Navigating the EU's Supplement Landscape: A Mid-Year Update
As we approach the halfway mark of 2026, the European supplement industry is in a state of flux, with regulatory updates reshaping the landscape. Companies are having to rethink their strategies, from product portfolios to packaging, as the rules governing manufacturing, marketing, and sales evolve. This mid-year review offers a glimpse into the challenges and opportunities facing the industry, with a focus on the regulatory scrutiny of ingredients, the evolving status of novel foods, and the impact of new legislative developments.
Ingredients Under the Microscope
Several ingredients are currently under regulatory scrutiny, with some undergoing formal safety reviews. Berberine, for instance, is being evaluated for its safety, while hydroxycitric acid (HCA) has prompted a public consultation to determine its regulatory status. The situation is particularly intriguing for monacolin K from red yeast rice, which is awaiting a final decision on a proposed ban, and for Mineral Oil Aromatic Hydrocarbons (MOAH) and Mineral Oil Saturated Hydrocarbons (MOSH), which are facing new restrictions. Ashwagandha, CBD, and caffeine are also attracting regulatory attention, although formal safety assessments are yet to begin. The European Parliament has convened experts to discuss the future regulatory status of ashwagandha, highlighting the importance of critical safety data in shaping the industry's trajectory.
Novel Foods: A Turbulent Year for CBD
The European Commission's Novel Food Catalogue is a key reference point for the industry, and 2026 has been a turbulent year for CBD. Multiple novel food rejections, including those covering isolated cannabidiol, synthetic cannabidiol, tinctures, and oils from Cannabis sativa, have left the industry reeling. EFSA has also rejected claims for broad-spectrum CBD extracts and distillates from hemp, further complicating the situation. However, not all botanical extracts are deemed novel; pomegranate extract and whey protein concentrate with alpha-lactalbumin have been classified as non-novel, providing a glimmer of hope for some ingredients.
Health Claims: A Delicate Balance
The evaluation of health claims by EFSA is a delicate process, with only one ingredient receiving a positive opinion so far this year. Oat-beta glucans, a soluble fiber found in oat kernels, has been approved for its ability to reduce postprandial glucose peaks. However, creatine for cognitive function and Echinacea angustifolia for anxiety reduction both received negative opinions, with many more claims still under review. EFSA has evaluated over 2,300 health claims, rejecting more than 70% of applications, highlighting the stringent criteria for approval.
QPS List Updates: Streamlining Safety Assessments
The QPS list, a positive list of microbes evaluated for safety by EFSA, plays a crucial role in streamlining safety assessments. The list helps applicants achieve fast-tracked assessments if the ingredient is included, and it is updated approximately every six months. The latest period covered January to July 2026, with notifications from companies seeking market authorization for microorganisms in the food or feed chain. This process is essential for ensuring the safety and regulatory compliance of ingredients in the European market.
New Legislative Developments: A Mixed Bag for the Industry
The European Commission has opened a call for evidence and a public consultation on setting Maximum Permissible Levels (MPLs) for vitamins and minerals in supplements and fortified foods. This development is expected to have significant implications for the industry, with stakeholders invited to submit scientific evidence for safe limits and evidence of the potential economic impact of the proposed regulation. The consultation is open for a minimum of six to eight weeks, with the adoption of the final legal act currently scheduled for the first quarter of 2028.
The supplement industry is also facing significant changes under the new Packaging and Packaging Waste Regulation (PPWR), including new rules on PFAS (per- and polyfluoroalkyl substances) or 'forever chemicals'. Starting August 12, all food-contact packaging containing PFAS above a certain threshold will be banned, and every piece of packaging on the EU market will be legally required to have its own declaration of conformity. The industry has raised concerns about the lack of time to implement these changes, calling for a temporary derogation similar to what has been granted to the pharmaceutical industry.
Finally, the new UK-EU Sanitary and Phytosanitary (SPS) agreement is designed to eliminate routine border checks and expensive certification paperwork for food, plants, and animal products moving between the UK and the EU. Expected to come into force in mid-2027, this legislation requires the UK to align its agricultural, food safety, and environmental standards with the EU's rules, affecting ingredient suppliers, manufacturers, retailers, and testing laboratories.
Conclusion: A Year of Adaptation and Innovation
As we reflect on the first half of 2026, it is clear that the European supplement industry is in a state of constant adaptation and innovation. The regulatory scrutiny of ingredients, the evolving status of novel foods, and the impact of new legislative developments are all shaping the industry's trajectory. While challenges abound, the industry is also embracing opportunities for growth and innovation, with a focus on safety, compliance, and consumer trust. As we move forward, the industry must continue to navigate these complexities, ensuring that the products on the market meet the highest standards of quality and safety.
