Fortification has a precise and narrow meaning in EU law, and whether a product is genuinely fortified food or merely food with added other substances determines three things: whether the term "fortified" may be used, what must mandatorily appear in the nutrition declaration table, and on what legal basis the product must be notified to the authorities. The following analysis examines this boundary and the resulting labelling and notification obligations.
Two regimes within a single Regulation
The primary instrument is Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. The title itself signals that the Regulation governs two distinct matters, addressed in two separate chapters operating under different logic.
Chapter II (Articles 3–7) concerns the addition of vitamins and minerals. This is a positive and closed regime: only the vitamins and minerals listed in Annex I may be added, in the chemical forms permitted under Annex II, subject to the conditions set out in the Regulation. It is this chapter that defines what "fortification" means in the technical sense, and it is this chapter that triggers the specific labelling obligations under Article 7.
Chapter III (Article 8) concerns the "addition of certain other substances". Its structure is the inverse. It is not a list of permitted substances but rather a mechanism for monitoring and restricting substances in respect of which safety concerns have arisen. A substance other than a vitamin or mineral — typically botanicals, amino acids, fatty acids, or substances with a nutritional or physiological effect — may in principle be used in food under general food law, unless and until the European Commission places it in Annex III. The procedural rules for this mechanism are set out in Implementing Regulation (EU) No 307/2012.
The distinction between these two chapters is the crux of the entire issue. Adding a vitamin or mineral constitutes fortification. Adding another substance does not constitute fortification in the sense that triggers the consumer-facing term and the obligations under Article 7 of Regulation 1925/2006, even though both activities are governed by the same instrument.
graph TD
R[Regulation 1925/2006] --> RII[Chapter II\nVitamins and minerals]
R --> RIII[Chapter III\nOther substances]
RII --> W[FORTIFICATION\n• nutrition declaration table\n• term 'fortified']
RIII --> I[MONITORING\n• Annex III\n• do not call 'fortified'\n• quantity outside table]
style W fill:#1e40af,color:#fff
style I fill:#0f766e,color:#fff
style RII fill:#334155,color:#e2e8f0
style RIII fill:#334155,color:#e2e8f0
What "fortification" means in law
Fortified food is food to which vitamins or minerals have been added. The term "fortified" conveys to the average consumer an unambiguous message: the product contains added vitamins or minerals that are absent from, or present in lower quantities in, an ordinary equivalent. If a product contains no added vitamin and no added mineral, describing it as "fortified food" is false and misleading as to its nature and nutritional value, in breach of Article 7(1) of Regulation (EU) No 1169/2011 and Article 7 of Regulation 1925/2006.
This is a trap that is easy to fall into with high-protein or high-fibre products containing botanical ingredients. A product containing whey protein, guar fibre, a botanical extract and inositol is sometimes described as "fortified", even though its composition includes not a single added vitamin or mineral. Protein and fibre are macronutrients, and the remaining substances are "other substances" within the meaning of Chapter III. Such a product is not fortified food and may not be described as such. If a manufacturer wishes for marketing reasons to use the term "fortified", the only lawful route is to actually add a vitamin or mineral — which then triggers the fortification regime together with its obligations.
"Other substances" — what makes them distinct
Adding a substance other than a vitamin or mineral does not make a product fortified food and does not trigger the obligation under Article 7(3) of Regulation 1925/2006 to declare the quantities of added vitamins and minerals in the nutrition declaration table. The reason is straightforward: there are no added nutrients with a reference intake value that could be included in that table. This does not mean, however, that such a product falls outside regulation. On the contrary, it is subject to several regimes simultaneously.
First, to general food law as regards safety. Second, to the rules on novel food — Regulation (EU) 2015/2283 — if the botanical ingredient or part thereof has no documented history of significant consumption in the Union before 15 May 1997. This is an obligation entirely separate from Regulation 1925/2006 and is frequently overlooked in the case of exotic raw materials. Third, to the mechanism under Article 8: if a substance is placed in Annex III, its use becomes prohibited, subject to conditions, or placed under EU monitoring. Fourth, to the rules on nutrition and health claims, if the manufacturer attributes any beneficial effect to the substance.
The most important practical difference in labelling is that "other substances" are not included in the nutrition declaration table. The table has a closed format, defined by Annex XIII to Regulation 1169/2011: energy, fat, saturates, carbohydrate, sugars, protein, salt, and only those vitamins and minerals for which a reference intake has been established. A botanical extract, choline or inositol is not a nutrient within the meaning of that table and may not be declared within it. Where a substance is the subject of a claim, its quantity must be stated in the same field of vision as the nutrition declaration table, but alongside it — not within it — as required by Article 7 of Regulation 1924/2006. This is precisely the opposite direction from added vitamins and minerals, which must be included in the table.
Labelling of fortified food
For fortified food, Regulation 1925/2006 establishes in Article 7 obligations that go beyond the general labelling rules. A nutrition declaration is mandatory, and within it the quantities of added vitamins and minerals must be stated. The value is expressed as the total content in the product — i.e. the sum of naturally occurring and added amounts — in the table, per 100 grams or millilitres and, where provided, per serving, together with the percentage of the reference intake from Annex XIII to Regulation 1169/2011. The most common practical error I encounter is declaring an added vitamin or mineral in a separate section labelled "active ingredients", outside the table. This is non-compliant with Article 7(3): an added nutrient must appear as a row within the table, not as an element of a separate block.
Article 7 also contains presentation prohibitions. The labelling of fortified food must not mislead or suggest that a balanced and varied diet cannot provide adequate amounts of nutrients. Nor may it suggest, through the addition of vitamins and minerals, health benefits that the product does not provide.
In addition, all general requirements of Regulation 1169/2011 apply: a food name that accurately reflects the nature of the product, a list of ingredients in descending order of weight, mandatory quantitative indication of an ingredient highlighted in the name or imagery, allergen emphasis, net quantity in the same field of vision as the name, and minimum character height. Where the manufacturer uses nutrition or health claims, the requirements of Regulation 1924/2006 also apply, including the declaration of the quantity of the substance subject to the claim in the same field of vision as the nutrition declaration, and the mandatory accompanying statements under Article 10(2).
The heading "active ingredients" as a section label deserves separate attention. This is the language of medicinal products and food supplements. In relation to ordinary food, including fortified food, its use not only lacks a legal basis but also increases the risk that the authority will classify the product as a food supplement or a borderline product. Where there is a need to highlight substances that are the subject of claims, a neutral heading describing the function should be used rather than one suggesting a "therapeutic action".
Annex III in practice — a substance permitted today may be restricted tomorrow
The mechanism under Article 8 is not theoretical. The European Commission uses it with increasing frequency, drawing on a precautionary interpretation of opinions from the European Food Safety Authority, which are sometimes inconclusive due to data gaps. Two examples illustrate how this regime operates and why manufacturers must monitor it.
Catechins from green tea containing epigallocatechin gallate were placed in Annex III by Regulation (EU) 2022/2340. They were simultaneously placed in Part B — substances permitted subject to conditions — and in Part C — substances under EU monitoring. The Part B condition means that a single serving of food intended for daily consumption must deliver less than 800 mg of epigallocatechin gallate, and the label must carry warnings, including a statement not to exceed that dose and that the product is not suitable for persons under eighteen years of age or for pregnant or breastfeeding women. Aqueous extracts of green tea that, when reconstituted as a beverage, have a composition comparable to a traditional infusion were excluded from the scope. The practical consequence is that a product containing a catechin extract is subject to this regime, whereas whole leaves in small quantities or a traditional infusion most likely remain outside it — a distinction that determines the presence or absence of mandatory warnings.
Monacolins from red yeast rice were placed in Annex III by Regulation (EU) 2022/860, subject to the condition that a single serving intended for daily consumption delivers less than 3 mg of monacolins, and placed under EU monitoring. As of 2026, work is ongoing to tighten the rules further, with a proposal to move monacolins to Part A of Annex III — i.e. to the list of prohibited substances. This is a clear illustration that the position of a substance in Annex III is not permanent and that a substance permitted subject to conditions may be prohibited within a short period.
Among the substances identified as candidates for assessment under the Article 8 procedure are, inter alia, alpha-lipoic acid, fennel, plants containing berberine, and hydroxycitric acid. The conclusion for manufacturers is unambiguous: before developing a formulation containing a botanical or active substance, the current status of Annex III must be verified, and after placing the product on the market, the Commission's work must be monitored, since a change in the status of a substance requires reformulation or relabelling, sometimes with only a short transitional period for selling off existing stock.
Notification obligation to the Polish Chief Sanitary Inspectorate (GIS)
In Poland, placing these products on the market entails a notification obligation under Article 29 of the Act of 25 August 2006 on Food and Nutrition Safety. A food business operator who for the first time places or intends to place on the market in the territory of the Republic of Poland a food supplement, a food for special nutritional purposes — including food for special medical purposes — or fortified food is required to notify the Polish Chief Sanitary Inspectorate (GIS). Notification is made electronically.
For the purposes of the boundary discussed here, it is important to note that the notification obligation covers not only food fortified with vitamins and minerals but also foodstuffs to which other substances within the meaning of Regulation 1925/2006 have been added. This means that the argument "it is ordinary food, so no notification is required" will not hold for a product containing added botanicals or a substance with a physiological effect that is positioned with a health-related message. The addition of other substances is an independent ground for notification, regardless of whether the product also contains vitamins or minerals. The practical boundary lies where the incidental, culinary use of a plant as a flavouring ingredient ends and its addition for a nutritional or physiological effect — or with an accompanying health message — begins.
The legal nature of the notification is frequently misunderstood. Notification is not registration or product approval. Placing on the market is not conditional on the authority's consent and may occur from the moment of notification. At the same time, notification does not close the matter. The Polish Chief Sanitary Inspectorate (GIS) may initiate an explanatory procedure in which it requests clarification, and in the event of doubt may seek an opinion — for example from the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products as to whether the product is not a medicinal product, or from a scientific body as to the safety or substantiation of claims. The moment of notification is precisely the moment at which the authority first examines the label. All prior decisions regarding the name, claims and classification cease to be academic and acquire procedural significance.
flowchart TD
P[Product with added substance] --> Q{Has a vitamin\nor mineral been added?}
Q -->|YES| ZW[Fortified food\nArt. 29 + Reg. 1925/2006 Chapter II]
Q -->|NO| IS[Food with other substance\nArt. 29 + Reg. 1925/2006 Chapter III]
ZW --> GIS[GIS Notification]
IS --> GIS
GIS --> OCENA[Authority assesses label\nname, claims, classification]
style ZW fill:#1e40af,color:#fff
style IS fill:#0f766e,color:#fff
style GIS fill:#7c3aed,color:#fff
style OCENA fill:#334155,color:#e2e8f0
The boundary with medicinal products and food for special medical purposes
Adding substances with a physiological effect — in particular botanical extracts at doses approaching those used therapeutically — opens a separate risk of reclassification. Under Directive 2001/83/EC and Article 3a of the Polish Pharmaceutical Law, if a product simultaneously meets the definition of a food and a medicinal product, the rules on medicinal products apply. The overall presentation is decisive: the name, slogans, declared doses, dosage instructions and target group. The more strongly the label suggests a pharmacological action or a special purpose, the greater the risk that the authority will classify the product as a medicinal product by function.
Fortified food must also be distinguished from food for special medical purposes within the meaning of Regulation (EU) No 609/2013. Fortified food is ordinary food intended to supplement the diet of the general population, not for dietary management of disease. A declaration that the product is not a meal replacement or food for special medical purposes can be a useful differentiating element, provided it remains consistent with the rest of the presentation.
Maximum levels — a harmonisation gap
Article 6 of Regulation 1925/2006 provides for the establishment of maximum and minimum levels of vitamins and minerals added to foods. However, maximum levels at EU level have not yet been established. In this gap, Member States apply their own approaches, drawing on national levels, advisory body opinions, and the tolerable upper intake levels set by the European Food Safety Authority as a reference point. The absence of full harmonisation means that a level permitted in one Member State need not be accepted in another, which is relevant when planning cross-border sales of the same product.
Practical conclusions
The product category must be determined honestly before the label is designed, not retrofitted to a finished graphic. The term "fortified" may only be used where a vitamin or mineral has actually been added to the product. Added vitamins and minerals are included in the nutrition declaration table; other substances remain outside the table, with their quantities declared alongside it where they are the subject of claims. Before selecting a botanical raw material or active substance, the current status of Annex III and the novel food status must be verified, and after placing the product on the market, the Commission's work under the Article 8 procedure must be monitored, since the status of a substance can change. Finally, each of these products requires notification to the Polish Chief Sanitary Inspectorate (GIS) upon first placing on the market, and notification should be treated as the moment at which the label, name and claims are submitted to regulatory scrutiny.
The above text is general and informational in nature. It does not constitute legal advice in any individual matter; assessment of a specific product requires analysis of its full composition, intended use and overall presentation.