Martek Applies for Novel Food Approval for New DHA and EPA Rich Algal Oil

Martek intends to market DHA-O at similar use levels and in similar food categories to those currently approved for its DHA-rich oil. These food categories include food supplements, bakery products, and breakfast cereals. Approval for uses in biscuits (cookies) and cooking oils is also sought.

4/5/2011 --- Martek Biosciences Corporation has applied to the UK Food Standards Agency for approval to market algal oil that is produced from Schizochytrium microalgae, as a novel food ingredient. A novel food is a food or food ingredient that does not have a significant history of consumption within the European Union before 15 May 1997.

Martek has previously gained approval to use docosahaexanoic acid (DHA)-rich oil, produced from the algae Schizochytrium sp, as a novel food ingredient. Martek has now developed an improved strain from another species of Schizochytrium microalgae that produces an oil rich in both DHA and eicosapentaenoic acid (EPA). The oil is known as DHA-O.

Martek intends to market DHA-O at similar use levels and in similar food categories to those currently approved for its DHA-rich oil. These food categories include food supplements, bakery products, and breakfast cereals. Approval for uses in biscuits (cookies) and cooking oils is also sought.

Before any new food product can be introduced on the European market, it must be assessed rigorously for safety. In the UK, the assessment of novel foods is carried out by the Advisory Committee on Novel Foods and Processes (ACNFP), an independent committee of scientists appointed by the Food Standards Agency.

According to the Martek application, the improved strain from Schizochytrium microalgae produces an oil which contains DHA as in DHA-S along with an eicosapentaenoic acid (EPA) content which is approximately half that of the DHA concentration. This DHA and EPA-rich oil (DHA-O) has a fatty acid profile that more closely represents that of other sources of long chain omega 3 oils. Martek intends to market DHA-O for similar categories to those currently approved for DHA-S, but with minor modifications to use levels to reflect recent developments in recommended daily intakes for DHA and EPA. Approval for use in biscuits (cookies) and cooking oils is also sought.

The company notes in its application that the specification of DHA-O is well defined with the principle composition being not less than 22.5% DHA and not less than 10% EPA. Oxidative stability is assured by the inclusion of acid value and peroxide value and non-detectable levels of recovery solvent residues and other contaminants are confirmed by extensive independent analyses. Detailed fatty acid and sterol analyses reveal a profile and ratio of DHA to EPA similar to those of fish/fish oils with no new components that are already present in the diet.

Dietary survey data show that mean estimated daily intakes from all uses would not exceed 0.9g of DHA+EPA (equivalent to 4 maximally fortified portions approximately) and 95th percentile intakes would not exceed 1.5g (6-7 maximally fortified portions approximately). These estimates are clearly huge over-estimations, the company writes. In addition to the extensive database already available on the Schizochytrium microalgae biomass, on DHA-S and on fish oil, Martek has conducted supporting confirmatory pre-clinical studies on DHA-O, which include a 90-day rat study and a suite of mutagenicity studies. All of these show no significant adverse effects at the maximum dose tested.

Royal DSM N.V. successfully completed the acquisition of Martek Biosciences Corporation at the end of February. The acquisition, announced on 21 December 2010, is the first major acquisition by DSM after its successful transformation into a Life Sciences and Materials Sciences company.

The acquisition, for a total consideration of about € 790 million (approximately US$ 1,087 million), is fully in line with DSM’s strategy for its Nutrition cluster (“continued value growth”) and adds a new growth platform for healthy and natural food ingredients for infant formula and other food and beverage applications, especially focused on Polyunsaturated Fatty Acids (PUFAs) such as microbial Omega-3 DHA (docosahexaenoic acid) and Omega-6 ARA (arachidonic acid).