Algae related regulation & legislation

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===== Novel Food =====

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.

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==== The Novel Food Concept ====

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. [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02015R2283-20210327|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:

  * point (ii): __food consisting of, isolated from or produced from micro-organisms, fungi or algae__.

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).

=== The exemption: history of consumption before 1997 ===

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.

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==== The Novel Food Catalogue ====

The [[https://food.ec.europa.eu/food-safety/novel-food/novel-food-status-catalogue_en|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:__

  * It has __no legal value__. An entry in the catalogue stating a product is "not novel" does not constitute a legal authorisation or guarantee; it is an indication based on available evidence at the time of entry.
  * It is __not exhaustive__. The absence of a species from the catalogue does not mean it is novel — it may simply not have been assessed yet.
  * It is subject to __revision__ as new evidence becomes available, including evidence that might reclassify a previously "non-novel" entry.
  * Searches must account for __taxonomic synonyms__. Because of ongoing taxonomic revision (see [[algae:purpose_scope_sources|Purpose, Scope and Sources]] for the //Spirulina/////Arthrospira/////Limnospira// example), a species may appear under an outdated name, and a producer should search multiple historical and current names before concluding a species is absent from 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.

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==== The Authorisation Pathway ====

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):

  * __Application__: submitted directly to the European Commission (not to a national authority, a change from the pre-2018 system), accompanied by a full safety dossier.
  * __EFSA risk assessment__: the Commission requests EFSA to carry out a safety assessment. EFSA's NDA Panel (Nutrition, Novel Foods and Food Allergens) is responsible for this evaluation. EFSA publishes administrative and scientific guidance for applicants, including a Scientific Guidance on the preparation of novel food applications and specific guidance addressing the data requirements for foods consisting of, isolated from or produced from micro-organisms, fungi or algae.
  * __Authorisation__: if EFSA's opinion is favourable, the Commission adopts an Implementing Regulation authorising the novel food and adding it to the __Union list of novel foods__, specifying conditions of use, labelling requirements and, where relevant, post-market monitoring requirements.
  * __Union list__: maintained via Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283, OJ L 351, 30.12.2017, p. 72. [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R2470-20260316|EUR-Lex]] This list is amended frequently to add newly authorised novel foods, including several algae-derived ingredients (for example, oil rich in DHA and EPA from //Schizochytrium// sp., which has been the subject of several amending Implementing Regulations updating permitted conditions of use).

=== Authorisation versus notification: two distinct routes ===

There are two distinct procedural routes under the Regulation, and algae producers should understand which applies to their situation:

  * __Full application route__ (Article 10): for genuinely new novel foods requiring a complete safety assessment. This is lengthy (statutory timelines run to many months, and in practice often longer) and the cost of preparing a full dossier — toxicological studies, compositional analysis, exposure assessment — frequently reaches the high hundreds of thousands to several million euros, depending on the complexity of the safety case required.
  * __Notification route for traditional foods from third countries__ (Articles 14–20): a simplified procedure available where the food has a history of safe use as a food in a third country for at least 25 years and is intended to be introduced into the EU market without modification of the production process. This route requires less extensive data (history of safe use rather than full toxicological testing) but is only available for foods with a genuine, well-documented third-country traditional use — relevant for some algae species traditionally consumed in parts of Asia, Africa or Latin America but not yet established in the EU.

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==== Practical Issues Specific to Algae ====

=== Extracts and fractions are assessed separately from whole biomass ===

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.

=== GM and biotechnology boundary ===

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 [[algae:gmo|GMO Regulation]] for the boundary between these two frameworks, which is particularly relevant for algae strains developed or improved through modern biotechnology techniques.

=== Heterotrophically produced algal ingredients ===

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.

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==== Resources for Applicants ====

  * EFSA Scientific Guidance for the preparation of novel food applications, published and periodically updated by EFSA. [[https://www.efsa.europa.eu/en/supporting/pub/en-6488|EFSA]]
  * The EU4Algae project has published practical guidance materials aimed at helping algae producers understand and navigate the novel food application process; see [[algae:specialised_sources|Specialised Sources — Bibliography]] for the relevant guide.
  * Pre-submission advice from the Commission and General Pre-submission advice mechanisms under Articles 32a–32b of the General Food Law (as amended by the Transparency Regulation, Regulation (EU) 2019/1381) are available to applicants before formal submission, and are a worthwhile early step for algae producers uncertain of their product's status.

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//See also: [[algae:food|Food]] | [[algae:food:quality_safety|Food Quality and Safety]] | [[algae:food:supplements|Food Supplements]] | [[algae:gmo|GMO Regulation]] | [[algae:purpose_scope_sources|Purpose, Scope and Sources]]//

//Last reviewed: June 2026.//