FoodChain ID warns EU vitamin and mineral limits could trigger supplement reformulation

The European Commission has confirmed the timeline for harmonizing the maximum levels for vitamins and minerals in fortified foods and supplements. If enacted as proposed, the Commission would determine a “residual amount” for each vitamin and mineral, based on what consumers obtain through diet. These levels could then be applied to fortified foods and supplements.

This could limit the maximum nutrient dose in supplements and create challenges for high-dose products.

Nutrition Insight speaks with Jerome Le Bloch, Ph.D., head of Scientific Affairs at FoodChain ID, to determine how the proposed legislation could impact the food supplement industry.

Le Bloch notes that a revised draft proposal is expected to enter public consultation during Q3 2026, with formal adoption of the final bill planned for Q1 2028. He tells us a draft of the proposal has been leaked, meaning there is a better understanding of the Commission’s plan.

“The idea is to calculate the difference between the upper limit and the dietary intake (at 95th percentile) to obtain the ‘residual amount’ for each nutrient. This residual amount is proposed to be divided equally between food supplements and fortified foods.”

However, Le Bloch notes that this plan is only a draft, and the Commission has already received many comments from Member States and trade associations. “It’s possible that the project that will be subject to public consultation will be an updated version. However, there is no information for the moment.”

“This project is important for the market, as the first draft proposes low amounts of vitamins and minerals in food supplements. While some nutrients are not impacted, some vitamins and many minerals may be reduced,” he cautions.

According to EFSA, the 95th percentile of dietary exposure means that at least 95% of the population is exposed to a nutrient at a specific level.He says reformulation of products will be mandatory, with new labels and re-notification of all products.

“This will have a major impact on all companies selling food supplements in Europe. The project also limits the chance for consumers to access effective and interesting products.”

Residual amount

Le Bloch says the residual amount that can be used in supplements and fortified foods is problematic, as this is based on two questionable parameters: the upper limit and dietary intake.

He notes that the upper limit or another safe limit is established by the European Food Safety Authority (EFSA) or other scientific authorities. “Such limits are highly questionable for many nutrients, really low, and evaluated with strong bias.”

Moreover, he says that the Commission used the 95th percentile, “which represents the worst case,” and uses the value from the country with the highest exposure.

According to EFSA, the 95th percentile of dietary exposure means that at least 95% of the population is exposed to a specific level, while only 5% are exposed to more.

Le Bloch says that the dietary intake estimates only use data in males and do not consider data in adolescents. “Moreover, the dietary assessment already included fortified foods, so such fortified foods are considered twice in the methodology.”

“Overall, the calculation presents many scientific limitations, which are reinforced by regulatory limits, such as novel food authorization, which may not comply with the new limits.”

Industry impact

According to Le Bloch, the regulation will impact all products containing vitamins and/or minerals with “strong consequences.”

“For me, this initiative could become the most significant regulatory development affecting the food supplements sector since Directive 2002/46/EC and Regulation (EC) No 1924/2006 on nutrition and health claims.”

“The project has, of course, a negative impact on the sector, with reduced dosages and the need to reformulate many products,” he explains. “However, it should also have beneficial effects, as harmonization of doses among all Member States will help operators to have the same formula within the whole EU.”

FoodChain ID’s Jerome Le Bloch warns the EU proposal could trigger sweeping supplement reformulation.Le Bloch highlights several important consequences of the legislation if enacted as it is currently proposed. These include:

• Change in all formulas if one nutrient exceeds the maximum value.
• Potential ban of some nutrients for some categories: no addition of boron, chloride, copper, iron, manganese, phosphorus, sodium, and zinc for children. Sodium, phosphorus, and chloride may be banned in products for adults.
• Need to review all labels in case of a change in a formula, and perhaps the regulation will make it mandatory to have additional labeling requirements.
• Need to re-notify new products.

Affected nutrients

Le Bloch says the proposed legislation would affect all supplements sold in Europe, with most reductions on vitamin B6, vitamin C, beta-carotene, and vitamin K1.

“For minerals, almost all are impacted, with notably strong reductions in chromium, magnesium, manganese, selenium, and zinc.”

He says that as long as an important part of food supplements contains minerals or vitamins, the consequences are important for all companies.

“As I mainly worked on the impact on food supplements, I have no information on the impact on fortified foods. But this sector will probably also have consequences in terms of formula and labels,” he details.

What’s next?

Le Bloch highlights two key points of action for companies to prepare for the Q3 2026 consultation and potential future limits. 

He advises them to compile scientific evidence supporting the safety of vitamins and minerals, to be able to propose higher doses for nutrients negatively impacted by the project.

In addition, Le Bloch suggests they assess the economic impact of the proposed regulation.

“Since the 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.”