REGUL ATIONS 
COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/1032 
of 20 July 2018 
author ising the extension of use of oil from the micro algae Schizochyt rium sp. 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 on updating the Union list. 
(4)  Commission Implementing Decision (EU) No 463/2014 (3) author ised, in accordance with Regulation 
(EC) No 258/97 of the European Parliament and of the Council (4) concer ning novel food and novel food 
ingredients, the placing on the mark et of oil containing docosahexaenoic acid (‘DHA ’) from the micro algae 
Schizochytr ium sp. as a novel food ingredient to be used in certain foods, foods intended for use in energy 
restr icted diets for weight reduction, dietar y foods for special medical purposes, other foods for particular 
nutr itional uses as defined in Directive 2009/39/EC of the European Parliament and of the Council (5) (excluding 
infant and follo w on formulae) and food supplements. 
(5)  Commission Implementing Decision (EU) 2015/545 (6) author ised, in accordance with Regulation (EC) 
No 258/97, the placing on the market of oil containing docosahexaenoic acid (‘DHA ’) from another strain of the 
micro algae Schizochytr ium sp. (ATCC PTA 9695), as a novel food ingredient to be used in certain foods, including 
infant and follo w on formulae and processed cereal-based foods and baby foods for infants and young children. 
(6)  On 21 November 2016, the compan y Mara Renewables Corporation made a request to the compe tent author ity 
of the United Kingdom for an extension of use of oil produced from a differ ent strain of the micro algae 
Schizochytr ium sp. (strain T18) within the meaning of point (d) of Article 1(2) of Regulation (EC) No 258/97. The 
application request ed to use oil from this Schizochytr ium sp. strain T18 for all foods author ised by Imple menting 
Decisions (EU) No 463/2014 and (EU) 2015/545, and extend its use to fruit and vegetable purees. 
(7)  On 10 Januar y 2017, the compan y Mara Renewables Corporation notifi ed the Commission that it placed the 
novel food ingredient ‘oil from Schizochytr ium sp.’ produced with strain T18 on the Union mark et pursuant to 
Article 5 of Regulation (EC) No 258/97. The compan y intended to use this novel food ingredient in all previously 
author ised foods under Implementing Decision (EU) No 463/2014. 23.7.2018 L 185/9 Official Jour nal of the European Union EN     
(1)OJ L 327, 11.12.2015, p. 1. 
(2)OJ L 351, 30.12.2017, p. 72. 
(3)OJ L 209, 16.7.2014, p. 55. 
(4)OJ L 43, 14.2.1997, p. 1. 
(5)OJ L 124, 20.5.2009, p. 56. 
(6)OJ L 90, 2.4.2015, p. 7. (8)  On 22 Sept ember 2017, the compan y Nutra veris notified the Commission that it placed the novel food 
ingredient ‘oil from Schizochytr ium sp.’ produced with strain T18 on the Union mark et pursuant to Article 5 of 
Regulation (EC) No 258/97. The compan y intended to use this novel food ingredient in all previously author ised 
foods under Implemen ting Decisions (EU) No 463/2014 and (EU) 2015/545. 
(9)  On 23 October 2017, the compan y BASF notified the Commission that it placed the novel food ingredient ‘oil 
from Schizochytr ium sp.’ produced with strain T18 on the Union mark et pursuant to Article 5 of Regulation (EC) 
No 258/97. The compan y intende d to use this novel food ingredient in all previously author ised foods under 
Implementing Decisions (EU) No 463/2014 and (EU) 2015/545. 
(10)  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. 
(11)  While the request for an extension of use of oil from the micro-algae species Schizochytr ium sp. strain T18 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. 
(12)  On 6 October 2017, the compet ent author ity of the United Kingdom issued its initial assessment repor t. In 
that repor t it came to the conclusion that the extension of use of oil from strain T18 of the micro-algae 
Schizochytr ium sp. meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97. 
(13)  On 7 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 whic h conf irmed the conclusions of the initial 
assessment. 
(14)  The initial repor t conclusions give sufficient grounds to establish that the extensi on of use of oil from strain T18 
of the micro-alga e Schizochytr ium sp. compl ies with Article 12(1) of Regulation (EU) 2015/2283. 
(15)  Regulation (EU) No 1308/2013 of the European Parliament and Council (1) establishing a common organisation 
of the mark ets in agricultural products lays down requirements for agricultural products, in particular on 
milk and milk products. The exte nsion of use of DHA-r ich oil from the micro-algae Schizochytr ium sp. strain T18 
should be author ised without prejudice to that Regulation. 
(16)  Directive 2002/46/EC of the European Parliament and of the Council (2) lays down requirements on food 
supplements. The extensi on of use of oil from the micro-algae species Schizochytr ium sp. strain T18 should be 
author ised without prejudice to that Directive. 
(17)  Regulation (EU) No 609/2013 of the European Parliament and of the Council (3) lays down requirements on food 
intende d for infants and young children, food for special medical purposes, and total diet replacement for weight 
control. The extension of use of oil from the micro-alga e species Schizochytr ium sp. strain T18 should be 
author ised without prejudice to that Regulation. 
(18)  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 oil from the micro-algae species Schizochytr ium sp. (T18) shall be amended as specifi ed in the Annex to this 
Regulation. 
The entr y in the Union list refer red to in the first paragraph shall include the conditions of use and labelling 
requirements laid down in the Annex to this Regulation. 23.7.2018 L 185/10 Official Jour nal of the European Union EN     
(1)OJ L 347, 20.12.2013, p. 671. 
(2)OJ L 183, 12.7.2002, p. 51. 
(3)OJ L 181, 29.6.2013, p. 181. The author isation provid ed for in this Article shall be without prejudice to the provisions of Regulation (EU) 
No 1308/2013, Directive 2002/46/EC and Regulation (EU) No 609/2013. 
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, 20 July 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  23.7.2018 L 185/11 Official Jour nal of the European Union EN     ANNEX 
In the Annex to Implementing Regulation (EU) 2017/2470, the entr y for ‘Schizochytr ium sp. (T18) oil’ in Table 1 (Author ised novel foods) is replaced by the follo wing: 
Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements 
‘Schizoc hytr ium sp. (T18) oil Specified food categor y Maximum levels 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 excep t 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 fats 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 popula ­
tion 
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 prod ­
ucts intended for young children 200 mg/100 g 
Foods intended to meet the ex­
penditure of intense muscular effort, 
especially for spor tsmen 
Foods bear ing state ments on the 
absence or reduced presence of gluten 
in accordance with the require ­
ments of Commission Implementing 
Regulation (EU) No 828/2014 23.7.2018 L 185/12 Official Jour nal of the European Union EN     Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements  
Specified food categor y Maximum levels    
Foods for special medical purposes 
as defined in Regulation (EU) 
No 609/2013 In accordance with the particular nu­
tritional requirements of the persons 
for whom the products are intended   
Bake ry products (breads, rolls and, 
sweet biscuits) 200 mg/100 g 
Cereal bars 500 mg/100 g 
Cooking fats 360 mg/100 g 
Non-alcoholic beverages (including 
dair y analogue and milk -based 
drinks) 80 mg/100 ml 
Infant formula and follow-on for­
mula as defined in Regulation (EU) 
No 609/2013 In accordance with Regulation (EU) 
No 609/2013 
Processed cereal-based foods and 
baby foods for infants and young 
children as defined in Regulation (EU) 
No 609/2013 200 mg/100 g 
Fruit/vegeta ble puree 100 mg/100 g   23.7.2018 L 185/13 Official Jour nal of the European Union EN