COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/108 
of 24 Januar y 2019 
author ising the change of specif ications of the novel food ingredient lipid extract from Antarctic 
Krill (Euphausia superba) 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 of the European Parliament and of the Council 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) 
establishing a Union list of author ised novel foods was adopt ed. 
(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 on the updating of the Union list. 
(4)  Commission Decision 2009/752/EC (3) author ised, in accordance with Regulation (EC) No 258/97 of the 
European Parliament and of the Council (4), the placing on the market of lipid extract from Antarctic Krill 
(Euphausia superba) as a novel food ingredient to be used in certain foods and foodstuffs. In that Decision, the 
maximum level of phospholipids was established at 50 %. 
(5)  Commission Implementing Decision (EU) 2016/598 (5) author ised, in accordance with Regulation (EC) 
No 258/97, an exte nsion of use of lipid extract from Antarctic Krill (Euphausia superba) as a novel food ingredient 
to be used in food supplements. In that Decision, the minimum level of phospholipid was established at 35 %. 
(6)  The novel food ingredient ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’ was author ised to be 
used in certain food catego ries by the Finnish compet ent author ities (6). The minimum level of phospholipids was 
established at 60 %. 
(7) The conditions of use for both ‘Antarctic Krill oil from Euphausia superba’ and ‘Antarctic Krill oil rich in phospho ­
lipids from Euphausia superba’ are identical and are based on the maximum levels of combined eicosapentaenoic 
acid and docosahexaenoic acid. However , they diffe r in the phospholipid content, whic h is established at a range 
of 35 % to 50 % for ‘Antarctic Krill oil from Euphausia superba’ and a minimum of 60 % for ‘Antarctic Krill oil 
rich in phospholipids from Euphausia superba’ . Theref ore, the current author isations do not cover the range of 
phospholipids in ‘Antarctic Krill oil from Euphausia superba’ between 50 % and 60 %. 25.1.2019 L 23/4 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 Decision 2009/752/EC of 12 October 2009 author ising the placing on the market of a lipid extract from Antarctic Krill 
Euphausia superba as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 268, 
13.10.2009, p. 33). 
(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). 
(5)Commission Implementing Decision (EU) 2016/598 of 14 Apr il 2016 author ising an extension of use of lipid extract from Antarctic 
Krill (Euphausia superba) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council 
(OJ L 103, 19.4.2016, p. 34). 
(6)Letter of 13 May 2015 (https://ec.europa.eu/f ood/sites/f ood/files/safety/docs/no vel-f ood_author isation_2015_auth-letter_krill -oil_en. 
pdf) (8)  On 29 August 2018, the compan y Aker BioMar ine A/S (‘the Applicant’ ) made a request to the Commission to 
change the specific ations of the novel food Antarctic Krill oil from Euphausia superba within the meaning of 
Article 10(1) of Regulation (EU) 2015/2283. The applicant request ed to increase the maximum phospholipid 
cont ent from 50 % to less than 60 % thereby covering the rang e in the phospholipid concentration, which is not 
currently author ised. 
(9)  The Commission considers that a safety evaluation of the current application by the European Food Safety 
Author ity in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessar y on the basis of the 
fact that if certain levels of a given novel food component have been assessed and deter mined to be safe, then 
lower levels of the same compo nent would also be safe. The author ised maximum levels of combined eicosapen ­
taenoic acid and docosahexaenoic acid for both ‘Antarctic Krill oil from Euphausia superba’ and ‘Antarctic Krill oil 
rich in phospholipids from Euphausia superba’ under Implementing Regulation (EU) 2017/2470 are the same. The 
proposed change in the phospholipid levels in the specif ication of the ‘Antarctic Krill oil from Euphausia superba’ 
does not chang e the safet y considerations that suppor ted its author isation and the author isation of the ‘Antarctic 
Krill oil rich in phospholipids from Euphausia superba’ whic h concluded that phospholipid levels above and below 
60 % are both safe. 
(10)  The proposed change to the specifi cations in the phospholipid conte nt will address the gap in phospholipid 
cont ent between ‘Antarctic Krill oil from Euphausia superba’ and ‘Antarctic Krill oil rich in phospholipids from 
Euphausia superba’ . Theref ore, it is appropr iate to amend the specifi cations of the novel food Antarctic Krill oil 
from Euphausia superba at the proposed level for phospholipids. 
(11)  The information provi ded in the application gives sufficient grounds to establish that the proposed chang es to 
the specific ations of the novel food ingredient ‘Antarctic Krill oil from Euphausia superba’ compl y with 
Article 12(2) of Regulation (EU) 2015/2283. 
(12)  Implementing Regulation (EU) 2017/2470 should theref ore be amended according ly. 
(13)  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 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 novel food ‘Antarctic Krill oil from Euphausia superba’ shall be amended as specifi ed 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, 24 Januar y 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  25.1.2019 L 23/5 Official Jour nal of the European Union EN     ANNEX 
The entr y for ‘Antarctic Krill oil from Euphausia superba’ in Table 2 (Specifi cations) of the Annex to Imp lementing 
Regulation (EU) 2017/2470 is replaced by the following: 
Autho rised Novel Food Specifications 
‘Antarctic Krill oil from 
Euphausia superba Descr iption/Def inition: 
To produce lipid extract from Antarctic Krill (Euphausia superba) deep-frozen crushed krill 
or dried krill meal is subjected to lipid extraction with an approved extraction solvent (un­
der Directive 2009/32/EC). Prot eins and krill mate rial are removed from the lipid extract 
by filtration. The extraction solvents and residual water are remo ved by evaporation. 
Saponif ication value: ≤ 230 mg KOH/g 
Pero xide value (PV): ≤ 3 meq O2/kg oil 
Oxidative stability: All food products containing Antarctic Krill oil from Euphausia superba 
should demonstrate oxidative stability by appropr iate and recognised national/internatio nal 
test methodology (e.g. AOAC). 
Moisture and volatiles: ≤ 3 % or 0,6 expressed as wate r activity at 25 °C 
Phospholipids: ≥ 35 % to < 60 % 
Trans-f atty acids: ≤ 1 % 
EPA (eicosapentaenoic acid): ≥ 9 % 
DHA (docosahexaenoic acid): ≥ 5 %’   25.1.2019 L 23/6 Official Jour nal of the European Union EN