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)

• CELEX: Regulation (EC) No 258/97
• Articles: 6

Article 1

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

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

Article 3

Decisions 2003/427/EC and 2009/778/EC are hereby repealed.

Article 4

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

Schedules & Appendices

ANNEX I SPECIFICATION OF OIL FROM THE MICRO-ALGAE SCHIZOCHYTRIUM SP.

ANNEX I

SPECIFICATION OF OIL FROM THE MICRO-ALGAE SCHIZOCHYTRIUM SP.

Test

Specification

Acid value

Not more than 0,5 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 %

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

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