02017R2470 — EN — 16.05.2021 — 023.001 — 1
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
►M14 Commission Implementing Regulation (EU) 2018/1293 of 26 September L 243 2 27.9.2018 2018
►M15 Commission Implementing Regulation (EU) 2018/1631 of 30 October L 272 17 31.10.2018 2018
►M16 Commission Implementing Regulation (EU) 2018/1632 of 30 October L 272 23 31.10.2018 2018 02017R2470 — EN — 16.05.2021 — 023.001 — 2
►M17 Commission Implementing Regulation (EU) 2018/1633 of 30 October L 272 29 31.10.2018 2018 ►M18 Commission Implementing Regulation (EU) 2018/1647 of 31 October L 274 51 5.11.2018 2018 ►M19 Commission Implementing Regulation (EU) 2018/1648 of 29 October L 275 1 6.11.2018 2018 ►M20 Commission Implementing Regulation (EU) 2018/1991 of 13 December L 320 22 17.12.2018 2018 ►M21 Commission Implementing Regulation (EU) 2018/2016 of 18 December L 323 1 19.12.2018 2018 ►M22 Commission Implementing Regulation (EU) 2018/2017 of 18 December L 323 4 19.12.2018 2018 ►M23 Commission Implementing Regulation (EU) 2019/108 of 24 January L 23 4 25.1.2019 2019 ►M24 Commission Implementing Regulation (EU) 2019/109 of 24 January L 23 7 25.1.2019 2019 ►M25 Commission Implementing Regulation (EU) 2019/110 of 24 January L 23 11 25.1.2019 2019 ►M26 Commission Implementing Regulation (EU) 2019/387 of 11 March L 70 17 12.3.2019 2019 ►M27 Commission Implementing Regulation (EU) 2019/388 of 11 March L 70 21 12.3.2019 2019 ►M28 Commission Implementing Regulation (EU) 2019/456 of 20 March L 79 13 21.3.2019 2019 ►M29 Commission Implementing Regulation (EU) 2019/506 of 26 March L 85 11 27.3.2019 2019 ►M30 Commission Implementing Regulation (EU) 2019/760 of 13 May 2019 L 125 13 14.5.2019 ►M31 Commission Implementing Regulation (EU) 2019/1272 of 29 July 2019 L 201 3 30.7.2019 ►M32 Commission Implementing Regulation (EU) 2019/1294 of 1 August L 204 16 2.8.2019 2019 ►M33 Commission Implementing Regulation (EU) 2019/1314 of 2 August L 205 4 5.8.2019 2019 ►M34 Commission Implementing Regulation (EU) 2019/1686 of 8 October L 258 13 9.10.2019 2019 ►M35 Commission Implementing Regulation (EU) 2019/1976 of 25 November L 308 40 29.11.2019 2019 ►M36 Commission implementing Regulation (EU) 2019/1979 of 26 November L 308 62 29.11.2019 2019 ►M37 Commission Implementing Regulation (EU) 2019/2165 of 17 December L 328 81 18.12.2019 2019 ►M38 Commission Implementing Regulation (EU) 2020/16 of 10 January L 7 6 13.1.2020 2020 ►M39 Commission Implementing Regulation (EU) 2020/24 of 13 January L 8 12 14.1.2020 2020 ►M40 Commission Implementing Regulation (EU) 2020/206 of 14 February L 43 66 17.2.2020 2020 ►M41 Commission Implementing Regulation (EU) 2020/443 of 25 March L 92 7 26.3.2020 2020 ►M42 Commission Implementing Regulation (EU) 2020/478 of 1 April 2020 L 102 1 2.4.2020 ►M43 Commission Implementing Regulation (EU) 2020/484 of 2 April 2020 L 103 3 3.4.2020 02017R2470 — EN — 16.05.2021 — 023.001 — 3
►M44 Commission Implementing Regulation (EU) 2020/500 of 6 April 2020 L 109 2 7.4.2020 ►M45 Commission Implementing Regulation (EU) 2020/916 of 1 July 2020 L 209 6 2.7.2020 ►M46 Commission Implementing Regulation (EU) 2020/917 of 1 July 2020 L 209 10 2.7.2020 ►M47 Commission Implementing Regulation (EU) 2020/973 of 6 July 2020 L 215 7 7.7.2020 ►M48 Commission Implementing Regulation (EU) 2020/1163 of 6 August L 258 1 7.8.2020 2020 ►M49 Commission Implementing Regulation (EU) 2020/1559 of 26 October L 357 7 27.10.2020 2020 ►M50 Commission Implementing Regulation (EU) 2020/1634 of 4 November L 367 39 5.11.2020 2020 ►M51 Commission Implementing Regulation (EU) 2020/1820 of 2 December L 406 29 3.12.2020 2020 ►M52 Commission Implementing Regulation (EU) 2020/1821 of 2 December L 406 34 3.12.2020 2020 ►M53 Commission Implementing Regulation (EU) 2020/1822 of 2 December L 406 39 3.12.2020 2020 ►M54 Commission Implementing Regulation (EU) 2020/1993 of 4 December L 410 62 7.12.2020 2020 ►M55 Commission Implementing Regulation (EU) 2021/50 of 22 January L 23 7 25.1.2021 2021 ►M56 Commission Implementing Regulation (EU) 2021/51 of 22 January L 23 10 25.1.2021 2021 ►M57 Commission Implementing Regulation (EU) 2021/82 of 27 January L 29 16 28.1.2021 2021 ►M58 Commission Implementing Regulation (EU) 2021/96 of 28 January L 31 201 29.1.2021 2021 ►M59 Commission Implementing Regulation (EU) 2021/120 of 2 February L 37 1 3.2.2021 2021 ►M60 Commission Implementing Regulation (EU) 2021/668 of 23 April 2021 L 141 3 26.4.2021 ►M61 Commission Implementing Regulation (EU) 2021/670 of 23 April 2021 L 141 14 26.4.2021 02017R2470 — EN — 16.05.2021 — 023.001 — 4
▼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 — 16.05.2021 — 023.001 — 5
▼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 — 16.05.2021 — 023.001 — 6
Data Protection ◄ M29 ►
Other requirements - N -acetyl-D- N
-acetyl-D-neuraminic N containing it shall be neuraminic acid’ ‘ Food supplements acetyl-D-neuraminic acid containing shall bear a statement that the food supplement should not young be children given and children 10 to under infants, years consume breast milk or of other foods with age added acid where they within four hour period. the same twenty on the labelling of the foodstuffs
The designation of the novel food
Additional specific labelling requirements
0,05 g/L 0,05 g/L of reconstituted formula 0,05 g/kg for solid foods In accordance with nutritional the particular requirements infants and of whom young the the children but products in any are case for not higher intended maximum than the levels specified category for the mentioned corresponding in to the products. the table 0,2 g/L (drinks) 1,7 g/kg (bars) 1,25 g/kg
)
2
Maximum levels Maximum
)
1
Specified food category
control as No 609/2013 defined by Regulation (EU) Foods bearing statements on the reduced absence or presence of with the gluten requirements of Commission in Imple accordance menting Regulation (EU) No 828/2014 ( Unflavoured (including pasteurised UHT) milk-based products and sterilised Regulation (EU) No 609/2013 Foods for infants special and medical young Regulation children (EU) No purposes 609/2013 as defined for by Total diet replacement foods for weight Infant and follow-on formulae as defined by Regulation (EU) No 609/2013 ( Processed cereal-based foods and baby foods for infants and young children as defined by Conditions under which the novel food may be used
-Acetyl-D-neur Authorised novel food Table 1: Authorised novel foods novel Authorised Table 1: N aminic acid
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 7
Data Protection ◄ M29 ►
Other requirements on the labelling containing of it shall the be foodstuffs ‘Baobab pulp’ fruit
Additional specific labelling requirements
0,05 g/L (beverages) 0,25 g/kg (solids) 0,2 g/kg 300 mg/day for general older population than 10 years 55 mg/day for infants 130 mg/day for young children 250 mg/day for children between 3 to 10 years of age 0,05 g/L (beverages) 0,4 g/kg (solids)
0,05 g/L 8,3 g/kg
0,05 g/L
)
The designation of the novel food
3 0,5 g/kg
Not specified Food Supplements as 2002/46/EC ( defined in Directive Table top sweeteners Fruit and vegetable-based drinks Flavoured drinks Speciality coffee, infusions, tea, chicory; herbal infusions tea, and and herbal chicory fruit and extracts; fruit cereal and preparations for infusions tea, fruit plant, Unflavoured Unflavoured fermented milk-based products, heat treated fermented after fermentation, heat-treated flavoured products milk products Dairy including whiteners analogues, including beverage Cereal bars Conditions under which the novel food may be used
Authorised novel food Adansonia digitata fruit (Baobab) dried pulp
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 8
Data Protection ◄ M29 ►
Other requirements
’ Ulkenia sp.
on the labelling containing of it shall the be ‘Oil foodstuffs from micro-algae the The designation of the novel food Ajuga
Additional specific labelling requirements
supplements of a similar extract the of flowering aerial parts of reptans In line with normal use in food 60 mg/100 ml 200 mg/100 g
Maximum levels DHA Maximum of levels Maximum Maximum levels Maximum
500 mg/100 g Specified food category Specified food Specified food category Specified food category
Bakery products (breads, biscuits) rolls and sweet Cereal bars Non-alcoholic beverages based beverages) (including milk Food Supplements as 2002/46/EC defined in Directive Foods for special medical purposes as defined in Regulation (EU) No 609/2013 foods for excluding infants and young children Drinks intended to meet the intense expenditure of muscular sportsmen effort especially for Food Supplements as 2002/46/EC defined in Directive Conditions under which the novel food may be used
Ulkenia
Authorised novel food L-Alanyl-L- Glutamine Ajuga reptans extract from cell cultures Algal oil from the the from Algal oil microalgae sp.
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 9
Data Protection ◄ M29 ►
Other requirements
Allanblackia
)’
Euphausia superba on the labelling containing of it the shall be foodstuffs ‘ seed oil’ The designation of the on novel the food labelling containing of it shall the be ‘Lipid foodstuffs extract from the crustacean Antarctic Krill (
The designation of the novel food (L.) Burm.
Additional specific labelling requirements VIII of Annex VII of
and EPA
from Aloe vera Maximum levels of combined of DHA Maximum levels 30 g/100 g In line with supplements normal use of in derived the food similar gel cheese 100 g products 600 mg/ 600 mg/100 g 30 g/100 g
200 mg/100 g or for cheese products
Maximum levels Maximum Maximum levels Maximum 200 mg/100 g or for analogues to
Specified food category Specified food category Regulation (EU) No 1308/2013. Dairy products except milk-based drinks Dairy analogues except drinks (*) Except olive oils and olive pomace oils as defined in Part Food Supplements as 2002/46/EC defined in Directive Yellow fat spreads and cream based spreads Mixtures of vegetable (falling oils under (*) analogues, the including and beverage whiteners) food milk category: Dairy Specified food category food Specified Conditions under which the novel food may be used
seed oil seed
Euphausia Authorised novel food superba Antarctic Krill oil from Aloe macroclada extract Baker leaf Allanblackia
M9 M25 M9 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 10
Data Protection ◄ M29 ►
Other requirements Additional specific labelling requirements
3 000 mg/day for the general popu lation 450 mg/day lactating women for pregnant and In accordance with nutritional the particular requirements persons for whom the of products intended are the 250 mg/meal 200 mg/100 g 80 mg/100 ml
600 mg/100 g 500 mg/100 g
500 mg/100 g 360 mg/100 ml
Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 and meal replacements for weight control Breakfast cereals Bakery products (breads, biscuits) rolls and sweet Nutrition bars/cereal bars Food Supplements as 2002/46/EC defined in Directive Non-alcoholic Non-alcoholic beverages Milk-based drinks Dairy analogue drinks Spreadable fat and dressings Cooking fats Conditions under which the novel food may be used Authorised novel food
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 11
Data Protection ◄ M29 ►
Other requirements
)’ Euphausia superba The designation of the on novel the food labelling containing of it shall the be ‘Lipid foodstuffs extract from the crustacean Antarctic Krill (
Additional specific labelling requirements
and EPA
Maximum levels of combined of DHA Maximum levels 200 mg/100 g 600 mg/100 g cheese 100 g products 600 80 mg/100 ml mg/ 200 mg/100 ml
200 mg/100 g or for cheese products
200 mg/100 g or for analogues to 600 mg/100 g 500 mg/100 g
500 mg/100 g 360 mg/100 ml Specified food category
Foods bearing statements on the reduced absence or presence of with the gluten requirements of Commission in Imple accordance menting Regulation (EU) No 828/2014 Spreadable fat and dressings Cooking fats Breakfast cereals Bakery products (breads, biscuits) rolls and sweet Nutrition bars/cereal bars Dairy products except milk-based drinks Dairy analogues except drinks Non-alcoholic beverages Milk-based drinks Dairy analogue drinks Processed cereal-based food and intended baby food for covered infants by Regulation (EU) and No 609/2013 young children Foods intended to meet intense the expenditure of muscular sportsmen effort, especially for Conditions under which the novel food may be used
Authorised novel food holipids from Euphausia superba Antarctic Krill oil rich in phosp
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 12
Data Protection ◄ M29 ►
Other requirements
Mortierella ’ or ‘
oil’ alpina on the labelling containing of the it foodstuffs shall Mortierella alpina be ‘Oil from The designation of the novel food Additional specific labelling requirements
No 609/2013 In accordance with nutritional the particular requirements persons for whom the of products intended are the In accordance with Regulation (EU) 3 000 mg/day for the general popu lation 450 mg/day lactating women for pregnant and In accordance with Regulation (EU) No 609/2013 250 mg/meal 200 mg/100 ml
Maximum levels Maximum
Specified food category
with the requirements of Commission Imple menting Regulation (EU) No 828/2014 Foods bearing statements on the reduced absence or presence of gluten in accordance Infant formula and defined in Regulation follow-on (EU) No 609/2013 formula as Foods for premature special medical Regulation (EU) No purposes infants 609/2013 for as defined in Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 and meal replacements for weight control Processed cereal-based food and intended baby food for covered infants by Regulation (EU) and No 609/2013 young children Foods intended to meet intense the expenditure of muscular sportsmen effort, especially for Food Supplements as 2002/46/EC defined in Directive Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Conditions under which the novel food may be used
Authorised novel food Arachidonic acid-rich oil from the fungus Mortierella alpina
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 13
Data Protection ◄ M29 ► Authorised on 2019. 22 August This based inclusion scientific is on scientific evidence data protected accordance in with proprietary and Article of 26 Regulation 2283. (EU) 2015/ Applicant: DuPont Nutrition Biosciences ApS, brogade 1 Lange Copenhagen DK-1411, Denmark. K, During the period of data protection, the novel food authorised betaine for is the market placing within the Union on only by Biosciences DuPont ApS Nutrition subsequent unless applicant obtains a
Other requirements
mentioned on the label on the labelling containing of it the shall be foodstuffs ‘Astaxanthin’ on the labelling containing of it the shall foodstuffs and be if used as ‘Argan seasoning ‘Vegetable oil’ oil only for seasoning’ shall be on the labelling containing of it shall be the ‘betaine’. foodstuffs The labelling of betaine foods shall containing bear a the statement that foods should food not be betaine used are consumed the same if supplements day. containing
)
The designation of the novel food )
The designation of the novel food The designation of the novel food
7
( Additional specific labelling requirements
Ocimum basilicum In line with vegetable oils normal food use of 40-80 mg/day of oleoresin, resulting in ≤ 8 mg astaxanthin per day 60 mg/100 g 500 mg/100 g (bar) 136 mg/100 g (soup) 188 mg/100 g (porridge) 60 mg/100 g (beverages) 400 mg/day 3 g/200 ml for basil addition seeds ( of whole 500 mg/100 g
20 mg/100 g Maximum levels levels Maximum levels Maximum Maximum Maximum levels Maximum
Not specified
Specified food Specified food category Specified food category Specified food category
Meal replacements intended for sportsmen Total diet replacement for weight control defined as under Regulation (EU) No 609/2013 Foods for defined under Special Regulation (EU) No Medical 609/2013 for adults Purposes as Fruit juice beverages and fruit/vegetable blend Drink powders, isotonic and intended for energy sportsmen drinks Protein and sportsmen cereal bars intended for As seasonings Food Supplements as 2002/46/EC defined in Directive Food Supplements as 2002/46/EC defined in Directive Conditions under which the novel food may be used
Ocimum
) algae Specified food category food Specified Authorised novel food oleoresin from Haematococcus pluvialis Astaxanthin-rich Argania spinosa Argan oil from Argan oil Betaine Basil seeds ( basilicum
M32 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 14
Data Protection ◄ M29 ► authorisation authorisation for the food novel without the reference to evidence proprietary or scientific scientific protected in accordance data with Article 26 of Regulation (EU) 2015/2283 or agreement with Nutrition Biosciences ApS, of the End DuPont date protection: 22 August 2024. of the data
Other requirements
on the labelling containing of it the foodstuffs shall black be ‘Fermented bean ‘Fermented Soya extract’ (Soya) extract’’ or on the labelling containing of it the shall foodstuffs from be cows’ milk’ ‘Lactoferrin The designation of the novel food The designation of the novel food Additional specific labelling requirements
4,5 g/day 200 mg/100 g 100 mg/100 ml Maximum levels Maximum levels Maximum
Specified food category Infant formula and defined follow-on in Regulation formula (ready to (EU) drink) as No 609/2013 Foods on dairy children (ready basis to eat/drink) intended for young Food Supplements as 2002/46/EC defined in Directive Conditions under which the novel food may be used Specified food category food Specified
Authorised novel food Bovine lactoferrin Fermented black bean extract
M9 M32 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 15
Data Protection ◄ M29 ►
Other requirements
Additional specific labelling requirements
vidual up to 3 g/day Depending on the needs of the indi 330 mg/100 g 50 mg/100 g
670 mg/100 g 80 mg/100 g
2 000 mg/100 g 200 mg/100 g 120 mg/100 g 1 000 mg/100 g 3 000 mg/100 g 130 mg/100 g
750 mg/100 g Ice cream Cakes and pastries Candies Chewing gum to drink) Beverages based (including yoghurt drinks) on fermented milk Non-alcoholic drinks Products based on yoghurt Products based on cheese Processed cereal food (solid) Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Beverages based on milk Powdered drink mixes based on milk (ready Conditions under which the novel food may be used Authorised novel food
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 16
Data Protection ◄ M29 ► applicant obtains ation authoris for without the novel reference proprietary food to evidence the or scientific protected in accordance data with Article 26 of Regulation (EU) scientific 2015/2283 or agreement with Protéines S.A.S. End date of of the the 20 November 2023. Armor data protection: Authorised on 20 November 2018. This inclusion is based on evidence proprietary and scientific data protected in scientific accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Saint-Brice-en- Libération France. During the period of 35460 data Coglès, protection food the bovine novel whey protein isolate is auth milk orised for basic placing market on within only the the by Union S.A.S. Armor unless a Protéines subsequent
Other requirements
containing it shall be protein isolate’. ‘Milk whey Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: ‘This food supplement should not be consumed adolescents under by the age three/eighteen (*) years’ of one/ infants/children/ (*) Depending on the age group the food supplement is intended for. on the labelling of the foodstuffs The designation of the novel food
Additional specific labelling requirements 58 mg/day for young children 250 mg/day adolescents from 3 for to age 18 years children of and 610 mg/day for adults 30 mg/100 g (powder) 3,9 mg/100 mL (reconstituted) 30 mg/100 g (powder) 4,2 mg/100 mL (reconstituted) 300 mg/day 30 mg/100 g (powder infants formula during for the life first until months the introduction of of priate appro complementary feeding) 3,9 mg/100 formula for infants during mL the months of first life until the introduction (reconstituted of feeding) appropriate 30 complementary mg/100 g (powder infants formula for when appropriate mentary feeding is introduced) comple 4,2 mg/100 formula for infants when appropriate mL complementary (reconstituted introduced) feeding 58 mg/day for young children 380 is mg/day adolescents from 3 for to age 18 years children of and 610 mg/day for adults 25 mg/day for infants Maximum levels Maximum
Specified food category Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Food Supplements as 2002/46/EC defined in Directive Infant Regulation (EU) No 609/2013 formulae Follow-on as Regulation (EU) formulae No 609/2013 Total as defined diet control replacement defined foods as in No for 609/2013 defined in weight by Regulation (EU)
Conditions under which the novel food may be used Authorised novel food Bovine milk basic Bovine milk isolate whey protein
M34 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 17
Data Protection ◄ M29 ►
Other requirements
oil’ The designation of the on novel the food labelling containing of the it foodstuffs Buglossoides shall be ‘Refined
Additional specific labelling requirements
acid (STA)
Maximum levels of stearidonic stearidonic of Maximum levels 500 mg/day 250 mg/meal 75 mg/100 g for drinks 750 mg/100 g In accordance with nutritional the particular requirements persons for whom the of products intended are the
250 mg/100 g 750 mg/100 g
625 mg/100 g Specified food Specified food category
Foods for special medical purposes as defined in Regulation (EU) No 609/2013, foods excluding for special medical purposes for intended infants and young children infants and young children Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 and meal replacements for weight control Cheese and cheese products Butter and including other spreads (not for fat cooking or purposes) frying and oil emulsions Breakfast cereals Food supplements as 2002/46/EC, defined excluding food supplements in for Directive Dairy products and analogues Conditions under which the novel food may be used
seed oil Authorised novel food Buglossoides Buglossoides arvensis
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 18
Data Protection ◄ M29 ►
Other requirements
(crustacean)’
)’
Salvia hispanica on the labelling containing of it the shall foodstuffs (including be 1,3-butadiene, ‘Gum 2-methyl- base homopolymer, maleated, esters with polyethylene ether)’ glycol or CAS ‘Gum No: 1246080-53-4)’ base mono-Me (including on the labelling containing of it the shall foodstuffs (including be ‘Gum base ether-maleic anhydride copolymer)’ or methyl ‘Gum No 9011-16-9)’ base (including CAS vinyl on the labelling containing of the it foodstuffs ( shall be ‘Chia oil on the labelling containing of the it foodstuffs Calanus finmarchicus shall be ‘oil from The designation of the novel food The designation of the novel food The designation of the novel food The designation of the novel food Additional specific labelling requirements
2 g/day 2,3 g/day Maximum levels Maximum levels Maximum levels Maximum Maximum levels Maximum 2 % 2 8 % 8 10 % 2 g/day
Specified food category Specified food category Specified food Specified food category Specified food category Fats and oils Pure chia oil Food Supplements as 2002/46/EC defined in Directive Chewing gum Food supplements as 2002/46/EC defined in Directive Chewing gum Conditions under which the novel food may be used
Salvia oil
Authorised novel food (monomethoxypoly ethylene glycol) Chewing gum base Calanus finmarchicus Chia oil from Chia oil hispanica Chewing gum base (Methyl vinyl ether-maleic anhydride copolymer)
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 19
Data Protection ◄ M29 ►
Other requirements
)’ Salvia hispanica containing it shall be ( ‘Chia seeds on the labelling of the foodstuffs
The designation of the novel food
Additional specific labelling requirements
5 % whole chia seeds
Maximum levels Maximum
10 % whole chia seeds 10 % whole chia seeds 5 % (whole or ground chia seeds)
Specified food category
Fruit and vegetables products (including fruit spreads, compotes fruit-preparations to underlay or to with/without be mixed with dairy cereals, products, fruits with fruit coconut milk for a desserts, twin pot) mixed Non-alcoholic beverages (including fruit juice and fruit/vegetable blend beverages) Puddings that do not require heat treatment at or above processing 120 or preparation °C in their manufacture, grains, pseudocereal grains and/or pulses Fruit, nut and seed mixes Chia seeds as such Confectionery (including chocolate products), excluding chewing gums chocolate and Dairy products analogues (including yoghurt) and Edible ices Bread products Baked products Breakfast cereals Sterilised ready to eat meals based on cereal Conditions under which the novel food may be used Salvia
) Authorised novel food Chia seeds ( hispanica
M60 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 20
Data Protection ◄ M29 ►
Other requirements
)
).
12
’
’
’ or ‘Chitosan ’ ) biomass shall Yarrowia lipolytica Aspergillus niger
Fomes fomentarius Aspergillus niger Agaricusbisporus Yarrowia lipolytica by infants and young children children young and ( bear infants a supplements should not statement be consumed by that the (children under food 3 from 3 children to 9 years of ( age years of age)/ on the labelling containing of it shall the be ‘Chitin-glucan foodstuffs from the labelling containing it shall be ‘Chitosan extract of from the extract from foodstuffs on the labelling containing of it the shall foodstuffs be sulphate ‘Chondroitin derived fermentation and sulphation’ from microbial the labelling containing it of containing shall yeast ( be the biomass’ ‘chromium- foodstuffs The labelling of containing chromium-containing yeast food supplements on the labelling containing of it shall the be ‘Chitin-glucan foodstuffs from on the labelling containing of it the foodstuffs shall Picolinate’ be ‘Chromium The designation of the novel food The designation of the novel food The of designation the novel food on The designation of the novel food The of designation the novel food on The designation of the novel food Additional specific labelling requirements
resulting in 92 μg of chromium per day 5 g/day In line with supplements normal of chitosan use from crus in taceans food 1 200 mg/day 250 μg/day 2 g/day for children years from of age, 3 resulting in to chromium 46 per 9 μg day of 4 g/day for children from 10 of years age, adolescents and adults, 5 g/day
Maximum levels levels chromium Maximum total levels Maximum of Maximum levels Maximum levels Maximum Maximum levels Maximum )
4
Specified food category Specified food category Specified food category Specified food category Specified food Specified food category Specified food category
Food supplements as 2002/46/EC, defined excluding food supplements in for Directive infants and young children Food supplements as 2002/46/EC defined for in adult population, Directive pregnant excluding and lactating women Foods covered by Regulation (EU) No 2013 609/ Foods Regulation fortified (EC) No 1925/2006 ( in accordance with Food Supplements as 2002/46/EC defined in Directive Food Supplements as 2002/46/EC defined in Directive Food Supplements as 2002/46/EC defined in Directive Conditions under which the novel food may be used
)
;
)
Authorised novel food Yarrowia lipolytica Agaricus bisporus biomass Chromium- containing yeast ( Chitosan extract from fungi ( Chitin-glucan complex from Fomes fomentarius Aspergillus niger Aspergillus Chitin-glucan from Chitin-glucan Chondroitin sulphate Chromium Picolinate Aspergillus niger
M53 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 21
Data Protection ◄ M29 ►
Other requirements
Cistus
Clostridium Clostridium butyricum
MIYAIRI 588 (CBM L. Pandalis herb’ on the labelling of the foodstuffs containing it shall be ‘Citicoline’ citicoline shall bear a that statement the product is not to be intended consumed by children (CBM 588)’ incanus on the labelling containing of it the shall foodstuffs be butyricum ‘ 588)’ or ‘ on the labelling containing of the foodstuffs it shall be ‘ 2. The labelling of foods containing
1. The designation of the novel food The designation of the novel food The designation of the novel food Additional specific labelling requirements
CFU/day
8
1,35 × 10 500 mg/day 250 mg per serving and a maximum daily consumption level of 1 000 mg (2 cups/day) Maximum levels Maximum levels Maximum Maximum levels Maximum
Intended daily intake: 3 g herbs/day
Specified food category Specified food category Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Food Supplements as 2002/46/EC defined in Directive Food Supplements as 2002/46/EC defined in Directive Herbal infusions Conditions under which the novel food may be used L.
Specified food category food Specified Authorised novel food Citicoline Cistus incanus Pandalis herb butyricum Clostridium
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 22
Data Protection ◄
M29 ► Science, subsequent Inc. applicant obtains authorisation unless for the food a novel without the reference to evidence proprietary or scientific scientific protected in accordance data with Article 26 of Regulation (EU) 2015/2283 or agreement of Bioenergy Life with Science, Inc. the End date protection: 16 April 2024 (5 of years). the data Authorised on 2019. 16 This based April inclusion scientific is on scientific evidence data protected accordance in with proprietary and Article of 26 Regulation 2283. (EU) 2015/ Applicant: Bioenergy Science, Life Johnson Inc., Minneapolis, 55304, 13840 St. USA. Minnesota, period During of the the data novel food protection, NE, authorised D-ribose is for the market placing within the Union on only by Bioenergy Life
Other requirements
containing it shall be ‘D-ribose’. The labelling of D-ribose foods shall bear a containing statement that the foods should not be used if food supplements containing D-ribose are consumed the same day. on the labelling of the foodstuffs The designation of the novel food
Additional specific labelling requirements
0,13 g/100 g 0,17 g/100 g 0,08 g/100 g 0,80 g/100 g 3,3 g/100 g 0,23 g/100 g 3,30 g/100 g
Maximum levels Maximum 0,31 g/100 g 0,20 g/100 g
0,20 g/100 g
Meal replacement for weight control (as bars) Confectionery Tea and infusions (in reconstituted) powder form to be Milk-based drinks shakes) (excluding malts and Drinks intended to meet the intense expenditure of muscular sportsmen, isotonic and energy drinks effort especially for Bars intended to intense meet the expenditure muscular sportsmen of effort especially for Meal replacement for drinks)' weight control (as Cereal bars Fine bakery wares Chocolate confectionery (excluding chocolate bars) Conditions under which the novel food may be used Specified food category food Specified Authorised novel food D-ribose
M29 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 23
Data Protection ◄ M29 ►
Other requirements
containing it shall seed oil’ be ‘Coriander per day consume more cocoa than flavanols per day 600 mg of on the labelling of the foodstuffs consume more than 600 phenols mg corresponding poly to extract 1,1 g of of defatted cocoa powder
Consumers shall be instructed not to The designation of the novel food Consumers shall be instructed not to Additional specific labelling requirements
600 mg/day corresponding to 550 not mg more cocoa than of powder extract in food (or food one supplement) of portion defatted of 730 mg per 1,2 g/day serving and around Maximum levels Maximum levels Maximum Maximum levels Maximum
1 g/day and 300 mg polyphenols
Specified food category Specified food category Specified food Specified food category Any other foods (including food supplements as defined in Directive have 2002/46/EC) become which established vehicles tional for func ingredients and positioned which are for typically conscious adults consumption by health Foods including food supplements as defined in Directive 2002/46/EC Food Supplements as 2002/46/EC defined in Directive Nutrition bars Milk based beverages Conditions under which the novel food may be used
Coriandrum Authorised novel food Coriander seed oil oil Coriander seed from sativum Extract of defatted Extract of cocoa powder Low fat cocoa Low fat extract
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 24
Data Protection ◄
M29 ► cranberry extract powder, is authorised for the market placing within the Union on only Cranberries by Inc. subsequent Ocean applicant unless obtains a authorisation Spray for the food novel without the reference to proprietary evidence or scientific scientific protected in accordance data with Article 26 of Regulation (EU) 2015/2283 or agreement of Ocean with Cranberries Inc. Spray the End date protection: of 20 2023. the November data Authorised on 20 November 2018. This inclusion is based on evidence proprietary and scientific data protected in scientific accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Cranberries Ocean Inc. One Ocean Spray Spray Middleboro, Drive MA, USA. Lakeville- 02349, During the period protection of the data novel food,
Other requirements
on the labelling containing of the it foodstuffs extract shall powder’ be ‘cranberry The designation of the novel food Additional specific labelling requirements
350 mg/day
Maximum levels Maximum Specified food category Food Supplements as 2002/46/EC defined for the in adult population Directive Conditions under which the novel food may be used
Authorised novel food Cranberry extract powder
M15 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 25
Data Protection ◄ M29 ►
Other requirements
Crataegus
) grains’ dried fruit’ Digitaria exilis on the labelling containing of it shall be the ‘Dextran’ foodstuffs on the labelling containing of the it foodstuffs shall pinnatifida be ‘ on the labelling containing of it shall the be foodstuffs ‘Alpha-cyclo dextrin’ or ‘α-cyclodextrin’ on the labelling containing of the it foodstuffs Cyclodextrin’ or shall ‘γ-Cyclodextrin’ be ‘Gamma- on the labelling containing of it the shall foodstuffs be fonio ( ‘decorticated
The designation of the novel food The designation of the novel food
Additional specific labelling requirements
Crataegus laevigata Maximum levels Maximum Maximum levels Maximum In line with normal food use of 5 % 5
)
5 The designation of the novel food The designation of the novel food The designation of the novel food Specified food category Specified food Specified food category
Bakery products Not specified Herbal infusions Jams and jellies in accordance with Directive 2001/113/EC ( Compotes Conditions under which the novel food may be used
Not specified Not specified
dried fruit Leuconostoc Digitaria exilis Authorised novel food -cyclodextrin -cyclodextrin Dextran prep aration produced by mesenteroides Decorticated grains of (Kippist) Stapf (Traditional food from a third country) α γ Crataegus pinna Crataegus tifida
M9 M9 M21 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 26
Data Protection ◄ M29 ►
Other requirements
on the labelling of the foodstuffs containing it shall be capsiate’ ‘Dihydro synthetic dihydrocapsiate will be labelled as children up ‘not to 4.5 years’ intended for on the labelling containing it of shall be ‘Diacylglycerol the foodstuffs oil of plant diacylglycerols)’ origin (at least 80 % 2. Food supplements containing 1. The designation of the novel food The designation of the novel food Additional specific labelling requirements
1,5 mg/100 ml 1,5 mg/100 ml Maximum levels Maximum Maximum levels Maximum 9 mg/100 g 2 mg/100 g 2,5 mg/100 g 4 mg/100 g 1 mg/100 ml
12 mg/100 g 2 mg/100 ml
4,5 mg/100 g
9 mg/100 g Specified food Specified food category Specified food category
Vegetable drinks Coffee based drinks, tea based drinks Flavoured water — still Precooked oatmeal cereal Other cereals Ice cream, dairy desserts Pudding mixes (ready to eat) Bakery products Yoghurt type products Cereal bars Biscuits, cookies and crackers Rice based snacks Carbonated drinks, juice dilutable based beverages drinks, fruit Cooking oils Fat spreads Salad dressings Mayonnaise Meal replacement for drinks) weight control (as Conditions under which the novel food may be used
Authorised novel food plant origin Diacylglycerol oil of Diacylglycerol Dihydrocapsiate (DHC)
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 27
Data Protection ◄
M29 ► Authorised on 23 December 2020. This inclusion is based on evidence proprietary and scientific data protected in scientific accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Kemin L.C., 2100 Foods Des Maury Moines, USA. Street IA 50317,
Other requirements
algae’. Euglena gracilis Euglena gracilis
).
12 on the labelling containing of the foodstuffs it biomass of shall The labelling be of food containing supplements ‘dried dried shall bear a food statement supplements that consumed should those by infants/children not under 3 be years of years age/children under 10 adolescents of under age ( 18 age/children years of and The designation of the novel food Additional specific labelling requirements
1 mg/100 ml 3 mg/single intake 9 mg/day years of age 225 mg/day for years children of age from and adolescents 10 (to 17 years of age) 375 mg/day for adults 1,5 mg/100 ml 630 mg/100 g 120 mg/100 g 100 mg/day for young children 150 mg/day for children from 3 to 9 3 mg/meal 14,5 mg/kg equivalent to Maximum levels Maximum 75 mg/100 g 2 mg/100 g
7,5 mg/100 g 40 mg/100 g 1,1 mg/100 g 3 mg/meal 95 mg/100 g 5 mg/100 g 40 mg/100 g 115 mg/100 g 16 mg/100 g
27 mg/100 g 200 mg/100 g Specified food category 150 mg/100 g
Fruit and vegetable vegetable blend beverages juices, nectars, fruit/ Fruit-Flavoured Drinks Meal replacement beverages Food supplements as 2002/46/EC, defined excluding food supplements in for Directive infants Meal replacements for weight control Meal replacement for drinks) weight control Food (as Supplements as 2002/46/EC defined in Directive Non-alcoholic powdered drink mixes Breakfast cereal protein bars bars, granola bars Yoghurt and Yoghurt Beverages Products based on yoghurt Chocolate confectionery Hard candy Sugar-free gum Whitener/creamer Sweeteners Soup (ready to eat) Salad dressing Vegetable protein Ready to eat meals Conditions under which the novel food may be used
Euglena Authorised novel food Dried gracilis
M51 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 28
Data Protection ◄
M29 ► Authorised on 3 September 2018. This inclusion is based on evidence proprietary and scientific data protected in scientific accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Desert Labs, Ltd Kibbutz Israel. Yotvata, 88820 During the period protection, the of novel food is data authorised for placing on the market within the Union only by Kemin Foods L.C. unless a obtains authorisation subsequent for that novel food without reference applicant to the proprietary evidence scientific or scientific protected in accordance data with Article 26 of Regulation (EU) 2015/2283 or agreement of Kemin with L.C. Foods the End date protection: of 23 2025. the December data
Other requirements
’ Hoodia parviflora on the labelling containing of it the shall foodstuffs be parts of ‘dried aerial The designation of the novel food
Additional specific labelling requirements
9,4 mg/day 190 mg/meal
Maximum levels Maximum
Specified food category Food Supplements as 2002/46/EC defined for adult in population Directive Total diet replacement for weight control defined as by Regulation (EU) No 609/2013
Conditions under which the novel food may be used
Authorised novel food Dried aerial parts of Hoodia parviflora
M51 M13 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 29
Hoodia is authorised for Data Protection ◄ M29 ► During the period protection of the data dried novel aerial parts of food parviflora placing on the market within the Union only Labs, Ltd unless a subsequent by Desert applicant obtains ation authoris for without the novel reference proprietary food to evidence the or scientific protected in accordance data with Article scientific lation 26 (EU) with the 2015/2283 agreement of Desert of or Labs, Ltd. Regu End date 2023. 3 September protection: of the data
Other requirements from cell
Vb’
® Lippia citriodora on the labelling containing of it shall the be foodstuffs ‘dried of extract cultures HTN
The designation of the novel food Lippia citriodora Additional specific labelling requirements Echinacea angus
In line with supplements normal of use in from a the food root similar of tifolia extract In line with supplements normal of use in from a the leaves of food similar extract Maximum levels levels Maximum Maximum
Specified food category Specified food category Food Supplements as 2002/46/EC defined in Directive Food Supplements as 2002/46/EC defined in Directive Conditions under which the novel food may be used
extract from Authorised novel food Echinacea angus tifolia cell cultures Dried extract of Lippia citriodora from cell cultures
M13 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 30
Data Protection ◄ M29 ►
Other requirements from cell
Echinacea purpurea containing it shall be ‘dried of extract cultures EchiPure-PC™’ on the labelling of the foodstuffs The designation of the on novel the food labelling containing of the it foodstuffs echium oil’ shall be ‘Refined The designation of the novel food
Additional specific labelling requirements
acid (STA)
Maximum levels of stearidonic of Maximum levels Echinacea purpurea intended In line with supplements normal of use in from a florets within food similar the flower head of extract 500 mg/day In accordance with nutritional the particular requirements persons for whom the of products are the 250 mg/meal 250 mg/100 g; drinks 75 mg/100 g for
Maximum levels Maximum
750 mg/100 g 750 mg/100 g 625 mg/100 g
Specified food category Specified food category Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Food supplements as 2002/46/EC defined in Directive Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 and meal replacements for weight control Milk-based products and drinkable products delivered yoghurt in a single dose Cheese preparations Spreadable fat and dressings Breakfast cereals Food Supplements as 2002/46/EC defined in Directive Conditions under which the novel food may be used
oil
Authorised novel food Echium plan tagineum Echinacea purpurea extract from cell cultures
M9 M9 M31 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 31
Data Protection ◄ M29 ►
Other requirements
years.
(*) Ecklonia phlorotannins shall Phlorotannins’. be consumed adolescents under by the twelve/fourteen/eighteen age children/ of food supplement is intended for. be consumed by thyroid persons disease with or who by are aware of persons or have identified been as being developing thyroid at disease. risk of be consumed supplements if containing other are iodine also consumed. food on the labelling containing of the it foodstuffs cava shall be ‘ Food Ecklonia cava supplements bear the following statement: containing (a) This food supplement should not (*) Depending on the age group the (b) This food supplement should not (c) This food supplement should not The designation of the novel food Additional specific labelling requirements
163 mg/day for adolescents from 12 to 14 years of age 230 mg/day for adolescents 14 years above of age 263 mg/day for adults Maximum levels Maximum Specified food category
12 years Food supplements as 2002/46/EC defined intended in for the Directive lation, general excluding popu children under the age of Conditions under which the novel food may be used phlo
Authorised novel food Ecklonia cava rotannins
M9 M49 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 32
Data Protection ◄
M29 ► membrane hydrolysate authorised for is the market placing within the Union on only by Biova, LLC. unless a subsequent applicant obtains authorisation for the food novel without the reference to evidence proprietary or scientific scientific protected in accordance data with Article 26 of Regulation (EU) 2015/2283 or agreement of Biova, LLC. with the End date protection: of 25 2023 the November data Authorised on 25 November 2018. This inclusion is based on evidence proprietary and scientific data protected in scientific accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: 5800 Biova, Merle Hay 14 Rd, LLC., Suite PO Box 50131, 394 Iowa Johnston USA. the period During of data protection the novel food egg
Other requirements
on the labelling containing of the foodstuffs membrane it hydrolysate’. shall be ‘egg The designation of the novel food
Additional specific labelling requirements 450 mg/day Maximum levels Maximum Specified food category
Food Supplements as 2002/46/EC defined intended in for Directive population the general adult Conditions under which the novel food may be used
Authorised novel food Egg membrane hydrolysate
M9 M18 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 33
Data Protection ◄ M29 ►
Other requirements
on the labelling containing of the it foodstuffs thioneine’ shall be ‘L-ergo that consumers should not consume more than 300 mg of extract per day The designation of the novel food The labelling shall bear a statement
Additional specific labelling requirements in whole or in part,
years food or food supplement 30 mg/day for (excluding general population pregnant and women) lactating 20 mg/day for children older than 3 150 mg of extract in one portion of Maximum levels Maximum Maximum levels Maximum
0,040 g/kg 0,25 g/kg 0,025 g/kg 0,025 g/kg
0,2 g/kg Specified food Specified food category any milk constituent Alcohol-free beverages Food supplements as 2002/46/EC defined in Directive (*) When used in milk products L-ergothioneine may not replace Milk-based drinks ‘Fresh’ milk products(*) Cereal bars Chocolate confectionery Foods including food supplements as defined in Directive 2002/46/EC Conditions under which the novel food may be used Specified food category food Specified Camellia
) Authorised novel food Epigallocatechin Epigallocatechin gallate as a purified extract from green tea leaves ( sinensis L-ergothioneine
M9 M49 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 34
Data Protection ◄ M29 ►
Other requirements
Cynanchum Phlomis
Angelica gigas Angelica
Turcz. and Hemsley, three herbal wilfordii roots umbrosa ( Nakai)’. The labelling of food containing the supplements extract of mixture of the three herbal roots statement shall in bear close a proximity to list the of ingredients indicating that should it not be viduals consumed with known by celery allergy. indi on the labelling containing of the it foodstuffs ammonium phosphate’ shall be ‘Ferrous on the labelling containing of it the foodstuffs shall be ‘extract of The designation of the on novel the food labelling containing of the foodstuffs it Sodium EDTA’ shall be ‘Ferric
The designation of the novel food The designation of the novel food
Additional specific labelling requirements
anhydrous EDTA) Maximum levels (expressed as (expressed Maximum levels (EU) No 609/2013 lation (EC) No and/or 1925/2006 Regu 18 mg/day for children 75 mg/day for adults 12 mg/100 g To be used Directive in 2002/46/EC, compliance Regulation with 175 mg/day levels Maximum Maximum levels Maximum
Specified food category Specified food category Specified food category
Foods Regulation fortified (EC) No 1925/2006 in accordance with Food supplements as 2002/46/EC defined in Directive Foods covered by Regulation (EU) No 2013 609/ Foods Regulation fortified (EC) No 1925/2006 in accordance with Food supplements as 2002/46/EC defined in Directive Foods covered by Regulation (EU) No 2013 609/ Food supplements as 2002/46/EC defined for adult population in Directive Conditions under which the novel food may be used
Angelica
Hemsley,
Nakai) Authorised novel food Cynanchum Ferrous ammonium phosphate Ferric Sodium EDTA Extract of three herbal roots ( wilfordii Phlomis umbrosa Turcz. and gigas
M9 M9 M49 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 35
Data Protection ◄ M29 ►
Beverages containing flavonoids shall be presented to the consumer single portions. as final Other requirements ’
) peptides’
Glycyrrhiza glabra L. consumed by pregnant breast and children feeding adolescents; and women, and drugs young should only the consume product supervision; under medical flavonoids per be day consumed. should final food shall be the indicated on labelling containing it. of the food on the labelling of the foodstuffs containing it shall be ‘Flavonoids from the product was added as a novel food ingredient statement that: shall bear a (a) the product should not be (b) people taking prescription (c) a maximum of 120 mg of Sardinops sagax 3. The amount of flavonoids in the 1. The designation of the novel food 2. The labelling of the foods where on the labelling containing of the foodstuffs it ( shall be ‘Fish The designation of the novel food
Additional specific labelling requirements
Glycyrrhiza glabra Maximum levels of flavonoids from flavonoids from of Maximum levels 120 mg/day 120 mg/day 120 mg/day 0,48 g/100 g (ready to eat/drink)
0,3 g/100 g (ready to drink)
Maximum levels fish peptide product peptide fish levels Maximum
0,3 g/100 g (ready to eat)
120 mg/day 2 g/100 g
Specified food category Specified food Specified food category Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Beverages based on yoghurt Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 Beverages based on milk Beverages based on fruit or vegetables Food Supplements as 2002/46/EC defined in Directive Foods based on fermented milk products, yoghurt, and powdered milk yoghurt drinks, Flavoured water, and vegetable-based drinks Breakfast cereals Soups, stews and soup powders Conditions under which the novel food may be used
Authorised novel food Flavonoids from Glycyrrhiza glabra Sardinops sagax Sardinops Fish peptides from Fish peptides
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 36
Data Protection ◄ M29 ►
Other requirements
Fucus vesi
’.
on the labelling of the foodstuffs containing it shall be ‘2′-fucosyl lactose’. supplements containing 2′-fuco syllactose shall bear a statement that the supplements should be not used added if other consumed the foods same 2′-fucosyllactose day. with are on the labelling containing of the it foodstuffs extract shall from be seaweed ‘Fucoidan on the labelling containing of the it foodstuffs extract from shall seaweed Undaria pinna be tifida’ ‘Fucoidan culosus 2. The labelling of food
L.) pulp The designation of the novel food The designation of the novel food 1. The designation of the novel food L.) pulp’, Theobroma cacao Additional specific labelling requirements
Theobroma cacao
Theobroma cacao 1,2 g/l beverages 1,2 g/l beverages 19,2 g/kg beverages products other than ( 250 mg/day 250 mg/day 1,2 g/l 19,2 g/kg beverages products other than on the labelling containing of the foodstuffs it shall be ‘cocoa ‘cocoa ‘cocoa ( juice’ or ‘cocoa ( L.) depending on concentrated the form used. pulp juice’ 1,2 g/l beverages
Maximum levels levels Maximum levels Maximum Maximum
The designation of the novel food Not specified Specified food category Specified food category
Unflavoured fermented milk-based products Flavoured fermented including heat-treated milk-based products products Dairy whiteners analogues, including beverage Foods including food supplements as defined in Directive 2002/46/EC population for the general Foods including food supplements as defined in Directive 2002/46/EC population for the general Unflavoured (including pasteurised UHT) milk-based products and sterilised Conditions under which the novel food may be used
L. Specified food category food Specified
-Fucosyllactose Authorised novel food ′ Fucoidan extract from the seaweed Fucus vesiculosus Fucoidan extract from the seaweed Undaria pinnatifida 2 Fruit pulp, pulp juice, concentrated from pulp juice Theobroma cacao (Traditional food from a third country)
M9 M9 M40 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 37
Data Protection ◄ M29 ►
Other requirements
that the supplements should be not used if breast foods milk or other with lactose are added consumed the day. 2′-fucosyl same supplements supplements containing 2′-fuco syllactose intended children for shall bear young a statement 3. The labelling of food -neotetraose -neotetraose N N
Additional specific labelling requirements
at a product ratio ready for of use, marketed such as 2:1 or reconstituted in as by the manufacturer instructed the final 1,2 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer 1,2 g/l alone or in combination with up to 0,6 g/l of lacto- at a product ratio ready for of use, marketed such as 2:1 or reconstituted in as by the manufacturer instructed the final 1,2 g/l alone or in combination with up to 0,6 g/l of lacto- 12 g/kg for beverages products other than 12 g/kg for beverages products other than 400 g/kg for whitener
200 g/kg
12 g/kg Processed cereal-based food and for baby infants food and young children as defined Regulation in (EU) No 609/2013 Infant formula as defined in Regulation (EU) No 609/2013 Follow-on Regulation (EU) No formula 609/2013 as defined in Cereal bars Table-top sweeteners Conditions under which the novel food may be used Authorised novel food
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 38
Data Protection ◄ M29 ►
Other requirements
Additional specific labelling requirements
-neotetraose, at a ratio of
N In accordance with nutritional the particular requirements persons for whom the of products intended are the 4,8 g/l for drinks 3,0 g/day for general population 1,2 g/day for young children 2:1 in the final use, product marketed ready for as stituted as such instructed by or the facturer manu recon 40 g/kg for bars 60 g/kg 9,6 g/l — the maximum level refers to the products ready to use 1,2 g/l for milk-based similar products drinks added and alone combination or in with lacto- up to 0,6 g/l
1,2 g/l
Flavoured drinks Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and infusions and chicory fruit extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products Food supplements as 2002/46/EC, defined excluding food supplements in for Directive infants Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance Commission with Implementing Regulation the (EU) No 828/2014 requirements of Milk-based drinks intended for young and children similar products Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Conditions under which the novel food may be used Authorised novel food
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 39
Data Protection ◄ M29 ► subsequent applicant obtains authorisation for the food novel without the reference to evidence proprietary or scientific scientific protected in accordance data with Article 26 of Regulation (EU) 2015/2283 or agreement of Glycom A/S. with the End date protection: 19.12.2024. of the data Authorised on This 19.12.2019. inclusion is proprietary based on evidence and scientific data protected in accordance with Article 26 of Regulation (EU) scientific 2015/2283. Applicant: Kogle Glycom Allé Hørsholm, A/S, Denmark. During 4, the period of DK-2970 data protection, the novel food lactose/Difucosyllactose 2'-Fucosyl mixture is placing authorised for on within the Union the Glycom only by market A/S, unless a
Other requirements
containing it shall lactose/Difucosyllactose be mixture’. ‘2'-Fucosyl The labelling of food containing supplements the Difucosyllactose mixture shall 2'-Fucosyllactose/ bear a statement that they should not used be if breast milk containing or other added foods 2'-Fucosyllactose and/or consumed the same day. Difucosyllactose are on the labelling of the foodstuffs
The designation of the novel food Additional specific labelling requirements
2,0 g/L (beverages) 20 g/kg beverages) (products other than product ready for use, marketed such as or reconstituted as by the manufacturer instructed 10 g/kg for beverages products other than 2,0 g/L 20 g/kg beverages) (products other than 1,6 g/L in the final product ready for use, marketed as stituted as such instructed by or the facturer manu recon 1,2 g/L in the final product ready for use, marketed as stituted as such instructed by or the facturer manu recon 1,2 g/L (beverages) in the final 2,0 g/L (beverages)
Maximum levels Maximum
2,0 g/L 20 g/kg Specified food category Follow-on formula Regulation (EU) No 609/2013 as defined under Processed cereal-based food and for baby food infants and under young Regulation (EU) children No 609/2013 as defined Flavoured fermented including heat-treated milk-based products products Beverages (flavoured drinks) Cereal bars Infant Regulation (EU) No formula 609/2013 as defined under Unflavoured pasteurised sterilised (including UHT) and milk products unflavoured Unflavoured fermented milk-based products Conditions under which the novel food may be used
Authorised novel food 2'-Fucosyllactose/ Difucosyllactose mixture (‘2'-FL/ DFL’) (microbial source)
M9 M36 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 40
Data Protection ◄ M29 ►
Other requirements
Additional specific labelling requirements final food)
ratio kg galacto-oligosaccharide/kg 4,0 g/day 0,333 0,020 In accordance with nutritional the particular requirements persons for whom the of products intended are the 1,2 g/L in the final product ready for use, marketed as stituted as such instructed by or the facturer manu recon 4,0 g/L (beverages) 40 g/kg beverages) (products other than
Maximum levels (expressed as (expressed levels Maximum
0,020 0,043 0,043
0,030
Specified food category 0,033
0,020 Food Supplements as 2002/46/EC defined in Directive Milk Milk drinks Meal replacement for drinks) weight control (as Dairy analogue drinks Yoghurt Dairy based deserts Frozen dairy deserts Milk-based drinks intended for young and children similar products Total diet control replacement as foods defined No for under 609/2013 Regulation weight (EU) Food for special medical purposes as defined under Regulation (EU) No 609/2013 Food Supplements as 2002/46/EC defined intended in for Directive the lation general excluding infants popu Conditions under which the novel food may be used
Authorised novel food Galacto-oligos accharide
M9 M36 M55 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 41
Data Protection ◄ M29 ►
Other requirements
Additional specific labelling requirements
0,008 In line with glucosamine from normal shell fish food use of 0,013
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 Infant formula and defined in Regulation follow-on (EU) No 609/2013 formula as Food Supplements as 2002/46/EC defined in Directive Foods covered by Regulation (EU) No 2013 609/ Meal replacement for weight control Drinks intended to meet the intense expenditure of muscular sportsmen effort especially Juice for Fruit pie fillings Fruit preparations Bars Cereals Fruit drinks and energy drinks Infant meal replacement drinks Baby juice Baby yogurt drink Baby desert Baby snack Baby cereals Conditions under which the novel food may be used Specified food category food Specified Authorised novel food Glucosamine HCl
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 42
Data Protection ◄ M29 ►
Other requirements
and cereal products respectively, the instructions clearly for specify the use need the to must cereal mix and the dairy product on the labelling of the foodstuffs containing it Gum’. shall be ‘Guar possible discomfort risks exposure of of linked children aged under 8 digestive to guar gum must be to visible on the label the containing it. of any For foodstuffs consumption of example, these may cause products digestive discomfort, especially for ‘Excessive children years under of age’. 8 compartments containing dairy 2. A specific mention of the 3. In the case of products with two
1. The designation of the novel food Additional specific labelling requirements
In line with glucosamine from normal shell fish food use of In line with glucosamine from normal shell fish food use of 1,5 g/100 g 1,8 g/100 g 10 g/100 g in the cereals None in the product accompanying dairy 1 g/100 g in the product when ready to eat
Maximum levels levels Maximum levels Maximum Maximum 3,25 g/100 g
Specified food category Specified food category
Foods bearing statements on the reduced absence or presence of with the gluten requirements of Commission in Imple accordance menting Regulation (EU) No 828/2014 packaging containing two compartments Food Supplements as 2002/46/EC defined in Directive Fresh dairy fermented products milks, fresh dairy-based such desserts. cheeses and as other yogurts, Fruit or vegetable-based liquid foodstuffs (of the ‘smoothie’ variety) Fruit or vegetable-based compotes Cereals accompanied by a dairy product, in Foods intended to meet intense the expenditure of muscular sportsmen effort, especially for Food Supplements as 2002/46/EC defined in Directive Conditions under which the novel food may be used
Specified food category food Specified Authorised novel food Guar Gum Glucosamine sulphate NaCl sulphate KCl Glucosamine
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 43
Data Protection ◄ M29 ►
Other requirements
’
Ilex guayusa Ilex
consumed by children under the age of women, three and lactating women; years, pregnant used for frying’ cooking, baking or on the labelling containing of it the shall foodstuffs be dried leaves of ‘Extracts of on the products labelling containing ‘hydroxytyrosol’. of it the shall The be food labelling of the containing food products bear hydroxytyrosol the following statements: shall (a) This food product should not be (b) This food product should not be on the labelling containing of it the foodstuffs shall turing Protein’ be ‘Ice Struc before consumption, in order to take into account the gastro-intestinal obstruction. potential risk of
The designation of the novel food The designation of the novel food The designation of the novel food
Additional specific labelling requirements
Ilex paraguariensis Ilex
0,215 g/kg infusions and food supplements a of similar aqueous extract leaves of of dried 0,175 g/kg
Maximum levels Maximum levels levels Maximum Maximum Maximum levels Maximum In line with normal use in herbal 0,01 % Specified food category Specified food category Specified food category )), placed as such on the market
6 Edible ices Herbal infusions Food Supplements as 2002/46/EC defined in Directive Fish and vegetable oils, (except olive oils and olive pomace oils as defined in Part Annex VIII of VII of 2013 ( Regulation (EU) No 1308/ Spreadable fats as Annex defined in VII Part of 2013, VII Regulation placed as of such (EU) on the No market 1308/ Fermented milk semi-liquid and spray-dried powder forms) products (in liquid, Conditions under which the novel food may be used Specified food category food Specified Ilex
Bacteroides Authorised novel food Ice Structuring Protein type III HPLC 12 Hydroxytyrosol Aqueous extracts of Aqueous extracts dried leaves of guayusa Heat-treated milk products fermented with xylanisolvens
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 44
Data Protection ◄ M29 ►
Other requirements
’. Coffea
Coffea canephora and/or on the labelling of the foodstuffs containing it altulose’. shall be ‘Isom on the labelling of the foodstuffs containing it altooligosaccharide’. shall be ‘Isom ingredient must be labelled as ‘a source of glucose’. from coffee arabica leaves of on the labelling containing of the it foodstuffs shall be ‘Infusion 2. Foods containing the novel 1. The designation of the novel food The designation of the novel food Additional specific labelling requirements
20 % 6,5 % 5 % 5
Maximum levels Maximum Maximum levels Maximum 6,5 % 25 % 25 % 5 % 5 20 %
5,0 % 97 % 1. The designation of the novel food 10 %
5 % 5 Specified food category Specified food Specified food category Processed Vegetables and Vegetable Juices Other Soft Drinks Cereals Bars Cookies, Biscuits Breakfast Cereal Bars Hard Candies Soft Candies/Chocolate Bars Meal replacement for weight control (as bars or milk based) Energy-Reduced Soft Drinks Energy Drinks Foods intended to meet intense the expenditure of muscular sportsmen (including isotonic drinks) efforts, especially Fruit Juices for Herbal infusions Conditions under which the novel food may be used
Not specified
Coffea
L. and/or Authorised novel food Isomalto-oligos accharide from a third country) Infusion from coffee Infusion from leaves of arabica Coffea canephora Pierre ex A. Froehner (Traditional food Isomaltulose
M9 M46 M9 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 45
Data Protection ◄ M29 ►
Other requirements - - - - - N N N N N
on the labelling shall be accom panied by ‘Isomaltulose indication is that glucose and the a fructose’. source of on the labelling of the foodstuffs containing it shall be ‘lacto- neotetraose’. neotetraose’. supplements containing lacto- neotetraose statement shall that the should supplements not bear foods be used a neotetraose with if are other same added day. consumed the lacto- supplements containing lacto- neotetraose intended for children young shall bear that a the statement supplements should be not used if breast foods milk or other with added lacto- neotetraose are same day. consumed the on the supplements containing labelling it shall ‘Lactitol’ of be the food 2. The designation of the novel food 2. The labelling of food 3. The labelling of food The designation of the novel food 1. The designation of the novel food
Additional specific labelling requirements
20 g/day 0,6 g/l for beverages 9,6 g/kg for beverages products other than 0,6 g/l for beverages 6 g/kg for beverages products other 200 g/kg than for whitener 0,6 g/l in combination 1,2 with g/l up of to ratio 2′-fucosyllactose of 1:2 at ready for in use, a marketed the as reconstituted such final or as product instructed manufacturer by the 0,6 g/l 9,6 g/kg for beverages products other than 0,6 g/l for beverages
Maximum levels levels Maximum Maximum
100 g/kg
6 g/kg
whiteners Cereal bars Table-top sweeteners Infant formula as defined in Regulation (EU) No 609/2013 Unflavoured (including pasteurised UHT) milk-based products and Unflavoured fermented milk-based sterilised products Flavoured fermented including heat-treated milk-based products products Dairy analogues, including beverage Food Supplements as 2002/46/EC defined in (capsules, Directive tablets intended for the adult or population powder) Conditions under which the novel food may be used Specified food category food Specified -neotetraose Specified food category food Specified N Authorised novel food Lacto- Lactitol
M9 M14 M9 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 46
Data Protection ◄ M29 ►
Other requirements
Additional specific labelling requirements
In accordance with nutritional the particular requirements persons for whom the of products intended are the 2,4 g/l for drinks 20 g/kg for bars manufacturer 6 g/kg for beverages products other 0,6 g/l than for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer 0,6 g/l for milk-based similar products drinks added and alone combination or in with 2′-fucosyllactose, at a product ratio ready for of use, marketed such as 1:2 or reconstituted in as by the manufacturer instructed the final 30 g/kg 0,6 g/l in combination 1,2 with g/l up of to ratio 2′-fucosyllactose of 1:2 at ready for in use, a the marketed as reconstituted such final or as product instructed by the
0,6 g/l
Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance Commission with Implementing Regulation the (EU) No 828/2014 requirements of Flavoured drinks Milk-based drinks intended for young and children similar products Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Follow-on Regulation (EU) No formula 609/2013 as defined in Processed cereal-based food and for baby infants food and young children as defined Regulation in (EU) No 609/2013 Conditions under which the novel food may be used Authorised novel food
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 47
N-
Data Protection ◄ M29 ► Applicant: Kogle Glycom Allé Hørsholm, A/S, Denmark. During 4, the period of DK-2970 data protection, the novel tetraose food is placing authorised lacto- for on within the Union the Glycom only by A/S, market subsequent applicant obtains unless authorisation for the a food novel without the reference to evidence proprietary or scientific scientific protected in accordance data with Article 26 (EU) 2015/2283 of or with the agreement Regulation of Glycom A/S. Authorised on This inclusion 23.4.2020. is proprietary based on evidence and scientific data protected in accordance with Article scientific 26 (EU) 2015/2283. of Regulation
Other requirements
N- N- tetraose shall N- on the labelling containing of the it foodstuffs tetraose’. shall be ‘lacto- The labelling of food containing supplements lacto- bear a statement not that be they used if should breast milk foods or other containing tetraose are consumed the added same day. lacto-
Additional specific labelling requirements The designation of the novel food
1,0 g/l (beverages) 10 g/kg beverages) (products other than 0,8 g/l in the final product ready for use, marketed as stituted as such instructed by or the facturer manu recon 1,5 g/day for general population 0,6 g/day for young children 1,0 g/l 10 g/kg beverages) (products other than 4,8 g/l — the maximum level refers to the products ready to use
1,0 g/l (beverages)
1,0 g/l Maximum levels Maximum
10 g/kg
Beverages (flavoured drinks) Cereal bars Infant formula as defined (EU) under No 609/2013 Regulation Specified food category Unflavoured pasteurised sterilised (including UHT) and milk products unflavoured Unflavoured fermented milk-based products Flavoured fermented including heat-treated milk-based products products Coffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and infusions and chicory fruit extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products Food supplements as 2002/46/EC, defined excluding food supplements in for Directive infants Conditions under which the novel food may be used
-tetraose N Authorised novel food Lacto- (microbial source) (‘LNT’)
M43 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 48
Data Protection ◄ M29 ► End date protection: 23.4.2025. of the data
Other requirements Additional specific labelling requirements
2,0 g/day children, adolescents, and adults for young children, 0,6 g/l in the final product ready for use, marketed as stituted as such instructed by or the facturer manu recon 0,6 g/l product (beverages) ready for in use, marketed such as the or reconstituted final as by the manufacturer instructed 5 g/kg beverages for products other than 0,6 g/l product (beverages) ready for in use, marketed such as the or reconstituted final as by the manufacturer instructed 5 g/kg beverages for products other than 2,0 g/l (beverages) 20 g/kg beverages) (products other than In accordance with nutritional the particular requirements persons for whom the of products intended are the
No 609/2013 Food for special medical purposes as defined under Regulation (EU) No 609/2013 Food Supplements as 2002/46/EC, defined excluding infants in Directive Milk based intended drinks for young children and similar products Total diet control replacement as foods defined for under Regulation weight (EU) Follow-on formula as defined lation under (EU) No 609/2013 Regu Processed cereal-based food, baby infants food and for young children as defined Regulation under (EU) No 609/2013 Conditions under which the novel food may be used Authorised novel food
M43 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 49
Data Protection ◄ M29 ►
Other requirements
) protein’. ) protein’ or ) berries’ Medicago sativa Lonicera caerulea Medicago sativa on the labelling containing of the it foodstuffs ( shall be ‘Lucerne on the labelling containing of it shall be the ‘Lycopene’ foodstuffs ( ‘Alfalfa ( on the labelling containing of the it foodstuffs shall be ‘haskap
The designation of the novel food The designation of the novel food Additional specific labelling requirements
10 g/day 2,5 mg/100 g 2,5 mg/100 g 8 mg/meal
Maximum levels Maximum levels Maximum 5 mg/100 g The designation of the novel food
Specified food category
Drinks intended to meet the intense expenditure of muscular sportsmen effort especially for Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 and meal replacements for weight control Breakfast cereals Food supplements as 2002/46/EC defined in Directive Fruit/vegetable juice-based drinks (including concentrates) Not specified Conditions under which the novel food may be used L. Specified food category food Specified
Medicago Authorised novel food Lucerne leaf extract Lucerne leaf from sativa Lonicera caerulea berries (haskap) (Traditional food from a third country) Lycopene
M20 M9 M9 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 50
Data Protection ◄ M29 ►
Other requirements
on the labelling containing of it shall be the ‘Lycopene’ foodstuffs The designation of the novel food Additional specific labelling requirements
nutritional requirements persons for whom the of products intended are the 15 mg/day In accordance with nutritional the particular requirements persons for whom the of products intended are the 15 mg/day In accordance with the particular 2,5 mg/100 g 2,5 mg/100 g 8 mg/meal
Maximum levels Maximum
3 mg/100 g 3 mg/100 g 1 mg/100 g 1 mg/100 g 10 mg/100 g 10 mg/100 g 5 mg/100 g
Specified food category
Fats and dressings Soups other than tomato soups Bread (including crispy breads) Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Food supplements as 2002/46/EC defined in Directive Fruit/vegetable juice-based drinks (including concentrates) Drinks intended to meet the intense expenditure of muscular sportsmen effort especially Total diet for replacement for weight control defined as in Regulation (EU) No 609/2013 and meal replacements for weight control Breakfast cereals Fats and dressings Soups other than tomato soups Bread (including crispy breads) Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Food supplements as 2002/46/EC defined in Directive Conditions under which the novel food may be used
Authorised novel food Lycopene from Blakeslea trispora
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 51
Data Protection ◄ M29 ►
Other requirements
on the labelling containing of it shall be the ‘Lycopene’ foodstuffs oleoresin from tomatoes’ on the labelling containing of the it foodstuffs shall be ‘Lycopene The designation of the novel food The designation of the novel food Additional specific labelling requirements
In accordance with nutritional the particular requirements persons for whom the of products intended are the 15 mg/day 2,5 mg/100 g 2,5 mg/100 g 8 mg/meal 2,5 mg/100 g 2,5 mg/100 g
Maximum levels of lycopene of levels Maximum Maximum levels Maximum
3 mg/100 g 1 mg/100 g 10 mg/100 g 5 mg/100 g
Specified food Specified food category Specified food category
Food supplements as 2002/46/EC defined in Directive Fruit/vegetable juice-based drinks (including concentrates) Drinks intended to meet the intense expenditure of muscular sportsmen effort especially for meal replacements for weight control Breakfast cereals Fats and dressings Soups other than tomato soups Bread (including crispy breads) Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Fruit/vegetable juice-based drinks (including concentrates) Drinks intended to meet the intense expenditure of muscular sportsmen effort especially for Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 and Conditions under which the novel food may be used
Authorised novel food tomatoes Lycopene from Lycopene from Lycopene oleoresin from tomatoes
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 52
Data Protection ◄ M29 ►
Other requirements
on the labelling containing of it the shall foodstuffs be oil extract’ ‘Maize-germ on the labelling of food supplements containing it shall be ‘Hen egg white lysozyme hydrolysate’. on the labelling containing of it the shall foodstuffs be citrate malate’ ‘Magnesium on the labelling containing of the it foodstuffs Bark shall Extract’ be ‘Magnolia The designation of the novel food The designation of the novel food The designation of the novel food The designation of the novel food
Additional specific labelling requirements
2 g/day In accordance with nutritional the particular requirements persons for whom the of products intended are the 8 mg/meal 1000 mg/day purposes. Based maximum incorporation level and a on maximum gum/mint a size each, of each 1,5 0,2 g % gum will contain or no more than mint 3 magnolia mg bark serving extract. of
Maximum levels Maximum Maximum levels levels Maximum levels Maximum Maximum
3 mg/100 g 1 mg/100 g 0,2 % for breath freshening 10 mg/100 g 5 mg/100 g 2 % 2
Specified food category Specified food category Specified food category Specified food category Chewing gum Mints (confectionary products) Food Supplements as 2002/46/EC defined in Directive Chewing gum Food supplements as 2002/46/EC defined intended for adult in population Directive Food Supplements as 2002/46/EC defined in Directive Total diet replacement covered for by weight Regulation and control (EU) meal replacements No for weight control 609/2013 Breakfast cereals Fats and dressings Soups other than tomato soups Bread (including crispy breads) Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Conditions under which the novel food may be used
Authorised novel food Magnolia Bark Extract Magnesium citrate malate lysozyme hydrolysate Hen egg white Maize-germ oil high in unsaponifiable matter
M9 M49 M9 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 53
Data Protection ◄ M29 ► Authorised on 2 September 2018. This inclusion is based on evidence proprietary and scientific data protected in scientific accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Pharmena Wolczanska SA, 178, Lodz, 90 Poland. 530 period During of data protection the the
Methylcellulose Methylcellulose is not used to in be specially foods prepared young children for Other requirements
This food supplement consumed by adults should only excluding be pregnant and lactating women on the labelling containing of it the shall foodstuffs be nicotinamide chloride’. ‘1- Methyl Food supplements Methylnicotinamide containing shall bear 1- following statement: the on the labelling containing of it the foodstuffs shall lulose’ be ‘Methylcel The designation of the novel food The designation of the novel food Additional specific labelling requirements
58 mg/day
Maximum levels Maximum Maximum levels Maximum
2 % 2 Specified food category
Cold desserts egg-based products) (dairy, fat, fruit, cereal, Flavoured drinks Food Supplements as 2002/46/EC defined in Directive for excluding pregnant and lactating women the adult population Fruit preparations (pulps, purees or compotes) Soups and broths Edible ices Flavoured or unflavoured products fermented milk Conditions under which the novel food may be used
Specified food category food Specified Authorised novel food 1-Methylnicoti namide chloride Methylcellulose
M11 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 54
Data Protection ◄ M29 ► novel food namide chloride 1-methylnicoti is authorised for placing on within the the market Union Pharmena only S.A. by subsequent applicant obtains unless authorisation a for the food without reference novel to the evidence scientific proprietary or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the Pharmena S.A. agreement of End date protection: 2 September 2023 of the data
Other requirements
on the labelling containing of the it foodstuffs methyltetrahydrofolic shall acid, samine be gluco salt’ ‘(6S)-5- samine’ or ‘5MTHF-gluco supplements containing it shall ‘Organic be silicon anetriol)’ (monomethylsil on the labelling of the food The designation of the novel food The designation of the novel food Additional specific labelling requirements
10,40 mg/day Maximum levels silicon Maximum of levels Maximum
Specified food category Specified food category
Food Supplements as 2002/46/EC defined as a in source of folate Directive Food Supplements as 2002/46/EC defined for in adult Directive population form) (in liquid Conditions under which the novel food may be used
Authorised novel food (6S)-5-methyltet rahydrofolic acid, glucosamine salt Monomethylsil anetriol (Organic Silicon)
M9 M11 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 55
Data Protection ◄
M29 ► 10900 Wilshire Suite 600, Boulevard Los Angeles, CA 90024 USA. period During of the data novel the food is protection, authorised for placing on within the the market Union ChromaDex only Inc. by subsequent unless applicant obtains a authorisation for that food novel without the reference to evidence proprietary or scientific scientific protected in accordance data with Article 26 of Regulation (EU) 2015/2283 or agreement of with Inc. ChromaDex the End date protection: of 2025. 20 the February data Authorised on 20 2020. February This based inclusion scientific is on scientific evidence data protected accordance in with proprietary and Article of 26 Regulation 2283. (EU) 2015/ Applicant: ChromaDex Inc.,
Other requirements
’ or
Lentinula edodes on the labelling containing of it shall the be ‘Nicotinamide foodstuffs riboside chloride’ on the labelling containing of it the shall be foodstuffs ‘extract the from mushroom ‘extract from Shiitake mushroom’ The designation of the novel food The designation of the novel food
Additional specific labelling requirements
2,5 ml per day dose 300 mg/day for population, the excluding general pregnant adult and lactating women 230 pregnant and lactating mg/day women for Maximum levels Maximum Maximum levels Maximum 1,5 ml/100 ml 2,5 ml per meal 2 ml/100 g
0,5 ml/100 ml Specified food Specified food category Specified food category Food Supplements as 2002/46/EC defined in Directive Bread products Soft drinks Ready prepared meals Foods based on yoghurt Food supplements as 2002/46/EC defined in Directive Conditions under which the novel food may be used
)
Authorised novel food Lentinula edodes Nicotinamide riboside chloride from Shiitake from Shiitake mushroom ( Mycelial extract Mycelial extract
M38 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 56
Data Protection ◄ M29 ►
Other requirements
’
fruit puree’ or
fruit concentrate’ ’ Morinda citrifolia Morinda citrifolia Morinda citrifolia on the labelling containing of it shall be: the foodstuffs For fruit puree: ‘ on the labelling containing of it the shall foodstuffs be or ‘Juice ‘Noni of juice’ The designation of the on novel the food labelling containing of it the shall foodstuffs powder’ be ‘Noni juice or Morinda citrifolia ‘Juice powder of ‘Noni fruit puree’ For fruit concentrate: ‘ or ‘Noni fruit concentrate’
The designation of the novel food The designation of the novel food Additional specific labelling requirements
6,6 g/day (equivalent to noni 30 juice) ml of 53 g/100 g or 20 ml twice a day, not more than 40 ml per day Fruit puree 100 % noni juice) 30 ml with one serving (up to Maximum levels Maximum Maximum levels Maximum 11 g/100 g 45 g/100 g 31 g/100 g
53 g/100 g Specified food category Specified food Specified food category 12 g/100 g 53 g/100 g
Powdered nutritional weight) drink mixes (dry Carbonated beverages Ice cream & sorbet Yoghurt Biscuits Candy/confectionery Cereal bars Pasteurised fruit and fruit nectar based drinks Food supplements as 2002/46/EC defined in Directive Conditions under which the novel food may be used
) ) Morinda
) Authorised novel food Morinda citrifolia Morinda citrifolia Noni fruit puree Noni fruit and concentrate ( Noni fruit juice Noni fruit powder ( citrifolia ( Noni fruit juice Noni fruit
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 57
Data Protection ◄ M29 ►
Other requirements
Additional specific labelling requirements
Fruit concentrate
30 g/100 g Based on pre-processing quantity to produce final 100 g product 26 g/day 12 g/100 g 133 g/100 g 88 g/100 g 7 g/100 g 31 g/100 g 20 g/100 g 88 g/100 g 12 g/100 g 53 g/100 g 3 g/100 g 10 g/100 g 7 g/100 g
12 g/100 g
3 g/100 g 12 g/100 g
Yoghurt Biscuits Buns, cakes and pastries Breakfast cereals (wholegrain) Jams and jellies in accordance with Directive 2001/113/EC Sweet spreads, fillings and icings Food Supplements as 2002/46/EC defined in Directive Candy/Confectionery Cereal bars Powdered nutritional weight) drink mixes (dry Carbonated beverages Ice cream & sorbet Buns, cakes and pastries Breakfast cereals (wholegrain) Jams and jellies in accordance with Directive 2001/113/EC Sweet spreads, fillings and icings Savoury sauces, condiments pickles, gravies and Conditions under which the novel food may be used Authorised novel food
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 58
Data Protection ◄ M29 ►
Other requirements
Odontella Morinda
’. microalgae’ on the labelling of the foodstuffs containing it leaves’ shall or ‘leaves be citrifolia of ‘Noni consumer that a cup of should infusion not be prepared with more than 1 g of leaves of Morinda dried citrifolia. and roasted on the labelling containing of the it foodstuffs citrifolia shall fruit be fruit powder’ powder’ ‘Morinda or ‘Noni on the labelling containing of the it foodstuffs shall aurita be ‘ 2. Instructions shall be given to the
1. The designation of the novel food The designation of the novel food The designation of the novel food
Additional specific labelling requirements
2,4 g per/day 6 g/day shall not be prepared with more than 1 g of dried and Morinda citrifolia roasted leaves of 20 g/100 g Maximum levels Maximum levels levels Maximum Maximum A cup of infusion to be consumed 1,5 % 1 % 1 1,5 % 0,5 %
Specified food category Specified food category Specified food category 1 % 1 1,5 % Marine terrines Crackers Flavoured pasta Fish soups Broth preparations Frozen breaded fish Food Supplements as 2002/46/EC defined in Directive Savoury sauces, condiments pickles, gravies Food and Supplements as 2002/46/EC defined in Directive For the preparation of infusions Conditions under which the novel food may be used
) )
Authorised novel food Morinda citrifolia Morinda citrifolia Noni leaves ( Noni fruit powder Noni fruit ( Odontella aurita microalgae
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 59
Data Protection ◄ M29 ►
Other requirements
In accordance with Annex Regulation III.5 (EU) No to 1169/2011
Additional specific labelling requirements phytostanols
novel food ingredient presented in shall such a be manner they that can be easily portions divided into that maximum contain of 3 g (in either case of one portion a per day) or a of maximum 1 g (in case of three per portions day) of added phytostanols. phytosterols/ phytostanols container of added beverages shall not exceed 3 g. to a spicy sauces shall be packed single portions. as Maximum levels of phytosterols/ of Maximum levels 1. The products containing the 2. The amount of phytosterols/ 3. Salad dressings, mayonnaise and
Specified food category
Salad dressings, mayonnaise and spicy sauces Soya drinks spreads based on butter or other animal fat Milk based products, such as products based on semi-skimmed products, possibly with the addition and of fruits and/or cereals, products skimmed based on milk fermented milk such as products (fat yoghurt content and where ≤ cheese possibly 12 g based reduced per the and 100 g), the milk partly fat or fat fully or replaced by protein protein has vegetable fat has or been been Spreadable fats as defined in Annex VII, Part VII and Appendix Regulation II, points B (EU) and excluding C cooking of No and 1308/2013, frying fats and and Conditions under which the novel food may be used
Authorised novel food Oil enriched with phytosterols/ phytostanols
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 60
Data Protection ◄ M29 ► Authorised on 23 December 2020. This inclusion is based on evidence proprietary and scientific data protected in scientific accordance with Article 26 of Regulation (EU) 2015/2283.
Other requirements
Astragalus Panax noto and
’ Astragalus membra and shall bear a statement that ginseng on the labelling containing of it shall the be ‘Extract foodstuffs from Panax notoginseng membranaceus The labelling of food containing extract supplements from naceus those food supplements should be not consumed under by 18 the pregnant years women. population of age and by The designation of the on novel the food labelling containing of it shall be the ‘Squid oil’. foodstuffs The designation of the novel food
Additional specific labelling requirements
combined
Maximum levels of DHA and DHA and of EPA Maximum levels 60 mg/100 ml 3 000 mg/day for general population 450 mg/day lactating women for pregnant In accordance and with nutritional the particular requirements persons for of intended whom the the products 200 mg/meal cheese 100 g products 600 mg/ 35 mg/day 600 mg/100 g
200 mg/100 g or for cheese products
200 mg/100 g Maximum levels Maximum
200 mg/100 g or for analogues to 600 mg/100 g
500 mg/100 g
500 mg/100 g Specified food Specified food category Specified food category
Food supplements as 2002/46/EC defined for the general in adult population, Directive excluding food women supplements for pregnant Non-alcoholic milk-based beverages) beverages Food Supplements as 2002/46/EC defined in (including Directive Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Total diet replacement defined for in weight Regulation and control meal (EU) replacements for weight No control 609/2013 Dairy products except milk-based beverages Dairy analogues except drinks Spreadable fat and dressings Breakfast cereals Bakery products (breads and bread rolls) Cereal bars Conditions under which the novel food may be used
Panax and
Authorised novel food Extract from notoginseng squids Oil extracted from Oil extracted Astragalus membra naceus
M52 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 61
Data Protection ◄
M29 ► protection: 23 2025. December Applicant: NuLiv 1050 Science, W. Building Central C, 92821, USA. Ave., Brea, During CA the period protection, the of novel food data is authorised for placing on the market within the Union only by NuLiv Science, unless subsequent a applicant obtains authorisation for that food novel without the reference to proprietary evidence or scientific scientific protected in accordance data with Article 26 of Regulation (EU) 2015/2283 or agreement of NuLiv Science. with End the date of the data
Other requirements ) Salvia hispanica
on the labelling containing of the it foodstuffs defatted chia seed shall ( be powder’ ‘Partially The designation of the novel food Additional specific labelling requirements
0,7 % 0,7 % 0,7 % Maximum levels Maximum
Powder with high protein content
Specified food category Unflavoured fermented including natural milk (excluding unflavoured sterilised products, treated buttermilk) after buttermilk fermentation non-heat- Unflavoured fermented heat-treated after fermentation milk products, Flavoured fermented milk products including heat-treated products Conditions under which the novel food may be used
Salvia ) powders Authorised novel food Partially defatted ( chia seed hispanica
M44 M52 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 62
Data Protection ◄ M29 ►
Other requirements
Brassica
L. and L.’ shall bear a statement on the labelling containing of the it foodstuffs defatted Rapeseed shall powder’. be ‘Partially Any foodstuff containing ‘Partially defatted Rapeseed Brassica rapa powder’ from allergic reaction to consumers who are allergic products thereof. to shall That appear in close statement mustard the list proximity of ingredients. to and napus that this ingredient may cause The designation of the novel food Additional specific labelling requirements
7,5 g/day 2,5 % 12 g/day 7 g/100 g 4 % 7 g/100 g 2,5 % 2,5 %
20 g/100 g 20 g/100 g Maximum levels Maximum 15 g/100 g
Powder with high fibre content
20 g/100 g 4 % 4 3 % 3 4 % 4 10 %
Specified food category
) and vegetable juices
8 Cereal bars mixed Muesli and similar breakfast cereals Extruded breakfast cereal products Snacks (excluding potato crisps) Breads and ingredients (such as seeds, raisins, rolls herbs) with Brown breads added bearing absence or special statements reduced on accordance presence the of gluten with Commission in Implementing Regulation (EU) the No 828/2014 requirements of Confectionery Fruit juices as defined by Directive 2001/112/ EC and vegetable juices Fruit nectars as defined by 112/EC Directive and 2001/ vegetable products nectars and similar Flavoured drinks Food supplements as 2002/46/EC defined excluding food in supplements for Directive infants and young children Confectionery Fruit juices as defined by Directive 2001/112/ EC ( Fruit nectars as defined by 112/EC Directive and 2001/ vegetable products nectars and similar Flavoured drinks Food supplements as 2002/46/EC defined excluding food in supplements for Directive infants and young children Conditions under which the novel food may be used
L.
Brassica rapa Authorised novel food Partially defatted rapeseed powder from L. and Brassica napus
M59 M44 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 63
Data Protection ◄ M29 ► protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: aXichem Södergatan 26, SE AB, 211 Malmö 34, Sweden. During the period of the data novel protection, food saicin phenylcap is placing authorised on within the for Union the aXichem only by AB, market subsequent applicant obtains unless authorisation for a the food novel without the reference to evidence proprietary or scientific scientific protected in accordance data with Article 26 of Regulation (EU) 2015/2283 or agreement of aXichem AB. with the Authorised on 19 December 2019. This inclusion is based on evidence proprietary and scientific data scientific
Other requirements
high-pressure treatment’ displayed shall next to be the fruit name of preparations the as any product such in which it and is used in on the labelling containing of it the shall foodstuffs saicin’. be ‘phenylcap The wording ‘pasteurised by The designation of the novel food Additional specific labelling requirements
2,5 mg/day 2,5 mg/day
Maximum levels Maximum levels Maximum 7 g/100 g 10 g/100 g Specified food category 10 g/100 g
pineapple, strawberry prune, raspberry, rhubarb, Foods for special medical purposes as defined under Regulation excluding foods for infants, (EU) young and children children under the age No of 11 years 609/2013 Food supplements as 2002/46/EC defined intended in for the Directive lation, general excluding popu children under 11 the years age of Multigrain bread and rolls Meat substitutes Meat balls Types of fruit: apple, apricot, banana, blackberry, blueberry, cherry, coconut, mandarin, fig, mango, grape, melon, grapefruit, peach, pear, Conditions under which the novel food may be used Specified food category food Specified
Authorised novel food arations produced using high-pressure treatment Pasteurised fruit-based prep Phenylcapsaicin
M35 M9 M59 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 64
Data Protection ◄ M29 ►
Other requirements
on the labelling containing of it the shall foodstuffs maize be starch’ ‘Phosphated The designation of the on novel the food labelling containing of it the shall foodstuffs phatidylserine’ be ‘Fish phos
The designation of the novel food
Additional specific labelling requirements
dylserine
Maximum levels of phosphati of Maximum levels No 609/2013 300 mg/day 40 mg/100 ml ready to drink) In compliance with Regulation (EU)
Maximum levels Maximum
3 500 mg/100 g (equivalent to 200 mg/100 g 50 mg/100 ml 80 mg/100 g 15 %
350 mg/100 g
Specified food category Specified food Specified food category
Cereal bars Chocolate based confectionary Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Food supplements as 2002/46/EC defined in Directive Cereal bars Beverages based on yoghurt Powders based on milk powders Foods based on yoghurt Baked bakery products Pasta Breakfast cereals Conditions under which the novel food may be used
Authorised novel food Phosphated maize Phosphated starch from fish phosp holipids Phosphatidylserine
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 65
Data Protection ◄ M29 ►
pregnant breast-feeding or women The product is not intended to be marketed to Other requirements
The designation of the on novel the food labelling containing of shall be the ‘Soy foodstuffs phosphati dylserine and phosphatidic acid’ The designation of the on novel the food labelling containing of it the shall foodstuffs be phatidylserine’ ‘Soya phos
Additional specific labelling requirements
dylserine dylserine
Maximum levels of phosphati of Maximum levels Maximum levels of phosphati of Maximum levels 800 mg/day In compliance with Regulation (EU) No 609/2013 In compliance with Regulation (EU) No 609/2013 40 mg/100 ml ready to drink) 40 mg/100 ml ready-to drink)
3,5 g/100 g (equivalent to 3,5 g/100 g (equivalent to 80 mg/100 g 200 mg/100 g 50 mg/100 g 50 mg/100 ml 80 mg/100 g 80 mg/100 g 50 mg/100 g 80 mg/100 g
350 mg/100 g 350 mg/100 g Specified food category Specified food Specified food category Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Yogurt based-drinks Soy-based yogurt-like drinks Powders based on milk powder Food Supplements as 2002/46/EC defined in Directive Chocolate based confectionary Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Breakfast cereals Cereal bars Foods based on yogurt Soy-based yogurt-like products Beverages based on yoghurt Powders based on milk powder Foods based on yoghurt Cereal bars Conditions under which the novel food may be used
Authorised novel food Phospholipid product containing equal amounts of phosphatidylserine and phosphatidic acid from soya phosp holipids Phosphatidylserine Phosphatidylserine
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 66
Data Protection ◄ M29 ►
Other requirements
containing it lycogen’ shall be ‘Phytog Regulation (EU) No 1169/2011 on the labelling of the foodstuffs In accordance with Annex III.5 of The designation of the novel food Additional specific labelling requirements
manner that they can divided be easily contain into either a 3 g portions (in case maximum of 1 portion/day) a or of maximum of that 1 g (in case portions/day) of 3 phytosterols/phytostanols. of The amount phytostanols of added container phytosterols/ of added beverages shall not exceed 3 g. to Salad dressings, a mayonnaise and spicy sauces shall be packed single portions as 3 g/day
Maximum levels Maximum Maximum levels levels Maximum Maximum
25 %
1. They shall be presented in such a
Specified food category Specified food Specified food category
Salad dressings, sauces. mayonnaise and spicy Products based on fermented yoghurt milk such and as content < cheese 12 % per type the 100 g), where milk possibly products fat milk has fat (fat been and/or reduced, protein fully replaced has by or vegetable fat been and/or protein where partly or Spreadable fats as defined in Annex VII, Part VII and Appendix Regulation II, points B (EU) and excluding C cooking of No spreads based and on butter 1308/2013, or frying other animal fat. fats and Food Supplements and as 2002/46/EC defined in Directive (wholemeal rye flour, whole or kernels cracked and rye rye flakes) and and with ≤ 4 ≤ % added sugar but 30 no % fat added. wheat; Soya drink Milk type products, such and as skimmed semi-skimmed milk type with products, the possibly addition where of fruits possibly and/or reduced, cereals, the or where milk has milk fat fat been and/or vegetable protein has fat and/or partly protein. been or fully replaced by Not specified Processed foods Rice drinks Rye bread with flour containing ≥ 50 % rye Conditions under which the novel food may be used Specified food category food Specified
Authorised novel food from egg yolk Phospholipides Phospholipides phytostanols Phytosterols/ Phytoglycogen
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 67
Data Protection ◄ M29 ►
Other requirements
on the labelling containing of it shall the be ‘Prolyl foodstuffs oligo peptidase’ on the labelling containing of the foodstuffs it protein’ shall be ‘Potato The designation of the novel food
PPI/day)
6
Additional specific labelling requirements
capsules or 3 tablets with a content of DAO of 0,3 mg/tablet) mg/capsule or 0,3 PPU – Prolyl Proline Protease Peptidase Units Units or PPI – national Protease Picomole Inter 3 capsules equalising 12,6 or extract mg a 3 pig (DAO) day kidney content: tablets/day; Diamine 0,9 oxidase mg/day (3 vegetable oils 120 PPU/day (2,7 g of enzyme prep aration/day) (2 × 10
Maximum levels Maximum levels Maximum Maximum levels Maximum In line with normal food use of The designation of the novel food
Specified food category Specified food category Food Supplements as 2002/46/EC defined in Directive Food for special medical purposes as defined in Regulation (EU) No 609/2013 Food Supplements as 2002/46/EC defined for general in adult population Directive For frying and as seasoning Not specified
Conditions under which the novel food may be used
Specified food category food Specified
Authorised novel food (coagulated) and hydrolysates thereof Potato proteins Protein extract from pig kidneys Prolyl oligopep tidase (enzyme preparation) Plum kernel Plum kernel oil
M47 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 68
Data Protection ◄ M29 ► novel food Pyrroloquinoline quinone disodium is auth salt orised for placing market within the Union only on by the Mitsubishi Gas Chemical Company, Inc., subsequent applicant unless obtains authorisation a for the food without reference novel to the evidence scientific proprietary or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the Mitsubishi agreement Gas of Company, Inc. Chemical End date protection: 2 september 2023 of the data Authorised on 2 September 2018. is This based scientific on scientific evidence inclusion data proprietary protected accordance in with and Article of 26 Regulation 2283. (EU) 2015/ Applicant: Mitsubishi Chemical Gas Company, Mitsubishi Inc., Marunouchi Building Chiyoda-ku, 5-2 Tokyo 8324, Japan. 2-chome, 100- period of data During protection the the
Other requirements
on the labelling containing of it the shall foodstuffs noline be quinone disodium ‘Pyrroloqui salt’. Food supplements containing Pyrro loquinoline quinone disodium shall bear the salt following statement: This food supplement consumed by adults should only excluding be pregnant and lactating women The designation of the novel food Additional specific labelling requirements 20 mg/day
Maximum levels Maximum Specified food category Food Supplements as 2002/46/EC defined intended for the adult population, in Directive excluding pregnant and lactating women Conditions under which the novel food may be used
Authorised novel food Pyrroloquinoline quinone disodium salt
M10 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 69
Data Protection ◄ M29 ► Authorised on 20 November 2018. This inclusion is based on evidence proprietary and scientific data protected in scientific accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Marealis Stortorget 1, AS., Kystens 2nd Hus, floor, N-9008 Postal Tromsø address: 1065, P.O. Box Norway. During the 9261 of period data protection the novel food refined Tromsø, shrimp peptide
Other requirements
on the labelling of the foodstuffs containing it shall be ‘Rapeseed protein’. ‘rapeseed protein’ shall statement bear a that may this cause allergic ingredient consumers reaction who to are mustard allergic and to Where products relevant, thereof. this shall appear statement in close to the list proximity of ingredients. on the labelling containing of the it foodstuffs shrimp peptide concentrate’. shall be ‘refined on the labelling containing of it shall the be ‘Rapeseed foodstuffs oil extract’ 1. The designation of the novel food 2. Any foodstuff containing The designation of the novel food The designation of the novel food
Additional specific labelling requirements
1,5 g per portion recommended for daily consumption 1 200 mg/day
Maximum levels Maximum Maximum levels Maximum
Specified food Specified food category Specified food category Food Supplements as 2002/46/EC defined for the in adult population Directive Food Supplements as 2002/46/EC defined in Directive in infant formula and follow-on formula Conditions under which the novel food may be used
As a vegetable protein source in foods except
Authorised novel food peptide concentrate Refined shrimp Rapeseed Protein unsaponifiable unsaponifiable matter Rapeseed oil high in Rapeseed oil
M17 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 70
Data Protection ◄
M29 ► concentrate is authorised for placing on the market within the Union only by Marealis AS unless applicant a obtains ation authoris subsequent for without the novel reference proprietary food to evidence the or scientific protected in accordance data with Article 26 of Regulation (EU) scientific 2015/2283 or agreement of Marealis with AS. the End date protection: of 20 2023. the November data
Other requirements - trans
-resveratrol’. -resveratrol’. Trans on the supplements labelling containing of it be the ‘ shall food supplements containing product supervision. under medical resveratrol shall bear a statement that people should using only medicines consume the 2. The labelling of food 1. The designation of the novel food Additional specific labelling requirements
150 mg/day
Maximum levels Maximum Food supplements as 2002/46/EC defined for the adult in population Directive Conditions under which the novel food may be used Specified food category food Specified -resveratrol Authorised novel food Trans
M56 M17 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 71
Data Protection ◄ M29 ►
Other requirements
-resveratrol’. -resveratrol’.
Trans the products are not intended for use by children. supplements trans-resveratrol shall statement bear that medicines a should only people containing consume the using product supervision. under medical on the labelling of the foodstuffs containing it shall energy fat be (salatrims)’. ‘reduced excessive consumption may lead to gastro-intestinal disturbance. on the supplements labelling containing of it be the ‘ shall food on the labelling containing of the it foodstuffs comb shall extract’ or extract’ be ‘Cockerel comb ‘Rooster on the labelling containing of it the shall foodstuffs be oil ‘Sacha (Plukenetia volubilis)’ inchi 3. There shall be a statement that 2. The labelling of food 2. There shall be a statement that
Fallopia
The designation of the novel food The designation of the novel food 1. The designation of the novel food 1. The designation of the novel food Additional specific labelling requirements
) japonica In line with supplements of normal resveratrol extracted use in from Japanese food knotweed ( linseed oil Maximum levels Maximum levels levels Maximum Maximum Maximum levels Maximum 80 mg/100 g or mg/100 ml 65 mg/100 g or mg/100 ml 40 mg/100 g or mg/100 ml In line with normal food use of 110 mg/100 g or mg/100 ml
Specified food category Specified food category Specified food Specified food category Bakery products and confectionary Milk-based drinks Milk based fermented drinks Yoghurt-type products Fromage frais As for linseed oil Food supplements as 2002/46/EC defined in Directive
Conditions under which the novel food may be used
Specified food category food Specified
Authorised novel food Salatrims Rooster comb extract (microbial source) (microbial Trans-resveratrol Trans-resveratrol Sacha inchi oil from oil Sacha inchi Plukenetia volubilis
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 72
Data Protection ◄ M29 ►
Other requirements
sp.’ The designation of the on novel the food labelling containing of it the foodstuffs shall EPA-rich be oil ‘DHA from Schizochytrium and the microalgae
: Additional specific labelling requirements
combined
Maximum levels of DHA and DHA and of EPA Maximum levels In accordance with nutritional the particular requirements persons for whom the of products intended are the 3 000 mg/day 200 mg/100 g 450 mg/day 250 mg/meal 200 mg/100 g
500 mg/100 g Specified food Specified food category
Foods bearing statements on the reduced absence or presence of with the gluten requirements of Commission in Imple accordance menting Regulation (EU) No 828/2014 in Regulation (EU) No 609/2013 Foods for special medical purposes as defined Foods intended to meet intense the expenditure of muscular sportsmen effort, especially for Bakery Products (Breads, Rolls Biscuits) and Sweet Breakfast Cereals Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 and meal replacements for weight control Milk-based drinks intended for young and children similar products Processed cereal based food and for baby infants and food young children as defined Regulation in (EU) No 609/2013 Food Supplements as 2002/46/EC defined for in adult Directive pregnant population and lactating excluding women Food Supplements as 2002/46/EC defined in Directive for women pregnant and lactating Conditions under which the novel food may be used
Authorised novel food oil rich DHA in and EPA Schizochytrium sp. Schizochytrium
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 73
Data Protection ◄ M29 ►
Other requirements
sp.’ Schizochytrium on the labelling containing of it shall the be ‘Oil foodstuffs from microalgae the
The designation of the novel food
Additional specific labelling requirements
450 mg DHA/day for pregnant and lactating women 250 mg DHA/day for general popu lation 250 mg/meal 100 g for milk products milk, (including fromage products; frais excluding drinks) and yoghurt 80 mg/100 g 600 mg/100 g cheese products 600 mg/100 g 100 g for soy products (excluding and drinks) imitation milk 600 mg/100 g for cheese; 200 mg/ 200 mg/100 g or for cheese products
Maximum levels of DHA of levels Maximum
600 mg/100 g for cheese; 200 mg/ 600 mg/100 g 200 mg/100 g or for analogues to 600 mg/100 g 500 mg/100 g 500 mg/100 g 360 mg/100 g
Specified food category analogue and milk-based drinks) Dairy analogues except drinks Non-alcoholic Beverages (including dairy Spreadable fats and dressings Breakfast cereals Food Supplements as 2002/46/EC defined in Directive Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 and meal replacements for weight control Cereal/Nutrition Bars Spreadable Fats and Dressings Dairy products except milk-based drinks Cooking Fats Dairy Analogues except drinks Dairy Products except milk-based drinks Conditions under which the novel food may be used sp.
Authorised novel food Schizochytrium (ATCC PTA-9695) oil
M26 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 74
Data Protection ◄ M29 ►
Other requirements Additional specific labelling requirements
In accordance with nutritional the particular requirements persons for whom the of products intended are the In accordance with Regulation (EU) No 609/2013 200 mg/100 g 200 mg/100 g 80 mg/100 ml 200 mg/100 g
100 mg/100 g 360 mg/100 g 500 mg/100 g
Foods bearing statements on the reduced absence or presence of with the gluten requirements of Commission in Imple accordance menting Regulation (EU) No 828/2014 Non-alcoholic beverages analogue and (including milk-based drinks) dairy Infant formula and defined in Regulation follow-on (EU) No 609/2013 formula as Processed cereal-based foods and baby foods for infants and young children as defined Regulation in (EU) No 609/2013 Fruit/vegetable puree Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Bakery products (breads, biscuits) rolls, and sweet Cereal bars Cooking fats Milk-based drinks intended for young and children similar products Foods intended to meet intense the expenditure of muscular sportsmen effort, especially for Conditions under which the novel food may be used Authorised novel food
M26 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 75
Data Protection ◄ M29 ►
Other requirements
sp.’ Schizochytrium containing it shall be ‘Oil from microalgae the on the labelling of the foodstuffs
The designation of the novel food Additional specific labelling requirements
250 mg DHA/day for general popu lation 450 mg DHA/day for pregnant and lactating women 600 mg/100 g cheese products 600 mg/100 g 250 mg/meal 200 mg/100 g 200 mg/100 g or for cheese products
Maximum levels of DHA of levels Maximum
200 mg/100 g or for analogues to 600 mg/100 g
500 mg/100 g
Specified food category Milk-based drinks intended for young and children similar products Processed cereal-based foods and baby foods for infants and young children as defined Regulation in (EU) No 609/2013 Foods intended to meet intense the expenditure of muscular sportsmen effort, especially for Spreadable fat and dressings Breakfast cereals Food Supplements as 2002/46/EC defined in Directive Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 and meal replacements for weight control Dairy products except milk-based drinks Dairy analogues except drinks Conditions under which the novel food may be used sp.
Authorised novel food Schizochytrium oil
M24 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 76
Data Protection ◄ M29 ►
Other requirements
sp.’. Schizochytrium on the labelling containing of it shall the be ‘Oil foodstuffs from microalgae the
The designation of the novel food Additional specific labelling requirements
In accordance with nutritional the particular requirements persons for whom the of products intended are the 200 mg/100 g 80 mg/100 ml 600 mg/100 g cheese products 600 mg/100 g 200 mg/100 g or for cheese products Maximum levels Maximum
200 mg/100 g or for analogues to 600 mg/100 g 100 mg/100 g 500 mg/100 g 360 mg/100 g 500 mg/100 g Specified food category
Dairy products except milk-based drinks Dairy analogues except drinks Spreadable fats and dressings Breakfast cereals biscuits) Cereal bars Cooking fats Non-alcoholic beverages analogue and (including milk-based drinks) dairy Fruit/vegetable puree Foods bearing statements on the reduced absence or presence of with gluten in the accordance Regulation (EU) No requirements 828/2014 of Implementing Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Bakery products (breads, rolls, and, sweet Conditions under which the novel food may be used sp.
Authorised novel food Schizochytrium (T18) oil
M49 M24 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 77
Data Protection ◄ M29 ►
Other requirements Additional specific labelling requirements
450 mg DHA/day for pregnant and lactating women In accordance with nutritional the particular requirements persons for whom the of products intended are the 250 mg DHA/day for general popu lation 200 mg/100 g 250 mg/meal 200 mg/100 g
500 mg/100g
Foods bearing statements on the reduced absence or presence of with the gluten requirements of Commission in Imple accordance menting Regulation (EU) No 828/2014 Foods for special medical purposes as defined in Regulation (EU) No 609/2013 Bakery products (breads, biscuits) rolls and, sweet Cereal bars Milk-based drinks intended for young and children similar products Foods intended to meet intense the expenditure of muscular sportsmen effort, especially for Food supplements as 2002/46/EC defined in Directive Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 and meal replacements for weight control Conditions under which the novel food may be used Authorised novel food
M49 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 78
Data Protection ◄ M29 ► Article 26 of Regulation (EU) 2015/2283. Applicant: Progress Biotech bv, Canaalstaete, Kanaalweg 33, 2903LR Capelle aan den Ijssel, the Netherlands. During the period protection, the of novel food is data authorised for placing on the market within the Union only by Progress unless Biotech applicant bv obtains a ation authoris for without that novel subsequent reference proprietary food to evidence the or scientific data scientific Authorised on 16 May 2021. This inclusion is proprietary based on evidence and scientific data protected in accordance with scientific
Other requirements
sp.’ Schizochytrium The designation of the on novel the food labelling containing of it shall the be ‘Oil foodstuffs from microalgae the
Additional specific labelling requirements
In accordance with Regulation (EU) No 609/2013 In accordance with Regulation (EU) No 609/2013 200 mg/100 g 80 mg/100 ml
Maximum levels of DHA of levels Maximum
100 mg/100 g 360 mg/100 g Specified food category Infant formula and defined in Regulation follow-on (EU) No 609/2013 formula as Cooking fats Non-alcoholic beverages analogue and (including milk-based drinks) dairy Infant formula and defined in Regulation follow-on (EU) No 609/2013 formula as Processed cereal-based foods and baby foods for infants and young children as defined Regulation in (EU) No 609/2013 Fruit/vegetable puree Conditions under which the novel food may be used sp.
Authorised novel food (WZU477) oil Schizochytrium
M61 M49 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 79
Data Protection ◄
M29 ► protected in accordance with Article 26 of Regulation (EU) 2015/2283 or agreement with Biotech bv. of the Progress End date protection: 16 May 2026 of (5 years). the data
Other requirements Yarrowia ) biomass ) biomass’.
Yarrowia lipolytica ).
12 on the labelling containing of the it foodstuffs shall containing be ‘selenium- lipolytica yeast The labelling of ( food containing supplements yeast ( shall bear selenium-containing a statement that the supplements food consumed should by infants under and 4 years children of not age/children under 7 years of be years age/children under 11 adolescents of under age ( 18 age/children years of and The designation of the novel food Additional specific labelling requirements
800 mg/day for adults, resulting 160 in μg of selenium per day 50 mg/day for children from 4 to years 6 of age, resulting in selenium 10 per μg day of 100 mg/day for children from 10 7 years to of age, resulting in of 20 selenium per μg day 500 mg/day for adolescents from 11 to 17 years of age, resulting in μg 100 of selenium per day
Maximum levels Maximum ), excluding food supplements
3 Specified food category for infants and children under 4 years of age Food supplements as 2002/46/EC ( defined in Directive Conditions under which the novel food may be used
) biomass Yarrowia Authorised novel food Selenium-containing yeast ( lipolytica
M54 M61 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 80
Data Protection ◄
M29 ► novel food without reference to the proprietary evidence scientific or scientific protected in accordance data with Article 26 of Regulation (EU) 2015/2283 or agreement of Glycom A/S. with the End date protection: of 2026. 18 the February data Authorised on 18 2021. February This based inclusion scientific is on scientific evidence data protected accordance in with proprietary and Article of 26 Regulation 2283. (EU) 2015/ Applicant: Kogle Glycom Allé Hørsholm, A/S, Denmark. During 4, the period of DK-2970 data protection, the novel lactose sodium food salt is orised auth 3'-sialyl for placing market on within only the by the Glycom A/S, unless Union a obtains authorisation subsequent for the applicant
Other requirements
Sialyllactose sodium consumed the same salt day. are The labelling of food containing supplements 3'-Sialyllactose salt sodium shall bear a statement that they should not be consumed: a) if foods containing added 3'- b) by infants and young children The designation of the on novel the food labelling containing of the it foodstuffs lactose shall sodium salt’. be ‘3'-Sialyl
Additional specific labelling requirements
3'- Sialyllactose)
5 g/kg beverages) (products other than 0,25 g/L (beverages) 1,25 g/kg for products beverages other than stituted as instructed by the facturer manu 0,5 g/L (beverages) 0,5 g/kg beverages) (products other than 2,5 g/kg beverages) (products other 0,25 g/L than 0,2 g/L in the final product ready for use, marketed as stituted as such instructed by or the facturer manu recon 0,15 g/L in the final product for use, ready marketed as such or recon stituted as instructed by the facturer manu 0,15 g/L (beverages) product in ready for the use, marketed final such as or reconstituted as by the manufacturer instructed 0,15 g/L in the final product for use, ready marketed as such or recon 0,25 g/L 0,25 g/L (beverages)
Maximum levels (expressed as (expressed levels Maximum
2,5 g/kg Specified food Specified food category for infants and under young Regulation (EU) children No 609/2013 as defined Milk-based drinks intended for young and children similar products Total diet control replacement as foods defined No for 609/2013 under Regulation weight (EU) Beverages (flavoured drinks, excluding drinks with a pH less than 5) Cereal bars Infant Regulation (EU) No formula 609/2013 as defined Follow-on under formula Regulation (EU) No 609/2013 as defined under Processed cereal-based food and baby food Unflavoured pasteurised sterilised (including UHT) and milk products unflavoured Flavoured fermented including heat-treated milk-based products products Unflavoured fermented milk-based products Conditions under which the novel food may be used
Authorised novel food 3'-Sialyllactose 3'-Sialyllactose (3'-SL) sodium salt (microbial source)
M58 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 81
Data Protection ◄ M29 ► the novel lactose sodium food salt is orised auth 6’-sialyl for placing market on within only the by the Glycom A/S, unless Union a obtains authorisation subsequent for the novel food without reference applicant to the proprietary evidence scientific or scientific protected in accordance data with Article 26 of Regulation (EU) 2015/2283 or agreement of Glycom A/S. with the End date of tection: 17 the February 2026. data pro Authorised on 17 2021. February This based on inclusion ntific proprietary evidence and scientific scie is data protected in accordance with Article 26 lation (EU) 2015/2283. of Regu Applicant: Kogle Glycom Allé Hørsholm, A/S, Denmark. During 4, the period of DK-2970 data protection,
Other requirements
Sialyllactose sodium consumed on the salt same day. are The designation of the on novel the food labelling containing of the it foodstuffs lactose shall sodium salt’. be ‘6’-Sialyl The labelling of food containing supplements 6’-Sialyllactose (6’-SL) sodium salt shall bear that a they statement should not be consumed: a) if foods containing added 6’- b) by infants and young children
Additional specific labelling requirements
6’-Sialyllactose)
2,5 g/kg for beverages products other than 2,5 g/kg beverages) (products other 0,5 g/L (beverages) than 5,0 g/kg beverages) (products other than 0,5 g/day product ready for use, marketed such as or reconstituted as by the manufacturer instructed 0,5 g/L 0,5 g/L 0,4 g/L in the final product ready for use, marketed as stituted as such instructed by or the facturer manu recon 0,3 g/L in the final product ready for use, marketed as stituted as such instructed by or the facturer manu recon 0,3 g/L (beverages) in the final In accordance with nutritional the particular requirements persons for whom the of products intended are the 0,5 g/L (beverages)
Maximum levels (expressed as (expressed levels Maximum
5,0 g/kg Specified food category Follow-on formula Regulation (EU) No 609/2013 as defined under Processed cereal-based food and for baby food infants and under young Regulation (EU) children No 609/2013 as defined sterilised (including UHT) milk products Unflavoured fermented milk-based products Flavoured fermented including heat-treated milk-based products products Beverages (flavoured drinks, excluding drinks with a pH less than 5) Cereal bars Infant Regulation (EU) No formula 609/2013 as defined under Food for special medical purposes as defined under Regulation (EU) No 609/2013 Food Supplements as 2002/46/EC, defined excluding food in supplements for Directive infants and young children Unflavoured pasteurised and unflavoured Conditions under which the novel food may be used
Authorised novel food 6’-Sialyllactose sodium salt (6’-SL) (microbial source)
M57 M58 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 82
Data Protection ◄ M29 ►
Other requirements
) syrup’ fermented soybean extract bear shall a taking statement medication that should consume persons only the medical supervision. product under on the labelling of the foodstuffs containing it shall be ‘Fermented soybean extract’. supplements containing Sorghum bicolor on the labelling containing of the it foodstuffs ( shall be ‘Sorghum 2. The labelling of food 1. The designation of the novel food
Additional specific labelling requirements
10,0 g/kg (products beverages) other than 1,0 g/day 1,0 g/L (beverages) In accordance with nutritional the particular requirements persons for whom the of products intended are the 100 mg/day 0,3 g/L (beverages) product ready in for use, the marketed such as or final reconstituted as by the manufacturer instructed
Maximum levels Maximum
The designation of the novel food
Specified food category Food Supplements as 2002/46/EC defined in (capsules, Directive form) tablets intended or excluding for pregnant powder and lactating the women adult population, Food Supplements as 2002/46/EC, defined excluding food in supplements for Directive infants and young children Not specified Milk based intended drinks for young children and similar products Total diet control replacement as foods defined No for 609/2013 under Regulation weight (EU) Food for special medical purposes as defined under Regulation (EU) No 609/2013 Conditions under which the novel food may be used
Authorised novel food (Traditional food from a third country) Fermented soybean extract Syrup from Sorghum bicolor (L.) Moench
M22 M9 M57 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 83
Data Protection ◄ M29 ►
Other requirements
L.) L.) pulp’, Theobroma
Theobroma cacao Theobroma cacao L.) pulp’, ‘Glucose obtained on the labelling of the foodstuffs containing it shall be ‘Sucromalt’. on the labelling shall be accom panied by product indication is that a and source fructose. the of glucose on the supplements containing labelling it shall ‘spermidine-rich wheat germ extract’ of be the food obtained from cocoa cacao ( from cocoa ( pulp’ or ‘Fructose cocoa ( obtained from 2. The designation of the novel food on the labelling containing of the foodstuffs it shall be ‘sugars depending on the form used. 1. The designation of the novel food The designation of the novel food Additional specific labelling requirements
Equivalent of max. 6 mg/day midine sper
Maximum levels Maximum levels Maximum Maximum levels Maximum 3 % 3 3 % 3 5 % 5 2 % 2 5 % 5 The designation of the novel food
Specified food Specified food category 5 % 5 2 % 2 8 % 8 Beverages Bakery goods Meat and muscle products Seasonings and spices Grated cheeses Special diet foods Sauces Not specified Bread Food Supplements as 2002/46/EC defined intended for the adult population, in Directive excluding pregnant and lactating women Not specified Conditions under which the novel food may be used
)
Specified food category food Specified Specified food category food Specified
Authorised novel food Theobroma cacao Triticum aestivum Sucromalt Sugars obtained from cocoa ( wheat germ extract wheat germ ( Spermidine-rich Spermidine-rich Sugar cane fibre Sugar cane L.) pulp
M9 M50 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 84
Data Protection ◄ M29 ►
Other requirements ’ or shall ’
T. chuii
Tetraselmis chuii Tetraselmis chuii
on the labelling of the foodstuffs containing it Tagatose’. shall be ‘D- where the level exceeds of 15 g per D-Tagatose serving and all beverages containing greater than 1 % D-Tagatose (as shall consumed) bear a statement ‘excessive consumption laxative effects’. may produce on the labelling containing of it shall the be foodstuffs ‘taxifolin-rich extract’ on the labelling containing of the foodstuffs it microalgae shall ‘Dried microalgae be ‘Dried Food supplements containing dried microalgae bear the ‘Contains negligible iodine’ following amounts of statement: on the labelling containing of the it foodstuffs shall oil extract’ be ‘Sunflower 2. The labelling of any product
The designation of the novel food The designation of the novel food 1. The designation of the novel food The designation of the novel food
sh products Additional specific labelling requirements ation of culinary fish
250 mg/day 1,1 g/day 0,020 g/kg 0,008 g/kg 0,005 g/kg Maximum levels Maximum Maximum levels Maximum levels Maximum Maximum levels Maximum
(*)
1 % 1
Specified food category Specified food category Specified food Specified food category 250 mg/day
(*)
20 % or 250mg/day (*) Condiment Food Supplements as 2002/46/EC defined in Directive Yogurt plain/Yogurt with fruits Kephir Buttermilk Intended use identical to that of the salmon, namely the products prepar and dishes, including cooked, raw, smoked and baked fi Not specified Food Supplements as 2002/46/EC defined in Directive Sauces Special salts Conditions under which the novel food may be used /
Specified food category food Specified
Tetraselmis microalgae Authorised novel food Taxifolin-rich extract Dried chuii extract Sunflower oil Sunflower Therapon barcoo Scortum D-Tagatose
M49 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 85
Data Protection ◄ M29 ►
Other requirements
on the labelling shall be accom panied by ‘Trehalose indication that is glucose’. the a source of on the labelling of the foodstuffs containing it shall be ‘Trehalose’ and shall be labelling displayed of the on product as the or such in the list foodstuffs containing it. of ingredients of 2. The designation of the novel food 1. The designation of the novel food Additional specific labelling requirements eplace in whole or in
0,052 g/kg 0,070 g/kg 0,050 g/kg 0,090 g/kg 0,164 g/kg 100 mg/day Maximum levels Maximum
0,020 g/L 0,070 g/kg
(*)
(*)
(*)
(*)
(*)
part, any milk constituent (*) When used in milk products Taxifolin-rich extract may not r Not specified Non-alcoholic beverages Food supplements as 2002/46/EC defined intended in for the Directive lation, general popu excluding children infants, and young adolescents years children, younger than 14 Milk powder Cream Sour cream Cheese Butter Chocolate confectionery Conditions under which the novel food may be used Specified food category food Specified Authorised novel food Trehalose
M9 M49 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 86
Data Protection ◄ M29 ►
Other requirements
2
in final
2
yeast’
)’. 2
yeast’. yeast’.
2
Agaricus bisporus shall bear instructions for the final for consumers so that use a maximum concentration of 5 μg/ 100 g of vitamin D levels’. on the labelling of the foodstuffs shall be ‘Vitamin ‘Vitamin D D yeast’ or shall bear a foodstuff statement that is the only baking and that intended it should for not eaten be raw. home-baked products exceeded. is not ‘UV-treated ( mushrooms the novel food as such or of foodstuffs the containing it shall accompanied be by indication that a ‘controlled light treatment used was to levels’ increase or ‘UV used vitamin treatment to D was increase vitamin D the novel food as such or of foodstuffs the containing it shall be 2. The designation on the label of The designation of the on novel the food labelling containing of it the shall foodstuffs yeast’ be or ‘Vitamin ‘Vitamin D D 1. The designation of the novel food 2. The labelling of the novel food 3. The labelling of the novel food 1. The designation on the label of
2 2
/100 g fresh
2
/100 g /100 g
2 2
Additional specific labelling requirements
45 μg/100 g for fresh yeast 200 μg/100 g for dried yeast weight Maximum levels of vitamin D vitamin of levels Maximum Maximum levels of vitamin D vitamin of levels Maximum 5 μg of vitamin D 20 μg of vitamin D 5 μg of vitamin D )
Agaricus bisporus
Specified food category Specified food Specified food category
Yeast-leavened breads and rolls Yeast-leavened fine bakery wares Food supplements as 2002/46/EC defined in Directive Pre-packed fresh or baking dry yeast for home Mushrooms ( Conditions under which the novel food may be used
)
) Sacchar Authorised novel food Agaricus bisporus omyces cerevisiae UV-treated UV-treated mushrooms ( UV-treated baker’s yeast (
M49 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 87
Data Protection ◄ M29 ►
Other requirements
the novel food treated’. shall be ‘UV- an amount of vitamin D considered that is accordance with Point 2 significant of A Part Regulation of (EU) in No of 1169/2011 the European Annex Parliament of and the Council, for the XIII the labelling designation shall be accom panied to by ‘contains produced vitamin by D UV-treatment’ ‘milk or containing resulting from UV-treatment’. vitamin D UV-treatment’ 1. The designation on the label of 2. Where UV-treated milk contains The designation on the label of novel the food shall be accompanied by ‘contains vitamin D produced by
3 2
Additional specific labelling requirements
/100 g
2
3 μg vitamin D 5-32 μg/kg for general excluding infants population 1-15 μg/kg for general excluding infants population Maximum levels of vitamin D vitamin of levels Maximum Maximum levels of vitamin D vitamin of levels Maximum
Pasteurised semi-skimmed milk as defined in Regulation (EU) consumed as such No 1308/2013 to be Pasteurised whole Regulation milk (EU) consumed as as such No defined 1308/2013 in to be Yeast leavened toppings) bread and rolls (without Conditions under which the novel food may be used Specified food category food Specified Specified food category food Specified Authorised novel food UV-treated bread UV-treated milk
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 88
2
Data Protection ◄ M29 ► Authorised on 2020. 27 August This based inclusion scientific is on scientific evidence data protected accordance in with proprietary and Article of 26 Regulation 2283. (EU) 2015/ Applicant: Oakshire Naturals, LP., PO Box Square, 388 Pennsylvania 19348, Kennett United States. period During of the the data novel food protection, vitamin D LP., unless applicant a obtains subsequent ation authoris for without the novel reference proprietary food to evidence the or scientific protected in accordance data with Article scientific 26 (EU) 2015/2283 of or with the agreement Regulation Naturals, LP. of Oakshire End date protection: 27 August 2025. of the data mushroom powder is orised auth for placing market on within only the the by Oakshire Union Naturals,
Other requirements mushroom
2
’
2
mushroom vitamin powder mushroom D’ containing vitamin D powder or containing ‘UV-treated powder shall bear a they statement that should not infants be consumed by on the labelling containing of it the shall foodstuffs be ‘UV-treated The labelling of food containing supplements vitamin D The designation of the novel food )
11 (
2
/100 mL /100 mL /100 mL
2 2 2
/100 mL
/100 g/1,125 /100 g/1,125 /100 g/1,125
2
/100 g /100 g /100 g /100 g /100 g /100 g /100 g
2 2 2
2 2 2 2 2 2 2
Additional specific labelling requirements
15 μg/day μg μg of vitamin D μg of vitamin D μg of vitamin D 1,125 μg of vitamin D 2,25 μg of vitamin D (beverages) 2,25 μg of vitamin D (beverages) (beverages) 15 μg/day 2,25 μg of vitamin D
2,25 μg of vitamin D
2,25 μg of vitamin D 2,25 μg of vitamin D
Maximum levels of vitamin D vitamin of levels Maximum 2,25 μg of vitamin D 2,25 μg of vitamin D 2,25 μg of vitamin D 2,25 μg of vitamin D
Soups and broths Extruded vegetable snacks Foods for defined under Special Regulation (EU) No Medical 609/2013 excluding those Purposes intended for infants as Food supplements as 2002/46/EC defined intended in for the Directive lation general excluding infants popu milks) Cheese (excluding cheese, cottage and hard-grating cheeses) cheese, ricotta Meal replacement bars and beverages Dairy analogues Meat analogues Specified food category Breakfast cereals Yeast-leavened bread and pastries Grain products and pastas Fruit juice beverages and fruit/vegetable Milk and dairy blend products (excluding fluid Conditions under which the novel food may be used
2
Authorised novel food Vitamin D mushroom powder
M48 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 89
Data Protection ◄ M29 ►
The Bran ‘Wheat Extract’ may not introduced onto be the market as a food ment supple or supplement food ingredient. Nor may added to it infant formula. be Other requirements
’
2
on the labelling containing of it the shall foodstuffs be extract’ ‘Wheat bran on the labelling containing of it the shall be foodstuffs ‘Xylo-oligos accharides’ The designation of the on novel the food labelling containing of it shall be ‘Menaquinone’ the foodstuffs or ‘Vitamin K The designation of the novel food )
The designation of the novel food
10 ( (EU) No 609/2013 Additional specific labelling requirements
2 g/day
Maximum levels Maximum levels Maximum 0,6 g/100 g 30 g/kg 9 g/100 g 0,4 g/100 g 2 g/100 g 14 g/kg 14 g/kg 2,4 g/100 g 30 g/kg 14 g/kg 3,5 g/kg 0,6 g/100 g Specified food category
) 3,5 g/kg
9 14 g/kg Breakfast cereals Biscuits Soy drink Yoghurt ( Fruit spreads Chocolate confectionery Food supplements as 2002/46/EC defined for the in general adult Directive population Fruit and vegetable juices Soft drinks Meat preparations White bread Wholemeal bread To be used in compliance with Directive 2002/46/EC, Regulation and/or Regulation (EC) No 1925/2006 Beer and substitutes Ready to eat cereals Dairy products Conditions under which the novel food may be used Specified food category food Specified (mena
2
Authorised novel food accharides Xylo-oligos Wheat bran extract Vitamin K quinone)
M45 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 90
Data Protection ◄ M29 ►
Other requirements
) beta- Yarrowia yeast heat-killed biomass’
Saccharomyces cerevisiae lipolytica on the labelling containing of the it foodstuffs shall be ‘ The designation of the on novel the food labelling containing of the foodstuffs it ( shall be ‘Yeast glucans’
The designation of the novel food
Additional specific labelling requirements
omyces cervisiae)
Maximum levels of pure of Maximum levels beta-glucans from yeast (Sacchar yeast beta-glucans from of age, adult population adolescents and general 3 g/day for children years from of age 3 to 9 1,275 g/day for children older 12 than years and lation general adult popu 0,675 g/day for than 12 children years younger 1,275 g/day 6 g/day for children from 10 years 7 g/kg (powder) 1,275 g/day 1,3 g/kg
38,3 g/kg (powder)
Maximum levels Maximum
0,8 g/kg 15,3 g/kg 0,8 g/kg (ready to drink) 6 g/kg Specified food category Specified food category
Beverages based on juices fruit including and/or concentrate vegetable and juices dehydrated Fruit-flavoured drinks Cocoa beverages preparation powder Other beverages Cereal bars Breakfast cereals Food supplements as 2002/46/EC, defined excluding food supplements in for Directive infants and young children Total diet replacement for weight control defined as in Regulation (EU) No 609/2013 Food for special medical purposes as defined in Regulation (EU) No 609/2013, food excluding for special medical for purposes infants and intended young children Food Supplements as 2002/46/EC, defined excluding food in supplements for Directive infants and young children Conditions under which the novel food may be used
Authorised novel food Yeast beta-glucans Yarrowia lipolytica yeast biomass
M9 M30 M9 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 91
Data Protection ◄ M29 ►
Other requirements
on the labelling containing of it the shall be foodstuffs ‘Zeaxanthin’. on the labelling containing of the foodstuffs it L-pidolate’ shall be ‘Zinc The designation of the novel food The designation of the novel food
Additional specific labelling requirements
2 mg/day 3 g/day 1,8 g/kg (condensed) 6,3 g/kg (powder) 1,5 g/kg 11,3 g/kg
Maximum levels levels Maximum Maximum 4 g/kg
19,1 g/kg 3,8 g/kg 25,5 g/kg 3,8 g/kg 0,9 g/kg (ready to eat) 3,8 g/kg 6,7 g/kg 6,7 g/kg
Foods covered by Regulation (EU) No 2013 609/ Milk based intended drinks for young children and similar Meal products replacement for weight control Foods intended to meet intense the expenditure of muscular sportsmen effort, especially for Soups and soup mixes Chocolate and confectionery Protein bars and powders Jam, marmalade and other fruit spreads Food Supplements as 2002/46/EC defined in Directive Wholegrain Wholegrain and breakfast cereals high fibre instant Cookie-type biscuits hot Cracker-type biscuits Milk based beverages Fermented milk products Milk product analogues Dried milk/milk powder Conditions under which the novel food may be used Specified food category food Specified Specified food category food Specified Authorised novel food Zinc L-pidolate Zeaxanthin
M9 M12 M9 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 92
mission 30.12.2006, p. 26). p. 51). ncil Regulation (EEC) (OJ L 228, 31.7.2014, Data Protection ◄ M29 ► t replacement for weight control
Other requirements 009/39/EC of the European Parliament and of the Council and Com onsumption (OJ L 10, 12.1.2002, p. 58). ◄
ation of the markets in agricultural products and repealing Cou ◄ nd minerals and of certain other substances to foods (OJ L 404, ember States relating to food supplements (OJ L 183, 12.7.2002, consumers on the absence or reduced presence of gluten in food e intended for human consumption (OJ L 10, 12.1.2002, p. 67). oung children, food for special medical purposes, and total die Specifications
/gram of mushroom powder is used. ◄
c acid (dihydrate)
2 owder
Additional specific labelling requirements
mushroom powder of 1 000 μg vitamin D fruit juices and certain similar products intended for human c
2
7 (OJ L 347, 20.12.2013, p. 671). ed as such or reconstituted as instructed by the manufacturer. place, in whole or in part, any milk constituent. 6.2013, p. 35). s 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2 y 2014 on the requirements for the provision of information to
f the Council of 20 December 2006 on the addition of vitamins a
f the Council of 17 December 2013 establishing a common organis fruit jams, jellies and marmalades and sweetened chestnut puré uncil of 10 June 2002 on the approximation of the laws of the M r. the Council of 12 June 2013 on food intended for infants and y of Powder form 1. ◄
-Acetyl-D-neuraminic acid is a white to off-white crystalline p -Acetyl-D-neuraminic acid (dihydrate) N Definition: Chemical name: IUPAC names: N 5-Acetamido-3,5-dideoxy-D-glycero-D-galacto-non-2-ulopyranosoni Synonyms: Sialic acid (dihydrate)
Description:
Food bearing statement on reduced the presence absence of or with the gluten requirements of Commission in Imple accordance menting Regulation (EU) No 828/2014 Food Supplements as 2002/46/EC defined in Directive Conditions under which the novel food may be used ) The ) minimum specification for vitamin D content in vitamin D
) Maximum use levels in the final product ) ready Council for Directive use, 2001/112/EC market of 20 December ) 2001 When relating used to in milk products xylo-oligosaccharides shall not re
Authorised Novel Food
7 8 9
11 ( ( ( ( and repealing Council Directive Regulations 92/52/EEC, (EC) No Commission 41/2009 Directive and (EC) No 953/2009 (OJ L 181, 29. No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) 1234/200 p. 5). ) Depending on the age group the food supplement is intended fo
M32 M44 M45 M48 ) Maximum levels calculated on the basis of the specifications
-Acetyl-D-neuraminic acid Authorised novel food ) Commission Implementing Regulation (EU) No 828/2014 of 30 Jul ) Directive 2002/46/EC of the European ) Parliament and of Regulation the (EC) Co No 1925/2006 ) of the European Council Parliament Directive and 2001/113/EC o of ) 20 December 2001 Regulation relating (EU) to No 1308/2013 of the European Parliament and o ) Regulation (EU) No 609/2013 of the European Parliament and of
12
10 2 3 4 5 6 1 ( Table 2: Specifications Table 2: ( ► ( ( ( ( ( ► N ► ( ►
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 93
Specifications
O) (dihydrate)
2
* 2H
9
NO
19
H
11
(C (acid)
Absence in 25 g
9 11
NO NO
19 23
H H
-Acetyl-D-neuraminic acid (dihydrate): > 97,0 % 11 11
Residual proteins: < 0,01 % (w/w) Residual solvents: 2-Propanol: < 0,1 % (w/w) Acetone: < 0,1 % (w/w) Ethyl acetate: < 0,1 % (w/w) Microbiological criteria: Salmonella: Aerobic mesophilic total count:< 500 CFU/g 50795-27-2 (dihydrate) Specifications: Description: white to off-white crystalline powder pH (20 °C, 5 % solution): 1,7 – 2,5 N Water (dihydrate calculates to 10,4 %): ≤ 12,5 % (w/w) Ash, sulphated: < 0,2 % (w/w) Acetic acid (as free acid and/or sodium acetate): < 0,5 % (w/w) Heavy Metals: Iron: < 20,0 mg/kg Lead: < 0,1 mg/kg C Molecular mass: 309,3 Da (acid) 345,3 (309,3 + 36,0) (dihydrate) CAS No.: 131-48-6 (free acid) Chemical formula: C
Authorised Novel Food
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 94 is obtained Ajuga reptans ts from flowering aerial parts of open and the pulp is separated from the seeds and the shell. Th
Specifications to 600 μ) and then packaged.
L. tissue cultures which is substantially equivalent to extrac
Absence in 10 g
) fruits are harvested from trees. The hard shells are cracked
Ajuga reptans
Absence in 25 g
< 50 CFU/g Adansonia digitata Description/Definition: Hydroalcoholic extract from Bacillus cereus: Yeasts: < 10 CFU/g Moulds: < 10 CFU/g Residual endotoxins: < 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units. Analytical specifications: Foreign matter: Not more than 0,2 % Moisture (loss on drying) (g/100 g): 4,5-13,7 Ash (g/100 g): 3,8-6,6 by traditional cultures. Description/Definition: The Baobab ( is milled, separated into coarse and fine lots (particle size 3 components: Typical nutritional Moisture (loss on drying) (g/100 g): 4,5-13,7 Protein (g/100 g): 1,8-9,3 Fat (g/100 g): 0-1,6 Total carbohydrate (g/100 g): 76,3-89,5 Total sugars (as glucose): 15,2-36,5 Sodium (mg/100 g): 0,1-25,2 Enterobacteriaceae: Enterobacteriaceae: Absence in 10 g sakazakii: Cronobacter (Enterobacter) Listeria monocytogenes:
(Baobab) dried extract from cell from extract
Authorised Novel Food
Adansonia digitata fruit pulp Ajuga reptans cultures
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 95 . During the fermentation process, the ingredient is Escherichia coli
Specifications eparated and purified to a concentration of > 98 %. ally modified strain of sp.
o
Ulkenia
): ≤ 0,020 %
4 : Absence/g ): ≤ 0,020 %
4 O): 5,0-6,0
2
Related substances (each): ≤ 0,2 % Residue on ignition: ≤ 0,1 % Loss on drying: ≤ 0,5 % Optical rotation: +9,0 - +11,0 secreted into the growth medium from which it is subsequently s Appearance: White crystalline powder Purity: > 98 % Infrared spectroscopy: Conformity with ref. standard Appearance of solution: Colourless and clear Assay (dry basis): 98-102 % Acid value: ≤ 0,5 mg KOH/g Peroxide value (PV): ≤ 5,0 meq/kg oil Moisture and volatiles: ≤ 0,05 % Unsaponifiables: ≤ 4,5 % Trans-fatty acids: ≤ 1,0 % DHA content: ≥ 32 % Ammonium (NH Chloride (Cl): ≤ 0,020 % Sulphate (SO Microbiological criteria: Escherichia coli L-Alanyl-L-Glutamine L-Alanyl-L-Glutamine is produced by fermentation with a genetic Description/Definition: Oil from the micro-algae pH (1 %; H
Description/Definition:
Authorised Novel Food sp. Algal oil from the microalgae the from Algal oil Ulkenia L-Alanyl-L-Glutamine
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 96
. (L.) Burm.f. Aloe vera A. stuhlmannii d from ) and A. parviflora (synonymous with
A. floribunda s: Specifications 6:0): sum of these acids < 4,0 % Baker which is substantially equivalent to the same gel derive
Aloe macroclada
seed oil is obtained from the seeds of the allanblackia specie Poly unsaturated fatty acids (PUFA): < 2 % Characteristics: Free fatty acids: max 0,1 % of total fatty acids Trans fatty acids: max 1,0 % of total fatty acids Peroxide value: max 1,0 meq/kg Unsaponifiable matter: max 1,0 % (w/w) of the oil Saponification value: 185-198 mg KOH/g Composition of fatty acids (as a % of the total fatty acids): acids (as a % fatty total Composition of fatty of the Lauric acid — Myristic acid — Palmitic acid (C12:0 – C14:0 – Stearic C1 acid (C18:0): 45-58 % Oleic acid (C18:1): 40-51 % Powdered gel extract derived from the leaves of leaves. Ash: 25 % Dietary fibres: 28,6 % Fat: 2,7 % Moisture: 4,7 % Polysaccharides: 9,5 % Protein: 1,63 % Glucose: 8,9 % Allanblackia Description/Definition:
Description/Definition: Baker leaf extract Baker leaf seed oil seed Authorised Novel Food Aloe macroclada Allanblackia
M9 M25 M9 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 97 Directive 2009/ lipid extraction with an ltration. The extraction solvents should demonstrate oxidative stability by appropriate and
) by repeated solvent washings with an approved solvent (under Euphausia superba Specifications ) deep-frozen crushed krill or dried krill meal is subjected to ll oil from
ins and krill material are removed from the lipid extract by fi y at 25 °C y at 25 °C e removed from the final product by evaporation. Euphausia superba Euphausia superba
/kg oil /kg oil
2 2
recognised national/international test methodology (e.g. AOAC). Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activit Phospholipids: ≥ 35 % to < 60 % Trans-fatty acids: ≤ 1 % EPA (eicosapentaenoic acid): ≥ 9 % DHA (docosahexaenoic acid): ≥ 5 % Oil rich in phospholipids is produced from Antarctic krill ( 32/EC) to increase phospholipid content of the oil. Solvents ar Saponification value: ≤ 230 mg KOH/g Peroxide value (PV): ≤ 3 meq O Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activit Phospholipids: ≥ 60 % Trans-fatty acids: ≤ 1 % EPA (eicosapentaenoic acid): ≥ 9 % DHA (docosahexaenoic acid): ≥ 5 % Description/Definition: Description/Definition: To produce lipid extract from approved Antarctic extraction solvent Krill (under Directive ( 2009/32/EC). Prote and residual water are removed by evaporation. Saponification value: ≤ 230 mg KOH/g Peroxide value (PV): ≤ 3 meq O Oxidative stability: All food products containing Antarctic Kri
Euphausia Euphausia superba Authorised Novel Food
Antarctic Krill oil rich in phosp holipids from Antarctic Krill oil from superba
M9 M23 M9 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 98 FJRK-MA01 and CBS 210.32 of (L.) Skeels. Kernels may be roasted prior to pressing, omass and purified. Argania spinosa
Specifications ent ntation of the non-genetically modified strains IS-4, I49-N18, ke kernels of the fruits of
/kg
2
using a suitable liquid. The oil is then extracted from the bi
Mortierella alpina Mortierella Stearic acid (C18:0): 5-7 % Oleic acid (C18:1): 43-50 % Linoleic acid (C18:2): 29-36 % Unsaponifiable matter: 0,3-2 % Total sterols: 100-500 mg/100 g Total tocopherols: 16-90 mg/100 g Oleic acidity: 0,2-1,5 % Peroxide value (PV): < 10 meq O Anisidin value: ≤ 20 Acid value: ≤ 1,0 KOH/g Moisture: ≤ 0,5 % Argan oil is the oil obtained by cold pressing of the almond li but with no direct contact with a flame. Composition: Palmitic acid (C16:0): 12-15 % Description/Definition: The clear yellow arachidonic acid-rich oil is obtained by ferme Arachidonic acid: ≥ 40 % by weight of the total fatty acid cont Free fatty acids: ≤ 0,45 % of the total fatty acid content Trans fatty acids: ≤ 0,5 % of the total fatty acid content Unsaponifiable matter: ≤ 1,5 % Peroxide value (PV): ≤ 5 meq/kg the fungus Description/Definition:
Argania spinosa Authorised Novel Food Mortierella alpina Mortierella Argan oil from Argan oil Arachidonic acid-rich oil from the oil from Arachidonic acid-rich fungus
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 99 able; using either closed e harvested and dried; the oleoresin andardized to 2,5 %, 5,0 %, 7,0 %, 10 %, 15 % or
Specifications algae. Production methods for the growth of the algae are vari um Chain Triglycerides). light; alternatively open ponds may be used. The algal cells ar or a solvent (ethyl acetate). The Astaxanthin is diluted and st
2
Haematococcus pluvialis
: Negative : Negative : Negative Description/Definition: Astaxanthin is a carotenoid produced by Canthaxanthin: 0-1,30 % Microbiological criteria: Total aerobic bacteria: < 3 000 CFU/g Yeast and Moulds: < 100 CFU/g Coliforms: < 10 CFU/g E. coli Salmonella Staphylococcus Fibre: < 1,0 % Ash: 0,0-4,2 % Specification of Carotenoids w/w% Total Astaxanthins: 2,9-11,1 % 9-cis-astaxanthin: 0,3-17,3 % 13-cis-astaxanthin: 0,2-7,0 % Astaxanthin monoesters: 79,8-91,5 % Astaxanthin diesters: 0,16-19,0 % Β-Carotene: 0,01-0,3 % Lutein: 0-1,8 % systems exposed to sunlight or strictly controlled illuminated is extracted using either super critical CO 20 % using olive oil, safflower oil, Sunflower oil or MCT (Medi Oleoresin: the Composition of Fat: 42,2- 99 % Protein: 0,3-4,4 % Carbohydrate: 0-52,8 %
algae Authorised Novel Food Astaxanthin-rich oleoresin Astaxanthin-rich oleoresin from Haematococcus pluvialis
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 100 obiological
ed mechanically. Flowers, leaves anical). Production process of fruit (CAS No: 107-43-7) and monohydrate
–
COO
2
CH
+ N
3 )
3 beets (i.e. molasses, vinasses or betaine-glycerol).
L.) includes seed pre-hydration and pasteurisation steps. Micr Specifications naminium), in anhydrous (CH Ocimum basilicum ’ within the order ‘Lamiales’. Post-harvest the seeds are clean s ( ty of Basil seeds has to be ensured by filtering (optical, mech Lamiaceae
L.) belongs to the family ‘
O (CAS No: 590-47-6) forms is obtained from processing of sugar
2
.H
–
COO
2
CH
+ Ocimum basilicum )3N
3
Moisture: ≤ 2,0 % (anhydrous); ≤ 15,0 % (monohydrate) Ash: ≤ 0,1 % pH: 5,0-7,0 Residual protein: ≤ 1,0 mg/g Heavy metals: Arsenic: < 0,1 mg/kg Mercury: < 0,005 mg/kg Cadmium: < 0,01 mg/kg Lead: < 0,05 mg/kg Betaine (N,N,N-trimethylglycine or carboxy-N,N,N-trimethylmetha (CH Characteristics/Composition Appearance: Free-flowing white crystals Betaine: ≥ 99,0 % (w/w on dry weight basis) Basil ( and other parts of the plant are removed. Highest level of puri Dietary Fibre: 40,5 % (Method: AOAC 958,29) Ash: 6,78 % juice and fruit/vegetable blend beverages containing Basil seed controls and monitoring systems are in place. Dry Matter: 94,1 % Protein: 20,7 % Fat: 24,4 % Carbohydrate: 1,7 % Description/Definition: )
Ocimum basilicum Authorised Novel Food Description/Definition: Betaine Basil seeds ( Basil seeds
M32 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 101 Glycine max (L.) soybeans (
Specifications rown protein-rich powder obtained by water extraction of small . The extract contains an α-glucosidase inhibitor.
Aspergillus oryzae Aspergillus
sp.: Negative/25 g ) fermented with Protein: ≥ 55 % Water: ≤ 7,0 % Ash: ≤ 10 % Carbohydrate: ≥ 20 % α-glucosidase inhibitory activity: IC50 min 0,025 mg/ml Soy isoflavone: ≤ 0,3 g/100 g Fermented black bean extract (Touchi extract) is a Merr. fine light-b Characteristics: Fat: ≤ 1,0 % CFU: Colony Forming Units. Microbiological criteria: Microbiological Total viable count: ≤ 100 CFU/g Coliforms: Negative/10 g Salmonella Yeast: ≤ 10 CFU/g Mould: ≤ 10 CFU/g Description/Definition:
Authorised Novel Food Fermented black bean extract
M9 M32 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 102
and purification steps. a and consists of a single ration steps. Finally, it is dried
Specifications er obtained from bovine skimmed milk via a series of isolation milk. It is an iron-binding glycoprotein of approximately 77 kD milk or cheese whey via ion exchange and subsequent ultra-filt out. It is a virtually odourless, light pinkish powder.
Bovine milk basic whey protein isolate is a yellowish grey powd Description Bovine lactoferrin is a protein that occurs naturally in cows’ Characteristics/Composition Total protein (w/weight of product): ≥ 90 % Lactoferrin (w/weight of product): 25-75 % Lactoperoxidase (w/weight of product): 10-40 % Other proteins (w/weight of product): ≤ 30 % TGF-β2: 12-18 mg/100 g Moisture: ≤ 6,0 % pH (5 % solution w/v): 5,5 – 7,6 Arsenic: < 2,0 mg/kg Iron: < 350 mg/kg Protein: > 93 % of which bovine lactoferrin: > 95 % of which other proteins: < 5,0 % pH (2 % solution, 20 °C): 5,2-7,2 Solubility (2 % solution, 20 °C): complete polypeptide chain of 689 amino acids. Production process: Bovine lactoferrin is isolated from skimmed by freeze drying or spraying and the large particles are sieved of Bovine Physical-Chemical properties lactoferrin: Moisture: < 4,5 % Ash: < 1,5 %
Description/Definition: Authorised Novel Food
Bovine milk basic whey protein basic Bovine milk isolate Bovine lactoferrin
M34 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 103
(L.) I.M.Johnst Specifications Buglossoides arvensis
Negative/g
: ≤ 10 CFU/g Staphylococci: : Negative/g
spp.: Negative/25 g : Negative/25 g : Negative/25 g Refined Buglossoides oil is extracted from the seeds of Alpha-linolenic acid: ≥ 35 % w/w of total fatty acids Stearidonic acid: ≥ 15 % w/w of total fatty acids Linoleic acid: ≥ 8,0 % w/w of total fatty acids Trans fatty acids: ≤ 2,0 % w/w of total fatty acids Microbiological criteria: Aerobic mesophilic count: ≤ 10 000 CFU/g Enterobacteriaceae Escherichia coli Coagulase positive Salmonella Listeria Cronobacter Moulds: ≤ 50 CFU/g Yeasts: ≤ 50 CFU/g CFU: Colony Forming Units Lactose: ≤ 3,0 % Fat: ≤ 4,5 % Ash: ≤ 3,5 % Iron: ≤ 25 mg/100 g Heavy Metals Lead: < 0,1 mg/kg Cadmium: < 0,2 mg/kg Mercury: < 0,6 mg/kg Arsenic: < 0,1 mg/kg Description/Definition:
seed oil seed Authorised Novel Food Buglossoides arvensis
M34 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 104 . polyethylene Calanus finmarchicus lankton)
Specifications WO2006016179). It consists of branched polymers of monomethoxy (PIP-g-MA), and unreacted MPEG (less than 35 % by weight). inor amounts of triglycerides and other neutral lipids. ight shellfish odour extracted from the crustacean (marine zoop of 4,0 μg/kg
/kg
2
/kg
2
Peroxide value (PV): < 3,0 meq. O Description/Definition: The novel food ingredient glycol (MPEG) is grafted onto polyisoprene-graft-maleic a anhydride synthetic polymer White (Patent to off-white number colour. CAS No.: 1246080-53-4 Characteristics: Moisture: < 5,0 % Specifications: Water: < 1,0 % Wax esters: > 85 % Total fatty acids: > 46 % Eicosapentaenoic acid (EPA): > 3,0 % Docosahexaenoic acid (DHA): > 4,0 % Total fatty alcohols: > 28 % C20:1 n-9 fatty alcohol: > 9,0 % C22:1 n-11 fatty alcohol: > 12 % Trans fatty acids: < 1,0 % Astaxanthinesters: < 0,1 % Unsaponifiable content: ≤ 2,0 % Protein content (total nitrogen): ≤ 10 μg/ml Pyrrolizidine alkaloids: Not detectable with a detection limit The novel food is ruby coloured, slightly viscous oil with The a sl ingredient consists primarily of wax esters (> 85 %) with m Acid value: ≤ 0,6 mg KOH/g Peroxide value (PV): ≤ 5,0 meq O
Description/Definition: oil Authorised Novel Food Chewing gum base (monome thoxypolyethylene glycol) Calanus finmarchicus
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 105
Specifications opolymer of methyl vinyl ether and maleic anhydride.
CAS No: 9011-16-9 Purity: Assay value: At least 99,5 % in dry matter Specific viscosity (1 % MEK): 2-10 Residual methyl vinyl ether: ≤ 150 ppm Residual maleic anhydride: ≤ 250 ppm Acetaldehyde: ≤ 500 ppm Methanol: ≤ 500 ppm Dilauroyl peroxide: ≤ 15 ppm Total heavy metals: ≤ 10 ppm Ethylene glycol: < 200 mg/kg Diethylene glycol: < 30 mg/kg Monoethylene glycol methyl ether: < 3,0 mg/kg Diethylene glycol methyl ether: < 4,0 mg/kg Triethylene glycol methyl ether: < 7,0 mg/kg 1,4-Dioxane: < 2,0 mg/kg Formaldehyde: < 10 mg/kg Description/Definition: Methyl vinyl ether-maleic anhydride copolymer is an anhydrous c Free-flowing, white to white-off powder Aluminium: Aluminium: < 3,0 mg/kg Lithium: < 0,5 mg/kg Nickel: < 0,5 mg/kg Residual anhydride: < 15 μmol/g Polydispersity index: < 1,4 Isoprene: < 0,05 mg/kg Ethylene oxide: < 0,2 mg/kg Free maleic anhydride: < 0,1 % Total oligomeres (less than 1 000 Dalton): ≤ 50 mg/kg
Authorised Novel Food ether-maleic anhydride copolymer) Chewing gum base (Methyl vinyl Chewing gum base (Methyl
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 106 rs,
.
2
ical CO ss employed to remove impurities. and, once pressed, the oil is held in family. Post-harvest the seeds are cleaned mechanically. Flowe
Labiatae Specifications mpurities. It can also be produced by extraction with supercrit ed, the oil is held in decantation tanks and a filtration proce le cellulose, pentosans and lignin L.) seeds (99,9 % pure) by cold pressing. No solvents are used
Salvia hispanica
: Negative to test
Negative to test
L.) is a summer annual herbaceous plant belonging to the
: Negative to test
: Negative to test Salvia hispanica (*) Carbohydrates include the fibre value Chia ( leaves and other parts of the plant are removed. Dry matter: 90-97 % Protein: 15-26 % Fat: 18-39 % Carbohydrate (*): 18-43 % Crude Fibre(**): 18-43 % Ash: 3-7 % (**) Crude fibre is the part of fibre made mainly of indigestib Chia oil is produced from Chia decantation tanks ( and a filtration process employed to remove i Production process: Produced by cold pressing. No solvents are used and, once press Acidity expressed as oleic acid: ≤ 2,0 % Peroxide value (PV): ≤ 10 meq/kg Insoluble impurities: ≤ 0,05 % Alpha linolenic acid: ≥ 60 % Linoleic acid: 15-20 % Microbiological criteria: Microbiological Total aerobic plate count: ≤ 500 CFU/g Mould/yeast: ≤ 500 CFU/g Escherichia coli Salmonella Staphylococcus aureus: Pseudomonas aeruginosa Description/Definition: Description/Definition: )
Salvia hispanica Salvia hispanica Authorised Novel Food Chia seeds ( Chia oil from Chia oil
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 107 heating in an alkaline solution, as a dry matter content of 90 % steurisation steps. Microbiological . It consists primarily of two polysaccharides: Fomes fomentarius
Specifications (CAS No: 1398-61-4); (CAS No: 1398-61-4), (CAS No: 9041-22-9). ucose (CAS No: 9041-22-9). ; it is a slightly yellow, odourless, free-flowing powder. It h uit bodies of the fungus process. eaning, reduction in size and grinding, softening in water and ages, containing Chia seeds, includes seed pre-hydration and pa
Aspergillus niger
— beta (1, 3)-glucan, composed of repeating units of Loss D-glucose on drying: ≤ 10 % Chitin-glucan: ≥ 90 % Ratio of chitin to glucan: 30:70 to 60:40 Ash: ≤ 3,0 % Lipids: ≤ 1,0 % Proteins: ≤ 6,0 % Description/Definition: Chitin-glucan is obtained from the mycelium of or more. Chitin-glucan is composed largely of two polysaccharides: — chitin, composed of repeating units of N-acetyl-D-glucosamine — Beta-(1,3)(1,6)-D-glucan, composed of repeating units of D-gl The production process consists of several steps, including: washing, cl drying. No hydrolysis is applied during the production Appearance: Powder, odourless, flavourless, brown Purity: Moisture: ≤ 15 % Ash: ≤ 3,0 % Chitin-glucan: ≥ 90 % Ratio of chitin to glucan: 70:20 Total carbohydrates, excluding glucans: ≤ 0,1 % Description/Definition: Chitin-glucan complex is obtained from the cell walls — of the Chitin, fr composed of repeating units of N-acetyl-D-glucosamine Production process: Production Production process of fruit juices and fruit juice blends bever controls and monitoring systems are in place. Fomes
Aspergillus
Authorised Novel Food
Chitin-glucan from niger Chitin-glucan complex from fomentarius
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 108 . Aspergillus niger dium, solubilisation in acidic or from the mycelium of Agaricus bisporus
Specifications obtained from stems of uding: extraction and deacetylation (hydrolysis) in alkaline me
/g
3
n )
4
/g
3
NO
/g
3
11
H
6
and other pathogenic bacteria: Absence/25 g
: ≤ 10/g Appearance: fine free-flowing powder Aspect: Off –white to slightly brownish Odour: Odourless Purity: Chitosan content (% w/w dry weight):≥ 85 Glucan content (% w/w dry weight): ≤ 15 Loss on drying (% w/w dry weight): ≤ 10 Viscosity (1 % in 1 % acetic acid): 1-15 Coliforms at 30 °C: ≤ 10 Arsenic (ppm): ≤ 0,20 Microbiological criteria: Total mesophilic bacteria: ≤ 10 Yeast and moulds: ≤ 10 E. coli Description/Definition: The chitosan extract (containing mainly poly(D-glucosamine)) is Proteins: ≤ 2,0 % Lipids: ≤ 1,0 % Melanins: ≤ 8,3 % Additives: None pH: 6,7-7,5 Heavy metals: Lead (ppm): ≤ 1,00 Cadmium (ppm): ≤ 1,00 Mercury (ppm): ≤ 0,03 Chitosan CAS number: 9012-76-4 Chitosan formula: (C Salmonella The patented production process consists of medium, several precipitation steps, in incl alkaline medium, washing and drying. Synonym: Poly(D-glucosamine)
Aspergillus ; Authorised Novel Food
) Agaricus bisporus Chitosan extract from fungi from Chitosan extract ( niger
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 109
m fermentation by the bacterium Agaricus bisporus
Specifications rom Aspergillus niger; 12-25 for chitin from t is obtained by chemical sulphation of chondroitin derived fro
3
3
: Absence/25g
): 0,7-1,0
3 ): ≤ 0,7
0,05 O5:K4:H4 strain U1-41 (ATCC 23502). (CFU/g): ≤ 10
/w
h : Absence/25g Escherichia coli Chondroitin sulphate (sodium salt) (% dry basis): 95-105 MWw (weight avg.) (kDa): 5-12 MWn (number avg.) (kDa): 4-11 Dispersity (w Sulphation pattern (ΔDi-6S) (%): ≤ 85 Loss on drying (%) (105 °C to constant weight): ≤ Residue 10,0 on ignition (% dry basis): 20-30 Protein (% dry basis): ≤ 0,5 Endotoxins (EU/mg): ≤ 100 Total organic impurities (mg/kg): ≤ 50 Lead (ppm): ≤ 1,0 Arsenic (ppm): ≤ 1,0 Cadmium (ppm): ≤ 0,5 Microbiological criteria: Aerobic count (CFU/g): ≤ 10 Yeast and mould count (CFU/g): ≤ 10 Escherichia coli Enterobacteriaceae (CFU/g): ≤ 10 Salmonella Listeria monocytogenes Chondroitin sulphate (sodium salt) is a biosynthetic product. I Ash (% w/w dry weight): ≤ 3,0 Proteins (% w/w dry weight): ≤ 2,0 Particle size: > 100 nm Tapped density (g/cm Fat binding capacity 800 × (w/w wet weight): pass Heavy metals: Mercury (ppm): ≤ 0,1 Degree of acetylation (in % mol/wet weight): 0-30 Viscosity (1 % in 1 % acetic acid) (mPa.s): 1-14 for chitosan f
Description/Definition: Authorised Novel Food Chondroitin sulphate
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 110 a heat-killing step of the anic solvents. . Yarrowia lipolytica
Specifications -pyridinecarboxylic acid chromium(III) salt biomass of the yeast hromium chloride followed by a number of purification steps and soluble in water at pH 7. The salt is also soluble in polar org cells in the novel food.
3 )
2
NO
4
H
6
Yarrowia lipolytica
Description/Definition: The novel food is the dried and heat-killed chromium-containing The novel food is produced by fermentation in the presence of c Chromium picolinate is a reddish free-flowing powder, slightly Chemical name: tris(2pyridinecarboxylato-N,O)chromium(III) or 2 CAS No.: 14639-25-9Chemical formula: Cr(C Chemical characteristics: Chromium Picolinate: ≥ 95 % Chromium (III): 12-13 % Chromium (VI): not detected Water: ≤ 4,0 % Sugars: < 2 g/100 g Fat: 6–12 g/100 g Total ash: ≤ 15 % Water: ≤ 5 % Dry matter: ≥ 95 % Heavy metals: Lead: ≤ 3,0 mg/kg Cadmium: ≤ 1,0 mg/kg Mercury: ≤ 0,1 mg/kg yeast to ensure the absence of viable Characteristics/Composition: Total chromium: 18–23 μg/g Chromium (VI): < 10 μg/kg (i.e. limit of detection) Protein: 40–50 g/100 g Dietary fibre: 24–32 g/100 g
Description/Definition: ) biomass Authorised Novel Food Yarrowia lipolytica ( Chromium-containing yeast Chromium Picolinate Chromium
M9 M53 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 111
nsula.
Specifications family and native to the Mediterranean region, Chalkidiki Peni Cistaceae CFU/g
3 CFU/g
2
): < 10 CFU/g (i.e. limit of detection)
14
( cells
L. Pandalis herb; species belonging to the
: 3,0 μg : 30 μg : 54 μg
spp.: Absence in 25 g 1 2 6
Yarrowia lipolytica Potassium: 0,75 g Magnesium: 0,24 g Calcium: 1,0 g Iron: 65 mg Sodium: 0,18 g Vitamin B Vitamin B Vitamin B Vitamin C: 28 mg Vitamin A: less than 0,1 mg Vitamin E: 40–50 mg 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 Microbiological criteria: Microbiological Total aerobic microbial count: ≤ 5 × 10 Total yeast and mould count: ≤ 10 Viable Coliforms: ≤ 10 CFU/g Salmonella CFU: colony forming units Description:
L. Pandalis herb L. Pandalis Authorised Novel Food Cistus incanus
M53 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 112 ry ner salt c, non-pathogenic, non-genetically modified bacterium. Deposito
Specifications trihydrogen diphosphate) P’-[2-(trimethylammonio)ethyl]ester in holine.
2
P
11
O
4
N
CFU/g
CFU/g 26
2
3
H
(CBM-588) is a Gram-positive, spore-forming, obligate anaerobi 14
: Absence in 1 g
Clostridium butyricum number FERM BP-2789 Citicoline is produced by a microbial process. Citicoline is composed of cytosine, ribose, pyrophosphate and c White crystalline powder Chemical name: Choline cytidine 5′-pyrophosphate, Cytidine 5′-( Microbiological criteria: Total plate count: ≤ 10 Yeast and moulds: ≤ 10 Escherichia coli Chemical formula: C Molecular weight: 488,32 g/mol CAS No.: 987-78-0 pH (sample solution of 1 %): 2,5-3,5 Purity: Assay value: ≥ 98 % of dry matter Loss on drying (100 °C for 4 hours): ≤ 5,0 % Ammonium: ≤ 0,05 % Arsenic: Not more than 2 ppm Free phosphoric acids: ≤ 0,1 % 5′-Cytidylic acid: ≤ 1,0 % Alpha-Tocopherol: Alpha-Tocopherol: 20–50 mg Beta and Gamma-Tocopherols: 2–15 mg Delta-Tocopherol: 0,1–2 mg
Description/Definition: Description/Definition: Authorised Novel Food Clostridium butyricum Citicoline
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 113 . Bacillus subtilis
Specifications fermentation using a transketolase-deficient strain of in colour
CFU/g
3
)/g
9
5
CFU/g
O
: Not detected in 1 g
2
10
: – 19,0° to – 21,0°
: Not detected in 1 g
H
25 5
D : Not detected in 1 g
) Method 98,0–102,0 %
8 Loss on drying (moisture): < 0,5 % Clarity on solution: ≥ 95 % transmittance Heavy metals Lead: ≤ 0,1 mg/kg Arsenic: ≤ 0,1 mg/kg Cadmium: ≤ 0,1 mg/kg Mercury: ≤ 0,1 mg/kg Microbiological criteria Total plate count: ≤ 100 CFU ( Yeast: ≤ 100 CFU/g D-ribose is an aldopentose monosaccharide which is produced by Chemical formula: C CAS No: 50-69-1 Molecular mass: 150,13 Da Characteristics/Composition Appearance: Dry with powdery texture, white to slightly yellow Specific rotation [α] Ash: < 0,2 % Escherichia coli Staphylococcus aureus Pseudomonas aeruginosa Yeast and moulds: ≤ 10 D-ribose purity (% dry basis): -HPLC/RI ( Microbiological criteria: Microbiological Total viable aerobic count: ≤ 10
Description Authorised Novel Food D-ribose
M9 M29 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 114
Euglena gracilis ce of viable . Euglena gracilis
Specifications biomass of the microalga on and a heat-killing step of the microalga to ensure the absen
: Absence in 25 g
: Absence in 10 g
: Absence in 10 g
: Absence in 25 g sp: Negative/25 g Listeria monocytogenes CFU: colony forming units. MPN: most probable number Microbiological criteria: Aerobic plate count: ≤ 10 000 CFU/g Coliforms: ≤ 100 MPN/g Yeast and mould: ≤ 500 CFU/g Escherichia coli Staphylococcus aureus Salmonella Characteristics/Composition: Total carbohydrates: ≤ 75 % β-glucan: > 50 % Protein: ≥ 15 % Fat: ≤ 15 % Ash: ≤ 10 % Moisture: ≤ 6 % Heavy metals: Lead: ≤ 0,5 mg/kg Cadmium: ≤ 0,5 mg/kg Mercury: ≤ 0,05 mg/kg Arsenic: ≤ 0,02 mg/kg The novel food is dried whole cell Euglena, which is the dried cells in the novel food. Moulds: ≤ 100 CFU/g Coliforms: ≤ 10 CFU/g Salmonella The novel food is produced by fermentation followed by filtrati
Description/Definition: Authorised Novel Food Euglena gracilis Dried
M29 M51 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 115 L. Coriandrum sativum
Specifications ds that is produced from the seeds of the coriander plant L.) extract
3
L.) Extract
Theobroma cacao Theobroma cacao Theobroma Description/Definition: Coriander seed oil is an oil containing glycerides of fatty aci Slight yellow colour, bland taste CAS No: 8008-52-4 pH: 5,0-6,5 Residual solvent: Max 500 ppm Appearance: Dark red to purple powder Cocoa extract, concentrate: Min 99 % Silicon dioxide (technological aid): Max 1,0 % Cocoa flavanols: Min. 300 mg/g — Epicatechin: Min. 45 mg/g Loss on drying: Max. 5,0 % Appearance: Dark brown powder free of visible impurities Physical and chemical properties: Polyphenol content: Min 55,0 % GAE Theobromine content: Max 10,0 % Ash content: Max 5,0 % Moisture content: Max 8,0 % Bulk density: 0,40-0,55 g/cm Cocoa (
Cori Low fat Cocoa (
Authorised Novel Food Coriander seed oil from oil Coriander seed Low fat cocoa extract cocoa Low fat Extract of defatted cocoa cocoa powder defatted Extract of andrum sativum
M9 M37 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 116 ce concentrate of sound, mature
Specifications r extract prepared through an ethanolic extraction from the jui
. )
5
Vaccinium macrocarpon
): 55.0-60.0 or
5 ): 15.0-18.0
5 ) ( )
3
) ( )
4 ), % w/w dry ( weight)
6
berries of the cranberry cultivar Characteristics/Composition Moisture (% w/w): ≤ 4 Proanthocyanidins — PACs (% w/w dry weight) — OSC-DMAC method ( Total phenolics (GAE ( — Folin-Ciocalteau method: > 46.2 Solubility (water): 100 %, with no visible insoluble particles Cranberry extract powder is a water-soluble phenolic-rich powde — BL-DMAC method ( Refractive index (20 °C): 1,466-1,474 Acid value: ≤ 2,5 mg KOH/g Peroxide value (PV): ≤ 5,0 meq/kg Iodine value: 88-110 units Saponification value: 179-200 mg KOH/g Unsaponifiable matter: ≤ 15 g/kg Composition Composition of fatty acids: Palmitic acid (C16:0): 2-5 % Stearic acid (C18:0): < 1,5 % Petroselinic acid (cis-C18:1(n-12)): 60-75 % Oleic acid (cis-C18:1 (n-9)): 7-15 % Linoleic acid (C18:2): 12-19 % α-Linolenic acid (C18:3): < 1,0 % Trans fatty acids: ≤ 1,0 % Purity:
Description/Definition: Authorised Novel Food Cranberry extract powder Cranberry extract
M37 M15 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 117 glucosyltransferase llowing procedures: , steam-stripping of the s, sieved or not, without
family and native to north China and Korea. Specifications cation of α-cyclodextrin may be carried out using one of the fo D-glucopyranosyl units produced by the action of cyclodextrin ble part of one or several species of fruits, whole or in piece ssolution in water at elevated temperature and re-precipitation Earthy aroma with no burnt character. Rosaceae on juice may be used. species belonging to the
)/g
7
: < 10 CFU/g
Crataegus pinnatifida
: Absent in 375 g significant concentration. Sugars, water, cider, spices and lem Fructose: 26,5–29,3 g/100 g Glucose: 25,5–28,1 g/100 g Vitamin C: 29,1 mg/100 g fresh weight Sodium: 2,9 g/100 g fresh weight Compotes are products obtained by thermal processing of the edi Dried fruits of Composition: Dry matter: 80 % Carbohydrates: 55 g/kg fresh weight A non-reducing cyclic (CGTase, saccharide EC consisting 2.4.1.19) of on precipitation hydrolyzed six starch. of α-1,4-linked Recovery a and complex purifi of α-cyclodextrin with 1-decanol, di Coliforms: < 10 CFU/g Escherichia coli Salmonella Ethanol Content (mg/kg): ≤ 100 Screen Analysis: 100 % through 30 mesh screen Appearance and aroma, as powder: Free-flowing, deep red colour. Heavy metals: Arsenic (ppm): < 3 Microbiological criteria: Yeast: < 100 CFU ( Mould: < 100 CFU/g Aerobic plate count: < 1 000 CFU/g Description/Definition:
dried fruit dried Description/Definition: Authorised Novel Food -cyclodextrin Crataegus pinnatifida α
M15 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 118
) xtrin in a chromatogram of cription: Virtually odourless, lowed by crystallisation of α- filter issolve the sample completely using completely sample the issolve
Specifications tohexaose, α-cycloamylase ation methods such as ultra-filtration and reverse osmosis: Des id chromatogram of the sample corresponds to that for α-cyclode ns: tion; or chromatography with ion-exchange or gel filtration fol nto a 10 ml volumetric flask and add 8 ml of deionised water. D water. deionised of ml 8 add and flask volumetric ml 10 a nto ith purified deionised water. Filter through a 0,45-micrometer
thanol (1 % solution)
o
and +151
Consortium Industrie GmbH, für Elektrochemische München, Germany or Biochem Group, Wacker Adrian, MI, USA o
6 )
5
O
10
: Between +145
H
25 6
D
(1-decanol) Reducing substances: ≤ 0,5 % (as glucose) Sulphated ash: ≤ 0,1 % Lead: ≤ 0,5 mg/kg Method of assay: Determine by liquid chromatography using the following conditio i sample test of mg 100 about accurately Weigh solution: Sample an ultra-sonification bath (10-15 min) and dilute to the mark w using the conditions described in the METHOD OF ASSAY Purity: Water: ≤ 11 % (Karl Fischer Method) Residual complexant: ≤ 20 mg/kg Chromatography: The retention time for the major peak in a liqu reference α-cyclodextrin (available from Assay: ≥ 98 % (dry basis) Identification: Melting range: Decomposes above 278 °C Solubility: Freely soluble in water; very slightly soluble in e Specific rotation: [α] complexant, complexant, and crystallisation of α-cyclodextrin from the solu cyclodextrin from the purified mother liquor; or membrane separ Formula weight: 972,85 white or almost white crystalline solid. Synonyms: α-cyclodextrin, α-dextrin, cyclohexaamylose, cyclomal Chemical name: Cyclohexaamylose CAS No.: 10016-20-3 Chemical formula: (C
Authorised Novel Food
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 119 gamma-CD from the
x of γ-cyclodextrin with 8-
n glucosyltransferase (CGTase, area of the area α-CD peak. Calculate ter. Dissolve the sample completely sample the Dissolve ter.
, Germany) or similar xtrin, respectively, after correcting for water content. solution and reference solution, respectively. Specifications n-decane, steam-stripping of the aqueous phase and recovery of index detector and an integrating recorder. tooctaose, γ-cycloamylase γ-cyclodextrin may be carried out by precipitation of a comple trin into a 10 ml volumetric flask and add 8 ml of deionised wa deionised of ml 8 add and flask volumetric ml 10 a into trin ed D-glucopyranosyl units produced by the action of cyclodextri to the chromatograph, record the chromatogram, and measure the rified deionised water.
) S
Macherey & Nagel Co. Düren /W
R ) (W
R
(10 μm) (
/A
2
S
8 )
5
O
10
H
6 are the weights (mg) of the test sample and reference α-cyclode
are the areas of the peaks due to α-cyclodextrin for the sample
R
R
and W and A
S
S
Flow rate: 2,0 ml/min the sample Inject solution in Injection volume: 10 μlProcedure: the percentage of α-cyclodextrin in the test sample as follows: % α-cyclodextrin (dry basis) = 100 × (A where A W Length: 250 mm Diameter: 4 mm Temperature: 40 °C Mobile phase: acetonitrile/water (67/33, v/v) EC 2.4.1.19) on hydrolysed starch. Recovery and purification cyclohexadecen-1-one, of dissolution of the complex solution with by water crystallisation. and Virtually odourless, white or almost white crystalline solid Synonyms: γ-cyclodextrin, γ-dextrin, cyclooctaamylose, cyclomal Chemical name: Cyclooctaamylose CAS number: 17465-86-0 Chemical formula: (C Assay: ≥ 98 % (dry basis) A non-reducing cyclic saccharide consisting of eight α-1,4-link Reference solution: Weigh accurately about 100 mg of α-cyclodex of mg 100 about accurately Weigh solution: Reference using an ultra-sonification bath and dilute to the mark with pu Chromatography: Liquid chromatograph equipped with a refractive Column and packing: Nucleosil-100-NH
Description/Definition: Authorised Novel Food -cyclodextrin γ
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 120
family.
(Kippist) Stapf. Poaceae e Specifications tose: 0,3 %, Leucrose: 9,2 %)
Digitaria exilis f thanol (1 % solution)
o
and + 180
o
: between + 174
25
D
(Kippist) Stapf) is an annual herbaceous plant belonging to th
Carbohydrates: 60 % with: (Dextran: 50 %, Mannitol: 0,5 %, Fruc Protein: 6,5 % Powdered form: Powdered 1. Fat: 1,2 g/100 g of fonio Fibre: 2,2 g/100 g of fonio Ash: 1,2 g/100 g of fonio Phytate content: ≤ 2,1 mg/g Sulphated ash: ≤ 0,1 % Description/Definition The traditional food is the decorticated grain (bran removed) o Digitaria exilis fonio grain of decorticated of components Typical nutritional Carbohydrates: 76,1 g/100 g of fonio Water: 12,4 g/100 g of fonio Protein: 6,9 g/100 g of fonio Purity: Water: ≤ 11 % Residual complexant (8-cyclohexadecen-1-one (CHDC)): ≤ 4 mg/kg Residual solvent (n-decane): ≤ 6mg/kg Reducing substances: ≤ 0,5 % (as glucose) Identification: Melting range: Decomposes above 285 °C Solubility: Freely soluble in water; very slightly soluble in e Specific rotation: [α]
Digitaria
Authorised Novel Food (Kippist) Stapf (fonio) (Kippist) Dextran preparation produced by Dextran preparation Leuconostoc mesenteroides Decorticated grains of exilis (Traditional food from a third country)
M9 M9 M21 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 121 Brassica ) or rapeseed oil ( Glycine max
Specifications ctose: 1,9 %, Leucrose: 2,2 %) vegetable oils, in particular from soybean oil (
) using a specific enzyme.
Lactic acid: 2,0 % Ethanol: 0,5 % Ash: 3,4 % Moisture: 80 % Lipid: 0,5 % Lactic acid: 10 % Ethanol: traces Ash: 13 % Moisture: 10 % Carbohydrates: 12 % with: (Dextran: 6,9 %, Mannitol: 1,1 %, Fru Protein: 2,0 % Lipid: 0,1 % Liquid form: Liquid 1,3-Diacylglycerols (1,3-DAG): ≥ 50 % Triacylglycerols (TAG): ≤ 20 % Monoacylglycerols (MAG): ≤ 5,0 % Fatty Acid Composition (MAG, DAG, TAG): Oleic acid (C18:1): 20-65 % Linoleic acid (C18:2): 15-65 % Linolenic acid (C18:3): ≤ 15 % Saturated fatty acids: ≤ 10 % Manufactured from glycerol and fatty campestris, Brassica napus acids derived from edible Acylglycerol Distribution: Diacylglycerols (DAG): ≥ 80 % 2. Description/Definition:
Authorised Novel Food Diacylglycerol oil of plant origin Diacylglycerol oil of plant
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 122 esterification dihydrocapsiate
)
Specifications Apocynaceae ycerols on of vanillyl alcohol and 8-methylnonanoic acid. Following the N.E.Br., (family
Hoodia parviflora
4
O
28
H
18
: < 0,3
w
Description/Definition: It is the whole dried aerial parts of Characteristics/Composition Plant material: Aerial parts of at least 3-year-old plants Appearance: Light green to tan fine powder Solubility (water): > 25 mg/mL Moisture: < 5,5 % A Dihydrocapsiate is synthesised by enzyme-catalysed esterificati is extracted with n-hexane. Viscous to colourless to yellow liquid Chemical formula: C CAS No: 205687-03-2 Physical-chemical properties: Dihydrocapsiate: > 94 % 8-Methylnonanoic acid: < 6,0 % Vanillyl acohol: < 1,0 % Other synthesis related substances: < 2,0 % Others: Acid value: ≤ 0,5 mg KOH/g Moisture and volatile: ≤ 0,1 % Peroxide value (PV): ≤ 1,0 meq/kg Unsaponifiables: ≤ 2,0 % Trans fatty acids≤ 1,0 % MAG = monoacylglycerols, DAG = diacylglycerols, TAG = triacylgl
Description/Definition: Hoodia
Authorised Novel Food Dihydrocapsiate (DHC) parviflora Dried aerial parts of
M9 M13 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 123
Specifications
CFU/g
5
: Negative/25 g : < 50 CFU/g
: < 10 CFU/g
species: Negative/25 g Escherichia coli Staphylococcus aureus Total coliforms: < 10 CFU/g Yeast: ≤ 100 CFU/g Mould: ≤ 100 CFU/g Salmonella Listeria monocytogenes CFU: Colony Forming Units P57: 5–50 mg/kg L: 1 000–6 000 mg/kg O: 500–5 000 mg/kg Total: 1 500–11 000 mg/kg Heavy metals: Arsenic: < 1,00 mg/kg Mercury: < 0,1 mg/kg Cadmium: < 0,1 mg/kg Lead: < 0,5 mg/kg Microbiological criteria: Aerobic plate count: < 10 pH: < 5,0 Protein: < 4,5 g/100 g Fat: < 3 g/100 g Carbohydrate (including dietary fibre): < 80 g/100 g Dietary fibre: < 55 g/100 g Total sugars: < 10,5 g/100 g Ash: < 20 % Hoodigosides
Authorised Novel Food
M13 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 124
Echinacea angustifolia L. Stearidonic acid: ≥ 10 % w/w of total fatty valent to a root extract from Echium plantagineum
Vb.
® Specifications
extracted from the seeds of 4,0 μg/kg
obtained from plant tissue culture which is substantially equi from cell cultures EchiPure-PC™ /kg
2
(Palau) Kunth from cell cultures HTN
Echinacea angustifolia Echinacea purpurea Lippia citriodora Acid value: ≤ 0,6 mg KOH/g Peroxide value (PV): ≤ 5,0 meq O Unsaponifiable content: ≤ 2,0 % Protein content (total nitrogen): ≤ 20 μg/ml Pyrrolizidine alkaloids: Not detectable with a detection limit Description/Definition: Dried extract of Echium oil is the pale yellow product obtained by refining oil acids Trans fatty acids: ≤ 2,0 % (w/w of total fatty acids) Description/Definition: Dried extract of Description/Definition: Extract of the roots of obtained in ethanol-water titrated to 4 % echinacoside.
Description/Definition: extract oil extract from extract
Lippia citriodora
Authorised Novel Food Echium plantagineum Echinacea purpurea cell cultures Dried extract of Dried extract Echinacea angustifolia from cell cultures from cell cultures
M9 M9 M31 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 125 The extract is a dark brown powder, rich in
Ecklonia cava.
ble marine alga
Specifications lites in certain brown algae species.
Negative to test
phlorotannins are obtained via alcohol extraction from the edi
spp.: Negative to test Heavy metals and Halogens and Heavy metals Lead: < 3,0 mg/kg Mercury: < 0,1 mg/kg Cadmium: < 3,0 mg/kg Arsenic: < 25,0 mg/kg Inorganic Arsenic: < 0,5 mg/kg Iodine: 150,0 – 650,0 mg/kg CFU: Colony Forming Units Antioxidant activity: > 85 % Moisture: < 5 % Ash: < 5 % Microbiological criteria Total viable cell count: < 3 000 CFU/g Mould/yeast: < 300 CFU/g Coliforms: Negative to test Salmonella Staphylococcus aureus: Ecklonia cava phlorotannins, polyphenolic compounds found as secondary metabo Characteristics/Composition Phlorotannin content: 90 ± 5 % Description/Definition
phlorotannins Authorised Novel Food Ecklonia cava
M9 M49 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 126 paration in order to
n process, the solution is
Elastin Assay Soluble Collagen Assay
TM
TM Specifications anes of chicken eggs. The eggshells undergo hydro-mechanical se g a patented solubilisation method. Following the solubilisatio Combustion according to AOAC 990.03 and AOAC 992.15
USP26 (chondroitin sulphate K0032 method)
Sircol
Fastin : ≤ 10 CFU/g Methods
: ≤ 5 MPN/g
: Negative (in 25 g) filtered, concentrated, spray-dried and packaged. Characteristics/Composition Arsenic ≤ 0,5 mg/kg Microbiological criteria Aerobic plate count: ≤ 2 500 CFU/g Escherichia coli Salmonella Coliforms: ≤ 10 MPN/g Staphylococcus aureus Mesophilic spore count: ≤ 25 CFU/g Thermophilic spore count: ≤ 10 CFU/10 g Total glycosaminoglycans (% w/w): ≥ 5 Physical parameters pH: 6,5 – 7,6 Ash (% w/w): ≤ 8 Moisture (% w/w): ≤ 9 Water activity: ≤ 0,3 Solubility (in water): soluble Bulk density: ≥ 0,6 g/cc Heavy metals The egg membrane hydrolysate is derived from obtain the the eggshell egg membr membranes, which are then further processed usin Chemical parameters Total nitrogen-containing compounds (% w/w): ≥ 88 Collagen (% w/w): ≥ 15 Elastin (% w/w): ≥ 20 Calcium: ≤ 1 %
Description Authorised Novel Food Egg membrane hydrolysate Egg membrane
M9 M18 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 127 omposed of a
Polarimetry
) in the form of a fine, off-white to pale pink powder. It is c
Specifications ted States Pharmacopeia.
Method
a) ting point between approx. 210 and 215 °C O)
2
and acetone -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 S
2
O
3
N
15
Specification H
9
[α]
Parameter White powder
Solubility: EGCG is fairly soluble in water, ethanol, methanol Chemical name (IUPAC): (2S)-3-(2-thioxo-2,3-dihydro-1 Chemical formula: C Molecular mass: 229,3 Da CAS No.: 497-30-3 Appearance Optical rotation Synonyms: epigallocatechin gallate (EGCG) CAS No.: 989-51-5 INCI name: epigallocatechin gallate Molecular mass: 458,4 g/mol Loss on drying: max 5,0 % Heavy metals: Arsenic: max 3,0 ppm Lead: max 5,0 ppm Assay: Min. 94 % EGCG (on dry material) max. 0,1 % caffeine Description/Definition: A highly purified extract from the leaves of green tea ( minimum of 90 % epigallo-catechin gallate (EGCG), and has a mel Appearance: off-white to pale pink powder Chemical name: polyphenol (-) epigallocatechin-3-gallate Yeast: ≤ Yeast: 10 CFU/g Mould: ≤ 200 CFU/g CFU: Colony Forming Units; MPN = Most Probable Number; USP: Uni
) Definition Authorised Novel Food Camellia sinensis L-ergothioneine leaves ( Epigallocatechin gallate as Epigallocatechin gallate a purified extract from green tea
M18 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 128
HPLC [Eur. Ph. 2,2.29] 1H-NMR 1H-NMR Elemental analysis Gas chromatography [Eur. Ph. 01/2008:20424]
Specifications [Eur. Ph. 01/2008:20232]
[Eur. Ph. 01/2011:50104]
CFU/g CFU/g ICP/AES (Pb, Cd) Atomic fluorescence (Hg)
2 3
HPLC/GPC or 1H-NMR ≤ 1 x 10 [Eur. Ph. 01/2008:50400] < 1 000 ppm ≥ 99,0 % C: 47,14 ± 0,4 % H: 6,59 ± 0,4 % N: 18,32 ± 0,4 % 10 x 1 ≤
b)
Absence in 1 g ≥ 99,5 % Internal standard < 0,5 %
b) c) Compliant with the structure < 0,8 % < 1,0 ppm
< 0,1 ppm < 3,0 ppm Mercury Microbiological specifications Total viable aerobic count (TVAC) Heavy metals Lead Cadmium Total yeast (TYMC) and mould count Escherichia coli (methanol, isopropanol, ethanol) ethyl Loss on drying acetate, Impurities Chemical purity Identification Total residual solvents
Authorised Novel Food
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 129
: gel permeation ation, and spray drying
Specifications
ic resonance; HPLC: high-performance liquid chromatography; GPC 06 sion spectroscopy; owder produced by hot-water extraction, concentration by evapor
O)
2
(c = 1, H
o
root: 32,5 % (w/w) root: 32,5 % (w/w)
root: 35,0 % (w/w)
= (+) 126,6
: Negative/25 g
D
Iridoids: 13,0 – 39,0 mg/g Saponins: 5,0 – 15,5 mg/g Nutritive components Carbohydrates: 600 – 880 mg/g Proteins: 70 – 170 mg/g Fats: < 4 mg/g Microbiological parameters Total viable plate count: < 5000 CFU/g Total mold and yeast: < 100 CFU/g Coliform bacteria: < 10 CFU/g Salmonella Composition of the extract of mixture of the 3 herbal roots of mixture extract Composition of the Cynanchum wilfordii Phlomis umbrosa Angelica gigas Specifications Loss on drying: NMT 100 mg/g Assay Cinnamic acid: 0,012 – 0,039 mg/g Shanzhiside methyl ester: 0,20 – 1,55 mg/g Nodakenin: 3,35 – 10,61 mg/g Methoxsalen: < 3 mg/g Phenols: 13,0 – 40,0 mg/g Coumarins: 13,0 – 40,0 mg/g chromatography; chromatography; ICP/AES: Inductively coupled plasma atomic emis CFU: colony-forming units. a) Lit. [α] The mixture of the three herbal roots is yellowish brown fine p Eur. Ph.: European Pharmacopoeia; 1H-NMR: proton nuclear magnet b) Analyses conducted on each batch c) Maximum levels in accordance with Regulation (EC) No 1881/20 Description/Definition
Authorised Novel Food Extract of three herbal roots Extract of three Hemsley, (Cynanchum wilfordii Phlomis umbrosa Turcz. and Angelica gigas Nakai)
M9 M49 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 130 ty of more than 99 % (w/w).
Specifications ally insoluble in water and soluble in dilute mineral acids. rless free-flowing, yellow to brown powder with a chemical puri O
2
* 3H
8
NaO
2
4
FeN
PO
4 12
H
: Negative/25 g 10
: Negative/25 g
Ferrous ammonium phosphate is a grey/green fine powder, practic CAS No.: 10101-60-7 Chemical formula: FeNH Chemical characteristics: pH of 5 % suspension in water: 6,8-7,8 Iron (total): ≥ 28 % Iron (II): 22-30 % (w/w) Iron (III): ≤ 7,0 % (w/w) Ammonia: 5-9 % (w/w) Water: ≤ 3,0 % Ferric Sodium EDTA (ethylenediaminetetraacetic acid) is an odou It is freely soluble in water. Chemical formula: C Chemical characteristics: pH of 1 % solution: 3,5-5,5 Iron: 12,5-13,5 % Sodium: 5,5 % Water: 12,8 % Organic matter (CHNO): 68,4 % EDTA: 65,5-70,5 % Water insoluble matter: ≤ 0,1 % Nitrilo-triacetic acid: ≤ 0,1 % Escherichia coli Escherichia aureus Staphylococcus Heavy metals Lead: < 0,65 mg/kg Arsenic: < 3,0 mg/kg Mercury: < 0,1 mg/kg Cadmium: < 1,0 mg/kg CFU: Colony Forming Units Description/Definition:
Description/Definition: Authorised Novel Food Ferrous ammonium phosphate Ferric Sodium EDTA
M9 M49 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 131
) muscle, subsequent ance in which the seeds f this ethanolic extract with pasteurisation and freezing. filtration, and concentration). Sardinops sagax cular weight of less than 2 kDa): ≥ 85 g/100 g
Specifications L) plant, which is the ‘aqueous, mucilaginous and acidic subst L. are extracted with ethanol followed by further extraction o centration under vacuum and spray drying. ced following processing (enzymatic treatment, pasteurization, y separation from husks and beans; the pulp is then subject to ed by an alkaline protease-catalysed hydrolysis of fish ( containing 2,5 % to 3,5 % of glabridin. Theobroma cacao Glycyrrhiza glabra )/g
9 ) (short chain peptides, dipeptides and tripeptides with a mole
1
: Absence in 25 g ) Kjeldahl method
1 are embedded’. Cocoa fruit pulp is obtained by splitting Cocoa cocoa pulp pods juice followed and/or b cocoa concentrated pulp juice are produ Typical compositional data of cocoa fruit pulp, pulp juice, concentrated pulp juice pulp concentrated juice, pulp pulp, cocoa fruit Typical compositional data of Protein (g/100 g): 0,0 to 2,0 Total fat (g/100 g): 0,0 to 0,2 Total sugars (g/100 g): > 11,0 Brix level (° Brix): ≥ 14 pH: 3,3 to 4,0 Microbiological criteria Total Plate Count (aerobic): < 10 000 cfu ( Enterobacteriaceae: ≤ 10 cfu/g Salmonella medium-chain triglycerides. It is a dark-brown coloured liquid, Moisture: < 0,5 % Ash: < 0,1 % Peroxide value (PV): < 0,5 meq/kg Glabridin: 2,5-3,5 % of fat Glycyrrhizinic acid: < 0,005 % Fat including polyphenol-type substances: ≥ 99 % Protein: < 0,1 % Carbohydrates: not detectable Description/Definition The traditional food is the fruit pulp from the cocoa ( Val-Tyr (dipeptide): 0,1-0,16 g/100 g Ash: ≤ 10 g/100 g Moisture: ≤ 8 g/100 g ( Flavonoids derived from the roots or rootstock of Description/Definition: The novel food ingredient is a peptide mixture, which is isolation obtain of the peptide fraction by column chromatography, con Yellowish white powderPeptides ( Description/Definition:
Theobroma Sardinops Glycyrrhiza glabra
Authorised Novel Food
L. Flavonoids from Fruit pulp, pulp juice, concen trated pulp juice from cacao (Traditional food from a third country) sagax Fish peptides from Fish peptides
M40 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 132 iltration processes without the use of organic
Specifications e level of fucoidan: eld the fucoidan extract with the following specifications: is extracted using aqueous extraction in acidic solution and f
Fucus vesiculosus
: Absence/g
: Absence/g
: Absence/10 g
Extract 1: Fucoidan: 75-95 % Alginate: 2,0-5,5 % Polyphloroglucinol: 0,5-15 % Mannitol: 1-5 % Natural salts/Free Minerals: 0,5-2,5 % Other carbohydrates: 0,5-1,0 % Protein: 2,0-2,5 % Extract 2: Fucoidan: 60-65 % Staphylococcus aureus Composition of the two permitted types of extracts, based on th Lead: < 2,0 ppm Mercury: < 1,0 ppm Microbiological criteria: Total aerobic microbial count: < 10 000 CFU/g and Yeast mould count: < 100 CFU/g Total enterobacteria count: Absence/g Escherichia coli Salmonella solvents. The resulting extract is concentrated and dried to yi Off-white to brown powder Odour and Taste: Bland odour and taste Moisture: < 10 % (105 °C for 2 hours) pH value: 4,0-7,0 (1 % suspension at 25 °C) Heavy metals: Arsenic (inorganic): < 1,0 ppm Cadmium: < 3,0 ppm Description/Definition: Fucoidan from the seaweed
Authorised Novel Food Fucus vesiculosus Fucoidan extract from the seaweed the from Fucoidan extract
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 133 iltration processes without the use of organic
Specifications for 2 hours) e level of fucoidan: eld the fucoidan extract with the following specifications:
is extracted using aqueous extraction in acidic solution and f
Undaria pinnatifida
: Absence/g
: Absence/g
: Absence/10 g
Yeast and mould count: < 100 CFU/g Total enterobacteria count: Absence/g Escherichia coli Salmonella Staphylococcus aureus Composition of the two permitted types of extracts, based on th Extract 1: Fucoidan: 75-95 % Alginate: 2,0-6,5 % Fucoidan from seaweed solvents. The resulting extract is concentrated and dried to yi Off-white to brown powder Odour and Taste: Bland odour and tasteMoisture: < 10 % (105 pH °C value: 4,0-7,0 (1 % suspension at 25 °C) Heavy metals: Arsenic (inorganic): < 1,0 ppm Cadmium: < 3,0 ppm Lead: < 2,0 ppm Mercury: < 1,0 ppm Microbiology: Total aerobic microbial count: < 10 000 CFU/g Description/Definition: Alginate: 3,0-6,0 % Polyphloroglucinol: 20-30 % Mannitol: < 1,0 % Natural salts/Free Minerals: 0,5-2,0 % Other carbohydrates: 0,5-2,0 % Protein: 2,0-2,5 %
Authorised Novel Food Fucoidan extract from the seaweed the from Fucoidan extract Undaria pinnatifida
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 134
Specifications 4)- D-glucopyranose ed by a chemical synthesis process.
15
O
32
H
18
2′-fucosyllactose is a white to off-white powder that is produc Purity: 2'-Fucosyllactose: ≥ 95 % D-Lactose: ≤ 1,0 w/w % L-Fucose: ≤ 1,0 w/w % Difucosyl- D-lactose isomers: ≤ 1,0 w/w % 2′-Fucosyl- D-lactulose: ≤ 0,6 w/w % pH (20 °C, 5 % solution): 3,2-7,0 Water (%): ≤ 9,0 % Ash, sulphated: ≤ 0,2 % Definition: Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→ Chemical formula: C CAS No: 41263-94-9 Molecular weight: 488,44 g/mol Description: Mannitol: 25-35 % Natural salts/Free Minerals: 8-10 % Other carbohydrates: 0,5-2,0 % Protein: 1,0-1,5 % Polyphloroglucinol: Polyphloroglucinol: 0,5-3,0 % Mannitol: 1-10 % Natural salts/Free Minerals: 0,5-1,0 % Other carbohydrates: 0,5-2,0 % Protein: 2,0-2,5 % Extract 2: Fucoidan: 50-55 % Alginate: 2,0-4,0 % Polyphloroglucinol: 1,0-3,0 %
Authorised Novel Food -Fucosyllactose ′ 2 (synthetic)
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 135
o
BL21
Escherichia coli
Description: 2′-Fucosyllactose is a white to off white concentrate (45 powder % ± and 5 % w/v) the aqueous solution liquid is a colourless t slight yellow produced clear by a microbiological process. aqueous solution. Purity: 2′-Fucosyllactose is 2′-Fucosyllactose: ≥ 90 % Lactose: ≤ 5,0 % Fucose: ≤ 3,0 % 3-Fucosyllactose: ≤ 5,0 % Fucosylgalactose: ≤ 3,0 % Difucosyllactose: ≤ 5,0 % Source: Genetically modified strain of
Specifications 4)-D-glucopyranose ucosyl-D-lactose, 2′- e): ≤ 50,0 mg/kg singly, ≤ 200,0 mg/kg in combination ed by a microbial process.
K-12
Escherichia coli
15
O
32
H
18
M27 Definition: Purity: 2′-Fucosyllactose: ≥ 83 % D-Lactose: ≤ 10,0 % L-Fucose: ≤ 2,0 % Difucosyl-D-lactose: ≤ 5,0 % 2′-Fucosyl-D-lactulose: ≤ 1,5 % Sum of saccharides Fucosyl-D-lactulose): (2′-Fucosyllactose, ≥ 90 % D-Lactose, L-Fucose, Dif pH (20 C, 5 % solution): 3,0-7,5 Water: ≤ 9,0 % CAS No: 41263-94-9 Molecular weight: 488,44 g/mol Residual endotoxins: ≤ 10 EU/mg ► Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→ Chemical formula: C Source: Genetically modified strain of Description: 2′-Fucosyllactose is a white to off-white powder that is produc Acetic acid: ≤ 0,3 % Residual solvents (methanol, 2-propanol, methyl acetate, aceton Residual proteins: ≤ 0,01 % Heavy Metals: Palladium: ≤ 0,1 mg/kg Nickel: ≤ 3,0 mg/kg Microbiological criteria: Aerobic mesophilic bacteria total count: ≤ 500 CFU/g Yeasts and Moulds: ≤ 10 CFU/g
Authorised Novel Food (microbial source) 2'-Fucosyllactose
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 136
y a microbial process.
CFU/g (powder), ≤ 5 000 CFU/g (liquid)
4
: negative/100 g (powder), negative/200 ml (liquid) : negative/100 g (powder), negative/200 ml (liquid)
Cronobacter Endotoxins: ≤ 100 EU/g (powder), ≤ 100 EU/ml (liquid) Aflatoxin M1: ≤ 0,025 μg/kg (powder and liquid) ◄ Salmonella Glucose: ≤ 3,0 % Galactose: ≤ 3,0 % Water: ≤ 9,0 % (powder) Ash, sulphated: ≤ 0,5 % (powder and liquid) Residual proteins: ≤ 0,01 % (powder and liquid) Heavy Metals: Lead: ≤ 0,02 mg/kg (powder and liquid) Arsenic: ≤ 0,2 mg/kg (powder and liquid) Cadmium: ≤ 0,1 mg/kg (powder and liquid) Mercury: ≤ 0,5 mg/kg (powder and liquid) Microbiological criteria: Total plate count: ≤ 10 Yeasts and Moulds: ≤ 100 CFU/g (powder); ≤ 50 CFU/g (liquid) Enterobacteriaceae/Coliforms: absence in liquid) 11 g (powder and
Specifications : ≥ 85,0 % (w/w) , and 3-Fucosyllactose (% of dry matter): ≥ 92,0 % (w/w)
to off-white powder or agglomerates thereof that is produced b strain K-12 DH1
Escherichia coli
: Genetically modified Description/Definition: 2′-Fucosyllactose/Difucosyllactose mixture is a purified, white Source Characteristics/Composition: Appearance: White to off white powder or agglomerates Sum of 2′-Fucosyllactose, Difucosyllactose, D-Lactose, L-Fucose Sum of 2′-Fucosyllactose and Difucosyllactose (% of dry matter) Sulphated ash: ≤ 2,0 % Acetic acid: ≤ 1,0 % Residual proteins: ≤ 0,01 % Microbiological criteria: Aerobic mesophilic bacteria total count: ≤ 3 000 CFU/g Yeasts: ≤ 100 CFU/g Moulds: ≤ 100 CFU/g Endotoxins: ≤ 10 EU/mg
-FL/DFL’) ′ Authorised Novel Food -Fucosyllactose/Difucosyllactose ′ mixture (‘2 (microbial source) 2
M55 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 137 Bifidobacterium , . Aspergillus oryzae -galactosidases from β
Specifications
): ≤ 6,0 % (w/w)
11
sp.: Negative/25 g Galacto-oligosaccharide is produced from milk lactose by an process using enzymatic milk Galacto-oligosaccharide is produced from bifidum, Pichia pastoris, Sporobolomyces Bacillus circulans, and singularis, Kluyveromyces lactis, Papiliotrema terrestris GOS: min 46 % Dry Matter (DM) Lactose: max 40 % DM Glucose: max 27 % DM Galactose: min 0,8 % DM Ash: max 4,0 % DM Protein: max 4,5 % DM Nitrite: max. 2 mg/kg Residual protein: ≤ 0,01 % (w/w) Microbiological criteria: Aerobic mesophilic total plate count: ≤ 1000 CFU/g Enterobacteriaceae: ≤ 10 CFU/g Salmonella Yeast: ≤ 100 CFU/g Mould: ≤ 100 CFU/g Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units 2′-Fucosyllactose 2′-Fucosyllactose (% of dry matter): ≥ 75,0 % (w/w) Difucosyllactose (% of dry matter): ≥ 5,0 % (w/w) D-Lactose: ≤ 10,0 % (w/w) L-Fucose: ≤ 1,0 % (w/w) 2′-Fucosyl-D-lactulose: ≤ 2,0 (w/w) Sum of other ( carbohydrates Moisture: ≤ 6,0 % (w/w) Ash, sulfated: ≤ 0,8 % (w/w) pH (20 °C, 5 % solution): 4,0 -6,0
Description/Definition: Authorised Novel Food Galacto-oligosaccharide
M9 M55 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 138 II and III to kages, which may be to contamination risks family). It consists of a high Leguminosae L. Taub. ( ) & by Commission Implementing Regulation (EU) 2015/175 of
1
Cyamopsis tetragonolobus laying down specifications for food additives listed in Annexes the Council ( Specifications (HPLC) not less than 75 %). yranose and mannopyranose units combined through glycosidic lin e import of guar gum originating in or consigned from India due trains of guar
· 2KCl · 2NaCl o
4 4
).
2
o
o
SO SO
- +54
2 2 · HCl
) )
o
5 5
5
NO NO
NO
to +52,0 - + 73,0 14 14
13
o
o
H H
H
6 6
6
molecular weight polysaccharide, primarily composed of galactop 5 February 2015 laying down special by conditions pentachlorophenol applicable and to dioxins ( th D-Glucosamine Sulphate 2KCl 98,0-102,0 % of reference standard Specific Rotation +50,0 White crystalline odourless powder Molecular formula: (C Relative molecular mass: 573,31 g/mol D-Glucosamine HCl: 98-102 % of reference standard (HPLC) Specific Optical Rotation: +52 White crystalline odourless powder Molecular formula: C Relative molecular mass: 215,63 g/mol D-Glucosamine HCl 98,0-102,0 % of reference standard (HPLC) Specific rotation + 70,0 White crystalline odourless powder Molecular formula: (C Relative molecular mass: 605,52 g/mol described chemically as a galactomannan (galactomannan content Appearance: White to yellowish powder Molecular weight: Between 50 000 – 8 000 000 Daltons CAS number: 9000-30-0 Einecs Number: 232-536-8 Purity: As specified by Regulation Commission (EC) Regulation No (EU) 1333/2008 No of 231/2012 the European Parliament and of Native guar gum is the ground endosperm of seeds from natural s
K-12 K-12 Aspergillus Aspergillus
E. coli E. coli and genetically and genetically K-12 Description/Definition: E. coli Authorised Novel Food and genetically modified and genetically Glucosamine sulphate KCl Glucosamine sulphate from Aspergillus niger modified strain of Guar Gum Glucosamine HCl from Glucosamine niger strain of Glucosamine sulphate NaCl from Aspergillus niger modified strain of
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 139
(DSM 23964) as starter culture. Specifications ck spots lowing conditions: 1 %, 25 °C, 20 rpm Bacteroides xylanisolvens
(*) The measurements of viscosity are carried out under the fol Description/Definition: Heat-treated fermented milk products are produced with Viscosity * at 24 hours — Solubility — Soluble in hot and cold water pH for 10g/L, at 25 °C - 5-7,5 Viscosity * at 24 hours: Min 4 000 mPa.s Solubility: Soluble in hot and cold water pH for 10g/L, at 25 °C - 6-7,5 Flakes Useful life: 1 year Colour: White/off white with absence or minimal presence of bla Odour: Light Average diameter of particles: 1-10 mm Moisture: Max 15 % Viscosity * at 1 hour: Min 3 000 mPa.s Viscosity * at 2 hours — Physico-chemical properties: Physico-chemical Powder Shelf-life: 2 years Colour: White Odour: Light Average diameter of particles: 60-70μm Moisture: Max 15 % Viscosity * at 1 hour — Viscosity * at 2 hours: Min 3 600 mPa.s
Bacteroides xylani Authorised Novel Food
Heat-treated milk products fermented with solvens
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 140
(DSM e starting the fermentation with Bacteroides xylanisolvens Bacteroides
).
1
ed to and inactivate then heat-treated
(DSM 23964)( Specifications (0,5 % fat or less) is pasteurised or ultra-heat-treated befor hydroxyphenylglycol: ≤ 0,3 % ical synthesis Bacteroides xylanisolvens Bacteroides
3
O
(DSM 23964). The milk product resulting fermented is homogenis 10
H
8
) Modified DIN EN ISO 21528-2.
1 ( Heavy Metals Lead: ≤ 0,03 mg/kg Cadmium: ≤ 0,01 mg/kg Mercury: ≤ 0,01 mg/kg Residual Solvents Ethyl acetate: ≤ 25,0 mg/kg Isopropanol: ≤ 2,50 mg/kg Methanol: ≤ 2,00 mg/kg Tetrahydrofuran: ≤ 0,01 mg/kg Bacteroides xylanisolvens Bacteroides 23964). The final product does not contain viable cells of Hydroxytyrosol is a pale yellow viscous liquid obtained by chem Molecular formula: C CAS No: 10597-60-1 Moisture ≤ 0,4 % Odour: CharacteristicTaste: Slightly bitter Solubility (water): Miscible with water pH: 3,5-4,5 Refractive Index: 1,571-1,575 Purity: Hydroxytyrosol: ≥ 99 % Acetic acid: ≤ 0,4 % Hydroxytyrosol acetate: ≤ 0,3 % Sum of homovanillic acid, iso-homovanilic acid, and 3-methoxy-4 Semi-skimmed Semi-skimmed milk (between 1,5 % and 1,8 % fat) or skimmed milk Molecular weight: 154,6 g/mol
Description/Definition: Authorised Novel Food Hydroxytyrosol
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 141 citric acid buffer. fied strain of food-grade Pierre ex A.Froehner with 1 L cosylated ISP and proteins and ation. As a result, the yeast cells Coffea canephora the yeast’s genome. The protein is expressed and Pierre ex A.Froehner (family: Rubiaceae). L. and/or Coffea canephora
Coffea arabica L. and/or Specifications
ommonly found in food. The concentrate is stabilised with 10 mM cted to pasteurization (at least 71 °C for 15 seconds). dried leaves from liquid produced by submerged fermentation of a genetically-modi yeast cells by micro-filtration and concentrated by ultra-filtr n altered form. The ISP preparation consists of native ISP, gly Coffea arabica Ilex guayusa. Ilex ) in which a synthetic gene for the ISP has been inserted into
Saccharomyces cerevisiae
Description/Definition: The traditional food consists of an infusion of leaves from The traditional food is prepared by mixing a maximum of 20 g of of hot water. Leaves are removed and the infusion is then subje secreted into the growth medium where it is separated from the are not transferred into the ISP preparation as such or peptides under a from the yeast and sugars as Assay: ≥ well 5 g/l as active ISP acids and salts c pH: 2,5-3,5 Ash: ≤ 2,0 % DNA: Not detectable Chlorogenic acids: 9,9–72,4 mg/100ml Description/Definition: Dark brown liquid. Aqueous extracts of dried leaves of 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 Description/Definition: The Ice Structuring Protein (ISP) preparation baker’s is yeast a ( light-brown
Coffea L. and/or
Pierre ex A. Froehner A. ex Pierre
Authorised Novel Food Aqueous extract of dried leaves of leaves dried of Aqueous extract Ilex guayusa country) Infusion from coffee leaves of Infusion from coffee Coffea arabica canephora (Traditional food from a third Ice Structuring Protein type III type Protein Ice Structuring HPLC 12
M46 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 142
Specifications
: Absence in 1 g
: Absence in 25 g
Solubility (water) (%): > 99 Glucose (% dry basis): ≤ 5,0 Isomaltose + DP3 to DP9 (% dry basis): ≥ 90 Moisture (%): ≤ 4,0 Sulphated ash(g/100 g): ≤ 0,3 Heavy metals: Lead (mg/kg): ≤ 0,5 Arsenic (mg/kg): ≤ 0,5 Heavy metals: Lead (Pb): < 3,0 mg/L Arsenic (As): < 2,0 mg/L Cadmium (Cd): < 1,0 mg/L CFU: Colony Forming Units Total yeast and mould count: < 100 CFU/g Total coliforms: < 100 CFU/g Escherichia coli Salmonella Composition: Visual: Brown green liquid Odour and taste: Characteristic Chlorogenic acid (5-CQA): < 100 mg/L Caffeine: < 80 mg/L Epigallocatechin gallate (EGCG): < 700 mg/L Microbiological criteria: Total plate count: < 500 CFU/g
Powder: Authorised Novel Food Isomalto-oligosaccharide
M9 M46 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 143 with a sweet taste ained from sucrose by an
Specifications rate ppearance: Virtually odourless, white or almost white crystals uctose moiety linked by an alpha-1,6-glycosidic bond. It is obt O
2
· H
11
O
22
H
12
Formula weight: 360,3 (monohydrate) A reducing disaccharide that consists of one glucose and one fr Chemical name: 6-O-α-D-glucopyranosyl-D-fructofuranose, monohyd CAS No.: 13718-94-0 Chemical formula: C Structural formula Arsenic (mg/kg): ≤ 0,5 enzymatic process. The commercial product is the monohydrate. A Syrup: Dried solids (g/100 g): > 75 Glucose (% dry basis): ≤ 5,0 Isomaltose + DP3 to DP9 (% dry basis): ≥ 90 pH: 4 - 6 Sulphated ash(g/100 g): ≤ 0,3 Heavy metals: Lead (mg/kg): ≤ 0,5
Description/Definition: Authorised Novel Food Isomaltulose
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 144 sample preparation may be nhydrous, monohydrate and on tests, test solutions and other reference
Specifications lytic hydrogenation of lactose. Crystalline products occur in a he specified level. The selection of sample size and method of or general notices, general analytical techniques, identificati
), ‘Instrumental methods’
1
o
to + 16
o
11
O
24
= + 13
H
20 12
D
materials (JECFA), 1991, 322 pp., English, ISBN 92-5-102991-1. ) Food and Nutrition Paper 5 Rev. 2 — Guide to specifications f
1 ( Water: ≤ 10,5 % Other polyols: ≤ 2,5 % d.b Reducing sugars: ≤ 0,2 % d.b Chlorides: ≤ 100 mg/kg d.b Sulphates: ≤ 200 mg/kg d.b Sulphated ash: ≤ 0,1 % d.b Nickel: ≤ 2,0 mg/kg d.b Arsenic: ≤ 3,0 mg/kg d.b Lead: ≤ 1,0 mg/kg d.b Crystalline powder or colourless solution manufactured dihydrate via forms. cata Nickel is used as a catalyst. Chemical name: 4-O-β-D-Galactopyranosyl-D-glucitol Chemical formula: C Molecular weight: 344,31 g/mol CAS No: 585-86-4 Purity: Solubility (in water): Very soluble in water Specific rotation [α] Assay: ≥ 95 % d.b (d.b — expressed on the dry weight basis) Purity: Assay: ≥ 98 % on the dry basis Loss on drying: ≤ 6,5 % (60 °C, 5 hours) Heavy metals: Lead: ≤ 0,1 mg/kg Determine using an atomic absorption technique appropriate to based t on the principles of the method described in FNP 5(
Authorised Novel Food Description/Definition: Lactitol
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 145 ose nose nation
ical synthesis process and is isolated by crystallisation. Specifications -D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)- -D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)- D-glucopyra -D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyran thyl acetate, acetone): ≤ 50 mg/kg singly, ≤ 200 mg/kg in combi
21 21
NO NO
45 45
H H
26 26
-neotetraose is a white to off-white powder. Produced by a chem
N CAS No: 13007-32-4 Molecular weight: 707,63 g/mol Definition: Chemical name: β-D-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β Chemical formula: C CAS No: 13007-32-4 Molecular weight: 707,63 g/mol Description: Lacto- Aerobic mesophilic bacteria total count: ≤ 500 CFU/g Yeasts: ≤ 10 CFU/g Moulds: ≤ 10 CFU/g Residual endotoxins: ≤ 10 EU/mg Definition: Chemical name: β-D-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β Chemical formula: C D-Lactose: ≤ 1,0 % Lacto-N-triose II: ≤ 0,3 % Lacto-N-neotetraose fructose isomer: ≤ 0,6 % pH (20 °C, 5 % solution): 5,0-7,0 Water: ≤ 9,0 % Ash, sulphated: ≤ 0,4 % Acetic acid: ≤ 0,3 %Residual solvents (methanol, 2-propanol, me Residual proteins: ≤ 0,01 % Palladium: ≤ 0,1 mg/kg Nickel: ≤ 3,0 mg/kg Microbiological criteria: Purity: Assay (water free): ≥ 96 %
neotetraose Authorised Novel Food - -neotetraose -neotetraose N N - Lacto Lacto- (microbial source) (synthetic)
M33 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 146 ose -neotetraose fructose isomer): ≥ 92 % N
-neohexaose, Lacto-
N -Lacto- Specifications a microbiological process. para -D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyran -triose II, N
K-12
Escherichia coli -neotetraose, D-Lactose, Lacto- 21
N O
45
H
26
-neohexaose: ≤ 5,0 %
N
-neotetraose fructose isomer: ≤ 1,0 % -neotetraose is a white to off-white powder that is produced by -triose II: ≤ 3,0 %
N N N -Lacto- Chemical name: β-D-Galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β Molecular mass: 707,63 Da CAS No 14116-68-8 Definition: Chemical formula: C CFU: Colony Forming Units; EU: Endotoxin Units. para Lacto- Sum of saccharides (Lacto- Source: Genetically modified strain of Description: Lacto- Purity: Assay (water free): ≥ 80 % D-Lactose: ≤ 10,0 % Lacto- Moulds: ≤ 10 CFU/g Residual endotoxins: ≤ 10 EU/mg pH (20 C, 5 % solution): 4,0-7,0 Water: ≤ 9,0 % Ash, sulphated: ≤ 0,4 % Residual solvents (methanol): ≤ 100 mg/kg Residual proteins: ≤ 0,01 % Microbiological criteria: Aerobic mesophilic bacteria total count: ≤ 500 CFU/g Yeasts: ≤ 10 CFU/g
Authorised Novel Food -tetraose (‘LNT’) -tetraose (‘LNT’) N Lacto- (microbial source)
M43 M33 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 147
family.
var. edulis. Specifications at is produced by a microbial process.
Caprifoliaceae strain K-12 DH1 Lonicera caerulea (given in fresh berries):
-tetraose II (% of dry matter): ≥ 90,0 % (w/w) N Escherichia coli
: ≤ 10 CFU/g L. is a deciduous shrub belonging to the -tetraose, D-Lactose and lacto- N
-hexaose-2: ≤ 3,5 % (w/w) N sp.: Negative/25 g Genetically modified strain of -tetraose is a purified, white to off-white amorphous powder th -tetraose (% of dry matter): ≥ 70,0 % (w/w) -tetraose II: ≤ 10,0 % (w/w) -tetraose fructose isomer: ≤ 1,0 % (w/w) N N N N -lacto- Lonicera caerulea haskap berries of components Typical nutritional Carbohydrates: 12,8 % Fibre: 2,1 % Lipids: 0,6 % Proteins: 0,7 % Description/Definition: The traditional food are fresh and frozen berries from Description: Lacto- Source: Sum of other carbohydrates: ≤ 5,0 % (w/w) Moisture: ≤ 6,0 % (w/w) Ash, sulfated: ≤ 0,5 % (w/w) pH (20 °C, 5 % solution): 4,0–6,0 Residual protein: ≤ 0,01 % (w/w) Microbiological criteria: Aerobic mesophilic bacteria total plate count: ≤ 1 000 CFU/g Enterobacteriaceae Salmonella Yeast: ≤ 100 CFU/g Mould: ≤ 100 CFU/g Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units. Characteristics/Composition: Appearance: White to off-white powder Sum of lacto- Lacto- D-Lactose: ≤ 12,0 % (w/w) Lacto- Para Lacto-
L. berries
Authorised Novel Food (haskap) (Traditional food from a third country) Lonicera caerulea
M20 M43 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 148 carotenoids used in food. ted either as a powder in a hyll pigments. The protein rude protein. The press juice (pH granulated and stored in inert gas nd crushed. By passing through an oleaginous-type press, the
Specifications ties of other related carotenoid components. Lycopene is presen nthetic intermediates commonly used in the production of other coagulation of proteins associated with carotenoid and chlorop r red-violet. Antioxidative protection has to be assured. matter). The dry matter of this juice contains about 35 % of c . After adding ascorbic acid the Lucerne protein concentrate is L.) is processed within 2 hours after harvest. It is chopped a
56
-trans lycopene)
H
all 40
Medicago sativa
L-canavanine: ≤ 4,5 mg/kg Synthetic lycopene is produced by the Wittig condensation of sy Chemical formula: C or in cold storage. Composition: Protein: 45-60 % Fat: 9-11 % Free carbohydrates (soluble fibre): 1-2 % Polysaccharides (insoluble fibre): 11-15 % including cellulose: 2-3 % Minerals: 8-13 % Saponins: ≤ 1,4 % Isoflavones: ≤ 350 mg/kg Coumestrol: ≤ 100 mg/kg Phytates: ≤ 200 mg/kg Synthetic lycopene consists of ≥ 96 % lycopene and minor suitable quanti matrix or an oily dispersion. The colour is dark red Chemical o name: Lycopene CAS No.: 502-65-8 ( Formula weight: 536,85 Da Ash: 0,4 % 85,5 Water: % Description/Definition: The Lucerne ( Lucerne provides a fibrous residue and press juice (10 % of dry 5,8-6,2) is neutralised. Preheating and precipitate vapour is separated injection by centrifugation and allows thereafter dried
Description/Definition: Authorised Novel Food Lycopene Lucerne leaf extract from Lucerne leaf extract Medicago sativa
M9 M20 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 149 t is presented either as a ssured. ) with subsequent removal of the solvent. presented either as a powder in a suitable matrix Lycopersicon esculentum Mill.
Specifications L.) consists of ≥ 95 % lycopene and ≤ 5 % other carotenoids. I ion of ripe tomatoes ( s dark red or red-violet. Anti-oxidative protection has to be a ti-oxidative protection has to be assured. %) consists of ≥ 95 % lycopene and ≤ 5 % other carotenoids. It is Lycopersicon esculantum
Blakeslea trispora
56 56
H H
40 40
The purified lycopene from tomatoes ( powder in a suitable matrix or an oily dispersion. The colour Chemical i name: Lycopene CAS No.: 502-65-8 (all trans lycopene) Chemical formula: C The purified lycopene from or an oily dispersion. The colour is dark red or red-violet. Chemical An name: Lycopene CAS No.: 502-65-8 (all trans lycopene) Chemical formula: C Total lycopene: 5-15 % Thereof trans-lycopene: 90-95 % Total carotenoids (calculated as lycopene): 6,5-16,5 % Other carotenoids: 1,75 % (Phytoene/phytofluene/β-carotene): (0,5-0,75/0,4-0,65/0,2-0,35 Total tocopherols: 1,5-3,0 % Unsaponifiable matter: 13-20 % Total fatty acids: 60-75 % Water (Karl Fischer): ≤ 0,5 % Formula weight: 536,85 Da Lycopene oleoresin from tomatoes is obtained by solvent extract It is a red to dark brown viscous, clear liquid. Formula weight: 536,85 Da Description/Definition: Description/Definition:
Description/Definition: Blakeslea trispora Authorised Novel Food Lycopene oleoresin from tomatoes from Lycopene oleoresin Lycopene from tomatoes Lycopene from Lycopene from
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 150 . Bacillus licheniformis
Specifications te lysozyme by an enzymatic process, using subtilisin from CFU/g
3
CFU/g
2
: Absence in 10 g Total aerobic count: < 10
: Absence in 10 g
: Absence in 10 g
spp: Absence in 25 g Degree of hydrolysis: 19-25 % Moisture: < 5 % Ash: < 10 % Sodium: < 6 % Heavy metals Arsenic: < 1 ppm Lead: < 1 ppm Cadmium: < 0,5 ppm Mercury: < 0,1 ppm Microbiological criteria The product is a white to light yellow powder. Specification Protein (TN(*) x 5,30): 80-90 % Tryptophan: 5-7 % Ratio Tryptophan/LNAA(**): 0,18-0.25 Enterobacteria: < 10 CFU/g Salmonella Escherichia coli Staphylococcus aureus Pseudomonas aeruginosa * TN: total nitrogen ** LNAA: large neutral amino acids Total combined yeasts/moulds count: < 10 Description/Definition Hen egg white lysozyme hydrolysate is obtained from hen egg whi
Authorised Novel Food Hen egg white lysozyme Hen egg white hydrolysate
M49 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 151 washed and solved in medical-grade ethanol
2 )
5
O
4
H
4
(C
2 )
7
O
5
H
6 (C
5
L. and produced with supercritical carbon dioxide. The bark is Specifications nds, magnolol and honokiol. hydroxypropane-1,2,3-tricarboxylate) us powder.Chemical formula: Mg extracted with supercritical carbon dioxide. The extract is dis Magnolia officinalis
Colour (solid): White to yellowish-white Colour (20 % aqueous solution): Colourless to yellowish Appearance (20 % aqueous solution): Clear solution pH (20 % aqueous solution): Approx. 6,0 Impurities: Chloride: ≤ 0,05 % Sulphate: ≤ 0,05 % Arsenic: ≤ 3,0 ppm Lead: ≤ 2,0 ppm Cadmium: ≤ 1 ppm Mercury: ≤ 0,1 ppm Magnesium citrate malate is a white to yellowish-white, amorpho Chemical name: Pentamagnesium di-(2-hydroxybutanedioate)-di-(2- CAS No.: 1259381-40-2 Molecular weight: 763,99 Daltons (anhydrous) Solubility: Freely soluble in water (about 20 g in 100 ml) Description of the physical state: Amorphous powder Assay magnesium: 12,0-15,0 % Loss on drying (120 °C/4 hours): ≤ 15 % Magnolia bark extract is obtained from the bark of the plant oven dried to reduce moisture content before being crushed and and re-crystallised to yield magnolia bark extract. Magnolia bark extract is mainly composed of two phenolic compou Appearance: Light brownish powder Purity: Magnolol: ≥ 85,2 % Honokiol: ≥ 0,5 %
Description/Definition: Description/Definition: Authorised Novel Food Magnesium citrate malate citrate Magnesium Magnolia Bark Extract
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 152 l in the concentration of the
Specifications uum distillation and it is different from refined maize-germ oi g in ‘maize-germ oil high in unsaponifiable matter’). /kg
2
Sterols, triterpenic alcohols, methylsterols: > 6,5 g/100 g Fatty acids in triglycerides: palmitic acid: 10,0-20,0 % stearic acid: < 3,3 % oleic acid: 20,0-42,2 % linoleic acid: 34,0-65,6 % linolenic acid: < 2,0 % Acid value: ≤ 6,0 mg KOH/g Peroxide value (PV): ≤ 10 mEq O unsaponifiable fraction (1,2 g in refined maize-germ oil and 10 Purity: Unsaponifiable matter: > 9,0 g/100 g Tocopherols: ≥ 1,3 g/100 g α-tocopherol (%): 10-25 % β-tocopherol (%): < 3,0 % γ-tocopherol (%): 68-89 % δ-tocopherol (%): < 7,0 % Description/Definition: Maize-germ oil high in unsaponifiable matter is produced by vac Total Total Alkaloid (ppm): ≤ 100 Magnolol & Honokiol: ≥ 94 % Total Eudesmol: ≤ 2 % Moisture: 0,50 % Heavy metals: Arsenic (ppm): ≤ 0,5 Lead (ppm): ≤ 0,5 Methyl eugenol (ppm): ≤ 10 Tubocurarine (ppm): ≤ 2,0
Authorised Novel Food nifiable matter Maize-germ oil high in unsapo
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 153 OH)
2
CH
2 ion of ‘maize-germ oil high in ethyl groups. hloroform. Soluble in glacial acetic ) and not more than 5 % of hydroxyethoxyl groups (-OCH
3
ollowing: Specifications 0) up to about 380 000 g/mol (n about 2 000) g hoxyl groups (-OCH se units with the following general formula: urless and tasteless, granular or fibrous powder. lic aromatic hydrocarbons (PAH) are not enriched in the product rains of fibrous plant material and partially etherified with m viscous, colloidal solution. Insoluble in ethanol, ether and c
3
or CH
3 2
Methyl cellulose is cellulose obtained directly from natural st Chemical name: Methyl ether of cellulose Chemical formula: The polymers contain substituted anhydrogluco C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of — the f H — CH Molecular weight: Macromolecules: from about 20 000 (n about 10 Assay: Content not less than 25 % and not more than 33 % of met — CH Slightly hygroscopic white or slightly yellowish or greyish odo Solubility: Swelling in water, producing a clear to opalescent, Heavy metals: Iron (Fe): < 1 500 μg/kg Copper (Cu): < 100 μg/kg Impurities: Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 μg/k Treatment with active carbon is required to ensure that polycyc unsaponifiable matter’ Purity: Loss on drying: ≤ 10 % (105 °C, 3 hours) Sulphated Ash: ≤ 1,5 % determined at 800 ± 25 pH: °C ≥ 5,0 and ≤ 8,0 (1 % colloidal solution) Heavy metals: Arsenic: ≤ 3,0 mg/kg Lead: ≤ 2,0 mg/kg Mercury: ≤ 1,0 mg/kg Cadmium: ≤ 1,0 mg/kg acid.
Description/Definition: Authorised Novel Food Methylcellulose
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 154
Specifications e solid produced by a chemical synthesis process. e in 2-propanol and dichloromethane
OCl
2
: absence in 1 g N
9
: absent in 1 g H
7
Chemical name: 3-carbamoyl-1-methyl-pyridinium chloride Chemical formula: C CAS No: 1005-24-9 Molecular weight: 172,61 Da Description 1-Methylnicotinamide chloride is white or off-white, crystallin Residual Solvents and Heavy Metals Methanol: ≤ 0,3 % Heavy metals: ≤ 0,002 % Microbiological criteria: Total aerobic microbial count: ≤ 100 CFU/g Mould/yeast: ≤ 10 CFU/g Enterobacteriaceae: absence in 1 g Pseudomonas aeruginosa Staphylococcus aureus CFU: Colony Forming Units Appearance: White – off-white, crystalline solid Purity: ≥ 98,5 % Trigonelline: ≤ 0,05 % Nicotinic Acid: ≤ 0,10 % Nicotinamide: ≤ 0,10 % Largest unknown impurity: ≤ 0,05 % Sum of unknown impurities: ≤ 0,20 % Sum of all impurities: ≤ 0,50 % Solubility: soluble in water and methanol. Practically insolubl Moisture: ≤ 0,3 % Loss on drying: ≤ 1,0 % Residue on ignition: ≤ 0,1 % Characteristics/Composition Definition:
Authorised Novel Food 1-Methylnicotinamide chloride 1-Methylnicotinamide
M11 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 155 lucosamine salt
Specifications hyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic hyl-4-oxo-6-pteridinyl]methyl]amino]benzoyl]-L-glutamic acid, g drofolic acid
16
O
9
N
Si
3
51
O
H
6
32
: Absence in 10g
Molecular weight: 94,14 g/mol CAS No: 2445-53-6 Chemical formula: C Escherichia coli Description/Definition: Chemical name: Silanetriol, 1-methyl- Chemical formula: CH Glucosamine assay: 34-46 % in dry basis 5-Methyltetrahydrofolic acid assay: 54-59 % in dry basis Water: ≤ 8,0 % Heavy metals: Lead: ≤ 2,0 ppm Cadmium: ≤ 1,0 ppm Mercury: ≤ 0,1 ppm Arsenic: ≤ 2,0 ppm Boron: ≤ 10 ppm Microbiological criteria: Total aerobic microbial count: ≤ 100 CFU/g Yeasts and moulds: ≤ 100 CFU/g Description/Definition: Chemical name: N-[4-[[[(6S)-2-amino-1,4,5,6,7,8-hexahydro-5-met Molecular weight: 817,80 g/mol (anhydrous) CAS No.: 1181972-37-1 Appearance: Creamy to light-brown powder Purity: Diastereoisomeric purity: At least 99 % of (6S)-5-methyltetrahy
Authorised Novel Food
Monomethylsilanetriol (Organic Silicon) (6S)-5-methyltetrahydrofolic acid, (6S)-5-methyltetrahydrofolic glucosamine salt
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 156 idual solvents, reaction cultivated in a submerged fermentation. It is a light Daltons, a degree of branching of 2/5 and a triple helical
5 Lentinula edodes
Specifications
: predominantly in its β form, the remaining components being res ight of approximately 5 × 10 lution): from the mycelium of Lentinula edodes Lentinula
): < 10 mg/ml
2
): < 0,1 mg/ml
1
) Bradford method ) Kjeldahl method
1 2 N-containing constituents( ( ( Description/Definition: The novel food ingredient is a sterile aqueous extract obtained Lentinan: 0,8 – 1,2 mg/ml\ The novel food is a synthetic form of nicotinamide riboside. The novel food contains ≥ 90 % by-products nicotinamide and degradation riboside products. chloride, Solvents: Methanol: ≤ 5,0 mg/kg (residual presence) brown, slightly turbid liquid. Lentinan is a β-(1-3) β-(1-6)-D-glucan which has tertiary a structure. molecular we Purity/Composition of mycelial extract from the Moisture: 98 % Dry matter: 2 % Free glucose: < 20 mg/ml Total protein( Purity: Organic Silicon (monomethylsilanetriol) preparation (aqueous so Acidity (pH): 6,4-6,8 Silicon: 100-150 mg Si/l Heavy metals: Lead: ≤ 1,0 μg/l Mercury: ≤ 1,0 μg/l Cadmium: ≤ 1,0 μg/l Arsenic: ≤ 3,0 μg/l Description/Definition:
)
Lentinula edodes Authorised Novel Food Nicotinamide riboside chloride mushroom ( Mycelial extract from Shiitake
M38 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 157 l fermentation step before or after the pressing may occur.
Specifications lan-2-yl]pyridin-1-ium-3-carboxamide;chloride
L.) are pressed. The obtained juice is pasteurised. An optiona
Cl
5
O
2
N
15
H
11
Morinda citrifolia
: Absence in 10 g
Rubiadin: ≤ 10 μg/kg Lucidin: ≤ 10 μg/kg Noni fruits (fruits of Arsenic: ≤ 1 mg/kg Microbiological criteria: Total Plate Count: ≤ 1 000 CFU/g Yeast and Mould: ≤ 100 CFU/g Escherichia coli Nicotinamide riboside chloride: ≥ 90 % Water content: ≤ 2 % Residual solvents: Acetone: ≤ 5 000 mg/kg Methanol: ≤ 1 000 mg/kg Acetonitrile: ≤ 50 mg/kg Methyl tert-butyl ether: ≤ 500 mg/kg Reaction by-products: Methyl acetate: ≤ 1 000 mg/kg Acetamide: ≤ 27 mg/kg Acetic acid: ≤ 5 000 mg/kg Heavy metals: Molecular weight: 290,7 g/mol Characteristics/Composition: Colour: White to light brown Form: Powder Identification: Conforms by NMR (nuclear magnetic resonance) Nicotinamide Nicotinamide riboside chloride: CAS number: 23111-00-4 EC number: 807-820-5 IUPAC name: 1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxo Chemical formula: C Description/Definition: )
Morinda citrifolia Authorised Novel Food Noni fruit juice ( juice Noni fruit
M9 M38 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 158 s odextrins constant ixed with maltodextrins (same 2 h). Then the puree is heated to s collected and pasteurised, prior to from the flesh. Desiccation of the
cally from the pureed fruits. After pasteurisation, the puree i
Specifications to a brix of 49 to 51 in the final concentrate.
this process allows the juice to be dried initially and then m . s obtained by keeping the rates of inflow of the juice and malt e is separated in a decanter centrifuge. Afterwards the juice i are separated. The obtained pulp is filtered to separate juice puree by treatment with pectinolytic enzymes (50– 60 °C for 1- M. citrifolia Morinda citrifolia
are harvested by hand. Seeds and skin may be separated mechani
concentrate is prepared from
Morinda citrifolia
packaged in aseptic containers and stored under cold conditions Morinda citrifolia inactivate the pectinases and then immediately cooled. The juic being concentrated in a vacuum evaporator from a brix of 6 to 8 Fructose: 0,5-3,82 g/100 g Glucose: 0,5-3,14 g/100 g Dietary fibre: < 0,5-3 g/100 g 5,15-dimethylmorindol (1): ≤ 0,254 μg/ml Lucidin (1): Not detectable Alizarin (1): Not detectable Rubiadin (1): Not detectable Concentrate: Moisture: 48-53 % The fruits of Composition: Puree: Moisture: 89-93 % Protein: < 0,6 g/100 g Fat: ≤ 0,4 g/100 g Ash: < 1,0 g/100 g Total carbohydrates: 5-10 g/100 g Description/Definition: Description/Definition: Seeds and skin of the sun-dried fruits of produced juice occurs in one or two ways: Either by atomisation using maize maltodextrins, this mixture i Or by zeodratation or drying and then mixing with amount an as excipient, used in atomisation).
Morinda
)
Authorised Novel Food ) Morinda citrifolia Noni fruit puree and concentrate puree Noni fruit ( Noni fruit juice powder ( juice Noni fruit citrifolia
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 159 ed. After freeze-drying imits of detection: 2,5 ng/ml rticle size ranging from broken leaves to coarse
Specifications fruits by freeze-drying. Fruits are pulped and seeds are remov oni pulp is milled to a powder and encapsulated.
Morinda citrifolia L.) Morinda citrifolia are subject to drying and roasting steps. The product has a pa
Morinda citrifolia ): ≤ 0,254 μg/ml
1
(5,15 dimethylmorindol); 50,0 ng/ml (lucidin); 6,3 ng/ml (alizarin) and 62,5 ng/ml (rubiadin). and 62,5 ng/ml (alizarin) ng/ml6,3 (lucidin); ng/ml50,0 dimethylmorindol); (5,15 By an HPLC-UV method developed and validated for the analysis of anthraquinones in Morinda citrifolia puree and concentrate.L anthraquinonespuree of analysis Morinda citrifolia the in methodan HPLC-UV developedand validated for By )
1 Oxalic acid: < 0,14 % Tannic acid: < 2,7 % 5,15-dimethylmorindol: < 47 mg/kg Rubiadin: non detectable, ≤ 10 μg/kg Lucidin: non detectable, ≤ 10 μg/kg After cutting, the leaves of powder with fines. It is of greenish brown to brown colour. Purity/Composition: Moisture: < 5,2 % Protein: 17- 20 % Carbohydrate: 55-65 % Ash: 10-13 % Fat: 4-9 % ( Description/Definition: Noni fruit powder is made from pulped during noni which ( water is removed from noni fruits, the remaining n Protein: 3-3,5 g/100 g Fat: < 0,04 g/100 g Ash: 4,5-5,0 g/100 g Total carbohydrates: 37-45 g/100 g Fructose: 9-11 g/100 g Glucose: 9-11 g/100 g Dietary fibre: 1,5-5,0 g/100 g 5,15-dimethylmorindol ( Description/Definition: )
Morinda Morinda citrifolia
Authorised Novel Food ) Noni leaves ( Noni fruit powder ( Noni fruit citrifolia
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 160
detection: 2,5 ng/ml (5,15 dimethylmorindol)
Specifications il fraction and a phytosterol fraction.
): ≤ 2,0 μg/ml
1
By an HPLC-UV method developed and validated for the analysis Limitsof of anthraquinones in Morinda fruit powder. citrifolia )
1 Diacylglycerols (DAG): ≤ 25 % Triacylglycerols (TAG): Making up the balance Phytosterol fraction: β-sitosterol: ≤ 80 % β-sitostanol: ≤ 15 % campesterol: ≤ 40 % campestanol: ≤ 5,0 % stigmasterol: ≤ 30 % brassicasterol ≤ 3,0 % other sterols/stanols: ≤ 3,0 % ( Crystalline silica: max 0,1-0,3 % as impurity Description/Definition: Oil enriched with phytosterols/phytostanols is composed of an o Acylglycerol Distribution: Free fatty acids (expressed as oleic acid): ≤ 2,0 % Monoacylglycerols (MAG): ≤ 10 % Dietary fibre: 15,4-24,5 g/100 g 5,15-dimethylmorindol ( Purity/Composition Moisture: 5,3-9 % Protein: 3,8-4,8 g/100 g Fat: 1-2 g/100 g Ash: 4,6-5,7 g/100 g Total carbohydrates: 80-85 g/100 g Fructose: 20,4-22,5 g/100 g Glucose: 22-25 g/100 g
Silicon: 3,3 % microalgae
Authorised Novel Food Oil enriched with phytosterols/ phytostanols Odontella aurita
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 161
L.
Salvia hispanica of s, best ensured by a purity of more powder with high fibre content
Salvia hispanica Salvia
Powder with high fibre content Specifications ) powders obtained by pressing and grinding of the whole seeds ols/phytostanols: vegetable oil suitable for food have to be free of contaminant powder with high protein content Salvia hispanica ≤ 400 μm ≥ 24,0 % Powder with high protein content ≤ 9,0 % ≤ 12 % ≥ 50 % ≥ 40,0 % ≤ 17 % ≤ 30 % ≤ 130 μm Salvia hispanica ≤ 9,0 % /kg oil
2
Particle size Chemical composition: Protein Fat Fibre p-Anisidine value: ≤ 20 Cold test at 0 °C: ≤ 3 hours Moisture: ≤ 0,1 % (w/w) Unsaponifiable matter: ≤ 5,0 %Trans fatty acids: ≤ 1,0 % Docosahexaeonic acid: ≥ 20 % Eicosapentaenoic acid: ≥ 10 % Description/Definition: The novel foods are partially defatted chia seed Physical–sensorial: ( Foreign matter: 0,1 % Moisture Others: Moisture and volatile: ≤ 0,5 % Peroxide value (PV): < 5,0 meq/kg Trans fatty acids: ≤ 1 % Contamination/Purity (GC-FID or equivalent method) of phytoster Phytosterols and phytostanols extracted from sources other than than 99 %. Peroxide value (PV): ≤ 5 meq O Salvia
Acid value: ≤ 0,5 KOH/g oil
) powders Authorised Novel Food Oil extracted from squids Partially defatted chia Partially defatted seed ( hispanica
M44 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 162 L. double low (00) Brassica napus L. and
Brassica rapa
n-genetically modified Specifications inolates and phytates.
L. seeds
Brassica napus
: Absence/g
L. and : ≤ 10 CFU/g
: < 10 MPN/g : ≤ 50 CFU/g : The powder is produced from the partially defatted seeds of no spp.: Absence in 25 g Brassica rapa Definition: cultivars through a series of processing steps to reduce glucos Source: Characteristics/Composition: Protein (N × 6,25): 33,0-43,0 % Lipids: 14,0 – 22,0 % Total Carbohydrates(*): 33,0 – 40,0 % Total Fibre(**): 33,0 – 43,0 % Listeria monocytogenes Salmonella Contaminants Arsenic: ≤ 0,1 ppm Cadmium: ≤ 0,1 ppm Lead: ≤ 0,1 ppm Mercury: ≤ 0,1 ppm Total aflatoxins: ≤ 4 ppb Ochratoxin A: ≤ 1 ppb Microbiological criteria: Microbiological Total plate count: ≤ 10 000 CFU/g Yeasts: ≤ 500 CFU/g Moulds: ≤ 500 CFU/g Staphylococcus aureus Coliforms: < 100 MPN/g Enterobacteriaceae: ≤ 100 CFU/g Bacillus cereus Escherichia coli
L. and L.
L. Authorised Novel Food Brassica rapa from Brassica napus Partially defatted rapeseed powder
M59 M44 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 163
(Fisch.) Bunge. The other is a hot water extract of ion on a resin and subsequent elution with 60 % ethanol. At the
Astragalus membranaceus Specifications ltural Chemists h %] ,5 % of each extract) with maltodextrin (5–10 %). of the roots of
/kg
2
(Burkill) F.H. Chen that is further concentrated using absorpt
: < 10 CFU/g
: < 100 CFU/g Panax notoginseng sp.: Negative/25 g the roots of end of the manufacturing process both extracts are mixed (45–47 Characteristics/Composition: Total saponins: 1,5-5 % Ginsenoside Rb1: 0,1-0,5 % Astragaloside I: 0,01-0,1 % Description/Definition: The novel food contains two extracts. One is an ethanol extract Mercury: < 0,1 mg/kg Aluminium: < 35,0 mg/kg Microbiological criteria: Total plate count (30 °C): < 5 000 CFU/g Enterobacteriaceae Salmonella Yeast and mould: < 100 CFU/g Bacillus cereus (*) By difference: 100 % – [protein % + moisture % + fat % + as (**) AOAC 2011.25 (Enzymatic gravimetry) CFU: Colony Forming Units, AOAC: Association of Official Agricu Moisture: < 7,0 % Ash: 2,0–5,0 % Total Glucosinolates: < 0,3 mmol/kg (≤ 120 mg/kg) Phytate: < 1,5 % Peroxide value (in novel food weight): ≤ 3,0 mEq O Heavy Metals: Lead: < 0,2 mg/kg Arsenic (inorganic): < 0,2 mg/kg Cadmium: < 0,2 mg/kg
Panax notoginseng Authorised Novel Food Astragalus membranaceus and Extract from
M52 M59 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 164
agricultural and manufacturing practices product
Equivalent to storage regimen for conventionally processed Specifications Fruit harvested and stored in conjunction with good/hygienic Fruit homogenised and added to other ingredients Comments
Assured by added sugars Assured by added sugars < 0,95 Minimum 15 days at – 20 °C
Target : Absence in 25 g
: Absence in 25 g
Parameter 60 days maximum at + 5 °C maximum
40 % to 60 % of thawed fruit : Absence in 375 g
7 to 42 3,2 to 4,2
Brix
w
pH Fruit added a Final storage Fruit storage before treatment high-pressure o Staphylococcus aureus CFU: colony forming units Total yeast and mould count: ≤ 500 CFU/g Enterobacteriaceae: < 10 CFU/g Escherichia coli Salmonella Carbohydrates: Carbohydrates: ≥ 90 % Protein: ≤ 4,5 % Ash: ≤ 1 % Moisture: ≤ 5 % Fat: ≤ 1,5 % Heavy metals: Arsenic: ≤ 0,3 mg/kg Microbiological criteria: Total plate count: ≤ 5 000 CFU/g
Authorised Novel Food Pasteurised fruit-based prep Pasteurised fruit-based using arations produced high-pressure treatment
M9 M52 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 165
oduce phenylcapsaicin. yl acetylene with a carboxylic acid
, CAS no: 848127-67-3), is synthesized chemically via a two
3
NO
23
H
21
Specifications cetylenic acid intermediate with vanillylamine derivative to pr of the acetylenic acid intermediate through a reaction of phen
-[(4-hydroxy-3-methoxyphenyl)methyl]-7-phenylhept-6-ynamide, -[(4-hydroxy-3-methoxyphenyl)methyl]-7-phenylhept-6-ynamide, C N : Negative/10 g
sp.: Negative/10 g -dimethyl formamide: ≤ 880 mg/kg Phenylcapsaicin ( step synthesis process involving in a first step the production derivative, and in a second step a series of reactions of the a Microbiological criteria: Total plate count: ≤ 10 CFU/g Coliforms: ≤ 10 CFU/g Escherichia coli Salmonella Yeast and mould: ≤ 10 CFU/g CFU: Colony Forming Units Total synthesis related production by-products: ≤ 1,0 % N,N Dichloromethane: ≤ 600 mg/kg Dimethoxyethane: ≤ 100 mg/kg Ethyl acetate: ≤ 0,5 % Other solvents: ≤ 0,5 % Heavy metals: Lead: ≤ 1,0 mg/kg Cadmium: ≤ 1,0 mg/kg Mercury: ≤ 0,1 mg/kg Arsenic: ≤ 1,0 mg/kg Characteristics/Composition: Purity (% of dry matter): ≥ 98 % Moisture: ≤ 0,5 %
Description/Definition: Authorised Novel Food Phenylcapsaicin
M35 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 166 ansphosphorylation with the arch by combining chemical
Specifications ]y
e maize’ as source 2
H
ylserine is obtained from fish phospholipids by an enzymatic tr
3 emically modified resistant starch derived from high amylose st residues and esterified hydroxyl groups. ion Regulation (EU) No 1129/2011 )PO
5
O
9
H
6 H]x [(C
2
PO
2 )
5
O
9
/kg
H
2
6 [(C
n )
5
O
)
10
1 H
6
) Tocopherols may be added as antioxidants according to Commiss
1 Specification of the phosphatidylserine product manufactured from fish phospholipids: Moisture: < 5,0 % Phospholipids: ≥ 75 % Phosphatidylserine: ≥ 35 % Glycerides: < 4,0 % Free L-serine: < 1,0 % Tocopherols: < 0,5 % ( amino acid L-serine. Peroxide value (PV): < 5,0 meq O ( pH: 4,5-7,5 Dietary fibre: ≥ 70 % Starch: 7-14 % Protein: ≤ 0,8 % Lipids: ≤ 0,8 % Residual bound phosphorus: ≤ 0,4 % (as phosphorus) ‘high amylos Description/Definition: The novel food ingredient is yellow to brown powder. Phosphatid Phosphated maize starch (phosphated distarch phosphate) is a ch treatments to create phosphate cross-links between carbohydrate The novel food ingredient is a white or nearly white powder. CAS No: 11120-02-8 Chemical formula: (C n = number of glucose units; x, y = degrees of The substitution chemical characteristics of phosphated distarch phosphate: Loss on drying: 10-14 %
Description/Definition:
Authorised Novel Food Phosphatidylserine from fish phospholipids Phosphated maize starch maize Phosphated
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 167
udes significant amounts of ellow-brown powder form of hosphodiester linkage. ybean lecithin with the amino e colour. The liquid form contains
Specifications lecithin. The phospholipid product is a highly concentrated, y lower levels of Phosphatidylserine due to the fact that it incl enzymatic transphosphatidylation of high-phosphatidylcholine so e skeleton conjugated with two fatty acids and L-serine via a p It is also available in liquid form with a clear brown to orang
medium chain triacylglycerides (MCT) as a oil carrier. (MCT). It contains Phosphatidylserine from soya phospholipids is obtained through Tocopherols: < 0,3 % Phytosterols: < 0,2 % Description/Definition: The product is manufactured through enzymatic conversion of soy phosphatidylserine and phosphatidic acid at an equal level. Specification of the product: Moisture: ≤ 2,0 % Phospholipids: ≥ 85 % Phosphatidylserine: ≥ 61 % Glycerides: < 2,0 % free L-serine: < 1,0 % Tocopherols: < 0,3 % Phytosterols: < 0,2 % Liquid form: Moisture: < 2,0 % Phospholipids: ≥ 25 % Phosphatidylserine: ≥ 20 % Glycerides: not applicable free L-serine: < 1,0 % Description/Definition: The novel food ingredient is off-white to light yellow powder. acid L-serine. Phosphatidylserine consists of a glycerophosphat Characteristics of Phosphatidylserine from soya phospholipids: Powder form: Moisture: < 2,0 %
Authorised Novel Food Phospholipid product containing equal amounts of phosphati dylserine and phosphatidic acid Phosphatidylserine from soya Phosphatidylserine phospholipids
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 168
conventional stanols or esterified with food very 8 to 12 glucose units by α(1 – 6) glycosidic bonds
lavourless polysaccharide derived from non-GM sweet corn using Specifications extracted from plants and may be presented as free sterols and
)n with linear linkages of α(1 – 4) glycosidic bonds branched e
6
O
12
H
6
(with GC-FID or equivalent method): White to off-white powder which is an odourless, colourless, f Glucose polymer (C Phytosterols and phytostanols are sterols and stanols that grade are fatty acids. Composition β-sitosterol: < 81 % β-sitostanol: < 35 % campesterol: < 40 % campestanol: < 15 % food processing techniques Definition: Specifications: Carbohydrates: 97 % Sugars: 0,5 % Fibre: 0,8 % Fat: 0,2 % Protein: 0,6 % Total Total phospholipids: ≥ 70 % Phosphatidylserine: ≥ 20 % Phosphatidic acid: ≥ 20 % Glycerides: ≤ 1,0 % Free L-serine: ≤ 1,0 % Tocopherols: ≤ 0,3 % Phytosterols: ≤ 2,0 % Silicon dioxide is used with a maximum content of 1,0 % 85 % and 100 % pure Phospholipides from egg yolk
Description/Definition: Description: Authorised Novel Food Phospholipides from egg Phospholipides from yolk Phytoglycogen Phytosterols/phytostanols
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 169 s, best ensured by a purity of
) kernels.
Specifications Prunus domestica endoprolylpeptidase vegetable oil suitable for food have to be free of contaminant plum (
(GC-FID or equivalent method):
Lysinoalanine (total): ≤ 500 mg/kg Lysinoalanine (free): ≤ 10 mg/kg Specification of the enzyme: Systematic name: Prolyl oligopeptidase Synonyms: Prolyl endopeptidase, proline-specific endopeptidase, Molecular weight: 66 kDa Enzyme Commission number: EC 3.4.21.26 CAS number: 72162-84-6 Oleic acid (C18:1): 68 % Linoleic acid (C18:2): 23 % γ-Tocopherol:80 % of total tocopherols β-Sitosterol: 80-90 % of total sterols Triolein: 40-55 % of triglycerides Cyanhydric acid: maximum 5 mg/kg oil Dry substance: ≥ 800 mg/g Protein (N * 6,25): ≥ 600 mg/g (dry substance) Ash: ≤ 400 mg/g (dry substance) Glycoalkaloid (total): ≤ 150 mg/kg Plum kernel oil is a vegetable oil obtained by cold pressing Composition: of stigmasterol: stigmasterol: < 30 % brassicasterol: < 3,0 % other sterols/stanols: < 3,0 % Contamination/Purity Phytosterols and phytostanols extracted from sources other than more than 99 % of the phytosterol/phytostanol ingredient.
Description/Definition:
Authorised Novel Food hydrolysates thereof Potato proteins (coagulated) and (coagulated) Potato proteins Plum kernel oil Prolyl oligopeptidase (enzyme preparation)
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 170 < 0,20 μg/kg), T-2 Toxin (< 5
ntaining approximately 30 % maltodextrin.
Specifications
g/kg) om batch to batch (< 0,25 μg/kg), total Aflatoxins (< 2,0 μg/kg), Ochratoxin A ( (GEP-44) )/g)
2
Aspergillus niger Aspergillus
CFU/g
CFU/g
3
2
)/g (> 34,8 PPU(
: Absence in 10 g
1 : Absence in 25 g : Absence in 10 g
: < 10 CFU/g
: Absence in 25 g
Prolyl oligopeptidase is available as an enzyme preparation co : Absence in 25 g ) PPI – Protease Picomole International ) PPU – Prolyl Peptidase Units or Proline Protease Units
1 2 Listeria monocytogenes Antimicrobial activity: Absent Mycotoxins: Below limits of detection: Aflatoxin B1, B2, G1, G2 μg/kg), Zearalenone (< 2,5 μg/kg), Fumonisin B1 and B2 (< 2,5 μ Escherichia coli Staphylococcus aureus Pseudomonas aeruginosa ( ( Heavy metals: Lead: ≤ 1,0 mg/kg Arsenic: ≤ 1,0 mg/kg Cadmium: ≤ 0,5 mg/kg Mercury: ≤ 0,1 mg/kg Microbiological criteria: Total aerobic plate count: ≤ 10 Sulphite reducing anaerobes: ≤ 30 CFU/g Enterobacteriaceae Salmonella Appearance: Microgranulate Colour: Off-white to orange yellowish. The colour may change fr Dry Matter: > 94 % Gluten: < 20 ppm Total yeasts and moulds: ≤ 10 Source: A genetically modified strain of Description: Specifications of the enzyme preparation of prolyl oligopeptidase: Activity: > 580 000 PPI(
Authorised Novel Food
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 171 fu . 1.4.3.22) and is resuspended c coated tablets to reach the active rough a combination of salt precipitation and high speed centri
actionassay)) Specifications REA (DAO Radioextractionassay)) f DAO (E.C. 1.4.3.22) in an enteric coated formulation:
of Diamine oxidase (DAO): is formulated as encapsulated enteric coated pellets or enteri with 7 % of the enzyme diamine oxidase (enzyme nomenclature E.C
CFU/g CFU/g
4
5
CFU/g
5
The protein extract is obtained from homogenised pig kidneys th : negative (Real Time PCR) : < 100 CFU/g : < 10 CFU/g
spp.: negative (Real Time PCR) : Absence/10g Yeasts/moulds count: < 10 Appearance: slightly turbid solution pH value: 6,4–6,8 Enzymatic activity: > 2 677 kHDU DAO/ml (DAO REA (DAO Radioextr Microbiological criteria: Brachyspira Listeria monocytogenes Staphylococcus aureus Influenza A: negative (Reverse Transcription Real Time PCR) Escherichia coli Total aerobic microbiological count: < 10 gation. The obtained precipitate contains essentially proteins in a physiologic buffer system. The obtained pig kidney extract sites of digestion. Basic Product: Specification: pig kidney protein excerpt with natural content Physical condition: liquid Colour: brownish Salmonella Bile salt resistant enterobacteriaceae: < 10 Final product: Specification pig kidney protein excerpt with natural content o Physical condition: solid Colour: yellow grey Appearance: micropellets or tablets Enzymatic activity: 110-220 kHDU DAO/g pellet or g tablet (DAO Description/Definition:
Authorised Novel Food Protein extract from pig Protein extract from kidneys
M47 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 172 strain tionassay)) Hyphomicrobium denitrificans
Specifications 0: > 68 kHDU DAO/g pellet or g tablet (DAO REA (DAO Radioextrac r produced by the non-genetically modified bacterium
-pyrrolo[5,4-f]quinoline-2,7-dicarboxylate H CFU/g CFU/g CFU/g
3
2
4
8
O
2
Na
2
N
4
H
: < 100 CFU/g 14
: < 10 CFU/g
: Absence/10g
Definition: Chemical name: disodium 9-carboxy-4,5-dioxo-1 Chemical formula: C Total combined yeasts/moulds count: < 10 Salmonella Bile salt resistant enterobacteriaceae: < 10 Purity: ≥ 99,0 % (dry weight) UV absorbance (A322/A259): 0,56 ± 0,03 UV absorbance (A233/A259): 0,90 ± 0,09 Moisture: ≤ 12,0 % Residual Solvent Ethanol: ≤ 0,05 % Heavy metals Lead: < 3 mg/kg Arsenic: < 2 mg/kg CAS No: 122628-50-6 Molecular weight: 374,17 Da Description Pyrroloquinoline quinone disodium salt is a reddish–brown powde CK-275. Characteristics/Composition Appearance: Reddish-brown powder Acid stability 15 min 0,1M HCl followed by 60 Humidity: < min 10 % Borat pH = 9, Staphylococcus aureus Escherichia coli Total aerobic microbiological count: < 10
Authorised Novel Food
Pyrroloquinoline quinone Pyrroloquinoline quinone disodium salt
M10 M47 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 173 n the concentration of the r reduction of triglycerides
Specifications um distillation and it is different from refined rapeseed oil i ‘rapeseed oil high in unsaponifiable matter’). There is a mino
/kg
2
: ≤ 25 CFU/g
Fatty acids in triglycerides: palmitic acid: 3-8 % stearic acid: 0,8-2,5 % oleic acid: 50-70 % linoleic acid: 15-28 % linolenic acid: 6-14 % erucic acid: < 2,0 % Acid value: ≤ 6,0 mg KOH/g Peroxide value (PV): ≤ 10 mEq O containing monounsaturated and polyunsaturated fatty acids. Purity: Unsaponifiable matter: > 7,0 g/100 g Tocopherols: > 0,8 g/100 g α-tocopherol (%): 30-50 % γ-tocopherol (%): 50-70 % δ-tocopherol (%): < 6,0 % Sterols, triterpenic alcohols, methylsterols: > 5,0 g/100 g Description/Definition: Rapeseed oil high in unsaponifiable unsaponifiable matter’ fraction is (1 produced g by in vacu refined rapeseed oil and 9 g in Microbiological criteria: Microbiological Total viable cell count: ≤ 300 CFU/g Mould/yeast: ≤ 12 CFU/g Coliforms: absent in 1 g denitrificans Hyphomicrobium CFU: Colony Forming Units
Authorised Novel Food Rapeseed oil high in unsapo in high Rapeseed oil nifiable matter
M9 M10 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 174
L. Brassica rapa Brassica L. and ion of ‘rapeseed oil high in Brassica napus Brassica
Specifications g lic aromatic hydrocarbons (PAH) are not enriched in the product ed press cake modified from originating non-genetically
Absence in Absence 10 g
: Absence : in Absence 25 g
Purity: ≤ phytate: Total 1,5 % ≤ Lead: 0,5 mg/kg criteria: Microbiological and Yeast mould ≤ count: 100 CFU/g ≤ count: 000 10 bacteria CFU/g Aerobic ≤ count: 10 coliform Total CFU/g coli: Escherichia Description: powder spray dried to White off-white, ≥ protein: Total 90 % ≥ protein: 85 Soluble % ≤ 7,0 Moisture: % ≤ 7,0 Carbohydrates: % Fat: ≤ 2,0 % Ash: ≤ 4,0 % ≤ Fibre: 0,5 % ≤ 1 glucosinolates: Total mmol/kg Salmonella Rapeseed Rapeseed protein is an aqueous extract from protein-rich rapese Heavy metals: Iron (Fe): < 1 000 μg/kg Copper (Cu): < 100 μg/kg Impurities: Polycyclic aromatic hydrocarbons (PAH) Benzo(a)pyrene: < 2 μg/k Treatment with active carbon is required to ensure that unsaponifiable polycyc matter.
Definition: Authorised Novel Food Rapeseed Protein
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 175
. ) shells and heads via a series of purification steps Pandalus borealis Bacillus amyloliquefaciens
and/or Specifications molecular weight < 2 kDa: ≥ 99,9 % d from northern shrimp (
Bacillus licheniformis ≤ 200 CFU/g
: ND/25g : ND/25g
Staphylococcus aureus:
: ≤ 20 CFU/g
: ND/25g CFU: Colony Forming Units Microbiological criteria: Total viable cell count: ≤ 20 000 CFU/g Salmonella Listeria monocytogenes Escherichia coli Coagulase positive Pseudomonas aeruginosa Mould/yeast: ≤ 20 CFU/g ND: Not Detectable Carbohydrates (w/w): ≤ 1,0 % Ash (w/w): ≤ 15,0 % Calcium: ≤ 2,0 % Potassium: ≤ 0,15 % Sodium: ≤ 3,5 % Heavy Metals Arsenic (inorganic): ≤ 0,22 mg/kg Arsenic (organic): ≤ 51,0 mg/kg Cadmium: ≤ 0,09 mg/kg Lead: ≤ 0,18 mg/kg Total mercury: ≤ 0,03 mg/kg Description Refined shrimp peptide concentrate is a peptide mixture obtaine following enzymatic proteolysis using a protease from Characteristics/Composition Total Dry matter (%): ≥ 95,0 % Peptides (w/weight dry matter): ≥ 87,0 % of which peptides with Fat (w/w): ≤ 1,0 %
Authorised Novel Food Refined shrimp peptide Refined shrimp peptide concentrate
M17 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 176 nd dermatan sulphate (chon ration, concentration and precipitation
Specifications ol he glycosaminoglycans hyaluronic acid, chondroitin sulphate A a by enzymatic hydrolysis of rooster comb and by subsequent filt Saccharomyces cerevisiae Gallus gallus
3
O
12
H
14
: A genetically modified strain of -resveratrol is off-white to beige crystals.
Trans
-resveratrol: ≥ 98 %-99 % Trans-resveratrol content: Min. 98 % w/w (dry weight basis) Ash: Max. 0,5 % w/w Moisture: Max. 3 % w/w Rooster comb extract is obtained from Any single related substance: ≤ 0,1 % Sulphated ash: ≤ 0,1 % Loss on drying: ≤ 0,5 % Heavy metals: Lead: ≤ 1,0 ppm Mercury: ≤ 0,1 ppm Arsenic: ≤ 1,0 ppm Impurities: Diisopropylamine: ≤ 50 mg/kg Microbial source Appearance: Off-white to slight yellow powder Particle size: 100 % less than 62,23 μm Synthetic Chemical name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-di Chemical formula: C Molecular weight: 228,25 Da CAS No: 501-36-0 Purity: Trans Total by-products (related substances): ≤ 0,5 % steps. The principal constituents of rooster comb extract droitin are sulphate t B). White or almost white hygroscopic powder.
Description/Definition: Description/Definition: Description/Definition: Authorised Novel Food Rooster comb extract Rooster comb Trans-resveratrol
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 177 L. It is a transparent, fluid (liquid) and shiny oil at room
Plukenetia volubiis Plukenetia Specifications
or odour ean, shiny yellow gold from the seeds of out undesirable flavours.
CFU/g
2
: Absence in 1g
: Absence in 1 g
: Absence in 1 g
: Absence in 1 g
Salmonella Staphylococcus aureus Pseudomonas aeruginosa Description/Definition: Sacha inchi oil is a 100 % cold pressed vegetable oil obtained temperature. It has a fruity, light, green vegetable taste with Aspect, limpidity, shine, colour: Fluid at room temperature, cl Odour and taste: Fruity, vegetable without non acceptable taste Escherichia coli Heavy metals: Mercury: ≤ 0,1 mg/kg Arsenic: ≤ 1,0 mg/kg Cadmium: ≤ 1,0 mg/kg Chromium: ≤ 10 mg/kg Lead: ≤ 0,5 mg/kg Microbiological criteria: Total viable aerobic count: ≤ 10 Hyaluronic acid: 60-80 % Chondroitin sulphate A: ≤ 5,0 % Dermatan sulphate (chondroitin sulphate B): ≤ 25 % pH: 5,0-8,5 Purity: Chlorides: ≤ 1,0 % Nitrogen: ≤ 8,0 % Loss on drying: (105 °C for 6 hours): ≤ 10 %
Plukenetia Authorised Novel Food
Sacha Inchi oil from oil Sacha Inchi volubilis
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 178 d by non-enzymatic rancid odour. or sunflower oil. Description:
Specifications nd long chain acyl triglyceride molecules). Salatrim is prepare id (ALA): > 45 % room temperature. Free of particulate matter and of foreign or their mixtures with hydrogenated canola, soybean, cottonseed, /kg
2
Clear, slightly amber liquid to a light coloured waxy solid at inter-esterification of triacetin, tripropionin, tributyrin, or Glycerol ester disribution: Triacylglycerols: > 87 % Diacylglycerols: ≤ 10 % Monoacylglycerols: ≤ 2,0 % Fatty acid composition: MOLE % LCFA (long chain fatty acids): 33-70 % Saturated fatty acids: < 10 % No trans fatty acids (< 0,5 %) No erucic acid (< 0,2 %) More than 50 % of tri-linolenin and di-linolenin-triglycerides Phytosterols composition and level No cholesterol (< 5,0 mg/100 g) Salatrim is the internationally recognised acronym for (short a Trans fatty acids: < 1,0 g/100 g Total unsaturated fatty acids: > 90 %Omega 3 alpha linolenic ac Purity: Water and Volatiles: < 0,2 g/100 g Impurities insoluble in hexane: < 0,05 g/100 g Oleic acidity: < 2,0 g/100 g Peroxide value (PV): < 15 meq O
Description/Definition: Authorised Novel Food Salatrims
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 179 by appropriate and sp.
Schizochytrium Specifications oil rich in DHA and EPA should demonstrate oxidative stability microalgae
Schizochytrium sp.
The novel food is obtained from the strain ATCC PTA-9695 of the Ash: ≤ 0,1 % Colour: ≤ 3,5 Red (Lovibond) Peroxide value (PV): ≤ 2,0 Meq/Kg Acid value: ≤ 0,5 mg KOH/g Peroxide value (PV): ≤ 5,0 meq/kg oil Oxidative stability: All food products containing recognised national/international test methodology (e.g. AOAC) Moisture and volatiles: ≤ 0,05 % Unsaponifiables: ≤ 4,5 % Trans-fatty acids: ≤ 1 % DHA content: ≥ 22,5 % EPA content: ≥ 10 % MOLE % SCFA (short chain fatty acids): 30-67 % Saturated long chain fatty acids: < 70 % by weight Trans fatty acids: ≤ 1,0 % Free fatty acids as oleic acid: ≤ 0,5 % Triacylglycerol profile: Triesters (short/long of 0,5 to 2,0): ≥ 90 % Triesters (short/long = 0): ≤ 10 % Unsaponifiable material: ≤ 1,0 % Moisture: ≤ 0,3 % Peroxide value (PV): ≤ 5,0 meq/kg oil Unsaponifiables: ≤ 3,5 % Trans-fatty acids: ≤ 2,0 % Free fatty acids: ≤ 0,4 % Docosapentaenoic acid (DPA) n-6: ≤ 7,5 % DHA content: ≥ 35 %
oil rich in DHA in rich oil sp. (ATCC
Authorised Novel Food Schizochytrium sp. and EPA Schizochytrium PTA-9695) oil
M26 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 180 )). ion, and evaporation including a heat treatment in Gramineae (alt.
sp. Poaceae
; family, Schizochytrium Sorghum Specifications
microalgae (L.) Moench (L.) (L.) Moench (genus,
, after applying production processes such as crushing, extract Sorghum bicolor S. bicolor Sorghum bicolor
The syrup is obtained from stalks of order to obtain a minimum of 74 °Brix syrup syrup from Compositional data of Docosahexaenoic acid (DHA): ≥ 32,0 % p-anisidine value: ≤ 10 Description/Definition The traditional food is syrup from Water: 22,7 g/100 g Ash: 2,4 Sugars, total: > 74,0 g/100 g Unsaponifiables: ≤ 3,5 % Trans-fatty acids: ≤ 2,0 % Free fatty acids: ≤ 0,4 % DHA content: ≥ 35 % The novel food is an oil produced from the strain Composition: WZU477 of the Acid value: ≤ 0,5 mg KOH/g Peroxide value (PV): ≤ 5,0 meq/kg oil Moisture and volatiles: ≤ 0,05 % Unsaponifiables: ≤ 4,5 % Trans-fatty acids: ≤ 1,0 % Peroxide value (PV): ≤ 5,0 meq/kg oil Moisture and volatiles: ≤ 0,05 % Unsaponifiables: ≤ 4,5 % Trans-fatty acids: ≤ 1,0 % DHA content: ≥ 32,0 % Peroxide value (PV): ≤ 5,0 meq/kg oil Moisture and volatiles: ≤ 0,05 % Description/Definition: (L.) Acid value: ≤ 0,8 mg KOH/g
Acid value: ≤ 0,5 mg KOH/g sp. (WZU477) oil sp. (T18) oil sp. oil Sorghum bicolor
Authorised Novel Food Syrup from Moench. (Traditional food from a third country) Schizochytrium Schizochytrium Schizochytrium
M22 M61 M42 M9 ▼ ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 181 Glycine and 70 % resistant dextrin ding a heat-killing step of the y modified soybeans ( . Yarrowia lipolytica
is removed during the manufacturing process.
2
Specifications tto, a foodstuff produced by the fermentation of non-geneticall owder. It is comprised of 30 % fermented soybean extract powder biomass of the yeast odium selenite followed by a number of purification steps inclu )
sing. Vitamin K
1 cells in the novel food. var. natto.
)/g
3 Yarrowia lipolytica
Bacillus subtilis Bacillus CFU(
3
CFU/g
2
): 100–140 μg/g
: Absence/25 g
13
: ≤ 0,1 mg/kg
: Absence/25 g 2
: Absence/25 g (L.)) with a selected strain of ) Assay method as described by Takaoka et al. (2010).
1 The novel food is the dried and heat-killed selenium-containing The novel food is produced by fermentation in the presence of s yeast to ensure the absence of viable Characteristics/Composition: Total selenium: 165–200 μg/g Se-methionine ( Arsenic: ≤ 3,0 mg/kg Microbiological criteria: Total viable aerobic count: ≤ 10 Yeast and mould: ≤ 10 Coliforms: ≤ 30 CFU/g Spore-forming bacteria: ≤ 10 CFU/g Escherichia coli Salmonella Listeria ( Description/Definition: Fermented soybean extract is an odourless milk-white coloured p (as carrier) from corn-starch, which is added during the proces Identity: Confirmable Condition: No offensive taste or smell Loss on drying: ≤ 10 % Vitamin K Heavy metals: Lead: ≤ 5,0 mg/kg Protein: 40–50 g/100 g Dietary fibre: 24–32 g/100 g Sugars: < 1 g/100 g Fat: 6–12 g/100 g Total ash: ≤ 15 % Water: ≤ 5 % Dry matter: ≥ 95 % Fermented soybean extract contains nattokinase isolated from na max Nattokinase activity: 20 000 -28 000 Fibrin degradation unit/g(
Description/Definition: ) biomass Authorised Novel Food Yarrowia lipolytica Selenium-containing yeast ( Fermented soybean Fermented extract
M54 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 182 rocess and contains limited levels se, sodium salt
Specifications
(% of dry matter): ≥ 90,0 % (w/w) f-white powder or agglomerate that is produced by a microbial p K-12 DH1
CFU/g
3 Escherichia coli CFU/g
2
): < 10 CFU/g (i.e. limit of detection)
14 Na
19
NO
( cells
38
H
23
-Acetyl-α-D-neuraminyl-(2→3)-β-D-galactopyranosyl-(1→4)-D-gluco N
spp.: Absence in 25 g Genetically modified strain of Yarrowia lipolytica Sum of 3'-Sialyllactose sodium salt, D-Lactose, and Sialic acid 3'-Sialyllactose sodium salt (% of dry matter): ≥ 88,0 % D-Lactose: (w/w) ≤ 5,0 % (w/w) Sialic acid: ≤ 1,5 % (w/w) 3'-Sialyl-lactulose: ≤ 5,0 % (w/w) Sum of other carbohydrates: ≤ 3,0 % (w/w) Moisture: ≤ 8,0 % (w/w) Sodium: 2,5 – 4,5 % (w/w) Chloride: ≤ 1,0 % (w/w) pH (20 °C, 5 % solution): 4,5 -6,0 Residual protein: ≤ 0,01 % (w/w) Molecular mass: 655,53 Da CAS No 128596-80-5 Characteristics/Composition: Appearance: White to off-white powder or agglomerate Chemical name: Description: 3'-Sialyllactose (3'-SL) sodium salt is a purified, white to of of lactose, 3'-sialyl-lactulose, and sialic acid Source: Definition: Chemical formula: C Heavy metals: Lead: ≤ 3,0 mg/kg Cadmium: ≤ 1,0 mg/kg Mercury: ≤ 0,1 mg/kg Microbiological criteria: Total aerobic microbial count: ≤ 5 × 10 Total yeast and mould count: ≤ 10 Viable Coliforms: ≤ 10 CFU/g Salmonella CFU: colony forming units
Authorised Novel Food (microbial source) 3'-Sialyllactose (3'-SL) sodium salt
M58 M54 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 183 rocess and contains limited levels
Specifications yl-(1→4)-D-glucose, yl-(1→4)-D-glucose, sodium salt
(% of dry matter): ≥ 94,0 % (w/w)
f-white powder or agglomerate that is produced by a microbial p K-12 DH1
Escherichia coli
Na
19
NO
38
H
23
: ≤ 10 CFU/g
sp.: Absence in 25 g Genetically modified strain of Sum of 6’-Sialyllactose sodium salt, D-Lactose and Sialic acid 6’-Sialyllactose sodium salt (% of dry matter): ≥ 90,0 % D-Lactose: (w/w) ≤ 5,0 % (w/w) Sialic acid: ≤ 2,0 % (w/w) 6’-Sialyl-lactulose: ≤ 3,0 % (w/w) Sum of other carbohydrates: ≤ 3,0 % (w/w) Moisture: ≤ 6,0 % (w/w) Sodium: 2,5-4,5 % (w/w) Chloride: ≤ 1,0 % (w/w) pH (20 °C, 5 % solution): 4,5-6,0 Residual protein: ≤ 0,01 % (w/w) Chemical name: N-Acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranos Molecular mass: 655,53 Da CAS No 157574-76-0 Characteristics/Composition: Appearance: White to off-white powder or agglomerate Description: 6’-Sialyllactose (6’-SL) sodium salt is a purified, white to of of lactose, 6’-sialyl-lactulose, and sialic acid. Source: Definition: Chemical formula: C Microbiological criteria: Microbiological Aerobic mesophilic bacteria total plate count: ≤ 1000 CFU/g Enterobacteriaceae Salmonella Yeast: ≤ 100 CFU/g Mould: ≤ 100 CFU/g Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units.
Authorised Novel Food salt (microbial source) 6’-Sialyllactose (‘6’-SL’) sodium 6’-Sialyllactose (‘6’-SL’)
M57 M58 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 184 or by means of a reaction. In this process, nce of α-(1→6) and α-(l→3) he disaccharide leucrose and other Leuconostoc citreum ) by the process of solid-liquid extraction Triticum aestivum
Specifications . The resulting oligosaccharides are characterised by the prese from sucrose and a starch hydrolysate by means of an enzymatic ed, non-sprouting wheat germs ( to these oligosaccharides, contains mainly fructose but also t
lysate by means of an enzyme produced by the bacterium
Bacillus licheniformis Bacillus
Absence/25g
: ≤ 10 CFU/g < 10 CFU/g
Absence/25g sp.: Absence in 25 g glucose units are attached to saccharides from the starch hydro recombinant strain of the production organism disaccharides. Total solids: 75-80 % Sucromalt is a complex mixture of saccharides which is produced glycosidic compounds. The overall product is syrup, in addition Listeria monocytogenes: Description/Definition: Spermidine-rich wheat germ extract is obtained from non-ferment targeting specifically, but not exclusively polyamines. Spermidine:(N-(3-aminopropyl)butane-1,4-diamine):0,8-2,4 mg/g Spermine: 0,4-1,2 mg/g Spermidine trichloride < 0,1 μg/g Putrescine: < 0,3 mg/g Cadaverine: ≤ 16,0 μg/g Mycotoxins: Aflatoxins (total): < 0,4 μg/kg Microbiological criteria: Total aerobic bacteria: < 10 000 CFU/g Yeast and moulds: < 100 CFU/g Escherichia coli: Salmonella: Microbiological criteria: Microbiological Aerobic mesophilic bacteria total plate count: ≤ 1 000 CFU/g Enterobacteriaceae Salmonella Yeast: ≤ 100 CFU/g Mould: ≤ 100 CFU/g Residual endotoxins: ≤ 10 EU/mg CFU: Colony Forming Units; EU: Endotoxin Units.
) Description/Definition: Triticum aestivum Authorised Novel Food Sucromalt Spermidine-rich wheat Spermidine-rich wheat germ extract (
M9 M41 M57 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 185 llulosic components, bleaching of from sugar cane, of the Saccharum
Specifications
ipping, alkaline digestion, removal of lignins and other non-ce esidue remaining after expression or extraction of sugar juice
: Absence
: Absence
pH: 4-7 Heavy metals: Mercury (ppm): ≤ 0,1 Lead (ppm): ≤ 1,0 Arsenic (ppm): ≤ 1,0 Cadmium (ppm): ≤ 0,1 Microbiological criteria: Yeast and moulds (CFU/g): ≤ 1 000 Salmonella Listeria monocytogenes Sugar Cane Fibre is derived from the dry cell wall or fibrous r genotype. It consists primarily of cellulose and hemicellulose. The production process consists of several steps, including: ch purified fibres, acid washing and neutralization. Moisture: ≤ 7,0 % Ash: ≤ 0,3 % Total Dietary Fibre (AOAC) dry basis (all insoluble): ≥ 95 of % which: Hemicellulose (20-25 %) and cellulose (70-75 %) Silica (ppm): ≤ 200 Protein: 0,0 % Fat: Trace Moisture: 20-25 % Sulphatase: Max 0,05 % pH: 3,5-6,0 Conductivity < 200 (30 %) Nitrogen < 10 ppm Fructose: 35-45 % d.w. Leucrose: 7-15 % d.w. Other disaccharides: Mах 3 % Higher saccharides: 40-60 % d.w
Description/Definition: Authorised Novel Food Sugar cane fibre Sugar cane
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 186 ocess to produce high L.) pulp:
L.) pulp: L.) pulp: L.) juice either via a drying process or via a purification pr Specifications Theobroma cacao cocoa ( Theobroma cacao Theobroma cacao Theobroma cacao
4 4
Absence in 50 g spp.: Absence in 25 g spp.: Absence in 25 g Total Plate Count (aerobic) (cfu/g): < 10 Moisture (%): < 1,0 Nutritional composition of Fructose obtained from cocoa ( Fructose content (%): > 98 Glucose content (%): < 0,5 % Ash (%): < 0,2 Moisture (%):< 0,5 Microbiological criteria for glucose and fructose obtained from Salmonella Microbiological criteria: Total Plate Count (aerobic) (cfu/g): < 10 Moulds and Yeasts (cfu/g): < 50 Enterobacteriaceae (cfu/g): < 10 Salmonella Alicyclobacillus: Thermo-acidophilic bacteria: Absence in 50 g process purification by a Sugars produced Nutritional composition of Glucose obtained from cocoa ( Glucose content (%): > 93 Ash (%): < 0,2 Description/Definition: Sugars are obtained from the concentrated cocoa pulp ( purity glucose or fructose. process drying by a Sugars produced Nutritional composition: Total sugars (g/100g): > 80 Moisture (%): < 5
L.) pulp Authorised Novel Food Theobroma cacao Sugars obtained from cocoa from Sugars obtained (
M50 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 187 iotechnology acted from the seeds of the family, cultivated in sterile sea water in Chlorodendraceae
, belonging to the sed no less than 1 600 base pairs) in the National Centre for B Specifications 10 of the unsaponifiable fraction of refined sunflower oil extr Tetraselmis chuii
L.
Helianthus Annuus Tocopherols: 1,1 % Composition: Oleic acid (C18:1): 20 % Linoleic acid (C18:2): 70 % Unsaponifiable matter: 8,0 % Phytosterols: 5,5 % Ashes: 14-16 % Carbohydrates: 30-32 % Fibre: 2-3 % Fat: 5-8 % Saturated fatty acids: 29-31 % of total fatty acids Monounsaturated fatty acids: 21-24 % of total fatty acids Polyunsaturated fatty acids: 44-49 % of total fatty acids Iodine: ≤ 15 mg/kg The dried product is obtained from the closed photobioreactors marine insulated microalgae from the outside air. Purity/Composition: Identified by means of information (NCBI) database: nuclear Not less marker than 99,9 % rDNA 18 Humidity: S ≤ 7,0 % (sequence analy Proteins: 35-40 % The sunflower extract is obtained by sunflower, a concentration factor of Description/Definition:
microalgae Description/Definition: Authorised Novel Food Tetraselmis chuii Dried Sunflower oil extract Sunflower
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 188 h farms.
se by means of enzymatic Scortum barcoo or Therapon mic fresh water species from Australia. It is now reared in fis
Specifications chemical or enzymatic conversion, or by epimerization of fructo ormes > family: Terapontidae > genus:
is a species of fish in the family Terapontidae. It is an ende
Therapon barcoo Tagatose is produced by isomerization of galactose by means conversion. of These are single-step conversions. Appearance: White or almost white crystals Chemical name: D-tagatose Energy (KJ/Kg): 6000-11500 Carbohydrates (%): 0,0 Fat (%): 5-15 Fatty acids (mg FA/g fillet): Σ PUFA n-3: 1,2-20,0 Σ PUFA n-6: 0,3-2,0 PUFA n-3/n-6: 1,5-15,0 Total omega 3 acids: 1,6-40,0 Total omega 6 acids: 2,6-10,0 Scortum/ Taxonomic Identification: Class: Actinopterygii > order: Percif Composition of fish flesh: Protein (%): 18-25 Moisture (%): 65-75 Ash (%): 0,5-2,0
Description/Definition: /Scortum Description/Definition: Authorised Novel Food D-Tagatose Therapon barcoo
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 189 es from hot aqueous droquercetin] and with no n tests, test solutions and other reference of sample preparation may be based on the
(Rupr.) Rupr) is a white to pale-yellow powder that crystalliz Specifications ).
y-2,3-dihydrochromen-4-one, also called (+) trans (2R,3R)- dihy )
1
1 r general notices, general analytical techniques, identificatio ods’(
to the specified level. The selection of sample size and method Larix gmelinii (1 % aqueous solution)(
o
6
O
: – 4 to – 5,6
12
20 H
D 6
Compound analysis -Hexulose
lyxo
principles of the method described in FNP 5. ‘Instrumental meth materials (JECFA) 1991, 307 p.; English – ISBN 92-5-102991-1 M49 Definition: ) Food and nutrition paper 5 Rev 2 – Guide to specifications fo
1 ( solutions. ► Melting range: 133– 137 °C Heavy metals: Lead: ≤ 1,0 mg/kg(*) (*) Determine using an atomic absorption technique appropriate Taxifolin-rich extract from the wood of Dahurian Larch ( Formula weight: 180,16 (g/mol) Purity: Assay: ≥ 98 % on a dry weight basis Loss on drying: ≤ 0,5 % (102 °C, 2 hours) Specific Rotation: [α] Chemical name: [(2R,3R)-2-(3,4 dihydroxyphenyl)-3,5,7-trihydrox more than 2 % of the ◄ cis-form Specifications: Physical parameter Moisture: ≤ 10 % Taxifolin (m/m): ≥ 90,0 % of the dry weight Synonym: D- CAS number: 87-81-0 Chemical formula: C Description: ◄
Authorised Novel Food M49 Taxifolin-rich extract M49 Taxifolin-rich ►
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 190 allisation allisation in a quantity of 1,5 %.
Specifications s is a crystal. This results on the inclusion of water of cryst
CFU/g
4
1 – 3 – 1 : Absence/1 g Content, usual observed range (%) range observed usual Content,
: Absence/1 g 2,5 – 3,5 : Absence/1g 0,05 – 0,12 0,01 – 0,1 : Absence/10 g 0,1 – 0,3 0,2 – 0,3 0,3 – 0,5 90 – 93 1,5 (*) Taxifolin in its hydrated form and during the drying proces Staphylococcus aureus Pseudomonas dry substance) per (as extract Taxifolin-rich the of components Usual range of Eriodictyol Quercetin Naringenin Kaempferol Pinocembrin Unidentified flavonoids Water(*) Enterobacteria: ≤ 100/g and Yeast Mould: ≤ 100 CFU/g Escherichia coli Salmonella Taxifolin Aromadendrin Total Total Plate Count (TPC): ≤ 10 Extract component Heavy Metals, Pesticide Heavy Metals, Lead: ≤ 0,5 mg/kg Arsenic: ≤ 0,02 mg/kg Cadmium: ≤ 0,5 mg/kg Mercury: ≤ 0,1 mg/kg Dichlorodiphenyltrichloroethane (DDT): ≤ 0,05 mg/kg Residual solvents Ethanol: < 5 000 mg/kg Microbiological criteria
Authorised Novel Food
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 191
purified, deionised water. sample preparation may be n a solution having known a sweet taste andard trehalose efied starch or from sucrose by a
Specifications e e trehalose peak rified deionised water. Filter through a 0,45 micron filter drate. Virtually odourless, white or almost white crystals with ex detector and integrating recorder Instrumental methods’ uantities of dry standard reference trehalose in water to obtai he specified level. The selection of sample size and method of ry sample into a 100 ml volumetric flask and add about 80 ml of le solution by the following formula: on and the standard solution into the chromatograph. es linkes by an α-1,1-glucosidic bond. It is obtained from liqu quantified by comparison to a reference standard containing st O (dihydrate)
2
· 2H
11
O
22
H
12
— length: 300 mm — diameter: 10 mm — temperature: 50 °C Mobile phase: water flow rate: 0,4 ml/min Injection volume: 8 μl Procedure: inject separately equal volumes of the sample soluti Record the chromatograms and measure the size of response of th Calculate the quantity, in mg, of trehalose in 1 ml of the samp Assay: ≥ 98 % on the dry basis Determine using an atomic absorption technique appropriate to based t on the principles of the method described in FNP 5 Method of assay: (1), ‘ Principle: trehalose is identified by liquid chromatography and Preparation of sample solution: weigh accurately about 3 g of Bring d sample to complete dissolution and dilute to mark with pu Preparation of standard solution: dissolve concentration accurately of weighed about 30 q mg of trehalose per ml. Apparatus: liquid chromatography equipped with a refractive ind Conditions: Column: Shodex Ionpack KS-801 (Showa Denko Co.) or equivalent Formula weight: 378,33 (dihydrate) A non-reducing disaccharide that consists of two glucose moieti multistep enzymatic process. The commercial product is the dihy Synonyms: α,α-trehalose Chemical name: α-D-glucopyranosyl-α-D-glucopyranoside, dihydrat CAS No.: 6138-23-4 (dihydrate) Chemical formula: C
Description/Definition: Authorised Novel Food Trehalose
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 192
ion of shelf life. (5 % aqueous solution, anhydrous substance)
o
Specifications traen-3-ol n the wavelength of 200-800 nm. thanol to which UV light treatment is applied to harvested mushrooms. )
U
/W (5 % aqueous solution, dihydrate), +199
S
o
) (W
S
/R
= +179
U
20 Agaricus bisporus
D
in the final product: 5-20 μg/100 g fresh weight at the expirat
2
2
= weight of dry sample in mg = weight in mg of trehalose in the standard preparation = peak area of trehalose in the sample preparation
= peak area of trehalose in the standard preparation
S U
S U
R Description/Definition Commercially grown UV radiation: a process of radiation in ultraviolet light withi Vitamin D Chemical name: (3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-te Synonym: Ergocalciferol CAS No: 50-14-6 Molecular weight: 396,65 g/mol Contents Vitamin D where R Solubility: Freely soluble in water, very slightly soluble in e Specific rotation: [α] Melting point: 97 °C (dihydrate) Purity: Loss on drying: ≤ 1,5 % (60 °C, 5h) Total ash: ≤ 0,05 % Heavy metals: Lead: ≤ 1,0 mg/kg % trehalose = 100 × (R W W Characteristics: Identification:
(Agaricus
Authorised Novel Food UV-treated mushrooms bisporus)
M49 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 193
.
2
2 ted. (ergocalciferol). Vitamin D ergy input of 10-50 mJ/cm r dry yeast for home baking.
2
ed after baking in order to convert ergosterol to vitamin D
Specifications )
1 traen-3-ol tetraen-3-ol tetraen-3-ol 00 IU vitamin D/100 g (200-875 μg/g). The yeast may be inactiva order not to exceed the maximum level in the pre-packed fresh o pings) to which a treatment with ultraviolet radiation is appli n the wavelength of 240-315 nm for maximum of 5 seconds with en
) is treated with ultraviolet light to induce the conversion of
)
2
(ergocalciferol).
2
/g
3
: ≤ 10/g Saccharomyces cerevisiae
(ergocalciferol) in the final product: 0,75-3 μg/100 g( :
2 2
: Absence in 25 g 2
) EN 12821, 2009, European Standard. ) Recipe calculation.
1 2 Vitamin D Chemical name: (5Z,7E,22E)-3S-9,10-secoergosta-5,7,10(19),22-te Synonym: Ergocalciferol CAS No: 50-14-6 Molecular weight: 396,65 g/mol Contents: Vitamin D Yeast in dough: 1-5 g/100 g ( ( ( CAS No.: 50-14-6 Molecular weight: 396,65 g/mol yeast concentrate for the Microbiological criteria Coliforms: ≤ 10 Escherichia coli UV-treated bread is yeast leavened bread and rolls (without top ergosterol to vitamin D Description/Definition Baker’s yeast ( content in the yeast concentrate varies between 800 000-3 500 0 The yeast concentrate is blended with regular baker’s yeast in Tan-coloured, free-flowing granules. Vitamin D Chemical name: (5Z,7E,22E)-(3S)-9,10-secoergosta-5,7,10(19),22- Synonym: Ergocalciferol UV radiation: A process of radiation in ultraviolet light withi Salmonella
) Description/Definition: Authorised Novel Food Saccharomyces cerevisiae UV-treated bread UV-treated baker’s yeast (
M9 M49 M9 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 194 a UV lamp. The e]ethylidene]-4-methyl is applied after pasteur
authorised under the novel food 007 (OJ L 347, 20.12.2013, p. 671). common organisation of the markets in (cholecalciferol) concentrations by conversion of 7-
3
mushrooms that have been exposed to UV light.
Agaricus bisporus Agaricus Specifications produce a mushroom slurry. The mushroom slurry is passed under )-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-yliden a treatment with ultraviolet (UV) radiation via turbulent flow )
mushroom powder.
12
n results in an increase in the vitamin D rliament rliament and of the Council of 17 December 2013 establishing a 2
n the wavelength of 200-310 nm with energy input of 1 045 J/l. o 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2 n a range of wavelength similar to those UV-treated novel foods
)
2
.
)
3
2
)0,5-3,2 μg/100 g(
1 mushroom powder is a granular powder made from homogenised content: 1 000–1 300 μg/g of mushroom powder ( in the final product: :
3
2 2 3
agricultural products and repealing Council Regulations (EEC) N ) As defined by Regulation (EU) No 1308/2013 of the European Pa ) HPLC
1 2 ( The mushrooms are washed, homogenised and suspended slurry in is water then to filtered, dried and ground, producing vitamin D UV radiation: A process of radiation in ultraviolet light withi Molecular weight: 384,6377 g/mol Contents: Vitamin D Whole milk( Semi-skimmed milk(1): 0,1–1,5 μg/100 g( ( UV-treated milk is cow’s milk (whole and isation. semi-skimmed) The to treatment which of the pasteurised milk with UV radiatio dehydrocholesterol to vitamin D UV radiation: A process of radiation in ultraviolet light withi Vitamin D Chemical name: idenecyclohexan-1-ol (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R Synonym: Cholecalciferol CAS No: 67-97-0 Vitamin D regulation. Characteristics/Composition Vitamin D Moisture: ≤ 10,0 % Ash: ≤ 13,5 % Description/Definition
Description/Definition: mushroom powder
2
Authorised Novel Food Vitamin D UV-treated milk UV-treated
M48 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 195 vatives. The and menaquinone-4
2
O
56
H
e menaquinone homologues 41
, menaquinone-6 (MK-6)(n = 5) being C
2
O
64
H
46
enaquinone series, is a group of prenylated naphthoquinone deri Specifications ,14,18,22,26-octacosaheptaenyl)-3-methyl-1,4-naphtalenedione 5 carbons comprising the side chain, is used to characterise th process.
)/g
7
.
2
O
2
40
O
H
64
31
H
: Absent in 25 g : ≤ 10 CFU/g 46
: ≤ 10 CFU/g : ≤ 10 CFU/g
(2-methyl-3-all-trans-polyprenyl-1,4-naphthoquinones), (2-methyl-3-all-trans-polyprenyl-1,4-naphthoquinones), or the m (menaquinones) series with menaquinone-7 (MK-7)(n = 6) being C
2
sp.: Absent in 25 g 2
number of isoprene residues, where 1 isoprene unit consists of Chemical Name: (all-E)-2-(3,7,11,15,19,23,27-Heptamethyl-2,6,10 CAS Number: 2124-57-4 Molecular formula: C Yeast and mould: ≤ 100 CFU/g Salmonella Staphylococcus aureus Escherichia coli Coliforms: ≤ 10 CFU/g Enterobacteriaceae Listeria monocytogenes Vitamin K containing primarily MK-7 and to a smaller extent MK-6. Vitamin K (MK-4)(n = 3) being C Total plate count: ≤ 5 000 CFU ( Heavy Metals Lead (as Pb): ≤ 0,5 mg/kg Cadmium: ≤ 0,5 mg/kg Mercury: ≤ 0,1 mg/kg Arsenic: ≤ 0,3 mg/kg Mycotoxins Aflatoxins (sum of B1+B2+G1+G2): < 4 μg/kg Microbiological criteria:
This novel food is produced by a synthetic or microbiological (menaquinone)
2
Authorised Novel Food Vitamin K
M9 M48 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 196
L. bran, rich in arabinoxylan oligosaccharides
Specifications ans Menaquinone-7) es: 3-8 Triticum aestivum dry matter
(menaquinone-7)
2
Bacillus licheniformis Bacillus (menaquinone-7)
2
spp. natto and
Bacillus subtilis Bacillus Appearance: Yellow powder or oil suspension Appearance: Yellow powder Purity: Max 6,0 % cis-isomer, max 2,0 % other impurities Content: 97-102 % Menaquinone-7 (including at least 92 % all-tr Specifications of microbiologically produced Vitamin K Source: White crystalline powder obtained by enzymatic extraction from Dry matter: Min. 94 % Arabinoxylan oligosaccharides: Min 70 % of dry matter Average degree of polymerisation of arabinoxylan oligosaccharid Ferulic acid (bound to arabinoxylan oligosaccharides): 1-3 % of Total poly/oligosaccharides: Min 90 % Protein: Max 2 % of dry matter Ash: Max 2 % of dry matter Specification of synthetic Vitamin K Molecular weight: 649 g/mol
Description/Definition: Authorised Novel Food Wheat bran extract
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 197
) via hydrolysis by a xylanase from mays Syrup form 26,5-42,5 70-75 ≥ 70 70 ≥ ≥ 1,5-31,5 0-29 0-4 0-10 0-15 subsp.
Zea mays ≤ 0,3 < 0,2 3,5-5,0
Specifications Powder form 2 25-43 2-16 ≤ 5,0 0-3 0-5 0-13 ≥ 95 70 ≥ ≥ h are obtained from corncobs ( 0-5
≥ 97 ≥ ≥ 95 ≥ 2,5-7,5
) 0-4,5
a
27,5-48
: Max 1000/g 0-1,5 Powder form 1 0-2 0-1,0 followed by a purification process.
: Max 1000/g Parameter ≤ 5,0
: Absence in 25g
Glucose (g/100 g) Arabinose (g/100 g) Xylose (g/100 g) Trichoderma reesei Characteristics/Composition Total carbohydrate content (g/100 g) XOS content (dry basis) (g/100 g) Other carbohydrates (g/100 g) ( Disaccharides total (g/100 g) The novel food is a mixture of xylo-oligosaccharides (XOS) whic Moisture (%) Ash (%) pH Clostridium perfringens Monosaccharides total (g/100 g) Protein (g/100 g) Microbiological parameters: Microbiological Mesophilic bacteria – total count: Max 10 000/g Yeasts: Max 100/g Fungi: Max 100/g Salmonella Bacillus cereus
Description: Authorised Novel Food Xylo-oligosaccharides
M19 M9 ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 198
0 25-40 32-71 18-30 8-20 3-10 1,5-2,5 1-5 2-6
< 10 < 10 < 0,3 < 5,0 < 0,5
Specifications 18-30 10-20 23-40 36-72 2-3 5-10 1-5 2-7 20-25 1-5 0-7 3-10 10-20 and arabinose) and cellobiose. ded in the process. 25-45 27-35 41-77 Negative 0 )
b Negative 2,5-3
)/25 g)
c )/100 g)
d
(CFU ( (MPN ( Xylobiose (XOS DP2) (g/100 g) Cellobiose (g/100 g) xylotriose (XOS DP3) (g/100 g) xylotetraose (XOS DP4) (g/100 g) xylohexaose (XOS DP6) (g/100 g) Xyloheptaose (XOS DP7) (g/100 g) xylopentaose (XOS DP5) (g/100 g) ) Maltodextrin content is calculated according to the amount ad ) MPN: Most Probable Number.
) Other carbohydrates include monosaccharides (glucose, xylose ) CFU: Colony Forming Units.
a b c d DP: Degree of polymerization ( ( Salmonella E, coli Yeast (CFU/g) ( ( Lead (mg/kg) Arsenic (mg/kg) Mould (CFU/g) Maltodextrin (g/100 g) ( Copper (mg/kg) Oligosaccharides total (g/100 g)
Authorised Novel Food
M19 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 199 by ß-1,6-linkages, . annoproteins are linked by ß-1-
.
consists of chains of ß-1,3-linked glucose residues, branched Specifications ysaccharides, found in the cell wall of many yeasts and cereals Yarrowia lipolytica ß-1,6-glucans and some mannoproteins. t lucans. . dues that are branched by ß-1-6-linkages, to which chitin and m Saccharomyces cerevisiae CFU/g
3
CFU/g
2
Saccharomyces cerevisiae ): < 10 CFU/g (i.e. limit of detection)
10
( cells
spp.: Absence in 25 g Yarrowia lipolytica Beta-glucans are complex, high molecular mass (100–200 kDa) pol The chemical name for ‘yeast beta-glucans’ is (1-3),(1-6)-ß-D-g Beta-glucans consist of a backbone of ß-1-3-linked glucose resi 4-bonds. Beta-glucans are isolated from yeast The tertiary structure of the glucan cell forming wall a of backbone to which are linked chitin via ß-1,4- bonds, Total ash: ≤ 12 % Water content: ≤ 5 % Dry matter content: ≥ 95 % Microbiological criteria: Total Aerobic Microbial Count: ≤ 5 × 10 Total Yeast and Mould Count: ≤ 10 Viable The novel food is the dried and heat-killed biomass of the yeas Characteristics/Composition: Protein: 45-55 g/100 g Dietary fibre: 24-30 g/100 g Sugars: < 1,0 g/100 g Fat: 7-10 g/100 g Coliforms: ≤ 10 CFU/g Salmonella Description/Definition:
Description/Definition: yeast biomass Authorised Novel Food Yeast beta-glucans Yarrowia lipolytica
M9 M30 M9 ▼ ▼ ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 200
id matrices.
Specifications
insoluble and insoluble in water, but dispersible in many liqu ) beta-glucans: Saccharomyces cerevisiae
Moisture: < 6,0 % Protein: < 4,0 % Total fat: < 3,0 % Microbiological data in many in water, for insoluble but dispersible liquid matrices: Total plate count: < 1 000 CFU/g Enterobacteriaceae: < 100 CFU/g Total coliforms: < 10 CFU/g Yeast: < 25 CFU/g Fat: < 10 % Insoluble form: Total carbohydrates: > 70 % Beta-glucans (1,3/1,6): > 70 % Ash: ≤ 12 % 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 % This novel food is available in three different forms: soluble, yeast ( Chemical characteristics Soluble form: Total carbohydrates: > 75 % Beta-glucans (1,3/1,6): > 75 % Ash: < 4,0 % Moisture: < 8,0 % Protein: < 3,5 %
Authorised Novel Food
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 201 r molecules. herol and ascorbyl palmitate or as
Specifications thin is produced by a multi-step chemical synthesis from smalle an oxygenated carotenoid. owder of gelatin or starch base (‘beadlets’) with added α-tocop
2
O
56
H
: Absence in 1 g 40
: Absence in 1 g : < 100 CFU/g : Absence in 25 g Lead: < 0,2 mg/kg -trans zeaxanthin: > 96 % M31 Staphylococcus aureus in many liquid matrices: but dispersible in water, Heavy metals for insoluble ► CAS No: 144-68-3 Molecular weight: 568,9 daltons Physical-chemical properties: Loss on drying: < 0,2 % All Cis-zeaxanthin: < 2,0 % Other carotenoids: < 1,5 % Triphenylphosphine oxid (CAS No 791-28-6): < 50 mg/kg Zeaxanthin is a naturally occurring xanthophyll pigment, it is The synthetic zeaxanthin is presented either as a spray-dried p a corn oil suspension with added α-tocopherol. Synthetic zeaxan Escherichia coli Bacillus cereus Mercury: < 0,1 mg/kg Cadmium: < 0,1 mg/kg ◄ Orange-red crystalline powder with little or no odour. Chemical formula: C Mould: < 25 CFU/g Salmonella Arsenic: < 0,2 mg/kg
Description/Definition: Authorised Novel Food Zeaxanthin
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 202
Specifications ne carboxylate, Zinc PCA, L-Zinc pidolate Zinc salt stic odour.
Zn
2 )
3
o
NO
6
H
- 22,8
5
o
Glutamic acid: < 2,0 % Heavy metals: Lead: ≤ 3,0 ppm Arsenic: ≤ 2,0 ppm Cadmium: ≤ 1,0 ppm Mercury: ≤ 0,1 ppm Relative anhydrous molecular mass: 321,4 Appearance: White to slightly white powder Purity: Zinc L-pidolate (purity): ≥ 98 % pH (10 % aqueous sol.): 5,0-6,0 Specific rotation: 19,6 Water: ≤ 10,0 % Zinc L-pidolate is a white to off-white powder, with characteri International non-proprietary name (INN): L-pyroglutamic acid, Synonyms: Zinc 5-oxoproline, Zinc pyroglutamate, Zinc pyrrolido CAS No.: 15454-75-8 Molecular formula: (C
Description/Definition: Authorised Novel Food Zinc L-pidolate
M9 ▼ 02017R2470 — EN — 16.05.2021 — 023.001 — 203 . mination risks by t and of the Council H, Howell A, Nio C, Quantitation of PACs by PACs Quantitationof ent step. Measures have to be in place to prevent cells during packaging and/or storage of the NF. vo-Clemente, L, Khoo C and Goya L. Food Res Intl 2015 71: 68-82 ls ACS Symposium series 803, Washington DC.
of guar gum originating in or consigned from India due to conta ng proanthocyanidins in cranberry powders. Prior RL, Fan E, Ji d III to Regulation (EC) No 1333/2008 of the European Parliamen Yarrowia lipolytica ble Specifications ated carbohydrates. cells and to be first tested immediately after the heat-treatm Yarrowia lipolytica Cranberries, Inc) Martin MA, Ramos S, Mateos R, Marais JPJ, Bra ) In: Ho C-T, Zheng QY (eds) Quality Management of Nutraceutica refractive refractive index detection. factor of 0,025 μg = 1 IU. ◄ Multi-laboratory validation of a standard method for quantifyi
y 2015 laying down special conditions applicable to the import down specifications for food additives listed in Annexes II an
res have to be in place to prevent cross-contamination with via
e different methods used. Galactitol, Trihexose, Allo-lactose and other structurally rel rantee the absence of viable
cells during packaging and/or storage of the novel food. Microbiological criteria: Microbiological Total viable mesophilic count: ≤ 1 000 CFU/g Yeasts and moulds: ≤ 100 CFU/g Pathogen: Absence 2010 Jul;90(9):1473-8. 151-166.
Yarrowia lipolytica
J Sci Food Sci Agric. J Modified from Cunningham DG, Vannozzi S, O'Shea E, Turk R DMAC Color Reaction pp (2002 ) Converted from International Units (IU) using the conversion
Authorised Novel Food ) HPLC/RI: High-performance liquid chromatography coupled with ) OSC-DMAC (4-dimethylaminocinnamaldehyde) method (Ocean Spray
12
8 3 ( ( ( Payne MJ, Reed J. (OJ L 83, 22.3.2012, p. 1). pentachlorophenol and dioxins (OJ L 30, 6.2.2015, p. 10). cross-contamination with viable ) The different values for these three ) parameters are GAE: due Gallic to Acid th Equivalents. ) CFU: Colony Forming Units. ◄ ) CFU: Colony-forming unit. ◄ ) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying ) Commission Implementing Regulation (EU) 2015/175 of 5 Februar ) BL-DMAC 4-dimethylaminocinnamaldehyde) method (Brunswick Lab) ) Expressed as selenium. ) Applicable at all stages after the heat-treatment step to gua ) To be tested immediately after the ) heat-treatment step. 2′-Fucosyl-galactose, Measu Glucose, Galactose, Mannitol, Sorbitol,
M29 M48 M15
5 6 7 9 1 2 4
( ( ( ( ( ( ( 13 14 10 11 ( ( ( ( ► ► ►
M9 ▼