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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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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(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(2).
(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(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), (EU) 2018/1011(10), (EU) 2018/1018(11), (EU) 2018/1032(12) 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:
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
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
The Annex is amended as follows.
Table 1 (Authorised novel foods) is amended as follows:
the following entry is inserted between the entry for ‘Echium plantagineum oil’ and the entry for ‘Egg membrane hydrolysate’:
the entry for ‘Taxifolin-rich extract’ is replaced by the following:
the entry for ‘L-ergothioneine’ is replaced by the following:
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’ |
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’ |
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 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’ |
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 D2 | The designation of the novel food on the labelling of the foodstuffs 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 bakery wares | 5 μg of vitamin D2/100 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 D2 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 D2 in final home‐baked products is not exceeded.’ |
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’ |
Table 2 (Specifications) is amended as follows:
the following entry is inserted between the entry for ‘Echium plantagineum oil’ and the entry for ‘Egg membrane hydrolysate’:
the entry for ‘Definition’ for ‘Taxifolin-rich extract’ is replaced by the following:
the following entry is inserted between the entry for ‘L-ergothioneine’ and the entry for ‘Ferric sodium EDTA’:
the following entry is inserted between the entry for ‘Lycopene oleoresin from tomatoes’ and the entry for ‘Magnesium citrate malate’:
the entry for ‘UV-treated mushrooms (Agaricus bisporus)’ is replaced by the following:
the entry for ‘UV- treated baker’s yeast (Saccharomyces cerevisiae)’ is replaced by the following:
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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