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)

Type Implementing Regulation
Publication 2018-07-24
State In force
Text As published
Department European Commission, SANTE
Source EUR-Lex
articles 2

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

Reform history JSON API
Authorised novel food Conditions under which the novel food may be used Conditions under which the novel food may be used Additional specific labelling requirements Other requirements
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.
N-Acetyl-D-neuraminic acid Infant and follow-on formulae as defined by Regulation (EU) No 609/201312 0,05 g/L of reconstituted formula 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.
N-Acetyl-D-neuraminic acid 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 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.
N-Acetyl-D-neuraminic acid 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. 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.
N-Acetyl-D-neuraminic acid 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) 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.
N-Acetyl-D-neuraminic acid Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/201413 1,25 g/kg 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.
N-Acetyl-D-neuraminic acid Unflavoured pasteurised and sterilised (including UHT) milk-based products 0,05 g/L 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.
N-Acetyl-D-neuraminic acid 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) 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.
N-Acetyl-D-neuraminic acid Dairy analogues, including beverage whiteners 0,05 g/L (beverages) 0,25 g/kg (solids) 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.
N-Acetyl-D-neuraminic acid Cereal bars 0,5 g/kg 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.
N-Acetyl-D-neuraminic acid Table top sweeteners 8,3 g/kg 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.
N-Acetyl-D-neuraminic acid Fruit and vegetable-based drinks 0,05 g/L 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.
N-Acetyl-D-neuraminic acid Flavoured drinks 0,05 g/L 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.
N-Acetyl-D-neuraminic acid 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 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.
N-Acetyl-D-neuraminic acid Food Supplements as defined in Directive 2002/46/EC14 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 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.
Adansonia digitata (Baobab) dried fruit pulp Not specified 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
L-Alanyl-L-Glutamine Food Supplements as defined in Directive 2002/46/EC
L-Alanyl-L-Glutamine Foods for special medical purposes as defined in Regulation (EU) No 609/2013 excluding foods for infants and young children
L-Alanyl-L-Glutamine 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.’
Algal oil from the microalgae Ulkenia sp. Bakery products (breads, rolls and sweet biscuits) 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the micro-algae Ulkenia sp.’
Algal oil from the microalgae Ulkenia sp. Cereal bars 500 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the micro-algae Ulkenia sp.’
Algal oil from the microalgae Ulkenia sp. Non-alcoholic beverages (including milk based beverages) 60 mg/100 ml The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the micro-algae Ulkenia sp.’
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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Allanblackia seed oil’
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)’
Antarctic Krill oil from Euphausia superba Dairy products except milk-based drinks 200 mg/100 g or for cheese products 600 mg/100 g 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)’
Antarctic Krill oil from Euphausia superba Dairy analogues except drinks 200 mg/100 g or for analogues to cheese products 600 mg/100 g 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)’
Antarctic Krill oil from Euphausia superba Non-alcoholic beverages Milk-based drinks Dairy analogue drinks 80 mg/100 ml 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)’
Antarctic Krill oil from Euphausia superba Spreadable fat and dressings 600 mg/100 g 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)’
Antarctic Krill oil from Euphausia superba Cooking fats 360 mg/100 ml 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)’
Antarctic Krill oil from Euphausia superba Breakfast cereals 500 mg/100 g 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)’
Antarctic Krill oil from Euphausia superba Bakery products (breads, rolls and sweet biscuits) 200 mg/100 g 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)’
Antarctic Krill oil from Euphausia superba Nutrition bars/cereal bars 500 mg/100 g 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)’
Antarctic Krill oil from Euphausia superba 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 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)’
Antarctic Krill oil from Euphausia superba 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 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)’
Antarctic Krill oil from Euphausia superba Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control 250 mg/meal 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)’
Antarctic Krill oil from Euphausia superba Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013 200 mg/100 ml 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)’
Antarctic Krill oil from Euphausia superba Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen 200 mg/100 ml 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)’
Antarctic Krill oil from Euphausia superba Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 200 mg/100 ml 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)’
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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba Dairy products except milk-based drinks 200 mg/100 g or for cheese products 600 mg/100 g 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba Dairy analogues except drinks 200 mg/100 g or for analogues to cheese products 600 mg/100 g 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba Non-alcoholic beverages Milk-based drinks Dairy analogue drinks 80 mg/100 ml 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba Spreadable fat and dressings 600 mg/100 g 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba Cooking fats 360 mg/100 ml 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba Breakfast cereals 500 mg/100 g 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba Bakery products (breads, rolls and sweet biscuits) 200 mg/100 g 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba Nutrition bars/cereal bars 500 mg/100 g 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba 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 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba 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 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control 250 mg/meal 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013 200 mg/100 ml 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen 200 mg/100 ml 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)’
Antarctic Krill oil rich in phospholipids from Euphausia superba Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 200 mg/100 ml 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)’
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’
Arachidonic acid-rich oil from the fungus Mortierella alpina Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 In accordance with Regulation (EU) No 609/2013 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from Mortierella alpina’ or ‘Mortierella alpina oil’
Arachidonic acid-rich oil from the fungus Mortierella alpina Foods for special medical purposes for premature infants as defined in Regulation (EU) No 609/2013 In accordance with Regulation (EU) No 609/2013 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from Mortierella alpina’ or ‘Mortierella alpina oil’
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
Argan oil from Argania spinosa As seasonings Not specified 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
Argan oil from Argania spinosa Food Supplements as defined in Directive 2002/46/EC In line with normal food use of vegetable oils 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
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’
Astaxanthin-rich oleoresin from Haematococcus pluvialis algae Food Supplements as defined in Directive 2002/46/EC 40-80 mg/day of oleoresin, resulting in ≤ 8 mg astaxanthin per day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Astaxanthin’
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 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’
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’
Bovine lactoferrin Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 (ready to drink) 100 mg/100 ml The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin Foods on dairy basis intended for young children (ready to eat/drink) 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin Processed cereal food (solid) 670 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin Beverages based on milk 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin Powdered drink mixes based on milk (ready to drink) 330 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin Beverages based on fermented milk (including yoghurt drinks) 50 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin Non-alcoholic drinks 120 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin Products based on yoghurt 80 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin Products based on cheese 2 000  mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin Ice cream 130 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin Cakes and pastries 1 000  mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin Candies 750 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
Bovine lactoferrin Chewing gum 3 000  mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows’ milk’
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’
Buglossoides arvensis seed oil Dairy products and analogues 250 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined Buglossoides oil’
Buglossoides arvensis seed oil Dairy products and analogues 75 mg/100 g for drinks The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined Buglossoides oil’
Buglossoides arvensis seed oil Cheese and cheese products 750 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined Buglossoides oil’
Buglossoides arvensis seed oil Butter and other fat and oil emulsions including spreads (not for cooking or frying purposes) 750 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined Buglossoides oil’
Buglossoides arvensis seed oil Breakfast cereals 625 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined Buglossoides oil’
Buglossoides arvensis seed oil Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children 500 mg/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined Buglossoides oil’
Buglossoides arvensis seed oil 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined Buglossoides oil’
Buglossoides arvensis seed oil Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control 250 mg/meal The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined Buglossoides oil’
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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘oil from Calanus finmarchicus (crustacean)’
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 % 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 (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 base (Methyl vinyl ether-maleic anhydride copolymer) Chewing gum 2 % 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)’
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)’
Chia oil from Salvia hispanica Fats and oils 10 % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chia oil (Salvia hispanica)’
Chia oil from Salvia hispanica Pure chia oil 2 g/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chia oil (Salvia hispanica)’
Chia oil from Salvia hispanica Food Supplements as defined in Directive 2002/46/EC 2 g/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chia oil (Salvia hispanica)’
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.
Chia seeds (Salvia hispanica) Bread products 5 % (whole or ground chia seeds) 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.
Chia seeds (Salvia hispanica) Baked products 10 % whole chia seeds 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.
Chia seeds (Salvia hispanica) Breakfast cereals 10 % whole chia seeds 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.
Chia seeds (Salvia hispanica) Fruit, nut and seed mixes 10 % whole chia seeds 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.
Chia seeds (Salvia hispanica) Fruit juice and fruit/vegetable blend beverages 15 g/day for addition of whole, mashed or ground chia seeds 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.
Chia seeds (Salvia hispanica) Pre-packaged Chia seed as such 15 g/day whole chia seeds 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.
Chia seeds (Salvia hispanica) Fruit spreads 1 % whole chia seeds 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.
Chia seeds (Salvia hispanica) 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) 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.
Chia seeds (Salvia hispanica) Sterilised ready to eat meals based on cereal grains, pseudocereals grains and/or pulses 5 % whole chia seeds 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.
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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitin-glucan from Aspergillus niger’
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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitin-glucan from Fomes fomentarius’
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’
Chitosan extract from fungi (Agaricus bisporus; Aspergillus niger) Food Supplements as defined in Directive 2002/46/EC In line with normal use in food supplements of chitosan from crustaceans 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’
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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chondroitin sulphate derived from microbial fermentation and sulphation’
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’
Chromium Picolinate Foods covered by Regulation (EU) No 609/2013 250 μg/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chromium Picolinate’
Chromium Picolinate Foods fortified in accordance with Regulation (EC) No 1925/200615 250 μg/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chromium Picolinate’
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) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Cistus incanus L. Pandalis herb’
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
Citicoline Food Supplements as defined in Directive 2002/46/EC 500 mg/day 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
Citicoline 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 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
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 × 108 CFU/day 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)’
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
Extract of defatted cocoa powder 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) 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
Extract of defatted cocoa powder Milk based beverages 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) 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
Extract of defatted cocoa powder 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 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) 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
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 Consumers shall be instructed not to consume more than 600 mg of cocoa flavanols per 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Coriander seed oil’
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’
Crataegus pinnatifida dried fruit Herbal infusions In line with normal food use of Crataegus laevigata The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Crataegus pinnatifida dried fruit’
Crataegus pinnatifida dried fruit Jams and jellies in accordance with Directive 2001/113/EC16 In line with normal food use of Crataegus laevigata The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Crataegus pinnatifida dried fruit’
Crataegus pinnatifida dried fruit Compotes In line with normal food use of Crataegus laevigata The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Crataegus pinnatifida dried fruit’
α-cyclodextrin Not specified 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 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 % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Dextran’
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)’
Diacylglycerol oil of plant origin Cooking oils 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)’
Diacylglycerol oil of plant origin Fat spreads 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)’
Diacylglycerol oil of plant origin Salad dressings 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)’
Diacylglycerol oil of plant origin Mayonnaise 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)’
Diacylglycerol oil of plant origin Meal replacement for weight control (as drinks) 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)’
Diacylglycerol oil of plant origin Bakery products 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)’
Diacylglycerol oil of plant origin Yoghurt type products 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)’
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’
Dihydrocapsiate (DHC) Cereal bars 9 mg/100 g 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’
Dihydrocapsiate (DHC) Biscuits, cookies and crackers 9 mg/100 g 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’
Dihydrocapsiate (DHC) Rice based snacks 12 mg/100 g 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’
Dihydrocapsiate (DHC) Carbonated drinks, dilutable drinks, fruit juice based beverages 1,5 mg/100 ml 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’
Dihydrocapsiate (DHC) Vegetable drinks 2 mg/100 ml 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’
Dihydrocapsiate (DHC) Coffee based drinks, tea based drinks 1,5 mg/100 ml 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’
Dihydrocapsiate (DHC) Flavoured water — still 1 mg/100 ml 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’
Dihydrocapsiate (DHC) Precooked oatmeal cereal 2,5 mg/100 g 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’
Dihydrocapsiate (DHC) Other cereals 4,5 mg/100 g 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’
Dihydrocapsiate (DHC) Ice cream, dairy desserts 4 mg/100 g 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’
Dihydrocapsiate (DHC) Pudding mixes (ready to eat) 2 mg/100 g 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’
Dihydrocapsiate (DHC) Products based on yoghurt 2 mg/100 g 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’
Dihydrocapsiate (DHC) Chocolate confectionery 7,5 mg/100 g 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’
Dihydrocapsiate (DHC) Hard candy 27 mg/100 g 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’
Dihydrocapsiate (DHC) Sugar-free gum 115 mg/100 g 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’
Dihydrocapsiate (DHC) Whitener/creamer 40 mg/100 g 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’
Dihydrocapsiate (DHC) Sweeteners 200 mg/100 g 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’
Dihydrocapsiate (DHC) Soup (ready to eat) 1,1 mg/100 g 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’
Dihydrocapsiate (DHC) Salad dressing 16 mg/100 g 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’
Dihydrocapsiate (DHC) Vegetable protein 5 mg/100 g 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’
Dihydrocapsiate (DHC) Ready to eat meals 3 mg/meal 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’
Dihydrocapsiate (DHC) Meal replacements for weight control 3 mg/meal 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’
Dihydrocapsiate (DHC) Meal replacement for weight control (as drinks) 1 mg/100 ml 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’
Dihydrocapsiate (DHC) Food Supplements as defined in Directive 2002/46/EC 3 mg/single intake 9 mg/day 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’
Dihydrocapsiate (DHC) Non-alcoholic powdered drink mixes 14,5 mg/kg equivalent to 1,5 mg/100 ml 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’
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 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’
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 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’
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’
Echium plantagineum oil Milk-based products and drinkable yoghurt products delivered in a single dose 250 mg/100 g; 75 mg/100 g for drinks The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined echium oil’
Echium plantagineum oil Cheese preparations 750 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined echium oil’
Echium plantagineum oil Spreadable fat and dressings 750 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined echium oil’
Echium plantagineum oil Breakfast cereals 625 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined echium oil’
Echium plantagineum oil Food supplements as defined in Directive 2002/46/EC 500 mg/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined echium oil’
Echium plantagineum oil 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined echium oil’
Echium plantagineum oil Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control 250 mg/meal The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined echium oil’
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
Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis) Foods including food supplements as defined in Directive 2002/46/EC 150 mg of extract in one portion of food or food supplement The labelling shall bear a statement that consumers should not consume more than 300 mg of extract per day
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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘L-ergothioneine’
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’
Ferric Sodium EDTA Food supplements as defined in Directive 2002/46/EC 18 mg/day for children 75 mg/day for adults The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ferric Sodium EDTA’
Ferric Sodium EDTA Foods covered by Regulation (EU) No 609/2013 12 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ferric Sodium EDTA’
Ferric Sodium EDTA Foods fortified in accordance with Regulation (EC) No 1925/2006 12 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ferric Sodium EDTA’
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’
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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ferrous ammonium phosphate’
Ferrous ammonium phosphate Foods covered by Regulation (EU) No 609/2013 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 ‘Ferrous ammonium phosphate’
Ferrous ammonium phosphate Foods fortified in accordance with Regulation (EC) No 1925/2006 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 ‘Ferrous ammonium phosphate’
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’
Fish peptides from Sardinops sagax Foods based on yoghurt, yoghurt drinks, fermented milk products, and powdered milk 0,48 g/100 g (ready to eat/drink) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish (Sardinops sagax) peptides’
Fish peptides from Sardinops sagax Flavoured water, and vegetable-based drinks 0,3 g/100 g (ready to drink) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish (Sardinops sagax) peptides’
Fish peptides from Sardinops sagax Breakfast cereals 2 g/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish (Sardinops sagax) peptides’
Fish peptides from Sardinops sagax Soups, stews and soup powders 0,3 g/100 g (ready to eat) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish (Sardinops sagax) peptides’
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.
Flavonoids from Glycyrrhiza glabra Beverages based on milk 120 mg/day 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.
Flavonoids from Glycyrrhiza glabra Beverages based on yoghurt 120 mg/day 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.
Flavonoids from Glycyrrhiza glabra Beverages based on fruit or vegetables 120 mg/day 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.
Flavonoids from Glycyrrhiza glabra Food Supplements as defined in Directive 2002/46/EC 120 mg/day 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.
Flavonoids from Glycyrrhiza glabra Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 120 mg/day 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.
Flavonoids from Glycyrrhiza glabra Foods for special medical purposes as defined in Regulation (EU) No 609/2013 120 mg/day 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.
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 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 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fucoidan extract from seaweed Undaria pinnatifida’
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.
2′-Fucosyllactose Unflavoured pasteurised and sterilised (including UHT) milk-based products 1,2 g/l 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.
2′-Fucosyllactose Unflavoured fermented milk-based products 1,2 g/l beverages 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.
2′-Fucosyllactose Unflavoured fermented milk-based products 19,2 g/kg products other than beverages 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.
2′-Fucosyllactose Flavoured fermented milk-based products including heat-treated products 1,2 g/l beverages 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.
2′-Fucosyllactose Flavoured fermented milk-based products including heat-treated products 19,2 g/kg products other than beverages 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.
2′-Fucosyllactose Dairy analogues, including beverage whiteners 1,2 g/l beverages 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.
2′-Fucosyllactose Dairy analogues, including beverage whiteners 12 g/kg for products other than beverages 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.
2′-Fucosyllactose Dairy analogues, including beverage whiteners 400 g/kg for whitener 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.
2′-Fucosyllactose Cereal bars 12 g/kg 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.
2′-Fucosyllactose Table-top sweeteners 200 g/kg 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.
2′-Fucosyllactose 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 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.
2′-Fucosyllactose 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 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.
2′-Fucosyllactose 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. 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.
2′-Fucosyllactose Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 1,2 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer 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.
2′-Fucosyllactose 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 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.
2′-Fucosyllactose 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 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.
2′-Fucosyllactose Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 4,8 g/l for drinks 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.
2′-Fucosyllactose Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 40 g/kg for bars 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.
2′-Fucosyllactose 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 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.
2′-Fucosyllactose Flavoured drinks 1,2 g/l 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.
2′-Fucosyllactose 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 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.
2′-Fucosyllactose Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants 3,0 g/day for general population 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.
2′-Fucosyllactose Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants 1,2 g/day for young children 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.
Galacto-oligosaccharide Specified food category Maximum levels (expressed as ratio kg galacto-oligosaccharide/kg final food)
Galacto-oligosaccharide Food Supplements as defined in Directive 2002/46/EC 0,333
Galacto-oligosaccharide Milk 0,020
Galacto-oligosaccharide Milk drinks 0,030
Galacto-oligosaccharide Meal replacement for weight control (as drinks) 0,020
Galacto-oligosaccharide Dairy analogue drinks 0,020
Galacto-oligosaccharide Yoghurt 0,033
Galacto-oligosaccharide Dairy based deserts 0,043
Galacto-oligosaccharide Frozen dairy deserts 0,043
Galacto-oligosaccharide Fruit drinks and energy drinks 0,021
Galacto-oligosaccharide Infant meal replacement drinks 0,012
Galacto-oligosaccharide Baby juice 0,025
Galacto-oligosaccharide Baby yogurt drink 0,024
Galacto-oligosaccharide Baby desert 0,027
Galacto-oligosaccharide Baby snack 0,143
Galacto-oligosaccharide Baby cereals 0,027
Galacto-oligosaccharide Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen 0,013
Galacto-oligosaccharide Juice 0,021
Galacto-oligosaccharide Fruit pie fillings 0,059
Galacto-oligosaccharide Fruit preparations 0,125
Galacto-oligosaccharide Bars 0,125
Galacto-oligosaccharide Cereals 0,125
Galacto-oligosaccharide Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 0,008
Glucosamine HCl Specified food category Maximum levels
Glucosamine HCl Food Supplements as defined in Directive 2002/46/EC In line with normal food use of glucosamine from shell fish
Glucosamine HCl Foods covered by Regulation (EU) No 609/2013 In line with normal food use of glucosamine from shell fish
Glucosamine HCl In line with normal food use of glucosamine from shell fish
Glucosamine HCl Meal replacement for weight control In line with normal food use of glucosamine from shell fish
Glucosamine HCl Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen In line with normal food use of glucosamine from shell fish
Glucosamine HCl Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 In line with normal food use of glucosamine from shell fish
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.
Guar Gum Fresh dairy products such as yogurts, fermented milks, fresh cheeses and other dairy-based desserts. 1,5 g/100 g 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.
Guar Gum Fruit or vegetable-based liquid foodstuffs (of the ‘smoothie’ variety) 1,8 g/100 g 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.
Guar Gum Fruit or vegetable-based compotes 3,25 g/100 g 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.
Guar Gum 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 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.
Heat-treated milk products fermented with Bacteroides xylanisolvens Specified food category Maximum levels
Heat-treated milk products fermented with Bacteroides xylanisolvens 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’
Hydroxytyrosol Fish and vegetable oils, (except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/201317), placed as such on the market 0,215 g/kg 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’
Hydroxytyrosol 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 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’
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  % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ice Structuring Protein’
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’
Aqueous 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Extracts of dried leaves of Ilex guayusa’
Aqueous extracts of dried leaves of Ilex guayusa Food Supplements as defined in Directive 2002/46/EC In line with normal use in herbal infusions and food supplements of a similar aqueous extract of dried leaves of Ilex paraguariensis The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Extracts of dried leaves of Ilex guayusa’
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’.
Isomalto-oligosaccharide Energy-Reduced Soft Drinks 6,5  % 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’.
Isomalto-oligosaccharide Energy Drinks 5,0  % 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’.
Isomalto-oligosaccharide Foods intended to meet the expenditure of intense muscular efforts, especially for sportsmen (including isotonic drinks) 6,5  % 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’.
Isomalto-oligosaccharide Fruit Juices 5 % 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’.
Isomalto-oligosaccharide Processed Vegetables and Vegetable Juices 5 % 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’.
Isomalto-oligosaccharide Other Soft Drinks 5 % 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’.
Isomalto-oligosaccharide Cereals Bars 10 % 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’.
Isomalto-oligosaccharide Cookies, Biscuits 20 % 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’.
Isomalto-oligosaccharide Breakfast Cereal Bars 25 % 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’.
Isomalto-oligosaccharide Hard Candies 97 % 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’.
Isomalto-oligosaccharide Soft Candies/Chocolate Bars 25 % 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’.
Isomalto-oligosaccharide Meal replacement for weight control (as bars or milk based) 20 % 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’.
Isomaltulose Not specified 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 The designation of the novel food on the labelling of the food supplements containing it shall be ‘Lactitol’
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.
Lacto-N-neotetraose Unflavoured pasteurised and sterilised (including UHT) milk-based products 0,6 g/l 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.
Lacto-N-neotetraose Unflavoured fermented milk-based products 0,6 g/l for beverages 9,6 g/kg for products other than beverages 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.
Lacto-N-neotetraose Flavoured fermented milk-based products including heat-treated products 0,6 g/l for beverages 9,6 g/kg for products other than beverages 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.
Lacto-N-neotetraose Dairy analogues, including beverage whiteners 0,6 g/l for beverages 6 g/kg for products other than beverages 200 g/kg for whitener 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.
Lacto-N-neotetraose Cereal bars 6 g/kg 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.
Lacto-N-neotetraose Table-top sweeteners 100 g/kg 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.
Lacto-N-neotetraose 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 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.
Lacto-N-neotetraose 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 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.
Lacto-N-neotetraose 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 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.
Lacto-N-neotetraose 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 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.
Lacto-N-neotetraose 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 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.
Lacto-N-neotetraose 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 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.
Lacto-N-neotetraose 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 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.
Lacto-N-neotetraose Flavoured drinks 0,6 g/l 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.
Lacto-N-neotetraose 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 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.
Lacto-N-neotetraose 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 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.
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 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’.
Lycopene Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene Fruit/vegetable juice-based drinks (including concentrates) 2,5 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen 2,5 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control 8 mg/meal The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene Breakfast cereals 5 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene Fats and dressings 10 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene Soups other than tomato soups 1 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene Bread (including crispy breads) 3 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene Food supplements as defined in Directive 2002/46/EC 15 mg/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
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’
Lycopene from Blakeslea trispora Fruit/vegetable juice-based drinks (including concentrates) 2,5 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from Blakeslea trispora Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen 2,5 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from Blakeslea trispora Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control 8 mg/meal The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from Blakeslea trispora Breakfast cereals 5 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from Blakeslea trispora Fats and dressings 10 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from Blakeslea trispora Soups other than tomato soups 1 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from Blakeslea trispora Bread (including crispy breads) 3 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from Blakeslea trispora 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from Blakeslea trispora Food supplements as defined in Directive 2002/46/EC 15 mg/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
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’
Lycopene from tomatoes Fruit/vegetable juice-based drinks (including concentrates) 2,5 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from tomatoes Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen 2,5 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from tomatoes Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control 8 mg/meal The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from tomatoes Breakfast cereals 5 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from tomatoes Fats and dressings 10 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from tomatoes Soups other than tomato soups 1 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from tomatoes Bread (including crispy breads) 3 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from tomatoes 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
Lycopene from tomatoes Food supplements as defined in Directive 2002/46/EC 15 mg/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’
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’
Lycopene oleoresin from tomatoes Fruit/vegetable juice-based drinks (including concentrates) 2,5 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene oleoresin from tomatoes’
Lycopene oleoresin from tomatoes Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen 2,5 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene oleoresin from tomatoes’
Lycopene oleoresin from tomatoes Total diet replacement for weight control covered by Regulation (EU) No 609/2013 and meal replacements for weight control 8 mg/meal The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene oleoresin from tomatoes’
Lycopene oleoresin from tomatoes Breakfast cereals 5 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene oleoresin from tomatoes’
Lycopene oleoresin from tomatoes Fats and dressings 10 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene oleoresin from tomatoes’
Lycopene oleoresin from tomatoes Soups other than tomato soups 1 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene oleoresin from tomatoes’
Lycopene oleoresin from tomatoes Bread (including crispy breads) 3 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene oleoresin from tomatoes’
Lycopene oleoresin from tomatoes 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene oleoresin from tomatoes’
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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Magnesium citrate malate’
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’
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. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Magnolia Bark Extract’
Magnolia Bark Extract Chewing gum 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. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Magnolia Bark Extract’
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’
Maize-germ oil high in unsaponifiable matter Food Supplements as defined in Directive 2002/46/EC 2 g/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Maize-germ oil extract’
Maize-germ oil high in unsaponifiable matter Chewing gum 2 % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Maize-germ oil extract’
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
Methylcellulose Edible ices 2 % 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
Methylcellulose Flavoured drinks 2 % 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
Methylcellulose Flavoured or unflavoured fermented milk products 2 % 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
Methylcellulose Cold desserts (dairy, fat, fruit, cereal, egg-based products) 2 % 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
Methylcellulose Fruit preparations (pulps, purees or compotes) 2 % 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
Methylcellulose Soups and broths 2 % 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
(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 The designation of the novel food on the labelling of the food supplements containing it shall be ‘Organic silicon (monomethylsilanetriol)’
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’
Mycelial extract from Shiitake mushroom (Lentinula edodes) Bread products 2 ml/100 g 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’
Mycelial extract from Shiitake mushroom (Lentinula edodes) Soft drinks 0,5 ml/100 ml 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’
Mycelial extract from Shiitake mushroom (Lentinula edodes) Ready prepared meals 2,5 ml per meal 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’
Mycelial extract from Shiitake mushroom (Lentinula edodes) Foods based on yoghurt 1,5 ml/100 ml 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’
Mycelial extract from Shiitake mushroom (Lentinula edodes) Food supplements as defined in Directive 2002/46/EC 2,5 ml per day dose 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’
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 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 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’
Noni fruit puree and concentrate (Morinda citrifolia) Fruit puree 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’
Noni fruit puree and concentrate (Morinda citrifolia) Candy/confectionery 45 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Cereal bars 53 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Powdered nutritional drink mixes (dry weight) 53 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Carbonated beverages 11 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Ice cream & sorbet 31 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Yoghurt 12 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Biscuits 53 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Buns, cakes and pastries 53 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Breakfast cereals (wholegrain) 88 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) 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 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’
Noni fruit puree and concentrate (Morinda citrifolia) Sweet spreads, fillings and icings 31 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Savoury sauces, pickles, gravies and condiments 88 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Food Supplements as defined in Directive 2002/46/EC 26 g/day 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’
Noni fruit puree and concentrate (Morinda citrifolia) Fruit concentrate 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’
Noni fruit puree and concentrate (Morinda citrifolia) Candy/Confectionery 10 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Cereal bars 12 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Powdered nutritional drink mixes (dry weight) 12 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Carbonated beverages 3 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Ice cream & sorbet 7 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Yoghurt 3 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Biscuits 12 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Buns, cakes and pastries 12 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Breakfast cereals (wholegrain) 20 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Jams and jellies in accordance with Directive 2001/113/EC 30 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Sweet spreads, fillings and icings 7 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Savoury sauces, pickles, gravies and condiments 20 g/100 g 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’
Noni fruit puree and concentrate (Morinda citrifolia) Food Supplements as defined in Directive 2002/46/EC 6 g/day 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’
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 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 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Morinda citrifolia fruit powder’ or ‘Noni fruit powder’
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’
Odontella aurita microalgae Flavoured pasta 1,5  % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Odontella aurita microalgae’
Odontella aurita microalgae Fish soups 1 % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Odontella aurita microalgae’
Odontella aurita microalgae Marine terrines 0,5  % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Odontella aurita microalgae’
Odontella aurita microalgae Broth preparations 1 % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Odontella aurita microalgae’
Odontella aurita microalgae Crackers 1,5  % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Odontella aurita microalgae’
Odontella aurita microalgae Frozen breaded fish 1,5  % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Odontella aurita microalgae’
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
Oil enriched with phytosterols/phytostanols 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. In accordance with Annex III.5 to Regulation (EU) No 1169/2011
Oil enriched with phytosterols/phytostanols 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 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. In accordance with Annex III.5 to Regulation (EU) No 1169/2011
Oil enriched with phytosterols/phytostanols Soya drinks 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. In accordance with Annex III.5 to Regulation (EU) No 1169/2011
Oil enriched with phytosterols/phytostanols Salad dressings, mayonnaise and spicy sauces 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. In accordance with Annex III.5 to Regulation (EU) No 1169/2011
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’.
Oil extracted from squids Dairy products except milk-based beverages 200 mg/100 g or for cheese products 600 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’.
Oil extracted from squids Dairy analogues except drinks 200 mg/100 g or for analogues to cheese products 600 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’.
Oil extracted from squids Spreadable fat and dressings 600 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’.
Oil extracted from squids Breakfast cereals 500 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’.
Oil extracted from squids Bakery products (breads and bread rolls) 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’.
Oil extracted from squids Cereal bars 500 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’.
Oil extracted from squids Non-alcoholic beverages (including milk-based beverages) 60 mg/100 ml The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’.
Oil extracted from squids Food Supplements as defined in Directive 2002/46/EC 3 000  mg/day for general population 450 mg/day for pregnant and lactating women The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’.
Oil extracted from squids 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’.
Oil extracted from squids Total diet replacement for weight control defined in Regulation (EU) No 609/2013 and meal replacements for weight control 200 mg/meal The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’.
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
Pasteurised fruit-based preparations produced using high-pressure treatment Types of fruit: apple, apricot, banana, blackberry, blueberry, cherry, coconut, fig, grape, grapefruit, mandarin, mango, melon, peach, pear, pineapple, prune, raspberry, rhubarb, strawberry 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
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’
Phosphated maize starch Baked bakery products 15 % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phosphated maize starch’
Phosphated maize starch Pasta 15 % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phosphated maize starch’
Phosphated maize starch Breakfast cereals 15 % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phosphated maize starch’
Phosphated maize starch Cereal bars 15 % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phosphated maize starch’
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’
Phosphatidylserine from fish phospholipids Beverages based on yoghurt 50 mg/100 ml The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish phosphatidylserine’
Phosphatidylserine from fish phospholipids Powders based on milk powders 3 500  mg/100 g (equivalent to 40 mg/100 ml ready to drink) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish phosphatidylserine’
Phosphatidylserine from fish phospholipids Foods based on yoghurt 80 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish phosphatidylserine’
Phosphatidylserine from fish phospholipids Cereal bars 350 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish phosphatidylserine’
Phosphatidylserine from fish phospholipids Chocolate based confectionary 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish phosphatidylserine’
Phosphatidylserine from fish phospholipids Foods for special medical purposes as defined in Regulation (EU) No 609/2013 In compliance with Regulation (EU) No 609/2013 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish phosphatidylserine’
Phosphatidylserine from fish phospholipids Food supplements as defined in Directive 2002/46/EC 300 mg/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish phosphatidylserine’
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’
Phosphatidylserine from soya phospholipids Beverages based on yoghurt 50 mg/100 ml The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Soya phosphatidylserine’
Phosphatidylserine from soya phospholipids Powders based on milk powder 3,5 g/100 g (equivalent to 40 mg/100 ml ready to drink) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Soya phosphatidylserine’
Phosphatidylserine from soya phospholipids Foods based on yoghurt 80 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Soya phosphatidylserine’
Phosphatidylserine from soya phospholipids Cereal bars 350 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Soya phosphatidylserine’
Phosphatidylserine from soya phospholipids Chocolate based confectionary 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Soya phosphatidylserine’
Phosphatidylserine from soya phospholipids Foods for special medical purposes as defined in Regulation (EU) No 609/2013 In compliance with Regulation (EU) No 609/2013 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Soya phosphatidylserine’
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
Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid Breakfast cereals 80 mg/100 g 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
Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid Cereal bars 350 mg/100 g 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
Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid Foods based on yogurt 80 mg/100 g 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
Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid Soy-based yogurt-like products 80 mg/100 g 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
Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid Yogurt based-drinks 50 mg/100 g 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
Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid Soy-based yogurt-like drinks 50 mg/100 g 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
Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid Powders based on milk powder 3,5 g/100 g (equivalent to 40 mg/100 ml ready-to drink) 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
Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid Food Supplements as defined in Directive 2002/46/EC 800 mg/day 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
Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid Foods for special medical purposes as defined in Regulation (EU) No 609/2013 In compliance with Regulation (EU) No 609/2013 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
Phospholipides from egg yolk Specified food category Maximum levels
Phospholipides from egg yolk Not specified 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 % The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phytoglycogen’
Phytosterols/phytostanols Specified food category Maximum levels In accordance with Annex III.5 of Regulation (EU) No 1169/2011
Phytosterols/phytostanols 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 In accordance with Annex III.5 of Regulation (EU) No 1169/2011
Phytosterols/phytostanols 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. 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 In accordance with Annex III.5 of Regulation (EU) No 1169/2011
Phytosterols/phytostanols Salad dressings, mayonnaise and spicy sauces. 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 In accordance with Annex III.5 of Regulation (EU) No 1169/2011
Phytosterols/phytostanols Soya drink 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 In accordance with Annex III.5 of Regulation (EU) No 1169/2011
Phytosterols/phytostanols 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. 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 In accordance with Annex III.5 of Regulation (EU) No 1169/2011
Phytosterols/phytostanols 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 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 In accordance with Annex III.5 of Regulation (EU) No 1169/2011
Phytosterols/phytostanols 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. 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 In accordance with Annex III.5 of Regulation (EU) No 1169/2011
Phytosterols/phytostanols Food Supplements as defined in Directive 2002/46/EC 3 g/day In accordance with Annex III.5 of Regulation (EU) No 1169/2011
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 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 × 106 PPI/day) PPU – Prolyl Peptidase Units or Proline Protease Units PPI – Protease Picomole International The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Prolyl oligopeptidase’
Protein extract from pig kidneys Specified food category Maximum levels
Protein extract from pig kidneys 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)
Protein extract from pig kidneys Food for special medical purposes as defined in Regulation (EU) No 609/2013 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)
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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rapeseed oil extract’
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 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) 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) 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.
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’
Rooster comb extract Milk-based drinks 40 mg/100 g or mg/100 ml The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rooster comb extract’ or ‘Cockerel comb extract’
Rooster comb extract Milk based fermented drinks 80 mg/100 g or mg/100 ml The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rooster comb extract’ or ‘Cockerel comb extract’
Rooster comb extract Yoghurt-type products 65 mg/100 g or mg/100 ml The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rooster comb extract’ or ‘Cockerel comb extract’
Rooster comb extract Fromage frais 110 mg/100 g or mg/100 ml The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rooster comb extract’ or ‘Cockerel comb extract’
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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sacha inchi oil (Plukenetia volubilis)’
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 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.
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.’
Schizochytrium sp. oil rich in DHA and EPA Food Supplements as defined in Directive 2002/46/EC for adult population excluding pregnant and lactating women 3 000  mg/day 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.’
Schizochytrium sp. oil rich in DHA and EPA Food Supplements as defined in Directive 2002/46/EC for pregnant and lactating women 450 mg/day 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.’
Schizochytrium sp. oil rich in DHA and EPA 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 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.’
Schizochytrium sp. oil rich in DHA and EPA Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control 250 mg/meal 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.’
Schizochytrium sp. oil rich in DHA and EPA Milk-based drinks and similar products intended for young children 200 mg/100 g 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.’
Schizochytrium sp. oil rich in DHA and EPA Processed cereal based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 200 mg/100 g 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.’
Schizochytrium sp. oil rich in DHA and EPA Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen 200 mg/100 g 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.’
Schizochytrium sp. oil rich in DHA and EPA Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 200 mg/100 g 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.’
Schizochytrium sp. oil rich in DHA and EPA Bakery Products (Breads, Rolls and Sweet Biscuits) 200 mg/100 g 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.’
Schizochytrium sp. oil rich in DHA and EPA Breakfast Cereals 500 mg/100 g 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.’
Schizochytrium sp. oil rich in DHA and EPA Cooking Fats 360 mg/100 g 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.’
Schizochytrium sp. oil rich in DHA and EPA Dairy Analogues except drinks 600 mg/100 g for cheese; 200 mg/100 g for soy and imitation milk products (excluding drinks) 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.’
Schizochytrium sp. oil rich in DHA and EPA 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) 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.’
Schizochytrium sp. oil rich in DHA and EPA Non-alcoholic Beverages (including dairy analogue and milk-based drinks) 80 mg/100 g 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.’
Schizochytrium sp. oil rich in DHA and EPA Cereal/Nutrition Bars 500 mg/100 g 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.’
Schizochytrium sp. oil rich in DHA and EPA Spreadable Fats and Dressings 600 mg/100 g 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.’
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)’
Schizochytrium sp. (ATCC PTA-9695) oil Dairy products except milk-based drinks 200 mg/100 g or for cheese products 600 mg/100 g 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Dairy analogues except drinks 200 mg/100 g or for analogues to cheese products 600 mg/100 g 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Spreadable fats and dressings 600 mg/100 g 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Breakfast cereals 500 mg/100 g 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Food Supplements as defined in Directive 2002/46/EC 250 mg DHA/day for general population 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Food Supplements as defined in Directive 2002/46/EC 450 mg DHA/day for pregnant and lactating women 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control 250 mg/meal 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Milk-based drinks and similar products intended for young children 200 mg/100 g 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen 200 mg/100 g 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 200 mg/100 g 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)’
Schizochytrium sp. (ATCC PTA-9695) oil 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 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Bakery products (breads,rolls, and, sweet biscuits) 200 mg/100 g 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Cereal bars 500 mg/100 g 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Cooking fats 360 mg/100 g 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Non-alcoholic beverages (including dairy analogue and milk-based drinks) 80 mg/100 ml 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 In accordance with Regulation (EU) No 609/2013 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)’
Schizochytrium sp. (ATCC PTA-9695) oil Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 200 mg/100 g 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)’
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.’
Schizochytrium sp. oil Dairy products except milk-based drinks 200 mg/100 g or for cheese products 600 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Dairy analogues except drinks 200 mg/100 g or for analogues to cheese products 600 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Spreadable fats and dressings 600 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Breakfast cereals 500 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Food Supplements as defined in Directive 2002/46/EC 250 mg DHA/day for general population The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Food Supplements as defined in Directive 2002/46/EC 450 mg DHA/day for pregnant and lactating women The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control 250 mg/meal The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Milk-based drinks and similar products intended for young children 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Bakery products (breads, rolls and sweet biscuits) 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Cereal bars 500 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Cooking fats 360 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. oil Non-alcoholic beverages (including dairy analogue and milk-based drinks) 80 mg/100 ml The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
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.’
Schizochytrium sp. (T18) oil Dairy products except milk-based drinks 200 mg/100 g or for cheese products 600 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Dairy analogues except drinks 200 mg/100 g or for analogues to cheese products 600 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Spreadable fats and dressings 600 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Breakfast cereals 500 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Food Supplements as defined in Directive 2002/46/EC 250 mg DHA/day for general population The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Food Supplements as defined in Directive 2002/46/EC 450 mg DHA/day for pregnant and lactating women The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control 250 mg/meal The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Milk-based drinks and similar products intended for young children 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Bakery products (breads, rolls and, sweet biscuits) 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Cereal bars 500 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Cooking fats 360 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Non-alcoholic beverages (including dairy analogue and milk-based drinks) 80 mg/100 ml The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 In accordance with Regulation (EU) No 609/2013 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
Schizochytrium sp. (T18) oil Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 200 mg/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’
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 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.
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’
Spermidine-rich wheat germ extract (Triticum aestivum) 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 The designation of the novel food on the labelling of the food supplements containing it shall be ‘spermidine-rich wheat germ extract’
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 Not specified 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.
Sugar cane fibre Specified food category Maximum levels
Sugar cane fibre Bread 8 %
Sugar cane fibre Bakery goods 5 %
Sugar cane fibre Meat and muscle products 3 %
Sugar cane fibre Seasonings and spices 3 %
Sugar cane fibre Grated cheeses 2 %
Sugar cane fibre Special diet foods 5 %
Sugar cane fibre Sauces 2 %
Sugar cane fibre 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sunflower oil extract’
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’
Dried Tetraselmis chuii microalgae Sauces 20 % or 250mg/day 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’
Dried Tetraselmis chuii microalgae Special salts 1 % 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’
Dried Tetraselmis chuii microalgae Condiment 250 mg/day 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’
Dried Tetraselmis chuii microalgae Food Supplements as defined in Directive 2002/46/EC 250 mg/day 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’
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 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 Not specified 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’.
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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘taxifolin-rich extract’.
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 Not specified 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’.
UV-treated mushrooms (Agaricus bisporus) Specified food category Maximum levels of vitamin D2
UV-treated mushrooms (Agaricus bisporus) 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’
UV-treated baker’s yeast (Saccharomyces cerevisiae) Yeast-leavened breads and rolls 5 μg of vitamin D2/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Vitamin D yeast’ or ‘Vitamin D2 yeast’
UV-treated baker’s yeast (Saccharomyces cerevisiae) Yeast-leavened fine bakery wares 5 μg of vitamin D2/100 g The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Vitamin D yeast’ or ‘Vitamin D2 yeast’
UV-treated baker’s yeast (Saccharomyces cerevisiae) Food Supplements as defined in Directive 2002/46/EC 5 μg of vitamin D2/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Vitamin D yeast’ or ‘Vitamin D2 yeast’
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’
UV-treated bread Yeast leavened bread and rolls (without toppings) 3 μg vitamin D2/100 g The designation on the label of the novel food shall be accompanied by ‘contains vitamin D produced by UV-treatment’
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’.
UV-treated milk 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 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’.
UV-treated milk 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 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’.
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 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.
Wheat bran extract Beer and substitutes 0,4 g/100 g 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.
Wheat bran extract Ready to eat cereals 9 g/100 g 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.
Wheat bran extract Dairy products 2,4 g/100 g 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.
Wheat bran extract Fruit and vegetable juices 0,6 g/100 g 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.
Wheat bran extract Soft drinks 0,6 g/100 g 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.
Wheat bran extract Meat preparations 2 g/100 g 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.
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’
Yeast 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 1,275 g/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans 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 The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Beverages based on fruit and/or vegetable juices including concentrate and dehydrated juices 1,3 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Fruit-flavoured drinks 0,8 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Cocoa beverages preparation powder 38,3 g/kg (powder) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Other beverages 0,8 g/kg (ready to drink) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Other beverages 7 g/kg (powder) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Cereal bars 6 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Breakfast cereals 15,3 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Wholegrain and high fibre instant hot breakfast cereals 1,5 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Cookie-type biscuits 6,7 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Cracker-type biscuits 6,7 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Milk based beverages 3,8 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Fermented milk products 3,8 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Milk product analogues 3,8 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Dried milk/milk powder 25,5 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Soups and soup mixes 0,9 g/kg (ready to eat) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Soups and soup mixes 1,8 g/kg (condensed) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Soups and soup mixes 6,3 g/kg (powder) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Chocolate and confectionery 4 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Protein bars and powders 19,1 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Yeast beta-glucans Jam, marmalade and other fruit spreads 11,3 g/kg The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’
Zeaxanthin Specified food category Maximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘synthetic zeaxanthin’
Zeaxanthin Food Supplements as defined in Directive 2002/46/EC 2 mg/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘synthetic zeaxanthin’
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’
Zinc L-pidolate Foods covered by Regulation (EU) No 609/2013 3 g/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Zinc L-pidolate’
Zinc L-pidolate Milk based drinks and similar products intended for young children 3 g/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Zinc L-pidolate’
Zinc L-pidolate Meal replacement for weight control 3 g/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Zinc L-pidolate’
Zinc L-pidolate Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen 3 g/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Zinc L-pidolate’
Zinc L-pidolate Food bearing statement on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 3 g/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Zinc L-pidolate’
Zinc L-pidolate Food Supplements as defined in Directive 2002/46/EC 3 g/day The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Zinc L-pidolate’

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