Choosing between algal DHA and fish oil isn’t just a formulation question, it’s a regulatory one too. Here’s what EU formulators actually need to check before locking in a source.

Summary

Schizochytrium oil is approved in the EU under the Novel Food Regulation (EU) 2015/2283, typically delivering 35–55% DHA by weight, with EPA usually low unless the strain or blend is specifically designed to include it. Standard fish oil sits at roughly 18% EPA and 12% DHA, around 30% combined omega-3.

Both sources can support an EU heart-health claim under Regulation (EU) 432/2012, which requires 250 mg of combined EPA and DHA per day. Independent, ISO-reviewed life cycle assessments generally show a lower climate impact per kilogram of omega-3 for algal DHA than average fish oil, though the picture isn’t uniform across every environmental category, more on that below.

What EU Approval Actually Covers

Every Schizochytrium approval in the EU is tied to a specific strain, so a supplier’s stated DHA percentage and permitted use level need to be checked against the actual EFSA opinion or Commission Implementing Regulation, not assumed from another product’s approval.

To give a sense of range: one EFSA-assessed oil, isolated by mechanical extraction, is authorised for infant and follow-on formulae at the DHA level required by Regulation (EU) 2016/127 (20–50 mg per 100 kcal). A separately assessed oil, produced via enzymatic lysis, is authorised for food supplements up to 3 g of combined DHA and EPA per day for adults (excluding pregnant and lactating women). A third assessed oil sits at 40–43% DHA of total fatty acids. The strains differ, and so do the permitted uses, which is exactly why the underlying EFSA opinion matters more than the headline percentage.

Fish oil doesn’t go through the Novel Food route, since it has a long history of use in the EU. But once a finished product carries a health claim, both ingredients are judged against the same bar: for the heart-health claim under (EU) 432/2012, a food needs to deliver at least 250 mg combined EPA and DHA per day. A related claim on DHA’s role in brain and vision function requires at least 40 mg DHA per 100 g and per 100 kcal, again at a 250 mg daily intake.

Quick Comparison

Product typeTypical DHATypical EPANote
Standard fish oil (18/12 type)~12%~18%Not Novel Food regulated in the EU
ALGANEX Schizochytrium sp. oil 400 DHA 200 EPA (code 10714)Min. 40% (400 mg/g as TG)Min. 20% (200 mg/g as TG)EU-produced, fermentation + physical extraction; one of several concentration grades available
Schizochytrium oil, EFSA-authorised for supplementsup to 55%low unless blendedAuthorised to 3 g/day (adults)
Schizochytrium oil, EFSA-authorised for infant formula40–43%lowAuthorised for infant/follow-on formula
Any EPA/DHA source, for EU heart claimn/an/a250 mg combined EPA + DHA/day required

Where ALGANEX fits: our Schizochytrium sp. oil 400 DHA 200 EPA is unusual in offering a meaningful EPA level alongside high DHA, min. 400 mg/g DHA and min. 200 mg/g EPA as triglycerides (385 mg/g and 192 mg/g as free fatty acids), with total omega-3 at min. 650 mg/g as TG. That’s closer to a balanced EPA:DHA profile than most algal oils on the market, which tend to be DHA-heavy with little to no EPA, making it useful for formulations seeking a more balanced omega-3 profile without sourcing fish. t’s sourced from European production using fermentation and physical extraction without solvent, refined in the EU, and not irradiated — with every batch independently tested by ALGANEX against our full specification before it reaches you. Quality parameters are tightly controlled (max. 0.5 mg KOH/g acid value, max. 3.0 meq O2/kg peroxide value, max. 20% Totox), with heavy metals, dioxins, PCBs and PAHs all tested against strict limits. It’s non-GMO, allergen-free under (EU) 1169/2011, and shelf-stable for 24 months at room temperature. Different DHA concentration levels are available on request, so formulators can get in touch to find the profile that best fits their specific formulation and nutritional requirements.

Sustainability: What the Evidence Actually Shows

This is the section where formulators most often get sold a story rather than a number, so it’s worth sticking to what’s been independently verified.

An independent, peer-reviewed life cycle assessment using real industrial process data found algal DHA production compares favourably to fish oil on climate change and acidification impact. The same study flagged a trade-off: particulate matter emissions were higher for the algal route, due to air emissions from combusting bagasse as a process fuel. It also pointed out a modelling gap that’s easy to miss, current LCA methods don’t capture marine fisheries under land-use impact categories the way they capture land-based fermentation, so land-use comparisons between the two ingredient types should be read with that gap in mind rather than taken at face value.

On the fish oil side, the industry itself has been moving away from simple metrics like Fish In:Fish Out, since a ratio alone doesn’t distinguish a well-managed fishery from a poorly managed one. Industry stock data indicates that roughly 46% of forage fish stocks tracked sit below the abundance level used to classify a stock as overfished, though these depleted stocks represent a smaller share, around 20%, of average catch volume. In other words: sustainability within fish oil varies a lot by species, fishing region and fishery management, it isn’t a single number either.

The practical takeaway: neither ingredient class wins across every environmental category. Algal oil tends to look better on climate impact per kilogram of omega-3; fish oil’s footprint is highly dependent on which fishery and species it comes from. If sustainability is part of your product story, ask your supplier which impact category their claim is based on, and whether it’s backed by an ISO-reviewed or peer-reviewed assessment, not just a headline percentage.

What This Means for You, in Three Checks

  1. Ask your supplier for written confirmation that the specific oil you’re sourcing is authorised under Regulation (EU) 2015/2283 for your intended use — not just that ‘Schizochytrium oil’ in general is approved. A supplier able to issue a Declaration of Compliance referencing the applicable Commission Implementing Regulation has already done the strain-specific check on your behalf.
  2. Decide whether you need a fish-oil-like EPA:DHA balance or a high-DHA, low-EPA profile. Most algal oils skew heavily toward DHA; ALGANEX’s 400/200 oil provides a comparatively balanced algal omega-3 profile, with minimum 40% DHA and 20% EPA as triglycerides, rather than the strongly DHA-dominant profile typical of many algal DHA oils. Other DHA concentrations are available on request, get in touch to discuss your specific requirements.
  3. Ask which environmental impact category any sustainability claim is measured against, and whether it’s independently verified, since algal and fish-sourced omega-3 don’t rank the same way across carbon, particulate matter, and land use.

References: 

Davis, D., Morão, A., Johnson, J. K., & Shen, L. (2021). Life cycle assessment of heterotrophic algae omega 3. Algal Research, 60, 102494. https://doi.org/10.1016/j.algal.2021.102494

European Commission. (2012). Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods. Official Journal of the European Union, L136, 1–40.

European Commission. (2016). Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 as regards specific compositional and information requirements for infant formula and follow-on formula. Official Journal of the European Union, L25.

European Commission. (2022). Commission Implementing Regulation (EU) 2022/1365 of 4 August 2022 authorising an extension of use of DHA and EPA rich oil from the microalgae Schizochytrium sp. as a novel food. Official Journal of the European Union.

European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens. (2014). Scientific opinion on the extension of use for DHA and EPA rich algal oil from Schizochytrium sp. as a novel food ingredient. EFSA Journal, 12(10), 3843. https://doi.org/10.2903/j.efsa.2014.3843

European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens. (2020). Safety of Schizochytrium sp. oil as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 18(10), e06242. https://doi.org/10.2903/j.efsa.2020.6242

European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens. (2025). Safety of oil from Schizochytrium limacinum (strain ATCC 20889) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal.

European Parliament and Council of the European Union. (2015). Regulation (EU) 2015/2283 of 25 November 2015 on novel foods. Official Journal of the European Union, L327, 1–22.

IFFO, The Marine Ingredients Organisation. (n.d.). The status of forage fish. https://www.iffo.com/status-forage-fish

IFFO, The Marine Ingredients Organisation. (2025). Upgrading the downgraded. https://www.iffo.com/upgrading-downgraded