Commission Implementing Decision (EU) 2015/546 of 31 March 2015 authorising an extension of use of DHA and EPA-rich 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 (notified under document C(2015) 2083)
DHA and EPA-rich 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 use defined and at the maximum level established in Annex II without prejudice to the provisions of Directive 2002/46/EC.
The designation of DHA- and EPA-rich oil from the micro-algae Schizochytrium sp. authorised by this Decision on the labelling of the foodstuffs containing it shall be βDHA and EPA-rich oil from the micro-algae Schizochytrium sp.β.
This Decision is addressed to DSM Nutritional Products, 6480 Dobbin Road, Columbia, MD 21045, USA.
Supplementary provisions
ANNEX ISupplementary provisions
ANNEX I
Specification of DHA (docosahexaneoic acid) and EPA (eicosapentaenoic acid)-rich 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 22,5 %
EPA content
Not less than 10 %
ANNEX IISupplementary provisions
ANNEX II
Authorised uses of DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid)-rich oil from the micro-algae Schizochytrium sp.
Food category
Maximum use level of DHA and EPA (mg/day)
Food supplements
3Β 000 mg as recommended by the manufacturer for adult population excluding pregnant and lactating women
Source: EUR-Lex (Publications Office of the EU), Β© European Union, reuse permitted under Commission Decision 2011/833/EU.