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| algae:cases_precedents [2026-09-06 15:35] – [Gracilaria vermiculophylla on the IAS 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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| 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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| === Gracilaria vermiculophylla on the IAS List === | === Gracilaria vermiculophylla on the IAS List === |
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| * //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, ]], [[https://www.iucngisd.org/gisd/pdf.php?sc=1698|]], [[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|]]. | * //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. |
| * //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. | |
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