Commission Implementing Regulation (EU) 2020/1559 of 26 October 2020 amending Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foodsText with EEA relevance.

Commission Implementing Regulation (EU) 2020/1559 of 26 October 2020 amending Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard 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 OJ L 327, 11.12.2015, p. 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 January 2018, the Union list of novel foods authorised or notified under Regulation (EC) No 258/97 of the European Parliament and of the Council Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1). . (2) The Union list of novel foods authorised or notified under Regulation (EC) No 258/97 was established by Commission Implementing Regulation (EU) 2017/2470 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). . (3) Commission Implementing Regulation (EU) 2018/1023 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). 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 Commission Implementing Regulation (EU) 2018/460 of 20 March 2018 authorising 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). , (EU) 2018/461 Commission Implementing Regulation (EU) 2018/461 of 20 March 2018 authorising an extension of use of taxifolin-rich 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). , (EU) 2018/462 Commission Implementing Regulation (EU) 2018/462 of 20 March 2018 authorising 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). , (EU) 2018/469 Commission Implementing Regulation (EU) 2018/469 of 21 March 2018 authorising the placing on the market of an extract of three herbal roots (Cynanchum wilfordii Hemsley, 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).

, (EU) 2018/991 Commission Implementing Regulation (EU) 2018/991 of 12 July 2018 authorising the placing on the market of hen egg white lysozyme hydrolysate 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). , (EU) 2018/1011 Commission Implementing Regulation (EU) 2018/1011 of 17 July 2018 authorising an extension 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). , (EU) 2018/1018 Commission Implementing Regulation (EU) 2018/1018 of 18 July 2018 authorising an extension of use of UV-treated baker’s yeast (Saccharomyces cerevisiae) 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). , (EU) 2018/1032 Commission Implementing Regulation (EU) 2018/1032 of 20 July 2018 authorising the extension of use of oil from the micro algae Schizochytrium 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). had been adopted authorising placing on the market of novel foods or extending the use of novel foods respectively. Those Implementing Regulations also updated the Union list. However, those novel foods and extensions of the use of novel foods no longer 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 Implementing Regulation (EU) 2017/2470 should therefore 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 entry into force of Implementing Regulation (EU) 2018/1023 on 13 August 2018, this Regulation should apply as of that date. (5) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS REGULATION:

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 October 2020. For the Commission The President Ursula von der Leyen

Annex

ANNEX The Annex is amended as follows. (1) Table 1 (Authorised novel foods) is amended as follows: (a) the following entry is inserted between the entry for Echium plantagineum oil and the entry for Egg membrane hydrolysate:

Authorised novel foodConditions under which the novel food may be usedAdditional specific labelling requirementsOther requirementsEcklonia cava phlorotanninsSpecified food categoryMaximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be Ecklonia cava Phlorotannins. Food supplements containing Ecklonia cava phlorotannins shall bear the following statement: (a) This food supplement should not be consumed by children/adolescents under the age of twelve/fourteen/eighteen() years. (b) This food supplement should not be consumed by persons with thyroid disease or by persons who are aware of or have been identified as being at risk of developing thyroid disease. (c) This food supplement should not be consumed if other food supplements containing iodine are also consumed. () Depending on the age group the food supplement is intended for. Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 12 years 163 mg/day for adolescents from 12 to 14 years of age 230 mg/day for adolescents above 14 years of age 263 mg/day for adults (b) the entry for Taxifolin-rich extract is replaced by the following: Taxifolin-rich extractSpecified food categoryMaximum levelsThe designation of the novel food on the labelling of the foodstuffs containing it shall be taxifolin-rich extractYogurt plain/Yogurt with fruits()0,020 g/kgKephir()0,008 g/kgButtermilk()0,005 g/kgMilk powder()0,052 g/kgCream()0,070 g/kgSour cream()0,050 g/kgCheese()0,090 g/kgButter()0,164 g/kgChocolate confectionery0,070 g/kg Non-alcoholic beverages0,020 g/LFood supplements as defined in Directive 2002/46/EC intended for the general population, excluding infants, young children, children and adolescents younger than 14 years100 mg/day () When used in milk products Taxifolin-rich extract may not replace in whole or in part, any milk constituent (c) the entry for L-ergothioneine is replaced by the following: L-ergothioneineSpecified food categoryMaximum levelsThe designation of the novel food on the labelling of the foodstuffs containing it shall be L-ergothioneineAlcohol-free beverages0,025 g/kgMilk-based drinks0,025 g/kgFresh milk products()0,040 g/kgCereal bars0,2 g/kgChocolate confectionery0,25 g/kgFood supplements as defined in Directive 2002/46/EC 30 mg/day for general population (excluding pregnant and lactating women) 20 mg/day for children older than 3 years () When used in milk products L-ergothioneine may not replace in whole or in part, any milk constituent (d) the following entry is inserted between the entry for L-ergothioneine and the entry for Ferric sodium EDTA: Extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)Specified food categoryMaximum levels The designation of the novel food on the labelling of the foodstuffs containing it shall be extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai).

The labelling of food supplements containing the extract of mixture of the three herbal roots shall bear a statement in close proximity to the list of ingredients indicating that it should not be consumed by individuals with known celery allergy. Food supplements as defined in Directive 2002/46/EC for adult population175 mg/day (e) the following entry is inserted between the entry for Lycopene oleoresin from tomatoes and the entry for Magnesium citrate malate: Hen egg white lysozyme hydrolysateSpecified food categoryMaximum levelsThe designation of the novel food on the labelling of food supplements containing it shall be Hen egg white lysozyme hydrolysate.Food supplements as defined in Directive 2002/46/EC intended for adult population1000 mg/day (f) the entry for UV-treated mushrooms (Agaricus bisporus) is replaced by the following: UV-treated mushrooms (Agaricus bisporus)Specified food categoryMaximum levels of vitamin D2

1. The designation on the label of the novel food as such or of the foodstuffs containing it shall be UV-treated mushrooms (Agaricus bisporus).
2. The designation on the label of the novel food as such or of the foodstuffs containing it shall be accompanied by indication that a controlled light treatment was used to increase vitamin D levels or UV treatment was used to increase vitamin D2 levels. Mushrooms (Agaricus bisporus)20 μg of vitamin D2/100 g fresh weight (g) the entry for UV- treated baker’s yeast (Saccharomyces cerevisiae) is replaced by the following: UV-treated baker’s yeast (Saccharomyces cerevisiae)Specified food categoryMaximum levels of vitamin D2The designation of the novel food on the labelling of the foodstuffs containing it shall be Vitamin D yeast or Vitamin D2 yeastYeast-leavened breads and rolls5 μg of vitamin D2/100 gYeast-leavened fine bakery wares5 μg of vitamin D2/100 gFood supplements as defined in Directive 2002/46/ECPre-packed fresh or dry yeast for home baking 45 μg/100 g for fresh yeast 200 μg/100 g for dried yeast
3. The designation of the novel food on the labelling of the foodstuffs shall be Vitamin D yeast or Vitamin D2 yeast.
4. The labelling of the novel food shall bear a statement that the foodstuff is only intended for baking and that it should not be eaten raw.
5. The labelling of the novel food shall bear instructions for use for the final consumers so that a maximum concentration of 5 μg/100 g of vitamin D2 in final home‐baked products is not exceeded. (h) the entry for Schizochytrium sp. (T18) oil is replaced by the following: Schizochytrium sp. (T18) oilSpecified food categoryMaximum levelsThe designation of the novel food on the labelling of the foodstuffs containing it shall be Oil from the microalgae Schizochytrium sp..Dairy products except milk-based drinks200 mg/100 g or for cheese products 600 mg/100 gDairy analogues except drinks200 mg/100 g or for analogues to cheese products 600 mg/100 gSpreadable fats and dressings600 mg/100 gBreakfast cereals500 mg/100 gFood supplements as defined in Directive 2002/46/EC250 mg DHA/day for general population450 mg DHA/day for pregnant and lactating womenTotal diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control250 mg/mealMilk-based drinks and similar products intended for young children200 mg/100 gFoods intended to meet the expenditure of intense muscular effort, especially for sportsmenFoods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014Foods for special medical purposes as defined in Regulation (EU) No 609/2013In accordance with the particular nutritional requirements of the persons for whom the products are intendedBakery products (breads, rolls and, sweet biscuits)200 mg/100 gCereal bars500 mg/100gCooking fats360 mg/100 gNon-alcoholic beverages (including dairy analogue and milk-based drinks)80 mg/100 ml

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013In accordance with Regulation (EU) No 609/2013Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013200 mg/100 gFruit/vegetable puree100 mg/100 g (2) Table 2 (Specifications) is amended as follows: (a) the following entry is inserted between the entry for Echium plantagineum oil and the entry for Egg membrane hydrolysate: Authorised Novel FoodSpecificationEcklonia cava phlorotannins Description/Definition Ecklonia cava phlorotannins are obtained via alcohol extraction from the edible marine alga Ecklonia cava. The extract is a dark brown powder, rich in phlorotannins, polyphenolic compounds found as secondary metabolites in certain brown algae species. Characteristics/Composition Phlorotannin content: 90 ± 5 % Antioxidant activity: > 85 % Moisture: < 5 % Ash: < 5 % Microbiological criteria Total viable cell count: < 3000 CFU/g Mould/yeast: < 300 CFU/g Coliforms: Negative to test Salmonella spp.: Negative to test Staphylococcus aureus: Negative to test Heavy metals and Halogens Lead: < 3,0 mg/kg Mercury: < 0,1 mg/kg Cadmium: < 3,0 mg/kg Arsenic: < 25,0 mg/kg Inorganic Arsenic: < 0,5 mg/kg Iodine: 150,0 – 650,0 mg/kg CFU: Colony Forming Units (b) the entry for Definition for Taxifolin-rich extract is replaced by the following: Taxifolin-rich extract Definition Chemical name: [(2R,3R)-2-(3,4 dihydroxyphenyl)-3,5,7-trihydroxy-2,3-dihydrochromen-4-one, also called (+) trans (2R,3R)- dihydroquercetin] and with no more than 2 % of the cis-form (c) the following entry is inserted between the entry for L-ergothioneine and the entry for Ferric sodium EDTA: Extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) Description/Definition The mixture of the three herbal roots is yellowish brown fine powder produced by hot-water extraction, concentration by evaporation, and spray drying Composition of the extract of mixture of the 3 herbal roots Cynanchum wilfordii root: 32,5 % (w/w) Phlomis umbrosa root: 32,5 % (w/w) Angelica gigas root: 35,0 % (w/w) Specifications Loss on drying: NMT 100 mg/g Assay Cinnamic acid: 0,012 – 0,039 mg/g Shanzhiside methyl ester: 0,20 – 1,55 mg/g Nodakenin: 3,35 – 10,61 mg/g Methoxsalen: < 3 mg/g Phenols: 13,0 – 40,0 mg/g Coumarins: 13,0 – 40,0 mg/g Iridoids: 13,0 – 39,0 mg/g Saponins: 5,0 – 15,5 mg/g Nutritive components Carbohydrates: 600 – 880 mg/g Proteins: 70 – 170 mg/g Fats: < 4 mg/g Microbiological parameters Total viable plate count: < 5000 CFU/g Total mold and yeast: < 100 CFU/g Coliform bacteria: < 10 CFU/g Salmonella: Negative/25 g Escherichia coli: Negative/25 g Staphylococcus aureus: Negative/25 g Heavy metals Lead: < 0,65 mg/kg Arsenic: < 3,0 mg/kg Mercury: < 0,1 mg/kg Cadmium: < 1,0 mg/kg CFU: Colony Forming Units (d) the following entry is inserted between the entry for Lycopene oleoresin from tomatoes and the entry for Magnesium citrate malate:

Hen egg white lysozyme hydrolysate Description/Definition Hen egg white lysozyme hydrolysate is obtained from hen egg white lysozyme by an enzymatic process, using subtilisin from Bacillus licheniformis. The product is a white to light yellow powder. Specification Protein (TN() x 5,30): 80-90 % Tryptophan: 5-7 % Ratio Tryptophan/LNAA(): 0,18-0.25 Degree of hydrolysis: 19-25 % Moisture: < 5 % Ash: < 10 % Sodium: < 6 % Heavy metals Arsenic: < 1 ppm Lead: < 1 ppm Cadmium: < 0,5 ppm Mercury: < 0,1 ppm Microbiological criteria Total aerobic count: < 103 CFU/g Total combined yeasts/moulds count: < 102 CFU/g Enterobacteria: < 10 CFU/g Salmonella spp: Absence in 25 g Escherichia coli: Absence in 10 g Staphylococcus aureus: Absence in 10 g Pseudomonas aeruginosa: Absence in 10 g

TN: total nitrogen

LNAA: large neutral amino acids (e) the entry for UV-treated mushrooms (Agaricus bisporus) is replaced by the following: UV-treated mushrooms (Agaricus bisporus) Description/Definition Commercially grown Agaricus bisporus to which UV light treatment is applied to harvested mushrooms. UV radiation: a process of radiation in ultraviolet light within the wavelength of 200-800 nm. Vitamin D2 Chemical name: (3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol Synonym: Ergocalciferol CAS No: 50-14-6 Molecular weight: 396,65 g/mol Contents Vitamin D2 in the final product: 5-20 μg/100 g fresh weight at the expiration of shelf life. (f) the entry for UV- treated baker’s yeast (Saccharomyces cerevisiae) is replaced by the following: UV-treated baker’s yeast (Saccharomyces cerevisiae) Description/Definition Baker’s yeast (Saccharomyces cerevisiae) is treated with ultraviolet light to induce the conversion of ergosterol to vitamin D2 (ergocalciferol). Vitamin D2 content in the yeast concentrate varies between 800000-3500000 IU vitamin D/100 g (200-875 μg/g). The yeast may be inactivated. The yeast concentrate is blended with regular baker’s yeast in order not to exceed the maximum level in the pre-packed fresh or dry yeast for home baking. Tan-coloured, free-flowing granules. Vitamin D2 Chemical name: (5Z,7E,22E)-(3S)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol Synonym: Ergocalciferol CAS No.: 50-14-6 Molecular weight: 396,65 g/mol Microbiological criteria for the yeast concentrate Coliforms: ≤ 103/g Escherichia coli: ≤ 10/g Salmonella: Absence in 25 g