For the great majority of algal species and products, novel food status is the single most consequential regulatory question standing between cultivation and market access in the EU. This page covers the Novel Food Regulation, the authorisation pathway, the Novel Food Catalogue, and the practical issues specific to algae.
Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001, OJ L 327, 11.12.2015, p. 1. EUR-Lex
Under Article 3(2)(a), “novel food” means any food that was not used for human consumption to a significant degree within the EU before 15 May 1997, irrespective of the date of accession of individual member states, and that falls under at least one of several categories. Of these, the category with by far the greatest relevance to algae is:
Algae are therefore explicitly named in the Regulation's own definition of novel food — there is no need to argue by analogy or extension; algae-derived foods are squarely within scope unless an exemption applies. Other potentially relevant categories include point (vi) (food from cell or tissue culture, relevant to emerging algal biomass-from-bioreactor cell culture approaches) and point (vii) (food resulting from a new production process causing significant compositional change, relevant where a novel extraction or processing method is applied to an otherwise conventional algal species).
A food or food ingredient consisting of, isolated from or produced from algae is not novel if it can be demonstrated to have been used for human consumption to a significant degree within the EU before 15 May 1997. This is the basis on which long-established uses — dried nori (Porphyra/Pyropia) in EU markets with established Japanese food culture, kombu and wakame in some member states, or Spirulina (Limnospira platensis, marketed under its older name Arthrospira platensis in most pre-1997 evidence) as a food supplement — are treated as non-novel.
Critically, “significant degree of consumption within the EU before 1997” must be demonstrated with evidence — it is not simply assumed because a species is well known or widely consumed outside the EU. The burden of proof rests on the food business operator placing the product on the market.
The Novel Food Catalogue, maintained by the Commission's Directorate-General for Health and Food Safety (DG SANTE), is a non-exhaustive, informational database listing foods and ingredients together with an indication of their likely novel food status, based on information submitted by member states. As of recent updates the catalogue includes more than 60 entries covering various microalgae and seaweed species, extracts and oils.
We have to distinguish between the Novel Food Catalogue and Union List of Novel Food, described in the Authorisation Pathway section. The first is an informative, searchable resource, while the second one is a formal regulation.
Important limitations of the catalogue:
A producer's practical starting point should always be to check the catalogue, but a favourable catalogue entry does not remove the need for proper legal diligence, and an unfavourable or absent entry does not necessarily mean authorisation will be difficult — only that the formal pathway must be followed.
Where a food or ingredient is determined to be novel, it must undergo a safety assessment and be authorised before it can be placed on the EU market. Regulation (EU) 2015/2283 introduced a centralised authorisation procedure (replacing the earlier member-state-led system under the repealed Regulation (EC) No 258/97):
There are two distinct procedural routes under the Regulation, and algae producers should understand which applies to their situation:
A critical and frequently underappreciated point: novel food status attaches to the specific food or ingredient as defined, not to the species as a whole. A whole, dried form of a given algal species may have an established history of consumption and therefore not be novel, while an extract, isolated fraction, or concentrate derived from the very same species, produced using a process not historically used, may itself be considered novel — because the extraction or concentration process can be judged to give rise to “significant changes in composition or structure… affecting nutritional value, metabolism or level of undesirable substances” (Article 3(2)(a)(vii)).
This has been a recurring issue for pigment extracts (e.g. phycocyanin from Spirulina/Limnospira, astaxanthin oleoresin from Haematococcus pluvialis) and for oil extracts. Producers intending to sell a processed fraction rather than whole biomass should not assume that the non-novel status of the source species extends automatically to their specific product.
Where a novel food is produced using genetically modified organisms, the Novel Food Regulation does not apply; instead the GM food and feed framework applies (Regulation (EC) No 1829/2003). See GMO Regulation for the boundary between these two frameworks, which is particularly relevant for algae strains developed or improved through modern biotechnology techniques.
Several of the most commercially significant algae-derived novel foods authorised to date are oils produced by heterotrophic fermentation (notably DHA/EPA-rich oils from Schizochytrium sp. and Crypthecodinium cohnii). These authorisations illustrate that the novel food pathway has been successfully navigated by industry for algae-derived ingredients, providing a degree of regulatory precedent that may inform future applications, even though each new species, strain or extraction process must still be separately assessed.
See also: Food | Food Quality and Safety | Food Supplements | GMO Regulation | Purpose, Scope and Sources
Last reviewed: June 2026.