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| algae:cases_precedents [2026-06-23 13:23] – created robert | algae:cases_precedents [2026-06-24 09:58] (current) – [Regulatory Cases and Precedents] robert |
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| ===== Specialised Sources — Bibliography ===== | ===== Regulatory Cases and Precedents ===== |
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| This page lists scientific and technical literature, industry reports, official guidance documents and databases relevant to EU algae regulation. Sources are grouped by topic. This is a curated reference list, not an exhaustive bibliography; the focus is on sources that directly inform regulatory understanding and compliance, rather than production technology or product chemistry. Links are provided where sources are publicly accessible. | !FIXME! |
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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 most 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. |
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| | 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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| ==== EU Official Documents (non-binding) ==== | ==== Novel Food — Authorisation Decisions and Opinions ==== |
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| * Commission Staff Working Document SWD(2022) 361 final, "Towards a Strong and Sustainable EU Algae Sector", 15 November 2022. [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022XC0629(04)|EUR-Lex]] The most comprehensive EU-level regulatory survey of the algae sector. | === DHA/EPA-rich oil from Schizochytrium sp. === |
| * EESC Opinion "Towards a strong and sustainable EU algae sector", EESC-2022-04884-00-00-AC-TRA. [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022AE5904|EUR-Lex]] | |
| * Commission Communication COM(2022) 592 final, "Towards a Strong and Sustainable EU Algae Sector". [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022DC0592|EUR-Lex]] | |
| * The Blue Guide on the implementation of EU product rules (2022 edition): CELEX_52022XC0629(04). Useful reference for CE marking, market surveillance and product safety obligations. | |
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| ---- | The authorisation of DHA-rich oil from the heterotrophic microalga //Schizochytrium sp.// was one of the earliest novel food authorisations for an algae-derived food ingredient and set important precedents for subsequent applications. |
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| ==== EFSA Scientific Opinions Relevant to Algae ==== | * The original authorisation was under the 1997 Novel Food Regulation; it was incorporated into the Union list under Regulation (EU) 2017/2470 (as amended). |
| | * The authorisation covers oil from //Schizochytrium sp.// with specific compositional specifications and is a restricted novel food (only the holder of the relevant data and its licensees are authorised to place the product on the market as a novel food, though this proprietary protection has expired or may be extended depending on the application type and date of authorisation). |
| | * This authorisation established that heterotrophic microalgae biomass-derived extracts (oils) are treatable as conventional food ingredients for safety assessment purposes, provided safety is established through the novel food assessment pathway. |
| | * Subsequent authorisations for DHA/EPA oils from //Crypthecodinium cohnii// followed a similar assessment logic. |
| | * EFSA NDA Panel opinion: EFSA Journal (2012) 10(2):2535. |
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| EFSA publishes scientific opinions that form the basis of EU decisions on novel foods, food additives, contaminant limits, and feed additives involving algae. Key opinions include (access via [[https://www.efsa.europa.eu|efsa.europa.eu]]): | === Astaxanthin from Haematococcus pluvialis === |
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| * EFSA NDA Panel: Scientific guidance for the preparation of applications for novel foods. (Updated periodically; latest version should be consulted for novel food dossier preparation.) | * Astaxanthin derived from //Haematococcus pluvialis// was assessed by EFSA and authorised as a novel food for various food categories. |
| * EFSA opinions on cyanotoxins in food and water (multiple opinions on microcystins, cylindrospermopsin, anatoxins, BMAA). | * 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 Panel on Contaminants in the Food Chain (CONTAM): opinions on arsenic speciation in food and feed, including seaweed, and on iodine exposure from seaweed consumption. | * EFSA NDA Panel opinion: EFSA Journal (2020) 18(7):6180. |
| * EFSA opinions on specific novel food authorisation applications for algae-derived ingredients: DHA/EPA-rich oils from Schizochytrium sp., Crypthecodinium cohnii; astaxanthin from Haematococcus pluvialis. | * The Commission Implementing Regulation authorising astaxanthin-rich biomass from //Haematococcus pluvialis// is included in Regulation (EU) 2017/2470 (consolidated, with amendments). |
| * EFSA re-evaluation opinions on algae-derived food additives under the EFSA re-evaluation programme (alginates, carrageenan, agar). | |
| * EFSA opinions on feed additives involving algae (astaxanthin authorisation in aquaculture feed). | === 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). |
| | * 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. |
| | * 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. |
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| | === Phycocyanin from Arthrospira (Spirulina) === |
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| | * C-phycocyanin, a blue pigment from //Arthrospira platensis//, was assessed by EFSA for use as a food colourant. The EFSA NDA and CONTAM panels evaluated safety and identity criteria. |
| | * Commission Implementing Regulation (EU) 2023/48 extended the use of phycocyanin (E 132a... — note: the specific E number assignment and scope should be verified against the consolidated Regulation 1333/2008 as at the current date). |
| | * This case illustrates the regulatory boundary between a "food additive" (if used as a colourant under Regulation 1333/2008) and a "novel food" (if sold as a food or food ingredient without coluring function), and demonstrates that the same substance may simultaneously require authorisation under both frameworks depending on its intended use. |
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| | === 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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| ==== Novel Food — Regulatory Resources ==== | ==== Food Safety — EFSA Contaminant Opinions Relevant to Algae ==== |
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| * EU Novel Food Catalogue: [[https://food.ec.europa.eu/food-safety/novel-food/novel-food-status-catalogue_en|DG SANTE]] — searchable database of novel food status assessments for specific ingredients. | === Iodine in Seaweed === |
| * Union list of authorised novel foods (Commission Implementing Regulation (EU) 2017/2470, consolidated). [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R2470-20260316|EUR-Lex]] | |
| * EU4Algae: "Protocol to apply for a Novel Food Dossier" (2025). Practical step-by-step guide specifically for algae. Available in EU4algae/ project folder. | * 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). |
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| | === 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 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. |
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| | === 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. |
| | * 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. |
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| ==== Food Safety and Contaminants ==== | ==== Feed — EFSA Opinions on Algae in Feed ==== |
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| * Commission Recommendation (EU) 2018/464 on monitoring of metals and iodine in seaweed. [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32018H0464|EUR-Lex]] | === Astaxanthin as Feed Additive === |
| * Cruz-Vasconcelos N. et al. (2024), "Legal Aspects of Microalgae in the European Food Sector", //Foods// 13(1), 124. doi:10.3390/foods13010124 — comprehensive review of the regulatory framework for microalgae in food. | |
| * "Chemical and Microbiological Contaminants in Algae for Food" — workgroup report, EU4Algae project (2024). [[https://maritime-forum.ec.europa.eu/document/download/2b1b0a8f-1bb6-4026-ae5d-5f4df0df06ea_en|EU4Algae]] | * 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). |
| * WHO Guidelines for Drinking-Water Quality (4th edition with 1st addendum, 2017), specifically the chapter on cyanotoxins. [[https://www.who.int/publications/i/item/9789241549950|WHO]] — while not EU law, WHO limits are frequently referenced in the absence of EU-specific algae contaminant limits. | * 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. |
| * RASFF (Rapid Alert System for Food and Feed): [[https://webgate.ec.europa.eu/rasff-window/screen/search|RASFF portal]] — search for historical alerts on algae products (search "algae", "seaweed", "spirulina", "chlorella") to understand which contaminant issues have triggered enforcement action. | |
| | === 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. |
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| ==== Feed ==== | ==== Environmental — IAS Regulation Decisions ==== |
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| * EU Feed Additives Register: [[https://ec.europa.eu/food/safety/feed/additives_en|DG SANTE]] — searchable register of authorised feed additives including algae-derived astaxanthin and carotenoids. | === Undaria pinnatifida on the IAS Union List === |
| * Catalogue of Feed Materials (Regulation (EU) No 68/2013, consolidated). [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02013R0068-20220724|EUR-Lex]] | |
| * Crespo N. et al. (2022), "Regulatory landscape for microalgae-based products as feed: the European case", //MultiStr3am-BBI// project report (available in bibliography/ folder of this project). | |
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| ==== Cosmetics ==== | * //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). |
| | * 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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| * COSING database: [[https://ec.europa.eu/growth/tools-databases/cosing/|European Commission]] — searchable ingredient database for cosmetic ingredients including algae-derived materials. | === Gracilaria vermiculophylla on the IAS List === |
| * CEN/TR 17611:2021 — Technical report on algae for use in personal care products. Available from national standards bodies. | |
| * COSMOS-standard: [[https://www.cosmos-standard.org|COSMOS-standard AISBL]] — the standard for organic and natural cosmetics certification. | |
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| ==== Organic Production ==== | * //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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| * EGTOP Final Report on Fertilisers IV (2019): European Commission Expert Group for Technical Advice on Organic Production. Available at [[https://ec.europa.eu/food/system/files/2019-07/org-farming_exp-grp_2019-07-01_egtop-final-rep-fertilisers-iv.pdf|European Commission]]. Key document confirming the special rules for microalgae nutrition under the organic regulation. | ---- |
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| ==== Fertilising Products ==== | ==== Organic Certification — EGTOP Opinions ==== |
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| * FAQs on Regulation (EU) 2019/1009 (FPR): DG GROW, updated version December 2025. Available in bibliography/ folder of this project. Practical guidance on CMC eligibility, CE marking, and contaminant limits. | === EGTOP Fertilisers IV (2019) and Microalgae === |
| * ESPP (European Sustainable Phosphorus Platform): policy briefs and position papers on nutrient recovery and the FPR. [[https://www.phosphorusplatform.eu|phosphorusplatform.eu]] | |
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| ==== Aquaculture and Wild Harvest ==== | * 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 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. |
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| * Bostock J. et al. (2016), "An assessment of the economic contribution of EU aquaculture production and the influence of policies for its sustainable development", //Aquaculture International// 24, 699–733. doi:10.1007/s10499-016-9992-1 — economic context for EU aquaculture policy. | ---- |
| * Alexander K.A. et al. (2015), "The implication of aquaculture policy and regulation for the development of integrated multi-trophic aquaculture in Europe", //Aquaculture// 443, 16–23. — regulatory assessment of IMTA including seaweed. | |
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| ==== Bioeconomy and Strategy ==== | ==== RASFF Notifications — Algae-Relevant Cases ==== |
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| * CINEA EU Algae Industry Study (WP2). Available in bibliography/ folder. Comprehensive economic study of the EU algae industry. | 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: |
| * EU Bioeconomy Strategy and Implementation Plan: [[https://ec.europa.eu/research/bioeconomy|European Commission]]. | |
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| ==== Regulatory Landscape — General Reviews ==== | * Cyanotoxin contamination in //Spirulina// and //Chlorella// food supplements (microcystin-LR exceedances against national guidance limits). |
| | * Heavy metal contamination (cadmium, lead, arsenic, mercury) in dried seaweed and seaweed-containing food supplements. |
| | * 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). |
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| * Dourado M.N. et al. (2016), "European regulatory framework on novel foods and novel food additives", //Chapter in Functional Food and Human Health//. — overview of the novel food framework. | Producers should search the RASFF portal for their specific product type to understand the contaminant and compliance issues that have historically triggered enforcement actions. |
| * CEVA Regulatory update for edible algae in France and the EU (2019). Available in bibliography/ folder. Comparative overview of French and EU rules for food and supplement use. | |
| * Hieke S. and Grunert K.G. (2018), "Consumers and health claims", //Reference Module in Food Science//. doi:10.1016/B978-0-08-100922-2.00002-4. — background on consumer understanding of health claims. | |
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| ==== Online Tools and Databases ==== | ==== Commission and EFSA Interpretations — Non-Binding but Significant ==== |
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| * EUR-Lex: [[https://eur-lex.europa.eu|eur-lex.europa.eu]] — authoritative source for all EU legal acts; use the CELEX number for direct access. | * 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. |
| * AlgaeBase: [[https://www.algaebase.org|algaebase.org]] — global taxonomic database for algae; essential for verifying scientific names and taxonomic status. | * 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. |
| * CyanoDB: [[https://www.cyanodb.cz|cyanodb.cz]] — database of cyanobacterial genera. | * 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. |
| * EFSA Open Scientific Data: [[https://open.efsa.europa.eu|open.efsa.europa.eu]] — EFSA opinions and supporting scientific data. | |
| * ECHA Substance Registry: [[https://echa.europa.eu/information-on-chemicals|echa.europa.eu]] — REACH registration and restriction information for algae-derived chemicals. | |
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| //See also: [[algae:eu_legislation_general|General on EU Legislation]] | [[algae:initiatives_strategic|Initiatives and Strategic Documents]] | [[algae:cases_precedents|Regulatory Cases and Precedents]] | [[algae:purpose_scope_sources|Purpose, Scope and Sources]]// | //See also: [[algae:food:novel_food|Novel Food]] | [[algae:food:quality_safety|Food Quality and Safety]] | [[algae:environment_alien_species|Environment and Use of Non-native Species]] | [[algae:specialised_sources|Specialised Sources — Bibliography]] | [[algae:faq|Frequently Asked Questions]]// |
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| //Last reviewed: June 2026.// | //Last reviewed: June 2026.// |
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