Commission Implementing Decision (EU) 2015/545 of 31 March 2015 authorising the placing on the market of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2015) 2082)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the uses defined and at the maximum levels established in Annex II without prejudice to the provisions of Directive 2002/46/EC, Regulation (EC) No 1925/2006, Directive 2009/39/EC, Directive 96/8/EC, Directive 1999/21/EC, Directive 2006/141/EC and Directive 2006/125/EC.
The designation of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695)’.
This Decision is addressed to DSM Nutritional Products, 6480 Dobbin Road, Columbia, MD 21045, USA.
ANNEX I Specification of oil from the micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695) Test Specification Free fatty acids Not more than 0,4 % Peroxide value (PV) Not more than 5,0 meq/kg oil Unsaponifiables Not more than 3,5 % DHA content Not less than 35 % Docosapentaenoic acid (DPA) n-6 Not more than 6 % Trans-fatty acids Not more than 2,0 %
ANNEX II Authorised uses of oil from the micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695) Food category Maximum use level of DHA 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 250 mg DHA per day as recommended by the manufacturer for normal population 450 mg DHA per day as recommended by the manufacturer for pregnant and lactating women Foods intended for use in energy-restricted diets for weight reduction as defined in Directive 96/8/EC 250 mg per meal replacement Other foods for particular nutritional uses as defined in Directive 2009/39/EC excluding infant and follow-on formulae 200 mg/100 g Dietary foods for special medical purposes In accordance with the particular nutritional requirements of the persons for whom the products are intended Bakery products (breads and rolls), 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 Used in accordance with Directive 2006/141/EC Processed cereal-based foods and baby foods for infants and young children including those used in accordance with Directive 2006/125/EC 200 mg/100 g
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.