Algae omega-3 & plant sterols seek EU approval

By Shane Starling

- Last updated on GMT

'The refined oil consistently meets a specification appropriate to its use as a food ingredient, with a minimum DHA content of 35%.' ©iStock/Magone
'The refined oil consistently meets a specification appropriate to its use as a food ingredient, with a minimum DHA content of 35%.' ©iStock/Magone

Related tags European union Docosahexaenoic acid Snack functional beverage beverage

Canadian and Chinese suppliers have applied for algae omega-3 and plant sterol approval under ‘substantial equivalence’ EU novel food rules.

Canadian algae specialist Mara Renewables Corporation has applied via the UK Food Standards Agency (FSA) to have its schizochytrum​ algae-sourced docosahexaenoic acid (DHA) omega-3 approved across the EU’s 28 member states.

Algae-sourced DHA omega-3 was first approved in the EU in 2003 in infant formulas and further approvals have extended it beyond its initial infant formula premise.

Mara seeks approval in fruit and vegetable purees, infant formula and other foods for special groups and baby foods.

“The refined oil consistently meets a specification appropriate to its use as a food ingredient, with a minimum DHA content of 35%,”​ Mara said. “The oil will provide an alternative to those other oils currently in use and it is compositionally and nutritionally equivalent to them.”

The Nova Scotia firm’s safety, efficacy and composition application to the FSA’s Advisory Committee on Novel Foods and Processes (ACNFP​) is here​.

Plant sterols

Chinese supplier X'ian Healthful Biotechnology has applied for substantial equivalence to an ADM phytosterol ester version approved in 2004.

cholesterol heart cardiovascular disease iStock vizualis
Chinese supplier X'ian wants to enter the European cholesterol-reducing sterols & stanols market. ©iStock/vizualis

Plant sterols and plant stanols are used as EU health claim-backed cholesterol-lowering nutrients in a variety of fortified food matrices in brands like Benecol (Raisio) and pro-activ (Unilever).

X'ian seeks to use its nutrient in the same categories as those approved for ADM’s sterol namely yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks and cheese type products.

Its 'LowChol'-branded sterol is manufactured by its subsidiary Shaanxi Healthful Bioengineering.

X'ian’s application is here​.

EU novel foods changes in 2018

EFSA's Parma, Italy HQ. ©EFSA

Between 1997 and 2014, there were about 170 novel food applications across the EU. That’s seven to 10 applications per year. Over 90 novel foods have been authorised for use under this member state managed system. 

The European Commission hopes this will increase under a new centralised new system, estimating EFSA will receive 15 novel food applications and 25 third country notifications each year when it takes the reins at the beginning of 2018.

The EC says the new regulation will cut average processing time from 3.5 years to around 18 months.

The ACNFP invited comments on both applications until 2 February at​.

From 2018 the European Food Safety Authority (EFSA) will process all novel food applications in a centralising move​ designed to streamline and speed up the approval process.  


The ACNFP referenced the Brexit situation noting that although Britain had by referendum voted to leave the EU on 23 June of last year, it presently remains a full member of the European Union and all the rights and obligations of EU membership remain in force.”

The agency added: “During this period the Government will continue to negotiate, implement and apply EU legislation. It will be for the Government, under the Prime Minister, to begin negotiations to exit the EU. The outcome of these negotiations will determine what arrangements apply in relation to EU legislation and funding in future once the UK has left the EU.”

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1 comment

Pilot study

Posted by Sandeep Saluja,

I use omega 3 widely in my clinical practice though many of my patients refuse non vegetarian source.
I would love to do a small informal pilot study on vegetarian source omega 3 to study patient acceptibility

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