Schizochytrium sp. oil rich in DHA and EPA: 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:

• Food supplements as defined in Directive 2002/46/EC for the adult population excluding pregnant and lactating women: 3 000 mg/day
• Food supplements as defined in Directive 2002/46/EC for pregnant and lactating women: 450 mg/day
• Food supplements as defined in Directive 2002/46/EC for children from 18 months to 18 years of age: 250 mg/day
• 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
• 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 food and baby food for infants and young children as defined in Regulation (EU) No 609/2013: 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 (2): 200 mg/100 g
• Bakery products (breads, rolls and sweet biscuits): 200 mg/100 g
• Breakfast cereals: 500 mg/100 g
• Cooking fats: 360 mg/100 g
• Dairy analogues, except drinks: 600 mg/100 g for cheese; 200 mg/100 g for soy and imitation milk products (excluding drinks)
• Dairy products except milk-based drinks: 600 mg/100 g for cheese; 200 mg/100 g for milk products (including milk, fromage frais and yoghurt products; excluding drinks)
• Non-alcoholic beverages (including dairy analogue and milk-based drinks): 80 mg/100 g
• Cereal/nutrition bars: 500 mg/100 g
• Spreadable fats and dressings: 600 mg/100 g
• Fish analogues: 300 mg/100 g
• Meat analogues: 300 mg/100 g

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the microalgae Schizochytrium sp.’

Specification (Table 2)

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

Acid value: ≤ 0,5 mg KOH/g

Peroxide value (PV): ≤ 5,0 meq/kg oil

Oxidative stability: All food products containing Schizochytrium sp. oil rich in DHA and EPA should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC)

Moisture and volatiles: ≤ 0,05 %

Unsaponifiables: ≤ 4,5 %

Trans-fatty acids: ≤ 1 %

DHA content: ≥ 15 %

EPA content: ≥ 10 %

Notes

(2) Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228, 31.7.2014, p. 5, ELI: http://data.europa.eu/eli/reg_impl/2014/828/oj).

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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