“2025 was an intense year for the food supplements sector, not necessarily because of what happened on the regulatory front, but rather because of what was announced to happen,” said Patrick Coppens, director of regulatory and scientific affairs at Food Supplements Europe.
Regulatory frameworks governing the sector became stricter in 2025, with EFSA and the European Commission providing clearer guidance on the communication of health claims and stepping up enforcement (particularly surrounding influencer marketing) to enhance industry safety.
The European Green Deal and the Circular Economy Action plan also set out new procedures to prevent the generation of excess waste, while EFSA issued positive opinions on several new ingredients, opening up new opportunities for product development and innovation.
Meanwhile, administrative delays slowed progress on several major regulatory projects including legislation related to botanical ingredients and maximum levels of vitamins and minerals, leaving the industry in a state of uncertainty.
These issues are expected to be addressed in 2026, which could provide long-awaited answers, but may also trigger significant structural changes, including product withdrawals and costly reformulations.
Harmonization of maximum levels of vitamins and minerals
Coppens highlighted the harmonization of maximum levels of vitamins and minerals in food and food supplements as a dossier of major importance for the sector.
“Although this work is long overdue, it is highly complex, and finding common ground will be challenging given the diversity of national regimes currently in place across the Member States,” he said.
In 2021, the European Commission re-initiated plans to harmonize the maximum levels of vitamins and minerals in dietary supplements in an attempt to publish a new set of regulations in 2024, but this has been further delayed.
Member states are now pushing for finalization in 2026. However, previously released documents suggests this new legislation could impose cautious upper daily limits—a change which could have significant consequences for supplement brands, according to Coppens.
“In January 2025, information became available that shed light on the Commission’s approach, suggesting that the modelling is based on overly conservative and largely hypothetical principles,” he said. “If such an approach were to be adopted, it is estimated that it would lead to the withdrawal of numerous products from the market and require costly reformulation of most of the other vitamin and mineral-containing products.”
Jerome Le Bloch, head of scientific affairs at FoodChain ID agreed, adding that these changes could entail significant costs, present technical challenges and add to regulatory workloads.
In response, Food Supplements Europe, alongside other organizations representing the supplement industry, is undertaking mitigatory measures to promote a more realistic and proportionate approach that limits negative market impact.
This follows the recent EU Agriculture and Fisheries (AGRI-FISH) Council meeting held from Dec. 10 to 11 in which Member States urged the Commission to present a proposal in the course of 2026.
Authorization of new ingredients and novel foods
EFSA conducted safety assessments for several ingredients in 2025, issuing positive opinions on a number of ingredients, including calcidiol monohydrate (25-OH-vitamin D3), the monosodium salt of L-5-methyltetrahydrofolic acid (L-5-MTHF) and magnesium L-threonate.
Le Bloch said these additions clarified permissible ingredient forms and opened the door to new formulations, while reinforcing the role of EFSA’s updated safety procedures. In 2026, several significant announcements are also anticipated.
“Final decisions are expected for fennel, berberine and hydroxycitric acid, as well as clarifications on a further group of botanicals that may enter the procedure,” he said. “The green tea catechins dossier will also reach its conclusion, potentially leading to strict limitations, or even a ban, on EGCG-rich extracts.”
“The industry is also awaiting the Court of Justice ruling on hydroxyanthracene derivatives (HADs),” he added. “This judgment is pivotal: It will determine the validity of the previous EU restrictions and will heavily influence all ongoing and future Article 8 assessments.”
Article 8 assessments, which allow the European Commission to initiate the prohibition or restriction of non-vitamin and mineral substances, have long been a concern for the industry. In 2024, the European Federation of Associations of Health Product Manufacturers (EHPM) expressed concern that Article 8 of Regulation (EC) No 1925/2006 could be misused for classification purposes, which could set a ‘concerning legal precedent’.
This regulation has already led to the restriction of several ingredients, including a range of plants and their preparations, such as buckthorn (Rhamnus frangula L., Rhamnus purshiana), senna (Cassia senna L.) and rhubarb (Rheum palmatum L., Rheum officinale). Ashwagandha is also facing possible Article 8 restrictions due to ongoing safety concerns.
“One of the issues that hampers these safety assessments is the lack of botanical-specific risk assessment methodologies, coupled with a lack of data,” Coppens explained. “This has resulted in insufficiently nuanced decisions which have attracted significant criticism from affected companies and have been challenged before courts.”
For example, preparations derived from the leaf of aloe species containing hydroxyanthracene derivatives were prohibited by the European Commission, but this ban was annulled by the European Court of Justice in November 2024. However, the Commission has since lodged an appeal which has suspended the annulment. The final outcome is expected to be published in 2026.
Health claim regulation: Concerns over on-hold botanical claims
Last year brought greater clarity across the industry about how health claims should be communicated, alongside stricter enforcement of these standards. Borderline medical claims were closely scrutinized, forcing food business operators to better justify functional claims, according to Le Bloch.
However, there is still a significant degree of uncertainty surrounding thousands of claims related to botanical extracts—a situation that has been ongoing for more than a decade but is hoped to be resolved by next year.
There are currently 2,087 health claims related to plant substances pending a final decision. These health claims are those which the European Commission was not able to evaluate when it drew up the first list of authorized health claims in 2012.
While these claims can currently be used under the responsibility of food business operators, provided they comply with EU regulations, there are industry-wide concerns that this could be reversed next year.
“In November 2024, the European Court of Auditors requested, inter alia, that the Commission address this situation by 2027,” Coppens said. “The Commission subsequently announced that it is working on these requests. The 2020 REFIT [Regulatory Fitness and Performance] evaluation already demonstrated that this is a very complex area, given the complexity and the diverging views across the Member States. Harmonization is therefore likely to be impossible.”
He stressed the importance of monitoring whether, when and how the Commission will address this issue in 2026, noting that the repercussions on the botanicals market would be severe should the decision to place these claims on hold be reversed without an alternative regulatory solution.
Coppens said growers and collectors of botanicals are also facing challenges arising from increasingly restrictive limits for certain contaminants, such as pyrrolizidine alkaloids.
“Pyrrolizidine alkaloids are naturally present in weeds, and the presence of only a few weeds is sufficient to render an entire batch non-compliant,” he said. “The sector has demonstrated that the current limits for pyrrolizidine alkaloids result in a significant rejection rate for certain raw materials, while technical mitigation means remain limited, as weed control has inherent limitations in practice.”
The rejection of raw materials results in a significant amount of waste. As a result, the sector has been calling for higher ‘more proportionate’ limits. If these limits are not introduced, Coppens said we could see an increasing number of farmers shift to alternative crops in 2026, meaning some botanical ingredients may no longer be saleable as food supplements.
“These discussions are crucial for the future of the sector and hoped to result in concrete proposals that will help the sector in the course of 2026,” he said.
How are new sustainability measures impacting the supplement industry?
Measures stemming from the European Green Deal and the Circular Economy Action plan had a significant impact on the dietary supplement industry in 2025 and will continue to do so in 2026, according to David Pineda Ereño, managing director and consultant at DPE International Consulting.
In 2025, EU stakeholders revised the waste framework (Directive (EU) 2025/1892) which requires all actors in the food supply chain to prevent the generation of waste in the processing and manufacturing of food and food supplements.
A packaging waste regulation also came into force last year, which regulates what type of packaging can be used in the EU market. From Aug. 12, 2026, all products will need to comply with these new regulations.
However, one piece of sustainability legislation (Regulation (EU) 2023/1115) was postponed until the end of the year (Dec. 30, 2026). When enacted, this new law will require companies to submit a due diligence statement demonstrating that food supplement ingredients, such as soybean oil or caffeine, do not originate from land deforested after Dec. 31, 2020.
While this delay will prevent food supplement companies from facing additional administrative burdens for now, Pineda Ereño warned that further consultations on the industry’s environmental impact are likely.
“It is expected that wider consultation will take place in 2026 to support policy developments for the revision of the food contact materials regulation where the focus would be on further harmonizing on their safety considering more sustainable alternatives with fewer hazardous chemicals,” he said.
EFSA’s performance evaluation expected in March
Finally, in March, the European Commission is expected to present an important report evaluating EFSA’s performance in providing relevant scientific advice. This report could encourage wider innovation across the industry, said Pineda Ereño.
“The food supplement industry is awaiting a report with recommendations that would allow EFSA to meet deadlines for conducting assessments on the safety of food and ingredients and on health claims, which will promote innovation in the food supplement sector in the EU,” he said.
On the novel food front, simplification of the application and approval process seems unlikely, according to Le Bloch. This is likely to slow down decision times even further, with the average wait time for a novel food approval currently sitting at two-and-a-half years.
“The latest updates to EFSA’s administrative guidance indicate a stricter and more procedural approach, with fewer opportunities to extend deadlines and new requirements that increase the complexity of submitting and maintaining applications,” he said. “This will make strategic planning and dossier quality even more critical for applicants. This will also slow down the process, which is already too long.”
