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Commission Implementing Decision of 14 July 2014 on authorising the placing on the market of oil from the micro-algae Schizochytrium sp. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council and repealing Decisions 2003/427/EC and 2009/778/EC (notified under document C(2014) 4670)

Commission Implementing Decision of 14 July 2014 on authorising the placing on the market of oil from the micro-algae Schizochytrium sp. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council and repealing Decisions 2003/427/EC and 2009/778/EC (notified under document C(2014) 4670)

Regulation (EC) No 258/97 Β· Decision Β· 6 articles

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†—

Article 1

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Oil from the micro-algae Schizochytrium sp. 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 the Annex II without prejudice to the provisions of Directive 2002/46/EC, Regulation (EC) No 1925/2006, Directive 2009/39/EC and Directive 96/8/EC.

Article 2

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The designation of oil from the micro-algae Schizochytrium sp. authorised by this Decision on the labelling of the foodstuffs containing it shall be β€˜oil from the micro-algae Schizochytrium sp.’.

Article 4

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This Decision is addressed to DSM Nutritional Products, 6480 Dobbin Road, Columbia, MD 21045, USA.

Supplementary provisions

SPECIFICATION OF OIL FROM THE MICRO-ALGAE SCHIZOCHYTRIUM SP.

ANNEX ISupplementary provisions

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ANNEX I SPECIFICATION OF OIL FROM THE MICRO-ALGAE SCHIZOCHYTRIUM SP. Test Specification Acid value Not more than 0,5Β mg KOH/g Peroxide value (PV) Not more than 5,0 meq/kg oil Moisture and volatiles Not more than 0,05 % Unsaponifiables Not more than 4,5 % Trans-fatty acids Not more than 1,0 % DHA content Not less than 32,0 %

AUTHORISED USES OF OIL FROM THE MICRO-ALGAE SCHIZOCHYTRIUM SP.

ANNEX IISupplementary provisions

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ANNEX II AUTHORISED USES OF OIL FROM THE MICRO-ALGAE SCHIZOCHYTRIUM SP. 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

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Source: EUR-Lex (Publications Office of the EU), Β© European Union, reuse permitted under Commission Decision 2011/833/EU.

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