DHA Algal Oil: EU Novel Food Approvals & Market Trends

The Development and Production of DHA Algal Oil

Long-chain polyunsaturated fatty acids (LCPUFAs) play a critical role in immune regulation and neurological development. As they cannot be synthesized by the human body, they must be obtained through dietary intake. Docosahexaenoic acid (DHA), in particular, is a key structural fatty acid in the brain and retina, and is essential for infant cognitive and visual development. Traditionally, DHA has been sourced from fish oil derived from marine fish such as salmon, mackerel, and tuna.

However, growing concerns over heavy metal contamination, microplastic pollution and the overexploitation of marine fish stocks are increasingly challenging the sustainability and safety of fish oil as a DHA source. These challenges, driven largely by global industrialization, have positioned microalgae oils, particularly Schizochytrium sp. oil, as a promising and sustainable alternative.

Microalgae oil is a functional lipid derived from natural microalgae, produced through microbial fermentation, high-density directed cultivation, and precision refining technologies. Its core advantage lies in its ability to efficiently enrich essential long-chain polyunsaturated fatty acids such as DHA and EPA through a sustainable, plant-based approach. The entire production process is conducted under strict clean-control conditions, eliminating the risk of harmful contaminants often found in natural environments. The resulting oil is fully compatible with the dietary needs of sensitive populations, including vegetarians and infants.

DHA microalgae oil is primarily produced via microbial fermentation using strains such as Schizochytrium sp., Ulkenia amoeboida, or Crypthecodinium cohnii. It delivers outstanding performance in terms of fatty acid purity, safety, and oxidative stability, and has been widely adopted in infant formula, nutritional products for pregnant and lactating women, and functional supplements.

EU Novel Food-Approved DHA Microalgae Oil

As one of the world's most rigorous food safety frameworks, the EU Novel Food regulation provides a strong validation of quality and safety for ingredients authorized under its system. The widespread approval of Schizochytrium sp. oil across multiple EU Novel Food authorizations represents a significant endorsement of its quality and safety on the international stage.

Currently authorized DHA microalgae oils include:

Market and Regulatory Analysis of Microalgae Oil

DHA Microalgae Oil

In 2024, global sales of DHA microalgae oil exceeded USD 1.6 billion and are projected to surpass USD 3 billion by 2031. North America and Europe, as the world's largest consumer markets for DHA microalgae oil, together account for over 50% of the global market share. Infant formula remains the largest downstream application, representing 50% of the total market.

Beyond its core application in infant nutrition, the application landscape for microalgae oil continues to expand, driven by growing consumer health awareness. Emerging use cases span functional foods for middle-aged and elderly populations (such as products supporting brain health and cardiovascular wellness), mainstream foods positioned around the "healthy nutrition" proposition, pet foods and supplements (with a focus on coat health), and cosmetics (leveraging antioxidant and moisturizing benefits). This diversification reflects a multi-scenario, multi-population application footprint.

To date, two Chinese companies, CABIO and Tianke Biotech, have obtained EU Novel Food authorization for their DHA-rich Schizochytrium sp. oils, primarily for use in infant and follow-on formula (IF and FOF). The EU Novel Food approval not only removes the key regulatory barrier to market entry and expansion across Europe, but also serves as a strong third-party validation of product safety and manufacturing quality, delivering multiple strategic benefits for business growth.

EPA Microalgae Oil

While DHA microalgae oil continues to dominate the maternal and infant nutrition segment, EPA microalgae oil occupies a smaller but fast-growing niche in the broader market. EPA microalgae oil is particularly well-suited for middle-aged and elderly populations, especially those at higher risk of hyperlipidemia and hypertension. With the acceleration of global population aging and rising consumer demand for cardiovascular health support and chronic inflammation management, the expansion of EPA microalgae oil into premium dietary supplements and foods for special medical purposes (FSMP) is expected to gain further momentum.

Concurrently, regulatory frameworks are evolving to support this growth. In 2024, China's National Health Commission approved Nannochloropsis gaditana oil as a novel food ingredient through Announcement No. 5 of 2024. This approval marks another breakthrough in the microalgae novel food space for Xiaozao Technology, following its 2021 authorization of Nannochloropsis gaditana biomass as a new food raw material. Nannochloropsis gaditana oil is primarily composed of lipids, with an EPA content exceeding 20 g per 100 g of fat, enabling the extraction of relatively high-purity EPA.

In the EU market, EPA continues to be sourced predominantly through co-extraction processes, relying on fish oil, krill oil, or Schizochytrium sp. oil production streams where EPA naturally co-exists with DHA and is enriched alongside it. In contrast, the U.S. market has taken a different approach, with the FDA issuing GRAS approvals for EPA oil produced via fermentation using a genetically engineered strain of Yarrowia lipolytica. This enables a more targeted and scalable production of EPA with a simpler fatty acid profile.

Preparing for EU Novel Food Application for Microalgae Oil

The EU Novel Food application process is administered by the European Commission (EC), which handles the administrative review, while the scientific risk assessment is conducted by the European Food Safety Authority (EFSA). Under the regulatory framework, EFSA is required to complete its assessment within nine months; however, this timeline may be extended if additional data or clarifications are requested. Based on EFSA's safety evaluation, the European Commission then makes the final decision on whether to grant the Novel Food authorization, with a regulatory timeline of seven months.

The dossier submitted for EFSA's scientific assessment primarily includes the following components:

For microalgae strain selection, it is advisable to prioritize strains that have already obtained relevant approvals or are included in the EU Qualified Presumption of Safety (QPS) list. This approach can significantly reduce the amount of toxicological data preparation required. Furthermore, based on statistical analysis of EFSA review timelines, a comprehensive and well-prepared dossier can shorten the overall approval cycle by over one year, effectively accelerating time-to-market and enabling products to capture a first-mover advantage.

As the development and application of novel food ingredients increasingly become a focal point of the global food industry, REACH24H has compiled the White Paper on Global Regulatory Frameworks for Novel Food Ingredients to help companies navigate regulatory requirements across different jurisdictions and efficiently execute their global market strategies. This white paper covers national regulatory frameworks, competent authorities, approval procedures, application documentation requirements, and key considerations for successful market access.