Supplement industry pushes for flexibility ahead of new EU regulations

Against this backdrop, policymakers, researchers and industry gathered in Brussels on June 23 for the inaugural Food Supplement Summit, organized by the European Federation of Associations of Health Product Manufacturers (EHPM), to discuss the latest regulatory developments and their implications for the sector. Under the theme ‘A positive narrative for food supplements – A focus on science, regulation and innovation’, sessions examined the latest regulatory and policy updates to areas spanning maximum permitted levels (MPLs) for vitamins and minerals, packaging and packaging waste, influencer marketing, contaminants and novel foods. For the past two decades, the European Commission has worked to establish EU-wide maximum permitted levels (MPLs) for vitamins and minerals . The initiative seeks to minimize the risks associated high doses of active ingredients while replacing the current fragmented regulatory system of differing national limits across member states. After a prolonged period of inactivity, the European Commission resumed work on the initiative in 2021. It has recently announced that a public consultation will open in the third quarter of 2026, with a draft regulation expected in the first quarter of 2028. The supplement industry has long raised concerns about the impact MPLs could have on the sector. There is significant apprehension that the new legislation may adopt overly cautious daily limits, which could require many supplement brands to reformulate or withdraw products from the market. A number of campaign groups have pushed back against these proposed restrictions, including Food Supplements Europe, which has advocated for a more balanced, scientifically sound approach to setting MPLs, and Health Stores Ireland which recently launched its Save Our Supplements campaign. Now, the EHPM is working on publishing its own impact assessment—an “ambitious project”, according to Livia Menichetti, director of the EHPM, which aims to provide sound data in the absence of an assessment by the European Commission. The impact assessment covers the potential cost and sales impact for companies, including qualitative and quantitative data from 100 companies from 20 Member States and five non-EU countries. Two scenarios are being assessed: a low impact scenario, under which more generous MPLs established, and a high impact scenario, where more restrictive limits would apply. The impact assessment is expected to be published in the coming months, although no official publication date has been announced. “Our common position is that we would like the Commission to substantially review this model,” Menichetti said. “We believe this model is based on some theoretical assumptions which are not based on science. The Commission tells us that the cost of reformulation will only happen once, but since we will have it once, it’s important that we have it right the first time, because the consequences will be significant.” Two regulatory upheavals under the new Packaging and Packaging Waste Regulation (PPWR) are causing an industry-wide headache. The first is regarding new rules on PFAS (per- and polyfluoroalkyl substances), or ‘forever chemicals’. From 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. Valérie Vercammen, managing director of Be-sup, the Belgian trade association for the food supplement industry, raised concern about these new rules. She highlighted that currently, there is no fully harmonized analytical methodology to analyze PFAS in packaging and it is still difficult to find a laboratory that is able to do this testing. She also raised concerns that stability testing can take two to three years and that alternative packaging may not protect active ingredients from degradation. Similar concerns were raised about the new Design for Recycling (DFR) requirements which are due to come into effect in 2030. These new regulations will require packaging to achieve recycling grades A, B or C. However, the DFR criteria is not expected to be published until 2028. “Stability validation typically requires 24 to 36 months,” Vercammen said. “Once the criteria has been established, companies will have to find compliant packaging solutions. They will need to test them, validate them and generate stability data. So, the question is, if the final criteria arrives in 2028, and if stability studies require between 24 to 36 months, how can you be fully compliant by January 2030? The math does not work.” The EHPM is therefore calling for a temporary derogation until 2035 for food supplements, recognizing them as stability-critical products. Similar exemptions have already been granted to the pharmaceutical industry, which relies on blister packs, vials and ampoules to protect medicines from contamination, degradation and moisture. The trade body is also asking the European Commission for greater legal certainty regarding packaging stocks to ensure they do not need to be thrown away—something which would create more waste and run counter to the regulation’s objectives. “We are not asking for less sustainability,” Vercammen said. “On the contrary, we are asking for implementation measures that are technical, feasible, economical, realistic and compatible with consumer protection.” Supplement brands have begun to lean more heavily on influencers for product marketing strategies in recent years. However, influencers are often unaware of the strict rules governing supplement marketing in the EU. As a result, the EHPM has published new influencer marketing guidelines , offering guidance to both influencers and food business operators (FBOs). The guidance highlights the importance of responsibility, honesty and transparency when communicating with consumers, providing FBOs with practical tips about how to comprehensively brief influencers before beginning partnerships. For example, the guidance recommends that influencers are informed about advertising rules regarding nutrition and health claims and provided with comprehensive briefings and training materials to ensure messages are portrayed correctly. FBOs should also ensure they have a written contract in place with each influencer they engage and that promotional materials are reviewed before publication. For influencers, the guidance focuses on ensuring that claims are not exaggerated and that testimonials reflect a genuine experience. Influencers are also warned not to guarantee the efficacy of a supplement or give the impression that when a product is not used, normal health can be compromised. Saskia Geurts, who leads the EHPM Influencer Marketing Working Group, said the guidance will help to protect the public image of the supplement industry and consumers who are vulnerable to misleading messages. “It’s time for self-regulation,” she said. “We need to show that we are a responsible industry and we need to safeguard responsible use of food supplements by consumers.” A critical portion of the Food Supplement Summit was dedicated to the evolving regulatory landscapes of novel foods and contaminants, two areas that directly impact the industry’s ability to bring safe, innovative products to the European market. The application of the novel food framework continues to be a point of significant discussion between industry and regulators. EHPM expressed concern that the current system is overly burdensome for ingredients with long histories of safe use. According to the EHPM Novel Foods Task Force, its current application is creating “increasing challenges” for long-established ingredients used in food supplements—especially where evidence of significant use before May 15, 1997 is difficult or impossible to retrieve. To address this, EHPM proposes that the EU recognizes a 25-year history of safe use in the EU as a pragmatic alternative to the strict 1997 cut-off date. The task force also argued that legal certainty should be strengthened by avoiding the retrospective classification of products and by limiting novel food reassessments to prevent unnecessary requests for additional information. Addressing these concerns, Dr. Ivona Babic, policy officer at the European Commission, DG Health and Food Safety (DG SANTE), explained that the regulation is designed to “ensure the effective functioning of the internal market while providing a high level of protection of human health and consumers’ interests”. She noted that, since 2018, 197 consultation conclusions have been issued. Of these, 51% classified the products as novel, 41% as non-novel, and the remaining 8% as novel in foods but not in food supplements. For businesses, a ‘not novel’ outcome results in fast, low-cost market access, Babic said. For those that are novel, the authorization process typically takes at least 18 months, although previous analyses have found that the process can take much longer. Contaminants were also a key topic of discussion during the summit. Frans Verstraete, administrator at the European Commission, explained that the fundamental rule is that contaminant levels should be kept “as low as can reasonably be achieved” (ALARA) by following good practices at all the stages of the food chain. Two specific groups of contaminants are currently under intense scrutiny, including Pyrrolizidine Alkaloids (PAs) and Mineral Oil Hydrocarbons (MOH). PAs are naturally occurring compounds found in certain plants. Because many are genotoxic and carcinogenic, maximum levels (ML) are set by the European Commission. For food supplements containing herbal ingredients/extracts, the current ML is 400 parts per billion (PPB). However, industry groups, including EHPM, have requested increases for specific herbs. Verstraete said discussions are ongoing to potentially increase MLs to 700 ppb for herbs like lemon balm, chamomile and peppermint. Parsley, sage, St. John’s wort and raspberry leaves are also being considered for an increase to 1000 ppb. The EU has also introduced new limits for MOHs, including Mineral Oil Aromatic Hydrocarbons (MOAH) and Mineral Oil Saturated Hydrocarbons (MOSH) which can be present in oil-based supplements such as omega-3s and some botanicals. Safety concerns raised by EFSA have led to new proposed maximum levels of 10 mg/kg for MOAH from 2027, tightening to 5 mg/kg in 2030. The EHPM has maintained ongoing dialogue with the European Commission on the draft regulations for mineral oils, acknowledging that ensuring reliable analysis is a significant challenge to be addressed. The trade body’s engagement has focused on ensuring that these levels are achievable and enforceable using standard analytical methods. It has also committed to continuing to gather industry feedback on the new restrictions and relay these concerns to the European Commission.