Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

►M29  Data Protection ◄

N-Acetyl-D-neuraminic acid

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘N-acetyl-D-neuraminic acid’

Food supplements containing N-acetyl-D-neuraminic acid shall bear a statement that the food supplement should not be given to infants, young children and children under 10 years of age where they consume breast milk or other foods with added N-acetyl-D-neuraminic acid within the same twenty four hour period.

Infant and follow-on formulae as defined by Regulation (EU) No 609/2013 (1)

0,05 g/L of reconstituted formula

Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013

0,05 g/kg for solid foods

Foods for special medical purposes for infants and young children as defined by 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 the maximum levels specified for the category mentioned in the table corresponding to the products.

Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013

0,2 g/L (drinks)

1,7 g/kg (bars)

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 (2)

1,25 g/kg

Unflavoured pasteurised and sterilised (including UHT) milk-based products

0,05 g/L

Unflavoured fermented milk-based products, heat treated after fermentation, flavoured fermented milk products including heat-treated products

0,05 g/L (beverages)

0,4 g/kg (solids)

Dairy analogues, including beverage whiteners

0,05 g/L (beverages)

0,25 g/kg (solids)

Cereal bars

0,5 g/kg

Table top sweeteners

8,3 g/kg

Fruit and vegetable-based drinks

0,05 g/L

Flavoured drinks

0,05 g/L

Speciality coffee, tea, herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions

0,2 g/kg

Food Supplements as defined in Directive 2002/46/EC (3)

300 mg/day for general population older than 10 years

55 mg/day for infants

130 mg/day for young children

250 mg/day for children between 3 to 10 years of age

Adansonia digitata (Baobab) dried fruit pulp

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Baobab fruit pulp’

Ajuga reptans extract from cell cultures

Specified food category

Maximum levels

Food Supplements as defined in Directive 2002/46/EC

In line with normal use in food supplements of a similar extract of the flowering aerial parts of Ajuga reptans

L-Alanyl-L-Glutamine

Specified food category

Maximum levels

Food Supplements as defined in Directive 2002/46/EC

Foods for special medical purposes as defined in Regulation (EU) No 609/2013 excluding foods for infants and young children

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

Algal oil from the microalgae Ulkenia sp.

Specified food category

Maximum levels of DHA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the micro-algae Ulkenia sp.’

Bakery products (breads, rolls and sweet biscuits)

200 mg/100 g

Cereal bars

500 mg/100 g

Non-alcoholic beverages (including milk based beverages)

60 mg/100 ml

▼M25

Allanblackia seed oil

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Allanblackia seed oil’

Yellow fat spreads and cream based spreads

30 g/100 g

Mixtures of vegetable oils (*) and milk (falling under the food category: Dairy analogues, including beverage whiteners)

30 g/100 g

(*)  Except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/2013.

▼M9

Aloe macroclada Baker leaf extract

Specified food category

Maximum levels

Food Supplements as defined in Directive 2002/46/EC

In line with normal use in food supplements of the similar gel derived from Aloe vera (L.) Burm.

Antarctic Krill oil from Euphausia superba

Specified food category

Maximum levels of combined DHA and EPA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lipid extract from the crustacean Antarctic Krill (Euphausia superba)’

Dairy products except milk-based drinks

200 mg/100 g or for cheese products 600 mg/100 g

Dairy analogues except drinks

200 mg/100 g or for analogues to cheese products 600 mg/100 g

Non-alcoholic beverages

Milk-based drinks

Dairy analogue drinks

80 mg/100 ml

Spreadable fat and dressings

600 mg/100 g

Cooking fats

360 mg/100 ml

Breakfast cereals

500 mg/100 g

Bakery products (breads, rolls and sweet biscuits)

200 mg/100 g

Nutrition bars/cereal bars

500 mg/100 g

Food Supplements as defined in Directive 2002/46/EC

3 000 mg/day for the general population

450 mg/day for pregnant and lactating women

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013

200 mg/100 ml

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Antarctic Krill oil rich in phospholipids from Euphausia superba

Specified food category

Maximum levels of combined DHA and EPA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lipid extract from the crustacean Antarctic Krill (Euphausia superba)’

Dairy products except milk-based drinks

200 mg/100 g or for cheese products 600 mg/100 g

Dairy analogues except drinks

200 mg/100 g or for analogues to cheese products 600 mg/100 g

Non-alcoholic beverages

Milk-based drinks

Dairy analogue drinks

80 mg/100 ml

Spreadable fat and dressings

600 mg/100 g

Cooking fats

360 mg/100 ml

Breakfast cereals

500 mg/100 g

Bakery products (breads, rolls and sweet biscuits)

200 mg/100 g

Nutrition bars/cereal bars

500 mg/100 g

Food Supplements as defined in Directive 2002/46/EC

3 000 mg/day for the general population

450 mg/day for pregnant and lactating women

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013

200 mg/100 ml

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Arachidonic acid-rich oil from the fungus Mortierella alpina

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from Mortierella alpina’ or ‘Mortierella alpina oil’

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Foods for special medical purposes for premature infants as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Argan oil from Argania spinosa

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Argan oil’ and if used as seasoning ‘Vegetable oil only for seasoning’ shall be mentioned on the label

As seasonings

Not specified

Food Supplements as defined in Directive 2002/46/EC

In line with normal food use of vegetable oils

Astaxanthin-rich oleoresin from Haematococcus pluvialis algae

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Astaxanthin’

Food Supplements as defined in Directive 2002/46/EC

40-80 mg/day of oleoresin, resulting in ≤ 8 mg astaxanthin per day

Basil seeds (Ocimum basilicum)

Specified food category

Maximum levels

Fruit juice and fruit/vegetable blend beverages

3 g/200 ml for addition of whole basil seeds (Ocimum basilicum)

▼M32

Betaine

Specified food category

Maximum levels (7)

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘betaine’.

The labelling of foods containing betaine shall bear a statement that the foods should not be used if food supplements containing betaine are consumed the same day.

Authorised on 22 August 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: DuPont Nutrition Biosciences ApS, Langebrogade 1 Copenhagen K, DK-1411, Denmark. During the period of data protection, the novel food betaine is authorised for placing on the market within the Union only by DuPont Nutrition Biosciences ApS unless a subsequent applicant obtainsauthorisation 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 DuPont Nutrition Biosciences ApS,

End date of the data protection: 22 August 2024.

Drink powders, isotonic and energy drinks intended for sportsmen

60 mg/100 g

Protein and cereal bars intended for sportsmen

500 mg/100 g

Meal replacements intended for sportsmen

20 mg/100 g

Total diet replacement for weight control as defined under Regulation (EU) No 609/2013

500 mg/100 g (bar)

136 mg/100 g (soup)

188 mg/100 g (porridge)

60 mg/100 g (beverages)

Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 for adults

400 mg/day

▼M9

Fermented black bean extract

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fermented black bean (Soya) extract’’ or ‘Fermented Soya extract’

Food Supplements as defined in Directive 2002/46/EC

4,5 g/day

Bovine lactoferrin

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 (ready to drink)

100 mg/100 ml

Foods on dairy basis intended for young children (ready to eat/drink)

200 mg/100 g

Processed cereal food (solid)

670 mg/100 g

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

Depending on the needs of the individual up to 3 g/day

Beverages based on milk

200 mg/100 g

Powdered drink mixes based on milk (ready to drink)

330 mg/100 g

Beverages based on fermented milk (including yoghurt drinks)

50 mg/100 g

Non-alcoholic drinks

120 mg/100 g

Products based on yoghurt

80 mg/100 g

Products based on cheese

2 000 mg/100 g

Ice cream

130 mg/100 g

Cakes and pastries

1 000 mg/100 g

Candies

750 mg/100 g

Chewing gum

3 000 mg/100 g

▼M34

Bovine milk basic whey protein isolate

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Milk whey protein isolate’.

Food supplements containing bovine milk basic whey protein isolate shall bear the following statement:

‘This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen (*) years’

(*) Depending on the age group the food supplement is intended for.

Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en- Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. unless a subsequent applicant obtains authorisation 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.

Infant formulae as defined in Regulation (EU) No 609/2013

Follow-on formulae as defined in Regulation (EU) No 609/2013

Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

Food Supplements as defined in Directive 2002/46/EC

30 mg/100 g (powder)

3,9 mg/100 mL (reconstituted)

30 mg/100 g (powder)

4,2 mg/100 mL (reconstituted)

300 mg/day

30 mg/100 g (powder formula for infants during the first months of life until the introduction of appropriate complementary feeding)

3,9 mg/100 mL (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding)

30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced)

4,2 mg/100 mL (reconstituted formula for infants when appropriate complementary feeding is introduced)

58 mg/day for young children

380 mg/day for children and adolescents from 3 to 18 years of age

610 mg/day for adults

25 mg/day for infants

58 mg/day for young children

250 mg/day for children and adolescents from 3 to 18 years of age

610 mg/day for adults

▼M9

Buglossoides arvensis seed oil

Specified food category

Maximum levels of stearidonic acid (STA)

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined Buglossoides oil’

Dairy products and analogues

250 mg/100 g

75 mg/100 g for drinks

Cheese and cheese products

750 mg/100 g

Butter and other fat and oil emulsions including spreads (not for cooking or frying purposes)

750 mg/100 g

Breakfast cereals

625 mg/100 g

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

500 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013, excluding foods for special medical purposes intended for infants and young children

In accordance with the particular nutritional requirements of the persons for whom the products are intended

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Calanus finmarchicus oil

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘oil from Calanus finmarchicus (crustacean)’

Food supplements as defined in Directive 2002/46/EC

2,3 g/day

Chewing gum base (monomethoxypolyethylene glycol)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Gum base (including 1,3-butadiene, 2-methyl-homopolymer, maleated, esters with polyethylene glycol mono-Me ether)’ or ‘Gum base (including CAS No: 1246080-53-4)’

Chewing gum

8 %

Chewing gum base (Methyl vinyl ether-maleic anhydride copolymer)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Gum base (including methyl vinyl ether-maleic anhydride copolymer)’ or ‘Gum base (including CAS No 9011-16-9)’

Chewing gum

2 %

Chia oil from Salvia hispanica

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chia oil (Salvia hispanica)’

Fats and oils

10 %

Pure chia oil

2 g/day

Food Supplements as defined in Directive 2002/46/EC

2 g/day

▼M39

Chia seeds (Salvia hispanica)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chia seeds (Salvia hispanica)’

Bread products

5 % (whole or ground chia seeds)

Baked products

10 % whole chia seeds

Breakfast cereals

10 % whole chia seeds

Sterilised ready to eat meals based on cereal grains, pseudocereals grains and/or pulses

5 % whole chia seeds

Fruit, nut and seed mixes

Pre-packaged Chia seed as such

Confectionery (including chocolate and chocolate products), excluding chewing gums

Dairy products (including yoghurt) and analogues

Edible ices

Fruit and vegetables products (including fruit spreads, compotes with/without cereals, fruit-preparations to underlay or to be mixed with dairy products, fruit desserts, mixed fruits with coconut milk for a twin pot)

Non-alcoholic beverages (including fruit juice and fruit/vegetable blend beverages)

Puddings that do not require heat treatment at or above 120 °C in their manufacture, processing or preparation

▼M9

Chitin-glucan from Aspergillus niger

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitin-glucan from Aspergillus niger’

Food Supplements as defined in Directive 2002/46/EC

5 g/day

Chitin-glucan complex from Fomes fomentarius

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitin-glucan from Fomes fomentarius’

Food Supplements as defined in Directive 2002/46/EC

5 g/day

Chitosan extract from fungi (Agaricus bisporus; Aspergillus niger)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitosan extract from Agaricus bisporus’ or ‘Chitosan extract from Aspergillus niger’

Food Supplements as defined in Directive 2002/46/EC

In line with normal use in food supplements of chitosan from crustaceans

Chondroitin sulphate

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chondroitin sulphate derived from microbial fermentation and sulphation’

Food supplements as defined in Directive 2002/46/EC for adult population, excluding pregnant and lactating women

1 200 mg/day

Chromium Picolinate

Specified food category

Maximum levels of total chromium

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chromium Picolinate’

Foods covered by Regulation (EU) No 609/2013

250 μg/day

Foods fortified in accordance with Regulation (EC) No 1925/2006 (4)

Cistus incanus L. Pandalis herb

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Cistus incanus L. Pandalis herb’

Herbal infusions

Intended daily intake: 3 g herbs/day (2 cups/day)

Citicoline

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Citicoline’

2.  The labelling of foods containing citicoline shall bear a statement that the product is not intended to be consumed by children

Food Supplements as defined in Directive 2002/46/EC

500 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

250 mg per serving and a maximum daily consumption level of 1 000 mg

Clostridium butyricum

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Clostridium butyricum MIYAIRI 588 (CBM 588)’ or ‘Clostridium butyricum (CBM 588)’

Food Supplements as defined in Directive 2002/46/EC

1,35 × 108 CFU/day

▼M29

D-ribose

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘D-ribose’.

The labelling of foods containing D-ribose shall bear a statement that the foods should not be used if food supplements containing D-ribose are consumed the same day.

Authorised on 16 April 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Bioenergy Life Science, Inc., 13840 Johnson St. NE, Minneapolis, Minnesota, 55304, USA. During the period of data protection, the novel food D-ribose is authorised for placing on the market within the Union only by Bioenergy Life Science, Inc. unless a subsequent applicant obtains authorisation 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 Bioenergy Life Science, Inc.

End date of the data protection: 16 April 2024 (5 years).

Cereal bars

0,20 g/100 g

Fine bakery wares

0,31 g/100 g

Chocolate confectionery (excluding chocolate bars)

0,17 g/100 g

Milk-based drinks (excluding malts and shakes)

0,08 g/100 g

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen, isotonic and energy drinks

0,80 g/100 g

Bars intended to meet the expenditure of intense muscular effort especially for sportsmen

3,3 g/100 g

Meal replacement for weight control (as drinks)'

0,13 g/100 g

Meal replacement for weight control (as bars)

3,30 g/100 g

Confectionery

0,20 g/100 g

Tea and infusions (in powder form to be reconstituted)

0,23 g/100 g

▼M9

Extract of defatted cocoa powder

Specified food category

Maximum levels

Consumers shall be instructed not to consume more than 600 mg polyphenols corresponding to 1,1 g of extract of defatted cocoa powder per day

Nutrition bars

1 g/day and 300 mg polyphenols corresponding to not more than 550 mg of extract of defatted cocoa powder in one portion of food (or food supplement)

Milk based beverages

Any other foods (including food supplements as defined in Directive 2002/46/EC) which have become established vehicles for functional ingredients and which are typically positioned for consumption by health conscious adults

Low fat cocoa extract

Specified food category

Maximum levels

Consumers shall be instructed not to consume more than 600 mg of cocoa flavanols per day

Foods including food supplements as defined in Directive 2002/46/EC

730 mg per serving and around 1,2 g/day

Coriander seed oil from Coriandrum sativum

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Coriander seed oil’

Food Supplements as defined in Directive 2002/46/EC

600 mg/day

▼M15

Cranberry extract powder

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘cranberry extract powder’

Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Ocean Spray Cranberries Inc. One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA.

During the period of data protection the novel food, cranberry extract powder, is authorised for placing on the market within the Union only by Ocean Spray Cranberries Inc. unless a subsequent applicant obtains authorisation 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 Ocean Spray Cranberries Inc.

End date of the data protection: 20 November 2023.

Food Supplements as defined in Directive 2002/46/EC for the adult population

350 mg/day

▼M9

Crataegus pinnatifida dried fruit

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Crataegus pinnatifida dried fruit’

Herbal infusions

In line with normal food use of Crataegus laevigata

Jams and jellies in accordance with Directive 2001/113/EC (5)

Compotes

α-cyclodextrin

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Alpha-cyclodextrin’ or ‘α-cyclodextrin’

γ-cyclodextrin

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Gamma-Cyclodextrin’ or ‘γ-Cyclodextrin’

▼M21

Decorticated grains of Digitaria exilis (Kippist) Stapf

(Traditional food from a third country)

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘decorticated fonio (Digitaria exilis) grains’

▼M9

Dextran preparation produced by Leuconostoc mesenteroides

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Dextran’

Bakery products

5 %

Diacylglycerol oil of plant origin

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Diacylglycerol oil of plant origin (at least 80 % diacylglycerols)’

Cooking oils

Fat spreads

Salad dressings

Mayonnaise

Meal replacement for weight control (as drinks)

Bakery products

Yoghurt type products

Dihydrocapsiate (DHC)

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Dihydrocapsiate’

2.  Food supplements containing synthetic dihydrocapsiate will be labelled as ‘not intended for children up to 4.5 years’

Cereal bars

9 mg/100 g

Biscuits, cookies and crackers

9 mg/100 g

Rice based snacks

12 mg/100 g

Carbonated drinks, dilutable drinks, fruit juice based beverages

1,5 mg/100 ml

Vegetable drinks

2 mg/100 ml

Coffee based drinks, tea based drinks

1,5 mg/100 ml

Flavoured water — still

1 mg/100 ml

Precooked oatmeal cereal

2,5 mg/100 g

Other cereals

4,5 mg/100 g

Ice cream, dairy desserts

4 mg/100 g

Pudding mixes (ready to eat)

2 mg/100 g

Products based on yoghurt

2 mg/100 g

Chocolate confectionery

7,5 mg/100 g

Hard candy

27 mg/100 g

Sugar-free gum

115 mg/100 g

Whitener/creamer

40 mg/100 g

Sweeteners

200 mg/100 g

Soup (ready to eat)

1,1 mg/100 g

Salad dressing

16 mg/100 g

Vegetable protein

5 mg/100 g

Ready to eat meals

3 mg/meal

Meal replacements for weight control

3 mg/meal

Meal replacement for weight control (as drinks)

1 mg/100 ml

Food Supplements as defined in Directive 2002/46/EC

3 mg/single intake

9 mg/day

Non-alcoholic powdered drink mixes

14,5 mg/kg equivalent to 1,5 mg/100 ml

▼M13

Dried aerial parts of Hoodia parviflora

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried aerial parts of Hoodia parviflora’

Authorised on 3 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Desert Labs, Ltd Kibbutz Yotvata, 88820 Israel.

During the period of data protection the novel food dried aerial parts of Hoodia parviflora is authorised for placing on the market within the Union only by Desert Labs, Ltd unless a subsequent applicant obtains authorisation 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 Desert Labs, Ltd.

End date of the data protection: 3 September 2023.

Food Supplements as defined in Directive 2002/46/EC for adult population

9,4 mg/day

▼M9

Dried extract of Lippia citriodora from cell cultures

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried extract of Lippia citriodora from cell cultures HTN®Vb’

Food Supplements as defined in Directive 2002/46/EC

In line with normal use in food supplements of a similar extract from the leaves of Lippia citriodora

Echinacea angustifolia extract from cell cultures

Specified food category

Maximum levels

Food Supplements as defined in Directive 2002/46/EC

In line with normal use in food supplements of a similar extract from the root of Echinacea angustifolia

▼M31

Echinacea purpurea extract from cell cultures

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried extract of Echinacea purpurea from cell cultures EchiPure-PC™’

Food Supplements as defined in Directive 2002/46/EC

In line with normal use in food supplements of a similar extract from florets within the flower head of Echinacea purpurea

▼M9

Echium plantagineum oil

Specified food category

Maximum levels of stearidonic acid (STA)

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined echium oil’

Milk-based products and drinkable yoghurt products delivered in a single dose

250 mg/100 g; 75 mg/100 g for drinks

Cheese preparations

750 mg/100 g

Spreadable fat and dressings

750 mg/100 g

Breakfast cereals

625 mg/100 g

Food supplements as defined in Directive 2002/46/EC

500 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

In accordance with the particular nutritional requirements of the persons for whom the products are intended

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

▼M49

Ecklonia cava phlorotannins

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ecklonia cava Phlorotannins’.

Food supplements containing Ecklonia cava phlorotannins shall bear the following statement:

(a)  This food supplement should not be consumed by children/adolescents under the age of twelve/fourteen/eighteen(*) years.

(b)  This food supplement should not be consumed by persons with thyroid disease or by persons who are aware of or have been identified as being at risk of developing thyroid disease.

(c)  This food supplement should not be consumed if other food supplements containing iodine are also consumed.

(*)  Depending on the age group the food supplement is intended for.

Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 12 years

163 mg/day for adolescents from 12 to 14 years of age

230 mg/day for adolescents above 14 years of age

263 mg/day for adults

▼M18

Egg membrane hydrolysate

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘egg membrane hydrolysate’.

Authorised on 25 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Biova, LLC., 5800 Merle Hay Rd, Suite 14 PO Box 394 Johnston 50131, Iowa USA. During the period of data protection the novel food egg membrane hydrolysate is authorised for placing on the market within the Union only by Biova, LLC. unless a subsequent applicant obtains authorisation 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 Biova, LLC.

End date of the data protection: 25 November 2023

Food Supplements as defined in Directive 2002/46/EC intended for the general adult population

450 mg/day

▼M9

Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis)

Specified food category

Maximum levels

The labelling shall bear a statement that consumers should not consume more than 300 mg of extract per day

Foods including food supplements as defined in Directive 2002/46/EC

150 mg of extract in one portion of food or food supplement

▼M49

L-ergothioneine

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘L-ergothioneine’

Alcohol-free beverages

0,025 g/kg

Milk-based drinks

0,025 g/kg

‘Fresh’ milk products(*)

0,040 g/kg

Cereal bars

0,2 g/kg

Chocolate confectionery

0,25 g/kg

Food supplements as defined in Directive 2002/46/EC

30 mg/day for general population (excluding pregnant and lactating women)

20 mg/day for children older than 3 years

(*)  When used in milk products L-ergothioneine may not replace in whole or in part, any milk constituent

▼M49

Extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)’.

The labelling of food supplements containing the extract of mixture of the three herbal roots shall bear a statement in close proximity to the list of ingredients indicating that it should not be consumed by individuals with known celery allergy.

Food supplements as defined in Directive 2002/46/EC for adult population

175 mg/day

▼M9

Ferric Sodium EDTA

Specified food category

Maximum levels (expressed as anhydrous EDTA)

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ferric Sodium EDTA’

Food supplements as defined in Directive 2002/46/EC

18 mg/day for children

75 mg/day for adults

Foods covered by Regulation (EU) No 609/2013

12 mg/100 g

Foods fortified in accordance with Regulation (EC) No 1925/2006

Ferrous ammonium phosphate

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ferrous ammonium phosphate’

Food supplements as defined in Directive 2002/46/EC

To be used in compliance with Directive 2002/46/EC, Regulation (EU) No 609/2013 and/or Regulation (EC) No 1925/2006

Foods covered by Regulation (EU) No 609/2013

Foods fortified in accordance with Regulation (EC) No 1925/2006

Fish peptides from Sardinops sagax

Specified food category

Maximum levels fish peptide product

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish (Sardinops sagax) peptides’

Foods based on yoghurt, yoghurt drinks, fermented milk products, and powdered milk

0,48 g/100 g (ready to eat/drink)

Flavoured water, and vegetable-based drinks

0,3 g/100 g (ready to drink)

Breakfast cereals

2 g/100 g

Soups, stews and soup powders

0,3 g/100 g (ready to eat)

Flavonoids from Glycyrrhiza glabra

Specified food category

Maximum levels of flavonoids from Glycyrrhiza glabra

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Flavonoids from Glycyrrhiza glabra L.’

2.  The labelling of the foods where the product was added as a novel food ingredient shall bear a statement that:

(a)  the product should not be consumed by pregnant and breast feeding women, children and young adolescents; and

(b)  people taking prescription drugs should only consume the product under medical supervision;

(c)  a maximum of 120 mg of flavonoids per day should be consumed.

3.  The amount of flavonoids in the final food shall be indicated on the labelling of the food containing it.

Beverages containing flavonoids shall be presented to the final consumer as single portions.

Beverages based on milk

120 mg/day

Beverages based on yoghurt

Beverages based on fruit or vegetables

Food Supplements as defined in Directive 2002/46/EC

120 mg/day

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

120 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

120 mg/day

▼M40

Fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. (Traditional food from a third country)

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘cocoa (Theobroma cacao L.) pulp’, ‘cocoa (Theobroma cacao L.) pulp juice’ or ‘cocoa (Theobroma cacao L.) concentrated pulp juice’ depending on the form used.

▼M9

Fucoidan extract from the seaweed Fucus vesiculosus

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fucoidan extract from seaweed Fucus vesiculosus’.

Foods including food supplements as defined in Directive 2002/46/EC for the general population

250 mg/day

Fucoidan extract from the seaweed Undaria pinnatifida

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fucoidan extract from seaweed Undaria pinnatifida’

Foods including food supplements as defined in Directive 2002/46/EC for the general population

250 mg/day

2′-Fucosyllactose

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘2′-fucosyllactose’.

2.  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.

3.  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.

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

Flavoured fermented milk-based products including heat-treated products

1,2 g/l beverages

19,2 g/kg products other than beverages

Dairy analogues, including beverage whiteners

1,2 g/l beverages

12 g/kg for products other than beverages

400 g/kg for whitener

Cereal bars

12 g/kg

Table-top sweeteners

200 g/kg

Infant formula as defined in Regulation (EU) No 609/2013

1,2 g/l alone or in combination with up to 0,6 g/l of lacto-N-neotetraose at a ratio of 2:1 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

1,2 g/l alone or in combination with up to 0,6 g/l of lacto-N-neotetraose at a ratio of 2:1 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 in Regulation (EU) No 609/2013

12 g/kg for products other than beverages

1,2 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer

Milk-based drinks and similar products intended for young children

1,2 g/l for milk-based drinks and similar products added alone or in combination with up to 0,6 g/l lacto-N-neotetraose, at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

4,8 g/l for drinks

40 g/kg for bars

Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

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 — the maximum level refers to the products ready to use

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants

3,0 g/day for general population

1,2 g/day for young children

▼M36

2'-Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’)

(microbial source)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘2'-Fucosyllactose/Difucosyllactose mixture’.

The labelling of food supplements containing the 2'-Fucosyllactose/Difucosyllactose mixture shall bear a statement that they should not be used if breast milk or other foods containing added 2'-Fucosyllactose and/or Difucosyllactose are consumed the same day.

Authorised on 19.12.2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 2'-Fucosyllactose/Difucosyllactose mixture is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation 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 Glycom A/S.

End date of the data protection: 19.12.2024.

Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products

2,0 g/L

Unflavoured fermented milk-based products

2,0 g/L (beverages)

20 g/kg (products other than beverages)

Flavoured fermented milk-based products including heat-treated products

2,0 g/L (beverages)

20 g/kg (products other than beverages)

Beverages (flavoured drinks)

2,0 g/L

Cereal bars

20 g/kg

Infant formula as defined under Regulation (EU) No 609/2013

1,6 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

1,2 g/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

1,2 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

10 g/kg for products other than beverages

Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013

4,0 g/L (beverages)

40 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 intended for the general population excluding infants

4,0 g/day

▼M9

Galacto-oligosaccharide

Specified food category

Maximum levels (expressed as ratio kg galacto-oligosaccharide/kg final food)

Food Supplements as defined in Directive 2002/46/EC

0,333

Milk

0,020

Milk drinks

0,030

Meal replacement for weight control (as drinks)

0,020

Dairy analogue drinks

0,020

Yoghurt

0,033

Dairy based deserts

0,043

Frozen dairy deserts

0,043

Fruit drinks and energy drinks

0,021

Infant meal replacement drinks

0,012

Baby juice

0,025

Baby yogurt drink

0,024

Baby desert

0,027

Baby snack

0,143

Baby cereals

0,027

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

0,013

Juice

0,021

Fruit pie fillings

0,059

Fruit preparations

0,125

Bars

0,125

Cereals

0,125

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

0,008

Glucosamine HCl

Specified food category

Maximum levels

Food Supplements as defined in Directive 2002/46/EC

In line with normal food use of glucosamine from shell fish

Foods covered by Regulation (EU) No 609/2013

Meal replacement for weight control

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Glucosamine sulphate KCl

Specified food category

Maximum levels

Food Supplements as defined in Directive 2002/46/EC

In line with normal food use of glucosamine from shell fish

Glucosamine sulphate NaCl

Specified food category

Maximum levels

Food Supplements as defined in Directive 2002/46/EC

In line with normal food use of glucosamine from shell fish

Guar Gum

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Guar Gum’.

2.  A specific mention of the possible risks of digestive discomfort linked to the exposure of children aged under 8 to guar gum must be visible on the label of any foodstuffs containing it.

For example, ‘Excessive consumption of these products may cause digestive discomfort, especially for children under 8 years of age’.

3.  In the case of products with two compartments containing dairy and cereal products respectively, the instructions for use must clearly specify the need to mix the cereal and the dairy productbefore consumption, in order to take into account the potential risk of gastro-intestinal obstruction.

Fresh dairy products such as yogurts, fermented milks, fresh cheeses and other dairy-based desserts.

1,5 g/100 g

Fruit or vegetable-based liquid foodstuffs (of the ‘smoothie’ variety)

1,8 g/100 g

Fruit or vegetable-based compotes

3,25 g/100 g

Cereals accompanied by a dairy product, in packaging containing two compartments

10 g/100 g in the cereals

None in the accompanying dairy product

1 g/100 g in the product when ready to eat

Heat-treated milk products fermented with Bacteroides xylanisolvens

Specified food category

Maximum levels

Fermented milk products (in liquid, semi-liquid and spray-dried powder forms)

Hydroxytyrosol

Specified food category

Maximum levels

The designation of the novel food on the labelling of the food products containing it shall be ‘hydroxytyrosol’.

The labelling of the food products containing hydroxytyrosol shall bear the following statements:

(a)  This food product should not be consumed by children under the age of three years, pregnant women, and lactating women;

(b)  This food product should not be used for cooking, baking or frying’

Fish and vegetable oils, (except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/2013 (6)), placed as such on the market

0,215 g/kg

Spreadable fats as defined in Part VII of Annex VII of Regulation (EU) No 1308/2013, placed as such on the market

0,175 g/kg

Ice Structuring Protein type III HPLC 12

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ice Structuring Protein’

Edible ices

0,01 %

Aqueous extracts of dried leaves of Ilex guayusa

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Extracts of dried leaves of Ilex guayusa’

Herbal infusions

In line with normal use in herbal infusions and food supplements of a similar aqueous extract of dried leaves of Ilex paraguariensis

Food Supplements as defined in Directive 2002/46/EC

▼M46

Infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner

(Traditional food from a third country)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Infusion from coffee leaves of Coffea arabica and/or Coffea canephora’.

Herbal infusions

▼M9

Isomalto-oligosaccharide

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Isomaltooligosaccharide’.

2.  Foods containing the novel ingredient must be labelled as ‘a source of glucose’.

Energy-Reduced Soft Drinks

6,5 %

Energy Drinks

5,0 %

Foods intended to meet the expenditure of intense muscular efforts, especially for sportsmen (including isotonic drinks)

6,5 %

Fruit Juices

5 %

Processed Vegetables and Vegetable Juices

5 %

Other Soft Drinks

5 %

Cereals Bars

10 %

Cookies, Biscuits

20 %

Breakfast Cereal Bars

25 %

Hard Candies

97 %

Soft Candies/Chocolate Bars

25 %

Meal replacement for weight control (as bars or milk based)

20 %

Isomaltulose

Not specified

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Isomaltulose’.

2.  The designation of the novel food on the labelling shall be accompanied by indication that the ‘Isomaltulose is a source of glucose and fructose’.

▼M14

Lactitol

Specified food category

Maximum levels

The designation of the novel food on the labelling of the food supplements containing it shall be ‘Lactitol’

Food Supplements as defined in Directive 2002/46/EC (capsules, tablets or powder) intended for the adult population

20 g/day

▼M9

Lacto-N-neotetraose

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘lacto-N-neotetraose’.

2.  The labelling of food supplements containing lacto-N-neotetraose shall bear a statement that the supplements should not be used if other foods with added lacto-N-neotetraose are consumed the same day.

3.  The labelling of food supplements containing lacto-N-neotetraose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added lacto-N-neotetraose are consumed the same day.

Unflavoured pasteurised and sterilised (including UHT) milk-based products

0,6 g/l

Unflavoured fermented milk-based products

0,6 g/l for beverages

9,6 g/kg for products other than beverages

Flavoured fermented milk-based products including heat-treated products

0,6 g/l for beverages

9,6 g/kg for products other than beverages

Dairy analogues, including beverage whiteners

0,6 g/l for beverages

6 g/kg for products other than beverages

200 g/kg for whitener

Cereal bars

6 g/kg

Table-top sweeteners

100 g/kg

Infant formula as defined in Regulation (EU) No 609/2013

0,6 g/l in combination with up to 1,2 g/l of 2′-fucosyllactose at a ratio of 1:2 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

0,6 g/l in combination with up to 1,2 g/l of 2′-fucosyllactose at a ratio of 1:2 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 in Regulation (EU) No 609/2013

6 g/kg for products other than beverages

0,6 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer

Milk-based drinks and similar products intended for young children

0,6 g/l for milk-based drinks and similar products added alone or in combination with 2′-fucosyllactose, at a ratio of 1:2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

2,4 g/l for drinks

20 g/kg for bars

Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

30 g/kg

Flavoured drinks

0,6 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

4,8 g/l — the maximum level refers to the products ready to use

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants

1,5 g/day for general population

0,6 g/day for young children

▼M43

Lacto-N-tetraose (‘LNT’)

(microbial source)

Specified food category

Maximum levels

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 shall bear a statement that they should not be used if breast milk or other foods containing added lacto-N-tetraose are consumed the same day.

Authorised on 23.4.2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food lacto-N-tetraose is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation 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 Glycom A/S.

End date of the data protection: 23.4.2025.

Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products

1,0 g/l

Unflavoured fermented milk-based products

1,0 g/l (beverages)

10 g/kg (products other than beverages)

Flavoured fermented milk-based products including heat-treated products

1,0 g/l (beverages)

10 g/kg (products other than beverages)

Beverages (flavoured drinks)

1,0 g/l

Cereal bars

10 g/kg

Infant formula as defined under Regulation (EU) No 609/2013

0,8 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

0,6 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

Processed cereal-based food, baby food for infants and young children as defined under Regulation (EU) No 609/2013

0,6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

5 g/kg for products other than beverages

Milk based drinks and similar products intended for young children

0,6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

5 g/kg for products other than beverages

Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013

2,0 g/l (beverages)

20 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 infants

2,0 g/day for young children, children, adolescents, and adults

▼M20

Lonicera caerulea L. berries (haskap)

(Traditional food from a third country)

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘haskap (Lonicera caerulea) berries’

▼M9

Lucerne leaf extract from Medicago sativa

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lucerne (Medicago sativa) protein’ or ‘Alfalfa (Medicago sativa) protein’.

Food supplements as defined in Directive 2002/46/EC

10 g/day

Lycopene

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’

Fruit/vegetable juice-based drinks (including concentrates)

2,5 mg/100 g

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

2,5 mg/100 g

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

8 mg/meal

Breakfast cereals

5 mg/100 g

Fats and dressings

10 mg/100 g

Soups other than tomato soups

1 mg/100 g

Bread (including crispy breads)

3 mg/100 g

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

Food supplements as defined in Directive 2002/46/EC

15 mg/day

Lycopene from Blakeslea trispora

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’

Fruit/vegetable juice-based drinks (including concentrates)

2,5 mg/100 g

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

2,5 mg/100 g

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

8 mg/meal

Breakfast cereals

5 mg/100 g

Fats and dressings

10 mg/100 g

Soups other than tomato soups

1 mg/100 g

Bread (including crispy breads)

3 mg/100 g

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

Food supplements as defined in Directive 2002/46/EC

15 mg/day

Lycopene from tomatoes

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’

Fruit/vegetable juice-based drinks (including concentrates)

2,5 mg/100 g

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

2,5 mg/100 g

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

8 mg/meal

Breakfast cereals

5 mg/100 g

Fats and dressings

10 mg/100 g

Soups other than tomato soups

1 mg/100 g

Bread (including crispy breads)

3 mg/100 g

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

Food supplements as defined in Directive 2002/46/EC

15 mg/day

Lycopene oleoresin from tomatoes

Specified food category

Maximum levels of lycopene

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene oleoresin from tomatoes’

Fruit/vegetable juice-based drinks (including concentrates)

2,5 mg/100 g

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

2,5 mg/100 g

Total diet replacement for weight control covered by Regulation (EU) No 609/2013 and meal replacements for weight control

8 mg/meal

Breakfast cereals

5 mg/100 g

Fats and dressings

10 mg/100 g

Soups other than tomato soups

1 mg/100 g

Bread (including crispy breads)

3 mg/100 g

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

▼M49

Hen egg white lysozyme hydrolysate

Specified food category

Maximum levels

The designation of the novel food on the labelling of food supplements containing it shall be ‘Hen egg white lysozyme hydrolysate’.

Food supplements as defined in Directive 2002/46/EC intended for adult population

1000 mg/day

▼M9

Magnesium citrate malate

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Magnesium citrate malate’

Food Supplements as defined in Directive 2002/46/EC

Magnolia Bark Extract

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Magnolia Bark Extract’

Mints (confectionary products)

0,2 % for breath freshening purposes. Based on a 0,2 % maximum incorporation level and a maximum gum/mint size of 1,5 g each, each gum or mint serving will contain no more than 3 mg of magnolia bark extract.

Chewing gum

Maize-germ oil high in unsaponifiable matter

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Maize-germ oil extract’

Food Supplements as defined in Directive 2002/46/EC

2 g/day

Chewing gum

2 %

Methylcellulose

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Methylcellulose’

Methylcellulose is not to be used in foods specially prepared for young children

Edible ices

2 %

Flavoured drinks

Flavoured or unflavoured fermented milk products

Cold desserts (dairy, fat, fruit, cereal, egg-based products)

Fruit preparations (pulps, purees or compotes)

Soups and broths

▼M11

1-Methylnicotinamide chloride

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘1- Methylnicotinamide chloride’.

Food supplements containing 1-Methylnicotinamide shall bear the following statement:

This food supplement should be consumed by adults only excluding pregnant and lactating women

Authorised on 2 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Pharmena SA, Wolczanska 178, 90 530 Lodz, Poland. During the period of data protection thenovel food 1-methylnicotinamide chloride is authorised for placing on the market within the Union only by Pharmena S.A. unless a subsequent applicant obtains authorisation 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 Pharmena S.A.

End date of the data protection: 2 September 2023

Food Supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women

58 mg/day

▼M9

(6S)-5-methyltetrahydrofolic acid, glucosamine salt

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘(6S)-5-methyltetrahydrofolic acid, glucosamine salt’ or ‘5MTHF-glucosamine’

Food Supplements as defined in Directive 2002/46/EC as a source of folate

Monomethylsilanetriol (Organic Silicon)

Specified food category

Maximum levels of silicon

The designation of the novel food on the labelling of the food supplements containing it shall be ‘Organic silicon (monomethylsilanetriol)’

Food Supplements as defined in Directive 2002/46/EC for adult population (in liquid form)

10,40 mg/day

Mycelial extract from Shiitake mushroom (Lentinula edodes)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘extract from the mushroom Lentinula edodes’ or ‘extract from Shiitake mushroom’

Bread products

2 ml/100 g

Soft drinks

0,5 ml/100 ml

Ready prepared meals

2,5 ml per meal

Foods based on yoghurt

1,5 ml/100 ml

Food supplements as defined in Directive 2002/46/EC

2,5 ml per day dose

▼M38

Nicotinamide riboside chloride

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Nicotinamide riboside chloride’

Authorised on 20 February 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: ChromaDex Inc., 10900 Wilshire Boulevard Suite 600, Los Angeles, CA 90024 USA. During the period of data protection, the novel food is authorised for placing on the market within the Union only by ChromaDex Inc. unless a subsequent applicant obtains authorisation for that 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 ChromaDex Inc.

End date of the data protection: 20 February 2025.

Food Supplements as defined in Directive 2002/46/EC

300 mg/day for the general adult population, excluding pregnant and lactating women

230 mg/day for pregnant and lactating women

▼M9

Noni fruit juice (Morinda citrifolia)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Noni juice’ or ‘Juice of Morinda citrifolia’

Pasteurised fruit and fruit nectar based drinks

30 ml with one serving (up to 100 % noni juice)

or

20 ml twice a day, not more than 40 ml per day

Noni fruit juice powder (Morinda citrifolia)

Food supplements as defined in Directive 2002/46/EC

6,6 g/day (equivalent to 30 ml of noni juice)

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Noni juice powder’ or ‘Juice powder of Morinda citrifolia’

Noni fruit puree and concentrate (Morinda citrifolia)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be:

For fruit puree:

‘Morinda citrifolia fruit puree’ or ‘Noni fruit puree’

For fruit concentrate:

‘Morinda citrifolia fruit concentrate’ or ‘Noni fruit concentrate’

Fruit puree

Candy/confectionery

45 g/100 g

Cereal bars

53 g/100 g

Powdered nutritional drink mixes (dry weight)

53 g/100 g

Carbonated beverages

11 g/100 g

Ice cream & sorbet

31 g/100 g

Yoghurt

12 g/100 g

Biscuits

53 g/100 g

Buns, cakes and pastries

53 g/100 g

Breakfast cereals (wholegrain)

88 g/100 g

Jams and jellies in accordance with Directive 2001/113/EC

133 g/100 g

Based on pre-processing quantity to produce final 100 g product

Sweet spreads, fillings and icings

31 g/100 g

Savoury sauces, pickles, gravies and condiments

88 g/100 g

Food Supplements as defined in Directive 2002/46/EC

26 g/day

Fruit concentrate

Candy/Confectionery

10 g/100 g

Cereal bars

12 g/100 g

Powdered nutritional drink mixes (dry weight)

12 g/100 g

Carbonated beverages

3 g/100 g

Ice cream & sorbet

7 g/100 g

Yoghurt

3 g/100 g

Biscuits

12 g/100 g

Buns, cakes and pastries

12 g/100 g

Breakfast cereals (wholegrain)

20 g/100 g

Jams and jellies in accordance with Directive 2001/113/EC

30 g/100 g

Sweet spreads, fillings and icings

7 g/100 g

Savoury sauces, pickles, gravies and condiments

20 g/100 g

Food Supplements as defined in Directive 2002/46/EC

6 g/day

Noni leaves (Morinda citrifolia)

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Noni leaves’ or ‘leaves of Morinda citrifolia’.

2.  Instructions shall be given to the consumer that a cup of infusion should not be prepared with more than 1 g of dried and roasted leaves of Morinda citrifolia.

For the preparation of infusions

A cup of infusion to be consumed shall not be prepared with more than 1 g of dried and roasted leaves of Morinda citrifolia

Noni fruit powder (Morinda citrifolia)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Morinda citrifolia fruit powder’ or ‘Noni fruit powder’

Food Supplements as defined in Directive 2002/46/EC

2,4 g per/day

Odontella aurita microalgae

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Odontella aurita microalgae’

Flavoured pasta

1,5 %

Fish soups

1 %

Marine terrines

0,5 %

Broth preparations

1 %

Crackers

1,5 %

Frozen breaded fish

1,5 %

Oil enriched with phytosterols/phytostanols

Specified food category

Maximum levels of phytosterols/ phytostanols

In accordance with Annex III.5 to Regulation (EU) No 1169/2011

Spreadable fats as defined in Annex VII, Part VII and Appendix II, points B and C of Regulation (EU) No 1308/2013, and excluding cooking and frying fats and spreads based on butter or other animal fat

1.  The products containing the novel food ingredient shall be presented in such a manner that they can be easily divided into portions that contain either a maximum of 3 g (in case of one portion per day) or a maximum of 1 g (in case of three portions per day) of added phytosterols/phytostanols.

2.  The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.

3.  Salad dressings, mayonnaise and spicy sauces shall be packed as single portions.

Milk based products, such as products based on semi-skimmed and skimmed milk products, possibly with the addition of fruits and/or cereals, products based on fermented milk such as yoghurt and cheese based products (fat content ≤ 12 g per 100 g), where possibly the milk fat has been reduced and the fat or protein has been partly or fully replaced by vegetable fat or protein

Soya drinks

Salad dressings, mayonnaise and spicy sauces

Oil extracted from squids

Specified food category

Maximum levels of DHA and EPA combined

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’.

Dairy products except milk-based beverages

200 mg/100 g or for cheese products 600 mg/100 g

Dairy analogues except drinks

200 mg/100 g or for analogues to cheese products 600 mg/100 g

Spreadable fat and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

Bakery products (breads and bread rolls)

200 mg/100 g

Cereal bars

500 mg/100 g

Non-alcoholic beverages (including milk-based beverages)

60 mg/100 ml

Food Supplements as defined in Directive 2002/46/EC

3 000 mg/day for general population

450 mg/day for pregnant and lactating women

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 intended

Total diet replacement for weight control defined in Regulation (EU) No 609/2013 and meal replacements for weight control

200 mg/meal

▼M44

Partially defatted chia seed (Salvia hispanica) powders

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Partially defatted chia seed (Salvia hispanica) powder’

Powder with high protein content

Unflavoured fermented milk products, including natural unflavoured buttermilk (excluding sterilised buttermilk) non-heat-treated after fermentation

0,7 %

Unflavoured fermented milk products, heat-treated after fermentation

0,7 %

Flavoured fermented milk products including heat-treated products

0,7 %

Confectionery

10 %

Fruit juices as defined by Directive 2001/112/EC (8) and vegetable juices

2,5 %

Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products

2,5 %

Flavoured drinks

3 %

Food supplements as defined in Directive 2002/46/EC excluding food supplements for infants and young children

7,5 g/day

Powder with high fibre content

Confectionery

4 %

Fruit juices as defined by Directive 2001/112/EC and vegetable juices

2,5 %

Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products

4 %

Flavoured drinks

4 %

Food supplements as defined in Directive 2002/46/EC excluding food supplements for infants and young children

12 g/day

▼M9

Pasteurised fruit-based preparations produced using high-pressure treatment

Specified food category

Maximum levels

The wording ‘pasteurised by high-pressure treatment’ shall be displayed next to the name of the fruit preparations as such and in any product in which it is used

Types of fruit:

apple, apricot, banana, blackberry, blueberry, cherry, coconut, fig, grape, grapefruit, mandarin, mango, melon, peach, pear, pineapple, prune, raspberry, rhubarb, strawberry

▼M35

Phenylcapsaicin

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘phenylcapsaicin’.

Authorised on 19 December 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: aXichem AB, Södergatan 26, SE 211 34, Malmö Sweden. During the period of data protection, the novel food phenylcapsaicin is authorised for placing on the market within the Union only by aXichem AB, unless a subsequent applicant obtains authorisation 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 aXichem AB.

Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants, young children and children under the age of 11 years

2,5 mg/day

Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 11 years

2,5 mg/day

▼M9

Phosphated maize starch

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phosphated maize starch’

Baked bakery products

15 %

Pasta

Breakfast cereals

Cereal bars

Phosphatidylserine from fish phospholipids

Specified food category

Maximum levels of phosphatidylserine

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish phosphatidylserine’

Beverages based on yoghurt

50 mg/100 ml

Powders based on milk powders

3 500 mg/100 g (equivalent to 40 mg/100 ml ready to drink)

Foods based on yoghurt

80 mg/100 g

Cereal bars

350 mg/100 g

Chocolate based confectionary

200 mg/100 g

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

In compliance with Regulation (EU) No 609/2013

Food supplements as defined in Directive 2002/46/EC

300 mg/day

Phosphatidylserine from soya phospholipids

Specified food category

Maximum levels of phosphatidylserine

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Soya phosphatidylserine’

Beverages based on yoghurt

50 mg/100 ml

Powders based on milk powder

3,5 g/100 g (equivalent to 40 mg/100 ml ready to drink)

Foods based on yoghurt

80 mg/100 g

Cereal bars

350 mg/100 g

Chocolate based confectionary

200 mg/100 g

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

In compliance with Regulation (EU) No 609/2013

Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid

Specified food category

Maximum levels of phosphatidylserine

The designation of the novel food on the labelling of the foodstuffs containing shall be ‘Soy phosphatidylserine and phosphatidic acid’

The product is not intended to be marketed to pregnant or breast-feeding women

Breakfast cereals

80 mg/100 g

Cereal bars

350 mg/100 g

Foods based on yogurt

80 mg/100 g

Soy-based yogurt-like products

80 mg/100 g

Yogurt based-drinks

50 mg/100 g

Soy-based yogurt-like drinks

50 mg/100 g

Powders based on milk powder

3,5 g/100 g (equivalent to 40 mg/100 ml ready-to drink)

Food Supplements as defined in Directive 2002/46/EC

800 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

In compliance with Regulation (EU) No 609/2013

Phospholipides from egg yolk

Specified food category

Maximum levels

Not specified

Phytoglycogen

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phytoglycogen’

Processed foods

25 %

Phytosterols/phytostanols

Specified food category

Maximum levels

In accordance with Annex III.5 of Regulation (EU) No 1169/2011

Rice drinks

1.  They shall be presented in such a manner that they can be easily divided into portions that contain either a maximum of 3 g (in case of 1 portion/day) or a maximum of 1 g (in case of 3 portions/day) of added phytosterols/phytostanols.

The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.

Salad dressings, mayonnaise and spicy sauces shall be packed as single portions

Rye bread with flour containing ≥ 50 % rye (wholemeal rye flour, whole or cracked rye kernels and rye flakes) and ≤ 30 % wheat; and with ≤ 4 % added sugar but no fat added.

Salad dressings, mayonnaise and spicy sauces.

Soya drink

Milk type products, such as semi-skimmed and skimmed milk type products, possibly with the addition of fruits and/or cereals, where possibly the milk fat has been reduced, or where milk fat and/or protein has been partly or fully replaced by vegetable fat and/or protein.

Products based on fermented milk such as yoghurt and cheese type products (fat content < 12 % per 100 g), where possibly the milk fat has been reduced, or where milk fat and/or protein has been partly or fully replaced by vegetable fat and/or protein

Spreadable fats as defined in Annex VII, Part VII and Appendix II, points B and C of Regulation (EU) No 1308/2013, and excluding cooking and frying fats and spreads based on butter or other animal fat.

Food Supplements as defined in Directive 2002/46/EC

3 g/day

Plum kernel oil

Specified food category

Maximum levels

For frying and as seasoning

In line with normal food use of vegetable oils

Potato proteins (coagulated) and hydrolysates thereof

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Potato protein’

Prolyl oligopeptidase (enzyme preparation)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Prolyl oligopeptidase’

Food Supplements as defined in Directive 2002/46/EC for general adult population

120 PPU/day (2,7 g of enzyme preparation/day) (2 × 106 PPI/day)

PPU – Prolyl Peptidase Units or Proline Protease Units

PPI – Protease Picomole International

▼M47

Protein extract from pig kidneys

Specified food category

Maximum levels

Food Supplements as defined in Directive 2002/46/EC

3 capsules or 3 tablets/day; equalising 12,6 mg pig kidney extract a day Diamine oxidase (DAO) content: 0,9 mg/day (3 capsules or 3 tablets with a content of DAO of 0,3 mg/capsule or 0,3 mg/tablet)

Food for special medical purposes as defined in Regulation (EU) No 609/2013

▼M10

Pyrroloquinoline quinone disodium salt

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Pyrroloquinoline quinone disodium salt’.

Food supplements containing Pyrroloquinoline quinone disodium salt shall bear the following statement:

This food supplement should be consumed by adults only excluding pregnant and lactating women

Authorised on 2 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Mitsubishi Gas Chemical Company, Inc., Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan. During the period of data protection the novel food Pyrroloquinoline quinone disodium salt is authorised for placing on the market within the Union only by Mitsubishi Gas Chemical Company, Inc., unless a subsequent applicant obtains authorisation 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 Mitsubishi Gas Chemical Company, Inc.

End date of the data protection: 2 september 2023

Food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women

20 mg/day

▼M9

Rapeseed oil high in unsaponifiable matter

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rapeseed oil extract’

Food Supplements as defined in Directive 2002/46/EC

1,5 g per portion recommended for daily consumption

Rapeseed Protein

As a vegetable protein source in foods except in infant formula and follow-on formula

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rapeseed protein’.

2.  Any foodstuff containing ‘rapeseed protein’ shall bear a statement that this ingredient may cause allergic reaction to consumers who are allergic to mustard and products thereof. Where relevant, this statement shall appear in close proximity to the list of ingredients.

▼M17

Refined shrimp peptide concentrate

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘refined shrimp peptide concentrate’.

Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Marealis AS., Stortorget 1, Kystens Hus, 2nd floor, N-9008 Tromsø Postal address: P.O. Box 1065, 9261 Tromsø, Norway. During the period of data protection the novel food refined shrimp peptideconcentrate is authorised for placing on the market within the Union only by Marealis AS unless a subsequent applicant obtains authorisation 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 Marealis AS.

End date of the data protection: 20 November 2023.

Food Supplements as defined in Directive 2002/46/EC for the adult population

1 200 mg/day

▼M9

Trans-resveratrol

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the food supplements containing it shall be ‘Trans-resveratrol’.

2.  The labelling of food supplements containing trans-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision.

Food Supplements as defined in Directive 2002/46/EC for adult population (capsule or tablet form)

150 mg/day

Trans-resveratrol (microbial source)

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the food supplements containing it shall be ‘Trans-resveratrol’.

2.  The labelling of food supplements containing trans-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision.

Food supplements as defined in Directive 2002/46/EC

In line with normal use in food supplements of resveratrol extracted from Japanese knotweed (Fallopia japonica)

Rooster comb extract

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rooster comb extract’ or ‘Cockerel comb extract’

Milk-based drinks

40 mg/100 g or mg/100 ml

Milk based fermented drinks

80 mg/100 g or mg/100 ml

Yoghurt-type products

65 mg/100 g or mg/100 ml

Fromage frais

110 mg/100 g or mg/100 ml

Sacha inchi oil from Plukenetia volubilis

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sacha inchi oil (Plukenetia volubilis)’

As for linseed oil

In line with normal food use of linseed oil

Salatrims

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘reduced energy fat (salatrims)’.

2.  There shall be a statement that excessive consumption may lead to gastro-intestinal disturbance.

3.  There shall be a statement that the products are not intended for use by children.

Bakery products and confectionary

Schizochytrium sp. oil rich in DHA and EPA

Specified food category

Maximum levels of DHA and EPA combined:

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’

Food Supplements as defined in Directive 2002/46/EC for adult population excluding pregnant and lactating women

3 000 mg/day

Food Supplements as defined in Directive 2002/46/EC for pregnant and lactating women

450 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

In accordance with the particular nutritional requirements of the persons for whom the products are intended

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Milk-based drinks and similar products intended for young children

200 mg/100 g

Processed cereal based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Bakery Products (Breads, Rolls and Sweet Biscuits)

200 mg/100 g

Breakfast Cereals

500 mg/100 g

Cooking Fats

360 mg/100 g

Dairy Analogues except drinks

600 mg/100 g for cheese; 200 mg/100 g for soy and imitation milk products (excluding drinks)

Dairy Products except milk-based drinks

600 mg/100 g for cheese; 200 mg/100 g for milk products (including milk, fromage frais and yoghurt products; excluding drinks)

Non-alcoholic Beverages (including dairy analogue and milk-based drinks)

80 mg/100 g

Cereal/Nutrition Bars

500 mg/100 g

Spreadable Fats and Dressings

600 mg/100 g

▼M26

Schizochytrium sp. (ATCC PTA-9695) oil

Specified food category

Maximum levels of DHA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’

Dairy products except milk-based drinks

200 mg/100 g or for cheese products 600 mg/100 g

Dairy analogues except drinks

200 mg/100 g or for analogues to cheese products 600 mg/100 g

Spreadable fats and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

Food Supplements as defined in Directive 2002/46/EC

250 mg DHA/day for general population

450 mg DHA/day for pregnant and lactating women

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Milk-based drinks and similar products intended for young children

200 mg/100 g

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

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

Bakery products (breads, rolls, and sweet biscuits)

200 mg/100 g

Cereal bars

500 mg/100 g

Cooking fats

360 mg/100 g

Non-alcoholic beverages (including dairy analogue and milk-based drinks)

80 mg/100 ml

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

200 mg/100 g

Fruit/vegetable puree

100 mg/100 g

▼M24

Schizochytrium sp. oil

Specified food category

Maximum levels of DHA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’

Dairy products except milk-based drinks

200 mg/100 g or for cheese products 600 mg/100 g

Dairy analogues except drinks

200 mg/100 g or for analogues to cheese products 600 mg/100 g

Spreadable fat and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

Food Supplements as defined in Directive 2002/46/EC

250 mg DHA/day for general population

450 mg DHA/day for pregnant and lactating women

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Milk-based drinks and similar products intended for young children

200 mg/100 g

Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No 828/2014

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

Bakery products (breads, rolls, and, sweet biscuits)

200 mg/100 g

Cereal bars

500 mg/100 g

Cooking fats

360 mg/100 g

Non-alcoholic beverages (including dairy analogue and milk-based drinks)

80 mg/100 ml

Fruit/vegetable puree

100 mg/100 g

▼M49

Schizochytrium sp. (T18) oil

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’.

Dairy products except milk-based drinks

200 mg/100 g or for cheese products 600 mg/100 g

Dairy analogues except drinks

200 mg/100 g or for analogues to cheese products 600 mg/100 g

Spreadable fats and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

Food supplements as defined in Directive 2002/46/EC

250 mg DHA/day for general population

450 mg DHA/day for pregnant and lactating women

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Milk-based drinks and similar products intended for young children

200 mg/100 g

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

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

Bakery products (breads, rolls and, sweet biscuits)

200 mg/100 g

Cereal bars

500 mg/100g

Cooking fats

360 mg/100 g

Non-alcoholic beverages (including dairy analogue and milk-based drinks)

80 mg/100 ml

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

200 mg/100 g

Fruit/vegetable puree

100 mg/100 g

▼M22

Syrup from Sorghum bicolor (L.) Moench

(Traditional food from a third country)

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sorghum (Sorghum bicolor) syrup’

▼M9

Fermented soybean extract

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fermented soybean extract’.

2.  The labelling of food supplements containing fermented soybean extract shall bear a statement that persons taking medication should only consume the product under medical supervision.

Food Supplements as defined in Directive 2002/46/EC (capsules, tablets or powder form) intended for the adult population, excluding pregnant and lactating women

100 mg/day

Spermidine-rich wheat germ extract (Triticum aestivum)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the food supplements containing it shall be ‘spermidine-rich wheat germ extract’

Food Supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women

Equivalent of max. 6 mg/day spermidine

Sucromalt

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sucromalt’.

2.  The designation of the novel food on the labelling shall be accompanied by indication that the product is a source of glucose and fructose.

Not specified

Sugar cane fibre

Specified food category

Maximum levels

Bread

8 %

Bakery goods

5 %

Meat and muscle products

3 %

Seasonings and spices

3 %

Grated cheeses

2 %

Special diet foods

5 %

Sauces

2 %

Beverages

5 %

Sunflower oil extract

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sunflower oil extract’

Food Supplements as defined in Directive 2002/46/EC

1,1 g/day

Dried Tetraselmis chuii microalgae

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Dried microalgae Tetraselmis chuii’ or ‘Dried microalgae T. chuii’

Food supplements containing dried microalgae Tetraselmis chuii shall bear the following statement: ‘Contains negligible amounts of iodine’

Sauces

20 % or 250mg/day

Special salts

1 %

Condiment

250 mg/day

Food Supplements as defined in Directive 2002/46/EC

250 mg/day

Therapon barcoo/Scortum

Intended use identical to that of the salmon, namely the preparation of culinary fish products and dishes, including cooked, raw, smoked and baked fish products

D-Tagatose

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘D-Tagatose’.

2.  The labelling of any product where the level of D-Tagatose exceeds 15 g per serving and all beverages containing greater than 1 % D-Tagatose (as consumed) shall bear a statement ‘excessive consumption may produce laxative effects’.

Not specified

▼M49

Taxifolin-rich extract

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘taxifolin-rich extract’

Yogurt plain/Yogurt with fruits(*)

0,020 g/kg

Kephir(*)

0,008 g/kg

Buttermilk(*)

0,005 g/kg

Milk powder(*)

0,052 g/kg

Cream(*)

0,070 g/kg

Sour cream(*)

0,050 g/kg

Cheese(*)

0,090 g/kg

Butter(*)

0,164 g/kg

Chocolate confectionery

0,070 g/kg

Non-alcoholic beverages

0,020 g/L

Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding infants, young children, children and adolescents younger than 14 years

100 mg/day

(*)  When used in milk products Taxifolin-rich extract may not replace in whole or in part, any milk constituent

▼M9

Trehalose

Specified food category

Maximum levels

1.  The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Trehalose’ and shall be displayed on the labelling of the product as such or in the list of ingredients of foodstuffs containing it.

2.  The designation of the novel food on the labelling shall be accompanied by indication that the ‘Trehalose is a source of glucose’.

Not specified

▼M49

UV-treated mushrooms (Agaricus bisporus)

Specified food category

Maximum levels of vitamin D2

1.  The designation on the label of the novel food as such or of the foodstuffs containing it shall be ‘UV-treated mushrooms (Agaricus bisporus)’.

2.  The designation on the label of the novel food as such or of the foodstuffs containing it shall be accompanied by indication that a ‘controlled light treatment was used to increase vitamin D levels’ or ‘UV treatment was used to increase vitamin D2 levels’.

Mushrooms (Agaricus bisporus)

20 μg of vitamin D2/100 g fresh weight

UV-treated baker’s yeast (Saccharomyces cerevisiae)

Specified food category

Maximum levels of vitamin D2

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Vitamin D yeast’ or ‘Vitamin D2 yeast’

Yeast-leavened breads and rolls

5 μg of vitamin D2/100 g

Yeast-leavened fine bakery wares

5 μg of vitamin D2/100 g

Food supplements as defined in Directive 2002/46/EC

Pre-packed fresh or dry yeast for home baking

45 μg/100 g for fresh yeast

200 μg/100 g for dried yeast

1.  The designation of the novel food on the labelling of the foodstuffs shall be ‘Vitamin D yeast’ or ‘Vitamin D2 yeast’.

2.  The labelling of the novel food shall bear a statement that the foodstuff is only intended for baking and that it should not be eaten raw.

3.  The labelling of the novel food shall bear instructions for use for the final consumers so that a maximum concentration of 5 μg/100 g of vitamin D2 in final home‐baked products is not exceeded.

▼M9

UV-treated bread

Specified food category

Maximum levels of vitamin D2

The designation on the label of the novel food shall be accompanied by ‘contains vitamin D produced by UV-treatment’

Yeast leavened bread and rolls (without toppings)

3 μg vitamin D2/100 g

UV-treated milk

Specified food category

Maximum levels of vitamin D3

1.  The designation on the label of the novel food shall be ‘UV-treated’.

2.  Where UV-treated milk contains an amount of vitamin D that is considered significant in accordance with Point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011 of the European Parliament and of the Council, the designation for the labelling shall be accompanied by ‘contains vitamin D produced by UV-treatment’ or ‘milk containing vitamin D resulting from UV-treatment’.

Pasteurised whole milk as defined in Regulation (EU) No 1308/2013 to be consumed as such

5-32 μg/kg for general population excluding infants

Pasteurised semi-skimmed milk as defined in Regulation (EU) No 1308/2013 to be consumed as such

1-15 μg/kg for general population excluding infants

▼M48

Vitamin D2 mushroom powder

Specified food category

Maximum levels of vitamin D2  ()

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘UV-treated mushroom powder containing vitamin D’ or ‘UV-treated mushroom powder containing vitamin D2’

The labelling of food supplements containing vitamin D2 mushroom powder shall bear a statement that they should not be consumed by infants

Authorised on 27 August 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Oakshire Naturals, LP., PO Box 388 Kennett Square, Pennsylvania 19348, United States. During the period of data protection, the novel food vitamin D2 mushroom powder is authorised for placing on the market within the Union only by Oakshire Naturals, LP., unless a subsequent applicant obtains authorisation 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 Oakshire Naturals, LP.

End date of the data protection: 27 August 2025.

Breakfast cereals

2,25 μg of vitamin D2/100 g

Yeast-leavened bread and pastries

2,25 μg of vitamin D2/100 g

Grain products and pastas

2,25 μg of vitamin D2/100 g

Fruit juice and fruit/vegetable blend beverages

1,125 μg of vitamin D2/100 mL

Milk and dairy products (excluding fluid milks)

2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages)

Cheese (excluding cottage cheese, ricotta cheese, and hard-grating cheeses)

2,25 μg of vitamin D2/100 g

Meal replacement bars and beverages

2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages)

Dairy analogues

2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages)

Meat analogues

2,25 μg of vitamin D2/100 g

Soups and broths

2,25 μg of vitamin D2/100 g

Extruded vegetable snacks

2,25 μg of vitamin D2/100 g

Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infants

15 μg/day

Food supplements as defined in Directive 2002/46/EC intended for the general population excluding infants

15 μg/day

▼M9

Vitamin K2 (menaquinone)

To be used in compliance with Directive 2002/46/EC, Regulation (EU) No 609/2013 and/or Regulation (EC) No 1925/2006

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Menaquinone’ or ‘Vitamin K2’

Wheat bran extract

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Wheat bran extract’

The ‘Wheat Bran Extract’ may not be introduced onto the market as a food supplement or food supplement ingredient. Nor may it be added to infant formula.

Beer and substitutes

0,4 g/100 g

Ready to eat cereals

9 g/100 g

Dairy products

2,4 g/100 g

Fruit and vegetable juices

0,6 g/100 g

Soft drinks

0,6 g/100 g

Meat preparations

2 g/100 g

▼M45

Xylo-oligosaccharides

Specified food category

Maximum levels (10)

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Xylo-oligosaccharides’

White bread

14 g/kg

Wholemeal bread

14 g/kg

Breakfast cereals

14 g/kg

Biscuits

14 g/kg

Soy drink

3,5 g/kg

Yoghurt (9)

3,5 g/kg

Fruit spreads

30 g/kg

Chocolate confectionery

30 g/kg

Food supplements as defined in Directive 2002/46/EC for the general adult population

2 g/day

▼M30

Yarrowia lipolytica yeast biomass

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yarrowia lipolytica yeast heat-killed biomass’

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

▼M9

Yeast beta-glucans

Specified food category

Maximum levels of pure beta-glucans from yeast (Saccharomyces cervisiae)

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

1,275 g/day for children older than 12 years and general adult population

0,675 g/day for children younger than 12 years

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

1,275 g/day

Food for special medical purposes as defined in Regulation (EU) No 609/2013, excluding food for special medical purposes intended for infants and young children

1,275 g/day

Beverages based on fruit and/or vegetable juices including concentrate and dehydrated juices

1,3 g/kg

Fruit-flavoured drinks

0,8 g/kg

Cocoa beverages preparation powder

38,3 g/kg (powder)

Other beverages

0,8 g/kg (ready to drink)

7 g/kg (powder)

Cereal bars

6 g/kg

Breakfast cereals

15,3 g/kg

Wholegrain and high fibre instant hot breakfast cereals

1,5 g/kg

Cookie-type biscuits

6,7 g/kg