The proposed Dutch rules would ban Huperzia serrata, huperzine A and ashwagandha (Withania somnifera) on the grounds of potential health risks, limit black cohosh (Cimicifuga racemosa) to 40 mg per day and require warning labels for products containing garlic, green tea, black cohosh, turmeric, ginkgo, St. John’s wort, Mucuna pruriens, American ginseng, red sage, milk thistle and valerian.
The changes could have a significant compliance impact on manufacturers, importers and distributors of herbal preparations and food supplements in the Netherlands, said Gaëlle Donaghy, head of consulting regulatory department at FoodChain ID.
“If adopted in its current form, products containing substances, plants or fungi included in the prohibited lists would need to be reformulated against the new Dutch requirements,” she explained. “Depending on the final text and the applicable transition arrangements, reformulation or other market measures might be necessary.”
If the Netherlands passes the proposal, the new rules could come into effect as early as the end of 2026, followed by a six-month transition period.
Netherlands proposes new rules for food supplement ingredients
Dutch rules already require that food supplements and herbal preparations are safe, but they do not apply the same specific restrictions proposed for these ingredients, Donaghy noted.
Dutch authorities currently advise against Huperzia serrata, huperzine A and ashwagandha, citing potential health risks. Meanwhile, companies may use black cohosh, garlic, green tea, turmeric, ginkgo, St John’s wort, Mucuna pruriens, American ginseng, red sage, milk thistle and valerian subject to the existing safety and labeling rules.
The proposal would move the detailed ingredient rules into separate annexes, which would list banned substances and plants, ingredients allowed only under certain conditions, as well plants requiring specific use instructions on their labels. It would also add two similar annexes for food supplements, covering banned substances and substances allowed under certain conditions.
The Dutch Ministry of Health first proposed the amendments in early 2025, and the Netherlands has now formally notified the EU of the draft rules. The European Commission and other Member States have the opportunity to xamine and comment on these rules through Dec. 7, 2026 before the Netherlands moves towards finalizing the legislation.
If adopted, the framework would require manufacturers, importers and distributors to review the ingredients used in affected products and assess whether they comply with the new requirements. However, as Donaghy explained, the rules are still under consultation and could change before the Netherlands adopts the final legislation.
What companies need to know about proposed changes
“At this stage, the proposal should be used for an initial impact assessment rather than treated as the final applicable legislation,” Donaghy said.
In assessing their portfolios, labeling and compliance ahead of the proposed changes, she advised that companies start by comparing their ingredients with the proposed prohibited and conditionally authorized lists— identifying products that contain any of the plants in the proposed Annex III, checking whether their products meet the proposed conditions, reviewing labels that may need mandatory recommendations for use and monitoring the consultation process, final Dutch legislation and six-month transition period.
Interestingly, a product that is legally sold in another EU country could potentially enter the Dutch market under the EU’s mutual recognition principle.
“In an area not fully harmonized, the principle of mutual recognition generally means that goods lawfully marketed in one Member State should be able to access the market of another Member State,” Donaghy explained.
“However, mutual recognition is not absolute. A Member State may restrict or deny market access where this is justified by a legitimate public-interest objective, such as the protection of health, and where the measure is appropriate and proportionate.”
