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Document 02017R2470-20200415

    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/2017/2470/2020-04-15

    02017R2470 — EN — 15.04.2020 — 015.001


    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




    ▼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 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 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

    ▼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

    L-ergothioneine

    Specified food category

    Maximum levels

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

     

     

    Food supplements as defined in Directive 2002/46/EC

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

    20 mg/day for children older than 3 years

    Ferric Sodium EDTA

    Specified food category

    Maximum levels (expressed as anhydrous EDTA)

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

     

     

    Food supplements as defined in Directive 2002/46/EC

    18 mg/day for children

    75 mg/day for adults

    Foods covered by Regulation (EU) No 609/2013

    12 mg/100 g

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

    Ferrous ammonium phosphate

    Specified food category

    Maximum levels

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

     

     

    Food supplements as defined in Directive 2002/46/EC

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

    Foods covered by Regulation (EU) No 609/2013

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

    Fish peptides from Sardinops sagax

    Specified food category

    Maximum levels fish peptide product

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

     

     

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

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

    Flavoured water, and vegetable-based drinks

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

    Breakfast cereals

    2 g/100 g

    Soups, stews and soup powders

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

    Flavonoids from Glycyrrhiza glabra

    Specified food category

    Maximum levels of flavonoids from Glycyrrhiza glabra

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

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

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

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

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

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

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

     

    Beverages based on milk

    120 mg/day

    Beverages based on yoghurt

    Beverages based on fruit or vegetables

    Food Supplements as defined in Directive 2002/46/EC

    120 mg/day

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

    120 mg/day

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

    120 mg/day

    ▼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

    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

    ▼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

    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 the novel 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

    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

    Protein extract from pig kidneys

    Specified food category

    Maximum levels

     

     

     

    Food Supplements as defined in Directive 2002/46/EC

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

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

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

    ▼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

    ▼M9

    Schizochytrium sp. (T18) oil

    Specified food category

    Maximum levels of DHA

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

     

     

    Dairy products except milk-based drinks

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

    Dairy analogues except drinks

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

    Spreadable fats and dressings

    600 mg/100 g

    Breakfast cereals

    500 mg/100 g

    Food Supplements as defined in Directive 2002/46/EC

    250 mg DHA/day for general population

    450 mg DHA/day for pregnant and lactating women

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

    250 mg/meal

    Milk-based drinks and similar products intended for young children

    200 mg/100 g

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

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

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

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

    Bakery products (breads, rolls and, sweet biscuits)

    200 mg/100 g

    Cereal bars

    500 mg/100 g

    Cooking fats

    360 mg/100 g

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

    80 mg/100 ml

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

    In accordance with Regulation (EU) No 609/2013

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

    200 mg/100 g

    ▼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

    Taxifolin-rich extract

    Specified food category

    Maximum levels

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

     

     

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

    100 mg/day

    Trehalose

    Specified food category

    Maximum levels

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

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

     

     

    Not specified

    UV-treated mushrooms (Agaricus bisporus)

    Specified food category

    Maximum levels of vitamin D2

     

     

     

    Mushrooms (Agaricus bisporus)

    10 μg of vitamin D2/100 g fresh weight

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

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

     

     

    UV-treated baker’s yeast (Saccharomyces cerevisiae)

    Specified food category

    Maximum levels of vitamin D2

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

     

     

    Yeast-leavened breads and rolls

    5 μg of vitamin D2/100 g

    Yeast-leavened fine bakery wares

    5 μg of vitamin D2/100 g

    Food Supplements as defined in Directive 2002/46/EC

    5 μg of vitamin D2/day

    UV-treated bread

    Specified food category

    Maximum levels of vitamin D2

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

     

     

    Yeast leavened bread and rolls (without toppings)

    3 μg vitamin D2/100 g

    UV-treated milk

    Specified food category

    Maximum levels of vitamin D3

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

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

     

     

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

    5-32 μg/kg for general population excluding infants

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

    1-15 μg/kg for general population excluding infants

    Vitamin K2 (menaquinone)

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

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

    Wheat bran extract

    Specified food category

    Maximum levels

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

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

     

    Beer and substitutes

    0,4 g/100 g

    Ready to eat cereals

    9 g/100 g

    Dairy products

    2,4 g/100 g

    Fruit and vegetable juices

    0,6 g/100 g

    Soft drinks

    0,6 g/100 g

    Meat preparations

    2 g/100 g

    ▼M19

    Xylo-oligosaccharides

    Specified food category

    Maximum levels (**)

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

     

     

    White bread

    14 g/kg

    Whole meal bread

    14 g/kg

    Breakfast cereals

    14 g/kg

    Biscuits

    14 g/kg

    Soy drink

    3,5 g/kg

    Yoghurt (*)

    3,5 g/kg

    Fruit spreads

    30 g/kg

    Chocolate confectionery

    30 g/kg

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

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

    ▼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.



    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

    ▼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

    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

    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.

    ▼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 %

    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 %

    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 added sugars

    aw

    < 0,95

    Assured by added sugars

    Final storage

    60 days maximum at + 5 °C maximum

    Equivalent to storage regimen for conventionally processed product

    ▼M35

    Phenylcapsaicin

    Description/Definition:

    Phenylcapsaicin (N-[(4-hydroxy-3-methoxyphenyl)methyl]-7-phenylhept-6-ynamide, C21H23NO3, CAS no: 848127-67-3), is synthesized chemically via a two step synthesis process involving in a first step the production of the acetylenic acid intermediate through a reaction of phenyl acetylene with a carboxylic acid derivative, and in a second step a series of reactions of the acetylenic acid intermediate with vanillylamine derivative to produce phenylcapsaicin.

    Characteristics/Composition:

    Purity (% of dry matter): ≥ 98 %

    Moisture: ≤ 0,5 %

    Total synthesis related production by-products: ≤ 1,0 %

    N,N-dimethyl formamide: ≤ 880 mg/kg

    Dichloromethane: ≤ 600 mg/kg

    Dimethoxyethane: ≤ 100 mg/kg

    Ethyl acetate: ≤ 0,5 %

    Other solvents: ≤ 0,5 %

    Heavy metals:

    Lead: ≤ 1,0 mg/kg

    Cadmium: ≤ 1,0 mg/kg

    Mercury: ≤ 0,1 mg/kg

    Arsenic: ≤ 1,0 mg/kg

    Microbiological criteria:

    Total plate count: ≤ 10 CFU/g

    Coliforms: ≤ 10 CFU/g

    Escherichia coli: Negative/10 g

    Salmonella sp.: Negative/10 g

    Yeast and mould: ≤ 10 CFU/g

    CFU: Colony Forming Units

    ▼M9

    Phosphated maize starch

    Description/Definition:

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

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

    CAS No: 11120-02-8

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

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

    The chemical characteristics of phosphated distarch phosphate:

    Loss on drying: 10-14 %

    pH: 4,5-7,5

    Dietary fibre: ≥ 70 %

    Starch: 7-14 %

    Protein: ≤ 0,8 %

    Lipids: ≤ 0,8 %

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

    Phosphatidylserine from fish phospholipids

    Description/Definition:

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

    Specification of the phosphatidylserine product manufactured from fish phospholipids:

    Moisture: < 5,0 %

    Phospholipids: ≥ 75 %

    Phosphatidylserine: ≥ 35 %

    Glycerides: < 4,0 %

    Free L-serine: < 1,0 %

    Tocopherols: < 0,5 % (1)

    Peroxide value (PV): < 5,0 meq O2/kg

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

    Phosphatidylserine from soya phospholipids

    Description/Definition:

    The novel food ingredient is off-white to light yellow powder. It is also available in liquid form with a clear brown to orange colour. The liquid form contains medium chain triacylglycerides (MCT) as a carrier. It contains lower levels of Phosphatidylserine due to the fact that it includes significant amounts of oil (MCT).

    Phosphatidylserine from soya phospholipids is obtained through enzymatic transphosphatidylation of high-phosphatidylcholine soybean lecithin with the amino acid L-serine. Phosphatidylserine consists of a glycerophosphate skeleton conjugated with two fatty acids and L-serine via a phosphodiester linkage.

    Characteristics of Phosphatidylserine from soya phospholipids:

    Powder form:

    Moisture: < 2,0 %

    Phospholipids: ≥ 85 %

    Phosphatidylserine: ≥ 61 %

    Glycerides: < 2,0 %

    free L-serine: < 1,0 %

    Tocopherols: < 0,3 %

    Phytosterols: < 0,2 %

    Liquid form:

    Moisture: < 2,0 %

    Phospholipids: ≥ 25 %Phosphatidylserine: ≥ 20 %

    Glycerides: not applicable

    free L-serine: < 1,0 %

    Tocopherols: < 0,3 %

    Phytosterols: < 0,2 %

    Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid

    Description/Definition:

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

    Specification of the product:

    Moisture: ≤ 2,0 %

    Total phospholipids: ≥ 70 %

    Phosphatidylserine: ≥ 20 %

    Phosphatidic acid: ≥ 20 %

    Glycerides: ≤ 1,0 %

    Free L-serine: ≤ 1,0 %

    Tocopherols: ≤ 0,3 %

    Phytosterols: ≤ 2,0 %

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

    Phospholipides from egg yolk

    85 % and 100 % pure Phospholipides from egg yolk

    Phytoglycogen

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

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

    Specifications:

    Carbohydrates: 97 %

    Sugars: 0,5 %

    Fibre: 0,8 %

    Fat: 0,2 %

    Protein: 0,6 %

    Phytosterols/phytostanols

    Description/Definition:

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

    Composition (with GC-FID or equivalent method):

    β-sitosterol: < 81 %

    β-sitostanol: < 35 %

    campesterol: < 40 %

    campestanol: < 15 %

    stigmasterol: < 30 %

    brassicasterol: < 3,0 %

    other sterols/stanols: < 3,0 %

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

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

    Plum kernel oil

    Description/Definition:

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

    Composition:

    Oleic acid (C18:1): 68 %

    Linoleic acid (C18:2): 23 %

    γ-Tocopherol:80 % of total tocopherols

    β-Sitosterol: 80-90 % of total sterols

    Triolein: 40-55 % of triglycerides

    Cyanhydric acid: maximum 5 mg/kg oil

    Potato proteins (coagulated) and hydrolysates thereof

    Dry substance: ≥ 800 mg/g

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

    Ash: ≤ 400 mg/g (dry substance)

    Glycoalkaloid (total): ≤ 150 mg/kg

    Lysinoalanine (total): ≤ 500 mg/kg

    Lysinoalanine (free): ≤ 10 mg/kg

    Prolyl oligopeptidase (enzyme preparation)

    Specification of the enzyme:

    Systematic name: Prolyl oligopeptidase

    Synonyms: Prolyl endopeptidase, proline-specific endopeptidase, endoprolylpeptidase

    Molecular weight: 66 kDa

    Enzyme Commission number: EC 3.4.21.26

    CAS number: 72162-84-6

    Source: A genetically modified strain of Aspergillus niger (GEP-44)

    Description: Prolyl oligopeptidase is available as an enzyme preparation containing approximately 30 % maltodextrin.

    Specifications of the enzyme preparation of prolyl oligopeptidase:

    Activity: > 580 000 PPI(1)/g (> 34,8 PPU(2)/g)

    Appearance: Microgranulate

    Colour: Off-white to orange yellowish. The colour may change from batch to batch

    Dry Matter: > 94 %

    Gluten: < 20 ppm

    Heavy metals:

    Lead: ≤ 1,0 mg/kg

    Arsenic: ≤ 1,0 mg/kg

    Cadmium: ≤ 0,5 mg/kg

    Mercury: ≤ 0,1 mg/kg

    Microbiological criteria:

    Total aerobic plate count: ≤ 103 CFU/g

    Total yeasts and moulds: ≤ 102 CFU/g

    Sulphite reducing anaerobes: ≤ 30 CFU/g

    Enterobacteriaceae: < 10 CFU/g

    Salmonella: Absence in 25 g

    Escherichia coli: Absence in 25 g

    Staphylococcus aureus: Absence in 10 g

    Pseudomonas aeruginosa: Absence in 10 g

    Listeria monocytogenes: Absence in 25 g

    Antimicrobial activity: AbsentMycotoxins: Below limits of detection: Aflatoxin B1, B2, G1, G2 (< 0,25 μg/kg), total Aflatoxins (< 2,0 μg/kg), Ochratoxin A (< 0,20 μg/kg), T-2 Toxin (< 5 μg/kg), Zearalenone (< 2,5 μg/kg), Fumonisin B1 and B2 (< 2,5 μg/kg)

    (1)  PPI – Protease Picomole International

    (2)  PPU – Prolyl Peptidase Units or Proline Protease Units

    Protein extract from pig kidneys

    Description/Definition:

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

    Basic Product:

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

    Physical condition: liquid

    Colour: brownish

    Appearance: slightly turbid solution

    pH value: 6,4-6,8

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

    Microbiological criteria:

    Brachyspira spp.: negative (Real Time PCR)

    Listeria monocytogenes: negative (Real Time PCR)

    Staphylococcus aureus: < 100 CFU/g

    Influenza A: negative (Reverse Transcription Real Time PCR)

    Escherichia coli: < 10 CFU/g

    Total aerobic microbiological count: < 105 CFU/g

    Yeasts/moulds count: < 105 CFU/g

    Salmonella: Absence/10g

    Bile salt resistant enterobacteriaceae: < 104 CFU/g

    Final product:

    Specification pig kidney protein excerpt with natural content of DAO (E.C. 1.4.3.22) in an enteric coated formulation:

    Physical condition: solid

    Colour: yellow grayAppearance: micropellets

    Enzymatic activity: 110-220 kHDU DAO/g pellet (DAO REA (DAO Radioextractionassay))

    Acid stability 15 min 0,1M HCl followed by 60 min Borat pH = 9,0: > 68 kHDU DAO/g pellet (DAO REA (DAO Radioextractionassay))

    Humidity: < 10 %

    Staphylococcus aureus: < 100 CFU/g

    Escherichia coli: < 10 CFU/g

    Total aerobic microbiological count: < 104 CFU/g

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

    Salmonella: Absence/10g

    Bile salt resistant enterobacteriaceae: < 102 CFU/g

    ▼M10

    Pyrroloquinoline quinone disodium salt

    Definition:

    Chemical name: disodium 9-carboxy-4,5-dioxo-1H-pyrrolo[5,4-f]quinoline-2,7-dicarboxylate

    Chemical formula: C14H4N2Na2O8

    CAS No: 122628-50-6

    Molecular weight: 374,17 Da

    Description

    Pyrroloquinoline quinone disodium salt is a reddish–brown powder produced by the non-genetically modified bacterium Hyphomicrobium denitrificans strain CK-275.

    Characteristics/Composition

    Appearance: Reddish-brown powder

    Purity: ≥ 99,0 % (dry weight)

    UV absorbance (A322/A259): 0,56 ± 0,03

    UV absorbance (A233/A259): 0,90 ± 0,09

    Moisture: ≤ 12,0 %

    Residual Solvent

    Ethanol: ≤ 0,05 %

    Heavy metals

    Lead: < 3 mg/kg

    Arsenic: < 2 mg/kg

    Microbiological criteria:

    Total viable cell count: ≤ 300 CFU/g

    Mould/yeast: ≤ 12 CFU/g

    Coliforms: absent in 1 g

    Hyphomicrobium denitrificans: ≤ 25 CFU/g

    CFU: Colony Forming Units

    ▼M9

    Rapeseed oil high in unsaponifiable matter

    Description/Definition:

    Rapeseed oil high in unsaponifiable matter’ is produced by vacuum distillation and it is different from refined rapeseed oil in the concentration of the unsaponifiable fraction (1 g in refined rapeseed oil and 9 g in ‘rapeseed oil high in unsaponifiable matter’). There is a minor reduction of triglycerides containing monounsaturated and polyunsaturated fatty acids.

    Purity:

    Unsaponifiable matter: > 7,0 g/100 g

    Tocopherols: > 0,8 g/100 g

    α-tocopherol (%): 30-50 %

    γ-tocopherol (%): 50-70 %

    δ-tocopherol (%): < 6,0 %

    Sterols, triterpenic alcohols, methylsterols: > 5,0 g/100 g

    Fatty acids in triglycerides:

    palmitic acid: 3-8 %

    stearic acid: 0,8-2,5 %

    oleic acid: 50-70 %

    linoleic acid: 15-28 %

    linolenic acid: 6-14 %

    erucic acid: < 2,0 %

    Acid value: ≤ 6,0 mg KOH/g

    Peroxide value (PV): ≤ 10 mEq O2/kg

    Heavy metals:

    Iron (Fe): < 1 000 μg/kg

    Copper (Cu): < 100 μg/kg

    Impurities:

    Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 μg/kg

    Treatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons (PAH) are not enriched in the production of ‘rapeseed oil high in unsaponifiable matter.

    Rapeseed Protein

    Definition:

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

    Description:

    White to off-white, spray dried powder

    Total protein: ≥ 90 %

    Soluble protein: ≥ 85 %

    Moisture: ≤ 7,0 %

    Carbohydrates: ≤ 7,0 %

    Fat: ≤ 2,0 %

    Ash: ≤ 4,0 %

    Fibre: ≤ 0,5 %

    Total glucosinolates: ≤ 1 mmol/kg

    Purity:

    Total phytate: ≤ 1,5 %

    Lead: ≤ 0,5 mg/kg

    Microbiological criteria:

    Yeast and mould count: ≤ 100 CFU/g

    Aerobic bacteria count: ≤ 10 000 CFU/g

    Total coliform count: ≤ 10 CFU/g

    Escherichia coli: Absence in 10 g

    Salmonella: Absence in 25 g

    ▼M17

    Refined shrimp peptide concentrate

    Description

    Refined shrimp peptide concentrate is a peptide mixture obtained from northern shrimp (Pandalus borealis) shells and heads via a series of purification steps following enzymatic proteolysis using a protease from Bacillus licheniformis and/or Bacillus amyloliquefaciens.

    Characteristics/Composition

    Total Dry matter (%): ≥ 95,0 %

    Peptides (w/weight dry matter): ≥ 87,0 % of which peptides with molecular weight < 2 kDa: ≥ 99,9 %

    Fat (w/w): ≤ 1,0 %

    Carbohydrates (w/w): ≤ 1,0 %

    Ash (w/w): ≤ 15,0 %

    Calcium: ≤ 2,0 %

    Potassium: ≤ 0,15 %

    Sodium: ≤ 3,5 %

    Heavy Metals

    Arsenic (inorganic): ≤ 0,22 mg/kg

    Arsenic (organic): ≤ 51,0 mg/kg

    Cadmium: ≤ 0,09 mg/kg

    Lead: ≤ 0,18 mg/kg

    Total mercury: ≤ 0,03 mg/kg

    Microbiological criteria:

    Total viable cell count: ≤ 20 000 CFU/g

    Salmonella: ND/25g

    Listeria monocytogenes: ND/25g

    Escherichia coli: ≤ 20 CFU/g

    Coagulase positive Staphylococcus aureus: ≤ 200 CFU/g

    Pseudomonas aeruginosa: ND/25g

    Mould/yeast: ≤ 20 CFU/g

    CFU: Colony Forming Units

    ND: Not Detectable

    ▼M9

    Trans-resveratrol

    Description/Definition:

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

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

    Chemical formula: C14H12O3

    Molecular weight: 228,25 Da

    CAS No: 501-36-0

    Purity:

    Trans-resveratrol: ≥ 98 %-99 %

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

    Any single related substance: ≤ 0,1 %

    Sulphated ash: ≤ 0,1 %

    Loss on drying: ≤ 0,5 %

    Heavy metals:

    Lead: ≤ 1,0 ppm

    Mercury: ≤ 0,1 ppm

    Arsenic: ≤ 1,0 ppm

    Impurities:

    Diisopropylamine: ≤ 50 mg/kg

    Microbial source : A genetically modified strain of Saccharomyces cerevisiae

    Appearance: Off-white to slight yellow powder

    Particle size: 100 % less than 62,23 μm

    Trans-resveratrol content: Min. 98 % w/w (dry weight basis)

    Ash: Max. 0,5 % w/w

    Moisture: Max. 3 % w/w

    Rooster comb extract

    Description/Definition:

    Rooster comb extract is obtained from Gallus gallus by enzymatic hydrolysis of rooster comb and by subsequent filtration, concentration and precipitation steps. The principal constituents of rooster comb extract are the glycosaminoglycans hyaluronic acid, chondroitin sulphate A and dermatan sulphate (chondroitin sulphate B). White or almost white hygroscopic powder.

    Hyaluronic acid: 60-80 %

    Chondroitin sulphate A: ≤ 5,0 %Dermatan sulphate (chondroitin sulphate B): ≤ 25 %

    pH: 5,0-8,5

    Purity:

    Chlorides: ≤ 1,0 %

    Nitrogen: ≤ 8,0 %

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

    Heavy metals:

    Mercury: ≤ 0,1 mg/kg

    Arsenic: ≤ 1,0 mg/kg

    Cadmium: ≤ 1,0 mg/kg

    Chromium: ≤ 10 mg/kg

    Lead: ≤ 0,5 mg/kg

    Microbiological criteria:

    Total viable aerobic count: ≤ 102 CFU/g

    Escherichia coli: Absence in 1 g

    Salmonella: Absence in 1 g

    Staphylococcus aureus: Absence in 1 g

    Pseudomonas aeruginosa: Absence in 1g

    Sacha Inchi oil from Plukenetia volubilis

    Description/Definition:

    Sacha inchi oil is a 100 % cold pressed vegetable oil obtained from the seeds of Plukenetia volubiis L. It is a transparent, fluid (liquid) and shiny oil at room temperature. It has a fruity, light, green vegetable taste without undesirable flavours.

    Aspect, limpidity, shine, colour: Fluid at room temperature, clean, shiny yellow gold

    Odour and taste: Fruity, vegetable without non acceptable taste or odour

    Purity:

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

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

    Oleic acidity: < 2,0 g/100 g

    Peroxide value (PV): < 15 meq O2/kg

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

    Total unsaturated fatty acids: > 90 %Omega 3 alpha linolenic acid (ALA): > 45 %

    Saturated fatty acids: < 10 %

    No trans fatty acids (< 0,5 %)

    No erucic acid (< 0,2 %)

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

    Phytosterols composition and level

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

    Salatrims

    Description/Definition:

    Salatrim is the internationally recognised acronym for (short and long chain acyl triglyceride molecules). Salatrim is prepared by non-enzymatic inter-esterification of triacetin, tripropionin, tributyrin, or their mixtures with hydrogenated canola, soybean, cottonseed, or sunflower oil. Description: Clear, slightly amber liquid to a light coloured waxy solid at room temperature. Free of particulate matter and of foreign or rancid odour.

    Glycerol ester disribution:

    Triacylglycerols: > 87 %

    Diacylglycerols: ≤ 10 %

    Monoacylglycerols: ≤ 2,0 %

    Fatty acid composition:

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

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

    Saturated long chain fatty acids: < 70 % by weight

    Trans fatty acids: ≤ 1,0 %

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

    Triacylglycerol profile:

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

    Triesters (short/long = 0): ≤ 10 %

    Unsaponifiable material: ≤ 1,0 %

    Moisture: ≤ 0,3 %

    Ash: ≤ 0,1 %

    Colour: ≤ 3,5 Red (Lovibond)

    Peroxide value (PV): ≤ 2,0 Meq/Kg

    Schizochytrium sp. oil rich in DHA and EPA

    Acid value: ≤ 0,5 mg KOH/g

    Peroxide value (PV): ≤ 5,0 meq/kg oil

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

    Moisture and volatiles: ≤ 0,05 %

    Unsaponifiables: ≤ 4,5 %

    Trans-fatty acids: ≤ 1 %

    DHA content: ≥ 22,5 %

    EPA content: ≥ 10 %

    ▼M26

    Schizochytrium sp. (ATCC PTA-9695) oil

    The novel food is obtained from the strain ATCC PTA-9695 of the microalgae Schizochytrium sp.

    Peroxide value (PV): ≤ 5,0 meq/kg oil

    Unsaponifiables: ≤ 3,5 %

    Trans-fatty acids: ≤ 2,0 %

    Free fatty acids: ≤ 0,4 %

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

    DHA content: ≥ 35 %

    ▼M9

    Schizochytrium sp. oil

    Acid value: ≤ 0,5 mg KOH/g

    Peroxide value (PV): ≤ 5,0 meq/kg oil

    Moisture and volatiles: ≤ 0,05 %

    Unsaponifiables: ≤ 4,5 %

    Trans-fatty acids: ≤ 1,0 %

    DHA content: ≥ 32,0 %

    Schizochytrium sp. (T18) oil

    Acid value: ≤ 0,5 mg KOH/g

    Peroxide value (PV): ≤ 5,0 meq/kg oil

    Moisture and volatiles: ≤ 0,05 %

    Unsaponifiables: ≤ 3,5 %

    Trans-fatty acids: ≤ 2,0 %

    Free fatty acids: ≤ 0,4 %

    DHA content: ≥ 35 %

    ▼M22

    Syrup from Sorghum bicolor (L.) Moench.

    (Traditional food from a third country)

    Description/Definition

    The traditional food is syrup from Sorghum bicolor (L.) Moench (genus, Sorghum; family, Poaceae (alt. Gramineae)).

    The syrup is obtained from stalks of S. bicolor, after applying production processes such as crushing, extraction, and evaporation including a heat treatment in order to obtain a minimum of 74 °Brix syrup

    Compositional data of syrup from Sorghum bicolor (L.) Moench

    Water: 22,7 g/100 g

    Ash: 2,4

    Sugars, total: > 74,0 g/100 g

    ▼M9

    Fermented soybean extract

    Description/Definition:

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

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

    Nattokinase activity: 20 000 -28 000 Fibrin degradation unit/g(1)

    Identity: Confirmable

    Condition: No offensive taste or smell

    Loss on drying: ≤ 10 %

    Vitamin K2: ≤ 0,1 mg/kg

    Heavy metals:

    Lead: ≤ 5,0 mg/kg

    Arsenic: ≤ 3,0 mg/kg

    Microbiological criteria:

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

    Yeast and mould: ≤ 102 CFU/g

    Coliforms: ≤ 30 CFU/g

    Spore-forming bacteria: ≤ 10 CFU/g

    Escherichia coli: Absence/25 g

    Salmonella: Absence/25 g

    Listeria: Absence/25 g

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

    ▼M41

    Spermidine-rich wheat germ extract (Triticum aestivum)

    Description/Definition:

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

    Spermidine:(N-(3-aminopropyl)butane-1,4-diamine):0,8-2,4 mg/g

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

    Spermidine trichloride < 0,1 μg/g

    Putrescine: < 0,3 mg/g

    Cadaverine: ≤ 16,0 μg/g

    Mycotoxins:

    Aflatoxins (total): < 0,4 μg/kg

    Microbiological criteria:

    Total aerobic bacteria: < 10 000 CFU/g

    Yeast and moulds: < 100 CFU/g

    Escherichia coli: < 10 CFU/g

    Salmonella: Absence/25g

    Listeria monocytogenes: Absence/25g

    ▼M9

    Sucromalt

    Description/Definition:

    Sucromalt is a complex mixture of saccharides which is produced from sucrose and a starch hydrolysate by means of an enzymatic reaction. In this process, glucose units are attached to saccharides from the starch hydrolysate by means of an enzyme produced by the bacterium Leuconostoc citreum or by means of a recombinant strain of the production organism Bacillus licheniformis. The resulting oligosaccharides are characterised by the presence of α-(1→6) and α-(l→3) glycosidic compounds. The overall product is syrup, in addition to these oligosaccharides, contains mainly fructose but also the disaccharide leucrose and other disaccharides.

    Total solids: 75-80 %

    Moisture: 20-25 %

    Sulphatase: Max 0,05 %

    pH: 3,5-6,0

    Conductivity < 200 (30 %)

    Nitrogen < 10 ppm

    Fructose: 35-45 % d.w.

    Leucrose: 7-15 % d.w.

    Other disaccharides: Mах 3 %

    Higher saccharides: 40-60 % d.w

    Sugar cane fibre

    Description/Definition:

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

    The production process consists of several steps, including: chipping, alkaline digestion, removal of lignins and other non-cellulosic components, bleaching of purified fibres, acid washing and neutralization.Moisture: ≤ 7,0 %

    Ash: ≤ 0,3 %

    Total Dietary Fibre (AOAC) dry basis (all insoluble): ≥ 95 %

    of which: Hemicellulose (20-25 %) and cellulose (70-75 %)

    Silica (ppm): ≤ 200

    Protein: 0,0 %

    Fat: Trace

    pH: 4-7

    Heavy metals:

    Mercury (ppm): ≤ 0,1

    Lead (ppm): ≤ 1,0

    Arsenic (ppm): ≤ 1,0

    Cadmium (ppm): ≤ 0,1

    Microbiological criteria:

    Yeast and moulds (CFU/g): ≤ 1 000

    Salmonella: Absence

    Listeria monocytogenes: Absence

    Sunflower oil extract

    Description/Definition:

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

    Composition:

    Oleic acid (C18:1): 20 %

    Linoleic acid (C18:2): 70 %

    Unsaponifiable matter: 8,0 %

    Phytosterols: 5,5 %

    Tocopherols: 1,1 %

    Dried Tetraselmis chuii microalgae

    Description/Definition:

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

    Identified by means of nuclear marker rDNA 18 S (sequence analysed no less than 1 600 base pairs) in the National Centre for Biotechnology information (NCBI) database: Not less than 99,9 %

    Humidity: ≤ 7,0 %

    Proteins: 35-40 %

    Ashes: 14-16 %

    Carbohydrates: 30-32 %

    Fibre: 2-3 %

    Fat: 5-8 %

    Saturated fatty acids: 29-31 % of total fatty acids

    Monounsaturated fatty acids: 21-24 % of total fatty acids

    Polyunsaturated fatty acids: 44-49 % of total fatty acids

    Iodine: ≤ 15 mg/kg

    Therapon barcoo/Scortum

    Description/Definition:

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

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

    Composition of fish flesh:

    Protein (%): 18-25

    Moisture (%): 65-75

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

    Energy (KJ/Kg): 6000-11500

    Carbohydrates (%): 0,0

    Fat (%): 5-15

    Fatty acids (mg FA/g fillet):

    Σ PUFA n-3: 1,2-20,0

    Σ PUFA n-6: 0,3-2,0

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

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

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

    D-Tagatose

    Description/Definition:

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

    Appearance: White or almost white crystals

    Chemical name: D-tagatose

    Synonym: D-lyxo-Hexulose

    CAS number: 87-81-0

    Chemical formula: C6H12O6

    Formula weight: 180,16 (g/mol)

    Purity:

    Assay: ≥ 98 % on a dry weight basis

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

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

    Melting range: 133– 137 °C

    Heavy metals:

    Lead: ≤ 1,0 mg/kg(*)

    (*)  Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5. ‘Instrumental methods’(1).

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

    Taxifolin-rich extract

    Description:

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

    Definition:

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

    Chemical formula: C15H12O7

    Molecular mass: 304,25 Da

    CAS No: 480-18-2

    Specifications:

    Physical parameter

    Moisture: ≤ 10 %Compound analysis

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

    Heavy Metals, Pesticide

    Lead: ≤ 0,5 mg/kg

    Arsenic: ≤ 0,02 mg/kg

    Cadmium: ≤ 0,5 mg/kg

    Mercury: ≤ 0,1 mg/kg

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

    Residual solvents

    Ethanol: < 5 000 mg/kg

    Microbiological criteria

    Total Plate Count (TPC): ≤ 104 CFU/g

    Enterobacteria: ≤ 100/g

    Yeast and Mould: ≤ 100 CFU/g

    Escherichia coli: Absence/1 g

    Salmonella: Absence/10 g

    Staphylococcus aureus: Absence/1 g

    Pseudomonas: Absence/1g

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

    Extract component

    Content, usual observed range (%)

    Taxifolin

    90 – 93

    Aromadendrin

    2,5 – 3,5

    Eriodictyol

    0,1 – 0,3

    Quercetin

    0,3 – 0,5

    Naringenin

    0,2 – 0,3

    Kaempferol

    0,01 – 0,1

    Pinocembrin

    0,05 – 0,12

    Unidentified flavonoids

    1 – 3

    Water(*)

    1,5

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

    Trehalose

    Description/Definition:

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

    Synonyms: α,α-trehalose

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

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

    Chemical formula: C12H22O11 · 2H2O (dihydrate)

    Formula weight: 378,33 (dihydrate)

    Assay: ≥ 98 % on the dry basis

    Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in FNP 5 (1), ‘Instrumental methods’

    Method of assay:

    Principle: trehalose is identified by liquid chromatography and quantified by comparison to a reference standard containing standard trehalose

    Preparation of sample solution: weigh accurately about 3 g of dry sample into a 100 ml volumetric flask and add about 80 ml of purified, deionised water. Bring sample to complete dissolution and dilute to mark with purified deionised water. Filter through a 0,45 micron filter

    Preparation of standard solution: dissolve accurately weighed quantities of dry standard reference trehalose in water to obtain a solution having known concentration of about 30 mg of trehalose per ml.

    Apparatus: liquid chromatography equipped with a refractive index detector and integrating recorder

    Conditions:

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

    — length: 300 mm

    — diameter: 10 mm

    — temperature: 50 °C

    Mobile phase: water

    flow rate: 0,4 ml/min

    Injection volume: 8 μl

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

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

    Calculate the quantity, in mg, of trehalose in 1 ml of the sample solution by the following formula:% trehalose = 100 × (RU/RS) (WS/WU)

    where

    RS = peak area of trehalose in the standard preparation

    RU = peak area of trehalose in the sample preparation

    WS = weight in mg of trehalose in the standard preparation

    WU = weight of dry sample in mg

    Characteristics:

    Identification:

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

    Specific rotation: [α]D 20 = +179o (5 % aqueous solution, dihydrate), +199o (5 % aqueous solution, anhydrous substance)

    Melting point: 97 °C (dihydrate)

    Purity:

    Loss on drying: ≤ 1,5 % (60 °C, 5h)

    Total ash: ≤ 0,05 %

    Heavy metals:

    Lead: ≤ 1,0 mg/kg

    UV treated mushrooms (Agaricus bisporus)

    Description/Definition:

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

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

    Vitamin D2:

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

    Synonym: Ergocalciferol

    CAS No: 50-14-6

    Molecular weight: 396,65 g/mol

    Contents:

    Vitamin D2 in the final product: 5