Commission Implementing Regulation (EU) 2019/109 of 24 January 2019 authorising an extension of use of Schizochytrium 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.)
Commission Implementing Regulation (EU) 2019/109 of 24 January 2019 authorising an extension of use of Schizochytrium 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.)
Data as of 2026-07-04 Β· Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. Β· Read the official text β
1.Β Β Β The entry in the Union list of authorised novel foods, established under Implementing Regulation (EU) 2017/2470, referring to the substance Schizochytrium sp.Β oil shall be amended as specified in the Annex to this Regulation.
2.Β Β Β The entry 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.
ANNEX
The entry for β
Schizochytrium sp.Β oilβ in Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470 is replaced by the following:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
β
Schizochytrium
sp. oil
Specified food category
Maximum levels of DHA
The designation of the novel food on the labelling of the foodstuffs containing it shall be βOil from the microalgae Schizochytrium sp.ββ
Β
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 fat 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
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 sportsmen
Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of 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
Fruit/vegetable puree
100 mg/100 g