Scientific Opinion on the extension of use for DHA and EPA-rich algal oil from Schizochytrium sp. as a Novel Food ingredient

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2014;12(10):3843 [17 pp.].
doi
10.2903/j.efsa.2014.3843
Panel members at the time of adoption
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Novel Foods: Paul Brantom, Karl-Heinz Engel, Marina Heinonen, Hannu Korhonen, Rosangela Marchelli, Monika Neuhäuser-Berthold, Annette Pöting, Morten Poulsen, Seppo Salminen, Josef Schlatter, Hendrik Van Loveren and Hans Verhagen for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2014-00218
Adopted
18 September 2014
Published
9 October 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on an extension of use for docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)-rich algal oil from Schizochytrium sp. as a novel food ingredient (NFI) in the context of Regulation (EC) No 258/97. The NFI is already authorised for use in a range of foodstuffs at specified maximum levels. The applicant requests an extension of use of the NFI in food supplements up to a maximum DHA and EPA content of 3 g per daily dose for the adult population, excluding pregnant and lactating women. In a previous opinion on the Tolerable Upper Intake Level of EPA, DHA and docosapentaenoic acid (DPA), the Panel concluded that supplemental intake of EPA and DHA combined at doses up to 5 g/day, does not give rise to safety concerns for adults. Based on estimations of high intake of DHA and EPA from the NFI which are considered to be conservative, the Panel considers that this level will not be exceeded by the use of the NFI. The conclusion that there are no safety concerns for the NFI is supported by a 90-day study in which no adverse effect was observed at the highest dose tested of 5 %, equivalentto 3.149 and 3.343 g NFI/kg body weight per day for male and female rats. Following a request from a Member State, the Panel reviewed the evidence for an association between DHA and/or EPA intake and risk of prostate cancer. The Panel considers that, on the basis of available data, there is no evidence for a role of EPA and/or DHA intake in the development of prostate cancer. The Panel concludes that the NFI is safe under the proposed extension of use.

Summary

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on a request for the extension of use for docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)-rich algal oil from Schizochytrium sp. as a novel food ingredient (NFI) in the context of Regulation (EC) No 258/97, taking into account the comments and objections of a scientific nature raised by Member States.

The NFI is already authorised for use in a range of foodstuffs at specified maximum levels of inclusion. The present application relates to the extension of the use of the NFI in food supplements up to a maximum DHA and EPA content of 3 g per daily dose for the adult population, excluding pregnant and lactating women.

The NFI is an algal oil derived from Schizochytrium sp. with minimum contents of 22.5 % DHA and 10 % EPA. No changes are proposed to the specification, the source and the production process of the authorised ingredient.

In a previous opinion on the Tolerable Upper Intake Level (UL) of EPA, DHA and docosapentaenoic acid (DPA), the Panel concluded that available data were insufficient to establish a UL for n-3 long-chain polyunsaturated fatty acids (EFSA NDA Panel, 2012). The Panel considered that supplemental intake of EPA and DHA combined at doses up to 5 g/day, does not give rise to safety concerns for adults.

Anticipated intake of DHA and EPA from the NFI was estimated by combining intake of the NFI through enriched foods and food supplements. High intakes of 4.65 g/day (combination of enriched foods and food supplements), based on consumption data from the UK, and 5.37 g (combination of conventional foods, enriched foods and food supplements), based on consumption data from Germany, were estimated. These assessments are considered conservative in that they assume that all food items within a food category contain the NFI at the maximum authorised level of use and that an individual consumes all food categories enriched with the NFI together with food supplements. The Panel considers that the long-term level of no concern of 5 g/day for supplemental DHA and EPA will not be exceeded by the use of the NFI.

The conclusion that there are no safety concerns for the NFI is further supported by a 90-day study carried out with the NFI in rats, in which no adverse effect was observed with the highest dose tested of 5 %whichis equivalentto 3.149 and 3.343 g NFI/kg body weight per day for male and female rats, respectively.

Following a request from a Member State, the Panel reviewed the evidence for an association between DHA and/or EPA intake and risk of prostate cancer. The Panel considers that, on the basis of available data, there is no evidence for a role of EPA and/or DHA intake in the development of prostate cancer.

The Panel concludes that the NFI is safe under the proposed extension of use.

Keywords
docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), Schizochytrium sp., algal oil, novel food, ingredient
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Number of Pages
17