COMMI SSION IMPLEMENTING REGUL ATION (EU) 2017/2470 
of 20 December 2017 
establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the 
European Parliament and of the Council on novel foods 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, amending 
Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) 
No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in 
particular Article 8 thereof, 
Whereas: 
(1)  Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods within the 
Union. 
(2)  Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission has to establish the Union list of novel 
foods author ised or notifi ed under Regulation (EC) No 258/97 of the European Parliament and of the Council (2). 
(3)  The Union list of novel foods is to apply without prejudice to other provisions laid down in sector specifi c 
legislation. 
(4)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Union list of author ised novel foods 
The Union list of novel foods author ised to be placed on the market within the Union as refer red to in Article 6(1) of 
Regulation (EU) 2015/2283 is hereby established and set out in the Annex to this Regulation. 
Article 2 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 20 December 2017. 
For the Commission 
The President 
Jean-Claude JUNCK ER  30.12.2017 L 351/72 Official Jour nal of the European Union EN     
(1)OJ L 327, 11.12.2015, p. 1. 
(2)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel foods and novel food 
ingredients (OJ L 43, 14.2.1997, p. 1). ANNEX 
UNION LIST OF NOVEL FOODS 
Content of the list 
1.  The Union list shall consist of Tables 1 and 2. 
2.  Table 1 includes the author ised novel foods and contains the followi ng information: 
Column 1:  Author ised novel food 
Column 2:  Conditions under which the novel food may be used. This column is further subdivided into two: 
Specified food catego ry and Maximum levels 
Column 3:  Additional specific labelling requirements 
Column 4:  Other requirements 
3.  Table 2 includes the specifi cations on novel foods and contains the followi ng information: 
Column 1:  Author ised novel food 
Column 2:  Specifications  30.12.2017 L 351/73 Official Jour nal of the European Union EN     Table 1: Author ised novel foods 
Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
N-A cetyl-D-neuraminic acid Specified food categor y 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 chil­
dren under 10 years of age where they 
consume breast milk or other foods with 
added N-acetyl-D-neuraminic acid within 
the same twenty four hour period.  Infant and follo w-on formulae as defined 
by Regulation (EU) No 609/2013 (1) 0,05 g/L of reconstitute d formula 
Processed cereal-based foods and baby 
foods for infants and young children 
as defined by Regulation (EU) 
No 609/2013 0,05 g/kg for solid foods 
Foods for special medical purposes for 
infants and young children as defined by 
Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the infants and 
young children for whom the products 
are intended but in any case not higher 
than the maximum levels specifi ed for 
the cate gory mentioned in the table cor­
responding to the products. 
Total diet replacement foods for weight 
control as defined by Regulation (EU) 
No 609/2013 0,2 g/L (drinks) 
1,7 g/kg (bars) 
Foods bear ing statements on the absence 
or reduced presence of gluten in accor ­
dance with the requirements of Com ­
mission Implementing Regulation (EU) 
No 828/2014 (2) 1,25 g/kg 
Unf lavoured pasteur ised and sterilised  
(including UHT) milk -based products 0,05 g/L 
Unf lavoured fermented milk -based prod ­
ucts, heat treated after fermentation, fla­
vour ed fermented milk products includ ­
ing heat-treated products 0,05 g/L (beverages) 
0,4 g/kg (solids) 30.12.2017 L 351/74 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
Dair y analogues, including beverage 
whit eners 0,05 g/L (beverages) 
0,25 g/kg (solids) 
Cereal bars 0,5 g/kg 
Table top sweeteners 8,3 g/kg 
Fruit and veget able-based drinks 0,05 g/L 
Flavoured drinks 0,05 g/L 
Speciality coffee , tea, herbal and fruit 
infusions, chicor y; tea, herbal and fruit 
infusions and chicor y extracts; tea, plant, 
fruit and cereal preparations for infu ­
sions 0,2 g/kg 
Food Supplements as defined in Direc ­
tive 2002/46/EC (3) 300 mg/da y for general population older 
than 10 years 
55 mg/da y for infants 
130 mg/da y for young children 
250 mg/da y for children between 3 to 
10 years of age 
Adansonia digitata (Baobab) 
dried fruit pulp Not specified The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Baobab fruit pulp’  
Ajug a reptans extract from 
cell cultures Specified food categor y Maximum levels   
Food Supplements as defined in Direc ­
tive 2002/46/EC In line with normal use in food supple ­
ments of a similar extract of the flower­
ing aerial parts of Ajug a reptans 30.12.2017 L 351/75 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
L-Alan yl-L -Glutamin e Specified food categor y Maximum levels   
Food Supplements as defined in Direc ­
tive 2002/46/EC  
Foods for special medical purposes as de­
fined in Regulation (EU) No 609/2013 
excl uding foods for infants and young 
children 
Algal oil from the 
microalgae Ulkenia sp. Specified food categor y 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.’  Baker y products (breads, rolls and sweet 
biscuits) 200 mg/100 g 
Cereal bars 500 mg/100 g 
Non-alcoholic beverages (including milk 
based beverages ) 60 mg/100 ml 
Allanblac kia seed oil Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Allanblackia seed oil’  Yellow fat spreads and cream based 
spreads 20 g/100 g 
Aloe macroclada Baker leaf 
extract Specified food categor y Maximum levels   
Food Supplements as defined in Direc ­
tive 2002/46/EC In line with normal use in food supple ­
ments of the similar gel derived from 
Aloe vera (L.) Burm. 
Ant arctic Krill oil from 
Euphausia superba Specified food categor y 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 crusta ­
cean Antarctic Krill (Euphausia superba)’  Dair y products excep t milk -based drinks 200 mg/100 g or for cheese products 
600 mg/100 g 
Dair y analogues exce pt drinks 200 mg/100 g or for analogues to 
cheese products 600 mg/100 g 30.12.2017 L 351/76 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels of combined DHA and EPA   
Non-alcoholic beverages 
Milk -based drinks 
Dair y analogue drinks 80 mg/100 ml 
Spreadable fat and dressings 600 mg/100 g 
Cooking fats 360 mg/100 ml 
Breakfa st cereals 500 mg/100 g 
Baker y products (breads, rolls and sweet 
biscuits) 200 mg/100 g 
Nutr ition bars/cereal bars 500 mg/100 g 
Food Supplements as defined in Direc ­
tive 2002/46/EC 3 000 mg/da y for the general population 
450 mg/da y for pregnant and lactating 
women 
Foods for special medical purposes as de­
fined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 250 mg/meal 
Processed cereal-based food and baby 
food intended for infants and young chil­
dren covered by Regulation (EU) 
No 609/2013 200 mg/100 ml 
Foods intended to meet the expenditure 
of intense muscular effort, especially for 
spor tsmen 
Foods bear ing statements on the absence 
or reduced presence of gluten in accor ­
dance with the requirements of Com ­
mission Implementing Regulation (EU) 
No 828/2014 30.12.2017 L 351/77 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Ant arctic Krill oil rich in 
phospholipids from 
Euphausia superba Specified food categor y 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 crusta ­
cean Antarctic Krill (Euphausia superba)’  Dair y products excep t milk -based drinks 200 mg/100 g or for cheese products 
600 mg/100 g 
Dair y analogues exce pt drinks 200 mg/100 g or for analogues to 
cheese products 600 mg/100 g 
Non-alcoholic beverages 
Milk -based drinks 
Dair y analogue drinks 80 mg/100 ml 
Spreadable fat and dressings 600 mg/100 g 
Cooking fats 360 mg/100 ml 
Breakfa st cereals 500 mg/100 g 
Baker y products (breads, rolls and sweet 
biscuits) 200 mg/100 g 
Nutr ition bars/cereal bars 500 mg/100 g 
Food Supplements as defined in Direc ­
tive 2002/46/EC 3 000 mg/da y for the general population 
450 mg/da y for pregnant and lactating 
women 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 250 mg/meal 30.12.2017 L 351/78 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels of combined DHA and EPA   
Processed cereal-based food and baby 
food intended for infants and young chil­
dren covered by Regulation (EU) 
No 609/2013 200 mg/100 ml 
Foods intended to meet the expenditure 
of intense muscular effort, especially for 
spor tsmen 
Foods bear ing statements on the absence 
or reduced presence of gluten in accor ­
dance with the requirements of Com ­
mission Implementing Regulation (EU) 
No 828/2014 
Arachidonic acid-r ich oil 
from the fungus Mor tierella 
alpina Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Oil from Mor tierel la alpina’ or 
‘Mor tierella alpina oil’  Infant formula and follow-on formula as 
defined in Regulation (EU) No 609/2013 In accordance with Regulation (EU) 
No 609/2013 
Foods for special medical purposes for 
premature infants as defined in Regu ­
lation (EU) No 609/2013 In accordance with Regulation (EU) 
No 609/2013 
Argan oil from Arg ania 
spinosa Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Argan oil’ and if used as season ­
ing ‘Vegetable oil only for seasoning’ 
shall be mentioned on the label  As seasonings Not specified 
Food Supplements as defined in Direc ­
tive 2002/46/EC In line with normal food use of vege table 
oils 
Astaxanthin-r ich oleoresin 
from Haematococcus 
pluvialis algae Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Astaxanthin’  Food Supplements as defined in Direc ­
tive 2002/46/EC 40-80 mg/da y of oleoresin, resulting in 
≤ 8 mg astaxanthin per day 30.12.2017 L 351/79 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Basil seeds (Ocimum 
basilicum) Specified food categor y Maximum levels   
Fruit juice and fruit/veget able blend bev­
erages 3 g/200 ml for addition of whole basil 
seeds (Ocimum basilicum) 
Fermented black bean 
extract Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Fermented blac k bean (Soya) 
extract’ or ‘Fermented Soya extract’  Food Supplements as defined in Direc ­
tive 2002/46/EC 4,5 g/da y 
Bovine lactof errin Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Lactof errin from cows' milk’  Infant formula and follow-on formula as 
defined in Regulation (EU) No 609/2013  
(ready to drink) 100 mg/100 ml 
Foods on dair y basis intended for young 
children (ready to eat/dr ink) 200 mg/100 g 
Processed cereal food (solid) 670 mg/100 g 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 Depending on the needs of the indi ­
vidual up to 3 g/da y 
Beverages based on milk 200 mg/100 g 
Powdered drink mixes based on milk  
(ready to drink) 330 mg/100 g 
Beverages based on fermented milk 
(including yoghur t drinks) 50 mg/100 g 
Non-alcoholic drinks 120 mg/100 g 
Products based on yoghur t 80 mg/100 g 
Products based on cheese 2 000 mg/100 g 30.12.2017 L 351/80 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
Ice cream 130 mg/100 g 
Cakes and pastr ies 1 000 mg/100 g 
Candies 750 mg/100 g 
Chewing gum 3 000 mg/100 g 
Buglo ssoides arvensis seed 
oil Specified food categor y Maximum levels of stear idonic acid (STA) The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Refined Buglossoides oil’  Dair y products and analogues 250 mg/100 g 
75 mg/100 g for drinks 
Cheese and cheese products 750 mg/100 g 
Butter and other fat and oil emulsions 
including spreads (not for cooking or 
frying purposes) 750 mg/100 g 
Breakfa st cereals 625 mg/100 g 
Food supplements as defined in Directive 
2002/46/EC, excluding food supple ­
ments for infants and young children 500 mg/da y 
Foods for special medical purposes as de­
fined in Regulation (EU) No 609/2013, 
excl uding foods for special medical pur­
poses intende d for infants and young 
children In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 250 mg/meal 30.12.2017 L 351/81 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Calanus finmar chicus oil Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘oil from Calanus finmarchicus  
(crustacean)’  Food supplements as defined in Directive 
2002/46/EC 2,3 g/da y 
Chewing gum base  
(monometho xypoly ethy lene 
glycol) Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Gum base (including 1,3-buta ­
diene, 2-methyl -homopolymer , maleat ed, 
esters with polyeth ylene glycol mono-Me 
ether)’ or ‘Gum base (including CAS 
No: 1246080-53-4)’  Chewing gum 8 % 
Chewing gum base (Methyl 
vinyl ether -maleic 
anhy dride copolymer) Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Gum base (including meth yl 
vinyl ether -maleic anhydr ide copolymer)’ 
or ‘Gum base (including CAS No 9011- 
16-9)’  Chewing gum 2 % 
Chia oil from Salvia 
hispanica Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Chia oil (Salvia hispanica)’  Fats and oils 10 % 
Pure chia oil 2 g/da y 
Food Supplements as defined in Direc ­
tive 2002/46/EC 2 g/da y 
Chia seeds (Salvia hispanica) Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Chia seeds (Salvia 
hispanica)’ 
2.  Pre-packag ed Chia (Salvia hispanica) 
seeds shall carry additional labelling 
to inform the consumer that the daily 
intake is no more than 15 g.  Bread products 5 % (whole or ground chia seeds) 
Baked products 10 % whole chia seeds 
Breakfa st cereals 10 % whole chia seeds 
Fruit, nut and seed mixes 10 % whole chia seeds 30.12.2017 L 351/82 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
Fruit juice and fruit/veget able blend bev­
erages 15 g/da y for addition of whole, mashed 
or ground chia seeds 
Pre-packag ed Chia seed as such 15 g/da y whole chia seeds 
Fruit spreads 1 % whole chia seeds 
Yoghur t 1,3 g whole chia seeds per 100 g of 
yoghur t or 4,3 g whole chia seeds per 
330 g of yoghur t (por tion) 
Ster ilised ready to eat meals based on 
cereal grains, pseudocereals grains and/or 
pulses 5 % whole chia seeds 
Chitin-glucan from 
Aspergillus niger Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Chitin-g lucan from Aspergillus 
niger’  Food Supplements as defined in Direc ­
tive 2002/46/EC 5 g/da y 
Chitin-glucan complex from 
Fomes fomentar ius Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing 
it shall be ‘Chitin-g lucan from Fomes 
fomentar ius’  Food Supplements as defined in Direc ­
tive 2002/46/EC 5 g/da y 
Chit osan extract from fungi  
(Agaricus bispor us; 
Aspergillus niger) Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Chitosan extract from Agaricus 
bispor us’ or ‘Chitosan extract from 
Aspergillus niger ’  Food Supplements as defined in Direc ­
tive 2002/46/EC In line with normal use in food supple ­
ments of chitosan from crustaceans 
Chondroitin sulphate Specified food categor y Maximum levels The designation of the novel on the 
labelling of the foodstuff containing it 
shall be ‘Chondroitin sulphate derived 
from microbial fermentation and sulpha ­
tion’  Food supplements as defined in Directive 
2002/46/EC for adult population, ex­
cluding pregnant and lactating women 1 200 mg/da y 30.12.2017 L 351/83 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Chromium Picolinate Specified food categor y Maximum levels of total chromium The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Chromium Picolinate’  Foods covered by Regulation (EU) 
No 609/2013 250 µg/da y 
Foods fortified in accordance with Regu ­
lation (EC) No 1925/2006 (4) 
Cistus incanus L. Pandalis 
herb Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Cistus incanus L. Pandalis herb’  Herbal infusions Intende d daily intake: 3 g herbs/da y  
(2 cups/da y) 
Citicoline Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Citicoline ’ 
2.The labelling of foods containing citi­
coline shall bear a statement that the 
product is not intended to be con­
sumed by children  Food Supplements as defined in Direc ­
tive 2002/46/EC 500 mg/da y 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 250 mg per serving and a maximum 
daily consum ption level of 1 000 mg 
Clos tridium butyr icum Specified food categor y Maximum levels The designation of the novel food on 
the labelling of the foodstuffs contain ­
ing it shall be ‘Clostr idium butyr icum 
MIY AIRI 588 (CBM 588)’ or ‘Clostr idium 
butyr icum (CBM 588)’  Food Supplements as defined in Direc ­
tive 2002/46/EC 1,35 × 108 CFU/da y 
Extract of defatted cocoa 
powder Specified food categor y Maximum levels Consumers shall be instr ucted not to 
consume more than 600 mg polyphe ­
nols corresponding to 1,1 g of extract of 
defa tted cocoa powder per day  Nutr ition bars 1 g/da y and 300 mg polyphenols corre­
sponding to not more than 550 mg of 
extract of defatted cocoa powder in one 
portion of food (or food supplement) Milk based beverages 
Any other foods (including food sup­
plements as defined in Directive 
2002/46/EC) whic h have become estab ­
lished vehicles for functional ingredients 
and which are typically positioned for 
consump tion by health conscious adults 30.12.2017 L 351/84 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Low fat cocoa extract Specified food categor y Maximum levels Consumers shall be instr ucted not to 
consume more than 600 mg of cocoa 
flavanols per day  Foods including food supplements as 
defined in Directive 2002/46/EC 730 mg per serving and around 
1,2 g/da y 
Cor iander seed oil from 
Coriandr um sativum Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Cor iander seed oil’  Food Supplements as defined in Direc ­
tive 2002/46/EC 600 mg/da y 
Crataegus pinnatifida dried 
fruit Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Crataegus pinnatif ida dried fruit’  Herbal infusions In line with normal food use of Crataegus 
laevigata 
Jams and jellies in accordance with 
Directive 2001/113/EC (5) 
Compot es 
α-cy clodextr in Not specified The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Alpha-cy clodextr in’ or ‘α-cy clo­
dextr in’  
γ-cy clodextr in Not specified The designation of the novel food on the 
labelling of the foodstuffs containing 
it shall be ‘Gamma-Cy clodextr in’ or 
‘γ-Cy clodextr in’  
Dextran preparation 
produced by Leuconostoc 
mesenteroides Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Dextran’  Baker y products 5 % 
Diacylgly cerol oil of plant 
origin Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Diacylg lycerol oil of plant origin  
(at least 80 % diacylg lycerols)’  Cooking oils  
Fat spreads 
Salad dressings 
Mayonnaise 
Meal replacement for weight control (as 
drinks) 30.12.2017 L 351/85 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
Baker y products  
Yoghur t type products 
Dihydroca psiate (DHC) Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Dihydrocapsiat e’ 
2.Food supplements containing syn­
thetic dihydrocapsiat e will be labelled 
as ‘not intended for children up to 
4,5 years’  Cereal bars 9 mg/100 g 
Biscuits, cookies and crack ers 9 mg/100 g 
Rice based snac ks 12 mg/100 g 
Carbonated drinks, dilutable drinks, fruit 
juice based beverages 1,5 mg/100 ml 
Vegetable drinks 2 mg/100 ml 
Coffee based drinks, tea based drinks 1,5 mg/100 ml 
Flavoured water - still 1 mg/100 ml 
Precooked oatmeal cereal 2,5 mg/100 g 
Other cereals 4,5 mg/100 g 
Ice cream, dair y desser ts 4 mg/100 g 
Pudding mixes (ready to eat) 2 mg/100 g 
Products based on yoghur t 2 mg/100 g 
Chocolate confecti oner y 7,5 mg/100 g 
Hard candy 27 mg/100 g 
Suga r-free gum 115 mg/100 g 30.12.2017 L 351/86 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
Whitener/crea mer 40 mg/100 g 
Sweet eners 200 mg/100 g 
Soup (ready to eat) 1,1 mg/100 g 
Salad dressing 16 mg/100 g 
Vegetable prote in 5 mg/100 g 
Ready to eat meals 3 mg/meal 
Meal replacements for weight control 3 mg/meal 
Meal replacement for weight control (as 
drinks) 1 mg/100 ml 
Food Supplements as defined in Direc ­
tive 2002/46/EC 3 mg/sing le intake 
9 mg/da y 
Non-alcoholic powdered drink mixes 14,5 mg/kg equivalent to 1,5 mg/100 ml 
Dried extract of Lippia 
citriodor a from cell cultures Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘dried extract of Lippia citriodor a 
from cell cultures HTN®Vb’  Food Supplements as defined in Direc ­
tive 2002/46/EC In line with normal use in food supple ­
ments of a similar extract from the 
leav es of Lippia citriodor a 
Echin acea angustif olia 
extract from cell cultures Specified food categor y Maximum levels   
Food Supplements as defined in Direc ­
tive 2002/46/EC In line with normal use in food supple ­
ments of a similar extract from the root 
of Echinacea angustif olia 30.12.2017 L 351/87 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Echium plantagineum oil Specified food categor y Maximum levels of stear idonic acid (STA) The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Refined echi um oil’  Milk -based products and drinkable 
yoghur t products delivered in a sing le 
dose 250 mg/100 g; 75 mg/100 g for drinks 
Cheese preparations 750 mg/100 g 
Spreadable fat and dressings 750 mg/100 g 
Breakfa st cereals 625 mg/100 g 
Food supplements as defined in Directive 
2002/46/EC 500 mg/da y 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 250 mg/meal 
Epigallocatechin gallate as 
a pur ified extract from 
green tea leaves (Camellia 
sinensis) Specified food categor y Maximum levels The labelling shall bear a statement that 
consumers should not consume more 
than 300 mg of extract per day  Food Supplements as defined in Direc ­
tive 2002/46/EC 150 mg of extract in one portion of 
food or food supplement 
Foods fortified in accordance with Regu ­
lation (EC) No 1925/2006 
L-ergothioneine Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘L-ergothioneine ’  Food supplements as defined in Directive 
2002/46/EC 30 mg/da y for general population (ex­
cluding pregnant and lactating women) 
20 mg/da y for children older than 
3 years 30.12.2017 L 351/88 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Ferric Sodium EDT A Specified food categor y Maximum levels (expressed as anhydro us EDT A) The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Ferric Sodium EDT A’  
Food supplements as defined in Directive 
2002/46/EC 18 mg/da y for children 
75 mg/da y for adults 
Foods covered by Regulation (EU) 
No 609/2013 12 mg/100 g 
Foods fortified in accordance with Regu ­
lation (EC) No 1925/2006 
Ferrous ammonium 
phosphate Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Ferrous ammonium phosphate’  
Food supplements as defined in Directive 
2002/46/EC To be used in compl iance with Direc ­
tive 2002/46/EC, Regulation (EU) 
No 609/2013 and/or Regulation (EC) 
No 1925/2006 
Foods covered by Regulation (EU) 
No 609/2013 
Foods fortified in accordance with Regu ­
lation (EC) No 1925/2006 
Fish peptides from 
Sardinops sagax Specified food categor y Maximum levels fish peptide product The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Fish (Sardinops sagax) peptides’  
Foods based on yoghur t, yoghur t drinks, 
fermente d milk products, and powdered 
milk 0,48 g/100 g (ready to eat/dr ink) 
Flavoured water , and vegetable-based 
drinks 0,3 g/100 g (ready to drink) 
Breakfa st cereals 2 g/100 g 
Soups, stews and soup powders 0,3 g/100 g (ready to eat) 30.12.2017 L 351/89 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Flavonoids from Glycyrrhiza 
glabra Specified food categor y Maximum levels of flavonoi ds from Glycyr rhiza 
glabr a 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Flavonoids from 
Glycyr rhiza 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 con­
sumed by pregnant and breast 
feeding women, children and 
young adolescents; and 
(b)  people taking prescr iption drugs 
should only consume the product 
under medical super vision; 
(c) a maximum of 120 mg of flavo­
noids per day should be con­
sumed. 
3.  The amount of flavonoids in the final 
food shall be indicated on the label ­
ling of the food containing it. Beverages containing 
flavonoids shall be 
presented to the final 
consumer as sing le 
portions. Beverages based on milk 120 mg/da y 
Beverages based on yoghur t 
Beverages based on fruit or vege tables 
Food Supplements as defined in Direc ­
tive 2002/46/EC 120 mg/da y 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 120 mg/da y 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 120 mg/da y 
Fucoidan extract from the 
seaw eed Fucus vesiculosus Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Fucoidan extract from seaweed 
Fucus vesiculosus’.  Foods including food supplements as de­
fined in Directive 2002/46/EC for the 
general population 250 mg/da y 
Fucoidan extract from the 
seaw eed Undar ia pinnatifida Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Fucoidan extract from seaweed 
Undar ia pinnatif ida’  Foods including food supplements as de­
fined in Directive 2002/46/EC for the 
general population 250 mg/da y 30.12.2017 L 351/90 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
2′-F ucosyllact ose Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining 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′-fucosyllact ose are con­
sumed the same day. 
3.  The labelling of food supplements 
containing 2′-fucosyllactose intended 
for young children shall bear a state ­
ment that the supplements should 
not be used if breast milk or other 
foods with added 2′-fucosyllactose 
are consumed the same day.  Unf lavoured pasteur ised and sterilised  
(including UHT) milk -based products 1,2 g/l 
Unf lavoured fermented milk -based prod ­
ucts 1,2 g/l beverages 
19,2 g/kg products other than beverages 
Flavoured fermented milk -based products 
including heat-treate d products 1,2 g/l beverages 
19,2 g/kg products other than beverages 
Dair y analogues, including beverage 
whit eners 1,2 g/l beverages 
12 g/kg for products other than bev­
erages 
400 g/kg for whit ener 
Cereal bars 12 g/kg 
Table-top sweet eners 200 g/kg 
Infant formula as defined in Regulation  
(EU) No 609/2013 1,2 g/l alone or in combination with up 
to 0,6 g/l of lacto-N-neot etraose at a ratio 
of 2:1 in the final product ready for use, 
mark eted as such or reconstituted as in­
structed by the manufacturer 
Follow-on formula as defined in Regu ­
lation (EU) No 609/2013 1,2 g/l alone or in combination with up 
to 0,6 g/l of lacto-N-neot etraose at a ratio 
of 2:1 in the final product ready for use, 
mark eted as such or reconstituted as in­
structed by the manufacturer 30.12.2017 L 351/91 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
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 bev­
erages 
1,2 g/l for liquid food ready for use, mar ­
keted as such or reconstituted as in­
structed by the manufacturer 
Milk -based drinks and similar products 
intended for young children 1,2 g/l for milk -based drinks and similar 
products added alone or in combination 
with up to 0,6 g/l lacto-N-neot etraose, at 
a ratio of 2:1 in the final product ready 
for use, mark eted as such or reconsti ­
tuted as instr ucted by the manufa cturer 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 4,8 g/l for drinks 
40 g/kg for bars 
Bread and pasta products bear ing state ­
ments on the absence or reduced 
presence of gluten in accordance with 
the requirements of Commission Imple ­
menting Regulation (EU) No 828/2014 60 g/kg 
Flavoured drinks 1,2 g/l 
Coffee, tea (excluding black tea), herbal 
and fruit infusions, chicor y; tea, herbal 
and fruit infusions and chicor y extracts; 
tea, plant, fruit and cereal preparations 
for infusions, as well as mixes and in­
stant mixes of these products 9,6 g/l - the maximum level refers to the 
products ready to use 
Food supplements as defined in Directive 
2002/46/EC, excluding food supple ­
ments for infants 3,0 g/da y for general population 
1,2 g/da y for young children 30.12.2017 L 351/92 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Galact o-oligosacchar ide Specified food categor y Maximum levels (expre ssed as ratio kg galacto-oli ­
gosacchar ide/kg final food)   
Food Supplements as defined in Direc ­
tive 2002/46/EC 0,333 
Milk 0,020 
Milk drinks 0,030 
Meal replacement for weight control (as 
drinks) 0,020 
Dair y analogue drinks 0,020 
Yoghur t 0,033 
Dair y based deser ts 0,043 
Frozen dair y deser ts 0,043 
Fruit drinks and energy drinks 0,021 
Infant meal replacement drinks 0,012 
Baby juice 0,025 
Baby yogur t drink 0,024 
Baby deser t 0,027 
Baby snack 0,143 
Baby cereals 0,027 
Drinks intended to meet the expenditure 
of intense muscular effort especially for 
spor tsmen 0,013 30.12.2017 L 351/93 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels (expre ssed as ratio kg galacto-oli ­
gosacchar ide/kg final food)   
Juice 0,021 
Fruit pie fillings 0,059 
Fruit preparations 0,125 
Bars 0,125 
Cereals 0,125 
Infant formula and follow-on formula as 
defined in Regulation (EU) No 609/2013 0,008 
Glucosamine HCl Specified food categor y Maximum levels   
Food Supplements as defined in Direc ­
tive 2002/46/EC In line with normal food use of glucos ­
amine from shell fish 
Foods covered by Regulation (EU) 
No 609/2013 
Milk -based drinks and similar products 
intended for young children 
Meal replacement for weight control 
Foods intended to meet the expenditure 
of intense muscular effort, especially for 
spor tsmen 
Foods bear ing statements on the absence 
or reduced presence of gluten in accor ­
dance with the requirements of Com ­
mission Implementing Regulation (EU) 
No 828/2014 30.12.2017 L 351/94 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Glucosamine sulphate KCl Specified food categor y Maximum levels   
Food Supplements as defined in Direc ­
tive 2002/46/EC In line with normal food use of glucos ­
amine from shell fish 
Glucosamine sulphate NaCl Specified food categor y Maximum levels   
Food Supplements as defined in Direc ­
tive 2002/46/EC In line with normal food use of glucos ­
amine from shell fish 
Guar Gum Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Guar Gum’. 
2.  A specifi c mention of the possible 
risks of digestive discomf ort linked to 
the exposure of children aged under 
8 to guar gum must be visible on the 
label of any foodstuffs containing it. 
For exam ple, ‘Excessive consum ption 
of these products may cause dige stive 
discomf ort, especially for children 
under 8 years of age’. 
3.  In the case of products with two 
compar tments containing dair y and 
cereal products respectively , the in­
structions for use must clearly specify 
the need to mix the cereal and the 
dair y product before consum ption, in 
order to take into account the poten ­
tial risk of gastro-int estinal obstr uc­
tion.  Fresh dair y products such as yogur ts, fer­
mented milks, fresh cheeses and other 
dair y-based desser ts. 1,5 g/100 g 
Fruit or vegetable-based liquid foodstuffs  
(of the ‘smoothie’ variety) 1,8 g/100 g 
Fruit or vegetable-based compot es 3,25 g/100 g 
Cereals accompan ied by a dair y product, 
in packaging containing two compar t­
ments 10 g/100 g in the cereals 
None in the accompan ying dair y product 
1 g/100 g in the product when ready to 
eat 
Heat-treated milk products 
ferment ed with Bacteroides 
xyla nisolv ens Specified food categor y Maximum levels   
Fermented milk products (in liquid, 
semi-liquid and spra y-dr ied powder 
forms)  30.12.2017 L 351/95 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Hydro xytyrosol Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the food products containing 
shall be ‘hydro xytyrosol’. 
The labelling of the food products con­
taining hydroxytyrosol shall bear the fol­
lowing statements: 
(a)  This food product should not be 
consumed by children under the age 
of three years, pregnant women, and 
lactating women; 
(b)  This food product should not be 
used for cooking, baking or frying  Fish and veget able oils, (excep t olive oils 
and olive pomace oils as defined in 
Part VIII of Annex VII of Regulation (EU) 
No 1308/2013 (6)), placed as such on 
the market 0,215 g/kg 
Spreadable fats as defined in Part VII of 
Annex VII of Regulation (EU) 
No 1308/2013, placed as such on the 
mark et 0,175 g/kg 
Ice Structur ing Protein 
type III HPL C 12 Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Ice Structur ing Protein’  Edible ices 0,01 % 
Aqueo us extracts of dried 
leaves of Ilex guayusa Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Extracts of dried leaves of Ilex 
guayusa’  Herbal infusions In line with normal use in herbal infu ­
sions and food supplements of a similar 
aqueous extract of dried leav es of Ilex 
paraguar iensis Food Supplements as defined in Direc ­
tive 2002/46/EC 
Isomalto-oligosa cchar ide Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Isomalt ooligosac ­
char ide’. 
2.  Foods containing the novel ingredient 
must be labelled as ‘a source of glu­
cose ’.  Energy-Reduced Soft Drinks 6,5 % 
Energy Drinks 5,0 % 
Foods intended to meet the expenditure 
of intense muscular efforts, especially for 
spor tsmen (including isotonic drinks) 6,5 % 
Fruit Juices 5 % 30.12.2017 L 351/96 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
Processed Vegetables and Vegetable 
Juices 5 % 
Other Soft Drinks 5 % 
Cereals Bars 10 % 
Cookies, Biscuits 20 % 
Breakfa st Cereal Bars 25 % 
Hard Candies 97 % 
Soft Candies/Chocolate Bars 25 % 
Meal replacement for weight control (as 
bars or milk based) 20 % 
Isomaltulose Not specified 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining 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’.  
Lactit ol Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the food supplements con­
taining it shall be ‘Lactito l’  
Food Supplements as defined in Direc ­
tive 2002/46/EC (capsules or tablets) in­
tended for the adult population 20 g/da y 30.12.2017 L 351/97 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Lacto -N-neotetraose Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Lacto-N- neo­
tetraose’. 
2.  The labelling of food supplements 
containing lacto-N-neot etraose shall 
bear a statement that the supplements 
should not be used if other foods 
with added lacto -N-neote traose are 
consumed the same day. 
3.  The labelling of food supplements 
containing lacto -N-neotetraose in­
tended for young children shall bear 
a statement that the supplements 
should not be used if breast milk or 
other foods with added lacto-N-neo ­
tetraose are consumed the same day.  Unf lavoured pasteur ised and sterilised  
(including UHT) milk -based products 0,6 g/l 
Unf lavoured fermented milk -based prod ­
ucts 0,6 g/l for beverages 
9,6 g/kg for products other than bev­
erages 
Flavoured fermented milk -based products 
including heat-treate d products 0,6 g/l for beverages 
9,6 g/kg for products other than bev­
erages 
Dair y analogues, including beverage 
whit eners 0,6 g/l for beverages 
6 g/kg for products other than beverag es 
200 g/kg for whit ener 
Cereal bars 6 g/kg 
Table-top sweet eners 100 g/kg 
Infant formula as defined in Regulation  
(EU) No 609/2013 0,6 g/l in combination with up to 1,2 g/l 
of 2′-fucosyllactose at a ratio of 1:2 in 
the final product ready for use, market ed 
as such or reconstituted as instr ucted by 
the manufact urer 
Follow-on formula as defined in Regu ­
lation (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, market ed 
as such or reconstituted as instr ucted by 
the manufact urer 30.12.2017 L 351/98 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
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 beverag es 
0,6 g/l for liquid food ready for use, mar ­
keted as such or reconstituted as in­
structed by the manufacturer 
Milk -based drinks and similar products 
intended for young children 0,6 g/l for milk -based drinks and similar 
products added alone or in combination 
with 2′-O-fucosyllacto se, at concentra ­
tions up to 1,2 g/l, at a ratio of 1:2 in 
the final product ready for use, market ed 
as such or reconstituted as instr ucted by 
the manufact urer 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 2,4 g/l for drinks 
20 g/kg for bars 
Bread and pasta products bear ing state ­
ments on the absence or reduced 
presence of gluten in accordance with 
the requirements of Commission Imple ­
menting Regulation (EU) No 828/2014 30 g/kg 
Flavoured drinks 0,6 g/l 
Coffee, tea (excluding black tea), herbal 
and fruit infusions, chicor y; tea, herbal 
and fruit infusions and chicor y extracts; 
tea, plant, fruit and cereal preparations 
for infusions, as well as mixes and in­
stant mixes of these products 4,8 g/l - the maximum level refers to the 
products ready to use 30.12.2017 L 351/99 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
Food supplements as defined in Directive 
2002/46/EC, excluding food supple ­
ments for infants 1,5 g/da y for general population 
0,6 g/da y for young children 
Lucer ne leaf extract from 
Medicago sativ a Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Lucer ne (Medicago sativa) pro­
tein’ or ‘Alfalf a (Medicago sativa) prot ein’.  Food supplements as defined in Directive 
2002/46/EC 10 g/da y 
Lycopene Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Lycopene’  Fruit/vegetab le juice-based drinks (in­
cluding concentrat es) 2,5 mg/100 g 
Drinks intended to meet the expenditure 
of intense muscular effort especially for 
spor tsmen 2,5 mg/100 g 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 8 mg/meal 
Breakfa st cereals 5 mg/100 g 
Fats and dressings 10 mg/100 g 
Soups other than tomat o soups 1 mg/100 g 
Bread (including crispy breads) 3 mg/100 g 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 
Food supplements as defined in Directive 
2002/46/EC 15 mg/da y 30.12.2017 L 351/100 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Lycopene from Blakeslea 
trispor a Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Lycopene’  Fruit/vegetab le juice-based drinks (in­
cluding concentrat es) 2,5 mg/100 g 
Drinks intended to meet the expenditure 
of intense muscular effort especially for 
spor tsmen 2,5 mg/100 g 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 8 mg/meal 
Breakfa st cereals 5 mg/100 g 
Fats and dressings 10 mg/100 g 
Soups other than tomat o soups 1 mg/100 g 
Bread (including crispy breads) 3 mg/100 g 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 
Food supplements as defined in Directive 
2002/46/EC 15 mg/da y 
Lycopene from tomatoes Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Lycopene’  Fruit/vegetab le juice-based drinks (in­
cluding concentrat es) 2,5 mg/100 g 
Drinks intended to meet the expenditure 
of intense muscular effort especially for 
spor tsmen 2,5 mg/100 g 30.12.2017 L 351/101 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 8 mg/meal 
Breakfa st cereals 5 mg/100 g 
Fats and dressings 10 mg/100 g 
Soups other than tomat o soups 1 mg/100 g 
Bread (including crispy breads) 3 mg/100 g 
Foods for special medical purposes as de­
fined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 
Lycopene oleoresin from 
tomatoes Specified food categor y Maximum levels of lycopene The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Lycopene oleoresin from toma ­
toes’  Fruit/vegetab le juice-based drinks (in­
cluding concentrat es) 2,5 mg/100 g 
Drinks intended to meet the expenditure 
of intense muscular effort especially for 
spor tsmen 2,5 mg/100 g 
Total diet replacement for weight con­
trol covered by Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 8 mg/meal 
Breakfa st cereals 5 mg/100 g 
Fats and dressings 10 mg/100 g 30.12.2017 L 351/102 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels of lycopene   
Soups other than tomat o soups 1 mg/100 g 
Bread (including crispy breads) 3 mg/100 g 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 
Magnesium citrate malate Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Magnesium citrate malate’  Food Supplements as defined in Direc ­
tive 2002/46/EC  
Magnolia Bark Extract Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Magnolia Bark Extract’  Mints (confectionar y products) 0,2 % for breath freshening purposes. 
Based on a 0,2 % maximum incor pora ­
tion level and a maximum gum/mint 
size of 1,5 g each, each gum or mint ser­
ving will contain no more than 3 mg of 
magnolia bark extract. Chewing gum 
Maize-ger m oil high in 
unsaponif iable matter Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Maize-g erm oil extract’  Food Supplements as defined in Direc ­
tive 2002/46/EC 2 g/da y 
Chewing gum 2 % 
Methyl cellulose Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Methy lcellulose’ Methylcellulose is not 
to be used in foods 
specially prepared for 
young children Edible ices 2 % 
Flavoured drinks 30.12.2017 L 351/103 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
Flavoured or unflavoured fermented milk 
products  
Cold desser ts (dair y, fat, fruit, cereal, egg- 
based products) 
Fruit preparations (pulps, purees or com ­
potes) 
Soups and broths 
(6S)-5- 
methy ltetrahydrof olic acid, 
glucosamine salt Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing 
it shall be ‘(6S)-5-methyl tetrahydrof olic 
acid, glucosamine salt’ or ‘5MTHF - 
glucosamine’  
Food Supplements as defined in Direc ­
tive 2002/46/EC as a source of folate    
Monometh ylsilanetr iol  
(Organic Silicon) Specified food categor y Maximum levels of silicon The designation of the novel food on the 
labelling of the food supplements con­
taining it shall be ‘Organi c silicon  
(monomethy lsilanetr iol)’  Food Supplements as defined in Direc ­
tive 2002/46/EC for adult population (in 
liquid form) 10,40 mg/da y 
Mycelial extract from 
Shiitake mushroom  
(Lentinula edodes) Specified food categor y 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 Shiitak e 
mushroom’  Bread products 2 ml/100 g 
Soft drinks 0,5 ml/100 ml 
Ready prepared meals 2,5 ml per meal 
Foods based on yoghur t 1,5 ml/100 ml 
Food supplements as defined in Directive 
2002/46/EC 2,5 ml per day dose 30.12.2017 L 351/104 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Noni fruit juice (Mor inda 
citrifolia) Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Noni juice ’ or ‘Juice of Mor inda 
citrifolia’  Pasteur ised fruit and fruit nectar based 
drinks 30 ml with one serving (up to 100 % 
noni juice) 
or 
20 ml twice a day, not more than 40 ml 
per day 
Noni fruit juice powder  
(Mor inda citrifolia) Food supplements as defined in Directive 
2002/46/EC 6,6 g/da y (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 Mor inda citrifolia’  
Noni fruit puree and 
concentrate (Mor inda 
citrifolia) Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be: 
For fruit puree: 
‘Mor inda citrifolia fruit puree’ or ‘Noni 
fruit puree’ 
For fruit concentrate: 
‘Mor inda citrifolia fruit concentrate’ or 
‘Noni fruit concentrate’   Fruit puree 
Candy/confe ctioner y 45 g/100 g 
Cereal bars 53 g/100 g 
Powdered nutr itional drink mixes (dry 
weight) 53 g/100 g 
Carbonated beverag es 11 g/100 g 
Ice cream & sorbet 31 g/100 g 
Yoghur t 12 g/100 g 
Biscuits 53 g/100 g 
Buns, cake s and pastr ies 53 g/100 g 
Breakfa st cereals (wholegrain) 88 g/100 g 
Jams and jellies in accordance with 
Directive 2001/113/EC 133 g/100 g 
Based on pre-processing quantity to pro­
duce final 100 g product 30.12.2017 L 351/105 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
Sweet spreads, fillings and icings 31 g/100 g 
Savoury sauces, pick les, gravies and 
condiments 88 g/100 g 
Food Supplements as defined in Direc ­
tive 2002/46/EC 26 g/da y  
Fruit concentrate 
Candy/Confectionery 10 g/100 g 
Cereal bars 12 g/100 g 
Powdered nutr itional drink mixes (dry 
weight) 12 g/100 g 
Carbonated beverag es 3 g/100 g 
Ice cream & sorbet 7 g/100 g 
Yoghur t 3 g/100 g 
Biscuits 12 g/100 g 
Buns, cake s and pastr ies 12 g/100 g 
Breakfa st cereals (wholegrain) 20 g/100 g 
Jams and jellies in accordance with 
Directive 2001/113/EC 30 g/100 g 30.12.2017 L 351/106 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
Sweet spreads, fillings and icings 7 g/100 g 
Savoury sauces, pick les, gravies and 
condiments 20 g/100 g 
Food Supplements as defined in Direc ­
tive 2002/46/EC 6 g/da y 
Noni leaves (Mor inda 
citrifolia) Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Noni leav es’ or 
‘leaves of Mor inda citrifolia’ . 
2.Instr uctions shall be given to the con­
sumer that a cup of infusion should 
not be prepared with more than 1 g 
of dried and roaste d leav es of Mor inda 
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 roast ed leav es of Mor inda 
citrifolia 
Noni fruit powder (Mor inda 
citrifolia) Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Mor inda citrifolia fruit powder ’ 
or ‘Noni fruit powder ’  Food Supplements as defined in Direc ­
tive 2002/46/EC 2,4 g per/da y 
Odontella aurita microalgae Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Odontella aurita microalg ae’  Flavoured pasta 1,5 % 
Fish soups 1 % 
Mar ine terrines 0,5 % 
Broth preparations 1 % 
Crack ers 1,5 % 
Frozen breaded fish 1,5 % 30.12.2017 L 351/107 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Oil enriched with 
phytosterols/phyt ostanols Specified food categor y Maximum levels of phytosterols/phy tostanols In accordance with Annex III.5 to Regu ­
lation (EU) No 1169/2011  
Spreadable fats as defined in Annex VII, 
Part VII, Appendix II points B and C, of 
Regulation (EU) No 1308/2013, and ex­
cluding cooking and frying fats and 
spreads based on butter or other animal 
fat 1.  The products containing the novel 
food ingredient shall be present ed 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 phytost erols/phy to­
stanols. 
2.The amount of phytost erols/phy to­
stanols added to a container of 
beverage s shall not exceed 3 g. 
3.  Salad dressings, mayonnaise and spicy 
sauces shall be pack ed as sing le por­
tions. 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 yoghur t and 
cheese based products (fat content ≤ 12 
g per 100 g), where possibly the milk fat 
has been reduced and the fat or prot ein 
has been partly or fully replaced by veg­
etable fat or protein 
Soya drinks 
Salad dressings, mayonnaise and spicy 
sauces 
Oil extracted from squids Specified food categor y 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’.  
Dair y products excep t milk -based bev­
erages 200 mg/100 g or for cheese products 
600 mg/100 g 
Dair y analogues exce pt drinks 200 mg/100 g or for analogues to 
cheese products 600 mg/100 g 
Spreadable fat and dressings 600 mg/100 g 
Breakfa st cereals 500 mg/100 g 30.12.2017 L 351/108 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels of DHA and EPA combined   
Baker y products (breads and bread rolls) 200 mg/100 g 
Cereal bars 500 mg/100 g 
Non-alcoholic beverages (including milk - 
based beverages ) 60 mg/100 ml 
Food Supplements as defined in Direc ­
tive 2002/46/EC 3 000 mg/da y for general population 
450 mg/da y for pregnant and lactating 
women 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products intended 
Total diet replacement for weight con­
trol defined in Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 200 mg/meal 
Pasteur ised fruit-based 
preparations produced 
using high-pressure 
treatment Specified food categor y Maximum levels The wording ‘pasteuri sed by high-pres ­
sure treatment’ shall be displa yed next to 
the name of the fruit preparations as 
such and in any product in which it is 
used  Types of fruit: 
apple, apricot, banana, blac kber ry, blue ­
berry, cherry, coconut, fig, grape, grape ­
fruit, mandar in, mango, melon, peac h, 
pear , pineapple, prune, raspber ry, rhu­
barb, strawber ry  
Phosphated maize starch Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Phosphate d maize starch’  Baked baker y products 15 % 
Pasta 
Breakfa st cereals 
Cereal bars 30.12.2017 L 351/109 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Phosphatidylser ine from 
fish phospholipids Specified food categor y Maximum levels of phosphatidylserin e The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Fish phosphatidylser ine’  Beverages based on yoghur t 50 mg/100 ml 
Powders based on milk powders 3 500 mg/100 g (equivalent to 40 mg/ 
100 ml ready to drink) 
Foods based on yoghur t 80 mg/100 g 
Cereal bars 350 mg/100 g 
Chocolate based confecti onar y 200 mg/100 g 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In compl iance with Regulation (EU) 
No 609/2013 
Food supplements as defined in Directive 
2002/46/EC 300 mg/da y 
Phosphatidylser ine from 
soya phospholipids Specified food categor y Maximum levels of phosphatidylserin e The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Soya phosphatidylser ine’  Beverages based on yoghur t 50 mg/100 ml 
Powders based on milk powder 3,5 g/100 g (equivalent to 40 mg/ 
100 ml ready to drink) 
Foods based on yoghur t 80 mg/100 g 
Cereal bars 350 mg/100 g 
Chocolate based confecti onar y 200 mg/100 g 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In compl iance with Regulation (EU) 
No 609/2013 
Phospholipid product 
cont aining equal amounts 
of phosphatidylser ine and 
phosphatidic acid Specified food categor y Maximum levels of phosphatidylserin e The designation of the novel food on the 
labelling of the foodstuffs containing 
shall be ‘Soy phosphatidylser ine and 
phosphatidic acid’ The product is not 
intended to be 
market ed to pregnant 
or breast-f eeding 
women Breakfa st cereals 80 mg/100 g 
Cereal bars 350 mg/100 g 30.12.2017 L 351/110 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels of phosphatidylserin e   
Foods based on yogur t 80 mg/100 g 
Soy-based yogur t-like products 80 mg/100 g 
Yogur t based-dr inks 50 mg/100 g 
Soy-based yogur t-like drinks 50 mg/100 g 
Powders based on milk powder 3,5 g/100 g (equivalent to 40 mg/100 
ml ready-t o drink) 
Food Supplements as defined in Direc ­
tive 2002/46/EC 800 mg/da y 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In compl iance with Regulation (EU) 
No 609/2013 
Phospholipides from egg 
yolk Specified food categor y Maximum levels   
Not specified 
Phyt ogly cogen Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Phytog lycogen’  Processed foods 25 % 
Phyt osterol s/ph ytost anols Specified food categor y Maximum levels In accordance with Annex III.5 of Regu ­
lation (EU) No 1169/2011  
Rice drinks 1.  They shall be presented in such 
a manner that they can be easily di­
vided into portions that contain 
either a maximum of 3 g (in case of 
1 portion/da y) or a maximum of 1 g  
(in case of 3 portions/da y) of added 
phytosterols/phyt ostanols. 
The amount of phytost erols/phy to­
stanols added to a container of 
beverage s shall not exceed 3 g. 
Salad dressings, mayonnaise and spicy 
sauces shall be pack ed as sing le por­
tions Rye bread with flour containing ≥ 50 % 
rye (wholemeal rye flour , whole or 
crack ed rye kernels and rye flakes) and 
≤ 30 % wheat ; and with ≤ 4 % added su­
gar but no fat added. 
Salad dressings, mayonnaise and spicy 
sauces. 30.12.2017 L 351/111 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels   
Soya drink  
Milk type products, such as semi- 
skimmed and skimmed milk type prod ­
ucts, 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 veget able fat and/or prote in. 
Products based on fermented milk such 
as yoghur t and cheese type products (fat 
content < 12 % per 100 g), where pos­
sibly the milk fat has been reduced, or 
where milk fat and/or prot ein has been 
partly or fully replaced by vege table fat 
and/or prote in 
Spreadable fats as defined in Annex VII, 
Part VII, Appendix II points B and C, of 
Regulation (EU) No 1308/2007, and 
excl uding cooking and frying fats and 
spreads based on butter or other animal 
fat. 
Plum kern el oil Specified food categor y Maximum levels   
For frying and as seasoning In line with normal food use of vege table 
oils 
Potato proteins (coagulated) 
and hydrolysates thereof Not specified The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Potato protein’  30.12.2017 L 351/112 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Prolyl oligopeptidase  
(enzyme preparation) Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Prolyl oligopeptidase’  
Food Supplements as defined in Direc ­
tive 2002/46/EC for general adult popu ­
lation 120 PPU/da y (2,7 g of enzyme prepara ­
tion/da y) (2 × 106 PPI/da y) 
PPU – Prolyl Peptidase Units or Proline 
Protea se Units 
PPI – Protease Picomole International 
Protein extract from pig 
kidne ys Specified food categor y Maximum levels   
Food Supplements as defined in Direc ­
tive 2002/46/EC 3 capsules/da y; equalizing 12,6 mg pig 
kidne y extract a day 
Diamine oxidase (DAO) cont ent: 
0,9 mg/da y (3 capsules with a content of 
DAO of 0,3 mg/capsule) Food for special medical purposes as 
defined in Regulation (EU) No 609/2013 
Rapeseed oil high in 
unsaponif iable matter Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Rapeseed oil extract’  
Food Supplements as defined in Direc ­
tive 2002/46/EC 1,5 g per portion recommended for daily 
consum ption 
Rapeseed Protein As a vege table prot ein source in foods 
excep t in infant formula and follo w-on 
formula  1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Rapeseed prote in’. 
2.  Any foodstuff containing ‘rapeseed 
protein’ shall bear a state ment that 
this ingredient may cause allergic re­
action to consumers who are allergic 
to mustard and products thereof. 
Where relevant, this statement shall 
appear in close proximity to the list 
of ingredients.  30.12.2017 L 351/113 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Trans-resv eratrol Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the food supplements 
containing it shall be ‘Trans-resvera ­
trol’. 
2.  The labelling of food supplements 
containing trans-resveratrol shall bear 
a statement that people using medi ­
cines should only consume the prod ­
uct under medical super vision.  Food Supplements as defined in Direc ­
tive 2002/46/EC for adult population  
(capsule or tablet form) 150 mg/da y 
Trans-resv eratrol (microbial 
source) Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the food supplements 
containing it shall be ‘Trans-resvera ­
trol’. 
2.  The labelling of food supplements 
containing trans-resveratrol shall bear 
a statement that people using medi ­
cines should only consume the prod ­
uct under medical super vision.  Food supplements as defined in Directive 
2002/46/EC In line with normal use in food supple ­
ments of resveratrol extracted from Japa ­
nese knotweed (Fallopia japonica) 
Rooster comb extract Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing 
it shall be ‘Rooster comb extract’ or 
‘Cock erel comb extract’  Milk -based drinks 40 mg/100 g or mg/100 ml 
Milk based fermented drinks 80 mg/100 g or mg/100 ml 
Yoghur t-type products 65 mg/100 g or mg/100 ml 
Fromage frais 110 mg/100 g or mg/100 ml 
Sacha Inchi oil from 
Plukenet ia volubilis Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing 
it shall be ‘Sacha inchi oil (Pluk enetia 
volubilis)’  As for linseed oil In line with normal food use of linseed 
oil 30.12.2017 L 351/114 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Salatr ims Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘reduced energy fat  
(salatr ims)’. 
2.There shall be a statement that exce s­
sive consum ption may lead to gastro- 
intestinal disturbance. 
3.  There shall be a statemen t that the 
products are not intended for use by 
children.  Baker y products and confectionary  
Schizo chytr ium sp. oil rich 
in DHA and EPA Specified food categor y 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 
microalg ae Schizochytr ium sp.’  Food Supplements as defined in Direc ­
tive 2002/46/EC for adult population 
excl uding pregnant and lactating women 3 000 mg/da y 
Food Supplements as defined in Direc ­
tive 2002/46/EC for pregnant and lactat ­
ing women 450 mg/da y 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 250 mg/meal 
Milk -based drinks and similar products 
intended for young children 200 mg/100 g 30.12.2017 L 351/115 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels of DHA and EPA combined   
Processed cereal based food and baby 
food for infants and young children as 
defined in Regulation (EU) No 609/2013  
Foods intended to meet the expenditure 
of intense muscular effort, especially for 
spor tsmen 
Foods bear ing statements on the absence 
or reduced presence of gluten in accor ­
dance with the requirements of Com ­
mission Implementing Regulation (EU) 
No 828/2014 
Baker y Products (Breads, Rolls and Sweet 
Biscuits) 200 mg/100 g 
Breakfa st Cereals 500 mg/100 g 
Cooking Fats 360 mg/100 g 
Dair y Analogues excep t drinks 600 mg/100 g for cheese; 200 mg/100 g 
for soy and imitation milk products 
(excluding drinks) 
Dair y Products excep t milk -based drinks 600 mg/100 g for cheese; 200 mg/100 g 
for milk products (including milk, fro­
mag e frais and yoghur t products; exclud ­
ing drinks) 
Non-alcoholic Beverages (including dair y 
analogue and milk -based drinks) 80 mg/100 g 
Cereal/Nutr ition Bars 500 mg/100 g 
Spreadable Fats and Dressings 600 mg/100 g 30.12.2017 L 351/116 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Schizo chytr ium sp. (ATCC 
PTA-9695) oil Specified food categor y Maximum levels of DHA The designation of the novel food on the 
labelling of the foodstuffs containing 
it shall be ‘Oil from the microalgae 
Schizochytr ium sp. (ATCC PTA-9695)’  Dair y products excep t milk -based drinks 200 mg/100 g or for cheese products 
600 mg/100 g 
Dair y analogues exce pt drinks 200 mg/100 g or for analogues to 
cheese products 600 mg/100 g 
Spreadable fats and dressings 600 mg/100 g 
Breakfa st cereals 500 mg/100 g 
Food Supplements as defined in Direc ­
tive 2002/46/EC 250 mg DHA/da y for general population 
450 mg DHA/da y for pregnant and lac­
tating women 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 250 mg/meal 
Milk -based drinks and similar products 
intended for young children 200 mg/100 g 
Foods intended to meet the expenditure 
of intense muscular effort, especially for 
spor tsmen 
Foods bear ing statements on the absence 
or reduced presence of gluten in accor ­
dance with the requirements of Com ­
mission Implementing Regulation (EU) 
No 828/2014 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 30.12.2017 L 351/117 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels of DHA   
Baker y products (breads,rolls, and, sweet 
biscuits) 200 mg/100 g 
Cereal bars 500 mg/100 g 
Cooking fats 360 mg/100 g 
Non-alcoholic beverages (including dair y 
analogue and milk -based drinks) 80 mg/100 ml 
Infant formula and follow-on formula as 
defined in Regulation (EU) No 609/2013 In accordance with Regulation (EU) 
No 609/2013 
Processed cereal-based foods and baby 
foods for infants and young children as 
defined in Regulation (EU) No 609/2013 200 mg/100 g 
Schizo chytr ium sp. oil Specified food categor y Maximum levels of DHA The designation of the novel food on the 
labelling of the foodstuffs containing 
it shall be ‘Oil from the microalgae 
Schizochytr ium sp.’  Dair y products excep t milk -based drinks 200 mg/100 g or for cheese products 
600 mg/100 g 
Dair y analogues exce pt drinks 200 mg/100 g or for analogues to 
cheese products 600 mg/100 g 
Spreadable fats and dressings 600 mg/100 g 
Breakfa st cereals 500 mg/100 g 
Food Supplements as defined in Direc ­
tive 2002/46/EC 250 mg DHA/da y for general population 
450 mg DHA/da y for pregnant and lac­
tating women 30.12.2017 L 351/118 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels of DHA   
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 250 mg/meal 
Milk -based drinks and similar products 
intended for young children 200 mg/100 g 
Processed cereal-based foods and baby 
foods for infants and young children as 
defined in Regulation (EU) No 609/2013 
Foods intended to meet the expenditure 
of intense muscular effort, especially for 
spor tsmen 
Foods bear ing statements on the absence 
or reduced presence of gluten in accor ­
dance with the requirements of Commis ­
sion Implemen ting Regulation (EU) 
No 828/2014 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 
Baker y products (breads, rolls and sweet 
biscuits) 200 mg/100 g 
Cereal bars 500 mg/100 g 
Cooking fats 360 mg/100 g 
Non-alcoholic beverages (including dair y 
analogue and milk -based drinks) 80 mg/100 ml 30.12.2017 L 351/119 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Schizo chytr ium sp. (T18) oil Specified food categor y Maximum levels of DHA The designation of the novel food on the 
labelling of the foodstuffs containing 
it shall be ‘Oil from the microalgae 
Schizochytr ium sp.’  Dair y products excep t milk -based drinks 200 mg/100 g or for cheese products 
600 mg/100 g 
Dair y analogues exce pt drinks 200 mg/100 g or for analogues to 
cheese products 600 mg/100 g 
Spreadable fats and dressings 600 mg/100 g 
Breakfa st cereals 500 mg/100 g 
Food Supplements as defined in Direc ­
tive 2002/46/EC 250 mg DHA/da y for general population 
450 mg DHA/da y for pregnant and lac­
tating women 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 and meal replacements for 
weight control 250 mg/meal 
Milk -based drinks and similar products 
intended for young children 200 mg/100 g 
Foods intended to meet the expenditure 
of intense muscular effort, especially for 
spor tsmen 
Foods bear ing statements on the absence 
or reduced presence of gluten in accor ­
dance with the requirements of Commis ­
sion Implemen ting Regulation (EU) 
No 828/2014 
Foods for special medical purposes as 
defined in Regulation (EU) No 609/2013 In accordance with the particular nutr i­
tional requirements of the persons for 
whom the products are intended 30.12.2017 L 351/120 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels of DHA   
Baker y products (breads, rolls and, sweet 
biscuits) 200 mg/100 g 
Cereal bars 500 mg/100 g 
Cooking fats 360 mg/100 g 
Non-alcoholic beverages (including dair y 
analogue and milk -based drinks) 80 mg/100 ml 
Infant formula and follow-on formula as 
defined in Regulation (EU) No 609/2013 In accordance with Regulation (EU) 
No 609/2013 
Processed cereal-based foods and baby 
foods for infants and young children as 
defined in Regulation (EU) No 609/2013 200 mg/100 g 
Fermented soybean extract Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Fermented soybean 
extract’. 
2.  The labelling of food supplements 
containing fermented soybean extract 
shall bear a state ment that persons 
taking medication should only con­
sume the product under medical 
super vision.  Food Supplements as defined in Direc ­
tive 2002/46/EC (capsules, tablets or 
powder form) intended for the adult 
population, excl uding pregnant and lac­
tating women 100 mg/da y 
Sper midine-r ich wheat 
germ extract (Triticum 
aeste vium) Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the food supplements con­
taining it shall be ‘sper midine-r ich wheat 
germ extract’  Food Supplements as defined in Direc ­
tive 2002/46/EC intended for the adult 
population Equivalent of max. 6 mg/da y sper midine 30.12.2017 L 351/121 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Sucromalt Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Sucromalt ’. 
2.  The designation of the novel food on 
the labelling shall be accompanied by 
indication that the product is a source 
of glucose and fructose.  Not specified 
Sugar cane fibre Specified food categor y Maximum levels   
Bread 8 % 
Baker y goods 5 % 
Meat and muscle products 3 % 
Seasonings and spices 3 % 
Grated cheeses 2 % 
Special diet foods 5 % 
Sauces 2 % 
Beverages 5 % 
Sunf lower oil extract Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Sunf lowe r oil extract’  Food Supplements as defined in Direc ­
tive 2002/46/EC 1,1 g/da y 
Dried Tetraselmis chuii 
microalgae Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Dried microalgae Tetraselmis 
chuii’ or ‘Dried microalg ae T. chuii’ 
Food supplements containing dried 
microalg ae Tetraselmis chuii shall bear the 
following statement : ‘Contains negligible 
amounts of iodine ’  Sauces 20 % or 250 mg/da y 
Special salts 1 % 
Condiment 250 mg/da y 
Food Supplements as defined in Direc ­
tive 2002/46/EC 250 mg/da y 30.12.2017 L 351/122 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Ther apon barcoo/Scor tum Intended use identical to that of the salmon, namely the preparation of culinar y fish 
products and dishes, including cooked, raw, smoked and bake d fish products   
D-Tagato se Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘D-Tagat ose’. 
2.  The labelling of any product where 
the level of D-Tagat ose exce eds 15 g 
per serving and all beverages contain ­
ing greater than 1 % D-Tagatose (as 
consumed) shall bear a state ment ‘ex­
cessive consum ption may produce 
laxative effects’.  Not specified 
Taxifo lin-r ich extract Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘taxif olin-r ich extract’.  
Food Supplements as defined in Direc ­
tive 2002/46/EC intended for the general 
population, excl uding infants, young 
children, children and adolescents 
younger than 14 years 100 mg/da y 
Trehalose Specified food categor y Maximum levels 1.  The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Trehalose’ and shall 
be displa yed on the labelling of the 
product as such or in the list of ingre ­
dients of foodstuffs containing it. 
2.  The designation of the novel food on 
the labelling shall be accompanied by 
indication that the ‘Trehalose is 
a source of glucose ’.  Not specified 30.12.2017 L 351/123 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
UV-treated mushrooms  
(Agaricus bispor us) Specified food categor y Maximum levels of vitamin D2   
Mushrooms (Agaricus bispor us) 10 µg of vitamin D2/100 g fresh weight 1.  The designation on the label of the 
novel food as such or of the food ­
stuffs containing it shall be ‘UV-treat ­
ed mushrooms (Agaricus bispor us)’. 
2.  The designation on the label of the 
novel food as such or of the food ­
stuffs containing it shall be accom ­
panied 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  
(Sacchar omy ces cerevisiae) Specified food categor y Maximum levels of vitamin D2 The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Vitamin D yeast’ or ‘Vitamin D2 
yeast’  
Yeast-leavened breads and rolls 5 µg of vitamin D2/100 g 
Yeast-leavened fine baker y wares 5 µg of vitamin D2/100 g 
Food Supplements as defined in Direc ­
tive 2002/46/EC 5 µg of vitamin D2/day 
UV-treated bread Specified food categor y Maximum levels of vitamin D2 The designation on the label of the novel 
food shall be accompan ied by ‘contains 
vitamin D produced by UV-treatment ’  
Yeast leav ened bread and rolls (without 
toppings) 3 µg vitamin D2/100 g 30.12.2017 L 351/124 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
UV-treated milk Specified food categor y Maximum levels of vitamin D3 1.  The designation on the label of the 
novel food shall be ‘UV-treated’ . 
2.  Where UV-treat ed milk contains an 
amount of vitamin D that is con­
sidered signif icant 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 accompan ied by 
‘contains vitamin D produced by 
UV-treatment’ or ‘milk containing 
vitamin D resulting from UV-treat ­
ment ’.  Pasteur ised whole milk as defined in 
Regulation (EU) No 1308/2013 to be 
consumed as such 5-32 µg/kg for general population ex­
cluding infants 
Pasteur ised semi-skimmed milk as de­
fined in Regulation (EU) No 1308/2013 
to be consumed as such 1-15 µg/kg for general population ex­
cluding infants 
Vitamin K2 (menaquinone) To be used in compl iance 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 categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Wheat bran extract’ The ‘Wheat Bran 
Extract ’ may not be 
introduced onto the 
market as a food 
supplement or food 
supplement ingredient. 
Nor may it be added to 
infant formula. Beer and substitut es 0,4 g/100 g 
Ready to eat cereals 9 g/100 g 
Dair y products 2,4 g/100 g 
Fruit and veget able juices 0,6 g/100 g 
Soft drinks 0,6 g/100 g 
Meat preparations 2 g/100 g 30.12.2017 L 351/125 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Yeast beta-glucans Specified food categor y Maximum levels of pure beta-glucans from yeast  
(Saccharom yces cervisiae) The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Yeast (Saccharo myces cerevisiae) 
beta-g lucans’  
Food supplements as defined in Directive 
2002/46/EC, excluding food supple ­
ments for infants and young children 1,275 g/da y for children older than 
12 years and general adult population 
0,675 g/da y for children younger than 
12 years 
Total diet replacement for weight con­
trol as defined in Regulation (EU) 
No 609/2013 1,275 g/da y 
Food for special medical purposes as de­
fined in Regulation (EU) No 609/2013, 
excl uding food for special medical pur­
poses intende d for infants and young 
children 1,275 g/da y 
Beverages based on fruit and/or veg­
etable juices including concentrat e and 
dehydrat ed juices 1,3 g/kg 
Fruit-f lavoured drinks 0,8 g/kg 
Cocoa beverages preparation powder 38,3 g/kg (powder) 
Other beverage s 0,8 g/kg (ready to drink) 
7 g/kg (powder) 
Cereal bars 6 g/kg 
Breakfa st cereals 15,3 g/kg 30.12.2017 L 351/126 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels of pure beta-glucans from yeast  
(Saccharom yces cervisiae)   
Wholegrain and high fibre instant hot 
breakfa st cereals 1,5 g/kg 
Cookie-type biscuits 6,7 g/kg 
Crack er-type biscuits 6,7 g/kg 
Milk based beverages 3,8 g/kg 
Fermented milk products 3,8 g/kg 
Milk product analogues 3,8 g/kg 
Dried milk/milk powder 25,5 g/kg 
Soups and soup mixe s 0,9 g/kg (ready to eat) 
1,8 g/kg (condensed) 
6,3 g/kg (powder) 
Chocolate and confecti oner y 4 g/kg 
Protein bars and powders 19,1 g/kg 
Jam, mar malade and other fruit spreads 11,3 g/kg 
Zeaxan thin Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘synthetic zeaxanthin’  Food Supplements as defined in Direc ­
tive 2002/46/EC 2 mg/da y 30.12.2017 L 351/127 Official Jour nal of the European Union EN     Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
Zinc L-pidolate Specified food categor y Maximum levels The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be ‘Zinc L-pi dolate’  
Foods covered by Regulation (EU) 
No 609/2013 3 g/da y 
Milk based drinks and similar products 
intended for young children 
Meal replacement for weight control 
Foods intended to meet the expenditure 
of intense muscular effort, especially for 
spor tsmen 
Food bear ing statement on the absence 
or reduced presence of gluten in accor ­
dance with the requirements of Com ­
mission Implementing Regulation (EU) 
No 828/2014 
Food Supplements as defined in Direc ­
tive 2002/46/EC 
(1)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement 
for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the 
Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35). 
(2)  Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228, 
31.7.2014, p. 5). 
(3)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51). 
(4)  Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 
30.12.2006, p. 26) 
(5)  Council Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and mar malades and sweetened chestnut purée inten ded for human consump tion (OJ L 10, 12.1.2002, p. 67) 
(6)  Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common orga nisation of the markets in agricultural products and repealing Council 
Regulation (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) 1234/2007 (OJ L 347, 20.12.2013, p. 671).  30.12.2017 L 351/128 Official Jour nal of the European Union EN     Table 2: Specif ications 
Authorised Novel Food Specification 
N-A cetyl-D-neuraminic acid Descr iption: 
N-A cetyl-D-neuraminic acid is a whit e to off-white crystalline powder 
Def inition: 
Chemical name: 
IUPAC names: 
N-A cetyl-D-neuraminic acid (dih ydrat e) 
5-Acetamido-3,5-dideo xy-D-g lycero-D-galact o-non-2-ulop yranosonic acid (dih ydrate), 
Synon yms: 
Sialic acid (dihydrat e) 
Chemical formula: 
C11H19NO9 (acid) 
C11H23NO11 (C11H19NO9 * 2H2O) (dih ydrate ) 
Molecular mass: 
309,3 Da (acid) 
345,3 (309,3 + 36,0) (dih ydrat e) 
CAS No.: 
131-48-6 (free acid) 
50795-27-2 (dih ydrate) 
Specif ications: 
Descr iption: white to off-white crystalline powder 
pH (20 °C, 5 % solution): 1,7 – 2,5 
N-A cetyl-D-neuraminic acid (dih ydrat e): > 97,0 % 
Water (dih ydrate calculates to 10,4 %): ≤ 12,5 % (w/w) 
Ash, sulphated: < 0,2 % (w/w) 
Acetic acid (as free acid and/or sodium acetate): < 0,5 % (w/w) 
Hea vy Met als: 
Iron: < 20,0 mg/kg 
Lead: < 0,1 mg/kg 
Residual prot eins: < 0,01 % (w/w)  30.12.2017 L 351/129 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Residual solv ents: 
2-Propanol: < 0,1 % (w/w) 
Aceton e: < 0,1 % (w/w) 
Ethyl acetate : < 0,1 % (w/w) 
Microbiological criter ia: 
Salmonella: Absence in 25 g 
Aerobic mesophilic total count : < 500 CFU/g 
Enterobacter iaceae: Absence in 10 g 
Crono bacter (Enterobacter) sakazakii: Absence in 10 g 
Lister ia monocytog enes: Absence in 25 g 
Bacillus cereus: < 50 CFU/g 
Yeasts: < 10 CFU/g 
Moulds: < 10 CFU/g 
Residual endoto xins: < 10 EU/mg 
CFU: Colon y Forming Units; EU: Endoto xin Units.   
Adansonia digitata (Baobab) 
dried fruit pulp Descr iption/Def inition: 
The Baobab (Adansonia digitata) fruits are harvested from trees. The hard shells are crac ked open and the pulp is separated from the seeds and the shell. 
This is milled, separate d into coarse and fine lots (par ticle size 3 to 600 µ) and then packag ed. 
Typical nutr itional components: 
Moisture (loss on drying) (g/100 g): 4,5-13,7 
Protein (g/100 g): 1,8-9,3 
Fat (g/100 g): 0-1,6 
Total carboh ydrate (g/100 g): 76,3-89,5 
Total sugars (as glucose): 15,2-36,5 
Sodium (mg/100 g): 0,1-25,2 
Analytical specif ications: 
Foreign matt er: Not more than 0,2 % 
Moisture (loss on drying) (g/100 g): 4,5-13,7 
Ash (g/100 g): 3,8-6,6 30.12.2017 L 351/130 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Ajug a reptans extract from 
cell cultures Descr iption/Def inition: 
Hydroalcoholic extract from Ajug a reptans L. tissue cultures whic h is substantially equivalent to extracts from flowe ring aerial parts of Ajug a reptans 
obtained by traditional cultures. 
L-Alan yl-L -Glutamin e Descr iption/Def inition: 
L-Alanyl-L-G lutamine is produced by fermentation with a genetically modifi ed strain of Escher ichia coli. Dur ing the fermentation process, the ingredient is 
secreted into the growth medium from which it is subsequently separated and purified to a concentration of > 98 %. 
Appearance: White crystalline powder 
Purity: > 98 % 
Infrared spectroscop y: Conf ormity with ref. standard 
Appearance of solution: Colourless and clear 
Assa y (dry basis): 98-102 % 
Related substances (each): ≤ 0,2 % 
Residue on ignition: ≤ 0,1 % 
Loss on drying: ≤ 0,5 % 
Opti cal rotation: + 9,0 - + 11,0° 
pH (1 %; H2O): 5,0-6,0 
Ammonium (NH4): ≤ 0,020 % 
Chlor ide (Cl): ≤ 0,020 % 
Sulphate (SO4): ≤ 0,020 % 
Microbiological criter ia: 
Escher ichia coli: Absence/g 
Algal oil from the microalgae 
Ulkenia sp. Descr iption/Def inition: 
Oil from the micro-algae Ulkenia sp. 
Acid value: ≤ 0,5 mg KOH/g 
Peroxide value (PV): ≤ 5,0 meq/kg oil 
Moisture and volatiles: ≤ 0,05 % 
Unsaponif iables: ≤ 4,5 % 
Trans-fatty acids: ≤ 1,0 % 
DHA cont ent: ≥ 32 % 30.12.2017 L 351/131 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Allanblackia seed oil Descr iption/Def inition: 
Allanblackia seed oil is obtained from the seeds of the allanblac kia species: A. floribunda (synon ymous with A. parviflora) and A. stuhlmannii. 
Composition of fatty acids: 
Laur ic acid (C12:0): < 1,0 % 
Myr istic acid (C14:0): < 1,0 % 
Palmitic acid (C16:0): < 2,0 % 
Palmitoleic acid (C16:1): < 1,0 % 
Stea ric acid (C18:0): 45-58 % 
Oleic acid (C18:1): 40-51 % 
Linoleic acid (C18:2): < 1,0 % 
γ-Linolenic acid (C18:3): < 1,0 % 
Arachi dic acid (C20:0): < 1,0 % 
Free fatty acids: max 0,1 % 
Character istics: 
Trans fatty acids: max 0,5 % 
Peroxide value: max 0,8 meq/kg 
Iodine value: < 46 g/100 g 
Unsaponif iable matt er: max 1,0 % 
Saponif ication value: 185-198 mg KOH/g 
Aloe macroclada Baker leaf 
extract Descr iption/Def inition: 
Powdered gel extract derived from the leaves of Aloe macroclada Baker whic h is substantially equivalent to the same gel derived from Aloe vera L. Burm. 
leav es. 
Ash: 25 % 
Dietar y fibres: 28,6 % 
Fat: 2,7 % 
Moisture: 4,7 % 
Polysacc harides: 9,5 % 
Protein : 1,63 % 
Glucose: 8,9 % 30.12.2017 L 351/132 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Ant arctic Krill oil from 
Euphausia superba Descr iption/Def inition: 
To produce lipid extract from Antarctic Krill (Euphausia superba) deep-frozen crushed krill or dried krill meal is subjecte d to lipid extraction with an 
approved extraction solvent (under Directive 2009/32/EC). Proteins and krill mate rial are removed from the lipid extract by filtration. The extraction 
solvents and residual water are removed by evaporation. 
Saponif ication value: ≤ 230 mg KOH/g 
Peroxide value (PV): ≤ 3 meq O 2/kg oil 
Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °C 
Phospholipids: 35-50 % 
Trans-fatty acids: ≤ 1 % 
EPA (eicosapentaenoic acid): ≥ 9 % 
DHA (docosahexaenoic acid): ≥ 5 % 
Ant arctic Krill oil rich in 
phospholipids from 
Euphausia superba Descr iption/Def inition: 
Oil rich in phospholipids is produced from Antarctic krill (Euphausia superba) by repeate d solvent washings with an approved solvent (under Directive 
2009/32/EC) to increase phospholipid cont ent of the oil. Solvents are removed from the final product by evaporation. 
Saponif ication value: ≤ 230 mg KOH/g 
Peroxide value (PV): ≤ 3 meq O2/kg oil 
Oxidative stability : All food products containing Antarctic Krill oil rich in phospholipids from Euphausia superba should demonstrate oxidative stability by 
appropr iate and recognised national/internati onal test methodology (e.g. AOAC). 
Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °C 
Phospholipids: ≥ 60 % 
Trans-fatty acids: ≤ 1 % 
EPA (eicosapentaenoic acid): ≥ 9 % 
DHA (docosahexaenoic acid): ≥ 5 % 
Arachidonic acid-r ich oil 
from the fungus Mor tierella 
alpina Descr iption/Def inition: 
The clear yello w arachidonic acid-r ich oil is obtained by fermentation of the non-ge netically modifi ed strains IS-4, I49-N18 and FJRK-MA01 of the 
fungus Mor tierel la alpina using a suitable liquid. The oil is then extracted from the biomass and purified. 
Arachi donic acid: ≥ 40 % by weight of the total fatty acid conte nt 
Free fatty acids: ≤ 0,45 % of the total fatty acid content 
Trans fatty acids: ≤ 0,5 % of the total fatty acid conte nt 
Unsaponif iable matt er: ≤ 1,5 %  30.12.2017 L 351/133 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Peroxide value: ≤ 5 meq/kg 
Anisidin value: ≤ 20 
Acid value: ≤ 1,0 KOH/g 
Moisture: ≤ 0,5 %   
Argan oil from Arg ania 
spinosa Descr iption/Def inition: 
Argan oil is the oil obtained by cold pressing of the almond like kern els of the fruits of Argania spinosa (L.) Skeels . Kernels may be roasted prior to press ­
ing, but with no direct contact with a flame. 
Composition: 
Palmitic acid (C16:0): 12-15 % 
Stea ric acid (C18:0): 5-7 % 
Oleic acid (C18:1): 43-50 % 
Linoleic acid (C18:2): 29-36 % 
Unsaponif iable matt er: 0,3-2 % 
Total sterols: 100-500 mg/100 g 
Total tocopherols: 16-90 mg/100 g 
Oleic acidity : 0,2-1,5 % 
Peroxide value: < 10 meq O2/kg 
Astaxanthin-r ich oleoresin 
from Haematococcus pluvialis 
algae Descr iption/Def inition: 
Astaxanthin is a carotenoid produced by Haematococcus pluvialis algae . Production methods for the growth of the algae are variable; using closed syste ms 
exposed to sunlight or strictly controlled illuminate d light alternati vely open ponds may be used. The algal cells are harvested and dried; the oleoresin is 
extract ed using either super critical CO2 or a solvent (ethyl acetate ). The Astaxanthin is dilut ed and standardized to 2,5 %, 5,0 %, 7,0 %, 10 %, 15 % or 
20 % using olive oil, safflower oil, Sunf lower oil or MCT (Medium Chain Triglycerides). 
Composition of the Oleoresin: 
Fat: 42,2- 99 % 
Protein : 0,3-4,4 % 
Carbohydr ate: 0-52,8 % 
Fibre: < 1,0 % 
Ash: 0,0-4,2 % 
Specific ation of Carotenoids w/w% 
Total Astaxanthins: 2,9-11,1 %  30.12.2017 L 351/134 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
9-cis-astaxanthin: 0,3-17,3 % 
13-cis-astaxanthin: 0,2-7,0 % 
Astaxanthin monoeste rs: 79,8-91,5 % 
Astaxanthin diest ers: 0,16-19,0 % 
Β-Carot ene: 0,01-0,3 % 
Lutein: 0-1,8 % 
Canthaxanthin: 0-1,30 % 
Microbiological criter ia: 
Total aerobic bacteri a: < 3 000 CFU/g 
Yeast and Moulds: < 100 CFU/g 
Colif orms: < 10 CFU/g 
E. coli: Neg ative 
Salmonella: Neg ative 
Staphy lococcus: Negative   
Basil seeds (Ocimum 
basilicum) Descr iption/Def inition: 
Basil (Ocimum basilicum L.) belongs to the family ‘Lamiaceae’ within the order ‘Lamiales’. Post-har vest the seeds are cleaned mec hanically . Flowers, leav es 
and other parts of the plant are remo ved. Highest level of purity of Basil seeds has to be ensured by filter ing (optical, mec hanical). Production process of 
fruit juice and fruit/veget able blend beverage s containing Basil seeds (Ocimum basilicum L.) includes seed pre-h ydration and past eurisation steps. Microbio ­
logical controls and monitoring systems are in place. 
Dry Matt er: 94,1 % 
Protein : 20,7 % 
Fat: 24,4 % 
Carbohydr ate: 1,7 % 
Dietar y Fibre 40,5 % (Method: AOAC 958.29) 
Ash: 6,78 % 
Fermented black bean extract Descr iption/Def inition: 
Fermented black bean extract (Touchi extract) is a fine light-brown protein-r ich powder obtained by water extraction of small soybeans (Glyc ine max (L.) 
Mer r.) fermented with Aspergillus oryzae. The extract contains an α-glucosidase inhibitor . 
Character istics: 
Fat: ≤ 1,0 % 
Protein : ≥ 55 %  30.12.2017 L 351/135 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Water: ≤ 7,0 % 
Ash: ≤ 10 % 
Carbohydr ate: ≥ 20 % 
a-glucosidase inhibitory activity : IC50 min 0,025 mg/ml 
Soy isoflavone: ≤ 0,3 g/100 g   
Bovine lactof errin Descr iption/Def inition: 
Bovine lacto ferrin is a prote in that occurs naturally in cows' milk. It is an iron-binding glycoprote in of appro ximately 77 kDa and consists of a sing le 
polypep tide chain of 689 amino acids. 
Production process: Bovine lactof errin is isolate d from skimmed milk or cheese whey via ion exchange and subsequent ultra-f iltration steps. Finally it is 
dried by freeze drying or spra ying and the large particles are sieved out. It is a virtually odourless, light pinkish powder . 
Physi cal-Chemical proper ties of Bovine lacto ferrin: 
Moisture: < 4,5 % 
Ash: < 1,5 % 
Arsenic: < 2,0 mg/kg 
Iron: < 350 mg/kg 
Protein : > 93 % 
of which bovine lactof errin: > 95 % 
of which other prot eins: < 5,0 % 
pH (2 % solution, 20 °C): 5,2-7,2 
Solubility (2 % solution, 20 °C): compl ete 
Buglo ssoides arvensis seed oil Descr iption/Def inition: 
Refin ed Buglossoides oil is extract ed from the seeds of Buglossoides arvensis (L.) I.M.Johnst 
Alpha-linolenic acid: ≥ 35 % w/w of total fatty acids 
Stea ridonic acid: ≥ 15 % w/w of total fatty acids 
Linoleic acid: ≥ 8,0 % w/w of total fatty acids 
Trans fatty acids: ≤ 2,0 % w/w of total fatty acids 
Acid value: ≤ 0,6 mg KOH/g 
Peroxide value: ≤ 5,0 meq O2/kg 
Unsaponif iable cont ent: ≤ 2,0 % 
Protein content (total nitrogen ): ≤ 10 µg/ml 
Pyrrolizidine alkaloids: Not detectable with a detection limit of 4,0 µg/kg 30.12.2017 L 351/136 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Calanus finmar chicus oil Descr iption/Def inition: 
The novel food is ruby coloured, slightly viscous oil with a slight shellfish odour extract ed from the crustacean (mar ine zooplankton) Calanus finmarch icus. 
The ingredient consists primar ily of wax esters (> 85 %) with minor amounts of triglycerides and other neutral lipids. 
Specif ications: 
Water: < 1,0 % 
Wax esters: > 85 % 
Total fatty acids: > 46 % 
Eicosapentaenoic acid (EPA): > 3,0 % 
Docosahexaenoic acid (DHA): > 4,0 % 
Total fatty alcohols: > 28 % 
C20:1 n-9 fatty alcohol: > 9,0 % 
C22:1 n-11 fatty alcohol: > 12 % 
Trans fatty acids: < 1,0 % 
Astaxanthineste rs: < 0,1 % 
Peroxide value: < 3,0 meq. O2/kg 
Chewing gum base  
(monometho xypoly ethy lene 
glycol) Descr iption/Def inition: 
The novel food ingredient is a synthetic polymer (Patent number WO2006016179). It consists of branche d polymers of monometho xypolyeth ylene 
glycol (MPEG) graf ted onto polyisoprene-graf t-maleic anhydr ide (PIP-g-MA), and unreacted MPEG (less than 35 % by weight). 
White to off-white colour . 
CAS No.: 1246080-53-4 
Character istics: 
Moisture: < 5,0 % 
Aluminium: < 3,0 mg/kg 
Lithium: < 0,5 mg/kg 
Nick el: < 0,5 mg/kg 
Residual anhydride: < 15 µmol/g 
Polydispersity index: < 1,4 
Isoprene: < 0,05 mg/kg 
Ethyl ene oxide: < 0,2 mg/kg 
Free maleic anhydride: < 0,1 %  30.12.2017 L 351/137 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Total oligomeres (less than 1 000 Dalton) : ≤ 50 mg/kg 
Ethyl ene glycol: < 200 mg/kg 
Dieth ylene glycol: < 30 mg/kg 
Monoethyle ne glycol methyl ether : < 3,0 mg/kg 
Dieth ylene glycol meth yl ether : < 4,0 mg/kg 
Triethylene glycol meth yl ether : < 7,0 mg/kg 
1,4-Dio xane: < 2,0 mg/kg 
Formaldeh yde: < 10 mg/kg   
Chewing gum base (Methyl 
vinyl ether -maleic anh ydride 
copolymer) Descr iption/Def inition: 
Methyl vinyl ether -maleic anhydride copolymer is an anhydrous copolymer of meth yl vinyl ether and maleic anhydr ide. 
Free-f lowin g, white to white-off powder 
CAS No: 9011-16-9 
Purity: 
Assa y value: At least 99,5 % in dry matter 
Specific viscosity (1 % MEK): 2-10 
Residual meth yl vinyl ether: ≤ 150 ppm 
Residual maleic anhydr ide: ≤ 250 ppm 
Acetaldehy de: ≤ 500 ppm 
Methanol: ≤ 500 ppm 
Dilauro yl pero xide: ≤ 15 ppm 
Total heavy metals: ≤ 10 ppm 
Microbiological criter ia: 
Total aerobic plate count: ≤ 500 CFU/g 
Mould/y east: ≤ 500 CFU/g 
Escher ichia coli: Negative to test 
Salmonella: Neg ative to test 
Staphy lococcus aureus: Nega tive to test 
Pseudomonas aeruginosa: Nega tive to test 30.12.2017 L 351/138 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Chia oil from Salvia hispanica Descr iption/Def inition: 
Chia oil is produced from Chia (Salvia hispanica L.) seeds (99,9 % pure) by cold-pressing. No solvents are used and, once pressed, the oil is held in decan ­
tation tank s and a filtration process emplo yed to remove impur ities. It can also be produced by extraction with supercr itical CO2. 
Production process: 
Produced by cold pressing. No solvents are used and, once pressed, the oil is held in decantation tank s and a filtration process emplo yed to remo ve 
impurities. 
Acidity expressed as oleic acid: ≤ 2,0 % 
Peroxide value: ≤ 10 meq/kg 
Insoluble impurities: ≤ 0,05 % 
Alpha linolenic acid: ≥ 60 % 
Linoleic acid: 15-20 % 
Chia seeds (Salvia hispanica) Descr iption/Def inition: 
Chia (Salvia hispanica L.) is a summer annual herbaceous plant belonging to the Labiatae family . Post-har vest the seeds are cleaned mechani cally . Flowers, 
leav es and other parts of the plant are remo ved. 
Dry matt er: 90-97 % 
Protein : 15-26 % 
Fat: 18-39 % 
Carbohydr ate (*): 18-43 % 
Crude Fibre (**): 18-43 % 
Ash: 3-7 %  
(*) Carbohydrat es include the fibre value (EU: carbohy drates are avail able = suga r + starch)  
(**) Crude fibre is the part of fibre made mainly of indigestib le cellulose, pent osans and lignin 
Production process: 
Production process of fruit juices and fruit juice blends beverages, containing Chia seeds, includes seed pre-hydration and past eurisation steps . Microbio ­
logical controls and monitoring systems are in place. 
Chitin-glucan from 
Aspergillus niger Descr iption/Def inition: 
Chitin-g lucan is obtained from the mycelium of Aspergillus niger; it is a slightly yello w, odourless, free-f lowing powder . It has a dry matte r content of 
90 % or more. 
Chitin-g lucan is compo sed largely of two polysacc harides: 
—  chitin, composed of repeating units of N-acetyl-D-g lucosamine (CAS No: 1398-61-4), 
—  beta (1, 3)-g lucan, composed of repeating units of D-glucose (CAS No: 9041-22-9).  30.12.2017 L 351/139 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Loss on drying: ≤ 10 % 
Chitin-g lucan: ≥ 90 % 
Ratio of chitin to glucan: 30:70 to 60:40 
Ash: ≤ 3,0 % 
Lipids: ≤ 1,0 % 
Protein s: ≤ 6,0 %   
Chitin-glucan complex from 
Fomes fomentar ius Descr iption/Def inition: 
Chitin-g lucan compl ex is obtained from the cell walls of the fruit bodies of the fungus Fomes fomentar ius. It consists primar ily of two polysacc harides: 
—  Chitin, composed of repeating units of N-acetyl-D-g lucosamine (CAS No: 1398-61-4); 
—  Beta-(1,3)(1,6)-D-g lucan, compo sed of repeating units of D-glucose (CA S No: 9041-22-9). 
The production process consists of several steps, including: cleaning, reduction in size and grinding, softening in wate r and heating in an alkaline 
solution, washing, drying. No hydrolysis is applied during the production process. 
Appearance: Powder , odourless, flavour less, brown 
Purity: 
Moisture: ≤ 15 % 
Ash: ≤ 3,0 % 
Chitin-g lucan: ≥ 90 % 
Ratio of chitin to glucan: 70:20 
Total carboh ydrates, excl uding glucans: ≤ 0,1 % 
Protein s: ≤ 2,0 % 
Lipids: ≤ 1,0 % 
Melanins: ≤ 8,3 % 
Additives: None 
pH: 6,7-7,5 
Hea vy metals : 
Lead (ppm): ≤ 1,00 
Cadmium (ppm): ≤ 1,00 
Mercur y (ppm): ≤ 0,03 
Arsenic (ppm): ≤ 0,20  30.12.2017 L 351/140 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Microbiological criter ia: 
Total mesophilic bacteria: ≤ 103/g 
Yeast and moulds: ≤ 103/g 
Colif orms at 30 °C: ≤ 103/g 
E. coli: ≤ 10/g 
Salmonella and other pathogen ic bacte ria: Absence/25 g   
Chit osan extract from fungi  
(Agaricus bispor us; 
Aspergillus niger) Descr iption/Def inition: 
The chitosan extract (containing mainly poly(D-g lucosamine)) is obtained from stems of Agaricus bispor us or from the mycelium of Aspergillus niger. 
The patent ed production process consists of several steps , including: extraction and deacetylation (hydrolysis) in alkaline medium, solubilisation in acidic 
medium, precipitation in alkaline medium, washing and drying. 
Synon ym: Poly(D-g lucosamine) 
Chitosa n CAS number: 9012-76-4 
Chitosa n formula: (C6H11NO4)n 
Appearance: fine free-f lowing powder 
Aspect : Off –white to slightly brownish 
Odour: Odourless 
Purity: 
Chitosa n cont ent (% w/w dry weight): 85 
Glucan conte nt (% w/w dry weight): ≤ 15 
Loss on drying (% w/w dry weight): ≤ 10 
Viscosity (1 % in 1 % acetic acid): 1-15 
Degree of acetylation (in % mol/wet weight): 0-30 
Viscosity (1 % in 1 % acetic acid) (mP a.s): 1-14 for chitosan from Aspergillus niger; 12-25 for chitin from Agaricus bispor us 
Ash (% w/dr y weight): ≤ 3,0 
Protein s (% w/dr y weight): ≤ 2,0 
Particle size: > 100 nm 
Taped density (g/cm3): 0,7-1,0 
Fat binding capacity 800 × 9 w/wet weight): pass  30.12.2017 L 351/141 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Hea vy metals : 
Mercur y (ppm): ≤ 0,1 
Lead (ppm): ≤ 1,0 
Arsenic (ppm): ≤ 1,0 
Cadmium (ppm): ≤ 0,5 
Microbiological criter ia: 
Aerobic count (CFU/g): ≤ 103 
Yeast and mould count (CFU/g): ≤ 103 
Escher ichia coli (CFU/g): ≤ 10 
Enterobacter iaceae (CFU/g): ≤ 10 
Salmonella: Absence/25 g 
Lister ia monocytog enes: Absence/25 g   
Chondroitin sulphate Descr iption/Def inition: 
Chondroitin sulphate (sodium salt) is a biosynthetic product. It is obtained by chemical sulphation of chond roitin derived from fermentation by the 
bacterium Escher ichia coli O5:K4:H4 strain U1-41 (ATCC 24502). 
Chondroitin sulphate (sodium salt) (% dry basis): 95-105 
MWw (weight avg.) (kDa): 5-12 
MWn (number avg.) (kDa): 4-11 
Dispersity (wh/w0,05): ≤ 0,7 
Sulphation patter n (ΔDi-6S) (%): ≤ 85 
Loss on drying (%) (105 °C to constant weight): ≤ 10,0 
Residue on ignition (% dry basis): 20-30 
Protein (% dry basis): ≤ 0,5 
Endoto xins (EU/mg): ≤ 100 
Total organic impurities (mg/kg): ≤ 50 
Chromium Picolinate Descr iption/Def inition: 
Chromium picolinate is a reddish free-f lowing powder , slightly soluble in water at pH 7. The salt is also soluble in polar organic solvents. 
Chemical name: tris(2p yridinecarbo xylat o-N,O)chromium(III) or 2-pyridinecarbo xylic acid chromium(III) salt 
CAS No.: 14639-25-9  30.12.2017 L 351/142 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Chemical formula: Cr(C6H4NO2)3 
Chemical character istics: 
Chromium Picolinat e: ≥ 95 % 
Chromium (III): 12-13 % 
Chromium (VI): not detect ed 
Water: ≤ 4,0 %   
Cistus incanus L. Pandalis 
herb Descr iption: 
Cistus incanus L. Pandalis herb; species belonging to the Cistaceae family and native to the Medite rranean region, Chalkidiki Penins ula. 
Composition: 
Moisture: 9–10 g/100 g herbs 
Protein : 6,1 g/100 g herbs 
Fat: 1,6 g/100 g herbs 
Carbohydr ates: 50,1 g/100 g herbs 
Fiber: 27,1 g/100 g herbs 
Minerals: 4,4 g/100 g herbs  
Sodium: 0,18 g 
Potassium: 0,75 g 
Magnesium: 0,24 g 
Calcium: 1,0 g 
Iron: 65 mg 
Vitamin B1: 3,0 µg 
Vitamin B2: 30 µg 
Vitamin B6: 54 µg 
Vitamin C: 28 mg 
Vitamin A: less than 0,1 mg 
Vitamin E: 40–50 mg 
Alpha- Tocopherol: 20–50 mg 
Beta and Gamma- Tocopherols: 2–15 mg 
Delta- Tocopherol: 0,1–2 mg 30.12.2017 L 351/143 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Citicoline Citicoline (synthetic) 
Descr iption/Def inition: 
Citicoline is compo sed of cytosine, ribose, pyrophosphat e and choline. 
White crystalline powder 
Chemical name: Choline cytidine 5′-p yrophosphate, Cytidine 5′-(tr ihydrogen diphosphat e) P′-[2-(tr imethyla mmonio)ethyl]est er inner salt 
Chemical formula: C14H26N4O11P2 
Molecular weight: 488,32 g/mol 
CAS No.: 987-78-0 
pH (sample solution of 1 %): 2,5-3,5 
Purity: 
Assa y value: ≥ 98 % of dry matter 
Loss on drying (100 °C for 4 hours): ≤ 5,0 % 
Ammonium: ≤ 0,05 % 
Arsenic: Not more than 2 ppm 
Free phosphor ic acids: ≤ 0,1 % 
5′-Cytidylic acid: ≤ 1,0 % 
Microbiological criter ia: 
Total plate count : ≤ 103 CFU/g 
Yeast and moulds: ≤ 102 CFU/g 
Escher ichia coli: Absence in 1 g 
Citicoline (micr obial sour ce) 
Descr iption/Def inition: 
It is produced by fermentation using a genetically modified strain of E. coli (BCT19/p40k) 
The specification on citicoline from the microbial source is identical to the author ised synthetic citicoline. 
Clos tridium butyr icum Descr iption/Def inition: 
Clostr idium butyr icum (CBM-588) is a Gram-positive, spore-f orming, oblig ate anaerobic, non-pathog enic, non-g enetically modifi ed bacte rium. Depository 
number FERM BP-2789 
Microbiological criter ia: 
Total viable aerobic count: ≤ 103 CFU/g 
Escher ichia coli: Not detec ted in 1 g  30.12.2017 L 351/144 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Staphy lococcus aureus: Not detected in 1 g 
Pseudomonas aeruginosa: Not detected in 1 g 
Yeast and moulds: ≤ 102 CFU/g   
Extract of defatted cocoa 
powder Cocoa (Theobroma cacao L.) Extract 
Appearance: Dark brown powder free of visible impurities 
Physical and chemical proper ties: 
Polyphenol conte nt: Min 55,0 % GAE 
Theobromine cont ent: Max 10,0 % 
Ash cont ent: Max 5,0 % 
Moisture content: Max 8,0 % 
Bulk density: 0,40-0,55 g/cm3 
pH: 5,0-6,5 
Residual solvent: Max 500 ppm 
Low fat cocoa extract Low fat Cocoa (Theobro ma cacao L.) extract 
Appearance: Dark red to purple powder 
Cocoa extract, concentrat e: Min 99 % 
Silicon dioxide (techn ological aid): Max 1,0 % 
Cocoa flavanols: Min. 300 mg/g 
(-) Epicatec hin: Min. 45 mg/g 
Loss on drying: Max. 5,0 % 
Cor iander seed oil from 
Coriandr um sativum Descr iption/Def inition: 
Coriander seed oil is an oil containing glycerides of fatty acids that is produced from the seeds of the coriander plant Coriandr um sativum L. 
Slight yello w colour , bland taste 
CAS No.: 8008-52-4 
Com position of fatty acids: 
Palmitic acid (C16:0): 2-5 % 
Stea ric acid (C18:0): < 1,5 % 
Petroselinic acid (cis-C18:1(n-12)): 60-75 % 
Oleic acid (cis-C18:1 (n-9)): 8-15 %  30.12.2017 L 351/145 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Linoleic acid (C18:2): 12-19 % 
α-Linolenic acid (C18:3): < 1,0 % 
Trans fatty acids: ≤ 1,0 % 
Purity: 
Refractive index (20°C): 1,466-1,474 
Acid value: ≤ 2,5 mg KOH/g 
Peroxide value: ≤ 5,0 meq/kg 
Iodine value: 88-110 units 
Saponif ication value: 186-200 mg KOH/g 
Unsaponif iable matt er: ≤ 15 g/kg   
Crataegus pinnatifida dried 
fruit Descr iption/Def inition: 
Dried fruits of Crataegus pinnatif ida species belonging to the Rosaceae family and native to north China and Korea. 
Composition: 
Dry matt er: 80 % 
Carbohydr ates: 55 g/kg fresh weight 
Fructo se: 26,5–29,3 g/100 g 
Glucose: 25,5–28,1 g/100 g 
Vitamin C: 29,1 mg/100 g fresh weight 
Sodium: 2,9 g/100 g fresh weight 
Com potes are products obtained by ther mal processing of the edible part of one or several species of fruits, whole or in pieces, sieved or not, without 
signif icant concentration. Sugars, water , cider , spices and lemon juice may be used. 
α-cy clodextr in Descr iption/Def inition: 
A non-reducing cyclic saccharide consisting of six α-1,4-link ed D-glucop yranosyl units produced by the action of cyclodextr in glucosyltransfe rase  
(CGT ase, EC 2.4.1.19) on hydrolyzed starc h. Recove ry and purification of α-cy clodextr in may be carried out using one of the followi ng procedures: 
precipitation of a compl ex of α-cy clodextr in with 1-decanol, dissolution in water at elevated temperature and re-precipitation, steam-str ipping of the 
compl exant, and crystallisation of α-cy clodextr in from the solution; or chromat ography with ion-ex change or gel filtration followed by crystallisation of 
α-cy clodextr in from the purified mother liquor; or membrane separation methods such as ultra-f iltration and reverse osmosis: Descr iption: Virtually 
odourless, white or almost white crystalline solid. 
Synon yms: α-cy clodextr in, α-dextr in, cyclohexaamyl ose, cyclomalt ohexaose, α-cy cloamylase 
Chemical name: Cyclohexaam ylose  30.12.2017 L 351/146 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
CAS No.: 10016-20-3 
Chemical formula: (C6H10O5)6 
Formula weight: 972,85 
Assa y: ≥ 98 % (dry basis) 
Identif ication: 
Melting rang e: Decom poses above 278 °C 
Solubility: Freely soluble in water; very slightly soluble in ethanol 
Specific rotation: [α]D 25: Between + 145° and +151° (1 % solution) 
Chromatograph y: The retention time for the major peak in a liquid chromatogram of the sam ple corresponds to that for α-cy clodextr in in a chromat o­
gram of reference α-cy clodextr in (available from Consor tium für Elektr ochemische Industr ie GmbH, München, Germany or Wacker Biochem Group, Adrian, MI, 
USA) using the conditions descr ibed in the METHOD OF ASSA Y 
Purity: 
Water: ≤ 11 % (Karl Fischer Method) 
Residual compl exant: ≤ 20 mg/kg 
(1-decanol) 
Reducing substances: ≤ 0,5 % (as glucose) 
Sulphate d ash: ≤ 0,1 % 
Lead: ≤ 0,5 mg/kg 
Method of assay: 
Determine by liquid chromat ography using the followi ng conditions: 
Sample solution: Weigh accurately about 100 mg of test sam ple into a 10 ml volumetr ic flask and add 8 ml of deionised water . Dissolve the sam ple 
compl etely using an ultra-sonif ication bath (10-15 min) and dilut e to the mark with purified deionised wate r. Filter through a 0,45-micrometer filter 
Reference solution: Weigh accurat ely about 100 mg of α-cy clodextr in into a 10 ml volumetr ic flask and add 8 ml of deionised water . Dissolve the sam ple 
compl etely using an ultra-sonif ication bath and dilut e to the mark with purified deionised water . 
Chromatograph y: Liquid chromat ograph equipped with a refractive index detect or and an integrating recorder . 
Column and packing: Nucleosil-100-NH2 (10 µm) (Macherey & Nagel Co. Düren, Germany) or similar 
Length: 250 mm 
Diamet er: 4 mm 
Temperature: 40 °C 
Mobile phase: aceton itrile/wate r (67/33, v/v) 
Flow rate: 2,0 ml/min 
Injection volume: 10 µl  30.12.2017 L 351/147 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Procedure: Inject the sample solution into the chromatograph, record the chromat ogram, and measure the area of the α-CD peak. Calculat e the 
percentage of α-cy clodextr in in the test sample as follows: 
% α-cy clodextr in (dry basis) = 100 × (AS/AR) (WR/WS) 
where 
As and AR are the areas of the peaks due to α-cy clodextr in for the sample solution and reference solution, respectively . Ws and WR are the weights (mg) 
of the test sample and reference α-cy clodextr in, respectively , after correcting for wate r cont ent.   
γ-cy clodextr in Descr iption/Def inition: 
A non-reducing cyclic saccharide consisting of eight α-1,4-link ed D-glucop yranosyl units produced by the action of cyclodextr in glucosyltransfe rase  
(CGT ase, EC 2.4.1.19) on hydrolysed starc h. Recove ry and purification of γ-cy clodextr in may be carried out by precipitation of a compl ex of γ-cy clo­
dextr in with 8-cy clohexadecen-1-one, dissolution of the compl ex with water and n-decane, steam-str ipping of the aqueous phase and recovery of 
gam ma-CD from the solution by crystallisation. 
Virtually odourless, whit e or almost white crystalline solid 
Synon yms: γ-cy clodextr in, γ-dextr in, cyclooctaamylose, cyclomalt ooctaose, γ-cy cloamylase 
Chemical name: Cyclooctaamy lose 
CAS number: 17465-86-0 
Chemical formula: (C6H10O5)8 
Assa y: ≥ 98 % (dry basis) 
Identif ication: 
Melting rang e: Decom poses above 285 °C 
Solubility: Freely soluble in water; very slightly soluble in ethanol 
Specific rotation: [α]D 25: between + 174° and + 180° (1 % solution) 
Purity: 
Water: ≤ 11 % 
Residual compl exant (8-cy clohexadecen-1-one (CHDC)): ≤ 4 mg/kg 
Residual solvent (n-decane): ≤ 6 mg/kg 
Reducing substances: ≤ 0,5 % (as glucose) 
Sulphate d ash: ≤ 0,1 % 
Dextran preparation 
produced by Leuconostoc 
mesenteroides 1.  Powdered form: 
Carbohydr ates: 60 % with: (Dextran: 50 %, Mannit ol: 0,5 %, Fructo se: 0,3 %, Leucrose: 9,2 %) 
Prote in: 6,5 % 
Lipid: 0,5 %  30.12.2017 L 351/148 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Lactic acid: 10 % 
Ethanol: traces 
Ash: 13 % 
Moisture: 10 % 
2.  Liquid form: 
Carbohydr ates: 12 % with: (Dextran: 6,9 %, Mannitol: 1,1 %, Fructose: 1,9 %, Leucrose: 2,2 %) 
Prote in: 2,0 % 
Lipid: 0,1 % 
Lactic acid: 2,0 % 
Ethanol: 0,5 % 
Ash: 3,4 % 
Moisture: 80 %   
Diacylgly cerol oil of plant 
origin Descr iption/Def inition: 
Manufactur ed from glycerol and fatty acids derived from edible vegetable oils, in particular from soybean oil (Glyc ine max) or rapeseed oil (Brassica 
campestr is, Brassica napus) using a specific enzyme. 
Acylgl ycerol Distr ibution: 
Diacylg lycerols (DAG): ≥ 80 % 
1,3-Diacylg lycerols (1,3-D AG): ≥ 50 % 
Triacylg lycerols (TAG): ≤ 20 % 
Monoacylg lycerols (MA G): ≤ 5,0 % 
Fatty Acid Composition (MA G, DAG, TAG): 
Oleic acid (C18:1): 20-65 % 
Linoleic acid (C18:2): 15-65 % 
Linolenic acid (C18:3): ≤ 15 % 
Saturated fatty acids: ≤ 10 % 
Others: 
Acid value: ≤ 0,5 mg KOH/g 
Moisture and volatile: ≤ 0,1 % 
Peroxide value: ≤ 1,0 meq/kg 
Unsaponif iables: ≤ 2,0 % 
Trans fatty acids≤ 1,0 % 
MAG = monoacylg lycerols, DAG = diacylg lycerols, TAG = triacylg lycerols 30.12.2017 L 351/149 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Dihydroca psiate (DHC) Descr iption/Def inition: 
Dihy drocapsiate is synthesised by enzyme-catalysed esterification of vanillyl alcohol and 8-methyl nonanoic acid. Following the ester ification dihy dro­
capsiate is extract ed with n-hexane. 
Viscous to colourless to yellow liquid 
Chemical formula: C18 H28 O4 
CAS No: 205687-03-2 
Physi cal-chemical proper ties: 
Dihy drocapsiate: > 94 % 
8-Methy lnonanoic acid: < 6,0 % 
Vanillyl acohol: < 1,0 % 
Other synthesis relat ed substances: < 2,0 % 
Dried extract of Lippia 
citriodor a from cell cultures Descr iption/Def inition: Dried extract of cell cultures HTN®Vb of Lippia citriodor a (Palau) Kunth. 
Echin acea angustif olia extract 
from cell cultures Extract of the roots of Echinacea angustif olia obtained from tissue culture plant which is substantially equivalent to a root extract from Echinacea angustifolia 
obtained in ethanol-water titrate d to 4 % echi nacoside. 
Echium plantagineum oil Descr iption/Def inition: 
Echium oil is the pale yellow product obtained by refining oil extract ed from the seeds of Echium plantagineum L. Stear idonic acid: ≥ 10 % w/w of total 
fatty acids 
Trans fatty acids: ≤ 2,0 % (w/w of total fatty acids) 
Acid value: ≤ 0,6 mg KOH/g 
Peroxide value: ≤ 5,0 meq O2/kg 
Unsaponif iable cont ent: ≤ 2,0 % 
Protein content (total nitrogen ): ≤ 20 µg/ml 
Pyrrolizidine alkaloids: Not detectable with a detection limit 4,0 µg/kg 
Epigallocatechin gallate as 
a pur ified extract from green 
tea leaves (Camellia sinensis) Descr iption/Def inition: 
A highly purified extract from the leaves of green tea (Camellia sinensis (L.) Kuntze) in the form of a fine, off-white to pale pink powder . It is compo sed of 
a minimum of 90 % epig allo-catec hin gallate (EGCG), and has a melting point between appro x. 210 and 215 °C 
Appearance: off-white to pale pink powder  30.12.2017 L 351/150 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Chemical name: polyphenol (-) epigalloc atec hin-3-gallat e 
Synon yms: epiga llocatec hin gallat e (EGCG) 
CAS No.: 989-51-5 
INCI name: epigallocat echin gallat e 
Molecular mass: 458,4 g/mol 
Loss on drying: max 5,0 % 
Hea vy metals : 
Arsenic: max 3,0 ppm 
Lead: max 5,0 ppm 
Assay: 
Min. 94 % EGCG (on dry mater ial) 
max. 0,1 % caffeine 
Solubility: EGCG is fairly soluble in water , ethanol, methanol and acet one   
L-ergothioneine Def inition 
Chemical name (IUP AC): (2S)-3-(2-thio xo-2,3-dihydro-1H-imid azol-4-yl)-2-(tr imeth ylammonio)-Propanoate 
Chemical formula: C9H15N3O2S 
Molecular mass: 229,3 Da 
CAS No.: 497-30-3 
Parameter Specif ication Method 
Appearance White powder Visual 
Opti cal rotation [α]D ≥ (+) 122° (c = 1, H2O)a) Polar imetr y 
Chemical purity ≥ 99,5 % 
≥ 99,0 % HPLC [Eur . Ph. 2.2.29] 
1H-NMR 
Identif ication Compliant with the structure 1H-NMR 
C: 47,14 ± 0,4 % 
H: 6,59 ± 0,4 % 
N: 18,32 ± 0,4 % Elemental analysis 
Total residual solvents 
(methanol, ethyl acetate, isopropanol, ethanol) [Eur . Ph. 01/2008:50400] 
< 1 000 ppm Gas chromat ography 
[Eur . Ph. 01/2008:20424] 
Loss on drying Intern al standard < 0,5 % [Eur . Ph. 01/2008:20232] 
Impurities < 0,8 % HPLC/ GPC or 1H-NMR 30.12.2017 L 351/151 Official Jour nal of the European Union EN     Authorised Novel Food Specification  
Parameter Specif ication Method 
Hea vy metalsb) c) 
Lead < 3,0 ppm ICP/AES 
(Pb, Cd) 
Atomic fluorescence (Hg) Cadmium < 1,0 ppm 
Mercur y < 0,1 ppm 
Microbiological specif icationsb) 
Total viable aerobic count (TVAC) ≤ 1 × 103 CFU/g [Eur . Ph. 01/2011:50104] 
Total yeast and mould count (TYMC) ≤ 1 × 102 CFU/g 
Escher ichia coli Absence in 1 g 
Eur. Ph.: European Phar macopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-perf ormance liquid chromat ography; GPC: gel permeation 
chromatograph y; ICP/AES: Inductively coupled plasma atom ic emission spectroscop y; CFU: colony-f orming units. 
a)  Lit. [α]D = (+) 126,6° (c = 1, H2O) 
b)  Analyses conducted on each batch 
c)  Maximum levels in accordance with Regulation (EC) No 1881/2006 
Ferric Sodium EDT A Descr iption/Def inition: 
Ferric Sodium EDT A (ethyl enediaminete traacetic acid) is an odourless free-f lowing, yello w to brown powder with a chemical purity of more than 
99 % (w/w). It is freely soluble in water . 
Chemical formula: C10H12FeN2NaO8 · 3H2O 
Chemical character istics: 
pH of 1 % solution: 3,5-5,5 
Iron: 12,5-13,5 % 
Sodium: 5,5 % 
Water: 12,8 % 
Org anic matt er (CHNO): 68,4 % 
EDT A: 65,5-70,5 % 
Water insoluble matte r: ≤ 0,1 % 
Nitr ilo-tr iacetic acid: ≤ 0,1 % 
Ferrous ammonium 
phosphate Descr iption/Def inition: 
Ferrous ammonium phosphate is a grey /green fine powder , practically insoluble in water and soluble in dilut e mineral acids. 
CAS No.: 10101-60-7  30.12.2017 L 351/152 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Chemical formula: FeNH4PO4 
Chemical character istics: 
pH of 5 % suspension in wate r: 6,8-7,8 
Iron (total): ≥ 28 % 
Iron (II): 22-30 % (w/w) 
Iron (III): ≤ 7,0 % (w/w) 
Ammonia: 5-9 % (w/w) 
Water: ≤ 3,0 %   
Fish peptides from Sardinops 
sagax Descr iption/Def inition: 
The novel food ingredient is a peptide mixture, which is obtained by an alkaline protease-catalysed hydrolysis of fish (Sardinops sagax) muscle, subsequent 
isolation of the peptide fraction by column chromat ography , concentration under vacuum and spra y drying. 
Yellowish white powder 
Peptides (*) (shor t chain peptides, dipepti des and tripep tides with a molecular weight of less than 2 kDa): ≥ 85 g/100 g 
Val-Tyr (dipeptide): 0,1-0,16 g/100 g 
Ash: ≤ 10 g/100 g 
Moisture: ≤ 8 g/100 g 
(*)  Kjeldahl method 
Flavonoids from Glycyrrhiza 
glabra Descr iption/Def inition: 
Flavonoids derived from the roots or rootstoc k of Glycy rrhiza glabr a L. are extract ed with ethanol follo wed by further extraction of this ethanolic extract 
with medium-cha in triglycerides. It is a dark -brown coloured liquid, containing 2,5 % to 3,5 % of glabr idin. 
Moisture: < 0,5 % 
Ash: < 0,1 % 
Peroxide value: < 0,5 meq/kg 
Glabr idin: 2,5-3,5 % of fat 
Glycyrrhizinic acid: < 0,005 % 
Fat including polyphenol-type substances: ≥ 99 % 
Protein : < 0,1 % 
Carbohydr ates: not detectable 30.12.2017 L 351/153 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Fucoidan extract from the 
seaw eed Fucus vesiculosus Descr iption/Def inition: 
Fucoidan from the seawe ed Fucus vesiculosus is extract ed using aqueous extraction in acidic solution and filtration processes without the use of organic 
solvents. The resulting extract is concentrat ed and dried to yield the fucoidan extract with the following specifi cations: 
Off-white to brown powder 
Odour and Taste: Bland odour and taste 
Moisture: < 10 % (105 °C for 2 hours) 
pH value: 4,0-7,0 (1 % suspension at 25 °C) 
Hea vy metals : 
Arsenic (inorganic): < 1,0 ppm 
Cadmium: < 3,0 ppm 
Lead: < 2,0 ppm 
Mercur y: < 1,0 ppm 
Microbiological criter ia: 
Total aerobic microbial count: < 10 000 CFU/g 
Yeast and mould count : < 100 CFU/g 
Total enterobact eria count : Absence/g 
Escher ichia coli: Absence/g 
Salmonella: Absence/10 g 
Staphy lococcus aureus: Absence/g 
Com position of the two permitted types of extracts, based on the level of fucoidan: 
Extract 1: 
Fucoidan: 75-95 % 
Alginate: 2,0-5,5 % 
Polyphlorog lucinol: 0,5-15 % 
Mannit ol: 1-5 % 
Natural salts/Free Minerals: 0,5-2,5 % 
Other carboh ydrates: 0,5-1,0 % 
Protein : 2,0-2,5 % 
Extract 2: 
Fucoidan: 60-65 % 
Alginate: 3,0-6,0 %  30.12.2017 L 351/154 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Polyphlorog lucinol: 20-30 % 
Mannit ol: < 1,0 % 
Natural salts/Free Minerals: 0,5-2,0 % 
Other carboh ydrates: 0,5-2,0 % 
Protein : 2,0-2,5 %   
Fucoidan extract from the 
seaw eed Undar ia pinnatifida Descr iption/Def inition: 
Fucoidan from seaweed Undar ia pinnatifida is extract ed using aqueous extraction in acidic solution and filtration processes without the use of organic sol­
vents. The resulting extract is concentrat ed and dried to yield the fucoidan extract with the following specifi cations: 
Off-white to brown powder 
Odour and Taste: Bland odour and taste 
Moisture: < 10 % (105 °C for 2 hours) 
pH value: 4,0-7,0 (1 % suspension at 25 °C) 
Hea vy metals : 
Arsenic (inorganic): < 1,0 ppm 
Cadmium: < 3,0 ppm 
Lead: < 2,0 ppm 
Mercur y: < 1,0 ppm 
Microbiology : 
Total aerobic microbial count: < 10 000 CFU/g 
Yeast and mould count : < 100 CFU/g 
Total enterobact eria count : Absence/g 
Escher ichia coli: Absence/g 
Salmonella: Absence/10 g 
Staphy lococcus aureus: Absence/g 
Com position of the two permitted types of extracts, based on the level of fucoidan: 
Extract 1: 
Fucoidan: 75-95 % 
Alginate: 2,0-6,5 % 
Polyphlorog lucinol: 0,5-3,0 % 
Mannit ol: 1-10 %  30.12.2017 L 351/155 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Natural salts/Free Minerals: 0,5-1,0 % 
Other carboh ydrates: 0,5-2,0 % 
Protein : 2,0-2,5 % 
Extract 2: 
Fucoidan: 50-55 % 
Alginate: 2,0-4,0 % 
Polyphlorog lucinol: 1,0-3,0 % 
Mannit ol: 25-35 % 
Natural salts/Free Minerals: 8-10 % 
Other carboh ydrates: 0,5-2,0 % 
Protein : 1,0-1,5 %   
2′-F ucosyllact ose 
(synthetic) Def inition: 
Chemical name: α-l-Fucop yranosyl-(1!2)-β-d-galact opyranosyl-(1!4)-d-g lucop yranose 
Chemical formula: C18H32O15 
CAS No: 41263-94-9 
Molecular weight: 488,44 g/mol 
Descr iption: 
2′- fucosyllactos e is a whit e to off-white powder that is produced by a chemical synthesis process and is isolate d by crystallisation. 
Purity: 
2′-Fucosyllact ose: ≥ 95 % 
D-Lactose: ≤ 1,0 w/w % 
L-Fucose: ≤ 1,0 w/w % 
Difucosyl-d-lactose isomers: ≤ 1,0 w/w % 
2′-Fucosyl-d-lactulose: ≤ 0,6 w/w % 
pH (20 °C, 5 % solution): 3,2-7,0 
Water (%): ≤ 9,0 % 
Ash, sulphated: ≤ 0,2 % 
Acetic acid: ≤ 0,3 % 
Residual solvents (methanol, 2-propanol, meth yl acetat e, acetone): ≤ 50,0 mg/kg sing ly, ≤ 200,0 mg/kg in combination) 
Residual prot eins: ≤ 0,01 %  30.12.2017 L 351/156 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Hea vy Met als: 
Palladium: ≤ 0,1 mg/kg 
Nick el: ≤ 3,0 mg/kg 
Microbiological criter ia: 
Aerobic mesophilic bacteri a total count: ≤ 500 CFU/g 
Yeasts and Moulds: ≤ 10 CFU/g 
Residual endoto xins: ≤ 10 EU/mg   
2′-F ucosyllact ose 
(microbial source) Def inition: 
Chemical name: α-L- Fucop yranosyl-(1!2)-β-D-galact opyranosyl-(1!4)-D-g lucop yranose 
Chemical formula: C18H32O15 
CAS No: 41263-94-9 
Molecular weight: 488,44 g/mol 
Source: 
Genetically modifi ed strain of Escher ichia coli K-12 Source: 
Genetically modif ied strain of Escher ichia coli BL21 
Descr iption: 
2′-Fucosyllact ose is a whit e to off-white crystalline powder that is pro­
duced by a microbial process. 2′-Fucosyllact ose is isolated by crystallisa ­
tion. 
Purity: 
2′-Fucosyllact ose: ≥ 94 % 
D-Lactose: ≤ 3,0 % 
L-Fucose: ≤ 1,0 
Difucosyl-D-lactose : ≤ 1,0 % 
2′-Fucosyl-D-lactulose: ≤ 1,0 % 
pH (20 °C, 5 % solution): 3,2-5,0 
Water: ≤ 5,0 % 
Ash, sulphated: ≤ 1,5 % 
Acetic acid: ≤ 1,0 % 
Residual prot eins: ≤ 0,01 %  Descr iption: 
2′-Fucosyllactose is a white to off whit e powder and the liquid concentrate  
(45 % ± 5 % w/v) aqueous solution is a colourless to slight yello w clear 
aqueous solution. 2′-Fucosyllactose is produced by a microbiological process. 
2′-Fucosyllactose is isolated by spra y drying. 
Purity: 
2′-Fucosyllactose: ≥ 90 % 
Lactose: ≤ 5,0 % 
Fucose: ≤ 3,0 % 
3-Fucosyllacto se: ≤ 5,0 % 
Fucosylgal actose: ≤ 3,0 % 
Difucosyllactose: ≤ 5,0 % 
Glucose: ≤ 3,0 % 
Galactose: ≤ 3,0 % 
Water: ≤ 9,0 % (powder) 
Ash, sulphat ed: ≤ 0,5 % (powder and liquid) 
Residual prote ins: ≤ 0,01 % (powder and liquid)  30.12.2017 L 351/157 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Microbiological criter ia: 
Aerobic mesophilic bacteri a total count: ≤ 500 CFU/g 
Yeasts: ≤ 10 CFU/g 
Moulds: ≤ 100 CFU/g 
Endoto xins: ≤ 10 EU/mg Heavy Met als: 
Lead: ≤ 0,02 mg/kg (powder and liquid); 
Arsenic: ≤ 0,2 mg/kg (powder and liquid) 
Cadmium: ≤ 0,1 mg/kg (powder and liquid) 
Mercur y: ≤ 0,5 mg/kg (powder and liquid) 
Microbiological criter ia: 
Total plate count: ≤ 104 CFU/g (powder), ≤ 5 000 CFU/g (liquid) 
Yeasts and Moulds: ≤ 100 CFU/g (powder); ≤ 50 CFU/g (liquid) 
Enterobact eriaceae/Colif orms: absence in 11 g (powder and liquid) 
Salmonella: negat ive/100 g (powder), nega tive/200 ml (liquid) 
Cronobacter: negativ e/100 g (powder), negat ive/200 ml (liquid) 
Endoto xins: ≤ 100 EU/g (powder), ≤ 100 EU/ml (liquid) 
Aflatoxin M1: ≤ 0,025 µg/kg (powder and liquid)    
Galact o-oligosacchar ide Descr iption/Def inition: 
Galact o-oligosacchar ide is produced from milk lactose by an enzymatic process using β-galactosidase s from Aspergillus oryzae, Bifidobacter ium 
bifidum and Bacillus circulans. 
GOS: min 46 % Dry Matter (DM) 
Lact ose: max 40 % DM 
Glucose: max 22 % DM 
Galactose : min 0,8 % DM 
Ash: max 4,0 % DM 
Protein : max 4,5 % DM 
Nitr ite: max. 2 mg/kg 
Glucosamine HCl from 
Aspergillus niger and 
genetically modif ied strain of 
E. Coli K12 White crystalline odourless powder 
Molecular formula: C6H13NO5 · HCl 
Relative molecular mass: 215,63 g/mol 
D-Glucosamine HCl 98,0-102,0 % of reference standard (HPL C) 
Specific rotation + 70,0° - + 73,0° 30.12.2017 L 351/158 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Glucosamine sulphate KCl 
from Aspergillus niger and 
genetically modif ied strain of 
E. Coli K12 White crystalline odourless powder 
Molecular formula: (C6H14NO5)2SO4 · 2KCl 
Relative molecular mass: 605,52 g/mol 
D-Glucosamine Sulphate 2KCl 98,0-102,0 % of reference standard (HPL C) 
Specific Rotation + 50,0° to + 52,0° 
Glucosamine sulphate NaCl 
from Aspergillus niger and 
genetically modif ied strain of 
E. Coli K12 White crystalline odourless powder 
Molecular formula: (C6H14NO5)2SO4 · 2NaCl 
Relative molecular mass: 573,31 g/mol 
D-Glucosamine HCl: 98-102 % of reference standard (HPL C) 
Specific Optical Rotation: + 52° - + 54° 
Guar Gum Descr iption/Def inition: 
Native guar gum is the ground endosper m of seeds from natural strains of guar Cyamopsis tetragonolobus L. Taub. (Leguminosae family). It consists of 
a high molecular weight polysacchar ide, primar ily compo sed of galactop yranose and mannop yranose units combined through glycosidic linkages, which 
may be descr ibed chemically as a galact omannan (galact omannan cont ent not less than 75 %). 
Appearance: White to yellowish powder 
Molecular weight: Between 50 000 – 8 000 000 Daltons 
CAS number: 9000-30-0 
EINECS Number: 232-536-8 
Purity: As specified by Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation  
(EC) No 1333/2008 of the European Parliament and of the Council (1) & by Commission Implementing Regulation (EU) 2015/175 of 5 Febr uary 2015 
laying down special conditions applicable to the impor t of guar gum originating in or consigned from India due to contamination risks by pentachlor o­
phenol and dioxins (2). 
Physi co-chemical proper ties: 
Powder 
Shelf-life: 2 years 
Colour: Whit e 
Odour: Light 
Averag e diameter of particles: 60-70 µm 
Moisture: Max 15 % 
Viscosity (*) at 1 hour —  30.12.2017 L 351/159 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Viscosity (*) at 2 hours: Min 3 600 mPa.s 
Viscosity (*) at 24 hours: Min 4 000 mPa. s 
Solubility: Soluble in hot and cold wate r 
pH for 10g/L, at 25 °C - 6-7,5 
Flakes 
Useful life: 1 year 
Colour: Whit e/off whit e with absence or minimal presence of blac k spots 
Odour: Light 
Averag e diameter of particles: 1-10 mm 
Moisture: Max 15 % 
Viscosity (*) at 1 hour: Min 3 000 mPa.s 
Viscosity (*) at 2 hours — 
Viscosity(*) at 24 hours — 
Solubility - Soluble in hot and cold water 
pH for 10g/L, at 25 °C - 5-7,5 
(*)  The measurements of viscosity are carried out under the follo wing conditions: 1 %, 25 °C, 20 rpm   
Heat-treated milk products 
ferment ed with Bacteroides 
xyla nisolv ens Descr iption/Def inition: 
Heat-treat ed fermented milk products are produced with Bacteroides xylanisolven s (DSM 23964) as starter culture. 
Semi-skimmed milk (between 1,5 % and 1,8 % fat) or skimmed milk (0,5 % fat or less) is pasteur ised or ultra-heat-treated before starting the fermentation 
with Bacteroides xylanisolvens (DSM 23964). The resulting fermented milk product is homogenised and then heat-treat ed to inactivate Bacteroi des xylani­
solve ns (DSM 23964). The final product does not contain viable cells of Bacter oides xylanisolvens (DSM 23964) (*). 
(*)  Modified DIN EN ISO 21528-2. 
Hydro xytyrosol Descr iption/Def inition: 
Hydro xytyrosol is a pale yello w viscous liquid obtained by chemical synthesis 
Molecular formula: C8H10O3 
Molecular weight: 154,6 g/mol 
CAS No: 10597-60-1 
Moisture ≤ 0,4 % 
Odour: Charact eristic  30.12.2017 L 351/160 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Taste: Slightly bitter 
Solubility (water): Miscible with water 
pH: 3,5-4,5 
Refractive Index: 1,571-1,575 
Purity: 
Hydro xytyrosol: ≥ 99 % 
Acetic acid: ≤ 0,4 % 
Hydro xytyrosol acetat e: ≤ 0,3 % 
Sum of homovanillic acid, iso-homo vanilic acid, and 3-metho xy-4h ydro xyphen ylglycol: ≤ 0,3 % 
Hea vy Met als 
Lead: ≤ 0,03 mg/kg 
Cadmium: ≤ 0,01 mg/kg 
Mercur y: ≤ 0,01 mg/kg 
Residual Solv ents 
Ethyl acetate : ≤ 25,0 mg/kg 
Isopropanol: ≤ 2,50 mg/kg 
Methanol: ≤ 2,00 mg/kg 
Tetrahy drofuran: ≤ 0,01 mg/kg   
Ice Structur ing Protein 
type III HPL C 12 Descr iption/Def inition: 
The Ice Structur ing Protein (ISP) preparation is a light-brown liquid produced by submerge d fermentation of a genetically-modif ied strain of food-grade 
baker's yeast (Saccharo myces cerevisiae) in which a synthetic gene for the ISP has been inser ted into the yeast's genome. The prote in is expressed and 
secreted into the growth medium where it is separate d from the yeast cells by micro-f iltration and concentrat ed by ultra-f iltration. As a result, the yeast 
cells are not transfe rred into the ISP preparation as such or under an alter ed form. The ISP preparation consists of native ISP, glycosylat ed ISP and 
prote ins and peptides from the yeast and sugars as well as acids and salts commonly found in food. The concentrat e is stabilised with 10 mM citric acid 
buffe r. 
Assa y: ≥ 5 g/l active ISP 
pH: 2,5-3,5 
Ash: ≤ 2,0 % 
DNA: Not detec table 
Aqueo us extract of dried 
leaves of Ilex guayusa Descr iption/Def inition: 
Dark brown liquid. Aqueous extracts of dried leaves of Ilex guayusa.  30.12.2017 L 351/161 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Composition: 
Protein : < 0,1 g/100 ml 
Fat: < 0,1 g/100 ml 
Carbohydr ate: 0,2–0,3 g/100 ml 
Total sugars: < 0,2 g/100 ml 
Caffei ne: 19,8–57,7 mg/100 ml 
Theobromine: 0,14–2,0 mg/100 ml 
Chloroge nic acids: 9,9–72,4 mg/100 ml   
Isomalto-oligosa cchar ide Powder : 
Solubility (water) (%): > 99 
Glucose (% dry basis): ≤ 5,0 
Isomalt ose + DP3 to DP9 (% dry basis): ≥ 90 
Moisture (%): ≤ 4,0 
Sulphate d ash (g/100 g): ≤ 0,3 
Hea vy metals : 
Lead (mg/kg): ≤ 0,5 
Arsenic (mg/kg): ≤ 0,5 
Syr up: 
Dried solids (g/100 g): > 75 
Glucose (% dry basis): ≤ 5,0 
Isomalt ose + DP3 to DP9 (% dry basis): ≥ 90 
pH: 4 - 6 
Sulphate d ash (g/100 g): ≤ 0,3 
Hea vy metals : 
Lead (mg/kg): ≤ 0,5 
Arsenic (mg/kg): ≤ 0,5 
Isomaltulose Descr iption/Def inition: 
A reducing disacc haride that consists of one glucose and one fructo se moiety linked by an alpha-1,6-g lycosidic bond. It is obtained from sucrose by an 
enzymatic process. The commercial product is the monohydrat e. Appearance: Virtually odourless, white or almost whit e crystals with a sweet taste  30.12.2017 L 351/162 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Chemical name: 6-O-α-D-g lucop yranosyl-D-fr ucto furanose, monoh ydrate 
CAS No.: 13718-94-0 
Chemical formula: C12H22O11 · H2O 
Structural formula 
Formula weight: 360,3 (monohydr ate) 
Purity: 
Assa y: ≥ 98 % on the dry basis 
Loss on drying: ≤ 6,5 % (60 °C, 5 hours) 
Hea vy metals : 
Lead: ≤ 0,1 mg/kg 
Determine using an atomic absor ption technique appropr iate to the specified level. The selection of sample size and method of sample preparation may 
be based on the principles of the method descr ibed in FNP 5 (*), ‘Instr umental methods ’ 
(*)  Food and Nutr ition Paper 5 Rev. 2 — Guide to specifications for general notices, general analytical techniques, identification tests, test solutions and other reference 
mat erials (JECF A), 1991, 322 pp., English, ISBN 92-5-102991-1.   
Lactit ol Descr iption/Def inition: 
Crystalline powder or colourless solution manufactured via catalytic hydrogenation of lactose. Crystalline products occur in anhydrous, monoh ydrate 
and dihy drate forms. Nick el is used as a catalyst. 
Chemical name: 4-O-β-D-Galactop yranosyl-D-g lucitol 
Chemical formula: C12H24O11 
Molecular weight: 344,31 g/mol 
CAS No: 585-86-4  30.12.2017 L 351/163 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Purity: 
Solubility (in water ): Very soluble in water 
Specific rotation [α] D20 = + 13° to + 16° 
Assa y: ≥ 95 % d.b (d.b - expressed on the dry weight basis) 
Water: ≤ 10,5 % 
Other poly ols: ≤ 2,5 % d.b 
Reducing sugars: ≤ 0,2 % d.b 
Chlor ides: ≤ 100 mg/kg d.b 
Sulphate s: ≤ 200 mg/kg d.b 
Sulphate d ash: ≤ 0,1 % d.b 
Nick el: ≤ 2,0 mg/kg d.b 
Arsenic: ≤ 3,0 mg/kg d.b 
Lead: ≤ 1,0 mg/kg d.b   
Lacto -N-neotetraose 
(synthetic) Def inition: 
Chemical name: β-d-Galactop yranosyl-(1!4)-2-acetamido-2-deo xy-β-d-g lucop yranosyl-(1!3)-β-d-galact opyranosyl-(1!4)-d-g lucop yranose 
Chemical formula: C26H45NO21 
CAS No: 13007-32-4 
Molecular weight: 707,63 g/mol 
Descr iption: 
Lact o-N-neotetraose is a whit e to off-white powder . Produced by a chemical synthesis process and is isolat ed by crystallisation. 
Purity: 
Assa y (wate r free): ≥ 96 % 
D-Lactose: ≤ 1,0 % 
Lact o-N-tr iose II: ≤ 0,3 % 
Lact o-N-neotetraose fructo se isomer: ≤ 0,6 % 
pH (20 °C, 5 % solution): 5,0-7,0 
Water: ≤ 9,0 % 
Ash, sulphated: ≤ 0,4 % 
Acetic acid: ≤ 0,3 %  30.12.2017 L 351/164 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Residual solvents (methanol, 2-propanol, meth yl acetat e, acetone): ≤ 50 mg/kg sing ly, ≤ 200 mg/kg in combination 
Residual prot eins: ≤ 0,01 % 
Palladium: ≤ 0,1 mg/kg 
Nick el: ≤ 3,0 mg/kg 
Microbiological criter ia: 
Aerobic mesophilic bacteri a total count: ≤ 500 CFU/g 
Yeasts: ≤ 10 CFU/g 
Moulds: ≤ 10 CFU/g 
Residual endoto xins: ≤ 10 EU/mg   
Lacto -N-neotetraose 
(microbial source) Def inition: 
Chemical name: β-d-Galactop yranosyl-(1!4)-2-acetamido-2-deo xy-β-d-g lucop yranosyl-(1!3)-β-d-galact opyranosyl-(1!4)-d-g lucop yranose 
Chemical formula: C26H45NO21 
CAS No: 13007-32-4 
Molecular weight: 707,63 g/mol 
Source: 
Genetically modifi ed strain of Escher ichia coli K-12 
Descr iption: 
Lact o-N-neotetraose is a white to off-white crystalline powder that is produced by a microbiological process. Lact o-N-neotet raose is isolat ed by crystalli ­
sation. 
Purity: 
Assa y (wate r free): ≥ 92 % 
D-Lactose: ≤ 3,0 % 
Lact o-N-tr iose II: ≤ 3,0 % 
para-Lact o-N-neohexaose: ≤ 3,0 % 
Lact o-N-neotetraose fructo se isomer: ≤ 1,0 % 
pH (20 °C, 5 % solution): 4,0-7,0 
Water: ≤ 9,0 % 
Ash, sulphated: ≤ 0,4 % 
Residual solvents (methanol): ≤ 100 mg/kg 
Residual prot eins: ≤ 0,01 %  30.12.2017 L 351/165 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Microbiological criter ia: 
Aerobic mesophilic bacteri a total count: ≤ 500 CFU/g 
Yeasts: ≤ 10 CFU/g 
Moulds: ≤ 10 CFU/g 
Residual endoto xins: ≤ 10 EU/mg   
Lucer ne leaf extract from 
Medicago sativ a Descr iption/Def inition: 
The Luce rne (Medicago sativa L.) is processed within 2 hours after harvest. It is chopped and crushed. By passing through an oleaginous-type press, the 
Luce rne provid es a fibrous residue and press juice (10 % of dry matte r). The dry matter of this juice contains about 35 % of crude prot ein. The press juice  
(pH 5,8-6,2) is neutralised. Preheating and vapour injection allows coagulation of prot eins associated with carote noid and chlorophyll pigments. The 
prote in precipitate is separated by centr ifugation and thereaf ter dried. After adding ascorbic acid the Lucer ne protein concentrat e is granulat ed and stored 
in iner t gas or in cold storag e. 
Composition: 
Protein : 45-60 % 
Fat: 9-11 % 
Free carboh ydrates (soluble fibre): 1-2 % 
Polysacc harides (insoluble fibre): 11-15 % 
including cellulose: 2-3 % 
Minerals: 8-13 % 
Saponins: ≤ 1,4 % 
Isoflavones: ≤ 350 mg/kg 
Coumestrol: ≤ 100 mg/kg 
Phytates: ≤ 200 mg/kg 
L-can avanine: ≤ 4,5 mg/kg 
Lycopene Descr iption/Def inition: 
Synthetic lycopene is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carot enoids used in 
food. Synthetic lycopene consists of ≥ 96 % lycopene and minor quantities of other related carote noid compo nents. Lycopene is presented either as 
a powder in a suitable matr ix or an oily dispersion. The colour is dark red or red-violet. Antio xidative prot ection has to be assured. 
Chemical name: Lycopene 
CAS No.: 502-65-8 (all-trans lycopene) 
Chemical formula: C40H56 
Formula weight: 536,85 Da 30.12.2017 L 351/166 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Lycopene from Blakeslea 
trispor a Descr iption/Def inition: 
The purified lycopene from Blak eslea trispor a consists of ≥ 95 % lycopene and ≤ 5 % other carote noids. It is present ed either as a powder in a suitable 
matr ix or an oily dispersion. The colour is dark red or red-violet. Anti-o xidative prot ection has to be assured. 
Chemical name: Lycopene 
CAS No.: 502-65-8 (all trans lycopene) 
Chemical formula: C40H56 
Formula weight: 536,85 Da 
Lycopene from tomatoes Descr iption/Def inition: 
The purified lycopene from tomat oes (Lycopersicon esculantum L.) consists of ≥ 95 % lycopene and ≤ 5 % other carotenoids. It is present ed either as a 
powder in a suitable matr ix or an oily dispersion. The colour is dark red or red-violet. Anti-o xidative protect ion has to be assured. 
Chemical name: Lycopene 
CAS No.: 502-65-8 (all trans lycopene) 
Chemical formula: C40H56 
Formula weight: 536,85 Da 
Lycopene oleoresin from 
tomatoes Descr iption/Def inition: 
Lycopene oleoresin from tomat oes is obtained by solvent extraction of ripe tomat oes (Lycopersicon esculentum Mill.) with subsequent remo val of the 
solvent. It is a red to dark brown viscous, clear liquid. 
Total lycopene: 5-15 % 
Thereof trans-ly copene: 90-95 % 
Total carot enoids (calculated as lycopene): 6,5-16,5 % 
Other carot enoids: 1,75 % 
(Phytoene/ph ytof luene/β-carote ne): (0,5-0,75/0,4-0,65/0,2-0,35 %) 
Total tocopherols: 1,5-3,0 % 
Unsaponif iable matt er: 13-20 % 
Total fatty acids: 60-75 % 
Water (Kar l Fischer): ≤ 0,5 % 
Magnesium citrate malate Descr iption/Def inition: 
Magnesium citrate malate is a white to yello wish-white, amor phous powder .  30.12.2017 L 351/167 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Chemical formula: Mg5(C6H5O7)2(C4H4O5)2 
Chemical name: Pentamagnesium di-(2-hy droxybutanedioat e)-di-(2-hydro xypropane-1,2,3-tr icarbo xylat e) 
CAS No.: 1259381-40-2 
Molecular weight: 763,99 Daltons (anh ydrous) 
Solubility: Freely soluble in water (about 20 g in 100 ml) 
Descr iption of the physical state: Amor phous powder 
Assa y magnesium: 12,0-15,0 % 
Loss on drying (120 °C/4 hours): ≤ 15 % 
Colour (solid): White to yellowish-whit e 
Colour (20 % aqueous solution): Colourless to yello wish 
Appearance (20 % aqueous solution): Clear solution 
pH (20 % aqueous solution): Appro x. 6,0 
Impur ities: 
Chlor ide: ≤ 0,05 % 
Sulphate : ≤ 0,05 % 
Arsenic: ≤ 3,0 ppm 
Lead: ≤ 2,0 ppm 
Cadmium: ≤ 1 ppm 
Mercur y: ≤ 0,1 ppm   
Magnolia Bark Extract Descr iption/Def inition: 
Magnolia bark extract is obtained from the bark of the plant Magnolia officinalis L. and produced with supercr itical carbon dioxide. The bark is washed 
and oven dried to reduce moisture content before being crushed and extract ed with supercr itical carbon dioxide. The extract is dissolved in medical-grade 
ethanol and re-cr ystallised to yield magnolia bark extract. 
Magnolia bark extract is mainly compo sed of two phenolic compo unds, magnolol and honokiol. 
Appearance: Light brown ish powder 
Purity: 
Magnolol: ≥ 85,2 % 
Honokiol: ≥ 0,5 % 
Magnolol & Honokiol: ≥ 94 % 
Total Eudesmol: ≤ 2 % 
Moisture: 0,50 %  30.12.2017 L 351/168 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Hea vy metals : 
Arsenic (ppm): ≤ 0,5 
Lead (ppm): ≤ 0,5 
Methyl eugenol (ppm): ≤ 10 
Tubocurar ine (ppm): ≤ 2,0 
Total Alkaloid (ppm): ≤ 100   
Maize-ger m oil high in 
unsaponif iable matter Descr iption/Def inition: 
Maize-ger m oil high in unsaponifi able matt er is produced by vacuum distillation and it is differ ent from refined maize-g erm oil in the concentration of 
the unsaponifi able fraction (1,2 g in refined maize-ger m oil and 10 g in ‘maize-ge rm oil high in unsaponifiable matt er’). 
Purity: 
Unsaponif iable matt er: > 9,0 g/100 g 
Tocopherols: ≥ 1,3 g/100 g 
α-tocopher ol (%): 10-25 % 
β-tocopherol (%): < 3,0 % 
γ-toco pherol (%): 68-89 % 
δ-tocopherol (%): < 7,0 % 
Stero ls, triterpenic alcohols, meth ylsterols: > 6,5 g/100 g 
Fatty acids in triglycerides: 
palmitic acid: 10,0-20,0 % 
stear ic acid: < 3,3 % 
oleic acid: 20,0-42,2 % 
linoleic acid: 34,0-65,6 % 
linolenic acid: < 2,0 % 
Acid value: ≤ 6,0 mg KOH/g 
Peroxide value: ≤ 10 mEq O2/kg 
Hea vy metals : 
Iron (Fe): < 1 500 µg/kg 
Copper (Cu): < 100 µg/kg 
Impur ities: 
Polycyclic aromatic hydrocarbons (PAH) Benzo(a)p yrene: < 2 µg/kg 
Treatment with active carbon is required to ensure that poly cyclic aromatic hydrocarbons (PAH) are not enriched in the production of ‘maize-ge rm oil 
high in unsaponifi able matte r’ 30.12.2017 L 351/169 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Methyl cellulose Descr iption/Def inition: 
Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant mat erial and partially ether ified with methyl groups. 
Chemical name: Methyl ether of cellulose 
Chemical formula: The polymers contain substituted anhydrog lucose units with the followi ng general formula: 
C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the followi ng: 
—  H 
—  CH3 or 
—  CH2CH3 
Molecular weight: Macromolecules: from about 20 000 (n about 100) up to about 380 000 g/mol (n about 2 000) 
Assa y: Content not less than 25 % and not more than 33 % of metho xyl groups (-OC H3) and not more than 5 % of hydroxyethoxyl groups  
(-OCH2CH2OH) 
Slightly hygroscopic white or slightly yellowish or grey ish odourless and tasteless, granular or fibrous powder . 
Solubility: Swelling in water , producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol, ether and chlorof orm. Soluble in glacial 
acetic acid. 
Purity: 
Loss on drying: ≤ 10 % (105 °C, 3 hours) 
Sulphate d Ash: ≤ 1,5 % deter mined at 800 ± 25 °C 
pH: ≥ 5,0 and ≤ 8,0 (1 % colloidal solution) 
Hea vy metals : 
Arsenic: ≤ 3,0 mg/kg 
Lead: ≤ 2,0 mg/kg 
Mercur y: ≤ 1,0 mg/kg 
Cadmium: ≤ 1,0 mg/kg 
(6S)-5-methylt etrahydrof olic 
acid, glucosamine salt Descr iption/Def inition: 
Chemical name: N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-meth yl-4-o xo-6-pt eridinyl]methyl]amino]benzo yl]-L-gl utamic acid, glucosamine salt 
Chemical formula: C32H51N9O16 
Molecular weight: 817,80 g/mol (anhydro us) 
CAS No.: 1181972-37-1 
Appearance: Creamy to light-bro wn powder  30.12.2017 L 351/170 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Purity: 
Diaste reoisomer ic purity: At least 99 % of (6S)-5-methylt etrahydrof olic acid 
Glucosamine assa y: 34-46 % in dry basis 
5-Methy ltetrah ydrof olic acid assa y: 54-59 % in dry basis 
Water: ≤8,0 % 
Hea vy metals : 
Lead: ≤ 2,0 ppm 
Cadmium: ≤ 1,0 ppm 
Mercur y: ≤ 0,1 ppm 
Arsenic: ≤ 2,0 ppm 
Boron: ≤ 10 ppm 
Microbiological criter ia: 
Total aerobic microbial count: ≤ 100 CFU/g 
Yeasts and moulds: ≤ 100 CFU/g 
Escher ichia coli: Absence in 10 g   
Monometh ylsilanetr iol  
(Organic Silicon) Descr iption/Def inition: 
Chemical name: Silanetr iol, 1-methyl - 
Chemical formula: CH6O3Si 
Molecular weight: 94,14 g/mol 
CAS No: 2445-53-6 
Purity: 
Org anic Silicon (monomethylsilan etriol) preparation (aqueous solution): 
Acidity (pH): 6,4-6,8 
Silicon: 100-150 mg Si/l 
Hea vy metals : 
Lead: ≤ 1,0 µg/l 
Mercur y: ≤ 1,0 µg/l 
Cadmium: ≤ 1,0 µg/l 
Arsenic: ≤ 3,0 µg/l 
Solv ents: 
Methanol: ≤ 5,0 mg/kg (residual presence) 30.12.2017 L 351/171 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Mycelial extract from 
Shiitake mushroom  
(Lentinula edodes) Descr iption/Def inition: 
The novel food ingredient is a sterile aqueous extract obtained from the mycelium of Lentinula edodes cultivated in a submerg ed fermentation. It is a light 
brown , slightly turbid liquid. 
Lentinan is a β-(1-3) β-(1-6)-D-g lucan which has a molecular weight of appro ximat ely 5 × 105 Daltons, a degree of branchi ng of 2/5 and a triple helical 
tertiary structure. 
Purity/Composition of the mycelial extract from Lentinula edodes: 
Moisture: 98 % 
Dry matt er: 2 % 
Free glucose: < 20 mg/ml 
Total prot ein (*): < 0,1 mg/ml 
N-containing constituents (**): < 10 mg/ml 
Lentinan: 0,8 – 1,2 mg/ml  
(*) Bradf ord method  
(**) Kjeldahl method 
Noni fruit juice (Mor inda 
citrifolia) Descr iption/Def inition: 
Noni fruits (fruits of Mor inda citrifolia L.) are pressed. The obtained juice is pasteur ised. An optional fermentation step before or after the pressing may 
occur . 
Rubiadin: ≤ 10 µg/kg 
Luci din: ≤ 10 µg/kg 
Noni fruit juice powder  
(Mor inda citrifolia) Descr iption/Def inition: 
Seeds and skin of the sun-dr ied fruits of Mor inda citrifolia are separate d. The obtained pulp is filtered to separate juice from the flesh. Desiccation of the 
produced juice occurs in one or two ways: 
Either by atomisation using maize maltod extr ins, this mixture is obtained by keeping the rates of inflow of the juice and maltodextr ins constant 
Or by zeodratation or drying and then mixing with an excipient, this process allows the juice to be dried initially and then mixed with maltodextr ins  
(same amount as used in atomisation). 
Noni fruit puree and 
concentrate (Mor inda 
citrifolia) Descr iption/Def inition: 
The fruits of Mor inda citrifolia are harvested by hand. Seeds and skin may be separated mechanically from the pureed fruits. After paste urisation, the 
puree is packag ed in aseptic containers and store d under cold conditions.  30.12.2017 L 351/172 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Mor inda citrifolia concentrate is prepared from M. citrifolia puree by treatment with pectinolytic enzymes (50-60 °C for 1-2 h). Then the puree is heate d 
to inactivat e the pectinases and then immediately cooled. The juice is separated in a decante r centr ifuge. Afterwards the juice is collect ed and pasteur ised, 
prior to being concentrat ed in a vacuum evaporator from a brix of 6 to 8 to a brix of 49 to 51 in the final concentrat e. 
Composition: 
Puree: 
Moisture: 89-93 % 
Protein : < 0,6 g/100 g 
Fat: ≤ 0,4 g/100 g 
Ash: < 1,0 g/100 g 
Total carboh ydrates: 5-10 g/100 g 
Fructo se: 0,5-3,82 g/100 g 
Glucose: 0,5-3,14 g/100 g 
Dietar y fibre: < 0,5-3 g/100 g 
5,15-dimethy lmor indol (*): ≤ 0,254 µg/ml 
Luci din (*): Not detectable 
Alizar in (*): Not detectable 
Rubiadin (*): Not detectable 
Concentrate: 
Moisture: 48-53 % 
Protein : 3-3,5 g/100 g 
Fat: < 0,04 g/100 g 
Ash: 4,5-5,0 g/100 g 
Total carboh ydrates: 37-45 g/100 g 
Fructo se: 9-11 g/100 g 
Glucose: 9-11 g/100 g 
Dietar y fibre: 1,5-5,0 g/100 g 
5,15-dimethy lmor indol (*): ≤ 0,254 µg/ml 
(*)  By an HPLC- UV method developed and validated for the analysis of anthraquinones in Mor inda citrifolia puree and concentrate. Limits of detect ion: 2,5 ng/ml 
(5,15 dimethylmorin dol); 50,0 ng/ml (lucidin); 6,3 ng/ml (alizar in) and 62,5 ng/ml (rubiadin).   30.12.2017 L 351/173 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Noni leaves (Mor inda 
citrifolia) Descr iption/Def inition: 
After cutting, the leav es of Mor inda citrifolia are subject to drying and roasting steps. The product has a particle size ranging from broke n leaves to coarse 
powder with fines. It is of greenish brown to brown colour . 
Purity/Composition: 
Moisture: < 5,2 % 
Protein : 17- 20 % 
Carbohydr ate: 55-65 % 
Ash: 10-13 % 
Fat: 4-9 % 
Oxalic acid: < 0,14 % 
Tannic acid: < 2,7 % 
5,15-dimethy lmor indol: < 47 mg/kg 
Rubiadin: non detectable, ≤ 10 µg/kg 
Luci din: non detectable, ≤ 10 µg/kg 
Noni fruit powder (Mor inda 
citrifolia) Descr iption/Def inition: 
Noni fruit powder is made from pulped noni (Mor inda citrifolia L.) fruits by freeze-dr ying. Fruits are pulped and seeds are remo ved. After freeze-dr ying 
during whic h water is remo ved from noni fruits, the remaining noni pulp is milled to a powder and encapsulated. 
Purity/Composition 
Moisture: 5,3-9 % 
Protein : 3,8-4,8 g/100 g 
Fat: 1-2 g/100 g 
Ash: 4,6-5,7 g/100 g 
Total carboh ydrates: 80-85 g/100 g 
Fructo se: 20,4-22,5 g/100 g 
Glucose: 22-25 g/100 g 
Dietar y fibre: 15,4-24,5 g/100 g 
5,15-dimethy lmor indol (*): ≤ 2,0 µg/ml 
(*) By an HPLC-UV method developed and validated for the analysis of anthraquinones in Mor inda citrifolia fruit powder . Limits of detect ion: 2,5 ng/ml (5,15 dimethyl ­
mor indol) 30.12.2017 L 351/174 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Odontella aurita microalgae Silicon: 3,3 % 
Crystalline silica: max 0,1-0,3 % as impurity 
Oil enriched with 
phytosterols/phyt ostanols Descr iption/Def inition: 
Oil enriched with phyt oste rols/phyt ostanols is compo sed of an oil fraction and a phyt oste rol fraction. 
Acylgl ycerol Distr ibution: 
Free fatty acids (expressed as oleic acid): ≤ 2,0 % 
Monoacylg lycerols (MA G): ≤ 10 % 
Diacylg lycerols (DAG): ≤ 25 % 
Triacylg lycerols (TAG): Making up the balance 
Phyt osterol fraction: 
β-sitos terol: ≤ 80 % 
β-sitos tanol: ≤ 15 % 
campes terol: ≤ 40 % 
campes tanol: ≤ 5,0 % 
stigmaster ol: ≤ 30 % 
brassicast erol ≤ 3,0 % 
other sterols/stanols: ≤ 3,0 % 
Others: 
Moisture and volatile: ≤ 0,5 % 
Peroxide value: < 5,0 meq/kg 
Trans fatty acids: ≤ 1 % 
Contamination/Pur ity (GC-FID or equivalent method) of phytosterols/phyt ostanols: 
Phytosterols and phytostanols extracted from sources other than vegeta ble oil suitable for food have to be free of contaminants, best ensured by a purity 
of more than 99 %. 
Oil extracted from squids Acid value: ≤ 0,5 KOH/g oil 
Peroxide value: ≤ 5 meq O2/kg oil 
p-Anisidine value: ≤ 20 
Cold test at 0 °C: ≤ 3 hours 
Moisture: ≤ 0,1 % (w/w) 
Unsaponif iable matt er: ≤ 5,0 %  30.12.2017 L 351/175 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Trans fatty acids: ≤ 1,0 % 
Docosahexaeonic acid: ≥ 20 % 
Eicosapentaenoic acid: ≥ 10 %   
Pasteur ised fruit-based 
preparations produced using 
high-pressure treatment Parameter Target Comments 
Fruit storag e before high-pressure treatment Minimum 15 days at – 20 °C Fruit harvested and stored in conjunction with 
good/hygienic agricultural and manufactur ing prac ­
tices 
Fruit added 40 % to 60 % of thawed fruit Fruit homogenised and added to other ingredients 
pH 3,2 to 4,2  
° Brix 7 to 42 Assured by added sugars 
aw < 0,95 Assured by added sugars 
Final storage 60 days maximum at + 5 °C maximum Equivalent to stora ge regimen for conven tionally 
processed product 
Phosphated maize starch Descr iption/Def inition: 
Phosphat ed maize starc h (phosphat ed distarch phosphat e) is a chemically modified resistant starch derived from high amy lose starc h by combining 
chemical treatments to create phosphate cross-links between carbohydrat e residues and ester ified hydroxyl groups. 
The novel food ingredient is a white or nearly white powder . 
CAS No: 11120-02-8 
Chemical formula: (C6H10O5)n [(C6H9O5)2PO2H]x [(C6H9O5)PO3H2]y 
n = number of glucose units; x, y = degrees of substitution 
The chemical charact eristics of phosphat ed distarch phosphate: 
Loss on drying: 10-14 % 
pH: 4,5-7,5 
Dietar y fibre: ≥ 70 % 
Starc h: 7-14 % 
Protein : ≤ 0,8 % 
Lipids: ≤ 0,8 % 
Residual bound phosphor us: ≤ 0,4 % (as phosphor us) ‘high amy lose maize’ as source 30.12.2017 L 351/176 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Phosphatidylser ine from fish 
phospholipids Descr iption/Def inition: 
The novel food ingredient is yello w to brown powder . Phosphatidylser ine is obtained from fish phospholipids by an enzymatic transphosphor ylation 
with the amino acid L-serine. 
Specif ication of the phosphatidylser ine product manufactured from fish phospholipids: 
Moisture: < 5,0 % 
Phospholipids: ≥ 75 % 
Phosphatidylser ine: ≥ 35 % 
Glycerides: < 4,0 % 
Free L-ser ine: < 1,0 % 
Tocopherols: < 0,5 % (1) 
Peroxide value: < 5,0 meq O2/kg 
(1)  Tocopherols may be added as antio xidants according to Commission Regulation (EU) No 1129/2011 
Phosphatidylser ine from soya 
phospholipids Descr iption/Def inition: 
The novel food ingredient is off-white to light yellow powder . It is also available in liquid form with a clear brown to orang e colour . The liquid form con­
tains medium chain triacylg lycerides (MCT) as a carrier. It contains lower levels of Phosphatidylser ine due to the fact that it includes signif icant amounts 
of oil (MCT). 
Phosphatidylser ine from soya phospholipids is obtained through enzymatic transphosphatidylation of high-phosphatidylcholine soybean lecithin with 
the amino acid L-ser ine. Phosphatidylser ine consists of a glycerophosphate skeleton conjugat ed with two fatty acids and L-ser ine via a phosphodiester 
linkag e. 
Character istics of Phosphatidylser ine from soya phospholipids: 
Powder form: 
Moisture: < 2,0 % 
Phospholipids: ≥ 85 % 
Phosphatidylser ine: ≥ 61 % 
Glycerides: < 2,0 % 
free L-ser ine: < 1,0 % 
Tocopherols: < 0,3 % 
Phytosterols: < 0,2 % 
Liquid form: 
Moisture: < 2,0 % 
Phospholipids: ≥ 25 %  30.12.2017 L 351/177 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Phosphatidylser ine: ≥ 20 % 
Glycerides: not applicable 
free L-ser ine: < 1,0 % 
Tocopherols: < 0,3 % 
Phytosterols: < 0,2 %   
Phospholipid product 
cont aining equal amounts of 
phosphatidylser ine and 
phosphatidic acid Descr iption/Def inition: 
The product is manufactured through enzymatic conversion of soy lecithin. The phospholipid product is a highly concentrat ed, yellow-bro wn powder 
form of phosphatidylser ine and phosphatidic acid at an equal level. 
Specif ication of the product : 
Moisture: ≤ 2,0 % 
Total phospholipids: ≥ 70 % 
Phosphatidylser ine: ≥20 % 
Phosphatidic acid: ≥ 20 % 
Glycerides: ≤ 1,0 % 
Free L-ser ine: ≤ 1,0 % 
Tocopherols: ≤ 0,3 % 
Phytosterols: ≤ 2,0 % 
Silicon dioxide is used with a maximum conte nt of 1,0 % 
Phospholipides from egg yolk 85 % and 100 % pure Phospholipides from egg yolk 
Phyt ogly cogen Descr iption: 
White to off-white powder which is an odourless, colourless, flavourle ss polysacchar ide derived from non-GM sweet corn using conven tional food 
processing techniques 
Def inition: 
Glucose polymer (C6H12O6)n with linear linkag es of α(1 – 4) glycosidic bonds branched ever y 8 to 12 glucose units by α(1 – 6) glycosidic bonds 
Specif ications: 
Carbohydr ates: 97 % 
Sugars: 0,5 % 
Fibre: 0,8 % 
Fat: 0,2 % 
Protein : 0,6 % 30.12.2017 L 351/178 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Phyt osterol s/ph ytost anols Descr iption/Def inition: 
Phytosterols and phytostano ls are sterols and stanols that are extracted from plants and may be presented as free sterols and stanols or esterified with 
food grade fatty acids. 
Composition (with GC-FID or equivalent method): 
β-sitos terol: < 81 % 
β-sitos tanol: < 35 % 
campes terol: < 40 % 
campes tanol: < 15 % 
stigmaster ol: < 30 % 
brassicast erol: < 3,0 % 
other sterols/stanols: < 3,0 % 
Conta mination/Pur ity (GC-FID or equivalent method): 
Phytosterols and phytostanols extracted from sources other than vegeta ble oil suitable for food have to be free of contaminants, best ensured by a purity 
of more than 99 % of the phytosterol/phyt ostanol ingredient. 
Plum kern el oil Descr iption/Def inition: 
Plum kernel oil is a vegetable oil obtained by cold pressing of plum (Prunus domestica) kernels. 
Composition: 
Oleic acid (C18:1): 68 % 
Linoleic acid (C18:2): 23 % 
γ-Tocopherol:80 % of total tocopherols 
β-Sit osterol: 80-90 % of total sterols 
Triolein: 40-55 % of triglycerides 
Cyanhy dric acid: maximum 5 mg/kg oil 
Potato proteins (coagulated) 
and hydrolysates thereof Dry substance: ≥ 800 mg/g 
Protein (N * 6,25): ≥ 600 mg/g (dry substance) 
Ash: ≤ 400 mg/g (dry substance) 
Glycoalkaloid (total): ≤ 150 mg/kg 
Lysinoalanine (total): ≤ 500 mg/kg 
Lysinoalanine (free): ≤ 10 mg/kg 30.12.2017 L 351/179 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Prolyl oligopeptidase  
(enzyme preparation) Specif ication of the enzyme: 
Systema tic name: Prolyl oligopeptidase 
Synon yms: Prolyl endopeptidas e, proline-specific endopep tidase, endoprolylpeptidase 
Molecular weight: 66 kDa 
Enzyme Commission number: EC 3.4.21.26 
CAS number: 72162-84-6 
Source: A genetically modifi ed strain of Aspergillus niger (GEP -44) 
Descr iption: 
Prolyl oligopeptidase is available as an enzyme preparation containing appro ximately 30 % maltode xtrin. 
Specif ications of the enzyme preparation of prolyl oligopeptidase: 
Activity: > 580 000 PPI (*)/g (> 34,8 PPU (**)/g) 
Appearance: Microgranulate 
Colour: Off-white to orange yello wish. The colour may change from batch to batch 
Dry Matt er: > 94 % 
Gluten: < 20 ppm 
Hea vy metals : 
Lead: ≤ 1,0 mg/kg 
Arsenic: ≤ 1,0 mg/kg 
Cadmium: ≤ 0,5 mg/kg 
Mercur y: ≤ 0,1 mg/kg 
Microbiological criter ia: 
Total aerobic plate count: ≤ 103 CFU/g 
Total yeasts and moulds: ≤ 102 CFU/g 
Sulphite reducing anaerobes: ≤ 30 CFU/g 
Entero bacter iaceae: < 10 CFU/g 
Salmonella: Absence in 25 g 
Escher ichia coli: Absence in 25 g 
Staphy lococcus aureus: Absence in 10 g 
Pseudomonas aeruginosa: Absence in 10 g 
Lister ia monocytog enes: Absence in 25 g 
Antimicrobial activity: Absent  30.12.2017 L 351/180 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Mycotoxins: Below limits of detection: Aflatoxin B1, B2, G1, G2 (< 0,25 µg/kg), total Aflatoxins (< 2,0 µg/kg), Ochrato xin A (< 0,20 µg/kg), T-2 Toxin  
(< 5 µg/kg), Zearalenone (< 2,5 µg/kg), Fumonisin B1 and B2 (< 2,5 µg/kg)  
(*) PPI – Prot ease Picomole Intern ational  
(**) PPU – Prolyl Peptidase Units or Proline Protease Units   
Protein extract from pig 
kidne ys Descr iption/Def inition: 
The prote in extract is obtained from homog enised pig kidne ys through a combination of salt precipitation and high speed centr ifugation. The obtained 
precipitate contains essentially proteins with 7 % of the enzyme diamine oxidase (enzyme nomenclature E.C. 1.4.3.22) and is resuspended in a physiologic 
buffe r system . The obtained pig kidne y extract is formulat ed as encapsulated enter ic coated pellets to reach the active sites of digestion. 
Basic Product: 
Specific ation: pig kidney prote in excerpt with natural content of Diamin oxidase (DAO): 
Physical condition: liquid 
Colour: brownish 
Appearance: slightly turbid solution 
pH value: 6,4-6,8 
Enzymatic activity : > 2 677 kHDU DAO/ml (DAO REA (DAO Radioextractionassa y)) 
Microbiological criteria: 
Brachyspi ra spp.: negative (Real Time PCR) 
Lister ia monocytog enes: negative (Real Time PCR) 
Staphy lococcus aureus: < 100 CFU/g 
Influenza A: negative (Reverse Transcr iption Real Time PCR) 
Escher ichia coli: < 10 CFU/g 
Total aerobic microbiological count: < 105 CFU/g 
Yeasts/moulds count : < 105 CFU/g 
Salmonella: Absence/10g 
Bile salt resistant enterobacteri aceae: < 104 CFU/g 
Final product : 
Specific ation pig kidne y protein exce rpt with natural conte nt of DAO (E.C. 1.4.3.22) in an enteri c coated formulation: 
Physical condition: solid 
Colour: yellow gray  30.12.2017 L 351/181 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Appearance: micropellets 
Enzymatic activity : 110-220 kHDU DAO/g pellet (DAO REA (DAO Radioextractionassa y)) 
Acid stability 15 min 0,1M HCl followed by 60 min Borat pH=9,0: > 68 kHDU DAO/g pellet (DAO REA (DAO Radioextractionassa y)) 
Humidity: < 10 % 
Staphy lococcus aureus: < 100 CFU/g 
Escher ichia coli: < 10 CFU/g 
Total aerobic microbiological count: < 104 CFU/g 
Total combined yeasts/moulds count : < 103 CFU/g 
Salmonella: Absence/10g 
Bile salt resistant enterobacteri aceae: < 102 CFU/g   
Rapeseed oil high in 
unsaponif iable matter Descr iption/Def inition: 
‘Rapes eed oil high in unsaponifiable matter ’ is produced by vacuum distillation and it is diffe rent from refined rapeseed oil in the concentration of the 
unsaponifi able fraction (1 g in refined rapeseed oil and 9 g in ‘rapeseed oil high in unsaponif iable matt er’). There is a minor reduction of triglycerides 
containing monounsaturated and polyunsaturated fatty acids. 
Purity: 
Unsaponif iable matt er: > 7,0 g/100 g 
Tocopherols: > 0,8 g/100 g 
α-tocopher ol (%): 30-50 % 
γ-toco pherol (%): 50-70 % 
δ-tocopherol (%): < 6,0 % 
Stero ls, triterpenic alcohols, meth ylsterols: > 5,0 g/100 g 
Fatty acids in trigly cerides: 
palmitic acid: 3-8 % 
stear ic acid: 0,8-2,5 % 
oleic acid: 50-70 % 
linoleic acid: 15-28 % 
linolenic acid: 6-14 % 
erucic acid: < 2,0 % 
Acid value: ≤ 6,0 mg KOH/g 
Peroxide value: ≤ 10 mEq O2/kg  30.12.2017 L 351/182 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Hea vy metals : 
Iron (Fe): < 1 000 µg/kg 
Copper (Cu): < 100 µg/kg 
Impur ities: 
Polycyclic aromatic hydrocarbons (PAH) Benzo(a)p yrene: < 2 µg/kg 
Treatment with active carbon is required to ensure that poly cyclic aromatic hydrocarbons (PAH) are not enriched in the production of ‘rapeseed oil high 
in unsaponifiable matt er’.   
Rapeseed Protein Def inition: 
Rapeseed prote in is an aqueous prote in-rich extract from rapeseed press cake originating from non-geneticall y modifi ed Brassica napus L. and Brassica 
rapa L. 
Descr iption: 
White to off-white, spra y dried powder 
Total prot ein: ≥ 90 % 
Soluble prot ein: ≥ 85 % 
Moisture: ≤ 7,0 % 
Carbohydr ates: ≤ 7,0 % 
Fat: ≤ 2,0 % 
Ash: ≤ 4,0 % 
Fibre: ≤ 0,5 % 
Total glucosinolat es: ≤ 1 mmol/kg 
Purity: 
Total phytate: ≤ 1,5 % 
Lead: ≤ 0,5 mg/kg 
Microbiological criter ia: 
Yeast and mould count : ≤ 100 CFU/g 
Aerobic bacteri a count: ≤ 10 000 CFU/g 
Total colif orm count: ≤ 10 CFU/g 
Escher ichia coli: Absence in 10 g 
Salmonella: Absence in 25 g 30.12.2017 L 351/183 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Trans-resv eratrol Descr iption/Def inition: 
Synthetic Trans-resveratrol is off-white to beige crystals. 
Chemical name: 5-[(E)-2-(4-hydro xyphen yl)ethenyl]benzene-1,3-diol 
Chemical formula: C14H12O3 
Molecular weight: 228,25 Da 
CAS No: 501-36-0 
Purity: 
Trans-resveratrol: ≥ 98 %-99 % 
Total by-products (related substances): ≤ 0,5 % 
Any sing le related substance: ≤ 0,1 % 
Sulphate d ash: ≤ 0,1 % 
Loss on drying: ≤ 0,5 % 
Hea vy metals : 
Lead: ≤ 1,0 ppm 
Mercur y: ≤ 0,1 ppm 
Arsenic: ≤ 1,0 ppm 
Impur ities: 
Diisoprop ylamine: ≤ 50 mg/kg 
Microb ial sour ce: A genetically modifi ed strain of Saccharomy ces cerevisiae 
Appearance: Off-white to slight yellow powder 
Particle size: 100 % less than 62,23 µm 
Trans-resveratrol content: Min. 98 % w/w (dry weight basis) 
Ash: Max. 0,5 % w/w 
Moisture: Max. 3 % w/w 
Rooster comb extract Descr iption/Def inition: 
Rooster comb extract is obtained from Gallus gallus by enzymatic hydrolysis of rooste r comb and by subsequent filtration, concentration and precipita ­
tion steps. The principal constituents of rooste r comb extract are the glycosaminog lycans hyaluronic acid, chondroitin sulphat e A and dermatan sulphat e  
(chondroitin sulphate B). White or almost whit e hygroscopic powder . 
Hyaluronic acid: 60-80 % 
Chondroitin sulphate A: ≤ 5,0 %  30.12.2017 L 351/184 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Dermatan sulphate (chondroitin sulphate B): ≤ 25 % 
pH: 5,0-8,5 
Purity: 
Chlor ides: ≤ 1,0 % 
Nitroge n: ≤ 8,0 % 
Loss on drying: (105 °C for 6 hours): ≤ 10 % 
Hea vy metals : 
Mercur y: ≤ 0,1 mg/kg 
Arsenic: ≤ 1,0 mg/kg 
Cadmium: ≤ 1,0 mg/kg 
Chromium: ≤ 10 mg/kg 
Lead: ≤ 0,5 mg/kg 
Microbiological criter ia: 
Total viable aerobic count: ≤ 102 CFU/g 
Escher ichia coli: Absence in 1 g 
Salmonella: Absence in 1 g 
Staphy lococcus aureus: Absence in 1 g 
Pseudomonas aeruginosa: Absence in 1 g   
Sacha Inchi oil from 
Plukenet ia volubilis Descr iption/Def inition: 
Sacha inchi oil is a 100 % cold pressed veget able oil obtained from the seeds of Pluken etia volubiis L. It is a transparent, fluid (liquid) and shiny oil at 
room temperature. It has a fruity, light, green vege table taste without undesirable flavour s. 
Aspect, limpidity , shine, colour: Fluid at room temperature, clean, shiny yellow gold 
Odour and taste: Fruity, veget able without non accept able taste or odour 
Purity: 
Water and Volatiles: < 0,2 g/100 g 
Impurities insoluble in hexane: < 0,05 g/100 g 
Oleic acidity : < 2,0 g/100 g 
Peroxide value: < 15 meq O2/kg 
Trans fatty acids: < 1,0 g/100 g 
Total unsaturat ed fatty acids: > 90 %  30.12.2017 L 351/185 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Omega 3 alpha linolenic acid (ALA): > 45 % 
Saturated fatty acids: < 10 % 
No trans fatty acids (< 0,5 %) 
No erucic acid (< 0,2 %) 
More than 50 % of tri-linolenin and di-linolenin-tr iglycerides 
Phytosterols compo sition and level 
No cholesterol (< 5,0 mg/100 g)   
Salatr ims Descr iption/Def inition: 
Salatr im is the internatio nally recognised acronym for (shor t and long chain acyl triglyceride molecules). Salatr im is prepared by non-enzymatic inter -es­
terif ication of triacetin, tripropionin, tributyr in, or their mixtures with hydrog enated canola, soybean, cottonseed, or sunf lower oil. Descr iption: Clear , 
slightly amber liquid to a light coloured waxy solid at room temperature. Free of particulate matter and of foreign or rancid odour . 
Glycerol ester disribution: 
Triacylg lycerols: > 87 % 
Diacylg lycerols: ≤ 10 % 
Monoacylg lycerols: ≤ 2,0 % 
Fatty acid compo sition: 
MOLE % LCFA (long chain fatty acids): 33-70 % 
MOLE % SCFA (shor t chain fatty acids): 30-67 % 
Saturated long chain fatty acids: < 70 % by weight 
Trans fatty acids: ≤ 1,0 % 
Free fatty acids as oleic acid: ≤ 0,5 % 
Triacylg lycerol profile: 
Triesters (shor t/long of 0,5 to 2,0): ≥ 90 % 
Triesters (shor t/long = 0): ≤ 10 % 
Unsaponif iable mat erial: ≤ 1,0 % 
Moisture: ≤ 0,3 % 
Ash: ≤ 0,1 % 
Colour: ≤ 3,5 Red (Lov ibond) 
Peroxide value: ≤ 2,0 Meq/Kg 30.12.2017 L 351/186 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Schizo chytr ium sp. oil rich in 
DHA and EPA Acid value: ≤ 0,5 mg KOH/g 
Peroxide value: ≤ 5,0 meq/kg oil 
Oxidative stability : All food products containing schizochytr ium sp. oil rich in DHA and EPA should demonstrate oxidative stability by appropr iate and 
recognised national/international test methodology (e.g. AOAC) 
Moisture and volatiles: ≤ 0,05 % 
Unsaponif iables: ≤ 4,5 % 
Trans-fatty acids: ≤ 1 % 
DHA cont ent: ≥ 22,5 % 
EPA content: ≥ 10 % 
Schizo chytr ium sp. (ATCC 
PTA-9695) oil Peroxide value: ≤ 5,0 meq/kg oil 
Unsaponif iables: ≤ 3,5 % 
Trans-fatty acids: ≤ 2,0 % 
Free fatty acids: ≤ 0,4 % 
Docosapentaenoic acid (DPA) n-6: ≤ 7,5 % 
DHA cont ent: ≥ 35 % 
Schizo chytr ium sp. oil Acid value: ≤ 0,5 mg KOH/g 
Peroxide value (PV): ≤ 5,0 meq/kg oil 
Moisture and volatiles: ≤ 0,05 % 
Unsaponif iables: ≤ 4,5 % 
Trans-fatty acids: ≤ 1,0 % 
DHA cont ent: ≥ 32,0 % 
Schizo chytr ium sp. (T18) oil Acid value: ≤ 0,5 mg KOH/g 
Peroxide value: ≤ 5,0 meq/kg oil 
Moisture and volatiles: ≤ 0,05 % 
Unsaponif iables: ≤ 3,5 % 
Trans-fatty acids: ≤ 2,0 % 
Free fatty acids: ≤ 0,4 % 
DHA cont ent: ≥ 35 % 30.12.2017 L 351/187 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Fermented soybean extract Descr iption/Def inition: 
Fermented soybean extract is an odourless milk -whit e coloured powder . It is compris ed of 30 % fermented soybean extract powder and 70 % resistant 
dextr in (as carrier) from corn-starch, which is added during the processing. Vitamin K2 is remo ved during the manuf actur ing process. 
Fermented soybean extract contains natto kinase isolate d from natto , a foodstuff produced by the fermentation of non-g enetically modified soybeans 
(Glyc ine max (L.)) with a select ed strain of Bacillus subtilis var. natto . 
Nattoki nase activity: 20 000-28 000 Fibr in degradation unit/g (*) 
Identity : Confir mable 
Condition: No offensive taste or smell 
Loss on drying: ≤ 10 % 
Vitamin K2: ≤ 0,1 mg/kg 
Hea vy metals : 
Lead: ≤ 5,0 mg/kg 
Arsenic: ≤ 3,0 mg/kg 
Microbiological criter ia: 
Total viable aerobic count: ≤ 103 CFU (3)/g 
Yeast and mould: ≤ 102 CFU/g 
Colif orms: ≤ 30 CFU/g 
Spore-f orming bacteria: ≤ 10 CFU/g 
Escher ichia coli: Absence/25 g 
Salmonella: Absence/25 g 
Lister ia: Absence/25 g 
(*)  Assa y method as descr ibed by Takaoka et al. (2010). 
Sper midine-r ich wheat germ 
extract (Triticum aeste vium) Descr iption/Def inition: 
Sper midine-r ich wheat germ extract is obtained from non-fer mented , non-sprouting wheat germs (Triticum aeste vium) by the process of solid-liquid extrac ­
tion targe ting specifi cally , but not excl usively polyamines. 
Sper midine: 0,8-2,4 mg/g 
Sper mine: 0,4-1,2 mg/g 
Sper midine trichloride < 0,1 µg/g  30.12.2017 L 351/188 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Putrescine: < 0,3 mg/g 
Cadav erine: < 0,1 µg/g 
Mycoto xins: 
Aflatoxins (total): < 0,4 µg/kg 
Microbiological criter ia: 
Total aerobic bacteri a: < 10 000 CFU/g 
Yeast and moulds: < 100 CFU/g 
Escher ichia coli: < 10 CFU/g 
Salmonella: Absence/25 g 
Lister ia monocytog enes: Absence/25 g   
Sucromalt Descr iption/Def inition: 
Sucromalt is a compl ex mixture of sacchari des which is produced from sucrose and a starc h hydrolysate by means of an enzymatic reaction. In this 
process, glucose units are attac hed to sacchari des from the starch hydrolysat e by means of an enzyme produced by the bacte rium Leuconostoc citreum or 
by means of a recombinant strain of the production organism Bacillus lichenifo rmis. The resulting oligosacc harides are charact erised by the presence of 
α-(1!6) and α-(l!3) glycosidic compo unds. The overall product is syrup, in addition to these oligosacchar ides, contains mainly fructo se but also the 
disacc haride leucrose and other disacchari des. 
Total solids: 75-80 % 
Moisture: 20-25 % 
Sulphatase: Max 0,05 % 
pH: 3,5-6,0 
Conductivity < 200 (30 %) 
Nitroge n < 10 ppm 
Fructo se: 35-45 % d.w. 
Leucrose: 7-15 % d.w. 
Other disacc harides: Mах 3 % 
Higher sacchari des: 40-60 % d.w 
Sugar cane fibre Descr iption/Def inition: 
Sugar Cane Fibre is derived from the dry cell wall or fibrous residue remaining after expression or extraction of sugar juice from sugar cane, of the 
Saccharum genotype. It consists primar ily of cellulose and hemicellulose. 
The production process consists of several steps , including: chipping, alkaline dige stion, removal of lignins and other non-cellulosic compo nents, bleach ­
ing of purified fibres, acid washing and neutralization.  30.12.2017 L 351/189 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Moisture: ≤ 7,0 % 
Ash: ≤ 0,3 % 
Total Dietar y Fibre (AOAC) dry basis (all insoluble): ≥ 95 % 
of which : Hemicellulose (20-25 %) and cellulose (70-75 %) 
Silica (ppm): ≤ 200 
Protein : 0,0 % 
Fat: Trace 
pH: 4-7 
Hea vy metals : 
Mercur y (ppm): ≤ 0,1 
Lead (ppm): ≤ 1,0 
Arsenic (ppm): ≤ 1,0 
Cadmium (ppm): ≤ 0,1 
Microbiological criter ia: 
Yeast and moulds (CFU/g): ≤ 1 000 
Salmonella: Absence 
Lister ia monocytog enes: Absence   
Sunf lower oil extract Descr iption/Def inition: 
The sunf lowe r extract is obtained by a concentration factor of 10 of the unsaponifi able fraction of refined sunf lower oil extract ed from the seeds of the 
sunf lowe r, Helianthus Annuus L. 
Composition: 
Oleic acid (C18:1): 20 % 
Linoleic acid (C18:2): 70 % 
Unsaponif iable matt er: 8,0 % 
Phytosterols: 5,5 % 
Tocopherols: 1,1 % 
Dried Tetraselmis chuii 
microalgae Descr iption/Def inition: 
The dried product is obtained from the mar ine microalgae Tetraselmis chuii, belonging to the Chlorod endr aceae family , cultivated in sterile sea water in 
closed photobioreact ors insulated from the outside air.  30.12.2017 L 351/190 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Purity/Composition: 
Identif ied by means of nuclear marker rDNA 18 S (sequence analysed no less than 1 600 base pairs) in the National Centre for Biotec hnology informa­
tion (NCBI) database: Not less than 99,9 % 
Humidity: ≤ 7,0 % 
Protein s: 35-40 % 
Ashes: 14-16 % 
Carbohydr ates: 30-32 % 
Fibre: 2-3 % 
Fat: 5-8 % 
Saturated fatty acids: 29-31 % of total fatty acids 
Monounsaturat ed fatty acids: 21-24 % of tota l fatty acids 
Polyunsaturat ed fatty acids: 44-49 % of total fatty acids 
Iodine: ≤ 15 mg/kg   
Ther apon barcoo/Scor tum Descr iption/Def inition: 
Scor tum/Therapon barcoo is a species of fish in the family Terapontidae. It is an endemic fresh water species from Australia. It is now reared in fish 
farms. 
Taxonomic Identif ication: Class: Actinopt erygii > order : Percif ormes > family : Terapontidae > genus: Therapon or Scor tum Barcoo 
Com position of fish flesh: 
Protein (%): 18-25 
Moisture (%): 65-75 
Ash (%): 0,5-2,0 
Energy (KJ/Kg): 6 000-11 500 
Carbohydr ates (%): 0,0 
Fat (%): 5-15 
Fatty acids (mg FA/g fillet): 
Σ PUF A n-3: 1,2-20,0 
Σ PUF A n-6: 0,3-2,0 
PUF A n-3/n-6: 1,5-15,0 
Total omeg a 3 acids: 1,6-40,0 
Total omeg a 6 acids: 2,6-10,0 30.12.2017 L 351/191 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
D-Tagato se Descr iption/Def inition: 
Tagatose is produced by isomer ization of galact ose by means of chemical or enzymatic conversion, or by epimer ization of fructo se by means of enzy ­
matic conver sion. These are sing le-ste p convers ions. 
Appearance: White or almost white crystals 
Chemical name: D-tagat ose 
Synon ym: D-lyxo-Hexulose 
CAS number: 87-81-0 
Chemical formula: C6H12O6 
Formula weight: 180,16 (g/mol) 
Purity: 
Assa y: ≥ 98 % on a dry weight basis 
Loss on drying: ≤ 0,5 % (102 °C, 2 hours) 
Specific Rotation: [α]20D: – 4 to – 5,6° (1 % aqueous solution) (*) 
Melting rang e: 133-137 °C 
Hea vy metals : 
Lead: ≤ 1,0 mg/kg (**) 
(*)Food and nutr ition paper 5 Rev 2 – Guide to specifications for general notices, general analytical techniques, identif ication tests, test solutions and other reference ma­
terial s (JECF A) 1991, 307 p.; English – ISBN 92-5-102991-1  
(**) Determ ine using an atomic absor ption technique appropr iate to the specified level. The selection of sample size and method of sample preparation may be based on 
the principles of the method descr ibed in FNP 5. ‘Instr umental methods’ (*). 
Taxifo lin-r ich extract Descr iption: 
Taxifolin-r ich extract from the wood of Dahur ian Larch (Larix gmelinii (Rupr .) Rupr) is a whit e to pale-yello w powder that crystallizes from hot aqueous 
solutions. 
Def inition: 
Chemical name: [(2R,3R)-2-(3,4 dihy droxyphenyl)-3,5,7-tr ihydro xy-2,3-dihy droch romen-4-one, also called (+) trans (2R,3R)- dihy droquercetin] 
Chemical formula: C15H12O7 
Molecular mass: 304,25 Da 
CAS No: 480-18-2 
Specif ications: 
Phys ical parameter 
Moisture: ≤ 10 %  30.12.2017 L 351/192 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Compound analysis 
Taxifolin (m/m): ≥ 90,0 % of the dry weight 
Heavy Metals, Pesticide 
Lead: ≤ 0,5 mg/kg 
Arsenic: ≤ 0,02 mg/kg 
Cadmium: ≤ 0,5 mg/kg 
Mercur y: ≤ 0,1 mg/kg 
Dichlorodiphenyltr ichloroethane (DDT): ≤ 0,05 mg/kg 
Residual solv ents 
Ethanol: < 5 000 mg/kg 
Microb iological criteria 
Total Plate Count (TPC): ≤ 104 CFU/g 
Enterobacter ia: ≤ 100/g 
Yeast and Mould: ≤ 100 CFU/g 
Escher ichia coli: Absence/1 g 
Salmonella: Absence/10 g 
Staphy lococcus aureus: Absence/1 g 
Pseudomonas: Absence/1 g 
Usual range of components of the Taxifo lin-r ich extract (as per dry subst ance) 
Extract component Content, usual obser ved range (%) 
Taxifolin 90 – 93 
Aromadendr in 2,5 – 3,5 
Eriodicty ol 0,1 – 0,3 
Quercetin 0,3 – 0,5 
Naringe nin 0,2 – 0,3 
Kaempf erol 0,01 – 0,1 
Pinocembr in 0,05 – 0,12 
Unidentif ied flavonoids 1 - 3 
Water (*) 1,5 
(*)  Taxifolin in its hydrated form and during the drying process is a crystal. This results on the inclusion of water of crystallisation in a quantity of 1,5 %.   30.12.2017 L 351/193 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Trehalose Descr iption/Def inition: 
A non-reducing disacc haride that consists of two glucose moieties linkes by an α-1,1-g lucosidic bond. It is obtained from liquefied starc h by a multiste p 
enzymatic process. The commercial product is the dihydrat e. Virutally odourless, whit e or almost whit e crystals with a sweet taste 
Synon yms: α,α-trehalose 
Chemical name: α-D-g lucop yranosyl-α-D-g lucop yranoside, dihydrat e 
CAS No.: 6138-23-4 (dih ydrate) 
Chemical formula: C12H22O11 · 2H2O (dih ydrate ) 
Formula weight: 378,33 (dihydrat e) 
Assa y: ≥ 98 % on the dry basis 
Determine using an atomic absor ption technique appropr iate to the specified level. The selection of sample size and method of sample preparation may 
be based on the principles of the method descr ibed in FNP 5 (1), ‘Instr umental methods ’ 
Method of assay: 
Principle: trehalose is identified by liquid chromatograph y and quantified by compari son to a reference standard containing standard trehalose 
Preparation of sample solution: weigh accurately about 3 g of dry sample into a 100 ml volumetr ic flask and add about 80 ml of purified, deionised 
water . Bring sam ple to compl ete dissolution and dilut e to mark with purified deionised wate r. Filter through a 0,45 micron filter 
Preparation of standard solution: dissolve accurate ly weighed quantities of dry standard reference trehalose in wate r to obtain a solution having known 
concentration of about 30 mg of trehalose per ml. 
Apparatus: liquid chromat ography equipped with a refractive index detector and integrating recorder 
Conditions: 
Column: Shodex Ionpac k KS-801 (Showa Denk o Co.) or equivalent 
—  length: 300 mm 
—  diamet er: 10 mm 
—  temperature: 50 °C 
Mobile phase: wate r 
flow rate: 0,4 ml/min 
Injection volume: 8 µl 
Procedure: inject separate ly equal volumes of the sample solution and the standard solution into the chromat ograph. 
Record the chromatograms and measure the size of response of the trehalose peak 
Calculate the quantity , in mg, of trehalose in 1 ml of the sample solution by the followi ng formula: 
% trehalose = 100 × (RU/RS) (WS/WU)  30.12.2017 L 351/194 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
where 
RS  =peak area of trehalose in the standard preparation 
RU  =peak area of trehalose in the sam ple preparation 
WS  =weight in mg of trehalose in the standard preparation 
WU  =weight of dry sample in mg 
Character istics: 
Identif ication: 
Solubility: Freely soluble in water , very slightly soluble in ethanol 
Specific rotation: [α]D20 + 199° (5 % aqueous solution) 
Melting point: 97 °C (dih ydrate) 
Purity: 
Loss on drying: ≤ 1,5 % (60 °C, 5 h) 
Total ash: ≤ 0,05 % 
Hea vy metals : 
Lead: ≤ 1,0 mg/kg   
UV treated mushrooms  
(Agaricus bispor us) Descr iption/Def inition: 
Commercially grown Agaricus bispor us to whic h UV light treatment is applied to harvested mushrooms. 
UV radiation: a process of radiation in ultraviolet light within the wav elength of 200-800 nm. 
Vitamin D2: 
Chemical name: (3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol 
Synon ym: Ergocalcif erol 
CAS No: 50-14-6 
Molecular weight: 396,65 g/mol 
Contents: 
Vitamin D2 in the final product: 5-10 µg/100 g fresh weight at the expiration of shelf life 
UV-treated baker's yeast  
(Sacchar omy ces cerevisiae) Descr iption/Def inition: 
Bake r's yeast (Saccharo myces cerevisiae) is treated with ultraviolet light to induce the conver sion of ergostero l to vitamin D2 (ergocalcif erol). Vitamin D2 
conte nt in the yeast concentrat e varies between 1 800 000-3 500 000 IU vitamin D/100 g (450-875 µg/g). 
Tan-coloured, free-f lowing granules  30.12.2017 L 351/195 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Vitamin D2: 
Chemical name: (5Z,7E,22E)-(3S)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol 
Synon ym: Ergocalcif erol 
CAS No.: 50-14-6 
Molecular weight: 396,65 g/mol 
Microbiological criter ia for the yeast concentrate: 
Colif orms: ≤ 103/g 
Escher ichia coli: ≤ 10/g 
Salmonella: Absence in 25 g   
UV-treated bread Descr iption/Def inition: 
UV-treat ed bread is yeast leav ened bread and rolls (without topping s) to which a treatment with ultraviolet radiation is applied after baking in order to 
conver t ergost erol to vitamin D2 (ergocalciferol). 
UV radiation: A process of radiation in ultraviolet light within the wavelength of 240-315 nm for maximum of 5 seconds with energy input of 
10-50 mJ/cm2. 
Vitamin D2: 
Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol 
Synon ym: Ergocalcif erol 
CAS No: 50-14-6 
Molecular weight: 396,65 g/mol 
Contents: 
Vitamin D2 (ergocalciferol) in the final product: 0,75-3 µg/100 g (*) 
Yeast in dough: 1-5 g/100 g (**)  
(*) EN 12821, 2009, European Standard.  
(**) Recipe calculation. 
UV-treated milk Descr iption/Def inition: 
UV-treat ed milk is cow's milk (whole and semi-skimmed) to whic h a treatment with ultravi olet (UV) radiation via turbulent flow is applied after pasteur i­
sation. The treatment of the pasteur ised milk with UV radiation results in an increase in the vitamin D3 (cholecalcif erol) concentrations by conver sion of 
7-dehydr ocholest erol to vitamin D3. 
UV radiation: A process of radiation in ultravi olet light within the wavelength of 200-310 nm with energy input of 1 045 J/l.  30.12.2017 L 351/196 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Vitamin D3: 
Chemical name: (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-meth yl-1-[(2R)-6-methylhep tan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]eth ylidene]-4- 
meth ylidenecy clohexan-1-ol 
Synon ym: Cholecalcif erol 
CAS No: 67-97-0 
Molecular weight: 384,6377 g/mol 
Contents: 
Vitamin D3 in the final product: 
Whole milk (*): 0,5-3,2 µg/100 g (**) 
Semi-skimmed milk (*): 0,1–1,5 µg/100 g (**) 
(*)As defin ed by Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisat ion of the mar ­
kets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 
20.12.2013, p. 671).  
(**) HPLC   
Vitamin K2 (menaquinone) This novel food is produced by a synthetic or microbiological process. 
Specification of synthetic Vitamin K2 (menaquinone-7) 
Chemical Name: (all-E)-2-(3,7,11,15,19,23,27-Heptame thyl-2,6,10,14,18,22,26-octacosahep taeny l)-3-methyl-1,4-naphtal enedione 
CAS Number: 2124-57-4 
Molecular formula: C46H64O2 
Molecular weight: 649 g/mol 
Appearance: Yellow powder 
Purity: Max 6,0 % cis-isomer , max 2,0 % other impur ities 
Content: 97-102 % Menaquinone-7 (including at least 92 % all-trans Menaquinone-7) 
Specifications of microbiolo gically produced Vitamin K2 (menaquinone-7) 
Source: Bacillus subtilis spp. natto 
Vitamin K2 (2-methy l-3-all-trans-polyprenyl-1,4-naphthoquinones), or the menaquinone series, is a group of prenylat ed naphthoquinone derivatives. The 
number of isoprene residues, where 1 isoprene unit consists of 5 carbons compris ing the side chain, is used to character ise the menaquinone homo ­
logues. It is present ed in an oil suspension that primar ily contains MK-7 and MK-6 to a smaller extent. 
Vitamin K2 (menaquinones) series with menaquinone-7 (MK -7)(n = 6) being C46H64O2, menaquinone-6 (MK -6)(n = 5) being C41H56O2 and 
menaquinone-4 (MK -4)(n = 3) being C31H40O2. 30.12.2017 L 351/197 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Wheat bran extract Descr iption/Def inition: 
White crystalline powder obtained by enzymatic extraction from Triticum aestivum L. bran, rich in arabino xylan oligosacc harides 
Dry matt er: Min. 94 % 
Arabino xylan oligosacc harides: Min 70 % of dry matter 
Averag e degree of polymer isation of arabino xylan oligosacchari des: 3-8 
Ferulic acid (bound to arabino xylan oligosacc harides): 1-3 % of dry matt er 
Total poly/oligosacc harides: Min 90 % 
Protein : Max 2 % of dry matt er 
Ash: Max 2 % of dry matter 
Microbiological parameters: 
Mesophilic bacteri a – total count : Max 10 000/g 
Yeasts: Max 100/g 
Fungi: Max 100/g 
Salmonella: Absence in 25 g 
Bacillus cereus: Max 1 000/g 
Clostr idium perfr ingens: Max 1 000/g 
Yeast beta-glucans Descr iption/Def inition: 
Beta-g lucans are compl ex, high molecular mass (100–200 kDa) polysacchar ides, found in the cell wall of man y yeasts and cereals. 
The chemical name for ‘yeast beta-g lucans’ is (1-3),(1-6)-β-D-g lucans. 
Beta-g lucans consist of a backbone of β-1-3-linked glucose residues that are branched by β-1-6-linkages, to whic h chitin and mannoprot eins are linked 
by β-1-4-bonds. 
Beta-g lucans are isolat ed from yeast Saccharomy ces cerevisiae. 
The tertiary structure of the glucan cell wall of Saccharom yces cerevisiae consists of chains of β-1,3-linke d glucose residues, branched by β-1,6-linkages, 
forming a backbon e to whic h are linked chitin via β-1,4- bonds, β-1,6-g lucans and some mannoproteins. 
This novel food is available in three differ ent forms: soluble, insoluble and insoluble in water , but dispersible in many liquid matr ices. 
Chemical character istics yeast (Sacc haromy ces cerevisiae) beta-glucans: 
Soluble form: 
Total carboh ydrates: > 75 %  30.12.2017 L 351/198 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Beta-g lucans (1,3/1,6): > 75 % 
Ash: < 4,0 % 
Moisture: < 8,0 % 
Protein : < 3,5 % 
Fat: < 10 % 
Insoluble form: 
Total carboh ydrates: > 70 % 
Beta-g lucans (1,3/1,6): > 70 % 
Ash: ≤ 12 % 
Moisture: < 8,0 % 
Protein : < 10 % 
Fat: < 20 % 
Insoluble in water , but dispersible in many liquid matr ices: 
(1,3)-(1,6)-β-D-Glucans: > 80 % 
Ash: < 2,0 % 
Moisture: < 6,0 % 
Protein : < 4,0 % 
Total fat: < 3,0 % 
Microbiological data: 
Total plate count : < 1 000 CFU/g 
Enterobacter iaceae: < 100 CFU/g 
Total colif orms: < 10 CFU/g 
Yeast: < 25 CFU/g 
Mould: < 25 CFU/g 
Salmonella: Absence in 25 g 
Escher ichia coli: Absence in 1 g 
Bacillus cereus: < 100 CFU/g 
Staphy lococcus aureus: Absence in 1 g 
Hea vy metals : 
Lead: < 0,2 mg/g 
Arsenic: < 0,2 mg/g  30.12.2017 L 351/199 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Mercur y: < 0,1 mg/g 
Cadmium: < 0,1 mg/g   
Zeaxan thin Descr iption/Def inition: 
Zeaxanthin is a naturally occur ring xanthophyll pigment, it is an oxygen ated carotenoid. 
The synthetic zeaxanthin is presented either as a spra y-dr ied powder of gelatin or starc h base (‘beadlets ’) with added α-tocopherol and ascorbyl palmitate 
or as a corn oil suspension with added α-tocopherol. Synthetic zeaxanthin is produced by a multi-step chemical synthesis from smaller molecules. 
Orange -red crystalline powder with little or no odour . 
Chemical formula: C40H56O2 
CAS No: 144-68-3 
Molecular weight: 568,9 dalton s 
Physi cal-chemical proper ties: 
Loss on drying: < 0,2 % 
All-trans zeaxanthin: > 96 % 
Cis-zeaxanthin: < 2,0 % 
Other carot enoids: < 1,5 % 
Triphenylphosphine oxid (CA S No 791-28-6): < 50 mg/kg 
Zinc L-pidolate Descr iption/Def inition: 
Zinc L-pi dolat e is a whit e to off-white powder , with character istic odour . 
Internatio nal non-propr ietar y name (INN): L-pyrog lutamic acid, Zinc salt 
Synon yms: Zinc 5-oxoproline, Zinc pyrog lutamate, Zinc pyrrolidone carbo xylate , Zinc PCA, L-Zinc pidolat e 
CAS No.: 15454-75-8 
Molecular formula: (C5H6NO3)2 Zn 
Relative anhydrous molecular mass: 321,4 
Appearance: White to slightly whit e powder 
Purity: 
Zinc L-pi dolat e (pur ity): ≥ 98 % 
pH (10 % aqueous sol.): 5,0-6,0 
Specific rotation: 19,6°- 22,8° 
Water: ≤ 10,0 % 
Glutamic acid: < 2,0 %  30.12.2017 L 351/200 Official Jour nal of the European Union EN     Authorised Novel Food Specification 
Hea vy metals : 
Lead: ≤ 3,0 ppm 
Arsenic: ≤ 2,0 ppm 
Cadmium: ≤ 1,0 ppm 
Mercur y: ≤ 0,1 ppm 
Microbiological criter ia: 
Total viable mesophilic count: ≤ 1 000 CFU/g 
Yeasts and moulds: ≤ 100 CFU/g 
Pathogen: Absence   
(1)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specificatio ns for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of 
the Council (OJ L 83, 22.3.2012, p. 1) 
(2)  Commission Implementing Regulation (EU) 2015/175 of 5 Febr uary 2015 laying down special conditions applicable to the impor t of guar gum originating in or consigned from India due to contamination 
risks by pentachlorop henol and dioxins (OJ L 30, 6.2.2015, p. 10)   30.12.2017 L 351/201 Official Jour nal of the European Union EN