The changes have implications for multiple areas of the regulatory framework, leading companies to reassess product portfolios, packaging strategies and compliance plans.
Some measures remain under consultation, but others are already reshaping the rules governing how supplements are manufactured, marketed and sold across the European Union.
Ingredients under regulatory scrutiny
Several food supplement ingredients are facing regulatory scrutiny, with some currently undergoing formal safety reviews.
Among these are berberine and hydroxycitric acid (HCA), for which EFSA opened a public consultation to determine their regulatory status.
Monacolin K from red yeast rice is also awaiting a final decision on a proposed ban expected later this year, 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. On July 14, ashwagandha experts convened at the European Parliament to discuss the future regulatory status of the botanical and the evidence surrounding its safety.
In a more positive development for the industry, β-NMN (nicotinamide mononucleotide) received a favorable safety opinion from EFSA, bringing the novel food a step closer to EU approval.
Novel foods
The European Commission regularly updates the EU Novel Food Catalogue to reflect changes to the regulatory status of ingredients, based on their history of consumption in the EU prior to May 1997.
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 also 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.
Key updates announced this year include 15 new authorizations and 21 rejections.
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 (a soluble fiber found naturally in the cell walls of oat kernels) 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.
To date, EFSA has evaluated more than 2,300 health claims, rejecting more than 70% of applications.
QPS list updates
The QPS is a positive list of microbes which EFSA has evaluated for safety purposes. EFSA conducts safety assessments on microbes which were submitted to the agency as part of technical dossiers for safety assessments.
These notifications are not requests for QPS status specifically, but are formal applications from companies seeking market authorization to use a microorganism in the food or feed chain.
The QPS approach assesses the taxonomic identity, body of relevant knowledge and safety concerns of microorganisms. 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 for vitamins in minerals in supplements and fortified foods.
Set to open in the third quarter of 2026, 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 adoption of the final legal act currently 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), including new rules on PFAS (per- and polyfluoroalkyl substances), or ‘forever chemicals’.
Starting Aug. 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. PFAS are widely used in flexible packaging and blister packs—both commonly used for supplement packaging.
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 similar to what has been granted to the pharmaceutical industry.
Sanitary and phytosanitary agreement (SPS): UK to align with EU rules
The new UK-EU Sanitary and Phytosanitary (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.
