The Dutch Ministry of Health, Welfare and Sport has submitted a proposal to amend the Commodities Act on Food Supplements and Herbal Preparations for online consultation and to the Regular Consultation on the Commodities Act (ROW). The consultation ran until 24 March 2025. The amendments are based on the risk assessments of the National Institute for Public Health and the Environment (RIVM) from 2020 to 2025.
The proposal bans several plants and plant substances, imposes a maximum and makes warnings on the label mandatory for several plants. [1] The most important amendments are listed below.
1. The following plants and plant substances are included in Annex I and are therefore banned.
a. Huperzia serrata and huperzine A: based on the lowest level of intake at which adverse effects occur, the RIVM concluded that the herbal preparations with Huperzia serrata and huperzine A that are available on the market may lead to acute adverse effects on the cholinergic system.
b. Withania somnifera (Ashwagandha): The risk assessment is based on case reports in which adverse effects after exposure to Withania somnifera extract have occurred, such as adverse effects on the liver, and on the concentrations of thyroid hormones and cortisol. These adverse effects have not been demonstrated in clinical studies; therefore, it is concluded that people who are sensitive to Withania somnifera could experience adverse effects. It is not known which people are sensitive. According to the World Health Organization, Withania somnifera was traditionally used to induce abortions. The RIVM advised against using herbal preparations with Withania somnifera, especially not during pregnancy.
2. For Cimicifuga racemosa (Silver Candle) a daily maximum amount of 40 mg is set. In Belgium this maximum is 30 mg dried rootstock.
3. A warning on the label is mandatory for the following plants:
a. Allium sativum (garlic): “This product may adversely affect the effect of various medicines, including blood pressure lowering agents and antiviral medicines. Consult your (family) doctor or pharmacist before use.”;
b. Camellia sinensis (green tea): “This product may adversely affect the effect of various medicines, including anti-anxiety agents, folic acid, blood pressure lowering agents and heart and vascular medicines. Consult your (family) doctor or pharmacist before use.”;
c. Cimicifuga racemosa (black cohosh): “This product is not suitable for children under 17 years of age. Do not use this product during pregnancy and breastfeeding. Page 5 of 13 Consult a doctor if you have a (history of) liver disease or are undergoing or have undergone treatment for (hormone-sensitive) cancer.”;
d. Curcuma longa (turmeric): “This product may adversely affect the effect of various medicines, including anti-cancer medicines, blood pressure lowering medicines and anti-inflammatories. Consult your (family) doctor or pharmacist before use.”;
e. Ginkgo biloba (ginkgo): “This product may adversely affect the effect of various medicines, including blood thinners and heart medicines. Consult your (family) doctor or pharmacist before use.”
f. Hypericum perforatum (St. John’s wort): “This product is not suitable for children under 17 years of age. Do not use this product during pregnancy and breastfeeding. When using this product, avoid exposure to intensive UV radiation (sunbathing, sunbeds, solariums). This product may adversely affect the effect of various medicines, including the contraceptive pill. Consult your doctor or pharmacist before use.”;
g. Mucuna pruriens: “Do not use this product during pregnancy, breastfeeding and liver/or kidney problems. This product may adversely affect the effect of various medicines. Consult your doctor or pharmacist before use.”;
h. Panax quinquefolius (American ginseng): “This product may adversely affect the effect of various medicines, including blood thinners. Consult your doctor or pharmacist before use.”;
i. Salvia miltiorrhiza (Red sage): “This product may adversely affect the effect of various medicines, including blood thinners. Consult your doctor or pharmacist before use.”;
j. Silybum marianum (milk thistle): “This product may adversely affect the effect of various medicines, including diabetes medicines, blood pressure lowering medicines, antibiotics and heart and vascular medicines. Consult your doctor or pharmacist before use.”;
k. Valeriana officinalis (valerian): “This product may adversely affect the effect of various medicines, including sedative medicines. Consult your doctor or pharmacist before use.”.
Various sector organisations from the Netherlands, Belgium, and Europe submitted their comments.
[1] Ministry of the Interior, Amendment of Commodities Act regulations in connection with the designation of harmful substances in food supplements and herbal preparations, see https://www.internetconsultatie.nl/voedingssupplementen_en_kruidenpreparaten/b1
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