Experts from European food safety agencies have produced a report on substances that should not be used or need conditions for dietary supplements.
The Heads of Food Safety Agencies (HoA) is made up of the leaders of food safety authorities in EU countries. The group meets once every six months in the country with the EU Council presidency.
The dietary supplement working group of HoA has been meeting since 2020 to identify substances in food supplements that may lead to adverse health effects. The current situation across the EU includes national policies and guidelines, which leads to a non-harmonized approach.
The group, which includes 26 European countries, identified 117 substances that may pose a health risk due to potentially hazardous properties. They then assessed which substances should either not be used or only used to a limited extent in dietary supplements. The working group said the final list can be used as a basis for EU legislators to take further steps.
Thirteen substances should be prioritized as they pose a possible health risk to consumers. Some showed potential carcinogenic, mutagenic, or reprotoxic properties.
Making supplements safer
According to the working group, the European Commission should now support the European Food Safety Authority (EFSA) to evaluate the substances. If EFSA backs the working group’s findings, legislative action can be taken by the EU Commission. For the remaining substances, the report recommends further regulatory measures.
“Making food supplements safer is an important component of our daily work to protect the health of citizens in Europe. The working group is making a significant contribution to this by developing the list of critical substances,” said Friedel Cramer, president of the Federal Office of Consumer Protection and Food Safety (BVL).
The European Commission is currently developing a model for setting safe maximum levels for vitamins and minerals in food supplements and fortified foods.
Working group experts had to modify their approach after finding that performing a risk assessment for each substance would not be realistic due to the large amount of time and resources needed and the lack of data.
Priority substances identified
Of the initial 117 substances, 65 were assumed to be novel, 49 were judged to be not novel or not novel in food supplements, and three substances had already been included in EU regulation.
Novel Food was not used for human consumption significantly in the EU before mid-May 1997. Any food that meets this definition falls under the Novel Food Regulation and needs pre-market approval at the EU level.
Thirteen substances were considered to pose a possible risk to consumers and for which the intake via food supplements exceeds normal levels. These include Coumarin in plant preparations, piperine, tryptophan, Actaea racemosa, Lepidium meyenii, and Ocimum tenuiflorum.
Other substances raised concern based on their hazard characteristics but more information on exposure is needed for a risk assessment. These include Solanum dulcamara, Cinnamomum verum, Carica papaya, Piper methysticum, and Ginkgo biloba.
For Carlina acaulis, Griffonia simplicifolia, Rhodiola rosea, Salvia Rosmarinus, and others, it was impossible to assess the risk due to the limited available information.
An evaluation of 1,500 Rapid Alert System for Food and Feed (RASFF) posts from 2017 to mid-2022 identified eight substances that had caused alerts, including curcumin, huperzine A, melatonin, monacolin K, piperine, and p-synephrine. The presence of alerts for these substances is evidence that they are used in food and/or food supplements on the market, said the working group.
Other substances, such as agmatine sulfate and 1,3-dimethylamylamine (DMAA), also caused alerts but have not been considered yet by the working group. Notifications also included forbidden substances like Yohimbe bark, emodin, and Ephedra herb.
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