The Commission has put harmonised maximum levels for vitamins and minerals back on the agenda, twenty-four years after the mandate in Directive 2002/46/EC. The fear that current formulations will become unlawful within months is misplaced. The real legal issues lie in the end of mutual recognition for doses and in a calculation method that sits uneasily with the case law of the Court of Justice.
The European Commission has returned to the regulation of harmonised maximum amounts of vitamins and minerals in food supplements and fortified foods. It does so twenty-four years after the mandate laid down in Article 5 of Directive 2002/46/EC, and after the note that Germany, supported by sixteen other countries, submitted in December 2025. The Commission's current plan is to launch a public consultation on the revised draft in the third quarter of 2026 and to adopt the final act in early 2028. Although the announcement has caused concern in the sector, the idea that formulations currently on the market will cease to comply within a matter of months is inaccurate.
This article examines how much truth there is in that perception and where the underlying legal problems lie: the procedure and timetable, the effect of harmonisation on the free movement of these products, and the compatibility of the Commission's calculation method with the case law of the Court of Justice.
Thesis
The immediate risk for operators does not arise from Union law, since no harmonised limit will apply before 2028 and national rules will prevail until then. The crux is that, as long as there is no harmonisation, the principle of mutual recognition allows — at least in theory — doses accepted in one Member State to be marketed in another. Harmonisation will close that route for maximum doses once and for all. The threshold at which maximum levels are set is therefore not a neutral technical decision, but the factor that will determine which products enjoy free movement throughout the Union. And that level will depend on the residual amount method, whose compatibility with the requirement of an individual, case-by-case assessment that the Court of Justice has derived from Article 5 of the Directive is, legally, highly questionable.
Timetable and procedure: what will not happen in six months
The Commission has announced that it will put a revised draft to public consultation in the third quarter of 2026 and expects to adopt the final act in the first quarter of 2028. The timetable is known from the specialist press and from sector firms, which reported it from June 2026. Even taking it as a reliable forecast, a look at the procedure is enough to rule out current formulations becoming unlawful in the short term.
Article 5(4) of Directive 2002/46/EC, as amended by Regulation (EC) No 1137/2008, entrusts the Commission with adopting maximum and minimum amounts under the regulatory procedure with scrutiny of Article 13(3). This means that, after the public consultation, the draft requires the consultation of EFSA that Article 14 imposes for provisions likely to have an effect on public health — although the Commission may consider that step already sufficiently covered by the opinions issued on tolerable upper intake levels and decide not to request a new one — and the opinion of the competent Standing Committee. A scrutiny period then opens in which the European Parliament and the Council may oppose the measure. Only at the end of that sequence would the regulation be published, and it will presumably include a transitional period of as yet unknown length.
The practical consequence is clear. Until that regulation applies, Article 11(2) of the Directive keeps national provisions in force, and it is against them that operators must check their products today. What opens now is not an adaptation period but a phase in which the design of the system can still be debated — and this is the key point: the public consultation is the moment when objections to the method have the best chance of being heard.
Mutual recognition, and why Spain is a special case
As long as there are no harmonised maximum amounts, cross-border trade in these products is governed by Articles 34 and 36 TFEU and by the principle of mutual recognition, now developed by Regulation (EU) 2019/515. Directive 2002/46/EC harmonises which vitamins and minerals may be used and in which forms, but not in which doses, so national limits fall within the scope of that principle. In Noria Distribution (C-672/15), the Court of Justice dealt with the criminal prosecution in France of the marketing of food supplements containing vitamins and minerals in doses above the national maximum levels, even though they were lawfully manufactured and sold in other Member States. The Court held that Member States setting maximum doses must provide a procedure that is accessible, of reasonable duration and subject to judicial review for authorising products that exceed those limits but are lawfully marketed in another Member State, and that authorisation may be refused only if the national authorities show, on the basis of up-to-date scientific data, that the product poses a real risk to public health (paragraphs 22 and 23).
Experience in other Member States shows, however, that mutual recognition achieves little where demanding national limits or criteria exist. The empirical study by Warda, Purnhagen and Molitorisová (Has Mutual Recognition in the EU Failed? — A Legal-Empirical Analysis on the Example of Food Supplements Containing Botanicals and Other Bioactive Substances, Journal of Consumer Policy, vol. 47, 2024), based on interviews with authorities in Austria, Belgium, the Czech Republic and Ireland, finds that those authorities do not see mutual recognition as a real route to market: operators adapt their products to each national rule rather than invoking it, and authorities do not regard another Member State as a sufficient reference for simply admitting what is sold there. The Commission itself, in the evaluation accompanying the proposal for Regulation 2019/515, identified maximum levels of vitamins and minerals as one of the main problems for mutual recognition in the food supplements sector, noting that companies tend to adapt their products and formulas to each Member State's levels, often marketing different products in different countries (SWD(2017) 475 final, section 7.2.3).
Spain sits at the opposite end. Royal Decree 1487/2009 sets no maximum amounts for vitamins and minerals; it does so only for the “other substances” in its annex. The Spanish Agency for Food Safety and Nutrition (AESAN) expressly acknowledges that such levels have not been set and refers to its table of tolerable upper intake levels assessed by EFSA, updated on 5 November 2024. Those values refer, with some exceptions such as magnesium, to total intake from all sources, not to the dose of a supplement. In addition, the sole additional provision of the Royal Decree excludes from its requirements food supplements lawfully manufactured or marketed in another Member State. In Spain, therefore, there are no maximum per-dose amounts of vitamins and minerals laid down by law: the available reference is the total-intake levels published by AESAN, which have no regulatory force, and products lawfully marketed in another Member State are excluded from the Royal Decree's requirements, without prejudice to the general safety requirement of Article 14 of Regulation (EC) No 178/2002. Mutual recognition barely needs to be invoked, because the market is open by design.
Harmonisation will change that balance structurally, and it will not mean the same thing in every Member State: where there were national limits, it will replace them; in Spain, it will introduce a legal per-dose limit for the first time. Once maximum amounts are set, Article 11(1) of the Directive will prevent Member States from restricting products that respect them on grounds of composition, subject only to the temporary safeguard clause of Article 12. But the rule also works in reverse: no Member State will be able to admit products that exceed them, and mutual recognition will cease to have any bearing on doses.
The residual amount method and the standard set in Noria Distribution
According to what has emerged about the draft, the Commission intends to apply the “residual amount” method to calculate the limit for each nutrient. The method takes the safe upper intake level set by EFSA and subtracts actual dietary intake in the population, measured at the 95th percentile, which represents consumers with the diets richest in that nutrient. The remaining margin — the residue — would be split equally, with 50% allocated to food supplements and 50% to fortified foods. Since the text is not public, these indications come from sector sources and should be treated with due caution.
Case law provides the right yardstick for assessing the legality of the method. In Solgar Vitamin's France (C-446/08) and, above all, in Noria Distribution (C-672/15), the Court of Justice held that the maximum amounts under Article 5 of the Directive must be set case by case, taking into account all the factors in paragraphs 1 and 2 and, in particular, the upper safe levels established after a comprehensive scientific risk assessment based not on general or hypothetical considerations but on relevant scientific data (Noria Distribution, paragraph 42). Although that case law was developed to review restrictions adopted by Member States, it is crucial to identify which elements carry over to the Commission. On the one hand, the obligation to provide a swift procedure for authorising products from other Member States (paragraph 22) is a corollary of mutual recognition and will fall away once the field is harmonised. On the other hand, the requirement of a case-by-case scientific assessment is not a mutual recognition rule but a mandate flowing directly from Article 5 of the Directive itself. It therefore binds the Commission with equal force when it exercises its regulatory power under paragraph 4, which rules out general and abstract mathematical formulas such as the residual amount method.
The strongest counter-argument must be stated plainly. The Court itself accepted that, once safe intake levels have been determined, the authorities may set maximum daily-dose limits significantly below those thresholds, provided the measure is justified under the criteria of Article 5 and respects the principle of proportionality (Noria Distribution, paragraph 35), and it recalled the obligation to take into account intake of the nutrient from other dietary sources (paragraph 36). From a strictly formal standpoint, the residual amount method is an almost literal translation of the correction factors in Article 5(1)(a) and (b) of the Directive. Setting a maximum amount well below the tolerable upper level cannot, therefore, be branded unlawful merely because it implies a drastic reduction in dose.
The Commission's method nevertheless has three main technical weaknesses: the accumulation of theoretical maxima through the use of the 95th percentile of the Member State with the highest exposure; the absence of any scientific basis for the 50% split between supplements and fortified foods; and possible double counting if dietary surveys already reflect that consumption. These shortcomings raise the question whether this is an assessment based on relevant data or on the kind of hypothetical considerations the Court has already rejected. The Court does, however, grant the institutions a broad margin of discretion in managing complex risks, which limits the intensity of subsequent judicial review.
Iron illustrates clearly where the draft's methodological flaw lies. Until recently it had no tolerable upper intake level; after a thorough re-evaluation, EFSA set a “safe level of total intake” of 40 mg/day for adults, a value AESAN has included in its reference table with the caveat that it is based on limited data. This is therefore not a tolerable upper intake level in the strict sense, but a threshold of scientific prudence. If the residual amount method took those 40 mg as its starting point and subtracted European dietary intake at the 95th percentile, which is around or above 15–20 mg/day in the highest-consuming countries, the margin left to share between supplements and fortified foods would be minimal. That scenario would clash head-on with two requirements of Article 5 of the Directive. First, with paragraph 1(a), which requires the starting point to be upper safe levels established by scientific risk assessment; a value the authority itself describes as provisional or of limited confidence is ill suited to serve as a fixed term in a rigid arithmetic operation. Second, with paragraph 2, which requires reference intakes for the population to be taken into account. Since EFSA set the reference intake for premenopausal women at 16 mg/day, a commercial maximum below or very close to that figure would undermine the internal coherence and nutritional purpose of the Directive's system.
What operators can do, and what remains open
The useful task at this stage is not to reformulate on the basis of figures that have not been published, but to know one's own exposure. That means checking each product in the portfolio against current tolerable upper intake levels, in order to identify the nutrients for which the recommended daily dose approaches or reaches those values, since they will be the first affected under any variant of the method. Iron, for the reasons set out above, deserves particular attention.
The public consultation is the channel through which methodological objections have the best chance of succeeding, and the submissions carrying most weight will be those that bring data: actual intakes by population group, the real contribution of fortified foods to intake, and the effects of the proposed limits on meeting reference intakes. The European sector association, EHPM, has announced that it is preparing its own impact assessment with data from around a hundred companies in twenty Member States, which may serve as a reference for individual or sector submissions.
The judicial route can only be assessed once the final text is known. A Commission regulation adopted under the regulatory procedure with scrutiny is an act of general application, and an operator's standing to challenge it directly will depend on meeting the requirements of the fourth paragraph of Article 263 TFEU. A preliminary reference on validity raised in national proceedings remains, in practice, the most foreseeable route.
Harmonisation will resolve a fragmentation that mutual recognition never managed to correct, as the Commission itself acknowledged in 2017. What remains to be seen is whether a uniform formula, applied across the Union with the highest available exposure data and, in some cases, on safety values that EFSA itself describes as provisional, satisfies the requirement of a case-by-case assessment that the Court of Justice derived from Article 5 of the Directive. On the answer will depend whether the new system widens the market or merely replaces the diversity of national limits with a common limit stricter than any the most open national markets have known so far.
Javier Gómez Sanz is the founder and director of Food Tech Legal. Comments on this analysis may be sent to editorial@foodtechlegal.com. Enquiries about a specific product or case are handled through the quote form. The original Spanish version of this analysis is available here.