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| algae:cases_precedents [2026-09-04 13:42] – [List of the microalgal species that have been added to the Union List] 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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| === Spirulina and Chlorella — Novel Food Status Assessment === | === Spirulina and Chlorella — Novel Food Status Assessment === |
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| * Both //Spirulina// (//Arthrospira platensis//, //A. maxima//) and //Chlorella// (//Chlorella vulgaris//, //C. pyrenoidosa//) have a documented history of use as food prior to 1997 in the EU (specifically in France, Belgium and other member states where commercial sales began in the 1980s and 1990s). | * 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 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. | * 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. |
| * CHANGES | * 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. |
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| ^Algal Species & Ingredient Form ^Date of Approval / Entry into Force ^Expiration Date of Protected Period ^Reference to EU Regulation ^Original Applicant Name ^ | ^Algal Species & Ingredient Form ^Date of Approval / Entry into Force ^Expiration Date of Protected Period ^Reference to EU Regulation ^Original Applicant Name ^ |
| |Odontella aurita (Dried whole-cell biomass) |2005 (Legacy Regulation) |None (Generic market use) |Commission Decision 2005/458/EC |Innovalg | | |//Odontella aurita// (Dried whole-cell biomass) |2005 (Legacy Regulation) |None (Generic market use) |Commission Decision 2005/458/EC |Innovalg | |
| |Ulkenia sp. (DHA-rich algal oil) |2009 (Legacy Regulation) |None (Generic market use) |Commission Decision 2009/777/EC |Nutrinova / Celanese | | |//Ulkenia sp.// (DHA-rich algal oil) |2009 (Legacy Regulation) |None (Generic market use) |Commission Decision 2009/777/EC |Nutrinova / Celanese | |
| |Tetraselmis chuii (Freeze-dried powder) |2014 (Legacy Regulation) |None (Generic market use) |Commission Implementing Decision 2014/155/EU |Fitoplancton Marino S.L. | | |//Tetraselmis chuii// (Freeze-dried powder) |2014 (Legacy Regulation) |None (Generic market use) |Commission Implementing Decision 2014/155/EU |Fitoplancton Marino S.L. | |
| |Haematococcus pluvialis (Astaxanthin-rich oleoresin) |2015 (Legacy Regulation) |None (Amended conditions in 2023) |Union List Entry (EU) 2017/2470 |Standardized Industry Dossier | | |//Haematococcus pluvialis// (Astaxanthin-rich oleoresin) |2015 (Legacy Regulation) |None (Amended conditions in 2023) |Union List Entry (EU) 2017/2470 |Standardized Industry Dossier | |
| |Schizochytrium sp. (DHA and EPA-rich oils) |Multiple Entries (2018–2021 variants) |April 23, 2026 (Varies by exact strain/extension) |Commission Implementing Regulation (EU) 2021/670 (Strain WZU477) |DSM (Martek) / Mara Renewables / Progress Biotech | | |//Schizochytrium sp.// (DHA and EPA-rich oils) |Multiple Entries (2018–2021 variants) |April 23, 2026 (Varies by exact strain/extension) |Commission Implementing Regulation (EU) 2021/670 (Strain WZU477) |DSM (Martek) / Mara Renewables / Progress Biotech | |
| |Euglena gracilis (Dried whole biomass) |December 23, 2020 |December 23, 2025 (Expired; now generic) |Commission Implementing Regulation (EU) 2020/1820 |Kemin Foods L.C. | | |//Euglena gracilis// (Dried whole biomass) |December 23, 2020 |December 23, 2025 (Expired; now generic) |Commission Implementing Regulation (EU) 2020/1820 |Kemin Foods L.C. | |
| |Euglena gracilis (Isolated beta-glucan) |April 9, 2024 |April 30, 2029 |Commission Implementing Regulation (EU) 2024/1046 |Kemin Foods L.C. | | |//Euglena gracilis// (Isolated beta-glucan) |April 9, 2024 |April 30, 2029 |Commission Implementing Regulation (EU) 2024/1046 |Kemin Foods L.C. | |
| |Galdieria sulphuraria (Blue extract / pigment) |Pending Authorization (EFSA cleared safety in March 2026) |TBD upon final publication |Pending EC implementing act |Givaudan (Everzure) | | |//Galdieria sulphuraria// (Blue extract / pigment) |Pending Authorization (EFSA cleared safety in March 2026) |TBD upon final publication |Pending EC implementing act |Givaudan (Everzure) | |
| |Chlamydomonas reinhardtii (Dried biomass powder) |Undefined / Terminated (Procedural closure) |None |Commission Implementing Decision (EU) 2025/5980 (Terminated Sept 2025)| NextFerm / THN | | |//Chlamydomonas reinhardtii// (Dried biomass powder) |Undefined / Terminated (Procedural closure) |None |Commission Implementing Decision (EU) 2025/5980 (Terminated Sept 2025)| NextFerm / THN | |
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| Notes: | Notes: |
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| 1. 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]]. |
| 2. 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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| 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). | 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). |
| === Nannochloropsis and Euglena === | |
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| * Novel food applications for whole biomass or fractions from //Nannochloropsis// spp. and //Euglena gracilis// have been under assessment at various stages. Status as of early 2026: consult the EFSA website and the novel food catalogue for the current status of individual applications. | |
| * These cases are relevant as demonstrations of the novel food pathway in practice for species with no documented EU consumption history. | |
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| ==== Food Safety — EFSA Contaminant Opinions Relevant to Algae ==== | ==== Food Safety — EFSA Contaminant Opinions Relevant to Algae ==== |
| === 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 CONTAM Panel (2016) Scientific Opinion on cyanotoxins in food: established 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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| ==== Organic Certification — EGTOP Opinions ==== | ==== Organic Certification — EGTOP Opinions ==== |
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| === EGTOP Fertilisers IV (2019) and Microalgae === | |
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| * The EGTOP (Expert Group for Technical Advice on Organic Production) issued its Final Report on Fertilisers IV in 2019, which addressed the use of nutrients for microalgae cultivation under the organic regulation. | 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. [[https://www.researchgate.net/publication/351933902_Directorate-General_for_Agriculture_and_Rural_Development_Expert_Group_for_Technical_Advice_on_Organic_Production_EGTOP_FINAL_REPORT_Fertilisers_IV_and_Plant_Protection_Products_VI|EGTOP 2021]], [[https://agriculture.ec.europa.eu/farming/organic-farming/co-operation-and-expert-advice/egtop-reports_en|EGTOP 2026]], [[https://www.parlament.gv.at/dokument/XXV/EU/18306/imfname_10451664.pdf|SWD (2014) 66]]. |
| * The EGTOP opinion confirmed that microalgae grown in closed systems can be certified organic where permitted inputs are used, but noted that the specific permissions for non-organic nutrient inputs required for microalgae cultivation (which cannot access soil nutrients) required explicit provision. This led to specific provisions in the implementing legislation under Regulation (EU) 2018/848. | |
| * Significance: this is the primary regulatory precedent for microalgae organic certification and the basis for understanding the scope of the organic production rules as applied to closed-system microalgae cultivation. | Here we list all EGTOP decisions related to algae: |
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| | ^Material ^Evaluation Date ^Originator of the Initiative ^Decision Context ^ |
| | |Sodium Nitrate |Published in the EGTOP Fertilisers IV Report in December 2018. |Submitted as technical dossiers by EU Member States under Article 16(3)(b) of the legacy Council Regulation (EC) No 834/2007. |Traditional organic fertilizers have low solubility. EGTOP recognized that microalgae require rapidly soluble nitrogen at an industrial scale that regular terrestrial fertilizers cannot provide. Thus, they made a specific exception allowing mineral sodium nitrate strictly for land-based algae production in closed systems. [[https://www.researchgate.net/publication/351933902_Directorate-General_for_Agriculture_and_Rural_Development_Expert_Group_for_Technical_Advice_on_Organic_Production_EGTOP_FINAL_REPORT_Fertilisers_IV_and_Plant_Protection_Products_VI|REPORT 2021]] | |
| | |Carbon Dioxide (CO₂) |Formalized in the EGTOP Fertilisers VI Report adopted on June 8, 2023. |Prompted by Member State dossiers alongside strategic momentum from the European Commission's Algae Initiative (2022), which explicitly mandated the identification of safe alternatives for nutrients and CO₂ in organic microalgae systems. |EGTOP recommended the use of carbon dioxide as a primary carbon nutrient source for land-based systems. However, they stipulated that it must prioritize sustainability—ideally sourced as a by-product of industrial processes or from renewable sources (e.g., anaerobic digestions)—and must meet strict contamination standards. [[https://agriculture.ec.europa.eu/document/download/a4561074-266c-40dd-881b-c27f150e3d8a_en?filename=egtop-report-fertilisers-vi-and-ppp-viii_en.pdf|REPORT 2023]] | |
| | |Ammonium Sulfate (Via Nitrogen Stripping) |Evaluated concurrently across recent nutrient recycling sessions, culminating in report discussions around 2022–2023. |Championed by industrial and circular-economy interest groups via Member State requests looking to utilize recovered nitrogen from off-gases. |Despite being championed as a circular technology to recover nutrients from animal waste or biogas plants, and despite EGTOP was in favor of including stripped ammonium sulphate in organic regulation Regulation (EU) 2018/848 (and its subsequent amending acts like Regulation (EU) 2021/1165), the Commission and member states rejected the inclusion of stripped ammonium sulfate due to a strict legal and systemic roadblock: Most nitrogen-stripping systems draw their input directly from anaerobic digestate or liquid manure sourced from conventional, intensive livestock farming. Because the EU organic framework explicitly prohibits using industrial/factory farming byproducts to maintain organic integrity, the Commission could not legally approve a chemically isolated synthetic-like mineral salt derived from those prohibited systems. | |
| | |Terrestrial Animal Manures |Baseline rules explicitly adjusted for algae/microalgae in the 2018 report iterations. |Standard operational review requested by Member States to bridge the gap between traditional aquaculture rules and microalgae requirements. |It was established that terrestrial manures could be used to feed macro- and microalgae cultures, provided they strictly follow restrictions of the core organic annexes and guarantee zero industrial or factory-farm origins to prevent chemical or biological pathogen risk. [[https://agriculture.ec.europa.eu/system/files/2021-12/egtop-report-on-factory-farming_en_0.pdf|EGTOP report on Factory Farming]] | |
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| ==== RASFF Notifications — Algae-Relevant Cases ==== | ==== RASFF Notifications — Algae-Relevant Cases ==== |
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| The RASFF (Rapid Alert System for Food and Feed) portal at [[https://webgate.ec.europa.eu/rasff-window/screen/search|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 RASFF notifications relating to algae products include: | The RASFF (Rapid Alert System for Food and Feed) portal at [[https://webgate.ec.europa.eu/rasff-window/screen/search|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: |
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| * Cyanotoxin contamination in //Spirulina// and //Chlorella// food supplements (microcystin-LR exceedances against national guidance limits). | * 52 had high iodine content, |
| * Heavy metal contamination (cadmium, lead, arsenic, mercury) in dried seaweed and seaweed-containing food supplements. | * 10 had norovirus presence, |
| * Unauthorised novel food status (products derived from species not in the Union list and without documented pre-1997 EU consumption history placed on market as food without authorisation). | * 6 had heavy metal contamination, |
| * Iodine levels exceeding national guidance thresholds in kelp and seaweed supplements. | * 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 |
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| Producers should search the RASFF portal for their specific product type to understand the contaminant and compliance issues that have historically triggered enforcement actions. | Producers should search the RASFF portal for their specific product type to understand the contaminant and compliance issues that have historically triggered enforcement actions. |
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| ==== Commission and EFSA Interpretations — Non-Binding but Significant ==== | |
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| * The EU Novel Food Catalogue (DG SANTE) provides status assessments for specific algae species and products — these are not legally binding decisions but represent the Commission's interpretation and are taken as authoritative by national authorities. | |
| * DG SANTE Q&As on the application of the novel food regulation to specific product types are available on the Europa website and provide important interpretive guidance. | |
| * The SWD(2022) 361 regulatory analysis of the algae sector (see [[algae:initiatives_strategic|Initiatives and Strategic Documents]]) contains Commission interpretations of how existing regulations apply to algae; these interpretations carry persuasive weight in interactions with national authorities. | |
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