Q1 2023 Novel Food Approval Summary: EFSA Newly Approved Nine Novel Food, including 3 HMOs and 2 Insects

Updated on April 21, 2023

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Some interesting novel food have been approved by European Food Safety Authority (EFSA) in the first quarter of 2023, including two varieties of insects. These products are listed below.

Table 1. Newly Approved Novel Food

No.	Date	Name
1	2023.1.4	Vitamin D2 mushroom powder
2		Acheta domesticus (house cricket) partially defatted powder
3		Pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia
4		Lacto-N-tetraose produced by derivative strains of E. coli BL21(DE3)
5	2023.1.5	3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3)
6	2023.1.6	Frozen, paste, dried and powder forms of Alphitobius diaperinus larvae
7	2023.1.17	3’-Sialyllactose sodium salt produced by derivative strains of E. coli BL21(DE3)
8	2023.2.9	Dried nuts of Canarium ovatum Engl.
9	2023.3.6	Bovine milk osteopontin
10	2023.3.29	Roasted and popped kernels from the seeds of Euryale ferox Salisb.

1. Vitamin D2 mushroom powder

On January 4, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/4, and authorizing the placing on the market of vitamin D2 mushroom powder as a novel food and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on January 24, 2023.

Applicant: Monterey Mushrooms Inc.

By the end of January 24, 2028 (data protection period), the novel food vitamin D2 mushroom powder is authorized for placing on the market within the Union only by Monterey Mushrooms Inc, unless:

a subsequent applicant obtains authorization for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or;
with the agreement of Monterey Mushrooms Inc.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
Vitamin D₂ mushroom powder	Specified food category	Maximum levels of vitamin D₂ (μg/100 g or 100 ml)
	Milk analogues	1,1
	Dairy analogues other than milks	2,2
	Breakfast cereals and cereal bars	2,2
	Soups	2,2
	Dried soups	22,5
	Whey powder	14,1
	Fruit/vegetable juices and nectars	1,1
	Fruit/vegetable juice powder	12,4
	Fruit/vegetable juice concentrate (liquid)	3,4
	Soft drinks marketed in relation to physical exercise and fermented non-alcoholic drinks (with exclusion of dairy fermented drinks)	1,1
	Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infants	In accordance with the particular nutritional requirements of the persons for whom the products are intended but not higher than 15 μg/day
	Total diet replacement for weight control as defined in Regulation (EU) No 609/2013	15 μg/day
	Meal replacements for weight control	5 μg/meal
	Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children	15 μg/day
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be ‘UV-treated mushroom powder containing vitamin D2’. The labeling of food supplements containing vitamin D₂ mushroom powder shall bear a statement that they should not be consumed by infants and children under 3 years of age.

2. Acheta domesticus (house cricket) partially defatted powder

On January 4, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/5, and authorizing the placing on the market of partially defatted powder as a novel food and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on January 24, 2023.

Applicant: Cricket One Co. Ltd

By the end of January 24, 2028 (data protection period), the novel food Acheta domesticus (house cricket) partially defatted powder is authorized for placing on the market within the Union only by Cricket One Co. Ltd, unless:

a subsequent applicant obtains authorization for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or;
with the agreement of Cricket One Co. Ltd.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
*Acheta domesticus* (house cricket) partially defatted powder	Specified food category	Maximum levels (g/100 g) (marketed as such or reconstituted according to the instructions)
	Multigrain bread and rolls; crackers and breadsticks	2
	Cereal bars	3
	Pre-mixes for baked products (dry)	3
	Biscuits	1,5
	Pasta-based products (dry)	0,25
	Stuffed pasta-based products (dry)	3
	Sauces	1
	Processed potato products, legume- and vegetable-based dishes, pizza, pasta-based dishes	1
	Whey powder	3
	Meat analogues	5
	Soups and soup concentrates or powders	1
	Maize flour based snacks	4
	Beer-like beverages	0,1
	Chocolate confectionary	2
	Nuts and oilseeds	2
	Snacks other than chips	5
	Meat preparations	2
	Additional specific labeling requirements
	The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Acheta domesticus (house cricket) partially defatted powder’. The labeling of the foodstuffs containing Acheta domesticus (house cricket) partially defatted powder shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, molluscs, and products thereof, and to dust mites. This statement shall appear in close proximity to the list of ingredients.

3. Pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia

On January 4, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/6, and authorizing the placing on the market of pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia as a novel food and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on January 24, 2023.

Applicant: MycoTechnology, Inc.

By the end of January 24, 2028 (data protection period), the novel food pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia is authorized for placing on the market within the Union only by MycoTechnology, Inc., unless:

a subsequent applicant obtains authorization for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or;
with the agreement of MycoTechnology, Inc.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
*Pea and rice protein fermented by Lentinula edodes* (Shiitake mushroom) mycelia**	Specified food category	Maximum levels (g/100 g)
	Bakery wares, breads, rolls, croutons, pizza	5
	Breakfast cereals and cereal bars	33
	Fruit- and vegetable-based drinks	20
	Ready-to-mix beverage powders	93
	Cocoa and chocolate confectionary	7
	Dairy analogues and non-dairy meal replacements for weight control	11
	Fermented milk-based products	5
	Pasta-based products	15
	Meat preparations and meat products	14
	Soups (ready-to-eat) and soup concentrates or powders	3
	Salads	26
	Meat analogues	40
	Milk-based drinks	1
	Single meal replacements for weight control	1
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be “Pea and rice protein fermented by Shiitake mushroom mycelia”.

4. **Lacto-N-tetraose produced by derivative strains of E. coli BL21(DE3)**

On January 4, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/7, and authorizing the placing on the market of Lacto-N-tetraose produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on January 24, 2023.

Applicant: Chr. Hansen A/S

By the end of January 24, 2028 (data protection period), the novel food Lacto-N-tetraose is authorized for placing on the market within the Union only by Chr. Hansen A/S, unless:

a subsequent applicant obtains authorization for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or;
with the agreement of Chr. Hansen A/S.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
Lacto-N-tetraose (‘LNT’) *(produced by derivative strains of E. coli* BL21(DE3))**	Specified food category	Maximum levels (expressed as lacto-N-tetraose)
	Infant formula as defined under Regulation (EU) No 609/2013	1,82 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	1,82 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 as defined under Regulation (EU) No 609/2013	1,82 g/L or 1,82 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Milk based drinks and similar products intended for young children	1,82 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013	In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than 1,82 g/L or 1,82 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.
	Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children	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, for the general population, excluding infants and young children	4,6 g/day
	Additional specific labeling requirements
	The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘lacto-N-tetraose’. The labelling of food supplements containing lacto-N-tetraose (LNT) shall bear a statement that: (a) they should not be consumed by children under 3 years of age; (b) they should not be used if other foods containing added lacto-N-tetraose are consumed the same day.

5. 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3)

On January 5, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/52, and authorizing the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on January 25, 2023.

Applicant: Chr. Hansen A/S

By the end of January 25, 2028 (data protection period), the novel food 3-Fucosyllactose is authorized for placing on the market within the Union only by Chr. Hansen A/S, unless:

a subsequent applicant obtains authorization for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or;
with the agreement of Chr. Hansen A/S.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
3-Fucosyllactose (‘3-FL’) (produced by a derivative strain of E. coli BL21(DE3))	Specified food category	Maximum levels
	Infant formula as defined under Regulation (EU) No 609/2013	0,90 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	1,20 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Processed cereal-based foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No 609/2013	1,20 g/l or 1,20 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Milk based drinks and similar products intended for young children	1,20 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013	In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than 0,9 g/l or 0,9 g/kg (if it is intended for infants from 0 until 6 months) and 1,2 g/l or 1,2 g/kg (if it is intended for infants of 6-12 months and/or for young children) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.
	Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children	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, for the general population, excluding infants and young children	3 g/day
	Additional specific labeling requirements
	The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘3-fucosyllactose’. The labelling of food supplements containing 3-Fucosyllactose (3-FL) shall bear a statement that: (a) they should not be consumed by children under 3 years of age; (b) they should not be used if other foods containing added 3-Fucosyllactose are consumed the same day.

6. **Frozen, paste, dried and powder forms of Alphitobius diaperinus larvae**

On January 6, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/58, and authorizing the placing on the market of the frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm) as a novel food and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on January 26, 2023.

Applicant: Ynsect NL B.V.

By the end of January 26, 2028 (data protection period), the novel food is authorized for placing on the market within the Union only by Ynsect NL B.V., unless:

a subsequent applicant obtains authorization for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or;
with the agreement of Ynsect NL B.V.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
*Frozen, paste, dried and powder forms of Alphitobius diaperinus* larvae (lesser mealworm)**	Specified food category	Maximum levels (g/100g)
	Cereal bars	25 (Dried form) 25 (Powder form)
	Bread and rolls	20 (Powder form)
	Processed and breakfast cereals	10 (Dried form) 10 (Powder form)
	Porridge	15 (Powder form)
	Pre-mixes (dry) for baked products	10 (Powder form)
	Dried pasta-based products	10 (Powder form)
	Stuffed pasta-based products	28 (Frozen or paste form) 10 (Powder form)
	Whey powder	35 (Powder form)
	Soups	15 (Powder form)
	Cereal-, pasta-based dishes	5 (Powder form)
	Pizza-based dishes	5 (Dried form) 5 (Powder form)
	Noodles	10 (Powder form)
	Snacks other than chips	10 (Dried form) 10 (Powder form)
	Chips/crisps	10 (Powder form)
	Crackers and bread sticks	10 (Powder form)
	Peanut butter	15 (Powder form)
	Ready-to-eat savoury based sandwich	20 (Powder form)
	Meat preparations	14 (Frozen or paste form) 5 (Powder form)
	Meat analogues	40 (Frozen or paste form) 15 (Powder form)
	Milk and dairy analogues	10 (Powder form)
	Chocolate confectionary	5 (Powder form)
	Food supplements as defined in Directive 2002/46/EC for the adult population	4 g/day (Powder form)
	Additional specific labeling requirements
	The designation of the novel food on the labelling of the foodstuffs containing it shall be “Frozen/paste Alphitobius diaperinus larvae (lesser mealworm)” or “Dried/powder Alphitobius diaperinus larvae (lesser mealworm)” depending on the form used. The labelling of food supplements containing the novel food shall bear a statement that those food supplements should not be consumed by persons under 18 years of age. The labelling of the foodstuffs containing frozen, paste, dried or powder forms of Alphitobius diaperinus larvae (lesser mealworm) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, and products thereof, and to dust mites. This statement shall appear in close proximity to the list of ingredients.

7. **3’-Sialyllactose sodium salt produced by derivative strains of E. coli BL21(DE3)**

On January 17, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/113, and authorizing the placing on the market of 3’-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on February 6, 2023.

Applicant: Chr. Hansen A/S

By the end of February 6, 2028 (data protection period), the novel food 3’-Sialyllactose sodium salt is authorized for placing on the market within the Union only by Chr. Hansen A/S, unless:

a subsequent applicant obtains authorization for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or;
with the agreement of Chr. Hansen A/S.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
3’-Sialyllactose (‘3’-SL’) sodium salt *(produced by derivative strains of E. coli* BL21(DE3))**	Specified food category	Maximum levels
	Infant formula as defined under Regulation (EU) No 609/2013	0,23 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	0,28 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Processed cereal-based foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No 609/2013	0,28 g/L or 0,28 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Milk based drinks and similar products intended for young children	0,28 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013	In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher 0,23 g/L or 0,28 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.
	Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children	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, for the general population, excluding infants and young children	0,7 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’. The labeling of food supplements containing 3’-Sialyllactose (3’-SL) sodium salt shall bear a statement that: (a) they should not be consumed by children under 3 years of age; (b) they should not be used if other foods containing added 3’-Sialyllactose (3’-SL) sodium salt shall bear a statement that are consumed the same day.

8. **Dried nuts of Canarium ovatum Engl.**

On February 9, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/267, and authorizing the placing on the market of dried nuts of Canarium ovatum Engl. as a traditional food from a third country and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on March 1, 2023.

Applicant: DOMENICO DE LUCIA SPA

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
*Dried nuts of Canarium ovatum* Engl.**	Specified food category	Maximum levels
	Not specified	-
	Additional specific labeling requirements
	The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘nuts of Canarium ovatum’ and/or ‘pilinuts’ and/or ‘pili (Canarium ovatum) nuts’. The labelling of the foodstuffs containing dried nuts of Canarium ovatum Engl. shall bear a statement that the dried nuts of Canarium ovatum Engl. may cause allergic reactions to consumers with known allergies to cashew and walnut. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredients, in close proximity to the name of the food.

9. Bovine milk osteopontin

On March 6, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/463, and authorizing the placing on the market of bovine milk osteopontin as a novel food and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on March 26, 2023.

Applicant: Arla Foods Ingredients Group P/S.

By the end of March 26, 2028 (data protection period), the novel food Bovine milk osteopontin is authorized for placing on the market within the Union only by Arla Foods Ingredients Group P/S., unless:

a subsequent applicant obtains authorization for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or;
with the agreement of Arla Foods Ingredients Group P/S.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
Bovine milk osteopontin	Specified food category	Maximum levels
	Infant formula as defined in Regulation (EU) No 609/2013	151 mg/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Follow-on formula as defined in Regulation (EU) No 609/2013	151 mg/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Milk-based drinks intended for young children	151 mg/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Additional specific labeling requirements
	The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Bovine milk Osteopontin’.

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

On March 21, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/652, and authorizing the placing on the market of roasted and popped kernels from the seeds of Euryale ferox Salisb. (makhana) as a traditional food from a third country and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on April 10, 2023.

Applicant: Zenko Superfoods Pte. Ltd.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
*Roasted and popped kernels from the seeds of Euryale ferox* Salisb. (makhana) (Traditional food from a third country)**	Specified food category	Maximum levels
	Processed nuts	-
	Additional specific labeling requirements
	The designation of the novel food on the labelling of the foodstuffs containing it shall be “roasted seeds of Euryale ferox” or “makhana (Euryale ferox) roasted seeds”.

Note: The data in this article is for reference only. Please refer to the official information published by Official Journal of the European Union.

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Q1 2023 Novel Food Approval Summary: EFSA Newly Approved Nine Novel Food, including 3 HMOs and 2 Insects

1. Vitamin D2 mushroom powder

2. Acheta domesticus (house cricket) partially defatted powder

3. Pea and rice protein fermented by Lentinula edodes (Shiitake mushroom) mycelia

4. Lacto-N-tetraose produced by derivative strains of E. coli BL21(DE3)

5. 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3)

6. Frozen, paste, dried and powder forms of Alphitobius diaperinus larvae

7. 3’-Sialyllactose sodium salt produced by derivative strains of E. coli BL21(DE3)

8. Dried nuts of Canarium ovatum Engl.

9. Bovine milk osteopontin

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

4. **Lacto-N-tetraose produced by derivative strains of E. coli BL21(DE3)**

6. **Frozen, paste, dried and powder forms of Alphitobius diaperinus larvae**

7. **3’-Sialyllactose sodium salt produced by derivative strains of E. coli BL21(DE3)**

8. **Dried nuts of Canarium ovatum Engl.**

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