1 
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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 authorised novel foods and contains the following information:  
Column 1: Authorised novel food  
Column 2: Conditions under which the novel food may be used. This column is 
further subdivided into two: Specified food category and Maximum levels  
Column 3: Additional specific labelling requirements  
Column 4: Other requirements  
3. Table 2 includes the s pecifications on novel foods and contains the following 
information:  
Column 1: Authorised novel food  
Column 2: Specifications  2 
 Table 1: Authorised novel foods  
Authorised novel 
food  Conditions under which the novel food may be used  Additional specific labelling 
requirements  Other 
requirements  
Adansonia digitata  
(Baobab) dried fruit 
pulp  Not specified  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Baobab fruit pulp"   
Ajuga reptans 
extract  Specified food category  Maximum levels  
  Food Supplements as defined 
in Directive 2002/46/EC  In line with normal use in food 
supplements of a similar 
extract of the flowering aerial 
parts of Ajuga reptans  
L-Alanyl -L-
Glutamine  Specified food category  Maximum levels  
  Food Supplements as defined 
in Directive 2002/46/EC  
 Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013 
excluding foods for infants 
and young children  
Algal oil from the 
microalgae Ulkenia  
sp. Specified food category  Maximum levels of DHA  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Oil from the micro -algae Ulkenia 
sp."  Bakery products (breads and 
bread rolls)  200 mg/100 g  
Cereal bars  500 mg/100 g  
Non-alcoholic beverages 
(including milk based 
beverages)  60 mg/100 ml  3 
 Allanblackia  seed oil  Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be " Allanblackia  seed oil’   Yellow fat spreads and cream 
based spreads   
Aloe macroclada 
Baker leaf extract  Specified food category  Maximum levels  
  Food Supplements as defined 
in Directive 2002/46/EC  In line with normal use in food 
supplements of the similar gel 
derived from Aloe vera  (L.) 
Burm.  
Antartic Krill  oil 
from  Euphasia 
superba  Specified food category  Maximum levels of combined 
DHA and EPA  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Lipid extract from the crustacean 
Antarctic Krill ( Euphausia superba )" All food products 
containing DHA - 
and EPA -rich oil 
from Antarctic Krill 
should demonstrate 
oxidative stability by 
appropriate and 
recognised 
national/internationa
l test methodology 
(e.g. AOAC)  Dairy products except milk -
based drinks  200 mg/100 g or for cheese 
products 600 mg/100 g  
Dairy analogues except drinks  200 mg/100 g or for analogues 
to cheese products 600 mg/100 
g 
Non-alcoholic beverages  
Milk -based drinks  
Dairy analogue drinks  80 mg/100 ml  
Spreadable fat and dressings  600 mg/100 g  
Cooking fats  360 mg/100 ml  
Breakfast cereals  500 mg/100 g  
Bakery products (bread and 
rolls)  200 mg/100 g  
Nutrition bars/cereal bars  500 mg/100 g  
Food Supplements as defined 
in Directive 2002/46/EC  3000 mg/day for the general 
population  
450 mg/day for pregnant and 4 
 lactating women  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  In accordance with the 
particular nutritional 
requirements of the persons for 
whom the products are 
intended  
Total diet replacement for 
weight control as defined in 
Regulation (EU) No 609/2013 
and meal replacements for 
weight control  250 mg/meal  
Processed cereal -based food 
and baby food intended for 
infants and young children 
covered by Regulation (EU) 
No 609/2013  
200 mg/100 ml  Foods intended to meet the 
expenditure of intense 
muscular effort, especially for 
sportsmen  
Foods bearing statements on 
the absence or reduced 
presence of gluten in 
accordance with the 
requirements of Commission 
Implementing Regulation 
(EU) No 828/2014  
Antartic Krill  oil Specified food category  Maximum levels of combined The designation of the novel food on the All food products 5 
 rich in 
phospholipids  from 
Euphasia superba  DHA and EPA  labelling of the foodstuffs containing it 
shall be "Lipid extract from the crustacean 
Antarctic Krill ( Euphausia superba )" containing DHA - 
and EPA -rich oil 
from Antarctic Krill 
should demonstrate 
oxidative stability by 
appropriate and 
recognised 
national/internationa
l test methodology 
(e.g. AOAC)  Dairy products except milk -
based drinks  200 mg/100 g or for cheese 
products 600 mg/100 g  
Dairy analogues except drinks  200 mg/100 g or for analogues 
to cheese products 600 mg/100 
g 
Non-alcoholic beverages  
Milk -based drinks  
Dairy analogue drinks  80 mg/100 ml  
Spreadable fat and dressings  600 mg/100 g  
Cooking fats  360 mg/100 ml  
Breakfast cereals  500 mg/100 g  
Bakery products (bread and 
rolls)  200 mg/100 g  
Nutrition bars/cereal bars  500 mg/100 g  
Food Supplements as defined 
in Directive 2002/46/EC  3000 mg/day for the general 
population  
450 mg/day for pregnant and 
lactating women  
Foods  for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  In accordance with the 
particular nutritional 
requirements of the persons for 
whom the products are 
intended  
Total diet replacement for 
weight as defined in 
Regulation (EU) No 609/2013 250 mg/meal  6 
 and meal replacements for 
weight control  
Processed cereal -based food 
and baby food intended for 
infants and young children 
covered by Regulation (EU) 
No 609/2013  
200 mg/100 ml  Foods intended to meet the 
expenditure of intense 
muscular effort, especially for 
sportsmen  
Foods bearing statements on 
the absence or reduced 
presence of gluten in 
accordance with the 
requirements of Commission 
Implementing Regulation 
(EU) No 828/2014   
Arachidonic acid -
rich oil from the 
fungus Mortierella 
alpina  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Oil from Mortierella alpina " or 
"Mortierella alpina  oil"  Infant formula  and follow -on 
formula as defined in 
Regulation (EU) No 609/2013  In accordance with Regulation 
(EU) No 609/2013  
Foods for special medical 
purposes for premature infants 
as defined in Regulation (EU) 
No 609/2013  In accordance with Regulation 
(EU) No 609/2013  
Argan oil from 
Argania spinose   Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it  
As seasonings  Not specified  7 
 Food Supplements as defined 
in Directive 2002/46/EC  In line with normal food use of 
a vegetable oils  shall be “Argan oil” and if used as 
seasoning “Vegetable oil only for 
seasoning" shall be mentioned on the label  
Astaxanthin from 
Haematococcus 
pluvialis  algae  Specified food category  Maximum levels  The designation of the novel on the 
labelling of the Food stuff containing it 
shall be "Astaxanthin"   Food Supplements as defined 
in Directive 2002/46/EC  2.4 mg/day  
Basil seeds ( Ocimum 
basilicum )  Specified food category  Maximum levels  
 The final product is 
sold in transparent 
containers so that 
Basil seed is visible 
to consumers  Beverages based on fruit juice 
and fruit juice blends  3 g/200 mL for addition of 
whole basil seeds (Ocimum 
basilicum ) 
Fermented black 
bean extract  Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Fermented black bean (Soya) 
extract"’ or "Fermented Soya extract"   Food Supplements as defined 
in Directive 2002/46/EC  4.5 g/day  
Bovine lactoferrin  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Lactoferrin from cows’ milk"   Infant formula and follow -on 
formula as defined in 
Regulation (EU) No 609/2013 
(ready to drink)  100 mg/100 ml  
Foods on dairy basis intended 
for young children (ready to 
eat/drink)  200 mg/100 g  
Processed cereal food (solid)  670 mg/100 g  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  Depending on the needs of the 
individual up to 3  g/day  
Beverages based on milk  200 mg/100 g  8 
 Powdered drink mixes based 
on milk (ready to drink)  330 mg/100 g  
Beverages based on fermented 
milk (including yoghurt 
drinks)  50 mg/100 g  
Non-alcoholic drinks  120 mg/100 g  
Products based on yoghurt  80 mg/100 g  
Products based on cheese  2000 mg/100 g  
Ice cream  130 mg/100 g  
Cakes and pastries  1000 mg/100 g  
Candies  750 mg/100 g  
Chewing gum  3000 mg/100 g  
Buglossoides 
arvensis seed oil  Specified food category  Maximum levels of 
stearidonic acid (STA)  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Refined Buglossoides  oil’  Dairy products and analogues  250 mg/100 g  
75 mg/100 g for drinks  
Cheese and cheese products  750 mg/100 g  
Butter and other fat and oil 
emulsions including spreads 
(not for cooking or frying 
purposes)  750 mg/100 g  
Breakfast cereals  625 mg/100 g  
Food supplements as defined 
in Directive 2002/46/EC, 
excluding food supplements 
for infants and young children  500 mg/day  9 
 Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013, 
excluding foods for special 
medical  purposes intended for 
infants and young children  In accordance with the 
particular nutritional 
requirements of the persons for 
whom the products are 
intended  
Total diet replacement for 
weight control as defined in 
Regulation (EU) No 609/2013 
and meal replacements for 
weight control  250 mg/meal  
Chewing gum base 
(monomethoxypolye
thylene glycol)  Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Gum base (including 1,3-
butadiene, 2 -methyl -homopolymer, 
maleated, esters with polyethylene glycol 
mono -Me ether)" or "Gum base (including 
CAS No: 1246080 -53-4)"  
Chewing gum  8% 
Chewing gum base 
(Methyl vinyl ether -
maleic anhydride 
copolymer)  Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Gum base (including methyl vinyl 
ether -maleic anhydride copolymer)" or 
"Gum base (including CAS No 9011 -16-
9)"  
Chewing gum  2% 
Chia oil from Salvia 
hispanica  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Chia oil ( Salvia hispanica )"  Fats and oils  10% 
Pure chia oil  2 g/day  
Food Supplements as defined  
in Directive 2002/46/EC  2 g/day  10 
 Chia seeds ( Salvia 
hispanica ) Specified food category  Maximum levels  
1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "Chia ( Salvia 
hispanica ) seeds"  
2. Additional labelling of pre -packaged 
Chia ( Salvia hispanica ) seed is 
required to inform the consumer that 
the daily intake is no more than 15 g.  Fruit juice and fruit 
juice blends: The 
final product is sold 
in transparent 
containers so that 
Chia seed is visible 
to consumers  Bread products  5% (whole or ground chia 
seeds)  
Baked  products  10% whole chia seeds  
Breakfast cereals  10% whole chia seeds  
Fruit, nut and seed mixes  10% whole chia seeds  
Beverages based on fruit juice 
and fruit juice blends  15 g/450 ml for addition of 
whole, mashed or ground chia 
seeds  
Pre-packaged Chia seed as 
such 15 g/day whole chia seeds  
Chitin -glucan from 
Aspergillus niger   Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Chitin -glucan from Aspergillus 
niger"   Food Supplements as defined 
in Directive 2002/46/EC  5 g/day  
Chitin -glucan 
complex from 
Fomes fomentarius  Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Chitin -glucan from Fomes 
fomentarius "  Food Supplements as defined 
in Directive 2002/46/EC  5 g/day  
Chitosan extract 
from fungi 
(Agaricus bisporus ; 
Aspergillus niger ) Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "C hitosan extract from Agaricus 
bisporus” or “Chitosan extract from 
Aspergillus niger ”  Food Supplements as defined 
in Directive 2002/46/EC  In line with normal use in food 
supplements of chitosan from 
crustaceans  
Chromium 
Picolinate  Specified food category  Maximum levels of total 
chromium  The designation of the novel food on the 
labelling of the foodstuffs containing it  11 
 Foods covered by Regulation 
(EU) No 609/2013  
250 µg/day  shall be "Chromium Picolinate"  
Milk -based drinks and similar 
products intended for young 
children  
Meal replacement for weight 
control  
Foods intended to meet the 
expenditure of intense 
muscular effort, especially for 
sportsmen  
Foods bearing statements on 
the absence or reduced 
presence of gluten in 
accordance with the 
requirements of Commission 
Implementing Regulation 
(EU) No 828/2014  
Citicoline  Specified food category  Maximum levels  1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "Citicoline"  
2. The labelling of foods containing 
citicoline shall  bear a statement that 
the product is not intended to be 
consumed by children   Food Supplements as defined 
in Directive 2002/46/EC  500 mg/day  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  250 mg per serving and a 
maximum daily consumption 
level of 1000 mg  
Clostridium 
butyricum (CBM 
588) Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Clostridium butyricum  MIYAIRI 
588 (CBM 588)" or " Clostridium  Food Supplements as defined 
in Directive 2002/46/EC  1,35 × 108 CFU/day  12 
 butyricum  (CBM 588)"  
Extract of defatted 
cocoa powder  Specified food category  Maximum levels  
Consumers shall be instructed not to 
consume more than 600 mg polyphenols 
corresponding to 1.1 g of extract of 
defatted cocoa powder per day   Nutrition bars  
1 g/day and 300 mg 
polyphenols corresponding to 
not more than 550 mg of 
extract of defatted cocoa 
powder in one portion of food 
(or food supplement)  Milk based beverages  
Any other foods (including 
food supplements as defined 
in Directive 2002/46/EC) 
which have become 
established vehicles for 
functional ingredients and 
which are typically positioned 
for consumption by health 
conscious adults  
Low fat cocoa 
extract  Specified food category  Maximum levels  
Consumers shall be instructed not to 
consume more than 600 mg of cocoa 
flavanols per day   Foods including food 
supplements as defined in 
Directive 2002/46/EC  730 mg per serving and around 
1.2 g/day  
Coriander seed oil 
from Coriandrum 
sativum  Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Coriander seed oil"   Food Supplements as defined 
in Directive 2002/46/EC  600 mg/day  
α-cyclodextrin  Not specified  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Alpha -cyclodextrin’ or "α -
cyclodextrin"   13 
 γ-Cyclodextrin  Not specified  The designation  of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Gamma -Cyclodextrin" or "γ -
Cyclodextrin"   
Dextran 
preparation 
produced by 
Leuconostoc 
mesenteroides  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Dextran"   
Bakery products  5% 
Diacylglycerol oil of 
plant origin  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of  the foodstuffs containing it 
shall be "Diacylglycerol oil of plant origin 
(at least 80 % diacylglycerols)"   Cooking oils  
 Fat spreads  
Salad dressings  
Mayonnaise  
Meal replacement for weight 
control (as drinks)  
Bakery products  
Yoghurt type products  
Dihydrocapsiate 
(DHC)  Specified food category  Maximum levels  
1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be 
"Dihydrocapsiate"  
2. Food supplements containing 
synthetic dihydrocapsiate will be 
labelled as "not intended for children 
up to 4.5 years"    Cereal bars  9 mg/100 g  
Biscuits, cookies and crackers  9 mg/100 g  
Rice based snacks  12 mg/100 g  
Carbonated drinks, dilutable 
drinks, fruit juice based drinks  1.5 mg/100 ml  
Vegetable drinks  2 mg/100 ml  
Coffee based drinks, tea based 1.5 mg/100 ml  14 
 drinks  
Flavoured water - still 1 mg/100 ml  
Precooked oatmeal cereal  2.5 mg/100 g  
Other cereals  4.5 mg/100  g 
Ice cream, dairy desserts  4 mg/100 g  
Pudding mixes (ready to eat)  2 mg/100 g  
Products based on yoghurt  2 mg/100 g  
Chocolate confectionery  7.5 mg/100 g  
Hard candy  27 mg/100 g  
Sugar -free gum  115 mg/100 g  
Whitener/creamer  40 mg/100 g  
Sweeteners  200 mg/100 g  
Soup (ready to eat)  1.1 mg/100 g  
Salad dressing  16 mg/100 g  
Vegetable protein  5 mg/100 g  
Ready to eat meals  3 mg/meal  
Meal replacements for weight 
control  3 mg/meal  
Meal replacement for weight 
control (as drinks)  1 mg/100 ml  
Food Supplem ents as defined 
in Directive 2002/46/EC  3 mg/single intake  
9 mg/day  
Non-alcoholic powdered drink 
mixes  14.5 mg/kg equivalent to 1.5 
mg/100ml  
Dried extract of Food Supplements as defined    15 
 Lippia citriodora  
from cell cultures  in Directive 2002/46/EC  
Echinacea 
angustifolia extract  Specified food category  Maximum levels  
  Food Supplements as defined 
in Directive 2002/46/EC  In line with normal use in food 
supplements of a similar 
extract from the root of 
Echinacea angustifolia   
Echium 
plantagineum  oil  Specified food category  Maximum levels of 
stearidonic acid (STA)  
The designation of the novel food on the 
labelling of the  foodstuffs containing it 
shall be "Refined echium oil’    Milk -based products and 
drinkable yoghurt products 
delivered in a single dose  250 mg/100 g; 75 mg/100 g for 
drinks  
Cheese preparations  750 mg/100 g  
Spreadable fat and dressings  750 mg/100 g 
Breakfast cereals  625 mg/100 g  
Food supplements as defined 
in Directive 2002/46/EC  500 mg/day  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  In accordance with the 
particular nutritional 
requirements of the persons for 
whom the products are 
intended  
Total diet replacement for 
weight control as defined in 
Regulation (EU) No 609/2013 
and meal replacements for 
weight control  250 mg/meal  
Epigallocatechin Specified food category  Maximum levels  The labelling shall bear a statements that  16 
 gallate as a purified 
extract from green 
tea leaves (Camellia 
sinensis ) Food Supplements as defined 
in Directive 2002/46/EC  150 mg of extract  in one 
portion of food or food 
supplement  consumers should not consume more than 
300 mg of extract per day  
Foods fortified in accordance 
with Regulation (EC) No 
1925/2006  
L-ergothioneine  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be " L-ergothioneine "  Food supplements as defined 
in Directive 2002/46/EC  30 mg/day  for general 
population (excluding pregnant 
and lactating women)  
20 mg/day for children older 
than 3 years  
Ferric Sodium 
EDTA  Specified food category  Maximum levels (anhydrous 
EDTA)  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Ferric Sodium EDTA"    Food supplements as defined 
in Directive 2002/46/EC  Children: 18 mg/day  
Adults: 75 mg/day  
Foods covered by Regulation 
(EU) No 609/2013  
12 mg/100 g  Foods fortified in accordance 
with Regulation (EC) No 
1925/2006  
Ferrous ammonium 
phosphate  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall  be "Ferrous ammonium phosphate"   Foods including food 
supplements as defined in 
Directive 2002/46/EC  To be used in compliance with 
Directive 2002/46/EC, 
Regulation (EU) No 609/2013 
and/or Regulation (EC) No 
1925/2006  Foods covered by Regulation 
(EU) No 609/2013  17 
 Milk -based drinks and similar 
products intended for young 
children  
Meal replacement for weight 
control  
Foods intended to meet the 
expenditure of intense 
muscular effort, especially for 
sportsmen  
Foods bearing statements on 
the absence or reduced 
presence of gluten in 
accordance with the 
requirements of Commission 
Implementing Regulation 
(EU) No 828/2014  
Fish peptides from 
Sardinops sagax   Specified food category  Maximum levels fish peptide 
product  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Fish ( Sardinops sagax ) peptides"    Foods based on yoghurt, 
yoghurt drinks, fermented 
milk products, and powdered 
milk 0.48 g/100 g (ready to 
eat/drink)  
Flavoured  water, and 
vegetable -based drinks  0.3 g/100 g (ready to drink)  
Breakfast cereals  2 g/100 g  
Soups, stews and soup 
powders  0.3 g/100 g (ready to eat)  
Flavonoids from  Specified food category  Maximum levels of glavonoid  1. The designation of the novel food on Beverages 18 
 Glycyrrhiza glabra  Beverages based on milk  
120 mg/day  the labelling of the foodstuffs 
containing it shall be "Flavonoids 
from Glycyrrhiza glabra L. " 
2. The labelling of the foods where the 
product was added as a novel food 
ingredient shall bear a statement that:  
(a) the product should not be 
consumed by pregnant and breast 
feeding women, children and 
young adolescents; and  
(b) people taking prescription drugs 
should only consume the product 
under medical supervision;  
(c) a maximum of 120 mg of 
Glavonoid per day should be 
consumed.  
3. The amount of Glavonoid in the final 
food shall be indicated on the labelling 
of the food containing it.  containing 
Glavonoid shall be 
presented to the final 
consumer as single 
portions.  Beverages based on yoghurt  
Beverages based on fruit or 
vegetables  
Food Supplements as defined 
in Directive 2002/46/EC  120 mg/portion of daily 
consumption  
Total diet replacement for 
weight control as defined in 
Regulation (EU) No 609/2013  120 mg/day  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  120 mg/day  
2′-O-fucosyllactose  Specified food category  Maximum levels  1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "2′ -O-
fucosyllactose".  
2. The labelling of food supplements 
containing 2′ -O-fucosyllactose shall 
bear a statement that the supplements 
should not be used if other foods with 
added 2′ -O-fucosyllactose are 
consumed the same day.  
3. The labelling of food s upplements  Unflavoured pasteurised and 
sterilised (including UHT) 
milk-based products  1.2 g/l  
Unflavoured fermented milk -
based products  1.2 g/l beverages  
19.2 g/kg products other than 
beverages  
Flavoured fermented milk -
based products including heat -
treated products  1.2 g/l beverages  
19.2 g/kg products other than 
beverages  19 
 Dairy analogues, including 
beverage whiteners  1.2 g/l beverages  containing 2′ -O-fucosyllactose 
intended for young children shall bear 
a statement that the supplements 
should not be used if breast milk or 
other foods with added 2′ -O-
fucosyllactose are consumed the same 
day. 12 g/kg for products other than 
beverages  
400 g/kg for whitener  
Cereal bars  12 g/kg  
Table -top sweeteners  200 g/kg  
Infant formula as defined in 
Regulation (EU) No 609/2013  1.2 g/l alone or in combination 
with 0,6  g/l of lacto -N-
neotetraose at a ratio of 2:1 in 
the final product ready for use, 
marketed as such or 
reconstituted as instructed by 
the manufacturer  
Follow -on formula as defined 
in Regulation (EU) No 
609/2013  1.2 g/l alone or in combination 
with 0.6  g/l of lacto -N-
neotetraose at a ratio of 2:1 in 
the final product ready for use, 
marketed as such or 
reconstituted as instructed by 
the manufacturer  
Processed cereal -based food 
and baby food for infants and 
young children as defined in 
Regulation (EU) No 609/2013  12 g/kg for products other than 
beverages  
1.2 g/l for liquid food ready for 
use, marketed as such or 
reconstituted as instructed by 
the manufacturer  
Milk -based drinks and similar 
products intended for young 1.2 g/l for milk -based drinks 
and similar products added 20 
 children  alone or in combination with 
lacto -N-neotetraose, at 
concentrations 0.6 g/l, at a ratio 
of 2:1 in the final product  ready 
for use, marketed as such or 
reconstituted as instructed by 
the manufacturer  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  In accordance with the 
particular nutritional 
requirements of the persons for 
whom the products are 
intended  
Total diet replacement for 
weight control as defined in 
Regulation (EU) No 609/2013  4.8 g/l for drinks  
40 g/kg for bars  
Bread and pasta products 
bearing statements on the 
absence or reduced presence 
of gluten in accordance with 
the requirements of 
Commission Implementing 
Regulation (EU) No 828/2014  60 g/kg  
Flavoured drinks  1.2 g/l  
Coffee, tea (excluding black 
tea), herbal and fruit infusions, 
chicory; tea, herbal and fruit 
infusions and chicory extracts; 
tea, plant, fruit and cereal 
preparations for infusions, as 
well as mixes and instant 9.6 g/l - the maximu m level 
refers to the products ready to 
use 21 
 mixes of these products  
Food supplements as defined 
in Directive 2002/46/EC, 
excluding food supplements 
for infants  3.0 g/day for general 
population  
1.2 g/day for young children  
Galacto -
oligosaccharide 
(GOS)  Specified food category  Maximum levels  
  General foodstuffs as well as 
infant formula and follow -on 
formula as defined in 
Regulation (EU) No 609/2013  At the same levels as the 
comparator on the EU market 
before 15 May 1997  
Glucosamine HCl 
from Aspergillus 
niger  Specified food category  Maximum levels  
  Food Supplements as defined 
in Directive 2002/46/EC  
In line with normal food use of 
glucosamine from shell fish  Foods covered by Regulation 
(EU) No 609/2013  
Milk -based drinks and similar 
products intended  for young 
children  
Meal replacement for weight 
control  
Foods intended to meet the 
expenditure of intense 
muscular effort, especially for 
sportsmen  
Foods bearing statements on 22 
 the absence or reduced 
presence of gluten in 
accordance with the 
requirements of Commission 
Implementing Regulation 
(EU) No 828/2014  
Glucosamine 
sulphate KCl from 
Aspergillus niger  Specified food category  Maximum levels  
  Food Supplements as defined 
in Directive 2002/46/EC  In line with normal food use of 
glucosamine from shell fish  
Glucosamine 
sulphate NaCl from 
Aspergillus niger  Specified food category  Maximum levels  
  Food Supplements as defined 
in Directive 2002/46/EC  In line with normal food use of 
glucosamine from shell fish  
Guar Gum  Specified food category  Maximum levels  1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "Guar Gum".  
2. A specific mention of the possible 
risks of digestive discomfort linked to 
the exposure of children aged un der 8 
to guar gum must be visible on the 
label of any foodstuffs containing it.  
 For example, ‘’Excessive 
consumption of these products may 
cause digestive discomfort, especially 
for children under 8 years of age’’.  
3. In the case of products with two 
compartments containing dairy and 
cereal products respectively, the 
instructions for use must clearly 
specify the need to mix the cereal and  Fresh dairy products such as 
yogurts, fermented milks, 
fresh cheeses and other dairy -
based desserts.  1.5 g/100 g  
Fruit or vegetable -based liquid 
foodstuffs (of the "smoothie" 
variety)  1.8 g/100 g  
Fruit or vegetable -based 
compotes  3.25 g/100 g  
Cereals accompanied by a 
dairy product, in packaging 
containing two compartments  10 g/100 g in the cereals  
None in the accompanying 
dairy product  
1 g/100 g in the product when 
ready to eat  23 
 the dairy product before consumption, 
in order to take into account the 
potential risk of gastro -intestinal 
obstruction.  
Heat -treated milk 
products fermented 
with Bacteroides 
xylanisolvens  Specified food category  Maximum levels  
    Fermented milk products (in 
liquid, semi -liquid and spray -
dried powder forms)   
Ice Structuring 
Protein type III 
HPLC 12  Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Ice Structuring Protein"    
Edible ices  0.01%  
Isomalto -
oligosaccharide  Specified food category  Maximum levels  
1. The designation of the  novel food on 
the labelling of the foodstuffs 
containing it shall be 
"Isomaltooligosaccharide".  
2. Foods containing the novel ingredient 
must be labelled as "a source of 
glucose".    Energy -Reduced Soft Drinks  6.5%  
Energy Drinks  5.0%  
Foods intended to meet the 
expenditure of intense 
muscular efforts, especially 
for sportsmen (including 
isotonic drinks)  6.5%  
Fruit Juices  5% 
Processed Vegetables and 
Vegetable Juices  5% 
Other Soft Drinks  5% 
Cereals Bars  10% 
Cookies, Biscuits  20% 
Breakfast Cereal Bars  25% 
Hard Candies  97% 24 
 Soft Candies/Chocolate Bars  25% 
Meal replacement for weight 
control (as bars or milk based)  20% 
Isomaltulose  Not specified  1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "Isomaltulose".  
2. The designation of the novel food on 
the labelling shall be accompanied by 
indication that the "Isomaltulose is a 
source of glucose and fructose".   
Lactitol  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the food supplements 
containing it shall be "Lactitol"    Food Supplements as defined 
in Directive 2002/46/EC 
(capsules or tablets) intended 
for the adult population  20 g/day  
Lacto -N-neotetraose  Specified food category  Maximum levels  1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "Lacto -N-
neotetraose".  
2. The labelling of food supplements 
containing lacto -N-neotetraose shall 
bear a statement that the  supplements 
should not be used if other foods with 
added lacto -N-neotetraose are 
consumed the same day.  
3. The labelling of food supplements 
containing lacto -N-neotetraose 
intended for young children shall bear 
a statement that the supplements  Unflavoured pasteurised and 
sterilised (including UHT) 
milk-based products  0.6 g/l  
Unflavoured fermented milk -
based products  0.6 g/l for beverages  
9.6 g/kg for products other than 
beverages  
Flavoured fermented milk -
based products including heat -
treated products  0.6 g/l for beverages  
9.6 g/kg for products other than 
beverages  
Dairy analogues, including 
beverage whiteners  0.6 g/l for beverages  
6 g/kg for products other than 
beverages  25 
 200 g/kg for whitener  should not be used if breast milk or 
other foods with added lacto -N-
neotetraose are consumed the same 
day. Cereal bars  6 g/kg  
Table -top sweeteners  100 g/kg  
Infant formula as defined in 
Regulation (EU) No 609/2013  0.6 g/l in combination with 1.2 
g/l of 2′ -O-fucosyllactose at a 
ratio of 1:2 in the final product 
ready for use, marketed as such 
or reconstituted as instructed 
by the manufacturer  
Follow -on formula as defined 
in Regulation (EU) No 
609/2013  0.6 g/l in combination with 1.2 
g/l of 2′ -O-fucosyllactose at a 
ratio of 1:2 in the fina l product 
ready for use, marketed as such 
or reconstituted as instructed 
by the manufacturer  
Processed cereal -based food 
and baby food for infants and 
young children as defined in 
Regulation (EU) No 609/2013  6 g/kg for products other than 
beverages  
0.6 g/l for liquid food ready for 
use, marketed as such or 
reconstituted as instructed by 
the manufacturer  
Milk -based drinks and similar 
products intended for young 
children  0.6 g/l for milk -based drinks 
and similar products added 
alone or in combination with 
2′-O-fucosyllactose, at 
concentrations 1.2 g/l, at a ratio 
of 1:2 in the final product ready 26 
 for use, marketed as such or 
reconstituted as instructed by 
the manufacturer  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  In accordance with the 
particular nutritional 
requirements of the persons for 
whom the products are 
intended  
Total diet replacement for 
weight control as defined in 
Regulation (UE) No 609/2013  2.4 g/l for drinks  
20 g/kg for bars  
Bread and pasta products 
bearing statements on the 
absence or reduced presence 
of gluten in accordance with 
the requirements of 
Commission Implementing 
Regulation (EU) No 828/2014  30 g/kg  
Flavoured drinks  0.6 g/l  
Coffee, tea (excluding black 
tea), herbal and fruit  infusions, 
chicory; tea, herbal and fruit 
infusions and chicory extracts; 
tea, plant, fruit and cereal 
preparations for infusions, as 
well as mixes and instant 
mixes of these products  4.8 g/l - the maximum level 
refers to the products ready to 
use 27 
 Food supplements as defined 
in Directive 2002/46/EC, 
excluding food supplements 
for infants  1.5 g/day for general 
population  
0.6 g/day for young children  
Lucerne leaf extract 
from Medicago 
sativa   Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Lucerne ( Medicago sativa ) 
protein" or "Alfalfa ( Medicago sativa ) 
protein".    Food supplements as defined 
in Directive 2002/46/EC  10 g/day  
Lycopene  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Lycopene"   Fruit/vegetable juice -based 
drinks (including 
concentrates)  2.5 mg/100 g  
Drinks intended to meet the 
expenditure of intense 
muscular effort especially for 
sportsmen  2.5 mg/100 g  
Total diet replacement for 
weight control as defined in 
Regulation (EU) No 609/2013 
and meal replacements for 
weight control  8 mg/meal  
Breakfast cereals  5 mg/100 g  
Fats and dressings  10 mg/100g  
Soups other than tomato soups  1 mg/100g  
Bread (including crispy 
breads)  3 mg/100g  
Foods for special medical In accordance with the 28 
 purposes as defined in 
Regulation (EU) No 609/2013  particular nutritional 
requirements of the persons for  
whom the products are 
intended  
Food supplements as defined 
in Directive 2002/46/EC  15 mg/day  
Lycopene from 
Blakeslea trispora  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Lycopene"   Fruit/vegetable juice -based 
drinks (including 
concentrates)  2.5 mg/100 g  
Drinks intended to meet the 
expenditure of intense 
muscular effort especially for 
sportsmen  2.5 mg/100 g  
Total diet replacement for 
weight control as defined in 
Regulation (EU) No 609/2013 
and meal replacements for 
weight control  8 mg/meal  
Breakfast cereals  5 mg/100 g  
Fats and dressings  10 mg/100g  
Soups other than tomato soups  1 mg/100g  
Bread (including crispy 
breads)  3 mg/100g  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  In accordance with the 
particular nutritional 
requirements of the persons for 
whom the products are 29 
 intended  
Food supplements as defined 
in Directive 2002/46/EC  15 mg/day  
Lycopene from 
tomatoes  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Lycopene"    Fruit/vegetable juice -based 
drinks (including 
concentrates)  2.5 mg/100 g  
Drinks intended to meet the 
expenditure of intense 
muscular effort especially for 
sportsmen  2.5 mg/100 g  
Total diet replacement for 
weight control as defined in 
Regulation (EU) No 609/2013 
and meal replacements for 
weight control  8 mg/meal  
Breakfast cereals  5 mg/100 g  
Fats and dressings  10 mg/100g  
Soups other than tomato soups  1 mg/100g  
Bread (including crispy 
breads)  3 mg/100g  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  In accordance with the 
particular nutritional 
requirements of the persons for 
whom the products are 
intended  
Food supplements as defined 15 mg per/day  30 
 in Directive 2002/46/EC  
Lycopene oleoresin 
from tomatoes  Specified food category  Maximum levels of lycopene  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Lycopene oleoresin from 
tomatoes"   Fruit/vegetable juice -based 
drinks (including 
concentrates)  2.5 mg/100 g  
Drinks intended to meet the 
expenditure of intense 
muscular effort especially for 
sportsmen  2.5 mg/100 g  
Total diet replacement for 
weight control covered by 
Regulation (EU) No 609/2013 
and meal replacements for 
weight control  8 mg/meal  
Breakfast cereals  5 mg/100 g  
Fats and dressings  10 mg/100g  
Soups other than tomato soups  1 mg/100g  
Bread (including crispy 
breads)  3 mg/100g  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  In accordance with the 
particular nutritional 
requirements of the persons for  
whom the products are 
intended  
Magnesium citrate 
malate  Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Magnesium citrate malate"   Food Supplements as defined 
in Directive 2002/46/EC  375 mg per/day  31 
 Magnolia Bark 
Extract  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Magnolia Bark Extract"   Mints (confectionary 
products)  0.2% for breath freshening 
purposes. Based on a 0.2% 
maximum incorporation level 
and a maximum gum/mint size 
of 1.5g each, each gum or mint 
serving will contain no more 
than 3 mg of magnolia bark 
extract.  Chewing gum  
Maize -germ oil high 
in unsaponifiable 
matter  Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Maize -germ oil high in 
unsaponifiable matter"    Food Supplements as defined 
in Directive 2002/46/EC  2 g/day  
Chewing gum  2% 
Methylcellulose  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Methylcellulose"  Methylcellulose is 
not to be used in 
foods specially 
prepared for young 
children  Edible ices  
2% Flavoured drinks  
Flavoured or unflavoured 
fermented milk products  
Cold desserts (dairy, fat, fruit, 
cereal, egg -based products)  
Fruit preparations (pulps, 
purees or compotes)  
Soups and broths  
(6S)-5-
methyltetrahydrofol
ic acid, glucosamine Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "(6S) -5-methyltetrahydrofolic acid, 
glucosamine salt" or "5MTHF -  32 
 salt  glucosamine"  
Food Supplements as defined 
in Directive 2002/46/EC as a 
source of folate     
Monomethylsilanetr
iol (Organic Silicon)  Specified food category  Maximum levels of silicon  The designation of the novel food on the 
labelling of the food supplements 
containing it shall be "Organic silicon 
(monomethylsilanetriol)"    Food Supplements as defined 
in Directive 2002/46/EC (in 
liquid form)  10.40 mg/day for adult 
population  
Mycelial extract 
from Shiitake 
mushroom 
(Lentinula edodes ) Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "extract from the mushroom 
Lentinula edodes"  or "extract from Shiitake 
mush room"    Bread products  2 ml/100 g  
Soft drinks  0.5 ml/100 ml  
Ready prepared meals  2.5 ml per meal  
Foods based on yoghurt  1.5 ml/100  ml 
Food supplements as defined 
in Directive 2002/46/EC  2.5 ml per day dose  
Noni fruit juice 
(Morinda citrifolia ) Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Noni juice" or "Juice of  Morinda 
citrifolia "    Pasteurised fruit juice and fruit 
nectar drinks  30 ml with one  serving (up to 
100 % noni juice)   
or  
20 ml twice a day, not more 
than 40 ml per day  
Noni fruit juice 
powder ( Morinda 
citrifolia ) Food supplements as defined 
in Directive 2002/46/EC  6.6 g/day (equivalent to 30 ml 
of noni juice)  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Noni juice powder" or "Juice 
powder of  Morinda citrifolia "  
Noni fruit puree and 
concentrate Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it   
 Fruit puree  33 
 (Morinda citrifolia ) Candy/confectionery  45 g/100 g  shall be:  
For fruit puree:  
"Morinda citrifolia  fruit puree" or "Noni 
fruit puree"  
For fruit concentrate:  
"Morinda citrifolia  fruit concentrate" or 
"Noni fruit concentrate"  Cereal bars  53 g/100 g  
Powdered nutritional drink 
mixes (dry weight)  53 g/100 g  
Carbonated beverages  11 g/100 g  
Ice cream & sorbet  31 g/100 g  
Yoghurt  12 g/100 g  
Biscuits  53 g/100 g  
Buns, cakes and pastries  53 g/100 g  
Breakfast cereals (wholegrain)  88 g/100 g  
Jams and jellies in accordance 
with Directive 2001/113/EC  133 g/100 g  
Based on pre -processing 
quantity to produce final 100 g 
product  
Sweet spreads, fillings and 
icings  31 g/100 g  
Savoury sauces, pickles, 
gravies and condiments  88 g/100 g  
Food Supplements as defined 
in Directive 2002/46/EC  26 g/day  
 Fruit concentrate  
Candy/Confectionery  10 g/100 g  
Cereal bars  12 g/100 g  
Powdered nutritional  drink 
mixes (dry weight)  12 g/100 g  34 
 Carbonated beverages  3 g/100 g  
Ice cream & sorbet  7 g/100 g  
Yoghurt  3 g/100 g  
Biscuits  12 g/100 g  
Buns, cakes and pastries  12 g/100 g  
Breakfast cereals (wholegrain)  20 g/100g  
Jams and jellies  in accordance 
with Directive 2001/113/EC  30 g/100 g  
Sweet spreads, fillings and 
icings  7 g/100 g  
Savoury sauces, pickles, 
gravies and condiments  20 g/100 g  
Food Supplements as defined 
in Directive 2002/46/EC  6 g/day  
Noni leaves 
(Morinda citrifolia ) Specified food category  Maximum levels  1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "Noni leaves" or 
"leaves of Morinda citrifolia".  
2. Instructions shall be given to the 
consumer that a cup of infusion should 
not be prepared with more than 1 g of 
dried and roasted leaves of Morinda 
citrifolia.    For the preparation of 
infusions  A cup of infusion to be 
consumed shall not be prepared 
with more than 1 g of dried and 
roasted leaves of Morinda 
citrifolia  
Noni fruit powder 
(Morinda citrifolia ) Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Morinda citrifolia fruit powder" 
or "Noni fruit powder"   Food Supplements as defined 
in Directive 2002/46/EC  2.4 g per/day  35 
 Odontella aurita 
microalgae  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be " Odontella aurita  microalgae"   Flavoured pasta  1.5%  
Fish soups  1% 
Marine terrines  0.5%  
Broth preparations  1% 
Crackers  1.5%  
Frozen breaded fish  1.5%  
Oil enriched with 
phytosterols/phytost
anols  Specified food category  Maximum levels of 
phytosterols/phytostanols  
In accordance with Annex III.5 to 
Regulation (EU) No 1169/2011    Spreadable fats as defined in 
Council Regulation (EC) No 
2991/94 Annex, points B and 
C, excluding cooking and 
frying fats and spreads based 
on butter or other anim al fat  1. The products containing 
the novel food ingredient 
shall be presented in such a 
manner that they can be 
easily divided into portions 
that contain either a 
maximum of 3 g (in case of 
one portion per day) or a 
maximum of 1 g (in case of 
three portions per day) of 
added 
phytosterols/phytostanols.  
2. The amount of 
phytosterols/phytostanols 
added to a container of 
beverages shall not exceed 
3 g. 
3. Spicy sauces and salad 
dressings including Milk based products, such as 
products based on semi -
skimmed and skimmed milk 
products, possibly with the 
addition of fruits and/or 
cereals, products based on 
fermented milk such as 
yoghurt and cheese based 
products (fat content ≤ 12 g 
per 100 g), where pos sibly the 
milk fat has been reduced and 
the fat or protein has been 
partly or fully replaced by 36 
 vegetable fat or protein.  mayonnaise shall be 
packed as single portions.  
Soya drinks  
Spicy sauces and salad 
dressings including 
mayonnaise.  
Oil extracted from 
squid ( Cephalopod  
sp.) Specified food category  Maximum levels of DHA and 
EPA combined  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be “Squid oil”.   Dairy products except milk -
based beverages  200 mg/100 g or for cheese 
products 600mg/100g  
Dairy analogues except drinks  200 mg/100 g or for analogues 
to cheese products 600 mg/100 
g 
Spreadable fat and dressings  600 mg/100 g  
Breakfast cereals  500 mg/100 g  
Bakery products (breads and 
bread rolls)  200 mg/100 g  
Cereal bars  500 mg/100 g  
Non-alcoholic beverages 
(including milk -based 
beverages)  60 mg/100 ml  
Food Supplements as defined 
in Directive 2002/46/EC  3000 mg/day for general 
population  
450 mg/day for pregnant and 
lactating women  
Foods for special medical 
purposes as defined in In accordance with the 
particular nutritional 37 
 Regulation (EU) No 609/2013  requirements of the persons for 
whom the products intended  
Total diet replacement for 
weight control defined in 
Regulation (EU) No 609/2013 
and meal replacements for 
weight control  200 mg/meal  
Pasteurised fruit -
based preparations 
produced using 
high -pressure 
pasteurisation  Specified food category  Maximum levels  
The wording "pasteurised by high -pressure 
treatment" shall be displayed next to the 
fruit preparations in question as such and in 
any product in which it is used"    Types of fruit:  
apple, apricot, banana, 
blackberry, blueberry, cherry, 
coconut, fig, grape, grapefruit, 
mandarine, mango, melon, 
peach, pear, pineaple,  prune, 
raspberry, rhubarb, strawberry   
Phosphated maize 
starch  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Phosphated maize starch"    Baked bakery products  
15% Pasta  
Breakfast cereals  
Cereal bars  
Phosphatidylserine 
from fish 
phospholipids  Specified food category  Maximum levels of 
phosphatidylserine  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be accompanied by indication that the 
novel food is "derived from fish lecithin"    Beverages based on yoghurt  50 mg/100mL  
Powders based on milk 
powders  3500 mg/100g (equivalent to 
40mg/100mL ready to drink)  
Foods based on yoghurt  80 mg/100g  
Cereal bars  350 mg/100g  38 
 Chocolate based confectionary  200 mg/100g  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  In compliance with Regulation 
(EU) No 609/2013  
Food supplements as defined 
in Directive 2002/46/EC  300 mg/day  
Phosphatidylserine 
from soya 
phospholipids  Specified food category  Maximum levels of 
phosphatidylserine  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Soya phosphatidylserine"   Beverages based on yoghurt  50 mg/100 ml  
Powders based on milk 
powder  3.5 g/100 g (equivalent to 40 
mg/100 ml ready to drink)  
Foods based on yoghurt  80 mg/100 g  
Cereal bars  350 mg/100 g  
Chocolate based confectionary  200 mg/100 g  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  In compliance with Regulation 
(EU) No 609/2013  
Phospholipids 
product containing 
phosphatidylserine 
and phosphatidic 
acid Specified food category  Maximum levels of 
phosphatidylserine + 
phosphatidic acid  
The designation of the novel food on the 
labelling of the foodstuffs containing shall 
be "Soy phosphatidylserine and 
phosphatidic acid"  The product is not 
intended to be 
marketed to pregnant 
ore breast -feeding 
women  Breakfast cereals  80 mg + 80 mg/100 g  
Cereal bars  350 mg + 350 mg/100 g  
Foods based on yogurt  80 mg + 80 mg/100 g  
Soy-based yogurt -like 
products  80 mg + 80 mg/100 g  
Yogurt based -drinks  50 mg + 50 mg/100 g  39 
 Soy-based yogurt -like drinks  50 mg + 50 mg/100 g  
Powders based on milk 
powder  3.5 g + 3.5 g/100g (equivalent 
to 40 mg + 40 mg/100ml 
ready -to drink)  
Food Supplements as defined 
in Directive 2002/46/EC  800 mg/day  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  In compliance with Regulation 
(EU) No 609/2013  
Phospholipides from 
egg yolk  Specified food category  Maximum levels    
Not specified    
Phytosterols/phytost
anols  Specified food category  Maximum levels  
In accordance with Annex III.5 of 
Regulation (EU) No 1169/2011   Rice drinks  1. They shall be presented in 
such a manner that they can 
be easily divided into 
portions that contain either 
a maximum of 3 g (in case 
of 1 portion/day) or a 
maximum of 1 g (in  case of 
3 portions/day) of added 
phytosterols/phytostanols.  
 The amount of 
phytosterols/phytostanols 
added to a container of 
beverages shall not exceed 
3 g. 
 Salad dressings and spicy 
sauces shall be packed as Rye bread with flour 
containing ≥ 50 % rye 
(wholemeal rye flour, whole 
or cracked rye kernels and rye 
flakes) and ≤ 30 % wheat; and 
with ≤ 4 % added sugar but no 
fat added.  
Spicy sauces  
Soya drink  
Milk type products, such as 
semi -skimmed and skimmed 
milk type products, possibly 
with the addition of fruits 
and/or cereals, where possibly 
the milk fat has been reduced, 40 
 or where milk fat and/or 
protein has been partly or fully 
replaced by vegetable fat 
and/or protein.  single portions  
Products based on fermented 
milk, such as yoghurt and 
cheese type products (fat 
content ≤ 12 g per 100 g), 
where possibly  the milk fat 
has been reduced, or where 
milk fat and/or protein has 
been partly or fully replaced 
by vegetable fat and/or 
protein .  
Yellow fat spreads as defined 
by Council Regulation (EC) 
No 2991/94(1), excluding 
cooking and frying fats and 
spreads based on butter or 
other animal fat.  
Plum kernel oil  Specified food category  Maximum levels    
For frying and as seasoning  In line with normal food use of 
vegetable oils    
Potato proteins 
(coagulated) and 
hydrolysates  Not specified  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Potato protein"   
Prolyl 
oligopeptidase 
(Enzyme Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "P rolyl oligopeptidase "  Food Supplements as defined 
in Directive 2002/46/EC  120 PPU/day (2.7 g of enzyme 
preparation/day) (2x106 41 
 preparation)  PPI/day) for general adult 
population  
PPU – Prolyl Peptidase Units 
or Proline Protease Units  
PPI – Protease Picomole 
International  
Protein extract from 
pig kidneys  Specified food category  Maximum levels  
  Food Supplements as defined 
in Directive 2002/46/EC  
3 capsules/day; equalizing 12.6 
mg pig kidney extract a day  Food for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  
Rapeseed oil high in 
unsaponifiable 
matter  Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Rapeseed oil extract"    Food Supplements as defined 
in Directive 2002/46/EC  1.5 g per portion recommended 
for daily consumption  
Rapeseed Protein  As a vegetable protein source 
in foods except in infant 
formula and follow -on 
formula   1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "Rapeseed 
protein".  
2. Any foodstuff containing "rapeseed 
protein" shall bear a statement that 
this ingredient may cause allergic 
reaction to consumers who are allergic 
to mustard and products thereof. 
Where relevant, this statement shall 
appear in close proximity to the list of 
ingredients.    
Trans -resveratrol  Specified food category  Maximum levels  1. The designation of the novel food on  42 
 Food Supplements as defined 
in Directive 2002/46/EC 
(capsule or tablet form)  150 mg/day for adult 
population  the labelling of the food supplements 
containing it shall be " Trans -
resveratol".  
2. The labelling of food supplements 
containing trans -resveratrol shall 
bear a statement that people using 
medicines should only consume the 
product under medical supervision.  
Trans -resveratrol 
(microbial source)  Specified food category  Maximum levels  1. The designation of the novel food on 
the labelling of the food supplements 
containing it shall be " Trans -
resveratol".  
2. The labelling of food supplements 
containing trans -resveratrol shall bear 
a statement that people using 
medicines should only consume the 
product under medical supervision.   Food supplements as defined 
in Directive 2002/46/EC  At comparable inclusion levels 
to resveratrol extracted from 
Japanese knotweed ( Fallopia 
japonica)  
Rooster comb 
extract  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Rooster comb extract" or 
"Cockerel comb extract"    Milk -based drinks  40 mg/100g or mg/100mL  
Milk based fermented drinks  80 mg/100g or mg/100mL  
Yoghurt -type products  65 mg/100g or mg/100mL  
Fromage frais  110 mg/100g or mg/100mL  
Sacha Inchi oil from 
Plukenetia volubilis  Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Sacha inchi oil (Plukenetia 
volubilis)    
As for linseed oil  In line with normal food use of 
linseed oil  
Salatrims  Specified food category  Maximum levels  1. The designation of the novel food on   43 
 Bakery products and 
confectionary   the labelling of the foodstuffs 
containing it shall be "reduced energy 
fat (salatrims)".  
2. There shall be a statement that 
excessive consumption may lead to 
gastro -intestinal disturbance.  
3. There shall be a statement that the 
products are not intended for use by 
children.  
Schizochytrium sp. 
oil rich in DHA and 
EPA  Specified food category  Maximum levels of DHA and 
EPA combined:  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "DHA and EPA -rich oil from the 
microalgae Schizochytrium  sp." All food products 
containing DHA -
rich oil from 
Schizochytrium  sp. 
should demonstrate 
oxidative stabili ty by 
appropriate and 
recognised 
national/internationa
l test methodology 
(e.g. AOAC)  Food Supplements as defined 
in Directive 2002/46/EC  3000 mg/day for adult 
population excluding pregnant 
and lactating women  
450 mg/day for pregnant and 
lactating women  
Foods for special medical 
purposes as defined in 
Regulation (EU) No 609/2013  In accordance with the 
particular nutritional 
requirements of the persons for 
whom the products are 
intended  
Total diet replacement for 
weight control as defined in 
Regulation (EU) No 609/2013 
and meal replacements for 
weight control  250 mg/meal  
Processed cereal based food 
and baby food for infants and 
young children as defined in 200 mg/100 g  44 
 Regulation (EU) No 609/2013  
Foods intended to meet the 
expenditure  of intense 
muscular effort, especially for 
sportsmen  
Foods bearing statements on 
the absence or reduced 
presence of gluten in 
accordance with the 
requirements of Commission 
Implementing Regulation 
(EU) No 828/2014  
Bakery Products, Breads and 
Rolls, Sweet Biscuits  200 mg/100 g  
Breakfast Cereals  500 mg/100 g  
Cooking Fats  360 mg/100 g  
Dairy Analogues except drinks  600 mg/100 g for cheese; 200 
mg/100 g for soy and imitation 
milk products (excluding 
drinks)  
Dairy Products (except milk-
based drinks)  600 mg/100 g for cheese; 200 
mg/100 g for milk products 
(including milk, fromage frais 
and yoghurt products; 
excluding drinks)  
Non-alcoholic Beverages 
(including dairy analogue and 80 mg/100 g  45 
 milk-based drinks)  
Cereal/Nutrition Bars 500 mg/100 g  
Spreadable Fats and Dressings  600 mg/100 g  
Schizochytrium  sp. 
(ATCC PTA -9695) 
oil  Specified food category  Maximum levels of DHA  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Oil from the micro -algae 
Schizochytrium  sp. (ATCC PTA -9695)"   Dairy products except milk -
based drinks  200 mg/100 g or for cheese 
products 600 mg/100 g  
Dairy analogues except drinks  200 mg/100 g or for analogues 
to cheese products 600 mg/100 
g 
Spreadable fat and dressings  600 mg/100 g  
Breakfast cereals  500 mg/100 g  
Food Supplements as defined 
in Directive 2002/46/EC  250 mg DHA/day for general 
population  
450 mg DHA/day for pregnant 
and lactating women  
Total diet replacement for 
weight control as defined in 
Regulation (EU) No 609/2013 
and meal replacements for 
weight control  250 mg/meal  
Milk -based drinks and similar 
products intended  for young 
children  200 mg/100 g  
In accordance with the 
particular nutritional 
requirements of the persons for 
whom the products are 
intended  Foods intended to meet the 
expenditure of intense 
muscular effort, especially for 
sportsmen  46 
 Foods bearing  statements on 
the absence or reduced 
presence of gluten in 
accordance with the 
requirements of Commission 
Implementing Regulation 
(EU) No 828/2014  
Bakery products (breads and 
rolls), sweet biscuits  200 mg/100 g  
500 mg/100 g  
Cooking fats  360 mg/100 g  
80 mg/100 ml  
Infant formula and follow -on 
formula as defined in 
Regulation (EU) No 609/2013  In accordance with Regulation 
(EU) No 609/2013  
Processed cereal -based foods 
and baby foods for infants and 
young children as defined in 
Regulation (EU) No 609/2013  200 mg/100 g  
Schizochytrium sp. 
oil  Specified food category  Maximum levels of DHA  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Oil from the microalgae 
Schizochytrium sp."   Dairy products except milk -
based drinks  200 mg/100 g or for cheese 
products 600 mg/100 g  
Dairy analogues except drinks  200 mg/100 g or for analogues 
to cheese products 600 mg/100 
g 
Spreadable fat and dressings  600 mg/100 g  
Breakfast cereals  500 mg/100 g  
Foods for special medical In accordance with the 47 
 purposes as defined in 
Regulation (EU) No 609/2013  particular nutritional 
requirements of the persons for 
whom the products are 
intended  
Bakery products (breads and 
bread rolls), sweet biscuits  200 mg/100 g  
Cereal bars  500 mg/100 g  
Food Supplements as defined 
in Directive 2002/46/EC  250 mg DHA/day for general 
population  
450 mg DHA/day for pregnant 
and lactating women  
Total diet replacement for 
weight control as defined in 
Regulation (EU) No 609/2013 
and meal replacements for 
weight control  250 mg/meal  
Processed cereal -based foods 
and baby foods for infants and 
young children as defined in 
Regulation (EU) No 609/2013  
200 mg/100 g  Foods intended to meet the 
expenditure of intense 
muscular effort, especially for 
sportsmen  
Foods bearing statements on 
the absence or reduced 
presence of gluten in 
accordance with the 
requirements of Commission 48 
 Implementing Regulation 
(EU) No 828/2014 - 
Cooking fats  360 mg/100 g  
Non-alcoholic beverages 
(including dairy analogue and 
milk-based drinks)  80 mg/100 ml  
Fermented soybean 
extract  Specified food category  Maximum levels  1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "Fermented 
soybean extract".  
2. The labelling of food supplements 
containing fermented soybean extract 
shall bear a statement that persons 
taking medication should only 
consume the product under medical 
supervision.    Food Supplements as defined  
in Directive 2002/46/EC 
(capsules, tablets or powder 
form) intended for the adult 
population, excluding 
pregnant and lactating women  100 mg/day  
Sucromalt  Specified food category  Maximum levels  1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "Sucromalt".  
2. The designation of the novel food on 
the labelling shall be accompanied by 
indication that the product is a source 
of glucose and fructose.   Not specified  
Sugar cane fibre  Specified food category  Maximum levels  
  Bread  8 % 
Bakery goods  5 % 
Meat and muscle products  3 % 
Seasonings and spices  3 % 49 
 Grated cheeses  2 % 
Special diet foods  5 % 
Sauces  2 % 
Beverages  5 % 
Sunflower oil 
extract  Specified food category  Maximum levels    
Food Supplements as defined 
in Directive 2002/46/EC  1.1 g/day  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Sunflower oil extract"   
Dried Tetraselmis 
chuii  microalgae  Specified food category  Maximum levels  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Dried microalgae  Tetraselmis 
chuii " or "Dried microalgae T. chuii "   Sauces  20% or 250mg /day 
Special salts  1%  
Condiment  250 mg/day  
Therapon barcoo / 
Scortum  Intended use identical to that of the salmon, namely the 
preparation of culinary fish products and dishes, including 
cooked, raw, smoked and baked fish products    
D-Tagatose  Specified food category  Maximum levels  1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "D -Tagatose".  
2. The labelling of any product where the 
level of D -Tagatose exceeds 15 g per 
serving and all beverages containing 
greater than 1% D -Tagatose (as 
consume d) shall bear a statement 
"excessive consumption may produce 
laxative effects".    
Not specified  
Taxifolin -rich Specified food category  Maximum levels  The designation of the novel food on the   50 
 extract  Food Supplements as defined 
in Directive 2002/46/EC 
intended for the general 
population, excluding infants, 
young children, children and 
adolescents younger than 14 
years  100 mg/day  labelling of the foodstuffs containing it 
shall be "taxifolin -rich extract".  
Trehalose  Specified food category  Maximum levels  1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "Trehalose" and 
shall be displayed on the labelling of 
the product as such or in the list of 
ingredients of foodstuffs containing it.  
2. The desig nation of the novel food on 
the labelling shall be accompanied by 
indication that the "Trehalose is a 
source of glucose".   
Not specified  
UV-treated 
mushrooms with 
increased levels of 
Vitamin D 2 1. The EU market approval applies to commercially grown 
Agaricus bisporus  
2. UV light treatment is applied to harvested mushrooms 
yielding a Vitamin D content of ≤10 µg/100g fresh weight  1. The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "UV -treated mushrooms ( Agaricu s 
bisporus ) with increased levels of Vitamin 
D2".  
2. The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be accompanied by indication that a 
"controlled light treatment was used to 
increase vitamin D levels" or "UV 
treatment was used to increase vitamin D 2 
levels".   
UV-treated baker's Specified food category  Maximum levels of vitamin The designation of the novel food on the  51 
 yeast 
(Saccharomyces 
cerevisiae ) D2 labelling of the foodstuffs containing it 
shall be "Vitamin D  yeast" or "Vitamin D 2 
yeast"  Yeast -leavened breads and 
rolls 5 μg of vitamin D 2/100 g  
Yeast -leavened fine bakery 
wares  5 μg of vitamin D 2/100 g  
Food Supplements as defined 
in Directive 2002/46/EC  5 μg of vitamin D 2/day 
UV-treated bread  Specified food category  Maximum levels of vitamin 
D2 The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be accompanied by "contains vitamin 
D produced by UV -treatment"   
Yeast leavened bread and rolls 
(without toppings)  3 μg vitamin D 2/100 g  
UV-treated milk  Specified food category  Maximum levels of vitamin 
D2 1. The designation of the novel food on 
the labelling of the foodstuffs 
containing it shall be "UV -treated".  
2. Where UV -treated milk contains an 
amount of vitamin D that is 
considered significant in accordance 
with Point 2 of Part A of Annex XIII 
to Regulation (EU) No 1169/2011 of 
the European Parliament and of the 
Council, the designation for the 
labelling shall be accompanied by 
"contains vitamin D produced by UV -
treatment" or "milk containing vitamin 
D resulting from UV -treatment".   Pasteurised whole milk  as 
defined in Regulation (EU) No 
1308/2013  to be consumed as 
such 5-32 μg/kg for general 
population excluding infants  
Pasteurised semi -skimmed 
milk as defined in Regulation 
(EU) No 1308/2013  to be 
consumed as such  1-15 μg/kg for general 
population excluding infants  
Vitamin K 2 
(menaquinone)  To be used in compliance with Directive 2002/46/EC, 
Regulation (EU) No 609/2013 and/or Regulation (EC) No 
1925/2006  The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Menaquinone" or "Vitamin K" or 
"vitamin K 2"  52 
 Wheat bran extract  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Wheat bran extract"  The "Wheat Bran 
Extract" may not be 
introduced onto the 
market as a food 
supplement or food 
supplement 
ingredient. Nor may 
it be added t o infant 
formula.  Beer and substitutes  0.4 g/100g  
Ready to eat cereals  9 g/100g  
Dairy products  2.4 g/100g  
Fruit and vegetable juices  0.6 g/100g  
Soft drinks  0.6 g/100g  
Meat preparations  2 g/100g  
Yeast beta -glucans  Specified food category  Maximum levels of pure 
beta-glucans from yeast 
(Saccharomyces cervisiae ) 
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Yeast ( Saccharomyces cerevisiae ) 
beta-glucans"   Food supplements as defined 
in Directive 2002/46/EC, 
excluding food supplements 
for infants and young children  1.275 g/day for children older 
than 12 years and general adult 
population  
0.675 g/day for children 
younger than 12 years  
Total diet replacement for 
weight control as defined in 
Regulation (EU) No 609/2013  1.275 g/day  
Food for special medical 
purposes as defined in 
Regulation (EU) No 609/2013, 
excluding food for special 
medical purposes intended for 
infants and young children  1.275 g/day  
Beverages based on fruit 
and/or vegetable juices 
including concentrate  and 1.3 g/kg  53 
 dehydrated juices  
Fruit -flavoured drinks  0.8 g/kg  
Cocoa beverages preparation 
powder   38.3 g/kg (powder)  
Other beverages  0.8 g/kg (ready to drink)  
0.7 g/kg (powder)  
Cereal bars  6 g/kg  
Breakfast cereals  15.3 g/kg  
Wholegrain and high fibre 
instant hot breakfast cereals  1.5 g/kg  
Cookie -type biscuits  6.7 g/kg  
Cracker -type biscuits  6.7 g/kg  
Milk based beverages  3.8 g/kg  
Fermented milk products  3.8 g/kg  
Milk product analogues  3.8 g/kg  
Dried milk/milk powder  25.5 g/kg  
Soups and soup mixes  0.9 g/kg (ready to eat)  
1.8 g/kg (condensed)  
6.3 g/kg (powder)  
Chocolate and confectionery  4 g/kg  
Protein bars and powders  19.1 g/kg  
Jam, marmalade and other 
fruit spreads  11.3 g/kg  54 
 Zeaxanthin 
(synthetic)  Specified food category  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 Directive 2002/46/EC  2 mg/day  
Zinc L -pidolate  Specified food category  Maximum levels  
The designation of the novel food on the 
labelling of the foodstuffs containing it 
shall be "Zinc L -pidolate"   Foods covered by Regulation 
(EU) No 609/2013  
3g/day  Milk based drinks and similar 
products intended for young 
children  
Meal replacement for weight 
control  
Foods intended to meet the 
expenditure of intense 
muscular effort, especially for 
sportsmen  
Food bearing statement on the 
absence or reduced presence 
of gluten in accordance with 
the requirements of 
Commission Implementing 
Regulation (EU No 828/2014  
Food Supplements as defined 
in Directive 2002/46/EC  55 
 Table 2: Specifications  
Authorised Novel  Food  Specification  
Baobab ( Adansonia digitata ) 
dried fruit pulp  Description/Definition:   
The Baobab ( Adansonia digitata ) fruits are harvested from trees. The hard shells are cracked open and the pulp is separated from the 
seeds and the shell. This is milled, separated into coarse and fine lots (particle size 3 to 600 μ) and then packaged.  
Typical nutritional 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 carbohydrate (g/100 g): 76.3 -89.5 
Total sugars (as glucose): 15.2 -36.5 
Sodium (mg/100 g): 0.1 -25.2 
Analytical specifications:  
Foreign matter: Not more than 0.2%  
Moisture (loss on drying) (g/100 g): 4.5 -13.7 
Ash (g/100 g): 3.8 -6.6  
Ajuga reptans extract  Description/Definition :  
Extracts from Ajuga reptans  L. tissue cultures are substantial equivalent to extracts from flowering aerial parts of Ajuga reptans  obtained 
by traditional cultures.  
L-Alanyl -L-Glutamine  Description/Definition:  
L-Alanyl -L-Glutamine is produced by bacterial fermentation which is purified from the growth media to a purity of greater than 98%.  
The ingredient is secreted by a modified strain of  Escherichia coli and isolated from the fermentation broth by conventional techniques 
without disruption.  
Appearance: White crystalline powder  
Purity: > 98%  
Infrared spectroscopy: Conformity with ref. standard  
State of solution: Colourless and clear  
Assay (dry basis): 98.0 -102.0%b  56 
 Related substances: ≤ 0.2%  
Residue on ignition: ≤ 0.10%  
Loss on drying: ≤ 0.5%  
Optical rotation: +9.0 - +11.0°  
pH (1%; H20): 5.0 - 6.0 
Ammonium (NH 4): ≤ 0.020%  
Chloride (Cl): ≤ 0.020%  
Sulphate (SO 4): ≤ 0.020% Escherich ia coli  : Negative/g  
Algal oil from the microalgae 
Ulkenia  sp. Description/Definition :  
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 %  
Unsaponifiables: ≤ 4.5 %  
Trans -fatty acids: ≤ 1 %  
DHA content: ≥ 32.0 %  
Allanblackia seed oil  Description/Definition:   
Allanblackia  seed oil is obtained from the seeds of the allanblackia species:  A. floribunda  (synonymous with A. parviflora ) and A. 
stuhlmannii.   
Composition of fatty acids:  
Lauric acid (C12:0): < 1%  
Myristic acid (C14:0): < 1%  
Palmitic acid (C16:0): < 2%  
Palmitoleic acid (C16:1): < 1%  
Stearic acid (C18:0): 45 -58% 
Oleic acid (C18:1): 40 -51% 
Linoleic acid (C18:2): < 1%  
γ-Linolenic acid (C18:3): < 1%  
Arachidic acid (C20:0): < 1%  
Free fatty acids: max 0.1%  57 
 Characteristics:  
Trans fatty acids: max 0.5%  
Peroxide value: max 0.8 meq/kg  
Iodine value: < 46 g/100 g  
Unsaponifiable matter: max 1.0%  
Saponification value: 185 -198 mg KOH/g  
Aloe macroclada  Baker leaf 
extract  Ash:  25% 
Dietary fibres: 28.6%  
Fat: 2.7%  
Moisture: 4.7%  
Polysaccharides: 9.5%  
Protein: 1.63%  
Glucose: 8.9%  
Antartic Krill  (Euphasia 
superba ) oil Description/Definition:   
To produce lipid extract from Antarctic Krill ( Euphausia superba ) deep -frozen crushed krill or dried krill meal is subjected to lipid 
extraction with an approved extraction solvent (under Directive 2009/32/EC). Proteins and krill material are removed from the  lipid 
extract by filtration. The extraction solvents and res idual water are removed by evaporation.  
Saponification value: ≤ 230 mg KOH/g  
Peroxide value (PV): ≤ 3 meq O  2 /kg oil  
Moisture and volatiles: ≤ 3%  
Phospholipids: ≤ 50%  
Trans -fatty acids: ≤ 1%  
EPA (eicosapentaenoic acid): ≥ 9%  
DHA (docosahexaenoic acid): ≥  5% 
Antartic Krill  (Euphasia 
superba ) oil rich in 
phospholipids  
 Description/Definition :  
Oil rich in phospholipids is produced from Antarctic krill ( Euphasia superba ) by repeated solvent washings with an approved solvents 
(under Directive 2009/32/EC) to increase phospholipid content of the oil. Solvents are removed from the final product by evaporation.  
Saponification value: ≤ 230 mg KOH/g  
Peroxide value (PV): ≤ 3 meq O 2 /kg oil  
Moisture and volatiles: ≤ 3%  58 
 Phospholipids: ≥ 60%  
Trans -fatty acids: ≤ 1%  
EPA  (eicosapentaenoic acid): ≥ 9%  
DHA (docosahexaenoic acid): ≥ 5%  
Arachidonic acid -rich oil from 
the fungus Mortierella alpina  Description/Definition:   
The clear yellow arachidonic acid -rich oil is obtained by fermentation of the fungus Mortierella alpina  using a suitable liquid. The oil is 
then extracted from the biomass and purified.  
Arachidonic acid: > 40% by weight of the total fatty acid content  
Free fatty acids: ≤ 0.45% of the total fatty acid content  
Trans fatty acids: ≤ 0.5 % of the total fatty aci d content  
Unsaponifiable matter: ≤ 1.5%  
Peroxide value: ≤ 5 meq/kg  
Anisidin value: ≤ 20  
Acid value: ≤ 1.0 KOH/g  
Argan oil  (Argania spinose ) Description/Definition :  
Argan oil is the oil obtained by cold pressing of the almond like kernels of the fruits of Argania spinosa  (L.) Skeels. Kernels may be 
roasted prior to pressing, but with no direct contact with a flame.  
Composition:  
Palmitic acid (C16:0) : 12 -15% 
Stearic a cid (C18:0): 5 -7% 
Oleic acid (C18:1): 43 -50% 
Linoleic acid (C18:2): 29 -36% 
Unsaponifiable matter: 0.3 -2% 
Total sterols: 130 -230 mg/100 g  
Total tocopherols: 16 -90 mg/100g  
Oleic acidity: 0.2 -1.5%  
Peroxide value: <10 meq O 2/kg 
Astaxanthin ( from 
Haematococcus pluvialis  algae)  Description/Definition :  
Astaxanthin is a carotenoid produced by Haematococcus pluvialis  algae. Production methods for the growth of the algae are variable; 
using closed systems exposed to sunlight or strictly controlled ill uminated light alternatively open ponds may be used. The algal cells are 59 
 harvested and dried; the oleoresin is extracted using either super critical CO2 or a solvent, ethyl acetate. The Astaxanthin is diluted and 
standardized to 2.5%, 5%, 7%, 10%, 15% or 2 0% using olive oil, safflower oil, Sunflower oil or MCT (Medium Chain Triglycerides).  
Composition of the Oleoresin:  
Fat 42.2 - 99% 
Protein 0.3 -4.4%  
Carbohydrate 0 -52.8%  
Fibre <1%  
Ash 0 -4.2%  
Specification of Carotenoids w/w%  
Total Astaxanthins: 2.9 -11.1%  
9-Z astaxanthin: 0.3 -9.0 
13-Z astaxathin: 0.2 -5.7 
Astaxanthin monoesters: 79.8 -91.5%  
Astaxanthin diesters: 0.16 -4.0%  
Β-Carotene: 0.01 -0.3%  
Lutein: 0 -1.8%  
Canthaxanthin: 0 -1.30%  
Microbiological criteria:  
Total aerobic bacteria: <3000 CFU/g  
Yeast and Moulds: <1 00 CFU/g  
Coliforms: <10 CFU/g  
E. coli : Negative  
Salmonella : Negative  
Staphylococcus : Negative  
Basil seed ( Ocimum basilicum )  Description/Definition :  
Basil ( Ocimum basilicum L.) belongs to the family " Lamiaceae " within the order "Lamiales". Post -harvest the seeds are cleaned 
mechanically. Flowers, leaves and other parts of the plant are removed. Highest level of purity of Basil seeds has to be ensu red by 
filtering (optical, mechanical). Production process of fruit juices and fruit juice blends containing Basil seeds ( Ocimum basilicum L.) 
includes seed pre -hydration and pasteurisation steps. Microbiological controls and monitoring systems are in place. During production, 
pasteurization steps and microbiological analyses of samples of basil seeds, the fruit juice and the final product shall ensure highest level 60 
 of confidence in the safety of the production process and the final product.  
Dry Matter: 94.1%  
Protein: 20.7%  
Fat: 24.4%  
Carbohydrate: 1.7%  
Crude Fibre*: 40.5% Dietary Fibre**  
(*) Crude fibre is the pa rt of dietary fibre mainly consisting of indigestible cellulose, pentosans and lignin  
(**) Method: AOAC 958.29  
Ash: 6.78%  
Fermented black bean extract  Description/Definition:  
Fermented black bean extract (Touchi extract) is a fine light -brown protein -rich powder obtained by water extraction of small soybeans 
(Glycine max (L.) Merr. ) fermented with Aspergillus oryzae . The extract contains an α -glucosidase inhibitor.  
Characteristics:  
Fat: ≤ 1 %  
Protein: ≥ 55 %  
Water: ≤ 7 %  
Ash: ≤ 10 %  
Carbohydrate: ≥ 20%  
a-glucosidase inhibitory activity: IC50 min 0.025 mg/ml  
Soy isoflavone: ≤ 0.3 g/100 g  
Bovine lactoferrin  Description /Definition :  
Bovine lactoferrin is a protein that occurs naturally in cows’ milk. It is an iron -binding glycoprotein of approximately 77 k Da and 
consists of a single polypeptide chain of 689 amino acids.  
Production process: Bovine lactoferrin is isolated from skimmed milk or cheese whey via ion exchange and subsequent ultra -filtration 
steps. Finally it is dried by freeze drying or spraying and the large particles are sieved out. It is a virtually odourless, light pinkish 
powder.  
Physical -Chemical properties of Bovine lactoferrin : 
Moisture: < 4.5%  
Ash: < 1.5%  
Arsenic: < 2 mg/kg  61 
 Iron: < 350 mg/kg  
Protein: > 93%  
of which bovine lactoferrin: > 9 0% 
of which other proteins: < 5%  
pH (2% solution, 20 °C): 5.2 -7.2 
Solubility (2% solution, 20 °C): complete  
Buglossoides arvensis seed oil  Description/Definition:   
Refined Buglossoides oil is extracted from the seeds of Buglossoides arvensis  (L.) I.M.Johnst  
Alpha -linolenic acid: ≥ 35% w/w of total fatty acids  
Stearidonic acid: ≥ 15% w/w of total fatty acids  
Linoleic acid: ≥ 8% w/w of total fatty acids  
Trans fatty acids: ≤ 2% w/w of total fatty acids  
Acid value: ≤ 0.6 mg KOH/g  
Peroxide value:  ≤ 5 meq /kg  
Unsaponifiable content: ≤ 2%  
Protein content (total nitrogen): ≤ 10 μg/ml  
Pyrrolizidine alkaloids: Not detectable with a detection limit of 4 μg/kg  
Chewing gum base 
(monomethoxypolyethylene 
glycol)  Description/Definition:   
The novel food ingredient is a synthetic polymer (Patent number WO2006016179). It consists of branched polymers of 
monomethoxypolyethylene glycol (MPEG) grafted onto polyisoprene -graft -maleic anhydride (PIP -g-MA), and unreacted MPEG (less 
than 35 % by weight).  
White to o ff-white colour.  
CAS No.: 1246080 -53-4  
Characteristics:  
Moisture: < 5%  
Aluminium: < 3 mg/kg  
Lithium: < 0.5 mg/kg  
Nickel: < 0.5 mg/kg  
Residual anhydride: < 15 μmol/g  
Polydispersity index: < 1.4  62 
 Isoprene: < 0.05 mg/kg  
Ethylene oxide: < 0.2 mg/kg  
Free maleic  anhydride: < 0.1%  
Total oligomeres (less than 1 000 Dalton): ≤ 50 mg/kg  
Ethylene glycol: < 200 mg/kg  
Diethylene glycol: < 30 mg/kg  
Monoethylene glycol methyl ether: < 3 mg/kg  
Diethylene glycol methyl ether: < 4 mg/kg  
Triethylene glycol methyl ether: < 7 m g/kg 
1,4-Dioxane: < 2 mg/kg  
Formaldehyde: < 10 mg/kg  
Chewing gum base (Methyl 
vinyl ether -maleic anhydride 
copolymer)  Description/Definition:  
Methyl vinyl ether -maleic anhydride copolymer is an anhydrous copolymer of methyl vinyl ether and maleic anhydri de.  
Free-flowing, white to white -off powder  
CAS No: 9011 -16-9 
Purity:  
Assay value: At least 99.5% in dry matter  
Specific viscosity (1 % MEK): 2 -10 
Residual methyl vinyl ether: ≤ 150 ppm  
Residual maleic anhydride: ≤ 250 ppm  
Acetaldehyde: ≤ 500 ppm  
Methanol : ≤ 500 ppm  
Dilauroyl peroxide: ≤ 15 ppm  
Total heavy metals: ≤ 10 ppm  
Microbiological criteria:  
Total aerobic plate count: ≤ 500 CFU/g  
Mould/yeast: ≤ 500 CFU/g  
Escherichia coli : Negative to test  
Salmonella spp.: Negative to test  
Staphylococcus aureus:  Negative to test  
Pseudomonas aeruginosa : Negative to test  63 
 Chia oil ( Salvia hispanica ) Description/Definition :  
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 decantation tanks and a filtration process employed to remove impurities. It can also be produced by extractio n with 
supercritical CO 2.  
Production proces s: 
Produced by cold pressing. No solvents are used and, once pressed, the oil is held in decantation tanks and a filtration proc ess employed 
to remove impurities.  
Acidity expressed as oleic acid: ≤ 2%  
Peroxide value: ≤ 10 meq/kg  
Insoluble impurities: ≤ 0. 05% 
Alpha linolenic acid: ≥ 60 %  
Linoleic acid: 15 -20% 
Chia seeds ( Salvia hispanica ) Description/Definition:  
Chia ( Salvia hispanica L.) is a summer annual herbaceous plant belonging to the Labiatae family. Post -harvest the seeds are cleaned 
mechanically. Flowers, leaves and other parts of the plant are removed.  
Dry matter: 90 -97% 
Protein: 15 -26% 
Fat: 18 -39% 
Carbohydrate (*): 18 -43% 
Crude Fibre (**): 18 -43%  
Ash: 3 -7% 
(*) Carbohydrates include the fi bre value (EU: CH are available carbohydrates = sugar + starch)  
(**) Crude fibre is the part of fibre made mainly of indigestible cellulose, pentosans and lignin  
Production process:   
Production process of fruit juices and fruit juice blends containing Chia seeds includes seed pre -hydration and pasteurisation steps. 
Microbiological controls and monitoring systems are in place.  
Chitin -glucan from  Aspergillus 
niger   Description/Definiti on:  
Chitin -glucan is obtained from the mycelium of Aspergillus niger;  it is a slightly yellow, odourless, free -flowing powder. It has a dry 
matter content of 90% or more.  64 
 Chitin -glucan is composed largely of two polysaccharides:  
-chitin, composed of repea ting units of N -acetyl -D-glucosamine (CAS No: 1398 -61-4), 
-beta (1, 3) -glucan, composed of repeating units of D -glucose (CAS No: 9041 -22-9). 
Loss on drying: ≤ 10%  
Chitin -glucan: ≥ 90%  
Ratio of chitin to glucan: 30:70 to 60:40  
Ash: ≤ 3%  
Lipids: ≤ 1%  
Protein s: ≤6 %  
Chitin -glucan complex from 
Fomes fomentarius  Description/Definition :  
Chitin -glucan complex is obtained from the cell walls of the fruit bodies of the fungus Fomes fomentarius . It consists primarily of two 
polysaccharides:  
 Chitin, composed of repeating units of N -acetyl -D-glucosamine (CAS No: 1398 -61-4); 
 Beta-(1,3)(1,6) -D-glucan, composed of repeating units of D -glucose (CAS No: 9041 -22-9).  
The production process consists of several steps, including: cleaning, reduction in size and grinding, s oftening in water and heating in an 
alkaline solution, washing, drying. No hydrolysis is applied during the production process.  
Appearance: Powder, odourless, flavourless, brown  
Moisture: ≤ 15%  
Ash: ≤ 3%  
Chitin -glucan: ≥ 90%  
Ratio of chitin to glucan: 7 0:20 
Total carbohydrates, excluding glucans: ≤ 0.1%  
proteins: ≤ 6%  
lipids: ≤ 1%  
Melanins: ≤ 8.3%  
Additives: None  
pH: 6.7 -7.5  
Lead (ppm): ≤ 1.00  
Cadmium (ppm): ≤ 1.00  
Mercury (ppm): ≤ 0.03  
Arsenic (ppm): ≤ 0.20  65 
 Total mesophilic bacteria: ≤ 1 000/g  
Yeast and moulds: ≤ 1 000/g  
Coliforms at 30 °C: ≤ 1 000/g  
E. coli : ≤ 10/g  
Salmonella  and other pathogenic bacteria: Absent/25 g  
Chitosan extract from fungi 
(Agaricus bisporus ; Aspergillus 
niger ) Description/Definition:  
The chitosan extract (containing mainly poly(D -glucosamine)) is obtained from stems of Agaricus bisporus  or from the mycelium of 
Aspergillus niger .  
The patented 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.  
Synonym: Poly(D -glucosamine)  
Chitosan CAS number: 9012 -76-4 
Chitosan formulae: (C6H11NO4)n  
Chitosan content (% w/dry weight): 85  
Glucan content (% w/dry weight): ≤ 15  
Loss on drying (% w/dry weight): ≤ 10  
Viscosity 1% in acetic acid 1%: 1 -15 
Degree of acetylation (in %mol/wet weight): 0 -30 
Viscosity (1% in acetic acid 1%) (mPa.s): 1 -14 for chitosan from Aspergillus niger; 12 -25 for chitin from Agaricus bisporus  
Ash (% w/dry weight): ≤ 3  
Proteins (% w/dry weight): ≤ 2  
Total heavy metals (ppm): ≤ 20  
Mercury (ppm): ≤ 0.1  
Lead (ppm): ≤ 1  
Arsenic (ppm): ≤ 1  
Cadmium (ppm): ≤ 0.5  
Aerobic count (cfu/g): ≤ 1000  
Yeast and mould count (cfu/g): ≤ 1000  
Escherichia coli  (cfu/g): ≤ 10  
Entreobacteriacare (cfu/g): ≤ 10  
Salmonella : absence/25g  66 
 Listeria monocytogenes : absence/25g  
Particle size: > 100 nm  
Taped density (g/cm3): 0.7 -1 
Appearance: fine free -flowing powder  
Aspect: Off - white to slightly brownish  
Odour: odourless  
Fat binding capacity 800x (w/wet weight): pass  
Chromium picolinate  Description/ Definition :  
Chromium picolinate is a reddish free -flowing powder, slightly soluble in water at pH 7. The salt is also soluble in polar organic solvents.  
Chemi cal name: tris(2pyridinecarboxylato -N,O)chromium(III) or 2 -pyridinecarboxylic acid chromium(III) salt  
CAS No.: 14639 -25-9 
Chemical formula: Cr(C 6H4NO 2)3  
Chemical characteristics:  
Chromium Picolinate: ≥ 95%  
Chromium (III): 12 -13% 
Chromium (VI): not detected  
Water: ≤ 4%  
Citicoline  Description/ Definition :  
Citicoline is composed of cytosine, ribose, pyrophosphate and choline.  
White crystalline powder  
Chemical name: Choline cytidine 5′ -pyrophosphate, Cytidine 5′ -(trihydrogen diphosphate) P′ -[2-(trimet hylammonio)ethyl]ester inner salt  
Chemical formula: C 14H26N4O11P2 
Molecular weight: 488.32 g/mol  
CAS No.: 987 -78-0 
pH (sample solution of 1%): 2.5 -3.5 
Purity:  
Assay value: ≥ 98% of dry matter  
Loss on drying (100 °C for 4 hours): ≤ 5.0%  
Ammonium: ≤ 0.05%  
Total heavy metals (as Pb): ≤ 10 ppm  67 
 Arsenic: Not more than 2 ppm  
Free phosphoric acids: ≤ 0.1%  
5′-Cytidylic acid: ≤ 1.0%  
Microbiological criteria:  
Total plate count: ≤ 1 000 cfu/g  
Yeast and moulds: ≤ 100 cfu/g   
Escherichia coli : Absent in 1 g  
Clostridium butyricum  (CBM 
588)  Description/Definition:  
Clostridium butyricum  (CBM 588) is a Gram -positive, spore -forming, obligate anaerobic, non -pathogenic, non -genetically modified 
bacterium.  
Microbiological criteria:  
Total viable aerobic count: ≤ 103 CFU/g  
Escherichia coli : Not detected in 1 g  
Staphylococcus aureus: Not detected in 1 g  
Pseudomonas aeruginosa: Not detected in 1 g  
Yeast and moulds: ≤ 102 CFU/g  
Extract of defatted cocoa 
powder  Appearance: Dark brown powder free of visible impurities  
Cocoa ( Theobroma cacao  L.) Extract  
Physical and chemical properties:  
Polyphenol content: Min 55.0% GAE  
Theobromine content: Max 10.0%  
Ash content: 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 ( Theobroma cacao  L.) extract   
Appearance: Dark red to purple powder  
Cocoa extract, concentrate: Min 99%  
Silicon dioxide (technological aid): Max 1%  68 
 Cocoa flavanols: Min. 300 mg/g  
(-) Epicatechin: Min. 45 mg/g  
Loss on drying: Max . 5% 
Coriander seed oil  Description/Definition:   
Coriander seed oil is an oil containing glycerides of fatty acids that is produced from the seeds of the coriander plant Coriandrum sativum  
L.  
Slight yellow colour, bland taste  
Composition of fatty acids:  
Palmitic acid (C16:0): 2 -5% 
Stearic acid (C18:0): < 1.5%  
Petroselinic acid (cis -C18:1(n -12)): 60 -75% 
Oleic acid (cis -C18:1 (n -9)): 8 -15% 
Linoleic acid (C18:2): 12 -19% 
α-Linolenic acid (C18:3): < 1.0%  
Trans fatty acids: ≤ 1%  
CAS No.: 8008 -52-4 
Purity:  
Refra ctive index (20°C): 1.466 -1.474  
Acid value: ≤ 0.6 mg KOH/g  
Peroxide value: ≤ 5 meq/kg  
Iodine value: 88 -102 units  
Saponification value: 186 -198 mg KOH/g  
Unsaponifiable matter: ≤ 15 g/kg  
α-cyclodextrin  Description/Definition:   
A non -reducing cyclic sacchari de consisting of six α -1,4-linked D -glucopyranosyl units produced by the action of cyclodextrin 
glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolyzed starch. Recovery and purification of α -cyclodextrin may be carried out using 
one of the following proced ures: precipitation of a complex of α -cyclodextrin with 1 -decanol, dissolution in water at elevated temperature 
and re -precipitation, steam -stripping of the complexant, and crystallisation of α -cyclodextrin from the solution; or chromatography with 
ion-exchange or gel filtration followed by crystallisation of α -cyclodextrin from the purified mother liquor; or membrane separation 
methods such as ultra -filtration and reverse osmosis: Description: Virtually odorless, white or almost white crystalline solid.  69 
 Synonyms: α -cyclodextrin, α -dextrin, cyclohexaamylose, cyclomaltohexaose, α -cycloamylase  
Chemical name: Cyclohexaamylose  
CAS No.: 10016 -20-3 
Chemical formula: (C 6H10O5)6  
Formula weight: 972.85  
Assay: ≥ 98% (dry basis)"  
Identification:  
Melting range: Decompo ses above 278 °C  
Solubility: Freely soluble in water; very slightly soluble in ethanol  
Specific rotation: [α]D 25: Between +145° and +151° (1 % solution)  
Chromatography: The retention time for the major peak in a liquid chromatogram of the sample correspon ds to that for α -cyclodextrin in 
a chromatogram of reference α -cyclodextrin (available from Consortium für Elektrochemische Industrie GmbH, München, Germany or 
Wacker Biochem Group, Adrian, MI,  USA) using the conditions described in the METHOD OF ASSAY  
Purity:  
Residual complexant: ≤ 20 mg/kg  
(1-decanol)  
Reducing substances: ≤ 0.5% (as glucose)  
Sulfated ash: ≤ 0.1%  
Lead: ≤ 0.5 mg/kg  
Method of assay:  
Determine by liquid chromatography using the following conditions:  
Sample solution: Weigh accurately about 100 mg of test sample into a 10 -ml volumetric flask and add 8 ml of deionised water. Dissolve 
the sample completely using an ultra -sonification bath (10 -15 min) and dilute to the mark with purified deionised water. Filter through a 
0.45-micrometer filter  
Reference solution: Weigh accurately about 100 mg of α -cyclodextrin into a 10 -ml volumetric flask and add 8 ml of deionised water. 
Dissolve the sample completely using an ultra -sonification bath and dilute to the mark with purified deionised water.  
Chromato graphy: Liquid chromatograph equipped with a refractive index detector and an integrating recorder.  
Column and packing: Nucleosil -100-NH 2 (10 μm) ( Macherey & Nagel Co. Düren , Germany) or similar  
Length: 250 mm  
Diameter: 4 mm  
Temperature: 40 °C  70 
 Mobile phase : acetonitrile/water (67/33, v/v)  
Flow rate: 2.0 ml/min  
Injection volume: 10 μl  
Procedure: Inject the sample solution into the chromatograph, record the chromatogram, and measure the area of the α -CD peak. 
Calculate the percentage of α -cyclodextrin in the test sample as follows:  
% α-cyclodextrin (dry basis) = 100 × (AS/AR) (WR/WS)  
where  
As and AR are the areas of the peaks due to α -cyclodextrin for the sample solution and reference solution, respectively. Ws and WR are 
the weights (mg) of the test sample an d reference α -cyclodextrin, respectively, after correcting for water content.  
γ-cyclodextrin  Description/Definition:  
A non -reducing cyclic saccharide consisting of eight α -1,4-linked D -glucopyranosyl units produced by the action of cyclodextrin 
glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolysed starch. Recovery and purification of γ -cyclodextrin may be carried out b y 
precipitation of a complex of γ -cyclodextrin with 8 -cyclohexadecen -1-one, dissolution of the complex with water and n -decane, steam -
stripping of the aqueous phase and recovery of gamma -CD from the solution by crystallisation.  
Virtually odourless, white or almost white crystalline solid"  
Synonyms: γ -cyclodextrin, γ -dextrin, cyclooctaamylose, cyclomaltooctaose, γ -cycloamylase  
Chemical name: Cyclooctaamylose  
CAS number: 17465 -86-0 
Chemical formula: (C 6H10O5)8 
Assay: ≥ 98% (dry basis)  
Identification:  
Melting  range: Decomposes 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:  
Purity:  Water: ≤ 11%  
Residual complexant (8 -cyclohexadecen -1-one (CHDC)): ≤ 4  mg/kg  
Residual solvent (n -decane): ≤ 6mg/kg  
Reducing substances: ≤ 0.5% (as glucose)  
Sulphated ash: ≤ 0.1%  71 
 Dextran preparation produced 
by Leuconostoc mesenteroides  1. Powdered form : 
Carbohydrates: 60% with: (Dextran: 50 %, Mannitol: 0.5%, Fructose: 0.3% , Leucrose: 9.2 %)  
Protein: 6.5%  
Lipid: 0.5%  
Lactic acid: 10%  
Ethanol: traces  
Ash: 13%  
Moisture: 10%  
2. Liquid form:  
Carbohydrates: 12% with: (Dextran: 6.9%, Mannitol: 1.1%, Fructose: 1.9%, Leucrose: 2.2 %)  
Protein: 2%  
Lipid: 0.1%  
Lactic acid: 2%  
Ethanol:  0.5%  
Ash: 3.4%  
Moisture: 80%  
Diacylglycerol oil of plant 
origin  Description/Definition:  
Manufactured from glycerol and fatty acids derived from edible vegetable oils, in particular from soybean oil ( Glycine max ) or rapseed 
oil (Brassica campestris, Brassica napus ) using a specific enzyme.  
Acylglycerol Distribution:  
Diacylglycerols (DAG): ≥ 80%  
1,3-Diacylglycerols (1,3 -DAG): ≥ 50%  
Triacylglycerols (TAG): ≤ 20%  
Monoacylglycerols (MAG): ≤ 5%  
Fatty Acid Composition (MAG, DAG, TAG):  
Oleic acid (C18:1): 20 -65% 
Linoleic acid (C18:2): 15 -65% 
Linolenic acid (C18:3): ≤ 15%  
Saturated fatty acids: ≤ 10%  
Others : 72 
 Acid value: ≤ 0.5 mg KOH/g  
Moisture and volatile: ≤ 0.1%  
Peroxide value: ≤ 1 meq/kg  
Unsaponifiables: ≤ 2%  
Trans fatty acids≤ 1%  
MAG = monoacylglycerols, D AG = diacylglycerols, TAG = triacylglycerols  
Dihydrocapsiate (DHC)  Description/Definition:  
Dihydrocapsiate is synthesised by enzyme -catalysed esterification of vanillyl alcohol and 8 -methylnonanoic acid. Following the 
esterification dihydrocapsiate is extracted with n -hexane.  
Viscous to colourless to yellow liquid  
Chemical formula: C 18 H28 O4 
CAS No: 205687 -03-2 
Physical -chemical properties:  
Dihydrocapsiate: > 94%  
8-Methylnonanoic acid: < 6%  
Vanillyl acohol: < 1%  
Other synthesis related substances: < 2%  
Dried extract of Lippia 
citriodora  from cell cultures  Cell cultures : HTN®Vb  
Echinacea angustifolia extract  Extract of the roots of Echinacea angustifolia  obtained from tissue culture plant are substantial equivalent to a commercially available 
extract from root of Echinacea angustifolia  obtained in ethanol -water titrated to 4% ech inacoside.  
Echium plantagineum  oil Description/Definition:  
Echium oil is the pale yellow product obtained by refining oil extracted from the seeds of  Echium plantagineum L. Stearidonic acid: ≥ 
10% w/w of total fatty acids  
Trans fatty acids: ≤ 2% (w/w of  total fatty acids)  
Acid value: ≤ 0,6 mg KOH/g  
Peroxide value: ≤ 5 meq O 2/kg 
Unsaponifiable content: ≤ 2 %  
Protein content (total nitrogen): ≤ 20 μg/mL  73 
 Pyrrolizidine alkaloids: Not detectable with a detection limit 4 μg/kg  
Epigallocatechin gallate as a 
purified extract from grean tea 
leaves ( Camellia sinensis ) Description/Definition:  
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 composed of a minimum of 90% epigallo -caechin gallate (EGCG), and has a melting point between approx. 210 and 215 °C  
Appearance: off -white to pale pink powder  
Chemical name: polyphenol ( -) epigallocatechin -3-gallate  
Synonyms: epigallocatechin gallate (EGCG)  
CAS No.: 989 -51-5 
INCI name: epigallocatechin gallate  
Molecular mass: 458.4g/mol  
Loss on drying: max 5%  
Heavy metals: max 10ppm  
Arsenic: max 3ppm  
Lead: max 5 ppm  
Assay:  
Min. 94% EGCG (on dry material)  
max. 0.1% caffeine  
Solubility: EGCG is fairly soluble in water, ethanol, meth anol and acetone  
L-ergothioneine  Definition  
Chemical name (IUPAC): (2S) -3-(2-thioxo -2,3-dihydro -1H-imidazol -4-yl)-2-(trimethylammonio) - 
Propanoate  
Chemical formula: C 9H15N3O2S 
Molecular mass: 229.3 Da  
CAS No.: 497 -30-3 
Parameter  Specification  Method  
Appearance  White powder  Visual  
Optical rotation  [α]D ≥ (+) 122° (c = 1, H 20)a) Polarimetry  
Chemical purity  ≥99.5%  HPLC [Eur. Ph. 2.2.29]  74 
 ≥99%  1H-NMR  
Identification  Compliant with the structure  
 
C: 47.14 ± 0.4%  
H: 6.59 ± 0.4%  
N: 18.32 ± 0.4%  1H-NMR  
 
 
 
Elemental analysis  
Total residual solvents  
(methanol, ethyl acetate, isopropanol, 
ethanol)  [Eur. Ph. 01/2008:50400]  
< 1000 ppm  Gas chromatography  
[Eur. Ph. 01/2008:20424]  
Loss on drying  Internal standard < 0.5%  [Eur. Ph. 01/2008:20232]  
Impurities  < 0.8%  HPLC/GPC or 1H -NMR  
Heavy metalsb) c) 
Lead  < 3 ppm  ICP/AES  
(Pb, Cd)  
Atomic fluorescence (Hg)  
 Cadmium  < 1 ppm  
Mercury  < 0.1 ppm  
Microbiological specificationsb) 
Total viable aerobic count (TVAC)  ≤ 1 x 103 CFU /g [Eur. Ph. 01/2011:50104]  
Total yeast and mould count (TYMC)  ≤ 1 x 102 CFU/g  
Escherichia coli  Absent in 1 g  
 
Eur. Ph.: European Pharmacopoeia; 1H -NMR: proton nuclear magnetic resonance; HPLC: high -performance liquid chromatography; 
GPC: gel permeation chromatography; ICP/AES: Inductively coupled plasma atomic emission spectroscopy;  
CFU: colony -forming units.  
a) Lit. [α] D = (+) 126.6° (c = 1, H 20) 
b) Analyses conducted on each batch  
c) Maximum levels in accordance with Regulation (EC) No 1881/2006  75 
 Ferric Sodium EDTA  Description/Definition :  
Ferric Sodium EDTA (ethylenediaminetetraacetic acid) is an odourless free -flowing, yellow to brown powder with a chemical purity of 
more than 99 % (w/w). It is freely soluble in water.  
Chemical formula: C 10H12FeN 2NaO 8 · 3H 2O 
Chemic al characteristics:  
pH of 1 % solution: 3.5 -5.5 
Iron: 12.5 -13.5 %  
Sodium: 5.5%  
Water: 12.8%  
Organic matter (CHNO): 68.4%  
EDTA: 65.5 -70.5%  
Water insoluble matter: ≤ 0.1 %  
Nitrilo -triacetic acid: ≤ 0.1 %  
Ferrous ammonium phosphate  Description/Definition:  
Ferrous ammonium phosphate is a grey/green fine powder, practically insoluble in water and soluble in dilute mineral acids.  
CAS No.: 10101 -60-7 
Chemical Formula: FeNH 4PO 4  
Chemical characteristics:  
pH of 5 % suspension in water: 6.8 -7.8 
Iron (total): ≥ 28% 
Iron (II): 22 -30% (w/w)  
Iron (III): ≤ 7% (w/w)  
Ammonia: 5 -9 % (w/w)  
Water: ≤ 3%  
Fish peptides from Sardinops 
sagax  Description/Definition:  
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 chromatography, concentration under vacuum and spray drying.  
Yellowish white powder  
Peptides (1) (short chain peptides, dipeptides and tripeptides with a molecular we ight of less than 2 kDa): ≥ 85 g/100 g  
Val-Tyr (dipeptide): 0.1 -0.16 g/100 g  76 
 Ash: ≤ 10 g/100 g  
Moisture: ≤ 8 g/100 g  
(1) Kjeldahl method  
Flavonoids from  Glycyrrhiza 
glabra  Description/Definition:  
Glavonoid is an extract derived from the roots or rootstoc k of Glycyrrhiza glabra  L. by extraction with ethanol followed by further 
extraction of this ethanolic extract with medium -chain triglycerides. It is a dark -brown coloured liquid, containing 2.5% to 3.5% of 
glabridin.  
Moisture: < 0.5%  
Ash: < 0.1%  
Peroxide value: < 0.5 meq/kg  
Glabridin: 2.5 -3.5% of fat  
Glycyrrhizinic acid: < 0.005%  
Fat including polyphenol -type substances: ≥ 99%  
Protein: < 0.1%  
Carbohydrates: not detectable  77 
 2′-O-fucosyllactose  Description/Definition :  
2′-O-fucosyllactose is a white to off -white powder and the liquid concentrate (45% ± 5% w/v) aqueous solution is a colourless to slight 
yellow clear aqueous solution. The 2' -O-fucosyllactose is produced by a specific authorised synthetic (synth.) or microb iological 
(microb.) process.  
Source (microb.) : genetically modified strain of Escherichia coli BL21  
Chemical name : α -l-Fucopyranosyl -(1→2) -β-d-galactopyranosyl -(1→4) -d-glucopyranose  
Chemical formula: C 18H32O15  
CAS No: 41263 -94-9 
Molecular weight: 488.4 4 g/mol  
Purity:  
Assay (water free): ≥ 94 % (synth.), ≥90 % (microb.)  
D-Lactose: ≤ 3.0 w/w % (synth.), ≤5.0 % (microb.)  
L-fucose: ≤ 1.0 w/w % (synth.), ≤3.0 % (microb.)  
Difucosyl -d-lactose isomers: ≤ 1.0 w/w % (synth.), ≤3.0 % singly (microb.)  
2′-Fucosyl -d-lactulose: ≤ 1.0 w/w % (synth.), .), ≤5.0 % singly (microb.)  
pH (20 °C, 5 % solution): 3.2 -7.0 
Water (%): ≤ 9.0% (synth. and microb. powder)  
Ash, sulphated: ≤ 1.5% (synth.), total Ash: ≤0.5. % (microb. powder and liquid)  
Acetic acid: ≤ 1.0% (synth.)  
Resid ual solvents (synth.) (methanol, 2 -propanol, methyl acetate, acetone): ≤50 mg/kg singly, ≤200 mg/kg in combination)  
Residual proteins: ≤ 0.01% (synth.), (0.001% microb. powder and liquid)  
Palladium: ≤ 0.1 mg/kg (synth.)  
Nickel: ≤ 3.0 mg/kg (synth.)  
Lead: 0 .02 mg/kg (microb. powder and liquid)  
Arsenic: 0.02 mg/kg (microb. powder and liquid)  
Cadmium: 0.01 mg/kg (microb. powder and liquid)  
Mercury: 0.5 mg/kg (microb. powder and liquid)  
Aflatoxin M 1: 0.025 µg/kg (microb. powder and liquid)  
Microbiological crite ria:  
Aerobic mesophilic bacteria total count: ≤ 500 CFU/g (synth.)  78 
 Total plate count: ≤ 104 CFU/g (microb. powder), ≤ 5000 CFU/g (microb. liquid)  
Yeasts and Moulds: ≤ 10 CFU/g (synth.), ≤10 CFU/g (microb. powder and liquid),  
Enterobaceriaciae: absent in 11 g (microb. powder and liquid)  
Salmonella: negative/100 g (microb. powder), negative/200 ml (microb. liquid)  
Chronobacter: negative/100 g (microb. powder), negative/200 ml (microb. liquid)  
Residual endotoxins: ≤ 10 EU/mg (synth. and microb. powder), ≤ 10  EU/ml (microb. liquid)  
Galacto -oligosaccharide (GOS)  GOS: min 46% Dry Matter (DM)  
Lactose: max 40% DM  
Glucose: max 27% DM  
Galactose: min 0.8% DM  
Ash: max 4% DM  
Protein: max 5% DM  
Glucosamine HCl from 
Aspergillus niger  White crystalline odourless powder  
Molecular formula: C 6H13NO 5•HCl  
Relative molecular mass: 215.63 g/mole  
D-Glucosamine HCl 98.0 -102.0% of reference standard (HPLC)  
Specific rotation + 70.0º - + 73.0º  
Glucosamine sulphate KCl 
from Aspergillus niger  White crystalline odourless powder  
Molecular formula: (C 6H14NO 5)2SO 4 •2KCl  
Relative molecular mass: 605.52 g/mole  
D-Glucosamine Sulfate 2KCl 98.0 -102.0% of reference standard (HPLC)  
Specific Rotation +50.0o to +52.0o  
Glucosamine sulphate NaCl 
from Aspergillus niger  White crystalline odourless powder  
Molecular formula: C 6H14NO 5)2SO 4̇ • 2NACL  
Relative molecular mass: 573.31 g/mole  
D-Glucosamine HCl: 98 -102% of reference standard (HPLC)  
Specific Optical Rotation: +52° - +54°  79 
 Guar Gum  Description/Definition:   
Native guar gum is the ground endosperm of seeds from natural strains of guar Cyamopsis tetragonolobus  L. Taub. ( Leguminosae  
family). It consists of a high molecular weight polysaccharide, primarily composed of galactopyranose and mannopyranose units  
combined through glycosidic linkages, which may be described chemically as a galactomannan (galactomannan content not less th an 
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 Directive No 2008/84/ EC laying down specific purity criteria on food additives other th an colours and 
sweeteners & by Regulation (EC) No. 258/2010 imposing special conditions on the imports of guar gum originating in or consign ed from 
India due to contamination risks by pentachlorophenol and dioxins, or by any possible subsequent instruments  concerning the same 
subject and laying down new purity criteria.  
Physico -chemical properties:  
Powder  
Shelf -life: 2 years  
Color: White  
Odour: Light  
Average diameter of particles: 60 -70µm  
Moisture: Max 15%  
Viscosity * at 1 hour -  
Viscosity* at 2 hours: Min 3600 mPa.s  
Viscosity* at 24 hours: Min 4000 mPa.s  
Solubility: Soluble in hot and cold water  
pH for 10g/ L, at 25 °C - 6-7.5 
Flakes  
Useful life: 1 year  
Color: White/off white with absence or minimal presence of black spots  
Odou r: Light  80 
 Average diameter of particles: 1 -10 mm  
Moisture: Max 15%  
Viscosity * at 1 hour: Min 3000 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 following conditions: 1%, 25°C, 20 rpm  
Heat -treated milk products 
fermented with Bacteroides 
xylanisolvens  Description/Definition:   
Heat -treated fermented milk products are produced with Bacteroides xylanisolvens (DSM 23964) as starter culture.  
Semi -skimmed milk (between 1.5% and 1.8% fat) or skimmed milk (0.5% fat or less) is pasteurised or ultra -heat-treated before starting 
the fermentation with Bacteroides xylanisolvens  (DSM 23964). The resulting fermented milk produ ct is homogenised and then heat -
treated to inactivate Bacteroides xylanisolvens  (DSM 23964). The final product does not contain viable cells of Bacteroides xylanisolvens 
(DSM 23964)1.  
1 Modified DIN EN ISO 21528 -2. 
Ice Structuring Protein type III 
HPLC 12  Description/Definition:  
The Ice Structuring Protein (ISP) preparation is a light -brown liquid produced by submerged fermentation of a genetically -modified 
strain of food -grade baker’s yeast ( Saccharomyces cerevisi ae) in which a synthetic gene for the ISP has been inserted into the yeast’s 
genome. The protein is expressed and secreted into the growth medium where it is separated from the yeast cells by micro -filtration and 
concentrated by ultra -filtration. As a resu lt, the yeast cells are not transferred into the ISP preparation as such or under an altered form. 
The ISP preparation consists of native ISP, glycosylated ISP and proteins and peptides from the yeast and sugars as well as a cids and 
salts commonly found in  food. The concentrate is stabilised with 10 mM citric acid buffer.  
Assay: ≥ 5 g/l active ISP  
pH: 2.5 -3.5 
Ash: ≤ 2%  
DNA: Not detectable  81 
 Isomaltooligosaccharide  Powder:  
Solubility (water) (%): > 99  
Glucose (% dry basis): ≤ 5  
Isomaltose + DP3 to DP9 (% dry  basis): ≥ 90  
Moisture (%): ≤ 4  
Sulfated ash(g/100g): ≤ 0.3  
Heavy metals:  
Lead (mg/kg): ≤ 0.5  
Arsenic (mg/kg): ≤ 0.5  
Syrup:  
Dried solids (g/100 g): > 75  
Glucose (% dry basis): ≤ 5  
Isomaltose + DP3 to DP9 (% dry basis): ≥ 90  
pH: 4 - 6 
Sulfated ash(g/100g): ≤ 0.3  
Heavy metals:  
Lead (mg/kg): ≤ 0.5  
Arsenic (mg/kg): ≤ 0.5  
Isomaltulose  Description/Definition:  
A reducing disaccharide that consists of one glucose and one fructose moiety linked by an alpha -1,6-glycosidic bond. It is obtained from 
sucrose by an enzymatic process. The commercial product is the monohydrate. Appearance: Virtually odourless, white or almost white 
crystals with a sweet taste  
Chemical name: 6 -O-α-D-glucopyranosyl -D-fructofuranose, monohydrate  
CAS No.: 13718 -94-0 
Chemical formula: C 12H22O11 · H 2O 
Formula weight: 360.3 (monohydrate)  
Assay: ≥ 98% on the dry basis  
Loss on drying: ≤ 6.5% (60 °C, 5 hours)  
Lead: ≤ 0.1 mg/kg  
Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample 
preparation may be based on the principles of the method described in FNP 5 (1), ‘Instrumental methods’  82 
 (1) Food and Nutrition Paper 5 Rev. 2 — Guide to specifications for general notices, general analytical techniques, identification test s, test 
solutions and other reference materials (JECFA), 1991, 322 pp., English, ISBN 92 -5-102991 -1. 
Lactitol  Description/Definition:  
Crystalline powder or colourless solution manufactured via catalytic hydrogenation of lactose. Crystalline products occ ur in anhydrous, 
monohydrate and dihydrate forms. Nickel is used as a catalyst.  
Chemical name: 4 -O-β-D-Galactopyranosyl -D-glucitol  
Chemical formula: C 12H24O11  
Molecular weight: 344.31 g/mol  
CAS No: 585 -86-4 
Solubility (in water): Very soluble in water  
Specific rotation [α] D20 = + 13° to + 16°  
Assay: ≥ 95% d.b (d.b - expressed on the dry weight basis)  
Water: ≤ 10.5%  
Other polyols: ≤ 2.5% d.b  
Reducing sugars: ≤ 0.2% d.b  
Chlorides: ≤ 100 mg/kg d.b  
Sulphates: ≤ 200 mg/kg d.b  
Sulphated ash: ≤ 0.1% d.b  
Nickel: ≤ 2 mg/kg d.b  
Arsenic: ≤ 3 mg/kg d.b  
Lead: ≤ 1 mg/kg d.b  
Lacto -N-neotetraose  Description/Definition :  
Lacto -N-neotetraose is a white to off -white powder. Produced by a specific authorised synthetic or microbiological proces.  
Chemical name : β -d-Galactopyranosyl -(1→4) -2-acetamido -2-deoxy -β-d-glucopyranosyl -(1→3) -β-d-galactopyranosyl -(1→4) -d-
glucopyranose  
Chemical formula: C 26H45NO 21  
CAS No: 13007 -32-4 
Molecular weight: 707.63 g/mol  
Purity:  
Assay (water free): ≥ 92%  83 
 D-Lactose: ≤ 3.0 w/w %  
Lacto -N-triose II: ≤ 3.0 w/w %  
Lacto -N-neotetraose fructose isomer: ≤ 1.0 w/w %  
para-lacto -N-neohexaose: ≤ 3.0 w/w %  
pH (20 °C, 5 % solution): 4.0 -7.0 
Water (%): ≤ 9.0%  
Ash, sulphated: ≤ 0.4%  
Acetic acid: ≤ 0.3%  
Residual solvents (methanol, 2 -propanol, methyl acetate, acetone): ≤ 50 mg/kg singly for 2 -propanol, methyl acetate, acetone. ≤ 100 
mg/kg for methanol. ≤200 mg/kg in combination  
Residual proteins: ≤ 0.01%  
Palladium: ≤ 0.1 mg/kg  
Nickel: ≤ 3.0 mg/kg  
Microbiological criteria:  
Aerobic mesophilic bacteria total count: ≤ 500 CFU/g  
Yeasts: ≤ 10 CFU/g  
Moulds: ≤ 10 CFU/g  
Residual endotoxins: ≤ 10 EU/mg  
Lucerne leaf extract from 
Medicago sativa  Description/Definition:   
The Lucerne (Medicago sativa  L.) is processed within 2 hours after harvest. It is chopped and  crushed. By passing through an oleaginous -
type press, the Lucerne provides a fibrous residue and press juice (10 % of dry matter). The dry matter of this juice contain s about 35 % 
of crude protein. The press juice (pH 5,8 -6,2) is neutralised. Preheating a nd vapour injection allows coagulation of proteins associated 
with carotenoid and chlorophyll pigments. The protein precipitate is separated by centrifugation and thereafter dried. After adding 
ascorbic acid the Lucerne protein concentrate is granulated an d stored in inert gas or in cold storage.  
Composition:  
Protein: 45 -60% 
Fat: 9 -11% 
Free carbohydrates (soluble fibre): 1 -2% 
Polysaccharides (insoluble fibre): 11 -15% 
including cellulose: 2 -3% 84 
 Minerals: 8 -13% 
Saponins: ≤ 1.4%  
Isoflavones: ≤ 350 mg/kg  
Coumest rol: ≤ 100 mg/kg  
Phytates: ≤ 200 mg/kg  
L-canavanine: ≤ 4.5 mg/kg  
Lycopene  Description/Definition:   
Synthetic lycopene is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other  
carotenoids used in food. Syn thetic lycopene consists of ≥ 96 % lycopene and minor quantities of other related carotenoid components. 
Lycopene is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red -violet. Antioxidative 
protection has  to be assured.  
Chemical name: Lycopene  
CAS No.: 502 -65-8 (all-trans lycopene)  
Chemical formula: C 40H56  
Formula weight: 536.85  
Lycopene from Blakeslea 
trispora  Description/Definition :  
The purified lycopene from Blakeslea trispora  consists of ≥ 95% lycopene and ≤ 5% other carotenoids. It is presented either as a powder 
in a suitable matrix or an oily dispersion. The colour is dark red or red -violet. Anti -oxidative protection has to be assured.  
Chemical name: Lycopene  
CAS No.: 502 -65-8 (all trans lycopene)  
Chemical formula: C 40H 56  
Formula weight: 536.85  
Lycopene from tomatoes  Description/Definition :  
The purified lycopene from tomatoes ( Lycopersicon esculantum  L.) consists of ≥ 95% lycopene and ≤ 5% other carotenoids. It is 
presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red -violet. Anti -oxidative protection has 
to be assured.  
Chemical name: Lycopene  
CAS No.: 502 -65-8 (all trans lycopene)  
Chemical formula: C 40H 56  85 
 Formula weight: 536.85  
Lycopene oleoresin from 
tomatoes  Description/Definition:  
Lycopene oleoresin from tomatoes is obtained by solvent extraction of ripe tomatoes ( Lycopersicon esculentum Mill. ) with subsequent 
removal of the solvent. It is a red to dark brown viscous, clear liquid.  
Total lycopene: 5 -15% 
Thereof trans -lycopene: 90 -95% 
Total carotenoids (calculated as lycopene): 6.5 -16.5%  
Other carotenoids: 1.75%  
(Phytoene/phytofluene/β -carotene ): (0.5 to 0.75/0.4 to 0.65/0.2 to 0.35%)  
Total tocopherols: 1.5 -3.0%  
Unsaponifiable matter: 13 -20% 
Total fatty acids: 60 -75% 
Water (Karl Fischer): ≤ 0.5%  
Magnesium citrate malate  Description/Definition : 
Magnesium Citrate Malate with a 1:2 mixture of tri -magnesium di -citrate and magnesium malate for adults  
Magnesium citrate malate is a white to yellowish -white, amorphous powder.  
Chemical formula: Mg 5(C6H5O7)2(C4H4O5)2 
Chemical name: Pentamagnesium di -(2-hydroxybutanedioate) -di-(2- 
hydroxypropane -1,2,3 -tricarboxylate)  
CAS No.: 1259381 -40-2 
Molecular weight: 763.99 Daltons (anhydrous)  
Solubility: Freely soluble in water (about 20 g in 100 ml)  
Description of the physical state: Amorphous powder  
Assay magnesium: 12.0 -15.0%  
Loss on dryin g (120°C/4 hours): ≤ 15%  
Colour (solid): White to yellowish -white  
Colour (20% aqueous solution): Colourless to yellowish  
Appearance (20% aqueous solution): Clear solution  
pH (20% aqueous solution): Approx. 6.0  
Impurities:  86 
 Chloride: ≤ 0.05%  
Sulphate: ≤ 0.05 % 
Arsenic: ≤ 3 ppm  
Lead: ≤ 2 ppm  
Cadmium: ≤ 1 ppm  
Mercury: ≤ 0.1 ppm  
Magnolia Bark Extract  Description/Definition:  
Magnolia bark extract is obtained from the bark of the plant Magnolia officinalis L. and produced with supercritical carbon dioxide. The 
bark is washed and oven dried to reduce moisture content before being crushed and extracted with supercritical carbon dioxide . The 
extract is dissolved in medical -grade ethanol and re -crystallised to yield magnolia bark extract.  
Magnolia bark extract is ma inly composed of two phenolic compounds, magnolol and honokiol.  
Appearance: Light brownish powder  
Magnolol: ≥ 92.5%  
Honokiol: ≥ 0.5%  
Magnolol & Honokiol: ≥ 94%  
Total Eudesmol: ≤ 2%  
Moisture: 0.50%  
Arsenic (ppm): ≤ 0.5  
Lead (ppm): ≤ 0.5  
Total Heavy Metals (ppm): ≤ 10  
Methyl eugenol (ppm): ≤ 10  
Turbocurarine (ppm): ≤ 2  
Total Alkaloid (ppm): ≤ 100  
Maize -germ oil high in 
unsaponifiable matter  Description/Definition :  
Maize -germ oil high in unsaponifiable matter is produced by vacuum distillation an d it is different from refined maize -germ oil in the 
concentration of the unsaponifiable fraction (1.2 g in refined maize -germ oil and 10 g in ‘maize -germ oil high in unsaponifiable matter’).  
Unsaponifiable matter: > 9 g/100 g  
Tocopherols: ≥ 1.3 g/100 g  
α-tocopherol (%): 10 -25% 
β-tocopherol (%): < 3%  87 
 γ-tocopherol (%): 68 -89% 
δ-tocopherol (%): < 7%  
Sterols, triterpenic alcohols, methylsterols: > 6.5 g/100 g  
Fatty acids in triglycerides:  
palmitic acid: 10 -20% 
stearic acid: < 3.3%  
oleic acid: 20 -42.2%  
linolei c acid: 34 -65.6%  
linolenic acid: < 2%  
Acid value: ≤ 6 mg KOH/g  
Peroxide value: ≤ 10 mEq O 2/kg 
Iron (Fe): < 1 500 μg/kg  
Copper (Cu): < 100 μg/kg  
Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 μg/kg  
Treatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons (PAH) are not enriched in the production of 
‘maize -germ oil high in unsaponifiable matter’  
Methylcellulose  Description/Definition:   
Methyl cellulose is cellulose obtained directly from natural strains of fibrou s plant material and partially etherified with methyl groups.  
Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder  
Chemical name: Methyl ether of cellulose  
Chemical formula: The polymers contain substituted anhydroglucose units with the following general formula:  
C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following:  
-H 
-CH 3 or 
-CH 2CH 3 
Molecular weight: Macromolecules: from about 20000 (n about 100) up to about 380 000 g/mol (n about 2,000)  
Assay: Content not less than 25 % and not more than 33 % of methoxyl groups ( -OCH 3) and not more than 5 % of hydroxyethoxyl 
groups ( -OCH 2CH 2OH) 
Solubility: Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insolu ble in ethanol, ether and chloroform. 
Soluble in glacial acetic acid.  88 
 Loss on drying: ≤ 10% (105 °C, 3 hours)  
Sulphated Ash: ≤ 1.5% determined at 800 ± 25°C  
pH: ≥ 5.0 and not more than 8.0 (1% colloidal solution)  
Arsenic: ≤ 3 mg/kg  
Lead: ≤ 2 mg/kg  
Mercury : ≤ 1 mg/kg  
Cadmium: ≤ 1 mg/kg  
(6S)-5-methyltetrahydrofolic 
acid, glucosamine salt  Description/Definition:   
Chemical name: N -[4-[[[(6S) -2-amino -1,4,5,6,7,8 -hexahydro -5-methyl -4-oxo-6-pteridinyl]methyl]amino]benzoyl] -L-glutamic acid, 
glucosamine salt  
Chem ical formula: C 32H51N9O16 
Molecular weight: 817.80 g/mol (anhydrous)  
CAS No.: 1181972 -37-1 
Appearance: Creamy to light -brown powder  
Purity:  
Diastereoisomeric purity: At least 99% of (6S) -5-methyltetrahydrofolic acid  
Glucosamine assay: 34 -46% in dry basis  
5-Methyltetrahydrofolic acid assay: 54 -59% in dry basis  
Water: ≤8.0 %  
Lead: ≤ 2.0 ppm  
Cadmium: ≤ 1.0 ppm  
Mercury: ≤ 0.1 ppm  
Arsenic: ≤ 2.0 ppm  
Boron: ≤ 10 ppm  
Microbiological criteria:  
Total aerobic microbial count: ≤ 100 cfu/g  
Total combined yeast and mo ulds: ≤ 100 cfu/g  
Escherichia coli : Absent in 10g  
Monomethylsilanetriol 
(Organic Silicon)  Description/Definition:  
Chemical name: Silanetriol, 1 -methyl - 89 
 Chemical formula: CH 6O3Si 
Molecular weight: 94.14 g/mol  
CAS No: 2445 -53-6 
Organic Silicon (monomethylsilanetriol) preparation (aqueous solution):  
Acidity (pH): 6.4 -6.8 
Silicon: 100 -150 mg Si/l  
Lead: ≤ 1 µg/l  
Mercury: ≤ 1 µg/l  
Cadmium: ≤ 1 µg/l  
Arsenic: ≤ 3 µg/l  
Methanol: ≤ 5 mg/kg (residual presence)  
Mycelial extract from Shiitake 
mushroom ( Lentinula edodes ) Description/Definition:  
The novel food ingredient is a sterile aqueous extract obtained from the mycelium of Lentinula edodes  cultivated in a submerged 
fermentation. It is a light brown, slightly turbid liquid.  
Lentinan is a β -(1-3) β-(1-6)-D-glucan which has a molecular weight of approximately 5 × 105 Daltons, a degree of branching of 2/5 and 
a triple helical tertiary structure.  
Composition of the mycelial extract from Lentinula edodes : 
Moisture: 98%  
Dry matter: 2%  
Free glucose: < 20 mg/ml  
Total protein (1): < 0.1 mg/ml  
N-containing constituents (2): < 10 mg/ml  
Lentinan: 0.8 – 1.2 mg/ml  
(1) Bradford method  
(2) Kjeldahl method  
Noni fruit juice ( Morinda 
citrifolia ) Description/Definition:   
Noni fruits (fruits of Morinda citrifolia  L.) are pressed. The obtained juice is pasteurised. An optional fermentation step before or after 
the pressing may occur.  
Rubiadin: ≤ 10 µg/kg  
Lucidin: ≤ 10 µg/kg  90 
 Noni fruit juice powder 
(Morinda citrifolia ) Description/Definition:  
Seeds and skin of the sun -dried fruits of Morinda citrifolia  are separated. 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 maltodextrins, this m ixture is obtained by keeping the rates of inflow of the juice and maltodextrins 
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 
maltodextrins (same amount as used in atomisation).  
Noni fruit puree and 
concentrate ( Morinda citrifolia ) Description/Definition:  
The fruits of Morinda citrifolia  are harvested by hand. Seeds and skin may be separated mechanically from the pureed fruits. After 
pasteurisation, the puree is packaged in aseptic containers and stored under cold conditions.  
Morinda citrifolia  concentrate is prepared from M. citrifolia  puree by treatment with pectinolytic enzymes (50 -60 °C for 1 -2 h). Then the 
puree is heated to inactivate the pectinases and then immediately cooled. The juice is separated in a decanter centrifuge. Af terwards the 
juice is collected and pasteurised, prior t o being concentrated in a vacuum evaporator from a brix of 6 to 8 to a brix of 49 to 51 in the 
final concentrate.  
Composition:   
Puree : 
Moisture: 89 -93%  
Protein: < 0.6 g/100 g  
Fat: ≤ 0.4 g/100 g  
Ash: < 1 g/100 g  
Total carbohydrates: 5 -10 g/100 g  
Fructose : 0.5-3.82 g/100 g  
Glucose: 0.5 -3.14 g/100 g  
Dietary fibre: < 0.5 -3 g/100 g  
5,15-dimethylmorindol (1): 0.19 -0.254 μg/mL  
Lucidin (1) : Not detectable  
Alizarin (1): Not detectable  
Rubiadin (1): Not detectable  
Concentrate : 
Moisture: 48 -53% 91 
 Protein: 3 -3.5 g/1 00 g 
Fat: < 0.04 g/100 g  
Ash: 4.5 -5 g/100 g  
Total carbohydrates: 37 -45 g/100 g  
Fructose: 9 -11 g/100 g  
Glucose: 9 -11 g/100 g  
Dietary fibre: 1.5 -5 g/100 g  
5,15-dimethylmorindol (1): ≤ 0.254 μg/mL  
(1) By an HPLC -UV method developed and validated for the anal ysis of anthraquinones in Morinda citrifolia puree and concentrate. 
Limits of detection: 2.5 ng/mL (5,15 dimethylmorindol); 50.0 ng/mL (lucidin); 6.3 ng/mL (alizarin) and 62.5 ng/mL (rubiadin).  
Noni leaves (Morinda citrifolia ) Description/Definition:   
After cutting, the leaves of Morinda citrifolia  are subject to drying and roasting steps. The product has a particle size ranging from 
broken leaves to coarse powder with fines. It is of greenish brown to brown colour.  
Composition:  
Moisture: < 5.2%  
Protein : 17 - 20% 
Carbohydrate: 55 -65% 
Ash: 10 -13% 
Fat: 4 -9% 
Oxalic acid: < 0.14%  
Tannic acid: < 2.7%  
5,15-dimethylmorindol: < 47 mg/kg  
Rubiadin: non detectable, ≤10 µg/kg  
Lucidin: non detectable, ≤ 10 µg/kg  
Noni fruit powder (Morinda 
citrifolia ) Description/Definition:  
Noni f ruit powder is made from pulped noni pulped noni ( Morinda citrifolia L.) fruits by freeze -drying. Fruits are pulped and seeds are 
removed. After freeze -drying during which water is removed from noni fruits, the remaining noni pulp is milled to a powder and 
encapsulated.  
Composition : 
Moisture: 5.3 -9% 
Protein: 3.8 -4.8 g/100 g  92 
 Fat: 1 -2 g/100 g  
Ash: 4.6 -5.7 g/100 g  
Total carbohydrates: 80 -85 g/100 g  
Fructose: 20.4 -22.5 g/100 g  
Glucose: 22 -25 g/100 g  
Dietary fibre: 15.4 -24.5 g/100 g  
5,15-dimethylmorindol (1): ≤ 2.0 μg/mL  
(1) By an HPLC -UV method developed and validated for the analysis of anthraquinones in Morinda citrifolia. Limits of detection: 2.5 
ng/mL (5,15 dimethylmorindol); 50.0 ng/mL (lucidin); 6.3 ng/mL (alizarin) and 62.5 ng/mL (rubiadin).  
Odontella aurita microalgae  Silicon: 3.3%  
Crystalline silica: max 0.1 -0.3% as impurity  
Oil enriched with 
phytosterols/phytostanols  Description/Definition:   
Oil enriched with phytosterols/phytostanols is composed of an oil fraction and a phytosterol fraction.  
Acylglycerol  Distribution:  
Free fatty acids (expressed as oleic acid): ≤ 2%  
Monoacylglycerols (MAG): ≤ 10%  
Diacylglycerols (DAG): ≤ 25%  
Triacylglycerols (TAG): Making up the balance  
Phytosterol fraction:  
β-sitosterol: ≤ 80%  
β-sitostanol: ≤ 15%  
campesterol: ≤ 40%  
campestanol: ≤ 5%  
stigmasterol: ≤ 30%  
brassicasterol ≤ 3%  
other sterols/stanols: ≤ 3%  
Others:  
Moisture and volatile: ≤ 0.5%  
Peroxide value: < 5 meq/kg  
Trans fatty acids: ≤ 1%  93 
 Contamination/Purity (GC -FID or equivalent method) of phytosterols/phytostanols:  
Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for fo od have to be free of contaminants, best 
ensured by a purity of more than 99%.  
Oil extracted from squid 
(Cephalopod  sp.) Acid value: ≤ 0.5 KOH/g oil  
Peroxide value: ≤ 5 meq O 2/kg oil  
p-Aniside value: ≤ 20  
Cold test at 0oC: ≤ 3 hours  
Moisture: ≤ 0.1% (w/w)  
Unsaponifiable matter: ≤ 5%  
Trans fatty acids: ≤ 1%  
Docosahexaeonic acid: ≥ 20%  
Eicosapentaenoic acid: ≥ 10%  
Pasteurised fruit -based 
preparations produced using 
high -pressure pasteurisation  Parameter  Target  Comments  
Fruit storage before high -pressure 
treatment  Minimum 15 days at – 20 °C  Fruit harvested and stored in 
conjunction with good/hygienic 
agricultural and manufacturing 
practices  
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 storage regimen for 
conventionally processed product  
 
Phosphated maize starch  Description/Definition:  
Phosphated maize starch (phosphated distarch phosphate) is a chemically modified resistant starch derived from high amylose starch by 
combining chemical treatments to create phosphate cross -links between carbohydrate residues and esterified hydroxyl groups.  
The novel food ingredient is a white or nearly white powder.  
CAS No: 11120 -02-8 94 
 Chemical formula: (C 6H10O5)n [(C 6H9O5)2PO 2H]x [(C 6H9O5)PO 3H2]y 
n = number of glucose units; x, y = degrees of substitution  
The chemical characteristics of phosphated distarch phosphate:  
Loss  on drying: 10 -14% 
pH: 4.5 -7.5 
Dietary fibre: ≥ 70%  
Starch : 7 -14% 
Protein: ≤ 0.8%  
Lipids: ≤ 0.8%  
Residual bound phosphorus: ≤ 0.4% (as phosphorus) ‘high amylose maize’ as source  
Phosphatidylserine from Fish 
Phospholipids  Description/Definition:   
The novel food ingredient is yellow to brown powder. Phosphatidylserine is obtained from fish phospholipids by an enzymatic 
transphosphorylation with the amino acid L -serine.  
Moisture: < 5%  
Phospholipids: ≥ 75%  
Phosphatidylserine: ≥ 35%  
Glycerides: < 4%  
Free L -serine: < 1%  
Tocopherols: < 0.5%  
Peroxide value: < 5 meq O 2/kg 
Phosphatidylserine from soya 
phospholipids  Description/Definition:   
The novel food ingredient is off -white to light yellow powder. It is also available in liquid form with a clear brown to or ange colour. The 
liquid form contains medium chain triacylglycerides (MCT) as a carrier. It contains lower levels of Phosphatidylserine due to  the fact that 
it includes significant amounts of oil (MCT). Phosphatidylserine from soya phospholipids is obtaine d through enzymatic 
transphosphatidylation of high -phosphatidylcholine soybean lecithin with the amino acid L -serine. Phosphatidylserine consists of a 
glycerophosphate skeleton conjugated with two fatty acids and L -serine via a phosphodiester linkage.  
Char acteristics of Phosphatidylserine from soya phospholipids  
Powder form:  
Moisture: < 2%  95 
 Phospholipids: ≥ 85%  
Phosphatidylserine: ≥ 61%  
Glycerides: < 2%  
free L -serine: < 1%  
Tocopherols: < 0.3%  
Phytosterols: < 0.2%  
Liquid form:  
Moisture: < 2%  
Phospholipids: ≥ 25%  
Phosphatidylserine: ≥ 20%  
Glycerides: not applicable  
free L -serine: < 1%  
Tocopherols: < 0.3%  
Phytosterols: < 0.2%  
Phospoholipid product 
containing phosphatidylserine 
and phosphatidic acid  Description/Definition:   
The product is manufactured through enzymatic conversion of soy lecithin. The phospholipid product is a highly concentrated, yellow -
brown powder form of phosphatidylserine and phosphatidic acid at an equal level.  
Moisture: ≤ 2%  
Total phospholipids: ≥ 70%  
Phosphatidylserine: ≥20%  
Phosphatidic acid: ≥ 20%  
Glycerines : ≤ 1%  
Free L -serine: ≤ 1%  
Tocopherols: ≤ 0.3%  
Phytosterols: ≤ 2%  
Silicon dioxide is used with a maximum content of 1%  
Phospholipides from egg yolk  85% and 100% pure Phospholipides from egg yolk  
Phytosterols/phytostanols  Description/Definition:  
Phytosterols and phytostanols 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.  96 
 Composition  (with GC -FID or equivalent method):  
β-sitosterol: < 81%  
β-sitostanol: < 35% (< 35% for Milk type products, such as semi -skimmed and skimmed milk type products, where the milk fat has been 
partly or fully replaced by veg etable fat)  
campesterol: < 40%  
campestanol: < 15% (< 15% for Milk type products, such as semi -skimmed and skimmed milk type products, where the milk fat has been 
partly or fully replaced by vegetable fat)  
stigmasterol: < 30%  
brassicasterol: < 3%  
other s terols/stanols: < 3%  
Contamination/Purity  (GC-FID or equivalent method):  
Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of contaminan ts, best 
ensured by a purity of more than 99% of the phyt osterol/phytostanol ingredient.  
Plum kernel oil  Description/Definition:  
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-Sitosterol: 80 -90% of total sterols  
Triolein: 40 -55% of triglycerides  
Cyanhydric acid: maximum 5 mg/kg oil  
Potato proteins (coagulated) 
and hydrolysates  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  
Prolyl oligopeptidase (enzyme 
preparation)  Specification of the enzyme:  
Systematic name: Prolyl oligopeptidase  97 
 Synonyms: Prolyl endopeptidase, proline -specific endopeptidase, endoprolylpeptidase  
Molecular weight: 66 kDa  
Enzyme Commission number: EC 3.4.21.26  
CAS number: 72162 -84-6 
Source: A genetically modified strain of Aspergillus niger  (GEP -44) 
Description: Prolyl oligopeptidase is available as an enzyme preparation containing approximately 30% maltodextrin.  
Specifications of the enzyme preparation of prolyl oligopeptidase:  
Activity:  > 580,000 PPI(1)/g (> 34.8 PPU(2)/g)  
Appearance: Microgranulate  
Colour: Off -white to orange yellowish. The colour may change from batch to batch  
Dry Matter: > 94%  
Gluten: < 20 ppm  
Heavy metals:  
Total heavy metals (as lead): ≤ 10 mg/kg  
Lead: ≤ 1.0 mg/ kg  
Arsenic: ≤ 1.0 mg/kg  
Cadmium: ≤ 0.5 mg/kg  
Mercury: ≤ 0.1 mg/kg  
Microbiological specifications:  
Total aerobic plate count: ≤ 103 CFU/g  
Total yeasts and moulds: ≤ 102 CFU/g  
Sulphite reducing anaerobes: ≤ 30 CFU/g  
Enterobacteriaceae : < 10 CFU/g  
Salmonella : Absent in 25 g  
Escherichia coli : Absent in 25 g  
Staphylococcus aureus : Absent in 10 g  
Pseudomonas aeruginosa : Absent in 10 g  98 
 Listeria monocytogenes : Absent in 25 g  
Antimicrobial activity: Absent  
Mycotoxins: Below limits of detection: Aflatoxin B1, B2, G1, G2 (< 0.25 μg/kg), total Aflatoxins (< 2.0 μg/kg), Ochratoxin A  (< 0.20 
μg/kg), T -2 Toxin (< 5 μg/kg), Zearalenone (< 2.5 μg/kg), Fumonisin B1 and B2 (< 2.5 μg/kg)  
(1) PPU – Prolyl Peptidase Units or Proline Protease Units  
(2) PPI – Protease Picomole International  
Protein extract from pig 
kidneys  Description/Definition :  
The protein extract is obtained from homogenised pig kidneys through a combination of salt precipitation and high speed centr ifugation. 
The obtained precipitate contains essentially proteins with 7% of the enzyme diamine oxidase (e nzyme nomenclature E.C. 1.4.3.22) and 
is resuspended in a physiologic buffer system. The obtained pig kidney extract is formulated as encapsulated enteric coated p ellets to 
reach the active sites of digestion.  
Basic Product:  
Specification: pig kidney prot ein excerpt with natural content of DiAminOxidase (DAO):  
Physical condition: liquid  
Colour: brownish  
Appearance: slightly turbid solution  
pH value: 6.4 -6.8 
Enzymatic activity: > 2677 kHDU DAO/ml (DAO REA (DAO Radioextractionassay))  
Brachyspira spp.: negati ve (Real Time PCR)  
Listeria monocytogenes: negative (Real Time PCR)  
Staphylococcus aureus: < 100 cfu/g  
Influenza A: negative (RevT. Real Time PCR)  
Escherichia coli: < 10 cfu/g  
Total aerobic microbiological count: < 105 cfu/g  
Total combined yeasts / moulds count: < 105 cfu/g  
Salmonella: absent/10g  
Bile salt resistant enterobacteriaceae: < 104 cfu/g  
Final product:  99 
 Specification pig kidney protein excerpt with natural content of DAO (E.C. 1.4.3.22) in an enteric coated formulation:  
Physical condition: solid  
Colour: yellow gray  
Appearance: micropellets  
Enzymatic activity: 110 -220 kHDU DAO/g pellet (DAO REA (DAO Radioextractionassay))  
Acid stability 15 min 0.1M HCl followed by 60 min Borat pH=9.0: > 68 kHDU DAO/g pellet (DAO REA (DAO Radioextractionassay))  
Humidity: < 10%  
Staphylococcus aureus: < 100 cfu/g  
Escherichia coli: < 10 cfu/g  
Total aerobic microbiological count: < 104cfu/g  
Total combined yeasts / moulds count: < 103 cfu/g  
Salmonella: absent/10g  
Bile salt resistant enterobacteriaceae: < 102 cfu/g  
Rapeseed oil high in 
unsaponifiable matter  Description/Definition:  
Rapeseed oil high in unsaponifiable matter’ is produced by vacuum distillation and it is different from refined rapeseed oil in the 
concentration of the unsaponifiable fraction (1 g in refi ned rapeseed oil and 9 g in ‘rapeseed oil high in unsaponifiable matter’). There is a 
minor reduction of triglycerides containing monounsaturated and polyunsaturated fatty acids.  
Unsaponifiable matter: > 7 g/100 g  
Tocopherols: > 0.8 g/100 g  
α-tocopherol (%): 30 -50% 
γ-tocopherol (%): 50 -70% 
δ-tocopherol (%): < 6%  
Sterols, triterpenic alcohols, methylsterols: > 5 g/100 g  
Fatty acids in triglycerides:  
palmitic acid: 3 -8% 
stearic acid: 0.8 -2.5%  
oleic acid: 50 -70% 
linoleic acid: 15 -28% 
linolenic acid: 6 -14% 100 
 erucic acid: < 2%  
Acid value: ≤ 6 mg KOH/g  
Peroxide value: ≤ 10 mEq O 2/kg 
Iron (Fe): < 1 000 μg/kg  
Copper (Cu): < 100 μg/kg  
Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 μg/kg  
Treatment with active carbon is required to ensure that polycyclic ar omatic hydrocarbons (PAH) are not enriched in the production of 
‘rapeseed oil high in unsaponifiable matter.  
Rapeseed Protein  Definition:  
Rapeseed protein is an aqueous protein -rich extract from rapeseed press cake originating from non -genetically modified Brassica napus  
L. and Brassica rapa  L. 
Description:  
White to off -white, spray dried powder  
Total protein: ≥ 90%  
Soluble protein: ≥ 85%  
Moisture: ≤ 7%  
Carbohydrates: ≤ 7%  
Fat: ≤ 2%  
Ash: ≤ 4%  
Fibre: ≤ 0.5%  
Total glucosinolates: ≤ 1 mmol/l  
Purity:  
Total phytate: ≤ 1.5%  
Lead: ≤ 0.5 mg/kg  
Microbiological criteria:  
Yeast and mould count: ≤ 100 cfu/g  
Aerobic bacteria count: ≤ 10 000 cfu/g  
Total coliform count: ≤ 10 cfu/g   
Escherichia coli:  Absent in 10 g  
Salmonella  spp.: Absent in 25 g  101 
 Trans -resveratrol  Description/Definition:   
Trans -resveratrol is off -white to beige crystals.  
Chemical name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene -1,3-diol 
Chemical formula: C 14H12O3  
Molecular weight: 228.25 Da  
CAS No: 501 -36-0 
Description: Trans -resveratrol is off -white to beige crystals.  
Purity:  
Trans -resveratrol: ≥ 98% - 99% (Includes range for positive SEO)  
Total by -products (related substances): ≤ 0.5%  
Any single related substance: ≤ 0.1%  
Lead: ≤ 1ppm  
Mercury: ≤ 0.1ppm  
Arsenic: ≤ 1ppm  
Sulphated ash: ≤ 0.1%  
Diisopropylamine: ≤ 50 mg/kg  
Loss on drying: ≤ 0.5%  
Trans -Resverastrol (microbial 
source)  Source: A genetically modified strain of Saccharomyces 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  Description/ Definition:  Rooster comb extract is obtained from Gallus gallus  by enzymatic hydrolysis of rooster comb and by 
subsequent filtration, concentration and precipitation steps. The principal constituents of rooster comb extrac t are the glycosaminoglycans 
hyaluronic acid, chondroitin sulphate A and dermatan sulphate (chondroitin sulphate B). White or almost white hygroscopic pow der. 
Hyaluronic acid: 60 -80% 
Chondroitin sulphate A: ≤ 5%  
Dermatan sulphate (chondroitin sulphate B): ≤ 25%  102 
 pH: 5.0 -8.5 
Purity:  
Chlorides: ≤ 1%  
Nitrogen: ≤ 8%  
Loss on drying: (105 °C for 6 hours): ≤ 10%  
Mercury: ≤ 0,1 mg/kg  
Arsenic: ≤ 1 mg/kg  
Cadmium: ≤ 1 mg/kg  
Chromium: ≤ 10 mg/kg  
Lead: ≤ 0.5 mg/kg  
Microbiological criteria:  
Total viable aerobic count: ≤ 102 cfu/g  
Escherichia coli: Absent in 1 g  
Salmonella spp.: Absent in 1 g  
Staphylococcus aureus: Absent in 1 g  
Pseudomonas aeruginosa: Absent in 1g  
Sacha Inchi oil from Plukenetia 
volubilis  
 Description/Definition :  
Sacha inchi oil is a 100% cold pressed v egetable oil obtained from the seeds of Plukenetia volubiis L. It is a transparent, fluid (liquid) and 
shiny oil at room temperature. It has a fruity, light green vegetable taste, without undesirable flavours.  
Aspect limpidity, shine colour: Fluid at room  temperature clean, shiny yellow gold  
Odour and taste: Fruity, vegetable without non acceptable taste or odour  
Water and Volatiles: < 0.2 g/100 g  
Impurities insoluble in hexane: < 0.05 g/100 g  
Oleic acidity: < 2 g/100 g  
Peroxide value: < 15 meq O 2/kg 
Trans  fatty acids: < 1 g/100 g  
Total unsaturated fatty acids: > 90%  
Omega 3 alpha linolenic acid (ALA): > 45%  
Saturated fatty acids: < 10%  
No trans fatty acids (< 0.5%)  103 
 No erucic acid (< 0.2%)  
More than 50 % of tri -linolenin and di -linolenin -triglycerides  
Phytosterols composition and level  
No cholesterol (< 5 mg/100 g)  
Salatrims  Description/Definition :  
Salatrim is the internationally recognised acronym for (short and long chain acyl triglyceride molecules). Salatrim is prepar ed by non -
enzymatic inter -ester ification of triacetin, tripropionin, tributyrin, or their mixtures with hydrogenated canola, soybean, cottonseed, or 
sunflower oil. Description: Clear, slightly amber liquid to a light coloured waxy solid at room temperature. Free of particul ate matter an d 
of foreign or rancid odour.  
Glycerol ester disribution:  
Triacylglycerols: > 87%  
Diacylglycerols: ≤ 10%  
Monoacylglycerols: ≤ 2%  
Fatty acid composition:  
MOLE % LCFA (long chain fatty acids): 33 -70% 
MOLE % SCFA (short chain fatty acids): 30 -67% 
Saturated lo ng chain fatty acids: < 70% by weight  
Trans fatty acids: ≤ 1%  
Free fatty acids as oleic acid: ≤ 0.5%  
Triacylglycerol profile:  
Triesters (short/long of 0.5 to 2.0): ≥ 90%  
Triesters (short/long = 0): ≤ 10%  
Unsaponifiable material: ≤ 1%  
Moisture: ≤ 0.3%  
Ash: ≤ 0.1%  
Colour: ≤ 3.5 Red (Lovibond)  
Peroxide value: ≤ 2.0 Meq/Kg  
Schizochytrium sp. oil rich in  
DHA and EPA  Description/Definition :  
DHA/EPA rich Schizochytrium  algal oil' is the winterized, deodorized oil derived from cultivated microalgae Schizochytrium sp.  
Docosahexaenoic acid (DHA) ≥ 24% w/w  104 
 Eicosapentaenoic acid (EPA) ≥ 12% w/w  
ratio of DHA to EPA is 2:1  
Acid value: ≤ 0.5 mg KOH/g  
Peroxide value: ≤ 5.0 meq /kg oil  
Moisture and volatiles: ≤ 0.05%  
Unsaponifiables: ≤ 4.5%  
Trans -fatty acids: ≤ 1%  
DHA content: ≥ 22.5%  
EPA content: ≥ 10%  
Schizochytrium  sp. (ATCC 
PTA -9695) oil  Free fatty acids: ≤ 0.4%  
Peroxide value: ≤ 5.0 meq/kg oil  
Unsaponifiables: ≤ 3.5%  
DHA co ntent: ≥ 35%  
Docosapentaenoic acid (DPA) n -6: ≤ 6%  
Trans -fatty acids: ≤ 2.0%  
Schizochytrium sp. oil  Acid value: ≤ 0.5 mg KOH/g  
Peroxide value (PV): ≤ 5.0 meq/kg oil  
Moisture and volatiles: ≤ 0.05%  
Unsaponifiables: ≤ 4.5%  
Trans -fatty acids: ≤ 1%  
DHA conten t: ≥ 32.0%  
Fermented soybean extract  Description/Definition:  
Fermented soybean extract is an odourless milk -white coloured powder. It is comprised of 30 % fermented soybean extract powder and 
70 % resistant dextrin (as carrier) from corn -starch, which is  added during the processing. Vitamin K2 is removed during the 
manufacturing process.  
Fermented soybean extract contains nattokinase isolated from natto, a foodstuff produced by the fermentation of non -genetically 
modified soybeans ( Glycine max  (L.)) with a selected strain of Bacillus subtilis  var. natto.  
Nattokinase activity: 20 000 -28 000 FU(1)/g (2)  
Identity: Confirmable  
Condition: No offensive taste or smell  105 
 Loss on drying: ≤ 10%  
Vitamin K2: ≤ 0.1 mg/kg  
Heavy metals: ≤ 20 mg/kg  
Lead: ≤ 5 m g/kg 
Arsenic: ≤ 3 mg/kg  
Total viable aerobic count: ≤ 1 000 CFU (3)/g  
Yeast and mould: ≤ 100 CFU/g  
Coliforms: ≤ 30 CFU/g  
Spore -forming bacteria: ≤ 10 CFU/g   
Escherichia coli : Absence/25 g  
Salmonella  sp.: Absence/25 g  
Listeria : Absence/25 g  
(1) FU: Fibrin d egradation unit  
(2) Assay method as described by Takaoka et al. (2010).  
(3) CFU: Colony forming unit  
Sucromalt  Description/Definition :  
Sucromalt is a complex mixture of saccharides which is produced from sucrose and a starch hydrolysate by means of an en zymatic 
reaction. In this process, glucose units are attached to saccharides from the starch hydrolysate by means of an enzyme produc ed by the 
bacterium Leuconostoc citreum or by means of a recombinant strain of the production organism Bacillus licheniform is. The resulting 
oligosaccharides are characterised by the presence of α -(1→6) and α -(l→3) glycosidic compounds. The overall product is syrup, in 
addition to these oligosaccharides, contains mainly fructose but also the disaccharide leucrose and other dis accharides.  
Total solids: 75 -80% 
Moisture: 20 -25% 
Sulphatase: Max 0.05%  
pH: 3.5 -6.0 
Conductivity < 200 (30%)  
Nitrogen < 10 ppm  
Fructose: 35 -45% d.w.  
Leucrose: 7 -15% d.w.  
Other disaccharides: Mах 3%  106 
 Higher saccharides: 40 -60% d.w  
Sugar Cane Fibre  Description/Definition :  
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 primarily of cellulose and hemicellulose.  
The pr oduction process consists of several steps, including: chipping, alkaline digestion, removal of lignins and other non -cellulosic 
components, bleaching of purified fibres, acid washing and neutralization.  
Moisture : ≤ 7.0%  
Ash: ≤ 0.3%  
Total Dietary Fibre (AOAC) dry basis (all insoluble): ≥ 95%  
of which: Hemicellulose (20 -25%) and cellulose (70 -75%)  
Silica (ppm): ≤200  
Protein: 0%  
Fat: Trace  
pH: 4 -7 
Mercury (ppm): ≤0.1  
Lead (ppm): ≤1  
Arsenic (ppm): ≤1  
Cadmium (ppm): ≤0.1  
Yeast and moulds (cfu/g): ≤1000  
Salmonella : absence  
Listeria monocytogenes : absence  
Sunflower oil extract  Description/Definition :  
The sunflower extract is obtained by a concentration factor of 10 of the unsaponifiable fraction of refined sunflower oil ext racted from 
the seeds of the sunflower, Helianthus Annuus  L). 
Composition:  
Oleic acid (C18:1): 20%  
Linoleic acid (C18:2): 70%  
Unsap onifiable matter: 8%  107 
 Phytosterols: 5.5%  
Tocopherols: 1.1%  
Dried Tetraselmis chuii  
microalgae  Description/Definition:  
The dried product is obtained from the marine microalgae Tetraselmis chuii , belonging to the Chlorodendraceae family, cultivated in 
sterile sea water in closed photobioreactors insulated from the outside air.  
Identified by means of nuclear marker rDNA 18 S (sequence analysed no less than 1,600 base pairs) in the National Centre for 
Biotechnology information (NCBI ) database: Not less than 99.9%  
Humidity: ≤ 7%  
Proteins: 35 -40% 
Ashes: 14 -16% 
Carbohydrates: 30 -32% 
Fibre: 2 -3% 
Fat: 5 -8% 
Saturated fatty acids: 29 -31% of total fatty acids  
Monounsaturated fatty acids: 21 -24% of total fatty acids  
Polyunsaturated fatty acid s: 44 -49% of total fatty acids  
Iodine: ≤ 15 mg/kg  
Therapon barcoo /Scortum  Description/Definition:  
Scortum/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 Identification: Class: Actinopterygii > order: Perciformes > family: Terapontidae > genus: Therapon or Scortum Barc oo 
Composition of fish flesh:  
Protein (%): 18 -25  
Moisture (%): 65 -75  
Ash (%): 0,5 -2  
Energy (KJ/Kg): 6000 -11500  
Carbohydr ates: 0  
Fat (%): 5 -15  
Fatty acids (mg FA/g fillet):  108 
 14:00: 0.5 -6.1  
15:00: 0.0 -0.4  
16:00: 8.8 -36.4  
16:1(n -7): 0.8 -13.1  
18:00: 2.2 -7.8  
18:1(n -9): 10.6 -65.3  
18:1(n -7): 0.4 -2.7  
18:2(n -6): 2.1 -42.1  
18:3(n -6): 0.0 -2.3  
18:3(n -3): 0.0 -27.3  
18:4(n -3): 0.0 -3.0  
20:00: 0.1 -0.8  
20:2(n -6): 0.2 -0.5  
20:4(n -6): 0.0 -0.3  
20:5(n -3): 0.1 -5.2  
22:5(n -3): 0.0 -2.4  
22:6(n -3): 0.6 -11.3  
Σ HUFA n -3: 1.2 -20.0  
Σ HUFA n -6: 0.3 -2.0  
HUFA n -3/n-6: 1.5 -15.0  
Total omega 3 acids: 1.6 -40.0  
Total omega 6 acids: 2.6-10.0 
D-Tagatose  Appearance: White or almost white crystals  
Chemical name: D -tagatose  
Synonym: D -lyxo-Hexulose  
CAS number: 87 -81-0 
Chemical formula: C 6H12O6 
Formula weight: 180.16  109 
 Assay: ≥ 98% on a dry weight basis  
Loss on drying: ≤ 0.5% (102°C, 2 hours)  
Lead: ≤ 1 mg/kg*  
Specific Rotation: [α]20 D: -4 to -5.6° (1% aqueous solution)1 
Melting range: 133 -137 C1  
* Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of  sample 
preparation may be based on the principles of the method described in FNP 5. 'Instrumental methods'1.  
1 Food and nutrition paper 5 Rev 2 – Guide to specifications for general notices, general analytical techniques, identification tests, test 
solutions and  other reference materials (JECFA) 1991, 307 p.; English – ISBN 92 -5-102991 -1 
Taxifolin -rich extract  Description:  Taxifolin -rich extract from the wood of Dahurian Larch ( Larix gmelinii  (Rupr.) Rupr) is a white to pale -yellow powder that 
crystallizes from hot aqueous solutions.  
Definition:  
Chemical name: [(2R,3R) -2-(3,4 dihydroxyphenyl) -3,5,7 -trihydroxy -2,3-dihydrochromen -4-one, also called (+) trans (2R,3R) - 
dihydroquercetin]  
Chemical f ormula: C15H12O7  
Molecular mass: 304.25 Da  
CAS No: 480 -18-2 
Specifications:  
Physical parameter  
Moisture: ≤ 10%  
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  
Mercury: ≤ 0.1 mg/kg  
Dichlorodiphenyldichloroethane (DDT): ≤ 0.05 mg/kg  110 
 Residual solvents   
Ethanol: < 5,000 mg/kg  
Microbial Parameters  
Total Plate Count (TPC): ≤ 104 CFU/g  
Enterobacteria: ≤ 100/g  
Yeast and Mould  : ≤ 100 CFU/g  
Escherichia coli : Negative/1 g 
Salmonella  spp.: Negative/10 g  
Staphylococcus aureus : Negative/1 g  
Pseudomonas  spp.: Negative/1 g  
Usual range of components of the Taxifolin -rich extract (as per dry substance)  
Extract component  Content, usual observed range (%)  
Taxifolin   90 – 93 
Aromadendrin   2.5 – 3.5 
Eriodictyol   0.1 – 0.3 
Quercetin   0.3 – 0.5 
Naringenin   0.2 – 0.3 
Kaempferol   0.01 – 0.1  
Pinocembrin   0.05 – 0.12 
Unidentified 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 %.  
Trehalose  Description/Definition : 
A non -reducing disaccharide that consists of two glucose moieties linkes by an α -1,1-glucosidic bond. It is obtained  from liquefied starch 
by a multistep enzymatic process. The commercial product is the dihydrate. Virutally odourless, white or almost white crystal s with a 
sweet taste  111 
 Synonyms: α,α -trehalose  
Chemical name: α -D-glucopyranosyl -α-D-glucopyranoside, dihydrat e 
CAS No.: 6138 -23-4 (dihydrate)  
Chemical formula: C 12H22O11 • 2H 2O (dihydrate)  
Formula weight: 378.33 (dihydrate)  
Assay: ≥ 98% on the dry basis  
Characteristics:  
Identification:  
Solubility: Freely soluble in water, very slightly soluble in ethanol  
Specific rotation: [α]D20 + 199° (5 % aqueous solution)  
Melting point: 97 °C (dihydrate)  
Purity:  
Loss on drying: ≤ 1.5% (60°C, 5h)  
Total ash: ≤ 0.05%  
Lead: ≤ 1 mg/kg  
Determine using an atomic absorption technique appropriate to the specified level. The sel ection of sample size and method of sample 
preparation may be based on the principles of the method described in FNP 5 (1), ‘Instrumental methods’  
Method of assay:  
Principle: trehalose is identified by liquid chromatography and quantified by comparison to a reference standard containing standard 
trehalose  
Preparation of sample solution: weigh accurately about 3 g of dry sample into a 100 -ml volumetric flask and add about 80 ml of purified, 
deionised water. Bring sample to complete dissolution and dilute to mark with purified deionised water. Filter through a 0,45 micron 
filter  
Preparation of standard solution: dissolve accurately weighed quantities of dry standard reference trehalose in water to obta in a solution 
having known concentration of about 30 mg of trehalose per ml  
Apparatus: liquid chromatography equipped with a refractive index detector and integrating recorder  
Conditions:  
Column: Shodex Ionpack KS -801 (Showa Denko Co.) or equivalent  
— length: 300 mm  
— diameter: 10 mm  
— temperature: 50 °C  112 
 Mobile ph ase: water  
flow rate: 0.4 ml/min  
Injection volume: 8 μl  
Procedure: inject separately equal volumes of the sample solution and the standard solution into the chromatograph.  
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 following formula:  
% trehalose = 100 × (R U/RS) (W S/W U) 
where  
RS = peak area of trehalose in the standard preparation  
RU = peak area of trehalose in the sample preparation  
WS = we ight in mg of trehalose in the standard preparation  
WU = weight of dry sample in mg  
UV treated mushrooms with 
increased levels of Vitamin D 2 Description/Definition:   
Commercially grown Agaricus bisporus  to which UV light treatment is applied to harvested mushrooms yielding a Vitamin D content of 
≤10 µg/100g fresh weight  
Vitamin D 2: 
Chemical name: (3β,5Z,7E,22E) -9,10-secoergosta -5,7,10(19),22 -tetraen -3-ol  
Synonym: Ergocalciferol  
CAS No: 50 -14-6 
Molecular weight: 396.65 g/mol  
Contents:  
Vitamin D in the final product: 5 -10 µg/100g fresh weight at the expiration of shelf life  
UV-treated baker's yeast 
(Saccharomyces cerevisiae ) Description/Definition:  
Baker's yeast ( Saccharomyces cerevisiae ) is tr eated with ultraviolet light to induce the conversion of ergosterol to vitamin D 2 
(ergocalciferol). Vitamin D 2 content in the yeast concentrate varies between 1 800 000 -3 500 000 IU vitamin D/100 g (450 -875 μg/g).  
Tan-coloured, free -flowing granules  
Vitam in D 2: 
Chemical name: (5Z,7E,22E) -3S-9,10-secoergosta -5,7,10(19),22 -tetraen -3-ol 
Synonym: Ergocalciferol  
CAS No.: 50 -14-6 113 
 Molecular weight: 396.65 g/mol  
Microbiological criteria for the yeast concentrate:  
Coliforms: ≤ 1000/g  
Escherichia coli : ≤ 10/g  
Salmonella  spp.: Absent in 25g  
UV-treated bread  Description/Definition:   
UV-treated bread is yeast leavened bread and rolls (without toppings) to which a treatment with ultraviolet radiation is applied  after 
baking in order to convert ergosterol to vitamin D 2 (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 D 2: 
Chemical name : (5Z,7E,22E) -3S-9,10-secoergosta -5,7,10(19),2 2-tetraen -3-ol 
Synonym:Ergocalciferol  
CAS No: 50 -14-6 
Molecular weight: 396.65 g/mol  
Contents:  
Vitamin D 2 (ergocalciferol) in the final product: 0.75 -3 μg/100 g (1)  
Yeast in dough: 1 -5 g/100 g (2)  
(1) EN 12821, 2009, European Standard.  
(2) Recipe calculation.  
UV-treated milk  Description/Definition :  
UV-treated milk is cow's milk (whole and semi -skimmed) to which a treatment with ultraviolet (UV) radiation via turbulent flow is 
applied after pasteurisation. The treatment of the pasteurised milk wit h UV radiation results in an increase in the vitamin D 3 
(cholecalciferol) concentrations by conversion of 7 -dehydrocholesterol to vitamin D 3. UV radiation: A process of radiation in ultraviolet 
light within the wavelength of 200 -310 nm with energy input of  1 045 J/l  
Vitamin D 3: 
Chemical name: (1S,3Z) -3-[(2E) -2-[(1R,3aS,7aR) -7a-methyl -1-[(2R) -6-methylheptan -2-yl]-2,3,3a,5,6,7 -hexahydro -1H-inden -4-
ylidene]ethylidene] -4-methylidenecyclohexan -1-ol 
Synonym: Cholecalciferol  
CAS No: 67 -97-0 114 
 Molecular weight: 384.6 377 g/mol  
Contents:  
Vitamin D 3 in the final product:  
Whole milk (1): 0.5-3.2 μg/100 g(2) 
Semi -skimmed milk(1): 0.1 –1.5 μg/100 g(2) 
(1) As defined by Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing  a 
common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/7 9, 
(EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671).  
(2) HPLC  
Vitamin K 2 (menaquinone)  This novel food is  produced by a specific authorised synthetic or microbiological process  
Specification of the synthetic source  
Chemical Name: (all -E)-2-(3,7,11,15,19,23,27 -Heptamethyl -2,6,10,14,18,22,26 -octacosaheptaenyl) -3-methyl -1,4-naphtalenedione  
CAS Number: 2124 -57-4 
Molecular formula: C 46H64O2 
Molecular weight: 649 g/mol  
Appearance: Yellow powder  
Purity: Max 6% cis -isomer, max 2% other impurities  
Content: 98 -102% Menaquinone -7 (including at least 92% all -trans Menaquinone -7) 
Specifications of the microbial process  
Source: Bacillus subtilis  spp. natto  
Vitamin K 2 (2-methyl -3-all-trans -polyprenyl -1,4-naphthoquinones), or the menaquinone series, is a group of prenylated naphthoquinone 
derivatives. The number of isoprene residues, where 1 isoprene unit consists of 5 carb ons comprising the side chain, is used to 
characterise the menaquinone homologues. It is presented in an oil suspension that primarily contains MK -7, and MK -6 to a smaller 
extent  115 
 Wheat bran extract  Description/Definition:  
White crystalline powder obtained by enzymatic extraction from Triticum aestivum L. bran, rich in arabinoxylan oligosaccharides  
Dry matter: Min. 94%  
Arabinoxylan oligosaccharides: Min 70% of dry matter  
Average degree of polymerisation of arabinoxylan oligo saccharides: 3 -8 
Ferulic acid (bound to arabinoxylan oligosaccharides): 1 -3% of dry matter  
Total poly/oligosaccharides: Min 90%  
Protein: Max % of dry matter  
Ash: Max 2% of dry matter  
Microbiological parameters:  
Mesophilic bacteria – total count: Max 10 000 /g 
Yeasts: Max 100/g  
Fungi: Max 100/g  
Salmonella : Absent in 25g  
Bacillus cereus : Max 1000/g  
Clostridium perfringens : Max 1000/g  
Yeast beta -glucans  Description/Definition :  
Beta-glucans are complex, high molecular mass (100 –200 kDa) polysaccharides, found in the cell wall of many yeasts and cereals.  
The chemical name for ‘yeast beta -glucans’ is (1 -3),(1 -6)-ß-D-glucans.  
Beta-glucans consist of a backbone of ß -1-3-linked glucose residues that are branched by ß -1-6-linkages, to which chitin and 
mannoproteins are linked by ß -1-4-bonds.  
Beta-glucans are isolated from yeast Saccharomyces cerevisiae . 
The tertiary structure of the glucan cell wall of Saccharomyces cerevisiae  consists of chains of ß -1,3-linked glucose residues, branched 
by ß-1,6-linkages, forming a backbone to which are linked chitin via ß -1,4- bonds, ß -1,6-glucans and some mannoproteins.  
This novel food is available in a soluble and insoluble form and insoluble i n water, but dispersible in many liquid matrices.  
Chemical characteristics yeast ( Saccharomyces cerevisiae ) beta -glucans : 
Soluble form:  
Total carbohydrates: > 75%  
Beta-glucans (1.3/1.6): > 75%  116 
 Ash: < 4%  
Moisture: < 8%  
Protein: < 3.5%  
Fat: < 10%  
Insolu ble form:  
Total carbohydrates: > 70%  
Beta-glucans (1.3/1.6): > 70%  
Ash: ≤ 12%  
Moisture: < 8%  
Protein: < 10%  
Fat: < 20%  
Insoluble in water, but dispersible in many liquid matrices:  
(1,3) -(1,6) -ß-D-Glucans: > 80%  
Ash: < 2%  
Moisture: < 6%  
Protein:  < 4%  
Total fat:  < 3%  
Microbiological data:  
Total plate count: < 1000 CFU/g  
Enterobacteriaceae: < 100 CFU/g  
Total coliforms: < 10 CFU/g  
Yeast: < 25 CFU/g  
Mould: < 25 CFU/g  
Salmonella  ssp.: Absent in 25 g  
Escherichia coli : Absent in 1 g  
Bacillus cereus : < 100 CFU/g  
Staphylococcus aureus : Absent in 1 g  
Heavy metals : 
Lead: < 0.2 mg/g  117 
 Arsenic: < 0.2 mg/g  
Mercury: < 0.1 mg/g  
Cadmium: < 0.1 mg/g  
Zeaxanthin (synthetic)  Description/Definition:   
Zeaxanthin is a naturally occurring xanthophyll pigment, it is an oxygenated carotenoid. Synthetic zeaxanthin is presented ei ther as a 
spray -dried powder of gelatin or starch base (‘beadlets’) with added α -tocopherol and ascorbyl palmitate or as a corn oil  suspension with 
added α -tocopherol.  
Production process: Synthetic zeaxanthin is produced by a multi -step chemical synthesis from smaller molecules. Orange -red crystalline 
powder with little or no odour  
Chemical formula: C 40H56O2 
CAS No: 144 -68-3 
Molecula r weight: 568.9 daltons  
Physical -chemical properties:  
Loss on drying: < 0.2%  
All-trans zeaxanthin: > 96%  
Cis-zeaxanthin: < 2%  
Other carotenoids: < 1.5%  
Triphenylphosphine oxid (CAS No 791 -28-6): < 50 mg/kg  
Zinc L -pidolate  Description/Definition:  
Zinc L -pidolate is a white to creamy white powder, with characteristic odor.  
International non -proprietary name (INN): L -pyroglutamic acid, Zinc salt  
Synonyms: Zinc 5 -oxoproline, Zinc pyroglutamate, Zinc pyrrolidone carboxylate, Zinc PCA, L -Zinc pidolate  
CAS No.:  15454 -75-8 
Molecular formula: (C 5 H6 NO 3)2 Zn 
Relative anhydrous molecular mass: 321.4  
Appearance: White to slightly white powder  
pH (10% aqueous sol.): 5.0 - 6.0 
Specific rotation: - 22.8° to - 19.6°  
Water: ≤ 10.0%  
Glutamic acid: <2.0%  118 
 Lead: ≤ 3 ppm  
Arse nic: ≤ 2 ppm  
Cadmium: ≤ 1 ppm  
Mercury: ≤ 0.1 ppm  
Zinc L -pidolate (purity): ≥ 98.0%  
Total viable mesophilic count: ≤ 10 E3 U.F.C/g  
Yeasts and moulds: ≤ 10 E2 U.F.C/g  
Pathogen: Absence