For two decades, the European Commission has been working to establish EU-wide MPLs for vitamins and minerals. The aim is to prevent the risk of adverse health effects caused by high doses of active ingredients and to replace the current fragmented system where different member states have their own national limits.
The work lay dormant until 2021 when the plans were re-initiated, with an initial target of implementation by 2024. Delays persisted, but at the EU Agriculture and Fisheries (AGRI-FISH) Council meeting in December 2025, Member States urged the Commission to present a formal proposal during the course of 2026.
It appears the Commission has listened, with the public consultation set to be opened in the third quarter of 2026. Luca Bucchini, Managing Director at Hylobates Consulting, predicts that the consultation document will be published in late June or July.
“The Commission has postponed the consultation date several times, but going public with a timeline makes a further delay less likely,” he told NutraIngredients. “We should expect a consultation document (call for evidence) to which stakeholders can reply and a survey-like public consultation for a wider audience.
“In essence, this suggests the political gridlock has been overcome, allowing the Commission to move forward. Depending on the actual proposal, this could be very good or very bad news for the food supplement industry.”
Cautious and conservative daily limits expected
Plans to set MPLs for vitamins and minerals in dietary supplements remain a contentious topic. There is significant concern within the supplement sector that the new legislation may adopt overly cautious daily limits, which could require many supplement brands to reformulate products.
These concerns heightened last year, when a draft policy was leaked, according to Patrick Coppens, director of regulatory affairs at Food Supplements Europe.
“In January 2025, information became available that shed light on the Commission’s approach, suggesting that the modeling is based on overly conservative and largely hypothetic principles,” he previously told NutraIngredients.
“If such an approach were to be adopted, it is estimated that it would lead to the withdrawal of numerous products from the market and require costly reformulation of most of the other vitamin and mineral-containing products.”
In response, Food Supplements Europe, alongside other organizations representing the supplement industry, is undertaking mitigatory measures to promote a more realistic and proportionate approach that limits negative market impact.
Other campaign groups have also begun to push back. For example, Health Stores Ireland recently relaunched its Save Our Supplements campaign which highlights concerns that MPLs could significantly reduce the potency and efficacy of dietary supplements.
The campaign argues that a ‘one size fits all’ approach is reductive and ignores the unique needs of different populations with different environmental exposures. For example, those living in the northern latitudes require higher levels of vitamin D.
The sports nutrition sector has also raised concerns that such an approach fails to account for the higher nutritional needs of active individuals and could weaken the efficacy of performance-oriented products.
The ‘most significant regulatory development’ since 2006
Currently, MPLs are set individually by EU member states, leading to a complex regulatory landscape where products are legal in some countries and prohibited in others.
For instance, while some countries allow up to 1,000 mg of vitamin C, France recently proposed a dramatic reduction of just 208 mg. Similarly, Germany has pushed for a low daily limit of 20 µg for Vitamin D, significantly lower than EFSA’s tolerable upper intake level of 100 µg.
Given the scale of the expected changes, including product reformulation, new notification requirements, and label revisions, Jerome Le Bloch, head of scientific department at Nutraveris, a FoodChain ID company, said this initiative could become the most significant regulatory development affecting the food supplements sector since the nutrition and health claims directive.
“This announcement is particularly important, as it provides the market with an opportunity to begin preparing its response to the European Commission,” he said. “Stakeholders should work not only on compiling scientific evidence supporting the safety of vitamins and minerals, but also on assessing the economic impact of the proposed regulation.
“Since the European Commission has chosen not to conduct a formal economic impact assessment, Food Business Operators should take the initiative to evaluate and document the potential consequences of the proposal for the sector.”