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Document 02017R2470-20200827

Consolidated text: 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)Text with EEA relevance

ELI: http://data.europa.eu/eli/reg_impl/2017/2470/2020-08-27

02017R2470 — EN — 27.08.2020 — 020.002


This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

►B

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)

(OJ L 351 30.12.2017, p. 72)

Amended by:

 

 

Official Journal

  No

page

date

 M1

COMMISSION IMPLEMENTING REGULATION (EU) 2018/460 of 20 March 2018

  L 78

2

21.3.2018

 M2

COMMISSION IMPLEMENTING REGULATION (EU) 2018/461 of 20 March 2018

  L 78

7

21.3.2018

 M3

COMMISSION IMPLEMENTING REGULATION (EU) 2018/462 of 20 March 2018

  L 78

11

21.3.2018

 M4

COMMISSION IMPLEMENTING REGULATION (EU) 2018/469 of 21 March 2018

  L 79

11

22.3.2018

 M5

COMMISSION IMPLEMENTING REGULATION (EU) 2018/991 of 12 July 2018

  L 177

9

13.7.2018

 M6

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1011 of 17 July 2018

  L 181

4

18.7.2018

 M7

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1018 of 18 July 2018

  L 183

9

19.7.2018

 M8

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1032 of 20 July 2018

  L 185

9

23.7.2018

►M9

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1023 of 23 July 2018

  L 187

1

24.7.2018

►M10

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1122 of 10 August 2018

  L 204

36

13.8.2018

►M11

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1123 of 10 August 2018

  L 204

41

13.8.2018

►M12

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1132 of 13 August 2018

  L 205

15

14.8.2018

►M13

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1133 of 13 August 2018

  L 205

18

14.8.2018

►M14

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1293 of 26 September 2018

  L 243

2

27.9.2018

►M15

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1631 of 30 October 2018

  L 272

17

31.10.2018

 M16

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1632 of 30 October 2018

  L 272

23

31.10.2018

►M17

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1633 of 30 October 2018

  L 272

29

31.10.2018

►M18

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1647 of 31 October 2018

  L 274

51

5.11.2018

►M19

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1648 of 29 October 2018

  L 275

1

6.11.2018

►M20

COMMISSION IMPLEMENTING REGULATION (EU) 2018/1991 of 13 December 2018

  L 320

22

17.12.2018

►M21

COMMISSION IMPLEMENTING REGULATION (EU) 2018/2016 of 18 December 2018

  L 323

1

19.12.2018

►M22

COMMISSION IMPLEMENTING REGULATION (EU) 2018/2017 of 18 December 2018

  L 323

4

19.12.2018

►M23

COMMISSION IMPLEMENTING REGULATION (EU) 2019/108 of 24 January 2019

  L 23

4

25.1.2019

►M24

COMMISSION IMPLEMENTING REGULATION (EU) 2019/109 of 24 January 2019

  L 23

7

25.1.2019

►M25

COMMISSION IMPLEMENTING REGULATION (EU) 2019/110 of 24 January 2019

  L 23

11

25.1.2019

►M26

COMMISSION IMPLEMENTING REGULATION (EU) 2019/387 of 11 March 2019

  L 70

17

12.3.2019

►M27

COMMISSION IMPLEMENTING REGULATION (EU) 2019/388 of 11 March 2019

  L 70

21

12.3.2019

 M28

COMMISSION IMPLEMENTING REGULATION (EU) 2019/456 of 20 March 2019

  L 79

13

21.3.2019

►M29

COMMISSION IMPLEMENTING REGULATION (EU) 2019/506 of 26 March 2019

  L 85

11

27.3.2019

►M30

COMMISSION IMPLEMENTING REGULATION (EU) 2019/760 of 13 May 2019

  L 125

13

14.5.2019

►M31

COMMISSION IMPLEMENTING REGULATION (EU) 2019/1272 of 29 July 2019

  L 201

3

30.7.2019

►M32

COMMISSION IMPLEMENTING REGULATION (EU) 2019/1294 of 1 August 2019

  L 204

16

2.8.2019

►M33

COMMISSION IMPLEMENTING REGULATION (EU) 2019/1314 of 2 August 2019

  L 205

4

5.8.2019

►M34

COMMISSION IMPLEMENTING REGULATION (EU) 2019/1686 of 8 October 2019

  L 258

13

9.10.2019

►M35

COMMISSION IMPLEMENTING REGULATION (EU) 2019/1976 of 25 November 2019

  L 308

40

29.11.2019

►M36

COMMISSION IMPLEMENTING REGULATION (EU) 2019/1979 of 26 November 2019

  L 308

62

29.11.2019

►M37

COMMISSION IMPLEMENTING REGULATION (EU) 2019/2165 of 17 December 2019

  L 328

81

18.12.2019

►M38

COMMISSION IMPLEMENTING REGULATION (EU) 2020/16 of 10 January 2020

  L 7

6

13.1.2020

►M39

COMMISSION IMPLEMENTING REGULATION (EU) 2020/24 of 13 January 2020

  L 8

12

14.1.2020

►M40

COMMISSION IMPLEMENTING REGULATION (EU) 2020/206 of 14 February 2020

  L 43

66

17.2.2020

►M41

COMMISSION IMPLEMENTING REGULATION (EU) 2020/443 of 25 March 2020

  L 92

7

26.3.2020

►M42

COMMISSION IMPLEMENTING REGULATION (EU) 2020/478 of 1 April 2020

  L 102

1

2.4.2020

►M43

COMMISSION IMPLEMENTING REGULATION (EU) 2020/484 of 2 April 2020

  L 103

3

3.4.2020

►M44

COMMISSION IMPLEMENTING REGULATION (EU) 2020/500 of 6 April 2020

  L 109

2

7.4.2020

►M45

COMMISSION IMPLEMENTING REGULATION (EU) 2020/916 of 1 July 2020

  L 209

6

2.7.2020

►M46

COMMISSION IMPLEMENTING REGULATION (EU) 2020/917 of 1 July 2020

  L 209

10

2.7.2020

►M47

COMMISSION IMPLEMENTING REGULATION (EU) 2020/973 of 6 July 2020

  L 215

7

7.7.2020

►M48

COMMISSION IMPLEMENTING REGULATION (EU) 2020/1163 of 6 August 2020

  L 258

1

7.8.2020

►M49

COMMISSION IMPLEMENTING REGULATION (EU) 2020/1559 of 26 October 2020

  L 357

7

27.10.2020




▼B

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)



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.

▼M9




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

►M29  Data Protection ◄

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

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

Algal oil from the microalgae Ulkenia sp.

Specified food category

Maximum levels of DHA

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

 

 

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

▼M25

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

30 g/100 g

Mixtures of vegetable oils (*) and milk (falling under the food category: Dairy analogues, including beverage whiteners)

30 g/100 g

(*)  Except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/2013.

▼M9

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)

▼M32

Betaine

Specified food category

Maximum levels (7)

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

The labelling of foods containing betaine shall bear a statement that the foods should not be used if food supplements containing betaine are consumed the same day.

 

Authorised on 22 August 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: DuPont Nutrition Biosciences ApS, Langebrogade 1 Copenhagen K, DK-1411, Denmark. During the period of data protection, the novel food betaine is authorised for placing on the market within the Union only by DuPont Nutrition Biosciences ApS unless a subsequent applicant obtainsauthorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of DuPont Nutrition Biosciences ApS,

End date of the data protection: 22 August 2024.

Drink powders, isotonic and energy drinks intended for sportsmen

60 mg/100 g

Protein and cereal bars intended for sportsmen

500 mg/100 g

Meal replacements intended for sportsmen

20 mg/100 g

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

500 mg/100 g (bar)

136 mg/100 g (soup)

188 mg/100 g (porridge)

60 mg/100 g (beverages)

Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 for adults

400 mg/day

▼M9

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

▼M34

Bovine milk basic whey protein isolate

Specified food category

Maximum levels

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

Food supplements containing bovine milk basic whey protein isolate shall bear the following statement:

‘This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen (*) years’

(*) Depending on the age group the food supplement is intended for.

 

Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en- Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Armor Protéines S.A.S. End date of the data protection: 20 November 2023.

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

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

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

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

Food Supplements as defined in Directive 2002/46/EC

30 mg/100 g (powder)

3,9 mg/100 mL (reconstituted)

30 mg/100 g (powder)

4,2 mg/100 mL (reconstituted)

300 mg/day

30 mg/100 g (powder formula for infants during the first months of life until the introduction of appropriate complementary feeding)

3,9 mg/100 mL (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding)

30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced)

4,2 mg/100 mL (reconstituted formula for infants when appropriate complementary feeding is introduced)

58 mg/day for young children

380 mg/day for children and adolescents from 3 to 18 years of age

610 mg/day for adults

25 mg/day for infants

58 mg/day for young children

250 mg/day for children and adolescents from 3 to 18 years of age

610 mg/day for adults

▼M9

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

▼M39

Chia seeds (Salvia hispanica)

Specified food category

Maximum levels

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

 

 

Bread products

5 % (whole or ground chia seeds)

Baked products

10 % whole chia seeds

Breakfast cereals

10 % whole chia seeds

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

5 % whole chia seeds

Fruit, nut and seed mixes

 

Pre-packaged Chia seed as such

 

Confectionery (including chocolate and chocolate products), excluding chewing gums

 

Dairy products (including yoghurt) and analogues

 

Edible ices

 

Fruit and vegetables products (including fruit spreads, compotes with/without cereals, fruit-preparations to underlay or to be mixed with dairy products, fruit desserts, mixed fruits with coconut milk for a twin pot)

 

Non-alcoholic beverages (including fruit juice and fruit/vegetable blend beverages)

 

 

Puddings that do not require heat treatment at or above 120 °C in their manufacture, processing or preparation

 

 

 

 

▼M9

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 food on the labelling of the foodstuffs 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

▼M29

D-ribose

Specified food category

Maximum levels

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

The labelling of foods containing D-ribose shall bear a statement that the foods should not be used if food supplements containing D-ribose are consumed the same day.

 

Authorised on 16 April 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Bioenergy Life Science, Inc., 13840 Johnson St. NE, Minneapolis, Minnesota, 55304, USA. During the period of data protection, the novel food D-ribose is authorised for placing on the market within the Union only by Bioenergy Life Science, Inc. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Bioenergy Life Science, Inc.

End date of the data protection: 16 April 2024 (5 years).

Cereal bars

0,20 g/100 g

Fine bakery wares

0,31 g/100 g

Chocolate confectionery (excluding chocolate bars)

0,17 g/100 g

Milk-based drinks (excluding malts and shakes)

0,08 g/100 g

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen, isotonic and energy drinks

0,80 g/100 g

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

3,3 g/100 g

Meal replacement for weight control (as drinks)'

0,13 g/100 g

Meal replacement for weight control (as bars)

3,30 g/100 g

Confectionery

0,20 g/100 g

Tea and infusions (in powder form to be reconstituted)

0,23 g/100 g

▼M9

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

▼M15

Cranberry extract powder

Specified food category

Maximum levels

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

 

Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Ocean Spray Cranberries Inc. One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA.

During the period of data protection the novel food, cranberry extract powder, is authorised for placing on the market within the Union only by Ocean Spray Cranberries Inc. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Ocean Spray Cranberries Inc.

End date of the data protection: 20 November 2023.

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

350 mg/day

▼M9

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’

 

 

▼M21

Decorticated grains of Digitaria exilis (Kippist) Stapf

(Traditional food from a third country)

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘decorticated fonio (Digitaria exilis) grains’

 

 

▼M9

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

▼M13

Dried aerial parts of Hoodia parviflora

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried aerial parts of Hoodia parviflora

 

Authorised on 3 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Desert Labs, Ltd Kibbutz Yotvata, 88820 Israel.

During the period of data protection the novel food dried aerial parts of Hoodia parviflora is authorised for placing on the market within the Union only by Desert Labs, Ltd unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Desert Labs, Ltd.

End date of the data protection: 3 September 2023.

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

9,4 mg/day

▼M9

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

▼M31

Echinacea purpurea extract from cell cultures

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried extract of Echinacea purpurea from cell cultures EchiPure-PC™’

 

 

Food Supplements as defined in Directive 2002/46/EC

In line with normal use in food supplements of a similar extract from florets within the flower head of Echinacea purpurea

▼M9

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

▼M49

Ecklonia cava phlorotannins

Specified food category

Maximum levels

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

Food supplements containing Ecklonia cava phlorotannins shall bear the following statement:

(a)  This food supplement should not be consumed by children/adolescents under the age of twelve/fourteen/eighteen(*) years.

(b)  This food supplement should not be consumed by persons with thyroid disease or by persons who are aware of or have been identified as being at risk of developing thyroid disease.

(c)  This food supplement should not be consumed if other food supplements containing iodine are also consumed.

(*)  Depending on the age group the food supplement is intended for.

 

 

Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 12 years

163 mg/day for adolescents from 12 to 14 years of age

230 mg/day for adolescents above 14 years of age

263 mg/day for adults

▼M18

Egg membrane hydrolysate

Specified food category

Maximum levels

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

 

Authorised on 25 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Biova, LLC., 5800 Merle Hay Rd, Suite 14 PO Box 394 Johnston 50131, Iowa USA. During the period of data protection the novel food egg membrane hydrolysate is authorised for placing on the market within the Union only by Biova, LLC. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Biova, LLC.

End date of the data protection: 25 November 2023

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

450 mg/day

▼M9

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

 

 

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

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

▼M49

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’

 

 

Alcohol-free beverages

0,025 g/kg

Milk-based drinks

0,025 g/kg

‘Fresh’ milk products(*)

0,040 g/kg

Cereal bars

0,2 g/kg

Chocolate confectionery

0,25 g/kg

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

(*)  When used in milk products L-ergothioneine may not replace in whole or in part, any milk constituent

▼M49

Extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)’.

The labelling of food supplements containing the extract of mixture of the three herbal roots shall bear a statement in close proximity to the list of ingredients indicating that it should not be consumed by individuals with known celery allergy.

 

 

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

175 mg/day

▼M9

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

▼M40

Fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. (Traditional food from a third country)

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘cocoa (Theobroma cacao L.) pulp’, ‘cocoa (Theobroma cacao L.) pulp juice’ or ‘cocoa (Theobroma cacao L.) concentrated pulp juice’ depending on the form used.

 

 

 

▼M9

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

▼M36

2'-Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’)

(microbial source)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘2'-Fucosyllactose/Difucosyllactose mixture’.

The labelling of food supplements containing the 2'-Fucosyllactose/Difucosyllactose mixture shall bear a statement that they should not be used if breast milk or other foods containing added 2'-Fucosyllactose and/or Difucosyllactose are consumed the same day.

 

Authorised on 19.12.2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 2'-Fucosyllactose/Difucosyllactose mixture is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.

End date of the data protection: 19.12.2024.

Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products

2,0 g/L

Unflavoured fermented milk-based products

2,0 g/L (beverages)

20 g/kg (products other than beverages)

Flavoured fermented milk-based products including heat-treated products

2,0 g/L (beverages)

20 g/kg (products other than beverages)

Beverages (flavoured drinks)

2,0 g/L

Cereal bars

20 g/kg

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

1,6 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

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

1,2 g/L 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 under Regulation (EU) No 609/2013

1,2 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

10 g/kg for products other than beverages

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

4,0 g/L (beverages)

40 g/kg (products other than beverages)

Food for special medical purposes as defined under 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 intended for the general population excluding infants

4,0 g/day

▼M9

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

 

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 productbefore 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 it shall be ‘hydroxytyrosol’.

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

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

(b)  This food product should not be used for cooking, baking or frying’

 

 

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

▼M46

Infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner

(Traditional food from a third country)

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Infusion from coffee leaves of Coffea arabica and/or Coffea canephora’.

 

 

Herbal infusions

 

▼M9

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’.

 

 

▼M14

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, tablets or powder) intended for the adult population

20 g/day

▼M9

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′-fucosyllactose, 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

▼M43

Lacto-N-tetraose (‘LNT’)

(microbial source)

Specified food category

Maximum levels

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

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

 

Authorised on 23.4.2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food lacto-N-tetraose is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.

End date of the data protection: 23.4.2025.

Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products

1,0 g/l

Unflavoured fermented milk-based products

1,0 g/l (beverages)

10 g/kg (products other than beverages)

Flavoured fermented milk-based products including heat-treated products

1,0 g/l (beverages)

10 g/kg (products other than beverages)

Beverages (flavoured drinks)

1,0 g/l

Cereal bars

10 g/kg

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

0,8 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

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

0,6 g/l in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

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

0,6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

5 g/kg for products other than beverages

Milk based drinks and similar products intended for young children

0,6 g/l (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

5 g/kg for products other than beverages

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

2,0 g/l (beverages)

20 g/kg (products other than beverages)

Food for special medical purposes as defined under 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, excluding infants

2,0 g/day for young children, children, adolescents, and adults

▼M20

Lonicera caerulea L. berries (haskap)

(Traditional food from a third country)

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘haskap (Lonicera caerulea) berries’

 

 

▼M9

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

Food supplements as defined in Directive 2002/46/EC

15 mg/day

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

▼M49

Hen egg white lysozyme hydrolysate

Specified food category

Maximum levels

The designation of the novel food on the labelling of food supplements containing it shall be ‘Hen egg white lysozyme hydrolysate’.

 

 

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

1000 mg/day

▼M9

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

▼M11

1-Methylnicotinamide chloride

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘1- Methylnicotinamide chloride’.

Food supplements containing 1-Methylnicotinamide shall bear the following statement:

This food supplement should be consumed by adults only excluding pregnant and lactating women

 

Authorised on 2 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Pharmena SA, Wolczanska 178, 90 530 Lodz, Poland. During the period of data protection thenovel food 1-methylnicotinamide chloride is authorised for placing on the market within the Union only by Pharmena S.A. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Pharmena S.A.

End date of the data protection: 2 September 2023

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

58 mg/day

▼M9

(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

▼M38

Nicotinamide riboside chloride

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Nicotinamide riboside chloride’

 

Authorised on 20 February 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: ChromaDex Inc., 10900 Wilshire Boulevard Suite 600, Los Angeles, CA 90024 USA. During the period of data protection, the novel food is authorised for placing on the market within the Union only by ChromaDex Inc. unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of ChromaDex Inc.

End date of the data protection: 20 February 2025.

Food Supplements as defined in Directive 2002/46/EC

300 mg/day for the general adult population, excluding pregnant and lactating women

230 mg/day for pregnant and lactating women

▼M9

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

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

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

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

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

▼M44

Partially defatted chia seed (Salvia hispanica) powders

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Partially defatted chia seed (Salvia hispanica) powder’

 

 

Powder with high protein content

Unflavoured fermented milk products, including natural unflavoured buttermilk (excluding sterilised buttermilk) non-heat-treated after fermentation

0,7 %

Unflavoured fermented milk products, heat-treated after fermentation

0,7 %

Flavoured fermented milk products including heat-treated products

0,7 %

Confectionery

10 %

Fruit juices as defined by Directive 2001/112/EC (8) and vegetable juices

2,5 %

Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products

2,5 %

Flavoured drinks

3 %

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

7,5 g/day

Powder with high fibre content

Confectionery

4 %

Fruit juices as defined by Directive 2001/112/EC and vegetable juices

2,5 %

Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products

4 %

Flavoured drinks

4 %

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

12 g/day

▼M9

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

 

▼M35

Phenylcapsaicin

Specified food category

Maximum levels

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

 

Authorised on 19 December 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: aXichem AB, Södergatan 26, SE 211 34, Malmö Sweden. During the period of data protection, the novel food phenylcapsaicin is authorised for placing on the market within the Union only by aXichem AB, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of aXichem AB.

Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants, young children and children under the age of 11 years

2,5 mg/day

Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 11 years

2,5 mg/day

▼M9

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 and Appendix II, points B and C of Regulation (EU) No 1308/2013, and excluding cooking and frying fats and spreads based on butter or other animal fat.

Food Supplements as defined in Directive 2002/46/EC

3 g/day

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

▼M47

Protein extract from pig kidneys

Specified food category

Maximum levels

 

 

 

Food Supplements as defined in Directive 2002/46/EC

3 capsules or 3 tablets/day; equalising 12,6 mg pig kidney extract a day Diamine oxidase (DAO) content: 0,9 mg/day (3 capsules or 3 tablets with a content of DAO of 0,3 mg/capsule or 0,3 mg/tablet)

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

▼M10

Pyrroloquinoline quinone disodium salt

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Pyrroloquinoline quinone disodium salt’.

Food supplements containing Pyrroloquinoline quinone disodium salt shall bear the following statement:

This food supplement should be consumed by adults only excluding pregnant and lactating women

 

Authorised on 2 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Mitsubishi Gas Chemical Company, Inc., Mitsubishi Building 5-2 Marunouchi 2-chome, Chiyoda-ku, Tokyo 100-8324, Japan. During the period of data protection the novel food Pyrroloquinoline quinone disodium salt is authorised for placing on the market within the Union only by Mitsubishi Gas Chemical Company, Inc., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Mitsubishi Gas Chemical Company, Inc.

End date of the data protection: 2 september 2023

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

20 mg/day

▼M9

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.

 

 

▼M17

Refined shrimp peptide concentrate

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘refined shrimp peptide concentrate’.

 

Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Marealis AS., Stortorget 1, Kystens Hus, 2nd floor, N-9008 Tromsø Postal address: P.O. Box 1065, 9261 Tromsø, Norway. During the period of data protection the novel food refined shrimp peptideconcentrate is authorised for placing on the market within the Union only by Marealis AS unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Marealis AS.

End date of the data protection: 20 November 2023.

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

1 200 mg/day

▼M9

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

▼M26

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.’

 

 

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

 

Fruit/vegetable puree

100 mg/100 g

▼M24

Schizochytrium sp. oil

Specified food category

Maximum levels of DHA

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

 

 

Dairy products except milk-based drinks

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

Dairy analogues except drinks

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

Spreadable fat and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

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 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

Fruit/vegetable puree

100 mg/100 g

▼M49

Schizochytrium sp. (T18) oil

Specified food category

Maximum levels

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/100g

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

Fruit/vegetable puree

100 mg/100 g

▼M22

Syrup from Sorghum bicolor (L.) Moench

(Traditional food from a third country)

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Sorghum (Sorghum bicolor) syrup’

 

 

▼M9

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 aestivum)

Specified food category

Maximum levels

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

 

 

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

Equivalent of max. 6 mg/day spermidine

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 250mg/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

▼M49

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’

 

 

Yogurt plain/Yogurt with fruits(*)

0,020 g/kg

Kephir(*)

0,008 g/kg

Buttermilk(*)

0,005 g/kg

Milk powder(*)

0,052 g/kg

Cream(*)

0,070 g/kg

Sour cream(*)

0,050 g/kg

Cheese(*)

0,090 g/kg

Butter(*)

0,164 g/kg

Chocolate confectionery

0,070 g/kg

Non-alcoholic beverages

0,020 g/L

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

(*)  When used in milk products Taxifolin-rich extract may not replace in whole or in part, any milk constituent

▼M9

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

▼M49

UV-treated mushrooms (Agaricus bisporus)

Specified food category

Maximum levels of vitamin D2

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’.

 

 

Mushrooms (Agaricus bisporus)

20 μg of vitamin D2/100 g fresh weight

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

 

Pre-packed fresh or dry yeast for home baking

45 μg/100 g for fresh yeast

200 μg/100 g for dried yeast

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

2.  The labelling of the novel food shall bear a statement that the foodstuff is only intended for baking and that it should not be eaten raw.

3.  The labelling of the novel food shall bear instructions for use for the final consumers so that a maximum concentration of 5 μg/100 g of vitamin D2 in final home‐baked products is not exceeded.

▼M9

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

▼M48

Vitamin D2 mushroom powder

Specified food category

Maximum levels of vitamin D2  ()

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘UV-treated mushroom powder containing vitamin D’ or ‘UV-treated mushroom powder containing vitamin D2

The labelling of food supplements containing vitamin D2 mushroom powder shall bear a statement that they should not be consumed by infants

 

Authorised on 27 August 2020. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Oakshire Naturals, LP., PO Box 388 Kennett Square, Pennsylvania 19348, United States. During the period of data protection, the novel food vitamin D2 mushroom powder is authorised for placing on the market within the Union only by Oakshire Naturals, LP., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Oakshire Naturals, LP.

End date of the data protection: 27 August 2025.

Breakfast cereals

2,25 μg of vitamin D2/100 g

Yeast-leavened bread and pastries

2,25 μg of vitamin D2/100 g

Grain products and pastas

2,25 μg of vitamin D2/100 g

Fruit juice and fruit/vegetable blend beverages

1,125 μg of vitamin D2/100 mL

Milk and dairy products (excluding fluid milks)

2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages)

Cheese (excluding cottage cheese, ricotta cheese, and hard-grating cheeses)

2,25 μg of vitamin D2/100 g

Meal replacement bars and beverages

2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages)

Dairy analogues

2,25 μg of vitamin D2/100 g/1,125 μg of vitamin D2/100 mL (beverages)

Meat analogues

2,25 μg of vitamin D2/100 g

Soups and broths

2,25 μg of vitamin D2/100 g

Extruded vegetable snacks

2,25 μg of vitamin D2/100 g

Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 excluding those intended for infants

15 μg/day

Food supplements as defined in Directive 2002/46/EC intended for the general population excluding infants

15 μg/day

▼M9

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

▼M45

Xylo-oligosaccharides

Specified food category

Maximum levels (10)

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

 

 

White bread

14 g/kg

Wholemeal bread

14 g/kg

Breakfast cereals

14 g/kg

Biscuits

14 g/kg

Soy drink

3,5 g/kg

Yoghurt (9)

3,5 g/kg

Fruit spreads

30 g/kg

Chocolate confectionery

30 g/kg

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

2 g/day

▼M30

Yarrowia lipolytica yeast biomass

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Yarrowia lipolytica yeast heat-killed biomass’

 

 

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

6 g/day for children from 10 years of age, adolescents and general adult population

3 g/day for children from 3 to 9 years of age

▼M9

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

▼M12

Zeaxanthin

Specified food category

Maximum levels

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

 

 

Food Supplements as defined in Directive 2002/46/EC

2 mg/day

▼M9

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

(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)   

Maximum use levels in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.

(8)   

Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption (OJ L 10, 12.1.2002, p. 58).

(9)   

When used in milk products xylo-oligosaccharides shall not replace, in whole or in part, any milk constituent.

(10)   

Maximum levels calculated on the basis of the specifications of Powder form 1.

(11)   

The minimum specification for vitamin D content in vitamin D2 mushroom powder of 1 000 μg vitamin D2/gram of mushroom powder is used.



Table 2: Specifications

Authorised Novel Food

Specifications

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 - +11,0o

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 %

▼M25

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 (as a % of the total fatty acids):

Lauric acid — Myristic acid — Palmitic acid (C12:0 – C14:0 – C16:0): sum of these acids < 4,0 %

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

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

Poly unsaturated fatty acids (PUFA): < 2 %

Characteristics:

Free fatty acids: max 0,1 % of total fatty acids

Trans fatty acids: max 1,0 % of total fatty acids

Peroxide value: max 1,0 meq/kg

Unsaponifiable matter: max 1,0 % (w/w) of the oil

Saponification value: 185-198 mg KOH/g

▼M9

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.f. leaves.

Ash: 25 %

Dietary fibres: 28,6 %

Fat: 2,7 %

Moisture: 4,7 %

Polysaccharides: 9,5 %

Protein: 1,63 %

Glucose: 8,9 %

▼M23

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 O2/kg oil

Oxidative stability: All food products containing Antarctic Krill oil 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: ≥ 35 % to < 60 %

Trans-fatty acids: ≤ 1 %

EPA (eicosapentaenoic acid): ≥ 9 %

DHA (docosahexaenoic acid): ≥ 5 %

▼M9

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

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, FJRK-MA01 and CBS 210.32 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 (PV): ≤ 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 (PV): < 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 either 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 %

▼M32

Betaine

Description/Definition:

Betaine (N,N,N-trimethylglycine or carboxy-N,N,N-trimethylmethanaminium), in anhydrous (CH3)3N+CH2COO (CAS No: 107-43-7) and monohydrate (CH3)3N+CH2COO.H2O (CAS No: 590-47-6) forms is obtained from processing of sugar beets (i.e. molasses, vinasses or betaine-glycerol).

Characteristics/Composition

Appearance: Free-flowing white crystals

Betaine: ≥ 99,0 % (w/w on dry weight basis)

Moisture: ≤ 2,0 % (anhydrous); ≤ 15,0 % (monohydrate)

Ash: ≤ 0,1 %

pH: 5,0-7,0

Residual protein: ≤ 1,0 mg/g

Heavy metals:

Arsenic: < 0,1 mg/kg

Mercury: < 0,005 mg/kg

Cadmium: < 0,01 mg/kg

Lead: < 0,05 mg/kg

Microbiological criteria:

Total viable count: ≤ 100 CFU/g

Coliforms: Negative/10 g

Salmonella sp.: Negative/25 g

Yeast: ≤ 10 CFU/g

Mould: ≤ 10 CFU/g

CFU: Colony Forming Units.

▼M9

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 %

α-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

▼M34

Bovine milk basic whey protein isolate

Description

Bovine milk basic whey protein isolate is a yellowish grey powder obtained from bovine skimmed milk via a series of isolation and purification steps.

Characteristics/Composition

Total protein (w/weight of product): ≥ 90 %

Lactoferrin (w/weight of product): 25-75 %

Lactoperoxidase (w/weight of product): 10-40 %

Other proteins (w/weight of product): ≤ 30 %

TGF-β2: 12-18 mg/100 g

Moisture: ≤ 6,0 %

pH (5 % solution w/v): 5,5 – 7,6

Lactose: ≤ 3,0 %

Fat: ≤ 4,5 %

Ash: ≤ 3,5 %

Iron: ≤ 25 mg/100 g

Heavy Metals

Lead: < 0,1 mg/kg

Cadmium: < 0,2 mg/kg

Mercury: < 0,6 mg/kg

Arsenic: < 0,1 mg/kg

Microbiological criteria:

Aerobic mesophilic count: ≤ 10 000 CFU/g

Enterobacteriaceae: ≤ 10 CFU/g

Escherichia coli: Negative/g

Coagulase positive Staphylococci: Negative/g

Salmonella: Negative/25 g

Listeria: Negative/25 g

Cronobacter spp.: Negative/25 g

Moulds: ≤ 50 CFU/g

Yeasts: ≤ 50 CFU/g

CFU: Colony Forming Units

▼M9

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 (PV): ≤ 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 (PV): < 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 (PV): ≤ 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

(**)  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): ≤ 0,20Microbiological 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/w dry weight): ≤ 3,0

Proteins (% w/w dry weight): ≤ 2,0

Particle size: > 100 nm

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

Fat binding capacity 800 × (w/w wet weight): passHeavy 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/25g

Listeria monocytogenes: Absence/25g

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 23502).

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.: 14639-25-9Chemical 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

Description/Definition:

Citicoline is produced by a microbial process.

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

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 gStaphylococcus aureus: Not detected in 1 g

Pseudomonas aeruginosa: Not detected in 1 g

Yeast and moulds: ≤ 102 CFU/g

▼M29

D-ribose

Description

D-ribose is an aldopentose monosaccharide which is produced by fermentation using a transketolase-deficient strain of Bacillus subtilis.

Chemical formula: C5H10O5

CAS No: 50-69-1

Molecular mass: 150,13 Da

Characteristics/Composition

Appearance: Dry with powdery texture, white to slightly yellow in colour

Specific rotation [α]D 25: – 19,0° to – 21,0°

D-ribose purity (% dry basis):

-HPLC/RI (8) Method 98,0–102,0 %

Ash: < 0,2 %

Loss on drying (moisture): < 0,5 %

Clarity on solution: ≥ 95 % transmittance

Heavy metals

Lead: ≤ 0,1 mg/kg

Arsenic: ≤ 0,1 mg/kg

Cadmium: ≤ 0,1 mg/kg

Mercury: ≤ 0,1 mg/kg

Microbiological criteria

Total plate count: ≤ 100 CFU (9)/g

Yeast: ≤ 100 CFU/g

Moulds: ≤ 100 CFU/g

Coliforms: ≤ 10 CFU/g

Salmonella sp: Negative/25 g

▼M9

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 %

▼M37

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)): 7-15 %

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 (PV): ≤ 5,0 meq/kg

Iodine value: 88-110 units

Saponification value: 179-200 mg KOH/g

Unsaponifiable matter: ≤ 15 g/kg

▼M15

Cranberry extract powder

Description/Definition:

Cranberry extract powder is a water-soluble phenolic-rich powder extract prepared through an ethanolic extraction from the juice concentrate of sound, mature berries of the cranberry cultivar Vaccinium macrocarpon.

Characteristics/Composition

Moisture (% w/w): ≤ 4

Proanthocyanidins — PACs (% w/w dry weight)

— OSC-DMAC method (3) (5): 55.0-60.0 or

— BL-DMAC method (4) (5): 15.0-18.0

Total phenolics (GAE (6), % w/w dry weight) (5)

— Folin-Ciocalteau method: > 46.2

Solubility (water): 100 %, with no visible insoluble particles

Ethanol Content (mg/kg): ≤ 100

Screen Analysis: 100 % through 30 mesh screen

Appearance and aroma, as powder: Free-flowing, deep red colour. Earthy aroma with no burnt character.

Heavy metals:

Arsenic (ppm): < 3

Microbiological criteria:

Yeast: < 100 CFU (7)/g

Mould: < 100 CFU/g

Aerobic plate count: < 1 000 CFU/g

Coliforms: < 10 CFU/g

Escherichia coli: < 10 CFU/g

Salmonella: Absent in 375 g

▼M9

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 thecomplexant, 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: CyclohexaamyloseCAS 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 +145o and +151o (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 μlProcedure: 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 + 174o and + 180o (1 % solution)

Purity:

Water: ≤ 11 %

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

Residual solvent (n-decane): ≤ 6mg/kg

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

Sulphated ash: ≤ 0,1 %

▼M21

Decorticated grains of Digitaria exilis (Kippist) Stapf (fonio)

(Traditional food from a third country)

Description/Definition

The traditional food is the decorticated grain (bran removed) of Digitaria exilis (Kippist) Stapf.

Digitaria exilis (Kippist) Stapf) is an annual herbaceous plant belonging to the Poaceae family.

Typical nutritional components of decorticated grain of fonio

Carbohydrates: 76,1 g/100 g of fonio

Water: 12,4 g/100 g of fonio

Protein: 6,9 g/100 g of fonio

Fat: 1,2 g/100 g of fonio

Fibre: 2,2 g/100 g of fonio

Ash: 1,2 g/100 g of fonio

Phytate content: ≤ 2,1 mg/g

▼M9

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 (PV): ≤ 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 %

▼M13

Dried aerial parts of Hoodia parviflora

Description/Definition:

It is the whole dried aerial parts of Hoodia parviflora N.E.Br., (family Apocynaceae)

Characteristics/Composition

Plant material: Aerial parts of at least 3-year-old plants

Appearance: Light green to tan fine powder

Solubility (water): > 25 mg/mL

Moisture: < 5,5 %

Aw: < 0,3

pH: < 5,0

Protein: < 4,5 g/100 g

Fat: < 3 g/100 g

Carbohydrate (including dietary fibre): < 80 g/100 g

Dietary fibre: < 55 g/100 g

Total sugars: < 10,5 g/100 g

Ash: < 20 %

Hoodigosides

P57: 5–50 mg/kg

L: 1 000 –6 000 mg/kg

O: 500–5 000 mg/kg

Total: 1 500 –11 000 mg/kg

Heavy metals:

Arsenic: < 1,00 mg/kg

Mercury: < 0,1 mg/kg

Cadmium: < 0,1 mg/kg

Lead: < 0,5 mg/kg

Microbiological criteria:

Aerobic plate count: < 105 CFU/g

Escherichia coli: < 10 CFU/g

Staphylococcus aureus: < 50 CFU/g

Total coliforms: < 10 CFU/g

Yeast: ≤ 100 CFU/g

Mould: ≤ 100 CFU/g

Salmonella species: Negative/25 g

Listeria monocytogenes: Negative/25 g

CFU: Colony Forming Units

▼M9

Dried extract of Lippia citriodora from cell cultures

Description/Definition:

Dried extract of Lippia citriodora (Palau) Kunth from cell cultures HTN®Vb.

Echinacea angustifolia extract from cell cultures

Description/Definition:

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

▼M31

Echinacea purpurea extract from cell cultures

Description/Definition:

Dried extract of Echinacea purpurea from cell cultures EchiPure-PC™

▼M9

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 (PV): ≤ 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

▼M49

Ecklonia cava phlorotannins

Description/Definition

Ecklonia cava phlorotannins are obtained via alcohol extraction from the edible marine alga Ecklonia cava. The extract is a dark brown powder, rich in phlorotannins, polyphenolic compounds found as secondary metabolites in certain brown algae species.

Characteristics/Composition

Phlorotannin content: 90 ± 5 %

Antioxidant activity: > 85 %

Moisture: < 5 %

Ash: < 5 %

Microbiological criteria

Total viable cell count: < 3 000 CFU/g

Mould/yeast: < 300 CFU/g

Coliforms: Negative to test

Salmonella spp.: Negative to test

Staphylococcus aureus: Negative to test

Heavy metals and Halogens

Lead: < 3,0 mg/kg

Mercury: < 0,1 mg/kg

Cadmium: < 3,0 mg/kg

Arsenic: < 25,0 mg/kg

Inorganic Arsenic: < 0,5 mg/kg

Iodine: 150,0 – 650,0 mg/kg

CFU: Colony Forming Units

▼M18

Egg membrane hydrolysate

Description

The egg membrane hydrolysate is derived from the eggshell membranes of chicken eggs. The eggshells undergo hydro-mechanical separation in order to obtain the egg membranes, which are then further processed using a patented solubilisation method. Following the solubilisation process, the solution is filtered, concentrated, spray-dried and packaged.

Characteristics/Composition

Chemical parameters

Methods

Total nitrogen-containing compounds (% w/w): ≥ 88

Combustion according to AOAC 990.03 and AOAC 992.15

Collagen (% w/w): ≥ 15

SircolTM Soluble Collagen Assay

Elastin (% w/w): ≥ 20

FastinTM Elastin Assay

Total glycosaminoglycans (% w/w): ≥ 5

USP26 (chondroitin sulphate K0032 method)

Calcium: ≤ 1 %

 

Physical parameters

pH: 6,5 – 7,6

Ash (% w/w): ≤ 8

Moisture (% w/w): ≤ 9

Water activity: ≤ 0,3

Solubility (in water): soluble

Bulk density: ≥ 0,6 g/cc

Heavy metals

Arsenic ≤ 0,5 mg/kg

Microbiological criteria

Aerobic plate count: ≤ 2 500 CFU/g

Escherichia coli: ≤ 5 MPN/g

Salmonella: Negative (in 25 g)

Coliforms: ≤ 10 MPN/g

Staphylococcus aureus: ≤ 10 CFU/g

Mesophilic spore count: ≤ 25 CFU/g

Thermophilic spore count: ≤ 10 CFU/10 g

Yeast: ≤ 10 CFU/g

Mould: ≤ 200 CFU/g

CFU: Colony Forming Units; MPN = Most Probable Number; USP: United States Pharmacopeia.

▼M9

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

C: 47,14 ± 0,4 %

H: 6,59 ± 0,4 %

N: 18,32 ± 0,4 %

1H-NMR

Elemental analysis

Total residual solvents

(methanol, ethyl acetate, isopropanol, ethanol)

[Eur. Ph. 01/2008:50400]

< 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

Cadmium

< 1,0 ppm

(Pb, Cd)

Mercury

< 0,1 ppm

Atomic fluorescence (Hg)

Microbiological specifications b)

Total viable aerobic count (TVAC)

≤ 1 x 103 CFU/g

[Eur. Ph. 01/2011:50104]

Total yeast and mould count (TYMC)

≤ 1 x 102 CFU/g

 

Escherichia coli

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 = (+) 126,6o (c = 1, H2O)

b)  Analyses conducted on each batch

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

▼M49

Extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)

Description/Definition

The mixture of the three herbal roots is yellowish brown fine powder produced by hot-water extraction, concentration by evaporation, and spray drying

Composition of the extract of mixture of the 3 herbal roots

Cynanchum wilfordii root: 32,5 % (w/w)

Phlomis umbrosa root: 32,5 % (w/w)

Angelica gigas root: 35,0 % (w/w)

Specifications

Loss on drying: NMT 100 mg/g

Assay

Cinnamic acid: 0,012 – 0,039 mg/g

Shanzhiside methyl ester: 0,20 – 1,55 mg/g

Nodakenin: 3,35 – 10,61 mg/g

Methoxsalen: < 3 mg/g

Phenols: 13,0 – 40,0 mg/g

Coumarins: 13,0 – 40,0 mg/g

Iridoids: 13,0 – 39,0 mg/g

Saponins: 5,0 – 15,5 mg/g

Nutritive components

Carbohydrates: 600 – 880 mg/g

Proteins: 70 – 170 mg/g

Fats: < 4 mg/g

Microbiological parameters

Total viable plate count: < 5000 CFU/g

Total mold and yeast: < 100 CFU/g

Coliform bacteria: < 10 CFU/g

Salmonella: Negative/25 g

Escherichia coli: Negative/25 g

Staphylococcus aureus: Negative/25 g

Heavy metals

Lead: < 0,65 mg/kg

Arsenic: < 3,0 mg/kg

Mercury: < 0,1 mg/kg

Cadmium: < 1,0 mg/kg

CFU: Colony Forming Units

▼M9

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 powderPeptides (1) (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

(1)  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 (PV): < 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

▼M40

Fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L.

(Traditional food from a third country)

Description/Definition

The traditional food is the fruit pulp from the cocoa (Theobroma cacao L) plant, which is the ‘aqueous, mucilaginous and acidic substance in which the seeds are embedded’.

Cocoa fruit pulp is obtained by splitting cocoa pods followed by separation from husks and beans; the pulp is then subject to pasteurisation and freezing. Cocoa pulp juice and/or cocoa concentrated pulp juice are produced following processing (enzymatic treatment, pasteurization, filtration, and concentration).

Typical compositional data of cocoa fruit pulp, pulp juice, concentrated pulp juice

Protein (g/100 g): 0,0 to 2,0

Total fat (g/100 g): 0,0 to 0,2

Total sugars (g/100 g): > 11,0

Brix level (° Brix): ≥ 14

pH: 3,3 to 4,0

Microbiological criteria

Total Plate Count (aerobic): < 10 000 cfu (9)/g

Enterobacteriaceae: ≤ 10 cfu/g

Salmonella: Absence in 25 g

▼M9

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 ppmMicrobiological 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 tasteMoisture: < 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.

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)

►M27  
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 powder that is produced by a microbial process.

Purity:

2′-Fucosyllactose: ≥ 83 %

D-Lactose: ≤ 10,0 %

L-Fucose: ≤ 2,0 %

Difucosyl-D-lactose: ≤ 5,0 %

2′-Fucosyl-D-lactulose: ≤ 1,5 %

Sum of saccharides (2′-Fucosyllactose, D-Lactose, L-Fucose, Difucosyl-D-lactose, 2′-Fucosyl-D-lactulose): ≥ 90 %

pH (20 C, 5 % solution): 3,0-7,5

Water: ≤ 9,0 %

Sulphated ash: ≤ 2,0 %

Acetic acid: ≤ 1,0 %

Residual proteins: ≤ 0,01 %

Microbiological criteria:

Aerobic mesophilic bacteria total count: ≤ 3 000 CFU/g

Yeasts: ≤ 100 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.
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)  ◄

▼M36

2'-Fucosyllactose/Difucosyllactose mixture (‘2'-FL/DFL’)

(microbial source)

Description/Definition:

2'-Fucosyllactose/Difucosyllactose mixture is a purified, white to off-white amorphous powder that is produced by a microbial process. After purification, the 2'-Fucosyllactose/Difucosyllactose mixture is isolated by spray drying.

Source: Genetically modified strain of Escherichia coli strain K-12 DH1

Characteristics/Composition

Appearance: White to off white powder or agglomerates

Sum of 2'-Fucosyllactose, Difucosyllactose, Lactose and Fucose (% of dry matter): ≥ 92,0 % (w/w)

Sum of 2'-fucosyllactose and difucosyllactose (% of dry matter): ≥ 85,0 % (w/w)

2'-Fucosyllactose (% of dry matter): ≥ 75,0 % (w/w)

Difucosyllactose (% of dry matter): ≥ 5,0 % (w/w)

D-Lactose: ≤ 10,0 % (w/w)

L-Fucose: ≤ 1,0 % (w/w)

2'-Fucosyl-D-lactulose: ≤ 2,0 % (w/w)

Sum of other carbohydrates (11): ≤ 6,0 % (w/w)

Moisture: ≤ 6,0 % (w/w)

Ash, sulfated: ≤ 0,8 % (w/w)

pH (20 °C, 5 % solution): 4,0-6,0

Residual protein: ≤ 0,01 % (w/w)

Microbiological criteria:

Aerobic mesophilic bacteria total plate count: ≤ 1000 CFU/g

Enterobacteriaceae: ≤ 10 CFU/g

Salmonella sp.: Negative/25 g

Yeast: ≤ 100 CFU/g

Mould: ≤ 100 CFU/g

Residual endotoxins: ≤ 10 EU/mg

CFU: Colony Forming Units; EU: Endotoxin Units

▼M9

Galacto-oligosaccharide

Description/Definition:

Galacto-oligosaccharide is produced from milk lactose by an enzymatic process using β-galactosidases from Aspergillus oryzae, Bifidobacterium bifidum, Pichia pastoris, Sporobolomyces singularis, Kluyveromyces lactis, Bacillus circulans, and Papiliotrema terrestris .

GOS: min 46 % Dry Matter (DM)

Lactose: max 40 % DM

Glucose: max 27 % 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 K-12

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 + 70,0o - + 73,0o

Glucosamine sulphate KCl from Aspergillus niger and genetically modified strain of E. coli K-12

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 +50,0o to +52,0o

Glucosamine sulphate NaCl from Aspergillus niger and genetically modified strain of E. coli K-12

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: +52o - +54o

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 (1) & 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 (2).

Physico-chemical properties:

Powder

Shelf-life: 2 years

Colour: White

Odour: Light

Average diameter of particles: 60-70μm

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)(1).

(1)  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: CharacteristicTaste: 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/100ml

▼M46

Infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner

(Traditional food from a third country)

Description/Definition:

The traditional food consists of an infusion of leaves from Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner (family: Rubiaceae).

The traditional food is prepared by mixing a maximum of 20 g of dried leaves from Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner with 1 L of hot water. Leaves are removed and the infusion is then subjected to pasteurization (at least 71 °C for 15 seconds).

Composition:

Visual: Brown green liquid

Odour and taste: Characteristic

Chlorogenic acid (5-CQA): < 100 mg/L

Caffeine: < 80 mg/L

Epigallocatechin gallate (EGCG): < 700 mg/L

Microbiological criteria:

Total plate count: < 500 CFU/g

Total yeast and mould count: < 100 CFU/g

Total coliforms: < 100 CFU/g

Escherichia coli: Absence in 1 g

Salmonella: Absence in 25 g

Heavy metals:

Lead (Pb): < 3,0 mg/L

Arsenic (As): < 2,0 mg/L

Cadmium (Cd): < 1,0 mg/L

CFU: Colony Forming Units

▼M9

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 tasteChemical 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(1), ‘Instrumental methods’

(1)  Food and Nutrition Paper 5 Rev. 2 — Guide to specifications for general notices, general analytical techniques, identification tests, test solutions and other reference materials (JECFA), 1991, 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: 585-86-4Purity:

Solubility (in water): Very soluble in water

Specific rotation [α]D 20 = + 13o to + 16o

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

▼M33

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 powder that is produced by a microbiological process.

Purity:

Assay (water free): ≥ 80 %

D-Lactose: ≤ 10,0 %

Lacto-N-triose II: ≤ 3,0 %

para-Lacto-N-neohexaose: ≤ 5,0 %

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

Sum of saccharides (Lacto-N-neotetraose, D-Lactose, Lacto-N-triose II, para-Lacto-N-neohexaose, Lacto-N-neotetraose fructose isomer): ≥ 92 %

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

CFU: Colony Forming Units; EU: Endotoxin Units.

▼M43

Lacto-N-tetraose (‘LNT’)

(microbial source)

Definition:

Chemical formula: C26H45O21

Chemical name: β-D-Galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose

Molecular mass: 707,63 Da

CAS No 14116-68-8

Description:

Lacto-N-tetraose is a purified, white to off-white amorphous powder that is produced by a microbial process.

Source: Genetically modified strain of Escherichia coli strain K-12 DH1

Characteristics/Composition:

Appearance: White to off-white powder

Sum of lacto-N-tetraose, D-Lactose and lacto-N-tetraose II (% of dry matter): ≥ 90,0 % (w/w)

Lacto-N-tetraose (% of dry matter): ≥ 70,0 % (w/w)

D-Lactose: ≤ 12,0 % (w/w)

Lacto-N-tetraose II: ≤ 10,0 % (w/w)

Para-lacto-N-hexaose-2: ≤ 3,5 % (w/w)

Lacto-N-tetraose fructose isomer: ≤ 1,0 % (w/w)

Sum of other carbohydrates: ≤ 5,0 % (w/w)

Moisture: ≤ 6,0 % (w/w)

Ash, sulfated: ≤ 0,5 % (w/w)

pH (20 °C, 5 % solution): 4,0–6,0

Residual protein: ≤ 0,01 % (w/w)

Microbiological criteria:

Aerobic mesophilic bacteria total plate count: ≤ 1 000 CFU/g

Enterobacteriaceae: ≤ 10 CFU/g

Salmonella sp.: Negative/25 g

Yeast: ≤ 100 CFU/g

Mould: ≤ 100 CFU/g

Residual endotoxins: ≤ 10 EU/mg

CFU: Colony Forming Units; EU: Endotoxin Units.

▼M20

Lonicera caerulea L. berries (haskap)

(Traditional food from a third country)

Description/Definition:

The traditional food are fresh and frozen berries from Lonicera caerulea var. edulis.

Lonicera caerulea L. is a deciduous shrub belonging to the Caprifoliaceae family.

Typical nutritional components of haskap berries (given in fresh berries):

Carbohydrates: 12,8 %

Fibre: 2,1 %

Lipids: 0,6 %

Proteins: 0,7 %

Ash: 0,4 %

Water: 85,5 %

▼M9

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 %

▼M49

Hen egg white lysozyme hydrolysate

Description/Definition

Hen egg white lysozyme hydrolysate is obtained from hen egg white lysozyme by an enzymatic process, using subtilisin from Bacillus licheniformis.

The product is a white to light yellow powder.

Specification

Protein (TN(*) x 5,30): 80-90 %

Tryptophan: 5-7 %

Ratio Tryptophan/LNAA(**): 0,18-0.25

Degree of hydrolysis: 19-25 %

Moisture: < 5 %

Ash: < 10 %

Sodium: < 6 %

Heavy metals

Arsenic: < 1 ppm

Lead: < 1 ppm

Cadmium: < 0,5 ppm

Mercury: < 0,1 ppm

Microbiological criteria

Total aerobic count: < 103 CFU/g

Total combined yeasts/moulds count: < 102 CFU/g

Enterobacteria: < 10 CFU/g

Salmonella spp: Absence in 25 g

Escherichia coli: Absence in 10 g

Staphylococcus aureus: Absence in 10 g

Pseudomonas aeruginosa: Absence in 10 g

*  TN: total nitrogen

**  LNAA: large neutral amino acids

▼M9

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 (PV): ≤ 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

▼M11

1-Methylnicotinamide chloride

Definition:

Chemical name: 3-carbamoyl-1-methyl-pyridinium chloride

Chemical formula: C7H9N2OCl

CAS No: 1005-24-9

Molecular weight: 172,61 Da

Description

1-Methylnicotinamide chloride is white or off-white, crystalline solid produced by a chemical synthesis process.

Characteristics/Composition

Appearance: White – off-white, crystalline solid

Purity: ≥ 98,5 %

Trigonelline: ≤ 0,05 %

Nicotinic Acid: ≤ 0,10 %

Nicotinamide: ≤ 0,10 %

Largest unknown impurity: ≤ 0,05 %

Sum of unknown impurities: ≤ 0,20 %

Sum of all impurities: ≤ 0,50 %

Solubility: soluble in water and methanol. Practically insoluble in 2-propanol and dichloromethane

Moisture: ≤ 0,3 %

Loss on drying: ≤ 1,0 %

Residue on ignition: ≤ 0,1 %

Residual Solvents and Heavy Metals

Methanol: ≤ 0,3 %

Heavy metals: ≤ 0,002 %

Microbiological criteria:

Total aerobic microbial count: ≤ 100 CFU/g

Mould/yeast: ≤ 10 CFU/g

Enterobacteriaceae: absence in 1 g

Pseudomonas aeruginosa: absence in 1 g

Staphylococcus aureus: absent in 1 g

CFU: Colony Forming Units

▼M9

(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 powderPurity:

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 10g

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(1): < 0,1 mg/ml

N-containing constituents(2): < 10 mg/ml

Lentinan: 0,8 – 1,2 mg/ml\

(1)  Bradford method

(2)  Kjeldahl method

▼M38

Nicotinamide riboside chloride

Description/Definition:

The novel food is a synthetic form of nicotinamide riboside.

The novel food contains ≥ 90 % nicotinamide riboside chloride, predominantly in its β form, the remaining components being residual solvents, reaction by-products and degradation products.

Nicotinamide riboside chloride:

CAS number: 23111-00-4

EC number: 807-820-5

IUPAC name: 1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]pyridin-1-ium-3-carboxamide;chloride

Chemical formula: C11H15N2O5Cl

Molecular weight: 290,7 g/mol

Characteristics/Composition:

Colour: White to light brown

Form: Powder

Identification: Conforms by NMR (nuclear magnetic resonance)

Nicotinamide riboside chloride: ≥ 90 %

Water content: ≤ 2 %

Residual solvents:

Acetone: ≤ 5 000 mg/kg

Methanol: ≤ 1 000 mg/kg

Acetonitrile: ≤ 50 mg/kg

Methyl tert-butyl ether: ≤ 500 mg/kg

Reaction by-products:

Methyl acetate: ≤ 1 000 mg/kg

Acetamide: ≤ 27 mg/kg

Acetic acid: ≤ 5 000 mg/kg

Heavy metals:

Arsenic: ≤ 1 mg/kg

Microbiological criteria:

Total Plate Count: ≤ 1 000 CFU/g

Yeast and Mould: ≤ 100 CFU/g

Escherichia coli: Absence in 10 g

▼M9

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.no_brMorinda 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 (1): ≤ 0,254 μg/ml

Lucidin (1): Not detectable

Alizarin (1): Not detectable

Rubiadin (1): 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 (1): ≤ 0,254 μg/ml

(1)  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 (1): ≤ 2,0 μg/ml

(1)  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 (PV): < 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 (PV): ≤ 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 %

▼M44

Partially defatted chia seed (Salvia hispanica) powders

Description/Definition:

The novel foods are partially defatted chia seed (Salvia hispanica) powders obtained by pressing and grinding of the whole seeds of Salvia hispanica L.

Physical–sensorial:

Foreign matter: 0,1 %

 

Powder with high protein content

Powder with high fibre content

 

Particle size

≤ 130 μm

≤ 400 μm

 

Chemical composition:

 

 

Salvia hispanica powder with high protein content

Salvia hispanica powder with high fibre content

 

Moisture

≤ 9,0 %

≤ 9,0 %

 

Protein

≥ 40,0 %

≥ 24,0 %

 

Fat

≤ 17 %

≤ 12 %

 

Fibre

≤ 30 %

≥ 50 %

 

Microbiological criteria:

Total plate count: ≤ 10 000 CFU/g

Yeasts: ≤ 500 CFU/g

Moulds: ≤ 500 CFU/g

Staphylococcus aureus: ≤ 10 CFU/g

Coliforms: < 100 MPN/g

Enterobacteriaceae: ≤ 100 CFU/g

Bacillus cereus: ≤ 50 CFU/g

Escherichia coli: < 10 MPN/g

Listeria monocytogenes: Absence/g

Salmonella spp.: Absence in 25 g

Contaminants:

Arsenic: ≤ 0,1 ppm

Cadmium: ≤ 0,1 ppm

Lead: ≤ 0,1 ppm

Mercury: ≤ 0,1 ppm

Total aflatoxins: ≤ 4 ppb

Ochratoxin A: ≤ 1 ppb

▼M9

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

 

o Brix

7 to 42

Assured by