COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/109 
of 24 Januar y 2019 
author ising an extension of use of Schizoc hytr ium sp. oil 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) 
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 Implementing Decision 2014/463/EU (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 oil from the microalgae Schizo ­
chytr ium sp. as a novel food to be used in a number of foods. 
(5)  Commission Implementing Regulation (EU) 2018/1032 (5) extended the author isation of oil from the microalgae 
Schizochytr ium sp. (T18) as a novel food under Regulation (EU) 2015/2283 to fruit/veg etable purees. 
(6)  On 10 Sept ember 2018, the compan y DSM Nutr itional Products Europe made a request to the Commission to 
change the conditions of use of the novel food Schizochytr ium sp. oil within the meaning of Article 10(1) of 
Regulation (EU) 2015/2283. The application requeste d to extend the use of Schizochytr ium sp. oil to fruit and 
vege table purees. 
(7)  The proposed exte nsion of use of the novel food does not chang e the safety considerations that suppor ted the 
author isation of Schizochytr ium sp. (T18) oil by Implemen ting Regulation (EU) 2018/1032 and it does not either 
pose any safet y concer n. Taking into account those considerations, the proposed extensi on of use compl ies with 
Article 12(1) of Regulation (EU) 2015/2283. 
(8)  The Commission did not request an opinion from the European Food Safety Auth ority in accordance with 
Article 10(3) of Regulation (EU) 2015/2283, as an extension of use of Schizochytr ium sp. oil and the subsequent 
updating of the Union list are not liable to have an effect on human health. 
(9)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 25.1.2019 L 23/7 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 2014/463/EU of 14 July 2014 on author ising the placing on the market of oil from the micro-algae 
Schizochytr ium sp. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council and 
repealing Decisions 2003/427/EC and 2009/778/EC (OJ L 209, 16.7.2014, p. 55). 
(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)Commission Implementing Regulation (EU) 2018/1032 of 20 July 2018 author ising the exten sion of use of oil from the micro algae 
Schizochytr ium sp. as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending 
Commission Implementin g Regulation (EU) 2017/2470 (OJ L 185, 23.7.2018, p. 9). HAS ADOPTED THIS REGUL ATION: 
Article 1 
1. The entr y in the Union list of author ised novel foods, established under Implementing Regulation (EU) 2017/2470, 
referring to the substance Schizochytr ium sp. oil 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, 24 Januar y 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  25.1.2019 L 23/8 Official Jour nal of the European Union EN     ANNEX 
The entr y for ‘Schizochytr ium sp. oil’ in Table 1 (Author ised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470 is replaced by the following: 
Authorised novel food Conditions under whic h the novel food may be used Additional specific labelling requirements Other require ­
ments 
‘Schizoc hytr ium sp. oil Specified food categor y Maximum levels of DHA The designation of the novel food on the la­
belling of the foodstuffs containing it shall be 
‘Oil from the microalgae Schizochytr ium sp.”’  Dair y products exce pt milk -based drinks 200 mg/100 g or for cheese products 
600 mg/100 g 
Dair y analogues excep t drinks 200 mg/100 g or for analogues to cheese 
products 600 mg/100 g 
Spreadable fat and dressings 600 mg/100 g 
Breakf ast cereals 500 mg/100 g 
Food Supplements as defined in Directive 
2002/46/EC 250 mg DHA/da y for general population 
450 mg DHA/da y 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 in­
tended for young children 200 mg/100 g 
Processed cereal-based foods and baby foods 
for infants and young children as defined in 
Regulation (EU) No 609/2013 
Foods intended to meet the expenditure of 
intense muscular effort, especially for spor ts­
men 
Foods bear ing statements on the absence or 
reduced presence of gluten in accordance 
with the requirements of Implementing Regu ­
lation (EU) No 828/2014 25.1.2019 L 23/9 Official Jour nal of the European Union EN     Authorised novel food Conditions under whic h the novel food may be used Additional specific labelling requirements Other require ­
ments  
Specified food categor y Maximum levels of DHA   
Foods for special medical purposes as defined 
in Regulation (EU) No 609/2013 In accordance with the particular nutr itional 
requirements of the persons for whom the 
products are intended 
Bakery products (breads, rolls, and, sweet bis­
cuits) 200 mg/100 g 
Cereal bars 500 mg/100 g 
Cooking fats 360 mg/100 g 
Non-alcoholic beverages (including dair y ana­
logue and milk -based drinks) 80 mg/100 ml 
Fruit/vege table puree 100 mg/100 g  25.1.2019 L 23/10 Official Jour nal of the European Union EN