Navigating Europe's Supplement Landscape: A Mid-Year Update
As we reach the halfway point of 2026, the European supplement industry is undergoing a period of significant transformation. Regulatory updates are reshaping the landscape, impacting everything from ingredient sourcing to packaging strategies. While some changes are still under consultation, others are already in effect, forcing companies to reassess their product portfolios and compliance plans.
Ingredients Under Scrutiny
Several key ingredients are currently under regulatory scrutiny. Berberine and hydroxycitric acid (HCA) are undergoing formal safety reviews, with EFSA opening public consultations to determine their regulatory status. Monacolin K from red yeast rice is 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 also 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. In a more positive development, β-NMN received a favorable safety opinion from EFSA, bringing the novel food a step closer to EU approval.
Novel Foods
The EU Novel Food Catalogue is regularly 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.
A number of botanical extracts, including gotu kola, southern ginseng, wild oregano, and white sage, have been deemed novel in food supplements and are therefore 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
So far this year, only one ingredient has received a positive health claim opinion from EFSA. The claim relates to oat-beta glucans and its ability to reduce postprandial glucose peaks. Creatine for cognitive function and Echinacea angustifolia (Anxiofit-1) for anxiety reduction both received negative opinions, with many more claims still under review.
EFSA has evaluated more than 2,300 health claims, rejecting more than 70% of applications. This highlights the stringent criteria that companies must meet to secure health claims for their products.
QPS List Updates
The QPS (Positive List of Microbes) is a list of microbes that EFSA has evaluated for safety purposes. The list helps to streamline further safety assessments, allowing applicants to achieve a fast-tracked assessment if the ingredient is included on the positive list. The list is updated approximately every six months, with the latest period covering January to July 2026.
New Legislative Developments
MPLs for Vitamins and Minerals
In June, the European Commission opened a call for evidence and a public consultation on setting MPLs (Maximum Permissible Levels) for vitamins and minerals in supplements and fortified foods. Stakeholders are invited to submit scientific evidence for safe limits and evidence of the potential economic impact of the proposed regulation.
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. These new regulations will require packaging to achieve recycling grades A, B, or C, with grade C becoming prohibited in 2038. The industry has raised concerns that the food supplement industry will not have enough time to implement these changes after the criteria has been published, calling for a temporary derogation.
Sanitary and Phytosanitary Agreement (SPS): UK to Align with EU Rules
The new UK-EU 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.
Alignment with EU rules will affect ingredient suppliers, manufacturers, retailers, and testing laboratories, updating requirements for numerous regulatory issues including contaminants, novel foods, and marketing.
Personal Reflection
As we navigate these regulatory changes, it's clear that the European supplement industry is at a critical juncture. Companies must be agile and responsive to these shifts, adapting their strategies to ensure compliance and maintain market competitiveness. The introduction of new regulations on packaging and novel foods, in particular, will require significant adjustments, and the industry must work closely with regulators to ensure a smooth transition.
In my opinion, the key to success in this evolving landscape will be a deep understanding of the regulatory environment and a commitment to innovation. Companies that can adapt quickly and find creative solutions to regulatory challenges will be well-positioned to thrive in the years ahead.
