Fortified foods, EU rules and national limitations

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Dario Dongo
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Regulation (EC) No. 1925/2006 of the European Parliament and of the Council has established a uniform regulatory framework for the addition of vitamins, minerals and other substances to foods in the European Union, with the aim of harmonising the internal market and ensuring a high level of consumer protection. Despite the directly applicable nature of EU regulations, critical analysis reveals how, almost two decades after its issuance, the application of Regulation 1925/2006 is still significantly hindered by divergent national rules and interpretations.

This analysis examines the persistent gap between EU rules and national practices, demonstrating how it harms free enterprise and competitiveness in the food sector. Through the use of specific economic data on the growing market value and detailed examples of national divergences (including a focus on the Italian case and the impact of Court of Justice of the EU jurisprudence in countering such trends), it highlights the urgent need for uniform application to support innovation and consumer protection.

Fortified foods: the EU rules

Regulation (EU) 1925/06 pursues the main objective of ensuring the effective functioning of the internal market, whilst providing a high level of consumer protection (European Commission, 2024). It:

  1. Establishes harmonised lists of vitamins and minerals that may be added to foods (Annex I);
  2. Defines the vitamin formulations and mineral substances authorised for addition to foods (Annex II);
  3. Creates a comprehensive framework for substances that are prohibited, restricted or under scrutiny (Annex III);
  4. Establishes the conditions for the addition of vitamins and minerals to foods;
  5. Implements a uniform approach to labelling, presentation and advertising;
  6. Establishes procedures for amendments to the lists and for safeguard measures.

Free movement of goods

Article 10 of Regulation (EU) 1925/06, ‘Free movement of goods‘, clearly expresses the European legislator’s intent to unify rules in the field of food fortification:

‘Without prejudice to the Treaty, in particular Articles 28 and 30, Member States may not restrict or forbid trade in food products that comply with this regulation and Community acts adopted for its implementation through the application of non-harmonised national provisions governing the addition of vitamins and minerals to foodstuffs‘.

This provision explicitly prohibits Member States from imposing further restrictions or bans on foods that comply with the cited regulation. As Bernard (2022) highlights, ‘this provision ensures the free movement of goods within the internal market and prevents the creation of trade barriers through divergent national rules‘ (p. 219).

The economic value of fortified foods in the European market

The fortified foods market represents a significant and growing segment of the European food economy. According to recent market studies, the fortified foods sector in the EU reached an estimated value of 131.6 billion euros in 2023, with a growth forecast to 281.5 billion euros by 2033, highlighting a compound annual growth rate (CAGR) of 7.9% (Market.us, 2024).

This remarkable development is driven by several factors: the growing consumer awareness regarding the importance of preventive nutrition, the increase in micronutrient deficiencies in some segments of the European population, and demographic ageing stimulating demand for functional foods supporting health. In particular, the European Food Safety Authority (EFSA) has found that approximately 80% of European consumers are willing to pay a premium price for fortified foods, especially those with functional ingredients that support immunity and digestive health (Market.us, 2024).

In the European context, fortified dairy products represent one of the most dynamic segments, with a projected growth of 6.5% annually until 2031 (The Insight Partners, 2024). Fortification with vitamin D, calcium and iron is particularly widespread in dairy products, bread and cereals, responding to the specific nutritional needs of the European population.

Technological innovation in the food fortification sector is creating significant market opportunities, with advanced techniques such as nanoencapsulation, extrusion and microencapsulation making it possible to fortify foods with micronutrients more efficiently and economically (Persistence Market Research, 2024). These developments not only improve the nutritional quality of foods, but also offer new possibilities for expansion for European food companies.

The narrow limits of competing national legislation

In ensuring the uniformity of the regulation on food fortification in the European Union, Regulation (EC) 1925/06 also defines:

  • the limited circumstances in which Member States may adopt certain national provisions;
  • the rigorous notification procedures for national rules and emergency measures potentially adopted.

Notification procedure

Member States, in the absence of specific European provisions, may adopt national rules regarding:

  • mandatory addition of vitamins and minerals to specific foods (e.g. folic acid)
  • prohibition or restriction of the use of certain substances in food production

Such measures must be notified to the Commission which has the power to issue an opinion and, where appropriate, ask the Member State to modify the rules or halt their iter legis (Reg. EC 1925/06, Article 11).

Safeguard measures

If a Member State has detailed grounds for establishing that a product represents a danger to human health, although it complies with the regulation, it may temporarily suspend or restrict the application of the relevant provisions in its territory.

In this case too, the Member State has the obligation to inform the other Member States and the Commission immediately, providing the reasons for its decision.

These limited exceptions do not undermine the uniform application of the regulation in the Internal Market, but provide the necessary safeguards in specific and justified circumstances (Reg. EC 1925/06, Article 13).

Jurisprudence of the Court of Justice of the EU

The Court of Justice of the European Union (CJEU) has played a fundamental role in the interpretation and application of Regulation (EU) 1925/06 and related legislation, establishing key principles that strengthen the uniform application of these rules throughout the Internal Market.

As Weatherill (2021) emphasises, ‘the Court has effectively addressed the tension between national public health measures and the free movement of goods‘ (p. 1612) in the context of the addition of vitamins, minerals and other substances to foods.

Commission v Germany (Case C-387/99): the proportionality requirement

An emblematic case concerning the classification of vitamin and mineral preparations is Commission v Germany (Case C-387/99), decided by the CJEU in 2004. The case concerned the German practice of classifying as medicinal products all vitamin and mineral preparations that contained more than three times the recommended daily allowance established by the German Food Association, even when these products were legally marketed as food supplements in other Member States (European Court of Justice, 2004).

The Court established that:

‘Germany’s generalised classification based solely on the recommended daily allowance does not adequately meet the requirement for a case-by-case assessment based on the pharmacological properties of each preparation‘ (CJEU, C-387/99, para. 68).

This practice created a barrier to trade, requiring vitamin preparations legally marketed in other Member States to undergo a marketing authorisation procedure for medicinal products before they could be sold in Germany (Purnhagen & van der Meulen, 2020).

This judgment established the crucial principle that Member States cannot adopt general rules that automatically classify products as medicinal products rather than as food supplements based solely on predetermined vitamin dosage thresholds. Instead, they must conduct case-by-case analyses, based on scientific risk assessment.

Noria Distribution SARL (2017): scientific assessment and maximum limits

In the Noria Distribution SARL case, concerning a French company marketing food supplements throughout the EU, the CJEU ruled on the criteria for establishing maximum quantities of vitamins and minerals in food supplements when the EU had not yet adopted harmonised maximum levels (European Court of Justice, 2017).

The Court established that:

‘Although Member States remain competent to adopt legislation relating to maximum quantities until EU harmonisation, they must respect the rules on the free movement of goods and the principles established by Article 5 of the Food Supplements Directive 2002/46/EC‘ (CJEU, C-672/15, para. 41).

In particular, the Court emphasised that any scientific risk assessment must be conducted on a case-by-case basis and based on ‘generally accepted scientific data‘.

This judgment reiterated that national measures prohibiting the marketing of food supplements legally manufactured or marketed in other Member States constitute measures having an effect equivalent to quantitative restrictions. Such measures can only be justified on grounds of public health protection if they are proportionate and based on a comprehensive scientific assessment.

CJEU, the key principles

The CJEU has established several key principles that must govern the implementation of Regulation (EU) 1925/06 and related legislation:

  1. Case-by-case assessment. Member States cannot apply general restrictions but must evaluate each product individually, based on its specific composition and properties;
  2. Scientific basis for restrictions. Any restriction on the marketing of food supplements must be based on a comprehensive scientific risk assessment, using generally accepted scientific data;
  3. Proportionality. National measures restricting the movement of goods must be proportionate to the public health objective pursued and not go beyond what is necessary to achieve that objective;
  4. Mutual recognition. In matters not fully harmonised, Member States must establish procedures for the mutual recognition of products legally marketed in other Member States.
  5. Burden of proof. The burden of proof regarding any health risk falls on the Member State imposing the restriction, not on the economic operator.

In the case of B S and C A (2020), the Court explicitly stated that:

‘National legislation subjecting food products legally marketed in other Member States to additional restrictions represents a measure having equivalent effect to a quantitative restriction within the meaning of Article 34 TFEU, admissible only if it is justified by one of the objectives of general interest referred to in Article 36 TFEU or by imperative requirements and is proportionate to that objective or requirement‘ (CJEU, C-663/18, para. 42).

These principles collectively strengthen the uniform application of Regulation (EU) 1925/06 throughout the Internal Market, defining strict limits for divergent national interpretations that could fragment the market or create unjustified barriers to trade.

Examples of national restrictions and applicative divergences

Despite the clear framework of Regulation (EC) 1925/2006 and the established jurisprudence of the CJEU, restrictive practices persist in various Member States that hinder the full harmonisation of the internal market for fortified foods. These cases illustrate the persistent tension between European harmonisation and national interpretations in the field of food safety.

Mandatory fortification and the different national positions

A significant example of applicative divergence concerns mandatory fortification with folic acid. While countries such as the United States, Canada and Australia have adopted policies of mandatory fortification of cereal flours with folic acid to reduce the incidence of neural tube defects in newborns, a fragmentation of approaches persists within the EU:

  • in England, the government adopted in 2024 an amendment to ‘The Bread and Flour Regulation’ (1988), introducing the obligation to fortify non-wholemeal wheat flour with 250 µg/100 g of folic acid from 13 December 2026. Wholemeal flours and gluten-free foods have been excluded from this obligation, as the former naturally contain more folates and some gluten-free products are already fortified on a voluntary basis;
  • in France, the National Food Safety Agency (ANSES) has recommended the systematic enrichment of all wheat flours – including wholemeal – with 200 μg/100 g of folic acid. The French authorities have emphasised the importance of including wholemeal flours in mandatory fortification, highlighting that “wheat flour was chosen as the food to be enriched for two reasons: it is an ingredient used in many products commonly consumed and these products are economically accessible to all target women“;
  • in Italy, the proposal for mandatory fortification of certain foods previously proposed by the Italian Society of Neonatology remains awaiting feedback.

Technical barriers to marketing

Beyond mandatory fortification, another area of applicative divergence concerns the maximum fortification limits allowed per vitamin or mineral in foods. In the absence of harmonised maximum levels at EU level, some Member States have established national thresholds that can differ significantly from each other, creating obstacles to the cross-border marketing of fortified products.

For example, some Member States apply more restrictive limits for vitamin D in dairy products or for caffeine in fortified foods, based on national risk assessments that may diverge from EFSA’s conclusions. These discrepancies require food companies to adapt product formulations to comply with different national requirements, with significant additional costs and possible distortions of competition (Purnhagen & van der Meulen, 2020).

The case of national administrative interpretations

A further problematic aspect is represented by national administrative interpretations that may unduly extend the scope of pre-existing regulations, creating regulatory confusion and legal uncertainty for food business operators.

Impact on national legal frameworks

The jurisprudence of the CJEU has had a significant impact on the national legal frameworks governing fortified foods and food supplements. Member States have had to adapt their regulatory approaches to comply with the Court’s judgments, and thus:

  1. Establish formal procedures for the assessment of products legally marketed in other Member States;
  2. Review their criteria for maximum levels of vitamins and minerals to ensure they are based on scientific evidence rather than arbitrary thresholds;
  3. Implement notification procedures rather than authorisation procedures for products already marketed in other Member States;
  4. Ensure that their public health measures are proportionate and specifically targeted at addressing actual risks.

The Court’s official and binding interpretation complements the legislative harmonisation achieved through Regulation (EU) 1925/06, ensuring that its uniform rules are effectively implemented throughout the Internal Market with minimal room for deviations by Member States.

The Italian case

The application of Regulation (EU) 1925/06 in Italy presents an interesting case study regarding the relationship between EU regulations and internal administrative acts. Indeed, the Italian Ministry of Health circular 6 March 2008, no. 4075-P stated that fortified foods ‘are temporarily included in the scope of Legislative Decree 27 January 1992, no. 111 on products intended for particular nutritional uses, as explained in Circular 16 April 1996, no. 8 (Official Gazette no. 102 of 3 May 1996)‘.

This ministerial position attempted to maintain the pre-existing Italian regulatory framework for fortified foods, despite the entry into force of Regulation (EU) 1925/06. Such an approach is however unconstitutional due to conflict with the fundamental principles of EU law, particularly regarding the direct applicability of regulations and their primacy over national law. It also presents problems of internal constitutionality, given that a ministerial circular – lacking the force of law – cannot extend the scope of a legislative decree.

Legal status of ministerial circulars

In the Italian legal system, ministerial circulars have a clearly defined legal status: they are administrative acts intended for internal use in the public administration. As Casetta and Fracchia (2023) highlight, ‘they provide interpretative guidance to subordinate offices but have no normative value outside these spheres‘ (p. 112).

The Italian Court of Cassation has consistently held that circulars are not sources of law. In a fundamental judgment, the Court established that ‘Administrative interpretation, whether contained in circulars or resolutions, binds neither taxpayers nor judges, nor does it constitute a source of law‘ (Court of Cassation, Civil Section V, Judgment 5 March 2014, no. 5137).

The primacy of EU regulations

The direct applicability of EU regulations is enshrined in Article 288 of the Treaty on the Functioning of the European Union (TFEU), which establishes that regulations ‘shall be binding in its entirety and directly applicable in all Member States‘. Lenaerts (2020) emphasises that ‘this principle has been consistently reinforced by the jurisprudence of the CJEU‘ (p. 31).

According to the principles of EU law, Member States cannot hinder the direct application of regulations through national administrative acts, including ministerial circulars. The CJEU has established in numerous cases that attempts by Member States to ‘filter’ EU regulations through national implementation measures are contrary to EU law and undermine the uniform application of EU legislation.

As Schütze (2022) emphasises, it is fundamental to “understand the hierarchy of legal sources in the EU and the limits of administrative acts in influencing the direct applicability of EU regulations” (p. 245).

Conclusions

Regulation (EU) 1925/06 exemplifies the EU’s approach to complete harmonisation of the regulatory framework applicable to fortified foods. By establishing uniform rules for the addition of vitamins, minerals and other substances to foods, it ensures consistency throughout the internal market, whilst maintaining a high level of consumer protection.

In light of the analysis carried out, however, the persistence of problematic applications and interpretations at national and local level emerges, which should be considered by the European Commission to guarantee operators in the sector and citizens equal conditions of production, marketing and purchasing choices.

The growing economic importance of the fortified foods sector, with a projected market value of 281.5 billion euros by 2033, further underlines the urgency of uniform application of EU legislation. Only through a harmonised and evidence-based approach will it be possible to reconcile the objectives of public health protection with those of competitiveness and innovation in the European food industry.

Dario Dongo

Cover art copyright © 2025 Dario Dongo (AI-assisted creation)

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Dario Dongo
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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.

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