This presentation will provide an up-to-date status on the various regulatory aspects relating to food supplements, with a peek into possible future developments. It will address future harmonsaition of maximum levels of vitamins and minerals and present Food Supplements Europe’s activities to promote the role of food supplements for public health and to strengthen innovation and competitiveness of the sector.

Food supplements play a significant role in the growing trend of self-medication and preventive health. Due to their effectiveness and pharmaceutical-like forms, consumers often perceive them as medicines. Global trends continue to introduce innovations, new ingredients, and diverse types of supplements.

When launching a product on the market, ensuring its safety is essential. However, the quality and quantity of biologically active ingredients, along with appropriate labeling, are also critical to overall health safety. Health claims serve to link active ingredients and their dosages with specific health benefits, helping consumers make informed choices based on their individual needs.

As the general population increasingly uses food supplements—and as their variety expands—the frequency of side effects is also rising. Interactions between active substances from multiple supplements, as well as with food or medications, further contribute to potential risks.

Nutrivigilance refers to the system of activities involved in identifying, evaluating, and monitoring adverse effects related to the consumption of food and food supplements. To assess and categorize these risks to individual health, some EU countries have proactively implemented national nutrivigilance systems. Croatia established its own Nutrivigilance National System five years ago, introducing a public reporting tool with a structured questionnaire designed to gather information on side effects, raise awareness, and support broader public health efforts.

The presentation provides an overview of the food supplements sector in Romania, highlighting both market dynamics and the regulatory environment. As an emerging market within the European Union, Romania illustrates key trends in consumer demand, the increasing need for proportionate regulation, and the growing importance of transparent, science-based communication with consumers.

The Romanian Food Supplements Industry Association outlines its role in supporting product safety, responsible marketing, and industry self-regulation, while also addressing national challenges—such as restrictive advertising rules and uneven implementation of EU law.

The presentation advocates for better regulatory harmonization, enhanced collaboration between stakeholders, and a shared commitment to consumer education. It concludes with key recommendations and an open invitation for cross-border cooperation in promoting responsible use of food supplements.

Europam is strongly committed to ensuring the quality of medicinal herbs cultivated in Europe. The high
standards demanded by the market—especially when these herbs are used as ingredients in the food
supplement industry—require continuous efforts in awareness and prevention among primary producers. In
this context, Europam maintains an active dialogue with European institutions to ensure that limits for certain
contaminants are defined in a way that is both realistic and practically applicable by primary operators in the
supply chain. To achieve these goals, data collection and analysis are essential tools. As illustrative case
studies, we will present the issues related to pyrrolizidine alkaloids and mineral oil residues.

National regulatory developments are continuous and activity at EU level is expected. The presentation will explore what possibilities, but also what pitfalls exist for further European harmonisation on botanicals and how companies should be prepared.

Herbal medicines (phytopharmaceuticals) are an important component of our healthcare system and have become particularly established in self-medication. They are readily available and are particularly suitable for the treatment of minor ailments and illnesses. They are most commonly used as remedies for colds, stomach and digestive problems, and as sedatives. At the same time Botanicals are also used in Food Supplement with the purpose to supplement the daily diet.

The current regulatory frameworks for both categories allow a coexistence of sometimes the same herbal ingredient in herbal medicinal products and food supplements at the same time.

While the market for phytopharmaceuticals is neither characterized by a significant grows nor a high dynamic, many new products are launched as food supplements.

This is somehow incomprehensive as health claims can be made for herbal medicinal products, higher prices are usually achieved, and long-life cycles are characteristic for herbal medicinal products.

Why do companies do not invest in the development of “new” herbal medicinal products but prefer to develop new food supplements?

The presentation will provide answers and give reasons why botanicals will continue to play an important role in food supplements.

Micronutrients are essential for life and optimal health. The link between a sufficient intake and long-term health is well supported by science as well as health organizations. There is evidence from food and intake surveys in many countries that a sufficient intake of micronutrients often is not reached according to recommendations using RDAs as reference. A significant scientific and medical consensus exists as to the importance of an optimal level of micronutrient intake and status throughout the life course to foster a healthy life.

The presentation will provide an overview on nutritional needs, an approach on the analysis of optimal intake and status of micronutrients and the benefit for long term health.

Omega-3 fatty acids remain one of the most scientifically validated and commercially significant categories in the global supplement industry. Recent advances in clinical research continue to expand the understanding of their role in cardiovascular health, central nervous system function, and inflammatory conditions. At the same time, new areas of investigation—such as skin health, sports recovery, and the gut-brain axis—are opening fresh opportunities for innovation.

Consumer trends are also reshaping the omega-3 market. While fish oil softgels remain dominant, growth in gummies and plant-based alternatives reflects changing preferences for convenience, taste, and sustainability. Emerging demographic segments—such as children, active lifestyle consumers, and healthy aging populations—are driving demand for personalized and condition-specific formulations. Additionally, transparency, traceability, and environmental stewardship are becoming key purchase drivers, with sustainably sourced fish oils and algae-based omega-3s gaining momentum.

This presentation will explore the intersection of science and market dynamics, highlighting breakthrough research, evolving regulatory landscapes, and consumer behavior shifts. By combining clinical evidence with real-world insights, we will identify how the omega-3 category can continue to grow through innovation, education, and strategic alignment with the needs of modern consumers.