Schizochytrium sp. (ATCC PTA-9695) oil: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• 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 the general population
• Food Supplements as defined in Directive 2002/46/EC: 1 g DHA/day for the general population excluding infants and young children
• 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: 200 mg/100 g
• Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014: 200 mg/100 g
• 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 g
• 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

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’. 2. The labelling of food supplements containing more than 250 mg DHA/day shall bear a statement that they should not be consumed by children under 3 years of age.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

The novel food is obtained from the strain ATCC PTA-9695 of the microalgae Schizochytrium 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 content: ≥ 35 %

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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