Ocean Nutrition Canada seeks algal omega-3 oil approval in EU

24-Jan-2012 - Last updated on 24-Jan-2012 at 13:36 GMT

Ocean Nutrition Canada has applied to have an omega-3 algal oil approved under European Union novel foods regulations – stating it is ‘substantially equivalent’ to an existing approved oil manufactured by Martek-DSM.

The novel foods process allows for the fast-track approval of nutrients and foods if they are proved to be similar to existing products on-market.

“The company, Ocean Nutrition, has applied for an opinion on the equivalence of a docosahaexanoic acid (DHA)-rich algal oil, compared with a DHA-rich algal oil from the microalgae Schizochytrium produced by Martek Biosciences,” said the UK’s Food Standards Agency expert Advisory Committee on Novel Foods and Processes (ACNFP).

The Martek approval came in 2003 and was broadened in 2009 to include a wide variety of foodstuffs including food supplements, bakery products and breakfast cereals.

Comments on the application are open until February 13 and can be submitted here.

Non-fish DHA

ONC is the world’s biggest omega-3 fish oil supplier for food and food supplement applications, but has been working on algal versions for some time. Approval will allow it to compete with Martek in the infant formula and other markets that Martek dominates with its well-established DHA versions.

Acquired by DSM for €800m in 2011, Martek is the world’s leading supplier of algal-sourced DHA ingredients whose most common application is the near-ubiquitous addition to infant formulas, often in combination with ARA (arichidonic acid).

Martek itself moved a little into ONC territory late last year when the ACNFP issued a preliminary novel foods approval for an algal-based DHA-EPA (eicosapentaenoic acid) blend, including new levels of 450mg per day for pregnant and lactating women. That approval remains to be ratified at EU level.

The draft novel foods approval acknowledged that much of the science was alread\ in place to back the safety and efficacy of the ingredient, as the DHA-EPA version was derived from the same Schizochytrium algae species as Martek's DHA version that is already approved in the EU.

“The applicant concludes that these studies demonstrate that the intake of DHA-O arising from consumption in the proposed food categories does not give rise to any safety concerns noting that their NOAEL value equates to consumption of approximately 200g of DHA-O per day for a 60kg adult,” the ACNFP said.

It added: “The Committee highlighted that current policy in the UK is to encourage the intake of long chain n-3 polyunsaturated fatty acids and that this product may help consumers with low intakes to increase their consumption of n-3 fatty acids.”

3 comments

n-hexane residue is not academically real

Posted by Scott Doughman, PhD, 03 February 2012 - 20:39 GMT

The lipid science indicates one thing, nothing. The possibility of residue is only created out of the use of the word residue. That no residue has ever been detected is not enough to convince, yet it is academically true that no residue exists in the detection, yet required listings of process to the FDA must acquiesce that it is under a minimum and no further information is allowed. This opens the door. Most omega-3 oils are extracted this way.

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What about the n-hexane residual in Martek's oils

Posted by F. Varga, 26 January 2012 - 23:00 GMT

The safety of the algae as a food stuff may be fine but the oil extraction process adding a neuro toxin, a toxic solvent, to extract the oil is a very different product.

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Substantial Equivalence Novel Foods and GRAS

Posted by Dr John Wilkinson, 25 January 2012 - 12:48 GMT

I have had so many enquiries regarding approval relating to DHA that if this one goes through, there will be an avalanche of applications like there were for phytosterols a few years ago.
At that point the FSA/EFSA start to slow down and limit applications because of potential of “overdosing” to the public of a particular nutraceutical.
The message: “don’t hang about waiting too long. In my experience, it takes 6 months – 1 year before other substantial equivalent applications are filed. That’s a long lag time that lets the initial applicants get ahead with marketing to over 500 million people in 27 EU member states. This is because once you get novel foods approval via one EU state and agreed by the European Commission, you also get to market it in all other 26 member states as well (conditions do apply). We have also used the novel food application as supporting evidence of safety to obtain GRAS status in the USA and makes it much easier to obtain.

Director, Herbal Sciences International Ltd, UK. Regulatory approval experts in the EU and USA

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