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 |
||
|
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 |
||
|
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) |
|
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 |
||
2. The labeling of food supplements containing 3’-Sialyllactose (3’-SL) sodium salt shall bear a statement that they should not be consumed:
(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 |
||
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 |
||
|
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 |
||
|
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
Specification of Carotenoids (% w/w)
|
|
Microbiological criteria:
|
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