COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/387 
of 11 March 2019 
author ising an extension of use of Schizochytr ium sp. (ATCC PTA-9695) oil as a novel food 
and the change of the designation and of the specif ic labelling requirement of Schizochytr ium 
sp. (ATCC PTA-9695) oil 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 (EU) 2015/545 (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 in the Union of oil from 
the micro-algae Schizochytr ium sp. (ATCC PTA-9695) 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. (ATCC PTA-9695) oil within the meaning of 
Article 10(1) of Regulation (EU) 2015/2283. The application request ed to extend the use of Schizochytr ium 
sp. (ATCC PTA-9695) oil to fruit and vegetable 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 for extension of use of Schizochytr ium sp. (T18) oil by Implementing Regulation (EU) 2018/1032 to 
fruit and vegetable purees and it does not either pose any safet y concer n. Taking into account those consider ­
ations, the proposed exte nsion of use compl ies with Article 12(1) of Regulation (EU) 2015/2283. 
(8)  On 10 Sept ember 2018, the compan y DSM Nutr itional Products Europe also made a request to the 
Commission to author ise the change of the designation and of the specific labelling requirement for Schizo ­
chytr ium sp. (ATCC PTA-9695) oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The 
application requests the deletion of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the 
novel food as listed in the Union list and from the labelling of foods containing it. 12.3.2019 L 70/17 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 (EU) 2015/545 of 31 March 2015 author ising the placing on the market of oil from the 
micro-alg ae Schizochytr ium sp. (ATCC PTA-9695) as a novel food ingredient under Regulation (EC) No 258/97 of the European 
Parliament and of the Council (OJ L 90, 2.4.2015, p. 7). 
(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). (9)  The Applicant considers that the change of the designation and the labelling requirements for Schizochytr ium 
sp. (ATCC PTA-9695) oil is necessar y because the indication of the strain ‘(ATCC PTA-9695)’ on the labelling of 
foods containing Schizochytr ium sp. (ATCC PTA-9695) oil is not understandable nor relevant for consumers. 
(10)  There are four oils from Schizochytr ium sp. currently author ised and listed in the Union list of novel 
foods. However , Schizochytr ium sp. (ATCC PTA-9695) oil is the only one for which the strain must be specif ied on 
the label. Theref ore, the chang e of the designation and labelling of Schizochytr ium sp. (ATCC PTA-9695) oil will 
ensure consistency in the designation and labelling of all oils from Schizochytr ium sp. author ised as novel foods 
without having a negativ e impact on human health and consumer interests. 
(11)  Consider ing the remo val of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the novel 
food and of the specific labelling requirement for Schizochytr ium sp. (ATCC PTA-9695) oil, the wording ‘(ATCC 
PTA 9695)’ should be included in the specific ations as it is necessar y for a proper identif ication of the novel 
food. Theref ore, the specifi cations of the entr y ‘Schizochytr ium sp. (ATCC PTA-9695) oil’ in Table 2 of the Annex 
to Implementing Regulation (EU) 2017/2470 should be amended according ly. 
(12)  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. (ATCC PTA-9695) oil, 
the change of the designation and of the specific labelling requirement for Schizochytr ium sp. (ATCC PTA-9695) 
oil and the subsequent updating of the Union list are not liable to have an effect on human health. 
(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 
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. (ATCC PTA-9695) oil shall be amended as specified in the Annex to this 
Regulation. 
2. The entr y in the Union list refer red to in paragraph 1 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, 11 Marc h 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  12.3.2019 L 70/18 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 ‘Schizochytr ium sp. (ATCC PTA-9695) oil’ in Table 1 (Author ised novel foods) is replaced by the following: 
Autho rised novel food Conditions under whic h the novel food may be used Additional specific labelling requirements Other requirements 
‘Schizochytriu m sp. 
(ATCC PTA-9695) oil Specified food categor y Maximum levels of DHA The designation of the novel food on 
the labelling of the foodstuffs con­
taining it shall be ‘Oil from the mi­
croalga e 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 exce pt drinks 200 mg/100 g or for analogues to cheese 
products 600 mg/100 g 
Spreadable fats and dressings 600 mg/100 g 
Breakfa st 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 
Foods intended to meet the expenditure 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 requirements of Commission Im­
plementing Regulation (EU) No 828/2014 
Foods for special medical purposes as de­
fined in Regulation (EU) No 609/2013 In accordance with the particular nutr itional 
requirements of the persons for whom the 
products are intended 12.3.2019 L 70/19 Official Jour nal of the European Union EN     Autho rised novel food Conditions under whic h the novel food may be used Additional specific labelling requirements Other requirements  
Baker y 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 follo w-on formula as de­
fined 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/vegetable puree 100 mg/100 g   
(2) The entr y for ‘Schizochytr ium sp. (ATCC PTA-9695) oil’ in Table 2 (Specifi cations) is replaced by the following: 
Autho rised novel food Specification 
‘Schizochytriu m sp. 
(ATCC PTA-9695) oil The novel food is obtained from the strain ATCC PTA-9695 of the microalg ae Schizochytr ium sp. 
Peroxide value (PV): ≤ 5,0 meq/kg oil 
Unsaponifiables: ≤ 3,5 % 
Trans-fatty acids: ≤ 2,0 % 
Free fatty acids: ≤ 0,4 % 
Docosapentaenoic acid (DPA) n-6: ≤ 7,5 % 
DHA cont ent: ≥ 35 %’   12.3.2019 L 70/20 Official Jour nal of the European Union EN