COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1559 
of 26 Oct ober 2020 
amending Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regar d to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing 
Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation 
(EC) No 1852/2001 (1), and in particular Article 12 thereof, 
Whereas: 
(1) Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission was to establish, by 1 Januar y 2018, the 
Union list of novel foods author ised or notified under Regulation (EC) No 258/97 of the European Parliament and 
of the Council (2). 
(2) The Union list of novel foods author ised or notified under Regulation (EC) No 258/97 was established by 
Commission Implementing Regulation (EU) 2017/2470 (3). 
(3) Commission Implementing Regulation (EU) 2018/1023 (4) corrected the initial Union list of novel foods established in the 
Annex to Implementing Regulation (EU) 2017/2470 by replacing that Annex. In the meantime eight Commission 
Implementing Regulations (EU) 2018/460 (5), (EU) 2018/461 (6), (EU) 2018/462 (7), (EU) 2018/469 (8), (EU) 2018/991 (9), 
(1)OJ L 327, 11.12.2015, p. 1. 
(2)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 Januar y 1997 concer ning novel foods and novel food 
ingredients (OJ L 43, 14.2.1997, p. 1). 
(3)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 (OJ L 351, 30.12.2017, p. 72). 
(4)Commission Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 
establishing the Union list of novel foods (OJ L 187, 24.7.2018, p. 1). 
(5)Commission Implementing Regulation (EU) 2018/460 of 20 March 2018 author ising the placing on the market of Ecklonia cava 
phlorotannins as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending 
Commission Implementing Regulation (EU) 2017/2470 (OJ L 78, 21.3.2018, p. 2). 
(6)Commission Implementing Regulation (EU) 2018/461 of 20 March 2018 author ising an exten sion of use of taxif olin-r ich extract as a 
novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission 
Implementing Regulation (EU) 2017/2470 (OJ L 78, 21.3.2018, p. 7). 
(7)Commission Implementing Regulation (EU) 2018/462 of 20 March 2018 author ising an extension of use of L-ergothioneine as a 
novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission 
Implementing Regulation (EU) 2017/2470 (OJ L 78, 21.3.2018, p. 11). 
(8)Commission Implementing Regulation (EU) 2018/469 of 21 March 2018 author ising the placing on the market of an extract of three 
herbal roots (Cynanchum wilfor dii Hemsle y, Phlomis umbrosa Turcz. and Angelica gigas Nakai) as a novel food under Regulation (EU) 
2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 
(OJ L 79, 22.3.2018, p. 11). 
(9)Commission Implementing Regulation (EU) 2018/991 of 12 July 2018 author ising the placing on the market of hen egg white 
lysozyme hydrolysat e as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and 
amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 177, 13.7.2018, p. 9). EN Offi cial Jour nal of the European Union 27.10.2020                                                                                                                                         L 357/7   (EU) 2018/1011 (10), (EU) 2018/1018 (11), (EU) 2018/1032 (12) had been adopt ed author ising placing on the marke t of 
novel foods or extending the use of novel foods respectively . Those Implementing Regulations also updated the Union list. 
Howe ver, those novel foods and extensions of the use of novel foods no longe r appear in the list, as replaced by 
Implementing Regulation (EU) 2018/1023. 
(4) For reasons of clarity and legal certainty , the Union list of novel foods set out in the Annex to Imple menting 
Regulation (EU) 2017/2470 should theref ore be amended to include those novel foods and extensions of the use of 
novel foods in the Union list again. Since those novel foods and extensions of the use of novel foods were included in 
the Union list until the entr y into force of Implementing Regulation (EU) 2018/1023 on 13 August 2018, this 
Regulation should apply as of that date. 
(5) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation. 
Article 2 
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. 
It shall apply from 13 August 2018. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 26 Octobe r 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     
(10)Commission Implementing Regulation (EU) 2018/1011 of 17 July 2018 author ising an exten sion of use levels of UV-treated 
mushrooms as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending 
Commission Implementing Regulation (EU) 2017/2470 (OJ L 181, 18.7.2018, p. 4). 
(11)Commission Implementin g Regulation (EU) 2018/1018 of 18 July 2018 author ising an extension of use of UV-treated baker ’s yeast 
(Saccharomy ces cerev isiae) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and 
amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 183, 19.7.2018, p. 9). 
(12)Commission Implementing Regulation (EU) 2018/1032 of 20 July 2018 author ising the extension of use of oil from the micro alga e 
Schizochytr ium sp. as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending 
Commission Implementing Regulation (EU) 2017/2470 (OJ L 185, 23.7.2018, p. 9). EN Offi cial Jour nal of the European Union L 357/8                                                                                                                                         27.10.2020   ANNEX 
The Annex is amended as follo ws. 
(1) Table 1 (Author ised novel foods) is amended as follows: 
(a) the follo wing entr y is inser ted between the entr y for ‘Echium plantagineum oil’ and the entr y for ‘Egg membrane hydrolysat e’: 
Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
‘Eckl onia cava 
phlorotannin s Specified food categor y Maximum levels The designation of the novel food on the labelling of the food­
stuffs containing it shall be “Ecklonia cava Phlorotannins”. 
Food supplements containing Ecklonia cava phlorotannins shall 
bear the follo wing statement: 
(a) This food supplement should not be consumed by 
children/adoles cents under the age of twelve/f ourtee­
n/eighteen(*) years. 
(b) This food supplement should not be consumed by persons 
with thyroid disease or by persons who are awar e of or have 
been identified as being at risk of developing thyroi d disease. 
(c) This food supplement should not be consumed if other food 
supplements containing iodine are also consumed. 
(*) Depending on the age group the food supplement is 
intended for.’  Food supplements as defined in 
Directive 2002/46/EC intended 
for the general population, 
excl uding children under the age 
of 12 years 163 mg/da y for adolescents from 
12 to 14 years of age 
230 mg/da y for adolescents 
abov e 14 years of age 
263 mg/da y for adults   
(b) the entr y for ‘Taxifolin-r ich extract’ is replaced by the follo wing: 
‘Taxif olin-r ich 
extract Specified food categor y Maximum levels The designation of the novel food on the labelling of the food­
stuffs containing it shall be “taxif olin-r ich extract”’  
Yogur t plain/Y ogur t with fruits(*) 0,020 g/kg 
Kephir(*) 0,008 g/kg 
Butte rmilk(*) 0,005 g/kg 
Milk powder(*) 0,052 g/kg 
Cream(*) 0,070 g/kg 
Sour cream(*) 0,050 g/kg 
Cheese(*) 0,090 g/kg 
Butte r(*) 0,164 g/kg 
Chocolat e confecti oner y 0,070 g/kg  EN Offi cial Jour nal of the European Union 27.10.2020                                                                                                                                         L 357/9   Non-alcoholic beverages 0,020 g/L 
Food supplements as defined in 
Directive 2002/46/EC intended 
for the general population, 
excl uding infants, young chil­
dren, children and adolescents 
younger than 14 years 100 mg/da y 
(*) When used in milk products Taxifolin-r ich extract may not replace in 
whole or in part, any milk constituent   
(c) the entr y for ‘L-ergothioneine’ is replaced by the follo wing: 
‘L-ergothioneine Specif ied food categor y Maximum levels The designation of the novel food on the labelling of the food­
stuffs containing it shall be “L-ergothioneine”’  
Alcohol-free beverage s 0,025 g/kg 
Milk -based drinks 0,025 g/kg 
“Fresh” milk products(*) 0,040 g/kg 
Cereal bars 0,2 g/kg 
Chocolat e confecti oner y 0,25 g/kg 
Food supplements as defined in 
Directive 2002/46/EC 30 mg/da y for general popula­
tion (excluding pregnant and lac­
tating women) 
20 mg/da y for children older 
than 3 years 
(*) When used in milk products L-ergothioneine may not replace in 
whole or in part, any milk constituent   
(d) the follo wing entr y is inser ted between the entr y for ‘L-ergothioneine’ and the entr y for ‘Ferric sodium EDT A’: 
‘Extract of three 
herbal roots 
(Cynanc hum wilf or­
dii Hemsley , Phlomis 
umbro sa Turcz. and 
Ang elica gigas 
Nakai) Specified food categor y Maximum levels The designation of the novel food on the labelling of the foodstuffs 
containing it shall be “extract of three herbal roots (Cynanchum 
wilfordii Hemsley , Phlomis umbrosa Turcz. and Angelica gigas 
Nakai)”. 
The labelling of food supplements containing the extract of mix­
ture of the three herbal roots shall bear a statement in close 
proximity to the list of ingredients indicating that it should not 
be consumed by individuals with known celer y allergy .’  Food supplements as defined in 
Directive 2002/46/EC for adult 
population 175 mg/da y   EN Offi cial Jour nal of the European Union L 357/10                                                                                                                                       27.10.2020   (e) the follo wing entr y is inser ted between the entr y for ‘Lycopene oleoresin from tomat oes’ and the entr y for ‘Magnesium citrate malate’: 
‘Hen egg white 
lysozyme hydroly­
sate Specified food categor y Maximum levels The designation of the novel food on the labelling of food sup­
plements containing it shall be “Hen egg whit e lysozyme hydro­
lysat e”.’  Food supplements as defined in 
Directive 2002/46/EC intended 
for adult population 1000 mg/da y   
(f) the entr y for ‘UV-treat ed mushrooms (Agaricus bispor us)’ is replaced by the followi ng: 
‘UV -treated mush­
rooms (Agaricus 
bispor us) Specified food categor y Maximum levels of vitamin D2 1. The designation on the label of the novel food as such or of 
the foodstuffs containing it shall be “UV -treated mushrooms 
(Agaricus bispor us)”. 
2. The designation on the label of the novel food as such or of 
the foodstuffs containing it shall be accompanied by 
indication that a “controlled light treatment was used to 
increase vitamin D levels” or “UV treatment was used to 
increase vitamin D2 levels”.’  Mushrooms (Agaricus bispor us) 20 μg of vitamin D2/100 g fresh 
weight   
(g) the entr y for ‘UV- treated baker’s yeast (Saccharomy ces cerevisiae)’ is replaced by the followi ng: 
‘UV -treated baker ’s 
yeast (Sacchar o­
myces cerevisiae) Specified food categor y Maximum levels of vitamin D2 The designation of the novel food on the labelling of the food­
stuffs containing it shall be “Vitamin D yeast” or “Vitamin D2 
yeast”  Yeast-leavened breads and rolls 5 μg of vitamin D2/100 g 
Yeast-leavened fine bake ry wares 5 μg of vitamin D2/100 g 
Food supplements as defined in 
Directive 2002/46/EC  
Pre-pack ed fresh or dry yeast for 
home baking 45 μg/100 g for fresh yeast 
200 μg/100 g for dried yeast 1. The designation of the novel food on the labelling of the 
foodstuffs shall be “Vitamin D yeast” or “Vitamin D2 yeast”. 
2. The labelling of the novel food shall bear a state ment that the 
foodstuff is only intended for baking and that it should not be 
eate n raw. 
3. The labelling of the novel food shall bear instr uctions for use 
for the final consumers so that a maximum concentration of 
5 μg/100 g of vitamin D2 in final home‐baked products is not 
excee ded.’   EN Offi cial Jour nal of the European Union 27.10.2020                                                                                                                                       L 357/11   (h) the entr y for ‘Schizochytr ium sp. (T18) oil’ is replaced by the followi ng: 
‘Schizochytriu m sp. 
(T18) oil Specified food categor y Maximum levels The designation of the novel food on the labelling of the food­
stuffs containing it shall be “Oil from the microalgae Schizochy­
trium sp.”.’  Dair y products exce pt milk - 
based drinks 200 mg/100 g or for cheese 
products 600 mg/100 g 
Dair y analogues excep t drinks 200 mg/100 g or for analogues to 
cheese products 600 mg/100 g 
Spreadable fats and dressings 600 mg/100 g 
Breakf ast cereals 500 mg/100 g 
Food supplements as defined in 
Directive 2002/46/EC 250 mg DHA/da y for general 
population 
450 mg DHA/da y for pregnant 
and lactating women 
Total diet replacement for weight 
control as defined in Regulation 
(EU) No 609/2013 and meal 
replacements for weight control 250 mg/meal 
Milk -based drinks and similar 
products intended for young 
children 200 mg/100 g 
Foods intended to meet the 
expenditure of intense muscular 
effort, especially for spor tsmen 
Foods bear ing statements on the 
absence or reduced presence of 
gluten in accordance with the 
requirements of Commission 
Implementing Regulation (EU) 
No 828/2014 
Foods for special medical pur­
poses as defined in Regulation 
(EU) No 609/2013 In accordance with the particular 
nutr itional requirements of the 
persons for whom the products 
are intended 
Bake ry products (breads, rolls 
and, sweet biscuits) 200 mg/100 g 
Cereal bars 500 mg/100g 
Cooking fats 360 mg/100 g EN Offi cial Jour nal of the European Union L 357/12                                                                                                                                       27.10.2020   Non-alcoholic beverages 
(including dair y analogue and 
milk -based drinks) 80 mg/100 ml 
Infant formula and follow-on 
formula as defined in Regulation 
(EU) No 609/2013 In accordance with Regulation 
(EU) No 609/2013 
Processed cereal-based foods and 
baby foods for infants and young 
children as defined in Regulation 
(EU) No 609/2013 200 mg/100 g 
Fruit/veget able puree 100 mg/100 g   
(2) Table 2 (Specifications) is amended as follows: 
(a) the follo wing entr y is inser ted between the entr y for ‘Echium plantagineum oil’ and the entr y for ‘Egg membrane hydrolysat e’: 
Authorised Novel Food Specification 
‘Eckl onia cava phlorotannins Descr iption/Def inition 
Ecklonia cava phlorotannins are obtained via alcohol extraction from the edible mar ine alga Ecklonia cava. The extract is a dark brown 
powder , rich in phlorotannins, polyphenolic compo unds found as secondar y metabolites in certain brown algae species. 
Character istics/Composition 
Phlorotannin conte nt: 90 ± 5 % 
Antio xidant activity: > 85 % 
Moisture: < 5 % 
Ash: < 5 % 
Microbiological criter ia 
Total viable cell count : < 3 000 CFU/g 
Mould/y east: < 300 CFU/g 
Colif orms: Neg ative to test 
Salmonella spp.: Negative to test 
Staphylo coccus aureus: Neg ative to test 
Hea vy metals and Halogens 
Lead: < 3,0 mg/kg 
Mercur y: < 0,1 mg/kg 
Cadmium: < 3,0 mg/kg 
Arsenic: < 25,0 mg/kg 
Inorg anic Arsenic: < 0,5 mg/kg 
Iodine: 150,0 – 650,0 mg/kg 
CFU: Colon y Forming Units’   EN Offi cial Jour nal of the European Union 27.10.2020                                                                                                                                       L 357/13   (b) the entr y for ‘Def inition’ for ‘Taxifolin-r ich extract’ is replaced by the followi ng: 
‘Taxifo lin-r ich extract Def inition 
Chemical name: [(2R,3R)-2-(3,4 dihy droxyphenyl) -3,5,7-tr ihydro xy-2,3-dihydroc hromen-4-one, also called (+) trans (2R,3R)- dihy­
droquercetin] and with no more than 2 % of the cis-f orm’   
(c) the follo wing entr y is inser ted between the entr y for ‘L-ergothioneine’ and the entr y for ‘Ferric sodium EDT A’: 
‘Extract of three herbal roots (Cynanchum 
wilf ordii Hemsle y, Phlomis umbrosa Turcz. 
and Ang elica gigas Nakai) Descr iption/Def inition 
The mixture of the three herbal roots is yello wish brown fine powder produced by hot-wat er extraction, concentration by evapora­
tion, and spra y drying 
Composition of the extract of mixture of the 3 herbal roots 
Cynanchum wilfor dii root: 32,5 % (w/w) 
Phlomis umbr osa root : 32,5 % (w/w) 
Angel ica gigas root : 35,0 % (w/w) 
Specif ications 
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 
Nodake nin: 3,35 – 10,61 mg/g 
Metho xsalen: < 3 mg/g 
Phenols: 13,0 – 40,0 mg/g 
Coumar ins: 13,0 – 40,0 mg/g 
Iridoids: 13,0 – 39,0 mg/g 
Saponins: 5,0 – 15,5 mg/g 
Nutr itive components 
Carbohydr ates: 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 
Colif orm bacteri a: < 10 CFU/g 
Salmonella: Negative/25 g 
Escher ichia coli: Negative/25 g 
Staphylo coccus aureus: Neg ative/25 g 
Hea vy metals 
Lead: < 0,65 mg/kg 
Arsenic: < 3,0 mg/kg 
Mercur y: < 0,1 mg/kg 
Cadmium: < 1,0 mg/kg 
CFU: Colon y Forming Units’   EN Offi cial Jour nal of the European Union L 357/14                                                                                                                                       27.10.2020   (d) the follo wing entr y is inser ted between the entr y for ‘Lycopene oleoresin from tomat oes’ and the entr y for ‘Magnesium citrate malate’: 
‘Hen egg white lysozyme hydrolysate Descr iption/Def inition 
Hen egg whit e lysozyme hydrolysate is obtained from hen egg whit e lysozyme by an enzymatic process, using subtilisin from Bacillus 
lichenifo rmis. 
The product is a whit e to light yellow powder . 
Specif ication 
Protein (TN(*) x 5,30): 80-90 % 
Tryptophan: 5-7 % 
Ratio Tryptophan/LNAA(**): 0,18-0.25 
Degree of hydrolysis: 19-25 % 
Moisture: < 5 % 
Ash: < 10 % 
Sodium: < 6 % 
Hea vy metals 
Arsenic: < 1 ppm 
Lead: < 1 ppm 
Cadmium: < 0,5 ppm 
Mercur y: < 0,1 ppm 
Microbiological criter ia 
Total aerobic count: < 103 CFU/g 
Total combined yeasts/moulds count: < 102 CFU/g 
Enterobacter ia: < 10 CFU/g 
Salmonella spp: Absence in 25 g 
Escher ichia coli: Absence in 10 g 
Staphylo coccus aureus: Absence in 10 g 
Pseudomonas aeruginosa: Absence in 10 g 
* TN: total nitrogen 
** LNAA: large neutral amino acids’   
(e) the entr y for ‘UV-treat ed mushrooms (Agaricus bispor us)’ is replaced by the followi ng: 
‘UV -treated mushrooms (Ag aricus bis­
porus) Descr iption/Def inition 
Commercially grown Agaricus bispor us to whic h UV light treatment is applied to harvested mushrooms. 
UV radiation: a process of radiation in ultraviolet light within the wavelength of 200-800 nm. 
Vitamin D2 
Chemical name: (3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-te traen-3-ol 
Synon ym: Ergocalcif erol 
CAS No: 50-14-6 
Molecular weight: 396,65 g/mol 
Contents 
Vitamin D2 in the final product: 5-20 μg/100 g fresh weight at the expiration of shelf life.’   EN Offi cial Jour nal of the European Union 27.10.2020                                                                                                                                       L 357/15   (f) the entr y for ‘UV- treate d bake r’s yeast (Saccharo myces cerevisiae)’ is replaced by the followi ng: 
‘UV -treated baker ’s yeast (Saccha romy ces 
cerevisiae) Descr iption/Def inition 
Baker ’s yeast (Saccharo myces cerevisiae) is treated with ultraviolet light to induce the conver sion of ergoste rol to vitamin D2 (ergocalci­
ferol). Vitamin D2 cont ent in the yeast concentrate varies between 800 000-3 500 000 IU vitamin D/100 g (200-875 μg/g). The 
yeast may be inactivat ed. 
The yeast concentrat e is blended with regular bake r’s yeast in order not to exceed the maximum level in the pre-pack ed fresh or dry 
yeast for home baking. 
Tan-coloured, free-f lowing granules. 
Vitamin D2 
Chemical name: (5Z,7E,22E)-(3S)-9,10-secoergosta-5,7,10(19),22-t etraen-3-ol 
Synon ym: Ergocalcif erol 
CAS No.: 50-14-6 
Molecular weight: 396,65 g/mol 
Microbiological criter ia for the yeast concentrate 
Colif orms: ≤ 103/g 
Escher ichia coli: ≤ 10/g 
Salmonella: Absence in 25 g’   EN Offi cial Jour nal of the European Union L 357/16                                                                                                                                       27.10.2020