COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/1018 
of 18 July 2018 
author ising an extension of use of UV-treated baker's yeast (Sacchar omy ces 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 
(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 submit a draf t implementing act 
author ising the placing on the Union market of a novel food and updating the Union list. 
(4)  Commission Implementing Decision 2014/396/EU (3) author ised, in accordance with Regulation (EC) No 258/97 
of the European Parliament and of the Council (4) and followi ng the European Food Safe ty Author ity's 
Opinion (5), the placing on the market of UV-treat ed bake r's yeast (Saccharomy ces cerevisiae) as a novel food 
ingredient to be used in certain foods, including yeast-lea vened breads and rolls and yeast-leavened fine bakery 
wares, as well as in food supplements. 
(5)  On 6 December 2016, the compan y Lallemand Bio-Ingredients made a request to the compet ent author ity of 
Denmark for an extension of use and use levels of UV-treated bake r's yeast (Saccharomy ces cerevisiae). The 
application request ed to extend the use of UV-treat ed baker's yeast (Saccharo myces cerevisiae) to additional food 
catego ries, namely , pre-pack ed fresh and dry yeast for home baking and in food supplements without indication 
of maximum permitte d levels. In addition, the applicant requeste d to amend the lower specification of the 
vitamin D2 content in the yeast concentrate from 1 800 000 IU (450 µg/g) to 800 000 IU (200 µg/g). 
(6)  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. 
(7)  While the request for an extension of uses and use levels of UV-treat ed baker's yeast (Saccharo myces cerevisiae) 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. 19.7.2018 L 183/9 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 2014/396/EU of 24 June 2014 author ising the placing on the market of UV-treated baker's yeast 
(Saccharom yces cerev isiae) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council 
(OJ L 186, 26.6.2014, p. 108). 
(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 foods 
ingredients (OJ L 43, 14.2.1997, p. 1). 
(5)Scientific Opinion on the safet y of vitamin D-enr iched UV-treat ed baker's yeast, EFSA Journal 2014; 12(1):3520. (8)  On 30 June 2017, the compet ent author ity of Denmark issued its initial assessment repor t. In that repor t it came 
to the conclusion that the extensi on of uses and proposed maximum use levels of UV-treated baker's yeast 
(Saccharo myces cerevisiae) meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97. 
(9)  On 7 July 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 regar d to methods employed to adequately identify poten tial 
mutants, lack of justification on safety grounds to suppor t the removal of the maximum level for food 
supplements, lack of information on storage stability for the new form of the novel food, lack of information on 
the accreditation of laboratori es, and as to whether the intake of the novel food might exceed the tolerable upper 
intak e levels for vitamin D set up by EFSA (1). 
(10)  In view of the comments made by the other Member States, the applicant provid ed additional explanations whic h 
alleviate d their concer ns to the satisf action of the Member States and the Commission. Those explanations give 
sufficient grounds to establish that the exte nsion of use and use levels of UV-treated baker's yeast (Saccharo myces 
cerevisiae) compl ies with Article 12(1) of Regulation (EU) 2015/2283. 
(11)  Directive 2002/46/EC of the European Parliament and of the Council (2) and Regulation (EC) No 1925/2006 of 
the European Parliament and of the Council (3) lay down specific provisions for the use of vitamins and minerals 
when added to food supplements and food. The extensi on of use of UV-treated baker's yeast should be author ised 
without prejudice to those specifi c provisions. 
(12)  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 the substance UV-treated bake r's yeast (Saccharomy ces cerevisiae) shall be amended as specif ied 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. 
3. The author isation provid ed for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC 
and Regulation (EC) No 1925/2006. 
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. 19.7.2018 L 183/10 Official Jour nal of the European Union EN     
(1)EFSA Journal 2012;10(7):2813 
(2)Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the appro ximation of the laws of the Member 
States relating to food supplements (OJ L 183, 12.7.2002, p. 51). 
(3)Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and 
minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26). This Regulation shall be binding in its entirety and directly applicable in all Member State s. 
Done at Brussels, 18 July 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  19.7.2018 L 183/11 Official Jour nal of the European Union EN     ANNEX 
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:  
(1) the entr y for ‘UV-treat ed baker's yeast (Saccharomy ces cerevisiae)’ in Table 1 (Aut horised novel foods) is replaced by the followi ng: 
Author ised novel food Conditions under which the novel food may be used Additio nal specif ic labelling requirements Other  
requirements 
‘UV -treated baker's yeast (Sacchar ­
omy ces cerevisiae) Specif ied food categor y 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 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 label ­
ling 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 in­
structions for use for the final consumers so 
that a maximum concentration of 5 µg/100 g 
of vitamin D2 in final home-bak ed products is 
not exceed ed.’   
(2) the entr y for ‘UV-treat ed baker's yeast (Saccharomy ces cerevisiae)’ in Table 2 (Specifications) is replaced by the followi ng: 
Author ised Novel Food Specif ication 
‘UV -treated baker's yeast (Sacchar ­
omy ces cerevisiae) Descr iption/Def inition: 
Baker's yeast (Saccharomy ces cerevisiae) is treated with ultraviolet light to induce the conver sion of ergost erol to vitamin D2 (ergocalcif erol). Vit­
amin D2 conte nt in the yeast concentrate varies between 800 000-3 500 000 IU vitamin D/100 g (200-875 µg/g). The yeast may be inacti ­
vated. 
The yeast concentrat e is blended with regular baker'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.  19.7.2018 L 183/12 Official Jour nal of the European Union EN     Author ised Novel Food Specif ication 
Vitamin D2: 
Chemical name: (5Z,7E,22E)-(3S)-9,10-secoergosta-5,7,10(19),22-tetraen-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’   19.7.2018 L 183/13 Official Jour nal of the European Union EN