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

from CIRS by

Updated on April 21, 2023

China,Food,Novel,Approval,Summary,HMO,Insects

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 containingAcheta 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 byLentinula 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 byLentinula 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 byLentinula 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 ofEscherichia 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 ofE. 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 ofAlphitobius diaperinuslarvae

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 ofAlphitobius 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/pasteAlphitobius diaperinus larvae (lesser mealworm)” or “Dried/powderAlphitobius 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 ofAlphitobius 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 ofEscherichia 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 ofCanarium ovatum’ and/or ‘pilinuts’ and/or ‘pili (Canarium ovatum) nuts’.
  • The labelling of the foodstuffs containing dried nuts ofCanarium 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 ofEuryale 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 ofEuryale 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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