COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/1011 
of 17 July 2018 
author ising 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 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having 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 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof, 
Whereas: 
(1)  Regulation (EU) 2015/2283 provi des that only novel foods author ised and included in the Union list may be 
placed on the market within the Union. 
(2)  Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) 
was adopt ed, which establishes a Union list of author ised novel foods. 
(3)  Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the author isation and on 
the placing on the Union market of a novel food and updating the Union list. 
(4)  Commission Implementing Decision (EU) 2017/2355 (3) author ised, in accordance with Regulation (EC) 
No 258/97 of the European Parliament and of the Council (4), the placing on the mark et of UV-treat ed 
mushrooms as a novel food. 
(5)  On 23 July 2015, the companies Banken Champ ignons Group BV and J.K. Holding BV made a request to the 
compet ent author ity of the Netherlands to place UV-treat ed mushrooms (Agaricus bispor us) with increased levels 
of vitamin D2 on the Union mark et as a novel food within the meaning of point (f) of Article 1(2) of Regulation 
(EC) No 258/97. 
(6)  With Implementing Regulation (EU) 2017/2470 that author isation became gener ic in Januar y 2018. As the 
application of this compan y concer ns mushrooms with higher vitamin D2 cont ent, this Regulation should be 
considered as an author isation for the exte nsion of use. 
(7)  Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the mark et 
within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and 
for which the final decision has not been taken before 1 Januar y 2018, shall be treated as an application 
submitte d under Regulation (EU) 2015/2283. 
(8)  While the request for placing UV-treat ed mushrooms (Agaricus bispor us) with increased levels of vitamin D2 
on the market as a novel food within the Union was submitte d to a Member State in accordance with Article 4 
of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation 
(EU) 2015/2283. 
(9)  On 20 Sept ember 2017, the compet ent author ity of the Netherlands issued its initial assessment repor t. In that 
repor t it came to the conclusion that the UV-treat ed mushrooms (Agaricus bispor us) with increased levels of 
vitamin D2 meet the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97. 18.7.2018 L 181/4 Official Jour nal of the European Union EN     
(1)OJ L 327, 11.12.2015, p. 1. 
(2)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 Decision (EU) 2017/2355 of 14 December 2017 author ising the placing on the market of UV-treat ed 
mushrooms as a novel food under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 336, 16.12.2017, 
p. 52). 
(4)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). (10)  On 5 October 2017, the Commission forwarded the initial assessment repor t to the other Member 
States. Comments were made by the other Member States within the 60-da y period laid down in the first 
subparagraph of Article 6(4) of Regulation (EC) No 258/97 with rega rd to ensure that the tolerable upper intake 
levels of vitamin D set up by EFSA (1) are not exceed ed. 
(11)  In view of the comments made by the other Member States, the applicant provid ed additional explanations whic h 
alleviate d the concer ns to the satisf action of the Member States and the Commission. 
(12)  Those explanations give suffi cient grounds to establish that UV-treat ed mushrooms (Agaricus bispor us) with 
increased levels of vitamin D2 at the proposed use levels, comply with Article 12(1) of Regulation 
(EU) 2015/2283. 
(13)  Point 1 of Part A of the Annex VI to Regulation (EU) No 1169/2011 of the European Parliament and of the 
Council (2) requires that the name of the food includes or is accompan ied by particulars as to the specif ic 
treatment that the food has undergone in all cases where omission of such information could mislead the 
consumers. As consumers do not normally expect mushrooms to be subject to UV treatments, the name of this 
food shall include or be accompan ied by such information in order to avoid misleading consumers. 
(14)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
1. The entr y in the Union list of author ised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 
referring to UV-treat ed mushrooms shall be amended as specifi ed in the annex to this Regulation. 
2. The entr y in the Union list referred to in the first paragraph shall include the conditions of use and labelling 
requirements laid down in the Annex to this Regulation. 
Article 2 
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation. 
Article 3 
This Regulation shall enter into force on the twentieth day followi ng 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 State s. 
Done at Brussels, 17 July 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  18.7.2018 L 181/5 Official Jour nal of the European Union EN     
(1)EFSA Journal 2012;10(7):2813 
(2)Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 Octo ber 2011 on the provision of food 
information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the 
Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, 
Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and 
Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18). ANNEX 
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:  
(1) the entr y for ‘UV-treat ed mushrooms (Agaricus bispor us)’ in Table 1 (Author ised novel foods) is replaced by the follo wing: 
Author ised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
‘UV -treated mushrooms 
(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 accom ­
panied by indication that a “controlled light treatment 
was used to increase vitamin D levels ’ or ‘UV treat ­
ment was used to increase vitamin D2 levels”.’  Mushrooms (Agaricus bispor us) 20 μg of vitamin D2/100 g 
fresh weight   
(2) the entr y for ‘UV-treat ed mushrooms (Agaricus bispor us)’ in Table 2 (Specif ications) is replaced by the follo wing: 
Author ised Novel Food Specification 
‘UV -treated mushrooms 
(Agaricus bispor us) Descr iption/Def inition: 
Commercially grown Agaricus bispor us to which UV light treatment is applied to harveste d mushrooms. 
UV radiation: a process of radiation in ultravi olet light within the wavelength of 200-800 nm. 
Vitamin D2: 
Chemical name: (3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-t etraen-3-ol 
Synon ym: 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.’   18.7.2018 L 181/6 Official Jour nal of the European Union EN