The safety assessment of microalgae-derived products as novel foods by the european food safety authority
Open accessAbstract
Recent advancements in food research alongside the growing interest in new sources with enhanced nutritional value have led to an increasing development of food products derived from microalgae. Some of these products fall under the category of novel foods (NFs) in the European Union (EU) and their safety must be evaluated by the European Food Safety Authority (EFSA) before being authorised on the EU market. By August 2024, EFSA had evaluated eleven NFs derived from microalgae, including oils rich in docosahexaenoic acid (DHA) from Schizochytrium spp., whole biomass of the microalga Euglena gracilis and its derivative beta-glucan polymer (paramylon), ethanolic extract from Phaeodactylum tricornutum and oleoresin rich in astaxanthin from Haematococcus pluvialis . One of the key scientific requirements for the safety assessment of these products is the characterisation of the microalga strain, including its unambiguous taxonomic identification at species level and pathogenicity. The “Qualified Presumption of Safety” (QPS) status of the microalgae also plays a significant role in determining the safety assessment approach to be applied. Other relevant requirements comprise a thorough chemical characterisation (e.g., biotoxins, undesirable substances, heavy metals) together with microbiological and nutritional characterisation of the product, description of the manufacturing process and a toxicological and allergenicity assessment. By illustrating examples of NF that consist of, are isolated from or are produced by microalgae we highlight the main requirements needed for their safety assessment alongside the challenges encountered. Taking into account the continuous evolution of the microalga sector leading to innovative products, we also extend these requirements to the safety assessment of microalgal proteins, considering potential future mandates to assess algae-derived proteins as NFs by EFSA.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Validation of the declared nutritional profile is performed, ensuring that levels of proteins, essential fatty acids, vitamins, and minerals correspond to the reported composition.
“At this stage, validation of the declared nutritional profile is also performed, ensuring that levels of proteins, essential fatty acids, vitamins, and minerals effectively correspond to the reported composition (Salehipour-Bavarsad et al., 2024; Garciarena et al., 2025).”
From Microalgae biotechnology and its role in sustainable and healthy food design (2025) · cites this paper as Garciarena et al., 2025
Section 3.2.3 (p. 5) says compositional characterisation assesses proteins, vitamins, minerals and fatty-acid profiles, using analytical methods intended to yield reliable data. It does not say that this assessment validates a declared nutritional profile by checking measured levels against the reported composition; nor does it single out essential fatty acids. (LLM, conf=0.84)
Experimental — accuracy not yet measuredCompositional characterization includes detection of contaminants originating from cultivation or processing, including mycotoxins, polycyclic aromatic hydrocarbons, residual solvents, and dioxins.
“as well as the detection of contaminants originating from cultivation or processing, including mycotoxins, polycyclic aromatic hydrocarbons, residual solvents, and dioxins (Kumar and Sharma, 2021; Salehipour-Bavarsad et al., 2024; Garciarena et al., 2025).”
From Microalgae biotechnology and its role in sustainable and healthy food design (2025) · cites this paper as Garciarena et al., 2025
Section 3.2.3 (p. 5) says compositional characterisation examines mycotoxins, polycyclic aromatic hydrocarbons, and total dioxins and dioxin-like compounds, including hazards that may arise during cultivation or processing. It does not list residual solvents among those contaminants; the production-process section (p. 4) mentions extraction-solvent regulations but does not establish that residual solvents are part of compositional characterisation. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn 2024, EFSA issued around eleven opinions on novel foods derived from microalgae, while six additional evaluations are still ongoing.
“In 2024, for instance, EFSA issued around eleven opinions on novel foods derived from microalgae, while six additional evaluations are still ongoing (Garciarena et al., 2025).”
From Microalgae biotechnology and its role in sustainable and healthy food design (2025) · cites this paper as Garciarena et al., 2025
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredThe strain under evaluation must have a valid deposit certificate issued by an internationally recognized culture collection, ensuring traceability and reliability.
“Furthermore, the strain under evaluation must have a valid deposit certificate issued by an internationally recognized culture collection, ensuring traceability and reliability (Garciarena et al., 2025).”
From Microalgae biotechnology and its role in sustainable and healthy food design (2025) · cites this paper as Garciarena et al., 2025
EFSA has highlighted specific cases where allergic reactions may occur, particularly in shrimp-allergic individuals due to cross-reactivity.
“it has also highlighted specific cases where allergic reactions may occur, particularly in shrimp-allergic individuals due to cross-reactivity, emphasizing the importance of rigorous pre-market evaluation and appropriate allergen labeling [256].”
From Navigating the potential of algal peptides: health effects, market applications, and scientific challenges (2026) · cites this paper as [256]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Algal Proteins: Extraction, Application, and Challenges Concerning Production
Bleakley, S., & Hayes, M. (2017) · Foods · doi:10.3390/foods6050033 · Cited by 1,092 · see citing works
Guidance on the characterisation of microorganisms used as feed additives or as production organisms
(FEEDAP), E. P. O. A. A. P. O. S. U. I. A. F., Rychen, G., Aquilina, G., Azimonti, G., Bampidis, V., Bastos, M. D. L., Bories, G., Chesson, A., Cocconcelli, P. S., Flachowsky, G., et al. (2018) · EFSA Journal · doi:10.2903/j.efsa.2018.5206 · Cited by 1,009 · see citing works
Scientific Opinion on Dietary Reference Values for protein
EFSA Panel on Dietetic Products, N. A. A. (. (2012) · EFSA Journal · doi:10.2903/j.efsa.2012.2557 · Cited by 739 · see citing works
Current Status of the Algae Production Industry in Europe: An Emerging Sector of the Blue Bioeconomy
Araújo, R., Vázquez Calderón, F., Sánchez López, J., Azevedo, I. C., Bruhn, A., Fluch, S., Garcia Tasende, M., Ghaderiardakani, F., Ilmjärv, T., Laurans, M., et al. (2021) · Frontiers in Marine Science · doi:10.3389/fmars.2020.626389 · Cited by 653 · see citing works
Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment
EFSA Scientific Committee (2011) · EFSA Journal · doi:10.2903/j.efsa.2011.2379 · Cited by 479 · see citing works
Scientific Guidance for the submission of dossiers on Food Enzymes
EFSA Panel on Food Contact Materials, E. A. P. A. (. C. P., Lambré, C., Baviera, J. M. B., Bolognesi, C., Cocconcelli, P. S., Crebelli, R., Gott, D. M., Grob, K., Lampi, E., Mengelers, M. J. B., et al. (2021) · EFSA Journal · doi:10.2903/j.efsa.2021.6851 · Cited by 468 · see citing works
Abiotic stresses as tools for metabolites in microalgae
Paliwal, C., Mitra, M., Bhayani, K., Bharadwaj, S. V. V., Ghosh, T., Dubey, S., & Mishra, S. (2017) · Bioresource Technology · doi:10.1016/j.biortech.2017.05.058 · Cited by 427 · see citing works
The potential of future foods for sustainable and healthy diets
Parodi, A., Leip, A., de Boer, I. J. M., Slegers, P. M., Ziegler, F., Temme, E. H. M., Herrero, M., Tuomisto, H. L., Valin, H., van Middelaar, C. E., et al. (2018) · Nature Sustainability · doi:10.1038/s41893-018-0189-7 · Cited by 378 · see citing works
Dietary protein quality evaluation in human nutrition. Report of an FAQ Expert Consultation.
(2013) · PubMed · Cited by 350 · see citing works
Hadi, J. L., & Brightwell, G. (2021) · Foods · doi:10.3390/foods10061226 · Cited by 341 · see citing works
(EFSA), E. F. S. A. (2021) · EFSA Journal · doi:10.2903/j.efsa.2021.6506 · Cited by 222 · see citing works
Microalgae-based products: Food and public health
Ferreira de Oliveira, A. P., & Bragotto, A. P. A. (2022) · Future Foods · doi:10.1016/j.fufo.2022.100157 · Cited by 190 · see citing works
Genotoxicity assessment of chemical mixtures
More, S. J., Bampidis, V., Benford, D., Boesten, J., Bragard, C., Halldorsson, T. I., Hernández, A. F., Bennekou, S. H., Koutsoumanis, K., Naegeli, H., et al. (2019) · EFSA Journal · doi:10.2903/j.efsa.2019.5519 · Cited by 187 · see citing works
Ververis, E., Ackerl, R., Azzollini, D., Colombo, P. A., de Sesmaisons, A., Dumas, C., Fernández‐Dumont, A., da Costa, L. F., Germini, A., Goumperis, T., et al. (2020) · Food Research International · doi:10.1016/j.foodres.2020.109515 · Cited by 162 · see citing works
Self-citationMicroalgae proteins as sustainable ingredients in novel foods: recent developments and challenges
Mosibo, O. K., Ferrentino, G., & Udenigwe, C. C. (2024) · Foods · doi:10.3390/foods13050733 · Cited by 140 · see citing works
Wu, J. Y., Tso, R., Teo, H. S., & Haldar, S. (2023) · Frontiers in Nutrition · doi:10.3389/fnut.2023.1277343 · Cited by 126 · see citing works
Microalgal Proteins and Bioactives for Food, Feed, and Other Applications
Lucáková, S., Brányiková, I., & Hayes, M. (2022) · Applied Sciences · doi:10.3390/app12094402 · Cited by 110 · see citing works
Marine biotoxins in shellfish – Summary on regulated marine biotoxins
(EFSA), E. F. S. A. (2009) · EFSA Journal · doi:10.2903/j.efsa.2009.1306 · Cited by 67 · see citing works
EFSA Panel on Dietetic Products, N. A. A. (. (2014) · EFSA Journal · doi:10.2903/j.efsa.2014.3757 · Cited by 66 · see citing works
EFSA Panel on Nutrition, N. F. A. F. A. (., Turck, D., Bohn, T., et al. (2024) · EFSA Journal · doi:10.2903/j.efsa.2024.8961 · Cited by 57 · see citing works
(BIOHAZ), E. P. O. B. H., Koutsoumanis, K., Allende, A., Alvarez‐Ordóñez, A., Bolton, D., Bover‐Cid, S., Chemaly, M., De Cesare, A., Hilbert, F., Lindqvist, R., et al. (2023) · EFSA Journal · doi:10.2903/j.efsa.2023.7746 · Cited by 56 · see citing works
(BIOHAZ), E. P. O. B. H., Allende, A., Álvarez‐Ordóñez, A., Bortolaia, V., Bover‐Cid, S., Cesare, A. D., Dohmen, W., Guillier, L., Jacxsens, L., Nauta, M. J., et al. (2025) · EFSA Journal · doi:10.2903/j.efsa.2025.9169 · Cited by 55 · see citing works
A Systemic Review on Microalgal Peptides: Bioprocess and Sustainable Applications
Sathya, R., MubarakAli, D., MohamedSaalis, J., & Kim, J.-W. (2021) · Sustainability · doi:10.3390/su13063262 · Cited by 48 · see citing works
Trends and prospects in dairy protein replacement in yogurt and cheese
Diaz-Bustamante, M. L., Keppler, J. K., Reyes, L. H., & Alvarez Solano, O. A. (2023) · Heliyon · doi:10.1016/j.heliyon.2023.e16974 · Cited by 48 · see citing works
Algae as a source of protein in the sustainable food and gastronomy industry
Procházka, P., Abrhám, J., Červený, J., Soukupová, J., Ouma, C. N., Mullen, K. J., Šánová, P., & Smutka, Ľ. (2023) · Frontiers in Sustainable Food Systems · doi:10.3389/fsufs.2023.1256473 · Cited by 31 · see citing works
EFSA Panel on Dietetic Products, N. A. A. (. (2014) · EFSA Journal · doi:10.2903/j.efsa.2014.3843 · Cited by 25 · see citing works
Endô, H., Hosoya, H., KOYAMA, T., & Ichioka, M. (1982) · Agricultural and Biological Chemistry · doi:10.1271/bbb1961.46.2183 · Cited by 22 · see citing works
Hwang, D., Yu-Shia, T. S. A. I., Chou, S. ‐., et al. (2005) · Food Hygiene and Safety Science (Shokuhin Eiseigaku Zasshi) · doi:10.3358/shokueishi.46.45 · Cited by 21 · see citing works
New developments in biotechnology applied to microorganisms
(GMO), E. P. O. G. M. O., Mullins, E. D., Bresson, J., Dewhurst, I. C., Epstein, M. M., Firbank, L. G., Guerche, P., Hejátko, J., Moreno, F. J., Naegeli, H., et al. (2024) · EFSA Journal · doi:10.2903/j.efsa.2024.8895 · Cited by 13 · see citing works
EFSA Panel on Nutrition, N. F. A. F. A. (., Turck, D., Bohn, T., et al. (2023) · EFSA Journal · doi:10.2903/j.efsa.2023.8415 · Cited by 5 · see citing works
EFSA Panel on Nutrition, N. F. A. F. A. (., Turck, D., Bohn, T., et al. (2023) · EFSA Journal · doi:10.2903/j.efsa.2023.8414 · Cited by 4 · see citing works
Turck, D., Castenmiller, J., De Henauw, S., et al. (2020) · NORA - Norwegian Open Research Archives · Cited by 3 · see citing works
Turck, D., Castenmiller, J., de Henauw, S., et al. (2021) · NORA - Norwegian Open Research Archives · Cited by 2 · see citing works
Flagged first, then by citations
Research works printed but not linked: 7
- Araújo, R., Peteiro, C., 2021. Algae as food and food supplements in Europe. Publications Office of the European Union. https://doi.org/10.2760/049515. · DOI
- EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck, D., Bohn, T., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K.I., Maciuk, A., Mangelsdorf, I., McArdle, H.J., Naska, A., Pelaez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Cubadda, F., Frenzel, T., Heinonen, M., Marchelli, R., Neuh ¨ auser-Berthold, M., Poulsen, M., Prieto Maradona, M., Schlatter, J.R., van Loveren, H., Turla, E., Knutsen, H.K., 2022. Scientific Opinion on the safety of oil from Schizochytrium sp. (strain ATCC 20889) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU)2015/2283. EFSA J. 20 (1), 7083. https://doi.org/10.2903/j.efsa.2022.7083, 15 pp. · DOI
- EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) Turck, D., Castenmiller, J., de Henauw, S., Hirsch-Ernst, K.I., Kearney, J., Maciuk, A., Mangelsdorf, I., McArdle, H.J., Naska, A., Pelaez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Cubadda, F., Engel, K., Frenzel, T., Heinonen, M., Marchelli, R., Neuh ¨ auser-Berthold, M., Poulsen, M., Sanz, Y., Schlatter, J.R., van Loveren, H., Ackerl, R., Gelbmann, W., Steinkellner, H., Knutsen, H.K., 2020a. Scientific Opinion on the safety of astaxanthin for its use as a novel food in food supplements. EFSA J. 18 (2), 5993. https://doi.org/10.2903/j.efsa.2020.5993, 9 pp. · DOI
- EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) Turck, D., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K.I., Kearney, J., Maciuk, A., Mangelsdorf, I., McArdle, H.J., Naska, A., Pelaez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Cubadda, F., Engel, K.H., Frenzel, T., Heinonen, M., Marchelli, R., Neuh ¨ auser-Berthold, M., Poulsen, M., Schlatter, J.R., van Loveren, H., Ackerl, R., Knutsen, H.K., 2020b. Scientific Opinion on the safety of dried whole cell Euglena gracilis as a novel food pursuant to Regulation (EU) 2015/2283. EFSA J. 18 (5), 6100. https://doi.org/10.2903/j.efsa.2020.6100, 15 pp. · DOI
- EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) Turck, D., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K.I., Kearney, J., Maciuk, A., Mangelsdorf, I., McArdle, H.J., Naska, A., Pelaez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Cubadda, F., Frenzel, T., Heinonen, M., Marchelli, R., Neuh ¨ auser-Berthold, M., Poulsen, M., Prieto Maradona, M., Schlatter, J.R., van Loveren, H., Turla, E., Knutsen, H.K., 2021a. Scientific Opinion on the safety of oil from Schizochytrium limacinum (strain FCC-3204) for use in food supplements as a novel food pursuant to Regulation (EU)2015/2283. EFSA J. 19 (1), 6345. https:// doi.org/10.2903/j.efsa.2021.6345, 23 pp. · DOI
- EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) Turck, D., Bohn, T., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K.I., Maciuk, A., Mangelsdorf, I., McArdle, H.J., Naska, A., Pelaez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Aguilera-G ´ omez, M., Cubadda, F., Frenzel, T., Heinonen, M., Marchelli, R., Neuh ¨ auser-Berthold, M., Poulsen, M., Prieto Maradona, M., Siskos, A., Schlatter, J.R., van Loveren, H., Mu ˜ noz-Gonz ´ alez, A., Rossi, A., Ververis, E., Knutsen, H.K., 2023a. Scientific Opinion on the safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food pursuant to Regulation (EU) 2015/2283. EFSA J. 21 (7), 8072. https:// doi.org/10.2903/j.efsa.2023.8072, 27 pp. · DOI
- EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) Turck, D., Bohn, T., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K.I., Maciuk, A., Mangelsdorf, I., McArdle, H.J., Naska, A., Pelaez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Aguilera G ´ omez, M., Cubadda, F., Frenzel, T., Heinonen, M., Prieto Maradona, M., Marchelli, R., Neuh ¨ auser-Berthold, M., Poulsen, M., Schlatter, J.R., van Loveren, H., Ackerl, R., Knutsen, H.K., 2023d. Scientific Opinion on the safety of paramylon as a novel food pursuant to Regulation (EU) 2015/2283. EFSA J. 21 (5), 7995. https://doi.org/10.2903/j.efsa.2023.7995, 18 pp. · DOI
Cited by
Sorted by citations
Microalgae biotechnology and its role in sustainable and healthy food design
Schneider, A. T., Machado, R. L. S., Dutra, D. A., Machado, E. F., Dias, R. R., Deprá, M. C., Zepka, L. Q., & Jacob-Lopes, E. (2025) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2025.1716473 · Cited by 15 · see citing works
Khaliq, M., Noor, Z., Moazzam, M., Saeed, F., Tul-Zohra, K., Tariq, E., Muhammad Shahbaz, H., & Khaliq, K. (2026) · Annals of Medicine · doi:10.1080/07853890.2026.2637282 · Cited by 4 · see citing works
“…associated with microalgal novel foods are low [255], it has also highlighted specific cases where allergic reactions may occur, particularly in shrimp-allergic individuals due to cross-reactivity, emphasizing the importance of rigorous pre-market evaluation and appropriate allergen labeling [256].”
- Authors
- Nuin Garciarena, I., Ackerl, R., García Ruiz, E., Glymenaki, M., Mendes, V., Muñoz-González, A., Noriega Fernández, E., Precup, G., Rodríguez-Fernández, P., Roldán-Torres, R., Rossi, A., Turla, E., Ververis, E., Germini, A., & Kass, G. E. N.
- Affiliations
- European Food Safety Authority (IT)
- ORCID
- Venue
- Future Foods
- Publisher
- Elsevier BV
- Published
- 2025-06
- Volume
- 11
- Pages
- 100661
- ISSN
- 2666-8335 (ISSN-L)
- OpenAlex
- W4410488645
- Cited by
- 19
- References
- 33
- Citations by year
- 2026: 14 · 2025: 5
- FWCI
- 8.92
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Future Foods (publishedVersion, cc-by-nc-nd)
- Zaguan (University of Zaragoza Repository) (submittedVersion, cc-by-nc-nd)
- Funders
- European Food Safety Authority
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
- Life Sciences › Agricultural and Biological Sciences › Aquatic Science › Seaweed-derived Bioactive Compounds
- Life Sciences › Agricultural and Biological Sciences › Food Science › Food Industry and Aquatic Biology
- Keywords
- novel foods, food safety assessment, EFSA, qualified presumption of safety, Schizochytrium, Euglena gracilis, paramylon, Phaeodactylum tricornutum, Haematococcus pluvialis, astaxanthin, docosahexaenoic acid, microalgal proteins, strain characterization, taxonomic identification, pathogenicity, chemical characterization, toxicity prediction, allergenicity, biotoxins, heavy metals
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
