Conventional Food, Fortified Food or Food Supplement?

Why classification must come first

Whether a functional product is developed as a conventional food, fortified food or food supplement determines far more than the designation on its label. Classification defines the permissible formulation parameters, reference quantities for nutrients, mandatory information, national procedures and the boundary with medicinal product regulation. Leaving this decision open means developing several products at once—and none on a sound basis.

Executive summary: 

The product category is not a label designation selected afterwards, but a legal consequence of composition, dosage form, intake, intended purpose and overall presentation. It determines which substances may be used in which forms, how quantities must be declared, which warnings and national procedures apply, and whether the communication still falls within food law. Robust development therefore requires documented classification, with clear assumptions and decision gates, before formulation, costing and artwork.

The designation on the label is mandatory—but does not alone determine the legal category

The EU definition of food is broad but expressly excludes medicinal products. [1] Within food law, conventional foods are the starting point; specific product regimes apply where their conditions are met. For functional product development, the decisive question is therefore not which category sounds most commercially attractive, but what overall impression the actual product conveys when used as intended. Food supplements must expressly bear the designation ‘food supplement’ on the packaging. Nevertheless, legal classification depends not only on this wording, but on composition, dosage, dosage form, intended purpose and overall presentation.

Under Directive 2002/46/EC, a food supplement must meet several characteristics simultaneously: it supplements the normal diet, is a concentrated source of nutrients or other substances with a nutritional or physiological effect, and is marketed in dose form for consumption in measured small unit quantities. Capsules, tablets, sachets of powder and drop-dispensing bottles are typical examples, but dosage form alone does not establish classification. [2] A capsule containing an ordinary culinary ingredient does not automatically become a food supplement; conversely, a liquid product supplied in small measured units may indeed fall within this regime.

A fortified food, by contrast, remains a conventional food to which vitamins, minerals or certain other substances have been added. Regulation (EC) No 1925/2006 expressly distinguishes its rules on vitamins and minerals from those for food supplements and makes fortification subject to permitted vitamins, minerals and compounds, as well as product-specific conditions. [3] A vitamin-enriched drink is therefore not simply the liquid version of a capsule. Consumption occasion, normal intake, matrix and presentation create a different regulatory and nutritional frame of reference.

This distinction is more than terminology. Transferring a blend of active ingredients initially conceived as a food supplement into a 330 ml drink changes exposure, technological stresses, flavour profile, stability, nutrition declaration and potentially the permitted uses of individual ingredients. A change of format therefore becomes a new product decision.

Classification defines the formulation parameters

Food supplements and fortified foods use EU positive lists for vitamins and minerals. This does not make them interchangeable. The permitted compound is only the first checkpoint. Purity, dosage, daily intake, other sources of intake, target group, interactions and, where applicable, national requirements must also be assessed. For ‘other substances’, the situation is even more varied: plant extracts, amino acids and other physiologically active substances may simultaneously be subject to EU restrictions, national substance assessments and the boundary with medicinal products.

The product category also determines which data the label must carry. Food supplements require, among other information, the recommended daily intake, a warning not to exceed it, a statement that they are not a substitute for a balanced diet, and the quantities of characteristic substances expressed per recommended daily portion. [2] A conventional or fortified food generally follows the EU Food Information to Consumers Regulation, with nutrition information per 100 g or 100 ml. Food supplements are exempt from the general mandatory nutrition declaration because their specific quantity-declaration regime applies. [4]

These different reference quantities directly affect formulation. A nutrient content that appears technically justified in a small daily portion of a food supplement may produce substantially higher or less controllable intake in a freely consumed drink. Conversely, a dosage technically suitable for a drink may be too low to support the intended nutritional statement under the relevant conditions of use.

Cross-border projects also frequently underestimate another point: there are still no binding EU-wide maximum amounts for vitamins and minerals in food supplements and fortified foods. Although the Directive and Fortification Regulation provide for their establishment, no harmonised system is yet in place. [5] A formulation developed using one national risk assessment is therefore not automatically ready for approval in every target market. Classification must be linked to a market matrix, rather than an assumption of a uniform product for Germany, Austria and Switzerland.

Purpose and communication can take a product outside the food regime

The boundary with medicinal product law is determined neither by a single substance name nor by a blanket dosage threshold. Directive 2001/83/EC covers products presented as treating or preventing human disease, as well as products intended to restore, correct or modify physiological functions through pharmacological, immunological or metabolic action. Where, taking all its characteristics into account, a product may fall within both the medicinal product definition and another EU-regulated product category, the Directive provides that medicinal product law applies in cases of doubt. Nevertheless, for a medicinal product by function, the Court requires a case-by-case assessment and a significant physiological effect; not every physiological influence is sufficient. [6]

This creates an important distinction between legal fact and risk assessment in development projects. The definitions and precedence rules are legal facts. Whether a particular plant extract has a pharmacological effect at the intended dosage, however, requires scientific, product-specific substantiation. A supplier statement such as ‘food supplement grade’ or ‘sold in the EU as a food supplement’ is initially a company statement. It proves neither the classification nor the legal marketability of the actual formulation.

An authorised health claim does not resolve this issue either. Regulation (EC) No 1924/2006 governs voluntary nutrition and health claims in labelling, presentation and advertising; it neither replaces product classification nor legitimises an overall therapeutic message. [7] Packaging, product name, online shop, dosage instructions, imagery, testimonials and sales context must therefore be assessed as interconnected communication. Embedding a permissible individual statement in a therapeutic narrative may convey a legally different overall impression from the approved claim.

The intended positioning must therefore precede the formulation. Deciding which effect to communicate only after product development is complete risks either a statement unsupported by the product profile or a product presentation that calls its intended food status into question. The following technical article on health claims explores this interaction between communication, nutrient quantity and product matrix in greater depth.

Novel food is an additional assessment dimension, not a product category

Projects involving novel raw materials often treat ‘novel food’ as a fourth category alongside conventional foods, fortified foods and food supplements. This is misleading. The Novel Food Regulation assesses the status of a food or ingredient and its authorised uses; it does not replace classification of the finished product. A food supplement may therefore contain an authorised novel food ingredient without losing the other requirements applicable to food supplements. Conversely, classification as a food supplement does not make an unauthorised novel substance eligible for marketing. Authorisation, specification, maximum quantity, target group, food category and special labelling must cover the actual use. [8]

This is particularly relevant when formats change. Documented use of an ingredient exclusively in food supplements before 15 May 1997 does not automatically permit its use in conventional foods. The Novel Food Regulation expressly addresses this change; the European Commission’s Novel Food Status Catalogue also notes that new uses outside food supplements may require authorisation. The catalogue remains non-binding and non-exhaustive. [9]

A project seeking subsequently to commercialise a capsule formulation as a bar, shot or drink must therefore not simply carry forward the previous classification or novel food evidence. Raw-material identity, manufacturing process, intended use, food category, intake and communication must be reassessed against the new product version.

Germany, Austria and Switzerland form a project region, but not a single market clearance

In Germany, the Food Supplements Ordinance specifies the definition, labelling and notification requirements. Manufacturers or importers must notify a food supplement to the Federal Office of Consumer Protection and Food Safety (BVL), submitting the label used, no later than when it is first placed on the market. The BVL expressly states that acknowledgement of receipt confirms only complete submission of the notification, not the product’s compliance with the requirements for marketing. [10] Treating that acknowledgement internally as regulatory clearance confuses a market-surveillance instrument with an authorisation.

Austria incorporates the EU definition in its Food Safety and Consumer Protection Act and specifies the designation, mandatory information and quantity declarations in its Food Supplements Ordinance. [11] A notification submitted in Germany replaces neither Austrian product assessment nor consideration of national enforcement practice. Equally, the absence of pre-market authorisation does not imply that the composition and presentation have been accepted by the authorities.

Switzerland must be treated as a separate jurisdiction. The Federal Food Safety and Veterinary Office (FSVO) clarifies that food supplements generally require no product notification, but the operator placing them on the market must ensure compliance through self-monitoring. The Swiss Ordinance on Food Supplements sets product-specific permitted substances, maximum amounts and warnings. [12] Particularly for high-dose micronutrients, the same formulation can therefore lead to different clearance outcomes in the EU and Switzerland.

The useful working unit is consequently not ‘DACH-compliant’, but a shared product file with separate country decisions. Product identity and specification may be managed jointly; classification rationale, substance assessment, dosage, labelling, notification or authorisation questions, and communication must be resolved for each market.

Robust classification must withstand change

The classification decision should describe the actual product version: matrix and dosage form, intended use, recommended intake, target group, complete formulation with specified raw materials, proposed claims and sales channels, and relevant target markets. What matters is not the length of the record, but whether its essential assumptions are clear. For a plant extract, for example, species, plant part, extraction solvent, extract ratio, standardisation and daily dose may be crucial to classification. If purchasing changes one of these parameters, the consequences may extend beyond the specification and reopen classification itself.

Approval tied to a defined version therefore works well in practice. It links the category decision to the formulation version, claims set, artwork and market matrix, and identifies unresolved issues as approval gates. This makes it possible to distinguish a technical adjustment within the same parameters from a change that creates a new regulatory product.

Conclusion

The correct product category is the starting point for development because it structures subsequent decisions. Only the combination of intended purpose, dosage form, dosage, composition and overall communication determines whether a product should be treated as a conventional or fortified food, a food supplement or potentially a product outside food law.

Early classification does not unnecessarily restrict development. It prevents formulation, packaging and communication from being built on conflicting assumptions and requiring redevelopment shortly before launch. Food Essentials helps companies substantiate the category decision, assess critical raw-material and dosage questions, and establish a robust development and approval framework for the intended markets.

Food Essentials supports the planning and development of functional foods and food supplements—from defining product form, dosage and positioning through regulatory classification to formulation and artwork approval, and any required notification procedures. Please get in touch.

Wishing you a pleasant Sunday, Andreas Gebhart

References

All sources checked on 7 August 2026.

1. VO (EG) 178/2002, Art. 2.
2. RL 2002/46/EG, Art. 1–4 und 6–10 sowie Anhänge I–II.
3. VO (EG) 1925/2006, Art. 1 und 3–8 sowie Anhänge I–III.
4. VO (EU) 1169/2011, Art. 9 und 30 sowie Anhang V Nr. 10.
5. Europäische Kommission: Food supplements – Levels of vitamins and minerals.
6. RL 2001/83/EG, Art. 1 Nr. 2 und Art. 2 Abs. 2 sowie EuGH, C-140/07, Rn. 37–45.
7. VO (EG) 1924/2006, Art. 1, 3, 5, 10 und 14.
8. VO (EU) 2015/2283, Art. 3, 6 und 9 sowie DVO (EU) 2017/2470, Anhang.
9. Europäische Kommission: Novel Food Status Catalogue.
10. NemV, §§ 1, 4 und 5 sowie BVL: Hinweise zur Anzeige nach § 5 NemV.
11. LMSVG, § 3 Z 4 sowie NEMV, §§ 1–5.
12. VNem, Art. 1–4 und Anhang 1 sowie BLV: Nahrungsergänzungsmittel.

Note: This article provides professional information and does not constitute legal advice. The specific product design, target market and legislation in force at the time of the decision are decisive. Image: AI-generated.