The European supplement industry is undergoing a period of intense regulatory scrutiny, with far-reaching implications for companies operating within the region. As of mid-year 2026, a multitude of changes are reshaping the regulatory landscape, forcing businesses to reevaluate their product portfolios, packaging strategies, and compliance plans. This article delves into the key areas of focus, highlighting the impact of these changes and the challenges they present.
Ingredients Under Regulatory Scrutiny
Several ingredients are currently under formal safety reviews, with their regulatory status in flux. Berberine, hydroxycitric acid (HCA), and monacolin K from red yeast rice are all facing potential bans or restrictions. The European Food Safety Authority (EFSA) has opened public consultations to determine the safety and regulatory status of these ingredients. Meanwhile, new restrictions are being introduced for Mineral Oil Aromatic Hydrocarbons (MOAH) and Mineral Oil Saturated Hydrocarbons (MOSH), further complicating the regulatory environment for supplement manufacturers.
Ashwagandha, CBD, and caffeine are also attracting regulatory attention, although formal safety assessments have yet to begin. The industry is eagerly awaiting the outcome of these reviews, as they could significantly impact the availability and marketing of these popular ingredients. On the positive side, β-NMN (nicotinamide mononucleotide) received a favorable safety opinion from EFSA, bringing it closer to EU approval.
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. This has left many CBD manufacturers in a state of uncertainty.
A number of botanical extracts, such as gotu kola, southern ginseng, wild oregano, and white sage, have been deemed novel in food supplements and are not currently authorized in the EU. 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.
Health Claim Updates
EFSA has been evaluating health claims for supplements, with a limited number of positive opinions issued so far this year. Oat-beta glucans, a soluble fiber found in oat kernels, received a positive health claim for its ability to reduce postprandial glucose peaks. Conversely, creatine for cognitive function and Echinacea angustifolia for anxiety reduction both received negative opinions. Many more claims are still under review, with EFSA having evaluated over 2,300 health claims and rejected more than 70% of applications.
QPS List Updates
The QPS (Positive List of Microbes) is a crucial tool for streamlining safety assessments. EFSA updates this list approximately every six months, and the latest period covered January to July 2026. The QPS approach assesses the taxonomic identity, body of relevant knowledge, and safety concerns of microorganisms. This allows applicants to achieve a fast-tracked assessment if the ingredient is included on the positive list.
New Legislative Developments
MPLs for Vitamins and Minerals
The European Commission is seeking evidence and input on setting Maximum Permissible Levels (MPLs) for vitamins and minerals in supplements and fortified foods. This regulation aims to harmonize vitamin and mineral limits across the EU. Stakeholders are invited to submit scientific evidence for safe limits and evidence of the potential economic impact of the proposed regulation. The consultation is expected to be open for a minimum of six to eight weeks, with the final legal act adoption scheduled for the first quarter of 2028.
Packaging and Packaging Waste
The supplement industry is facing significant changes under the new Packaging and Packaging Waste Regulation (PPWR). This includes new rules on PFAS (per- and polyfluoroalkyl substances), or 'forever chemicals', which will ban food-contact packaging containing PFAS above a certain threshold. All packaging on the EU market will be required to have a declaration of conformity. The industry is concerned that the food supplement sector will not have enough time to implement these changes, calling for a temporary derogation similar to what has been granted to the pharmaceutical industry.
Sanitary and Phytosanitary Agreement (SPS): UK Alignment with EU Rules
The new UK-EU Sanitary and Phytosanitary (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 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. The alignment will impact numerous regulatory issues, including contaminants, novel foods, and marketing.
In conclusion, the European supplement industry is navigating a complex web of regulatory changes, with far-reaching implications for businesses. As these regulations continue to evolve, companies must stay agile and adaptable to ensure compliance and maintain their market presence. The future of the industry hinges on the successful navigation of these challenges, requiring a deep understanding of the regulatory landscape and a commitment to innovation and compliance.
