Implementing regulation 2017/2470 - Union list of novel foods in accordance with Regulation 2015/2283 on novel foods - Main contents

5 % (whole or ground chia seeds)

10 % whole chia seeds

10 % whole chia seeds

10 % whole chia seeds

15 g/day for addition of whole, mashed or ground chia seeds

15 g/day whole chia seeds

1 % whole chia seeds

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

5 % whole chia seeds

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’

5 g/day

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’

5 g/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitosan extract from Agaricus bisporus’ or ‘Chitosan extract from Aspergillus niger’

In line with normal use in food supplements of chitosan from crustaceans

Specified food category

Maximum levels

The designation of the novel on the labelling of the foodstuff containing it shall be ‘Chondroitin sulphate derived from microbial fermentation and sulphation’

1 200 mg/day

Specified food category

Maximum levels of total chromium

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chromium Picolinate’

250 μg/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Cistus incanus L. Pandalis herb’

Intended daily intake: 3 g herbs/day (2 cups/day)

Specified food category

Maximum levels

500 mg/day

250 mg per serving and a maximum daily consumption level of 1 000 mg

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Clostridium butyricum MIYAIRI 588 (CBM 588)’ or ‘Clostridium butyricum (CBM 588)’

1,35 × 108 CFU/day

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

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)

Specified food category

Maximum levels

Consumers shall be instructed not to consume more than 600 mg of cocoa flavanols per day

730 mg per serving and around 1,2 g/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Coriander seed oil’

600 mg/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Crataegus pinnatifida dried fruit’

In line with normal food use of Crataegus laevigata

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Alpha-cyclodextrin’ or ‘α-cyclodextrin’

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Gamma-Cyclodextrin’ or ‘γ-Cyclodextrin’

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Dextran’

5 %

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)’

Specified food category

Maximum levels

9 mg/100 g

9 mg/100 g

12 mg/100 g

1,5 mg/100 ml

2 mg/100 ml

1,5 mg/100 ml

1 mg/100 ml

2,5 mg/100 g

4,5 mg/100 g

4 mg/100 g

2 mg/100 g

2 mg/100 g

7,5 mg/100 g

27 mg/100 g

115 mg/100 g

40 mg/100 g

200 mg/100 g

1,1 mg/100 g

16 mg/100 g

5 mg/100 g

3 mg/meal

3 mg/meal

1 mg/100 ml

3 mg/single intake

9 mg/day

14,5 mg/kg equivalent to 1,5 mg/100 ml

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried extract of Lippia citriodora from cell cultures HTN®Vb’

In line with normal use in food supplements of a similar extract from the leaves of Lippia citriodora

Specified food category

Maximum levels

In line with normal use in food supplements of a similar extract from the root of Echinacea angustifolia

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’

250 mg/100 g; 75 mg/100 g for drinks

750 mg/100 g

750 mg/100 g

625 mg/100 g

500 mg/day

In accordance with the particular nutritional requirements of the persons for whom the products are intended

250 mg/meal

Specified food category

Maximum levels

The labelling shall bear a statement that consumers should not consume more than 300 mg of extract per day

150 mg of extract in one portion of food or food supplement

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘L-ergothioneine’

30 mg/day for general population (excluding pregnant and lactating women)

20 mg/day for children older than 3 years

Specified food category

Maximum levels (expressed as anhydrous EDTA)

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ferric Sodium EDTA’

18 mg/day for children

75 mg/day for adults

12 mg/100 g

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ferrous ammonium phosphate’

To be used in compliance with Directive 2002/46/EC, Regulation (EU) No 609/2013 and/or Regulation (EC) No 1925/2006

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’

0,48 g/100 g (ready to eat/drink)

0,3 g/100 g (ready to drink)

2 g/100 g

0,3 g/100 g (ready to eat)

Specified food category

Maximum levels of flavonoids from Glycyrrhiza glabra

Beverages containing flavonoids shall be presented to the final consumer as single portions.

120 mg/day

120 mg/day

120 mg/day

120 mg/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fucoidan extract from seaweed Fucus vesiculosus’.

250 mg/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fucoidan extract from seaweed Undaria pinnatifida’

250 mg/day

Specified food category

Maximum levels

1,2 g/l

1,2 g/l beverages

1,2 g/l beverages

1,2 g/l beverages

12 g/kg

200 g/kg

1,2 g/l alone or in combination with up to 0,6 g/l of lacto-N-neotetraose at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

1,2 g/l alone or in combination with up to 0,6 g/l of lacto-N-neotetraose at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

12 g/kg for products other than beverages

1,2 g/l for milk-based drinks and similar products added alone or in combination with up to 0,6 g/l lacto-N-neotetraose, at a ratio of 2:1 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

In accordance with the particular nutritional requirements of the persons for whom the products are intended

4,8 g/l for drinks

60 g/kg

1,2 g/l

9,6 g/l - the maximum level refers to the products ready to use

3,0 g/day for general population

Specified food category

Maximum levels (expressed as ratio kg galacto-oligosaccharide/kg final food)

0,333

0,020

0,030

0,020

0,020

0,033

0,043

0,043

0,021

0,012

0,025

0,024

0,027

0,143

0,027

0,013

0,021

0,059

0,125

0,125

0,125

0,008

Specified food category

Maximum levels

In line with normal food use of glucosamine from shell fish

Specified food category

Maximum levels

In line with normal food use of glucosamine from shell fish

Specified food category

Maximum levels

In line with normal food use of glucosamine from shell fish

Specified food category

Maximum levels

1,5 g/100 g

1,8 g/100 g

3,25 g/100 g

10 g/100 g in the cereals

None in the accompanying dairy product

1 g/100 g in the product when ready to eat

Specified food category

Maximum levels

Specified food category

Maximum levels

The designation of the novel food on the labelling of the food products containing shall be ‘hydroxytyrosol’.

The labelling of the food products containing hydroxytyrosol shall bear the following statements:

0,215 g/kg

0,175 g/kg

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ice Structuring Protein’

0,01 %

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Extracts of dried leaves of Ilex guayusa’

In line with normal use in herbal infusions and food supplements of a similar aqueous extract of dried leaves of Ilex paraguariensis

Specified food category

Maximum levels

6,5 %

5,0 %

6,5 %

5 %

5 %

5 %

10 %

20 %

25 %

97 %

25 %

20 %

Not specified

Specified food category

Maximum levels

The designation of the novel food on the labelling of the food supplements containing it shall be ‘Lactitol’

20 g/day

Specified food category

Maximum levels

0,6 g/l

0,6 g/l for beverages

9,6 g/kg for products other than beverages

0,6 g/l for beverages

9,6 g/kg for products other than beverages

0,6 g/l for beverages

6 g/kg for products other than beverages

200 g/kg for whitener

6 g/kg

100 g/kg

0,6 g/l in combination with up to 1,2 g/l of 2′-fucosyllactose at a ratio of 1:2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

0,6 g/l in combination with up to 1,2 g/l of 2′-fucosyllactose at a ratio of 1: 2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

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

0,6 g/l for milk-based drinks and similar products added alone or in combination with 2′-O-fucosyllactose, at concentrations up to 1,2 g/l, at a ratio of 1:2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

In accordance with the particular nutritional requirements of the persons for whom the products are intended

2,4 g/l for drinks

20 g/kg for bars

30 g/kg

0,6 g/l

4,8 g/l - the maximum level refers to the products ready to use

1,5 g/day for general population

0,6 g/day for young children

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’.

10 g/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’

2,5 mg/100 g

2,5 mg/100 g

8 mg/meal

5 mg/100 g

10 mg/100 g

1 mg/100 g

3 mg/100 g

In accordance with the particular nutritional requirements of the persons for whom the products are intended

15 mg/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’

2,5 mg/100 g

2,5 mg/100 g

8 mg/meal

5 mg/100 g

10 mg/100 g

1 mg/100 g

3 mg/100 g

In accordance with the particular nutritional requirements of the persons for whom the products are intended

15 mg/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lycopene’

2,5 mg/100 g

2,5 mg/100 g

8 mg/meal

5 mg/100 g

10 mg/100 g

1 mg/100 g

3 mg/100 g

In accordance with the particular nutritional requirements of the persons for whom the products are intended

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’

2,5 mg/100 g

2,5 mg/100 g

8 mg/meal

5 mg/100 g

10 mg/100 g

1 mg/100 g

3 mg/100 g

In accordance with the particular nutritional requirements of the persons for whom the products are intended

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Magnesium citrate malate’

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Magnolia Bark Extract’

0,2 % for breath freshening purposes. Based on a 0,2 % maximum incorporation level and a maximum gum/mint size of 1,5 g each, each gum or mint serving will contain no more than 3 mg of magnolia bark extract.

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Maize-germ oil extract’

2 g/day

2 %

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

2 %

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘(6S)-5-methyltetrahydrofolic acid, glucosamine salt’ or ‘5MTHF-glucosamine’

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)’

10,40 mg/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘extract from the mushroom Lentinula edodes’ or ‘extract from Shiitake mushroom’

2 ml/100 g

0,5 ml/100 ml

2,5 ml per meal

1,5 ml/100 ml

2,5 ml per day dose

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’

30 ml with one serving (up to 100 % noni juice)

or

20 ml twice a day, not more than 40 ml per day

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’

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be:

Fruit puree

45 g/100 g

53 g/100 g

53 g/100 g

11 g/100 g

31 g/100 g

12 g/100 g

53 g/100 g

53 g/100 g

88 g/100 g

133 g/100 g

Based on pre-processing quantity to produce final 100 g product

31 g/100 g

88 g/100 g

26 g/day

Fruit concentrate

10 g/100 g

12 g/100 g

12 g/100 g

3 g/100 g

7 g/100 g

3 g/100 g

12 g/100 g

12 g/100 g

20 g/100 g

30 g/100 g

7 g/100 g

20 g/100 g

6 g/day

Specified food category

Maximum levels

A cup of infusion to be consumed shall not be prepared with more than 1 g of dried and roasted leaves of 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’

2,4 g per/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Odontella aurita microalgae’

1,5 %

1 %

0,5 %

1 %

1,5 %

1,5 %

Specified food category

Maximum levels of phytosterols/phytostanols

In accordance with Annex III.5 to Regulation (EU) No 1169/2011

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’.

200 mg/100 g or for cheese products 600 mg/100 g

200 mg/100 g or for analogues to cheese products 600 mg/100 g

600 mg/100 g

500 mg/100 g

200 mg/100 g

500 mg/100 g

60 mg/100 ml

3 000 mg/day for general population

450 mg/day for pregnant and lactating women

In accordance with the particular nutritional requirements of the persons for whom the products intended

200 mg/meal

Specified food category

Maximum levels

The wording ‘pasteurised by high-pressure treatment’ shall be displayed next to the name of the fruit preparations as such and in any product in which it is used

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phosphated maize starch’

15 %

Specified food category

Maximum levels of phosphatidylserine

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish phosphatidylserine’

50 mg/100 ml

3 500 mg/100 g (equivalent to 40 mg/100 ml ready to drink)

80 mg/100 g

350 mg/100 g

200 mg/100 g

In compliance with Regulation (EU) No 609/2013

300 mg/day

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’

50 mg/100 ml

3,5 g/100 g (equivalent to 40 mg/100 ml ready to drink)

80 mg/100 g

350 mg/100 g

200 mg/100 g

In compliance with Regulation (EU) No 609/2013

Specified food category

Maximum levels of phosphatidylserine

The designation of the novel food on the labelling of the foodstuffs containing shall be ‘Soy phosphatidylserine and phosphatidic acid’

The product is not intended to be marketed to pregnant or breast-feeding women

80 mg/100 g

350 mg/100 g

80 mg/100 g

80 mg/100 g

50 mg/100 g

50 mg/100 g

3,5 g/100 g (equivalent to 40 mg/100 ml ready-to drink)

800 mg/day

In compliance with Regulation (EU) No 609/2013

Specified food category

Maximum levels

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Phytoglycogen’

25 %

Specified food category

Maximum levels

In accordance with Annex III.5 of Regulation (EU) No 1169/2011

Specified food category

Maximum levels

In line with normal food use of vegetable oils

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Potato protein’

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Prolyl oligopeptidase’

120 PPU/day (2,7 g of enzyme preparation/day) (2 × 106 PPI/day)

PPU – Prolyl Peptidase Units or Proline Protease Units

PPI – Protease Picomole International

Specified food category

Maximum levels

3 capsules/day; equalizing 12,6 mg pig kidney extract a day

Diamine oxidase (DAO) content: 0,9 mg/day (3 capsules with a content of DAO of 0,3 mg/capsule)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rapeseed oil extract’

1,5 g per portion recommended for daily consumption

As a vegetable protein source in foods except in infant formula and follow-on formula

Specified food category

Maximum levels

150 mg/day

Specified food category

Maximum levels

In line with normal use in food supplements of resveratrol extracted from Japanese knotweed (Fallopia japonica)

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’

40 mg/100 g or mg/100 ml

80 mg/100 g or mg/100 ml

65 mg/100 g or mg/100 ml

110 mg/100 g or mg/100 ml

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)’

In line with normal food use of linseed oil

Specified food category

Maximum levels

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.’

3 000 mg/day

450 mg/day

In accordance with the particular nutritional requirements of the persons for whom the products are intended

250 mg/meal

200 mg/100 g

200 mg/100 g

500 mg/100 g

360 mg/100 g

600 mg/100 g for cheese; 200 mg/100 g for soy and imitation milk products (excluding drinks)

600 mg/100 g for cheese; 200 mg/100 g for milk products (including milk, fromage frais and yoghurt products; excluding drinks)

80 mg/100 g

500 mg/100 g

600 mg/100 g

Specified food category

Maximum levels of DHA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp. (ATCC PTA-9695)’

200 mg/100 g or for cheese products 600 mg/100 g

200 mg/100 g or for analogues to cheese products 600 mg/100 g

600 mg/100 g

500 mg/100 g

250 mg DHA/day for general population

250 mg/meal

200 mg/100 g

In accordance with the particular nutritional requirements of the persons for whom the products are intended

200 mg/100 g

500 mg/100 g

360 mg/100 g

80 mg/100 ml

In accordance with Regulation (EU) No 609/2013

200 mg/100 g

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.’

200 mg/100 g or for cheese products 600 mg/100 g

200 mg/100 g or for analogues to cheese products 600 mg/100 g

600 mg/100 g

500 mg/100 g

250 mg DHA/day for general population

250 mg/meal

200 mg/100 g

In accordance with the particular nutritional requirements of the persons for whom the products are intended

200 mg/100 g

500 mg/100 g

360 mg/100 g

80 mg/100 ml

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.’

200 mg/100 g or for cheese products 600 mg/100 g

200 mg/100 g or for analogues to cheese products 600 mg/100 g

600 mg/100 g

500 mg/100 g

250 mg DHA/day for general population

250 mg/meal

200 mg/100 g

In accordance with the particular nutritional requirements of the persons for whom the products are intended

200 mg/100 g

500 mg/100 g

360 mg/100 g

80 mg/100 ml

In accordance with Regulation (EU) No 609/2013

200 mg/100 g

Specified food category

Maximum levels

100 mg/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the food supplements containing it shall be ‘spermidine-rich wheat germ extract’

Equivalent of max. 6 mg/day spermidine

Specified food category

Maximum levels

Specified food category

Maximum levels

8 %

5 %

3 %

3 %

2 %

5 %

2 %

5 %

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sunflower oil extract’

1,1 g/day

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Dried microalgae Tetraselmis chuii’ or ‘Dried microalgae T. chuii’

Food supplements containing dried microalgae Tetraselmis chuii shall bear the following statement: ‘Contains negligible amounts of iodine’

20 % or 250 mg/day

1 %

250 mg/day

250 mg/day

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

Specified food category

Maximum levels

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘taxifolin-rich extract’.

100 mg/day

Specified food category

Maximum levels

Specified food category

Maximum levels of vitamin D2

10 μg of vitamin D2/100 g fresh weight

Specified food category

Maximum levels of vitamin D2

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Vitamin D yeast’ or ‘Vitamin D2 yeast’

5 μg of vitamin D2/100 g

5 μg of vitamin D2/100 g

5 μg of vitamin D2/day

Specified food category

Maximum levels of vitamin D2

The designation on the label of the novel food shall be accompanied by ‘contains vitamin D produced by UV-treatment’

3 μg vitamin D2/100 g

Specified food category

Maximum levels of vitamin D3

5-32 μg/kg for general population excluding infants

1-15 μg/kg for general population excluding infants

To be used in compliance with Directive 2002/46/EC, Regulation (EU) No 609/2013 and/or Regulation (EC) No 1925/2006

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Menaquinone’ or ‘Vitamin K2’

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Wheat bran extract’

The ‘Wheat Bran Extract’ may not be introduced onto the market as a food supplement or food supplement ingredient. Nor may it be added to infant formula.

0,4 g/100 g

9 g/100 g

2,4 g/100 g

0,6 g/100 g

0,6 g/100 g

2 g/100 g

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’

1,275 g/day for children older than 12 years and general adult population

0,675 g/day for children younger than 12 years

1,275 g/day

1,275 g/day

1,3 g/kg

0,8 g/kg

38,3 g/kg (powder)

0,8 g/kg (ready to drink)

6 g/kg

15,3 g/kg

1,5 g/kg

6,7 g/kg

6,7 g/kg

3,8 g/kg

3,8 g/kg

3,8 g/kg

25,5 g/kg

0,9 g/kg (ready to eat)

4 g/kg

19,1 g/kg

11,3 g/kg

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘synthetic zeaxanthin’

2 mg/day

Specified food category

Maximum levels

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

3 g/day

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

Description/Definition:

Hydroalcoholic extract from Ajuga reptans L. tissue cultures which is substantially equivalent to extracts from flowering aerial parts of Ajuga reptans obtained by traditional cultures.

Description/Definition:

L-Alanyl-L-Glutamine is produced by fermentation with a genetically modified strain of Escherichia coli. During the fermentation process, the ingredient is secreted into the growth medium from which it is subsequently separated and purified to a concentration of > 98 %.

Appearance: White crystalline powder

Purity: > 98 %

Infrared spectroscopy: Conformity with ref. standard

Appearance of solution: Colourless and clear

Assay (dry basis): 98-102 %

Related substances (each): ≤ 0,2 %

Residue on ignition: ≤ 0,1 %

Loss on drying: ≤ 0,5 %

Optical rotation: + 9,0 - + 11,0°

pH (1 %; H2O): 5,0-6,0

Ammonium (NH4): ≤ 0,020 %

Chloride (Cl): ≤ 0,020 %

Sulphate (SO4): ≤ 0,020 %

Microbiological criteria:

Escherichia coli: Absence/g

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: ≤ 1,0 %

DHA content: ≥ 32 %

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): < 1,0 %

Myristic acid (C14:0): < 1,0 %

Palmitic acid (C16:0): < 2,0 %

Palmitoleic acid (C16:1): < 1,0 %

Stearic acid (C18:0): 45-58 %

Oleic acid (C18:1): 40-51 %

Linoleic acid (C18:2): < 1,0 %

γ-Linolenic acid (C18:3): < 1,0 %

Arachidic acid (C20:0): < 1,0 %

Free fatty acids: max 0,1 %

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

Description/Definition:

Powdered gel extract derived from the leaves of Aloe macroclada Baker which is substantially equivalent to the same gel derived from Aloe vera L. Burm. leaves.

Ash: 25 %

Dietary fibres: 28,6 %

Fat: 2,7 %

Moisture: 4,7 %

Polysaccharides: 9,5 %

Protein: 1,63 %

Glucose: 8,9 %

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 residual water are removed by evaporation.

Saponification value: ≤ 230 mg KOH/g

Peroxide value (PV): ≤ 3 meq O 2/kg oil

Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °C

Phospholipids: 35-50 %

Trans-fatty acids: ≤ 1 %

EPA (eicosapentaenoic acid): ≥ 9 %

DHA (docosahexaenoic acid): ≥ 5 %

Description/Definition:

Oil rich in phospholipids is produced from Antarctic krill (Euphausia superba) by repeated solvent washings with an approved solvent (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 O2/kg oil

Oxidative stability: All food products containing Antarctic Krill oil rich in phospholipids from Euphausia superba should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC).

Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °C

Phospholipids: ≥ 60 %

Trans-fatty acids: ≤ 1 %

EPA (eicosapentaenoic acid): ≥ 9 %

DHA (docosahexaenoic acid): ≥ 5 %

Description/Definition:

The clear yellow arachidonic acid-rich oil is obtained by fermentation of the non-genetically modified strains IS-4, I49-N18 and FJRK-MA01 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 acid content

Unsaponifiable matter: ≤ 1,5 %

Peroxide value: ≤ 5 meq/kg

Anisidin value: ≤ 20

Acid value: ≤ 1,0 KOH/g

Moisture: ≤ 0,5 %

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 acid (C18:0): 5-7 %

Oleic acid (C18:1): 43-50 %

Linoleic acid (C18:2): 29-36 %

Unsaponifiable matter: 0,3-2 %

Total sterols: 100-500 mg/100 g

Total tocopherols: 16-90 mg/100 g

Oleic acidity: 0,2-1,5 %

Peroxide value: < 10 meq O2/kg

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 illuminated light alternatively open ponds may be used. The algal cells are 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 %, 5,0 %, 7,0 %, 10 %, 15 % or 20 % 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: < 1,0 %

Ash: 0,0-4,2 %

Specification of Carotenoids w/w%

Total Astaxanthins: 2,9-11,1 %

9-cis-astaxanthin: 0,3-17,3 %

13-cis-astaxanthin: 0,2-7,0 %

Astaxanthin monoesters: 79,8-91,5 %

Astaxanthin diesters: 0,16-19,0 %

Β-Carotene: 0,01-0,3 %

Lutein: 0-1,8 %

Canthaxanthin: 0-1,30 %

Microbiological criteria:

Total aerobic bacteria: < 3 000 CFU/g

Yeast and Moulds: < 100 CFU/g

Coliforms: < 10 CFU/g

• E. 

  coli: Negative

Salmonella: Negative

Staphylococcus: Negative

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 ensured by filtering (optical, mechanical). Production process of fruit juice and fruit/vegetable blend beverages containing Basil seeds (Ocimum basilicum L.) includes seed pre-hydration and pasteurisation steps. Microbiological controls and monitoring systems are in place.

Dry Matter: 94,1 %

Protein: 20,7 %

Fat: 24,4 %

Carbohydrate: 1,7 %

Dietary Fibre 40,5 % (Method: AOAC 958.29)

Ash: 6,78 %

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: ≤ 1,0 %

Protein: ≥ 55 %

Water: ≤ 7,0 %

Ash: ≤ 10 %

Carbohydrate: ≥ 20 %

a-glucosidase inhibitory activity: IC50 min 0,025 mg/ml

Soy isoflavone: ≤ 0,3 g/100 g

Description/Definition:

Bovine lactoferrin is a protein that occurs naturally in cows' milk. It is an iron-binding glycoprotein of approximately 77 kDa 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: < 2,0 mg/kg

Iron: < 350 mg/kg

Protein: > 93 %

of which bovine lactoferrin: > 95 %

of which other proteins: < 5,0 %

pH (2 % solution, 20 °C): 5,2-7,2

Solubility (2 % solution, 20 °C): complete

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: ≥ 8,0 % w/w of total fatty acids

Trans fatty acids: ≤ 2,0 % w/w of total fatty acids

Acid value: ≤ 0,6 mg KOH/g

Peroxide value: ≤ 5,0 meq O2/kg

Unsaponifiable content: ≤ 2,0 %

Protein content (total nitrogen): ≤ 10 μg/ml

Pyrrolizidine alkaloids: Not detectable with a detection limit of 4,0 μg/kg

Description/Definition:

The novel food is ruby coloured, slightly viscous oil with a slight shellfish odour extracted from the crustacean (marine zooplankton) Calanus finmarchicus. The ingredient consists primarily of wax esters (> 85 %) with minor amounts of triglycerides and other neutral lipids.

Specifications:

Water: < 1,0 %

Wax esters: > 85 %

Total fatty acids: > 46 %

Eicosapentaenoic acid (EPA): > 3,0 %

Docosahexaenoic acid (DHA): > 4,0 %

Total fatty alcohols: > 28 %

C20:1 n-9 fatty alcohol: > 9,0 %

C22:1 n-11 fatty alcohol: > 12 %

Trans fatty acids: < 1,0 %

Astaxanthinesters: < 0,1 %

Peroxide value: < 3,0 meq. O2/kg

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 off-white colour.

CAS No.: 1246080-53-4

Characteristics:

Moisture: < 5,0 %

Aluminium: < 3,0 mg/kg

Lithium: < 0,5 mg/kg

Nickel: < 0,5 mg/kg

Residual anhydride: < 15 μmol/g

Polydispersity index: < 1,4

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: < 3,0 mg/kg

Diethylene glycol methyl ether: < 4,0 mg/kg

Triethylene glycol methyl ether: < 7,0 mg/kg

1,4-Dioxane: < 2,0 mg/kg

Formaldehyde: < 10 mg/kg

Description/Definition:

Methyl vinyl ether-maleic anhydride copolymer is an anhydrous copolymer of methyl vinyl ether and maleic anhydride.

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: Negative to test

Staphylococcus aureus: Negative to test

Pseudomonas aeruginosa: Negative to test

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 extraction with supercritical CO2.

Production process:

Produced 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.

Acidity expressed as oleic acid: ≤ 2,0 %

Peroxide value: ≤ 10 meq/kg

Insoluble impurities: ≤ 0,05 %

Alpha linolenic acid: ≥ 60 %

Linoleic acid: 15-20 %

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 %

Production process:

Production process of fruit juices and fruit juice blends beverages, containing Chia seeds, includes seed pre-hydration and pasteurisation steps. Microbiological controls and monitoring systems are in place.

Description/Definition:

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.

Chitin-glucan is composed largely of two polysaccharides:

Loss on drying: ≤ 10 %

Chitin-glucan: ≥ 90 %

Ratio of chitin to glucan: 30:70 to 60:40

Ash: ≤ 3,0 %

Lipids: ≤ 1,0 %

Proteins: ≤ 6,0 %

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:

The production process consists of several steps, including: cleaning, reduction in size and grinding, softening in water and heating in an alkaline solution, washing, drying. No hydrolysis is applied during the production process.

Appearance: Powder, odourless, flavourless, brown

Purity:

Moisture: ≤ 15 %

Ash: ≤ 3,0 %

Chitin-glucan: ≥ 90 %

Ratio of chitin to glucan: 70:20

Total carbohydrates, excluding glucans: ≤ 0,1 %

Proteins: ≤ 2,0 %

Lipids: ≤ 1,0 %

Melanins: ≤ 8,3 %

Additives: None

pH: 6,7-7,5

Heavy metals:

Lead (ppm): ≤ 1,00

Cadmium (ppm): ≤ 1,00

Mercury (ppm): ≤ 0,03

Arsenic (ppm): ≤ 0,20

Microbiological criteria:

Total mesophilic bacteria: ≤ 103/g

Yeast and moulds: ≤ 103/g

Coliforms at 30 °C: ≤ 103/g

• E. 

  coli: ≤ 10/g

Salmonella and other pathogenic bacteria: Absence/25 g

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 formula: (C6H11NO4)n

Appearance: fine free-flowing powder

Aspect: Off –white to slightly brownish

Odour: Odourless

Purity:

Chitosan content (% w/w dry weight): 85

Glucan content (% w/w dry weight): ≤ 15

Loss on drying (% w/w dry weight): ≤ 10

Viscosity (1 % in 1 % acetic acid): 1-15

Degree of acetylation (in % mol/wet weight): 0-30

Viscosity (1 % in 1 % acetic acid) (mPa.s): 1-14 for chitosan from Aspergillus niger; 12-25 for chitin from Agaricus bisporus

Ash (% w/dry weight): ≤ 3,0

Proteins (% w/dry weight): ≤ 2,0

Particle size: > 100 nm

Taped density (g/cm3): 0,7-1,0

Fat binding capacity 800 × 9 w/wet weight): pass

Heavy metals:

Mercury (ppm): ≤ 0,1

Lead (ppm): ≤ 1,0

Arsenic (ppm): ≤ 1,0

Cadmium (ppm): ≤ 0,5

Microbiological criteria:

Aerobic count (CFU/g): ≤ 103

Yeast and mould count (CFU/g): ≤ 103

Escherichia coli (CFU/g): ≤ 10

Enterobacteriaceae (CFU/g): ≤ 10

Salmonella: Absence/25 g

Listeria monocytogenes: Absence/25 g

Description/Definition:

Chondroitin sulphate (sodium salt) is a biosynthetic product. It is obtained by chemical sulphation of chondroitin derived from fermentation by the bacterium Escherichia coli O5:K4:H4 strain U1-41 (ATCC 24502).

Chondroitin sulphate (sodium salt) (% dry basis): 95-105

MWw (weight avg.) (kDa): 5-12

MWn (number avg.) (kDa): 4-11

Dispersity (wh/w0,05): ≤ 0,7

Sulphation pattern (ΔDi-6S) (%): ≤ 85

Loss on drying (%) (105 °C to constant weight): ≤ 10,0

Residue on ignition (% dry basis): 20-30

Protein (% dry basis): ≤ 0,5

Endotoxins (EU/mg): ≤ 100

Total organic impurities (mg/kg): ≤ 50

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.

Chemical name: tris(2pyridinecarboxylato-N,O)chromium(III) or 2-pyridinecarboxylic acid chromium(III) salt

CAS No.: 14639-25-9

Chemical formula: Cr(C6H4NO2)3

Chemical characteristics:

Chromium Picolinate: ≥ 95 %

Chromium (III): 12-13 %

Chromium (VI): not detected

Water: ≤ 4,0 %

Description:

Cistus incanus L. Pandalis herb; species belonging to the Cistaceae family and native to the Mediterranean region, Chalkidiki Peninsula.

Composition:

Moisture: 9–10 g/100 g herbs

Protein: 6,1 g/100 g herbs

Fat: 1,6 g/100 g herbs

Carbohydrates: 50,1 g/100 g herbs

Fiber: 27,1 g/100 g herbs

Minerals: 4,4 g/100 g herbs

Sodium: 0,18 g

Potassium: 0,75 g

Magnesium: 0,24 g

Calcium: 1,0 g

Iron: 65 mg

Citicoline (synthetic)

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-(trimethylammonio)ethyl]ester inner salt

Chemical formula: C14H26N4O11P2

Molecular weight: 488,32 g/mol

CAS No.: 987-78-0

pH (sample solution of 1 %): 2,5-3,5

Purity:

Assay value: ≥ 98 % of dry matter

Loss on drying (100 °C for 4 hours): ≤ 5,0 %

Ammonium: ≤ 0,05 %

Arsenic: Not more than 2 ppm

Free phosphoric acids: ≤ 0,1 %

5′-Cytidylic acid: ≤ 1,0 %

Microbiological criteria:

Total plate count: ≤ 103 CFU/g

Yeast and moulds: ≤ 102 CFU/g

Escherichia coli: Absence in 1 g

Citicoline (microbial source)

Description/Definition:

It is produced by fermentation using a genetically modified strain of E. coli (BCT19/p40k)

The specification on citicoline from the microbial source is identical to the authorised synthetic citicoline.

Description/Definition:

Clostridium butyricum (CBM-588) is a Gram-positive, spore-forming, obligate anaerobic, non-pathogenic, non-genetically modified bacterium. Depository number FERM BP-2789

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

Cocoa (Theobroma cacao L.) Extract

Appearance: Dark brown powder free of visible impurities

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 (Theobroma cacao L.) extract

Appearance: Dark red to purple powder

Cocoa extract, concentrate: Min 99 %

Silicon dioxide (technological aid): Max 1,0 %

Cocoa flavanols: Min. 300 mg/g

(-) Epicatechin: Min. 45 mg/g

Loss on drying: Max. 5,0 %

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

CAS No.: 8008-52-4

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: ≤ 1,0 %

Purity:

Refractive index (20°C): 1,466-1,474

Acid value: ≤ 2,5 mg KOH/g

Peroxide value: ≤ 5,0 meq/kg

Iodine value: 88-110 units

Saponification value: 186-200 mg KOH/g

Unsaponifiable matter: ≤ 15 g/kg

Description/Definition:

Dried fruits of Crataegus pinnatifida species belonging to the Rosaceae family and native to north China and Korea.

Composition:

Dry matter: 80 %

Carbohydrates: 55 g/kg fresh weight

Fructose: 26,5–29,3 g/100 g

Glucose: 25,5–28,1 g/100 g

Vitamin C: 29,1 mg/100 g fresh weight

Sodium: 2,9 g/100 g fresh weight

Compotes are products obtained by thermal processing of the edible part of one or several species of fruits, whole or in pieces, sieved or not, without significant concentration. Sugars, water, cider, spices and lemon juice may be used.

Description/Definition:

A non-reducing cyclic saccharide 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 procedures: 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 odourless, white or almost white crystalline solid.

Synonyms: α-cyclodextrin, α-dextrin, cyclohexaamylose, cyclomaltohexaose, α-cycloamylase

Chemical name: Cyclohexaamylose

CAS No.: 10016-20-3

Chemical formula: (C6H10O5)6

Formula weight: 972,85

Assay: ≥ 98 % (dry basis)

Identification:

Melting range: Decomposes 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 corresponds 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:

Water: ≤ 11 % (Karl Fischer Method)

Residual complexant: ≤ 20 mg/kg

(1-decanol)

Reducing substances: ≤ 0,5 % (as glucose)

Sulphated ash: ≤ 0,1 %

Lead: ≤ 0,5 mg/kg

Method of assay:

Determine by liquid chromatography using the following conditions:

Chromatography: Liquid chromatograph equipped with a refractive index detector and an integrating recorder.

Column and packing: Nucleosil-100-NH2 (10 μm) (Macherey & Nagel Co. Düren, Germany) or similar

Length: 250 mm

Diameter: 4 mm

Temperature: 40 °C

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 and reference α-cyclodextrin, respectively, after correcting for water content.

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 by 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: (C6H10O5)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:

Water: ≤ 11 %

Residual complexant (8-cyclohexadecen-1-one (CHDC)): ≤ 4 mg/kg

Residual solvent (n-decane): ≤ 6 mg/kg

Reducing substances: ≤ 0,5 % (as glucose)

Sulphated ash: ≤ 0,1 %

Description/Definition:

Manufactured from glycerol and fatty acids derived from edible vegetable oils, in particular from soybean oil (Glycine max) or rapeseed 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): ≤ 5,0 %

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:

Acid value: ≤ 0,5 mg KOH/g

Moisture and volatile: ≤ 0,1 %

Peroxide value: ≤ 1,0 meq/kg

Unsaponifiables: ≤ 2,0 %

Trans fatty acids≤ 1,0 %

MAG = monoacylglycerols, DAG = diacylglycerols, TAG = triacylglycerols

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: C18 H28 O4

CAS No: 205687-03-2

Physical-chemical properties:

Dihydrocapsiate: > 94 %

8-Methylnonanoic acid: < 6,0 %

Vanillyl acohol: < 1,0 %

Other synthesis related substances: < 2,0 %

Description/Definition: Dried extract of cell cultures HTN®Vb of Lippia citriodora (Palau) Kunth.

Extract of the roots of Echinacea angustifolia obtained from tissue culture plant which is substantially equivalent to a root extract from Echinacea angustifolia obtained in ethanol-water titrated to 4 % echinacoside.

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: ≤ 2,0 % (w/w of total fatty acids)

Acid value: ≤ 0,6 mg KOH/g

Peroxide value: ≤ 5,0 meq O2/kg

Unsaponifiable content: ≤ 2,0 %

Protein content (total nitrogen): ≤ 20 μg/ml

Pyrrolizidine alkaloids: Not detectable with a detection limit 4,0 μg/kg

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-catechin 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: 458,4 g/mol

Loss on drying: max 5,0 %

Heavy metals:

Arsenic: max 3,0 ppm

Lead: max 5,0 ppm

Assay:

Min. 94 % EGCG (on dry material)

max. 0,1 % caffeine

Solubility: EGCG is fairly soluble in water, ethanol, methanol and acetone

Definition

Chemical name (IUPAC): (2S)-3-(2-thioxo-2,3-dihydro-1H-imidazol-4-yl)-2-(trimethylammonio)-Propanoate

Chemical formula: C9H15N3O2S

Molecular mass: 229,3 Da

CAS No.: 497-30-3

Specification

Method

White powder

Visual

[α]D ≥ (+) 122° (c = 1, H2O)a)

Polarimetry

≥ 99,5 %

≥ 99,0 %

HPLC [Eur. Ph. 2.2.29]

1H-NMR

Compliant with the structure

1H-NMR

Elemental analysis

[Eur. Ph. 01/2008:50400]

< 1 000 ppm

Gas chromatography

[Eur. Ph. 01/2008:20424]

Internal standard < 0,5 %

[Eur. Ph. 01/2008:20232]

< 0,8 %

HPLC/GPC or 1H-NMR

< 3,0 ppm

ICP/AES

(Pb, Cd)

Atomic fluorescence (Hg)

< 1,0 ppm

< 0,1 ppm

≤ 1 × 103 CFU/g

[Eur. Ph. 01/2011:50104]

≤ 1 × 102 CFU/g

Absence in 1 g

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: C10H12FeN2NaO8 · 3H2O

Chemical 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 %

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: FeNH4PO4

Chemical characteristics:

pH of 5 % suspension in water: 6,8-7,8

Iron (total): ≥ 28 %

Iron (II): 22-30 % (w/w)

Iron (III): ≤ 7,0 % (w/w)

Ammonia: 5-9 % (w/w)

Water: ≤ 3,0 %

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 (*) (short chain peptides, dipeptides and tripeptides with a molecular weight of less than 2 kDa): ≥ 85 g/100 g

Val-Tyr (dipeptide): 0,1-0,16 g/100 g

Ash: ≤ 10 g/100 g

Moisture: ≤ 8 g/100 g

Description/Definition:

Flavonoids derived from the roots or rootstock of Glycyrrhiza glabra L. are extracted 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

Description/Definition:

Fucoidan from the seaweed Fucus vesiculosus is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic solvents. The resulting extract is concentrated and dried to yield the fucoidan extract with the following specifications:

Heavy metals:

Arsenic (inorganic): < 1,0 ppm

Cadmium: < 3,0 ppm

Lead: < 2,0 ppm

Mercury: < 1,0 ppm

Microbiological criteria:

Total aerobic microbial count: < 10 000 CFU/g

Yeast and mould count: < 100 CFU/g

Total enterobacteria count: Absence/g

Escherichia coli: Absence/g

Salmonella: Absence/10 g

Staphylococcus aureus: Absence/g

Composition of the two permitted types of extracts, based on the level of fucoidan:

Description/Definition:

Fucoidan from seaweed Undaria pinnatifida is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic solvents. The resulting extract is concentrated and dried to yield the fucoidan extract with the following specifications:

Heavy metals:

Arsenic (inorganic): < 1,0 ppm

Cadmium: < 3,0 ppm

Lead: < 2,0 ppm

Mercury: < 1,0 ppm

Microbiology:

Total aerobic microbial count: < 10 000 CFU/g

Yeast and mould count: < 100 CFU/g

Total enterobacteria count: Absence/g

Escherichia coli: Absence/g

Salmonella: Absence/10 g

Staphylococcus aureus: Absence/g

Composition of the two permitted types of extracts, based on the level of fucoidan:

Definition:

Chemical name: α-l-Fucopyranosyl-(1→2)-β-d-galactopyranosyl-(1→4)-d-glucopyranose

Chemical formula: C18H32O15

CAS No: 41263-94-9

Molecular weight: 488,44 g/mol

Description:

2′- fucosyllactose is a white to off-white powder that is produced by a chemical synthesis process and is isolated by crystallisation.

Purity:

2′-Fucosyllactose: ≥ 95 %

D-Lactose: ≤ 1,0 w/w %

L-Fucose: ≤ 1,0 w/w %

Difucosyl-d-lactose isomers: ≤ 1,0 w/w %

2′-Fucosyl-d-lactulose: ≤ 0,6 w/w %

pH (20 °C, 5 % solution): 3,2-7,0

Water (%): ≤ 9,0 %

Ash, sulphated: ≤ 0,2 %

Acetic acid: ≤ 0,3 %

Residual solvents (methanol, 2-propanol, methyl acetate, acetone): ≤ 50,0 mg/kg singly, ≤ 200,0 mg/kg in combination)

Residual proteins: ≤ 0,01 %

Heavy Metals:

Palladium: ≤ 0,1 mg/kg

Nickel: ≤ 3,0 mg/kg

Microbiological criteria:

Aerobic mesophilic bacteria total count: ≤ 500 CFU/g

Yeasts and Moulds: ≤ 10 CFU/g

Residual endotoxins: ≤ 10 EU/mg

Definition:

Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose

Chemical formula: C18H32O15

CAS No: 41263-94-9

Molecular weight: 488,44 g/mol

Source:

Genetically modified strain of Escherichia coli BL21

Description:

2′-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. 2′-Fucosyllactose is produced by a microbiological process. 2′-Fucosyllactose is isolated by spray drying.

Purity:

2′-Fucosyllactose: ≥ 90 %

Lactose: ≤ 5,0 %

Fucose: ≤ 3,0 %

3-Fucosyllactose: ≤ 5,0 %

Fucosylgalactose: ≤ 3,0 %

Difucosyllactose: ≤ 5,0 %

Glucose: ≤ 3,0 %

Galactose: ≤ 3,0 %

Water: ≤ 9,0 % (powder)

Ash, sulphated: ≤ 0,5 % (powder and liquid)

Residual proteins: ≤ 0,01 % (powder and liquid)

Heavy Metals:

Lead: ≤ 0,02 mg/kg (powder and liquid);

Arsenic: ≤ 0,2 mg/kg (powder and liquid)

Cadmium: ≤ 0,1 mg/kg (powder and liquid)

Mercury: ≤ 0,5 mg/kg (powder and liquid)

Microbiological criteria:

Total plate count: ≤ 104 CFU/g (powder), ≤ 5 000 CFU/g (liquid)

Yeasts and Moulds: ≤ 100 CFU/g (powder); ≤ 50 CFU/g (liquid)

Enterobacteriaceae/Coliforms: absence in 11 g (powder and liquid)

Salmonella: negative/100 g (powder), negative/200 ml (liquid)

Cronobacter: negative/100 g (powder), negative/200 ml (liquid)

Endotoxins: ≤ 100 EU/g (powder), ≤ 100 EU/ml (liquid)

Aflatoxin M1: ≤ 0,025 μg/kg (powder and liquid)

Description/Definition:

Galacto-oligosaccharide is produced from milk lactose by an enzymatic process using β-galactosidases from Aspergillus oryzae, Bifidobacterium bifidum and Bacillus circulans.

GOS: min 46 % Dry Matter (DM)

Lactose: max 40 % DM

Glucose: max 22 % DM

Galactose: min 0,8 % DM

Ash: max 4,0 % DM

Protein: max 4,5 % DM

Nitrite: max. 2 mg/kg

White crystalline odourless powder

Molecular formula: C6H13NO5 · HCl

Relative molecular mass: 215,63 g/mol

D-Glucosamine HCl 98,0-102,0 % of reference standard (HPLC)

Specific rotation + 70,0° - + 73,0°

White crystalline odourless powder

Molecular formula: (C6H14NO5)2SO4 · 2KCl

Relative molecular mass: 605,52 g/mol

D-Glucosamine Sulphate 2KCl 98,0-102,0 % of reference standard (HPLC)

Specific Rotation + 50,0° to + 52,0°

White crystalline odourless powder

Molecular formula: (C6H14NO5)2SO4 · 2NaCl

Relative molecular mass: 573,31 g/mol

D-Glucosamine HCl: 98-102 % of reference standard (HPLC)

Specific Optical Rotation: + 52° - + 54°

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 than 75 %).

Appearance: White to yellowish powder

Molecular weight: Between 50 000 – 8 000 000 Daltons

CAS number: 9000-30-0

EINECS Number: 232-536-8

Purity: As specified by Commission Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (7) & by Commission Implementing Regulation (EU) 2015/175 of 5 February 2015 laying down special conditions applicable to the import of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins (8).

Physico-chemical properties:

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 product 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) (*).

Description/Definition:

Hydroxytyrosol is a pale yellow viscous liquid obtained by chemical synthesis

Molecular formula: C8H10O3

Molecular weight: 154,6 g/mol

CAS No: 10597-60-1

Moisture ≤ 0,4 %

Odour: Characteristic

Taste: Slightly bitter

Solubility (water): Miscible with water

pH: 3,5-4,5

Refractive Index: 1,571-1,575

Purity:

Hydroxytyrosol: ≥ 99 %

Acetic acid: ≤ 0,4 %

Hydroxytyrosol acetate: ≤ 0,3 %

Sum of homovanillic acid, iso-homovanilic acid, and 3-methoxy-4hydroxyphenylglycol: ≤ 0,3 %

Heavy Metals

Lead: ≤ 0,03 mg/kg

Cadmium: ≤ 0,01 mg/kg

Mercury: ≤ 0,01 mg/kg

Residual Solvents

Ethyl acetate: ≤ 25,0 mg/kg

Isopropanol: ≤ 2,50 mg/kg

Methanol: ≤ 2,00 mg/kg

Tetrahydrofuran: ≤ 0,01 mg/kg

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 cerevisiae) 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 result, 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 acids 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: ≤ 2,0 %

DNA: Not detectable

Description/Definition:

Dark brown liquid. Aqueous extracts of dried leaves of Ilex guayusa.

Composition:

Protein: < 0,1 g/100 ml

Fat: < 0,1 g/100 ml

Carbohydrate: 0,2–0,3 g/100 ml

Total sugars: < 0,2 g/100 ml

Caffeine: 19,8–57,7 mg/100 ml

Theobromine: 0,14–2,0 mg/100 ml

Chlorogenic acids: 9,9–72,4 mg/100 ml

Powder:

Solubility (water) (%): > 99

Glucose (% dry basis): ≤ 5,0

Isomaltose + DP3 to DP9 (% dry basis): ≥ 90

Moisture (%): ≤ 4,0

Sulphated ash (g/100 g): ≤ 0,3

Heavy metals:

Lead (mg/kg): ≤ 0,5

Arsenic (mg/kg): ≤ 0,5

Syrup:

Dried solids (g/100 g): > 75

Glucose (% dry basis): ≤ 5,0

Isomaltose + DP3 to DP9 (% dry basis): ≥ 90

pH: 4 - 6

Sulphated ash (g/100 g): ≤ 0,3

Heavy metals:

Lead (mg/kg): ≤ 0,5

Arsenic (mg/kg): ≤ 0,5

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: C12H22O11 · H2O

Structural formula

Formula weight: 360,3 (monohydrate)

Purity:

Assay: ≥ 98 % on the dry basis

Loss on drying: ≤ 6,5 % (60 °C, 5 hours)

Heavy metals:

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 (*), ‘Instrumental methods’

Description/Definition:

Crystalline powder or colourless solution manufactured via catalytic hydrogenation of lactose. Crystalline products occur in anhydrous, monohydrate and dihydrate forms. Nickel is used as a catalyst.

Chemical name: 4-O-β-D-Galactopyranosyl-D-glucitol

Chemical formula: C12H24O11

Molecular weight: 344,31 g/mol

CAS No: 585-86-4

Purity:

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: ≤ 2,0 mg/kg d.b

Arsenic: ≤ 3,0 mg/kg d.b

Lead: ≤ 1,0 mg/kg d.b

Definition:

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: C26H45NO21

CAS No: 13007-32-4

Molecular weight: 707,63 g/mol

Description:

Lacto-N-neotetraose is a white to off-white powder. Produced by a chemical synthesis process and is isolated by crystallisation.

Purity:

Assay (water free): ≥ 96 %

D-Lactose: ≤ 1,0 %

Lacto-N-triose II: ≤ 0,3 %

Lacto-N-neotetraose fructose isomer: ≤ 0,6 %

pH (20 °C, 5 % solution): 5,0-7,0

Water: ≤ 9,0 %

Ash, sulphated: ≤ 0,4 %

Acetic acid: ≤ 0,3 %

Residual solvents (methanol, 2-propanol, methyl acetate, acetone): ≤ 50 mg/kg singly, ≤ 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

Definition:

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: C26H45NO21

CAS No: 13007-32-4

Molecular weight: 707,63 g/mol

Source:

Genetically modified strain of Escherichia coli K-12

Description:

Lacto-N-neotetraose is a white to off-white crystalline powder that is produced by a microbiological process. Lacto-N-neotetraose is isolated by crystallisation.

Purity:

Assay (water free): ≥ 92 %

D-Lactose: ≤ 3,0 %

Lacto-N-triose II: ≤ 3,0 %

para-Lacto-N-neohexaose: ≤ 3,0 %

Lacto-N-neotetraose fructose isomer: ≤ 1,0 %

pH (20 °C, 5 % solution): 4,0-7,0

Water: ≤ 9,0 %

Ash, sulphated: ≤ 0,4 %

Residual solvents (methanol): ≤ 100 mg/kg

Residual proteins: ≤ 0,01 %

Microbiological criteria:

Aerobic mesophilic bacteria total count: ≤ 500 CFU/g

Yeasts: ≤ 10 CFU/g

Moulds: ≤ 10 CFU/g

Residual endotoxins: ≤ 10 EU/mg

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 contains about 35 % of crude protein. The press juice (pH 5,8-6,2) is neutralised. Preheating and 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 and 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 %

Minerals: 8-13 %

Saponins: ≤ 1,4 %

Isoflavones: ≤ 350 mg/kg

Coumestrol: ≤ 100 mg/kg

Phytates: ≤ 200 mg/kg

L-canavanine: ≤ 4,5 mg/kg

Description/Definition:

Synthetic lycopene is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Synthetic 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: C40H56

Formula weight: 536,85 Da

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: C40H56

Formula weight: 536,85 Da

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: C40H56

Formula weight: 536,85 Da

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): (0,5-0,75/0,4-0,65/0,2-0,35 %)

Total tocopherols: 1,5-3,0 %

Unsaponifiable matter: 13-20 %

Total fatty acids: 60-75 %

Water (Karl Fischer): ≤ 0,5 %

Description/Definition:

Magnesium citrate malate is a white to yellowish-white, amorphous powder.

Chemical formula: Mg5(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 drying (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:

Chloride: ≤ 0,05 %

Sulphate: ≤ 0,05 %

Arsenic: ≤ 3,0 ppm

Lead: ≤ 2,0 ppm

Cadmium: ≤ 1 ppm

Mercury: ≤ 0,1 ppm

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 mainly composed of two phenolic compounds, magnolol and honokiol.

Appearance: Light brownish powder

Purity:

Magnolol: ≥ 85,2 %

Honokiol: ≥ 0,5 %

Magnolol & Honokiol: ≥ 94 %

Total Eudesmol: ≤ 2 %

Moisture: 0,50 %

Heavy metals:

Arsenic (ppm): ≤ 0,5

Lead (ppm): ≤ 0,5

Methyl eugenol (ppm): ≤ 10

Tubocurarine (ppm): ≤ 2,0

Total Alkaloid (ppm): ≤ 100

Description/Definition:

Maize-germ oil high in unsaponifiable matter is produced by vacuum distillation and 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’).

Purity:

Unsaponifiable matter: > 9,0 g/100 g

Tocopherols: ≥ 1,3 g/100 g

α-tocopherol (%): 10-25 %

β-tocopherol (%): < 3,0 %

γ-tocopherol (%): 68-89 %

δ-tocopherol (%): < 7,0 %

Sterols, triterpenic alcohols, methylsterols: > 6,5 g/100 g

Fatty acids in triglycerides:

palmitic acid: 10,0-20,0 %

stearic acid: < 3,3 %

oleic acid: 20,0-42,2 %

linoleic acid: 34,0-65,6 %

linolenic acid: < 2,0 %

Acid value: ≤ 6,0 mg KOH/g

Peroxide value: ≤ 10 mEq O2/kg

Heavy metals:

Iron (Fe): < 1 500 μg/kg

Copper (Cu): < 100 μg/kg

Impurities:

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’

Description/Definition:

Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups.

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:

Molecular weight: Macromolecules: from about 20 000 (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 (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)

Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder.

Solubility: Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol, ether and chloroform. Soluble in glacial acetic acid.

Purity:

Loss on drying: ≤ 10 % (105 °C, 3 hours)

Sulphated Ash: ≤ 1,5 % determined at 800 ± 25 °C

pH: ≥ 5,0 and ≤ 8,0 (1 % colloidal solution)

Heavy metals:

Arsenic: ≤ 3,0 mg/kg

Lead: ≤ 2,0 mg/kg

Mercury: ≤ 1,0 mg/kg

Cadmium: ≤ 1,0 mg/kg

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

Chemical formula: C32H51N9O16

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 %

Heavy metals:

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

Yeasts and moulds: ≤ 100 CFU/g

Escherichia coli: Absence in 10 g

Description/Definition:

Chemical name: Silanetriol, 1-methyl-

Chemical formula: CH6O3Si

Molecular weight: 94,14 g/mol

CAS No: 2445-53-6

Purity:

Organic Silicon (monomethylsilanetriol) preparation (aqueous solution):

Acidity (pH): 6,4-6,8

Silicon: 100-150 mg Si/l

Heavy metals:

Lead: ≤ 1,0 μg/l

Mercury: ≤ 1,0 μg/l

Cadmium: ≤ 1,0 μg/l

Arsenic: ≤ 3,0 μg/l

Solvents:

Methanol: ≤ 5,0 mg/kg (residual presence)

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.

Purity/Composition of the mycelial extract from Lentinula edodes:

Moisture: 98 %

Dry matter: 2 %

Free glucose: < 20 mg/ml

Total protein (*): < 0,1 mg/ml

N-containing constituents (**): < 10 mg/ml

Lentinan: 0,8 – 1,2 mg/ml

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

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:

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. Afterwards the juice is collected and pasteurised, prior to 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:

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.

Purity/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

Description/Definition:

Noni fruit powder is made from 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.

Purity/Composition

Moisture: 5,3-9 %

Protein: 3,8-4,8 g/100 g

Fat: 1-2 g/100 g

Ash: 4,6-5,7 g/100 g

Total 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 (*): ≤ 2,0 μg/ml

Silicon: 3,3 %

Crystalline silica: max 0,1-0,3 % as impurity

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): ≤ 2,0 %

Monoacylglycerols (MAG): ≤ 10 %

Diacylglycerols (DAG): ≤ 25 %

Triacylglycerols (TAG): Making up the balance

Phytosterol fraction:

β-sitosterol: ≤ 80 %

β-sitostanol: ≤ 15 %

campesterol: ≤ 40 %

campestanol: ≤ 5,0 %

stigmasterol: ≤ 30 %

brassicasterol ≤ 3,0 %

other sterols/stanols: ≤ 3,0 %

Others:

Moisture and volatile: ≤ 0,5 %

Peroxide value: < 5,0 meq/kg

Trans fatty acids: ≤ 1 %

Contamination/Purity (GC-FID or equivalent method) of phytosterols/phytostanols:

Phytosterols and phytostanols extracted from sources other than vegetable oil suitable for food have to be free of contaminants, best ensured by a purity of more than 99 %.

Acid value: ≤ 0,5 KOH/g oil

Peroxide value: ≤ 5 meq O2/kg oil

p-Anisidine value: ≤ 20

Cold test at 0 °C: ≤ 3 hours

Moisture: ≤ 0,1 % (w/w)

Unsaponifiable matter: ≤ 5,0 %

Trans fatty acids: ≤ 1,0 %

Docosahexaeonic acid: ≥ 20 %

Eicosapentaenoic acid: ≥ 10 %

Parameter

Target

Comments

Minimum 15 days at – 20 °C

Fruit harvested and stored in conjunction with good/hygienic agricultural and manufacturing practices

40 % to 60 % of thawed fruit

Fruit homogenised and added to other ingredients

3,2 to 4,2

7 to 42

Assured by added sugars

< 0,95

Assured by added sugars

60 days maximum at + 5 °C maximum

Equivalent to storage regimen for conventionally processed product

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

Chemical formula: (C6H10O5)n [(C6H9O5)2PO2H]x [(C6H9O5)PO3H2]y

n = number of glucose units; x, y = degrees of substitution

The chemical characteristics of phosphated distarch phosphate:

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.

Specification of the phosphatidylserine product manufactured from fish phospholipids:

Moisture: < 5,0 %

Phospholipids: ≥ 75 %

Phosphatidylserine: ≥ 35 %

Glycerides: < 4,0 %

Free L-serine: < 1,0 %

Tocopherols: < 0,5 % (1)

Peroxide value: < 5,0 meq O2/kg

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 orange 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 obtained 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.

Characteristics of Phosphatidylserine from soya phospholipids:

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.

Specification of the product:

Moisture: ≤ 2,0 %

Total phospholipids: ≥ 70 %

Phosphatidylserine: ≥20 %

Phosphatidic acid: ≥ 20 %

Glycerides: ≤ 1,0 %

Free L-serine: ≤ 1,0 %

Tocopherols: ≤ 0,3 %

Phytosterols: ≤ 2,0 %

Silicon dioxide is used with a maximum content of 1,0 %

85 % and 100 % pure Phospholipides from egg yolk

Description:

White to off-white powder which is an odourless, colourless, flavourless polysaccharide derived from non-GM sweet corn using conventional food processing techniques

Definition:

Glucose polymer (C6H12O6)n with linear linkages of α(1 – 4) glycosidic bonds branched every 8 to 12 glucose units by α(1 – 6) glycosidic bonds

Specifications:

Carbohydrates: 97 %

Sugars: 0,5 %

Fibre: 0,8 %

Fat: 0,2 %

Protein: 0,6 %

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.

Composition (with GC-FID or equivalent method):

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 contaminants, best ensured by a purity of more than 99 % of the phytosterol/phytostanol ingredient.

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

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

Specification of the enzyme:

Systematic name: Prolyl oligopeptidase

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 (*)/g (> 34,8 PPU (**)/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:

Lead: ≤ 1,0 mg/kg

Arsenic: ≤ 1,0 mg/kg

Cadmium: ≤ 0,5 mg/kg

Mercury: ≤ 0,1 mg/kg

Microbiological criteria:

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: Absence in 25 g

Escherichia coli: Absence in 25 g

Staphylococcus aureus: Absence in 10 g

Pseudomonas aeruginosa: Absence in 10 g

Listeria monocytogenes: Absence 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)

Description/Definition:

The protein extract is obtained from homogenised pig kidneys through a combination of salt precipitation and high speed centrifugation. The obtained precipitate contains essentially proteins with 7 % of the enzyme diamine oxidase (enzyme nomenclature E.C. 1.4.3.22) and is resuspended in a physiologic buffer system. The obtained pig kidney extract is formulated as encapsulated enteric coated pellets to reach the active sites of digestion.

Basic Product:

Microbiological criteria:

Final product:

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: < 104 CFU/g

Total combined yeasts/moulds count: < 103 CFU/g

Salmonella: Absence/10g

Bile salt resistant enterobacteriaceae: < 102 CFU/g

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 refined 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.

Purity:

Unsaponifiable matter: > 7,0 g/100 g

Tocopherols: > 0,8 g/100 g

α-tocopherol (%): 30-50 %

γ-tocopherol (%): 50-70 %

δ-tocopherol (%): < 6,0 %

Sterols, triterpenic alcohols, methylsterols: > 5,0 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 %

erucic acid: < 2,0 %

Acid value: ≤ 6,0 mg KOH/g

Peroxide value: ≤ 10 mEq O2/kg

Heavy metals:

Iron (Fe): < 1 000 μg/kg

Copper (Cu): < 100 μg/kg

Impurities:

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 ‘rapeseed oil high in unsaponifiable matter’.

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: ≤ 7,0 %

Carbohydrates: ≤ 7,0 %

Fat: ≤ 2,0 %

Ash: ≤ 4,0 %

Fibre: ≤ 0,5 %

Total glucosinolates: ≤ 1 mmol/kg

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: Absence in 10 g

Salmonella: Absence in 25 g

Description/Definition:

Synthetic Trans-resveratrol is off-white to beige crystals.

Chemical name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol

Chemical formula: C14H12O3

Molecular weight: 228,25 Da

CAS No: 501-36-0

Purity:

Trans-resveratrol: ≥ 98 %-99 %

Total by-products (related substances): ≤ 0,5 %

Any single related substance: ≤ 0,1 %

Sulphated ash: ≤ 0,1 %

Loss on drying: ≤ 0,5 %

Heavy metals:

Lead: ≤ 1,0 ppm

Mercury: ≤ 0,1 ppm

Arsenic: ≤ 1,0 ppm

Impurities:

Diisopropylamine: ≤ 50 mg/kg

Microbial 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

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 extract are the glycosaminoglycans hyaluronic acid, chondroitin sulphate A and dermatan sulphate (chondroitin sulphate B). White or almost white hygroscopic powder.

Hyaluronic acid: 60-80 %

Chondroitin sulphate A: ≤ 5,0 %

Dermatan sulphate (chondroitin sulphate B): ≤ 25 %

pH: 5,0-8,5

Purity:

Chlorides: ≤ 1,0 %

Nitrogen: ≤ 8,0 %

Loss on drying: (105 °C for 6 hours): ≤ 10 %

Heavy metals:

Mercury: ≤ 0,1 mg/kg

Arsenic: ≤ 1,0 mg/kg

Cadmium: ≤ 1,0 mg/kg

Chromium: ≤ 10 mg/kg

Lead: ≤ 0,5 mg/kg

Microbiological criteria:

Total viable aerobic count: ≤ 102 CFU/g

Escherichia coli: Absence in 1 g

Salmonella: Absence in 1 g

Staphylococcus aureus: Absence in 1 g

Pseudomonas aeruginosa: Absence in 1 g

Description/Definition:

Sacha inchi oil is a 100 % cold pressed vegetable 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

Purity:

Water and Volatiles: < 0,2 g/100 g

Impurities insoluble in hexane: < 0,05 g/100 g

Oleic acidity: < 2,0 g/100 g

Peroxide value: < 15 meq O2/kg

Trans fatty acids: < 1,0 g/100 g

Total unsaturated fatty acids: > 90 %

Omega 3 alpha linolenic acid (ALA): > 45 %

Saturated fatty acids: < 10 %

No trans fatty acids (< 0,5 %)

No erucic acid (< 0,2 %)

More than 50 % of tri-linolenin and di-linolenin-triglycerides

Phytosterols composition and level

No cholesterol (< 5,0 mg/100 g)

Description/Definition:

Salatrim is the internationally recognised acronym for (short and long chain acyl triglyceride molecules). Salatrim is prepared by non-enzymatic inter-esterification 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 particulate matter and of foreign or rancid odour.

Glycerol ester disribution:

Fatty acid composition:

Triacylglycerol profile:

Unsaponifiable material: ≤ 1,0 %

Moisture: ≤ 0,3 %

Ash: ≤ 0,1 %

Colour: ≤ 3,5 Red (Lovibond)

Peroxide value: ≤ 2,0 Meq/Kg

Acid value: ≤ 0,5 mg KOH/g

Peroxide value: ≤ 5,0 meq/kg oil

Oxidative stability: All food products containing schizochytrium sp. oil rich in DHA and EPA should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC)

Moisture and volatiles: ≤ 0,05 %

Unsaponifiables: ≤ 4,5 %

Trans-fatty acids: ≤ 1 %

DHA content: ≥ 22,5 %

EPA content: ≥ 10 %

Peroxide value: ≤ 5,0 meq/kg oil

Unsaponifiables: ≤ 3,5 %

Trans-fatty acids: ≤ 2,0 %

Free fatty acids: ≤ 0,4 %

Docosapentaenoic acid (DPA) n-6: ≤ 7,5 %

DHA content: ≥ 35 %

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: ≤ 1,0 %

DHA content: ≥ 32,0 %

Acid value: ≤ 0,5 mg KOH/g

Peroxide value: ≤ 5,0 meq/kg oil

Moisture and volatiles: ≤ 0,05 %

Unsaponifiables: ≤ 3,5 %

Trans-fatty acids: ≤ 2,0 %

Free fatty acids: ≤ 0,4 %

DHA content: ≥ 35 %

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 Fibrin degradation unit/g (*)

Identity: Confirmable

Condition: No offensive taste or smell

Loss on drying: ≤ 10 %

Vitamin K2: ≤ 0,1 mg/kg

Heavy metals:

Lead: ≤ 5,0 mg/kg

Arsenic: ≤ 3,0 mg/kg

Microbiological criteria:

Total viable aerobic count: ≤ 103 CFU (3)/g

Yeast and mould: ≤ 102 CFU/g

Coliforms: ≤ 30 CFU/g

Spore-forming bacteria: ≤ 10 CFU/g

Escherichia coli: Absence/25 g

Salmonella: Absence/25 g

Listeria: Absence/25 g

Description/Definition:

Spermidine-rich wheat germ extract is obtained from non-fermented, non-sprouting wheat germs (Triticum aestevium) by the process of solid-liquid extraction targeting specifically, but not exclusively polyamines.

Spermidine: 0,8-2,4 mg/g

Spermine: 0,4-1,2 mg/g

Spermidine trichloride < 0,1 μg/g

Putrescine: < 0,3 mg/g

Cadaverine: < 0,1 μg/g

Mycotoxins:

Aflatoxins (total): < 0,4 μg/kg

Microbiological criteria:

Total aerobic bacteria: < 10 000 CFU/g

Yeast and moulds: < 100 CFU/g

Escherichia coli: < 10 CFU/g

Salmonella: Absence/25 g

Listeria monocytogenes: Absence/25 g

Description/Definition:

Sucromalt is a complex mixture of saccharides which is produced from sucrose and a starch hydrolysate by means of an enzymatic reaction. In this process, glucose units are attached to saccharides from the starch hydrolysate by means of an enzyme produced by the bacterium Leuconostoc citreum or by means of a recombinant strain of the production organism Bacillus licheniformis. 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 disaccharides.

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 %

Higher saccharides: 40-60 % d.w

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 production 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: 0,0 %

Fat: Trace

pH: 4-7

Heavy metals:

Mercury (ppm): ≤ 0,1

Lead (ppm): ≤ 1,0

Arsenic (ppm): ≤ 1,0

Cadmium (ppm): ≤ 0,1

Microbiological criteria:

Yeast and moulds (CFU/g): ≤ 1 000

Salmonella: Absence

Listeria monocytogenes: Absence

Description/Definition:

The sunflower extract is obtained by a concentration factor of 10 of the unsaponifiable fraction of refined sunflower oil extracted from the seeds of the sunflower, Helianthus Annuus L.

Composition:

Oleic acid (C18:1): 20 %

Linoleic acid (C18:2): 70 %

Unsaponifiable matter: 8,0 %

Phytosterols: 5,5 %

Tocopherols: 1,1 %

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.

Purity/Composition:

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: ≤ 7,0 %

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 acids: 44-49 % of total fatty acids

Iodine: ≤ 15 mg/kg

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 Barcoo

Composition of fish flesh:

Fatty acids (mg FA/g fillet):

Description/Definition:

Tagatose is produced by isomerization of galactose by means of chemical or enzymatic conversion, or by epimerization of fructose by means of enzymatic conversion. These are single-step conversions.

Appearance: White or almost white crystals

Chemical name: D-tagatose

Synonym: D-lyxo-Hexulose

CAS number: 87-81-0

Chemical formula: C6H12O6

Formula weight: 180,16 (g/mol)

Purity:

Assay: ≥ 98 % on a dry weight basis

Loss on drying: ≤ 0,5 % (102 °C, 2 hours)

Specific Rotation: [α]20D: – 4 to – 5,6° (1 % aqueous solution) (*)

Melting range: 133-137 °C

Heavy metals:

Lead: ≤ 1,0 mg/kg (**)

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 formula: C15H12O7

Molecular mass: 304,25 Da

CAS No: 480-18-2

Specifications:

Heavy Metals, Pesticide

Lead: ≤ 0,5 mg/kg

Arsenic: ≤ 0,02 mg/kg

Cadmium: ≤ 0,5 mg/kg

Mercury: ≤ 0,1 mg/kg

Dichlorodiphenyltrichloroethane (DDT): ≤ 0,05 mg/kg

Residual solvents

Ethanol: < 5 000 mg/kg

Microbiological criteria

Total Plate Count (TPC): ≤ 104 CFU/g

Enterobacteria: ≤ 100/g

Yeast and Mould: ≤ 100 CFU/g

Escherichia coli: Absence/1 g

Salmonella: Absence/10 g

Staphylococcus aureus: Absence/1 g

Pseudomonas: Absence/1 g

Usual range of components of the Taxifolin-rich extract (as per dry substance)

Content, usual observed range (%)

90 – 93

2,5 – 3,5

0,1 – 0,3

0,3 – 0,5

0,2 – 0,3

0,01 – 0,1

0,05 – 0,12

1 - 3

1,5

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 crystals with a sweet taste

Synonyms: α,α-trehalose

Chemical name: α-D-glucopyranosyl-α-D-glucopyranoside, dihydrate

CAS No.: 6138-23-4 (dihydrate)

Chemical formula: C12H22O11 · 2H2O (dihydrate)

Formula weight: 378,33 (dihydrate)

Assay: ≥ 98 % on the dry basis

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’

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 obtain 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:

Characteristics:

Identification:

Purity:

Loss on drying: ≤ 1,5 % (60 °C, 5 h)

Total ash: ≤ 0,05 %

Heavy metals:

Lead: ≤ 1,0 mg/kg

Description/Definition:

Commercially grown Agaricus bisporus to which UV light treatment is applied to harvested mushrooms.

UV radiation: a process of radiation in ultraviolet light within the wavelength of 200-800 nm.

Vitamin D2:

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 D2 in the final product: 5-10 μg/100 g fresh weight at the expiration of shelf life

Description/Definition:

Baker's yeast (Saccharomyces cerevisiae) is treated with ultraviolet light to induce the conversion of ergosterol to vitamin D2 (ergocalciferol). Vitamin D2 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

Vitamin D2:

Chemical name: (5Z,7E,22E)-(3S)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol

Synonym: Ergocalciferol

CAS No.: 50-14-6

Molecular weight: 396,65 g/mol

Microbiological criteria for the yeast concentrate:

Coliforms: ≤ 103/g

Escherichia coli: ≤ 10/g

Salmonella: Absence in 25 g

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 D2 (ergocalciferol).

UV radiation: A process of radiation in ultraviolet light within the wavelength of 240-315 nm for maximum of 5 seconds with energy input of 10-50 mJ/cm2.

Vitamin D2:

Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol

Synonym: Ergocalciferol

CAS No: 50-14-6

Molecular weight: 396,65 g/mol

Contents:

Vitamin D2 (ergocalciferol) in the final product: 0,75-3 μg/100 g (*)

Yeast in dough: 1-5 g/100 g (**)

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 with UV radiation results in an increase in the vitamin D3 (cholecalciferol) concentrations by conversion of 7-dehydrocholesterol to vitamin D3.

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 D3:

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

Molecular weight: 384,6377 g/mol

Contents:

Vitamin D3 in the final product:

Whole milk (*): 0,5-3,2 μg/100 g (**)

Semi-skimmed milk (*): 0,1–1,5 μg/100 g (**)

This novel food is produced by a synthetic or microbiological process.

Specification of synthetic Vitamin K2 (menaquinone-7)

Chemical Name: (all-E)-2-(3,7,11,15,19,23,27-Heptamethyl-2,6,10,14,18,22,26-octacosaheptaenyl)-3-methyl-1,4-naphtalenedione

CAS Number: 2124-57-4

Molecular formula: C46H64O2

Molecular weight: 649 g/mol

Appearance: Yellow powder

Purity: Max 6,0 % cis-isomer, max 2,0 % other impurities

Content: 97-102 % Menaquinone-7 (including at least 92 % all-trans Menaquinone-7)

Specifications of microbiologically produced Vitamin K2 (menaquinone-7)

Source: Bacillus subtilis spp. natto

Vitamin K2 (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 carbons 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.

Vitamin K2 (menaquinones) series with menaquinone-7 (MK-7)(n = 6) being C46H64O2, menaquinone-6 (MK-6)(n = 5) being C41H56O2 and menaquinone-4 (MK-4)(n = 3) being C31H40O2.

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