This chapter documents significant regulatory decisions, EFSA scientific opinions, Commission implementing decisions, and enforcement cases relevant to algae. It is not a comprehensive legal digest; rather it identifies the some practically important rulings and decisions that establish the current regulatory framework and that any serious algae producer or compliance professional should know. Decisions are grouped by application area.

Where a decision results in a binding measure (e.g. a Commission Implementing Regulation authorising a novel food), the binding measure is the primary reference and is cited in the relevant subject chapter; this chapter provides the regulatory context and reasoning behind key decisions.

This chapter is the place to list & describe experience in particular cases by invited contributors. Any description of the interplay between EU-level regulation and local implementation is very welcome.

• Both Spirulina (Arthrospira platensis, Limnospira fusiformis, Limnospira indica, Limnospira maxima, Spirulina major) and Chlorella (Auxenochlorella protothecoides, Auxenochlorella pyrenoidosa, Chlorella pyrenoidosa, Chlorella sorokiniana, Chlorella vulgaris, Coelastrella vacuolata, Graesiella emersonii, Heterochlorella luteoviridis, Jaagichlorella luteoviridis, Parichlorella kessleri) have a documented history of use as food prior to 1997 in the EU.
• The Commission's Novel Food Catalogue and EFSA assessments confirm that dried Spirulina and Chlorella biomass in tablet and powder form sold as food supplements and food ingredients have a sufficiently documented history of use in the EU to be considered established foods, not novel foods, when used in equivalent forms and at equivalent intakes to those historically marketed.
• The list is extended as requested by national competent bodies demonstrating use before May 1997; several of the above species were added in 2025.
• The list vaguely follows taxonomic changes (e.g. Arthrospira renamed to Limnospira); at some point there were 3 species of Chlorella listed and none of them existed in the up-to date taxonomy.
• This determination is product and use-specific: new forms of Spirulina-derived ingredients (extracts, phycocyanin isolates at higher purity levels, etc.) may have different novel food status — check the Novel Food Catalogue for each specific product form.
• Entry to the list of non-novel foods is voluntary: it is up to the Food Business Operator, when placing products on the market, to be able to prove a history of consumption as a foodstuff before 15 May 1997; presence on the non-novel food list is an easy way to provide such proof.

The following comprehensive table includes all algal species and major algae-derived ingredients (oils, extracts) that have been formally entered into the EU Union List of Novel Foods, alongside the respective historical entries, current status, original applicants, and the two requested pending/terminated cases (Galdieria and Chlamydomonas):

Notes:

• The Chlamydomonas reinhardtii Status: While Chlamydomonas reinhardtii is commonly utilized as a laboratory model organism and has seen limited clearances in other jurisdictions like the US FDA, it is not authorized as a novel food ingredient in the EU. The European Commission officially issued an Implementing Decision on September 10, 2025, terminating the evaluation procedure for its authorisation without adding it to the Union list due to unresolved safety documentation bottlenecks. EFSA, NIH, BioSafe.
• The Galdieria sulphuraria Status: Galdieria sulphuraria is on the final stretch of the EU pipeline. In March 2026, EFSA published an update establishing a stable Acceptable Daily Intake (ADI) and concluding that it did not present safety concerns under defined quantities. It is currently waiting for the European Commission and SCoPAFF to codify its maximum use limits into law before it can officially debut on the market Givaudan, Sagenta.

• Subsequent authorisations for DHA/EPA oils from Crypthecodinium cohnii followed a similar assessment logic.
• EFSA NDA Panel opinion: Scientific Opinion on the Tolerable Upper Intake Level of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA), EFSA Journal 2012; 10(7):2815, 48 pp. https://doi.org/10.2903/j.efsa.2012.2815, also see EFSA articles referenced there.

• The EFSA opinion noted concerns about upper limit intakes due to potential accumulation and interactions with other carotenoid sources (particularly from aquaculture-origin astaxanthin); the authorisation includes specific conditions of use limiting the daily intake and requiring labelling advisory notes for certain population groups.
• EFSA NDA Panel, Scientific Opinion on the safety of astaxanthin for its use as a novel food in food supplements. EFSA Journal 2020;18(2):5993, 9 pp. https://doi.org/10.2903/j.efsa.2020.5993

• Although it is commonly known (or at least assumed) that Astaxanthin is one of the most powerful antioxidants, it is not allowed to claim “antioxidant activity” as a health claim label on Astaxanthin extract packages by Regulation (EC) No 1924/2006.
• Any health claim displayed on a product label must be explicitly evaluated by the EFSA and authorized by the European Commission.
• “Antioxidant” is a Specific Health Claim: The term “antioxidant” or “antioxidant activity” is not a simple description; EFSA considers it a specific health claim because it implies a physiological function or benefit within the human body. ASA/CAP UK, Nutraingredients.
• EFSA's Negative Opinions: The EFSA evaluated multiple submissions seeking to link astaxanthin consumption to antioxidant properties, protection of DNA/proteins/lipids from oxidative damage, or skin protection. EFSA issued negative opinions, concluding that a cause-and-effect relationship between astaxanthin intake and these specific health benefits had not been sufficiently substantiated by clinical data. EFSA Journal 2009; 7(9):1253, EFSA Journal 2011;9(6):2206, Stachowiak-Szulc 2021, deBoer, etal 2014.
• Not in the Union Register: Because of EFSA's rejection, astaxanthin does not possess any authorised health claims on the official EU Register of Nutrition and Health Claims. EU labelling, ASA/CAP UK.

Phycocyanin extract is a common ingredient. It is produced in large quantities from Limnospira sp.; recently, new sources are available, such as Galdieria sp.. Several authors have also proposed using wastewater-grown cyanobacteria for phycocyanin extraction. Some producers call the extract Blue Spirulina (which might be misleading for consumers). Let us examine various options.

The regulatory framework for phycocyanin extract in the EU depends heavily on its microalgal source and intended technological function (e.g., whether it is used as a food supplement, a general food ingredient, or a food additive/colourant). Novel food catalogue. Phycocyanin is governed by several distinct EU listings and regulations:

• From Standard Spirulina (Limnospira platensis): Whole dried Spirulina has a documented history of consumption in the EU prior to May 15, 1997. Therefore, standard Spirulina is not novel
• The Novel Food Status (Regulation 2015/2283) The EU Novel Food Status Catalogue treats phycocyanin differently based on the organism it was extracted from:
  • Liquid or powder phycocyanin extracts derived directly from Limnospira platensis can be sold as food supplements or general food ingredients without a full pre-market novel food authorisation, provided the extraction process does not alter the nature of the plant or introduce concentrated hazards. EABA Novel Food.
  • From Novel Algae Sources: If phycocyanin is extracted from a microalgae species that lacks a consumption history before 1997, the extract must go through a novel food safety assessment and be added to the Union List of Novel Foods (Regulation (EU) 2017/2470) before hitting the market. EU4Algae – Protocol to apply for a Novel Food dossier, 2025

• The Food Additives Regulation (EC 1333/2008)
  • When phycocyanin extract is isolated and added to food specifically for its vibrant blue pigment (to impart colour), it legally falls under the scope of EU Food Additive rules rather than general food ingredients. Safety evaluation of blue galdieria extract as a food additive. EFSA Journal, 24(3), e9960, EABA Novel Food
  • Colouring Foods vs. Food Additives: Standard aqueous extracts of phycocyanin from Limnospira platensis are highly utilized across Europe as a “colouring foodstuff” (clean-label ingredient, no E-number required) because they retain the essential characteristics of the parent algae Lauzeri et al 2023.

• New Additive Approvals: For other species, explicit additive evaluations take place. For instance, the European Food Safety Authority (EFSA) evaluated an application for “Blue Galdieria Extract” (a phycocyanin-rich extract from the microalgae Galdieria sulphuraria) to authorise it as an official food additive/colorant across several food categories. Safety evaluation of blue galdieria extract as a food additive. EFSA Journal, 24(3), e9960.

• Cosmetics Regulation (EC 1223/2009): If you intend to use phycocyanin extract topically, it is catalogued in the EC Cosmetic Ingredient Database (CosIng). It is officially recognised with the functions of an antioxidant, colourant, and light stabiliser in cosmetics. COSING database

• Textiles: If you intend to use phycocyanin extract as a textile coloring the relevant ECO labelling and Ecodesign for Sustainable Products are described in Chapter Textiles.

• Extraction from wastewater grown cyanobacterua: Phycocyanin extracted from cyanobacteria grown on wastewater could be a powerful opportunity for circular economy biorefineries, blending environmental remediation with high-value bioproduct recovery. However, the specific medium (wastewater) introduces rigorous guardrails, especially regarding human consumption.
  • In some cases (e.g. some food and beverage industries), the waste stream may be reclassified as a side-product. This includes strict separation of any waste streams from the stream that will be declared as a sideproduct and depending on the circumstances implementation of quality monitoring. Examples of such strems: cleaning solutions in milk industry, cooking water of vegetables and similar. In those cases cultivation of cyanobacteria in such media is no different than cultivation in artificial media: we have to monitor the species for any toxic cyanobacteria strains and any foreign heterotrophic bacteria, funghi or other organisms that may contaminate the product.
  • We may produce extracts for non-food use, like textile colorants, biostimulants (but cyanobacteria are not allowed as CMC 2 or CMC 4 by Fertilizer Product Regulation). A final product quality monitoring would be required in such cases as part of the end-of-waste process.
  • We may overdo the extraction and purification steps. For example te purification required to produce ultra pure pycocyanin extract used as a fluorescent marker in biochemical applications might be good enough to remove all potential contaminants.
  • the same processes applied to pjycocyanin extract may render it clean and safe enough for food applications. The usual food grade phycocyanin criteria is absorbance ratio (A₆₂₀/A₂₈₀) > 0.7. Such process would have to be continuously monitored well beyond this criteria for zero trace levels of: Heavy metals (e.g., lead, cadmium, mercury, arsenic), Contaminants of emerging concern (CECs), including antibiotics, microplastics, endocrine disruptors, and industrial detergents, Pathogens (e.g., E. coli, Salmonella) and harmful cyanotoxins (like microcystins) which can co-occur if the culture is contaminated by wild strains. Bellver et al, 2025

When we factor in all the risks and overheads involved in using wastewater as the growth medium for producing a high-value product, it usually turns out that reduced environmental impact and reduced costs are simply not commercially justified. It is simply too hard to merge the bioremediation with production of high-value products (but some good working use cases do exist).

• EFSA CONTAM Panel, “Risks for human health related to the presence of chromium in food” and the companion opinion on iodine exposure are foundational for understanding iodine limits in seaweed products, .
• EFSA CONTAM Panel (2006) Scientific Opinion on iodine in food: established the Upper Tolerable Intake Level for iodine for adults and specific population groups.
• These opinions underpin Commission Recommendation (EU) 2018/464 on monitoring metals and iodine in seaweed, and the use of member state guidance values for maximum iodine in seaweed products (absence of EU harmonised MRL for iodine in dried seaweed as of 2026 — relevant EFSA opinion to follow) EFSA Journal 2023; 21(1):7798.

• EFSA has commissioned a study Review and analysis of occurrence, exposure and toxicity of cyanotoxins in food prepared in 2016 by ISS and ANSES Testai, et al., 2016. It proposes tolerable daily intakes (TDIs) for microcystin-LR, cylindrospermopsin, and other cyanotoxins. These TDIs form the basis for risk management guidance at the member-state level and for RASFF notifications relating to cyanotoxin contamination in Spirulina and Chlorella supplements.
• EFSA has established an Emerging Risks Exchange Network and Stakeholders Discussion Groiup in 2021. As part of this activity, significant discussion focused on BMAA (β-methylamino L-alanine), a cyanoneurotoxin present in cyanobacteria, presumably including Spirulina. Because of intense analytical challenges and key data gaps, it didn't debut as a standard independent CONTAM opinion with strict regulatory limits, but was heavily processed through EFSA's internal bodies and external mandates focusing on natural toxins in food supplements EFSA’s activities on emerging risks in 2021, EFSA's Activities on Emerging risks in 2023, Manolidi, et al, 2018. Recent work even questions the fact that cyanobacteria produce BMMA as it is highly toxic to them. Wang et al, 2023

• EFSA CONTAM Panel (2009, updated) established a benchmark dose for inorganic arsenic. Seaweed, particularly hijiki (Sargassum fusiforme), accumulates inorganic arsenic at levels of concern. Several EU member states issued advisories against consumption of hijiki; some member states (UK pre-Brexit, France, Belgium) set guidance values or issued warnings EFSA Arsenic Update.
• The hijiki case is the most significant enforcement-relevant case for seaweed contaminants in EU history and explains why EU-harvested seaweed (generally lower in inorganic arsenic than Asian seaweeds) is positioned as a lower-risk alternative in regulatory discussions Seaweeds for food: from production to consumer Ch 3.

• EFSA FEEDAP Panel opinions on astaxanthin for use in aquaculture feed (Salmo salar, other salmonids) established the safety, efficacy and conditions of use for synthetic and algae-derived astaxanthin as a feed colourant (zootechnical additive — skin colourant) EFSA Journal 2014; 12(6):3725.
• The Commission authorisations under Regulation 1831/2003 are binding measures; the EFSA FEEDAP opinions (multiple, updated several times) provide the scientific basis. The most recent opinions assess the tolerance of target animals, environmental impact, and consumer safety of residues EFSA Journal 2014; 12(6):3724.

• EFSA FEEDAP opinions on specific microalgae species as whole biomass feed materials (e.g. Schizochytrium sp., Thraustochytrid microalgae, Nannochloropsis spp.) address safety for target animals and the environment. These opinions inform feed business operator decisions on species use within and outside the Catalogue of Feed Materials framework. EFSA Journal 2005; 3(12):291 , EFSA Journal 2022; 20(2):e07161, EFSA Journal 2014; 12(6):3724, EFSA Journal. 2023;21:e8415

• While Undaria pinnatifida (wakame, a Pacific kelp) is classified as an invasive alien species globally and is listed as a species of Member State concern within the EU, it is not currently included on the IAS List of Union Concern under Regulation (EU) No 1143/2014. This means there is no blanket EU-wide ban on its commercial use or open-water cultivation. 100 World Most Invasive species, EASIN, Marine Strategy Framework Directive – Descriptor 2, Non-Indigenous Species
• However, because it is recognized as a highly disruptive marine invader, aquaculture operators face a fragmented legal landscape. Restrictions are heavily enforced at national borders Alien Species Alert: Undaria pinnatifida.
• National Restrictions: Individual nations have placed strict localized bans on it. For example, in Ireland, it is explicitly prohibited to plant or distribute wakame under strict domestic biodiversity laws Ireland list of Invasive Species.
• The Aquaculture Regulation: For many EU producers, introduction is governed by Regulation (EC) No 708/2007 concerning the use of alien and locally absent species in aquaculture, which requires robust risk assessments for open-water farming Food Risk Assess Europe.

• Gracilaria vermiculophylla is not listed as an Invasive Alien Species (IAS) of Union Concern under Regulation (EU) No 1143/2014 van der Loos, et al, 2023. While it is a highly invasive Asian red alga that has widely naturalised across European coastal lagoons and estuaries, it has been repeatedly passed over for inclusion on the Union List. Tsiamis et al, 2020, Global Invasive Species Database, Sfriso et al, 2012.
• Its widespread naturalization means it fails the EU’s criteria for coordinated Union-level containment. Consequently, commercial cultivation bottlenecks or wild-harvest allowances are determined strictly by national legislation (e.g. listed in Spain Invasive algae species, monitored and exploited in Danmark Jensen et al, 2023 ) and regional environmental agencies rather than an overarching EU-wide ban.

The Expert Group for Technical Advice on Organic Production (EGTOP) operates as an independent technical advisory body for the European Commission. It does not act on its own accord; instead, the initiative for evaluating these substances originates from EU Member States, who formally submit product dossiers to the European Commission. The Commission then issues an official mandate to EGTOP to evaluate if the inputs align with the core principles of the EU organic framework. EGTOP 2021, EGTOP 2026, SWD (2014) 66.

Here we list all EGTOP decisions related to algae:

The RASFF (Rapid Alert System for Food and Feed) portal at rasff-window contains historical notifications relevant to algae. Searching for “algae”, “spirulina”, “chlorella”, “seaweed”, “nori”, “wakame”, and “kelp” reveals patterns of enforcement action. Common grounds for 100 checked RASFF notifications relating to algae products include:

• 52 had high iodine content,
• 10 had norovirus presence,
• 6 had heavy metal contamination,
• 6 had undeclared sulphite content in organic Spirulina,
• 6 had ingredients not on novel food list,
• 6 had unauthorized ingredients (undeclared colorants or similar)
• 5 had other toxic substances (disinfectant, dioxin, biphenyl
• 4 had elevated PAH in Spirulina food supplement,
• 4 had bacterial contamination
• 1 contained microcystin

Producers should search the RASFF portal for their specific product type to understand the contaminant and compliance issues that have historically triggered enforcement actions.

See also: Novel Food | Food Quality and Safety | Environment and Use of Non-native Species | Specialised Sources — Bibliography | Frequently Asked Questions

Last reviewed: June 2026.