Algae related regulation & legislation

Food supplements are, for many algae species — particularly microalgae such as Limnospira platensis (Spirulina), Chlorella vulgaris and Haematococcus pluvialis extracts — the single most established and accessible route to market in the EU food sector. This page covers the dedicated EU legal framework for food supplements as it applies to algae, including the important and frequently overlooked role of member state permitted-plant lists.

Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, OJ L 183, 12.7.2002, p. 51. EUR-Lex

Relevance to algae: This Directive establishes the EU framework for food supplements — concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form (capsules, tablets, powders, ampoules, etc.). Critically, this is a Directive, not a Regulation (see General on EU Legislation for the distinction): it sets harmonised rules for vitamins and minerals used in supplements, but for other substances — including the great majority of algal biomass and algal extracts used in supplements — it leaves considerable scope to national implementation. This is the source of one of the most practically important features of EU algae regulation for supplement producers.

Key provisions:

• Art. 4 and Annexes I–II — harmonised, positive lists of vitamins and minerals and their permitted forms (chemical sources) that may be used in supplements EU-wide. Several algae-derived ingredients are notable natural sources of some of these nutrients (e.g. iodine, iron), but the vitamin/mineral list itself does not directly govern whether the algal source material itself may be used.
• Art. 6 and Art. 8 — labelling requirements specific to supplements: mandatory statement of the categories of nutrients/substances characterising the product, recommended daily dose, a warning against exceeding the stated dose, and a statement that supplements should not replace a varied diet.
• Art. 11 — explicitly preserves member states' freedom to maintain or introduce national provisions on substances other than vitamins and minerals, in the absence of EU rules, subject to the Treaty rules on free movement of goods. This is the legal basis for the patchwork of national “permitted plant and substance” lists discussed below.

Because Directive 2002/46/EC does not harmonise the use of plant, algal, fungal or other non-vitamin/non-mineral substances in food supplements, each EU member state has developed its own national list (or, in some cases, no formal list at all, relying on general food safety law and case-by-case assessment) of which such substances and species may be used in supplements, and under what conditions. This is a genuinely significant practical barrier for algae producers seeking to sell food supplements across multiple EU markets, because:

• A species permitted for supplement use in one member state may not be on the corresponding list in another, even though both lists are notionally implementing the same Directive.
• National lists vary in their scientific basis, update frequency, and willingness to add new algal species as evidence becomes available.
• Mutual recognition under EU free movement rules exists in principle (a product lawfully marketed in one member state should, in general, be able to be marketed in another), but invoking mutual recognition in practice can be administratively burdensome and is not always straightforward, especially where the destination member state has specific public health concerns about a given species or substance.

France's ministerial order of 24 June 2014 (known as the “Arrêté Plantes”) establishes a list of plant and mushroom species, including a substantial list of macro- and microalgae, permitted for use in food supplements in France, together with their conditions of use. This list has been a frequently used reference point across the EU industry, partly because it is one of the more detailed and species-specific national lists available, but it is a French national instrument, not an EU list, and its content does not automatically apply in or bind other member states.

The French list and the EU Novel Food Catalogue's “not novel” determinations for food do not perfectly align: as documented in sector analyses, a number of algal species appear on the French supplement list that are not separately confirmed in the EU food catalogue (and vice versa), reflecting the different legal bases, different update cycles, and different scope (supplements specifically, versus food generally) of the two instruments. A producer cannot assume that inclusion on one list implies status under the other.

For an algae producer intending to sell a supplement EU-wide, the practical consequence of this fragmented framework is that market access for the non-vitamin/non-mineral active ingredient (the algal species or extract itself) must be checked country by country, in addition to the EU-wide novel food and contaminant safety questions covered in Novel Food and Food Quality and Safety. This is frequently the single most time-consuming aspect of bringing a new algal supplement product to the EU market, more so in practice than the EU-level novel food question for species that are already well-established as non-novel.

A food supplement containing an algal species or extract must separately satisfy:

• Novel food status (see Novel Food) — if the species or specific extract/fraction used is novel, EU-wide authorisation is required regardless of its status on any national supplement list.
• Contaminant and safety limits (see Food Quality and Safety) — including the cyanotoxin, iodine and heavy metal considerations that are particularly significant for concentrated supplement forms, where intake per unit weight is higher than for the same species consumed as a minor component of a varied diet.
• National permitted-substance list status, as described above.
• Where the product or its packaging carries a claim about health or nutritional effects, the Health and Nutrition Claims framework (see Health and Nutrition Claims) applies in addition.

These are four genuinely independent compliance questions, and a favourable answer to one does not imply a favourable answer to the others.

Because food supplements are, by design, concentrated sources consumed regularly and at defined doses, the safety considerations described in Food Quality and Safety apply with particular force:

• Cyanotoxins in Spirulina/Limnospira-based supplements are a recurring focus of national enforcement action and consumer body testing, given the concentrated and regular consumption pattern typical of supplement use.
• Iodine content in seaweed-based supplements (notably kelp-based products) has prompted specific national warnings and, in some member states, maximum dose recommendations, given the risk of excessive intake from concentrated, regularly consumed supplement forms.
• Heavy metals and inorganic arsenic limits under Regulation (EU) 2023/915 apply to food supplements as a distinct food category, often with stricter limits than for the equivalent fresh or minimally processed food form, in recognition of the more concentrated nature of supplement consumption.

• Check the national permitted-substance list (or equivalent regime) in every target member state before launching a supplement — this is frequently the binding constraint on market access, not the EU-level novel food question.
• Use the French Arrêté Plantes list as a useful reference point, but never as a substitute for checking the rules of the actual target market.
• Verify novel food status independently of national supplement-list inclusion — these are separate legal questions governed by different instruments.
• Pay particular attention to cyanotoxin and iodine testing for concentrated supplement products, given the elevated practical and reputational risk associated with this product category.
• Consider engaging with mutual recognition procedures where a product is already lawfully marketed in one member state and market access in another is contested, while recognising this is not always a fast or guaranteed route.

See also: Food | Novel Food | Food Quality and Safety | Health and Nutrition Claims | Food Labelling

Last reviewed: June 2026.