Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance)

Status:

Point in time view as at 03/09/2018.

Changes to legislation:

There are currently no known outstanding effects for the Commission Implementing Regulation (EU) 2017/2470.

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[F1Table 1: Authorised novel foods

Authorised novel food	Conditions under which the novel food may be used		Additional specific labelling requirements	Other requirements	[F2Data Protection]
^a Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 ( OJ L 181, 29.6.2013, p. 35 ).
^b Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food ( OJ L 228, 31.7.2014, p. 5 ).
^c Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements ( OJ L 183, 12.7.2002, p. 51 ).
^d Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods ( OJ L 404, 30.12.2006, p. 26 ).
^e Council Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption ( OJ L 10, 12.1.2002, p. 67 ).
^f Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulation (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) 1234/2007 ( OJ L 347, 20.12.2013, p. 671 ).]
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 ^a	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 ^b	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 ^c	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
Ajuga reptans extract from cell cultures	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’
Allanblackia seed oil	Yellow fat spreads and cream based spreads	20 g/100 g
Aloe macroclada Baker leaf extract	Specified food category	Maximum levels
Aloe macroclada Baker leaf extract	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
*Basil seeds ( Ocimum basilicum* )**	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 ’
Fermented black bean 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
	Dairy products and analogues	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)’
Calanus finmarchicus oil	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 base (monomethoxypolyethylene glycol)	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 ’
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 ’
Chitin-glucan complex 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 ’
Chondroitin sulphate	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 ^d	250 μg/day
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’
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)’
*Clostridium butyricum*	Food Supplements as defined in Directive 2002/46/EC	1,35 × 10 ⁸ 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
Low fat cocoa extract	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 ’
Coriander seed oil from Coriandrum sativum	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 ^e
	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 ’
Dextran preparation produced by Leuconostoc mesenteroides	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
[F2Dried 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 .
[F2Dried aerial parts of Hoodia parviflora	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’
*Dried extract of Lippia citriodora* from cell cultures**	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
Echinacea angustifolia extract from cell cultures	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’
Echinacea purpurea extract from cell cultures	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 ’
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	12 mg/100 g
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 ’.
Fucoidan extract from the 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 ’
Fucoidan extract from the 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
	Unflavoured fermented milk-based products	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	0,02
	Milk drinks	0,03
	Meal replacement for weight control (as drinks)	0,02
	Dairy analogue drinks	0,02
	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
Glucosamine sulphate KCl	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
Glucosamine sulphate NaCl	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 ^f ), 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 ’
Ice Structuring Protein type III HPLC 12	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 ’
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’.
Lucerne leaf extract from Medicago sativa	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 ’
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
[F31-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
[F31-Methylnicotinamide chloride	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 ’
(6S)-5-methyltetrahydrofolic acid, glucosamine salt	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) ’
Monomethylsilanetriol (Organic Silicon)	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 ’
*Noni fruit juice ( 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.
*Noni leaves ( 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 ’
*Noni fruit powder ( Morinda citrifolia* )**	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
Phospholipides from egg yolk	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 ’
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
Plum kernel oil	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 ’
Prolyl oligopeptidase (enzyme preparation)	Food Supplements as defined in Directive 2002/46/EC for general adult population	120 PPU/day (2,7 g of enzyme preparation/day) (2 × 10 ⁶ 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
[F4Pyrroloquinoline 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
[F4Pyrroloquinoline quinone disodium salt	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 ’
Rapeseed oil high in unsaponifiable matter	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.
Trans-resveratrol	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.
Trans-resveratrol (microbial source)	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) ’
Sacha inchi oil from 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.
Salatrims	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
	Food Supplements as defined in Directive 2002/46/EC	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
	Food Supplements as defined in Directive 2002/46/EC	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
	Food Supplements as defined in Directive 2002/46/EC	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.
Fermented soybean extract	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.
Sucromalt	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 ’
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 ’ .
D-Tagatose	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 ’ .
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 ’ .
Trehalose	Not specified
*UV-treated mushrooms ( Agaricus bisporus* )**	Specified food category	Maximum levels of vitamin D ₂
*UV-treated mushrooms ( Agaricus bisporus* )**	Mushrooms ( Agaricus bisporus )	10 μg of vitamin D ₂ /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 D ₂ levels’.
*UV-treated baker’s yeast ( Saccharomyces cerevisiae* )**	Specified food category	Maximum levels of vitamin D ₂	The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Vitamin D yeast’ or ‘Vitamin D ₂ yeast’
	Yeast-leavened breads and rolls	5 μg of vitamin D ₂ /100 g
	Yeast-leavened fine bakery wares	5 μg of vitamin D ₂ /100 g
	Food Supplements as defined in Directive 2002/46/EC	5 μg of vitamin D ₂ /day
UV-treated bread	Specified food category	Maximum levels of vitamin D ₂	The designation on the label of the novel food shall be accompanied by ‘ contains vitamin D produced by UV-treatment ’
UV-treated bread	Yeast leavened bread and rolls (without toppings)	3 μg vitamin D ₂ /100 g
UV-treated milk	Specified food category	Maximum levels of vitamin D ₃	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 K ₂ (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 K ₂’
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)
	Other beverages	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
[F5Zeaxanthin	Specified food category	Maximum levels	The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘ Zeaxanthin ’ .
[F5Zeaxanthin	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

Textual Amendments

F1 Substituted by Commission Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods (Text with EEA relevance).

F2 Inserted by Commission Implementing Regulation (EU) 2018/1133 of 13 August 2018 authorising the placing on the market of dried aerial parts of Hoodia parviflora as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance).

F3 Inserted by Commission Implementing Regulation (EU) 2018/1123 of 10 August 2018 authorising the placing on the market of 1-methylnicotinamide chloride as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance).

F4 Inserted by Commission Implementing Regulation (EU) 2018/1122 of 10 August 2018 authorising the placing on the market of pyrroloquinoline quinone disodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance).

F5 Substituted by Commission Implementing Regulation (EU) 2018/1132 of 13 August 2018 authorising the change of the designation and specific labelling requirement of the novel food synthetic zeaxanthin under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance).

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[F1Table 1: Authorised novel foods

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.

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[F1Table 1: Authorised novel foods

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.

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