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| algae:cases_precedents [2026-09-06 12:36] – [Cyanotoxins in Food] robert | algae:cases_precedents [2026-09-06 15:58] (current) – [List of the microalgal species that have been added to the Union List] robert |
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| ===== Regulatory Cases and Precedents ===== | ===== Regulatory Cases and Precedents ===== |
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| 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. | 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. | 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. |
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| 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. | **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.** |
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| Notes: | Notes: |
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| * The //Chlamydomonas reinhardtii// Status | * __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. [[https://food.ec.europa.eu/food-safety/novel-food/decisions-terminating-procedure_en|EFSA]], [[https://pmc.ncbi.nlm.nih.gov/articles/PMC10778407/|NIH]], [[https://www.biosafe.fi/insight/microalgae-to-market-regulatory-essentials-for-food-innovators|BioSafe]]. |
| 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. [[https://food.ec.europa.eu/food-safety/novel-food/decisions-terminating-procedure_en|EFSA]], [[https://pmc.ncbi.nlm.nih.gov/articles/PMC10778407/|NIH]], [[https://www.biosafe.fi/insight/microalgae-to-market-regulatory-essentials-for-food-innovators|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 [[https://www.foodingredientsfirst.com/news/givaudan-everzure-galdieria-natural-blue-color.html|Givaudan]], [[https://sagentia.com/blog/natural-colours-food-and-beverage-regulations/|Sagenta]]. |
| * 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 [[https://www.foodingredientsfirst.com/news/givaudan-everzure-galdieria-natural-blue-color.html|Givaudan]], [[https://sagentia.com/blog/natural-colours-food-and-beverage-regulations/|Sagenta]]. | |
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| === Iodine in Seaweed === | === Iodine in Seaweed === |
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| * 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, "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. | * 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). | * 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) [[https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.7798|EFSA Journal 2023; 21(1):7798]]. |
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| === Cyanotoxins in Food === | === Cyanotoxins in Food === |
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| * EFSA has commissioned a study //Review and analysis of occurrence, exposure and toxicity of cyanotoxins in food// prepared in 2016 by ISS and ANSES [[https://anses.hal.science/anses-01348179/document|Testai, et al., 2016]]. It proposes tolerable daily intakes (TDIs) for microcystin-LR, cylindrospermopsin, and other cyanotoxins. These TDIs are the basis for risk management guidance at member state level and for RASFF notifications relating to cyanotoxin contamination in //Spirulina// and //Chlorella// supplements. | * EFSA has commissioned a study //Review and analysis of occurrence, exposure and toxicity of cyanotoxins in food// prepared in 2016 by ISS and ANSES [[https://anses.hal.science/anses-01348179/document|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 CONTAM Panel (2021) Scientific Opinion on BMAA (β-N-methylamino-l-alanine), a cyanotoxin present in cyanobacteria including //Spirulina//. The opinion concluded that BMAA as a neurotoxin was a concern; however data gaps limited the ability to set a health-based guidance value. This opinion will inform future regulatory action on BMAA in food 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 [[https://efsa.onlinelibrary.wiley.com/doi/pdfdirect/10.2903/sp.efsa.2023.EN-8233|EFSA’s activities on emerging risks in 2021]], [[https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/sp.efsa.2024.EN-9198|EFSA's Activities on Emerging risks in 2023]], [[https://www.researchgate.net/publication/328619194_Neurotoxin_BMAA_and_its_isomeric_amino_acids_in_cyanobacteria_and_cyanobacteria-based_food_supplements|Manolidi, et al, 2018]]. Recent work even questions the fact that cyanobacteria produce BMMA as it is highly toxic to them. [[https://www.researchgate.net/publication/373057646_Investigation_on_cyanobacterial_production_of_the_proposed_neurotoxin_b-N-methylamino-L-alanine_BMAA|Wang et al, 2023]] |
| === Inorganic Arsenic in Seaweed === | === Inorganic Arsenic in Seaweed === |
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| * 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 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 [[https://www.efsa.europa.eu/en/plain-language-summary/update-risk-assessment-inorganic-arsenic-food|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. | * 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 [[https://pub.norden.org/temanord2026-510/3-food-safety.html|Seaweeds for food: from production to consumer Ch 3]]. |
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| === Astaxanthin as Feed Additive === | === Astaxanthin as Feed Additive === |
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| * 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 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) [[https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2014.3725|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. | * 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 [[https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2014.3724|EFSA Journal 2014; 12(6):3724]]. |
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| === Algae Biomass in Feed === | === Algae Biomass in Feed === |
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| * 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 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. [[https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2005.291|EFSA Journal 2005; 3(12):291 ]], [[https://pmc.ncbi.nlm.nih.gov/articles/PMC8867524/|EFSA Journal 2022; 20(2):e07161]], [[https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2014.3724|EFSA Journal 2014; 12(6):3724]], [[https://www.efsa.europa.eu/sites/default/files/2023-12/EFS2_8415_Rev5.pdf|EFSA Journal. 2023;21:e8415]] |
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| ==== Environmental — IAS Regulation Decisions ==== | ==== Environmental — IAS Regulation Decisions ==== |
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| === Undaria pinnatifida on the IAS Union List === | |
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| * //Undaria pinnatifida// (wakame), a Pacific kelp, is listed as an Invasive Alien Species of Union Concern under Regulation (EU) 1143/2014. This listing means that deliberate release, breeding, and commercial use of live //Undaria pinnatifida// is prohibited in the EU (subject to Commission-permitted derogations for contained use under strict conditions). | === Biosecurity Status of Undaria pinnatifida in EU === |
| * This is one of the most directly commercially relevant IAS decisions for algae producers: wakame is a high-value commercial seaweed but its IAS status makes legal EU cultivation in open water systems impossible without a derogation. | |
| * Sources: Commission Implementing Regulation (EU) 2016/1141 (Union list); updated by Commission Implementing Regulations (EU) 2017/1263 and 2019/1262. Check the current consolidated list for the most recent status. | |
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| | * 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. [[https://portals.iucn.org/library/sites/library/files/documents/2000-126.pdf|100 World Most Invasive species]], [[https://easin.jrc.ec.europa.eu/spexplorer/species/factsheet/R15692|EASIN]], [[https://publications.jrc.ec.europa.eu/repository/handle/JRC124136|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 [[https://ices-library.figshare.com/articles/report/Alien_Species_Alert_Undaria_Pinnatifida_Wakame_or_Japanese_Kelp_/18624197|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 [[https://www.irishstatutebook.ie/eli/2024/si/374/made/en/print|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 [[https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/fr.efsa.2026.FR-00108|Food Risk Assess Europe]]. |
| === Gracilaria vermiculophylla on the IAS List === | === Gracilaria vermiculophylla on the IAS List === |
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| * //Gracilaria vermiculophylla//, a red alga originating from Asia, is also listed as an IAS of Union Concern. This species has become naturalised in European coastal waters and is harvested in some areas; the IAS listing complicates commercial cultivation and potentially the sale of intentionally cultivated stock, though the specifics of the derogation provisions are relevant. | * //Gracilaria vermiculophylla// is not listed as an Invasive Alien Species (IAS) of Union Concern under Regulation (EU) No 1143/2014 [[https://hal.science/hal-04373042v1/file/vanderLoos_2023_EurJPhycol.pdf|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. [[https://onlinelibrary.wiley.com/doi/full/10.1002/aqc.3267|Tsiamis et al, 2020]], [[https://www.iucngisd.org/gisd/pdf.php?sc=1698|Global Invasive Species Database]], [[https://www.researchgate.net/publication/234038502_Spreading_and_autoecology_of_the_invasive_species_Gracilaria_vermiculophylla_Gracilariales_Rhodophyta_in_the_lagoons_of_the_north-western_Adriatic_Sea_Mediterranean_Sea_Italy|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 [[https://encyclopedia.pub/entry/8862|Invasive algae species]], monitored and exploited in Danmark [[https://backend.orbit.dtu.dk/ws/files/318772859/diversity_15_00434_v4.pdf|Jensen et al, 2023]] ) and regional environmental agencies rather than an overarching EU-wide ban. |
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