The European dietary supplements market is facing one of its most significant regulatory changes since the adoption of Directive 2002/46/EC. The European Commission is currently working on unified Maximum Permitted Levels (MPLs) for vitamins and minerals in both dietary supplements and fortified foods. The new legislation aims to improve consumer safety, harmonize regulations across Member States, and facilitate the functioning of the EU internal market.
What changes can manufacturers expect, and why will laboratory testing become even more important?
Why Is the European Union Introducing Unified Limits?
At present, there are no uniform EU-wide limits for vitamin and mineral levels in dietary supplements. Although Directive 2002/46/EC provides the legal basis for establishing such limits, Member States have developed their own national regulations, guidance, or recommendations over the past two decades.
As a result, the same dietary supplement may be legally marketed in one country while failing to comply with regulations in another.
The planned harmonization aims to eliminate these discrepancies and establish consistent rules for the entire European dietary supplements market.
How Will the New Limits Be Determined?
The proposed Maximum Permitted Levels (MPLs) will be based on scientific risk assessments carried out by the European Food Safety Authority (EFSA).
The starting point for determining these limits will be the Tolerable Upper Intake Levels (ULs), which represent the highest daily intake of vitamins and minerals considered safe for different population groups.
The methodology will also take into account the amount of each nutrient already consumed through:
- the regular diet,
- fortified foods.
The remaining amount will define the maximum level permitted in dietary supplements.
This approach is intended to ensure a high level of consumer protection while allowing supplementation to remain effective and safe.
Which Nutrients Are Expected to Be Most Affected?
The greatest impact is expected to concern high-dose dietary supplements.
Current discussions focus particularly on products containing:
- vitamin D,
- vitamin B6,
- folic acid,
- vitamin A,
- iron,
- zinc.
Many products currently available on the market may require reformulation or adjustments to their vitamin and mineral content in order to comply with the new regulatory requirements.
How Will the New Regulations Affect Dietary Supplement Manufacturers?
The introduction of harmonized limits will require manufacturers to adapt several aspects of product development and commercialization.
Companies may need to:
- reformulate existing products,
- update labels and product information,
- re-notify dietary supplements in multiple EU countries,
- revise quality and regulatory documentation.
These changes will require close cooperation between research and development, quality assurance, regulatory affairs, and analytical laboratories responsible for verifying product compliance.
Why Will Laboratory Testing Become Even More Important?
Once the new legislation comes into force, precise determination of vitamin and mineral content will become increasingly important.
Reliable laboratory testing will enable manufacturers to:
- verify compliance between the product composition and label claims,
- confirm conformity with the new harmonized EU limits,
- reduce the risk of non-compliance during official inspections,
- support successful product registration and market placement.
Analytical accuracy will be particularly critical for supplements containing nutrients expected to be subject to the most significant regulatory changes.
Current Status of the Legislative Process
In July 2026, the European Commission confirmed the timeline for further work on the harmonization of maximum permitted vitamin and mineral levels. However, the final MPL values for individual nutrients have not yet been published.
Consultations are still ongoing regarding the methodology used to establish these limits and the potential impact of the new regulations on the dietary supplements market.
For manufacturers, this represents an opportunity to review their product portfolios and begin preparing for the upcoming regulatory changes.
The Role of Laboratories in Adapting to New Requirements
The forthcoming legislation will require manufacturers not only to reformulate products where necessary but also to demonstrate compliance with the new requirements through appropriate laboratory testing.
J.S. Hamilton laboratories are actively preparing for the implementation of the new regulations by supporting manufacturers with the determination of vitamin and mineral content and the verification of dietary supplement compliance with future quality and regulatory requirements.
The Future of Dietary Supplement Regulation in the EU
The planned harmonization of maximum permitted levels for vitamins and minerals represents one of the most significant regulatory developments in the European dietary supplements market in recent years. The new framework is intended to enhance consumer safety, facilitate the free movement of products within the EU, and ensure that regulatory requirements are based on the latest scientific evidence.
For manufacturers, these changes will require careful preparation and adaptation. Laboratory testing will play a fundamental role in verifying compliance with the new limits while supporting product quality, safety, and regulatory conformity.