The dietary supplements industry is one of the fastest-growing sectors in both Poland and worldwide. Increasing consumer awareness of a healthy lifestyle, preventive healthcare and the need for dietary support is driving dynamic market changes. As a result, manufacturers and distributors must keep up with new trends and legal requirements. However, to ensure the safety and quality of these products, proper regulations are essential. The year 2025 brings significant regulatory changes that will impact both manufacturers and consumers of dietary supplements.
In 2007, the Minister of Health introduced a regulation on the composition and labeling of dietary supplements, which has served as the legal foundation for the industry for years. However, scientific advancements and evolving European standards have made it necessary to update these regulations.
In October 2024, a draft amendment to the Minister of Health’s regulation on dietary supplement composition and labeling was published. The most significant change is the addition of new chemical forms of iron, such as iron hydroxide adipate tartrate (nano) and milk-derived iron caseinate, to the list of approved substances. This update is particularly important for manufacturers, as it allows the use of more advanced and bioavailable forms of iron.
Additionally, the amendment introduces stricter limits in permissible doses of active ingredients in dietary supplements. New procedures for product registration and notification will also be implemented to enhance oversight of new supplements entering the market. Manufacturers will need to adapt their production processes and documentation to comply with these new requirements, which may result in additional costs and logistical challenges.
The amendment aligns Polish regulations with EU standards set by Commission Regulations (EU) 2024/248 and 2024/1821. These changes will enable Polish manufacturers to compete more effectively in the international market while meeting stringent quality and safety requirements.
It is widely known that vitamin B6 plays a crucial role in many metabolic processes. However, recent studies indicate that excessive intake can lead to various unwanted side effects. In response to these findings, the Dietary Supplements Committee, operating under the Chief Sanitary Inspectorate, adopted Resolution No. 2/2024 in September 2024, limiting the maximum daily dose of vitamin B6 in supplements to 6 mg for adults. This marks a significant change, as the previous limit was 18 mg—three times higher. The restriction is based on scientific research suggesting that excessive vitamin B6 intake may negatively affect the nervous system.
This decision was also influenced by the latest research from the European Food Safety Authority (EFSA), which in 2023 lowered the tolerable upper intake level for vitamin B6 to 12 mg per day. As a result, dietary supplement manufacturers must adjust their product formulations to meet the new requirements and ensure consumer safety. These new regulations require companies to refine their formulas more carefully, potentially increasing production costs, but ultimately contributing to greater consumer protection.
Helath claims on dietary supplement labels play a key role in communication between manufacturers and consumers, providing information about the benefits of a given product. While current regulations define which claims can be used, further changes are planned to tighten the criteria for approved health claims.
In January 2024, the European Parliament adopted a resolution restricting the use of nutritional claims such as “no added sugar” for products containing sweeteners or high levels of free sugars. These regulations aim to protect consumers from misleading information that may suggest a product is healthier than it actually is.
The new rules will also introduce stricter verification and approval procedures to eliminate misleading or scientifically unsubstantiated claims. For manufacturers, this means a greater need for precise documentation of their products’ effects and an adjustment of marketing strategies to comply with new requirements. Educating marketing teams on the latest regulations will be essential to avoid potential sanctions and maintain consumer trust. What does this mean in practice?
Manufacturers will need to provide solid scientific evidence proving the effectiveness of active ingredients in their dietary supplements. Health claims must be precise and cannot imply medicinal properties, which are reserved for pharmaceutical products. Additionally, a ban is expected on health claims related to plant-based ingredients unless they have been approved by the European Food Safety Authority (EFSA). This could significantly impact the market for supplements containing herbal extracts.
Special attention has also been given to so-called “pending claims”—those awaiting EFSA approval. Manufacturers have been advised to reassess claims that have been negatively evaluated to ensure compliance with the upcoming regulations.
A key event for the industry will be the International Nutraceuticals & Functional Food Exhibition – NutraFood Poland, taking place on April 8–10, 2025, at EXPO XXI Warsaw. This event is not only an opportunity to showcase products, but also a valuable platform for gaining insights into the latest trends and regulatory changes in the sector.
Attendees will have the chance to network, listen to expert presentations, and explore cutting-edge technological innovations in the nutraceutical industry. That’s why we warmly invite you to join us in April—participation is completely free for industry professionals!
The year 2025 brings significant regulatory changes for the dietary supplements industry, requiring manufacturers and distributors to continuously monitor legilsation and adapt their operations accordingly. Staying up to date with these changes, participating in industry events a competitive edge in the market.
Rozporządzenie Ministra Zdrowia z dnia 9 października 2007 r. i jego nowelizacje.
Rozporządzenie Komisji (UE) 2024/248 oraz 2024/1821.
Uchwała nr 2/2024 Zespołu ds. Suplementów Diety.
Rezolucja Parlamentu Europejskiego ze stycznia 2024 r.
przemyslfarmaceutyczny.pl
gov.pl
foodfakty.pl
prawo.pl