EU Herbal Monographs Explained: "Traditional Use" and "Well-Established Use"
How to read European herbal monographs and public summaries: what traditional use and well-established use mean, what they do not mean, and what they say about pregnancy.
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What an EU herbal monograph is
The European Medicines Agency (EMA) has a Committee on Herbal Medicinal Products (HMPC). It issues scientific opinions on herbal substances and preparations, with information on recommended uses and safe conditions, as a reference point for companies and national authorities. [1] Those opinions are published as EU herbal monographs, with a plain-language public summary for many plants. Most herbal medicines are still licensed by individual member states, not by EMA itself. [1]Two clarifications help. First, EU herbal monographs are not the same as European Pharmacopoeia monographs, which set quality requirements. [1] Second, the monographs describe herbal medicines that go through the registration route. EMA's valerian summary says other products, like food and food supplements, do not follow the same criteria. [2] A tea bag sold as a food is therefore not automatically covered. See are herbal teas regulated? for the product categories. The United States uses different rules, and this page does not describe them.
"Traditional use" and "well-established use"
These are the two labels on nearly every monograph. They are regulatory categories with set requirements.| Traditional use | Well-established use | |
|---|---|---|
| Evidence required | No clinical tests and trials on safety and efficacy are required, if sufficient safety data and plausible efficacy are shown. [1] | Scientific literature showing well-established medicinal use within the EU for at least ten years, with recognised efficacy and acceptable safety. [1] |
| Time of use | At least 30 years, including at least 15 within the EU. [1] | At least ten years in the EU. [1] |
| What it means in plain terms | Effectiveness is plausible but clinical trial evidence is insufficient. [3] | There are bibliographic data providing scientific evidence of effectiveness and safety. [4] |
| Evidence label on this site | Traditional use only | Depends on the studies behind it; read them |
Plants that drink as tea, and the label each carries
The label belongs to a plant, a plant part, a preparation and a use. Read it as a sentence, not a badge.| Plant and part | Label and use in EMA's public summary | Note |
|---|---|---|
| Chamomile flower, Matricaria recutita L. (accepted name Matricaria chamomilla L.) [5] | Traditional use for minor stomach and gut complaints such as bloating and minor spasms. [3] | Available as herbal tea to be drunk. [3] |
| Peppermint leaf, Mentha x piperita L. | Traditional use for indigestion and gas. [6] | Adults and children over 4 years. [6] |
| Lemon balm leaf, Melissa officinalis L. | Based on long-standing use for mild symptoms of stress, to aid sleep, and for mild digestive disorders. [7] | Adults and children over 12. [7] |
| Raspberry leaf, Rubus idaeus L. | Traditional use; the committee noted the lack of clinical studies. [8] | Adults only. [8] |
| Elder flower | Traditional use for early symptoms of the common cold. [9] | Adults and adolescents over 12. [9] |
| Senna leaf, Senna alexandrina Mill. | Well-established use for short-term occasional constipation. [4] | Usually available as herbal tea; long-term use should be avoided. [4] |
| Valerian root, Valeriana officinalis L. | A specific ethanolic dry extract is supported by clinical studies; root preparations have traditional use only. [2] | Comminuted root is usually available as herbal tea. [2] |
The valerian row is the clearest warning against assuming a label transfers. The studies support one extract, not the plant in every form. For the tea, see valerian tea.
Frequently asked questions
What is the difference between traditional use and well-established use?
Traditional use needs at least 30 years of use (15 in the EU) with plausible effectiveness and no clinical trials required. [1] Well-established use needs published scientific evidence of effectiveness and safety over at least ten years in the EU. [1]
Does an EU monograph mean a tea is approved in the United States?
No. The monographs are EU documents used by EU member states. How US rules treat a given tea is not described in the sources we read.
Does "traditional use" mean the tea has been proven to work?
No. EMA's own wording is that effectiveness is plausible although clinical trial evidence is insufficient. [3] See traditional use vs clinical evidence.
Is it safe to drink herbal tea while pregnant if there is an EU monograph?
A monograph is not a safety clearance. Some summaries say not to use the medicine in pregnancy, such as valerian, ginger and senna. [2][10][4] Others, in the parts we read, do not mention pregnancy. Ask a clinician or pharmacist about the specific tea.
Where can I read a monograph myself?
EMA publishes EU herbal monographs and public summaries on its website, as part of its herbal medicinal products section. [1] Public summaries are shorter and written for general readers.
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
Reading the safety sections, including pregnancy
- Valerian and ginger: EMA's public summaries say not to use these medicines when pregnant or breastfeeding. [2][10]
- Senna leaf: must not be taken during pregnancy, when breastfeeding or by children under 12. [4]
- Chamomile, peppermint, lemon balm, raspberry leaf and elder flower: the public summaries we read give age limits but no pregnancy statement. [3][6][7][8][9] We could not read the full monograph documents (PDF files), so we cannot say what they add. This is a gap in what we read, not evidence that these teas are safe in pregnancy. Ask a clinician; see herbal tea in pregnancy and the pregnancy and breastfeeding guide.
- "No side effects reported": raspberry leaf's summary says none had been reported at the time of the assessment. [8] That describes the reports available then, not a guarantee.
Limits of monographs
- Traditional-use medicines are intended to be used without a medical practitioner's supervision, [1] and the summaries tell readers to see a doctor or qualified practitioner if symptoms persist. [3]
- They cover defined preparations. A full quality dossier is required for registered herbal medicines. [1] A food-category tea may differ in strength and content.
- They do not cover interactions in the way a pharmacist can for your own medicines; use our medication interactions guide.
- The tea amounts monographs describe are regulatory descriptions, not advice. See EU monograph tea amounts.
References
- European Medicines Agency (EMA). Herbal medicinal products: regulatory pathways, Committee on Herbal Medicinal Products (HMPC) and EU monographs. Read 2026-10-23.
- European Medicines Agency, HMPC. Valerianae radix (valerian root): herbal medicinal product, summary for the public. Read 2026-10-23.
- European Medicines Agency, HMPC. Matricariae flos (matricaria flower): herbal medicinal product, summary for the public, EMA/490629/2015, 2016. Read 2026-10-23.
- European Medicines Agency, HMPC. Sennae folium (senna leaf): herbal medicinal product, summary for the public. Read 2026-10-23.
- GBIF Secretariat. GBIF Backbone Taxonomy, species match service (accepted names checked for the plants named on these pages). Read 2026-10-23.
- European Medicines Agency, HMPC. Menthae piperitae folium (peppermint leaf): herbal medicinal product, summary for the public. Read 2026-10-23.
- European Medicines Agency, HMPC. Melissae folium (melissa leaf): herbal medicinal product, summary for the public. Read 2026-10-23.
- European Medicines Agency, HMPC. Rubi idaei folium (raspberry leaf): herbal medicinal product, summary for the public, EMA/237849/2017. Read 2026-10-23.
- European Medicines Agency, HMPC. Sambuci flos (elder flower): herbal medicinal product, summary for the public. Read 2026-10-23.
- European Medicines Agency, HMPC. Zingiberis rhizoma (ginger rhizome): herbal medicinal product, summary for the public. Read 2026-10-23.