In recent years, clear guidelines have been issued in Belgium and France to ensure the safety of volatile or essential oils in supplements.
Plants produce volatile oils for several reasons, including protection from animal feeding, attracting pollinators and competition with other plants. These volatile and fragrant substances can be extracted using various techniques to obtain volatile oils. They are mainly obtained by distillation, but in the case of Citrus fruits also by cold pressing. A volatile oil is by definition a concentrate of chemical substances derived from a vegetable raw material. These substances can interact with the body and produce effects that justify their use for physiological purposes in nutritional supplements. However, certain substances can also cause harmful effects under certain circumstances, against which precautions must be taken.
Belgium
In Belgium For food supplements in capsule form that contain volatile oils from plants, additional information about the safety of the products is requested. The necessary data must be included in the “Data Sheet for Essential Oils and Concretes” [1] and this must be attached to the notification file. This data sheet is intended to determine a safe level for the volatile oil in galenic forms that bypass the emetic reflex (capsules, gels, tablets, etc.). Completing this data sheet is not necessary for liquid products or pastilles. The analysis of heavy metals is not required if the volatile oils are obtained by steam distillation.
In this way, a monograph was drawn up for 9 volatile oils with detailed scientific information on the safety of these volatile oils.[2] Based on these monographs, the Belgian Advisory Committee for Plant Preparations published an overview of limits for active substances in volatile oils for oral use. This concerns 20 substances such as thymol, menthol, pinene, cinnamaldehyde, limonene. The set limits may not be exceeded in products placed on the Belgian market and are important for the notification of products in Belgium.
Although these maximums have not yet been included in a legal text, they will have to be observed by companies that market supplements with volatile oils.
France
In France, authorities have drawn up a list of plants from which essential oils are extracted, the use of which in human food is considered traditional.[3]
The essential oils mentioned in this list may be used in food supplements, provided they are safe. Any company that produces a food supplement containing one or more volatile oils must carry out a detailed risk analysis to ensure the safe use of the food. This risk analysis must be based on a study of the available literature and a sound knowledge of the chemical composition of the essential oil used. The comparison of this information may subsequently give rise to specific conditions of use.
To help operators with this process, the French authorities themselves also provide recommendations. These recommendations identify the components likely to pose a risk to the health of consumers, list for each essential oil the components that are present according to the literature and then propose appropriate measures to ensure the safety of the use of these essential oils in food supplements to ensure.
Based on their risk analysis, operators can propose other control measures. These must be justified in the declaration.
Synadiet, the French association of food supplement manufacturers, offers on its website two lists of 64 essential oils commonly used in this sector. These essential oils can be considered traditional. Each essential oil is accompanied by quantitative and qualitative conditions of use and appropriate warnings. Food supplements that comply with the use restrictions (daily dose and precautions for use) proposed by Synadiet may be exempt from such justification.
[1] Federal Public Service (FPS) Public Health, Food Chain Safety and Environment. Data Sheet for Essential Oils and Concretes. https://www.health.belgium.be/en/data-sheet-essential-oils-and-concretes-0.
[2] Federal Public Service (FPS) Public Health, Food Chain Safety and Environment. List of plants for which the Advisory Committee on Plant Preparations provided advice. https://www.health.belgium.be/nl/lijst-met-planten-waarvoor-de-commissie-van-advies-voor-plantbereidingen-een-advies-gaf.
[3] General Directorate for Competition, Consumer Affairs and Fraud Prevention. Food supplements – Essential oils. https://www.economie.gouv.fr/dgccrf/complements-alimentaires-huiles-essentielles.
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