
Article 1 

1. The entry in the Union list of authorised novel foods, established under Implementing Regulation (EU) 2017/2470, referring to the substance Schizochytrium sp. (ATCC PTA-9695) oil shall be amended as specified in the Annex to this Regulation.
2. The entry in the Union list referred 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 following 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 States.Done at Brussels, 11 March 2019.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

((1)) The entry for ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 1 (Authorised novel foods) is replaced by the following:

Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements
‘Schizochytriumsp. (ATCC PTA-9695) oil Specified food category Maximum levels of DHA The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’’ 
Dairy products except milk-based drinks 200 mg/100 g or for cheese products 600 mg/100 g
Dairy analogues except drinks 200 mg/100 g or for analogues to cheese products 600 mg/100 g
Spreadable fats and dressings 600 mg/100 g
Breakfast cereals 500 mg/100 g
Food Supplements as defined in Directive 2002/46/EC 250 mg DHA/day for general population
450 mg DHA/day 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 intended for young children 200 mg/100 g
Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen
Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014
Foods for special medical purposes as defined in Regulation (EU) No 609/2013 In accordance with the particular nutritional requirements of the persons for whom the products are intended
Bakery 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 dairy analogue and milk-based drinks) 80 mg/100 ml
Infant formula and follow-on formula 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/vegetable puree 100 mg/100 g
((2)) The entry for ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 2 (Specifications) is replaced by the following:

Authorised novel food Specification
‘Schizochytriumsp. (ATCC PTA-9695) oil The novel food is obtained from the strain ATCC PTA-9695 of the microalgae Schizochytrium sp.Peroxide value (PV): ≤ 5,0 meq/kg oilUnsaponifiables: ≤ 3,5 %Trans-fatty acids: ≤ 2,0 %Free fatty acids: ≤ 0,4 %Docosapentaenoic acid (DPA) n-6: ≤ 7,5 %DHA content: ≥ 35 %’
