COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/1272 
of 29 July 2019 
correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods and 
Implementing Decision (EU) 2017/2078 author ising an extension of use of yeast beta-gluca ns as 
a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the 
Council 
(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 of the European Parliament and of the Council and Commission Regulation (EC) 
No 1852/2001 (1), and in particular Articles 8 and 12 thereof, 
Whereas: 
(1)  Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission was to establish, by 1 Januar y 2018, the 
Union list of novel foods author ised or notified under Regulation (EC) No 258/97 of the European Parliament 
and of the Council (2). 
(2)  The Union list of novel foods author ised 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) correcte d Implementing Regulation (EU) 2017/2470 
establishing the Union list of novel foods in order to include a number of author ised or notified novel foods not 
included in the initial Union list. 
(4)  After the publication of Implemen ting Regulation (EU) 2017/2470 and Implementing Regulation 
(EU) 2018/1023, the Commission identif ied additional errors in the Annex to Implementing Regulation 
(EU) 2017/2470. 
(5)  Corrections are needed in order to provid e clarity and legal certainty to food business operat ors and to Member 
States' compet ent author ities, thus provi ding for the proper imp lementation and use of the Union list of novel 
foods. 
(6)  On 22 November 2018, the compet ent author ity of Italy made a request to the Commission for the correction in 
the Union list relating to the designation and the specifi c labelling requirement of the novel food Echinacea 
purpurea extract from cell cultures. This novel food was author ised through notific ation procedure pursuant to 
Article 5 of Regulation (EC) No 258/97. The compet ent author ity of Italy has made an error by notifying the 
wrong name for the cell cultures and theref ore, the request asks to replace the name of the cell cultures HTN®Vb 
with the name EchiPure-PC™ in the designation of the novel food as liste d in the Union list and in the specif ic 
labelling requirement of foods containing it, as well as in the specifications of the novel food. 
(7)  A correction of the designation and of the specific labelling requirement in Table 1 and a correction of the 
specifications in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 of the novel food Echinacea 
purpurea extract from cell cultures are theref ore necessar y. 30.7.2019 L 201/3 Official Jour nal of the European Union EN     
(1)OJ L 327, 11.12.2015, p. 1. 
(2)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). 
(3)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). 
(4)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). (8)  The novel foods yeast beta-g lucans were author ised under certain conditions of use by Commission 
Implementing Decision 2011/762/EU (5). Use of yeast beta-g lucans in additional food categor ies was later 
author ised by Commission Implementing Decision (EU) 2017/2078 (6). In the specifi cations of yeast beta-g lucans 
in Implementing Decision (EU) 2017/2078, the measurement units for heavy metals are wrong ly expressed in 
mg/g inste ad of mg/kg. This error was transfe rred in the Union list established by Implementing Regulation 
(EU) 2017/2470. Theref ore, the specifi cations of the yeast beta-g lucans relating to heavy metals in Annex I to 
Implementing Decision (EU) 2017/2078 and in Table 2 of the Annex to Implementing Regulation 
(EU) 2017/2470 should be corrected according ly. 
(9)  Implementing Regulation (EU) 2017/2470 and Implementing Decision (EU) 2017/2078 should be corrected 
according ly. 
(10)  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 
The Annex to Implementing Regulation (EU) 2017/2470 is corrected in accordance with the Annex to this Regulation. 
Article 2 
Annex I to Implementing Decision (EU) 2017/2078 is corrected 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, 29 July 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  30.7.2019 L 201/4 Official Jour nal of the European Union EN     
(5)Commission Implementing Decision 2011/762/EU of 24 November 2011 author ising the placing on the market of yeast beta-g lucans as 
a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 313, 26.11.2011, p. 41). 
(6)Commission Implementing Decision (EU) 2017/2078 of 10 November 2017 author ising an exten sion of use of yeast beta-g lucans as 
a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 295, 14.11.2017, p. 77). ANNEX 
(1)  The Annex to Implementing Regulation (EU) 2017/2470 is corrected as follows: 
(a)  the entr y for Echinacea purpurea extract from cell cultures in Table 1 (Author ised novel foods) is replaced by the follo wing: 
Autho rised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other  
requirements 
‘Ech inacea purpurea extract 
from cell cultures Specified food categor y Maximum levels The designation of the novel food on the la­
belling of the foodstuffs containing it shall be 
‘dried extract of Echinacea purpurea from cell 
cultures EchiPure-PC™’’  Food Supplements as defined in Di­
rective 2002/46/EC In line with normal use in food sup­
plements of a similar extract from 
florets within the flowe r head of Echi ­
nacea purpurea  
(b)  the entr y for Echinacea purpurea extract from cell cultures in Table 2 (Specif ications) is replaced by the follo wing: 
Autho rised novel food Specification 
‘Ech inacea purpurea extract from cell cultures Descr iption/Def inition: 
Dried extract of Echinacea purpurea from cell cultures EchiPure-PC™’  
(c)  the entr ies for Yeast beta-g lucans in Table 2 (Specifi cations) under the heading Heavy metals for insoluble in water, but dispersible in many liquid matr ices are replaced by the followi ng:  
‘Lead: < 0,2 mg/kg 
Arsenic: < 0,2 mg/kg 
Mercur y: < 0,1 mg/kg 
Cadmium: < 0,1 mg/kg’  
(2)  Annex I to Implementing Decision (EU) 2017/2078 is corrected as follows: 
The entr ies for Lead, Arsenic, Mercur y and Cadmium in the Table Specifications of Yeast (Sacchar omyces cerevisiae) beta-g lucans are replaced by the followi ng: 
‘Lead < 0,2 mg/kg 
Arsenic < 0,2 mg/kg 
Mercur y < 0,1 mg/kg 
Cadmium < 0,1 mg/kg’   30.7.2019 L 201/5 Official Jour nal of the European Union EN