Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements ►M13 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

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 20 g/100 g

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)

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

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

Chia seeds (Salvia hispanica) Specified food category Maximum levels 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chia seeds (Salvia hispanica)’ 2. Pre-packaged Chia (Salvia hispanica) seeds shall carry additional labelling to inform the consumer that the daily intake is no more than 15 g.

Bread products 5 % (whole or ground chia seeds)

Baked products 10 % whole chia seeds

Breakfast cereals 10 % whole chia seeds

Fruit, nut and seed mixes 10 % whole chia seeds

Fruit juice and fruit/vegetable blend beverages 15 g/day for addition of whole, mashed or ground chia seeds

Pre-packaged Chia seed as such 15 g/day whole chia seeds

Fruit spreads 1 % whole chia seeds

Yoghurt 1,3 g whole chia seeds per 100 g of yoghurt or 4,3 g whole chia seeds per 330 g of yoghurt (portion)

Sterilised ready to eat meals based on cereal grains, pseudocereals grains and/or pulses 5 % whole chia seeds

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

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

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’

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

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

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

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 HTN®Vb’

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

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

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

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’

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

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

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

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 product before 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

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’.

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 or tablets) intended for the adult population 20 g/day

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

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

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

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 the novel 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

(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

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

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

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

Protein extract from pig kidneys Specified food category Maximum levels

Food Supplements as defined in Directive 2002/46/EC 3 capsules/day; equalizing 12,6 mg pig kidney extract a day Diamine oxidase (DAO) content: 0,9 mg/day (3 capsules with a content of DAO of 0,3 mg/capsule)

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

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

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.

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

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. (ATCC PTA-9695)’

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

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 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

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 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

Schizochytrium sp. (T18) 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

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

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’.

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

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

UV-treated mushrooms (Agaricus bisporus) Specified food category Maximum levels of vitamin D2

Mushrooms (Agaricus bisporus) 10 μg of vitamin D2/100 g fresh weight 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’.

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 5 μg of vitamin D2/day

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

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

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

Cracker-type biscuits 6,7 g/kg

Milk based beverages 3,8 g/kg

Fermented milk products 3,8 g/kg

Milk product analogues 3,8 g/kg

Dried milk/milk powder 25,5 g/kg

Soups and soup mixes 0,9 g/kg (ready to eat)

1,8 g/kg (condensed)

6,3 g/kg (powder)

Chocolate and confectionery 4 g/kg

Protein bars and powders 19,1 g/kg

Jam, marmalade and other fruit spreads 11,3 g/kg

Zeaxanthin Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Zeaxanthin’.

Food Supplements as defined in Directive 2002/46/EC 2 mg/day

Zinc L-pidolate Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Zinc L-pidolate’

Foods covered by Regulation (EU) No 609/2013 3 g/day

Milk based drinks and similar products intended for young children

Meal replacement for weight control

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

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

Food Supplements as defined in Directive 2002/46/EC