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)

• CELEX: Implementing Decision (EU) 2015/545
• Articles: 5

Article 1

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.

Article 2

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)’.

Article 3

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

Schedules & Appendices

ANNEX I

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

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