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Document 32017R2470

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

C/2017/8878
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OJ L 351, 30.12.2017, p. 72–201 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

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  • Date of document: 20/12/2017; Date of adoption
  • Date of effect: 19/01/2018; Entry into force Date pub. +20 See Art 2
  • Date of end of validity: 31/12/9999
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  • Author: European Commission, Directorate-General for Health and Food Safety
  • Form: Implementing regulation
  • Additional information: EEA relevance
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  • Department responsible: SANTE
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Text

30.12.2017   

EN

Official Journal of the European Union

L 351/72


COMMISSION IMPLEMENTING REGULATION (EU) 2017/2470

of 20 December 2017

establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 8 thereof,

Whereas:

(1)

Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission has to establish the Union list of novel foods authorised or notified under Regulation (EC) No 258/97 of the European Parliament and of the Council (2).

(3)

The Union list of novel foods is to apply without prejudice to other provisions laid down in sector specific legislation.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Union list of authorised novel foods

The Union list of novel foods authorised to be placed on the market within the Union as referred to in Article 6(1) of Regulation (EU) 2015/2283 is hereby established and set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 December 2017.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 327, 11.12.2015, p. 1.

(2)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).


ANNEX

UNION LIST OF NOVEL FOODS

Content of the list

1.

The Union list shall consist of Tables 1 and 2.

2.

Table 1 includes the authorised novel foods and contains the following information:

Column 1

:

Authorised novel food

Column 2

:

Conditions under which the novel food may be used. This column is further subdivided into two: Specified food category and Maximum levels

Column 3

:

Additional specific labelling requirements

Column 4

:

Other requirements

3.

Table 2 includes the specifications on novel foods and contains the following information:

Column 1

:

Authorised novel food

Column 2

:

Specifications

Table 1: Authorised novel foods

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

N-Acetyl-D-neuraminic acid

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘N-acetyl-D-neuraminic acid’

Food supplements containing N-acetyl-D-neuraminic acid shall bear a statement that the food supplement should not be given to infants, young children and children under 10 years of age where they consume breast milk or other foods with added N-acetyl-D-neuraminic acid within the same twenty four hour period.

 

Infant and follow-on formulae as defined by Regulation (EU) No 609/2013 (1)

0,05 g/L of reconstituted formula

Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013

0,05 g/kg for solid foods

Foods for special medical purposes for infants and young children as defined by Regulation (EU) No 609/2013

In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than the maximum levels specified for the category mentioned in the table corresponding to the products.

Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013

0,2 g/L (drinks)

1,7 g/kg (bars)

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 (2)

1,25 g/kg

Unflavoured pasteurised and sterilised (including UHT) milk-based products

0,05 g/L

Unflavoured fermented milk-based products, heat treated after fermentation, flavoured fermented milk products including heat-treated products

0,05 g/L (beverages)

0,4 g/kg (solids)

Dairy analogues, including beverage whiteners

0,05 g/L (beverages)

0,25 g/kg (solids)

Cereal bars

0,5 g/kg

Table top sweeteners

8,3 g/kg

Fruit and vegetable-based drinks

0,05 g/L

Flavoured drinks

0,05 g/L

Speciality coffee, tea, herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions

0,2 g/kg

Food Supplements as defined in Directive 2002/46/EC (3)

300 mg/day for general population older than 10 years

55 mg/day for infants

130 mg/day for young children

250 mg/day for children between 3 to 10 years of age

Adansonia digitata (Baobab) dried fruit pulp

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Baobab fruit pulp’

 

Ajuga reptans extract from cell cultures

Specified food category

Maximum levels

 

 

Food Supplements as defined in Directive 2002/46/EC

In line with normal use in food supplements of a similar extract of the flowering aerial parts of Ajuga reptans

L-Alanyl-L-Glutamine

Specified food category

Maximum levels

 

 

Food Supplements as defined in Directive 2002/46/EC

 

Foods for special medical purposes as defined in Regulation (EU) No 609/2013 excluding foods for infants and young children

Algal oil from the microalgae Ulkenia sp.

Specified food category

Maximum levels of DHA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the micro-algae Ulkenia sp.

 

Bakery products (breads, rolls and sweet biscuits)

200 mg/100 g

Cereal bars

500 mg/100 g

Non-alcoholic beverages (including milk based beverages)

60 mg/100 ml

Allanblackia seed oil

Specified food category

Maximum levels

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

 

Yellow fat spreads and cream based spreads

20 g/100 g

Aloe macroclada Baker leaf extract

Specified food category

Maximum levels

 

 

Food Supplements as defined in Directive 2002/46/EC

In line with normal use in food supplements of the similar gel derived from Aloe vera (L.) Burm.

Antarctic Krill oil from Euphausia superba

Specified food category

Maximum levels of combined DHA and EPA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lipid extract from the crustacean Antarctic Krill (Euphausia superba)’

 

Dairy products except milk-based drinks

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

Dairy analogues except drinks

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

Non-alcoholic beverages

Milk-based drinks

Dairy analogue drinks

80 mg/100 ml

Spreadable fat and dressings

600 mg/100 g

Cooking fats

360 mg/100 ml

Breakfast cereals

500 mg/100 g

Bakery products (breads, rolls and sweet biscuits)

200 mg/100 g

Nutrition bars/cereal bars

500 mg/100 g

Food Supplements as defined in Directive 2002/46/EC

3 000 mg/day for the general population

450 mg/day for pregnant and lactating women

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013

200 mg/100 ml

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Antarctic Krill oil rich in phospholipids from Euphausia superba

Specified food category

Maximum levels of combined DHA and EPA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lipid extract from the crustacean Antarctic Krill (Euphausia superba)’

 

Dairy products except milk-based drinks

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

Dairy analogues except drinks

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

Non-alcoholic beverages

Milk-based drinks

Dairy analogue drinks

80 mg/100 ml

Spreadable fat and dressings

600 mg/100 g

Cooking fats

360 mg/100 ml

Breakfast cereals

500 mg/100 g

Bakery products (breads, rolls and sweet biscuits)

200 mg/100 g

Nutrition bars/cereal bars

500 mg/100 g

Food Supplements as defined in Directive 2002/46/EC

3 000 mg/day for the general population

450 mg/day for pregnant and lactating women

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Processed cereal-based food and baby food intended for infants and young children covered by Regulation (EU) No 609/2013

200 mg/100 ml

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Arachidonic acid-rich oil from the fungus Mortierella alpina

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from Mortierella alpina’ or ‘Mortierella alpina oil’

 

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Foods for special medical purposes for premature infants as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Argan oil from Argania spinosa

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Argan oil’ and if used as seasoning ‘Vegetable oil only for seasoning’ shall be mentioned on the label

 

As seasonings

Not specified

Food Supplements as defined in Directive 2002/46/EC

In line with normal food use of vegetable oils

Astaxanthin-rich oleoresin from Haematococcus pluvialis algae

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC

40-80 mg/day of oleoresin, resulting in ≤ 8 mg astaxanthin per day

Basil seeds (Ocimum basilicum)

Specified food category

Maximum levels

 

 

Fruit juice and fruit/vegetable blend beverages

3 g/200 ml for addition of whole basil seeds (Ocimum basilicum)

Fermented black bean extract

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fermented black bean (Soya) extract’ or ‘Fermented Soya extract’

 

Food Supplements as defined in Directive 2002/46/EC

4,5 g/day

Bovine lactoferrin

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cows' milk’

 

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 (ready to drink)

100 mg/100 ml

Foods on dairy basis intended for young children (ready to eat/drink)

200 mg/100 g

Processed cereal food (solid)

670 mg/100 g

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

Depending on the needs of the individual up to 3 g/day

Beverages based on milk

200 mg/100 g

Powdered drink mixes based on milk (ready to drink)

330 mg/100 g

Beverages based on fermented milk (including yoghurt drinks)

50 mg/100 g

Non-alcoholic drinks

120 mg/100 g

Products based on yoghurt

80 mg/100 g

Products based on cheese

2 000 mg/100 g

Ice cream

130 mg/100 g

Cakes and pastries

1 000 mg/100 g

Candies

750 mg/100 g

Chewing gum

3 000 mg/100 g

Buglossoides arvensis seed oil

Specified food category

Maximum levels of stearidonic acid (STA)

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

 

Dairy products and analogues

250 mg/100 g

75 mg/100 g for drinks

Cheese and cheese products

750 mg/100 g

Butter and other fat and oil emulsions including spreads (not for cooking or frying purposes)

750 mg/100 g

Breakfast cereals

625 mg/100 g

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

500 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013, excluding foods for special medical purposes intended for infants and young children

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Calanus finmarchicus oil

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘oil from Calanus finmarchicus (crustacean)’

 

Food supplements as defined in Directive 2002/46/EC

2,3 g/day

Chewing gum base (monomethoxypolyethylene glycol)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Gum base (including 1,3-butadiene, 2-methyl-homopolymer, maleated, esters with polyethylene glycol mono-Me ether)’ or ‘Gum base (including CAS No: 1246080-53-4)’

 

Chewing gum

8 %

Chewing gum base (Methyl vinyl ether-maleic anhydride copolymer)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Gum base (including methyl vinyl ether-maleic anhydride copolymer)’ or ‘Gum base (including CAS No 9011-16-9)’

 

Chewing gum

2 %

Chia oil from Salvia hispanica

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chia oil (Salvia hispanica)’

 

Fats and oils

10 %

Pure chia oil

2 g/day

Food Supplements as defined in Directive 2002/46/EC

2 g/day

Chia seeds (Salvia hispanica)

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chia seeds (Salvia hispanica)’

2.

Pre-packaged Chia (Salvia hispanica) seeds shall carry additional labelling to inform the consumer that the daily intake is no more than 15 g.

 

Bread products

5 % (whole or ground chia seeds)

Baked products

10 % whole chia seeds

Breakfast cereals

10 % whole chia seeds

Fruit, nut and seed mixes

10 % whole chia seeds

Fruit juice and fruit/vegetable blend beverages

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

Pre-packaged Chia seed as such

15 g/day whole chia seeds

Fruit spreads

1 % whole chia seeds

Yoghurt

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

Sterilised ready to eat meals based on cereal grains, pseudocereals grains and/or pulses

5 % whole chia seeds

Chitin-glucan from Aspergillus niger

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitin-glucan from Aspergillus niger

 

Food Supplements as defined in Directive 2002/46/EC

5 g/day

Chitin-glucan complex from Fomes fomentarius

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chitin-glucan from Fomes fomentarius

 

Food Supplements as defined in Directive 2002/46/EC

5 g/day

Chitosan extract from fungi (Agaricus bisporus; Aspergillus niger)

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC

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

Chondroitin sulphate

Specified food category

Maximum levels

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

 

Food supplements as defined in Directive 2002/46/EC for adult population, excluding pregnant and lactating women

1 200 mg/day

Chromium Picolinate

Specified food category

Maximum levels of total chromium

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

 

Foods covered by Regulation (EU) No 609/2013

250 μg/day

Foods fortified in accordance with Regulation (EC) No 1925/2006 (4)

Cistus incanus L. Pandalis herb

Specified food category

Maximum levels

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

 

Herbal infusions

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

Citicoline

Specified food category

Maximum levels

1.

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

2.

The labelling of foods containing citicoline shall bear a statement that the product is not intended to be consumed by children

 

Food Supplements as defined in Directive 2002/46/EC

500 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Clostridium butyricum

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC

1,35 × 108 CFU/day

Extract of defatted cocoa powder

Specified food category

Maximum levels

Consumers shall be instructed not to consume more than 600 mg polyphenols corresponding to 1,1 g of extract of defatted cocoa powder per day

 

Nutrition bars

1 g/day and 300 mg polyphenols corresponding to not more than 550 mg of extract of defatted cocoa powder in one portion of food (or food supplement)

Milk based beverages

Any other foods (including food supplements as defined in Directive 2002/46/EC) which have become established vehicles for functional ingredients and which are typically positioned for consumption by health conscious adults

Low fat cocoa extract

Specified food category

Maximum levels

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

 

Foods including food supplements as defined in Directive 2002/46/EC

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

Coriander seed oil from Coriandrum sativum

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC

600 mg/day

Crataegus pinnatifida dried fruit

Specified food category

Maximum levels

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

 

Herbal infusions

In line with normal food use of Crataegus laevigata

Jams and jellies in accordance with Directive 2001/113/EC (5)

Compotes

α-cyclodextrin

Not specified

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

 

γ-cyclodextrin

Not specified

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

 

Dextran preparation produced by Leuconostoc mesenteroides

Specified food category

Maximum levels

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

 

Bakery products

5 %

Diacylglycerol oil of plant origin

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Diacylglycerol oil of plant origin (at least 80 % diacylglycerols)’

 

Cooking oils

 

Fat spreads

Salad dressings

Mayonnaise

Meal replacement for weight control (as drinks)

Bakery products

Yoghurt type products

Dihydrocapsiate (DHC)

Specified food category

Maximum levels

1.

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

2.

Food supplements containing synthetic dihydrocapsiate will be labelled as ‘not intended for children up to 4,5 years’

 

Cereal bars

9 mg/100 g

Biscuits, cookies and crackers

9 mg/100 g

Rice based snacks

12 mg/100 g

Carbonated drinks, dilutable drinks, fruit juice based beverages

1,5 mg/100 ml

Vegetable drinks

2 mg/100 ml

Coffee based drinks, tea based drinks

1,5 mg/100 ml

Flavoured water - still

1 mg/100 ml

Precooked oatmeal cereal

2,5 mg/100 g

Other cereals

4,5 mg/100 g

Ice cream, dairy desserts

4 mg/100 g

Pudding mixes (ready to eat)

2 mg/100 g

Products based on yoghurt

2 mg/100 g

Chocolate confectionery

7,5 mg/100 g

Hard candy

27 mg/100 g

Sugar-free gum

115 mg/100 g

Whitener/creamer

40 mg/100 g

Sweeteners

200 mg/100 g

Soup (ready to eat)

1,1 mg/100 g

Salad dressing

16 mg/100 g

Vegetable protein

5 mg/100 g

Ready to eat meals

3 mg/meal

Meal replacements for weight control

3 mg/meal

Meal replacement for weight control (as drinks)

1 mg/100 ml

Food Supplements as defined in Directive 2002/46/EC

3 mg/single intake

9 mg/day

Non-alcoholic powdered drink mixes

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

Dried extract of Lippia citriodora from cell cultures

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC

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

Echinacea angustifolia extract from cell cultures

Specified food category

Maximum levels

 

 

Food Supplements as defined in Directive 2002/46/EC

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

Echium plantagineum oil

Specified food category

Maximum levels of stearidonic acid (STA)

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

 

Milk-based products and drinkable yoghurt products delivered in a single dose

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

Cheese preparations

750 mg/100 g

Spreadable fat and dressings

750 mg/100 g

Breakfast cereals

625 mg/100 g

Food supplements as defined in Directive 2002/46/EC

500 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis)

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC

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

Foods fortified in accordance with Regulation (EC) No 1925/2006

L-ergothioneine

Specified food category

Maximum levels

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

 

Food supplements as defined in Directive 2002/46/EC

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

20 mg/day for children older than 3 years

Ferric Sodium EDTA

Specified food category

Maximum levels (expressed as anhydrous EDTA)

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

 

Food supplements as defined in Directive 2002/46/EC

18 mg/day for children

75 mg/day for adults

Foods covered by Regulation (EU) No 609/2013

12 mg/100 g

Foods fortified in accordance with Regulation (EC) No 1925/2006

Ferrous ammonium phosphate

Specified food category

Maximum levels

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

 

Food supplements as defined in Directive 2002/46/EC

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

Foods covered by Regulation (EU) No 609/2013

Foods fortified in accordance with Regulation (EC) No 1925/2006

Fish peptides from Sardinops sagax

Specified food category

Maximum levels fish peptide product

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish (Sardinops sagax) peptides’

 

Foods based on yoghurt, yoghurt drinks, fermented milk products, and powdered milk

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

Flavoured water, and vegetable-based drinks

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

Breakfast cereals

2 g/100 g

Soups, stews and soup powders

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

Flavonoids from Glycyrrhiza glabra

Specified food category

Maximum levels of flavonoids from Glycyrrhiza glabra

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Flavonoids from Glycyrrhiza glabra L.

2.

The labelling of the foods where the product was added as a novel food ingredient shall bear a statement that:

(a)

the product should not be consumed by pregnant and breast feeding women, children and young adolescents; and

(b)

people taking prescription drugs should only consume the product under medical supervision;

(c)

a maximum of 120 mg of flavonoids per day should be consumed.

3.

The amount of flavonoids in the final food shall be indicated on the labelling of the food containing it.

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

Beverages based on milk

120 mg/day

Beverages based on yoghurt

Beverages based on fruit or vegetables

Food Supplements as defined in Directive 2002/46/EC

120 mg/day

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

120 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

120 mg/day

Fucoidan extract from the seaweed Fucus vesiculosus

Specified food category

Maximum levels

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

 

Foods including food supplements as defined in Directive 2002/46/EC for the general population

250 mg/day

Fucoidan extract from the seaweed Undaria pinnatifida

Specified food category

Maximum levels

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

 

Foods including food supplements as defined in Directive 2002/46/EC for the general population

250 mg/day

2′-Fucosyllactose

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘2′-fucosyllactose’.

2.

The labelling of food supplements containing 2′-fucosyllactose shall bear a statement that the supplements should not be used if other foods with added 2′-fucosyllactose are consumed the same day.

3.

The labelling of food supplements containing 2′-fucosyllactose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added 2′-fucosyllactose are consumed the same day.

 

Unflavoured pasteurised and sterilised (including UHT) milk-based products

1,2 g/l

Unflavoured fermented milk-based products

1,2 g/l beverages

19,2 g/kg products other than beverages

Flavoured fermented milk-based products including heat-treated products

1,2 g/l beverages

19,2 g/kg products other than beverages

Dairy analogues, including beverage whiteners

1,2 g/l beverages

12 g/kg for products other than beverages

400 g/kg for whitener

Cereal bars

12 g/kg

Table-top sweeteners

200 g/kg

Infant formula as defined in Regulation (EU) No 609/2013

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

Follow-on formula as defined in Regulation (EU) No 609/2013

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

Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013

12 g/kg for products other than beverages

1,2 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer

Milk-based drinks and similar products intended for young children

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

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

4,8 g/l for drinks

40 g/kg for bars

Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

60 g/kg

Flavoured drinks

1,2 g/l

Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products

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

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants

3,0 g/day for general population

1,2 g/day for young children

Galacto-oligosaccharide

Specified food category

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

 

 

Food Supplements as defined in Directive 2002/46/EC

0,333

Milk

0,020

Milk drinks

0,030

Meal replacement for weight control (as drinks)

0,020

Dairy analogue drinks

0,020

Yoghurt

0,033

Dairy based deserts

0,043

Frozen dairy deserts

0,043

Fruit drinks and energy drinks

0,021

Infant meal replacement drinks

0,012

Baby juice

0,025

Baby yogurt drink

0,024

Baby desert

0,027

Baby snack

0,143

Baby cereals

0,027

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

0,013

Juice

0,021

Fruit pie fillings

0,059

Fruit preparations

0,125

Bars

0,125

Cereals

0,125

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

0,008

Glucosamine HCl

Specified food category

Maximum levels

 

 

Food Supplements as defined in Directive 2002/46/EC

In line with normal food use of glucosamine from shell fish

Foods covered by Regulation (EU) No 609/2013

Milk-based drinks and similar products intended for young children

Meal replacement for weight control

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Glucosamine sulphate KCl

Specified food category

Maximum levels

 

 

Food Supplements as defined in Directive 2002/46/EC

In line with normal food use of glucosamine from shell fish

Glucosamine sulphate NaCl

Specified food category

Maximum levels

 

 

Food Supplements as defined in Directive 2002/46/EC

In line with normal food use of glucosamine from shell fish

Guar Gum

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Guar Gum’.

2.

A specific mention of the possible risks of digestive discomfort linked to the exposure of children aged under 8 to guar gum must be visible on the label of any foodstuffs containing it.

For example, ‘Excessive consumption of these products may cause digestive discomfort, especially for children under 8 years of age’.

3.

In the case of products with two compartments containing dairy and cereal products respectively, the instructions for use must clearly specify the need to mix the cereal and the dairy product before consumption, in order to take into account the potential risk of gastro-intestinal obstruction.

 

Fresh dairy products such as yogurts, fermented milks, fresh cheeses and other dairy-based desserts.

1,5 g/100 g

Fruit or vegetable-based liquid foodstuffs (of the ‘smoothie’ variety)

1,8 g/100 g

Fruit or vegetable-based compotes

3,25 g/100 g

Cereals accompanied by a dairy product, in packaging containing two compartments

10 g/100 g in the cereals

None in the accompanying dairy product

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

Heat-treated milk products fermented with Bacteroides xylanisolvens

Specified food category

Maximum levels

 

 

Fermented milk products (in liquid, semi-liquid and spray-dried powder forms)

 

Hydroxytyrosol

Specified food category

Maximum levels

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

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

(a)

This food product should not be consumed by children under the age of three years, pregnant women, and lactating women;

(b)

This food product should not be used for cooking, baking or frying

 

Fish and vegetable oils, (except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/2013 (6)), placed as such on the market

0,215 g/kg

Spreadable fats as defined in Part VII of Annex VII of Regulation (EU) No 1308/2013, placed as such on the market

0,175 g/kg

Ice Structuring Protein type III HPLC 12

Specified food category

Maximum levels

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

 

Edible ices

0,01 %

Aqueous extracts of dried leaves of Ilex guayusa

Specified food category

Maximum levels

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

 

Herbal infusions

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

Food Supplements as defined in Directive 2002/46/EC

Isomalto-oligosaccharide

Specified food category

Maximum levels

1.

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

2.

Foods containing the novel ingredient must be labelled as ‘a source of glucose’.

 

Energy-Reduced Soft Drinks

6,5 %

Energy Drinks

5,0 %

Foods intended to meet the expenditure of intense muscular efforts, especially for sportsmen (including isotonic drinks)

6,5 %

Fruit Juices

5 %

Processed Vegetables and Vegetable Juices

5 %

Other Soft Drinks

5 %

Cereals Bars

10 %

Cookies, Biscuits

20 %

Breakfast Cereal Bars

25 %

Hard Candies

97 %

Soft Candies/Chocolate Bars

25 %

Meal replacement for weight control (as bars or milk based)

20 %

Isomaltulose

Not specified

1.

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

2.

The designation of the novel food on the labelling shall be accompanied by indication that the ‘Isomaltulose is a source of glucose and fructose’.

 

Lactitol

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC (capsules or tablets) intended for the adult population

20 g/day

Lacto-N-neotetraose

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lacto-N-neotetraose’.

2.

The labelling of food supplements containing lacto-N-neotetraose shall bear a statement that the supplements should not be used if other foods with added lacto-N-neotetraose are consumed the same day.

3.

The labelling of food supplements containing lacto-N-neotetraose intended for young children shall bear a statement that the supplements should not be used if breast milk or other foods with added lacto-N-neotetraose are consumed the same day.

 

Unflavoured pasteurised and sterilised (including UHT) milk-based products

0,6 g/l

Unflavoured fermented milk-based products

0,6 g/l for beverages

9,6 g/kg for products other than beverages

Flavoured fermented milk-based products including heat-treated products

0,6 g/l for beverages

9,6 g/kg for products other than beverages

Dairy analogues, including beverage whiteners

0,6 g/l for beverages

6 g/kg for products other than beverages

200 g/kg for whitener

Cereal bars

6 g/kg

Table-top sweeteners

100 g/kg

Infant formula as defined in Regulation (EU) No 609/2013

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

Follow-on formula as defined in Regulation (EU) No 609/2013

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

Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013

6 g/kg for products other than beverages

0,6 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer

Milk-based drinks and similar products intended for young children

0,6 g/l for milk-based drinks and similar products added alone or in combination with 2′-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

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

2,4 g/l for drinks

20 g/kg for bars

Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

30 g/kg

Flavoured drinks

0,6 g/l

Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products

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

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants

1,5 g/day for general population

0,6 g/day for young children

Lucerne leaf extract from Medicago sativa

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Lucerne (Medicago sativa) protein’ or ‘Alfalfa (Medicago sativa) protein’.

 

Food supplements as defined in Directive 2002/46/EC

10 g/day

Lycopene

Specified food category

Maximum levels

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

 

Fruit/vegetable juice-based drinks (including concentrates)

2,5 mg/100 g

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

2,5 mg/100 g

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

8 mg/meal

Breakfast cereals

5 mg/100 g

Fats and dressings

10 mg/100 g

Soups other than tomato soups

1 mg/100 g

Bread (including crispy breads)

3 mg/100 g

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Food supplements as defined in Directive 2002/46/EC

15 mg/day

Lycopene from Blakeslea trispora

Specified food category

Maximum levels

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

 

Fruit/vegetable juice-based drinks (including concentrates)

2,5 mg/100 g

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

2,5 mg/100 g

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

8 mg/meal

Breakfast cereals

5 mg/100 g

Fats and dressings

10 mg/100 g

Soups other than tomato soups

1 mg/100 g

Bread (including crispy breads)

3 mg/100 g

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Food supplements as defined in Directive 2002/46/EC

15 mg/day

Lycopene from tomatoes

Specified food category

Maximum levels

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

 

Fruit/vegetable juice-based drinks (including concentrates)

2,5 mg/100 g

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

2,5 mg/100 g

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

8 mg/meal

Breakfast cereals

5 mg/100 g

Fats and dressings

10 mg/100 g

Soups other than tomato soups

1 mg/100 g

Bread (including crispy breads)

3 mg/100 g

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Lycopene oleoresin from tomatoes

Specified food category

Maximum levels of lycopene

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

 

Fruit/vegetable juice-based drinks (including concentrates)

2,5 mg/100 g

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

2,5 mg/100 g

Total diet replacement for weight control covered by Regulation (EU) No 609/2013 and meal replacements for weight control

8 mg/meal

Breakfast cereals

5 mg/100 g

Fats and dressings

10 mg/100 g

Soups other than tomato soups

1 mg/100 g

Bread (including crispy breads)

3 mg/100 g

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Magnesium citrate malate

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC

 

Magnolia Bark Extract

Specified food category

Maximum levels

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

 

Mints (confectionary products)

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

Chewing gum

Maize-germ oil high in unsaponifiable matter

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC

2 g/day

Chewing gum

2 %

Methylcellulose

Specified food category

Maximum levels

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

Methylcellulose is not to be used in foods specially prepared for young children

Edible ices

2 %

Flavoured drinks

Flavoured or unflavoured fermented milk products

Cold desserts (dairy, fat, fruit, cereal, egg-based products)

Fruit preparations (pulps, purees or compotes)

Soups and broths

(6S)-5-methyltetrahydrofolic acid, glucosamine salt

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC as a source of folate

 

 

 

Monomethylsilanetriol (Organic Silicon)

Specified food category

Maximum levels of silicon

The designation of the novel food on the labelling of the food supplements containing it shall be ‘Organic silicon (monomethylsilanetriol)’

 

Food Supplements as defined in Directive 2002/46/EC for adult population (in liquid form)

10,40 mg/day

Mycelial extract from Shiitake mushroom (Lentinula edodes)

Specified food category

Maximum levels

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

 

Bread products

2 ml/100 g

Soft drinks

0,5 ml/100 ml

Ready prepared meals

2,5 ml per meal

Foods based on yoghurt

1,5 ml/100 ml

Food supplements as defined in Directive 2002/46/EC

2,5 ml per day dose

Noni fruit juice (Morinda citrifolia)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Noni juice’ or ‘Juice of Morinda citrifolia

 

Pasteurised fruit and fruit nectar based drinks

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

or

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

Noni fruit juice powder (Morinda citrifolia)

Food supplements as defined in Directive 2002/46/EC

6,6 g/day (equivalent to 30 ml of noni juice)

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Noni juice powder’ or ‘Juice powder of Morinda citrifolia

 

Noni fruit puree and concentrate (Morinda citrifolia)

Specified food category

Maximum levels

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

 

For fruit puree:

Morinda citrifolia fruit puree’ or ‘Noni fruit puree’

 

For fruit concentrate:

Morinda citrifolia fruit concentrate’ or ‘Noni fruit concentrate’

 

 

Fruit puree

Candy/confectionery

45 g/100 g

Cereal bars

53 g/100 g

Powdered nutritional drink mixes (dry weight)

53 g/100 g

Carbonated beverages

11 g/100 g

Ice cream & sorbet

31 g/100 g

Yoghurt

12 g/100 g

Biscuits

53 g/100 g

Buns, cakes and pastries

53 g/100 g

Breakfast cereals (wholegrain)

88 g/100 g

Jams and jellies in accordance with Directive 2001/113/EC

133 g/100 g

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

Sweet spreads, fillings and icings

31 g/100 g

Savoury sauces, pickles, gravies and condiments

88 g/100 g

Food Supplements as defined in Directive 2002/46/EC

26 g/day

 

Fruit concentrate

Candy/Confectionery

10 g/100 g

Cereal bars

12 g/100 g

Powdered nutritional drink mixes (dry weight)

12 g/100 g

Carbonated beverages

3 g/100 g

Ice cream & sorbet

7 g/100 g

Yoghurt

3 g/100 g

Biscuits

12 g/100 g

Buns, cakes and pastries

12 g/100 g

Breakfast cereals (wholegrain)

20 g/100 g

Jams and jellies in accordance with Directive 2001/113/EC

30 g/100 g

Sweet spreads, fillings and icings

7 g/100 g

Savoury sauces, pickles, gravies and condiments

20 g/100 g

Food Supplements as defined in Directive 2002/46/EC

6 g/day

Noni leaves (Morinda citrifolia)

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Noni leaves’ or ‘leaves of Morinda citrifolia’.

2.

Instructions shall be given to the consumer that a cup of infusion should not be prepared with more than 1 g of dried and roasted leaves of Morinda citrifolia.

 

For the preparation of infusions

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

Noni fruit powder (Morinda citrifolia)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Morinda citrifolia fruit powder’ or ‘Noni fruit powder’

 

Food Supplements as defined in Directive 2002/46/EC

2,4 g per/day

Odontella aurita microalgae

Specified food category

Maximum levels

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

 

Flavoured pasta

1,5 %

Fish soups

1 %

Marine terrines

0,5 %

Broth preparations

1 %

Crackers

1,5 %

Frozen breaded fish

1,5 %

Oil enriched with phytosterols/phytostanols

Specified food category

Maximum levels of phytosterols/phytostanols

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

 

Spreadable fats as defined in Annex VII, Part VII, Appendix II points B and C, of Regulation (EU) No 1308/2013, and excluding cooking and frying fats and spreads based on butter or other animal fat

1.

The products containing the novel food ingredient shall be presented in such a manner that they can be easily divided into portions that contain either a maximum of 3 g (in case of one portion per day) or a maximum of 1 g (in case of three portions per day) of added phytosterols/phytostanols.

2.

The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.

3.

Salad dressings, mayonnaise and spicy sauces shall be packed as single portions.

Milk based products, such as products based on semi-skimmed and skimmed milk products, possibly with the addition of fruits and/or cereals, products based on fermented milk such as yoghurt and cheese based products (fat content ≤ 12 g per 100 g), where possibly the milk fat has been reduced and the fat or protein has been partly or fully replaced by vegetable fat or protein

Soya drinks

Salad dressings, mayonnaise and spicy sauces

Oil extracted from squids

Specified food category

Maximum levels of DHA and EPA combined

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

 

Dairy products except milk-based beverages

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

Dairy analogues except drinks

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

Spreadable fat and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

Bakery products (breads and bread rolls)

200 mg/100 g

Cereal bars

500 mg/100 g

Non-alcoholic beverages (including milk-based beverages)

60 mg/100 ml

Food Supplements as defined in Directive 2002/46/EC

3 000 mg/day for general population

450 mg/day for pregnant and lactating women

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Total diet replacement for weight control defined in Regulation (EU) No 609/2013 and meal replacements for weight control

200 mg/meal

Pasteurised fruit-based preparations produced using high-pressure treatment

Specified food category

Maximum levels

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

 

Types of fruit:

apple, apricot, banana, blackberry, blueberry, cherry, coconut, fig, grape, grapefruit, mandarin, mango, melon, peach, pear, pineapple, prune, raspberry, rhubarb, strawberry

 

Phosphated maize starch

Specified food category

Maximum levels

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

 

Baked bakery products

15 %

Pasta

Breakfast cereals

Cereal bars

Phosphatidylserine from fish phospholipids

Specified food category

Maximum levels of phosphatidylserine

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

 

Beverages based on yoghurt

50 mg/100 ml

Powders based on milk powders

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

Foods based on yoghurt

80 mg/100 g

Cereal bars

350 mg/100 g

Chocolate based confectionary

200 mg/100 g

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

In compliance with Regulation (EU) No 609/2013

Food supplements as defined in Directive 2002/46/EC

300 mg/day

Phosphatidylserine from soya phospholipids

Specified food category

Maximum levels of phosphatidylserine

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

 

Beverages based on yoghurt

50 mg/100 ml

Powders based on milk powder

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

Foods based on yoghurt

80 mg/100 g

Cereal bars

350 mg/100 g

Chocolate based confectionary

200 mg/100 g

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

In compliance with Regulation (EU) No 609/2013

Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid

Specified food category

Maximum levels of phosphatidylserine

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

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

Breakfast cereals

80 mg/100 g

Cereal bars

350 mg/100 g

Foods based on yogurt

80 mg/100 g

Soy-based yogurt-like products

80 mg/100 g

Yogurt based-drinks

50 mg/100 g

Soy-based yogurt-like drinks

50 mg/100 g

Powders based on milk powder

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

Food Supplements as defined in Directive 2002/46/EC

800 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

In compliance with Regulation (EU) No 609/2013

Phospholipides from egg yolk

Specified food category

Maximum levels

 

 

Not specified

Phytoglycogen

Specified food category

Maximum levels

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

 

Processed foods

25 %

Phytosterols/phytostanols

Specified food category

Maximum levels

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

 

Rice drinks

1.

They shall be presented in such a manner that they can be easily divided into portions that contain either a maximum of 3 g (in case of 1 portion/day) or a maximum of 1 g (in case of 3 portions/day) of added phytosterols/phytostanols.

The amount of phytosterols/phytostanols added to a container of beverages shall not exceed 3 g.

Salad dressings, mayonnaise and spicy sauces shall be packed as single portions

Rye bread with flour containing ≥ 50 % rye (wholemeal rye flour, whole or cracked rye kernels and rye flakes) and ≤ 30 % wheat; and with ≤ 4 % added sugar but no fat added.

Salad dressings, mayonnaise and spicy sauces.

Soya drink

Milk type products, such as semi-skimmed and skimmed milk type products, possibly with the addition of fruits and/or cereals, where possibly the milk fat has been reduced, or where milk fat and/or protein has been partly or fully replaced by vegetable fat and/or protein.

Products based on fermented milk such as yoghurt and cheese type products (fat content < 12 % per 100 g), where possibly the milk fat has been reduced, or where milk fat and/or protein has been partly or fully replaced by vegetable fat and/or protein

Spreadable fats as defined in Annex VII, Part VII, Appendix II points B and C, of Regulation (EU) No 1308/2007, and excluding cooking and frying fats and spreads based on butter or other animal fat.

Plum kernel oil

Specified food category

Maximum levels

 

 

For frying and as seasoning

In line with normal food use of vegetable oils

Potato proteins (coagulated) and hydrolysates thereof

Not specified

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

 

Prolyl oligopeptidase (enzyme preparation)

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC for general adult population

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

PPU – Prolyl Peptidase Units or Proline Protease Units

PPI – Protease Picomole International

Protein extract from pig kidneys

Specified food category

Maximum levels

 

 

Food Supplements as defined in Directive 2002/46/EC

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

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

Food for special medical purposes as defined in Regulation (EU) No 609/2013

Rapeseed oil high in unsaponifiable matter

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC

1,5 g per portion recommended for daily consumption

Rapeseed Protein

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

 

1.

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

2.

Any foodstuff containing ‘rapeseed protein’ shall bear a statement that this ingredient may cause allergic reaction to consumers who are allergic to mustard and products thereof. Where relevant, this statement shall appear in close proximity to the list of ingredients.

 

Trans-resveratrol

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the food supplements containing it shall be ‘Trans-resveratrol’.

2.

The labelling of food supplements containing trans-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision.

 

Food Supplements as defined in Directive 2002/46/EC for adult population (capsule or tablet form)

150 mg/day

Trans-resveratrol (microbial source)

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the food supplements containing it shall be ‘Trans-resveratrol’.

2.

The labelling of food supplements containing trans-resveratrol shall bear a statement that people using medicines should only consume the product under medical supervision.

 

Food supplements as defined in Directive 2002/46/EC

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

Rooster comb extract

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Rooster comb extract’ or ‘Cockerel comb extract’

 

Milk-based drinks

40 mg/100 g or mg/100 ml

Milk based fermented drinks

80 mg/100 g or mg/100 ml

Yoghurt-type products

65 mg/100 g or mg/100 ml

Fromage frais

110 mg/100 g or mg/100 ml

Sacha Inchi oil from Plukenetia volubilis

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sacha inchi oil (Plukenetia volubilis)’

 

As for linseed oil

In line with normal food use of linseed oil

Salatrims

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘reduced energy fat (salatrims)’.

2.

There shall be a statement that excessive consumption may lead to gastro-intestinal disturbance.

3.

There shall be a statement that the products are not intended for use by children.

 

Bakery products and confectionary

 

Schizochytrium sp. oil rich in DHA and EPA

Specified food category

Maximum levels of DHA and EPA combined

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’

 

Food Supplements as defined in Directive 2002/46/EC for adult population excluding pregnant and lactating women

3 000 mg/day

Food Supplements as defined in Directive 2002/46/EC for pregnant and lactating women

450 mg/day

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Milk-based drinks and similar products intended for young children

200 mg/100 g

Processed cereal based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Bakery Products (Breads, Rolls and Sweet Biscuits)

200 mg/100 g

Breakfast Cereals

500 mg/100 g

Cooking Fats

360 mg/100 g

Dairy Analogues except drinks

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

Dairy Products except milk-based drinks

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

Non-alcoholic Beverages (including dairy analogue and milk-based drinks)

80 mg/100 g

Cereal/Nutrition Bars

500 mg/100 g

Spreadable Fats and Dressings

600 mg/100 g

Schizochytrium sp. (ATCC PTA-9695) oil

Specified food category

Maximum levels of DHA

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

 

Dairy products except milk-based drinks

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

Dairy analogues except drinks

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

Spreadable fats and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

Food Supplements as defined in Directive 2002/46/EC

250 mg DHA/day for general population

450 mg DHA/day for pregnant and lactating women

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Milk-based drinks and similar products intended for young children

200 mg/100 g

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Bakery products (breads,rolls, and, sweet biscuits)

200 mg/100 g

Cereal bars

500 mg/100 g

Cooking fats

360 mg/100 g

Non-alcoholic beverages (including dairy analogue and milk-based drinks)

80 mg/100 ml

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013

200 mg/100 g

Schizochytrium sp. oil

Specified food category

Maximum levels of DHA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’

 

Dairy products except milk-based drinks

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

Dairy analogues except drinks

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

Spreadable fats and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

Food Supplements as defined in Directive 2002/46/EC

250 mg DHA/day for general population

450 mg DHA/day for pregnant and lactating women

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Milk-based drinks and similar products intended for young children

200 mg/100 g

Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Bakery products (breads, rolls and sweet biscuits)

200 mg/100 g

Cereal bars

500 mg/100 g

Cooking fats

360 mg/100 g

Non-alcoholic beverages (including dairy analogue and milk-based drinks)

80 mg/100 ml

Schizochytrium sp. (T18) oil

Specified food category

Maximum levels of DHA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’

 

Dairy products except milk-based drinks

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

Dairy analogues except drinks

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

Spreadable fats and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

Food Supplements as defined in Directive 2002/46/EC

250 mg DHA/day for general population

450 mg DHA/day for pregnant and lactating women

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Milk-based drinks and similar products intended for young children

200 mg/100 g

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Bakery products (breads, rolls and, sweet biscuits)

200 mg/100 g

Cereal bars

500 mg/100 g

Cooking fats

360 mg/100 g

Non-alcoholic beverages (including dairy analogue and milk-based drinks)

80 mg/100 ml

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013

200 mg/100 g

Fermented soybean extract

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fermented soybean extract’.

2.

The labelling of food supplements containing fermented soybean extract shall bear a statement that persons taking medication should only consume the product under medical supervision.

 

Food Supplements as defined in Directive 2002/46/EC (capsules, tablets or powder form) intended for the adult population, excluding pregnant and lactating women

100 mg/day

Spermidine-rich wheat germ extract (Triticum aestevium)

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC intended for the adult population

Equivalent of max. 6 mg/day spermidine

Sucromalt

Specified food category

Maximum levels

1.

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

2.

The designation of the novel food on the labelling shall be accompanied by indication that the product is a source of glucose and fructose.

 

Not specified

Sugar cane fibre

Specified food category

Maximum levels

 

 

Bread

8 %

Bakery goods

5 %

Meat and muscle products

3 %

Seasonings and spices

3 %

Grated cheeses

2 %

Special diet foods

5 %

Sauces

2 %

Beverages

5 %

Sunflower oil extract

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC

1,1 g/day

Dried Tetraselmis chuii microalgae

Specified food category

Maximum levels

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

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

 

Sauces

20 % or 250 mg/day

Special salts

1 %

Condiment

250 mg/day

Food Supplements as defined in Directive 2002/46/EC

250 mg/day

Therapon barcoo/Scortum

Intended use identical to that of the salmon, namely the preparation of culinary fish products and dishes, including cooked, raw, smoked and baked fish products

 

 

D-Tagatose

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘D-Tagatose’.

2.

The labelling of any product where the level of D-Tagatose exceeds 15 g per serving and all beverages containing greater than 1 % D-Tagatose (as consumed) shall bear a statement ‘excessive consumption may produce laxative effects’.

 

Not specified

Taxifolin-rich extract

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC intended for the general population, excluding infants, young children, children and adolescents younger than 14 years

100 mg/day

Trehalose

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Trehalose’ and shall be displayed on the labelling of the product as such or in the list of ingredients of foodstuffs containing it.

2.

The designation of the novel food on the labelling shall be accompanied by indication that the ‘Trehalose is a source of glucose’.

 

Not specified

UV-treated mushrooms (Agaricus bisporus)

Specified food category

Maximum levels of vitamin D2

 

 

Mushrooms (Agaricus bisporus)

10 μg of vitamin D2/100 g fresh weight

1.

The designation on the label of the novel food as such or of the foodstuffs containing it shall be ‘UV-treated mushrooms (Agaricus bisporus)’.

2.

The designation on the label of the novel food as such or of the foodstuffs containing it shall be accompanied by indication that a ‘controlled light treatment was used to increase vitamin D levels’ or ‘UV treatment was used to increase vitamin D2 levels’.

 

UV-treated baker's yeast (Saccharomyces cerevisiae)

Specified food category

Maximum levels of vitamin D2

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

 

Yeast-leavened breads and rolls

5 μg of vitamin D2/100 g

Yeast-leavened fine bakery wares

5 μg of vitamin D2/100 g

Food Supplements as defined in Directive 2002/46/EC

5 μg of vitamin D2/day

UV-treated bread

Specified food category

Maximum levels of vitamin D2

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

 

Yeast leavened bread and rolls (without toppings)

3 μg vitamin D2/100 g

UV-treated milk

Specified food category

Maximum levels of vitamin D3

1.

The designation on the label of the novel food shall be ‘UV-treated’.

2.

Where UV-treated milk contains an amount of vitamin D that is considered significant in accordance with Point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011 of the European Parliament and of the Council, the designation for the labelling shall be accompanied by ‘contains vitamin D produced by UV-treatment’ or ‘milk containing vitamin D resulting from UV-treatment’.

 

Pasteurised whole milk as defined in Regulation (EU) No 1308/2013 to be consumed as such

5-32 μg/kg for general population excluding infants

Pasteurised semi-skimmed milk as defined in Regulation (EU) No 1308/2013 to be consumed as such

1-15 μg/kg for general population excluding infants

Vitamin K2 (menaquinone)

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

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

Wheat bran extract

Specified food category

Maximum levels

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

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

Beer and substitutes

0,4 g/100 g

Ready to eat cereals

9 g/100 g

Dairy products

2,4 g/100 g

Fruit and vegetable juices

0,6 g/100 g

Soft drinks

0,6 g/100 g

Meat preparations

2 g/100 g

Yeast beta-glucans

Specified food category

Maximum levels of pure beta-glucans from yeast (Saccharomyces cervisiae)

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yeast (Saccharomyces cerevisiae) beta-glucans’

 

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

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

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

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013

1,275 g/day

Food for special medical purposes as defined in Regulation (EU) No 609/2013, excluding food for special medical purposes intended for infants and young children

1,275 g/day

Beverages based on fruit and/or vegetable juices including concentrate and dehydrated juices

1,3 g/kg

Fruit-flavoured drinks

0,8 g/kg

Cocoa beverages preparation powder

38,3 g/kg (powder)

Other beverages

0,8 g/kg (ready to drink)

7 g/kg (powder)

Cereal bars

6 g/kg

Breakfast cereals

15,3 g/kg

Wholegrain and high fibre instant hot breakfast cereals

1,5 g/kg

Cookie-type biscuits

6,7 g/kg

Cracker-type biscuits

6,7 g/kg

Milk based beverages

3,8 g/kg

Fermented milk products

3,8 g/kg

Milk product analogues

3,8 g/kg

Dried milk/milk powder

25,5 g/kg

Soups and soup mixes

0,9 g/kg (ready to eat)

1,8 g/kg (condensed)

6,3 g/kg (powder)

Chocolate and confectionery

4 g/kg

Protein bars and powders

19,1 g/kg

Jam, marmalade and other fruit spreads

11,3 g/kg

Zeaxanthin

Specified food category

Maximum levels

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

 

Food Supplements as defined in Directive 2002/46/EC

2 mg/day

Zinc L-pidolate

Specified food category

Maximum levels

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

 

Foods covered by Regulation (EU) No 609/2013

3 g/day

Milk based drinks and similar products intended for young children

Meal replacement for weight control

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Food bearing statement on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Food Supplements as defined in Directive 2002/46/EC


Table 2: Specifications

Authorised Novel Food

Specification

N-Acetyl-D-neuraminic acid

Description:

N-Acetyl-D-neuraminic acid is a white to off-white crystalline powder

Definition:

Chemical name:

IUPAC names:

 

N-Acetyl-D-neuraminic acid (dihydrate)

 

5-Acetamido-3,5-dideoxy-D-glycero-D-galacto-non-2-ulopyranosonic acid (dihydrate),

Synonyms:

Sialic acid (dihydrate)

Chemical formula:

C11H19NO9 (acid)

C11H23NO11 (C11H19NO9 * 2H2O) (dihydrate)

Molecular mass:

309,3 Da (acid)

345,3 (309,3 + 36,0) (dihydrate)

CAS No.:

131-48-6 (free acid)

50795-27-2 (dihydrate)

Specifications:

Description: white to off-white crystalline powder

pH (20 °C, 5 % solution): 1,7 – 2,5

N-Acetyl-D-neuraminic acid (dihydrate): > 97,0 %

Water (dihydrate calculates to 10,4 %): ≤ 12,5 % (w/w)

Ash, sulphated: < 0,2 % (w/w)

Acetic acid (as free acid and/or sodium acetate): < 0,5 % (w/w)

Heavy Metals:

Iron: < 20,0 mg/kg

Lead: < 0,1 mg/kg

Residual proteins: < 0,01 % (w/w)

Residual solvents:

2-Propanol: < 0,1 % (w/w)

Acetone: < 0,1 % (w/w)

Ethyl acetate: < 0,1 % (w/w)

Microbiological criteria:

Salmonella: Absence in 25 g

Aerobic mesophilic total count: < 500 CFU/g

Enterobacteriaceae: Absence in 10 g

Cronobacter (Enterobacter) sakazakii: Absence in 10 g

Listeria monocytogenes: Absence in 25 g

Bacillus cereus: < 50 CFU/g

Yeasts: < 10 CFU/g

Moulds: < 10 CFU/g

Residual endotoxins: < 10 EU/mg

CFU: Colony Forming Units; EU: Endotoxin Units.

Adansonia digitata (Baobab) dried fruit pulp

Description/Definition:

The Baobab (Adansonia digitata) fruits are harvested from trees. The hard shells are cracked open and the pulp is separated from the seeds and the shell. This is milled, separated into coarse and fine lots (particle size 3 to 600 μ) and then packaged.

Typical nutritional components:

Moisture (loss on drying) (g/100 g): 4,5-13,7

Protein (g/100 g): 1,8-9,3

Fat (g/100 g): 0-1,6

Total carbohydrate (g/100 g): 76,3-89,5

Total sugars (as glucose): 15,2-36,5

Sodium (mg/100 g): 0,1-25,2

Analytical specifications:

Foreign matter: Not more than 0,2 %

Moisture (loss on drying) (g/100 g): 4,5-13,7

Ash (g/100 g): 3,8-6,6

Ajuga reptans extract from cell cultures

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.

L-Alanyl-L-Glutamine

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

Algal oil from the microalgae Ulkenia sp.

Description/Definition:

Oil from the micro-algae Ulkenia sp.

Acid value: ≤ 0,5 mg KOH/g

Peroxide value (PV): ≤ 5,0 meq/kg oil

Moisture and volatiles: ≤ 0,05 %

Unsaponifiables: ≤ 4,5 %

Trans-fatty acids: ≤ 1,0 %

DHA content: ≥ 32 %

Allanblackia seed oil

Description/Definition:

Allanblackia seed oil is obtained from the seeds of the allanblackia species: A. floribunda (synonymous with A. parviflora) and A. stuhlmannii.

Composition of fatty acids:

Lauric acid (C12:0): < 1,0 %

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

Aloe macroclada Baker leaf extract

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 %

Antarctic Krill oil from Euphausia superba

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 %

Antarctic Krill oil rich in phospholipids from Euphausia superba

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 %

Arachidonic acid-rich oil from the fungus Mortierella alpina

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 %

Argan oil from Argania spinosa

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

Astaxanthin-rich oleoresin from Haematococcus pluvialis algae

Description/Definition:

Astaxanthin is a carotenoid produced by Haematococcus pluvialis algae. Production methods for the growth of the algae are variable; using closed systems exposed to sunlight or strictly controlled 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

Basil seeds (Ocimum basilicum)

Description/Definition:

Basil (Ocimum basilicum L.) belongs to the family ‘Lamiaceae’ within the order ‘Lamiales’. Post-harvest the seeds are cleaned mechanically. Flowers, leaves and other parts of the plant are removed. Highest level of purity of Basil seeds has to be 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 %

Fermented black bean extract

Description/Definition:

Fermented black bean extract (Touchi extract) is a fine light-brown protein-rich powder obtained by water extraction of small soybeans (Glycine max (L.) Merr.) fermented with Aspergillus oryzae. The extract contains an α-glucosidase inhibitor.

Characteristics:

Fat: ≤ 1,0 %

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

Bovine lactoferrin

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

Buglossoides arvensis seed oil

Description/Definition:

Refined Buglossoides oil is extracted from the seeds of Buglossoides arvensis (L.) I.M.Johnst

Alpha-linolenic acid: ≥ 35 % w/w of total fatty acids

Stearidonic acid: ≥ 15 % w/w of total fatty acids

Linoleic acid: ≥ 8,0 % 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

Calanus finmarchicus oil

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

Chewing gum base (monomethoxypolyethylene glycol)

Description/Definition:

The novel food ingredient is a synthetic polymer (Patent number WO2006016179). It consists of branched polymers of monomethoxypolyethylene glycol (MPEG) grafted onto polyisoprene-graft-maleic anhydride (PIP-g-MA), and unreacted MPEG (less than 35 % by weight).

White to 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

Chewing gum base (Methyl vinyl ether-maleic anhydride copolymer)

Description/Definition:

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

Chia oil from Salvia hispanica

Description/Definition:

Chia oil is produced from Chia (Salvia hispanica L.) seeds (99,9 % pure) by cold-pressing. No solvents are used and, once pressed, the oil is held in decantation tanks and a filtration process employed to remove impurities. It can also be produced by 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 %

Chia seeds (Salvia hispanica)

Description/Definition:

Chia (Salvia hispanica L.) is a summer annual herbaceous plant belonging to the Labiatae family. Post-harvest the seeds are cleaned mechanically. Flowers, leaves and other parts of the plant are removed.

Dry matter: 90-97 %

Protein: 15-26 %

Fat: 18-39 %

Carbohydrate (*): 18-43 %

Crude Fibre (**): 18-43 %

Ash: 3-7 %

(*)

Carbohydrates include the fibre value (EU: carbohydrates are available = sugar + starch)

(**)

Crude fibre is the part of fibre made mainly of indigestible cellulose, pentosans and lignin

Production process:

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

Chitin-glucan from Aspergillus niger

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:

chitin, composed of repeating units of N-acetyl-D-glucosamine (CAS No: 1398-61-4),

beta (1, 3)-glucan, composed of repeating units of D-glucose (CAS No: 9041-22-9).

Loss on drying: ≤ 10 %

Chitin-glucan: ≥ 90 %

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

Ash: ≤ 3,0 %

Lipids: ≤ 1,0 %

Proteins: ≤ 6,0 %

Chitin-glucan complex from Fomes fomentarius

Description/Definition:

Chitin-glucan complex is obtained from the cell walls of the fruit bodies of the fungus Fomes fomentarius. It consists primarily of two polysaccharides:

Chitin, composed of repeating units of N-acetyl-D-glucosamine (CAS No: 1398-61-4);

Beta-(1,3)(1,6)-D-glucan, composed of repeating units of D-glucose (CAS No: 9041-22-9).

The production process consists of several steps, including: cleaning, reduction in size and grinding, 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

Chitosan extract from fungi (Agaricus bisporus; Aspergillus niger)

Description/Definition:

The chitosan extract (containing mainly poly(D-glucosamine)) is obtained from stems of Agaricus bisporus or from the mycelium of Aspergillus niger.

The patented production process consists of several steps, including: extraction and deacetylation (hydrolysis) in alkaline medium, solubilisation in acidic medium, precipitation in alkaline medium, washing and drying.

Synonym: Poly(D-glucosamine)

Chitosan CAS number: 9012-76-4

Chitosan 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

Chondroitin sulphate

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

Chromium Picolinate

Description/Definition:

Chromium picolinate is a reddish free-flowing powder, slightly soluble in water at pH 7. The salt is also soluble in polar organic solvents.

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 %

Cistus incanus L. Pandalis herb

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

Vitamin B1: 3,0 μg

Vitamin B2: 30 μg

Vitamin B6: 54 μg

Vitamin C: 28 mg

Vitamin A: less than 0,1 mg

Vitamin E: 40–50 mg

Alpha-Tocopherol: 20–50 mg

Beta and Gamma-Tocopherols: 2–15 mg

Delta-Tocopherol: 0,1–2 mg

Citicoline

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.

Clostridium butyricum

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

Extract of defatted cocoa powder

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 extract

Low fat Cocoa (Theobroma cacao L.) extract

Appearance: Dark red to purple powder

Cocoa extract, concentrate: Min 99 %

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

Cocoa flavanols: Min. 300 mg/g

(-) Epicatechin: Min. 45 mg/g

Loss on drying: Max. 5,0 %

Coriander seed oil from Coriandrum sativum

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

Crataegus pinnatifida dried fruit

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.

α-cyclodextrin

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:

 

Sample solution: Weigh accurately about 100 mg of test sample into a 10 ml volumetric flask and add 8 ml of deionised water. Dissolve the sample completely using an ultra-sonification bath (10-15 min) and dilute to the mark with purified deionised water. Filter through a 0,45-micrometer filter

 

Reference solution: Weigh accurately about 100 mg of α-cyclodextrin into a 10 ml volumetric flask and add 8 ml of deionised water. Dissolve the sample completely using an ultra-sonification bath and dilute to the mark with purified deionised water.

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.

γ-cyclodextrin

Description/Definition:

A non-reducing cyclic saccharide consisting of eight α-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolysed starch. Recovery and purification of γ-cyclodextrin may be carried out 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 %

Dextran preparation produced by Leuconostoc mesenteroides

1.

Powdered form:

Carbohydrates: 60 % with: (Dextran: 50 %, Mannitol: 0,5 %, Fructose: 0,3 %, Leucrose: 9,2 %)

Protein: 6,5 %

Lipid: 0,5 %

Lactic acid: 10 %

Ethanol: traces

Ash: 13 %

Moisture: 10 %

2.

Liquid form:

Carbohydrates: 12 % with: (Dextran: 6,9 %, Mannitol: 1,1 %, Fructose: 1,9 %, Leucrose: 2,2 %)

Protein: 2,0 %

Lipid: 0,1 %

Lactic acid: 2,0 %

Ethanol: 0,5 %

Ash: 3,4 %

Moisture: 80 %

Diacylglycerol oil of plant origin

Description/Definition:

Manufactured from glycerol and fatty acids derived from edible vegetable oils, in particular from soybean oil (Glycine max) or 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

Dihydrocapsiate (DHC)

Description/Definition:

Dihydrocapsiate is synthesised by enzyme-catalysed esterification of vanillyl alcohol and 8-methylnonanoic acid. Following the esterification dihydrocapsiate is extracted with n-hexane.

Viscous to colourless to yellow liquid

Chemical formula: 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 %

Dried extract of Lippia citriodora from cell cultures

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

Echinacea angustifolia extract from cell cultures

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.

Echium plantagineum oil

Description/Definition:

Echium oil is the pale yellow product obtained by refining oil extracted from the seeds of Echium plantagineum L. Stearidonic acid: ≥ 10 % w/w of total fatty acids

Trans fatty acids: ≤ 2,0 % (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

Epigallocatechin gallate as a purified extract from green tea leaves (Camellia sinensis)

Description/Definition:

A highly purified extract from the leaves of green tea (Camellia sinensis (L.) Kuntze) in the form of a fine, off-white to pale pink powder. It is composed of a minimum of 90 % epigallo-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

L-ergothioneine

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

Parameter

Specification

Method

Appearance

White powder

Visual

Optical rotation

[α]D ≥ (+) 122° (c = 1, H2O)a)

Polarimetry

Chemical purity

≥ 99,5 %

≥ 99,0 %

HPLC [Eur. Ph. 2.2.29]

1H-NMR

Identification

Compliant with the structure

1H-NMR

C: 47,14 ± 0,4 %

H: 6,59 ± 0,4 %

N: 18,32 ± 0,4 %

Elemental analysis

Total residual solvents

(methanol, ethyl acetate, isopropanol, ethanol)

[Eur. Ph. 01/2008:50400]

< 1 000 ppm

Gas chromatography

[Eur. Ph. 01/2008:20424]

Loss on drying

Internal standard < 0,5 %

[Eur. Ph. 01/2008:20232]

Impurities

< 0,8 %

HPLC/GPC or 1H-NMR

Heavy metals b) c)

Lead

< 3,0 ppm

ICP/AES

(Pb, Cd)

Atomic fluorescence (Hg)

Cadmium

< 1,0 ppm

Mercury

< 0,1 ppm

Microbiological specifications b)

Total viable aerobic count (TVAC)

≤ 1 × 103 CFU/g

[Eur. Ph. 01/2011:50104]

Total yeast and mould count (TYMC)

≤ 1 × 102 CFU/g

Escherichia coli

Absence in 1 g

Eur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-performance liquid chromatography; GPC: gel permeation chromatography; ICP/AES: Inductively coupled plasma atomic emission spectroscopy; CFU: colony-forming units.

a)

Lit. [α]D = (+) 126,6° (c = 1, H2O)

b)

Analyses conducted on each batch

c)

Maximum levels in accordance with Regulation (EC) No 1881/2006

Ferric Sodium EDTA

Description/Definition:

Ferric Sodium EDTA (ethylenediaminetetraacetic acid) is an odourless free-flowing, yellow to brown powder with a chemical purity of more than 99 % (w/w). It is freely soluble in water.

Chemical formula: 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 %

Ferrous ammonium phosphate

Description/Definition:

Ferrous ammonium phosphate is a grey/green fine powder, practically insoluble in water and soluble in dilute mineral acids.

CAS No.: 10101-60-7

Chemical formula: 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 %

Fish peptides from Sardinops sagax

Description/Definition:

The novel food ingredient is a peptide mixture, which is obtained by an alkaline protease-catalysed hydrolysis of fish (Sardinops sagax) muscle, subsequent isolation of the peptide fraction by column chromatography, concentration under vacuum and spray drying.

Yellowish white powder

Peptides (*) (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

(*)

Kjeldahl method

Flavonoids from Glycyrrhiza glabra

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

Fucoidan extract from the seaweed Fucus vesiculosus

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:

 

Off-white to brown powder

 

Odour and Taste: Bland odour and taste

 

Moisture: < 10 % (105 °C for 2 hours)

 

pH value: 4,0-7,0 (1 % suspension at 25 °C)

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:

 

Extract 1:

 

Fucoidan: 75-95 %

 

Alginate: 2,0-5,5 %

 

Polyphloroglucinol: 0,5-15 %

 

Mannitol: 1-5 %

 

Natural salts/Free Minerals: 0,5-2,5 %

 

Other carbohydrates: 0,5-1,0 %

 

Protein: 2,0-2,5 %

 

Extract 2:

 

Fucoidan: 60-65 %

 

Alginate: 3,0-6,0 %

 

Polyphloroglucinol: 20-30 %

 

Mannitol: < 1,0 %

 

Natural salts/Free Minerals: 0,5-2,0 %

 

Other carbohydrates: 0,5-2,0 %

 

Protein: 2,0-2,5 %

Fucoidan extract from the seaweed Undaria pinnatifida

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:

 

Off-white to brown powder

 

Odour and Taste: Bland odour and taste

 

Moisture: < 10 % (105 °C for 2 hours)

 

pH value: 4,0-7,0 (1 % suspension at 25 °C)

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:

 

Extract 1:

 

Fucoidan: 75-95 %

 

Alginate: 2,0-6,5 %

 

Polyphloroglucinol: 0,5-3,0 %

 

Mannitol: 1-10 %

 

Natural salts/Free Minerals: 0,5-1,0 %

 

Other carbohydrates: 0,5-2,0 %

 

Protein: 2,0-2,5 %

 

Extract 2:

 

Fucoidan: 50-55 %

 

Alginate: 2,0-4,0 %

 

Polyphloroglucinol: 1,0-3,0 %

 

Mannitol: 25-35 %

 

Natural salts/Free Minerals: 8-10 %

 

Other carbohydrates: 0,5-2,0 %

 

Protein: 1,0-1,5 %

2′-Fucosyllactose

(synthetic)

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

2′-Fucosyllactose

(microbial source)

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 K-12

Source:

Genetically modified strain of Escherichia coli BL21

Description:

2′-Fucosyllactose is a white to off-white crystalline powder that is produced by a microbial process. 2′-Fucosyllactose is isolated by crystallisation.

Purity:

2′-Fucosyllactose: ≥ 94 %

D-Lactose: ≤ 3,0 %

L-Fucose: ≤ 1,0

Difucosyl-D-lactose: ≤ 1,0 %

2′-Fucosyl-D-lactulose: ≤ 1,0 %

pH (20 °C, 5 % solution): 3,2-5,0

Water: ≤ 5,0 %

Ash, sulphated: ≤ 1,5 %

Acetic acid: ≤ 1,0 %

Residual proteins: ≤ 0,01 %

Microbiological criteria:

Aerobic mesophilic bacteria total count: ≤ 500 CFU/g

Yeasts: ≤ 10 CFU/g

Moulds: ≤ 100 CFU/g

Endotoxins: ≤ 10 EU/mg

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)

Galacto-oligosaccharide

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

Glucosamine HCl from Aspergillus niger and genetically modified strain of E. Coli K12

White crystalline odourless powder

Molecular formula: C6H13NO5 · HCl

Relative molecular mass: 215,63 g/mol

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

Specific rotation + 70,0° - + 73,0°

Glucosamine sulphate KCl from Aspergillus niger and genetically modified strain of E. Coli K12

White crystalline odourless powder

Molecular formula: (C6H14NO5)2SO4 · 2KCl

Relative molecular mass: 605,52 g/mol

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

Specific Rotation + 50,0° to + 52,0°

Glucosamine sulphate NaCl from Aspergillus niger and genetically modified strain of E. Coli K12

White crystalline odourless powder

Molecular formula: (C6H14NO5)2SO4 · 2NaCl

Relative molecular mass: 573,31 g/mol

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

Specific Optical Rotation: + 52° - + 54°

Guar Gum

Description/Definition:

Native guar gum is the ground endosperm of seeds from natural strains of guar Cyamopsis tetragonolobus L. Taub. (Leguminosae family). It consists of a high molecular weight polysaccharide, primarily composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as a galactomannan (galactomannan content not less 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:

 

Powder

Shelf-life: 2 years

Colour: White

Odour: Light

Average diameter of particles: 60-70 μm

Moisture: Max 15 %

Viscosity (*) at 1 hour —

Viscosity (*) at 2 hours: Min 3 600 mPa.s

Viscosity (*) at 24 hours: Min 4 000 mPa.s

Solubility: Soluble in hot and cold water

pH for 10g/L, at 25 °C - 6-7,5

 

Flakes

Useful life: 1 year

Colour: White/off white with absence or minimal presence of black spots

Odour: Light

Average diameter of particles: 1-10 mm

Moisture: Max 15 %

Viscosity (*) at 1 hour: Min 3 000 mPa.s

Viscosity (*) at 2 hours —

Viscosity(*) at 24 hours —

Solubility - Soluble in hot and cold water

pH for 10g/L, at 25 °C - 5-7,5

(*)

The measurements of viscosity are carried out under the following conditions: 1 %, 25 °C, 20 rpm

Heat-treated milk products fermented with Bacteroides xylanisolvens

Description/Definition:

Heat-treated fermented milk products are produced with Bacteroides xylanisolvens (DSM 23964) as starter culture.

Semi-skimmed milk (between 1,5 % and 1,8 % fat) or skimmed milk (0,5 % fat or less) is pasteurised or ultra-heat-treated before starting the fermentation with Bacteroides xylanisolvens (DSM 23964). The resulting fermented milk 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) (*).

(*)

Modified DIN EN ISO 21528-2.

Hydroxytyrosol

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

Ice Structuring Protein type III HPLC 12

Description/Definition:

The Ice Structuring Protein (ISP) preparation is a light-brown liquid produced by submerged fermentation of a genetically-modified strain of food-grade baker's yeast (Saccharomyces 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

Aqueous extract of dried leaves of Ilex guayusa

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

Isomalto-oligosaccharide

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

Isomaltulose

Description/Definition:

A reducing disaccharide that consists of one glucose and one fructose moiety linked by an alpha-1,6-glycosidic bond. It is obtained from sucrose by an enzymatic process. The commercial product is the monohydrate. Appearance: Virtually odourless, white or almost white crystals with a sweet taste

Chemical name: 6-O-α-D-glucopyranosyl-D-fructofuranose, monohydrate

CAS No.: 13718-94-0

Chemical formula: C12H22O11 · H2O

Structural formula

Image

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’

(*)

Food and Nutrition Paper 5 Rev. 2 — Guide to specifications for general notices, general analytical techniques, identification tests, test solutions and other reference materials (JECFA), 1991, 322 pp., English, ISBN 92-5-102991-1.

Lactitol

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

Lacto-N-neotetraose

(synthetic)

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

Lacto-N-neotetraose

(microbial source)

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

Lucerne leaf extract from Medicago sativa

Description/Definition:

The Lucerne (Medicago sativa L.) is processed within 2 hours after harvest. It is chopped and crushed. By passing through an oleaginous-type press, the Lucerne provides a fibrous residue and press juice (10 % of dry matter). The dry matter of this juice 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

Lycopene

Description/Definition:

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

Lycopene from Blakeslea trispora

Description/Definition:

The purified lycopene from Blakeslea trispora consists of ≥ 95 % lycopene and ≤ 5 % other carotenoids. It is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Anti-oxidative protection has to be assured.

Chemical name: Lycopene

CAS No.: 502-65-8 (all trans lycopene)

Chemical formula: C40H56

Formula weight: 536,85 Da

Lycopene from tomatoes

Description/Definition:

The purified lycopene from tomatoes (Lycopersicon esculantum L.) consists of ≥ 95 % lycopene and ≤ 5 % other carotenoids. It is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Anti-oxidative protection has to be assured.

Chemical name: Lycopene

CAS No.: 502-65-8 (all trans lycopene)

Chemical formula: C40H56

Formula weight: 536,85 Da

Lycopene oleoresin from tomatoes

Description/Definition:

Lycopene oleoresin from tomatoes is obtained by solvent extraction of ripe tomatoes (Lycopersicon esculentum Mill.) with subsequent removal of the solvent. It is a red to dark brown viscous, clear liquid.

Total lycopene: 5-15 %

Thereof trans-lycopene: 90-95 %

Total carotenoids (calculated as lycopene): 6,5-16,5 %

Other carotenoids: 1,75 %

(Phytoene/phytofluene/β-carotene): (0,5-0,75/0,4-0,65/0,2-0,35 %)

Total tocopherols: 1,5-3,0 %

Unsaponifiable matter: 13-20 %

Total fatty acids: 60-75 %

Water (Karl Fischer): ≤ 0,5 %

Magnesium citrate malate

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

Magnolia Bark Extract

Description/Definition:

Magnolia bark extract is obtained from the bark of the plant Magnolia officinalis L. and produced with supercritical carbon dioxide. The bark is washed and oven dried to reduce moisture content before being crushed and extracted with supercritical carbon dioxide. The extract is dissolved in medical-grade ethanol and re-crystallised to yield magnolia bark extract.

Magnolia bark extract is 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

Maize-germ oil high in unsaponifiable matter

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’

Methylcellulose

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:

H

CH3 or

CH2CH3

Molecular weight: Macromolecules: from about 20 000 (n about 100) up to about 380 000 g/mol (n about 2 000 )

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

(6S)-5-methyltetrahydrofolic acid, glucosamine salt

Description/Definition:

Chemical name: N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, glucosamine salt

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

Monomethylsilanetriol (Organic Silicon)

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)

Mycelial extract from Shiitake mushroom (Lentinula edodes)

Description/Definition:

The novel food ingredient is a sterile aqueous extract obtained from the mycelium of Lentinula edodes cultivated in a submerged fermentation. It is a light brown, slightly turbid liquid.

Lentinan is a β-(1-3) β-(1-6)-D-glucan which has a molecular weight of approximately 5 × 105 Daltons, a degree of branching of 2/5 and a triple helical tertiary structure.

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

(*)

Bradford method

(**)

Kjeldahl method

Noni fruit juice (Morinda citrifolia)

Description/Definition:

Noni fruits (fruits of Morinda citrifolia L.) are pressed. The obtained juice is pasteurised. An optional fermentation step before or after the pressing may occur.

Rubiadin: ≤ 10 μg/kg

Lucidin: ≤ 10 μg/kg

Noni fruit juice powder (Morinda citrifolia)

Description/Definition:

Seeds and skin of the sun-dried fruits of Morinda citrifolia are separated. The obtained pulp is filtered to separate juice from the flesh. Desiccation of the produced juice occurs in one or two ways:

 

Either by atomisation using maize maltodextrins, this mixture is obtained by keeping the rates of inflow of the juice and maltodextrins constant

 

Or by zeodratation or drying and then mixing with an excipient, this process allows the juice to be dried initially and then mixed with maltodextrins (same amount as used in atomisation).

Noni fruit puree and concentrate (Morinda citrifolia)

Description/Definition:

The fruits of Morinda citrifolia are harvested by hand. Seeds and skin may be separated mechanically from the pureed fruits. After pasteurisation, the puree is packaged in aseptic containers and stored under cold conditions.

Morinda citrifolia concentrate is prepared from M. citrifolia puree by treatment with pectinolytic enzymes (50-60 °C for 1-2 h). Then the puree is heated to inactivate the pectinases and then immediately cooled. The juice is separated in a decanter centrifuge. 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:

 

Puree:

Moisture: 89-93 %

Protein: < 0,6 g/100 g

Fat: ≤ 0,4 g/100 g

Ash: < 1,0 g/100 g

Total carbohydrates: 5-10 g/100 g

Fructose: 0,5-3,82 g/100 g

Glucose: 0,5-3,14 g/100 g

Dietary fibre: < 0,5-3 g/100 g

5,15-dimethylmorindol (*): ≤ 0,254 μg/ml

Lucidin (*): Not detectable

Alizarin (*): Not detectable

Rubiadin (*): Not detectable

 

Concentrate:

Moisture: 48-53 %

Protein: 3-3,5 g/100 g

Fat: < 0,04 g/100 g

Ash: 4,5-5,0 g/100 g

Total carbohydrates: 37-45 g/100 g

Fructose: 9-11 g/100 g

Glucose: 9-11 g/100 g

Dietary fibre: 1,5-5,0 g/100 g

5,15-dimethylmorindol (*): ≤ 0,254 μg/ml

(*)

By an HPLC-UV method developed and validated for the analysis of anthraquinones in Morinda citrifolia puree and concentrate. Limits of detection: 2,5 ng/ml (5,15 dimethylmorindol); 50,0 ng/ml (lucidin); 6,3 ng/ml (alizarin) and 62,5 ng/ml (rubiadin).

Noni leaves (Morinda citrifolia)

Description/Definition:

After cutting, the leaves of Morinda citrifolia are subject to drying and roasting steps. The product has a particle size ranging from broken leaves to coarse powder with fines. It is of greenish brown to brown colour.

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

Noni fruit powder (Morinda citrifolia)

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

(*)

By an HPLC-UV method developed and validated for the analysis of anthraquinones in Morinda citrifolia fruit powder. Limits of detection: 2,5 ng/ml (5,15 dimethylmorindol)

Odontella aurita microalgae

Silicon: 3,3 %

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

Oil enriched with phytosterols/phytostanols

Description/Definition:

Oil enriched with phytosterols/phytostanols is composed of an oil fraction and a phytosterol fraction.

Acylglycerol Distribution:

Free fatty acids (expressed as oleic acid): ≤ 2,0 %

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 %.

Oil extracted from squids

Acid value: ≤ 0,5 KOH/g oil

Peroxide value: ≤ 5 meq O2/kg oil

p-Anisidine value: ≤ 20

Cold test at 0 °C: ≤ 3 hours

Moisture: ≤ 0,1 % (w/w)

Unsaponifiable matter: ≤ 5,0 %

Trans fatty acids: ≤ 1,0 %

Docosahexaeonic acid: ≥ 20 %

Eicosapentaenoic acid: ≥ 10 %

Pasteurised fruit-based preparations produced using high-pressure treatment

Parameter

Target

Comments

Fruit storage before high-pressure treatment

Minimum 15 days at – 20 °C

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

Fruit added

40 % to 60 % of thawed fruit

Fruit homogenised and added to other ingredients

pH

3,2 to 4,2

 

° Brix

7 to 42

Assured by added sugars

aw

< 0,95

Assured by added sugars

Final storage

60 days maximum at + 5 °C maximum

Equivalent to storage regimen for conventionally processed product

Phosphated maize starch

Description/Definition:

Phosphated maize starch (phosphated distarch phosphate) is a chemically modified resistant starch derived from high amylose starch by combining chemical treatments to create phosphate cross-links between carbohydrate residues and esterified hydroxyl groups.

The novel food ingredient is a white or nearly white powder.

CAS No: 11120-02-8

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:

 

Loss on drying: 10-14 %

 

pH: 4,5-7,5

 

Dietary fibre: ≥ 70 %

 

Starch: 7-14 %

 

Protein: ≤ 0,8 %

 

Lipids: ≤ 0,8 %

 

Residual bound phosphorus: ≤ 0,4 % (as phosphorus) ‘high amylose maize’ as source

Phosphatidylserine from fish phospholipids

Description/Definition:

The novel food ingredient is yellow to brown powder. Phosphatidylserine is obtained from fish phospholipids by an enzymatic transphosphorylation with the amino acid L-serine.

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

(1)

Tocopherols may be added as antioxidants according to Commission Regulation (EU) No 1129/2011

Phosphatidylserine from soya phospholipids

Description/Definition:

The novel food ingredient is off-white to light yellow powder. It is also available in liquid form with a clear brown to 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:

 

Powder form:

Moisture: < 2,0 %

Phospholipids: ≥ 85 %

Phosphatidylserine: ≥ 61 %

Glycerides: < 2,0 %

free L-serine: < 1,0 %

Tocopherols: < 0,3 %

Phytosterols: < 0,2 %

 

Liquid form:

Moisture: < 2,0 %

Phospholipids: ≥ 25 %

Phosphatidylserine: ≥ 20 %

Glycerides: not applicable

free L-serine: < 1,0 %

Tocopherols: < 0,3 %

Phytosterols: < 0,2 %

Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid

Description/Definition:

The product is manufactured through enzymatic conversion of soy lecithin. The phospholipid product is a highly concentrated, yellow-brown powder form of phosphatidylserine and phosphatidic acid at an equal level.

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 %

Phospholipides from egg yolk

85 % and 100 % pure Phospholipides from egg yolk

Phytoglycogen

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 %

Phytosterols/phytostanols

Description/Definition:

Phytosterols and phytostanols are sterols and stanols that are extracted from plants and may be presented as free sterols and stanols or esterified with food grade fatty acids.

Composition (with GC-FID or equivalent method):

 

β-sitosterol: < 81 %

 

β-sitostanol: < 35 %

 

campesterol: < 40 %

 

campestanol: < 15 %

 

stigmasterol: < 30 %

 

brassicasterol: < 3,0 %

 

other sterols/stanols: < 3,0 %

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.

Plum kernel oil

Description/Definition:

Plum kernel oil is a vegetable oil obtained by cold pressing of plum (Prunus domestica) kernels.

Composition:

Oleic acid (C18:1): 68 %

Linoleic acid (C18:2): 23 %

γ-Tocopherol:80 % of total tocopherols

β-Sitosterol: 80-90 % of total sterols

Triolein: 40-55 % of triglycerides

Cyanhydric acid: maximum 5 mg/kg oil

Potato proteins (coagulated) and hydrolysates thereof

Dry substance: ≥ 800 mg/g

Protein (N * 6,25): ≥ 600 mg/g (dry substance)

Ash: ≤ 400 mg/g (dry substance)

Glycoalkaloid (total): ≤ 150 mg/kg

Lysinoalanine (total): ≤ 500 mg/kg

Lysinoalanine (free): ≤ 10 mg/kg

Prolyl oligopeptidase (enzyme preparation)

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)

(*)

PPI – Protease Picomole International

(**)

PPU – Prolyl Peptidase Units or Proline Protease Units

Protein extract from pig kidneys

Description/Definition:

The protein extract is obtained from homogenised pig kidneys through a combination of salt precipitation and high speed 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:

 

Specification: pig kidney protein excerpt with natural content of Diamin oxidase (DAO):

 

Physical condition: liquid

 

Colour: brownish

 

Appearance: slightly turbid solution

 

pH value: 6,4-6,8

 

Enzymatic activity: > 2 677 kHDU DAO/ml (DAO REA (DAO Radioextractionassay))

Microbiological criteria:

 

Brachyspira spp.: negative (Real Time PCR)

 

Listeria monocytogenes: negative (Real Time PCR)

 

Staphylococcus aureus: < 100 CFU/g

 

Influenza A: negative (Reverse Transcription Real Time PCR)

 

Escherichia coli: < 10 CFU/g

 

Total aerobic microbiological count: < 105 CFU/g

 

Yeasts/moulds count: < 105 CFU/g

 

Salmonella: Absence/10g

 

Bile salt resistant enterobacteriaceae: < 104 CFU/g

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

Rapeseed oil high in unsaponifiable matter

Description/Definition:

‘Rapeseed oil high in unsaponifiable matter’ is produced by vacuum distillation and it is different from refined rapeseed oil in the concentration of the unsaponifiable fraction (1 g in 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’.

Rapeseed Protein

Definition:

Rapeseed protein is an aqueous protein-rich extract from rapeseed press cake originating from non-genetically modified Brassica napus L. and Brassica rapa L.

Description:

White to off-white, spray dried powder

Total protein: ≥ 90 %

Soluble protein: ≥ 85 %

Moisture: ≤ 7,0 %

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

Trans-resveratrol

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

Rooster comb extract

Description/Definition:

Rooster comb extract is obtained from Gallus gallus by enzymatic hydrolysis of rooster comb and by subsequent filtration, concentration and precipitation steps. The principal constituents of rooster comb 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

Sacha Inchi oil from Plukenetia volubilis

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)

Salatrims

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:

 

Triacylglycerols: > 87 %

 

Diacylglycerols: ≤ 10 %

 

Monoacylglycerols: ≤ 2,0 %

Fatty acid composition:

 

MOLE % LCFA (long chain fatty acids): 33-70 %

 

MOLE % SCFA (short chain fatty acids): 30-67 %

 

Saturated long chain fatty acids: < 70 % by weight

 

Trans fatty acids: ≤ 1,0 %

 

Free fatty acids as oleic acid: ≤ 0,5 %

Triacylglycerol profile:

 

Triesters (short/long of 0,5 to 2,0): ≥ 90 %

 

Triesters (short/long = 0): ≤ 10 %

Unsaponifiable material: ≤ 1,0 %

Moisture: ≤ 0,3 %

Ash: ≤ 0,1 %

Colour: ≤ 3,5 Red (Lovibond)

Peroxide value: ≤ 2,0 Meq/Kg

Schizochytrium sp. oil rich in DHA and EPA

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 %

Schizochytrium sp. (ATCC PTA-9695) oil

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 %

Schizochytrium sp. oil

Acid value: ≤ 0,5 mg KOH/g

Peroxide value (PV): ≤ 5,0 meq/kg oil

Moisture and volatiles: ≤ 0,05 %

Unsaponifiables: ≤ 4,5 %

Trans-fatty acids: ≤ 1,0 %

DHA content: ≥ 32,0 %

Schizochytrium sp. (T18) oil

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 %

Fermented soybean extract

Description/Definition:

Fermented soybean extract is an odourless milk-white coloured powder. It is comprised of 30 % fermented soybean extract powder and 70 % resistant dextrin (as carrier) from corn-starch, which is added during the processing. Vitamin K2 is removed during the manufacturing process.

Fermented soybean extract contains nattokinase isolated from natto, a foodstuff produced by the fermentation of non-genetically modified soybeans (Glycine max (L.)) with a selected strain of Bacillus subtilis var. natto.

Nattokinase activity: 20 000 -28 000 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

(*)

Assay method as described by Takaoka et al. (2010).

Spermidine-rich wheat germ extract (Triticum aestevium)

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

Sucromalt

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

Sugar cane fibre

Description/Definition:

Sugar Cane Fibre is derived from the dry cell wall or fibrous residue remaining after expression or extraction of sugar juice from sugar cane, of the Saccharum genotype. It consists primarily of cellulose and hemicellulose.

The 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

Sunflower oil extract

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 %

Dried Tetraselmis chuii microalgae

Description/Definition:

The dried product is obtained from the marine microalgae Tetraselmis chuii, belonging to the Chlorodendraceae family, cultivated in sterile sea water in closed photobioreactors insulated from the outside air.

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

Therapon barcoo/Scortum

Description/Definition:

Scortum/Therapon barcoo is a species of fish in the family Terapontidae. It is an endemic fresh water species from Australia. It is now reared in fish farms.

Taxonomic Identification: Class: Actinopterygii > order: Perciformes > family: Terapontidae > genus: Therapon or Scortum Barcoo

Composition of fish flesh:

 

Protein (%): 18-25

 

Moisture (%): 65-75

 

Ash (%): 0,5-2,0

 

Energy (KJ/Kg): 6 000 -11 500

 

Carbohydrates (%): 0,0

 

Fat (%): 5-15

Fatty acids (mg FA/g fillet):

 

Σ PUFA n-3: 1,2-20,0

 

Σ PUFA n-6: 0,3-2,0

 

PUFA n-3/n-6: 1,5-15,0

 

Total omega 3 acids: 1,6-40,0

 

Total omega 6 acids: 2,6-10,0

D-Tagatose

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 (**)

(*)

Food and nutrition paper 5 Rev 2 – Guide to specifications for general notices, general analytical techniques, identification tests, test solutions and other reference materials (JECFA) 1991, 307 p.; English – ISBN 92-5-102991-1

(**)

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’ (*).

Taxifolin-rich extract

Description:

Taxifolin-rich extract from the wood of Dahurian Larch (Larix gmelinii (Rupr.) Rupr) is a white to pale-yellow powder that crystallizes from hot aqueous solutions.

Definition:

Chemical name: [(2R,3R)-2-(3,4 dihydroxyphenyl)-3,5,7-trihydroxy-2,3-dihydrochromen-4-one, also called (+) trans (2R,3R)- dihydroquercetin]

Chemical formula: C15H12O7

Molecular mass: 304,25 Da

CAS No: 480-18-2

Specifications:

 

Physical parameter

Moisture: ≤ 10 %

 

Compound analysis

Taxifolin (m/m): ≥ 90,0 % of the dry weight

Heavy Metals, Pesticide

Lead: ≤ 0,5 mg/kg

Arsenic: ≤ 0,02 mg/kg

Cadmium: ≤ 0,5 mg/kg

Mercury: ≤ 0,1 mg/kg

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)

Extract component

Content, usual observed range (%)

Taxifolin

90 – 93

Aromadendrin

2,5 – 3,5

Eriodictyol

0,1 – 0,3

Quercetin

0,3 – 0,5

Naringenin

0,2 – 0,3

Kaempferol

0,01 – 0,1

Pinocembrin

0,05 – 0,12

Unidentified flavonoids

1 - 3

Water (*)

1,5

(*)

Taxifolin in its hydrated form and during the drying process is a crystal. This results on the inclusion of water of crystallisation in a quantity of 1,5 %.

Trehalose

Description/Definition:

A non-reducing disaccharide that consists of two glucose moieties linkes by an α-1,1-glucosidic bond. It is obtained from liquefied starch by a multistep enzymatic process. The commercial product is the dihydrate. Virutally odourless, white or almost white 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:

 

Column: Shodex Ionpack KS-801 (Showa Denko Co.) or equivalent

length: 300 mm

diameter: 10 mm

temperature: 50 °C

 

Mobile phase: water

 

flow rate: 0,4 ml/min

 

Injection volume: 8 μl

 

Procedure: inject separately equal volumes of the sample solution and the standard solution into the chromatograph.

Record the chromatograms and measure the size of response of the trehalose peak

Calculate the quantity, in mg, of trehalose in 1 ml of the sample solution by the following formula:

% trehalose = 100 × (RU/RS) (WS/WU)

where

RS

=

peak area of trehalose in the standard preparation

RU

=

peak area of trehalose in the sample preparation

WS

=

weight in mg of trehalose in the standard preparation

WU

=

weight of dry sample in mg

Characteristics:

Identification:

 

Solubility: Freely soluble in water, very slightly soluble in ethanol

 

Specific rotation: [α]D20 + 199° (5 % aqueous solution)

 

Melting point: 97 °C (dihydrate)

Purity:

Loss on drying: ≤ 1,5 % (60 °C, 5 h)

Total ash: ≤ 0,05 %

Heavy metals:

Lead: ≤ 1,0 mg/kg

UV treated mushrooms (Agaricus bisporus)

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

UV-treated baker's yeast (Saccharomyces cerevisiae)

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

UV-treated bread

Description/Definition:

UV-treated bread is yeast leavened bread and rolls (without toppings) to which a treatment with ultraviolet radiation is applied after baking in order to convert ergosterol to vitamin 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 (**)

(*)

EN 12821, 2009, European Standard.

(**)

Recipe calculation.

UV-treated milk

Description/Definition:

UV-treated milk is cow's milk (whole and semi-skimmed) to which a treatment with ultraviolet (UV) radiation via turbulent flow is applied after pasteurisation. The treatment of the pasteurised milk 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 (**)

(*)

As defined by Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671).

(**)

HPLC

Vitamin K2 (menaquinone)

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

Specification of synthetic Vitamin K2 (menaquinone-7)

Chemical Name: (all-E)-2-(3,7,11,15,19,23,27-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.

Wheat bran extract

Description/Definition:

White crystalline powder obtained by enzymatic extraction from Triticum aestivum L. bran, rich in arabinoxylan oligosaccharides

Dry matter: Min. 94 %

Arabinoxylan oligosaccharides: Min 70 % of dry matter

Average degree of polymerisation of arabinoxylan oligosaccharides: 3-8

Ferulic acid (bound to arabinoxylan oligosaccharides): 1-3 % of dry matter

Total poly/oligosaccharides: Min 90 %

Protein: Max 2 % of dry matter

Ash: Max 2 % of dry matter

Microbiological parameters:

Mesophilic bacteria – total count: Max 10 000 /g

Yeasts: Max 100/g

Fungi: Max 100/g

Salmonella: Absence in 25 g

Bacillus cereus: Max 1 000 /g

Clostridium perfringens: Max 1 000 /g

Yeast beta-glucans

Description/Definition:

Beta-glucans are complex, high molecular mass (100–200 kDa) polysaccharides, found in the cell wall of many yeasts and cereals.

The chemical name for ‘yeast beta-glucans’ is (1-3),(1-6)-β-D-glucans.

Beta-glucans consist of a backbone of β-1-3-linked glucose residues that are branched by β-1-6-linkages, to which chitin and mannoproteins are linked by β-1-4-bonds.

Beta-glucans are isolated from yeast Saccharomyces cerevisiae.

The tertiary structure of the glucan cell wall of Saccharomyces cerevisiae consists of chains of β-1,3-linked glucose residues, branched by β-1,6-linkages, forming a backbone to which are linked chitin via β-1,4- bonds, β-1,6-glucans and some mannoproteins.

This novel food is available in three different forms: soluble, insoluble and insoluble in water, but dispersible in many liquid matrices.

Chemical characteristics yeast (Saccharomyces cerevisiae) beta-glucans:

 

Soluble form:

Total carbohydrates: > 75 %

Beta-glucans (1,3/1,6): > 75 %

Ash: < 4,0 %

Moisture: < 8,0 %

Protein: < 3,5 %

Fat: < 10 %

 

Insoluble form:

Total carbohydrates: > 70 %

Beta-glucans (1,3/1,6): > 70 %

Ash: ≤ 12 %

Moisture: < 8,0 %

Protein: < 10 %

Fat: < 20 %

 

Insoluble in water, but dispersible in many liquid matrices:

(1,3)-(1,6)-β-D-Glucans: > 80 %

Ash: < 2,0 %

Moisture: < 6,0 %

Protein: < 4,0 %

Total fat: < 3,0 %

Microbiological data:

Total plate count: < 1 000 CFU/g

Enterobacteriaceae: < 100 CFU/g

Total coliforms: < 10 CFU/g

Yeast: < 25 CFU/g

Mould: < 25 CFU/g

Salmonella: Absence in 25 g

Escherichia coli: Absence in 1 g

Bacillus cereus: < 100 CFU/g

Staphylococcus aureus: Absence in 1 g

Heavy metals:

Lead: < 0,2 mg/g

Arsenic: < 0,2 mg/g

Mercury: < 0,1 mg/g

Cadmium: < 0,1 mg/g

Zeaxanthin

Description/Definition:

Zeaxanthin is a naturally occurring xanthophyll pigment, it is an oxygenated carotenoid.

The synthetic zeaxanthin is presented either as a spray-dried powder of gelatin or starch base (‘beadlets’) with added α-tocopherol and ascorbyl palmitate or as a corn oil suspension with added α-tocopherol. Synthetic zeaxanthin is produced by a multi-step chemical synthesis from smaller molecules.

Orange-red crystalline powder with little or no odour.

Chemical formula: C40H56O2

CAS No: 144-68-3

Molecular weight: 568,9 daltons

Physical-chemical properties:

Loss on drying: < 0,2 %

All-trans zeaxanthin: > 96 %

Cis-zeaxanthin: < 2,0 %

Other carotenoids: < 1,5 %

Triphenylphosphine oxid (CAS No 791-28-6): < 50 mg/kg

Zinc L-pidolate

Description/Definition:

Zinc L-pidolate is a white to off-white powder, with characteristic odour.

International non-proprietary name (INN): L-pyroglutamic acid, Zinc salt

Synonyms: Zinc 5-oxoproline, Zinc pyroglutamate, Zinc pyrrolidone carboxylate, Zinc PCA, L-Zinc pidolate

CAS No.: 15454-75-8

Molecular formula: (C5H6NO3)2 Zn

Relative anhydrous molecular mass: 321,4

Appearance: White to slightly white powder

Purity:

Zinc L-pidolate (purity): ≥ 98 %

pH (10 % aqueous sol.): 5,0-6,0

Specific rotation: 19,6°- 22,8°

Water: ≤ 10,0 %

Glutamic acid: < 2,0 %

Heavy metals:

Lead: ≤ 3,0 ppm

Arsenic: ≤ 2,0 ppm

Cadmium: ≤ 1,0 ppm

Mercury: ≤ 0,1 ppm

Microbiological criteria:

Total viable mesophilic count: ≤ 1 000 CFU/g

Yeasts and moulds: ≤ 100 CFU/g

Pathogen: Absence


(1)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

(2)  Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228, 31.7.2014, p. 5).

(3)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

(4)  Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26)

(5)  Council Directive 2001/113/EC of 20 December 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption (OJ L 10, 12.1.2002, p. 67)

(6)  Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulation (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) 1234/2007 (OJ L 347, 20.12.2013, p. 671).

(7)  Commission Regulation (EU) No 231/2012 of 9 March 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 (OJ L 83, 22.3.2012, p. 1)

(8)  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 (OJ L 30, 6.2.2015, p. 10)


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