Regulation must match the evidence

Herbal medicine is currently facing potentially significant regulatory change. Two distinct but interconnected pieces of European legislation are moving forward rapidly, which may impact on our access, as clinical herbalists, to herbal and botanical products.

We have outlined the two legislative areas of concern below, but in advance of the upcoming consultations, we are publishing our official positioning statement:

Positioning Statement 

“The National Institute of Medical Herbalists (NIMH) opposes the current EU consultation proposals concerning the restriction or prohibition of 13 botanicals because we support proportionate, evidence-based regulation. We oppose restrictions on these botanicals, including Ashwagandha, St John’s wort and Turmeric, based on single-constituent toxicology that fails to account for the distinct pharmacology of whole-herb preparations. This is a category error that risks eliminating effective clinical tools while leaving low-dose, therapeutically redundant products untouched. Maximum Permitted Levels that reduce Vitamin D, B vitamins and magnesium to sub-clinical doses are similarly based on calculations that are not fit for purpose. Northern Ireland’s direct exposure to EU goods law under the Windsor Framework, coupled with the absence of a Northern Ireland-specific impact assessment, makes this uniquely urgent. NIMH will submit a formal consultation response, coordinate with other professional registers, and pursue direct engagement with the European Food Safety Authority with one clear message: regulation must match the evidence, respect traditional use, and preserve clinically meaningful doses.” 

 

 

1. Maximum Permitted Levels (MPLs) for Vitamins and Minerals

After two decades of debate, the European Commission has confirmed a public consultation for Q3 2026. The goal is to set EU-wide maximum limits for vitamins and minerals. However, the proposed methodology for determining these limits,  by subtracting average dietary intake from conservative safety levels, the remaining “permitted” doses for supplements would be so low they lose all therapeutic meaning.

2. New Restrictions on Botanicals and Herbal Substances

A priority list of thirteen key substances is under review, including essentials ashwagandha, curcumin, St John’s Wort, and melatonin. The full list of 13 substances is:

• Coumarin in plant preparations
• Curcumin in Curcuma preparations
• Hypericum perforatum
• Melaleuca essential oils
• melatonin
• piperin
• p-synefin in Citrus preparations
• tryptophan
• Actaea rhizome
• Lepidium meyenii
• Ocimum tenuiflorum
• Tribulus terrestris
• Withania somnifera  

The momentum toward restriction is already visible: Monacolin K (red yeast rice) faces a full ban by late 2027, and EFSA has recently declared that no safe intake level can be established for berberine.. With Denmark already banning ashwagandha and Belgium reclassifying it as a medicine, the threat to traditional herbal medicine is immediate.

The Impact on Northern Ireland and the Windsor Framework

Under the Windsor Framework, Northern Ireland remains aligned with the EU single market for goods. This means that any new EU restrictions on food supplements and botanicals will become domestic law in Northern Ireland automatically. While Great Britain currently follows a different timeline, our members in Northern Ireland face a uniquely urgent situation.