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) (Only the English text is authentic)
Grade B
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Address https://gelex.eu/eli/EU/decision/2015/546@2015-03-31/en
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, and in particular Article 7 thereof,
Whereas:
(1) On 6 July 2012, the competent authorities of the United Kingdom authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of docosahexaenoic acid (DHA) and eicosapentaenoic (EPA)-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient to be used in certain foods.
(2) On 19 November 2012, the company DSM Nutritional Products made a request to the competent authorities of the United Kingdom for extension of use of DHA and EPA-rich oil from micro-algae Schizochytrium sp. as a novel food ingredient.
(3) On 29 April 2013, the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that the extension of use of this algal oil meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.
(4) On 9 July 2013, the Commission forwarded the initial assessment report to the other Member States.
(5) Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.
(6) On 25 March 2014, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment of the extension of use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient in accordance with Regulation (EC) No 258/97.
(7) On 18 September 2014, EFSA adopted a scientific opinion on the extension of use for DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient, concluding that it is safe under the proposed uses and use levels.
(8) That opinion gives sufficient grounds to establish that DHA and EPA-rich oil from the micro-algae Schizochytrium sp. in the proposed uses and use levels complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.
(9) Directive 2002/46/EC of the European Parliament and of the Council lays down requirements on food supplements. The use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. should be authorised without prejudice to the requirements of that legislation.
(10) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS DECISION:
Article 1
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.
Article 2
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 DHA and EPA-rich oil from the micro-algae Schizochytrium sp..
Article 3
This Decision is addressed to DSM Nutritional Products, 6480 Dobbin Road, Columbia, MD 21045, USA.
Done at Brussels, 31 March 2015. For the Commission Vytenis Andriukaitis Member of the Commission
ANNEX
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 0,5 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 22,5 % EPA content Not less than 10 %
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 3000 mg as recommended by the manufacturer for adult population excluding pregnant and lactating women
Versions
Cited by
- Commission Implementing Regulation (EU) 2025/1549 of 30 July 2025 correcting Implementing Regulations (EU) 2023/2210 and (EU) 2022/1365 as regards the conditions of use of the novel foods 3-Fucosyllactose produced by a derivative strain of Escherichia coli K-12 DH1 and Schizochytrium sp. oil rich in DHA and EPA (Text with EEA relevance) Regulation · Grade B
In 2015, Commission Implementing Decision (EU) 2015/546 authorised a change to the conditions of use of Schizochytrium sp. oil rich in DHA and EPA, increasing the maximum levels of DHA and EPA in food supplements for the adult population, with the exception of pregnant and lactating women, to 3000 mg/day.
- Commission Implementing Regulation (EU) 2022/1365 of 4 August 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA (Text with EEA relevance) Regulation · Grade B
Commission Implementing Decision (EU) 2015/546 amended the conditions of use of Schizochytrium sp. oil rich in DHA and EPA. In particular, the use of Schizochytrium sp. oil rich in DHA and EPA has been extended to additional foods, namely, food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council.
- Commission Implementing Regulation (EU) 2022/1365 of 4 August 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA (Text with EEA relevance) Regulation · Grade B
The Commission considers that the requested update of the Union list is not liable to have an effect on human health and that a safety evaluation by the European Food Safety Authority (the Authority) in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. The requested extension of use will result in intakes of Schizochytrium sp. oil rich in DHA and EPA which, combined with the intakes from the currently authorised uses of the novel food, are comparable with the intakes assessed by the Authority as safe and which supported the authorisation of an extension of use of Sch