorised novel food |
Conditions under which the novel food may be used |
|
|
‘2′-Fucosyllactose (microbial source) |
Food category |
Max use level |
|
Unflavoured pasteurised and sterilised (including UHT) milk-based products |
1.2 g/L |
|
|
Unflavoured fermented milk-based products |
1.2 g/L (beverages) |
|
|
19.2 g/kg (products other than beverages) |
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Flavoured fermented milk-based products including heat-treated products |
1.2 g/L (beverages) |
|
|
19.2 g/kg (products other than beverages) |
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|
Dairy analogues, including beverage whiteners |
1.2 g/L (beverages) |
|
|
12 g/kg (products other than beverages) |
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|
400 g/kg for whitener |
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|
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) |
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|
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) |
|
|
40g/kg (products other than beverages) |
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|
Bread and pasta products bearing statements on the absence or reduced presence of gluten |
60 g/kg |
|
|
Flavoured 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 |
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|
Labelling requirements |
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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 recognised 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
