The European supplement industry is undergoing a significant transformation in 2026, with regulatory updates impacting various aspects of the market. These changes are reshaping the landscape for companies, forcing them to reevaluate their product strategies, packaging, and compliance measures. Here's a deep dive into some of the key developments and their implications.
Ingredients Under Regulatory Scrutiny
Several ingredients are currently under formal safety reviews, with potential implications for their availability and usage in supplements. Berberine and hydroxycitric acid (HCA) are among the ingredients under scrutiny, with EFSA opening public consultations to determine their regulatory status. The future of monacolin K from red yeast rice hangs in the balance, awaiting a final decision on a proposed ban. New restrictions are also 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 critical safety data on ashwagandha, as the industry prepares for a Europe-wide assessment. On a positive note, 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 turbulent year, with multiple novel food rejections, including those for isolated cannabidiol, synthetic cannabidiol, tinctures, and oils from Cannabis sativa. EFSA has also rejected claims for broad-spectrum CBD extracts and distillates from hemp. Several botanical extracts, such as gotu kola, southern ginseng, wild oregano, and white sage, have been deemed novel and are not currently authorized in the EU.
However, pomegranate extract and whey protein concentrate with alpha-lactalbumin were classified as non-novel, allowing them to remain available on the European market. Key updates this year include 15 new authorizations and 21 rejections, indicating a rigorous evaluation process for novel foods.
Health Claim Updates
EFSA has been evaluating health claims, with only one ingredient receiving a positive opinion so far this year. Oat-beta glucans, a soluble fiber found in oat kernels, was approved for 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. EFSA has evaluated over 2,300 health claims, rejecting more than 70% of applications, indicating a stringent evaluation process.
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, assessing the taxonomic identity, relevant knowledge, and safety concerns of microorganisms. The latest update covers January to July 2026. This list helps applicants achieve fast-tracked assessments if the ingredient is included, streamlining the regulatory process.
New Legislative Developments
MPLs for Vitamins and Minerals
The European Commission is seeking evidence and opinions on setting Maximum Permissible Levels (MPLs) for vitamins in minerals in supplements and fortified foods. This regulation aims to ensure safe limits and assess the potential economic impact. The consultation is expected to be open for six to eight weeks, with a 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). New rules on PFAS (per- and polyfluoroalkyl substances) will ban food-contact packaging containing PFAS above a certain threshold. All packaging on the EU market will need a declaration of conformity. The industry is concerned about the timeline for these changes, calling for a temporary derogation similar to that granted to the pharmaceutical industry.
Sanitary and Phytosanitary Agreement (SPS)
The UK-EU SPS agreement aims to eliminate routine border checks and certification paperwork for food, plants, and animal products. Expected to come into force in mid-2027, this agreement requires the UK to align its agricultural, food safety, and environmental standards with EU rules. This alignment will impact ingredient suppliers, manufacturers, retailers, and testing laboratories, updating requirements for contaminants, novel foods, and marketing.
In conclusion, the European supplement industry is experiencing a period of rapid change and adaptation. These regulatory updates have far-reaching implications, impacting ingredients, novel foods, health claims, and packaging. Companies must stay agile and responsive to these changes to ensure compliance and maintain their market presence in this evolving regulatory landscape.
