The European supplement industry is undergoing a period of intense regulatory change, with far-reaching implications for companies operating within the region. As of mid-year 2026, several key developments are shaping the future of the industry, impacting product portfolios, packaging strategies, and compliance plans. This article delves into these regulatory updates, highlighting the scrutiny of ingredients, the status of novel foods, health claim updates, QPS list changes, and new legislative developments in packaging and trade agreements.
Ingredients Under Regulatory Scrutiny
The spotlight is on several ingredients, with some undergoing formal safety reviews and others facing potential bans. Berberine and hydroxycitric acid (HCA) are under public consultation for their regulatory status, while monacolin K from red yeast rice awaits 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, though formal safety assessments have yet to begin. A significant development is the positive safety opinion from EFSA for β-NMN (nicotinamide mononucleotide), bringing it closer to EU approval.
Novel Foods
The EU Novel Food Catalogue is regularly updated to reflect changes in ingredient regulatory status. CBD has faced 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 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 their continued availability on the European market.
Health Claim Updates
Only one ingredient, oat-beta glucans, has received a positive health claim opinion from EFSA this year, relating to 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 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 list, a positive list of microbes evaluated for safety, is updated approximately every six months. The latest update covers January to July 2026. This list helps streamline safety assessments, allowing for fast-tracked evaluations for ingredients included on the positive list.
New Legislative Developments
MPLS for Vitamins and Minerals
The European Commission has opened a call for evidence and public consultation on setting MPLS for vitamins and minerals in supplements and fortified foods. Stakeholders are invited to submit scientific evidence for safe limits and the potential economic impact of the proposed regulation.
Packaging and Packaging Waste Regulation (PPWR)
The supplement industry is facing significant changes under the PPWR, including new rules on PFAS (per- and polyfluoroalkyl substances) or 'forever chemicals'. All food-contact packaging containing PFAS above a certain threshold will be banned, and every piece of packaging on the EU market will need a declaration of conformity.
New Design for Recycling (DFR) requirements are also due in 2030, mandating recycling grades A, B, or C for packaging. Grade C will be prohibited in 2038.
The industry has raised concerns about the timeline for these changes, calling for a temporary derogation similar to that granted to the pharmaceutical industry.
Sanitary and Phytosanitary (SPS) Agreement
The new UK-EU SPS agreement aims to eliminate routine border checks and certification paperwork for food, plants, and animal products moving between the UK and the EU. Expected to come into force in mid-2027, it 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 navigating a complex regulatory landscape with far-reaching implications. These updates reflect a dynamic and evolving regulatory environment, requiring companies to stay agile and responsive to changes in ingredient status, health claims, and packaging regulations.
