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)

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 food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
‘
Ecklonia cava phlorotannins
Specified food category
Maximum 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 extract
Specified food category
Maximum levels
The designation of the novel food on the labelling of the foodstuffs containing it shall be “taxifolin-rich extract”’
Yogurt plain/Yogurt with fruits (*)
0,020 g/kg
Kephir (*)
0,008 g/kg
Buttermilk (*)
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
Butter (*)
0,164 g/kg
Chocolate confectionery
0,070 g/kg
Non-alcoholic beverages
0,020 g/L
Food supplements as defined in Directive 2002/46/EC intended for the general population, excluding infants, young children, children and adolescents younger than 14 years
100 mg/day
(*)
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-ergothioneine
Specified food category
Maximum levels
The designation of the novel food on the labelling of the foodstuffs containing it shall be “L-ergothioneine”’
Alcohol-free beverages
0,025 g/kg
Milk-based drinks
0,025 g/kg
“Fresh” milk products(*)
0,040 g/kg
Cereal bars
0,2 g/kg
Chocolate confectionery
0,25 g/kg
Food supplements as defined in Directive 2002/46/EC
30 mg/day for general population (excluding pregnant and lactating women)
20 mg/day for children older than 3 years
(*)
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 category
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 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 population
175 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 hydrolysate
Specified food category
Maximum levels
The 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 population
1000 mg/day
(f)
the entry for ‘UV-treated mushrooms ( Agaricus bisporus )’ is replaced by the following:
‘ UV-treated mushrooms ( Agaricus bisporus )
Specified food category
Maximum levels of vitamin D 2
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 D 2 levels”.’
Mushrooms ( Agaricus bisporus )
20 μg of vitamin D 2 /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 category
Maximum levels of vitamin D 2
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Vitamin D yeast” or “Vitamin D 2 yeast”
Yeast-leavened breads and rolls
5 μg of vitamin D 2 /100 g
Yeast-leavened fine bakery wares
5 μg of vitamin D 2 /100 g
Food supplements as defined in Directive 2002/46/EC
Pre-packed 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 D 2 yeast”.
2.
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.
3.
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 D 2 in final home‐baked products is not exceeded.’
(h)
the entry for ‘ Schizochytrium sp. (T18) oil’ is replaced by the following:
‘
Schizochytrium sp. (T18) oil
Specified food category
Maximum levels
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Oil from the microalgae Schizochytrium sp.”.’
Dairy products except milk-based drinks
200 mg/100 g or for cheese products 600 mg/100 g
Dairy analogues except drinks
200 mg/100 g or for analogues to cheese products 600 mg/100 g
Spreadable fats and dressings
600 mg/100 g
Breakfast cereals
500 mg/100 g
Food supplements as defined in Directive 2002/46/EC
250 mg DHA/day for general population
450 mg DHA/day for pregnant and lactating women
Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control
250 mg/meal
Milk-based drinks and similar products intended for young children
200 mg/100 g
Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen
Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014
Foods for special medical purposes as defined in Regulation (EU) No 609/2013
In accordance with the particular nutritional requirements of the persons for whom the products are intended
Bakery products (breads, rolls and, sweet biscuits)
200 mg/100 g
Cereal bars
500 mg/100g
Cooking fats
360 mg/100 g
Non-alcoholic beverages (including dairy analogue and milk-based drinks)
80 mg/100 ml
Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013
In accordance with Regulation (EU) No 609/2013
Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013
200 mg/100 g
Fruit/vegetable puree
100 mg/100 g
(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 Food
Specification
‘
Ecklonia 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: < 3 000 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: < 10 3 CFU/g
Total combined yeasts/moulds count: < 10 2 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 D 2
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 D 2 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 D 2 (ergocalciferol). Vitamin D 2 content in the yeast concentrate varies between 800 000 -3 500 000 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 D 2
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: ≤ 10 3 /g
Escherichia coli : ≤ 10/g
Salmonella : Absence in 25 g’
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)

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