B Commission Implementing Regulation (Eu

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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 L 78 2 21.3.2018 2018 ►M2 Commission Implementing Regulation (EU) 2018/461 of 20 March L 78 7 21.3.2018 2018 ►M3 Commission Implementing Regulation (EU) 2018/462 of 20 March L 78 11 21.3.2018 2018 ►M4 Commission Implementing Regulation (EU) 2018/469 of 21 March L 79 11 22.3.2018 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 L 204 36 13.8.2018 2018 ►M11 Commission Implementing Regulation (EU) 2018/1123 of 10 August L 204 41 13.8.2018 2018 ►M12 Commission Implementing Regulation (EU) 2018/1132 of 13 August L 205 15 14.8.2018 2018 ►M13 Commission Implementing Regulation (EU) 2018/1133 of 13 August L 205 18 14.8.2018 2018 02017R2470 — EN — 03.09.2018 — 003.001 — 2

▼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 Regu lation.

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. 02017R2470 — EN — 03.09.2018 — 003.001 — 3

▼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 02017R2470 — EN — 03.09.2018 — 003.001 — 4

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-acetyl- N -acetyl-D-neur N

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

The designation of the novel food on the on food novel the of designation The Additional specific labelling requirements labelling specific Additional

0,05 g/kg for solid foods solid 0,05 g/kg for In accordance with the particular of nutritional requirements the infants and young children for intended products are whom the not higher than but in any case the maximum for levels specified the category mentioned in the table corresponding to the prod ucts. 0,05 g/L of reconstituted formula reconstituted of 0,05 g/L (drinks) 0,2 g/L 1,7 g/kg (bars) 1,25 g/kg 0,05 g/L

)

Maximum levels Maximum

) 1

Specified food category

Infant and follow-on formulae as defined by ( No 609/2013 Regulation (EU) for purposes medical special Foods for infants and young children as defined by No 609/2013 Regulation (EU) foods Total diet replacement for weight control as defined by Regulation No (EU) 609/2013 Processed cereal-based foods and Processed cereal-based baby foods for infants and young children as defined by No 609/2013 Regulation (EU) or absence on the statements Foods bearing reduced presence of gluten in accordance of Commission with the requirements Imple ( No 828/2014 menting Regulation (EU) and sterilised Unflavoured pasteurised (including UHT) milk-based products Conditions under which the novel food may be used be may food novel the which under Conditions

-Acetyl-D-neur Authorised novel food Table 1: Authorised novel foods novel Authorised Table 1: N aminic acid M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 5

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labelling of the foodstuffs containing it pulp’shall be ‘Baobab fruit

Additional specific labelling requirements labelling specific Additional

0,05 g/L (beverages) 0,05 g/L 0,4 g/kg (solids) (beverages) 0,05 g/L 0,25 g/kg (solids) 0,2 g/kg 300 mg/day for general popu general 300 mg/day for lation older than 10 years infants 55 mg/day for young children 130 mg/day for between children for 250 mg/day 3 to 10 of age years 0,05 g/L 0,05

8,3 g/kg 8,3 0,05 g/L 0,05

) The designation of the novel food on the on food novel the of designation The 3 0,5 g/kg 0,5

Unflavoured fermented milk-based products, milk-based Unflavoured fermented flavoured fermentation, after heat treated fermented milk products including heat- treated products Dairy analogues, including beverage whiteners Cereal bars Flavoured drinks Speciality coffee, tea, herbal and fruit infu infusions and fruit herbal tea, sions, chicory; and plant, fruit tea, and chicory extracts; cereal preparations for infusions Not specified Table top sweeteners Fruit and vegetable-based drinks Directive in defined Food Supplements as 2002/46/EC ( Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Adansonia digitata fruit (Baobab) dried pulp

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seed oil’

’ Allanblackia labelling of the foodstuffs containing it the micro-algae shall be ‘Oil from Ulkenia sp. labelling of the foodstuffs containing it shall be ‘

The designation of the novel food on the on food novel the of designation The (L.) the on food novel the of designation The Additional specific labelling requirements labelling specific Additional

from Aloe vera

In line with normal use in food with normal In line extract supplements of a similar parts of aerial of the flowering Ajuga reptans 200 mg/100 g 60 mg/100 ml use in food with normal In line gel supplements of the similar derived Burm. 20 g/100 g g/100 20 Maximum levels levels Maximum DHA Maximum of levels Maximum levels levels Maximum Maximum

500 mg/100 g mg/100 500 Specified food category Specified food category Specified food category Specified food category

Foods for special medical purposes as purposes medical special Foods for defined in No Regulation (EU) 609/2013 and young infants excluding foods for children and sweet rolls (breads, Bakery products biscuits) based and spreads spreads cream Yellow fat Food Supplements as defined in Directive in defined Food Supplements as 2002/46/EC Directive in defined Food Supplements as 2002/46/EC Drinks intended the expenditure of to meet for especially intense muscular effort sportsmen Cereal bars Non-alcoholic beverages (including milk based beverages) Directive in defined Food Supplements as 2002/46/EC Specified food category food Specified Conditions under which the novel food may be used be may food novel the which under Conditions

seed oil seed Ulkenia

Authorised novel food L-Alanyl-L- Glutamine the from Algal oil microalgae sp. Aloe macroclada extract Baker leaf Allanblackia Ajuga reptans extract from cell cultures

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Euphausia

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

Additional specific labelling requirements labelling specific Additional

DHA and EPA Maximum levels of combined of Maximum levels products 600 mg/100 g 80 mg/100 ml 200 mg/100 g 3 000 mg/day for population the general and pregnant 450 mg/day for lactating women In accordance with the particular of nutritional requirements the whom the products persons for are intended 250 mg/meal to cheese products 600 mg/100 g

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

200 mg/100 g or for analogues for or g mg/100 200 600 mg/100 g mg/100 600 500 mg/100 g mg/100 500

500 mg/100 g mg/100 500 360 mg/100 ml mg/100 360

Specified food category

Dairy products except milk-based drinks Dairy analogues except drinks Non-alcoholic beverages Milk-based drinks Dairy analogue drinks and Spreadable fat dressings Breakfast cereals as purposes medical special Foods for defined in Regulation (EU) No 609/2013 for weight Total diet control replacement as No 609/2013 defined in Regulation (EU) and meal replacements for weight control Cooking fats and sweet rolls (breads, Bakery products biscuits) bars Nutrition bars/cereal Directive in defined Food Supplements as 2002/46/EC Conditions under which the novel food may be used be may food novel the which under Conditions

Euphausia Authorised novel food Antarctic Krill oil from superba

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Euphausia

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

Additional specific labelling requirements labelling specific Additional

DHA and EPA Maximum levels of combined of Maximum levels products 600 mg/100 g 80 mg/100 ml 200 mg/100 g 200 mg/100 ml to cheese products 600 mg/100 g

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

200 mg/100 g or for analogues for or g mg/100 200 600 mg/100 g mg/100 600 500 mg/100 g mg/100 500

500 mg/100 g mg/100 500 360 mg/100 ml mg/100 360 Specified food category

Processed cereal-based food and Processed cereal-based baby food and young infants intended for children No 609/2013covered by Regulation (EU) of expenditure the meet to Foods intended especially for intense muscular effort, sportsmen Dairy products except milk-based drinks Dairy analogues except drinks Non-alcoholic beverages Milk-based drinks Dairy analogue drinks and Spreadable fat dressings Breakfast cereals Foods bearing statements on the absence or absence on the statements Foods bearing reduced presence of gluten in accordance of Commission with the requirements Imple No 828/2014 menting Regulation (EU) Cooking fats and sweet rolls (breads, Bakery products biscuits) bars Nutrition bars/cereal Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Antarctic Krill oil rich in phosp holipids from Euphausia superba

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’ or

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

Additional specific labelling requirements labelling specific Additional

3 000 mg/day for population the general and pregnant 450 mg/day for lactating women In accordance with the particular of nutritional requirements the whom the products persons for are intended 250 mg/meal In accordance with Regulation (EU) No 609/2013 In accordance with Regulation (EU) No 609/2013 200 mg/100 ml

Maximum levels Maximum

Specified food category

Food Supplements as defined in Directive in defined Food Supplements as 2002/46/EC as purposes medical special Foods for defined in Regulation (EU) No 609/2013 for weight Total diet control replacement as No 609/2013 defined in Regulation (EU) and meal replacements for weight control food and Processed cereal-based baby food and young infants intended for children No 609/2013covered by Regulation (EU) of expenditure the meet to Foods intended especially for intense muscular effort, sportsmen Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 for purposes medical special Foods for premature infants as defined in Regulation (EU) No 609/2013 Foods bearing statements on the absence or absence on the statements Foods bearing reduced presence of gluten in accordance of Commission with the requirements Imple No 828/2014 menting Regulation (EU) Conditions under which the novel food may be used be may food novel the which under Conditions Mortierella Mortierella

Authorised novel food Arachidonic acid- rich oil from the fungus alpina

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labelling of the foodstuffs containing it used and as oil’ if shall be ‘Argan only for oil seasoning ‘Vegetable seasoning’ shall be mentioned on the label labelling of the foodstuffs containing it shall be ‘Astaxanthin’ labelling of the foodstuffs containing it shall be ‘Fermented black bean (Soya) or ‘Fermented extract’’ Soya extract’ labelling of the foodstuffs containing it cows’ milk’ from shall be ‘Lactoferrin

) The designation of the novel food on the on food the novel on the food of novel designation the the The on of the food designation on novel The food the novel of the designation of The designation The Additional specific labelling requirements labelling specific Additional

8 mg astaxanthin

Ocimum basilicum ≤

In line with normal food use of vegetable oils oleoresin, 40-80 mg/day of resulting in per day whole addition of 3 g/200 for ml basil seeds ( 4,5 g/day 100 mg/100 ml 200 mg/100 g Maximum levels Maximum levels levels Maximum levels Maximum levels Maximum Maximum 670 mg/100 g mg/100 670

Not specified Not

Specified food category Specified food category Specified food category Specified food category

As seasonings Directive in defined Food Supplements as 2002/46/EC Directive in defined Food Supplements as 2002/46/EC Directive in defined Food Supplements as 2002/46/EC Infant formula and follow-on formula as defined in No Regulation (EU) 609/2013 (ready to drink) young intended for basis Foods on dairy children (ready to eat/drink) Fruit juice and blend fruit/vegetable beverages food (solid) Processed cereal Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified

Ocimum

) algae Authorised novel food Astaxanthin-rich Astaxanthin-rich oleoresin from Haematococcus pluvialis Fermented black bean extract Bovine lactoferrin Argan oil from Argan oil Argania spinosa Basil seeds ( basilicum

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

Additional specific labelling requirements labelling specific Additional

acid (STA) Maximum levels of stearidonic of Maximum levels Depending on the needs of the of needs the Depending on 3 g/day individual up to 330 mg/100 g 75 mg/100 drinks g for 750 mg/100 g 50 mg/100 g

250 mg/100 g mg/100 250 750 mg/100 g mg/100 750 80 mg/100 g mg/100 80

2 000 mg/100 g mg/100 000 2 200 mg/100 g mg/100 200 120 mg/100 g mg/100 120 1 000 mg/100 g mg/100 000 1 3 000 mg/100 g mg/100 000 3 Specified food category 130 mg/100 g mg/100 130

750 mg/100 g mg/100 750 Foods for special medical purposes as purposes medical special Foods for defined in Regulation (EU) No 609/2013 Beverages based on milk Ice cream Candies Dairy products and analogues products Cheese and cheese Powdered drink mixes based on milk (ready based on milk mixes Powdered drink to drink) Beverages based milk on fermented (including yoghurt drinks) Non-alcoholic drinks Products based on yoghurt Products based on cheese Cakes and pastries Chewing gum Butter and and other fat oil emulsions frying cooking or for (not including spreads purposes) Conditions under which the novel food may be used be may food novel the which under Conditions

seed oil Authorised novel food Buglossoides arvensis

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Calanus finmarchicus

labelling of the foodstuffs containing it from shall be ‘oil (crustacean)’ labelling of the foodstuffs containing it shall be ‘Gum base (including 1,3-buta diene, 2-methyl-homopolymer, maleated, esters with polyethylene glycol mono- ‘Gum base (including or Me ether)’ 1246080-53-4)’CAS No: labelling of the foodstuffs containing it shall be ‘Gum base (including methyl anhydride vinyl ether-maleic copolymer)’ or ‘Gum base (including 9011-16-9)’CAS No The designation of the novel food on the on the food on novel food the the novel of on the designation food of The novel designation the The of designation The Additional specific labelling requirements labelling specific Additional

500 mg/day In accordance with the particular of nutritional requirements the whom the products persons for are intended 250 mg/meal 2,3 g/day

Maximum levels levels Maximum Maximum levels Maximum

625 mg/100 g mg/100 625 8 % % 8 2

Specified food category Specified food category Specified food category

Breakfast cereals as purposes medical special Foods for defined in Regulation (EU) No 609/2013, medical special excluding foods for and young infants for purposes intended children for weight Total diet control replacement as No 609/2013 defined in Regulation (EU) and meal replacements for weight control Directive in defined as Food supplements 2002/46/EC Chewing gum Food supplements as defined in Directive in defined as Food supplements supplements food 2002/46/EC, excluding for infants and young children Chewing gum Conditions under which the novel food may be used be may food novel the which under Conditions

oil

Authorised novel food Calanus finmarchicus Chewing gum base (Methyl vinyl ether- maleic anhydride copolymer) Chewing gum base (monomethoxypoly ethylene glycol)

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)’

Salvia hispanica )’ Salvia hispanica Salvia hispanica the labelling of the foodstuffs of the labelling seeds ‘Chia be shall containing it ( labelling additional carry seeds shall to inform the consumer that the daily intake is no more than 15 g. labelling of the foodstuffs containing it shall be ‘Chia oil ( 2. Pre-packaged Chia ( Chia 2. Pre-packaged

The designation of the novel food on the on food novel on the food of novel designation the The of designation The 1.

Additional specific labelling requirements labelling specific Additional

2 g/day seeds) whole, of addition 15 g/day for seeds ground chia mashed or 5 % whole chia seeds of yoghurt or 4,3 g whole chia seeds per 330 g of yoghurt (por tion)

Maximum levels Maximum levels Maximum 15 g/day whole chia seeds chia whole g/day 15 10 % whole chia seeds chia whole % 10 10 % whole chia seeds chia whole % 10 10 % whole chia seeds chia whole % 10 % (whole or ground chia 5 10 % 10 2 g/day 2 1 % whole chia seeds chia whole % 1

Specified food category Specified food category

1,3 g whole chia seeds per 100 g 100 per seeds chia whole g 1,3 Pure chia oil Pure chia Directive in defined Food Supplements as 2002/46/EC Baked products Fruit spreads Yoghurt Sterilised ready to eat meals based on cereal grains, pseudocereals grains and/or pulses Fats and oils Bread products Breakfast cereals Fruit, nut and seed mixes Fruit juice and blend fruit/vegetable beverages such as seed Chia Pre-packaged Conditions under which the novel food may be used be may food novel the which under Conditions Salvia Salvia

)

Authorised novel food Chia seeds ( hispanica Chia oil from Chia oil hispanica

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Fomes

Agaricus Aspergillus L. Pandalis L.

’

’ Cistus incanus ’ or ‘Chitosan extract from

’

labelling of the foodstuffs containing it shall be from ‘Chitin-glucan niger labelling of the foodstuffs containing it shall be ‘Chitin-glucan from fomentarius labelling of the foodstuffs containing it shall be ‘Chitosan from extract bisporus Aspergillus niger labelling of the foodstuffs containing it shall be ‘Chondroitin sulphate derived and sulpha fermentation from microbial tion’ The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Chromium Picolinate’ labelling of the foodstuffs containing it shall be ‘ herb’ The designation of the novel food on the on the food on novel the food the on novel of the food the designation on novel of The food the designation novel of The the designation the of The on designation food The novel the of designation The

Additional specific labelling requirements labelling specific Additional

chromium

g/day μ Maximum levels of total of Maximum levels 5 g/day 5 g/day use in food with normal In line chitosan from supplements of crustaceans 1 200 mg/day 250 day (2 cups/day) day (2 Maximum levels levels Maximum levels Maximum levels Maximum Maximum levels Maximum

) 4 Intended daily intake: 3 g herbs/ g 3 intake: daily Intended

Specified food category Specified food category Specified food category Specified food category Specified food category Specified food category

Food Supplements as defined in Directive in defined Food Supplements as 2002/46/EC Directive in defined Food Supplements as 2002/46/EC Directive in defined Food Supplements as 2002/46/EC Directive in defined as Food supplements excluding population, adult 2002/46/EC for women pregnant and lactating 609/ No Regulation (EU) by Foods covered 2013 Herbal infusions Foods fortified in accordance with Regu with accordance in Foods fortified ( lation (EC) No 1925/2006 Conditions under which the novel food may be used be may food novel the which under Conditions

Fomes Agaricus

Aspergillus

;

) Authorised novel food Chondroitin sulphate Chitin-glucan complex from fomentarius Chitosan extract from fungi ( bisporus niger Chromium Picolinate Cistus incanus Pandalis herb Chitin-glucan from Aspergillus niger

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Clos

(CBM 588)’

Clostridium butyricum the labelling of the foodstuffs of the labelling ‘Citicoline’ be shall containing it coline shall bear a statement that the that a statement coline shall bear be to not intended product is children consumed by labelling of the foodstuffs containing it shall be ‘ MIYAIRI 588 (CBM or ‘ 588)’ tridium butyricum polyphenols600 mg than consume more of extract of g 1,1 corresponding to defatted cocoa powder per day cocoa of 600 mg than consume more day flavanols per 2. The labelling of foods containing citi containing foods of labelling 2. The

1. The designation of the novel food on food novel the the of on designation food The novel 1. the to of not designation instructed The be shall to Consumers not instructed be shall Consumers

Additional specific labelling requirements labelling specific Additional CFU/day

500 mg/day and a serving per 250 mg consumption maximum daily 000 mg level of 1 10 1,35 × than more not corresponding to of defatted 550 mg of extract cocoa powder in one portion of food supplement) food (or around and serving per 730 mg 1,2 g/day

Maximum levels Maximum levels Maximum levels Maximum levels Maximum

1 g/day and 300 mg polyphenols mg 300 and g/day 1

Specified food category Specified food category Specified food category Food Supplements as defined in Directive in defined Food Supplements as 2002/46/EC as purposes medical special Foods for defined in Regulation (EU) No 609/2013 Milk based beverages Food Supplements as defined in Directive in defined Food Supplements as 2002/46/EC Nutrition bars food supplements foods (including Any other 2002/46/EC) as defined in Directive which func for have become established vehicles tional ingredients and which are typically consumption by health positioned for conscious adults defined as supplements food Foods including 2002/46/EC in Directive Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified

Authorised novel food Clostridium butyricum Extract of defatted cocoa powder Low fat cocoa Low fat extract Citicoline

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dried

Crataegus pinnatifida

labelling of the foodstuffs containing it shall be ‘Coriander seed oil’ labelling of the foodstuffs containing it shall be ‘ fruit’ labelling of the foodstuffs containing it shall be or ‘ ‘Alpha-cyclodextrin’ labelling of the foodstuffs containing it shall be or ‘ ‘Gamma-Cyclodextrin’ Cyclodextrin’ labelling of the foodstuffs containing it shall be ‘Dextran’ labelling of the foodstuffs containing it oil of plant shall be ‘Diacylglycerol % diacylglycerols)’ 80 least origin (at cyclodextrin’

The designation of the novel food on the on the food on novel food the novel of the designation the of The on the designation food on The novel food the novel of the designation of The designation The

Additional specific labelling requirements labelling specific Additional

600 mg/day Crataegus laevigata Maximum levels levels Maximum Maximum levels levels Maximum Maximum

In line with normal food use of use food normal with line In 5 % 5

)

5 The designation of the novel food on the the on on food food novel novel the the of of designation designation The The

Specified food category Specified food category Specified food category Specified food category

Food Supplements as defined in Directive in defined Food Supplements as 2002/46/EC Herbal infusions Compotes Fat spreads Salad dressings Mayonnaise for weight control (as Meal replacement drinks) Bakery products products Yoghurt type Jams and jellies in accordance with Directive with in accordance Directive Jams and jellies 2001/113/EC ( Bakery products Cooking oils

Conditions under which the novel food may be used be may food novel the which under Conditions

Not specified Not Not specified Not Leuco

dried fruit Coriandrum Authorised novel food -cyclodextrin -cyclodextrin α γ Diacylglycerol oil of plant origin Crataegus pinna tifida Dextran preparation produced by nostoc mesenteroides Coriander seed oil Coriander seed from sativum

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the labelling of the foodstuffs of the labelling ‘Dihydrocap be shall containing it siate’ be synthetic dihydrocapsiate will labelled as ‘not intended for children up to 4.5 years’ 2. Food supplements containing 1. The designation of the novel food on food novel the of designation The 1. Additional specific labelling requirements labelling specific Additional

1,5 mg/100 ml 1,5 mg/100 ml mg/100 1,5 Maximum levels Maximum 9 mg/100 g mg/100 9 2 mg/100 g mg/100 2 2 mg/100 g mg/100 2 2,5 mg/100 g mg/100 2,5 4 mg/100 g mg/100 4 1 mg/100 ml mg/100 1 7,5 mg/100 g mg/100 7,5

12 mg/100 g mg/100 12 40 mg/100 g mg/100 40 2 mg/100 ml mg/100 2 115 mg/100 g mg/100 115 4,5 mg/100 g mg/100 4,5 27 mg/100 g mg/100 27 9 mg/100 g mg/100 9 200 mg/100 g mg/100 200 Specified food category Vegetable drinks based drinks based drinks, tea Coffee — still Flavoured water cereal Precooked oatmeal Cereal bars Biscuits, cookies and crackers Rice based snacks drinks, fruit Carbonated drinks, dilutable juice based beverages Other cereals Ice cream, dairy desserts eat) to (ready Pudding mixes Products based on yoghurt Chocolate confectionery Hard candy Sugar-free gum Whitener/creamer Sweeteners Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Dihydrocapsiate (DHC)

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◄ is auth is Data Protection Data M13 ► Authorised on 3 September is inclusion 2018. This based on proprietary scientific evidence and scientific data protected in accordance with Article 26 2015/ of Regulation (EU) 2283. Labs, Applicant: Desert Ltd 88820 Kibbutz Yotvata, Israel. data of period During the protection the novel food of parts dried aerial Hoodia parviflora orised for placing on the

ments Other require

Hoodia

’ labelling of the foodstuffs containing it of parts shall be ‘dried aerial parviflora The designation of the novel food on the on food novel the of designation The Additional specific labelling requirements labelling specific Additional

3 mg/single intake 9 mg/day 9,4 mg/day 1 mg/100 ml mg/100 ml 3 mg/meal 3 14,5 mg/kg equivalent to 1,5 to equivalent mg/kg 14,5 Maximum levels Maximum

1,1 mg/100 g mg/100 1,1 3 mg/meal 3 5 mg/100 g mg/100 5 16 mg/100 g mg/100 16

Specified food category

Soup (ready to eat) to Soup (ready Directive in defined Food Supplements as 2002/46/EC Salad dressing Vegetable protein meals eat Ready to Meal replacements for weight control for weight control (as Meal replacement drinks) Non-alcoholic powdered drink mixes Directive in defined Food Supplements as population adult 2002/46/EC for

Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Dried aerial parts of Hoodia parviflora

M13 M9 ▼ ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 19

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M13 ► market within the Union Ltd Labs, Desert only by unless a subsequent applicant obtains authoris the novel ation for food the to without reference proprietary scientific data scientific evidence or protected in accordance with Regulation of Article 26 with or (EU) 2015/2283 of Desert the agreement Labs, Ltd. data the of End date protection: 3 September 2023.

ments Other require

Vb’

® Lippia from cell cultures HTN cultures cell from labelling of the foodstuffs containing it of shall be extract ‘dried citriodora The designation of the novel food on the on food novel the of designation The Lippia Echinacea Additional specific labelling requirements labelling specific Additional

In line with normal use in food with normal In line extract supplements of a similar from the leaves of citriodora use in food with normal In line extract supplements of a similar from the root of angustifolia Maximum levels Maximum levels Maximum

Specified food category Specified food category Food Supplements as defined in Directive in defined Food Supplements as 2002/46/EC Food Supplements as defined in Directive in defined Food Supplements as 2002/46/EC Conditions under which the novel food may be used be may food novel the which under Conditions

extract from Authorised novel food Dried extract of Lippia citriodora from cell cultures Echinacea angus tifolia cell cultures

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Vb’

Echinacea from cell cultures HTN cultures cell from labelling of the foodstuffs containing it of shall be extract ‘dried purpurea The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Refined echium oil’ consumers should not consume more per day than 300 mg of extract

The designation of the novel food on the on food novel the of designation The that statement a bear shall labelling The

Additional specific labelling requirements labelling specific Additional

acid (STA) Echinacea purpurea

Maximum levels of stearidonic of Maximum levels In line with normal use in food with normal In line extract supplements of a similar within from florets the flower head of 500 mg/day In accordance with the particular of nutritional requirements the whom the products persons for are intended 250 mg/meal one portion in extract of 150 mg of food or food supplement 250 mg/100 g; 75 mg/100 g for mg/100 g 75 250 mg/100 g; drinks

Maximum levels Maximum levels Maximum 750 mg/100 g mg/100 750

750 mg/100 g mg/100 750 625 mg/100 g mg/100 625

Specified food category Specified food category Specified food category Milk-based products and drinkable yoghurt dose single a in products delivered as purposes medical special Foods for defined in Regulation (EU) No 609/2013 for weight Total diet control replacement as No 609/2013 defined in Regulation (EU) and meal replacements for weight control defined as supplements food Foods including 2002/46/EC in Directive Food Supplements as defined in Directive in defined Food Supplements as 2002/46/EC Cheese preparations and Spreadable fat dressings Breakfast cereals Directive in defined as Food supplements 2002/46/EC Conditions under which the novel food may be used be may food novel the which under Conditions

Camellia oil

) Authorised novel food Echium plan tagineum Epigallocatechin gallate as a purified extract from green tea leaves ( sinensis Echinacea purpurea extract from cell cultures M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 21

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ments Other require

)

Sardinops sagax

labelling of the foodstuffs containing it shall be ‘L-ergothioneine’ labelling of the foodstuffs containing it shall be ‘Ferrous ammonium phosphate’ The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fish ( peptides’ The designation of the novel food on the labelling of the foodstuffs containing it Sodium EDTA’ shall be ‘Ferric

The designation of the novel food on the on food novel the of the designation on The food novel the of designation The

Additional specific labelling requirements labelling specific Additional

product

anhydrous EDTA) Maximum levels fish peptide fish Maximum levels Maximum levels (expressed as (expressed Maximum levels 30 mg/day for general popu general for 30 mg/day lation (excluding pregnant and lactating women) older children 20 mg/day for than 3 years children 18 mg/day for adults 75 mg/day for 12 mg/100 g To be used in compliance with Directive 2002/46/EC, Regu No lation (EU) 609/2013 and/or No 1925/2006 Regulation (EC) eat/drink) to (ready 0,48 g/100 g

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

Specified food category Specified food category Specified food category

Food supplements as defined in Directive in defined as Food supplements 2002/46/EC Directive in defined as Food supplements 2002/46/EC Directive in defined as Food supplements 2002/46/EC 609/ No Regulation (EU) by Foods covered 2013 Regu with accordance in Foods fortified lation (EC) No 1925/2006 drinks, on yoghurt, yoghurt Foods based fermented milk products, and powdered milk drinks and vegetable-based Flavoured water, Foods covered by Regulation (EU) No 609/ No Regulation (EU) by Foods covered 2013 Regu with accordance in Foods fortified lation (EC) No 1925/2006 Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified

Authorised novel food Ferrous ammonium phosphate from Fish peptides Sardinops sagax Ferric Sodium EDTA L-ergothioneine

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◄ Data Protection Data M13 ►

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

’

’. Glycyrrhiza glabra L. consumed by pregnant and pregnant consumed by breast feeding women, children and young and adolescents; the should only consume super product under medical vision; day should flavonoids per be consumed. product was added as a novel food a added as product was that: ingredient shall bear a statement (a) the product should not be (b) people taking prescription drugs (c) a maximum of 120 mg of on the be indicated food shall the food labelling of containing it. the labelling of the foodstuffs of the labelling ‘Flavonoids be shall containing it from 1. The designation of the novel food on food novel the of designation 1. The 2. The labelling of the foods where the where foods the of labelling 2. The 3. final The amount of flavonoids in the labelling of the foodstuffs containing it shall be from seaweed ‘Fucoidan extract Fucus vesiculosus

The designation of the novel food on the on food novel the of designation The Additional specific labelling requirements labelling specific Additional

from Glycyrrhiza glabra from Glycyrrhiza Maximum levels of flavonoids of Maximum levels 120 mg/day 120 mg/day 120 mg/day 250 mg/day

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

120 mg/day 120 2 g/100 g g/100 2

Specified food category Specified food category

Breakfast cereals soup powders and Soups, stews Beverages based on yoghurt Directive in defined Food Supplements as 2002/46/EC for weight Total diet control replacement as defined in Regulation (EU) No 609/2013 as purposes medical special Foods for defined in Regulation (EU) No 609/2013 defined as supplements food Foods including 2002/46/EC the general in Directive for population Beverages based on milk Beverages based on or vegetables fruit Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Flavonoids from Glycyrrhiza glabra Fucoidan extract from the seaweed Fucus vesiculosus

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ments Other require

-fucosyl ′ -fucosyllac ′ -fucosyllactose are

′ -fucosyllactose shall ′ -fucosyllactose intended -fucosyllactose ′ the labelling of the foodstuffs of the labelling ‘2 be shall containing it tose’. containing 2 that the supplements bear a statement foods other if used be should not with added 2 day. same consumed the containing 2 for young children shall bear a statement that the supplements or milk breast if used be should not other foods with added 2 lactose are consumed the same day. labelling of the foodstuffs containing it shall be from seaweed ‘Fucoidan extract Undaria pinnatifida’ 2. The labelling of food supplements 3. The labelling of food supplements

- N The designation of the novel food on the on on food food novel novel the the of of designation designation The The 1.

Additional specific labelling requirements labelling specific Additional

250 mg/day beverages 1,2 g/l beverages 1,2 g/l 1,2 g/l than other 19,2 g/kg products beverages than other 19,2 g/kg products beverages than other products 12 g/kg for beverages whitener for 400 g/kg combination in or alone 1,2 g/l with up to 0,6 g/l of lacto- neotetraose at a ratio of 2:1 in product for use, ready the final as such marketed or reconstituted by as instructed the manufacturer 1,2 g/l beverages g/l 1,2

Maximum levels levels Maximum Maximum

200 g/kg 200

12 g/kg 12 Specified food category

Unflavoured pasteurised and sterilised Unflavoured pasteurised (including UHT) milk-based products products milk-based Unflavoured fermented products milk-based Flavoured fermented products including heat-treated Dairy analogues, including beverage whiteners Cereal bars Foods including food supplements as defined as supplements food Foods including 2002/46/EC the general in Directive for population Table-top sweeteners Infant formula as defined in Regulation (EU) No 609/2013 Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified -Fucosyllactose Authorised novel food ′ 2 Fucoidan extract from the seaweed Undaria pinnatifida

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ments Other require

- N

Additional specific labelling requirements labelling specific Additional

-neotetraose, at a ratio of N 1,2 g/l alone or in combination in or alone 1,2 g/l with up to 0,6 g/l of lacto- than other products 12 g/kg for beverages and drinks milk-based for 1,2 g/l similar products added alone or in combination with up to 0,6 g/l lacto- In accordance with the particular of nutritional requirements the whom the products persons for are intended drinks for 4,8 g/l bars 40 g/kg for neotetraose at a ratio of 2:1 in product for use, ready the final as such marketed or reconstituted by as instructed the manufacturer for food ready liquid for 1,2 g/l use, marketed as such or recon stituted as instructed by the manufacturer for product ready final 2:1 in the use, marketed as such or recon stituted as instructed by the manufacturer

Follow-on formula as defined in Regulation in defined as Follow-on formula (EU) No 609/2013 Milk-based drinks products and similar young children intended for as purposes medical special Foods for defined in Regulation (EU) No 609/2013 for weight Total diet control replacement as defined in Regulation (EU) No 609/2013 Processed cereal-based food and Processed cereal-based baby food for infants and young children as defined in No 609/2013 Regulation (EU) Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food

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ments Other require

Additional specific labelling requirements labelling specific Additional kg final food) kg final

Maximum levels (expressed as (expressed Maximum levels 9,6 g/l — the maximum level maximum the — 9,6 g/l refers to the products ready to use population general 3,0 g/day for 0,333 60 g/kg young 1,2 g/day for children galacto-oligosaccharide/ ratio kg 0,020

0,020 0,043 0,043 1,2 g/l 1,2

0,030

0,033

0,020 Bread and pasta products bearing statements on the absence or reduced presence of gluten of with the requirements in accordance Regulation (EU) Commission Implementing No 828/2014 (excluding herbal and Coffee, tea black tea), fruit infusions, chicory; tea, herbal and fruit plant, tea, infusions and chicory extracts; fruit and cereal preparations for infusions, as well mixes and instant mixes of these products Directive in defined Food Supplements as 2002/46/EC Flavoured drinks Directive in defined as Food supplements supplements food 2002/46/EC, excluding for infants Milk Milk drinks for weight control (as Meal replacement drinks) Dairy analogue drinks Yoghurt Dairy based deserts deserts Frozen dairy Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Authorised novel food Galacto-oligos accharide

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ments Other require

Additional specific labelling requirements labelling specific Additional

0,013 0,008 In line with normal food use of fish glucosamine from shell

Maximum levels Maximum 0,012 0,021 0,024 0,125 0,059 0,027 0,027

0,143 0,025

0,125 0,021

0,125 Fruit drinks and energy drinks Meal replacement for weight control Infant meal replacement drinks Baby juice Baby yogurt drink Baby desert Baby snack Baby cereals Drinks intended the expenditure of to meet for especially intense muscular effort sportsmen Juice Fruit pie fillings Fruit preparations Bars Cereals Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 Directive in defined Food Supplements as 2002/46/EC 609/ No Regulation (EU) by Foods covered 2013 Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Authorised novel food Glucosamine HCl

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◄ Data Protection Data M13 ►

ments Other require

the labelling of the foodstuffs of the labelling Gum’.‘Guar be shall containing it linked risks of digestive discomfort to the exposure aged of children be gum must to guar under 8 visible on the label of any foodstuffs containing it. For example, ‘Excessive consumption products may cause digestive of these discomfort, especially for children age’. of under 8 years compartments containing dairy and cereal products respectively, the instructions for use must clearly specify the need to mix the cereal product before dairy and the into take to order consumption, in gastro- of risk account the potential intestinal obstruction. 2. A specific mention of the possible of products with two In the case 3.

1. The designation of the novel food on food novel the of designation The 1. Additional specific labelling requirements labelling specific Additional

In line with normal food use of fish glucosamine from shell In line with normal food use of fish glucosamine from shell 1,5 g/100 g 1,8 g/100 g 10 g/100 cereals the g in accompanying dairy None in the product 1 g/100 the product when g in ready to eat

3,25 g/100 g g/100 3,25 Maximum levels levels Maximum levels Maximum Maximum

Specified food category Specified food category

Foods intended to meet the expenditure of expenditure the meet to Foods intended especially for intense muscular effort, sportsmen Fresh dairy products such as yogurts, fermented milks, fresh cheeses and other dairy-based desserts. Fruit or vegetable-based liquid foodstuffs (of variety) the ‘smoothie’ Fruit or vegetable-based compotes Cereals accompanied by a dairy product, in compartments packaging containing two Foods bearing statements on the absence or absence on the statements Foods bearing reduced presence of gluten in accordance of Commission with the requirements Imple No 828/2014 menting Regulation (EU) Directive in defined Food Supplements as 2002/46/EC Directive in defined Food Supplements as 2002/46/EC Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified Authorised novel food Glucosamine sulphate NaCl Guar Gum Glucosamine sulphate KCl

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ments Other require

Ilex

’ consumed by children under the under consumed by children pregnant years, age of three women; lactating women, and cooking, frying’ baking used for or labelling of the food labelling of products containing it shall be ‘hydroxytyrosol’. food products the of The labelling containing hydroxytyrosol bear shall the following statements: (a) This food product should not be (b) This food product should not be labelling of the foodstuffs containing it Protein’ Structuring shall be ‘Ice labelling of the foodstuffs containing it of of dried leaves shall be ‘Extracts guayusa The designation of the novel food on the on food novel the the of on designation the food The on novel food the novel of the designation of The designation The Ilex paragua Ilex Additional specific labelling requirements labelling specific Additional

0,215 g/kg 0,175 g/kg infusions and food supplements of aqueous extract of a similar dried leaves of riensis

Maximum levels levels Maximum Maximum levels levels Maximum Maximum In line with normal use in herbal in use normal with line In )), placed as such on the market

0,01 % 0,01 Specified food category Specified food category Specified food category Fish and vegetable oils, (except olive oils Fish and oils, (except vegetable Part in defined as oils pomace and olive No of Annex of Regulation (EU) VII VIII 1308/2013 ( of VII as defined in Part Spreadable fats 1308/ No Regulation (EU) of Annex VII market the on such as 2013, placed Herbal infusions Fermented milk products (in liquid, semi- powder forms) liquid and spray-dried Edible ices Directive in defined Food Supplements as 2002/46/EC Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Ilex

Bacteroides Authorised novel food Hydroxytyrosol Ice Structuring Protein type III HPLC 12 Aqueous extracts of Aqueous extracts dried leaves of guayusa Heat-treated milk Heat-treated products fermented with xylanisolvens

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ments Other require

the labelling of the foodstuffs of the labelling ‘Isomaltooligos be shall containing it accharide’. as ‘a source of must be labelled glucose’. the foodstuffs of the labelling ‘Isomaltulose’. be shall containing it shall be accompanied by the labelling is a indication that the ‘Isomaltulose source of glucose and fructose’. 2. The designation of the novel food on food novel the of designation 2. The labelling of the food supplements be ‘Lactitol’ shall containing it 2. Foods containing the novel ingredient novel the containing 2. Foods 1. The designation of the novel food on food novel the of designation The 1. the on food novel the of designation The Additional specific labelling requirements labelling specific Additional

6,5 % 20 % 20 g/day 5 % 5

Maximum levels Maximum levels Maximum 6,5 % 6,5 25 % 25

25 % 25 5 % 5 20 % 20

5,0 % 5,0 97 % 97 1. The designation of the novel food on food novel the of designation The 1. 10 % 10 5 % 5 Specified food category Energy Drinks of expenditure the meet to Foods intended for especially intense muscular efforts, sportsmen (including isotonic drinks) Fruit Juices Cookies, Biscuits Breakfast Cereal Bars Hard Candies Soft Candies/Chocolate Bars Meal for weight replacement control (as bars or milk based) Directive in defined Food Supplements as intended tablets) or 2002/46/EC (capsules for the adult population Energy-Reduced Soft Drinks Energy-Reduced Soft Processed Vegetables and Vegetable Juices Other Soft Drinks Cereals Bars Conditions under which the novel food may be used be may food novel the which under Conditions Not specified Not

Specified food category food Specified Authorised novel food Lactitol Isomaltulose Isomalto-oligos accharide

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◄ Data Protection Data M13 ►

ments Other require -

N -neotet N -neotetraose N -neotetraose are N -neotetraose shall N

the labelling of the foodstuffs of the labelling ‘lacto- be shall containing it raose’. raose’. containing lacto- that the supplements bear a statement foods other if used be should not with added lacto- day. same consumed the containing lacto- intended for young shall children intended for that the supplements bear a statement or milk breast if used be should not other foods with added lacto- neotetraose are consumed the same day. 2. The labelling of food supplements 3. The labelling of food supplements 1. The designation of the novel food on food novel the of designation The 1.

Additional specific labelling requirements labelling specific Additional -fucosyllactose at a -fucosyllactose at a ′ ′

0,6 g/l for beverages for 0,6 g/l than other products 9,6 g/kg for beverages beverages for 0,6 g/l than products other 6 g/kg for beverages whitener for 200 g/kg to up with combination in 0,6 g/l 2 of 1,2 g/l 0,6 g/l than other products 9,6 g/kg for beverages to up with combination in 0,6 g/l 2 of 1,2 g/l ratio of 1:2 in the final product use, ready for marketed as such by as instructed or reconstituted the manufacturer ratio of 1:2 in the final product use, ready for marketed as such by as instructed or reconstituted the manufacturer 0,6 g/l for beverages for g/l 0,6

Maximum levels Maximum

100 g/kg 100

6 g/kg 6

Unflavoured fermented milk-based products milk-based Unflavoured fermented products milk-based Flavoured fermented products including heat-treated Dairy analogues, including beverage whiteners Cereal bars Regulation in defined as Follow-on formula (EU) No 609/2013 Unflavoured pasteurised and sterilised Unflavoured pasteurised (including UHT) milk-based products Table-top sweeteners Infant formula as defined in Regulation (EU) No 609/2013 Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified -neotetraose N Authorised novel food Lacto-

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ments Other require

-fucosyl ′

Additional specific labelling requirements labelling specific Additional

6 g/kg for products other than products other 6 g/kg for beverages for food ready liquid for 0,6 g/l use, marketed as such or recon stituted as instructed by the manufacturer and drinks milk-based for 0,6 g/l similar products added alone or in combination with 2 lactose, at a ratio of 1:2 in the final product ready for use, as such marketed or reconstituted by as instructed the manufacturer In accordance with the particular of nutritional requirements the whom the products persons for are intended drinks for 2,4 g/l bars 20 g/kg for 30 g/kg

0,6 g/l 0,6

Processed cereal-based food and Processed cereal-based baby food for infants and young children as defined in No 609/2013 Regulation (EU) Milk-based drinks products and similar young children intended for for weight Total diet control replacement as defined in Regulation (EU) No 609/2013 Bread and pasta products bearing statements on the absence or reduced presence of gluten of with the requirements in accordance Regulation (EU) Commission Implementing No 828/2014 Foods for special medical purposes as purposes medical special Foods for defined in Regulation (EU) No 609/2013 Flavoured drinks Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food

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◄ Data Protection Data M13 ►

ments Other require ) )

Medicago sativa Medicago sativa

labelling of the foodstuffs containing it shall be ‘Lucerne ( ( protein’ or ‘Alfalfa labelling of the foodstuffs containing it shall be ‘Lycopene’ protein’.

The designation of the novel food on the on the food on novel food the novel of the designation of The designation The Additional specific labelling requirements labelling specific Additional

4,8 g/l — the maximum level maximum the — 4,8 g/l refers to the products ready to use population general for 1,5 g/day young 0,6 g/day for children 10 g/day 2,5 mg/100 g 2,5 mg/100 g 8 mg/meal

Maximum levels levels Maximum Maximum 3 mg/100 g mg/100 3 1 mg/100 g mg/100 1 10 mg/100 g mg/100 10 5 mg/100 g mg/100 5

Specified food category

Coffee, tea (excluding herbal and Coffee, tea black tea), fruit infusions, chicory; tea, herbal and fruit plant, tea, infusions and chicory extracts; fruit and cereal preparations for infusions, as well mixes and instant mixes of these products Directive in defined as Food supplements 2002/46/EC Fruit/vegetable juice-based drinks (including concentrates) Food supplements as defined in Directive in defined as Food supplements supplements food 2002/46/EC, excluding for infants Drinks intended the expenditure of to meet for especially intense muscular effort sportsmen for weight Total diet control replacement as No 609/2013 defined in Regulation (EU) and meal replacements for weight control Breakfast cereals Fats and dressings soups tomato than Soups other Bread (including crispy breads) Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified

Medicago Authorised novel food Lucerne leaf extract from sativa Lycopene

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◄ Data Protection Data M13 ►

ments Other require

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

In accordance with the particular of nutritional requirements the whom the products persons for are intended 15 mg/day 2,5 mg/100 g 2,5 mg/100 g 8 mg/meal In accordance with the particular of nutritional requirements the whom the products persons for are intended 15 mg/day

Maximum levels Maximum 3 mg/100 g mg/100 3 1 mg/100 g mg/100 1 10 mg/100 g mg/100 10 5 mg/100 g mg/100 5

Specified food category

Foods for special medical purposes as purposes medical special Foods for defined in Regulation (EU) No 609/2013 Directive in defined as Food supplements 2002/46/EC Fruit/vegetable juice-based drinks (including concentrates) Directive in defined as Food supplements 2002/46/EC Drinks intended the expenditure of to meet for especially intense muscular effort sportsmen for weight Total diet control replacement as No 609/2013 defined in Regulation (EU) and meal replacements for weight control Breakfast cereals Fats and dressings soups tomato than Soups other Bread (including crispy breads) as purposes medical special Foods for defined in Regulation (EU) No 609/2013 Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Lycopene from Blakeslea trispora

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◄ Data Protection Data M13 ►

ments Other require

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

2,5 mg/100 g 2,5 mg/100 g 8 mg/meal In accordance with the particular of nutritional requirements the whom the products persons for are intended 15 mg/day 2,5 mg/100 g 2,5 mg/100 g

Maximum levels Maximum lycopene of levels Maximum 3 mg/100 g mg/100 3 1 mg/100 g mg/100 1 10 mg/100 g mg/100 10 5 mg/100 g mg/100 5

Specified food category Specified food category

Fruit/vegetable juice-based drinks (including concentrates) Directive in defined as Food supplements 2002/46/EC Fruit/vegetable juice-based drinks (including concentrates) Drinks intended the expenditure of to meet for especially intense muscular effort sportsmen for weight Total diet control replacement as No 609/2013 defined in Regulation (EU) and meal replacements for weight control Breakfast cereals Fats and dressings soups tomato than Soups other Bread (including crispy breads) as purposes medical special Foods for defined in Regulation (EU) No 609/2013 Drinks intended the expenditure of to meet for especially intense muscular effort sportsmen Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Lycopene oleoresin from tomatoes Lycopene from tomatoes

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ments Other require

labelling of the foodstuffs containing it malate’ shall be ‘Magnesium citrate labelling of the foodstuffs containing it shall be ‘Magnolia Bark Extract’ labelling of the foodstuffs containing it oil extract’ shall be ‘Maize-germ The designation of the novel food on the on the food on novel food the novel the of the on designation of food The designation novel The the of designation The Additional specific labelling requirements labelling specific Additional

8 mg/meal In accordance with the particular of nutritional requirements the whom the products persons for are intended % 0,2 a on purposes. Based level maximum incorporation size maximum gum/mint and a of 1,5 g each, each gum or contain no mint serving will more than 3 mg of magnolia bark extract. 2 g/day

Maximum levels levels Maximum Maximum levels Maximum 3 mg/100 g mg/100 3 1 mg/100 g mg/100 1 0,2 % for breath freshening breath for % 0,2 10 mg/100 g mg/100 10 5 mg/100 g mg/100 5 % 2

Specified food category Specified food category Specified food category Total diet replacement for weight control covered by Regulation No 609/2013 (EU) weight control for replacements and meal Directive in defined Food Supplements as 2002/46/EC products) Mints (confectionary Chewing gum Breakfast cereals Fats and dressings soups tomato than Soups other Bread (including crispy breads) as purposes medical special Foods for defined in Regulation (EU) No 609/2013 Chewing gum Directive in defined Food Supplements as 2002/46/EC Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Magnesium citrate malate Magnolia Bark Extract Maize-germ oil high in unsaponifiable matter

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◄ Data Protection Data M13 ► Authorised on 2 September is inclusion 2018. This based on proprietary scientific evidence and scientific data protected in accordance with Article 26 2015/ of Regulation (EU) 2283. SA, Applicant: Pharmena Wolczanska 178, 90 530 Lodz, Poland. During the protection data period of the novel food 1-methyl nicotinamide chloride is placing on authorised for within the the market by Pharmena Union only subsequent a S.A. unless

ments Other require Methylcel lulose is not to be used in foods specially prepared for young children

labelling of the foodstuffs containing it shall be ‘Methylcellulose’ labelling of the foodstuffs containing it shall be ‘1- Methylnicotinamide chloride’. 1-Methyl containing Food supplements nicotinamide shall bear the following statement: This food supplement should be excluding only adults consumed by women pregnant and lactating The designation of the novel food on the on food novel the of the designation on The food novel the of designation The Additional specific labelling requirements labelling specific Additional

58 mg/day

Maximum levels Maximum levels Maximum

2 % 2 Specified food category

Edible ices milk unflavoured fermented Flavoured or products Fruit preparations (pulps, purees or compotes) broths Soups and Directive in defined Food Supplements as population adult the 2002/46/EC for women excluding pregnant and lactating Flavoured drinks egg- cereal, fruit, fat, (dairy, Cold desserts based products) Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified Authorised novel food 1-Methylnicoti namide chloride Methylcellulose

M11 M9 ▼ ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 37

◄ Data Protection Data

M13 ► applicant obtains authoris the novel ation for food the to without reference proprietary scientific data scientific evidence or protected in accordance with Article Regu 26 of lation (EU) 2015/2283 or of with the agreement Pharmena S.A. data the of End date protection: 2 September 2023

ments Other require

’ or from ‘extract

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘(6S)-5-methyltetrahydrofolic or ‘5MTHF- acid, glucosamine salt’ glucosamine’ labelling of the foodstuffs containing it from the mushroom shall be ‘extract Lentinula edodes Shiitake mushroom’ labelling of the food supplements silicon ‘Organic be shall containing it (monomethylsilanetriol)’ The designation of the novel food on the on food novel the of designation The The designation of the novel food on the on food novel the of designation The

Additional specific labelling requirements labelling specific Additional

10,40 mg/day day dose per 2,5 ml Maximum levels of silicon levels of Maximum levels levels Maximum Maximum

1,5 ml/100 ml ml/100 1,5 2,5 ml per meal per ml 2,5 2 ml/100 g ml/100 2

0,5 ml/100 ml ml/100 0,5 Specified food category Specified food category

Food Supplements as defined in Directive in defined Food Supplements as 2002/46/EC as a source of folate Directive in defined Food Supplements as liquid (in population adult 2002/46/EC for form) Bread products Soft drinks yoghurt on Foods based Ready prepared meals Ready prepared Directive in defined as Food supplements 2002/46/EC Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified

) Len

Authorised novel food (6S)-5-methyltet rahydrofolic acid, glucosamine salt Monomethylsil anetriol (Organic Silicon) Mycelial extract from Shiitake mushroom ( tinula edodes

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ments Other require

’

fruit concentrate’ or fruit concentrate’ fruit puree’ or ‘Noni

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

The designation of the novel food on the on food novel the the on of food designation novel The the of designation The Additional specific labelling requirements labelling specific Additional

6,6 g/day (equivalent to 30 ml of ml 30 to 6,6 g/day (equivalent noni juice) 53 g/100 g g 133 g/100 quantity Based on pre-processing 100 to produce g product final 100 % noni juice) or than day, not more a twice 20 ml day per 40 ml Fruit puree 30 ml with one serving (up to (up serving one with ml 30 Maximum levels Maximum levels Maximum 31 g/100 g g/100 31 88 g/100 g g/100 88 53 g/100 g g/100 53 11 g/100 g g/100 11 45 g/100 g g/100 45 31 g/100 g g/100 31

53 g/100 g g/100 53 Specified food category Specified food category 12 g/100 g g/100 12 53 g/100 g g/100 53

Food supplements as defined in Directive in defined as Food supplements 2002/46/EC Cereal bars (dry drink mixes Powdered nutritional weight) Carbonated beverages Ice cream & sorbet Yoghurt Biscuits pastries and Buns, cakes (wholegrain) Breakfast cereals with in accordance Directive Jams and jellies 2001/113/EC and icings spreads, fillings Sweet Pasteurised fruit and nectar based fruit drinks Candy/confectionery Conditions under which the novel food may be used be may food novel the which under Conditions

) ) Morinda

) Authorised novel food Morinda citrifolia Morinda citrifolia Noni fruit juice Noni fruit powder ( citrifolia juice Noni fruit ( and puree Noni fruit concentrate ( M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 39

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ments Other require

’.

Morinda citrifolia consumer that a cup of infusion cup of a consumer that more with prepared be should not leaves and roasted dried than 1 g of of Morinda citrifolia. the labelling of the foodstuffs of the labelling ‘Noni leaves’ be shall containing it of or ‘leaves 2. Instructions shall be given to the

1. The designation of the novel food on food novel the of designation The 1. Morinda citri Additional specific labelling requirements labelling specific Additional

Fruit concentrate

88 g/100 g 26 g/day 12 g/100 g 30 g/100 g 20 g/100 g 6 g/day prepared be not consumed shall with more than 1 g and of dried roasted leaves of folia Maximum levels Maximum 7 g/100 g g/100 7 A cup of infusion to be to infusion of cup A 20 g/100 g g/100 20 12 g/100 g g/100 12 3 g/100 g g/100 3 10 g/100 g g/100 10 7 g/100 g g/100 7

12 g/100 g g/100 12

Specified food category 3 g/100 g g/100 3 12 g/100 g g/100 12

Savoury sauces, pickles, gravies and gravies pickles, Savoury sauces, condiments Directive in defined Food Supplements as 2002/46/EC Candy/Confectionery Cereal bars (dry drink mixes Powdered nutritional weight) Carbonated beverages Ice cream & sorbet Yoghurt Biscuits pastries and Buns, cakes (wholegrain) Breakfast cereals with in accordance Directive Jams and jellies 2001/113/EC and icings spreads, fillings Sweet and gravies pickles, Savoury sauces, condiments Directive in defined Food Supplements as 2002/46/EC For the preparation of infusions of For the preparation Conditions under which the novel food may be used be may food novel the which under Conditions

) Authorised novel food Morinda citrifolia Noni leaves (

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ments Other require

microalgae’

Odontella aurita labelling of the foodstuffs containing it powder’fruit shall be citrifolia ‘Morinda powder’or ‘Noni fruit labelling of the foodstuffs containing it shall be ‘ with Annex Regu to In accordance III.5 No lation (EU) 1169/2011

The designation of the novel food on the on the food on novel food the novel of the designation of The designation The

Additional specific labelling requirements labelling specific Additional

phytostanols

novel food ingredient shall novel food ingredient in such be presented a manner that they can be easily divided into portions that contain either a of case maximum of 3 g (in a day) or one portion per of case maximum of 1 g (in three portions per day) of added phytosterols/phytost anols. a phytostanols added to container of beverages shall not exceed 3 g. be shall sauces and spicy portions. single packed as Maximum levels of phytosterols/ of Maximum levels 2,4 g per/day 2,4 g 1. The products containing the 2. The amount of phytosterols/ 3. Salad dressings, mayonnaise

Maximum levels levels Maximum Maximum 12 g per 100 ≤ 1,5 % 1,5 1 % 1 1,5 % 1,5 0,5 % 0,5

1 % 1 Specified food category Specified food category Specified food category 1,5 % 1,5

Food Supplements as defined in Directive in defined Food Supplements as 2002/46/EC Flavoured pasta Fish soups Broth preparations Frozen breaded fish as defined in Spreadable fats Annex VII, Part and Appendix points B and C of VII II, No 1308/2013, Regulation (EU) and and excluding cooking fats and frying spreads based on butter or other animal fat Soya drinks Salad dressings, mayonnaise and spicy sauces Marine terrines Crackers Milk based products, such as products milk and skimmed on semi-skimmed the addition of products, possibly with fruits and/or cereals, products based on fermented milk such as yoghurt and cheese content based products (fat g), where possibly has been the milk fat or protein has reduced and been the fat partly or fully replaced by vegetable fat or protein Conditions under which the novel food may be used be may food novel the which under Conditions

)

Authorised novel food Morinda citrifolia Odontella aurita microalgae Oil enriched with phytosterols/phytost anols Noni fruit powder Noni fruit (

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ments Other require

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Squid oil’. shall be displayed pressure treatment’ preparations next to the name of fruit is which it in any product such and in as used

The wording ‘pasteurised by high- by ‘pasteurised wording The

Additional specific labelling requirements labelling specific Additional

EPA combined

Maximum levels of DHA and of Maximum levels products 600 mg/100 g 60 mg/100 ml 3 000 mg/day for general popu lation and pregnant 450 mg/day for lactating women In accordance with the particular of nutritional requirements the whom the products persons for intended 200 mg/meal to cheese products 600 mg/100 g

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

200 mg/100 g mg/100 200 levels Maximum 200 mg/100 g or for analogues for or g mg/100 200 600 mg/100 g mg/100 600

500 mg/100 g mg/100 500

500 mg/100 g mg/100 500 Specified food category Specified food category Dairy products except milk-based beverages Dairy analogues except drinks and Spreadable fat dressings Directive in defined Food Supplements as 2002/46/EC as purposes medical special Foods for defined in Regulation (EU) No 609/2013 Total diet replacement for weight control defined in No Regulation (EU) 609/2013 weight control for replacements and meal fruit: Types of banana, apple, apricot, blackberry, blueberry, cherry, coconut, fig, grape, grapefruit, mandarin, mango, melon, peach, pine pear, rhubarb, strawberry apple, prune, raspberry, Breakfast cereals and bread rolls) Bakery products (breads Cereal bars Non-alcoholic beverages (including milk- based beverages) Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Pasteurised fruit- based preparations produced using high-pressure treatment Oil extracted from squids

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ments Other require

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

The designation of the novel food on the on food novel the of designation The

Additional specific labelling requirements labelling specific Additional

dylserine dylserine

Maximum levels of phosphati of Maximum levels phosphati of Maximum levels 40 mg/100 ml ready to drink) 40 mg/100 ready ml In compliance with Regulation (EU) No 609/2013 300 mg/day mg/100 ml ready to drink) to ready mg/100 ml

Maximum levels Maximum 3 500 mg/100 g (equivalent to (equivalent g mg/100 500 3 3,5 g/100 g (equivalent to 40 to (equivalent g g/100 3,5 200 mg/100 g mg/100 200 50 mg/100 ml mg/100 50 ml mg/100 50 80 mg/100 g mg/100 80 g mg/100 80 15 % 15

350 mg/100 g mg/100 g 350 mg/100 350 Specified food category Specified food category Specified food category

Baked bakery products Pasta Breakfast cereals Cereal bars powders Powders based on milk Directive in defined as Food supplements 2002/46/EC Beverages based on yoghurt powder Powders based on milk Beverages based on yoghurt yoghurt on Foods based Cereal bars Chocolate based confectionary as purposes medical special Foods for defined in Regulation (EU) No 609/2013 yoghurt on Foods based Cereal bars Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Phosphatidylserine from soya phosp holipids Phosphated maize starch Phosphatidylserine from fish phosp holipids

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◄ Data Protection Data M13 ►

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

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

The designation of the novel food on the on food novel the of designation The

Additional specific labelling requirements labelling specific Additional

dylserine

Maximum levels of phosphati of Maximum levels In compliance with Regulation (EU) No 609/2013 800 mg/day In compliance with Regulation (EU) No 609/2013 mg/100 ml ready-to drink) ready-to mg/100 ml

levels levels Maximum Maximum 3,5 g/100 g (equivalent to 40 to (equivalent g g/100 3,5 80 mg/100 g mg/100 80 200 mg/100 g mg/100 200 50 mg/100 g mg/100 50 80 mg/100 g mg/100 80 50 mg/100 g mg/100 50 80 mg/100 g mg/100 80 25 % 25

350 mg/100 g mg/100 350 Specified food category Specified food category Chocolate based confectionary Directive in defined Food Supplements as 2002/46/EC as purposes medical special Foods for defined in Regulation (EU) No 609/2013 Foods for special medical purposes as purposes medical special Foods for defined in Regulation (EU) No 609/2013 Breakfast cereals Cereal bars yogurt on Foods based products Soy-based yogurt-like Yogurt based-drinks drinks Soy-based yogurt-like powder Powders based on milk Not specified Processed foods Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified

Authorised novel food Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid Phospholipides from egg yolk Phytoglycogen

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ments Other require

lation (EU) No lation (EU) 1169/2011

In accordance with Annex of Regu III.5 Additional specific labelling requirements labelling specific Additional

such a manner that they can that manner such a divided into be easily a portions that contain either maximum of 3 g of 1 (in case portion/day) or a maximum of of 3 portions/day) 1 g case (in of added phytosterols/phytost anols. The amount of phytosterols/ a phytostanols added to container of beverages shall not exceed 3 g. Salad dressings, mayonnaise be shall sauces and spicy portions single packed as 3 g/day

50 % rye % 50 Maximum levels Maximum ≥ 30 % wheat; 30 ≤

4 % added sugar but no fat 4

1. They shall be presented in presented be shall They 1. ≤

Specified food category

Rice drinks Salad dressings, mayonnaise and spicy sauces. Products based such on milk as fermented products (fat type yoghurt and cheese % per 100 where possibly g), content < 12 has the milk been fat reduced, or where milk fat and/or protein has been partly or fully replaced by vegetable fat and/or protein as defined in Spreadable fats Annex VII, Part and Appendix points B and C of VII II, No 1308/2013, Regulation (EU) and and excluding cooking fats and frying spreads based on butter or other animal fat. Directive in defined Food Supplements as 2002/46/EC Rye bread with flour containing flour with Rye bread (wholemeal rye flour, whole or cracked rye kernels and and rye flakes) Soya drink Milk type products, such as semi-skimmed type products, possibly and skimmed milk and/or cereals, addition of fruits with the where possibly the milk fat has been and/or protein reduced, or where milk fat by replaced has been or fully partly and/or protein. vegetable fat and with added. Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Phytosterols/phytost anols

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ments Other require

labelling of the foodstuffs containing it shall be ‘Potato protein’ labelling of the foodstuffs containing it oligopeptidase’ shall be ‘Prolyl PPI/

6 The designation of the novel food on the on food novel the of designation The Additional specific labelling requirements labelling specific Additional

vegetable oils day) Units or Peptidase PPU – Prolyl Proline Protease Units Picomole Inter PPI – Protease national 12,6 equalizing 3 capsules/day; day a mg pig kidney extract Diamine oxidase (DAO) content: a with capsules (3 0,9 mg/day content of DAO 0,3 mg/ capsule) 120 PPU/day (2,7 g of enzyme of g 120 PPU/day (2,7 × 10 (2 preparation/day)

Maximum levels Maximum levels Maximum levels Maximum

In line with normal food use of use food normal with line In The designation of the novel food on the on food novel the of designation The

Specified food category Specified food category Not specified Directive in defined Food Supplements as population adult general 2002/46/EC for defined purposes as medical special Food for No in Regulation 609/2013(EU) For frying and For frying as seasoning Directive in defined Food Supplements as 2002/46/EC Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified

Authorised novel food Potato proteins (coagulated) and hydrolysates thereof Protein extract from pig kidneys Plum kernel oil Prolyl oligopeptidase (enzyme prepara tion)

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◄ Data Protection Data

M13 ► Authorised on 2 September inclusion 2018. This is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 2015/ of Regulation (EU) 2283. Applicant: Mitsubishi Gas Chemical Company, Inc., Mitsubishi Building 5-2 Marunouchi 2-chome, 100- Chiyoda-ku, Tokyo the During 8324, Japan. protection data period of the novel food Pyrroloqui noline quinone disodium salt is authorised for placing on the market within the Union only by Mitsubishi Gas Chemical a unless Company, Inc., subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 2015/ of Regulation (EU) the with 2283 or agreement of Mitsubishi Gas Chemical Company, Inc. data the of End date protection: 2 september 2023

ments Other require

labelling of the foodstuffs containing it quinone shall be ‘Pyrroloquinoline disodium salt’. Pyrrolo containing Food supplements shall quinoline quinone disodium salt bear the following statement: This food supplement should be excluding only adults consumed by women pregnant and lactating The designation of the novel food on the on food novel the of designation The Additional specific labelling requirements labelling specific Additional

20 mg/day Maximum levels Maximum Specified food category

Food Supplements as defined in Directive in defined Food Supplements as popu adult the for 2002/46/EC intended lation, excluding pregnant and lactating women Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Pyrroloquinoline quinone disodium salt

M10 M9 ▼ ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 47

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ments Other require

-resver

Trans the labelling of the foodstuffs of the labelling be ‘Rapeseed shall containing it protein’. 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 of ingredients. proximity to the list the food supplements of the labelling ‘ be shall containing it atrol’. shall containing trans-resveratrol that people using bear a statement medicines should only consume the supervision. product under medical 1. The designation of the novel food on food novel the of designation 1. The labelling of the foodstuffs containing it shall be ‘Rapeseed oil extract’ 2. Any foodstuff containing ‘rapeseed 2. The labelling of food supplements The designation of the novel food on the on food novel the of designation The on food novel the of designation The 1.

Additional specific labelling requirements labelling specific Additional

1,5 g per portion recommended portion per 1,5 g for daily consumption 150 mg/day Maximum levels Maximum levels Maximum

Specified food category

Food Supplements as defined in Directive in defined Food Supplements as 2002/46/EC and follow-on formula except in infant formula Directive in defined Food Supplements as or (capsule population adult 2002/46/EC for tablet form) Conditions under which the novel food may be used be may food novel the which under Conditions As a vegetable protein source in foods in source protein vegetable a As Specified food category food Specified

Authorised novel food Rapeseed Protein Trans-resveratrol Rapeseed oil high in Rapeseed oil unsaponifiable matter

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ments Other require

-resver Trans

the labelling of the food supplements of the labelling ‘ be shall containing it atrol’. shall containing trans-resveratrol that people using bear a statement medicines should only consume the supervision. product under medical the foodstuffs of the labelling ‘reduced be shall containing it (salatrims)’. energy fat excessive consumption may lead to gastro-intestinal disturbance. use by not intended for products are children. labelling of the foodstuffs containing it shall be ‘Rooster or comb extract’ ‘Cockerel comb extract’ labelling of the foodstuffs containing it inchi oil (Plukenetia shall be ‘Sacha volubilis)’ 2. The labelling of food supplements 2. There shall be a statement that 3. There shall be a statement that the

)

1. The designation of the novel food on food novel the the of on designation food The novel the 1. the on on of food food designation novel novel The the the of of designation designation The The 1. Additional specific labelling requirements labelling specific Additional Fallopia japonica

In line with normal use in food with normal In line resveratrol supplements of extracted from Japanese knotweed ( linseed oil

Maximum levels Maximum levels Maximum levels levels Maximum Maximum mg/100 ml or mg/100 g 80 mg/100 ml or mg/100 g 65 mg/100 ml or mg/100 g 40 In line with normal food use of use food normal with line In 110 mg/100 g or mg/100 ml mg/100 or g mg/100 110

Specified food category Specified food category Specified food category Food supplements as defined in Directive in defined as Food supplements 2002/46/EC Milk-based drinks Milk based fermented drinks Milk based fermented Yoghurt-type products Fromage frais oil linseed As for Bakery products and confectionary

Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified

Authorised novel food Sacha inchi oil from oil Sacha inchi Plukenetia volubilis Salatrims Rooster comb extract Trans-resveratrol Trans-resveratrol (microbial source)

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ments Other require

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

: Additional specific labelling requirements labelling specific Additional

EPA combined Maximum levels of DHA and of Maximum levels 3 000 mg/day 450 mg/day In accordance with the particular of nutritional requirements the whom the products persons for are intended 250 mg/meal 200 mg/100 g 200 mg/100 g

500 mg/100 g mg/100 500 Specified food category

Food Supplements as defined in Directive in defined Food Supplements as excluding population adult 2002/46/EC for women pregnant and lactating Directive in defined Food Supplements as lactating and pregnant 2002/46/EC for women as purposes medical special Foods for defined in Regulation (EU) No 609/2013 for weight Total diet control replacement as No 609/2013 defined in Regulation (EU) and meal replacements for weight control Milk-based drinks products and similar young children intended for Rolls and Sweet (Breads, Bakery Products Biscuits) Processed cereal based food Processed cereal and baby food for infants and young children as defined in No 609/2013 Regulation (EU) of expenditure the meet to Foods intended especially for intense muscular effort, sportsmen or absence on the statements Foods bearing reduced presence of gluten in accordance of Commission with the requirements Imple No 828/2014 menting Regulation (EU) Breakfast Cereals Conditions under which the novel food may be used be may food novel the which under Conditions

Authorised novel food Schizochytrium sp. in DHA oil rich and EPA

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ments Other require

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

The designation of the novel food on the on food novel the of designation The

Additional specific labelling requirements labelling specific Additional

mg/100 g for soy and imitation and soy for mg/100 g milk products (excluding drinks) products milk mg/100 g for frais (including milk, fromage and yoghurt excluding products; drinks) 80 mg/100 g products 600 mg/100 g general 250 mg DHA/day for population pregnant DHA/day for 450 mg women and lactating 250 mg/meal to cheese products 600 mg/100 g 600 mg/100 g for cheese; 200 cheese; for g mg/100 600 200 mg/100 g or for cheese for or g mg/100 200

Maximum levels of DHA of levels Maximum

600 mg/100 g for cheese; 200 cheese; for g mg/100 600 600 mg/100 g mg/100 600 200 mg/100 g or for analogues for or g mg/100 200 600 mg/100 g mg/100 600 500 mg/100 g mg/100 500 500 mg/100 g mg/100 500 360 mg/100 g mg/100 360

Specified food category Cooking Fats Dairy Products except milk-based drinks Dairy products except milk-based drinks Dairy analogues except drinks and Spreadable fats dressings Dairy Analogues except drinks Non-alcoholic Beverages (including dairy drinks) analogue and milk-based Bars Cereal/Nutrition Spreadable Fats and Dressings Breakfast cereals Directive in defined Food Supplements as 2002/46/EC for weight Total diet control replacement as No 609/2013 defined in Regulation (EU) and meal replacements for weight control Conditions under which the novel food may be used be may food novel the which under Conditions sp.

Authorised novel food Schizochytrium (ATCC PTA-9695) oil

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ments Other require

sp.’ labelling of the foodstuffs containing it the microalgae from shall be ‘Oil Schizochytrium

The designation of the novel food on the on food novel the of designation The

Additional specific labelling requirements labelling specific Additional

200 mg/100 g In accordance with the particular of nutritional requirements the whom the products persons for are intended 200 mg/100 g 80 mg/100 ml In accordance with Regulation (EU) No 609/2013 200 mg/100 g products 600 mg/100 g to cheese products 600 mg/100 g

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

Maximum levels of DHA of levels Maximum

200 mg/100 g or for analogues for or g mg/100 200

360 mg/100 g mg/100 360 500 mg/100 g mg/100 500 Specified food category

Milk-based drinks products and similar young children intended for as purposes medical special Foods for defined in Regulation (EU) No 609/2013 and, sweet Bakery products (breads,rolls, biscuits) Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 foods and Processed cereal-based baby foods for infants and young children as defined in No 609/2013 Regulation (EU) Dairy products except milk-based drinks Dairy analogues except drinks Foods intended to meet the expenditure of expenditure the meet to Foods intended especially for intense muscular effort, sportsmen or absence on the statements Foods bearing reduced presence of gluten in accordance of Commission with the requirements Imple No 828/2014 menting Regulation (EU) Cereal bars Cooking fats (including dairy Non-alcoholic beverages drinks) analogue and milk-based Conditions under which the novel food may be used be may food novel the which under Conditions sp.

Authorised novel food Schizochytrium oil

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ments Other require

Additional specific labelling requirements labelling specific Additional

250 mg DHA/day for general 250 mg DHA/day for population pregnant DHA/day for 450 mg women and lactating 250 mg/meal 200 mg/100 g In accordance with the particular of nutritional requirements the whom the products persons for are intended 200 mg/100 g

600 mg/100 g mg/100 600

500 mg/100 g mg/100 500

Spreadable fats and Spreadable fats dressings Milk-based drinks products and similar young children intended for as purposes medical special Foods for defined in Regulation (EU) No 609/2013 and sweet rolls (breads, Bakery products biscuits) Breakfast cereals Directive in defined Food Supplements as 2002/46/EC for weight Total diet control replacement as No 609/2013 defined in Regulation (EU) and meal replacements for weight control foods and Processed cereal-based baby foods for infants and young children as defined in No 609/2013 Regulation (EU) of expenditure the meet to Foods intended especially for intense muscular effort, sportsmen or absence on the statements Foods bearing reduced presence of gluten in accordance of Commission with the requirements Imple No 828/2014 menting Regulation (EU) Cereal bars Conditions under which the novel food may be used be may food novel the which under Conditions Authorised novel food

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◄ Data Protection Data M13 ►

ments Other require

sp.’ labelling of the foodstuffs containing it the microalgae from shall be ‘Oil Schizochytrium

The designation of the novel food on the on food novel the of designation The

Additional specific labelling requirements labelling specific Additional

80 mg/100 ml products 600 mg/100 g general 250 mg DHA/day for population pregnant DHA/day for 450 mg women and lactating 250 mg/meal 200 mg/100 g to cheese products 600 mg/100 g 200 mg/100 g or for cheese for or g mg/100 200

Maximum levels of DHA of levels Maximum

200 mg/100 g or for analogues for or g mg/100 200 600 mg/100 g mg/100 600

500 mg/100 g mg/100 500 360 mg/100 g mg/100 360

Specified food category

Cooking fats Dairy products except milk-based drinks Dairy analogues except drinks and Spreadable fats dressings Milk-based drinks products and similar young children intended for Non-alcoholic beverages (including dairy Non-alcoholic beverages drinks) analogue and milk-based Breakfast cereals Directive in defined Food Supplements as 2002/46/EC for weight Total diet control replacement as No 609/2013 defined in Regulation (EU) and meal replacements for weight control of expenditure the meet to Foods intended especially for intense muscular effort, sportsmen or absence on the statements Foods bearing reduced presence of gluten in accordance of Commission with the requirements Imple No 828/2014 menting Regulation (EU) Conditions under which the novel food may be used be may food novel the which under Conditions sp.

Authorised novel food Schizochytrium (T18) oil

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ments Other require

the labelling of the foodstuffs of the labelling be ‘Fermented shall containing it soybean extract’. soybean extract containing fermented that persons shall bear a statement should taking medication only under medical product consume the supervision. labelling of the food supplements be ‘spermidine-rich shall containing it wheat germ extract’ 2. The labelling of food supplements 1. The designation of the novel food on food novel the the of on designation food The novel 1. the of designation The

Additional specific labelling requirements labelling specific Additional

In accordance with the particular of nutritional requirements the whom the products persons for are intended 200 mg/100 g 80 mg/100 ml In accordance with Regulation (EU) No 609/2013 200 mg/100 g 100 mg/day Equivalent of max. 6 mg/day spermidine

Maximum levels Maximum levels Maximum

360 mg/100 g mg/100 360 500 mg/100 g mg/100 500 Specified food category Specified food category

Foods for special medical purposes as purposes medical special Foods for defined in Regulation (EU) No 609/2013 and, sweet rolls Bakery products (breads, biscuits) Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 foods and Processed cereal-based baby foods for infants and young children as defined in No 609/2013 Regulation (EU) Cereal bars Cooking fats (including dairy Non-alcoholic beverages drinks) analogue and milk-based Directive in defined Food Supplements as powder or tablets 2002/46/EC (capsules, form) intended for the adult population, women excluding pregnant and lactating Directive in defined Food Supplements as popu adult the for 2002/46/EC intended lation, excluding pregnant and lactating women Conditions under which the novel food may be used be may food novel the which under Conditions

)

Authorised novel food Triticum aestivum Fermented soybean extract Spermidine-rich Spermidine-rich extract wheat germ (

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ments Other require

’

shall bear Tetraselmis T. chuii

Tetraselmis chuii Tetraselmis ’ or ‘Dried microalgae ’ or ‘Dried the labelling of the foodstuffs of the labelling ‘Sucromalt’. be shall containing it shall be accompanied by the labelling indication that the product is a source of glucose and fructose. labelling of the foodstuffs containing it shall be ‘Sunflower oil extract’ labelling of the foodstuffs containing it microalgae shall be ‘Dried chuii dried containing Food supplements microalgae ‘Contains the following statement: negligible amounts of iodine’ 2. The designation of the novel food on food novel the of designation 2. The 1. The designation of the novel food on food novel the of designation The 1. the on the food on novel food the novel of the designation of The designation The

Additional specific labelling requirements labelling specific Additional

1,1 g/day 250 mg/day Maximum levels Maximum levels Maximum levels levels Maximum Maximum 3 % 3 3 % 3 5 % 5 2 % 2 5 % 5

1 % 1

250 mg/day 250 Specified food category 5 % 5 2 % 2 % or 250mg/day 20 8 % 8 Sauces Special salts Directive in defined Food Supplements as 2002/46/EC Not specified Bread Bakery goods Meat and muscle products spices Seasonings and Grated cheeses Special diet foods Sauces Beverages Directive in defined Food Supplements as 2002/46/EC Condiment Specified food category food Specified Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified

Specified food category food Specified Tetraselmis microalgae Authorised novel food Sunflower oil extract Sugar cane fibre Sugar cane Dried chuii Sucromalt

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ments Other require

Agaricus bispo

)’. the labelling of the foodstuffs of the labelling ‘D-Tagatose’. be shall containing it exceeds 15 the level of D-Tagatose beverages and all g per serving D- % than 1 containing greater a bear consumed) shall Tagatose (as statement ‘excessive consumption effects’. may produce laxative the foodstuffs of the labelling ‘Trehalose’ be shall containing it displayed on the be and shall labelling of the product as such or foodstuffs of of ingredients list in the containing it. shall be accompanied by the labelling is a indication that the ‘Trehalose source of glucose’. novel food as such or of the food stuffs containing it shall be ‘UV- treated mushrooms ( rus 1. The designation on the label of the labelling of the foodstuffs containing it extract’. shall be ‘taxifolin-rich 2. The labelling of any product where on food novel the of designation 2. The

1. The designation of the novel food on food novel the the of on designation food on The novel food 1. the novel of the designation of The designation The 1. /100 g fresh /100 g 2

Additional specific labelling requirements labelling specific Additional

g of vitamin D vitamin g of μ 100 mg/day weight Maximum levels Maximum levels Maximum levels D vitamin Maximum of levels Maximum 10 ) Agaricus bisporus

Specified food category Specified food category

Intended use identical to that of the salmon, namely the preparation of culinary to that of the salmon, namely preparation Intended use identical fish products and dishes, including cooked, raw, smoked and baked fish products Not specified Mushrooms ( Not specified Directive in defined Food Supplements as popu general the for 2002/46/EC intended lation, excluding infants, young children, children and adolescents younger than 14 years Conditions under which the novel food may be used be may food novel the which under Conditions

) / Specified food category food Specified Specified food category food Specified

Authorised novel food Agaricus bisporus Trehalose Taxifolin-rich Taxifolin-rich extract UV-treated mushrooms ( Therapon barcoo Scortum D-Tagatose

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 57

◄ Data Protection Data M13 ►

ments Other require

levels’.

yeast’ novel food shall be ‘UV-treated’. be ‘UV-treated’. novel food shall is that D vitamin amount of in accordance considered significant Annex A of with Point 2 of Part XIII to Regulation (EU) No 1169/ Parliament European the 2011 of and of the Council, the designation for the shall be labelling accom D vitamin panied by ‘contains ‘milk or produced by UV-treatment’ from resulting D containing vitamin UV-treatment’. novel food as such or of the food stuffs containing it shall be accom ‘con a that panied by indication trolled light was treatment used to increase vitamin D or levels’ ‘UV treatment was used to increase vitamin D

1. The designation on the label of the 2. The designation on of the the label 2. Where UV-treated milk contains an The designation of the novel food on the labelling of the foodstuffs containing it or ‘Vitamin D yeast’ shall be ‘Vitamin D The designation on of the novel the label by ‘contains be accompanied food shall vitamin D produced by UV-treatment’

2 2 3

/100 g /100 g /day 2 2 2

/100 g Additional specific labelling requirements labelling specific Additional 2

g/kg for general popu general g/kg for popu general g/kg for μ μ g of vitamin D g of vitamin D g of vitamin D g vitamin D μ μ μ μ 5 lation excluding infants lation excluding infants 3 5-32 1-15 Maximum levels of vitamin D vitamin of D levels vitamin D Maximum of vitamin levels of Maximum levels Maximum 5 5

Specified food category

Yeast-leavened breads and rolls Yeast leavened bread and rolls (without toppings) Pasteurised whole milk as defined in Regu No lation (EU) 1308/2013 to be consumed as such Yeast-leavened fine bakery wares Directive in defined Food Supplements as 2002/46/EC Pasteurised semi-skimmed milk as defined in No 1308/2013 Regulation (EU) to be such consumed as Conditions under which the novel food may be used be may food novel the which under Conditions

Specified food category food Specified ) Specified food category food Specified Sacchar Authorised novel food UV-treated baker’s yeast ( omyces cerevisiae UV-treated milk UV-treated bread

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◄ Data Protection Data M13 ►

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

’ 2

Saccharomyces

) beta-glucans’ The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Menaquinone’ K or ‘Vitamin labelling of the foodstuffs containing it shall be ‘Wheat bran extract’ The designation of the novel food on the labelling of the foodstuffs containing it ( shall be ‘Yeast cerevisiae

The designation of the novel food on the on food novel the of designation The Additional specific labelling requirements labelling specific Additional

omyces cervisiae) glucans from yeast (Sacchar yeast glucans from Maximum levels of pure beta- of Maximum levels 1,275 g/day for children older children for 1,275 g/day adult than 12 and general years population younger children for 0,675 g/day than 12 years 1,275 g/day 1,275 g/day

Maximum levels Maximum

0,6 g/100 g g/100 0,6 9 g/100 g g/100 9 0,4 g/100 g g/100 0,4 2 g/100 g g/100 2 2,4 g/100 g g/100 2,4 0,6 g/100 g g/100 0,6 Specified food category Beer and substitutes cereals eat Ready to Dairy products Fruit and vegetable juices Soft drinks Meat preparations Directive in defined as Food supplements supplements food 2002/46/EC, excluding for infants and young children defined purposes as medical special Food for in Regulation No (EU) 609/2013, excluding purposes intended medical special food for for infants and young children To be used in compliance with Directive 2002/46/EC,To be used No in compliance with Directive 609/ Regulation (EU) 1925/2006 No (EC) Regulation 2013 and/or for weight Total diet control replacement as defined in Regulation (EU) No 609/2013 Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified

(mena

Authorised novel food Wheat bran extract quinone) Yeast beta-glucans Vitamin K

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 59

◄ Data Protection Data M13 ►

ments Other require

labelling of the foodstuffs containing it shall be ‘Zeaxanthin’.

Additional specific labelling requirements labelling specific Additional The designation of the novel food on the on food novel the of designation The

1,8 g/kg (condensed) 2 mg/day 1,3 g/kg 7 g/kg (powder) 1,5 g/kg 6,3 g/kg (powder) 11,3 g/kg 11,3 38,3 g/kg (powder) g/kg 38,3 Maximum levels Maximum 4 g/kg 4 19,1 g/kg 19,1 3,8 g/kg 3,8 25,5 g/kg 25,5 3,8 g/kg 3,8 0,9 g/kg (ready to eat) to (ready g/kg 0,9 3,8 g/kg 3,8 0,8 g/kg 0,8 6,7 g/kg 6,7 6,7 g/kg 6,7 15,3 g/kg 15,3

0,8 g/kg (ready to drink) to (ready g/kg 0,8

6 g/kg 6

Beverages based on fruit and/or vegetable Beverages based on fruit juices including and concentrate dehydrated juices Cereal bars Directive in defined Food Supplements as 2002/46/EC Fruit-flavoured drinks powder preparation Cocoa beverages Other beverages Breakfast cereals Wholegrain and instant hot high fibre breakfast cereals Cookie-type biscuits Cracker-type biscuits Milk based beverages Fermented milk products Milk product analogues Dried milk/milk powder soup mixes Soups and Chocolate and confectionery Protein bars and powders spreads and other fruit Jam, marmalade Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified Authorised novel food Zeaxanthin

M12 M9 ▼ ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 60

◄ Data Protection Data M13 ►

ments Other require

ctive 2009/39/EC ctive of the European and Parliament of the Council and Commission tion of the markets in agricultural products and repealing Council Regulation (EEC) repealing products and agricultural in markets the tion of d minerals and of certain other substances to foods (OJ certain and of d minerals L 404, 30.12.2006, p. 26). mber States relating to food supplements (OJ relating mber States L 183, 12.7.2002, p. 51). ung children, food for special medical purposes, and total diet replacement for weight for replacement diet total and purposes, medical special for food ung children, intended for human consumption (OJ L 10, 12.1.2002, p. 67). onsumers on the absence or reduced presence of gluten in food (OJ L 228, 31.7.2014, labelling of the foodstuffs containing it shall be ‘Zinc L-pidolate’

The designation of the novel food on the on food novel the of designation The Additional specific labelling requirements labelling specific Additional

3 g/day

Maximum levels Maximum

Foods covered by Regulation (EU) No 609/ No Regulation (EU) by Foods covered 2013 Milk based products drinks and similar young children intended for of expenditure the meet to Foods intended especially for intense muscular effort, sportsmen Directive in defined Food Supplements as 2002/46/EC Meal replacement for weight control on Food the absence or bearing statement reduced presence of gluten in accordance of Commission with the requirements Imple No 828/2014 menting Regulation (EU) Conditions under which the novel food may be used be may food novel the which under Conditions Specified food category food Specified control and repealing Council 92/52/EEC, Directive Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Dire 953/2009 No (OJ No 41/2009 (EC) and Regulations (EC) L 181, 29.6.2013, p. 35). p. 5). No 922/72, No 234/79, (EEC) No 1037/2001 (EC) 1234/2007 and (EC) (OJ L 347, 20.12.2013, p. 671). Authorised novel food ) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and yo and infants for intended food on 2013 June 12 of Council the of and Parliament European the of 609/2013 No (EU) ) Regulation purée chestnut sweetened ) and marmalades Commission Implementing Regulation No (EU) 828/2014 of 30 July 2014 on the provision the requirements for of information to c and jellies jams, fruit to ) relating 2002/46/EC Directive of the European and Parliament of the Council of 10 2001 June 2002 on the approximation of the laws Me December 20 ) of Regulation (EC) No 1925/2006 of the European and Parliament of the Council of 20 2001/113/EC December 2006 on the addition of vitamins an Directive ) Council ) Regulation No (EU) 1308/2013 of the European and Parliament of the Council of 17 December 2013 establishing a common organisa

1 2 3 4 5 6 ( ( ( ( Zinc L-pidolate ( (

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 61

Specifications

12,5 % (w/w) 12,5 ≤

O) (dihydrate) 2

* 2H

(acid)

9 11

NO NO 19 23

H H -Acetyl-D-neuraminic acid (dihydrate): > 97,0 % acid (dihydrate): > 97,0 -Acetyl-D-neuraminic -Acetyl-D-neuraminic acid is a -Acetyl-D-neuraminic white to crystalline powder off-white acid (dihydrate) -Acetyl-D-neuraminic 11 11

Molecular mass: (acid) 309,3 Da (dihydrate) 36,0) + 345,3 (309,3 CAS No.: acid) 131-48-6 (free 50795-27-2 (dihydrate) Specifications: Description: white powder crystalline to off-white 1,7 – 2,5 solution): % pH (20 5 °C, N %): Water (dihydrate calculates to 10,4 N Definition: Chemical name: IUPAC names: N acid (dihydrate) 5-Acetamido-3,5-dideoxy-D-glycero-D-galacto-non-2-ulopyranosonic Synonyms: Sialic acid (dihydrate) Chemical formula: C C (w/w) % < 0,2 Ash, sulphated: % (w/w) Acetic acid (as free acid and/or sodium < acetate): 0,5 Heavy Metals: Iron: < 20,0 mg/kg Lead: < 0,1 mg/kg Description:

Authorised Novel Food -Acetyl-D-neuraminic acid -Acetyl-D-neuraminic N Table 2: Specifications Table 2:

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 62

) and then packaged. μ Specifications

Absence in 10 g

Residual solvents:

) fruits are harvested from trees. The hard shells are cracked open and The hard shells are trees. from the seeds and the pulp the shell. is separated harvested from are ) fruits

Absence in 25 g

< 50 CFU/g Adansonia digitata Absence in 25 g Absence in Residual proteins: < 0,01 % (w/w) % < 0,01 Residual proteins: % (w/w) 2-Propanol: < 0,1 % (w/w) Acetone: < 0,1 % (w/w) < 0,1 Ethyl acetate: Microbiological criteria: Salmonella: count:< 500 total Aerobic mesophilic CFU/g Enterobacteriaceae: Absence in 10 g sakazakii: Cronobacter (Enterobacter) Listeria monocytogenes: Description/Definition: The Baobab ( 3 to 600 size lots (particle and fine into coarse separated This is milled, components: Typical nutritional on 4,5-13,7 Moisture (loss drying) (g/100 g): Protein (g/100 1,8-9,3 g): Fat (g/100 g): 0-1,6 Total carbohydrate (g/100 g): 76,3-89,5 glucose): 15,2-36,5 Total sugars (as 0,1-25,2 g): Sodium (mg/100 Analytical specifications: % than 0,2 Not more Foreign matter: on 4,5-13,7 Moisture (loss drying) (g/100 g): 3,8-6,6 g): Ash (g/100 Bacillus cereus: Yeasts: < 10 CFU/g 10 CFU/g Moulds: < Residual endotoxins: < 10 EU/mg Endotoxin Units. EU: Units; CFU: Colony Forming

(Baobab)

Authorised Novel Food Adansonia digitata pulp dried fruit

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 63

Ajuga reptans . During the fermentation process, the ingredient is . During the fermentation Escherichia coli

Specifications L. tissue cultures which is substantially equivalent to extracts from flowering aerial parts of parts aerial flowering from extracts equivalent to substantially which is cultures L. tissue sp.

o 0,2 % 0,2 Ajuga reptans

≤

0,05 % 0,05 Ulkenia ≤

5,0 meq/kg oil 0,1 % 0,1

≤ 0,020 % 0,020 ≤ ≤ 1,0 % 1,0 4,5 % 4,5 0,5 % 0,5 ≤ 0,020 % 0,020 ): ≤

4 ≤ ≤ 32 % 32 0,020 % 0,020 : Absence/g ≥ ≤ ): 0,5 mg KOH/g

4 O): 5,0-6,0 ≤ 2

Acid value: Peroxide value (PV): Moisture and volatiles: Unsaponifiables: Trans-fatty acids: Description/Definition: from Hydroalcoholic extract cultures. obtained by traditional L-Alanyl-L-Glutamine is produced by fermentation with a genetically modified strain of secreted into the growth medium %. from which it is subsequently separated and purified to a concentration of > 98 powder Appearance: White crystalline % Purity: > 98 Infrared spectroscopy: Conformity with ref. standard solution: Colourless and clear Appearance of % 98-102 basis): Assay (dry Related substances (each): Residue on ignition: Loss on drying: Optical rotation: +9,0 - +11,0 H %; pH (1 Ammonium (NH Chloride (Cl): Microbiological criteria: Escherichia coli Description/Definition: the micro-algae Oil from DHA content: Sulphate (SO

Description/Definition: extract from cell from extract

sp. Authorised Novel Food Algal oil from the microalgae the from Algal oil Ulkenia Ajuga reptans cultures L-Alanyl-L-Glutamine

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 64 (L.)

Aloe vera A. stuhlmannii. A. ) and A. parviflora (synonymouswith

A. floribunda Specifications Baker which equivalent to the same gel derived from is substantially Aloe macroclada

seed oil is obtained from the seeds of the allanblackia species: allanblackia the seeds of the obtained from is seed oil -Linolenic acid (C18:3): < 1,0 % -Linolenic acid (C18:3): < 1,0 Allanblackia acids: fatty Composition of % Lauric acid (C12:0): < 1,0 % Myristic acid (C14:0): < 1,0 % Palmitic acid (C16:0): < 2,0 % Palmitoleic acid (C16:1): < 1,0 % Stearic acid (C18:0): 45-58 % Oleic acid (C18:1): 40-51 % Linoleic acid (C18:2): < 1,0 γ % Arachidic acid (C20:0): < 1,0 % max acids: 0,1 Free fatty Characteristics: % max 0,5 acids: Trans fatty max 0,8 meq/kg Peroxide value (PV): Iodine value: < 46 g/100 g % max 1,0 Unsaponifiable matter: Saponification value: 185-198 mg KOH/g Description/Definition: the leaves of Powdered derived from gel extract Burm.f. leaves. % Ash: 25 % 28,6 Dietary fibres: % Fat: 2,7 % Moisture: 4,7 % Polysaccharides: 9,5 % Protein: 1,63 % Glucose: 8,9

Description/Definition: Baker leaf Baker

Authorised Novel Food Allanblackia seed oil Allanblackia seed Aloe macroclada extract

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 65 tration. The extraction JRK-MA01 and CBS 210.32 CBS JRK-MA01 and should demonstrate oxidative stability by appropriate and appropriate by stability oxidative should demonstrate

) by repeated solvent washings with an approved by repeated solvent (under Directive ) Euphausia superba Specifications ) deep-frozen ) deep-frozen crushed krill or dried krill meal is subjected to lipid extraction with an Euphausia superba Euphausia superba

/kg oil 2 /kg oil 2

using a suitable liquid. The oil is then extracted from the biomass and purified. biomass the from extracted then is oil The liquid. suitable a using 5 % 5 % 5 9 % 9 % 9

≥ ≥ ≥ ≥ 3 % or 0,6 expressed as water activity at 25 % or 0,6 at activity expressed as water °C 3 25 % or 0,6 at activity expressed as water °C 3 1,5 % 1,5 ≤ ≤

≤ 3 meq O 3 meq O 230 mg KOH/g 230 mg KOH/g ≤ ≤ ≤ ≤ 40 % by weight of the total fatty acid content fatty % by weight of the total 40 0,5 % of the total fatty acid content acid % of the total fatty 0,5 1 % 1 % 1 ≥ 0,45 % of the total fatty acid content acid % of the total fatty 0,45 ≤ ≤ ≤ ≤ 60 % 60 ≥ Mortierella alpina Mortierella Description/Definition: in phospholipids ( Oil rich krill is produced Antarctic from product by evaporation. final the removed from phospholipid Solvents are 2009/32/EC) oil. the content of to increase Saponification value: Description/Definition: ( Krill Antarctic from extract To produce lipid by fil extract lipid the from removed are material krill and 2009/32/EC).Proteins Directive (under solvent approved extraction removed by evaporation. are water solvents and residual Saponification value: Peroxide value (PV): from oil Krill food products containing All Antarctic Oxidative stability: methodology test (e.g. AOAC). recognised national/international Moisture and volatiles: % Phospholipids: 35-50 Trans-fatty acids: Peroxide value (PV): Moisture and volatiles: Phospholipids: Trans-fatty acids: Description/Definition: I49-N18, F IS-4, strains modified the non-genetically of obtained by fermentation is oil acid-rich arachidonic yellow The clear of the fungus Arachidonic acid: acids: Free fatty acids: Trans fatty Unsaponifiable matter: EPA (eicosapentaenoic acid): EPA (eicosapentaenoic acid): DHA (docosahexaenoic acid): EPA (eicosapentaenoic acid): DHA (docosahexaenoic

Euphausia

Mortierella alpina Mortierella

Authorised Novel Food Antarctic Krill oil rich in phospholipids from superba oil from Arachidonic acid-rich the fungus Antarctic Krill oil from Euphausia superba

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 66 harvested and dried; the (L.) Skeels. Kernels may be roasted prior to prior roasted be may Kernels Skeels. (L.)

Argania spinosa

Specifications algae. Production methods for the growth of the algae are variable; using either closed using Production either algae. methods variable; growth are for the of the algae or a solvent (ethyl acetate). The Astaxanthin is diluted and standardized to 2,5 %, 5,0 %, %, 7,0 %, 10

Haematococcus pluvialis

/kg 2

5 meq/kg ≤

20 ≤

1,0 KOH/g ≤ 0,5 % 0,5 ≤ Peroxide value (PV): Anisidin value: Acid value: Moisture: Description/Definition: Argan oil is the oil obtained by cold pressing of the almond of like kernels of the fruits flame. a with contact no direct pressing, but with 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 % 0,3-2 Unsaponifiable matter: 100-500 Total sterols: mg/100 g Total tocopherols: 16-90 mg/100 g % 0,2-1,5 Oleic acidity: < 10 meq O Peroxide value (PV): Description/Definition: produced by carotenoid a Astaxanthin is open ponds light; alternatively systems exposed illuminated may controlled to sunlight be used. are cells The or strictly algal CO using super critical either oleoresin is extracted 15 % or 20 % using olive oil, safflower oil, Sunflower oil or MCT (Medium Chain % using Triglycerides). olive oil, safflower % or 20 15 Oleoresin: the Composition of % 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

Argania

Authorised Novel Food

Haematococcus pluvialis Astaxanthin-rich oleoresin Astaxanthin-rich from algae Argan oil from Argan oil spinosa

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 67 Glycine max (L.) , mechanical). Production , mechanical). oybeans ( L.) includes seed pre-hydration and pasteurisation

Ocimum basilicum

Specifications -glucosidase inhibitor. α ’ within the order ‘Lamiales’. Post-harvest the seeds are cleaned mechanically. Flowers, mechanically. cleaned the seeds are Post-harvest ‘Lamiales’. within the order ’ Lamiaceae . The extract contains an . The extract

L.) belongs to the family ‘ belongs L.) to the family

Aspergillus oryzae Aspergillus

: Negative

: Negative Ocimum basilicum : Negative 1,0 % 1,0 ) fermented with ) fermented ≤ -Carotene: 0,01-0,3 % 0,01-0,3 -Carotene: 9-cis-astaxanthin: 0,3-17,3 % 9-cis-astaxanthin: 0,3-17,3 % 13-cis-astaxanthin: 0,2-7,0 % 79,8-91,5 Astaxanthin monoesters: % 0,16-19,0 Astaxanthin diesters: Β % Lutein: 0-1,8 % Canthaxanthin: 0-1,30 Microbiological criteria: 000 CFU/g < 3 bacteria: Total aerobic Yeast and Moulds: < 100 CFU/g Coliforms: < 10 CFU/g E. coli Salmonella Staphylococcus s small of extraction powder obtained by water light-brown protein-rich fine a is extract) (Touchi bean extract black Fermented Merr. Description/Definition: Basil ( (optical seeds has to be ensured by of purity Basil filtering removed. Highest level are plant of the parts and other leaves blend beverages containing ( and Basil seeds juice fruit/vegetable fruit process of in place. controls and monitoring systems are steps. Microbiological % 94,1 Dry Matter: % Protein: 20,7 % Fat: 24,4 % Carbohydrate: 1,7 % (Method: AOAC 958,29) Dietary Fibre: 40,5 % Ash: 6,78 Characteristics: Fat: Description/Definition:

Ocimum basil Authorised Novel Food

) Basil seeds ( icum Fermented black bean extract

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 68 ation steps. Finally, it is and consists of a single a of and consists

(L.) I.M.Johnst (L.) Specifications Buglossoides arvensis

35 % w/w of total fatty acids fatty % w/w of total 35 ≥ 2,0 % w/w of total fatty acids % w/w of total fatty 2,0 15 % w/w of total fatty acids fatty % w/w of total 15 ≤ 0,3 g/100 g ≥ ≤ 20 % 20 8,0 % w/w of total fatty acids fatty % w/w of total 8,0 ≥ ≥ 55 % 55 7,0 % 7,0 ≥ ≤ 10 % 10 ≤ -glucosidase inhibitory activity: IC50 -glucosidase inhibitory activity: min 0,025 mg/ml Protein: Water: Ash: Carbohydrate: is an iron-binding in cows’ milk. It glycoprotein occurs naturally of approximately 77 is a protein that kDa Bovine lactoferrin acids. 689 amino of polypeptide chain from skimmed milk or cheese whey is isolated via ion Production exchange process: Bovine and lactoferrin subsequent ultra-filtr odourless, light pinkish is a virtually sieved out. powder. It are drying or spraying particles dried by and freeze the large Physical-Chemical properties of Bovine lactoferrin: % Moisture: < 4,5 % Ash: < 1,5 Arsenic: < 2,0 mg/kg Iron: < 350 mg/kg % Protein: > 93 % > 95 of which bovine lactoferrin: % < of which 5,0 other proteins: solution, 20 % 5,2-7,2 °C): pH (2 % solution, 20 complete °C): Solubility (2 the seeds of from Refined Buglossoides extracted oil is Alpha-linolenic acid: Stearidonic acid: α Soy isoflavone: Linoleic acid: Trans fatty acids: Trans fatty Description/Definition:

seed oil seed Description/Definition: Authorised Novel Food Buglossoides arvensis Bovine lactoferrin

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 69 . olyethylene glycol Calanus finmarchicus ankton)

Specifications g/kg μ

g/ml μ /kg /kg 2

10 ≤ 2,0 % 2,0

≤

5,0 meq O ≤

0,6 mg KOH/g ≤ Acid value: Peroxide value (PV): zoopl (marine the crustacean The novel odour from ruby food is coloured, slightly viscous oil with a slight shellfish extracted and lipids. %) with minor amounts other neutral of triglycerides (> 85 of wax esters consists primarily The ingredient Specifications: % Water: < 1,0 % > 85 Wax esters: % > acids: 46 Total fatty % > 3,0 Eicosapentaenoic acid (EPA): % 4,0 > (DHA): Docosahexaenoic acid % alcohols: > Total fatty 28 % 9,0 > alcohol: fatty C20:1 n-9 % 12 > alcohol: fatty C22:1 n-11 % < 1,0 acids: Trans fatty % Astaxanthinesters: < 0,1 < 3,0 meq. O Peroxide value (PV): Description/Definition: number WO2006016179). of monomethoxyp polymer (Patent branched polymers synthetic consists of a is It The novel food ingredient % by weight). than 35 and MPEG anhydride unreacted (less (PIP-g-MA), onto polyisoprene-graft-maleic (MPEG) grafted colour. White to off-white 1246080-53-4CAS No.: Characteristics: % Moisture: < 5,0 Unsaponifiable content: nitrogen): Protein content (total Pyrrolizidine alkaloids: Not detectable with a detection limit of 4,0

Description/Definition: oil Authorised Novel Food Chewing gum base (monome thoxypolyethylene glycol) Calanus finmarchicus

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 70

Specifications 50 mg/kg ≤ 150 ppm

≤ 250 ppm ≤ mol/g

10 ppm 15 ppm ≤

≤ 500 ppm ≤ 500 ppm ≤

Polydispersity index: < 1,4 Isoprene: < 0,05 mg/kg Ethylene oxide: < 0,2 mg/kg % anhydride: < 0,1 maleic Free 000 Dalton): than 1 Total oligomeres (less Ethylene glycol: < 200 mg/kg < 30 mg/kg Diethylene glycol: mg/kg 3,0 < ether: methyl Monoethylene glycol < 4,0 mg/kg ether: Diethylene glycol methyl Triethylene glycol methyl ether: < 7,0 mg/kg 2,0 mg/kg 1,4-Dioxane: < 10 mg/kg Formaldehyde: < Aluminium: < 3,0 mg/kg Lithium: < 0,5 mg/kg Nickel: < 0,5 mg/kg Residual anhydride: < 15 Description/Definition: anhydride. and maleic vinyl an anhydrous ether methyl anhydride copolymer is copolymer of Methyl vinyl ether-maleic Free-flowing, white to white-off powder 9011-16-9 CAS No: Purity: dry matter in % 99,5 least At Assay value: % MEK): 2-10 Specific viscosity (1 Residual methyl vinyl ether: anhydride: Residual maleic Acetaldehyde: Methanol: Dilauroyl peroxide: Total heavy metals:

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

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 71

. 2

s employed remove to cal CO family. Post-harvest the seeds are cleaned mechanically. mechanically. cleaned are seeds the Post-harvest family.

Labiatae

Specifications L.) seeds (99,9 % pure) by cold pressing. No solvents are used and, once pressed, the oil is held in used by is oil and, once cold pressing. No solvents are % pure) pressed, the seeds (99,9 L.)

2,0 % 2,0 Salvia hispanica

≤

500 CFU/g

≤

: Negative to test

Negative to test Negative to 10 meq/kg 60 % 60 L.) is a summer annual herbaceous plant belonging to the belonging to plant herbaceous annual summer a is L.)

0,05 % 0,05 ≤ ≥ ≤

: Negative to test 500 CFU/g ≤

: Negative to test Salvia hispanica (*) Carbohydrates include the fibre value fibre the (*) Carbohydratesinclude Flowers, leaves and other parts of the plant are removed. of the plant are Flowers, leaves and other parts % 90-97 Dry matter: % Protein: 15-26 % Fat: 18-39 % 18-43 Carbohydrate (*): % 18-43 Crude Fibre(**): % Ash: 3-7 Microbiological criteria: count: plate Total aerobic Mould/yeast: Chia ( produced is from Chia oil can also be produced with supercriti by It employed extraction process impurities. to remove decantation tanks and a filtration Chia ( lignin and pentosans cellulose, indigestible of mainly made fibre of part the is fibre (**) Crude Escherichia coli Salmonella Staphylococcus aureus: Pseudomonas aeruginosa Production process: proces filtration tanks and a held in decantation is Produced used and, by cold pressing. No once pressed, the oil solvents are impurities. Acidity expressed as oleic acid: Peroxide value (PV): Insoluble impurities: acid: Alpha linolenic % Linoleic acid: 15-20 Description/Definition: Description/Definition: )

Salvia hispanica Salvia hispanica Authorised Novel Food Chia oil from Chia oil Chia seeds (

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 72 eating in an alkaline solution, eating in an alkaline teurisation steps. Microbiological . It consists primarily of two polysaccharides: of consists primarily . It Fomes fomentarius Fomes

Specifications ; it is a slightly yellow, odourless, free-flowing ; it is a slightly yellow, powder. has odourless, content of It a dry free-flowing matter

Aspergillus niger

0,1 % 0,1 ≤

10 % 10

≤ 90 % 90 90 % 90 ≥ ≥ 15 % 15 6,0 % 6,0 ≤ ≤ 1,0 % 1,0 ≤

3,0 % 3,0 3,0 % 3,0 ≤ ≤ Production process: and pas seed pre-hydration blends beverages, containing Chia seeds, includes juice and fruit juices fruit Production process of in place. controls and monitoring are systems Description/Definition: mycelium of obtained the Chitin-glucan is from % or more. 90 two polysaccharides: of composed Chitin-glucan is largely — (CAS No: 1398-61-4), chitin, composed units of N-acetyl-D-glucosamine of repeating — beta (1, 3)-glucan, composed units of D-glucose (CAS No: 9041-22-9). of repeating Loss on drying: Chitin-glucan: Ratio of chitin to glucan: 30:70 to 60:40 Ash: Lipids: Proteins: Description/Definition: Chitin-glucan bodies complex is obtained of the fungus walls of the fruit the cell from — (CAS No: 1398-61-4); Chitin, composed units of N-acetyl-D-glucosamine of repeating — composed units of D-glucose (CAS No: 9041-22-9). Beta-(1,3)(1,6)-D-glucan, of repeating and and grinding, h steps, including: cleaning, reduction in size softening in water The production consists of several process production process. the during applied is hydrolysis washing, drying. No Appearance: Powder, odourless, flavourless, brown Purity: Moisture: Ash: Chitin-glucan: Ratio of chitin to glucan: 70:20 Total carbohydrates, excluding glucans:

Aspergillus

Authorised Novel Food

Chitin-glucan complex from Fomes fomentarius Chitin-glucan from niger

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 73 . Aspergillus niger ium, solubilisation in acidic ium, solubilisation or from the mycelium of mycelium the from or Agaricus bisporus

Specifications

85 10 15 ≥ ≤ ≤ /g

n ) 4

10 /g

≤ 3 NO

3 11

H ≤ 6

10 ≤ 1,00 0,03 ≤

0,20 ≤ ≤

1,00 ≤ 8,3 % 8,3

and other pathogenic bacteria: Absence/25 g pathogenic bacteria: and other 2,0 % 2,0 ≤ 10/g ≤ 1,0 % 1,0 ≤ ≤

: Proteins: Lipids: Melanins: Additives: None pH: 6,7-7,5 Heavy metals: Lead (ppm): Yeast and moulds: Coliforms at 30 °C: E. coli Description/Definition: of stems obtained from is (containing mainly poly(D-glucosamine)) The chitosan extract The patented production process consists of several steps, including: and extraction deacetylation (hydrolysis) in alkaline med medium, washing and drying. alkaline in medium, precipitation Synonym: Poly(D-glucosamine) Chitosan CAS 9012-76-4 number: (C Chitosan formula: Cadmium (ppm): Mercury (ppm): Arsenic (ppm): Salmonella powder Appearance: fine free-flowing –white to slightly brownish Aspect: Off Odour: Odourless Purity: weight): dry w/w (% Chitosan content w/w dry weight): Glucan content (% Loss on w/w dry weight): drying (% 1-15 acid): % acetic % in 1 Viscosity (1 Microbiological criteria: Total mesophilic bacteria:

Aspergillus ; Authorised Novel Food

) Agaricus bisporus Chitosan extract from fungi from Chitosan extract ( niger

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 74 fermentation by fermentation the

Agaricus bisporus

Specifications 10,0

≤

50 10 85 ≤ ≤ ≤

2,0 ≤

10 3 ≤ 3,0 10 ≤ ≤ O5:K4:H4 strain U1-41 (ATCC 23502). 10

≤ 0,5

0,7 100 : Absence/25g

≤ ): 0,7-1,0

≤ ≤ 3 Di-6S) (%): ): Δ 0,5 0,1 ≤ 1,0 ≤ 0,05

(CFU/g): ≤

1,0 /w

h ≤ : Absence/25g Escherichia coli Chondroitin sulphate (sodium salt) (% dry basis): 95-105 basis): dry (% salt) (sodium Chondroitin sulphate 5-12 (kDa): avg.) MWw (weight 4-11 (kDa): avg.) MWn (number Dispersity (w Degree of acetylation (in % mol/wet weight): 0-30 weight): (in % mol/wet Degree of acetylation Aspergillus niger; 12-25 1-14 chitin from for chitosan from for (mPa.s): acid) % acetic % in 1 Viscosity (1 weight): dry w/w Ash (% w/w dry weight): Proteins (% Particle size: > 100 nm Tapped density (g/cm Yeast and mould count (CFU/g): Escherichia coli Enterobacteriaceae (CFU/g): Salmonella Listeria monocytogenes from derived chondroitin sulphation of by chemical obtained is It product. biosynthetic a is salt) (sodium Chondroitin sulphate bacterium ( Sulphation pattern (105 Loss on drying (%) °C to constant weight): 20-30 dry basis): Residue on ignition (% dry basis): Protein (% Fat binding 800 capacity pass × (w/w wet weight): Heavy metals: Mercury (ppm): Lead (ppm): Endotoxins (EU/mg): (mg/kg): Total organic impurities Arsenic (ppm): Cadmium (ppm): Microbiological criteria: Aerobic count (CFU/g):

Description/Definition: Authorised Novel Food Chondroitin sulphate

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 75

nic solvents.

Specifications family and native to the Mediterranean region, Chalkidiki Peninsula. and native to the Mediterranean family Cistaceae

3 ) 2

NO 4

H 6

95 % 95

≥

g g g μ μ μ

L. Pandalis herb; species belonging to the belonging to species herb; Pandalis L.

: 3,0 : 30 : 54 1 2 6

4,0 % 4,0 ≤ Sodium: 0,18 g Potassium: 0,75 g Magnesium: 0,24 g Calcium: 1,0 g Iron: 65 mg Chromium picolinate is a reddish free-flowing powder, Chromium at pH is a reddish slightly soluble free-flowing picolinate in water 7. is also soluble in The polar orga salt salt acid chromium(III) or 2-pyridinecarboxylic Chemical name: tris(2pyridinecarboxylato-N,O)chromium(III) Cr(C formula: 14639-25-9ChemicalCAS No.: Chemical characteristics: Chromium Picolinate: % 12-13 Chromium (III): detected not Chromium (VI): Water: Description: Cistus incanus 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 Vitamin B Vitamin B Vitamin B Vitamin C: 28 mg than 0,1 Vitamin A: less mg 40–50Vitamin E: mg

Description/Definition: L. Pandalis Authorised Novel Food

Cistus incanus herb Chromium Picolinate

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 76 y

Specifications -(trihydrogen diphosphate) P’-[2-(trimethylammonio)ethyl]ester inner salt -(trihydrogen diphosphate) P’-[2-(trimethylammonio)ethyl]ester ′ 5,0 % 5,0 ≤

-pyrophosphate, Cytidine 5 -pyrophosphate, Cytidine ′

P 11

O 4

N CFU/g

CFU/g

0,1 % 0,1 26

≤ 3 H (CBM-588) is a Gram-positive, spore-forming, obligate anaerobic, non-pathogenic, Depositor obligate anaerobic, bacterium. spore-forming, non-genetically modified (CBM-588) Gram-positive, is a 14

10 10 ≤ 1,0 % 1,0 ≤ ≤ : Absence in 1 g 98 % of dry matter dry % of matter 98 0,05 % 0,05 ≥ ≤

-Cytidylic acid: ′ Alpha-Tocopherol: 20–50 mg Beta and Gamma-Tocopherols: 2–15 mg Delta-Tocopherol: 0,1–2 mg Citicoline is produced by a microbial process. Citicoline is composed of cytosine, ribose, pyrophosphate and choline. powder White crystalline Chemical name: Choline cytidine 5 Yeast and moulds: Escherichia coli Clostridium butyricum number FERM BP-2789 Chemical formula: C Chemical formula: Molecular weight: 488,32 g/mol 987-78-0 CAS No.: 2,5-3,5 %): 1 of solution pH (sample Purity: Assay value: Loss on drying (100 4 hours): °C for Ammonium: Arsenic: Not more than 2 ppm Free phosphoric acids: 5 Microbiological criteria: count: Total plate

Description/Definition: Description/Definition: Authorised Novel Food Clostridium butyricum Citicoline

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 77 L. Coriandrum sativum

Specifications : Not detected in 1 : Not detected g

Staphylococcus aureus L.) extract L.) CFU/g

3 10

≤ CFU/g L.) Extract Extract L.)

: Not detected in 1 : Not g detected

10 ≤ Theobroma cacao : Not detected in 1 : Not detected g Theobroma cacao Microbiological criteria: count: Total viable aerobic Appearance: Dark red to purple powder % 99 Min concentrate: Cocoa extract, % Max 1,0 Silicon dioxide aid): (technological 300 mg/g Min. Cocoa flavanols: mg/g 45 Min. — Epicatechin: % Loss on drying: Max. 5,0 Description/Definition: is produced plant acids that from the seeds of coriander is an oil containing of fatty Coriander seed oil glycerides Slight yellow colour, bland taste Escherichia coli Cocoa ( Appearance: Dark brown of visible impurities powder free properties: Physical and chemical GAE % 55,0 Min Polyphenol content: % Max 10,0 Theobromine content: % 5,0 Max Ash content: % Max 8,0 Moisture content: 0,40-0,55 g/cm Bulk density: pH: 5,0-6,5 Residual solvent: Max 500 ppm Pseudomonas aeruginosa Yeast and moulds:

Cori Low fat Cocoa ( Cocoa fat Low

Authorised Novel Food Coriander seed oil from oil Coriander seed andrum sativum Low fat cocoa extract cocoa Low fat Extract of defatted cocoa Extract of defatted powder

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 78 , sieved or not, without

family and native to north China and Korea. to and native family Specifications Rosaceae species belonging the to species

15 g/kg

≤ 5,0 meq/kg ≤ 1,0 % 1,0 ≤ Crataegus pinnatifida

2,5 mg KOH/g ≤

-Linolenic acid (C18:3): < 1,0 % -Linolenic acid (C18:3): < 1,0 CAS No.: 8008-52-4 CAS No.: acids: fatty Composition of % Palmitic acid (C16:0): 2-5 % Stearic acid (C18:0): < 1,5 % Petroselinic acid 60-75 (cis-C18:1(n-12)): % %Linoleic acid (C18:2): 12-19 8-15 Oleic acid (cis-C18:1 (n-9)): α acids: Trans fatty Purity: Refractive index (20 °C): 1,466-1,474 Acid value: Peroxide value (PV): Iodine value: 88-110 units Saponification value: 186-200 mg KOH/g Unsaponifiable matter: Description/Definition: of Dried fruits Composition: % 80 Dry matter: weight Carbohydrates: 55 g/kg fresh Fructose: 26,5–29,3 g/100 g Glucose: 25,5–28,1 g/100 g Vitamin C: 29,1 mg/100 weight g fresh weight Sodium: 2,9 g/100 g fresh whole pieces or in of fruits, species several of one Compotes products or edible part obtained processing of the are by thermal significant concentration. Sugars, water, cider, spices and lemon juice may be used.

dried Authorised Novel Food

Crataegus pinnatifida fruit

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 79

- α ssolve the sample ssolve the 0,45-micrometer filter ription: Virtually odourless, -cyclodextrin in a chromatogram α

-cyclodextrin may be carried out -cyclodextrin may be carried using one of the following procedures: -cycloamylase α α Specifications

-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase of cyclodextrin action produced by the -1,4-linked D-glucopyranosyl units α (1 % solution)

o Consortium für Elektrochemische Industrie GmbH, München, Germany or Wacker Biochem Group, Adrian, MI, and +151

o -cyclodextrin from the solution; or chromatography with ion-exchange or gel filtration followed by crystallisation of followed by crystallisation the solution; or chromatography with ion-exchange from gel filtration -cyclodextrin or α -cyclodextrin with 1-decanol, dissolution in water at elevated temperature and re-precipitation, steam-stripping the of steam-stripping and re-precipitation, temperature at elevated with 1-decanol, dissolution in water -cyclodextrin α

6 ) -dextrin, cyclohexaamylose, cyclomaltohexaose, 5

O 10

: Between +145

20 mg/kg 0,5 % (as glucose) % (as 0,5 H ≤ ≤ 25 6

D ]

0,1 % 0,1 ≤

-cyclodextrin (available from -cyclodextrin (available -cyclodextrin, α α 98 % (dry basis) % (dry 98 11 % (Karl Fischer Method) Fischer % (Karl 11 0,5 mg/kg ≥ ≤

≤ ) using the conditions described in the METHOD OF ASSAY A non-reducing cyclic saccharide consisting of six consisting of saccharide A non-reducing cyclic (CGTase, EC 2.4.1.19) of on Recovery and hydrolyzed purification starch. precipitation of a complex of complexant, and crystallisation of complexant, and crystallisation 972,85 Formula weight: Assay: Identification: Decomposes Melting range: above 278 °C soluble in ethanol very slightly soluble in water; Freely Solubility: Specific rotation: [ for corresponds to that sample the of liquid chromatogram peak in a major the for time Chromatography: The retention of reference cyclodextrin from the purified mother liquor; or membrane separation methods such as ultra-filtration and osmosis: Desc reverse cyclodextrin from the purified mother liquor; or membrane separation methods such as ultra-filtration solid. white crystalline white or almost Synonyms: Chemical name: Cyclohexaamylose 10016-20-3CAS No.: (C Chemical formula: USA Purity: Water: Residual complexant: (1-decanol) Reducing substances: Sulphated ash: Lead: Method of assay: Determine by liquid chromatography using the following conditions: about Sample solution: and 100 Weigh add accurately flask sample into a 10 deionised Di ml volumetric mg 8 ml of of test water. through a Filter deionised water. with purified to bath (10-15 min) and the mark dilute completely using an ultra-sonification

Description/Definition: Authorised Novel Food -cyclodextrin α

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 80 -cyclo γ -CD peak. α

nd recovery of gamma- of nd recovery , Germany) or similar or , Germany)

-cyclodextrin may out be carried by precipitation of a complex of -cycloamylase γ γ Specifications -cyclodextrin, respectively, after correcting for water content. for water correcting after -cyclodextrin, respectively, α -1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase -cyclodextrin into a 10 ml volumetric flask and flask into a 10 add -cyclodextrin ml volumetric 8 ml of deionised Dissolve the sample water. ) α α S

Macherey & Nagel Co. Düren /W

R m) ( -cyclodextrin for the sample solution and reference solution, respectively. solution and the sample for reference -cyclodextrin μ α ) (W

R /A (10

8 -cyclodextrin in the test sample as follows: ) -dextrin, cyclooctaamylose, cyclomaltooctaose, -dextrin, cyclooctaamylose, cyclomaltooctaose, α 5

O 10

lProcedure: Inject the sample lProcedure: Inject solution into the chromatograph, record the chromatogram, and measure the of the area H 6

μ are the weights (mg) of the test sample and reference of the test the weights (mg) are -cyclodextrin, -cyclodextrin,

are the areas of the peaks due to the areas are γ

98 % (dry basis) % (dry 98 ≥ and W -cyclodextrin (dry basis) = 100 (dry basis) × -cyclodextrin (A and A

Reference solution: Weigh about accurately 100 mg of Length: 250 mm Diameter: 4 mm Temperature: 40 °C (67/33, v/v) Mobile phase: acetonitrile/water 2,0 ml/min Flow rate: Injection volume: 10 Calculate the percentage of % where A eight consisting of saccharide A non-reducing cyclic (CGTase, EC 2.4.1.19) on hydrolysed of Recovery and starch. purification dextrin with 8-cyclohexadecen-1-one, of the aqueous dissolution and of the complex with water n-decane, steam-stripping phase a by crystallisation. solution the CD from odourless, Virtually solid white or almost white crystalline Synonyms: Chemical name: Cyclooctaamylose 17465-86-0CAS number: (C Chemical formula: completely using bath and an ultra-sonification dilute to the mark with purified deionised water. recorder. integrating and an index detector refractive a equipped with chromatograph Chromatography: Liquid Nucleosil-100-NH packing: Column and W Assay:

Description/Definition: Authorised Novel Food -cyclodextrin γ

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 81

Specifications

4 mg/kg ≤ (1 % solution)

o and + 180 and +

o 6mg/kg ≤ : between + 174

0,5 % (as glucose) % (as 0,5

≤ 25

] α

0,1 % 0,1 ≤

11 % 11 ≤

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 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 Powdered form: Powdered form: Liquid Identification: Decomposes Melting range: above 285 °C soluble in ethanol very slightly soluble in water; Freely Solubility: Specific rotation: [ Purity: Water: (CHDC)): Residual complexant (8-cyclohexadecen-1-one 1. 2. Residual solvent (n-decane): Reducing substances: Sulphated ash:

Authorised Novel Food Leuconostoc mesenteroides Dextran preparation produced by

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 82 Brassica esterification dihydro esterification ) or rapeseed oil ( ) or rapeseed Glycine max

Specifications

50 % 50 ≥

5,0 % 5,0

≤ O

) using a specific enzyme. ) using a specific

20 % 20 80 % 80 15 % 15 28

≤ ≥ ≤ 0,1 % 0,1 H

1,0 meq/kg 10 % 10 ≤

≤ ≤ 18

2,0 % 2,0 1,0 % 1,0 ≤ ≤ 0,5 mg KOH/g ≤

Dihydrocapsiate is synthesised by enzyme-catalysed esterification of vanillyl alcohol and 8-methylnonanoic Dihydrocapsiate is synthesised acid. Following by esterification the enzyme-catalysed capsiate is extracted with n-hexane. Viscous to colourless yellow liquid C Chemical formula: Description/Definition: from soybean Manufactured from glycerol and edible vegetable oils, acids derived oil ( in particular from fatty campestris, Brassica napus Acylglycerol Distribution: Diacylglycerols (DAG): 1,3-Diacylglycerols (1,3-DAG): Triacylglycerols (TAG): Monoacylglycerols (MAG): 205687-03-2 CAS No: Physical-chemical properties: % Dihydrocapsiate: > 94 % 6,0 < 8-Methylnonanoic acid: % Vanillyl acohol: < 1,0 % substances: < 2,0 Other synthesis related Fatty Acid Composition (MAG, DAG, TAG): % Oleic acid (C18:1): 20-65 % Linoleic acid (C18:2): 15-65 (C18:3): Linolenic acid Saturated fatty acids: Others: Acid value: Moisture and volatile: Peroxide value (PV): Unsaponifiables: acids Trans fatty TAG = triacylglycerols MAG DAG diacylglycerols, = monoacylglycerols, =

Description/Definition: Authorised Novel Food

Diacylglycerol oil of plant origin Dihydrocapsiate (DHC)

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 83

)

Apocynaceae Specifications N.E.Br., (family Hoodia parviflora

CFU/g

: < 10 CFU/g

: < 0,3 w

pH: < 5,0 Protein: < 4,5 g/100 g Fat: < 3 g/100 g < 80 g/100 g fibre): dietary Carbohydrate (including < Dietary fibre: 55 g/100 g Total sugars: < 10,5 g/100 g % Ash: < 20 Hoodigosides mg/kg P57: 5–50 000 mg/kg 000–6 L: 1 000 mg/kg O: 500–5 000 mg/kg 500–11 Total: 1 Heavy metals: Arsenic: < 1,00 mg/kg Mercury: < 0,1 mg/kg Cadmium: < 0,1 mg/kg Lead: < 0,5 mg/kg Microbiological criteria: count: < 10 Aerobic plate Description/Definition: It is the whole parts of dried aerial Characteristics/Composition plants 3-year-old of at least parts Aerial Plant material: powder Appearance: Light green to tan fine > 25 mg/mL Solubility (water): % Moisture: < 5,5 A Escherichia coli

Hoodia

Authorised Novel Food Dried aerial parts of parviflora

M13 M9 ▼ ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 84 Echinacea 10 % w/w of total 10 ≥ L. Stearidonic acid: Stearidonic L. Echium plantagineum

Vb.

Specifications

g/kg

Vb ® obtained from plant tissue culture which is substantially equivalent to a root extract from extract root to a equivalent substantially which is culture tissue plant obtained from g/ml μ from cell cultures HTN cultures cell from /kg 2

(Palau) Kunth from cell cultures HTN cultures Kunth cell (Palau) from

20 ≤

2,0 % 2,0 ≤

Echinacea angustifolia 5,0 meq O : Negative/25 g : < 50 CFU/g ≤

2,0 % (w/w of total fatty acids) fatty % (w/w of total 2,0 ≤ Lippia citriodora Echinacea purpurea 0,6 mg KOH/g ≤ obtained in ethanol-water titrated to 4 % echinacoside. to 4 titrated obtained in ethanol-water species: Negative/25 g species: 100 CFU/g 100 CFU/g ≤ ≤ Staphylococcus aureus < 10 CFU/g Total coliforms: Yeast: Mould: Salmonella Listeria monocytogenes CFU: Colony Forming Units Description/Definition: of Dried extract Description/Definition: Extract of the roots of Description/Definition: of Dried extract of the seeds from extracted oil product obtained by yellow pale refining the is Echium oil fatty acids acids: Trans fatty Acid value: Peroxide value (PV): Unsaponifiable content: nitrogen): Protein content (total Pyrrolizidine alkaloids: Not detectable with a detection limit 4,0 angustifolia

Description/Definition: extract oil extract

Lippia from cell cultures cell from Authorised Novel Food Echium plantagineum Dried extract of citriodora Echinacea angustifolia from cell cultures Echinacea purpurea from cell cultures

M9 M13 ▼ ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 85

Polarimetry ) in the form of a fine, off-white to pale pink powder. It is composed pink is to pale powder. of It off-white a fine, of in the form )

Specifications

a) Method O) 2

-imidazol-4-yl)-2-(trimethylammonio)-Propanoate -imidazol-4-yl)-2-(trimethylammonio)-Propanoate H Camellia sinensis (L.) Kuntze Camellia sinensis (L.) Visual (+) 122° (c = 1, H ≥

D ] α S 2

N 15

H 9

Specification

[

White powder White Parameter

Description/Definition: ( tea of green the leaves from extract A highly purified (EGCG), and has a melting point between gallate approx. 210 % epigallo-catechin and 215 °C a minimum of 90 to pale pink powder Appearance: off-white Chemical name: polyphenol epigallocatechin-3-gallate (-) (EGCG) gallate Synonyms: epigallocatechin 989-51-5 CAS No.: gallate epigallocatechin INCI name: 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: material) EGCG (on dry % Min. 94 caffeine % max. 0,1 ethanol, Solubility: EGCG soluble in methanol and water, is fairly acetone (2S)-3-(2-thioxo-2,3-dihydro-1 Chemical name (IUPAC): C Chemical formula: Molecular mass: 229,3 Da 497-30-3 CAS No.: Appearance Optical rotation

)

Definition Camellia sinensis Authorised Novel Food

Epigallocatechin gallate as a purified extract from green tea leaves ( L-ergothioneine M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 86

HPLC [Eur. Ph. 2,2.29] HPLC [Eur. 1H-NMR 1H-NMR Elemental analysis Gas chromatography [Eur. Ph. 01/2008:20424]

Specifications [Eur. Ph. 01/2008:20232] Ph. [Eur.

[Eur. Ph. 01/2011:50104] Ph. [Eur.

CFU/g CFU/g Atomic fluorescence (Hg) Cd) fluorescence ICP/AES (Pb, Atomic

3 2 HPLC/GPC or 1H-NMR or HPLC/GPC 1 x 10 1 x 10 99,5 % 99,5 % 99,0 ≥ ≥ % C: 47,14 0,4 ± % H: 6,59 ± 0,4 % N: 18,32 ± 0,4 [Eur. Ph. 01/2008:50400] 000 ppm < 1 ≤ ≤

Absence in 1 g 1 in Absence

Internal standard < 0,5 % 0,5 < standard Internal

b) c) Compliant with the structure the with Compliant < 0,8 % 0,8 < < 1,0 ppm 1,0 <

< 0,1 ppm 0,1 <

< 3,0 ppm 3,0 < Chemical purity Identification solvents Total residual isopro (methanol, ethyl acetate, panol, ethanol) Total viable aerobic count (TVAC) Escherichia coli Loss on drying Impurities Heavy metals Lead Cadmium Mercury Microbiological specifications Total yeast and mould count (TYMC)

Authorised Novel Food

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 87 gel permeation gel y of more than 99 % (w/ y of more than 99

Specifications O 2

* 3H

O) 8

NaO 2

FeN (c = 1, H PO 0,1 % 0,1

o ≤

H 0,1 % 0,1 ≤ 10

28 % 28 = (+) 126,6 = (+) ≥

D ] α Eur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnetic resonance; HPLC: high-performance liquid chromatography; GPC: HPLC: high-performance magnetic resonance; 1H-NMR: proton nuclear Eur. Ph.: European Pharmacopoeia; spectroscopy; emission atomic coupled plasma Inductively chromatography; ICP/AES: units. CFU: colony-forming [ a) Lit. batch each on conducted b) Analyses 1881/2006 No (EC) Regulation with accordance in levels c) Maximum Ferric Sodium EDTA acid) is (ethylenediaminetetraacetic an odourless free-flowing, yellow to brown powder with a chemical purit soluble in water. freely is w). It C Chemical formula: Chemical characteristics: % solution: 3,5-5,5 pH of 1 % Iron: 12,5-13,5 % Sodium: 5,5 % Water: 12,8 % (CHNO): 68,4 Organic matter % EDTA: 65,5-70,5 Water insoluble matter: Nitrilo-triacetic acid: Chemical characteristics: % suspension 6,8-7,8 in water: pH of 5 Iron (total): Ferrous ammonium phosphate is a grey/green fine powder, practically insoluble in water and soluble in dilute mineral acids. and mineral soluble in dilute insoluble in water Ferrous ammonium powder, phosphate fine practically is a grey/green 10101-60-7CAS No.: FeNH Chemical formula: Description/Definition:

Description/Definition: Authorised Novel Food Ferrous ammonium phosphate Ferric Sodium EDTA

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 88 85 g/100 g ) muscle, subsequent ≥

Sardinops sagax

Specifications L. are extracted with ethanol followed by further extraction of this ethanolic extract this ethanolic of extraction with ethanol followed by further extracted L. are Glycyrrhiza glabra is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic of use the without processes and filtration solution acidic in using aqueous extraction extracted is 99 % 99 ≥ ) (short chain ) (short peptides, dipeptides and weight with a molecular of less than tripeptides 2 kDa):

Fucus vesiculosus

7,0 % (w/w) 7,0 8 g/100 g ≤ ≤ 3,0 % 3,0 ≤ 10 g/100 g ≤ ) Kjeldahl method ) Kjeldahl

1 Iron (II): 22-30 % (w/w) 22-30 Iron (II): Iron (III): (w/w) % Ammonia: 5-9 Water: ( Description/Definition: of rootstock or roots the from Flavonoids derived % of glabridin. to % 3,5 is a dark-brown coloured It liquid, containing 2,5 with medium-chain triglycerides. % Moisture: < 0,5 % Ash: < 0,1 < 0,5 meq/kg Peroxide value (PV): % of fat 2,5-3,5 Glabridin: % Glycyrrhizinic acid: < 0,005 Fat including polyphenol-type substances: % Protein: < 0,1 Carbohydrates: not detectable Description/Definition: seaweed the Fucoidan from solvents. The resulting extract is concentrated and dried to yield the fucoidan extract with the following specifications: Description/Definition: ( fish hydrolysis of protease-catalysed obtained by an alkaline which is mixture, a peptide is The novel food ingredient by column peptide fraction chromatography, under isolation of the vacuum concentration and spray drying. Yellowish white powderPeptides ( Val-Tyr (dipeptide): 0,1-0,16 g/100 g Ash: Moisture:

Sardinops Glycyrrhiza Glycyrrhiza Fucus vesiculosus

Authorised Novel Food

Fish peptides from Fish peptides sagax Flavonoids from glabra Fucoidan extract from the from Fucoidan extract seaweed

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 89

Specifications

: Absence/g

: Absence/10 g

Staphylococcus aureus based on of fucoidan: Composition types of extracts, the level two permitted of the Extract 1: % Fucoidan: 75-95 % Alginate: 2,0-5,5 % Polyphloroglucinol: 0,5-15 % Mannitol: 1-5 % Minerals: 0,5-2,5 Natural salts/Free % 0,5-1,0 Other carbohydrates: % Protein: 2,0-2,5 Extract 2: % Fucoidan: 60-65 Off-white to brown powder Bland odour and taste Odour and Taste: % (105 Moisture: < 10 °C for 2 hours) 25 suspension at % °C) 4,0-7,0 (1 pH value: Heavy metals: < Arsenic (inorganic): 1,0 ppm Cadmium: < 3,0 ppm Lead: < 2,0 ppm Mercury: < 1,0 ppm Microbiological criteria: 000 CFU/g count: < 10 microbial Total aerobic Yeast and mould count: < 100 CFU/g count: Absence/g Total enterobacteria Escherichia coli Salmonella

Authorised Novel Food

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 90

Specifications

is extracted using aqueous extraction in acidic solution and filtration processes without the use of organic of use without the processes solution and filtration in acidic using aqueous extraction extracted is

Undaria pinnatifida

: Absence/g

: Absence/10 g

Alginate: 3,0-6,0 % Alginate: 3,0-6,0 % Polyphloroglucinol: 20-30 % Mannitol: < 1,0 % Minerals: 0,5-2,0 Natural salts/Free % 0,5-2,0 Other carbohydrates: % Protein: 2,0-2,5 Description/Definition: seaweed Fucoidan from solvents. The resulting extract is concentrated and dried to yield the fucoidan extract with the following specifications: Off-white to brown powder (105 % 2 hours) °C for < 10 Bland odour and tasteMoisture: Odour and Taste: 25 suspension at % °C) 4,0-7,0 (1 pH value: Heavy metals: < 1,0 Arsenic (inorganic): ppm Cadmium: < 3,0 ppm Lead: < 2,0 ppm Mercury: < 1,0 ppm Microbiology: 000 CFU/g count: < 10 microbial Total aerobic Yeast and mould count: < 100 CFU/g count: Absence/g Total enterobacteria Escherichia coli Salmonella Staphylococcus aureus based of fucoidan: Composition on types of extracts, the level two of the permitted Extract 1: % Fucoidan: 75-95 % Alginate: 2,0-6,5

Undaria pinnatifida Authorised Novel Food Fucoidan extract from the from Fucoidan extract seaweed

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Specifications 4)- D-glucopyranose → -D-galactopyranosyl-(1 β 2)- →

1,0 w/w % ≤

O 0,6 w/w % ≤ 32

H 18

95 % 95 ≥ -L-Fucopyranosyl-(1

0,2 % 0,2 α ≤ 9,0 % 9,0 1,0 w/w %

1,0 w/w % ≤ ≤

≤

-fucosyllactose is a white to off-white powder is produced that a white to off-white synthesis by is process. a chemical -fucosyllactose -Fucosyl- D-lactulose: -Fucosyl- D-lactulose: ′ ′ Polyphloroglucinol: 0,5-3,0 % Polyphloroglucinol: 0,5-3,0 % Mannitol: 1-10 % Minerals: 0,5-1,0 Natural salts/Free % 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 % Minerals: 8-10 Natural salts/Free % Other carbohydrates: 0,5-2,0 % Protein: 1,0-1,5 Definition: Chemical name: C Chemical formula: CAS No: 41263-94-9 CAS No: Molecular weight: 488,44 g/mol Description: 2 Purity: 2'-Fucosyllactose: D-Lactose: L-Fucose: Difucosyl- D-lactose isomers: 2 3,2-7,0 solution): % pH (20 5 °C, Water (%): Ash, sulphated:

Authorised Novel Food -Fucosyllactose ′ (synthetic) 2

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 92

BL21 Escherichia coli

90 % 90 3,0 % 3,0 5,0 % 5,0 5,0 % 5,0 ≥ ≤ ≤ ≤

5,0 % 5,0 3,0 % 3,0 ≤ ≤

200,0 mg/kg in combination

≤ -Fucosyllactose is a white white powder to off and the liquid ′ Source: Genetically modified strain of Description: 2 % w/v) aqueous solution is a colourless to % ± 5 (45 concentrate aqueous slight yellow clear solution. 2'-Fucosyllactose is produced by process. a microbiological Purity: 2'-Fucosyllactose: Lactose: Fucose: 3-Fucosyllactose: Fucosylgalactose: Difucosyllactose:

Specifications 4)-D-glucopyranose 4)-D-glucopyranose 50,0 mg/kg singly, → ≤

K-12 -D-galactopyranosyl-(1 β 500 CFU/g ≤ 2)- →

Escherichia coli 15

1,0 % 1,0 32

≤ 10 EU/mg H 2,0 % 2,0 10 CFU/g ≤ ≤ 18

≤

0,01 % 0,01 90 % 90 ≤ ≥ -L-Fucopyranosyl-(1 α

0,3 % 0,3 3,0 % 3,0 ≤

0,1 mg/kg 2,0 ≤ ≤

≤ 3,0 mg/kg 9,0 % 9,0 ≤

≤

-Fucosyllactose is a white to off-white powder is produced that -Fucosyllactose is a white to off-white by a microbial -Fucosyl-D-lactulose: ′ ′ Acetic acid: acetone): 2-propanol, methyl acetate, Residual solvents (methanol, Description: 2 process. Purity: 2'-Fucosyllactose: D-Lactose: L-Fucose: Residual proteins: Definition: Chemical name: C Chemical formula: 41263-94-9 CAS No: Molecular weight: 488,44 g/mol Source: Genetically modified strain of Difucosyl-D-lactose: Heavy Metals: Palladium: Nickel: Microbiological criteria: count: total bacteria Aerobic mesophilic Yeasts and Moulds: 2 3,0-7,5 solution): % pH (20 5 °C, Water: Residual endotoxins:

Authorised Novel Food 2'-Fucosyllactose 2'-Fucosyllactose (microbial source)

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 93

Bifidobacterium ,

Heavy Metals: 50 CFU/g (liquid) ≤ 5 000 CFU/g (liquid) 5

≤ . 100 EU/ml (liquid) ≤ Aspergillus oryzae

CFU/g (powder), g/kg (powder and liquid)

μ 4 100 CFU/g (powder); ≤ 0,01 % (powder and liquid) 0,01 10 ≤ ≤ 0,5 % (powder and liquid) 0,5 0,025 ≤ ≤ 100 EU/g (powder), ≤ 0,1 mg/kg (powder and liquid) 3,0 % 3,0 : negative/100 g (powder), negative/200 (liquid) ml -galactosidases from 0,5 mg/kg (powder and liquid) ≤ ≤ : negative/100 g (powder), negative/200 ml (liquid) negative/200 ml (powder), negative/100 g : 3,0 % 3,0 0,2 mg/kg (powder and liquid) β ≤ ≤ ≤ 9,0 % (powder) 9,0 0,02 mg/kg (powder and liquid); ≤ ≤ Glucose: Galactose: Water: Ash, sulphated: Residual proteins: Lead: Arsenic: Yeasts and Moulds: Cadmium: Mercury: Microbiological criteria: count: Total plate Enterobacteriaceae/Coliforms: absence in 11g (powder and liquid) Salmonella Cronobacter Endotoxins: Aflatoxin M1:

Specifications 3 000 CFU/g 3 ≤

0,01 % 0,01 ≤ 2,0 % 2,0 ≤ 1,0 % 1,0 10 EU/mg ≤ ≤ 100 CFU/g 100 CFU/g ≤ ≤ Sulphated ash: Galacto-oligosaccharide is produced from milk lactose by process using an enzymatic bifidum, Pichia pastoris, Sporobolomyces singularis, Kluyveromyces lactis, Bacillus circulans, and Papiliotrema terrestris (DM) % Dry Matter GOS: min 46 % DM Lactose: max 40 % DM Glucose: max 27 % DM Galactose: min 0,8 % DM Ash: max 4,0 % DM Protein: max 4,5 Nitrite: max. 2 mg/kg Acetic acid: Residual proteins: Microbiological criteria: count: total bacteria Aerobic mesophilic Yeasts: Moulds: Endotoxins:

Description/Definition: Authorised Novel Food Galacto-oligosaccharide

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 94 risks by pentach risks linkages, which may II and III to Regulation family). It consists of a of consists It family). Leguminosae L. Taub. ( Taub. L.

Cyamopsis tetragonolobus Specifications ) & by Commission Implementing Regulation (EU) 2015/175 of 5 February 2015

2KCl 2NaCl · · o

4 4

o o SO SO - +54 HCl

2 2 ·

) ) o

5 5

NO NO

NO - + 73,0 to +52,0 ).

14 14

2 13

o o

H H H 6 6

laying down of guar gum special conditions to the import applicable originating in or consigned India due to from contamination ( lorophenol and dioxins White crystalline odourless powder White crystalline C Molecular formula: Relative molecular mass: 215,63 g/mol standard (HPLC) % of reference D-Glucosamine HCl 98,0-102,0 Specific rotation + 70,0 odourless powder White crystalline (C Molecular formula: Relative molecular mass: 605,52 g/mol standard (HPLC) % of reference D-Glucosamine Sulphate 2KCl 98,0-102,0 Specific Rotation +50,0 odourless powder White crystalline (C Molecular formula: Relative molecular mass: 573,31 g/mol standard (HPLC) % of reference D-Glucosamine HCl: 98-102 Specific Optical Rotation: +52 Native guar gum is the ground of guar endosperm strains of seeds from natural combined through glycosidic and mannopyranose units galactopyranose composed of primarily polysaccharide, weight high molecular %). be described chemically as a galactomannan (galactomannan content not less than 75 Appearance: White to yellowish powder 000 Daltons 000 000 – 8 Between 50 weight: Molecular 9000-30-0 CAS number: Einecs Number: 232-536-8 by Purity: As Commission specified Regulation No (EU) 231/2012 laying food in Annexes down for additives listed specifications ( (EC) No 1333/2008 of the European and Parliament of the Council

K-12 Asper and and E. coli

Description/Definition: and genetically and genetically K-12 K-12 Authorised Novel Food Aspergillus niger Aspergillus niger Glucosamine HCl from gillus niger modified strain of Guar Gum Glucosamine sulphate KCl from genetically modified strain of E. coli Glucosamine sulphate NaCl from genetically modified strain of E. coli

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 95

(DSM culture. 23964) as starter

Specifications Bacteroides xylanisolvens m

Moisture: Max 15 % Moisture: Max 15 1 hour — Viscosity * at 600 mPa.s 2 hours: Min 3 Viscosity * at 000 mPa.s 24 hours: Min Viscosity * at 4 Solubility: Soluble in hot and cold water 25 10g/L, at 6-7,5 pH for - °C Flakes 1 year Useful life: of black spots presence white with absence or minimal Colour: White/off Odour: Light 1-10 mm of particles: Average diameter % Moisture: Max 15 000 mPa.s 1 hour: Min 3 Viscosity * at 2 hours — Viscosity * at 24 hours Viscosity * at — Solubility — Soluble in hot and cold water 25 10g/L, at 5-7,5 pH for - °C Physico-chemical properties:Powder Shelf-life: 2 years Colour: White Odour: Light 60-70 of particles: Average diameter (*) The measurements of viscosity are carried out under the %, following 25 conditions: 1 °C, 20 rpm Description/Definition: Heat-treated fermented milk products are produced with

Bacteroides

Authorised Novel Food Heat-treated milk products milk Heat-treated fermented with xylanisolvens

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 96

Bacteroides xylanisolvens starting the fermentation with starting the fermentation

0,3 % 0,3 (DSM 23964)( (DSM ≤

Specifications Bacteroides xylanisolvens

O 0,3 % 0,3 (DSM 23964). milk product is homogenised fermented to inactivate The resulting and then heat-treated ≤ 10

H 8

0,01 mg/kg

99 % 99 ≤ ≥ 25,0 mg/kg

2,50 mg/kg ≤ 0,4 % 0,4 ≤ ≤ 0,01 mg/kg 2,00 mg/kg 0,01 mg/kg ≤ 0,4 % 0,4 ≤ ≤ ≤ 0,03 mg/kg

≤ ) Modified DIN EN ISO 21528-2. ISO EN DIN ) Modified

1 ( 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 or ultra-heat-treated is pasteurised less) or % fat or skimmed milk (0,5 and % fat) % 1,5 1,8 (between milk Semi-skimmed Bacteroides xylanisolvens (DSM 23964). The final product does not contain viable cells of synthesis chemical by obtained liquid viscous yellow pale a Hydroxytyrosol is C Molecular formula: Molecular weight: 154,6 g/mol 10597-60-1 CAS No: Moisture bitter Slightly Odour: CharacteristicTaste: with water Miscible Solubility (water): pH: 3,5-4,5 Refractive Index: 1,571-1,575 Purity: Hydroxytyrosol: Acetic acid: Hydroxytyrosol acetate: 3-methoxy-4hydroxyphenylglycol:and acid, iso-homovanilic acid, homovanillic Sum of Heavy Metals Lead: Cadmium: Mercury: Residual Solvents Ethyl acetate: Isopropanol: Methanol: Tetrahydrofuran:

Description/Definition: Authorised Novel Food Hydroxytyrosol

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 97 citric acid buffer. ied strain of food-grade osylated ISP and proteins and tion. As a result, the yeast cells

Specifications

Ilex guayusa. Ilex 90 ≥ ) in which a gene the ISP has into synthetic genome. been for the yeast’s inserted The protein is expressed and

0,3 5,0 ≤ ≤

0,5 ≤ 0,5 4,0 ≤

≤ Saccharomyces cerevisiae

5 g/l active ISP 5 g/l active

≥ 2,0 % 2,0 ≤ secreted into the growth medium where it is separated from the yeast cells by micro-filtration and by concentrated ultra-filtra by cells micro-filtration from the yeast into the growth is separated medium secreted where it ISP, glyc consists of native form. The ISP preparation as such or under ISP preparation an altered into the not transferred are commonly and as acids found salts the yeast and with 10 sugars as well mM peptides from is stabilised in food. The concentrate Assay: Description/Definition: Dark brown liquid. of Aqueous of dried leaves extracts 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 9,9–72,4 mg/100ml Chlorogenic acids: > (%): Solubility (water) 99 dry basis): Glucose (% Description/Definition: The Ice Structuring Protein (ISP) preparation is a light-brown liquid produced by submerged of fermentation a genetically-modif ( yeast baker’s pH: 2,5-3,5 Ash: DNA: Not detectable dry basis): + DP3 to DP9 (% Isomaltose Moisture (%): Sulphated ash(g/100 g): Heavy metals: Lead (mg/kg): Arsenic (mg/kg):

Powder:

Ilex guayusa Ilex Authorised Novel Food Aqueous extract of dried of Aqueous extract leaves of Ice Structuring Protein type Protein Ice Structuring III HPLC 12 Isomalto-oligosaccharide

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 98 ith a sweet taste ined from sucrose by an ined from

Specifications 90 ≥

O 2

H ·

O 0,3 5,0 22

≤

≤ H -D-glucopyranosyl-D-fructofuranose, monohydrate

α 12

0,5

≤ 0,5

≤

Syrup: > Dried solids (g/100 g): 75 dry basis): Glucose (% Isomaltose + DP3 to DP9 (% dry basis): pH: 4 - 6 Sulphated ash(g/100 g): Heavy metals: Lead (mg/kg): Arsenic (mg/kg): 360,3 Formula weight: (monohydrate) A reducing disaccharide that consists of one glucose and one fructose moiety linked by an alpha-1,6-glycosidic bond. It is obta is bond. linked by an alpha-1,6-glycosidic It moiety one glucose and fructose consists of that A reducing disaccharide product w is the monohydrate. process. odourless, enzymatic white crystals The commercial Appearance: Virtually white or almost Chemical name: 6-O- 13718-94-0CAS No.: C Chemical formula: Structural formula

Description/Definition: Authorised Novel Food Isomaltulose

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 99 ample preparation may be ample preparation hydrous, monohydrate and hydrous, monohydrate n tests, test solutions and other reference solutions and other test n tests,

Specifications

), ‘Instrumental methods’ ), ‘Instrumental

o to + 16

O 24

= + 13

H -D-Galactopyranosyl-D-glucitol -D-Galactopyranosyl-D-glucitol β 20 12

D 0,2 % d.b 0,2 ]

6,5 % (60 °C, 5 hours) 6,5 α ≤ ≤ 0,1 % d.b 0,1 2,5 % d.b 2,5 ≤ ≤

100 mg/kg d.b 200 mg/kg d.b ≤ ≤ 3,0 mg/kg d.b 2,0 mg/kg d.b ≤ 98 % on the dry basis 98 d.b dry weight basis) % (d.b — expressed on the 95 10,5 % 10,5 ≤ 0,1 mg/kg 1,0 mg/kg d.b ≥ ≥ ≤

≤ ≤ materials (JECFA), 1991, 322 pp., English, ISBN 92-5-102991-1. ) Food and techniques, Paper 5 Rev. Nutrition identificatio general notices, analytical 2 — for Guide to specifications

1 ( Purity: Assay: products hydrogenation occur in an Crystalline of lactose. powder via catalytic or colourless solution manufactured Crystalline used as a catalyst. is Nickel dihydrate forms. Chemical name: 4-O- C Chemical formula: Assay: Loss on drying: Heavy metals: Lead: Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of s based on of the method in FNP 5( described the principles Molecular weight: 344,31 g/mol 585-86-4 CAS No: Purity: Very soluble in water water): Solubility (in Specific rotation [ Water: Other polyols: Reducing sugars: Chlorides: Sulphates: Sulphated ash: Nickel: Arsenic: Lead:

Description/Definition: Authorised Novel Food Lactitol

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 100

4)- D-glucopyranose 4)-D-glucopyranose → → 200 mg/kg in combination ≤ -D-galactopyranosyl-(1 -D-galactopyranosyl-(1 β β 3)- 3)- → → 50 mg/kg singly, ≤

Specifications -D-glucopyranosyl-(1 -D-glucopyranosyl-(1 β β 4)-2-acetamido-2-deoxy- 4)-2-acetamido-2-deoxy- 500 CFU/g → → ≤ 0,6 % 0,6 ≤

21 21

NO NO

45 45

10 EU/mg H H ≤ 96 % 96 26 26

0,01 % 0,01 ≥ 0,3 % 0,3 ≤ ≤ -D-Galactopyranosyl-(1 -D-Galactopyranosyl-(1 0,4 % 0,4 β β ≤ 0,3 %Residual solvents (methanol, 2-propanol, acetone): methyl acetate, 0,3 1,0 % 1,0 ≤

0,1 mg/kg ≤ ≤

10 CFU/g 3,0 mg/kg 10 CFU/g ≤ 9,0 % 9,0 ≤ ≤ -neotetraose is a white to off-white powder. to off-white Produced is a white synthesis by process and by -neotetraose a chemical is isolated crystallisation. ≤

N Chemical formula: C Chemical formula: Definition: Chemical name: 13007-32-4 CAS No: Molecular weight: 707,63 g/mol Description: Lacto- C Chemical formula: 13007-32-4 CAS No: Molecular weight: 707,63 g/mol Purity: free): Assay (water D-Lactose: Lacto-N-triose II: Lacto-N-neotetraose fructose isomer: 5,0-7,0 solution): % pH (20 5 °C, Water: Ash, sulphated: Definition: Chemical name: Acetic acid: Residual proteins: Palladium: Nickel: Microbiological criteria: count: total bacteria Aerobic mesophilic Yeasts: Moulds: Residual endotoxins:

-neotetraose -neotetraose N N Authorised Novel Food Lacto- Lacto- (synthetic) (microbial source)

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 101

ude protein. The press juice rophyll pigments. The protein rophyll pigments. The granulated and stored in inert -neotetraose is isolated by is isolated crystallisation. -neotetraose N

Specifications

K-12 500 CFU/g

≤ 1,0 % 1,0 ≤

100 mg/kg L.) is processed within 2 hours harvest. It is chopped after and crushed. By passing through an oleaginous-type press, the ≤ Escherichia coli 3,0 % 3,0

≤

10 EU/mg ≤ 92 % 92 0,01 % 0,01 ≥ 3,0 % 3,0 ≤ ≤ 0,4 % 0,4 ≤ Medicago sativa

3,0 % 3,0

≤ 10 CFU/g 10 CFU/g ≤ 9,0 % 9,0

-neotetraose is a white to off-white powder is produced that is a white to off-white by process. Lacto- -neotetraose a microbiological ≤

≤ N -Lacto-N-neohexaose: Source: Genetically modified strain of Description: Lacto- Purity: free): Assay (water D-Lactose: Lacto-N-triose II: para % of cr contains about 35 of this juice The dry matter of dry matter). % (10 and press juice Lucerne provides a fibrous residue and chlo with carotenoid associated proteins coagulation of allows and vapour injection Preheating neutralised. (pH 5,8-6,2) is precipitate is separated by centrifugation and dried. thereafter After adding ascorbic acid the Lucerne protein concentrate is gas or in cold storage. Composition: % Protein: 45-60 % Fat: 9-11 % 1-2 Free carbohydrates (soluble fibre): Lacto-N-neotetraose fructose isomer: 4,0-7,0 solution): % pH (20 5 °C, Water: Ash, sulphated: Residual solvents (methanol): Description/Definition: ( The Lucerne Residual proteins: Microbiological criteria: count: total bacteria Aerobic mesophilic Yeasts: Moulds: Residual endotoxins:

Authorised Novel Food Lucerne leaf extract from Lucerne leaf extract Medicago sativa

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 102

arotenoids used in food. sured. 5 % other carotenoids. It is presented either as a is presented either carotenoids. It % other 5 ≤

5 % other carotenoids. It is presented either as a powder is presented either in % other carotenoids. It a suitable 5 95 % lycopene and 95 ≤ ≥ Specifications L.) consists of consists L.) 95 % lycopene and 95 ≥ consists of Lycopersicon esculantum 96 % lycopene and minor quantities of other related carotenoid as a powder in components. carotenoid Lycopene either related is presented of other lycopene quantities % and minor 96 ≥

Blakeslea trispora Blakeslea

56 56

-trans lycopene)

H H all 40 40

4,5 mg/kg ≤ 100 mg/kg 350 mg/kg ≤ ≤ 1,4 % 1,4 200 mg/kg ≤ ≤ Chemical formula: C Chemical formula: Polysaccharides (insoluble fibre): 11-15 % 11-15 Polysaccharides (insoluble fibre): % 2-3 including cellulose: % Minerals: 8-13 Saponins: Isoflavones: Coumestrol: Phytates: L-canavanine: Synthetic lycopene is produced commonly by condensation used the Wittig of synthetic intermediates in the production of other c Synthetic lycopene consists of has to be assured. Antioxidative protection or an oily dispersion. The colour is dark red or red-violet. suitable matrix Chemical name: Lycopene 502-65-8 ( CAS No.: tomatoes ( lycopene The purified from Formula weight: 536,85 Formula weight: Da Description/Definition: lycopene from The purified 536,85 Formula weight: Da protection has to be as Anti-oxidative or red-violet. dark red or an oily dispersion. The colour is suitable matrix powder in a matrix or an oily dispersion. The colour is dark red or red-violet. Anti-oxidative protection has to be assured. Anti-oxidative protection or an oily dispersion. The colour is dark red or red-violet. matrix Chemical name: Lycopene lycopene) trans 502-65-8 (all CAS No.: C Chemical formula:

Description/Definition: Blakeslea Description/Definition:

Authorised Novel Food Lycopene Lycopene from trispora tomatoes Lycopene from

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 103

2 ) ) with subsequent removal of the 5

O 4

H 4

2 ) 7

O 5

H 6

(C 5

Lycopersicon esculentum Mill.

Specifications

15 % 15 ≤

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

0,5 % 0,5 H β ≤ 40

Total tocopherols: 1,5-3,0 % Total tocopherols: 1,5-3,0 % 13-20 Unsaponifiable matter: % 60-75 acids: Total fatty Water (Karl Fischer): Chemical name: Lycopene lycopene) trans 502-65-8 (all CAS No.: C Chemical formula: liquid. brown viscous, clear dark to red a is solvent. It % Total lycopene: 5-15 % Thereof trans-lycopene: 90-95 % as lycopene): 6,5-16,5 Total carotenoids (calculated % 1,75 Other carotenoids: (Phytoene/phytofluene/ amorphous is a white to yellowish-white, Mg powder.Chemicalmalate formula: Magnesium citrate hydroxypropane-1,2,3-tricarboxylate) Chemical name: Pentamagnesium di-(2-hydroxybutanedioate)-di-(2- 1259381-40-2CAS No.: Molecular weight: 763,99 Daltons (anhydrous) 100 ml) 20 g in (about water in soluble Freely Solubility: Description of the physical Amorphous state: powder % Assay magnesium: 12,0-15,0 Loss on drying (120 °C/4 hours): yellowish-white to White Colour (solid): yellowish to Colourless aqueous solution): % Colour (20 Formula weight: 536,85 Formula weight: Da Description/Definition: Lycopene tomatoes is obtained oleoresin from by solvent extraction of ripe tomatoes ( Description/Definition:

Authorised Novel Food Magnesium citrate malate Magnesium citrate Lycopene oleoresin from Lycopene oleoresin tomatoes

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 104 dissolved in medical-grade dissolved in

L. and produced carbon with supercritical dioxide. The bark is washed Specifications Magnolia officinalis

10 94 % 94 100 ≤ ≥

≤ 2,0 ≤

2 % 2 ≤ 0,5

≤

0,5 ≤ 1 ppm 85,2 % 85,2 0,5 % 0,5

0,05 % 0,05 % 0,05 0,1 ppm ≤ ≥ ≥ 3,0 ppm ≤ ≤ ≤ ≤ 2,0 ppm

≤ Appearance (20 % aqueous solution): Clear solution aqueous Clear % solution): Appearance (20 Approx. 6,0 aqueous solution): % pH (20 Impurities: Chloride: Sulphate: Arsenic: Lead: Cadmium: Mercury: is obtained the bark of plant from Magnolia bark extract is extract dioxide. The carbon supercritical with and extracted being crushed before content moisture reduce to and oven dried magnolia bark extract. to yield ethanol and re-crystallised composed two phenolic compounds,mainly of is magnolol and honokiol.extract Magnolia bark Appearance: Light brownish powder Purity: Magnolol: Honokiol: Honokiol: Magnolol & Total Eudesmol: % Moisture: 0,50 Heavy metals: Arsenic (ppm): Lead (ppm): Methyl eugenol (ppm): Tubocurarine (ppm): Total Alkaloid (ppm):

Description/Definition: Authorised Novel Food Magnolia Bark Extract

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 105 on of ‘maize-germ oil high oil ‘maize-germ on of in the concentration of thyl groups.

Specifications g/kg μ

/kg 2

10 mEq O g/kg ≤ μ g/kg μ

1,3 g/100 g 6,0 mg KOH/g ≥ ≤

-tocopherol (%): 10-25 % 10-25 -tocopherol (%): -tocopherol (%): < 3,0 % < 3,0 -tocopherol (%): -tocopherol (%): < 7,0 % < 7,0 -tocopherol (%): -tocopherol (%): 68-89 % 68-89 -tocopherol (%): Description/Definition: Maize-germ oil high in unsaponifiable matter is produced by vacuum distillation and it is from refined different maize-germ oil oil high and in unsaponifiable matter’). oil 10 g maize-germ in ‘maize-germ (1,2 g in refined unsaponifiable fraction Purity: > 9,0 g/100 g Unsaponifiable matter: Tocopherols: α β γ δ alcohols, > methylsterols: 6,5 Sterols, triterpenic g/100 g Fatty acids in triglycerides: % palmitic acid: 10,0-20,0 % stearic acid: < 3,3 % 20,0-42,2 oleic acid: % linoleic acid: 34,0-65,6 % linolenic acid: < 2,0 Acid value: Peroxide value (PV): Heavy metals: 500 < 1 Iron (Fe): 100 < Copper (Cu): Methyl cellulose is cellulose obtained directly from natural strains of fibrous with and plant me etherified material partially of cellulose Chemical name: Methyl ether Impurities: hydrocarbons < 2 (PAH) Benzo(a)pyrene: Polycyclic aromatic Treatment with active carbon is required to ensure that polycyclic aromatic hydrocarbons not enriched in the producti carbon (PAH) are to ensure that polycyclic aromatic is required with active Treatment in unsaponifiable matter’

Description/Definition: Authorised Novel Food Maize-germ oil high in unsa ponifiable matter Methylcellulose

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 106 OH) 2

CH 2

loroform. Soluble in glacial

) and not more than 5 % of hydroxyethoxyl ) and groups not more than (-OCH 5 3

Specifications

OCl 2

N 9

H 7

10 % (105 °C, 3 hours) 10 1,5 % determined at 800 determined % ± 25 °C 1,5 ≤ 8,0 (1 % colloidal solution) 8,0 (1

≤ ≤

1,0 mg/kg

≤

3,0 mg/kg ≤ ≤ or 98,5 % 98,5 CH

2,0 mg/kg ≥

3 2

≤ 5,0 and ≥ Chemical formula: The polymers contain substituted anhydroglucose formula: Chemical formula: the following general units with following: the of one be may C6H7O2(OR1)(OR2)(OR3) R1, R2, R3 each where — H — CH 000) 000 about 2 g/mol (n 000 about 100) up about 380 (n to about 20 from Macromolecules: weight: Molecular of methoxyl groups (-OCH % 33 than and not more % than 25 Assay: Content not less chloride Chemical name: 3-carbamoyl-1-methyl-pyridinium C Chemical formula: — CH or fibrous powder. Slightly hygroscopic yellowish granular or greyish odourless white or slightly and tasteless, and ch ether solution. Insoluble in ethanol, opalescent, viscous, to colloidal producing clear a in water, Swelling Solubility: acetic acid. Purity: Loss on drying: Sulphated Ash: pH: Heavy metals: Arsenic: 1005-24-9 CAS No: Molecular weight: 172,61 Da Description solid produced by synthesis process. crystalline a chemical is white or off-white, 1-Methylnicotinamide chloride Characteristics/Composition solid crystalline Appearance: White – off-white, Purity: Lead: Mercury: Cadmium: Definition:

Authorised Novel Food 1-Methylnicotinamide chloride 1-Methylnicotinamide

M11 M9 ▼ ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 107 ucosamine salt

Specifications 100 CFU/g ≤

0,20 % 0,20 O ≤ 0,05 % 0,05

≤ N Total aerobic microbial count: microbial Total aerobic : absence in 1 g

0,50 % 0,50

H ≤ : absent in 1 g 0,1 % 0,1 32

≤ 1,0 % 1,0 0,10 % 0,10 ≤ 0,002 % 0,002 ≤ 0,10 % 0,10 10 CFU/g ≤ 0,05 % 0,05 ≤ ≤ ≤ 0,3 % 0,3 0,3 % 0,3 ≤ ≤

Trigonelline: Nicotinic Acid: Nicotinamide: Largest unknown impurity: Sum of unknown Sum of impurities: Description/Definition: acid, gl 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 C Chemical formula: Molecular weight: 817,80 g/mol (anhydrous) 1181972-37-1CAS No.: Appearance: Creamy to light-brown powder Purity: acid % of (6S)-5-methyltetrahydrofolic 99 At least purity: Diastereoisomeric Sum of all impurities: all Sum of insoluble in 2-propanol Solubility: soluble in water and and dichloromethane methanol. Practically Moisture: Loss on drying: Residue on ignition: and Residual Solvents Heavy Metals Methanol: Heavy metals: Microbiological criteria: Mould/yeast: Enterobacteriaceae: absence in 1 g Pseudomonas aeruginosa Staphylococcus aureus CFU: Colony Forming Units

Authorised Novel Food (6S)-5-methyltetrahydrofolic (6S)-5-methyltetrahydrofolic acid, glucosamine salt

M9 M11 ▼ ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 108

Specifications

100 CFU/g ≤ Si 3

100 CFU/g

≤

g/l g/l μ

g/l μ : Absence in 10g μ

g/l μ 1,0 1,0 ppm 5,0 presence) mg/kg (residual 1,0 ≤ 0,1 ppm ≤ ≤ 3,0 2,0 ppm ≤ ≤

≤ ≤ 10 ppm 8,0 % 8,0 1,0 2,0 ppm ≤

≤ ≤ ≤ Glucosamine assay: 34-46 % in dry basis in % 34-46 Glucosamine assay: % in 5-Methyltetrahydrofolic acid dry assay: basis 54-59 Water: Heavy metals: Lead: Description/Definition: 1-methyl- Chemical name: Silanetriol, CH Chemical formula: Molecular weight: 94,14 g/mol 2445-53-6 CAS No: Purity: (aqueous solution): preparation (monomethylsilanetriol) Organic Silicon 6,4-6,8 Acidity (pH): Silicon: 100-150 mg Si/l Heavy metals: Lead: Cadmium: Mercury: Arsenic: Boron: Mercury: Cadmium: Arsenic: Solvents: Methanol: Microbiological criteria: count: microbial Total aerobic Yeasts and moulds: Escherichia coli

Authorised Novel Food

Monomethylsilanetriol (Organic Silicon) M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 109 dextrins constant xed with maltodextrins (same maltodextrins xed with cultivated in a submerged fermentation. It is a light a is It in a submerged fermentation. cultivated Daltons, a degree of branching of 2/5 helical and a triple

5 Lentinula edodes

Specifications

are separated. The obtained pulp to is filtered separate juice from the flesh. Desiccation of the Lentinula edodes Lentinula Morinda citrifolia L.) are pressed. The obtained juice is pasteurised. An the optional step pressing before or fermentation may after

are harvested by are hand. Seeds and pasteurisation, the puree skin After from the pureed may be fruits. separated mechanically

): < 10 mg/ml

-(1-6)-D-glucan which has a molecular weight of approximately 5 × 10 β Morinda citrifolia

g/kg

μ g/kg -(1-3) μ ): < 0,1 mg/ml

β 1 Morinda citrifolia 10 ≤ 10 ≤ ) Bradford method ) Bradford method ) Kjeldahl

1 2 N-containing constituents( 1,2 mg/ml\ 0,8 – Lentinan: ( ( Description/Definition: of Seeds and skin of the sun-dried fruits ways: two or one in occurs produced juice is obtained by and maltodextrins, this mixture by using malto Either of inflow the juice atomisation keeping maize the rates and then mi initially be dried to juice the allows process this drying and then mixing with an excipient, or by zeodratation Or atomisation). used in amount as Description/Definition: of The fruits is packaged and containers in aseptic stored under cold conditions. Description/Definition: of mycelium the obtained from aqueous extract a sterile is The novel food ingredient liquid. turbid brown, slightly a Lentinan is tertiary structure. Purity/Composition of the mycelial extract from % Moisture: 98 % 2 Dry matter: Free glucose: < 20 mg/ml Total protein( Description/Definition: of (fruits Noni fruits occur. Rubiadin: Lucidin:

)

) Morinda Morinda citri Lentinula edodes

) Authorised Novel Food

) Morinda citrifolia Mycelial extract from Shiitake Mycelial extract mushroom ( Noni fruit puree and puree Noni fruit concentrate ( Noni fruit juice powder juice Noni fruit ( Noni fruit juice ( juice Noni fruit citrifolia folia

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 110 imits of detection: 2,5 imits of detection: ng/ml collected and to collected pasteurised, prior

Specifications puree by treatment with puree pectinolytic enzymes (50– by 60 treatment °C for 1-2 h). Then the puree is heated to M. citrifolia

g/ml g/ml μ μ 0,254 0,254

≤ ≤ ):

1 concentrate is prepared from

0,4 g/100 g ≤ (5,15 dimethylmorindol); 50,0 ng/ml (lucidin); 6,3 ng/ml (alizarin) and (5,15 62,5 6,3 ng/ml (alizarin) dimethylmorindol);50,0 ng/ml (rubiadin). ng/ml (lucidin); By an HPLC-UV method developed and validated for the analysis of anthraquinones in Morinda puree and citrifolia concentrate. L )

1 Morinda citrifolia inactivate the pectinases and then immediately cooled. The juice is separated in a the decanter centrifuge. Afterwards juice is 6 a brix of being in a vacuum to 8 a brix of 49 concentrated concentrate. to 51 evaporator from in the final Composition: Puree: % Moisture: 89-93 Protein: < 0,6 g/100 g Fat: Ash: < 1,0 g/100 g 5-10 Total carbohydrates: 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): ( Lucidin (1): Not detectable Lucidin (1): Alizarin (1): Not detectable detectable Not Rubiadin (1): 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 37-45 Total carbohydrates: g/100 g Fructose: 9-11 g/100 g Glucose: 9-11 g/100 g 1,5-5,0 Dietary fibre: g/100 g 5,15-dimethylmorindol (

Authorised Novel Food

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 111 detection: 2,5 ng/ml (5,15 dimethyl

Specifications fruits by Fruits are pulped freeze-drying. and seeds are removed. freeze-drying After

Morinda citrifolia L.) Morinda citrifolia are subject to drying and roasting steps. The product has a particle size ranging from broken to coarse leaves ranging from size drying steps. The product has a particle to and roasting subject are

g/ml μ g/kg μ g/kg μ 2,0 10 ≤ Morinda citrifolia ≤ 10 ):

≤ 1

morindol) By an HPLC-UV method developed and validated the analysis for of anthraquinones powder. in Morinda fruit citrifolia Limits of )

1 After cutting, the leaves of ( powder with fines. It is of greenish brown to colour. greenish of is It fines. powder with Purity/Composition: % Moisture: < 5,2 % Protein: 17- 20 % Carbohydrate: 55-65 % Ash: 10-13 % Fat: 4-9 % < 0,14 Oxalic acid: % < 2,7 Tannic acid: 5,15-dimethylmorindol: < 47 mg/kg Rubiadin: non detectable, Description/Definition: pulped noni ( from made is powder Noni fruit powder and encapsulated. a to milled noni pulp is remaining the noni fruits, from removed is during which water 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 80-85 Total carbohydrates: g/100 g Fructose: 20,4-22,5 g/100 g Glucose: 22-25 g/100 g 15,4-24,5 Dietary fibre: g/100 g 5,15-dimethylmorindol ( Lucidin: non detectable, Lucidin: non detectable, Description/Definition: )

Morinda Morinda citrifolia

) Authorised Novel Food Noni leaves ( Noni leaves Noni fruit powder ( Noni fruit citrifolia

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 112 , best ensured by a purity of

Specifications

2,0 % 2,0 ≤ /kg oil 2

10 % 10

≤

25 % 25

≤ 0,5 % 0,5

5 meq O ≤ 3,0 % 3,0 ≤

≤ 3 hours 20 1 % 1 ≤ ≤ ≤

3,0 % 3,0 5,0 % 5,0 30 % 30 40 % 40 15 % 15 ≤ 0,5 KOH/g oil 80 % 80 ≤ ≤ ≤ ≤ ≤ ≤ 0,1 % (w/w) 0,1 ≤

-sitosterol: -sitostanol: Crystalline silica: max 0,1-0,3 % as impurity max 0,1-0,3 silica: Crystalline Description/Definition: Oil enriched with phytosterols/phytostanols is composed and a phytosterol fraction. of an oil fraction Acylglycerol Distribution: acids (expressed as oleic acid): Free fatty Monoacylglycerols (MAG): Diacylglycerols (DAG): Triacylglycerols (TAG): Making up the balance Phytosterol fraction: β β campesterol: campestanol: Peroxide value (PV): p-Anisidine value: 0 at Cold test °C: Moisture: stigmasterol: brassicasterol other sterols/stanols: Others: Moisture and volatile: Peroxide value (PV): < 5,0 meq/kg Peroxide value (PV): acids: Trans fatty or equivalent method) of phytosterols/phytostanols: Contamination/Purity (GC-FID of contaminants food have to be free for sources other than vegetable oil suitable Phytosterols and phytostanols from extracted %. more than 99 Silicon: 3,3 % 3,3 Silicon: Acid value: Acid

microalgae

Authorised Novel Food Odontella aurita Oil enriched with phytosterols/ phytostanols Oil extracted from squids

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 113

rch by combining chemical

cultural and manufacturing practices

conventionally processed product for regimen to storage Equivalent Specifications ]y 2

3 Fruit harvested and stored in conjunction with good/hygienic agri good/hygienic with conjunction in stored and harvested Fruit Fruit homogenised and added to other ingredients other to added and homogenised Fruit )PO Comments 5

O 9

6 1,0 % 1,0 ≤ H]x [(C 2

2 Assured by added sugars added by Assured ) Assured by added sugars added by Assured 5

O 9

6 Minimum 15 days at – 20 Minimum 15 days at °C < 0,95 [(C

n ) 5

O 20 % 20 10

10 % 10 5,0 %Trans fatty acids: %Trans fatty 5,0

≥ ≥ ≤ H 6

Target

70 % 70

≥ 60 days maximum at + 5 °C maximum °C 5 + at maximum days 60 % of thawed fruit % to 60 40 Parameter 7 to 42 to 7 3,2 to 4,2 to 3,2

Brix

Unsaponifiable matter: Fruit added a Final storage sta high amylose from derived starch resistant modified chemically a phosphate) is (phosphated distarch starch Phosphated maize treatments to phosphate create cross-links between carbohydrate residues and hydroxyl esterified groups. The novel nearly white powder. food is a white or ingredient 11120-02-8 CAS No: (C Chemical formula: Docosahexaeonic acid: Eicosapentaenoic acid: Fruit storage before high- pressure treatment pH o n = number of glucose units; x, y = of substitution degrees of phosphated phosphate: distarch characteristics The chemical % Loss on drying: 10-14 pH: 4,5-7,5 Dietary fibre: % Starch: 7-14

Description/Definition:

Authorised Novel Food Phosphated maize starch Phosphated maize Pasteurised fruit-based prep Pasteurised fruit-based arations produced using high- pressure treatment

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 114

bean lecithin with the with bean lecithin it includes significant nsphosphorylation with colour. The liquid form a a phosphodiesterlinkage. a

Specifications

/kg 2

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

)

35 % 35 % 61 ≥ ≥ 75 % 75 % 85 ≥ ≥

0,8 % 0,8 0,8 % 0,8 ≤ ≤ ) Tocopherols may be added as antioxidants according to Commission Regulation (EU) No 1129/2011 No (EU) Regulation Commission to according antioxidants as added be may ) Tocopherols

1 Protein: Lipids: Residual bound phosphorus: Description/Definition: The novel food ingredient is yellow to brown powder. Phosphatidylserine is obtained from fish phospholipids by an enzymatic tra the amino acid L-serine. phospholipids: of the phosphatidylserine product manufactured from fish Specification % Moisture: < 5,0 Phospholipids: Phosphatidylserine: % Glycerides: < 4,0 % < 1,0 Free L-serine: ( % Tocopherols: < 0,5 ( Description/Definition: The novel food to light yellow powder. brown in liquid ingredient is off-white with a to It is also available clear form orange that of Phosphatidylserine due contains lower levels to the fact It as a carrier. (MCT) contains medium chain triacylglycerides (MCT). oil amounts of high-phosphatidylcholine soya phospholipids transphosphatidylation of Phosphatidylserine from obtained through soy enzymatic is vi acids and glycerophosphate Phosphatidylserine consists of a L-serine skeleton conjugated with two fatty L-serine. amino acid Characteristics of Phosphatidylserine from soya phospholipids: Powder form: % Moisture: < 2,0 Phospholipids: Phosphatidylserine: % Glycerides: < 2,0 % < free L-serine: 1,0 % Tocopherols: < 0,3 Peroxide value (PV): < 5,0 meq O Peroxide value (PV):

Authorised Novel Food Phosphatidylserine from fish phospholipids Phosphatidylserine from soya phospholipids

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 115 onventional (1 – 6) glycosidic α llow-brown powder form

Specifications (1 – 4) glycosidic bonds branched every 8 to 12 glucose units by bonds 12 glucose units – 4) glycosidic branched every 8 to (1 α

)n with linear linkages of )n with linear 6

O 12

70 % 70 20 % 20 ≥

20 % 20 20 % 20 ≥ ≥ ≥ 25 % 25 1,0 % 1,0 ≥ 0,3 % 0,3 2,0 % 2,0 ≤ ≤

≤ 1,0 % 1,0 White to powder off-white which is an odourless, colourless, flavourless polysaccharide derived from non-GM sweet corn using c ≤ 2,0 % 2,0 Glucose polymer (C ≤

Phytosterols: < 0,2 % Phytosterols: < 0,2 Liquid form: % Moisture: < 2,0 Phospholipids: Phosphatidylserine: Glycerides: not applicable % < free L-serine: 1,0 % 0,3 Tocopherols: < % Phytosterols: < 0,2 Description/Definition: through The phospholipid conversion manufactured of soy lecithin. The product is enzymatic a highly product is concentrated, ye of phosphatidylserine and an equal level. phosphatidic acid at Specification of the product: Moisture: Total phospholipids: Phosphatidylserine: Phosphatidic acid: Glycerides: techniques food processing Definition: bonds Free L-serine: Tocopherols: Phytosterols: Silicon dioxide is used with a maximum content of 1,0 % Silicon dioxide is used with a maximum content of 1,0 % pure Phospholipides egg from yolk % and 100 85

Description:

Authorised Novel Food Phospholipides from egg yolk Phytoglycogen Phospholipid product containing equal amounts of phosphatidylserine and phos phatidic acid

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 116 , best ensured by a purity of tanols or esterified with food tanols or esterified

) kernels.

Prunus domestica Specifications

(GC-FID or equivalent method):

(with GC-FID or equivalent method): equivalent GC-FID or (with -sitosterol: < 81 % -sitosterol: < 81 % -sitostanol: < 35 % of total sterols 80-90 -Sitosterol: -Tocopherol:80 % of total tocopherols % of total -Tocopherol:80 Specifications: % Carbohydrates: 97 % Sugars: 0,5 % Fibre: 0,8 % Fat: 0,2 % Protein: 0,6 and s sterols free plants and as may be presented from extracted are and stanols that sterols Phytosterols and phytostanols are acids. grade fatty Composition β β % campesterol: < 40 % campestanol: < 15 % stigmasterol: < 30 % brassicasterol: < 3,0 % < 3,0 other sterols/stanols: Contamination/Purity of contaminants food have to be free for sources other than vegetable oil suitable Phytosterols and phytostanols from extracted % of the phytosterol/phytostanol ingredient. more than 99 obtained by a vegetable oil cold pressing of plum ( Plum kernel oil is Composition: % Oleic acid (C18:1): 68 % Linoleic acid (C18:2): 23 γ β % of triglycerides 40-55 Triolein: mg/kg oil 5 maximum Cyanhydric acid:

Description/Definition: Description/Definition: Authorised Novel Food Plum kernel oil Phytosterols/phytostanols

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 117

Specifications

(GEP-44) )/g)

Aspergillus niger

CFU/g CFU/g

3 30 CFU/g 2

≤ 10 10 ≤ ≤ )/g (> 34,8 PPU(

1 150 mg/kg 500 mg/kg 10 mg/kg

≤ ≤ 600 mg/g (dry substance) ≤ ≥

800 mg/g ≥

Prolyl oligopeptidase is available as an enzyme preparation containing approximately 30 % maltodextrin. containing as an enzyme preparation approximately 30 oligopeptidase Prolyl is available 0,5 mg/kg 0,1 mg/kg ≤ 1,0 mg/kg ≤ ≤ 1,0 mg/kg 400 mg/g (dry substance) ≤ ≤ Dry substance: Protein (N * Protein (N 6,25): Specification of the enzyme: Systematic name: Prolyl oligopeptidase endopeptidase, endoprolylpeptidaseSynonyms: endopeptidase,Prolyl proline-specific Molecular weight: 66 kDa Enzyme Commission number: EC 3.4.21.26 72162-84-6CAS number: of strain modified Source: A genetically Description: of the enzyme preparation of prolyl oligopeptidase: Specifications 000 PPI( Activity: > 580 Appearance: Microgranulate batch to to orange yellowish. The colour may change from Colour: Off-white % > 94 Dry Matter: Gluten: < 20 ppm Heavy metals: Lead: Arsenic: Total yeasts and moulds: Sulphite reducing anaerobes: Ash: Glycoalkaloid (total): Lysinoalanine (total): Lysinoalanine (free): Cadmium: Mercury: Microbiological criteria: count: plate Total aerobic

Authorised Novel Food Potato proteins (coagulated) Potato proteins and hydrolysates thereof Prolyl oligopeptidase (enzyme preparation)

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 118 g/kg), T-2 Toxin μ ugation. The obtained uspended in a physiologic a uspended in f digestion. g/kg), Ochratoxin A (< 0,20 (< A g/kg), Ochratoxin μ

g/kg), total Aflatoxins (< 2,0 Aflatoxins (< g/kg), total μ g/kg) μ Specifications

g/kg), Fumonisin B1 and B2 (< 2,5 B2 (< Fumonisin B1 and g/kg),

: Absence in 10 g

: negative (Real Time PCR) : Absence in 25 g : Absence in 10 g : < 100 CFU/g : < 10 CFU/g : < 10 CFU/g : Absence in 25 g spp.: negative (Real Time PCR) Time (Real spp.: negative : Absence in 25 g g/kg), Zearalenone (< 2,5 g/kg), Zearalenone μ ) PPI – Protease Picomole International Picomole Protease – Units ) PPI Protease Proline or Units Peptidase Prolyl – ) PPU

1 2 (< 5 ( Listeria monocytogenes Staphylococcus aureus Influenza A: negative Real (Reverse Transcription Time PCR) Escherichia coli Enterobacteriaceae Salmonella Escherichia coli Staphylococcus aureus Pseudomonas aeruginosa Listeria monocytogenes Absent Antimicrobial activity: 0,25 (< B1, B2, G1, G2 Aflatoxin detection: of limits Mycotoxins: Below ( Description/Definition: homogenised obtained from and high is pig kidneys through speed centrif precipitation The protein extract a combination of salt enzyme % of the diamine oxidase (enzyme nomenclature E.C. 1.4.3.22) and res is proteins with 7 contains essentially precipitate buffer system. The obtained pig kidney extract is formulated as encapsulated coated enteric pellets to reach the active sites o Basic Product: Specification: pig kidney protein excerpt with natural content of Diamin oxidase (DAO): Physical condition: liquid Colour: brownish Appearance: slightly turbid solution 6,4-6,8 pH value: 677 kHDU DAO/ml (DAO REA Radioextractionassay)) > 2 activity: Enzymatic Microbiological criteria: Brachyspira

Authorised Novel Food Protein extract from pig kidneys

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 119

Hyphomicrobium denitrificans

Specifications -pyrrolo[5,4-f]quinoline-2,7-dicarboxylate -pyrrolo[5,4-f]quinoline-2,7-dicarboxylate

H CFU/g CFU/g CFU/g

CFU/g CFU/g

3 4 2 5 4

O 2

Na CFU/g

5 N 4

H : < 100 CFU/g 14

: < 10 CFU/g

: Absence/10g : Absence/10g Total aerobic microbiological count: < microbiological 10 Total aerobic 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 micropellets Colour: yellow grayAppearance: 110-220 (DAO REA Radioextractionassay)) kHDU activity: DAO/g Enzymatic pellet 15 min 0,1M Acid stability Borat pH HCl followed by 60 (DAO REA Radioextractionassay)) = 9,0: > 68 kHDU min DAO/g pellet % Humidity: < 10 Staphylococcus aureus Escherichia coli count: < microbiological 10 Total aerobic Yeasts/moulds count: < 10 Yeasts/moulds count: Salmonella < 10 enterobacteriaceae: resistant Bile salt Total combined yeasts/moulds count: < 10 Salmonella < 10 enterobacteriaceae: resistant Bile salt Definition: Chemical name: disodium 9-carboxy-4,5-dioxo-1 C Chemical formula: 122628-50-6 CAS No: Molecular weight: 374,17 Da Description bacterium modified reddish–brown powder a produced by the non-genetically Pyrroloquinoline quinone is disodium salt strain CK-275.

Authorised Novel Food Pyrroloquinoline quinone disodium salt

M10 M9 ▼ ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 120 the of the concentration reduction of triglycerides

Specifications

25 CFU/g ≤ :

300 CFU/g

≤

12 CFU/g

≤ 12,0 % 12,0 0,05 % 0,05 ≤ ≤ 99,0 % (dry weight) 99,0

≥ -tocopherol (%): 30-50 % 30-50 -tocopherol (%): -tocopherol (%): < 6,0 % < 6,0 -tocopherol (%): -tocopherol (%): 50-70 % 50-70 -tocopherol (%): Characteristics/Composition Appearance: Reddish-brown powder Purity: 0,03 (A322/A259): 0,56 ± UV absorbance 0,09 (A233/A259): 0,90 ± UV absorbance Moisture: Residual Solvent Ethanol: Heavy metals Lead: < 3 mg/kg Arsenic: < 2 mg/kg Microbiological criteria: count: Total viable cell Mould/yeast: Description/Definition: Rapeseed oil high is produced in unsaponifiable matter’ rapeseed oil in by from refined and vacuum distillation it is different minor a is There matter’). unsaponifiable high in oil ‘rapeseed g in and 9 oil rapeseed refined g in (1 unsaponifiable fraction acids. containing monounsaturated and polyunsaturated fatty Purity: > 7,0 g/100 g Unsaponifiable matter: Tocopherols: > 0,8 g/100 g α γ δ alcohols, > methylsterols: 5,0 Sterols, triterpenic g/100 g Coliforms: absent in 1 g Hyphomicrobium denitrificans CFU: Colony Forming Units

Authorised Novel Food Rapeseed oil high in unsapo high in Rapeseed oil nifiable matter

M9 M10 ▼ ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 121 Brassica L. and L. on of ‘rapeseed oil high in oil ‘rapeseed on of Brassica napus

Specifications g/kg μ

/kg

10 mEq O 1 mmol/kg g/kg

≤ ≤ μ g/kg μ 85 % 85 7,0 % 7,0 ≥ 90 % 90 ≤

≥ 6,0 mg KOH/g

≤

7,0 % 7,0

≤ 0,5 % 0,5

4,0 % 4,0 ≤ 2,0 % 2,0 ≤ ≤ L. Fatty acids in triglycerides: Fatty acids in % palmitic acid: 3-8 % stearic acid: 0,8-2,5 % 50-70 oleic acid: % linoleic acid: 15-28 % linolenic acid: 6-14 % erucic acid: < 2,0 Acid value: Rapeseed from non-genetically modified from rapeseed press cake originating protein is an aqueous extract protein-rich rapa Description: spray dried powder White to off-white, Total protein: Soluble protein: Moisture: Carbohydrates: Fat: Peroxide value (PV): Heavy metals: 000 < 1 Iron (Fe): 100 < Copper (Cu): Impurities: hydrocarbons < 2 (PAH) Benzo(a)pyrene: Polycyclic aromatic not in the producti hydrocarbons enriched are polycyclic aromatic (PAH) to ensure that carbon is required active with Treatment unsaponifiable matter. Ash: Fibre: Total glucosinolates:

Definition: Authorised Novel Food

Rapeseed Protein M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 122

Specifications Saccharomyces cerevisiae

0,5 % 0,5 ≤

0,1 % 0,1

≤

O 100 CFU/g 10 000 CFU/g 10

≤

≤ 10 CFU/g H ≤ 14

50 mg/kg

98 %-99 % %-99 98

≤

≥ 0,5 % 0,5 : A genetically modified strain of : A modified strain genetically Absence in 10 g ≤ 0,1 % 0,1 -resveratrol is off-white to beige crystals. 1,5 % 1,5 ≤

≤

0,1 ppm : Absence in 25 g 1,0 ppm ≤ Trans ≤ 0,5 mg/kg 1,0 ppm

≤ ≤ -resveratrol: -resveratrol: Purity: Total phytate: Lead: Microbiological criteria: Yeast and mould count: Synthetic Chemical name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol C Chemical formula: Molecular weight: 228,25 Da 501-36-0 CAS No: Purity: Trans substances): Total by-products (related substance: related Any single Sulphated ash: Aerobic bacteria count: Aerobic bacteria count: Total coliform Escherichia coli: Salmonella Loss on drying: Heavy metals: Lead: Mercury: Arsenic: Impurities: Diisopropylamine: Microbial source to slight yellow powder Appearance: Off-white

Description/Definition: Authorised Novel Food Trans-resveratrol

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 123 d dermatan sulphate d dermatan

25 % 25 ≤ Specifications by enzymatic hydrolysis of rooster comb and by subsequent filtration, concentration and precipitation concentration comb and by subsequent filtration, rooster hydrolysis of by enzymatic

10 % 10

≤ m Gallus gallus μ CFU/g

2 10

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

: Absence in 1g

≤

: Absence in 1 g

10 mg/kg 1,0 mg/kg 1,0 % 1,0 ≤ 8,0 % 8,0

0,1 mg/kg ≤ ≤ : Absence in 1 g 1,0 mg/kg ≤ ≤ ≤ 0,5 mg/kg

≤ Trans-resveratrol content: Min. 98 % Trans-resveratrol content: w/w Min. (dry 98 weight basis) % w/w Ash: Max. 0,5 % w/w Moisture: Max. 3 Particle size: 100 % less than 62,23 Particle size: 100 obtained from is Rooster comb extract the glycosaminoglycans chondroitin hyaluronic acid, sulphate A an are comb extract constituents of rooster steps. The principal white hygroscopic or almost powder. B). White (chondroitin sulphate % 60-80 Hyaluronic acid: A: Chondroitin sulphate pH: 5,0-8,5 Purity: Chlorides: Nitrogen: Loss on drying: (105 6 hours): °C for Escherichia coli Salmonella Staphylococcus aureus Pseudomonas aeruginosa Heavy metals: Mercury: Arsenic: Cadmium: Chromium: Lead: Microbiological criteria: count: Total viable aerobic

Description/Definition: Authorised Novel Food Rooster comb extract Rooster comb

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 124 by non-enzymatic inter- dour. lower oil. Description: Clear, lower oil. Description: L. It is a transparent, fluid (liquid) and fluid (liquid) shiny is a transparent, oil at L. It

Plukenetia volubiis

Specifications

/kg 2

2,0 % 2,0 ≤ 10 % 10 ≤

Description/Definition: % cold pressed vegetable oil obtained the seeds of from Sacha inchi oil is a 100 flavours. without undesirable vegetable taste light, green has a fruity, It room temperature. shiny yellow gold clean, room temperature, Fluid at shine, colour: Aspect, limpidity, odour or taste non acceptable without vegetable Fruity, taste: Odour and Purity: Water and < Volatiles: 0,2 g/100 g Impurities insoluble in hexane: < 0,05 g/100 g < 2,0 Oleic acidity: g/100 g < 15 meq O Peroxide value (PV): < 1,0 acids: Trans fatty g/100 g % > 45 (ALA): acid %Omega 3 alpha linolenic > 90 acids: fatty unsaturated Total % Saturated fatty acids: < 10 %) 0,5 (< acids fatty No trans %) 0,2 (< acid No erucic and di-linolenin-triglycerides % of tri-linolenin More than 50 Phytosterols composition and level 5,0 mg/100 g) (< No cholesterol Salatrim is the internationally recognised acronym for (short and long chain acyl molecules). triglyceride Salatrim is prepared mixtures with hydrogenated tripropionin, or their tributyrin, canola, soybean, of triacetin, cottonseed, or sunf esterification or rancid o and of foreign matter of particulate Free liquid to a light coloured waxy slightly amber solid at room temperature. disribution: Glycerol ester % Triacylglycerols: > 87 Diacylglycerols: Monoacylglycerols: Fatty acid composition: % 33-70 acids): LCFA MOLE % (long chain fatty

Description/Definition: Authorised Novel Food Sacha Inchi oil from oil Sacha Inchi Plukenetia volubilis Salatrims

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 125

Specifications oil rich in DHA and EPA should demonstrate oxidative stability by appropriate and by appropriate in DHA and EPA should oil rich oxidative stability demonstrate Schizochytrium sp. 90 % 90 7,5 % 7,5

≥ ≤ 0,5 % 0,5 ≤ 10 % 10 ≤ 1,0 % 1,0 0,05 % 0,05 ≤ ≤ 2,0 Meq/Kg 5,0 meq/kg oil 5,0 meq/kg oil

≤ ≤ ≤

1,0 % 1,0 1 % 1 % 2,0 4,5 % 4,5 % 3,5 0,4 % 0,4 ≤ ≤ ≤ ≤ ≤ ≤ 22,5 % 22,5 % 35 10 % 10 ≥ ≥ ≥ 0,5 mg KOH/g ≤ 0,3 % 0,3 ≤ 3,5 Red (Lovibond) ≤ 0,1 % 0,1 ≤ MOLE % SCFA (short chain fatty acids): 30-67 % 30-67 acids): chain fatty SCFA MOLE % (short % by weight Saturated long chain fatty acids: < 70 acids: Trans fatty acids as oleic acid: Free fatty Triacylglycerol profile: Triesters (short/long of 0,5 to 2,0): Triesters (short/long = 0): Unsaponifiable material: Moisture: Ash: Colour: Peroxide value (PV): Acid value: Peroxide value (PV): food products containing All Oxidative stability: methodology test (e.g. AOAC) recognised national/international Moisture and volatiles: Unsaponifiables: Trans-fatty acids: Peroxide value (PV): Unsaponifiables: Trans-fatty acids: DHA content: EPA content: acids: Free fatty n-6: (DPA) Docosapentaenoic acid DHA content:

oil rich in rich oil

sp. (ATCC

Authorised Novel Food Schizochytrium sp. DHA and EPA Schizochytrium PTA-9695) oil

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 126 and 70 % resistant % and 70 modified soybeans is removed during the manufacturing process.

Specifications )

1 var. natto. Bacillus subtilis

)/g

3 CFU(

3 10 ≤

0,05 % 0,05 0,05 % 0,05

≤ ≤

5,0 meq/kg oil 5,0 meq/kg oil

≤ ≤

2,0 % 2,0 1,0 % 1,0 4,5 % 4,5 % 3,5 0,4 % 0,4 10 % 10 ≤ ≤ ≤ ≤ ≤ ≤ 35 % 35 32,0 % 32,0

≥ ≥ 0,1 mg/kg 0,5 mg KOH/g 0,5 mg KOH/g (L.)) with a selected strain of strain selected a with (L.)) ≤ ≤ ≤ : 2

3,0 mg/kg ≤ 5,0 mg/kg ≤ Glycine max Peroxide value (PV): Moisture and volatiles: Unsaponifiables: Trans-fatty acids: soybean powder % fermented extract an soybean coloured Fermented is powder. odourless milk-white is comprised of 30 extract It which is added corn-starch, during from the processing. K Vitamin carrier) dextrin (as Peroxide value (PV): Moisture and volatiles: Unsaponifiables: Trans-fatty acids: acids: Free fatty DHA content: Fermented soybean contains nattokinase extract from natto, isolated a foodstuff produced by of non-genetically the fermentation ( 000 Fibrin degradation unit/g( 000 -28 20 Nattokinase activity: Identity: Confirmable smell or taste offensive Condition: No Loss on drying: Vitamin K Heavy metals: Lead: Arsenic: Microbiological criteria: count: Total viable aerobic DHA content: Acid value: Acid Description/Definition:

Acid value: Acid sp. oil sp. (T18) oil Authorised Novel Food Fermented soybean extract Schizochytrium Schizochytrium

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 127 6) and → -(1 α or by means the disaccharide the reaction. In this process, ) by the process of solid-liquid ) by the process of solid-liquid Leuconostoc citreum Triticum aestivum

. The resulting oligosaccharides are characterised by of the presence characterised are oligosaccharides . The resulting Specifications

Bacillus licheniformis Bacillus

g/gPutrescine: < 0,3 g/gPutrescine: mg/g

μ g/kg

10 CFU/g

CFU/g

≤ Absence/25g

g/g 10 μ ≤ < 10 CFU/g : Absence/25 g

30 CFU/g Absence/25g ≤ : Absence/25 g : Absence/25 g 3) glycosidic compounds. but also product contains mainly fructose is syrup, The overall in addition to these oligosaccharides, → ) Assay method as described by Takaoka et al. (2010). al. et Takaoka by described as method ) Assay

-(l 1 Microbiological criteria: 000 CFU/g < 10 bacteria: Total aerobic Yeast and moulds: < 100 CFU/g Escherichia coli: Salmonella: Listeria monocytogenes: Yeast and mould: Escherichia coli Salmonella Listeria ( Cadaverine: < 0,1 Mycotoxins: < 0,4 Aflatoxins (total): which is produced complex is a of saccharides sucrose and hydrolysate by Sucromalt mixture from a starch means of an enzymatic bacterium produced by the an enzyme by means of hydrolysate starch the from saccharides to attached are glucose units of a of the production recombinant strain organism α leucrose and other disaccharides. % Total solids: 75-80 Coliforms: Spore-forming bacteria: Description/Definition: Spermidine-rich wheat germ extract is obtained from non-fermented, non-sprouting wheat germs ( but not exclusively polyamines. specifically, targeting extraction Spermidine: 0,8-2,4 mg/g Spermine: 0,4-1,2 mg/g < 0,1 Spermidine trichloride

)

Description/Definition: Triticum aestivum Authorised Novel Food Spermidine-rich wheat germ Spermidine-rich extract ( Sucromalt

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 128 rom sugar cane, of the lulosic components, bleaching

Specifications 95 % 95 ≥

1 000 1 ≤

3 % 3

: Absence

ах

0,1 0,1 ≤ 1,0 ≤ ≤ 200

1,0 ≤ ≤ 7,0 % 7,0 : Absence ≤

0,3 % 0,3 ≤ Moisture: 20-25 % Moisture: 20-25 % Sulphatase: Max 0,05 pH: 3,5-6,0 %) 200 (30 Conductivity < Nitrogen < 10 ppm % d.w. Fructose: 35-45 % d.w. Leucrose: 7-15 M Other disaccharides: f of sugar juice expression or extraction after residue remaining or fibrous wall the dry cell is derived from Sugar Cane Fibre Saccharum genotype. of cellulose and It consists hemicellulose. primarily of lignins and non-cel other steps, including: chipping, digestion, removal alkaline The production process consists of several washing acid fibres, and neutralization. of purified Moisture: Ash: insoluble): (AOAC) dry Fibre basis (all Total Dietary of which: Hemicellulose (20-25 %) and cellulose (70-75 %) Silica (ppm): % Protein: 0,0 Fat: Trace pH: 4-7 Heavy metals: Mercury (ppm): Lead (ppm): Higher saccharides: 40-60 % d.w 40-60 Higher saccharides: Arsenic (ppm): Cadmium (ppm): Microbiological criteria: Yeast and moulds (CFU/g): Salmonella Listeria monocytogenes

Description/Definition: Authorised Novel Food Sugar cane fibre Sugar cane

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 129 otechnology information cted from the seeds of the family, cultivated in sterile sea water in water sea sterile in cultivated family, Chlorodendraceae

, belonging to the Specifications Tetraselmis chuii

7,0 % 7,0 ≤ Helianthus Annuus 15 mg/kg ≤ The sunflower extract is obtained by a concentration factor of 10 of the unsaponifiable fraction of refined sunflower oil extra oil sunflower refined of unsaponifiable fraction the of 10 factor obtained by a concentration is The sunflower extract sunflower, Composition: % Oleic acid (C18:1): 20 % Linoleic acid (C18:2): 70 % 8,0 Unsaponifiable matter: % Phytosterols: 5,5 % Tocopherols: 1,1 Description/Definition: microalgae the marine obtained from product is The dried the outside air. closed photobioreactors insulated from Purity/Composition: Bi for Centre National the in 600 base pairs) than 1 analysed no less (sequence rDNA 18 S marker nuclear by means of Identified % Not less than 99,9 (NCBI) database: Humidity: % Proteins: 35-40 % Ashes: 14-16 % Carbohydrates: 30-32 % Fibre: 2-3 % Fat: 5-8 % of total fatty acids Saturated fatty acids: 29-31 % of total fatty acids Monounsaturated fatty acids: 21-24 acids fatty % of total 44-49 acids: Polyunsaturated fatty Iodine:

micro Description/Definition: Authorised Novel Food Tetraselmis chuii

Dried algae Sunflower oil extract

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 130 farms.

e by means of enzymatic Scortum barcoo or Therapon

Specifications

is a species of fish in the family Terapontidae. It is an endemic fresh water species from Australia. It is now in fish species from Australia. reared water Terapontidae. It is an endemic fresh is a species of fish in the family O 12

H 6

-Hexulose lyxo Therapon barcoo PUFA n-3: 1,2-20,0 PUFA n-6: 0,3-2,0 Scortum/ > genus: Terapontidae > family: Perciformes > order: Actinopterygii Class: Taxonomic Identification: flesh: fish Composition of 18-25 Protein (%): 65-75 Moisture (%): 0,5-2,0 Ash (%): 6000-11500 Energy (KJ/Kg): 0,0 Carbohydrates (%): 5-15 Fat (%): Fatty acids (mg FA/g fillet): Σ Σ 1,5-15,0 PUFA n-3/n-6: Total omega 1,6-40,0 3 acids: Total omega 2,6-10,0 6 acids: Tagatose is produced of galactose by conversion, by means or enzymatic isomerization or by of chemical of fructos epimerization conversions. single-step are conversion. These Appearance: White or almost white crystals Chemical name: D-tagatose Synonym: D- 87-81-0 CAS number: C Chemical formula: 180,16 Formula weight: (g/mol) Description/Definition:

/Scortum Description/Definition: Authorised Novel Food Therapon barcoo D-Tagatose

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 131 roquercetin] of sample preparation may be based on the tests, test solutions and materials other reference

(Rupr.) Rupr) is a white to from hot pale-yellow powder that crystallizes aqueous Specifications ).

)

1 1 Larix gmelinii

(1 % aqueous solution)(

O : – : 4 to – 5,6

20 H

D 15

] α

90,0 % of the dry weight 90,0 0,5 % (102 °C, 2 hours) 0,5 Compound analysis ≥ ≤

0,5 mg/kg 10 % 10 0,1 mg/kg ≤

0,02 mg/kg ≤ ≤

≤ 98 % on a dry weight basis 98 1,0 mg/kg(*) 0,5 mg/kg ≥

≤ ≤ principles of the method described in FNP 5. methods’(‘Instrumental (JECFA) 1991, 307 p.; English – ISBN 92-5-102991-1 ) techniques, identification notices, general analytical Food general for and paper 5 Rev nutrition 2 – Guide to specifications

1 Purity: Assay: method and size sample of selection The level. specified the to appropriate technique absorption atomic an using (*) Determine ( Loss on drying: Specific Rotation: [ 133–Melting range: 137 °C Heavy metals: Lead: Taxifolin-rich extract from the wood of Dahurian Larch ( solutions. Definition: Chemical name: [(2R,3R)-2-(3,4 dihydroxyphenyl)-3,5,7-trihydroxy-2,3-dihydrochromen-4-one,trans (2R,3R)- dihyd (+) also called C Chemical formula: Molecular mass: 304,25 Da 480-18-2 CAS No: Specifications: Physical parameter Moisture: Taxifolin (m/m): Heavy Metals, Pesticide Lead: Arsenic: Cadmium: Mercury:

Description: Authorised Novel Food Taxifolin-rich extract Taxifolin-rich

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 132

llisation in a quantity of 1,5 %. llisation in a quantity of 1,5

Specifications

0,05 mg/kg ≤

CFU/g

≤

1 – 3 – 1 : Absence/1 g 100 CFU/g ≤ Content, usual observed range (%) range observed usual Content,

100/g : Absence/1 g ≤ 2,5 – 3,5 – 2,5 : Absence/1g 0,05 – 0,12 – 0,05 0,01 – 0,1 – 0,01 : Absence/10 g 0,1 – 0,3 – 0,1 0,2 – 0,3 – 0,2 0,3 – 0,5 – 0,3 90 – 93 – 90 1,5 Dichlorodiphenyltrichloroethane (DDT): Staphylococcus aureus Pseudomonas per dry substance) (as extract Taxifolin-rich Usual range of components the Extract component Aromadendrin Pinocembrin Unidentified flavonoids Water(*) crysta of water (*) inclusion of on the This results crystal. a and hydrated during the drying process is form in its Taxifolin Residual solvents 000 mg/kg Ethanol: < 5 Microbiological criteria Count Total Plate (TPC): Enterobacteria: Yeast and Mould : Escherichia coli Salmonella Taxifolin Eriodictyol Quercetin Naringenin Kaempferol

Authorised Novel Food

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 133 with a sweet taste purified, deionised water. ndard trehalose ample preparation may be ample preparation a solution a having known

-1,1-glucosidic bond. It is obtained from liquefied starch or from sucrose α Specifications -D-glucopyranoside, dihydrate α O (dihydrate) 2

2H ·

O 22

H l 12

μ -D-glucopyranosyl-

α -trehalose α , α 98 % on the dry basis 98 ≥ A non-reducing disaccharide that consists of two glucose moieties linkes by an linkes two glucose moieties of consists that A non-reducing disaccharide by a multistep enzymatic process. The commercial product is the dihydrate. Virtually odourless, white or almost white crystals white almost or odourless, white Virtually dihydrate. the is product commercial The process. enzymatic multistep by a Synonyms: Chemical name: 378,33 Formula weight: (dihydrate) Assay: Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of s methods’ based on of the method in FNP 5 ‘Instrumental described (1), the principles Method of assay: Principle: trehalose is identified by liquid chromatography and quantified by comparison to a standard reference containing sta about of sample solution: weigh Preparation 3 g accurately of dry sample into a 100 flask and add ml volumetric about 80 ml of through a 0,45 Filter filter micron dissolution deionised and water. Bring sample to complete dilute to mark with purified to obtain in water trehalose of dry standard reference weighed quantities of standard solution: dissolve accurately Preparation concentration of about 30 per ml. mg of trehalose recorder and integrating index detector Apparatus: liquid chromatography equipped a refractive with Conditions: equivalent or Denko Co.) KS-801 (Showa Column: Shodex Ionpack mm 300 — length: mm 10 — diameter: °C 50 — temperature: Mobile phase: water 0,4 ml/min flow rate: Injection volume: 8 equal volumes solution and of the sample separately the standard solution inject into the chromatograph. Procedure: peak Record the chromatograms and the size of response trehalose measure in 1 the quantity, the sample solution by ml of in mg, Calculate trehalose the following formula: of CAS No.: 6138-23-4 (dihydrate) CAS No.: C Chemical formula:

Description/Definition: Authorised Novel Food Trehalose

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 134

(5 % aqueous solution, anhydrous substance)

o Specifications g/100 g fresh weight at the expiration of shelf life shelf of expiration the at weight fresh g/100 g to which UV light treatment is applied to harvested mushrooms. to which UV light treatment μ ) U

/W (5 % aqueous solution, dihydrate), +199

o ) (W S

/R = +179

20 Agaricus bisporus

D ,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol ]

α 1,5 % (60 1,5 °C, 5h)

≤

in the final product: 5-10 in the final : 0,05 % 0,05

≤

1,0 mg/kg

≤ = weight of dry sample in mg = weight in mg of trehalose in the standard preparation the in trehalose mg of in = weight = peak area of trehalose in the sample preparation sample in the trehalose of = peak area

= peak area of trehalose in the standard preparation standard the in trehalose of = peak area

S U

R % trehalose = 100 × (R trehalose % where R Melting point: 97 °C (dihydrate) Purity: Loss on drying: Total ash: Heavy metals: Lead: Description/Definition: Commercially grown light within the wavelength of 200-800 in ultraviolet nm. a process of radiation UV radiation: Vitamin D Chemical name: (3 Synonym: Ergocalciferol 50-14-6 CAS No: Molecular weight: 396,65 g/mol Contents: Vitamin D W W Characteristics: Identification: very slightly soluble in ethanol soluble in water, Freely Solubility: Specific rotation: [

) Authorised Novel Food Agaricus bisporus UV treated mushrooms UV treated (

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 135

rgy input of 10-50 mJ/ of rgy input d after baking to in order d after (ergocalciferol). Vitamin (ergocalciferol). D

g/g). μ

Specifications )

1 g/100 g( μ

) is treated with ultraviolet light to induce the conversion of ergosterol to vitamin D to vitamin to induce the conversion ergosterol light of with ultraviolet is treated )

(ergocalciferol).

)

10/g

≤ /g

3 : Saccharomyces cerevisiae

10 (ergocalciferol) in the final product: 0,75-3 : :

≤ 2 2

: Absence in 25g 2

2 ) EN 12821, 2009, European Standard. European 2009, 12821, ) EN calculation. ) Recipe

1 2 content in the yeast concentrate varies between 800 000-3 500 000 1 IU vitamin D/100 g (450-875 Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol Synonym: Ergocalciferol 50-14-6 CAS No.: Molecular weight: 396,65 g/mol yeast concentrate: for the Microbiological criteria Coliforms: Escherichia coli is applie radiation (without toppings) with ultraviolet bread is yeast leavened and rolls to which a treatment UV-treated D to vitamin convert ergosterol UV radiation: A process of light within radiation in ultraviolet the wavelength of 240-315 nm for maximum of 5 seconds with ene cm Vitamin D Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol Synonym: Ergocalciferol 50-14-6 CAS No: Molecular weight: 396,65 g/mol Contents: Vitamin D Yeast in dough: 1-5 g/100 g ( ( ( Description/Definition: ( yeast Baker’s granules Tan-coloured, free-flowing Vitamin D Salmonella

) Description/Definition: Authorised Novel Food Saccharomyces cerevisiae UV-treated baker’s yeast ( UV-treated bread

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 136 atives. The is applied after and menaquinone-

O ]ethylidene]-4-methyl 56

menaquinone homologues 41

07 (OJ L 20.12.2013, p. 347, 671). ommon organisation of the markets in markets the of ommon organisation (cholecalciferol) concentrations by

, menaquinone-6 = 5) being C (MK-6)(n 2

H 46

Specifications . 3

)

. g/100 g( 2

)

μ 2 O

H O 31

H g/100 g( μ 46

)0,5-3,2

1 (2-methyl-3-all-trans-polyprenyl-1,4-naphthoquinones), or the menaquinone series, is a group of prenylated naphthoquinonederiv prenylated of group a is series, menaquinone the or (2-methyl-3-all-trans-polyprenyl-1,4-naphthoquinones), in the final product: in the final (menaquinones) series with menaquinone-7 (MK-7)(n = 6) being with menaquinone-7C (MK-7)(n (menaquinones) series :

agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 No 234/79, No 922/72, No 1234/20 (EC) (EEC) Council Regulations (EEC) (EC) products and repealing and agricultural ) As defined by Regulation (EU) No 1308/2013 of the European and Parliament of the Council of 17 December 2013 establishing a c ) HPLC

1 2 ( UV-treated milk is cow’s milk (whole and semi-skimmed) to which a treatment with ultraviolet (UV) radiation via turbulent flow milk is cow’s with to milk (whole and which ultraviolet UV-treated a semi-skimmed) treatment pasteurisation. The of the treatment pasteurised milk with UV radiation results in an increase in the vitamin D D vitamin to 7-dehydrocholesterol conversion of 045 J/l. within the wavelength light of 200-310 A in ultraviolet UV process of radiation nm with energy input radiation: of 1 Vitamin D Chemical name: (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene 0,1–1,5Semi-skimmed milk(1): number of isoprene residues, where 1 isoprene unit consists of 5 the carbons comprising the side chain, is used to characterise MK-6. extent smaller a MK-7 and to containing primarily Vitamin K (all-E)-2-(3,7,11,15,19,23,27-Heptamethyl-2,6,10,14,18,22,26-octacosaheptaenyl)-3-methyl-1,4-naphtalenedioneChemical Name: 2124-57-4 CAS Number: C Molecular formula: idenecyclohexan-1-ol Synonym: Cholecalciferol 67-97-0 CAS No: Molecular weight: 384,6377 g/mol Contents: Vitamin D Whole milk( ( Vitamin K being C 3) = 4 (MK-4)(n This novel food is produced by a synthetic or microbiological process. microbiological or synthetic a by produced is food novel This

Description/Definition: (menaquinone)

Authorised Novel Food UV-treated milk Vitamin K

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 137

L. bran, rich in arabinoxylan oligosaccharides L. bran, rich

Specifications Triticum aestivum

(menaquinone-7)

Bacillus licheniformis Bacillus (menaquinone-7)

spp. natto and

Bacillus subtilis Bacillus Molecular weight: 649 g/mol Specification of Vitamin synthetic K Appearance: Yellow powder % other impurities max 2,0 % cis-isomer, Purity: Max 6,0 Menaquinone-7) % all-trans % Menaquinone-7 92 (including at least Content: 97-102 Specifications of microbiologically produced Vitamin K Source: Appearance: Yellow powder or oil suspension powder obtained from by extraction White crystalline enzymatic % Min. 94 Dry matter: % of dry matter Arabinoxylan Min 70 oligosaccharides: 3-8 of polymerisation arabinoxylan Average degree oligosaccharides: % of dry matter acid (bound 1-3 Ferulic to arabinoxylan oligosaccharides): % Min 90 Total poly/oligosaccharides: % of dry matter Max Protein: 2 % of dry matter Ash: Max 2

Description/Definition: Authorised Novel Food Wheat bran extract

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 138

nnoproteins are linked by nnoproteins are d matrices.

consists of chains of ß-1,3-linked glucose residues, branched by ß-1,6-linkages, Specifications . ) beta-glucans: Saccharomyces cerevisiae

Saccharomyces cerevisiae Saccharomyces cerevisiae

: Max 1000/g

: Absence in 25g Clostridium perfringens Microbiological parameters: count: Max 10 000/g – total Mesophilic bacteria Yeasts: Max 100/g Fungi: Max 100/g Salmonella Bacillus cereus Beta-glucans are complex, high mass (100–200molecular kDa) polysaccharides, found wall of many yeasts and in the cell cereals. (1-3),(1-6)-ß-D-glucans. is ‘yeast beta-glucans’ name for The chemical Beta-glucans consist of a backbone are branched by of ß-1-3-linked glucose residues that ß-1-6-linkages, to which and chitin ma ß-1-4-bonds. yeast Beta-glucans are isolated from of wall of the glucan cell structure The tertiary forming a backbone via ß-1,4- bonds, linked chitin to which are ß-1,6-glucans and some mannoproteins. soluble, insoluble and forms: but in many insoluble dispersible liqui in water, This novel different in food three is available yeast ( Chemical characteristics Soluble form: % > 75 Total carbohydrates: % Beta-glucans (1,3/1,6): > 75 % Ash: < 4,0 % Moisture: < 8,0 % Protein: < 3,5 % Fat: < 10 Insoluble form: % > 70 Total carbohydrates: % Beta-glucans (1,3/1,6): > 70

Description/Definition: Authorised Novel Food Yeast beta-glucans

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 139

Specifications

: Absence in 1 g

: Absence in 1 g : < 100 CFU/g

: Absence in 25 g 12 % 12 ≤ Ash: % Moisture: < 8,0 % Protein: < 10 % Fat: < 20 in many matrices: liquid Insoluble in water, but dispersible % (1,3)-(1,6)-ß-D-Glucans: > 80 % Ash: < 2,0 % Moisture: < 6,0 % Protein: < 4,0 % < 3,0 Total fat: Microbiological data for insoluble in water, in many but dispersible liquid matrices: 000 CFU/g count: < Total plate 1 Enterobacteriaceae: < 100 CFU/g < 10 Total coliforms: CFU/g Yeast: < 25 CFU/g 25 CFU/g Mould: < Salmonella Escherichia coli Bacillus cereus Staphylococcus aureus Heavy metals for insoluble in water, but dispersible in many liquid matrices: Lead: < 0,2 mg/g Arsenic: < 0,2 mg/g Mercury: < 0,1 mg/g Cadmium: < 0,1 mg/g

Authorised Novel Food

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 140 -tocopherol and ascorbyl palmitate or -tocopherol and palmitate ascorbyl α

Specifications

-tocopherol. Synthetic zeaxanthin is produced by a multi-step chemical synthesis from smaller molecules. smaller synthesis from -tocopherol. Synthetic zeaxanthin is produced chemical by a multi-step α Zn

)

98 % 98 O 6

≥

H 5

-trans zeaxanthin: > 96 % -trans zeaxanthin: > 96 Zeaxanthin is a naturally occurring xanthophyll pigment, it is an oxygenated carotenoid. is xanthophyll pigment, it occurring naturally a Zeaxanthin is with added The as a spray-dried powder base synthetic zeaxanthin of gelatin or starch (‘beadlets’) is presented either odour. powder, with characteristic to off-white is a white Zinc L-pidolate International non-proprietary name (INN): L-pyroglutamic acid, Zinc salt Synonyms: PCA, pyrrolidone Zinc 5-oxoproline, pidolate carboxylate, Zinc Zinc pyroglutamate, L-Zinc 15454-75-8CAS No.: (C Molecular formula: as a corn oil suspension with added powder or no Orange-red crystalline with little odour. C Chemical formula: 144-68-3 CAS No: Molecular weight: 568,9 daltons Physical-chemical properties: % Loss on drying: < 0,2 All % Cis-zeaxanthin: < 2,0 % < Other carotenoids: 1,5 mg/kg 50 < 791-28-6): No (CAS Triphenylphosphine oxid Relative anhydrous molecular mass: 321,4 Appearance: White to slightly white powder Purity: (purity): Zinc L-pidolate 5,0-6,0 aqueous sol.): % pH (10

Description/Definition: Description/Definition: Authorised Novel Food Zeaxanthin Zinc L-pidolate

M9 ▼ 02017R2470 — EN — 03.09.2018 — 003.001 — 141 III to Regulation No (EC) 1333/2008 III and of the European of the Parliament f guar gum originating in or consigned from India due to contamination risks by

Specifications 1 000 CFU/g 1 ≤

- 22,8

o 100 CFU/g

≤

1,0 ppm 0,1 ppm ≤ 2,0 ppm ≤ ≤ 10,0 % 10,0 3,0 ppm ≤ ≤ Specific rotation: 19,6 Water: % Glutamic acid: < 2,0 Heavy metals: Lead: Arsenic: Cadmium: Mercury: Microbiological criteria: Total viable mesophilic count: Yeasts and moulds: Pathogen: Absence

Authorised Novel Food Council (OJ L 83, 22.3.2012, p. 1). pentachlorophenol and dioxins (OJ L 30, 6.2.2015, p. 10). ) Commission Regulation No 231/2012 (EU) of 9 March 2012 Annexes and food laying in down additives listed for II specifications ) Commission Implementing Regulation 2015/175 (EU) 5 of February 2015 laying down conditions import o special applicable to the

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