The European supplement industry is undergoing a significant transformation in 2026, with a series of regulatory updates that are reshaping the landscape. These changes have far-reaching implications for companies, impacting product portfolios, packaging strategies, and compliance plans. Here's a deep dive into some of the key developments and their broader implications.
Ingredients Under Regulatory Scrutiny
Several ingredients are currently under formal safety reviews, with potential regulatory changes on the horizon. Berberine and hydroxycitric acid (HCA) are among the ingredients under scrutiny, with EFSA opening public consultations to determine their regulatory status. Monacolin K from red yeast rice is also awaiting a final decision on a proposed ban, while new restrictions are being introduced for Mineral Oil Aromatic Hydrocarbons (MOAH) and Mineral Oil Saturated Hydrocarbons (MOSH).
Ashwagandha, CBD, and caffeine are attracting regulatory attention, although formal safety assessments have yet to begin. A recent meeting at the European Parliament highlighted the need for further evidence on the safety of ashwagandha, underscoring the importance of robust data in the regulatory process.
Novel Foods
The EU Novel Food Catalogue is being updated to reflect changes in the regulatory status of ingredients. CBD has had a particularly turbulent year, with multiple novel food rejections, including those covering isolated cannabidiol, synthetic cannabidiol, tinctures, and oils from Cannabis sativa. EFSA has also rejected claims for broad-spectrum CBD extracts and distillates from hemp.
However, pomegranate extract and whey protein concentrate with alpha-lactalbumin were classified as non-novel, allowing these ingredients to remain available on the European market. Key updates this year include 15 new authorizations and 21 rejections, indicating a rigorous evaluation process.
Health Claim Updates
EFSA has been evaluating health claims, with only one ingredient receiving a positive opinion so far this year. The claim relates to oat-beta glucans and its ability to reduce postprandial glucose peaks. Creatine for cognitive function and Echinacea angustifolia for anxiety reduction both received negative opinions, with many more claims still under review.
To date, EFSA has evaluated over 2,300 health claims, rejecting more than 70% of applications. This indicates a stringent evaluation process, ensuring that only the most scientifically supported claims are approved.
QPS List Updates
The QPS (Positive List of Microbes) is a crucial tool for streamlining safety assessments. The list is updated approximately every six months, with the latest period covering January to July 2026. The QPS approach assesses the taxonomic identity, body of relevant knowledge, and safety concerns of microorganisms, allowing for fast-tracked assessments if the ingredient is included on the positive list.
New Legislative Developments
MPLs for Vitamins and Minerals
The European Commission has opened a call for evidence and a public consultation on setting MPLs (Maximum Permissible Levels) for vitamins in minerals in supplements and fortified foods. This is a significant development, as it will impact the formulation and marketing of vitamin-mineral products.
Packaging and Packaging Waste
The supplement industry is 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 new Design for Recycling (DFR) requirements are also due to come into effect in 2030, with grade C becoming prohibited in 2038. These regulations will impact the entire supply chain, from manufacturers to retailers, and will require significant investments in packaging redesign and recycling infrastructure.
Sanitary and Phytosanitary Agreement (SPS): UK to Align with EU Rules
The new UK-EU SPS agreement aims to eliminate routine border checks and expensive certification paperwork for food, plants, and animal products moving between the UK and the EU. This agreement 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.
In conclusion, the European supplement industry is facing a series of regulatory updates that will significantly impact the market. These changes require companies to reassess their product portfolios, packaging strategies, and compliance plans. As the industry navigates these challenges, it is crucial to stay informed about the latest developments and adapt to the evolving regulatory landscape.
